e10vk
United States
Securities and Exchange Commission
Washington, D.C.
20549
Form 10-K
Annual report pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
for the fiscal year ended December 31, 2009
Commission file number
001-06351
Eli Lilly and
Company
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An Indiana corporation
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I.R.S. employer identification no. 35-0470950
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Lilly Corporate
Center, Indianapolis, Indiana 46285
(317) 276-2000
Securities
registered pursuant to Section 12(b) of the Act:
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Title of Each Class
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Name of Each Exchange On Which Registered
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Common Stock (no par value)
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New York Stock Exchange
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6.57% Notes Due January 1, 2016
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New York Stock Exchange
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71/8% Notes
Due June 1, 2025
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New York Stock Exchange
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6.77% Notes Due January 1, 2036
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New York Stock Exchange
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Securities
registered pursuant to Section 12(g) of the Act:
None
Indicate by check mark if the Registrant is a well-known
seasoned issuer, as defined in Rule 405 of the Securities
Act. Yes þ No o
Indicate by check mark if the Registrant is not required to file
reports pursuant to Section 13 or 15(d) of the
Act. Yes o No þ
Indicate by check mark whether the Registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of
the Securities Exchange Act of 1934 during the preceding
12 months, and (2) has been subject to such filing
requirements for the past
90 days. Yes þ No o
Indicate by check mark whether the Registrant has submitted
electronically and posted on its corporate Web site, if any,
every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of
Regulation S-T
during the preceding 12 months (or for such shorter period
that the Registrant was required to submit and post such
files. Yes þ No o
Indicate by check mark if disclosure of delinquent filers
pursuant to Item 405 of
Regulation S-K
is not contained herein, and will not be contained, to the best
of Registrants knowledge, in the definitive proxy
statement incorporated by reference in Part III of this
Form 10-K
or any amendment to this
Form 10-K. o
Indicate by check mark whether the Registrant is a large
accelerated filer, an accelerated filer, a non-accelerated
filer, or a smaller reporting company. See the definitions of
large accelerated filer, accelerated
filer and smaller reporting company in
Rule 12b-2
of the Exchange Act. (Check one):
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Large accelerated
filer þ
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Accelerated
filer o
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Non-accelerated
filer o
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Smaller reporting
company o
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Indicate by check mark whether the Registrant is a shell company
as defined in
Rule 12b-2
of the
Act: Yes o No þ
Aggregate market value of the common equity held by
non-affiliates computed by reference to the price at which the
common equity was last sold as of the last business day of the
Registrants most recently completed second fiscal quarter
(Common Stock): approximately $35,217,500,000
Number of shares of common stock outstanding as of
February 12, 2010: 1,153,145,432
Portions of the Registrants Proxy Statement to be filed on
or about March 8, 2010 have been incorporated by reference
into Part III of this report.
Part I
Eli Lilly and Company (the Company or
Registrant) was incorporated in 1901 in Indiana to
succeed to the drug manufacturing business founded in
Indianapolis, Indiana, in 1876 by Colonel Eli Lilly. We
discover, develop, manufacture, and sell products in one
significant business segmentpharmaceutical products. We
also have an animal health business segment, whose operations
are not material to our financial statements.
Our mission is to make medicines that help people live longer,
healthier, more active lives. Our strategy is to create value
for all our stakeholders by accelerating the flow of innovative
new medicines that provide improved outcomes for individual
patients. Most of the products we sell today were discovered or
developed by our own scientists, and our success depends to a
great extent on our ability to continue to discover, develop,
and bring to market innovative new medicines.
We manufacture and distribute our products through facilities in
the United States, Puerto Rico, and 17 other countries. Our
products are sold in approximately 128 countries.
Products
Our products include:
Neuroscience products, our largest-selling product
group, including:
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Zyprexa®,
for the treatment of schizophrenia, acute mixed or manic
episodes associated with bipolar I disorder, and bipolar
maintenance
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Zyprexa
Relprevvtm
(Zypadheratm
in the European Union), a long-acting intramuscular injection
formulation of Zyprexa
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Cymbalta®,
for the treatment of major depressive disorder, diabetic
peripheral neuropathic pain, generalized anxiety disorder, and
in the United States for the management of fibromyalgia
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Strattera®,
for the treatment of attention-deficit hyperactivity
disorder in children, adolescents, and in the United States in
adults
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Prozac®,
for the treatment of major depressive disorder,
obsessive-compulsive disorder, bulimia nervosa, and panic
disorder
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Symbyax®,
for the treatment of bipolar depression and
treatment-resistant depression
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Endocrinology products, including:
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Humalog®,
Humalog Mix
75/25tm,
and Humalog Mix
50/50tm,
for the treatment of diabetes
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Humulin®,
for the treatment of diabetes
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Byetta®,
for the treatment of type 2 diabetes
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Actos®,
for the treatment of type 2 diabetes
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Evista®,
for the prevention and treatment of osteoporosis in
postmenopausal women and for the reduction of the risk of
invasive breast cancer in postmenopausal women with osteoporosis
and postmenopausal women at high risk for invasive breast cancer
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Forteo®,
for the treatment of osteoporosis in postmenopausal women
and men at high risk for fracture and for glucocorticoid-induced
osteoporosis in postmenopausal women and men
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Humatrope®,
for the treatment of human growth hormone deficiency and
certain pediatric growth conditions
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Oncology products, including:
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Alimta®,
for the first-line treatment, in combination with another
agent, of non-small cell lung cancer for patients with
non-squamous histology; for the second-line treatment of
non-small cell lung cancer; and in combination with another
agent, for the treatment of malignant pleural mesothelioma
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Gemzar®,
for the treatment of pancreatic cancer; in combination with
other agents, for the treatment of metastatic breast cancer,
non-small cell lung cancer, and advanced or recurrent ovarian
cancer; and in the European Union for the treatment of bladder
cancer
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Erbitux®,
indicated both as a single agent and with another
chemotherapy agent for the treatment of certain types of
colorectal cancers; and as a single agent or in combination with
radiation therapy for the treatment of certain types of head and
neck cancers
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Cardiovascular products, including:
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Cialis®,
for the treatment of erectile dysfunction
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Effient®,
for the reduction of thrombotic cardiovascular events
(including stent thrombosis) in patients with acute coronary
syndrome who are managed with an artery-opening procedure known
as percutaneous coronary intervention (PCI),
including patients undergoing angioplasty, atherectomy, or stent
placement
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ReoPro®,
for use as an adjunct to PCI
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Xigris®,
for the treatment of adults with severe sepsis at high risk
of death
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Animal health products, including:
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Rumensin®,
a cattle feed additive that improves feed efficiency and
growth and also controls and prevents coccidiosis
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Tylan®,
an antibiotic used to control certain diseases in cattle,
swine, and poultry
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Micotil®,
Pulmotil®,
and Pulmotil
AC®,
antibiotics used to treat respiratory disease in cattle,
swine, and poultry, respectively
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Paylean®
and
Optaflexx®,
leanness and performance enhancers for swine and cattle,
respectively
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Posilac®,
a protein supplement to improve milk productivity in dairy cows.
We acquired the worldwide rights to Posilac from Monsanto
Company in August 2008.
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Coban®,
Monteban®,
and
Maxiban®,
anticoccidial agents for use in poultry
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Apralan®,
an antibiotic used to control enteric infections in calves and
swine
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Surmax®
(sold as
Maxus®
in some countries), a performance enhancer for swine and poultry
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Elector®,
a parasiticide for use on cattle and premises
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Two products for dogs:
Comfortis®,
the first FDA-approved, chewable tablet that kills fleas and
prevents flea infestations on dogs; and
Reconcile®,
for treatment of canine separation anxiety in conjunction with
behavior modification training
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Other pharmaceuticals, including:
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Vancocin®
HCl, used primarily to treat staphylococcal infections
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Ceclortm,
for the treatment of a wide range of bacterial infections.
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Marketing
We sell most of our products worldwide. We adapt our marketing
methods and product emphasis in various countries to meet local
needs.
PharmaceuticalsUnited
States
In the United States, we distribute pharmaceutical products
principally through independent wholesale distributors, with
some sales directly to pharmacies. Our marketing policy is
designed to assure that products and relevant medical
information are immediately available to physicians, pharmacies,
hospitals, public and private payers, and appropriate health
care professionals. Three wholesale distributors in the United
StatesAmerisourceBergen Corporation, McKesson Corporation,
and Cardinal Health, Inc.each accounted for between 12
percent and 17 percent of our worldwide consolidated net
sales in 2009. No other distributor accounted for more than
10 percent of consolidated net sales. We also sell
pharmaceutical products directly to the United States government
and other manufacturers, but those sales are not material.
We promote our major pharmaceutical products in the United
States through sales representatives who call upon physicians
and other health care professionals. We advertise in medical
journals, distribute literature and samples of certain products
to physicians, and exhibit at medical meetings. In addition, we
advertise certain products directly to consumers in the United
States and we maintain web sites with information about all our
major products. Divisions of our sales force are assigned to
therapeutic areas, such as neuroscience, diabetes, osteoporosis,
and oncology. We supplement our employee sales force with
contract sales organizations as appropriate to leverage our own
resources and the strengths of our partners in various markets.
Large purchasers of pharmaceuticals, such as managed-care
groups, government agencies, and long-term care institutions,
account for a significant portion of total pharmaceutical
purchases in the United States. We maintain special business
groups to service wholesalers, managed-care organizations,
government and long-term care institutions, hospitals, and
certain retail pharmacies. In response to competitive pressures,
we have entered into arrangements with these organizations which
provide for discounts or rebates on one or more Lilly products.
PharmaceuticalsOutside
the United States
Outside the United States, we promote our pharmaceutical
products primarily through sales representatives. While the
products marketed vary from country to country, neuroscience
products constitute the largest single group in total sales.
Distribution patterns vary from country to country. In most
countries,
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we maintain our own sales organizations, but in some countries
we market our products through independent distributors.
Pharmaceutical
Marketing Collaborations
We market certain of our significant products in collaboration
with other pharmaceutical companies:
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Under an arrangement that ended in 2009, Cymbalta was
co-promoted in the United States by Quintiles Transnational
Corp. Cymbalta is co-marketed in Japan by Shionogi &
Co. Ltd. and is co-promoted or co-marketed in most other major
countries outside the U.S. by Boehringer Ingelheim GmbH.
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Evista is marketed in major European markets by Daiichi Sankyo
Europe GmbH, a subsidiary of Daiichi Sankyo Co., Ltd. of Japan.
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We co-promote Byetta with Amylin Pharmaceuticals, Inc. in the
United States and Puerto Rico, and we have exclusive marketing
rights in other territories.
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Erbitux is marketed in North America by Bristol-Myers Squibb. We
co-promote Erbitux in North America. Outside North America,
Erbitux is commercialized by Merck KGaA. We receive royalties
from Bristol-Myers Squibb and Merck KGaA.
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Effient is co-promoted with us by Daiichi Sankyo in the United
States, major European markets, Brazil, Mexico, China, and
several other Asian countries. Daiichi Sanko retains sole
marketing rights in Japan, and we retain sole marketing rights
in Canada, Australia, Russia, and certain other countries.
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Animal Health
Products
Our Elanco animal health business unit employs field salespeople
throughout the United States. Elanco also has an extensive sales
force outside the United States. Elanco sells its products
primarily to wholesale distributors.
Competition
Our pharmaceutical products compete with products manufactured
by many other companies in highly competitive markets throughout
the world. Our animal health products compete on a worldwide
basis with products of animal health care companies as well as
pharmaceutical, chemical, and other companies that operate
animal health divisions or subsidiaries.
Important competitive factors include safety, effectiveness, and
ease of use of our products; price and demonstrated
cost-effectiveness; marketing effectiveness; and research and
development of new products and processes. Most new products
that we introduce must compete with other products already on
the market or products that are later developed by competitors.
If competitors introduce new products or delivery systems with
therapeutic or cost advantages, our products can be subject to
progressive price reductions, decreased volume of sales, or
both. Manufacturers of generic pharmaceuticals invest far less
in research and development than research-based pharmaceutical
companies and therefore can price their products much lower than
branded products. Accordingly, when a branded pharmaceutical
loses its market exclusivity, it normally faces intense price
competition from generic forms of the product. In many countries
outside the United States, intellectual property protection is
weak or nonexistent and we must compete with generic or
counterfeit versions of our products. Increasingly, to obtain
favorable reimbursement and formulary positioning with
government payers, managed care and pharmacy benefits management
organizations, we must demonstrate that our products offer not
only medical benefits but also cost advantages as compared with
other forms of care.
We believe our long-term competitive position depends upon our
success in discovering and developing (either alone or in
collaboration with others) innovative, cost-effective medicines
that provide improved outcomes to individual patients and
deliver value to payers, together with our ability to
continuously improve the productivity of our discovery,
development, manufacturing, marketing, and support operations in
a highly competitive environment. There can be no assurance that
our research and development efforts will result in commercially
successful products or that our products or processes will not
become uncompetitive from time to time as a result of products
or processes developed by our competitors.
Patents,
Trademarks, and Other Intellectual Property Rights
Overview
Intellectual property protection is critical to our ability to
successfully commercialize our life sciences innovations and
invest in the search for new medicines. We own, have applied
for, or are licensed under, a large number of patents in the
United States and many other countries relating to products,
product uses, formulations, and manufacturing processes. There
is no assurance that the patents we are seeking will be granted
or that the patents we hold would be found valid and enforceable
if challenged. Moreover, patents relating to particular
products, uses, formulations, or processes do not preclude other
manufacturers
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from employing alternative processes or from marketing
alternative products or formulations that might successfully
compete with our patented products. In addition, from time to
time, competitors or other third parties assert claims that our
activities infringe patents or other intellectual property
rights held by them, or allege a third-party right of ownership
in our existing intellectual property.
Outside the United States, the adequacy and effectiveness of
intellectual property protection for pharmaceuticals varies
widely. Under the Trade-Related Aspects of Intellectual Property
Agreement (TRIPs) administered by the World Trade Organization
(WTO), over 140 countries have now agreed to provide
non-discriminatory protection for most pharmaceutical inventions
and to assure that adequate and effective rights are available
to all patent owners. Because of TRIPs transition provisions,
dispute resolution mechanisms, and substantive limitations, it
is difficult to assess when and how much, if at all, we will
benefit commercially from this protection.
When a product patent expires, the patent holder often loses
effective market exclusivity for the product. This can result in
a severe and rapid decline in sales of the formerly patented
product, particularly in the United States. However, in some
cases the innovator company may achieve exclusivity beyond the
expiry of the product patent through manufacturing trade
secrets, later-expiring patents on methods of use or
formulations, or data-based exclusivity that may be available
under pharmaceutical regulatory laws.
Some of our current products, including Erbitux, Forteo, ReoPro,
and Xigris, and many of the potential products in our research
pipeline, are biological products (biologics).
Currently, generic versions of biologics cannot be approved
under U.S. law. Competitors seeking approval of biologics
must file their own safety and efficacy data, and address the
challenges of biologics manufacturing, which typically involves
more complex and costly processes than those of traditional
pharmaceutical operations. However, certain health care reform
bills recently debated in Congress included provisions that
would create a regulatory pathway to allow generic biologics.
Under these proposals, the innovator would receive data-based
exclusivity for a period of years following regulatory approval
for marketing. Even in the absence of new legislation, the
U.S. Food and Drug Administration (FDA) is taking steps
toward allowing generic versions of certain biologics.
Our Intellectual
Property Portfolio
We consider intellectual property protection for certain
products, processes, and usesparticularly those products
discussed belowto be important to our operations. For many
of our products, in addition to the compound patent we hold
other patents on manufacturing processes, formulations, or uses
that may extend exclusivity beyond the expiration of the product
patent.
The most relevant U.S. patent protection, together with
expected expiration, for our major marketed products is as
follows:
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Alimta is protected by a compound patent (2016).
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Byetta is protected by a patent covering its use in
treating type 2 diabetes (2017).
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Cialis is protected by compound and use patents (2017).
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Cymbalta is protected by a compound patent (2013).
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Effient is protected by a compound patent (2017).
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Evista is protected by patents on the treatment and
prevention of osteoporosis (2012 and 2014), and its dosage form
(2017)1.
Evista for use in breast cancer risk reduction is protected by
orphan drug exclusivity (2014).
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Gemzar is protected by a compound patent (November
2010) and a patent covering its antineoplastic use
(2013)1.
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Humalog is protected by a compound patent (2013).
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Strattera is protected by a patent covering its use in
treating attention deficit-hyperactivity disorder (2016).
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Zyprexa is protected by a compound patent (October 2011).
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1 |
The Evista dosage form patent and Gemzar use patent have been
held invalid by federal district courts, and we have appealed
those decisions. For more information, see Item 7,
Managements Discussion and AnalysisLegal and
Regulatory Matters.
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Worldwide, we sell all of our major products under trademarks
that we consider in the aggregate to be important to our
operations. Trademark protection varies throughout the world,
with protection continuing in some countries as long as the mark
is used, and in other countries as long as it is registered.
Registrations are normally for fixed but renewable terms.
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Patent
Licenses
Most of our important products were discovered in our own
laboratories and are not subject to significant license
agreements. Two of our larger products, Cialis and Alimta, are
subject to patent assignments or licenses granted to us by
others.
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The compound patent for Cialis is the subject of a license
agreement with Glaxo SmithKline which assigns to us exclusively
all rights in the compound. The agreement calls for royalties of
a single-digit percentage of net sales. The agreement is not
subject to termination by Glaxo for any reason other than a
material breach by Lilly of the royalty obligation, after a
substantial cure period.
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The compound patent for Alimta is the subject of a license
agreement with Princeton University, granting us an irrevocable
exclusive worldwide license to the compound patents for the
lives of the patents in the respective territories. The
agreement calls for royalties of a single-digit percentage of
net sales. The agreement is not subject to termination by
Princeton for any reason other than a material breach by Lilly
of the royalty obligation, after a substantial cure period.
Alimta is also the subject of a worldwide, nonexclusive license
to certain compound and process patents owned by Takeda
Pharmaceutical Company Limited. The agreement calls for
royalties of a single-digit percentage of net sales in countries
covered by a relevant patent. The agreement is subject to
termination for material default and failure to cure by Lilly
and in the event that Lilly becomes bankrupt or insolvent.
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Patent
Challenges
In the United States, the Drug Price Competition and Patent Term
Restoration Act of 1984, commonly known as
Hatch-Waxman, made a complex set of changes to both
patent and new-drug-approval laws. Before Hatch-Waxman, no drug
could be approved without providing the FDA complete safety and
efficacy studies, i.e., a complete New Drug Application
(NDA). Hatch-Waxman authorizes the FDA to approve generic
versions of innovative pharmaceuticals (other than biologics)
without such information by filing an Abbreviated New Drug
Application (ANDA). In an ANDA, the generic manufacturer must
demonstrate only bioequivalence between the generic
version and the NDA-approved drugnot safety and efficacy.
Absent a patent challenge, the FDA cannot approve an ANDA until
after the innovators patents expire. However, after the
innovator has marketed its product for four years, a generic
manufacturer may file an ANDA alleging that one or more of the
patents listed in the innovators NDA are invalid or not
infringed. This allegation is commonly known as a
Paragraph IV certification. The innovator must
then file suit against the generic manufacturer to protect its
patents. The FDA is then prohibited from approving the generic
companys application for a 30- to
42-month
period (which can be shortened or extended by the trial court
judge hearing the patent challenge). If one or more of the
NDA-listed patents are challenged, the first filer of a
Paragraph IV certification may be entitled to a
180-day
period of market exclusivity over all other generic
manufacturers.
In recent years, generic manufacturers have used
Paragraph IV certifications extensively to challenge
patents on a wide array of innovative pharmaceuticals, and we
expect this trend to continue. In addition, generic companies
have shown an increasing willingness to launch at
risk, i.e., after receiving ANDA approval but before final
resolution of their patent challenge. We are currently in
litigation with numerous generic manufacturers arising from
their Paragraph IV certifications on Alimta, Cymbalta,
Evista, Gemzar, and Strattera. For more information on this
litigation, see Item 7, Managements Discussion
and AnalysisLegal and Regulatory Matters.
Outside the United States, the legal doctrines and processes by
which pharmaceutical patents can be challenged vary widely. In
recent years, we have experienced an increase in patent
challenges from generic manufacturers in many countries outside
the United States, and we expect this trend to continue. For
more information on significant patent challenges outside the
United States, see Item 7, Managements
Discussion and AnalysisLegal and Regulatory Matters.
Government
Regulation
Regulation of Our
Operations
Our operations are regulated extensively by numerous national,
state, and local agencies. The lengthy process of laboratory and
clinical testing, data analysis, manufacturing development, and
regulatory review necessary for governmental approvals is
extremely costly and can significantly delay product
introductions. Promotion, marketing, manufacturing, and
distribution of pharmaceutical and animal health products are
extensively regulated in all major world markets. We are
required to conduct extensive post-marketing surveillance of the
safety of the products we sell. In addition, our operations are
subject to complex federal, state, local, and foreign laws and
regulations concerning the environment, occupational health and
safety, and privacy. The laws and regulations affecting the
manufacture and sale of current products and the discovery,
development, and introduction of new products will continue to
require substantial scientific and technical effort, time, and
expense and significant capital investment.
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Of particular importance is the FDA in the United States.
Pursuant to the Federal Food, Drug, and Cosmetic Act, the FDA
has jurisdiction over all of our products and administers
requirements covering the testing, safety, effectiveness,
manufacturing, quality control, distribution, labeling,
marketing, advertising, dissemination of information, and
post-marketing surveillance of our pharmaceutical products. The
FDA, along with the U.S. Department of Agriculture (USDA),
also regulates our animal health products. The
U.S. Environmental Protection Agency also regulates some
animal health products. In 2007, Congress passed the Food and
Drug Administration Amendments Act (FDAAA), which imposes
additional requirements for drug development and
commercialization and provides the FDA with further authorities
and resources, particularly in the area of drug safety.
The FDA extensively regulates all aspects of manufacturing
quality under its current Good Manufacturing Practices (cGMP)
regulations. In recent years, we have made, and we continue to
make, substantial investments of capital and operating expenses
to implement comprehensive, company-wide improvements in our
manufacturing, product and process development, and quality
operations to ensure sustained cGMP compliance. However, in the
event we fail to adhere to cGMP requirements in the future, we
could be subject to interruptions in production, fines and
penalties, and delays in new product approvals.
Outside the United States, our products and operations are
subject to similar regulatory requirements, notably by the
European Medicines Agency (EMA) in the European Union and the
Ministry of Health, Labor and Welfare (MHLW) in Japan. Specific
regulatory requirements vary from country to country.
The marketing, promotional, and pricing practices of
pharmaceutical manufacturers, as well as the manner in which
manufacturers interact with purchasers and prescribers, are
subject to various other federal and state laws, including the
federal anti-kickback statute and the False Claims Act and state
laws governing kickbacks, false claims, unfair trade practices,
and consumer protection. These laws are administered by, among
others, the Department of Justice, the Office of Inspector
General of the Department of Health and Human Services, the
Federal Trade Commission, the Office of Personnel Management and
state attorneys general. Over the past several years, the FDA,
the Department of Justice, and many of these other agencies have
increased their enforcement activities with respect to
pharmaceutical companies and increased the inter-agency
coordination of enforcement activities. Over this period,
several claims brought by these agencies against Lilly and other
companies under these and other laws have resulted in corporate
criminal sanctions and very substantial civil settlements. See
Item 3, Legal Proceedings, and Item 7,
Managements Discussion and AnalysisLegal and
Regulatory Matters, for information about currently
pending and recently resolved marketing and promotional
practices investigations involving Lilly, including information
regarding a Corporate Integrity Agreement entered into by Lilly
in connection with the resolution of a U.S. federal
marketing practices investigation and certain related state
investigations involving Zyprexa.
The U.S. Foreign Corrupt Practices Act (FCPA)
prohibits certain individuals and entities, including
U.S. publicly traded companies, from promising, offering,
or giving anything of value to foreign officials with the
corrupt intent of influencing the foreign official for the
purpose of helping the company obtain or retain business or gain
any improper advantage. The FCPA also imposes specific
recordkeeping and internal controls requirements on
U.S. publicly traded companies. As noted above, outside the
U.S., our business is heavily regulated and therefore involves
significant interaction with foreign officials. Additionally, in
many countries outside the U.S., the health care providers who
prescribe pharmaceuticals are employed by the government and the
purchasers of pharmaceuticals are government entities;
therefore, our payments to these prescribers and purchasers are
subject to regulation under the FCPA. Recently the
U.S. Securities and Exchange Commission (SEC) and the
Department of Justice have increased their FCPA enforcement
activities with respect to pharmaceutical companies. See
Item 3, Legal Proceedings, for information
about a currently pending investigation involving our operations
in several countries.
It is possible that we could become subject to additional
administrative and legal proceedings and actions, which could
include claims for civil penalties (including treble damages
under the False Claims Act), criminal sanctions, and
administrative remedies, including exclusion from federal health
care programs. It is possible that an adverse outcome in pending
or future actions could have a material adverse impact on our
consolidated results of operations, liquidity, and financial
position.
Regulations
Affecting Pharmaceutical Pricing and Reimbursement
In the United States, we are required to provide rebates to
state governments on their purchases of certain of our products
under state Medicaid programs. Additional cost containment
measures have been adopted or proposed by federal, state, and
local government entities that provide or pay for health care.
In most international markets, we operate in an environment of
government-mandated cost containment programs, which may include
price controls, reference pricing, discounts and rebates,
restrictions on physician prescription levels, restrictions on
reimbursement, compulsory licenses, health economic assessments,
and generic substitution.
In the U.S., the Medicare Prescription Drug Improvement and
Modernization Act of 2003 (MMA) provides a prescription drug
benefit for seniors under the Medicare program, known as
Medicare Part D. Pricing to manufacturers for drugs covered
by the program is currently established through competitive
negotiations
7
between the manufacturers and private payers. In addition,
comprehensive health care reform was the subject of recent
intense debate in Congress, and we expect the health care reform
debate to continue. Although it is difficult to predict the
direction of the debate, the ultimate outcome could have a
material adverse impact on our business. See Item 7,
Managements Discussion and AnalysisExecutive
OverviewLegal, Regulatory, and Other Matters, for
more discussion of MMA and U.S. health care reform. At the
state level, budget pressures are causing various states to
impose cost-control measures such as higher rebates and more
restrictive formularies.
International operations are also generally subject to extensive
price and market regulations, and there are many proposals for
additional cost-containment measures, including proposals that
would directly or indirectly impose additional price controls,
limit access to or reimbursement for our products, or reduce the
value of our intellectual property protection.
We cannot predict the extent to which our business may be
affected by these or other potential future legislative or
regulatory developments. However, we expect that pressures on
pharmaceutical pricing will become more severe.
Research
and Development
Our commitment to research and development dates back more than
100 years. Our research and development activities are
responsible for the discovery and development of most of the
products we offer today. We invest heavily in research and
development because we believe it is critical to our long-term
competitiveness. At the end of 2009, we employed approximately
7,600 people in pharmaceutical and animal health research
and development activities, including a substantial number of
physicians, scientists holding graduate or postgraduate degrees,
and highly skilled technical personnel. Our research and
development expenses were $3.49 billion in 2007,
$3.84 billion in 2008, and $4.33 billion in 2009.
Our pharmaceutical research and development focuses on four
therapeutic categories: central nervous system and related
diseases; endocrine diseases, including diabetes, obesity, and
musculoskeletal disorders; cancer; and cardiovascular diseases.
However, we remain opportunistic, selectively pursuing promising
leads in other therapeutic areas. We are actively engaged in a
strong biotechnology research program, including therapeutic
proteins, antibodies, and antisense oligonucleotides as well as
genomics (the development of therapeutics through identification
of disease-causing genes and their cellular function),
biomarkers, and targeted therapeutics. In addition to
discovering and developing new chemical entities, we seek to
expand the value of existing products through new uses,
formulations and therapeutic approaches that provide additional
value to patients. We also conduct research in animal health,
including animal nutrition and physiology, control of parasites,
and veterinary medicine (both food and companion animal).
To supplement our internal efforts, we collaborate with others,
including educational institutions and research-based
pharmaceutical and biotechnology companies, and we contract with
others for the performance of research in their facilities. We
use the services of physicians, hospitals, medical schools, and
other research organizations worldwide to conduct clinical
trials to establish the safety and effectiveness of our
pharmaceutical products. We actively seek out investments in
external research and technologies that hold the promise to
complement and strengthen our own research efforts. These
investments can take many forms, including licensing
arrangements, co-development and co-marketing agreements,
co-promotion arrangements, joint ventures, and acquisitions.
Drug development is time-consuming, expensive, and risky. On
average, only one out of many thousands of chemical compounds
discovered by researchers proves to be both medically effective
and safe enough to become an approved medicine. The process from
discovery to regulatory approval can take 12 to 15 years or
longer. Drug candidates can fail at any stage of the process,
and even late-stage drug candidates sometimes fail to receive
regulatory approval or achieve commercial success. Even after
approval and launch of a product, we expend considerable
resources on post-marketing surveillance and clinical studies.
We believe our investments in research, both internally and in
collaboration with others, have been rewarded by the number of
new compounds and new indications for existing compounds that we
have in all stages of development. At present we have over 60
drug candidates across all stages of human testing. Among our
new investigational compounds in the later stages of human
testing are potential therapies for diabetes, cancers, and
Alzheimers disease. We are studying many other drug
candidates in the earlier stages of development, including
compounds targeting cancers, diabetes, schizophrenia, obesity,
depression, sleep disorders, pain, alcohol dependence,
musculoskeletal disorders, atherosclerosis, and autoimmune
disorders including rheumatoid arthritis. We are also developing
new uses, formulations, or delivery methods for many of these
compounds as well as our currently marketed products, such as
Alimta, Byetta, Cialis, Cymbalta, Effient, Erbitux, Forteo,
Gemzar, and Humalog.
Raw
Materials and Product Supply
Most of the principal materials we use in our manufacturing
operations are available from more than one source. However, we
obtain certain raw materials principally from only one source.
In addition, Byetta is manufactured by third-party suppliers to
Amylin. In the event one of these suppliers was unable to
provide the materials or product, we generally have sufficient
inventory to supply the market until an alternative
8
source of supply can be implemented. However, in the event of an
extended failure of a supplier, it is possible that we could
experience an interruption in supply until we established new
sources or, in some cases, implemented alternative processes.
Our primary bulk manufacturing occurs at five sites in the
United States as well as locations in Ireland, Puerto Rico, and
the United Kingdom. Finishing operations, including labeling and
packaging, take place at a number of sites throughout the world.
Effective in January 2010, we sold one of our U.S. sites,
Tippecanoe Laboratories in West Lafayette, Indiana, to an
affiliate of Evonik Industries AG, and entered into a nine-year
supply and services agreement whereby Evonik will manufacture
final and intermediate step active pharmaceutical ingredients
for certain Lilly human and animal health products.
We manage our supply chain (including our own facilities,
contracted arrangements, and inventory) in a way that should
allow us to meet all expected product demand while maintaining
flexibility to reallocate manufacturing capacity to improve
efficiency and respond to changes in supply and demand. However,
pharmaceutical production processes are complex, highly
regulated, and vary widely from product to product. Shifting or
adding manufacturing capacity can be a very lengthy process
requiring significant capital expenditures and regulatory
approvals. Accordingly, if we were to experience extended plant
shutdowns at one of our own facilities, extended failure of a
contract supplier, or extraordinary unplanned increases in
demand, we could experience an interruption in supply of certain
products or product shortages until production could be resumed
or expanded.
Quality
Assurance
Our success depends in great measure upon customer confidence in
the quality of our products and in the integrity of the data
that support their safety and effectiveness. Product quality
arises from a total commitment to quality in all parts of our
operations, including research and development, purchasing,
facilities planning, manufacturing, and distribution. We have
implemented quality-assurance procedures relating to the quality
and integrity of scientific information and production processes.
Control of production processes involves rigid specifications
for ingredients, equipment, facilities, manufacturing methods,
packaging materials, and labeling. We perform tests at various
stages of production processes and on the final product to
assure that the product meets all regulatory requirements and
our standards. These tests may involve chemical and physical
chemical analyses, microbiological testing, testing in animals,
or a combination. Additional assurance of quality is provided by
a corporate quality-assurance group that monitors existing
pharmaceutical and animal health manufacturing procedures and
systems in the parent company, subsidiaries and affiliates, and
third-party suppliers.
Executive
Officers of the Company
The following table sets forth certain information regarding our
executive officers. Except as otherwise noted, all executive
officers have been employed by the Company in executive
positions during the last five years.
The term of office for each executive officer expires on the
date of the annual meeting of the Board of Directors, to be held
on April 19, 2010, or on the date his or her successor is
chosen and qualified. No director or executive officer has a
family relationship with any other director or
executive officer of the Company, as that term is defined for
purposes of this disclosure requirement. There is no
understanding between any executive officer and any other person
pursuant to which the executive officer was selected.
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Name
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Age
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Offices and Business Experience
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John C. Lechleiter, Ph.D.
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56
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Chairman (since January 2009), President (since October 2005),
Chief Executive Officer (since April 2008) and a Director (since
October 2005)
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Robert A. Armitage
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61
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Senior Vice President and General Counsel (since January 2003)
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Bryce D. Carmine
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58
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Executive Vice President and President, Lilly Bio-Medicines
(since November 2009)
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Enrique A. Conterno
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43
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Senior Vice President and President, Lilly Diabetes (since
November 2009)
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Frank M. Deane, Ph.D.
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60
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President, Manufacturing Operations (since June 2007)
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9
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Name
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Age
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Offices and Business Experience
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John H. Johnson
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52
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Senior Vice President and President, Lilly Oncology (since
November 2009). Mr. Johnson was chief executive officer and a
director of ImClone Systems Inc. from 2007 until its acquisition
by Lilly in November 2008. From 2002 to 2007 he served in
various executive positions at Johnson & Johnson, including
Group Chairman of that companys worldwide
biopharmaceuticals unit from 2005 to 2007. He first joined
Johnson & Johnson in 1988. In 2000, Mr. Johnson left
J&J to serve as chief executive officer of Parkstone
Medical Information Systems, a start-up company that developed a
hand-held device for doctors to write prescriptions. That
company filed for bankruptcy protection in 2001.
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Jan M. Lundberg, Ph.D.
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56
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Executive Vice President, Science and Technology and President,
Lilly Research Laboratories (since January 2010). From 2002
until he joined Lilly in January 2010, Dr. Lundberg was
executive vice president and head of discovery research at
AstraZeneca.
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Susan Mahony, Ph.D.
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45
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Senior Vice President, Human Resources (since May 2009)
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Anne Nobles
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53
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Senior Vice President, Enterprise Risk Management (since April
2009) and Chief Ethics and Compliance Officer (since June 2007)
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Steven M. Paul, M.D.
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59
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Executive Vice President, Science and Technology and President,
Lilly Research Laboratories (since July 2003; retiring February
28, 2010)
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Barton R. Peterson
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51
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Senior Vice President, Corporate Affairs and Communications
(since June 2009). Mr. Peterson served as mayor of
Indianapolis, Indiana from 2000 to 2007. From 2008 to 2009, he
was managing director at Strategic Capital Partners, LLC and
distinguished visiting professor of public policy at Ball State
University.
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Derica W. Rice
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45
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Executive Vice President, Global Services (since January 2010)
and Chief Financial Officer (since May 2006)
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Jeffrey N. Simmons
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42
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Senior Vice President and President, Elanco Animal Health (since
January 2008)
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Jacques Tapiero
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51
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Senior Vice President and President, Emerging Markets (since
January 2010)
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Employees
At the end of 2009, we employed approximately
40,360 people, including approximately
20,300 employees outside the United States. A substantial
number of our employees have long records of continuous service.
Financial
Information Relating to Business Segments and Classes of
Products
You can find financial information relating to our business
segments and classes of products in Item 8 of this
Form 10-K,
Segment Information. That information is
incorporated here by reference.
The relative contribution of any particular product to our
consolidated net sales changes from year to year. This is due to
several factors, including the introduction of new products by
us and by other manufacturers and the introduction of generic
pharmaceuticals upon patent expirations. In addition, margins
vary for our different products due to various factors,
including differences in the cost to manufacture and market the
products, the value of the products to the marketplace, and
government restrictions on pricing and reimbursement. Our major
product sales are generally not seasonal.
Financial
Information Relating to Foreign and Domestic
Operations
You can find financial information relating to foreign and
domestic operations in Item 8, Segment
Information. That information is incorporated here by
reference. To date, our overall operations abroad have not been
significantly deterred by local restrictions on the transfer of
funds from branches and subsidiaries located abroad, including
the availability of U.S. dollar exchange. We cannot predict
what effect these restrictions or the other risks inherent in
foreign operations, including possible nationalization, might
have on our future operations or what other restrictions may be
imposed in the future. In addition, changing currency values can
either favorably or unfavorably affect our financial position,
10
liquidity, and results of operations. We mitigate foreign
exchange risk through various hedging techniques including the
use of foreign currency contracts.
Available
Information on Our Web Site
We make available through our company web site, free of charge,
our company filings with the Securities and Exchange Commission
(SEC) as soon as reasonably practicable after we electronically
file them with, or furnish them to, the SEC. These include our
annual reports on
Form 10-K,
quarterly reports on
Form 10-Q,
current reports on
Form 8-K,
proxy statements, registration statements, and any amendments to
those documents. The company web site link to our SEC filings is
http://investor.lilly.com/sec.cfm.
In addition, the Corporate Governance portion of our web site
includes our corporate governance guidelines, board and
committee information (including committee charters), and our
articles of incorporation and by-laws. The link to our corporate
governance information is
http://investor.lilly.com/governance.cfm.
We will provide paper copies of our SEC filings free of charge
upon request to the companys secretary at the address
listed on the front of this
Form 10-K.
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Item 1A.
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Risk
Factors; Cautionary Statement Regarding Forward Looking
Statements
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In addition to the other information contained in this
Form 10-K,
the following risk factors should be considered carefully in
evaluating our company. It is possible that our business,
financial condition, liquidity, or results of operations could
be materially adversely affected by any of these risks.
We make certain forward-looking statements in this
Form 10-K,
and company spokespersons may make such statements in the
future. Where possible, we try to identify forward-looking
statements by using such words as expect,
plan, will, estimate,
forecast, project, believe,
and anticipate. Forward-looking statements do not
relate strictly to historical or current facts. They are likely
to address our growth strategy, sales of current and anticipated
products, financial results, our research and development
programs, the status of product approvals, legislative and
regulatory developments, and the outcome of contingencies such
as litigation and investigations. All forward-looking statements
are based on our expectations at the time we make them. They are
subject to risks and uncertainties, including those summarized
below.
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Pharmaceutical research and development is very costly and
highly uncertain. There are many difficulties and
uncertainties inherent in pharmaceutical research and
development and the introduction of new products. There is a
high rate of failure inherent in new drug discovery and
development. To bring a drug from the discovery phase to market
typically takes a decade or more and costs over $1 billion.
Failure can occur at any point in the process, including late in
the process after substantial investment. As a result, most
funds invested in research programs will not generate financial
returns. New product candidates that appear promising in
development may fail to reach the market or may have only
limited commercial success because of efficacy or safety
concerns, inability to obtain necessary regulatory approvals,
limited scope of approved uses, difficulty or excessive costs to
manufacture, or infringement of the patents or intellectual
property rights of others. Delays and uncertainties in the FDA
approval process and the approval processes in other countries
can result in delays in product launches and lost market
opportunity. In recent years, FDA review times have increased
substantially and fewer new drugs are being approved. In
addition, it can be very difficult to predict sales growth rates
of new products.
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We face intense competition. We compete with a large
number of multinational pharmaceutical companies, biotechnology
companies and generic pharmaceutical companies. To compete
successfully, we must continue to deliver to the market
innovative, cost-effective products that meet important medical
needs. Our product sales can be adversely affected by the
introduction by competitors of branded products that are
perceived as superior by the marketplace, by generic versions of
our branded products, and by generic versions of other products
in the same therapeutic class as our branded products. See
Item 1, BusinessCompetition, for more
details.
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We depend on patent-protected products for most of our
revenues, cash flows, and earnings, and we will lose effective
intellectual property protection for many of them in the next
several years. Eight significant products, which
together comprise 74 percent of our worldwide revenue, will
lose their
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11
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most significant remaining U.S. patent protection, as well
as their intellectual property-based exclusivity in most
countries outside the U.S., in the next several years:
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Worldwide Revenues
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Percent of Total
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Product
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(2009)
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2009 Revenues
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Relevant U.S. Patent Protection
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Zyprexa
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$4.92 billion
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23
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2011
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Cymbalta
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$3.07 billion
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14
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2013
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Humalog
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$1.96 billion
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9
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2013
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Alimta
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$1.71 billion
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8
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2016
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Cialis
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$1.56 billion
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7
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2017
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Gemzar
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$1.36 billion
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6
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2010 (compound); 2013
(use)1
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Evista
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$1.03 billion
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5
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2014 (use); 2017 (dosage
form)1
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Strattera
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$609.4 million
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3
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2016
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1The
Gemzar use patent and Evista dosage form patent have been held
invalid by federal district courts, and we have appealed those
decisions. For more information, see Item 7,
Managements Discussion and AnalysisLegal and
Regulatory Matters.
Loss of exclusivity typically results in a rapid and severe
decline in sales. See Item 1, BusinessPatents,
Trademarks, and Other Intellectual Property Protection,
for more details. Additionally, if these or other significant
products were to become subject to a problem such as an early
loss of patent protection as a result of litigation, unexpected
side effects, regulatory proceedings, material product liability
litigation, publicity affecting doctor or patient confidence, or
pressure from competitive products, the adverse impact on our
revenues, cash flows, and earnings could be significant.
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Our long-term success depends on intellectual property
protection. Our long-term success depends on our
ability to continually discover, develop, and commercialize
innovative new pharmaceutical products. Without strong
intellectual property protection, we would be unable to generate
the returns necessary to support the enormous investments in
research and development and capital as well as other
expenditures required to bring new drugs to the market.
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Intellectual property protection varies throughout the world and
is subject to change over time. In the U.S., the Hatch-Waxman
Act provides generic companies powerful incentives to seek to
invalidate our patents; as a result, we expect that our
U.S. patents on major products will be routinely
challenged, and there can be no assurance that our patents will
be upheld. See Item 1, BusinessPatents,
Trademarks, and Other Intellectual Property Protection,
for more details. We are increasingly facing generic
manufacturer challenges to our patents outside the U.S. as
well. In addition, competitors or other third parties may claim
that our activities infringe patents or other intellectual
property rights held by them. If successful, such claims could
result in our being unable to market a product in a particular
territory or being required to pay damages for past infringement
or royalties on future sales. See Item 1,
BusinessPatents, Trademarks, and Other Intellectual
Property Protection, for more details.
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Our business is subject to increasing government price
controls and other health care cost containment measures.
Government health care cost-containment measures can
significantly affect our sales and profitability. In many
countries outside the United States, government agencies
strictly control, directly or indirectly, the prices at which
our products are sold. In the United States, we are subject to
substantial pricing pressures from state Medicaid programs and
private insurance programs and pharmacy benefit managers,
including those operating under the Medicare Part D
pharmaceutical benefit. Many federal and state legislative
proposals, including the comprehensive health care reform bills
that were the subject of recent debate in Congress, would
further negatively affect our pricing
and/or
reimbursement for our products. We expect pricing pressures from
both governments and private payers inside and outside the
United States to become more severe. See Item I,
BusinessRegulations Affecting Pharmaceutical Pricing
and Reimbursement, for more details.
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Pharmaceutical products can develop unexpected safety or
efficacy concerns. Unexpected safety or efficacy
concerns can arise with respect to marketed products, leading to
product recalls, withdrawals, or declining sales, as well as
costly product liability claims.
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Regulatory compliance problems could be damaging to the
company. The marketing, promotional, and pricing
practices of pharmaceutical manufacturers, as well as the manner
in which manufacturers interact with purchasers, prescribers,
and patients, are subject to extensive regulation. Many
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12
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companies, including Lilly, have been subject to claims related
to these practices asserted by federal, state and foreign
governmental authorities and private payers and consumers. These
claims have resulted in substantial expense and other
significant consequences to us. It is possible other products
could become subject to investigation and that the outcome of
these matters could include criminal charges and fines,
penalties, or other monetary or nonmonetary remedies. In
particular, See Item 7, Managements Discussion
and AnalysisLegal and Regulatory Matters, for the
discussions of the U.S. sales and marketing practices
investigations. In addition, regulatory issues concerning
compliance with current Good Manufacturing Practice (cGMP)
regulations for pharmaceutical products can lead to product
recalls and seizures, interruption of production leading to
product shortages, and delays in the approvals of new products
pending resolution of the cGMP issues. We are now operating
under a Corporate Integrity Agreement with the Office of
Inspector General of the U.S. Department of Health and
Human Services that requires us to maintain comprehensive
compliance programs governing our research, manufacturing, and
sales and marketing of pharmaceuticals. A material failure to
comply with the Agreement could result in severe sanctions to
the company. See Item 1, BusinessRegulation of
our Operations, for more details.
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We face many product liability claims today, and future
claims will be largely self-insured. We are
subject to a substantial number of product liability claims
involving primarily Zyprexa, diethylstilbestrol
(DES), thimerosal, and Byetta, and because of the
nature of pharmaceutical products, it is possible that we could
become subject to large numbers of product liability claims for
other products in the future. See Item 7,
Managements Discussion and AnalysisLegal and
Regulatory Matters, and Item 3, Legal
Proceedings, for more information on our current product
liability litigation. Due to a very restrictive market for
product liability insurance, we have been and will continue to
be largely self-insured for future product liability losses for
substantially all our currently marketed products. In addition,
there is no assurance that we will be able to fully collect from
our insurance carriers on past claims.
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Manufacturing difficulties could lead to product supply
problems. Pharmaceutical manufacturing is complex and
highly regulated. Manufacturing difficulties at our facilities
or contracted facilities, or the failure or refusal of a
contract manufacturer to supply contracted quantities, could
result in product shortages, leading to lost sales. See
Item 1, BusinessRaw Materials and Product
Supply, for more details.
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A prolonged economic downturn could adversely affect our
business and operating results. While pharmaceuticals
have not generally been sensitive to overall economic cycles, a
prolonged economic downturn coupled with rising unemployment
(and a corresponding increase in the uninsured and underinsured
population) could lead to decreased utilization of drugs,
affecting our sales volume. Declining tax revenues attributable
to the downturn are increasing the pressure on governments to
reduce health care spending, leading to increasing government
efforts to control drug prices and utilization. In addition, a
prolonged economic downturn could adversely affect our
investment portfolio, which could lead to the recognition of
losses on our corporate investments and increased benefit
expense related to our pension obligations. Also, if our
customers, suppliers or collaboration partners experience
financial difficulties, we could experience slower customer
collections, greater bad debt expense, and performance defaults
by suppliers or collaboration partners.
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We face other risks to our business and operating
results. Our business is subject to a number of other
risks and uncertainties, including:
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Economic factors over which we have no control, including
changes in inflation, interest rates, and foreign currency
exchange rates, can affect our results of operations.
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Changes in tax laws, including laws related to the remittance of
foreign earnings or investments in foreign countries with
favorable tax rates, and settlements of federal, state, and
foreign tax audits, can affect our results of operations. In its
budget submission to Congress in February 2010, the Obama
administration proposed changes to the manner in which the
U.S. would tax the international income of
U.S.-based
companies. While it is uncertain how the U.S. Congress may
address this issue, reform of U.S. taxation, including
taxation of international income, continues to be a topic of
discussion for the U.S. Congress. A significant change to
the U.S. tax system, including changes to the taxation of
international income, could have a material adverse effect on
our results of operations.
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Changes in accounting standards promulgated by the Financial
Accounting Standards Board and the Securities and Exchange
Commission can affect our financial statements.
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Our financial statements can also be affected by internal
factors, such as changes in business strategies and the impact
of restructurings, asset impairments, technology acquisition and
disposition transactions, and business combinations.
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We undertake no duty to update forward-looking statements.
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Item 1B.
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Unresolved
Staff Comments
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None.
13
Our principal domestic and international executive offices are
located in Indianapolis. At December 31, 2009, we owned 12
production and distribution sites in the United States and
Puerto Rico. Together with the corporate administrative offices,
these facilities contain an aggregate of approximately
14.1 million square feet of floor area dedicated to
production, distribution, and administration. Major production
sites include Indianapolis and Clinton, Indiana; Carolina,
Puerto Rico; Branchburg, New Jersey; and Augusta, Georgia.
We own production and distribution sites in 12 countries outside
the United States and Puerto Rico, containing an aggregate of
approximately 3.6 million square feet of floor area. Major
production sites include facilities in France, Ireland, Spain,
Brazil, Italy, Mexico, and the United Kingdom.
Our research and development facilities in the United States
consist of approximately 3.7 million square feet and are
located primarily in Indianapolis, with smaller sites in
San Diego and New York City. Our major research and
development facilities abroad are located in United Kingdom,
Canada, Singapore, and Spain, and contain an aggregate of
approximately 350,000 square feet.
We believe that none of our properties is subject to any
encumbrance, easement, or other restriction that would detract
materially from its value or impair its use in the operation of
the business. The buildings we own are of varying ages and in
good condition.
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Item 3.
|
Legal
Proceedings
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We are a party to various currently pending legal actions,
government investigations, and environmental proceedings, and we
anticipate that such actions could be brought against us in the
future. The most significant of these matters are described
below or, as noted, in Item 7, Managements
Discussion and AnalysisLegal and Regulatory Matters.
While it is not possible to determine the outcome of the legal
actions, investigations and proceedings brought against us, we
believe that, except as otherwise specifically noted below or in
Item 7, the resolution of all such matters will not have a
material adverse effect on our consolidated financial position
or liquidity, but could be material to our consolidated results
of operations in any one accounting period.
Legal
Proceedings Described in Managements Discussion and
Analysis
See Item 7, Managements Discussion and
AnalysisLegal and Regulatory Matters, for
information on various legal proceedings, including but not
limited to:
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The U.S. patent litigation involving Alimta, Cymbalta,
Evista, Gemzar, Strattera, and Xigris
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The patent litigation outside the U.S. involving Zyprexa
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The various federal and state investigations relating to our
sales, marketing, and promotional practices
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The Zyprexa product liability and related litigation, including
claims brought on behalf of state Medicaid agencies and private
healthcare payers
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That information is incorporated into this Item by reference.
Other
Patent Litigation
Cialis: In July 2005, Vanderbilt University filed a
lawsuit in the United States District Court in Delaware against
ICOS Corporation seeking to add three of its scientists as
co-inventors on the Cialis compound and
method-of-use
patents. In January 2009, the district court judge ruled in our
favor, declining to add any of these scientists as an inventor
on either patent. The plaintiff appealed this ruling to the
Court of Appeals for the Federal Circuit, which heard oral
arguments in November 2009. We await the courts decision.
We believe these claims are without legal merit and expect to
prevail in the appeal; however, it is not possible to determine
the outcome. An unfavorable final outcome could have a material
adverse impact on our consolidated results of operations,
liquidity, and financial position.
In October 2002, Pfizer Inc. was issued a
method-of-use
patent in the United States and commenced a lawsuit in the
United States District Court in Delaware against us, Lilly ICOS
LLC, and ICOS Corporation (both later acquired by Lilly)
alleging that the marketing of Cialis for erectile dysfunction
infringed this patent. This litigation has been stayed pending
the outcome of a reexamination of the patent by the
U.S. Patent and Trademark Office. The Office has made a
final rejection of the relevant patent claims which Pfizer has
appealed to the Board of Patent Appeals and Interferences. In
February 2010, the Board affirmed the Offices rejection of
these claims. Pfizer has the right to appeal this decision. We
believe Pfizers claims are without merit and expect to
prevail. However, it is not possible to determine the outcome of
this litigation.
14
Other
Product Liability Litigation
We are currently a defendant in a variety of product liability
lawsuits in the United States involving primarily Zyprexa,
thimerosal, Byetta, and DES.
We have been named as a defendant in approximately 200 actions
in the U.S., involving approximately 270 claimants, brought
in various state courts and federal district courts on behalf of
children with autism or other neurological disorders who
received childhood vaccines (manufactured by other companies)
that contained thimerosal, a generic preservative used in
certain vaccines in the U.S. beginning in the 1930s. We
purchased patents and conducted research pertaining to
thimerosal in the 1920s. We have been named in the suits even
though we discontinued manufacturing the raw material in 1974
and discontinued selling it in the United States to vaccine
manufacturers in 1992. The lawsuits typically name the vaccine
manufacturers as well as Lilly and other distributors of
thimerosal, and allege that the childrens exposure to
thimerosal-containing vaccines caused their autism or other
neurological disorders. We strongly deny any liability in these
cases. There is no credible scientific evidence establishing a
causal relationship between thimerosal-containing vaccines and
autism or other neurological disorders. In addition, we believe
the majority of the cases should not be prosecuted in the courts
in which they have been brought because the underlying claims
are subject to the National Childhood Vaccine Injury Act of
1986. Implemented in 1988, the Act established a mandatory,
federally administered no-fault claims process for individuals
who allege that they were harmed by the administration of
childhood vaccines. Under the Act, claims must first be brought
before the U.S. Court of Claims for an award determination
under the compensation guidelines established pursuant to the
Act. Claimants who are unsatisfied with their awards under the
Act may reject the award and seek traditional judicial remedies.
We have been named a defendant in approximately 55 Byetta
product liability lawsuits involving approximately 280
plaintiffs, primarily seeking to recover damages for
pancreatitis experienced by patients prescribed Byetta. We are
aware of approximately 40 additional claimants who have not yet
filed suit. The majority of the cases are filed in California
and coordinated in a Los Angeles Superior Court. In June 2009, a
lawsuit was filed in Louisiana State Court (Ralph
Jackson v. Eli Lilly and Company, et al.) seeking to assert
similar product liability claims on behalf of Louisiana
residents who were prescribed Byetta; however, the plaintiff
dropped the class action allegations in a recently-filed amended
complaint. We believe these claims are without merit and are
prepared to defend against them vigorously.
In approximately 25 U.S. lawsuits against us involving
approximately 50 claimants, plaintiffs seek to recover damages
on behalf of children or grandchildren of women who were
prescribed DES during pregnancy in the 1950s and 1960s. In
December 2009, a lawsuit was filed in U.S. District Court
in Washington, D.C. against Lilly and other manufacturers
(Michele Fecho, et al v. Eli Lilly and Company, et
al) seeking to assert product liability claims on behalf of
a putative class of men and women allegedly exposed to the
medicine who claim to have later developed breast cancer. We
believe these claims are without merit and are prepared to
defend against them vigorously.
Other
Marketing Practices Investigations
In November 2008, we received a subpoena from the
U.S. Department of Health and Human Services Office of
Inspector General in coordination with the U.S. Attorney
for the Western District of New York seeking production of a
wide range of documents and information relating to
reimbursement of Alimta. We are cooperating in this
investigation.
In August 2003, we received notice that the staff of the SEC is
conducting an investigation into the compliance by Polish
subsidiaries of certain pharmaceutical companies, including
Lilly, with the U.S. Foreign Corrupt Practices Act of 1977.
The staff has issued subpoenas to us requesting production of
documents related to the investigation. In connection with that
matter, staffs of the SEC and the Department of Justice (DOJ)
have expanded their investigation and have asked us to
voluntarily provide additional information related to certain
activities of Lilly affiliates in a number of other countries.
The SEC staff has also issued a subpoena related to activities
in these countries. We are cooperating with the SEC and the DOJ
in this investigation.
Shareholder
Derivative Litigation
In 2007, the company received two demands from shareholders that
the board of directors cause the company to take legal action
against current and former directors and others for allegedly
causing damage to the company through improper marketing of
Evista, Prozac, and Zyprexa. In accordance with procedures
established under the Indiana Business Corporation Law (Ind.
Code
§ 23-1-32),
the board has appointed a committee of independent persons to
consider the demands and determine what action, if any, the
company should take in response. Since January 2008, we have
been served with seven shareholder derivative lawsuits:
Lambrecht, et al. v. Taurel, et al., filed
January 17, 2008, in the United States District Court for
the Southern District of Indiana; Staehr, et al. v. Eli
Lilly and Company, et al., filed March 27, 2008, in
Marion County Superior Court in Indianapolis, Indiana;
Waldman, et al., v. Eli Lilly and Company, et al.,
filed February 11, 2008, in the United States District
Court for the Eastern District of New York; Solomon v.
Eli Lilly and Company, et al., filed March 27, 2008, in
Marion County Superior Court in
15
Indianapolis, Indiana; Robbins v. Taurel, et al.,
filed April 9, 2008, in the United States District Court
for the Eastern District of New York; City of Taylor General
Employees Retirement System v. Taurel, et al., filed
April 15, 2008, in the United States District Court for the
Eastern District of New York; and Zemprelli v. Taurel,
et al., filed June 24, 2008, in the United States
District Court for the Southern District of Indiana. Two of
these lawsuits were filed by the shareholders who served the
demands described above. All seven lawsuits are nominally filed
on behalf of the company, against various current and former
directors and officers and allege that the named officers and
directors harmed the company through the improper marketing of
Zyprexa, and in certain suits, Evista and Prozac. The Zemprelli
suit also claims that certain defendants violated
Sections 10(b) and 20(a) of the Securities Exchange Act of
1934. We believe these lawsuits are without merit and are
prepared to defend against them vigorously.
Employee
Litigation
In April 2006, three former employees and one current employee
filed a complaint against the company in the U.S. District
Court for the Southern District of Indiana (Welch, et
al. v. Eli Lilly and Company, filed April 20,
2006) alleging racial discrimination. Plaintiffs have since
amended their complaint twice, and the lawsuit currently
involves 145 individual plaintiffs as well as the national and
local chapters of the National Association for the Advancement
of Colored People (NAACP). Although the case was originally
filed as a putative class action, in September 2009, plaintiffs
withdrew their request for class certification. We believe these
claims are without merit and are prepared to defend against them
vigorously.
We have also been named as a defendant in a lawsuit filed in the
U.S. District Court for the Northern District of New York
(Schaefer-LaRose, et al. v. Eli Lilly and Company,
filed November 14, 2006) claiming that our
pharmaceutical sales representatives should have been
categorized as non-exempt rather than
exempt employees, and claiming that the company owes
them back wages for overtime worked, as well as penalties,
interest, and attorneys fees. Other pharmaceutical
industry participants face identical lawsuits. The case was
transferred to the U.S. District Court for the Southern
District of Indiana in August 2007. In February 2008, the
Indianapolis court conditionally certified a nationwide opt-in
collective action under the Fair Labor Standards Act of all
current and former employees who served as a Lilly
pharmaceutical sales representative at any time from November
2003 to the present. As of the close of the opt-in period, fewer
than 400 of the over 7,500 potential plaintiffs elected to
participate in the lawsuit. In September 2009, the District
Court granted our motion for summary judgment with regard to
Ms. Schaefer-LaRoses claims and ordered the
plaintiffs to demonstrate why the entire collective action
should not be decertified within 30 days. Plaintiffs have
filed a motion for reconsideration of the summary judgment
decision and have also opposed decertification, and all other
matters have been stayed pending a ruling on these issues. If
summary judgment is not reconsidered, we expect plaintiffs will
appeal the ruling to the 7th Circuit Court of Appeals. We
believe this lawsuit is without merit and are prepared to defend
against it vigorously.
In September 2009, one of the opt-in plaintiffs in
Schaefer-LaRose, et al v. Eli Lilly and Company
filed an action in the Superior Court for Alameda County,
California, alleging on behalf of a putative class that the
company violated Californias Business and Professions Code
by failing to pay sales representatives overtime and by not
providing them with rest and meal breaks under California law.
After removing the lawsuit to the federal district court in the
Northern District of California, the parties agreed, and the
Court ordered, that the lawsuit would be stayed pending a
decision from the 9th Circuit in one of the other several
lawsuits addressing the exempt status of pharmaceutical sales
representatives. We believe the lawsuit is without merit and are
prepared to defend against it vigorously.
We have been named in a lawsuit brought by the Labor Attorney
for 15th Region in the Labor Court of Paulinia, State of
Sao Paulo, Brazil, alleging possible harm to employees and
former employees caused by exposure to heavy metals. We have
also been named in approximately 50 lawsuits filed in the same
court by individual former employees making similar claims. We
have also been named, along with several other companies, in a
lawsuit filed by certain of these individuals in
U.S. District Court for the Southern District of Indiana on
April 21, 2009, alleging possible harm caused by exposure
to pesticides related to our former agricultural chemical
manufacturing facility in Cosmopolis, Brazil. We believe these
lawsuits are without merit and are prepared to defend against
them vigorously.
Other
Matters
In October 2005, the U.S. Attorneys office for the
Eastern District of Pennsylvania advised that it is conducting
an inquiry regarding certain rebate agreements we entered into
with a pharmacy benefit manager covering
Axid®,
Evista, Humalog, Humulin, Prozac, and Zyprexa. The inquiry
includes a review of our Medicaid best price reporting related
to the product sales covered by the rebate agreements. We are
cooperating in this matter.
In October 2005, we received a subpoena from the
U.S. Attorneys office for the District of
Massachusetts for the production of documents relating to our
business relationship with a long-term care pharmacy
organization concerning Actos, Evista, Humalog, Humulin, and
Zyprexa. We are cooperating in this matter.
16
Between 2003 and 2005, various municipalities in New York sued
us and many other pharmaceutical manufacturers, claiming in
general that as a result of alleged improprieties by the
manufacturers in the calculation and reporting of average
wholesale prices for purposes of Medicaid reimbursement, the
municipalities overpaid their portion of the cost of
pharmaceuticals. The suits seek monetary and other relief,
including civil penalties and treble damages. Similar suits were
filed against us and many other manufacturers by the States of
Mississippi, Iowa, Utah, and Kansas. These suits are pending
either in the U.S. District Court for the District of
Massachusetts or in various state courts. All of these suits are
in early stages or discovery is ongoing. We believe these
lawsuits are without merit and are prepared to defend against
them vigorously.
During 2004 we, along with several other pharmaceutical
companies, were named in a consolidated lawsuit in California
state court brought on behalf of consumers alleging that the
conduct of pharmaceutical companies in preventing commercial
importation of prescription drugs from outside the United States
violated antitrust laws. The case sought restitution for alleged
overpayments for pharmaceuticals and an injunction against the
allegedly violative conduct. Summary judgment was granted to us
and the other defendants. In July 2008, the California Court of
Appeals affirmed that decision. The California Supreme Court has
accepted plaintiffs appeal, and we expect it to be heard
later this year.
In July 2008, we received a request from the Civil Division of
the United States Department of Justice requesting the
production of documents related to nominal pricing. In June
2009, we received a Civil Investigative Demand from the office
of the Attorney General of Texas requesting documents related to
nominal pricing of Axid; we divested the marketing rights for
Axid in 2000. We are cooperating in these matters.
Along with over 100 other pharmaceutical companies operating in
Europe, in 2008 we received questionnaires from the European
Commission as part of its inquiry into whether pharmaceutical
companies improperly blocked or created artificial barriers to
pharmaceutical innovation or market entry of medicines through
the misuse of patent rights, settlements of claims, litigation,
or other means. In July 2009, the Commission released its report
in which it concluded that the practices of companies
contributed to delays in the entry of medicines onto the market,
but that shortcomings in the regulatory framework were also a
contributing factor. The Commission has subsequently requested
additional information from the companies. We are cooperating
with the Commission in this matter.
Under the Comprehensive Environmental Response, Compensation,
and Liability Act, commonly known as Superfund, we have been
designated as one of several potentially responsible parties
with respect to the cleanup of fewer than 10 sites. Under
Superfund, each responsible party may be jointly and severally
liable for the entire amount of the cleanup.
During routine inspections in 2006 and 2007, the
U.S. Environmental Protection Agency (EPA) identified
potential gaps in our leak detection and repair program (LDAR).
In addition, in 2006 we voluntarily reported to the state and
city environmental agencies that we had exceeded an annual limit
for air emissions. In response to these events, we have
implemented numerous corrective actions and enhancements to our
LDAR program. We are currently working with the EPA towards
resolution of this matter, which will likely require the payment
of a fine. We do not believe the amount of the fine will be
material.
We are also a defendant in other litigation and investigations,
including product liability, patent, employment, and premises
liability litigation, of a character we regard as normal to our
business.
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Item 4.
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Submission
of Matters to a Vote of Security Holders
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During the fourth quarter of 2009, no matters were submitted to
a vote of security holders.
Part II
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Item 5.
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Market
for the Registrants Common Equity, Related Stockholder
Matters, and Issuer Purchases of Equity Securities
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You can find information relating to the principal market for
our common stock and related stockholder matters at Item 8
under Selected Quarterly Data (unaudited) and
Selected Financial Data (unaudited). That
information is incorporated here by reference.
17
The following table summarizes the activity related to
repurchases of our equity securities during the fourth quarter
ended December 31, 2009:
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Approximate Dollar Value
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Total Number of Shares
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of Shares that May Yet Be
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Total Number of
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Purchased as Part of
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Purchased Under the
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Shares Purchased
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Average Price Paid
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Publicly Announced
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Plans or Programs
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(in thousands)
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per Share
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Plans or Programs
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(Dollars in millions)
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Period
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(a)
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(b)
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(c)
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(d)
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October 2009
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0
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$
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$
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419.2
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November 2009
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1
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34.01
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419.2
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December 2009
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0
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419.2
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Total
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1
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The amounts presented in columns (a) and (b) above
represent purchases of common stock related to employee stock
option exercises. The amounts presented in columns (c) and
(d) in the above table represent activity related to our
$3.00 billion share repurchase program announced in March
2000. As of December 31, 2009, we have purchased
$2.58 billion related to this program.
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Item 6.
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Selected
Financial Data
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You can find selected financial data for each of our five most
recent fiscal years in Item 8 under Selected
Financial Data (unaudited). That information is
incorporated here by reference.
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Item 7.
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Managements
Discussion and Analysis of Results of Operations and Financial
Condition
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RESULTS
OF OPERATIONS
EXECUTIVE
OVERVIEW
This section provides an overview of our financial results,
recent product and late-stage pipeline developments, significant
business development, and legal, regulatory, and other matters
affecting our company and the pharmaceutical industry.
Financial
Results
We achieved revenue growth of 7 percent in 2009, which was
primarily driven by the collective growth of Alimta, Cymbalta,
Humalog, and Zyprexa and the inclusion of Erbitux revenue as a
result of the ImClone Systems Inc. (Imclone) acquisition in
November 2008. The impact of changes in foreign currencies
compared to the U.S. dollar on international inventories
sold during the year decreased our cost of sales in 2009 and
increased our cost of sales in 2008, which contributed to an
improvement in gross margin. Marketing, selling, and
administrative expenses grew at a slower rate than revenue,
while our investment in research and development grew at a
greater rate than sales. We incurred income tax expense of
$1.03 billion in 2009 resulting in an effective tax rate of
19.2 percent. Earnings increased to $4.33 billion, and
earnings per share increased to $3.94 per share, in 2009 as
compared to a net loss of $2.07 billion, and a loss per
share of $1.89 in 2008. Net income comparisons between 2009 and
2008 are affected by the impact of the following significant
items:
2009
Acquisitions (Note 3)
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We incurred acquired in-process research and development
(IPR&D) charges associated with an in-licensing arrangement
with Incyte Corporation (Incyte) of $90.0 million (pretax),
which decreased earnings per share by $.05.
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Asset Impairments and Related Restructuring and Other Special
Charges (Notes 5 and 14)
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We recognized asset impairments, restructuring, and other
special charges of $462.7 million (pretax), which decreased
earnings per share by $.29 for asset impairments and
restructuring primarily related to the sale of our Tippecanoe
Laboratories manufacturing site to an affiliate of Evonik
Industries AG.
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We incurred pretax charges of $230.0 million representing
the currently probable and estimable exposures in connection
with the claims of several states related to Zyprexa, which
decreased earnings per share by $.13.
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18
2008
Acquisitions (Note 3)
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We recognized charges totaling $4.73 billion (pretax)
associated with the acquisition of ImClone, which decreased
earnings per share by $4.46. These amounts include an IPR&D
charge of $4.69 billion (pretax). The remaining net
expenses are related to ImClones operating results
subsequent to the acquisition, incremental interest costs, and
amortization of the intangible asset associated with Erbitux. We
also incurred IPR&D charges of $28.0 million (pretax)
associated with the acquisition of SGX Pharmaceuticals, Inc.
(SGX), which decreased earnings per share by $.03.
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We incurred IPR&D charges associated with licensing
arrangements with BioMS Medical Corp. (BioMS) and TransPharma
Medical Ltd. totaling $122.0 million (pretax), which
decreased earnings per share by $.07.
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Asset Impairments and Related Restructuring and Other Special
Charges (Notes 5 and 14)
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We recognized asset impairments, restructuring, and other
special charges totaling $497.0 million (pretax), which
decreased earnings per share by $.30. A similar charge of
$57.1 million (pretax), which decreased earnings per share
by $.04, was included in cost of sales. These charges were
primarily associated with the sale of our Greenfield, Indiana
site, the termination of the
AIR®
Insulin program; and strategic exit activities related to
manufacturing operations.
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We recorded charges of $1.48 billion (pretax) related to
the federal and state Zyprexa investigations led by the
U.S. Attorney for the Eastern District of Pennsylvania
(EDPA), as well as the resolution of a multi-state investigation
regarding Zyprexa involving 32 states and the District of
Columbia, which decreased earnings per share by $1.20.
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Other (Note 12)
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We recognized a discrete income tax benefit of
$210.3 million as a result of the resolution of a
substantial portion of the IRS audit of our federal income tax
returns for the years 2001 through 2004, which increased
earnings per share by $.19.
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Late-Stage
Pipeline Developments and Business Development
Activity
Our long-term success depends, to a great extent, on our ability
to continue to discover and develop innovative pharmaceutical
products and acquire or collaborate on compounds currently in
development by other biotechnology or pharmaceutical companies.
We currently have over 60 potential new drugs in human testing.
A number of late-stage pipeline developments and business
development transactions occurred within the past year,
including:
Pipeline
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The United States Food and Drug Administration (FDA) approved an
expanded indication for Byetta as a standalone medication
(monotherapy) along with diet and exercise to improve glycemic
control in adults with type 2 diabetes.
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The FDA approved Zyprexa Relprevv for extended release
injectable suspension for the treatment of schizophrenia in
adults. We also launched this product under the tradename
Zypadhera in several countries within the European Union.
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We announced initial results from a Phase III clinical
trial for arzoxifene. After reviewing the overall clinical
profile of arzoxifene in light of currently available
treatments, including our own osteoporosis products, we decided
not to submit the compound for regulatory review.
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The FDA approved a new use for Forteo to treat osteoporosis
associated with sustained, systemic glucocorticoid therapy in
men and women at high risk of fracture.
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We and our partner BioMS discontinued Phase III clinical
trials for dirucotide in patients with secondary progressive
multiple sclerosis. Data showed that dirucotide did not meet the
primary endpoint of delaying disease progression and there were
no statistically significant differences between dirucotide and
placebo on the secondary endpoints of the study.
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The FDA approved Effient tablets for the reduction of thrombotic
cardiovascular events (including stent thrombosis) in patients
with acute coronary syndromes (ACS) who are managed with an
artery-opening procedure known as percutaneous coronary
intervention (PCI). We and our partner, Daiichi Sankyo, Inc.,
launched Effient in the U.S. in August. The European
Commission granted marketing authorization for
Efient®
for the prevention of atherothrombotic events in patients with
ACS undergoing PCI.
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The FDA approved Alimta as a maintenance therapy for locally
advanced or metastatic non-small cell lung cancer (NSCLC),
specifically for patients with a nonsquamous histology whose
disease has not progressed after four cycles of platinum-based
first-line chemotherapy.
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The European Commission granted approval for the use of Alimta
as monotherapy for maintenance treatment of patients with other
than predominantly squamous cell histology in locally-advanced
or
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metastatic NSCLC, whose disease has not progressed immediately
following platinum-based chemotherapy.
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Alimta received regulatory approval in Japan as both a first-
and second-line treatment of NSCLC.
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We and our partners Amylin Pharmaceuticals, Inc. (Amylin) and
Alkermes, Inc., submitted a New Drug Application (NDA) to the
FDA for exenatide once weekly. Exenatide once weekly is an
investigational sustained release medication for type 2 diabetes
that is injected subcutaneously and administered only once a
week.
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We began enrolling patients in two separate but identical
Phase III clinical trials of solanezumab, an
anti-amyloid
beta monoclonal antibody being investigated as a potential
treatment to delay the progression of mild to moderate
Alzheimers disease. The trials each include a treatment
period that lasts 18 months and are expected to enroll a
total of 2,000 patients age 55 and over from
16 countries.
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The FDA approved two new combination indications for Zyprexa
(olanzapine) and fluoxetine for the acute treatment of bipolar
depression and TRD in adults.
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We received a complete response letter from the FDA for the
first-line squamous cell carcinoma of the head and neck (SCCHN)
supplemental Biologics License Application (sBLA) for Erbitux.
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Business
Development
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We entered into an exclusive worldwide license and collaboration
agreement with Incyte for the development and commercialization
of Incytes oral JAK1/JAK2 inhibitor, and certain follow-on
compounds, for inflammatory and autoimmune diseases. The lead
compound is currently being studied in a six-month dose-ranging
Phase II trial for rheumatoid arthritis.
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We entered into a co-promotion agreement with Kowa
Pharmaceutical America to commercialize
Livalo®
(pitavastatin) in the United States. Lilly and Kowa Company,
Limited have also entered into a licensing agreement in Latin
America. Livalo is a statin approved by the FDA in August 2009
for the treatment of primary hyperlipidemia and mixed
dyslipidemia. We plan to launch Livalo in the U.S. in
mid-2010.
|
|
|
|
In January 2010, we restructured the collaboration agreement
executed by Bristol-Myers Squibb and ImClone in 2001 to allow
for the co-development and co-commercialization of the
late-stage oncology molecule necitumumab (IMC-11F8), which is
currently in Phase III clinical testing for non-small cell
lung cancer. Under the restructured agreement, both companies
will share in the cost of developing and potentially
commercializing necitumumab in the U.S., Canada and Japan. We
maintain exclusive rights to necitumumab in all other markets.
|
Legal,
Regulatory, and Other Matters
In September 2009, we set a goal to reduce our expected cost
structure by $1 billion by the end of 2011. We also plan to
lower global headcount to 35,000 by the end of 2011, excluding
strategic sales force additions in high-growth emerging markets
and Japan, which could result in future periodic restructuring
charges.
In January 2009, we reached resolution with the Office of the
U.S. Attorney for the EDPA, and the State Medicaid Fraud
Control Units of 36 states and the District of Columbia, of
an investigation related to our U.S. marketing and
promotional practices with respect to Zyprexa. We recorded a
charge of $1.42 billion for this matter in the third
quarter of 2008. In 2009, we paid substantially all of this
amount, as required by the settlement agreements. In addition,
in October 2008, we reached a settlement with 32 states and
the District of Columbia related to a multistate investigation
brought under various state consumer protection laws, under
which we paid $62.0 million. However, we were served with
lawsuits brought by attorneys general of a number of states,
alleging that Zyprexa caused or contributed to diabetes or high
blood-glucose levels, and that we improperly promoted the drug
and seeking to recover the costs paid for Zyprexa through
Medicaid and other drug-benefit programs, as well as the costs
alleged to have been incurred and that will be incurred to treat
Zyprexa-related illnesses. In 2009, we incurred pretax charges
of $230.0 million, reflecting the probable and estimable
exposures in connection with these claims. We have reached
settlements or are in advanced discussions to settle all of the
remaining state claims. The Pennsylvania case is set for trial
in April 2010 in state court.
Health care reform is currently the subject of intense debate in
the U.S. Congress. The impact of reform on the
pharmaceutical industry is uncertain. Most reform proposals
intend to provide coverage for the uninsured, include increasing
existing price rebates in federally funded health care programs
and the expansion of rebates, or other pharmaceutical company
discounts, into new programs. There are also proposals that will
impose new fees on pharmaceutical industry sales of certain
prescription pharmaceutical products. Certain federal and state
health care reform proposals that go beyond providing additional
health insurance coverage for the uninsured may also place
downward pressure on pharmaceutical industry sales or prices.
These proposals include reducing incentives for
employer-sponsored health care;
20
the creation of an independent commission to propose changes to
Medicare, with a particular focus on the cost of
biopharmaceuticals in Medicare Part D, which lowers the
projections for future government spending in Medicare; and a
government-run public option with biopharmaceutical
price-setting capabilities. Additionally, various proposals
could legalize the importation of prescription drugs and either
allow, or require, the Secretary of Health and Human Services to
negotiate drug prices within Medicare Part D directly with
pharmaceutical manufacturers. In addition, the federal
government is considering creating an expedited regulatory
approval pathway for biosimilars (copies of biological
compounds) for biologic products in the U.S.; the proposals vary
as to which biologic products would be eligible, how quickly a
biosimilar might reach the market, and the ability to
interchange the biosimilar and the original biologic product at
the pharmacy. We expect pricing pressures at the federal and
state levels to become more severe, which could have a material
adverse effect on our consolidated results of operations.
In its budget submission to Congress in February 2010, the Obama
administration proposed changes to the manner in which the
U.S. would tax the international income of
U.S.-based
companies. While it is uncertain how the U.S. Congress may
address this issue, reform of U.S. taxation, including
taxation of international income, continues to be a topic of
discussion for the U.S. Congress. A significant change to
the U.S. tax system, including changes to the taxation of
international income, could have a material adverse effect on
our consolidated results of operations.
International operations also are generally subject to extensive
price and market regulations, and there are many proposals for
additional cost-containment measures, including proposals that
would directly or indirectly impose additional price controls,
limit access to or reimbursement for our products, or reduce the
value of our intellectual property protection. These proposals
are expected to increase in both frequency and impact, given the
effect of the downturn in the global economy on local
governments.
OPERATING
RESULTS2009
Revenue
Our worldwide revenue for 2009 increased 7 percent, to
$21.84 billion, driven primarily by growth of Alimta,
Cymbalta, Humalog, and Zyprexa, and the inclusion of Erbitux
revenue as a result of the ImClone acquisition. Worldwide sales
volume increased 7 percent, while selling prices
contributed 3 percent of revenue growth, partially offset
by the unfavorable impact of foreign exchange rates of
3 percent. Revenue in the U.S. increased
12 percent, to $12.29 billion, due to higher prices
and higher demand. Revenue outside the U.S. increased
1 percent, to $9.54 billion, due to increased demand,
partially offset by the negative impact of foreign exchange
rates and lower prices.
The following table summarizes our revenue activity in 2009
compared with 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended
|
|
|
Year Ended
|
|
|
Percent
|
|
|
|
December 31, 2009
|
|
|
December 31, 2008
|
|
|
Change
|
|
Product
|
|
U.S.1
|
|
|
Outside U.S.
|
|
|
Total3
|
|
|
Total
|
|
|
from 2008
|
|
|
|
|
|
(Dollars in millions)
|
|
|
Zyprexa
|
|
$
|
2,331.7
|
|
|
$
|
2,583.9
|
|
|
$
|
4,915.7
|
|
|
$
|
4,696.1
|
|
|
|
5
|
|
Cymbalta
|
|
|
2,551.8
|
|
|
|
523.0
|
|
|
|
3,074.7
|
|
|
|
2,697.1
|
|
|
|
14
|
|
Humalog
|
|
|
1,208.4
|
|
|
|
750.6
|
|
|
|
1,959.0
|
|
|
|
1,735.8
|
|
|
|
13
|
|
Alimta
|
|
|
815.6
|
|
|
|
890.4
|
|
|
|
1,706.0
|
|
|
|
1,154.7
|
|
|
|
48
|
|
Cialis
|
|
|
623.3
|
|
|
|
935.8
|
|
|
|
1,559.1
|
|
|
|
1,444.5
|
|
|
|
8
|
|
Gemzar
|
|
|
747.4
|
|
|
|
615.8
|
|
|
|
1,363.2
|
|
|
|
1,719.8
|
|
|
|
(21
|
)
|
Animal health products
|
|
|
672.2
|
|
|
|
535.0
|
|
|
|
1,207.2
|
|
|
|
1,093.3
|
|
|
|
10
|
|
Evista
|
|
|
682.2
|
|
|
|
348.1
|
|
|
|
1,030.4
|
|
|
|
1,075.6
|
|
|
|
(4
|
)
|
Humulin
|
|
|
402.4
|
|
|
|
619.6
|
|
|
|
1,022.0
|
|
|
|
1,063.2
|
|
|
|
(4
|
)
|
Forteo
|
|
|
518.3
|
|
|
|
298.4
|
|
|
|
816.7
|
|
|
|
778.7
|
|
|
|
5
|
|
Strattera
|
|
|
445.6
|
|
|
|
163.7
|
|
|
|
609.4
|
|
|
|
579.5
|
|
|
|
5
|
|
Other pharmaceutical products
|
|
|
739.9
|
|
|
|
1,168.4
|
|
|
|
1,908.1
|
|
|
|
1,887.5
|
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net product sales
|
|
|
11,738.8
|
|
|
|
9,432.7
|
|
|
|
21,171.5
|
|
|
|
19,925.8
|
|
|
|
6
|
|
Collaboration and other
revenue2
|
|
|
555.6
|
|
|
|
108.9
|
|
|
|
664.5
|
|
|
|
446.1
|
|
|
|
49
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
$
|
12,294.4
|
|
|
$
|
9,541.6
|
|
|
$
|
21,836.0
|
|
|
$
|
20,371.9
|
|
|
|
7
|
|
|
|
|
|
|
|
|
|
1
|
U.S. revenue includes revenue in Puerto Rico.
|
|
2
|
Collaboration and other revenue is primarily composed of Erbitux
royalties and 50 percent of Byettas gross margin in
the U.S.
|
|
3
|
Numbers may not add due to rounding.
|
21
Zyprexa, our top-selling product, is a treatment for
schizophrenia, acute mixed or manic episodes associated with
bipolar I disorder, and bipolar maintenance. Zyprexa sales in
the U.S. increased 6 percent in 2009, due to higher
prices, partially offset by reduced demand. Sales outside the
U.S. increased 4 percent driven by increased demand,
partially offset by the unfavorable impact of foreign exchange
rates. Demand outside the U.S. was favorably impacted by
the withdrawal of generic competition in Germany in early 2009.
Sales of Cymbalta, a product for the treatment of major
depressive disorder, diabetic peripheral neuropathic pain,
generalized anxiety disorder, and fibromyalgia, increased
13 percent in the U.S., driven by higher prices and
increased demand. Sales outside the U.S. increased
18 percent, driven by increased demand, partially offset by
the unfavorable impact of foreign exchange rates and lower
prices.
Sales of Humalog, our injectable human insulin analog for the
treatment of diabetes, increased 20 percent in the U.S.,
driven by higher prices, increased demand, and wholesaler buying
patterns. Sales outside the U.S. increased 3 percent,
driven by increased demand, partially offset by the unfavorable
impact of foreign exchange rates.
Sales of Alimta, a treatment for various cancers, increased
45 percent in the U.S., primarily driven by increased
demand. Sales outside the U.S. increased 50 percent,
driven by increased demand, partially offset by the unfavorable
impact of foreign exchange rates. Demand outside the
U.S. benefited from the addition of the non-small cell lung
cancer indication in Japan.
Our sales of Cialis, a treatment for erectile dysfunction,
increased 16 percent in the U.S., driven by higher prices,
increased demand, and wholesaler buying patterns. Sales outside
the U.S. increased 3 percent, driven by increased
demand and to a lesser extent, higher prices, partially offset
by the unfavorable impact of foreign exchange rates.
Sales of Gemzar, a product approved to treat various cancers,
increased 2 percent in the U.S., due primarily to higher
prices. Sales outside the U.S. decreased 37 percent,
driven by reduced demand and lower prices as a result of the
entry of generic competition in most major markets, and to a
lesser extent, the unfavorable impact of foreign exchange rates.
Sales of Evista, a product for the prevention and treatment of
osteoporosis in postmenopausal women and for reduction of risk
of invasive breast cancer in postmenopausal women with
osteoporosis and postmenopausal women at high risk for invasive
breast cancer, decreased 3 percent in the U.S., driven by
reduced demand, partially offset by higher prices. Sales outside
the U.S. decreased 7 percent, driven by the
outlicensing of Evista in most European markets and, to a lesser
extent, lower prices.
Sales of Humulin, an injectable human insulin for the treatment
of diabetes, increased 6 percent in the U.S., due primarily
to higher prices, partially offset by reduced demand. Sales
outside the U.S. decreased 9 percent, driven by the
unfavorable impact of foreign exchange rates and, to a lesser
extent, lower prices, partially offset by increased demand.
Sales of Forteo, an injectable treatment for osteoporosis in
postmenopausal women and men at high risk for fracture,
increased 6 percent in the U.S., driven by higher prices,
partially offset by reduced demand. Sales outside the
U.S. increased 3 percent, driven by increased demand
and prices, partially offset by the unfavorable impact of
foreign exchange rates.
Sales of Strattera, a treatment for attention-deficit
hyperactivity disorder in children, adolescents, and adults,
increased 2 percent in the U.S., driven by higher prices,
partially offset by reduced demand. Sales outside the
U.S. increased 15 percent, driven by increased demand
and higher prices, partially offset by the unfavorable impact of
foreign exchange rates.
Worldwide sales of Byetta, an injectable product for the
treatment of type 2 diabetes, increased 6 percent to
$796.5 million during 2009. We report as revenue our
50 percent share of Byettas gross margin in the U.S.,
100 percent of Byetta sales outside the U.S., and our sales
of Byetta pen delivery devices to Amylin. Our revenues increased
13 percent to $448.5 million in 2009.
We report as revenue for Erbitux, a product approved to treat
various cancers, the net royalties received from our
collaboration partners and our product sales. Our revenues were
$390.8 million in 2009, compared with $29.4 million in
2008. We acquired Erbitux as part of our acquisition of ImClone
in November 2008.
Animal health product sales in the U.S. increased
25 percent, primarily driven by the inclusion of Posilac
sales following the acquisition completed October 2008. Sales
outside the U.S. decreased 4 percent, driven primarily
by the unfavorable impact of foreign exchange rates.
Gross
Margin, Costs, and Expenses
The 2009 gross margin increased to 80.6 percent of
total revenue compared with 78.5 percent for 2008. This
increase was due to the impact of changes in foreign currencies
compared to the U.S. dollar on
22
international inventories sold during the year, which decreased
cost of sales as in 2009, but increased cost of sales in 2008.
Marketing, selling, and administrative expenses increased
4 percent in 2009 to $6.89 billion. The increase was
driven by the increased marketing and selling expenses outside
the U.S., higher incentive compensation, and the impact of the
ImClone acquisition, partially offset by the movement of foreign
exchange rates. Investment in research and development increased
13 percent, to $4.33 billion, due primarily to the
ImClone acquisition and increased late-stage clinical trial
costs.
We incurred an IPR&D charge of $90.0 million in 2009,
associated with the in-licensing agreement with Incyte, compared
with $4.84 billion in 2008. The 2008 IPR&D charge
included $4.69 billion resulting from the acquisition of
ImClone. We recognized asset impairments, restructuring, and
other special charges of $692.7 million in 2009, primarily
related to asset impairment charges related to the sale of our
Tippecanoe Laboratories manufacturing site and special charges
related to Zyprexa litigation with multiple state attorneys
general, compared with $1.97 billion in 2008. The 2008
charges were primarily associated with the resolution of Zyprexa
investigations with the U.S. Attorney for the EDPA and
multiple states. See Notes 3, 5 and 14 to the consolidated
financial statements for additional information.
Othernet, expense, (income) was a net expense in both
years, increasing by $203.4 million, to $229.5 million
in 2009, primarily due to lower interest income and higher
interest expense resulting from the ImClone acquisition.
We incurred income tax expense of $1.03 billion in 2009
resulting in an effective tax rate of 19.2 percent. The
effective tax rate for 2009 was reduced due to the tax benefit
of asset impairment and restructuring charges associated with
the sale of the Tippecanoe site. We incurred tax expense of
$764.3 million in 2008, despite having a loss before income
taxes of $1.31 billion. Our net loss was driven by the
$4.69 billion IPR&D charge for ImClone and the
$1.48 billion Zyprexa investigation settlements. The
IPR&D charge was not tax deductible, and only a portion of
the Zyprexa investigation settlements was deductible. In
addition, we recorded tax expense associated with the ImClone
acquisition, as well as a discrete income tax benefit of
$210.3 million for the resolution of a substantial portion
of the
2001-2004
IRS audit. See Note 12 to the consolidated financial
statements for additional information.
OPERATING
RESULTS2008
Financial
Results
We achieved worldwide sales growth of 9 percent, which was
primarily driven by volume increases in several key products.
The favorable impact of foreign exchange rates on cost of sales
contributed to an improvement in gross margin. Marketing,
selling, and administrative expenses grew at the same rate as
sales, driven by pre-launch activities associated with Effient,
marketing costs associated with Cymbalta and Evista, the impact
of foreign exchange rates, and increased litigation-related
expenses, while our investment in research and development grew
10 percent. We completed our acquisition of ImClone,
resulting in a significant charge of $4.69 billion for
IPR&D and reached resolution on government investigations
related to our past U.S. marketing and promotional
practices for Zyprexa, resulting in an additional charge of
$1.48 billion. We incurred tax expense of
$764.3 million, despite a loss before income taxes of
$1.31 billion, primarily caused by the non-deductibility of
the ImClone IPR&D charge and the partial deductibility of
the Zyprexa investigation settlements. Accordingly, earnings
decreased to a net loss of $2.07 billion, and earnings per
share decreased to a loss of $1.89 per share, in 2008 as
compared with net income of $2.95 billion, and earnings per
share of $2.71, in 2007. Net income comparisons between 2008 and
2007 are affected by the impact of several significant items.
The significant items for 2008 are summarized in the Executive
Overview. The 2007 items are summarized as follows:
Acquisitions (Note 3)
|
|
|
|
|
We incurred IPR&D charges associated with the acquisitions
of ICOS Corporation (ICOS), Hypnion, Inc. (Hypnion), and
Ivy Animal Health, Inc. (Ivy), totaling $631.6 million
(pretax), which decreased earnings per share by $.57.
|
|
|
|
We incurred IPR&D charges associated with our licensing
arrangements with Glenmark Pharmaceuticals Limited India,
MacroGenics, Inc., and OSI Pharmaceuticals, totaling
$114.0 million (pretax), which decreased earnings per share
by $.06.
|
Asset Impairments and Related Restructuring and Other Special
Charges (Notes 5 and 14)
|
|
|
|
|
We recognized asset impairments, restructuring, and other
special charges of $190.6 million (pretax), which decreased
earnings per share by $.12. These charges were primarily
associated with previously announced strategic decisions
affecting manufacturing and research facilities.
|
|
|
|
We incurred a special charge following a settlement with one of
our insurance carriers over Zyprexa product liability claims,
which led to a reduction of our expected product liability
insurance recoveries, and other product liability charges. This
resulted in a charge totaling $111.9 million (pretax),
which decreased earnings per share by $.09.
|
23
Revenue
Our worldwide revenue for 2008 increased 9 percent, to
$20.37 billion, driven primarily by growth of Cymbalta,
Cialis, Alimta, Humalog, and Gemzar. Worldwide sales volume
increased 5 percent, while foreign exchange rates
contributed 3 percent, and selling prices contributed
2 percent. (Numbers do not add due to rounding.) Revenue in
the U.S. increased 8 percent, to $10.93 billion,
driven primarily by increased sales of Cymbalta, Humalog,
Cialis, and Alimta. Revenue outside the U.S. increased
11 percent, to $9.44 billion, driven primarily by
revenue growth of Alimta, Cialis, Cymbalta, and Humalog.
The following table summarizes our revenue activity in 2008
compared with 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended
|
|
|
Year Ended
|
|
|
Percent
|
|
|
|
December 31, 2008
|
|
|
December 31, 2007
|
|
|
Change
|
|
Product
|
|
U.S.1
|
|
|
Outside U.S.
|
|
|
Total
|
|
|
Total
|
|
|
from 2007
|
|
|
|
|
|
(Dollars in millions)
|
|
Zyprexa
|
|
$
|
2,202.5
|
|
|
$
|
2,493.6
|
|
|
$
|
4,696.1
|
|
|
$
|
4,761.0
|
|
|
|
(1
|
)
|
Cymbalta
|
|
|
2,253.8
|
|
|
|
443.3
|
|
|
|
2,697.1
|
|
|
|
2,102.9
|
|
|
|
28
|
|
Humalog
|
|
|
1,008.4
|
|
|
|
727.4
|
|
|
|
1,735.8
|
|
|
|
1,474.6
|
|
|
|
18
|
|
Gemzar
|
|
|
734.8
|
|
|
|
985.0
|
|
|
|
1,719.8
|
|
|
|
1,592.4
|
|
|
|
8
|
|
Cialis2
|
|
|
539.0
|
|
|
|
905.5
|
|
|
|
1,444.5
|
|
|
|
1,143.8
|
|
|
|
26
|
|
Alimta
|
|
|
561.9
|
|
|
|
592.8
|
|
|
|
1,154.7
|
|
|
|
854.0
|
|
|
|
35
|
|
Animal health products
|
|
|
537.3
|
|
|
|
556.0
|
|
|
|
1,093.3
|
|
|
|
995.8
|
|
|
|
10
|
|
Evista
|
|
|
700.5
|
|
|
|
375.1
|
|
|
|
1,075.6
|
|
|
|
1,090.7
|
|
|
|
(1
|
)
|
Humulin
|
|
|
380.9
|
|
|
|
682.3
|
|
|
|
1,063.2
|
|
|
|
985.2
|
|
|
|
8
|
|
Forteo
|
|
|
489.9
|
|
|
|
288.8
|
|
|
|
778.7
|
|
|
|
709.3
|
|
|
|
10
|
|
Strattera
|
|
|
437.8
|
|
|
|
141.7
|
|
|
|
579.5
|
|
|
|
569.4
|
|
|
|
2
|
|
Other pharmaceutical products
|
|
|
664.8
|
|
|
|
1,222.7
|
|
|
|
1,887.5
|
|
|
|
1,895.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net product sales
|
|
|
10,511.6
|
|
|
|
9,414.2
|
|
|
|
19,925.8
|
|
|
|
18,174.7
|
|
|
|
10
|
|
Collaboration and other
revenue3
|
|
|
418.5
|
|
|
|
27.6
|
|
|
|
446.1
|
|
|
|
458.8
|
|
|
|
(3
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
$
|
10,930.1
|
|
|
$
|
9,441.8
|
|
|
$
|
20,371.9
|
|
|
$
|
18,633.5
|
|
|
|
9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1
|
U.S. revenue includes revenue in Puerto Rico.
|
|
2
|
Prior to the acquisition of ICOS in late January 2007, the
Cialis revenue shown does not include net product sales in the
joint-venture territories of Lilly ICOS LLC (North America,
excluding Puerto Rico, and Europe). Our share of the
joint-venture territory net product sales for January 2007, net
of expenses and income taxes, is reported in
othernet, expense (income) in our consolidated
statements of operations. Subsequent to the acquisition, all
Cialis net product sales are reported in our net revenue.
Worldwide 2008 revenue for Cialis grew 19 percent from 2007
revenue of $1.22 billion.
|
|
3
|
Collaboration and other revenue is primarily composed of
50 percent of Byettas gross margin in the U.S.
|
Zyprexa sales in the U.S. decreased 1 percent in 2008,
driven by reduced demand, partially offset by higher prices.
Sales outside the U.S. decreased 1 percent, driven by
decreased demand and, to a lesser extent, lower prices,
partially offset by the favorable impact of foreign exchange
rates. Demand outside the U.S. was unfavorably impacted by
generic competition in Germany and Canada.
Sales of Cymbalta increased 23 percent in the U.S., driven
by increased demand and, to a lesser extent, higher prices.
Sales outside the U.S. increased 66 percent, driven by
increased demand and, to a lesser extent, the favorable impact
of foreign exchange rates and higher prices. Higher demand
outside the U.S. reflects increased demand in established
markets as well as recent launches in new markets.
Sales of Humalog increased 14 percent in the U.S., driven
by increased demand and higher prices. Sales outside the
U.S. increased 24 percent, driven by increased demand
and, to a lesser extent, the favorable impact of foreign
exchange rates.
Sales of Gemzar increased 10 percent in the U.S., driven by
increased demand and higher prices. Sales outside the
U.S. increased 7 percent, driven primarily by the
favorable impact of foreign exchange rates and, to a lesser
extent, increased demand, partially offset by lower prices.
Sales of Cialis increased 27 percent in the U.S., driven by
increased demand and higher prices. Sales outside the
U.S. increased 26 percent, driven by increased demand
and, to a lesser extent, the favorable impact of foreign
exchange rates and higher prices. Total worldwide sales of
Cialis increased 19 percent
24
to $1.44 billion in 2008 as compared to $1.22 billion
in 2007. This includes $72.7 million of sales in the Lilly
ICOS joint-venture territories for the 2007 period prior to the
acquisition of ICOS.
Sales of Alimta increased 25 percent in the U.S., driven by
increased demand and, to a lesser extent, higher prices. Sales
outside the U.S. increased 46 percent, driven by
increased demand and, to a lesser extent, the favorable impact
of foreign exchange rates.
Sales of Evista decreased 1 percent in the U.S., driven by
decreased demand, partially offset by higher prices. Sales
outside the U.S. decreased 2 percent, driven by
reduced demand and lower prices, partially offset by the
favorable impact of foreign exchange rates.
Sales of Humulin increased 4 percent in the U.S., driven by
higher prices. Sales outside the U.S. increased
10 percent, driven by the favorable impact of foreign
exchange rates and increased demand.
Sales of Forteo decreased 1 percent in the U.S., driven by
decreased demand, partially offset by higher prices. Sales
outside the U.S. increased 34 percent, driven by
increased demand and, to a lesser extent, the favorable impact
of foreign exchange rates.
Sales of Strattera decreased 6 percent in the U.S., driven
by decreased demand, partially offset by higher prices. Sales
outside the U.S. increased 35 percent, driven
primarily by increased demand.
Worldwide sales of Byetta increased 16 percent to
$751.4 million during 2008. Our revenues increased
20 percent to $396.1 million in 2008.
Animal health product sales in the U.S. increased
12 percent, driven by the inclusion of U.S. Posilac
sales since the date of acquisition. Sales outside the
U.S. increased 8 percent, driven by increased demand
and, to a lesser extent, the favorable impact of foreign
exchange rates.
Gross
Margin, Costs, and Expenses
The 2008 gross margin increased to 78.5 percent of
total revenue compared with 77.2 percent for 2007. This
increase was primarily due to the favorable impact of foreign
exchange rates.
Marketing, selling, and administrative expenses increased
9 percent in 2008, to $6.63 billion. This increase was
due to increased marketing and selling expenses, including
prelaunch expenses for Effient and marketing costs associated
with Cymbalta and Evista; the impact of foreign exchange rates;
and increased litigation-related expenses. Investment in
research and development increased 10 percent, to
$3.84 billion, due to increased late-stage clinical trial
and discovery research costs.
Acquired IPR&D charges related to the acquisitions of
ImClone and SGX, as well as our in-licensing arrangements with
BioMS and TransPharma, were $4.84 billion in 2008 as
compared to $745.6 million in 2007. We recognized asset
impairments, restructuring, and other special charges of
$1.97 billion in 2008, as compared to $302.5 million
in 2007. The 2008 charges were primarily associated with the
resolution of Zyprexa investigations with the U.S. Attorney
for the EDPA and multiple states. See Notes 3, 5 and 14 to
the consolidated financial statements for additional information.
Othernet, expense (income) changed from net income
of $122.0 million in 2007 to net expense of
$26.1 million in 2008, primarily as a result of lower
outlicensing income and increased net losses on investment
securities in 2008 (the majority of which consisted of
unrealized losses).
We incurred tax expense of $764.3 million in 2008, despite
having a loss before income taxes of $1.31 billion. Our net
loss was driven by the $4.69 billion acquired IPR&D
charge for ImClone and the $1.48 billion Zyprexa
investigation settlements. The IPR&D charge was not tax
deductible, and only a portion of the Zyprexa investigation
settlements was deductible. In addition, we recorded tax expense
associated with the ImClone acquisition, as well as a discrete
income tax benefit of $210.3 million for the resolution of
a substantial portion of the
2001-2004
IRS audit. The effective tax rate was 23.8 percent in 2007.
See Note 12 to the consolidated financial statements for
additional information.
FINANCIAL
CONDITION
As of December 31, 2009, cash, cash equivalents, and
short-term investments totaled $4.50 billion compared with
$5.93 billion at December 31, 2008. The decrease in
cash was driven by a reduction in short-term borrowings of
$5.82 billion and dividends paid of $2.15 billion,
partially offset by cash from operations of $4.34 billion
(which included payments related to the Zyprexa EDPA settlement
of $1.39 billion) and proceeds of long-term debt issuances
of $2.40 billion.
Capital expenditures of $765.0 million during 2009 were
$182.2 million less than in 2008. We expect 2010 capital
expenditures to be approximately $1.0 billion as we invest
in our biotechnology capabilities, continue to upgrade our
manufacturing and research facilities to enhance productivity
and quality systems, and invest in the long-term growth of our
diabetes care products.
Total debt at December 31, 2009, was $6.66 billion, a
decrease of $3.80 billion from December 31, 2008
reflecting the pay-down of our commercial paper that was issued
to finance our acquisition of ImClone, partially offset by
$2.40 billion of long-term debt we issued in March 2009.
Our current debt ratings from Standard & Poors
and Moodys remain at AA and A1, respectively.
25
Dividends of $1.96 per share were paid in 2009, an increase of
4 percent from 2008. In the fourth quarter of 2009,
effective for the first-quarter dividend in 2010, the quarterly
dividend was maintained at $.49 per share, resulting in an
indicated annual rate for 2010 of $1.96 per share. The year 2009
was the 125th consecutive year in which we made dividend
payments.
Despite increasing unemployment and declines in real consumer
spending, consumer confidence has grown and job losses have
slowed during the second half of 2009. Many financial
institutions continue to have tightened lines of credit, thus
reducing funding available to stimulate near-term economic
growth. While there are some positive signs, the prospects for
recovery are uncertain. Pharmaceutical consumption has
traditionally been relatively unaffected by economic downturns;
however, an extended downturn could lead to a decline in overall
prescriptions corresponding to the growth of the uninsured and
underinsured population in the U.S. In addition, both
private and public health care payers are facing heightened
fiscal challenges due to the economic slowdown and are taking
aggressive steps to reduce the costs of care, including
pressures for increased pharmaceutical discounts and rebates and
efforts to drive greater use of generic drugs. We continue to
monitor the potential near-term impact of prescription trends,
the creditworthiness of our wholesalers and other customers and
suppliers, the evolving health care debate, the federal
governments involvement in the economic crisis, and
various international government funding levels.
We believe that cash generated from operations, along with
available cash and cash equivalents, will be sufficient to fund
our normal operating needs, including debt service, capital
expenditures, costs associated with litigation and government
investigations, and dividends in 2010. We believe that amounts
accessible through existing commercial paper markets should be
adequate to fund short-term borrowings. Our access to credit
markets has not been adversely affected by the illiquidity in
the markets because of the high credit quality of our short- and
long-term debt. We currently have $1.24 billion of unused
committed bank credit facilities, $1.20 billion of which
backs our commercial paper program and matures in May 2011.
Various risks and uncertainties, including those discussed in
Item 1A, Risk Factors, may affect our operating
results and cash generated from operations.
We depend on patents or other forms of intellectual property
protection for most of our revenues, cash flows, and earnings.
In the next three years we will lose effective exclusivity for
Zyprexa in major European countries (September 2011) and
the U.S. (October 2011); and for Humalog in major European
countries (November 2010). Gemzar has already lost effective
exclusivity in major European countries. In addition, we face
U.S. patent litigation over several key patent-protected
products whose exclusivity extends beyond 2012, including
Alimta, Cymbalta, Evista, Gemzar, and Strattera and it is
possible we could face an unexpected loss of our effective
exclusivity for one or more of these products prior to the end
of 2012. Revenue from each of these products contributes
materially to our results of operations, liquidity, and
financial position, and the loss of exclusivity could result in
a rapid and severe decline in revenue from the affected product.
However, we plan to mitigate the effect on our operations,
liquidity and financial position through growth in our remaining
business and the previously announced plan to reduce our
expected cost structure by $1 billion by the end of 2011.
In the normal course of business, our operations are exposed to
fluctuations in interest rates and currency values. These
fluctuations can vary the costs of financing, investing, and
operating. We address a portion of these risks through a
controlled program of risk management that includes the use of
derivative financial instruments. The objective of controlling
these risks is to limit the impact on earnings of fluctuations
in interest and currency exchange rates. All derivative
activities are for purposes other than trading.
Our primary interest rate risk exposure results from changes in
short-term U.S. dollar interest rates. In an effort to
manage interest rate exposures, we strive to achieve an
acceptable balance between fixed and floating rate debt
positions and may enter into interest rate derivatives to help
maintain that balance. Based on our overall interest rate
exposure at December 31, 2009 and 2008, including
derivatives and other interest rate risk-sensitive instruments,
a hypothetical 10 percent change in interest rates applied
to the fair value of the instruments as of December 31,
2009 and 2008, respectively, would have no material impact on
earnings, cash flows, or fair values of interest rate
risk-sensitive instruments over a one-year period.
Our foreign currency risk exposure results from fluctuating
currency exchange rates, primarily the U.S. dollar against
the euro and the Japanese yen, and the British pound against the
euro. We face transactional currency exposures that arise when
we enter into transactions, generally on an intercompany basis,
denominated in currencies other than the local currency. We also
face currency exposure that arises from translating the results
of our global operations to the U.S. dollar at exchange
rates that have fluctuated from the beginning of the period. We
may use forward contracts and purchased options to manage our
foreign currency exposures. Our policy outlines the minimum and
maximum hedge coverage of such exposures. Gains and losses on
these derivative positions offset, in part, the impact of
currency fluctuations on the existing assets, liabilities,
commitments, and anticipated revenues. Considering our
derivative financial instruments outstanding at
December 31, 2009 and 2008, a hypothetical 10 percent
change in exchange rates (primarily against the
U.S. dollar) as of December 31, 2009 and 2008,
26
respectively, would have no material impact on earnings, cash
flows, or fair values of foreign currency rate risk-sensitive
instruments over a one-year period. These calculations do not
reflect the impact of the exchange gains or losses on the
underlying positions that would be offset, in part, by the
results of the derivative instruments.
Off-Balance
Sheet Arrangements and Contractual Obligations
We have no off-balance sheet arrangements that have a material
current effect or that are reasonably likely to have a material
future effect on our financial condition, changes in financial
condition, revenues or expenses, results of operations,
liquidity, capital expenditures, or capital resources. We
acquire and collaborate on assets still in development and enter
into research and development arrangements with third parties
that often require milestone and royalty payments to the third
party contingent upon the occurrence of certain future events
linked to the success of the asset in development. Milestone
payments may be required contingent upon the successful
achievement of an important point in the development life cycle
of the pharmaceutical product (e.g., approval of the product for
marketing by the appropriate regulatory agency or upon the
achievement of certain sales levels). If required by the
arrangement, we may have to make royalty payments based upon a
percentage of the sales of the pharmaceutical product in the
event that regulatory approval for marketing is obtained.
Because of the contingent nature of these payments, they are not
included in the table of contractual obligations.
Individually, these arrangements are not material in any one
annual reporting period. However, if milestones for multiple
products covered by these arrangements would happen to be
reached in the same reporting period, the aggregate charge to
expense could be material to the results of operations in any
one period. These arrangements often give us the discretion to
unilaterally terminate development of the product, which would
allow us to avoid making the contingent payments; however, we
are unlikely to cease development if the compound successfully
achieves clinical testing objectives. We also note that, from a
business perspective, we view these payments as positive because
they signify that the product is successfully moving through
development and is now generating or is more likely to generate
cash flows from sales of products.
Our current noncancelable contractual obligations that will
require future cash payments are as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period
|
|
|
|
|
|
|
|
|
|
|
Less Than
|
|
|
1-3
|
|
|
3-5
|
|
|
More Than
|
|
|
|
Total
|
|
|
1 Year
|
|
|
Years
|
|
|
Years
|
|
|
5 Years
|
|
|
|
|
Long-term debt, including interest
payments1
|
|
$
|
10,519.8
|
|
|
$
|
243.4
|
|
|
$
|
2,093.4
|
|
|
$
|
1,563.7
|
|
|
$
|
6,619.3
|
|
Capital lease obligations
|
|
|
39.2
|
|
|
|
13.5
|
|
|
|
13.3
|
|
|
|
9.0
|
|
|
|
3.4
|
|
Operating leases
|
|
|
403.4
|
|
|
|
109.1
|
|
|
|
156.1
|
|
|
|
78.3
|
|
|
|
59.9
|
|
Purchase
obligations2
|
|
|
11,367.1
|
|
|
|
7,259.9
|
|
|
|
1,599.6
|
|
|
|
1,471.5
|
|
|
|
1,036.1
|
|
Other long-term liabilities reflected on our balance
sheet3
|
|
|
1,136.9
|
|
|
|
|
|
|
|
298.6
|
|
|
|
195.0
|
|
|
|
643.3
|
|
Other4
|
|
|
198.8
|
|
|
|
198.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
23,665.2
|
|
|
$
|
7,824.7
|
|
|
$
|
4,161.0
|
|
|
$
|
3,317.5
|
|
|
$
|
8,362.0
|
|
|
|
|
|
|
|
|
|
1
|
Our long-term debt obligations include both our expected
principal and interest obligations and our interest rate swaps.
We used the interest rate forward curve at December 31,
2009 to compute the amount of the contractual obligation for
interest on the variable rate debt instruments and swaps.
|
|
2
|
We have included the following:
|
|
|
|
|
|
Purchase obligations, consisting primarily of all open purchase
orders at our significant operating locations as of
December 31, 2009. Some of these purchase orders may be
cancelable; however, for purposes of this disclosure, we have
not distinguished between cancelable and noncancelable purchase
obligations.
|
|
|
Contractual payment obligations with each of our significant
vendors, which are noncancelable and are not contingent.
|
|
|
3
|
We have included long-term liabilities consisting primarily of
our nonqualified supplemental pension funding requirements and
deferred compensation liabilities. We excluded liabilities for
unrecognized tax benefits of $1,088.4 million, as we cannot
reasonably estimate the timing of future cash outflows
associated with those liabilities.
|
|
4
|
This category comprises primarily minimum pension funding
requirements.
|
27
The contractual obligations table is current as of
December 31, 2009. We expect the amount of these
obligations to change materially over time as new contracts are
initiated and existing contracts are completed, terminated, or
modified.
APPLICATION
OF CRITICAL ACCOUNTING POLICIES
In preparing our financial statements in accordance with
generally accepted accounting principles (GAAP), we must often
make estimates and assumptions that affect the reported amounts
of assets, liabilities, revenues, expenses, and related
disclosures. Some of those judgments can be subjective and
complex, and consequently actual results could differ from those
estimates. For any given individual estimate or assumption we
make, it is possible that other people applying reasonable
judgment to the same facts and circumstances could develop
different estimates. We believe that, given current facts and
circumstances, it is unlikely that applying any such other
reasonable judgment would cause a material adverse effect on our
consolidated results of operations, financial position, or
liquidity for the periods presented in this report. Our most
critical accounting policies have been discussed with our audit
committee and are described below.
Revenue
Recognition and Sales Return, Rebate, and Discount
Accruals
We recognize revenue from sales of products at the time title of
goods passes to the buyer and the buyer assumes the risks and
rewards of ownership. For more than 85 percent of our
sales, this is at the time products are shipped to the customer,
typically a wholesale distributor or a major retail chain. The
remaining sales, which are outside the U.S., are recorded at the
point of delivery. Provisions for returns, rebates, and
discounts are established in the same period the related sales
are recorded.
We regularly review the supply levels of our significant
products sold to major wholesalers in the U.S. and in major
markets outside the U.S., primarily by reviewing periodic
inventory reports supplied by our major wholesalers and
available prescription volume information for our products, or
alternative approaches. We attempt to maintain wholesaler
inventory levels at an average of approximately one month or
less on a consistent basis across our product portfolio. Causes
of unusual wholesaler buying patterns include actual or
anticipated product supply issues, weather patterns, anticipated
changes in the transportation network, redundant holiday
stocking, and changes in wholesaler business operations. In the
U.S., the current structure of our arrangements does not provide
an incentive for speculative wholesaler buying and provides us
with data on inventory levels at our wholesalers. When we
believe wholesaler purchasing patterns have caused an unusual
increase or decrease in the sales of a major product compared
with underlying demand, we disclose this in our product sales
discussion if we believe the amount is material to the product
sales trend; however, we are not always able to accurately
quantify the amount of stocking or destocking. Wholesaler
stocking and destocking activity historically has not caused any
material changes in the rate of actual product returns.
We establish sales return accruals for anticipated product
returns. We record the return amounts as a deduction to arrive
at our net product sales. Once the product is returned, it is
destroyed. Consistent with Revenue Recognition accounting
guidance, we estimate a reserve when the sales occur for future
product returns related to those sales. This estimate is
primarily based on historical return rates as well as
specifically identified anticipated returns due to known
business conditions and product expiry dates. Actual product
returns have been less than one percent of our net sales over
the past three years and have not fluctuated significantly as a
percent of sales.
We establish sales rebate and discount accruals in the same
period as the related sales. The rebate and discount amounts are
recorded as a deduction to arrive at our net product sales.
Sales rebates and discounts that require the use of judgment in
the establishment of the accrual include Medicaid, managed care,
Medicare, chargebacks, long-term-care, hospital, patient
assistance programs, and various other government programs. We
base these accruals primarily upon our historical rebate and
discount payments made to our customer segment groups and the
provisions of current rebate and discount contracts.
The largest of our sales rebate and discount amounts are rebates
associated with sales covered by Medicaid. In determining the
appropriate accrual amount, we consider our historical Medicaid
rebate payments by product as a percentage of our historical
sales as well as any significant changes in sales trends, an
evaluation of the current Medicaid rebate laws and
interpretations, the percentage of our products that are sold to
Medicaid recipients, and our product pricing and current rebate
and discount contracts. Although we accrue a liability for
Medicaid rebates at the time we record the sale (when the
product is shipped), the Medicaid rebate related to that sale is
typically paid up to six months later. Because of this time lag,
in any particular period our rebate adjustments may incorporate
revisions of accruals for several periods.
Most of our rebates outside the U.S. are contractual or
legislatively mandated and are estimated and recognized in the
same period as the related sales. In some large European
countries, government rebates are based on the anticipated
pharmaceutical budget deficit in the country. A best estimate of
these
28
rebates, updated as governmental authorities revise budgeted
deficits, is recognized in the same period as the related sale.
If our estimates are not reflective of the actual pharmaceutical
budget deficit, we adjust our rebate reserves.
We believe that our accruals for sales returns, rebates, and
discounts are reasonable and appropriate based on current facts
and circumstances. U.S. sales returns, federally mandated
Medicaid rebate and state pharmaceutical assistance programs
(Medicaid) and Medicare rebates reduced sales by
$1.20 billion, $1.03 billion, and $738.8 million
in 2009, 2008, and 2007, respectively. A 5 percent change
in the sales return, Medicaid, and Medicare rebate amounts we
recognized in 2009 would lead to an approximate $60 million
effect on our income before income taxes. As of
December 31, 2009, our sales returns, Medicaid, and
Medicare rebate liability was $692.3 million.
Our global rebate and discount liabilities are included in sales
rebates and discounts on our consolidated balance sheet. Our
global sales return liability is included in other current
liabilities and other noncurrent liabilities on our consolidated
balance sheet. Approximately 84 percent and 80 percent
of our global sales return, rebate, and discount liability
resulted from sales of our products in the U.S. as of
December 31, 2009 and 2008, respectively. The following
represents a roll-forward of our most significant
U.S. returns, rebate, and discount liability balances,
including Medicaid (in millions):
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
Sales return, rebate, and discount liabilities, beginning of year
|
|
$
|
806.5
|
|
|
$
|
693.5
|
|
Reduction of net sales due to sales returns, discounts, and
rebates1
|
|
|
2,233.8
|
|
|
|
1,864.9
|
|
Cash payments of discounts and rebates
|
|
|
(2,076.7
|
)
|
|
|
(1,751.9
|
)
|
|
|
|
|
|
|
Sales return, rebate, and discount liabilities, end of year
|
|
$
|
963.6
|
|
|
$
|
806.5
|
|
|
|
|
|
|
|
|
|
1 |
Adjustments of the estimates for these returns, rebates, and
discounts to actual results were less than 0.1 percent of
net sales for each of the years presented.
|
Product
Litigation Liabilities and Other Contingencies
Product litigation liabilities and other contingencies are, by
their nature, uncertain and are based upon complex judgments and
probabilities. The factors we consider in developing our product
litigation liability reserves and other contingent liability
amounts include the merits and jurisdiction of the litigation,
the nature and the number of other similar current and past
litigation cases, the nature of the product and the current
assessment of the science subject to the litigation, and the
likelihood of settlement and current state of settlement
discussions, if any. In addition, we accrue for certain product
liability claims incurred, but not filed, to the extent we can
formulate a reasonable estimate of their costs. We estimate
these expenses based primarily on historical claims experience
and data regarding product usage. We accrue legal defense costs
expected to be incurred in connection with significant product
liability contingencies when probable and reasonably estimable.
We also consider the insurance coverage we have to diminish the
exposure for periods covered by insurance. In assessing our
insurance coverage, we consider the policy coverage limits and
exclusions, the potential for denial of coverage by the
insurance company, the financial condition of the insurers, and
the possibility of and length of time for collection. In the
past few years, we have been unable to obtain product liability
insurance due to a very restrictive insurance market. Therefore,
for substantially all of our currently marketed products, we
have been and expect that we will continue to be completely
self-insured for future product liability losses. In addition,
there can be no assurance that we will be able to fully collect
from our insurance carriers in the future.
The litigation accruals and environmental liabilities and the
related estimated insurance recoverables have been reflected on
a gross basis as liabilities and assets, respectively, on our
consolidated balance sheets.
We believe that the accruals and related insurance recoveries we
have established for product litigation liabilities and other
contingencies are appropriate based on current facts and
circumstances.
Pension
and Retiree Medical Plan Assumptions
Pension benefit costs include assumptions for the discount rate,
retirement age, and expected return on plan assets. Retiree
medical plan costs include assumptions for the discount rate,
retirement age, expected return on plan assets, and
health-care-cost trend rates. These assumptions have a
significant effect on the amounts reported. In addition to the
analysis below, see Note 13 to the consolidated financial
statements for additional information regarding our retirement
benefits.
Periodically, we evaluate the discount rate and the expected
return on plan assets in our defined benefit pension and retiree
health benefit plans. In evaluating these assumptions, we
consider many factors, including an evaluation of the discount
rates, expected return on plan assets, and health-care-cost
trend
29
rates of other companies; our historical assumptions compared
with actual results; an analysis of current market conditions
and asset allocations (approximately 88 percent of which
are growth investments); and the views of leading financial
advisers and economists. We use an actuarially determined,
company-specific yield curve to determine the discount rate. In
evaluating our expected retirement age assumption, we consider
the retirement ages of our past employees eligible for pension
and medical benefits together with our expectations of future
retirement ages.
We believe our pension and retiree medical plan assumptions are
appropriate based upon the above factors. If the
health-care-cost trend rates were to be increased by one
percentage point each future year, the aggregate of the service
cost and interest cost components of the 2009 annual expense
would increase by $18.9 million. A one-percentage-point
decrease would lower the aggregate of the 2009 service cost and
interest cost by $15.8 million. If the 2009 discount rate
for the U.S. defined benefit pension and retiree health
benefit plans (U.S. plans) were to be changed by a quarter
percentage point, income before income taxes would change by
$23.6 million. If the 2009 expected return on plan assets
for U.S. plans were to be changed by a quarter percentage
point, income before income taxes would change by
$16.8 million. If our assumption regarding the 2009
expected age of future retirees for U.S. plans were
adjusted by one year, our income before income taxes would be
affected by $27.7 million. The U.S. plans represent
approximately 82 percent of the total accumulated
postretirement benefit obligation and approximately
83 percent of total plan assets at December 31, 2009.
Impairment
of Long-Lived Assets
We review the carrying value of long-lived assets (both
intangible and tangible) for potential impairment on a periodic
basis and whenever events or changes in circumstances indicate
the carrying value of an asset may not be recoverable. We
determine impairment by comparing the projected undiscounted
cash flows to be generated by the asset to its carrying value.
If an impairment is identified, a loss is recorded equal to the
excess of the assets net book value over its fair value,
and the cost basis is adjusted. The estimated future cash flows,
based on reasonable and supportable assumptions and projections,
require managements judgment. Actual results could vary
from these estimates.
Income
Taxes
We prepare and file tax returns based on our interpretation of
tax laws and regulations and record estimates based on these
judgments and interpretations. In the normal course of business,
our tax returns are subject to examination by various taxing
authorities, which may result in future tax, interest, and
penalty assessments by these authorities. Inherent uncertainties
exist in estimates of many tax positions due to changes in tax
law resulting from legislation, regulation,
and/or as
concluded through the various jurisdictions tax court
systems. We recognize the tax benefit from an uncertain tax
position only if it is more likely than not that the tax
position will be sustained on examination by the taxing
authorities, based on the technical merits of the position. The
tax benefits recognized in the financial statements from such a
position are measured based on the largest benefit that has a
greater than 50 percent likelihood of being realized upon
ultimate resolution. The amount of unrecognized tax benefits is
adjusted for changes in facts and circumstances. For example,
adjustments could result from significant amendments to existing
tax law and the issuance of regulations or interpretations by
the taxing authorities, new information obtained during a tax
examination, or resolution of an examination. We believe that
our estimates for uncertain tax positions are appropriate and
sufficient to pay assessments that may result from examinations
of our tax returns. We recognize both accrued interest and
penalties related to unrecognized tax benefits in income tax
expense.
We have recorded valuation allowances against certain of our
deferred tax assets, primarily those that have been generated
from net operating losses and tax credit carryforwards in
certain taxing jurisdictions. In evaluating whether we would
more likely than not recover these deferred tax assets, we have
not assumed any future taxable income or tax planning strategies
in the jurisdictions associated with these carryforwards where
history does not support such an assumption. Implementation of
tax planning strategies to recover these deferred tax assets or
future income generation in these jurisdictions could lead to
the reversal of these valuation allowances and a reduction of
income tax expense.
We believe that our estimates for the uncertain tax positions
and valuation allowances against the deferred tax assets are
appropriate based on current facts and circumstances. A
5 percent change in the amount of the uncertain tax
positions and the valuation allowance would result in a change
in net income of $41.8 million and $41.8 million,
respectively.
FINANCIAL
EXPECTATIONS FOR 2010
For the full year of 2010, we expect earnings per share to be in
the range of $4.65 to $4.85, excluding the potential impact of
health care reform in the U.S. and restructuring charges
resulting from previously announced strategic headcount
reductions. We expect volume-driven revenue growth in the
high-single digits, driven primarily by Alimta, Cymbalta,
Humalog, Cialis, Effient and the exenatide franchise. We
anticipate that gross margin as a percent of revenue will be
flat to declining. Marketing, selling, and
30
administrative expenses are projected to grow in the low- to
mid-single digits while research and development expenses are
projected to grow in the low-double digits. Othernet,
expense (income) is expected to be a net expense of between
$150.0 million and $200.0 million. Cash flows are expected
to be sufficient to fund capital expenditures of approximately
$1.0 billion, anticipated business development activity,
and our dividend.
We caution investors that any forward-looking statements or
projections made by us, including those above, are based on
managements belief at the time they are made. However,
they are subject to risks and uncertainties. Actual results
could differ materially and will depend on, among other things,
the continuing growth of our currently marketed products;
developments with competitive products; the timing and scope of
regulatory approvals and the success of our new product
launches; asset impairments, restructurings, and acquisitions of
compounds under development resulting in acquired in-process
research and development charges; foreign exchange rates and
global macroeconomic conditions; changes in effective tax rates;
wholesaler inventory changes; other regulatory developments,
litigation, patent disputes, and government investigations; and
the impact of governmental actions regarding pricing,
importation, and reimbursement for pharmaceuticals, as well as
proposed health care reform currently being discussed by the
U.S. Congress. We undertake no duty to update these
forward-looking statements.
LEGAL
AND REGULATORY MATTERS
We are a party to various legal actions and government
investigations. The most significant of these are described
below. While it is not possible to determine the outcome of
these matters, we believe that, except as specifically noted
below, the resolution of all such matters will not have a
material adverse effect on our consolidated financial position
or liquidity, but could possibly be material to our consolidated
results of operations in any one accounting period.
Patent
Litigation
We are engaged in the following patent litigation matters
brought pursuant to procedures set out in the Hatch-Waxman Act
(the Drug Price Competition and Patent Term Restoration Act of
1984):
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Cymbalta: Sixteen generic drug manufacturers
have submitted Abbreviated New Drug Applications (ANDAs) seeking
permission to market generic versions of Cymbalta prior to the
expiration of our relevant U.S. patents (the earliest of
which expires in 2013). Of these challengers, all allege
non-infringement of the patent claims directed to the commercial
formulation, and nine allege invalidity of the patent claims
directed to the active ingredient duloxetine. Of the nine
challengers to the compound patent claims, one further alleges
invalidity of the claims directed to the use of Cymbalta for
treating fibromyalgia, and one alleges the patent having claims
directed to the active ingredient is unenforceable. In November
2008 we filed lawsuits in U.S. District Court for the
Southern District of Indiana against Actavis Elizabeth LLC;
Aurobindo Pharma Ltd.; Cobalt Laboratories, Inc.; Impax
Laboratories, Inc.; Lupin Limited; Sandoz Inc.; and Wockhardt
Limited, seeking rulings that the patents are valid, infringed,
and enforceable. We filed similar lawsuits in the same court
against Sun Pharma Global, Inc. in December 2008 and against
Anchen Pharmaceuticals, Inc. in August 2009. The cases have been
consolidated and actions against all but Wockhardt Limited have
been stayed pursuant to stipulations by the defendants to be
bound by the outcome of the litigation through appeal.
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Gemzar: Mayne Pharma (USA) Inc., now Hospira,
Inc. (Hospira); Fresenius Kabi Oncology Plc (Fresenius); Sicor
Pharmaceuticals, Inc., now Teva Parenteral Medicines, Inc.
(Teva); and Sun Pharmaceutical Industries Inc. (Sun) each
submitted an ANDA seeking permission to market generic versions
of Gemzar prior to the expiration of our relevant
U.S. patents (compound patent expiring in 2010 and
method-of-use
patent expiring in 2013), and alleging that these patents are
invalid. Sandoz Inc. (Sandoz) and APP Pharmaceuticals, LLC (APP)
have similarly challenged our
method-of-use
patent. We filed lawsuits in the U.S. District Court for
the Southern District of Indiana against Teva (February 2006),
Hospira (October 2006 and January 2008), Sandoz (October 2009),
APP (December 2009), and Fresenius (February 2010), seeking
rulings that our patents are valid and are being infringed.
Sandoz withdrew its ANDA and the suit against it was dismissed
in February 2010. The trial against Teva was held in September
2009 and we are waiting for a ruling. Tevas ANDAs have
been approved by the FDA; however, Teva must provide
90 days notice prior to marketing generic Gemzar to allow
time for us to seek a preliminary injunction. Both suits against
Hospira have been administratively closed, and the parties have
agreed to be bound by the results of the Teva suit. In November
2007, Sun filed a declaratory judgment action in the United
States District Court for the Eastern District of Michigan,
seeking rulings that our
method-of-use
and compound patents are invalid or unenforceable, or would not
be infringed by the sale of Suns generic product. In
August 2009, the District Court granted a motion by Sun for
partial summary judgment, invalidating our
method-of-use
patent. We have appealed this decision. This ruling has no
bearing on the compound patent. The trial originally scheduled
for December 2009 has been postponed while the court considers
Suns second summary judgment motion, related to the
validity of our compound patent.
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Sun and APP have received tentative approval for their products
from the FDA, but are prohibited from entering the market by
30-month
stays, which expire in June 2010 for Sun and May 2012 for APP.
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Alimta: Teva Parenteral Medicines, Inc.
(Teva), APP, and Barr Laboratories, Inc. (Barr) each submitted
ANDAs seeking approval to market generic versions of Alimta
prior to the expiration of the relevant U.S. patent
(licensed from the Trustees of Princeton University and expiring
in 2016), and alleging the patent is invalid. We, along with
Princeton, filed lawsuits in the U.S. District Court for
the District of Delaware against Teva, APP, and Barr seeking
rulings that the compound patent is valid and infringed. Trial
is scheduled for November 2010 against Teva and APP.
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Evista: In 2006, Teva Pharmaceuticals USA,
Inc. (Teva) submitted an ANDA seeking permission to market a
generic version of Evista prior to the expiration of our
relevant U.S. patents (expiring in
2012-2017)
and alleging that these patents are invalid, not enforceable, or
not infringed. In June 2006, we filed a lawsuit against Teva in
the U.S. District Court for the Southern District of
Indiana, seeking a ruling that these patents are valid,
enforceable, and being infringed by Teva. The trial against Teva
was completed in March 2009. In September 2009, the court upheld
our
method-of-use
patents (the last expires in 2014). Teva has appealed that
ruling. In addition, the court held that our particle-size
patent (expiring 2017) is invalid. We have appealed that
ruling.
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Strattera: Actavis Elizabeth LLC (Actavis),
Apotex Inc. (Apotex), Aurobindo Pharma Ltd. (Aurobindo), Mylan
Pharmaceuticals Inc. (Mylan), Sandoz Inc. (Sandoz), Sun
Pharmaceutical Industries Limited (Sun), and Teva
Pharmaceuticals USA, Inc. (Teva) each submitted an ANDA seeking
permission to market generic versions of Strattera prior to the
expiration of our relevant U.S. patent (expiring in 2017),
and alleging that this patent is invalid. In 2007, we brought a
lawsuit against Actavis, Apotex, Aurobindo, Mylan, Sandoz, Sun,
and Teva in the United States District Court for the District of
New Jersey. The court has ruled on all pending summary judgment
motions, and granted our infringement motion. The remaining
invalidity defenses will be decided at trial, which could take
place as early as the third quarter of 2010. Several companies
have received tentative approval to market generic atomoxetine,
but are prohibited from entering the market by a
30-month
stay which expires in November 2010.
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We believe each of these Hatch-Waxman challenges is without
merit and expect to prevail in this litigation. However, it is
not possible to determine the outcome of this litigation, and
accordingly, we can provide no assurance that we will prevail.
An unfavorable outcome in any of these cases could have a
material adverse impact on our future consolidated results of
operations, liquidity, and financial position.
We have received challenges to Zyprexa patents in a number of
countries outside the U.S.:
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In Canada, several generic pharmaceutical manufacturers have
challenged the validity of our Zyprexa patent (expiring in
2011). In April 2007, the Canadian Federal Court ruled against
the first challenger, Apotex Inc. (Apotex), and that ruling was
affirmed on appeal in February 2008. In June 2007, the Canadian
Federal Court held that an invalidity allegation of a second
challenger, Novopharm Ltd. (Novopharm), was justified and denied
our request that Novopharm be prohibited from receiving
marketing approval for generic olanzapine in Canada. Novopharm
began selling generic olanzapine in Canada in the third quarter
of 2007. In September 2009, the Canadian Federal Court ruled
against us in the Novapharm suit, finding our patent invalid. We
have appealed this decision. If the decision is upheld, we could
face liability for damages related to delays in the launch of
generic olanzapine products; however, we have concluded at this
time that the damages are not probable or estimable.
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In Germany, the German Federal Supreme Court upheld the validity
of our Zyprexa patent (expiring in 2011) in December 2008,
reversing an earlier decision of the Federal Patent Court.
Following the decision of the Supreme Court, the generic
companies who launched generic olanzapine based on the earlier
decision either agreed to withdraw from the market or were
subject to injunction. We are pursuing these companies for
damages arising from infringement.
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We have received challenges in a number of other countries,
including Spain, the United Kingdom (U.K.), and several smaller
European countries. In Spain, we have been successful at both
the trial and appellate court levels in defeating the generic
manufacturers challenges, but additional actions are now
pending. In the U.K., the generic pharmaceutical manufacturer
Dr. Reddys Laboratories (UK) Limited
(Dr. Reddys) has challenged the validity of our
Zyprexa patent (expiring in 2011). In October 2008, the Patents
Court in the High Court, London ruled that our patent was valid.
Dr. Reddys appealed this decision. The U.K. Court of
Appeal affirmed the validity of the patent in December 2009.
Dr. Reddys did not seek further appeal to the U.K.
Supreme Court, therefore the U.K. proceedings are concluded.
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We are vigorously contesting the various legal challenges to our
Zyprexa patents on a
country-by-country
basis. We cannot determine the outcome of this litigation. The
availability of generic olanzapine in additional markets could
have a material adverse impact on our consolidated results of
operations.
Xigris and Evista: In June 2002, Ariad
Pharmaceuticals, Inc. (Ariad), the Massachusetts Institute of
Technology, the Whitehead Institute for Biomedical Research, and
the President and Fellows of Harvard
32
College in the U.S. District Court for the District of
Massachusetts sued us, alleging that sales of two of our
products, Xigris and Evista, were inducing the infringement of a
patent related to the discovery of a natural cell signaling
phenomenon in the human body, and seeking royalties on past and
future sales of these products. Following jury and bench trials
on separate issues, the U.S. District Court of
Massachusetts entered final judgment in September 2007 that
Ariads claims were valid, infringed, and enforceable, and
finding damages in the amount of $65 million plus a
2.3 percent royalty on net U.S. sales of Xigris and
Evista since the time of the jury decision. However, the Court
deferred the requirement to pay any damages until after all
rights to appeal are exhausted. In April 2009, the Court of
Appeals for the Federal Circuit overturned the District Court
judgment, concluding that Ariads asserted patent claims
are invalid. In August 2009, the Court of Appeals agreed to
review this decision en banc, thereby vacating the Court of
Appeals decision. The en banc hearing occurred in December 2009
and we are awaiting a decision. Nevertheless, we believe that
these allegations are without legal merit, that we will
ultimately prevail on these issues, and therefore that the
likelihood of any monetary damages is remote.
Zyprexa
Litigation
We have been named as a defendant in a large number of Zyprexa
product liability lawsuits in the U.S. and have been
notified of many other claims of individuals who have not filed
suit. The lawsuits and unfiled claims (together the
claims) allege a variety of injuries from the use of
Zyprexa, with the majority alleging that the product caused or
contributed to diabetes or high blood-glucose levels. The claims
seek substantial compensatory and punitive damages and typically
accuse us of inadequately testing for and warning about side
effects of Zyprexa. Many of the claims also allege that we
improperly promoted the drug. Almost all of the federal lawsuits
are part of a Multi-District Litigation (MDL) proceeding
before The Honorable Jack Weinstein in the Federal District
Court for the Eastern District of New York (MDL No. 1596).
Since June 2005, we have entered into agreements with various
claimants attorneys involved in U.S. Zyprexa product
liability litigation to settle a substantial majority of the
claims. The agreements cover a total of approximately 32,670
claimants, including a large number of previously filed lawsuits
and other asserted claims. The two primary settlements were as
follows:
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In 2005, we settled and paid more than 8,000 claims for
$690.0 million, plus $10.0 million to cover
administration of the settlement.
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In 2007, we settled and paid more than 18,000 claims for
approximately $500 million.
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We are prepared to continue our vigorous defense of Zyprexa in
all remaining claims. The U.S. Zyprexa product liability
claims not subject to these agreements include approximately 170
lawsuits in the U.S. covering approximately 260 plaintiffs,
of which about 140 cases covering about 150 plaintiffs are part
of the MDL. The MDL cases have been scheduled for trial in
groups, and no specific trial dates for trial groups have been
assigned. We also have trials scheduled in Texas state court in
May and August 2010 and in Ohio in August 2010.
In January 2009, we reached resolution with the Office of the
U.S. Attorney for the Eastern District of Pennsylvania
(EDPA), and the State Medicaid Fraud Control Units of
36 states and the District of Columbia, of an investigation
related to our U.S. marketing and promotional practices
with respect to Zyprexa. As part of the resolution, we pled
guilty to one misdemeanor violation of the Food, Drug, and
Cosmetic Act for the off-label promotion of Zyprexa in elderly
populations as treatment for dementia, including
Alzheimers dementia, between September 1999 and March
2001. We recorded a charge of $1.42 billion for this matter
in the third quarter of 2008. In 2009, we paid substantially all
of this amount, as required by the settlement agreements. As
part of the settlement, we have entered into a corporate
integrity agreement with the Office of Inspector General (OIG)
of the U.S. Department of Health and Human Services (HHS),
which requires us to maintain our compliance program and to
undertake a set of defined corporate integrity obligations for
five years. The agreement also provides for an independent
third-party review organization to assess and report on the
companys systems, processes, policies, procedures, and
practices.
In October 2008, we reached a settlement with 32 states and
the District of Columbia related to a multistate investigation
brought under various state consumer protection laws. While
there is no finding that we have violated any provision of the
state laws under which the investigations were conducted, we
accrued and paid $62.0 million and agreed to undertake
certain commitments regarding Zyprexa for a period of six years,
through consent decrees filed with the settling states.
We have been served with lawsuits filed by the states of Alaska,
Arkansas, Connecticut, Idaho, Louisiana, Minnesota, Mississippi,
Montana, New Mexico, Pennsylvania, South Carolina, Utah, and
West Virginia alleging that Zyprexa caused or contributed to
diabetes or high blood-glucose levels, and that we improperly
promoted the drug. These suits seek to recover the costs paid
for Zyprexa through Medicaid and other drug-benefit programs, as
well as the costs alleged to have been incurred and that will be
incurred by the states to treat Zyprexa-related illnesses. The
Connecticut, Idaho, Louisiana, Minnesota, Mississippi, Montana,
New Mexico, and West Virginia cases are part of the MDL
proceedings in the EDNY.
33
The Alaska case was settled in March 2008 for a payment of
$15.0 million, plus terms designed to ensure, subject to
certain limitations and conditions, that Alaska is treated as
favorably as certain other states that may settle with us in the
future over similar claims. We are in advanced discussions with
the attorneys general for several of these states, seeking to
resolve their Zyprexa-related claims, and we have agreed to
settlements with the states of Arkansas, Connecticut, Idaho,
Mississippi, New Mexico, South Carolina, Utah, and West
Virginia. In the second and third quarters of 2009, we incurred
pretax charges of $105.0 million and $125.0 million,
respectively, reflecting the currently probable and estimable
exposures in connection with these claims. The Pennsylvania case
is set for trial in April 2010 in state court.
In 2005, two lawsuits were filed in the EDNY purporting to be
nationwide class actions on behalf of all consumers and
third-party payors, excluding governmental entities, which have
made or will make payments for their members or insured patients
being prescribed Zyprexa. These actions have now been
consolidated into a single lawsuit, which is brought under
certain state consumer protection statutes, the federal civil
RICO statute, and common law theories, seeking a refund of the
cost of Zyprexa, treble damages, punitive damages, and
attorneys fees. Two additional lawsuits were filed in the
EDNY in 2006 on similar grounds. In September 2008, Judge
Weinstein certified a class consisting of third-party payors,
excluding governmental entities and individual consumers. We
appealed the certification order, and Judge Weinsteins
order denying our motion for summary judgment, in September
2008. While the Second Circuit Court of Appeals heard oral
arguments on the appeal in December 2009, no opinions have been
rendered. In 2007, The Pennsylvania Employees Trust Fund
brought claims in state court in Pennsylvania as insurer of
Pennsylvania state employees, who were prescribed Zyprexa on
similar grounds as described in the New York cases. As with the
product liability suits, these lawsuits allege that we
inadequately tested for and warned about side effects of Zyprexa
and improperly promoted the drug. In December 2009, the court
granted our summary judgment motion, dismissing the case.
Plaintiffs have appealed this decision.
In early 2005, we were served with four lawsuits seeking class
action status in Canada on behalf of patients who took Zyprexa.
One of these four lawsuits has been certified for residents of
Quebec, and a second has been certified in Ontario and includes
all Canadian residents except for residents of Quebec and
British Columbia. The allegations in the Canadian actions are
similar to those in the product liability litigation pending in
the U.S. We are in advanced discussions to resolve all
Zyprexa class-action litigation in Canada.
We cannot determine with certainty the additional number of
lawsuits and claims that may be asserted. The ultimate
resolution of Zyprexa product liability and related litigation
could have a material adverse impact on our consolidated results
of operations, liquidity, and financial position.
Other
Product Liability Litigation
We have been named as a defendant in numerous other product
liability lawsuits involving primarily diethylstilbestrol (DES),
thimerosal, and Byetta. The majority of these claims are covered
by insurance, subject to deductibles and coverage limits.
Product
Liability Insurance
Because of the nature of pharmaceutical products, it is possible
that we could become subject to large numbers of product
liability and related claims for other products in the future.
In the past several years, we have been unable to attain product
liability insurance due to a very restrictive insurance market.
Therefore, for substantially all of our currently marketed
products, we have been and expect that we will continue to be
completely self-insured for future product liability losses. In
addition, there is no assurance that we will be able to fully
collect from our insurance carriers in the future.
PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995
A CAUTION CONCERNING FORWARD-LOOKING STATEMENTS
Under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, we caution investors that any
forward-looking statements or projections made by us, including
those made in this document, are based on managements
expectations at the time they are made, but they are subject to
risks and uncertainties that may cause actual results to differ
materially from those projected. Economic, competitive,
governmental, technological, legal, and other factors that may
affect our operations and prospects are discussed earlier in
this section and in Item 1A, Risk Factors. We
undertake no duty to update forward-looking statements.
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Item 7A.
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Quantitative
and Qualitative Disclosures About Market Risk
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You can find quantitative and qualitative disclosures about
market risk (e.g., interest rate risk) in Item 7 at
Managements Discussion and AnalysisFinancial
Condition. That information is incorporated in this report
by reference.
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Item 8.
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Financial
Statements and Supplementary Data
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Consolidated
Statements of Operations
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ELI LILLY AND COMPANY AND SUBSIDIARIES
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(Dollars in millions, except per-share data) Year Ended
December 31
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2009
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2008
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2007
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Revenue
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$
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21,836.0
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$
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20,371.9
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$
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18,633.5
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Cost of sales
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4,247.0
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4,376.7
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4,248.8
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Research and development
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4,326.5
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3,840.9
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3,486.7
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Marketing, selling, and administrative
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6,892.5
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6,626.4
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6,095.1
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Acquired in-process research and development (Note 3)
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90.0
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4,835.4
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745.6
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Asset impairments, restructuring, and other special charges
(Note 5)
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692.7
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1,974.0
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302.5
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Othernet, expense (income)
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229.5
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26.1
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(122.0)
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16,478.2
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21,679.5
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14,756.7
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Income (loss) before income taxes
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5,357.8
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(1,307.6)
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3,876.8
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Income taxes (Note 12)
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1,029.0
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764.3
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923.8
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Net income (loss)
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$
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4,328.8
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$
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(2,071.9)
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$
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2,953.0
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Earnings (loss) per sharebasic and diluted (Note 11)
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$
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3.94
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$
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(1.89)
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$
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2.71
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See notes to consolidated financial statements.
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Consolidated
Balance Sheets
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ELI LILLY AND COMPANY AND SUBSIDIARIES
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|
|
|
|
|
(Dollars in millions) December 31
|
|
2009
|
|
2008
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Current Assets
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
4,462.9
|
|
|
$
|
5,496.7
|
|
Short-term investments
|
|
|
34.7
|
|
|
|
429.4
|
|
Accounts receivable, net of allowances of $109.9 (2009) and
$97.4 (2008)
|
|
|
3,343.3
|
|
|
|
2,778.8
|
|
Other receivables (Note 9)
|
|
|
488.5
|
|
|
|
498.5
|
|
Inventories
|
|
|
2,849.9
|
|
|
|
2,493.2
|
|
Deferred income taxes (Note 12)
|
|
|
271.0
|
|
|
|
382.1
|
|
Prepaid expenses (Note 9)
|
|
|
1,036.2
|
|
|
|
374.6
|
|
|
|
|
|
|
|
Total current assets
|
|
|
12,486.5
|
|
|
|
12,453.3
|
|
|
|
|
|
|
|
|
|
|
Other Assets
|
|
|
|
|
|
|
|
|
Investments (Note 6)
|
|
|
1,155.8
|
|
|
|
1,544.6
|
|
Goodwill and other intangiblesnet (Note 3)
|
|
|
3,699.8
|
|
|
|
3,929.1
|
|
Sundry (Note 9)
|
|
|
1,921.4
|
|
|
|
2,659.3
|
|
|
|
|
|
|
|
|
|
|
6,777.0
|
|
|
|
8,133.0
|
|
|
|
|
|
|
|
|
|
|
Property and Equipment, net
|
|
|
8,197.4
|
|
|
|
8,626.3
|
|
|
|
|
|
|
|
|
|
$
|
27,460.9
|
|
|
$
|
29,212.6
|
|
|
|
|
|
|
|
Liabilities and Shareholders Equity
|
|
|
|
|
|
|
|
|
Current Liabilities
|
|
|
|
|
|
|
|
|
Short-term borrowings and current maturities of long-term debt
(Note 7)
|
|
$
|
27.4
|
|
|
$
|
5,846.3
|
|
Accounts payable
|
|
|
968.1
|
|
|
|
885.8
|
|
Employee compensation
|
|
|
894.2
|
|
|
|
771.0
|
|
Sales rebates and discounts
|
|
|
1,109.8
|
|
|
|
873.4
|
|
Dividends payable
|
|
|
538.0
|
|
|
|
536.8
|
|
Income taxes payable (Note 12)
|
|
|
346.7
|
|
|
|
229.2
|
|
Other current liabilities (Note 9)
|
|
|
2,683.9
|
|
|
|
3,967.2
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
6,568.1
|
|
|
|
13,109.7
|
|
|
|
|
|
|
|
|
|
|
Other Liabilities
|
|
|
|
|
|
|
|
|
Long-term debt (Note 7)
|
|
|
6,634.7
|
|
|
|
4,615.7
|
|
Accrued retirement benefits (Note 13)
|
|
|
2,334.7
|
|
|
|
2,387.6
|
|
Long-term income taxes payable (Note 12)
|
|
|
1,088.4
|
|
|
|
906.2
|
|
Deferred income taxes (Note 12)
|
|
|
84.8
|
|
|
|
74.7
|
|
Other noncurrent liabilities (Note 9)
|
|
|
1,224.9
|
|
|
|
1,381.0
|
|
|
|
|
|
|
|
|
|
|
11,367.5
|
|
|
|
9,365.2
|
|
Commitments and contingencies (Note 14)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders Equity (Notes 8 and 10)
|
|
|
|
|
|
|
|
|
Common stockno par value
|
|
|
|
|
|
|
|
|
Authorized shares: 3,200,000,000
|
|
|
|
|
|
|
|
|
Issued shares: 1,149,916,107 (2009) and 1,137,837,608 (2008)
|
|
|
718.7
|
|
|
|
711.1
|
|
Additional paid-in capital
|
|
|
4,635.6
|
|
|
|
3,976.6
|
|
Retained earnings
|
|
|
9,830.4
|
|
|
|
7,654.9
|
|
Employee benefit trust
|
|
|
(3,013.2)
|
|
|
|
(2,635.0)
|
|
Deferred costsESOP
|
|
|
(77.4)
|
|
|
|
(86.3)
|
|
Accumulated other comprehensive loss (Note 15)
|
|
|
(2,471.9)
|
|
|
|
(2,786.8)
|
|
Noncontrolling interests
|
|
|
1.6
|
|
|
|
2.4
|
|
|
|
|
|
|
|
|
|
|
9,623.8
|
|
|
|
6,836.9
|
|
Less cost of common stock in treasury
|
|
|
|
|
|
|
|
|
2009 882,340 shares
|
|
|
|
|
|
|
|
|
2008 888,998 shares
|
|
|
98.5
|
|
|
|
99.2
|
|
|
|
|
|
|
|
|
|
|
9,525.3
|
|
|
|
6,737.7
|
|
|
|
|
|
|
|
|
|
$
|
27,460.9
|
|
|
$
|
29,212.6
|
|
|
|
|
|
|
|
See notes to consolidated financial statements.
36
Consolidated
Statements of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
ELI LILLY AND COMPANY AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
(Dollars in millions) Year Ended December 31
|
|
2009
|
|
2008
|
|
|
2007
|
|
|
|
|
Cash Flows From Operating Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
4,328.8
|
|
|
$
|
(2,071.9)
|
|
|
$
|
2,953.0
|
|
Adjustments To Reconcile Net Income To
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows From Operating Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Net marketing investigation charges accrued (paid) (Note 14)
|
|
|
(1,313.6)
|
|
|
|
1,423.6
|
|
|
|
|
|
Depreciation and amortization
|
|
|
1,297.8
|
|
|
|
1,122.6
|
|
|
|
1,047.9
|
|
Change in deferred taxes
|
|
|
189.9
|
|
|
|
442.6
|
|
|
|
60.7
|
|
Stock-based compensation expense
|
|
|
368.5
|
|
|
|
255.3
|
|
|
|
282.0
|
|
Acquired in-process research and development, net of tax
|
|
|
58.5
|
|
|
|
4,792.7
|
|
|
|
692.6
|
|
Other, net
|
|
|
362.5
|
|
|
|
406.5
|
|
|
|
172.1
|
|
|
|
|
|
|
|
|
|
|
5,292.4
|
|
|
|
6,371.4
|
|
|
|
5,208.3
|
|
Changes in operating assets and liabilities, net of acquisitions
|
|
|
|
|
|
|
|
|
|
|
|
|
Receivables(increase) decrease
|
|
|
(492.9)
|
|
|
|
799.1
|
|
|
|
(842.7)
|
|
Inventories(increase) decrease
|
|
|
(179.0)
|
|
|
|
84.8
|
|
|
|
154.3
|
|
Other assets(increase) decrease
|
|
|
(84.9)
|
|
|
|
1,648.6
|
|
|
|
(355.8)
|
|
Accounts payable and other liabilitiesincrease (decrease)
|
|
|
(200.1)
|
|
|
|
(1,608.3)
|
|
|
|
990.4
|
|
|
|
|
|
|
|
|
|
|
(956.9)
|
|
|
|
924.2
|
|
|
|
(53.8)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash Provided by Operating Activities
|
|
|
4,335.5
|
|
|
|
7,295.6
|
|
|
|
5,154.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows From Investing Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
|
(765.0)
|
|
|
|
(947.2)
|
|
|
|
(1,082.4)
|
|
Disposals of property and equipment
|
|
|
17.7
|
|
|
|
25.7
|
|
|
|
32.3
|
|
Net change in short-term investments
|
|
|
399.1
|
|
|
|
957.6
|
|
|
|
(376.9)
|
|
Proceeds from sales and maturities of noncurrent investments
|
|
|
1,107.8
|
|
|
|
1,597.3
|
|
|
|
800.1
|
|
Purchases of noncurrent investments
|
|
|
(432.3)
|
|
|
|
(2,412.4)
|
|
|
|
(750.7)
|
|
Purchases of in-process research and development
|
|
|
(90.0)
|
|
|
|
(122.0)
|
|
|
|
(111.0)
|
|
Cash paid for acquisitions, net of cash acquired
|
|
|
|
|
|
|
(6,083.0)
|
|
|
|
(2,673.2)
|
|
Other, net
|
|
|
(94.5)
|
|
|
|
(284.8)
|
|
|
|
(166.3)
|
|
|
|
|
|
|
|
Net Cash Provided by (Used for) Investing Activities
|
|
|
142.8
|
|
|
|
(7,268.8)
|
|
|
|
(4,328.1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows From Financing Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends paid
|
|
|
(2,152.1)
|
|
|
|
(2,056.7)
|
|
|
|
(1,853.6)
|
|
Net change in short-term borrowings
|
|
|
(5,824.2)
|
|
|
|
5,060.5
|
|
|
|
(468.5)
|
|
Proceeds from issuance of long-term debt
|
|
|
2,400.0
|
|
|
|
0.1
|
|
|
|
2,512.6
|
|
Repayments of long-term debt
|
|
|
|
|
|
|
(649.8)
|
|
|
|
(1,059.5)
|
|
Other, net
|
|
|
42.6
|
|
|
|
(8.1)
|
|
|
|
24.1
|
|
|
|
|
|
|
|
Net Cash Provided by (Used for) Financing Activities
|
|
|
(5,533.7)
|
|
|
|
2,346.0
|
|
|
|
(844.9)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents
|
|
|
21.6
|
|
|
|
(96.6)
|
|
|
|
129.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
(1,033.8)
|
|
|
|
2,276.2
|
|
|
|
111.2
|
|
Cash and cash equivalents at beginning of year
|
|
|
5,496.7
|
|
|
|
3,220.5
|
|
|
|
3,109.3
|
|
|
|
|
|
|
|
Cash and Cash Equivalents at End of Year
|
|
$
|
4,462.9
|
|
|
$
|
5,496.7
|
|
|
$
|
3,220.5
|
|
|
|
|
|
|
|
See notes to consolidated financial statements.
37
Consolidated
Statements of Comprehensive Income (Loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
ELI LILLY AND COMPANY AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
(Dollars in millions) Year Ended December 31
|
|
2009
|
|
2008
|
|
|
2007
|
|
|
|
|
Net income (loss)
|
|
$
|
4,328.8
|
|
|
$
|
(2,071.9)
|
|
|
$
|
2,953.0
|
|
Other comprehensive income (loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation gains (losses)
|
|
|
284.9
|
|
|
|
(766.1)
|
|
|
|
756.6
|
|
Net unrealized gains (losses) on securities
|
|
|
289.8
|
|
|
|
(190.6)
|
|
|
|
(11.4)
|
|
Defined benefit pension and retiree health benefit plans
(Note 13)
|
|
|
(280.3)
|
|
|
|
(2,941.2)
|
|
|
|
943.8
|
|
Effective portion of cash flow hedges
|
|
|
48.2
|
|
|
|
23.2
|
|
|
|
(0.1)
|
|
|
|
|
|
|
|
Other comprehensive income (loss) before income taxes
|
|
|
342.6
|
|
|
|
(3,874.7)
|
|
|
|
1,688.9
|
|
Provision for income taxes related to other comprehensive income
(loss) items
|
|
|
(27.7)
|
|
|
|
1,074.7
|
|
|
|
(287.0)
|
|
|
|
|
|
|
|
Other comprehensive income (loss) (Note 15)
|
|
|
314.9
|
|
|
|
(2,800.0)
|
|
|
|
1,401.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss)
|
|
$
|
4,643.7
|
|
|
$
|
(4,871.9)
|
|
|
$
|
4,354.9
|
|
|
|
|
|
|
|
See notes to consolidated financial statements.
38
Segment
Information
We operate in one significant business segmenthuman
pharmaceutical products. Operations of the animal health
business segment are not material and share many of the same
economic and operating characteristics as human pharmaceutical
products. Therefore, they are included with pharmaceutical
products for purposes of segment reporting.
|
|
|
|
|
|
|
|
|
|
|
|
|
ELI LILLY AND COMPANY AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
(Dollars in millions) Year Ended December 31
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
|
|
Net salesto unaffiliated customers
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuroscience
|
|
$
|
8,976.4
|
|
|
$
|
8,371.5
|
|
|
$
|
7,851.0
|
|
Endocrinology
|
|
|
5,677.4
|
|
|
|
5,493.5
|
|
|
|
5,037.7
|
|
Oncology
|
|
|
3,161.7
|
|
|
|
2,877.1
|
|
|
|
2,446.4
|
|
Cardiovascular
|
|
|
1,971.1
|
|
|
|
1,882.7
|
|
|
|
1,624.1
|
|
Animal health
|
|
|
1,207.2
|
|
|
|
1,093.3
|
|
|
|
995.8
|
|
Other pharmaceuticals
|
|
|
177.7
|
|
|
|
207.7
|
|
|
|
219.7
|
|
|
|
|
|
|
|
Net product sales
|
|
|
21,171.5
|
|
|
|
19,925.8
|
|
|
|
18,174.7
|
|
Collaboration and other revenue
|
|
|
664.5
|
|
|
|
446.1
|
|
|
|
458.8
|
|
|
|
|
|
|
|
Total revenue
|
|
$
|
21,836.0
|
|
|
$
|
20,371.9
|
|
|
$
|
18,633.5
|
|
|
|
|
|
|
|
Geographic Information
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenueto unaffiliated
customers1
|
|
|
|
|
|
|
|
|
|
|
|
|
United States
|
|
$
|
12,294.4
|
|
|
$
|
10,930.1
|
|
|
$
|
10,145.5
|
|
Europe
|
|
|
5,227.2
|
|
|
|
5,333.5
|
|
|
|
4,731.8
|
|
Other foreign countries
|
|
|
4,314.4
|
|
|
|
4,108.3
|
|
|
|
3,756.2
|
|
|
|
|
|
|
|
|
|
$
|
21,836.0
|
|
|
$
|
20,371.9
|
|
|
$
|
18,633.5
|
|
|
|
|
|
|
|
Long-lived assets
|
|
|
|
|
|
|
|
|
|
|
|
|
United States
|
|
$
|
5,310.0
|
|
|
$
|
5,750.0
|
|
|
$
|
5,905.4
|
|
Europe
|
|
|
2,313.3
|
|
|
|
2,119.0
|
|
|
|
2,057.7
|
|
Other foreign countries
|
|
|
1,723.3
|
|
|
|
1,753.0
|
|
|
|
1,768.6
|
|
|
|
|
|
|
|
|
|
$
|
9,346.6
|
|
|
$
|
9,622.0
|
|
|
$
|
9,731.7
|
|
|
|
|
|
|
|
|
|
1 |
Net sales are attributed to the countries based on the location
of the customer.
|
Our neuroscience group of products includes Zyprexa, Cymbalta,
Strattera, and Prozac. Endocrinology products consist primarily
of Humalog, Humulin, Byetta, Actos, Evista, Forteo, and
Humatrope. Oncology products consist primarily of Alimta and
Gemzar. Cardiovascular products consist primarily of Cialis,
ReoPro, Xigris, and Effient. Animal health products include
Posilac, Tylan, Rumensin, Coban, and other products for
livestock and poultry, and Comfortis and other products for
companion animals. The other pharmaceuticals category includes
anti-infectives, primarily Vancocin and Ceclor, and other
miscellaneous pharmaceutical products and services.
Collaboration and other revenue includes our share of the
U.S. gross margin on Byetta and the global Erbitux royalty.
See Note 4 for additional information.
Most of our pharmaceutical products are distributed through
wholesalers that serve pharmacies, physicians and other health
care professionals, and hospitals. In 2009, our three largest
wholesalers each accounted for between 12 percent and
17 percent of consolidated total revenue. Further, they
each accounted for between 9 percent and 16 percent of
accounts receivable as of December 31, 2009. Animal health
products are sold primarily to wholesale distributors.
Our business segments are distinguished by the ultimate end user
of the product: humans or animals. Performance is evaluated
based on profit or loss from operations before income taxes. The
accounting policies of the individual segments are substantially
the same as those described in the summary of significant
accounting policies in Note 1 to the consolidated financial
statements. Income before income taxes for the animal health
business was approximately $217 million, $192 million,
and $173 million in 2009, 2008, and 2007, respectively.
The assets of the animal health business are intermixed with
those of the pharmaceutical products business. Long-lived assets
disclosed above consist of property and equipment and certain
sundry assets.
We are exposed to the risk of changes in social, political, and
economic conditions inherent in foreign operations, and our
results of operations and the value of our foreign assets are
affected by fluctuations in foreign currency exchange rates.
39
Selected
Quarterly Data (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ELI LILLY AND COMPANY AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
|
(Dollars in millions, except per-share data) 2009
|
|
Fourth
|
|
Third
|
|
|
Second
|
|
|
First
|
|
|
|
|
Revenue
|
|
$
|
5,934.2
|
|
|
$
|
5,562.0
|
|
|
$
|
5,292.8
|
|
|
$
|
5,047.0
|
|
Cost of sales
|
|
|
1,431.3
|
|
|
|
1,051.9
|
|
|
|
947.4
|
|
|
|
816.4
|
|
Operating expenses
|
|
|
3,170.0
|
|
|
|
2,823.9
|
|
|
|
2,748.6
|
|
|
|
2,476.5
|
|
Acquired in-process research and development
|
|
|
90.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asset impairments, restructuring, and other special charges
|
|
|
37.9
|
|
|
|
549.8
|
|
|
|
105.0
|
|
|
|
|
|
Othernet, expense
|
|
|
67.8
|
|
|
|
66.9
|
|
|
|
24.1
|
|
|
|
70.7
|
|
Income before income taxes
|
|
|
1,137.2
|
|
|
|
1,069.5
|
|
|
|
1,467.7
|
|
|
|
1,683.4
|
|
Net income
|
|
|
915.4
|
|
|
|
941.8
|
|
|
|
1,158.5
|
|
|
|
1,313.1
|
|
Earnings per sharebasic and diluted
|
|
|
.83
|
|
|
|
.86
|
|
|
|
1.06
|
|
|
|
1.20
|
|
Dividends paid per share
|
|
|
.49
|
|
|
|
.49
|
|
|
|
.49
|
|
|
|
.49
|
|
Common stock closing prices
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
High
|
|
|
37.51
|
|
|
|
35.15
|
|
|
|
35.95
|
|
|
|
40.57
|
|
Low
|
|
|
32.47
|
|
|
|
32.40
|
|
|
|
31.88
|
|
|
|
27.47
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
Fourth
|
|
Third
|
|
|
Second
|
|
|
First
|
|
|
|
|
Revenue
|
|
$
|
5,204.4
|
|
|
$
|
5,209.5
|
|
|
$
|
5,150.4
|
|
|
$
|
4,807.6
|
|
Cost of sales
|
|
|
909.3
|
|
|
|
1,155.2
|
|
|
|
1,200.9
|
|
|
|
1,111.3
|
|
Operating expenses
|
|
|
2,785.9
|
|
|
|
2,602.2
|
|
|
|
2,651.6
|
|
|
|
2,427.6
|
|
Acquired in-process research and development
|
|
|
4,685.4
|
|
|
|
28.0
|
|
|
|
35.0
|
|
|
|
87.0
|
|
Asset impairments, restructuring, and other special charges
|
|
|
80.0
|
|
|
|
1,659.4
|
|
|
|
88.9
|
|
|
|
145.7
|
|
Othernet, expense (income)
|
|
|
81.2
|
|
|
|
(2.5)
|
|
|
|
(32.3)
|
|
|
|
(20.3)
|
|
Income (loss) before income taxes
|
|
|
(3,337.4)
|
|
|
|
(232.8)
|
|
|
|
1,206.3
|
|
|
|
1,056.3
|
|
Net income
(loss)1
|
|
|
(3,629.4)
|
|
|
|
(465.6)
|
|
|
|
958.8
|
|
|
|
1,064.3
|
|
Earnings (loss) per sharebasic and diluted
|
|
|
(3.31)
|
|
|
|
(.43)
|
|
|
|
.88
|
|
|
|
.97
|
|
Dividends paid per share
|
|
|
.47
|
|
|
|
.47
|
|
|
|
.47
|
|
|
|
.47
|
|
Common stock closing prices
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
High
|
|
|
43.69
|
|
|
|
49.25
|
|
|
|
53.06
|
|
|
|
57.18
|
|
Low
|
|
|
29.91
|
|
|
|
43.92
|
|
|
|
45.61
|
|
|
|
47.81
|
|
Our common stock is listed on the New York, London, and Swiss
stock exchanges.
|
|
1 |
We incurred tax expense of $764.3 million in 2008, despite
having a loss before income taxes of $1.31 billion. Our net
loss was driven by the $4.69 billion acquired in-process
research and development (IPR&D) charge for ImClone in the
fourth quarter and the $1.48 billion Zyprexa investigation
settlements recorded in the third quarter. The IPR&D charge
was not tax deductible, and only a portion of the Zyprexa
investigation settlements was deductible. In addition, we
recorded tax expense associated with the ImClone acquisition in
the fourth quarter in 2008, as well as a discrete income tax
benefit of $210.3 million in the first quarter of 2008 for
the resolution of a substantial portion of the
2001-2004
Internal Revenue Service (IRS) audit.
|
40
Selected
Financial Data (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ELI LILLY AND COMPANY AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
|
|
(Dollars in millions, except total revenue per employee and
per-share data)
|
|
2009
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
|
|
Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
21,836.0
|
|
|
$
|
20,371.9
|
|
|
$
|
18,633.5
|
|
|
$
|
15,691.0
|
|
|
$
|
14,645.3
|
|
Cost of sales
|
|
|
4,247.0
|
|
|
|
4,376.7
|
|
|
|
4,248.8
|
|
|
|
3,546.5
|
|
|
|
3,474.2
|
|
Research and development
|
|
|
4,326.5
|
|
|
|
3,840.9
|
|
|
|
3,486.7
|
|
|
|
3,129.3
|
|
|
|
3,025.5
|
|
Marketing, selling, and administrative
|
|
|
6,892.5
|
|
|
|
6,626.4
|
|
|
|
6,095.1
|
|
|
|
4,889.8
|
|
|
|
4,497.0
|
|
Other
|
|
|
1,012.2
|
|
|
|
6,835.51
|
|
|
|
926.1
|
|
|
|
707.4
|
|
|
|
931.1
|
|
Income (loss) before income taxes and cumulative effect of a
change in accounting principle
|
|
|
5,357.8
|
|
|
|
(1,307.6)
|
|
|
|
3,876.8
|
|
|
|
3,418.0
|
|
|
|
2,717.5
|
|
Income taxes
|
|
|
1,029.0
|
|
|
|
764.3
|
|
|
|
923.8
|
|
|
|
755.3
|
|
|
|
715.9
|
|
Net income (loss)
|
|
|
4,328.8
|
|
|
|
(2,071.9)
|
|
|
|
2,953.0
|
|
|
|
2,662.7
|
|
|
|
1,979.6
|
|
Net income as a percent of revenue
|
|
|
19.8%
|
|
|
|
NM
|
|
|
|
15.8%
|
|
|
|
17.0%
|
|
|
|
13.5%
|
|
Net income (loss) per share diluted
|
|
|
3.94
|
|
|
|
(1.89)
|
|
|
|
2.71
|
|
|
|
2.45
|
|
|
|
1.81
|
|
Dividends declared per share
|
|
|
1.96
|
|
|
|
1.90
|
|
|
|
1.75
|
|
|
|
1.63
|
|
|
|
1.54
|
|
Weighted-average number of shares outstandingdiluted
(thousands)
|
|
|
1,098,367
|
|
|
|
1,094,499
|
|
|
|
1,090,750
|
|
|
|
1,087,490
|
|
|
|
1,092,150
|
|
|
|
|
|
|
|
Financial Position
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets
|
|
$
|
12,486.5
|
|
|
$
|
12,453.3
|
|
|
$
|
12,316.1
|
|
|
$
|
9,753.6
|
|
|
$
|
10,855.0
|
|
Current liabilities
|
|
|
6,568.1
|
|
|
|
13,109.7
|
|
|
|
5,436.8
|
|
|
|
5,254.0
|
|
|
|
5,884.8
|
|
Property and equipmentnet
|
|
|
8,197.4
|
|
|
|
8,626.3
|
|
|
|
8,575.1
|
|
|
|
8,152.3
|
|
|
|
7,912.5
|
|
Total assets
|
|
|
27,460.9
|
|
|
|
29,212.6
|
|
|
|
26,874.8
|
|
|
|
22,042.4
|
|
|
|
24,667.8
|
|
Long-term debt
|
|
|
6,634.7
|
|
|
|
4,615.7
|
|
|
|
4,593.5
|
|
|
|
3,494.4
|
|
|
|
5,763.5
|
|
Shareholders equity
|
|
|
9,525.3
|
|
|
|
6,737.7
|
|
|
|
13,510.3
|
|
|
|
10,825.3
|
|
|
|
10,636.6
|
|
|
|
|
|
|
|
Supplementary Data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Return on shareholders equity
|
|
|
51.0%
|
|
|
|
(16.3)%
|
|
|
|
24.3%
|
|
|
|
24.8%
|
|
|
|
18.5%
|
|
Return on assets
|
|
|
15.8%
|
|
|
|
(7.5)%
|
|
|
|
12.1%
|
|
|
|
11.1%
|
|
|
|
8.2%
|
|
Capital expenditures
|
|
$
|
765.0
|
|
|
$
|
947.2
|
|
|
$
|
1,082.4
|
|
|
$
|
1,077.8
|
|
|
$
|
1,298.1
|
|
Depreciation and amortization
|
|
|
1,297.8
|
|
|
|
1,122.6
|
|
|
|
1,047.9
|
|
|
|
801.8
|
|
|
|
726.4
|
|
Effective tax rate
|
|
|
19.2%
|
|
|
|
NM 2
|
|
|
|
23.8%
|
|
|
|
22.1%
|
|
|
|
26.3%
|
|
Revenue per employee
|
|
$
|
540,000
|
|
|
$
|
504,000
|
|
|
$
|
459,000
|
|
|
$
|
378,000
|
|
|
$
|
344,000
|
|
Number of employees
|
|
|
40,360
|
|
|
|
40,450
|
|
|
|
40,600
|
|
|
|
41,500
|
|
|
|
42,600
|
|
Number of shareholders of record
|
|
|
38,400
|
|
|
|
39,800
|
|
|
|
41,700
|
|
|
|
44,800
|
|
|
|
50,800
|
|
|
|
|
|
|
|
NMNot Meaningful
|
|
1
|
The increase reflects the in-process research and development
expense of $4.69 billion associated with the ImClone
acquisition and $1.48 billion associated with the Zyprexa
investigation settlements.
|
|
2
|
We incurred tax expense of $764.3 million in 2008, despite
having a loss before income taxes of $1.31 billion. Our net
loss was driven by the $4.69 billion acquired IPR&D
charge for ImClone and the $1.48 billion Zyprexa
investigation settlements. The IPR&D charge was not tax
deductible, and only a portion of the Zyprexa investigation
settlements was deductible. In addition, we recorded tax expense
associated with the ImClone acquisition, as well as a discrete
income tax benefit of $210.3 million for the resolution of
a substantial portion of the
2001-2004
IRS audit.
|
41
PERFORMANCE
GRAPH
This graph compares the return on Lilly stock with that of the
Standard & Poors 500 Stock Index and our peer
group for the years 2005 through 2009. The graph assumes that,
on December 31, 2004, a person invested $100 each in Lilly
stock, the S&P 500 Stock Index, and the peer groups
common stock. The graph measures total shareholder return, which
takes into account both stock price and dividends. It assumes
that dividends paid by a company are reinvested in that
companys stock.
Value
of $100 Invested on Last Business Day of 2004
Comparison of Five-Year Cumulative Total Return Among Lilly,
S&P 500 Stock Index, Peer
Group1,
and Peer Group
(Previous)2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Peer Group
|
|
|
|
|
Lilly
|
|
Peer Group
|
|
(Previous)
|
|
S&P 500
|
|
|
Dec-04
|
|
$
|
100.00
|
|
|
$
|
100.00
|
|
|
$
|
100.00
|
|
|
$
|
100.00
|
|
Dec-05
|
|
$
|
102.53
|
|
|
$
|
103.28
|
|
|
$
|
99.29
|
|
|
$
|
104.90
|
|
Dec-06
|
|
$
|
97.18
|
|
|
$
|
116.07
|
|
|
$
|
112.42
|
|
|
$
|
121.43
|
|
Dec-07
|
|
$
|
102.70
|
|
|
$
|
116.21
|
|
|
$
|
114.87
|
|
|
$
|
128.09
|
|
Dec-08
|
|
$
|
80.74
|
|
|
$
|
99.55
|
|
|
$
|
97.59
|
|
|
$
|
80.77
|
|
Dec-09
|
|
$
|
75.80
|
|
|
$
|
113.46
|
|
|
$
|
108.78
|
|
|
$
|
102.08
|
|
|
|
1
|
We constructed the peer group as the industry index for this
graph. It comprises the ten companies in the pharmaceutical
industry that we used to benchmark 2009 compensation of
executive officers: Abbott Laboratories; Amgen Inc.; AstraZeneca
PLC; Bristol-Myers Squibb Company; GlaxoSmithKline plc;
Johnson & Johnson; Merck & Co., Inc.;
Novartis AG.; Pfizer Inc.; and Sanofi-Aventis.
|
|
2
|
Due to changes in the pharmaceutical industry, the peer group
used to benchmark 2008 compensation of executive officers was
revised, with the previous peer group consisting of the
following companies: Abbott Laboratories; Amgen Inc.;
Bristol-Myers Squibb Company; GlaxoSmithKline plc;
Johnson & Johnson; Merck & Co., Inc.; Pfizer
Inc.; Schering-Plough Corporation; and Wyeth. The Peer Group
(Previous) excludes Schering-Plough Corporation and Wyeth as
both companies were acquired during 2009.
|
42
Notes
to Consolidated Financial Statements
ELI
LILLY AND COMPANY AND SUBSIDIARIES
(Dollars in millions, except per-share data)
|
|
Note 1:
|
Summary
of Significant Accounting Policies
|
Basis of presentation: The accompanying
consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the
United States (GAAP). The accounts of all
wholly-owned
and majority-owned subsidiaries are included in the consolidated
financial statements. Where our ownership of consolidated
subsidiaries is less than 100 percent, the non-controlling
shareholders interests are reflected in shareholders
equity. All intercompany balances and transactions have been
eliminated.
The preparation of financial statements in conformity with GAAP
requires management to make estimates and assumptions that
affect the reported amounts of assets, liabilities, revenues,
expenses, and related disclosures at the date of the financial
statements and during the reporting period. Actual results could
differ from those estimates. We issued our financial statements
by filing with the Securities and Exchange Commission on
February 22, 2010. We have evaluated subsequent events up
to the time of the filing.
All per-share amounts, unless otherwise noted in the footnotes,
are presented on a diluted basis, that is, based on the
weighted-average number of outstanding common shares plus the
effect of dilutive stock options and other incremental shares.
Cash equivalents: We consider all highly
liquid investments with a maturity of three months or less from
the date of purchase to be cash equivalents. The cost of these
investments approximates fair value.
Inventories: We state all inventories at the
lower of cost or market. We use the
last-in,
first-out (LIFO) method for the majority of our inventories
located in the continental United States, or approximately
40 percent of our total inventories. Other inventories are
valued by the
first-in,
first-out (FIFO) method. FIFO cost approximates current
replacement cost. Inventories at December 31 consisted of the
following:
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
Finished products
|
|
$
|
938.3
|
|
|
$
|
771.0
|
|
Work in process
|
|
|
1,830.1
|
|
|
|
1,657.1
|
|
Raw materials and supplies
|
|
|
227.8
|
|
|
|
236.3
|
|
|
|
|
|
|
|
|
|
|
2,996.2
|
|
|
|
2,664.4
|
|
Reduction to LIFO cost
|
|
|
(146.3
|
)
|
|
|
(171.2
|
)
|
|
|
|
|
|
|
|
|
$
|
2,849.9
|
|
|
$
|
2,493.2
|
|
|
|
|
|
|
|
Investments: Substantially all of our
investments in debt and marketable equity securities are
classified as
available-for-sale.
Investment securities with maturity dates of less than one year
from the date of the balance sheet are classified as short-term.
Available-for-sale
securities are carried at fair value with the unrealized gains
and losses, net of tax, reported in other comprehensive income
(loss). The credit portion of unrealized losses on our debt
securities considered to be
other-than-temporary
are recognized in earnings. The remaining portion of the
other-than-temporary
impairment on our debt securities is then recorded in other
comprehensive income (loss). The entire amount of
other-than-temporary
impairment on our equity securities is recognized in earnings.
We do not evaluate cost-method investments for impairment unless
there is an indicator of impairment. We review these investments
for indicators of impairment on a regular basis. Realized gains
and losses on sales of
available-for-sale
securities are computed based upon specific identification of
the initial cost adjusted for any
other-than-temporary
declines in fair value that were recorded in earnings.
Investments in companies over which we have significant
influence but not a controlling interest are accounted for using
the equity method with our share of earnings or losses reported
in othernet, expense (income). We own no
investments that are considered to be trading securities.
Risk-management instruments: Our derivative
activities are initiated within the guidelines of documented
corporate risk-management policies and do not create additional
risk because gains and losses on derivative contracts offset
losses and gains on the assets, liabilities, and transactions
being hedged. As derivative contracts are initiated, we
designate the instruments individually as either a fair value
hedge or a cash flow hedge. Management reviews the correlation
and effectiveness of our derivatives on a quarterly basis.
For derivative contracts that are designated and qualify as fair
value hedges, the derivative instrument is marked to market with
gains and losses recognized currently in income to offset the
respective losses and gains recognized on the underlying
exposure. For derivative contracts that are designated and
qualify as cash flow hedges, the effective portion of gains and
losses on these contracts is reported as a component of other
comprehensive income (loss) and reclassified into earnings in
the same period the hedged
43
transaction affects earnings. Hedge ineffectiveness is
immediately recognized in earnings. Derivative contracts that
are not designated as hedging instruments are recorded at fair
value with the gain or loss recognized in current earnings
during the period of change.
We may enter into foreign currency forward and option contracts
to reduce the effect of fluctuating currency exchange rates
(principally the euro, the British pound, and the Japanese yen).
Foreign currency derivatives used for hedging are put in place
using the same or like currencies and duration as the underlying
exposures. Forward contracts are principally used to manage
exposures arising from subsidiary trade and loan payables and
receivables denominated in foreign currencies. These contracts
are recorded at fair value with the gain or loss recognized in
othernet, expense (income). The purchased option
contracts are used to hedge anticipated foreign currency
transactions, primarily intercompany inventory activities
expected to occur within the next year. These contracts are
designated as cash flow hedges of those future transactions and
the impact on earnings is included in cost of sales. We may
enter into foreign currency forward contracts and currency swaps
as fair value hedges of firm commitments. Forward and option
contracts generally have maturities not exceeding 12 months.
In the normal course of business, our operations are exposed to
fluctuations in interest rates. These fluctuations can vary the
costs of financing, investing, and operating. We address a
portion of these risks through a controlled program of risk
management that includes the use of derivative financial
instruments. The objective of controlling these risks is to
limit the impact of fluctuations in interest rates on earnings.
Our primary interest rate risk exposure results from changes in
short-term U.S. dollar interest rates. In an effort to
manage interest rate exposures, we strive to achieve an
acceptable balance between fixed and floating rate debt and
investment positions and may enter into interest rate swaps or
collars to help maintain that balance. Interest rate swaps or
collars that convert our fixed-rate debt or investments to a
floating rate are designated as fair value hedges of the
underlying instruments. Interest rate swaps or collars that
convert floating rate debt or investments to a fixed rate are
designated as cash flow hedges. Interest expense on the debt is
adjusted to include the payments made or received under the swap
agreements.
Goodwill and other intangibles: Goodwill is
not amortized. All other intangibles arising from acquisitions
and research alliances have finite lives and are amortized over
their estimated useful lives, ranging from 5 to
20 years, using the straight-line method. The remaining
weighted-average amortization period for developed product
technology is approximately 11 years. Amortization expense
for 2009, 2008, and 2007 was $277.0 million,
$193.4 million, and $172.8 million before tax,
respectively. The estimated amortization expense for each of the
five succeeding years approximates $280.0 million before
tax, per year. Substantially all of the amortization expense is
included in cost of sales. See Note 3 for further
discussion of goodwill and other intangibles acquired in 2009,
2008, and 2007.
Goodwill and other intangible assets at December 31 were as
follows:
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
Goodwill
|
|
$
|
1,175.0
|
|
|
$
|
1,167.5
|
|
|
|
|
|
|
|
|
|
|
Developed product technologygross
|
|
|
3,035.4
|
|
|
|
3,035.4
|
|
Less accumulated amortization
|
|
|
(612.8
|
)
|
|
|
(346.6
|
)
|
|
|
|
|
|
|
Developed product technologynet
|
|
|
2,422.6
|
|
|
|
2,688.8
|
|
|
|
|
|
|
|
|
|
|
Other intangiblesgross
|
|
|
158.4
|
|
|
|
118.2
|
|
Less accumulated amortization
|
|
|
(56.2
|
)
|
|
|
(45.4
|
)
|
|
|
|
|
|
|
Other intangiblesnet
|
|
|
102.2
|
|
|
|
72.8
|
|
|
|
|
|
|
|
Total intangiblesnet
|
|
$
|
3,699.8
|
|
|
$
|
3,929.1
|
|
|
|
|
|
|
|
Goodwill and net other intangibles are reviewed to assess
recoverability at least annually and when certain impairment
indicators are present. No significant impairments occurred with
respect to the carrying value of our goodwill or other
intangible assets in 2009, 2008, or 2007.
Property and equipment: Property and equipment
is stated on the basis of cost. Provisions for depreciation of
buildings and equipment are computed generally by the
straight-line method at rates based on their estimated useful
lives (12 to 50 years for buildings and 3 to 18 years
for equipment). We review the carrying value of long-lived
assets for potential impairment on a periodic basis and whenever
events or changes in circumstances indicate the carrying value
of an asset may not be recoverable. Impairment is determined by
comparing projected undiscounted cash flows to be generated by
the asset to its carrying value. If an impairment is identified,
a loss is recorded equal to the excess of the assets net
book value over its fair value, and the cost basis is adjusted.
44
At December 31, property and equipment consisted of the
following:
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
Land
|
|
$
|
216.8
|
|
|
$
|
219.0
|
|
Buildings
|
|
|
6,121.9
|
|
|
|
5,953.4
|
|
Equipment
|
|
|
7,813.0
|
|
|
|
8,045.2
|
|
Construction in progress
|
|
|
948.3
|
|
|
|
1,098.3
|
|
|
|
|
|
|
|
|
|
|
15,100.0
|
|
|
|
15,315.9
|
|
Less accumulated depreciation
|
|
|
(6,902.6
|
)
|
|
|
(6,689.6
|
)
|
|
|
|
|
|
|
|
|
$
|
8,197.4
|
|
|
$
|
8,626.3
|
|
|
|
|
|
|
|
Depreciation expense for 2009, 2008, and 2007 was
$813.5 million, $731.7 million, and
$682.3 million, respectively. Interest costs of
$30.2 million, $48.2 million, and $95.3 million
were capitalized as part of property and equipment in 2009,
2008, and 2007, respectively. Total rental expense for all
leases, including contingent rentals (not material), amounted to
$337.8 million, $327.4 million, and
$294.2 million for 2009, 2008, and 2007, respectively.
Assets under capital leases included in property and equipment
in the consolidated balance sheets, capital lease obligations
entered into, and future minimum rental commitments are not
material.
Litigation and environmental
liabilities: Litigation accruals and
environmental liabilities and the related estimated insurance
recoverables are reflected on a gross basis as liabilities and
assets, respectively, on our consolidated balance sheets. With
respect to the product liability claims currently asserted
against us, we have accrued for our estimated exposures to the
extent they are both probable and estimable based on the
information available to us. We accrue for certain product
liability claims incurred but not filed to the extent we can
formulate a reasonable estimate of their costs. We estimate
these expenses based primarily on historical claims experience
and data regarding product usage. Legal defense costs expected
to be incurred in connection with significant product liability
loss contingencies are accrued when probable and reasonably
estimable. A portion of the costs associated with defending and
disposing of these suits is covered by insurance. We record
receivables for insurance-related recoveries when it is probable
they will be realized. These receivables are classified as a
reduction of the litigation charges on the statement of
operations. We estimate insurance recoverables based on existing
deductibles, coverage limits, our assessment of any defenses to
coverage that might be raised by the carriers, and the existing
and projected future level of insolvencies among the insurance
carriers. However, for substantially all of our currently
marketed products, we are completely self-insured for future
product liability losses.
Revenue recognition: We recognize revenue from
sales of products at the time title of goods passes to the buyer
and the buyer assumes the risks and rewards of ownership. For
more than 85 percent of our sales, this is at the time
products are shipped to the customer, typically a wholesale
distributor or a major retail chain. The remaining sales are
recorded at the point of delivery. Provisions for returns,
discounts, and rebates are established in the same period the
related sales are recorded.
We also generate income as a result of collaboration agreements.
Revenue from co-promotion services is based upon net sales
reported by our co-promotion partners and, if applicable, the
number of sales calls we perform. Initial fees we receive from
the partnering of our compounds under development are amortized
through the expected product approval date. Initial fees
received from out-licensing agreements that include both the
sale of marketing rights to our commercialized products and a
related commitment to supply the products are generally
recognized in net product sales over the term of the supply
agreement. We immediately recognize the full amount of
developmental milestone payments due to us upon the achievement
of the milestone event if the event is substantive, objectively
determinable, and represents an important point in the
development life cycle of the pharmaceutical product. Milestone
payments earned by us are generally recorded in
othernet, expense (income). If the payment to us is
a commercialization payment that is part of a multiple-element
collaborative commercialization arrangement and is a result of
the initiation of the commercialization period (e.g., payments
triggered by regulatory approval for marketing or launch of the
product), we amortize the payment to income as we perform under
the terms of the arrangement.
Royalty revenue from licensees, which are based on third-party
sales of licensed products and technology, are recorded as
earned in accordance with the contract terms when third-party
sales can be reasonably measured and collection of the funds is
reasonably assured. This royalty revenue is included in
collaboration and other revenue.
45
Following is the composition of revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
|
|
Net product sales
|
|
$
|
21,171.5
|
|
|
$
|
19,925.8
|
|
|
$
|
18,174.7
|
|
Collaboration and other revenue (Note 4)
|
|
|
664.5
|
|
|
|
446.1
|
|
|
|
458.8
|
|
|
|
|
|
|
|
Total revenue
|
|
$
|
21,836.0
|
|
|
$
|
20,371.9
|
|
|
$
|
18,633.5
|
|
|
|
|
|
|
|
Acquired research and development: We
recognize as incurred the cost of directly acquiring assets to
be used in the research and development process that have not
yet received regulatory approval for marketing and for which no
alternative future use has been identified. Beginning in 2009,
in process research and development acquired in a business
combination is capitalized at the fair value as of the time of
the acquisition. For in-process research and development assets
acquired in both direct acquisitions and business combinations,
once the product has obtained regulatory approval, we capitalize
any milestones paid and amortize them over the period benefited.
Milestones paid prior to regulatory approval of the product are
generally expensed when the event requiring payment of the
milestone occurs.
Othernet, expense
(income): Othernet, expense (income)
consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
|
|
Interest expense
|
|
$
|
261.3
|
|
|
$
|
228.3
|
|
|
$
|
228.3
|
|
Interest income
|
|
|
(75.2
|
)
|
|
|
(210.7
|
)
|
|
|
(215.3
|
)
|
Other
|
|
|
43.4
|
|
|
|
8.5
|
|
|
|
(135.0
|
)
|
|
|
|
|
|
|
|
|
$
|
229.5
|
|
|
$
|
26.1
|
|
|
$
|
(122.0
|
)
|
|
|
|
|
|
|
Income taxes: Deferred taxes are recognized
for the future tax effects of temporary differences between
financial and income tax reporting based on enacted tax laws and
rates. Federal income taxes are provided on the portion of the
income of foreign subsidiaries that is expected to be remitted
to the United States and be taxable.
We recognize the tax benefit from an uncertain tax position only
if it is more likely than not that the tax position will be
sustained on examination by the taxing authorities, based on the
technical merits of the position. The tax benefits recognized in
the financial statements from such a position are measured based
on the largest benefit that has a greater than 50 percent
likelihood of being realized upon ultimate resolution.
Earnings per share: We calculate basic
earnings per share based on the weighted-average number of
outstanding common shares and incremental shares. We calculate
diluted earnings per share based on the weighted-average number
of outstanding common shares plus the effect of dilutive stock
options and other incremental shares. See Note 11 for
further discussion.
Stock-based compensation: We recognize the
fair value of stock-based compensation as expense over the
requisite service period of the individual grantees, which
generally equals the vesting period. Under our policy all
stock-based awards are approved prior to the date of grant. The
Compensation Committee of the Board of Directors approves the
value of the award and date of grant. Stock-based compensation
that is awarded as part of our annual equity grant is made on a
specific grant date scheduled in advance.
Reclassifications: Certain reclassifications
have been made to the December 31, 2008 and 2007
consolidated financial statements and accompanying notes to
conform with the December 31, 2009 presentation.
Note 2: Implementation
of New Financial Accounting Pronouncements
The Financial Accounting Standards Board (FASB) Statement on
Business Combinations was effective for us for business
combinations with the acquisition date on or after
January 1, 2009. This Statement, with its amendment,
changes the way in which the acquisition method is to be applied
in a business combination. The primary revisions require an
acquirer in a business combination to measure assets acquired,
liabilities assumed, and any noncontrolling interest in the
acquiree at the acquisition date, at their fair values as of
that date, with limited exceptions specified in the Statement.
This Statement also requires the acquirer in a business
combination achieved in stages to recognize the identifiable
assets and liabilities, as well as the noncontrolling interest
in the acquiree, at the full amounts of their fair values (or
other amounts determined in accordance with the Statement).
Assets acquired and liabilities assumed arising from
contingencies are to be measured at fair value if it can be
determined during the measurement period. If fair value cannot
be determined, the asset or liability should be recognized at
the acquisition date if it is probable that an asset existed or
a liability had been incurred and the amount can be reasonably
estimated. This Statement significantly amends other
authoritative guidance on Business
46
Combinations as well, and now requires the capitalization of
research and development assets acquired in a business
combination at their acquisition-date fair values, separately
from goodwill. The accounting for income taxes was also amended
by this Statement to require the acquirer to recognize changes
in the amount of its deferred tax benefits that are recognizable
because of a business combination either in income from
continuing operations in the period of the combination or
directly in contributed capital, depending on the circumstances.
We adopted the provisions of the FASB Statement on
Consolidations relating to the accounting for noncontrolling
interests on January 1, 2009. This Statement amends
previous authoritative guidance, by requiring companies to
report a noncontrolling interest in a subsidiary as equity in
its consolidated financial statements. Disclosure of the amounts
of consolidated net income attributable to the parent and the
noncontrolling interest will be required. This Statement also
clarifies that transactions that result in a change in a
parents ownership interest in a subsidiary that do not
result in deconsolidation will be treated as equity
transactions, while a gain or loss will be recognized by the
parent when a subsidiary is deconsolidated. We now classify our
noncontrolling interest in a subsidiary as part of
shareholders equity in our consolidated statements of
financial position at December 31, 2009 and reclassified
the December 31, 2008 balances accordingly. The net income
attributed to the noncontrolling interest in a subsidiary for
2009 and 2008 is not material and is included in
other-net,
expense (income).
We adopted the provisions of the FASB Statement on disclosures
relating to Derivatives and Hedging on January 1, 2009.
This Statement requires entities to provide enhanced disclosures
about how and why an entity uses derivative instruments, how
derivative instruments and related hedged items are accounted
for, and how derivative instruments and related hedged items
affect an entitys financial position, results of
operations, and cash flows. These disclosures are included in
Note 6.
We adopted the provisions of the Emerging Issues Task Force
(EITF) guidance related to Collaborative Arrangements on
January 1, 2009. This guidance defines collaborative
arrangements and establishes reporting requirements for
transactions between participants in a collaborative arrangement
and between participants in the arrangement and third parties.
This guidance has been applied retrospectively to all prior
periods presented for significant collaborative arrangements
existing as of the effective date by classifying revenues into
two separate components: net product sales and collaboration and
other revenue. See Note 4 for additional information.
We adopted the provisions of the FASB Staff Position (FSP)
relating to Investments on January 1, 2009. This FSP amends
the
other-than-temporary
recognition guidance for debt securities and requires additional
interim and annual disclosures of
other-than-temporary
impairments on debt and equity securities. Pursuant to the new
guidance, an
other-than-temporary
impairment has occurred if a company does not expect to recover
the entire amortized cost basis of the security. In this
situation, if the company does not intend to sell the impaired
security, and it is not more likely than not it will be required
to sell the security before the recovery of its amortized cost
basis, the amount of the
other-than-temporary
impairment recognized in earnings is limited to the portion
attributed to the credit loss. The remaining portion of the
other-than-temporary
impairment is then recorded in other comprehensive income
(loss). This FSP has been applied to existing and new securities
as of January 1, 2009. The applicable disclosures are
included in Note 6. The implementation of this FSP was not
material to our consolidated financial position or results of
operations and there was no cumulative effect adjustment.
We adopted the provisions of a FSP relating to Fair Value
Measurements and Disclosures, as of March 31, 2009. This
FSP provides additional guidance on estimating fair value when
the volume and level of activity for an asset or liability have
significantly decreased in relation to normal market activity.
The FSP also provides additional guidance on circumstances that
may indicate that a transaction is not orderly and requires
additional disclosures. The implementation of this FSP had no
effect on our consolidated financial position or results of
operations.
We adopted the provisions of a FSP on Financial Instruments, as
of March 31, 2009. This FSP required disclosures about fair
value of all financial instruments for interim reporting
periods. The implementation of this FSP had no effect on our
consolidated financial position or results of operations.
We adopted the provisions of a FSP on
CompensationRetirement Benefits, as of December 31,
2009. This FSP required disclosures about plan assets of a
defined benefit pension or other postretirement plan. The
applicable disclosures are included in Note 13. The
implementation of this FSP had no effect on our consolidated
financial position or results of operations.
During 2009, we adopted the provisions of the FASB Statement on
Subsequent Events. This Statement provides authoritative
accounting literature and disclosure requirements for material
events occurring subsequent to the balance sheet date and prior
to the issuance of the financial statements. The implementation
of this Statement had no effect on our consolidated financial
position or results of operations.
47
In 2009, the FASB issued a Statement on Transfers and Servicing,
an amendment of previous authoritative guidance. The most
significant amendments resulting from this Statement consist of
the removal of the concept of a qualifying special-purpose
entity (SPE) from previous authoritative guidance, and the
elimination of the exception for qualifying SPEs from the
Consolidation guidance regarding variable interest entities.
This Statement is effective for us January 1, 2010 and is
not expected to be material to our consolidated financial
position or results of operations.
In 2009, the FASB issued a Statement which amends the previous
Consolidations guidance regarding variable interest entities and
addresses the effects of eliminating the qualifying SPE concept
from the guidance on Transfers and Servicing. This Statement
responds to concerns about the application of certain key
provisions of the previous guidance on Consolidations regarding
variable interest entities, including concerns over the
transparency of enterprises involvement with variable
interest entities. This Statement is effective for us
January 1, 2010 and is not expected to be material to our
consolidated financial position or results of operations.
In 2009, the FASB ratified EITF guidance related to Revenue
Recognition that amends the previous guidance on arrangements
with multiple deliverables. This guidance provides principles
and application guidance on whether multiple deliverables exist,
how the arrangements should be separated, and how the
consideration should be allocated. It also clarifies the method
to allocate revenue in an arrangement using the estimated
selling price. This guidance is effective for us January 1,
2011 and is not expected to be material to our consolidated
financial position or results of operations.
Note 3: Acquisitions
During 2008 and 2007 we acquired several businesses. These
acquisitions were accounted for as business combinations under
the purchase method of accounting. Under the purchase method of
accounting, the assets acquired and liabilities assumed were
recorded at their respective fair values as of the acquisition
date in our consolidated financial statements. The determination
of estimated fair value required management to make significant
estimates and assumptions. The excess of the purchase price over
the fair value of the acquired net assets, where applicable, has
been recorded as goodwill. The results of operations of these
acquisitions are included in our consolidated financial
statements from the date of acquisition.
Most of these acquisitions included IPR&D, which
represented compounds, new indications, or line extensions under
development that had not yet achieved regulatory approval for
marketing. There are several methods that can be used to
determine the estimated fair value of the IPR&D acquired in
a business combination. We utilized the income
method, which applies a probability weighting to the
estimated future net cash flows that are derived from projected
sales revenues and estimated costs. These projections are based
on factors such as relevant market size, patent protection,
historical pricing of similar products, and expected industry
trends. The estimated future net cash flows are then discounted
to the present value using an appropriate discount rate. This
analysis is performed for each project independently. Pursuant
to the existing rules, these acquired IPR&D intangible
assets totaling $4.71 billion and $340.5 million in
2008 and 2007, respectively, were expensed immediately
subsequent to the acquisition because the products had no
alternative future use. The ongoing expenses with respect to
each of these products in development are not material to our
total research and development expense currently and are not
expected to be material to our total research and development
expense on an annual basis in the future.
In addition to the acquisitions of businesses, we also acquired
several products in development. The acquired IPR&D related
to these products of $90.0 million, $122.0 million,
and $405.1 million in 2009, 2008, and 2007, respectively,
was also written off by a charge to income immediately upon
acquisition because the products had no alternative future use.
ImClone
Acquisition
On November 24, 2008, we acquired all of the outstanding
shares of ImClone Systems Inc. (ImClone), a biopharmaceutical
company focused on advancing oncology care, for a total purchase
price of approximately $6.5 billion, which was financed
through borrowings. This strategic combination offered both
targeted therapies and oncolytic agents along with a pipeline
spanning all phases of clinical development. The combination
also expanded our biotechnology capabilities.
The acquisition was accounted for as a business combination
under the purchase method of accounting, resulting in goodwill
of $425.9 million. No portion of this goodwill was or is
expected to be deductible for tax purposes.
48
Allocation of
Purchase Price
The purchase price was allocated based on the fair value of
assets acquired and liabilities assumed as of the date of
acquisition.
|
|
|
|
|
|
|
Fair Value
|
|
|
|
at November 24,
|
|
|
|
2008
|
|
|
|
|
Cash and short-term investments
|
|
$
|
982.9
|
|
Inventories
|
|
|
136.2
|
|
Developed product technology
(Erbitux)1
|
|
|
1,057.9
|
|
Goodwill
|
|
|
425.9
|
|
Property and equipment
|
|
|
338.9
|
|
Debt assumed
|
|
|
(600.0
|
)
|
Deferred taxes
|
|
|
(311.5
|
)
|
Deferred income
|
|
|
(127.7
|
)
|
Other assets and liabilitiesnet
|
|
|
(81.1
|
)
|
Acquired in-process research and development
|
|
|
4,685.4
|
|
|
|
|
|
|
Total purchase price
|
|
$
|
6,506.9
|
|
|
|
|
|
|
|
|
1 |
This intangible asset is being amortized on a straight-line
basis through 2023 in the U.S. and 2018 in the rest of the world.
|
All of the estimated fair value of the acquired IPR&D was
attributable to oncology-related products in development,
including $1.33 billion to line extensions for Erbitux. A
significant portion (81 percent) of the remaining value of
acquired IPR&D was attributable to ramucirumab,
necitumumab, and cixutumumab. At the time of the acquisition,
ramucirumab was in Phase III clinical testing, while
necitumumab and cixutumumab were in Phase II clinical
testing. The discount rate we used in valuing the acquired
IPR&D projects was 13.5 percent, and the charge for
acquired IPR&D of $4.69 billion recorded in the fourth
quarter of 2008 was not deductible for tax purposes.
Pro Forma
Financial Information (unaudited)
The following pro forma financial information presents the
combined results of our operations with ImClone as if the
acquisition and the financing for the acquisition had occurred
as of the beginning of each of the years presented. We have
adjusted the historical consolidated financial information to
give effect to pro forma events that are directly attributable
to the acquisition. The pro forma financial information is not
necessarily indicative of what our consolidated results of
operations actually would have been had we completed the
acquisition at the beginning of each year. In addition, the pro
forma financial information does not attempt to project the
future results of operations of our combined company.
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
Revenue
|
|
$
|
20,732.2
|
|
|
$
|
19,051.4
|
|
Net
income1
|
|
|
2,356.2
|
|
|
|
2,704.1
|
|
Earnings per share:
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
|
2.15
|
|
|
|
2.48
|
|
|
|
1 |
The pro forma financial information above excludes the
non-recurring charge incurred for acquired IPR&D of
$4.69 billion and other merger-related costs.
|
The pro forma financial information above reflects the following:
|
|
|
|
|
a reduction of the amortization of ImClones deferred
income of $86.2 million (2008) and $98.4 million
(2007);
|
|
|
|
the increase of amortization expense of $78.8 million in
2008 and 2007 related to the estimated fair value of
identifiable intangible assets from the purchase price
allocation which are being amortized over their estimated useful
lives through 2023 in the U.S. and through 2018 in the rest
of the world. The change in depreciation expense related to the
change in the estimated fair value of property and equipment
from the book value at the time of the acquisition was not
material;
|
|
|
|
the adjustment to increase interest expense related to the debt
incurred to finance the acquisition and the adjustment to
decrease interest income related to the lost interest income on
the cash used to purchase ImClone by a total of
$301.0 million in 2008 and 2007;
|
49
|
|
|
|
|
the reduction of ImClones income tax expense to provide
for income taxes at the statutory tax rate and the adjustment to
income taxes for pro forma adjustments at the statutory tax
rate, totaling $139.3 million (2008) and
$189.5 million (2007). This excludes the acquired
IPR&D charge of $4.69 billion, which was not tax
deductible;
|
|
|
|
certain reclassifications to conform to accounting policies and
classifications that are consistent with our practices (e.g.,
ImClones license fees and milestones were classified as
othernet, expense (income), rather than net sales).
|
Posilac
On October 1, 2008, we acquired the worldwide rights to the
dairy cow supplement Posilac, as well as the products
supporting operations, from Monsanto Company (Monsanto). The
acquisition of Posilac provides us with a product that
complements those of our animal health business. Under the terms
of the agreement, we acquired the rights to the Posilac brand,
as well as the products U.S. sales force and
manufacturing facility, for an aggregate purchase price of
$403.9 million, which included a $300.0 million
upfront payment, transaction costs, and an accrual for
contingent consideration to Monsanto based on estimated future
Posilac sales for which payment is considered likely beyond a
reasonable doubt.
This acquisition has been accounted for as a business
combination under the purchase method of accounting. We
allocated $204.3 million to identifiable intangible assets
related to Posilac, $167.6 million to inventories, and
$99.5 million of the purchase price to property and
equipment. We also assumed $67.5 million of liabilities.
Substantially all of the identifiable intangible assets are
being amortized over their estimated remaining useful lives of
20 years. The amount allocated to each of the intangible
assets acquired is deductible for tax purposes.
SGX
Pharmaceuticals, Inc.
On August 20, 2008, we acquired all of the outstanding
common stock of SGX Pharmaceuticals, Inc. (SGX), a collaboration
partner since 2003. The acquisition allows us to integrate
SGXs structure-guided drug discovery platform into our
drug discovery efforts. It also gives us access to
FASTtm,
SGXs fragment-based, protein structure guided drug
discovery technology, and to a portfolio of preclinical oncology
compounds focused on a number of kinase targets. Under the terms
of the agreement, the outstanding shares of SGX common stock
were redeemed for an aggregate purchase price of
$66.8 million.
The acquisition has been accounted for as a business combination
under the purchase method of accounting. We allocated
$29.6 million of the purchase price to deferred tax assets
and $28.0 million to acquired IPR&D. The acquired
IPR&D charge of $28.0 million was recorded in the
third quarter of 2008 and was not deductible for tax purposes.
ICOS
Corporation
On January 29, 2007, we acquired all of the outstanding
common stock of ICOS Corporation (ICOS), our partner in the
Lilly ICOS LLC joint venture for the manufacture and sale of
Cialis for the treatment of erectile dysfunction. The
acquisition brought the full value of Cialis to us and enabled
us to realize operational efficiencies in the further
development, marketing, and selling of this product. The
aggregate cash purchase price of approximately $2.3 billion
was financed through borrowings.
The acquisition has been accounted for as a business combination
under the purchase method of accounting, resulting in goodwill
of $646.7 million. No portion of this goodwill is expected
to be deductible for tax purposes.
The other significant components of the purchase price
allocation were developed product technology (Cialis) of
$1,659.9 million, the tax benefit of net operating losses
of $404.1 million, acquired IPR&D of
$303.5 million, cash and short-term investments of
$197.7 million, deferred tax liability of
$583.5 million and long-term debt assumed of
$275.6 million. The developed product technology is being
amortized over the remaining expected patent lives of Cialis in
each country; patent expiration dates range from 2015 to 2017.
Other
Acquisitions
During the second quarter of 2007, we acquired all of the
outstanding stock of both Hypnion, Inc. (Hypnion), a privately
held neuroscience drug discovery company focused on sleep
disorders, and Ivy Animal Health, Inc. (Ivy), a privately held
applied research and pharmaceutical product development company
focused on the animal health industry, for $445.0 million
in cash.
The acquisition of Hypnion provided us with a broader and more
substantive presence in the area of sleep disorder research and
ownership of LY2624803, a novel Phase II compound with a
dual mechanism of action aimed at promoting better sleep onset
and sleep maintenance. This was Hypnions only significant
asset. For this acquisition, we recorded an acquired IPR&D
charge of $291.1 million, which was not deductible for tax
purposes. Because Hypnion was a development-stage company, the
transaction was
50
accounted for as an acquisition of assets rather than as a
business combination and, therefore, goodwill was not recorded.
The acquisition of Ivy provided us with products that complement
those of our animal health business. This acquisition has been
accounted for as a business combination under the purchase
method of accounting. We allocated $88.7 million of the
purchase price to other identifiable intangible assets,
primarily related to marketed products, $37.0 million to
acquired IPR&D, and $25.0 million to goodwill. The
other identifiable intangible assets are being amortized over
their estimated remaining useful lives of 10 to 20 years.
The $37.0 million allocated to acquired IPR&D was
charged to expense in the second quarter of 2007. Goodwill
resulting from this acquisition was fully allocated to the
animal health business segment. The amount allocated to each of
the intangible assets acquired, including goodwill of
$25.0 million and the acquired IPR&D of
$37.0 million, was deductible for tax purposes.
Product
Acquisitions
In December 2009, we entered into a licensing and collaboration
agreement with Incyte Corporation to acquire rights to its
compound, and certain follow-on compounds, for the treatment of
inflammatory and autoimmune diseases. The lead compound was in
the development stage (Phase II clinical trials for
rheumatoid arthritis) and had no alternative future use. As with
many development-phase compounds, launch of the product, if
approved, was not expected in the near term. The charge of
$90.0 million for acquired IPR&D related to this
arrangement was included in expense in the fourth quarter of
2009 and is deductible for tax purposes. As part of this
agreement, Incyte has the option to co-develop these compounds
and the option to co-promote in the United States.
In June 2008, we entered into a licensing and development
agreement with TransPharma Medical Ltd. (TransPharma) to acquire
rights to its product and related drug delivery system for the
treatment of osteoporosis. The product, which is administered
transdermally using TransPharmas proprietary technology,
was in Phase II clinical testing, and had no alternative
future use. Under the arrangement, we also gained non-exclusive
access to TransPharmas ViaDerm drug delivery system for
the product. As with many development-phase products, launch of
the product, if approved, was not expected in the near term. The
charge of $35.0 million for acquired IPR&D related to
this arrangement was included as expense in the second quarter
of 2008 and is deductible for tax purposes.
In January 2008, our agreement with BioMS Medical Corp. to
acquire the rights to its compound for the treatment of multiple
sclerosis became effective. At the inception of this agreement,
this compound was in the development stage (Phase III
clinical trials) and had no alternative future use. As with many
development-phase compounds, launch of the product, if approved,
was not expected in the near term. In the third quarter of 2009,
data from the Phase III clinical trials showed there were
no statistically significant differences between dirucotide and
placebo on the primary or secondary endpoints of the study, and
ongoing clinical trials and the arrangement were discontinued.
The charge of $87.0 million for acquired IPR&D related
to this arrangement was included as expense in the first quarter
of 2008 and is deductible for tax purposes.
In October 2007, we entered into an agreement with Glenmark
Pharmaceuticals Limited India to acquire the rights to a
portfolio of transient receptor potential vanilloid
sub-family 1
(TRPV1) antagonist molecules, including a clinical-phase
compound. The compound was in early clinical phase development
as a potential next-generation treatment for various pain
conditions, including osteoarthritic pain, and had no
alternative future use. As with many development-phase
compounds, launch of the product, if approved, was not expected
in the near term. The charge of $45.0 million for acquired
IPR&D was deductible for tax purposes and was included as
expense in the fourth quarter of 2007. Development of this
compound has been suspended.
In October 2007, we entered into a global strategic alliance
with MacroGenics, Inc. (MacroGenics) to develop and
commercialize teplizumab, a humanized anti-CD3 monoclonal
antibody, as well as other potential next-generation anti-CD3
molecules for use in the treatment of autoimmune diseases. As
part of the arrangement, we acquired the exclusive rights to the
molecule, which was in the development stage (Phase II/III
clinical trial for individuals with recent-onset type 1
diabetes) and had no alternative future use. As with many
development-phase compounds, launch of the product, if approved,
was not expected in the near term. The charge of
$44.0 million for acquired IPR&D was deductible for
tax purposes and was included as expense in the fourth quarter
of 2007.
In January 2007, we entered into an agreement with OSI
Pharmaceuticals, Inc. to acquire the rights to its compound for
the treatment of type 2 diabetes. At the inception of this
agreement, this compound was in the development stage (Phase I
clinical trials) and had no alternative future use. As with many
development-phase compounds, launch of the product, if approved,
was not expected in the near term. The charge of
$25.0 million for acquired IPR&D related to this
arrangement was included as expense in the first quarter of 2007
and was deductible for tax purposes.
51
In connection with these arrangements, our partners are
generally entitled to future milestones and royalties based on
sales should these products be approved for commercialization.
Note 4: Collaborations
We often enter into collaborative arrangements to develop and
commercialize drug candidates. Collaborative activities might
include research and development, marketing and selling
(including promotional activities and physician detailing),
manufacturing, and distribution. These collaborations often
require milestone and royalty or profit share payments,
contingent upon the occurrence of certain future events linked
to the success of the asset in development, as well as expense
reimbursements or payments to the third party. Revenues related
to products sold by us pursuant to these arrangements are
included in net product sales, while other sources of revenue
(e.g., royalties and profit share payments) are included in
collaboration and other revenue. Operating expenses for costs
incurred pursuant to these arrangements are reported in their
respective expense line item, net of any payments made to or
reimbursements received from our collaboration partners. Each
collaboration is unique in nature, and our more significant
arrangements are discussed below.
Erbitux
Prior to our acquisition in November 2008, ImClone entered into
several collaborations with respect to Erbitux, a product
approved to fight cancer, while still in its development phase.
The most significant collaborations operate in these geographic
territories: the U.S., Japan, and Canada (Bristol-Myers Squibb
Company); and worldwide except the U.S. and Canada (Merck
KGaA). The agreements are expected to expire in 2018, upon which
all of the rights with respect to Erbitux in the U.S. and
Canada return to us. The following table summarizes the revenue
recognized with respect to Erbitux:
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
Net product sales
|
|
$
|
92.5
|
|
|
$
|
2.7
|
|
Collaboration and other revenue
|
|
|
298.3
|
|
|
|
26.7
|
|
|
|
|
|
|
|
Total revenue
|
|
$
|
390.8
|
|
|
$
|
29.4
|
|
|
|
|
|
|
|
Bristol-Myers
Squibb Company
Pursuant to a commercial agreement with Bristol-Myers Squibb
Company and E.R. Squibb (collectively, BMS), relating to
Erbitux, ImClone is co-developing and co-promoting Erbitux in
the U.S. and Canada with BMS, exclusively, and in Japan
with BMS and Merck KGaA. The companies have jointly agreed to
expand the investment in the ongoing clinical development plan
for Erbitux to further explore its use in additional tumor
types. Under this arrangement, Erbitux research and development
and other costs, up to threshold amounts, are the sole
responsibility of BMS, with costs in excess of the thresholds
shared by both companies according to a predetermined ratio.
Responsibilities associated with clinical and other ongoing
studies are apportioned between the parties as determined
pursuant to the agreement. Collaborative reimbursements received
by ImClone for supply of clinical trial materials; for research
and development; and for a portion of marketing, selling, and
administrative expenses are recorded as a reduction to the
respective expense line items on the consolidated statement of
operations. We receive a distribution fee in the form of a
royalty from BMS, based on a percentage of net sales in the
U.S. and Canada, which is recorded in collaboration and
other revenue. Royalty expense paid to third parties, net of any
reimbursements received, is recorded as a reduction of
collaboration and other revenue.
We are responsible for the manufacture and supply of all
requirements of Erbitux in bulk-form active pharmaceutical
ingredient (API) for clinical and commercial use in the
territory, and BMS will purchase all of its requirements of API
for commercial use from us, subject to certain stipulations per
the agreement. Sales of Erbitux to BMS for commercial use are
reported in net product sales.
Merck
KGaA
A development and license agreement between ImClone and Merck
KGaA (Merck) with respect to Erbitux granted Merck exclusive
rights to market Erbitux outside of the U.S. and Canada,
and co-exclusive rights with BMS and ImClone in Japan. Merck
also has rights to manufacture Erbitux for supply in its
territory. We manufacture and provide a portion of Mercks
requirements for API, which is included in net product sales. We
also receive a royalty on the sales of Erbitux outside of the
U.S. and Canada, which is included in collaboration and
other revenue as earned. Collaborative reimbursements received
for supply of product; for research and development; and
marketing, selling, and administrative expenses are recorded as
a reduction to the respective expense line items on the
consolidated statement of operations. Royalty
52
expense paid to third parties, net of any royalty reimbursements
received, is recorded as a reduction of collaboration and other
revenue.
Necitumumab
In January 2010, we restructured the collaboration agreement
executed by ImClone and BMS in 2001 to allow for the
co-development and co-commercialization of necitumumab, which is
currently in Phase III clinical testing for non-small cell
lung cancer. Within this restructured arrangement, we and BMS
have agreed to share in the cost of developing and potentially
commercializing necitumumab in the U.S., Canada, and Japan. We
maintain exclusive rights to necitumumab in all other markets.
We will fund 45 percent of the development costs for
studies that will be used only in the U.S., and 72.5 percent for
global studies. We will be responsible for the manufacturing of
API and BMS will be responsible for manufacturing the finished
product. We could receive a payment of $250.0 million upon
approval in the U.S. In the U.S. and Canada, BMS will
record sales and we will receive 45 percent of the profits for
necitumumab, while we will provide 50 percent of the selling
effort. In Japan, we and BMS will share costs and profits evenly.
Exenatide
We are in a collaborative arrangement with Amylin
Pharmaceuticals (Amylin) for the joint development, marketing,
and selling of Byetta (exenatide injection) and other forms of
exenatide such as exenatide once weekly. Byetta is presently
approved as an adjunctive therapy to improve glycemic control in
patients with type 2 diabetes who have not achieved adequate
glycemic control using metformin, a sulfonylurea or a
combination of metformin and sulfonylurea; and in the U.S. only,
using a thiazolidinedione (with or without metformin) and as a
monotherapy. Lilly and Amylin are co-promoting exenatide in the
U.S. Amylin is responsible for manufacturing and primarily
utilizes third-party contract manufacturers to supply Byetta.
However, we are manufacturing Byetta pen delivery devices for
Amylin. We are responsible for development and commercialization
costs outside the U.S.
Under the terms of our arrangement, we report as collaboration
and other revenue our 50 percent share of gross margin on
Amylins net product sales in the U.S. We report as
net product sales 100 percent of sales outside the
U.S. and our sales of Byetta pen delivery devices to
Amylin. The following table summarizes the revenue recognized
with respect to Byetta:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
|
|
Net product sales
|
|
$
|
147.7
|
|
|
$
|
96.7
|
|
|
$
|
39.6
|
|
Collaboration and other revenue
|
|
|
300.8
|
|
|
|
299.4
|
|
|
|
291.1
|
|
|
|
|
|
|
|
Total revenue
|
|
$
|
448.5
|
|
|
$
|
396.1
|
|
|
$
|
330.7
|
|
|
|
|
|
|
|
We pay Amylin a percentage of the gross margin of exenatide
sales outside of the U.S., and these costs are recorded in cost
of sales. Under the
50/50
profit-sharing arrangement for the U.S., in addition to
recording as revenue our 50 percent share of
exenatides gross margin, we also report 50 percent of
U.S. research and development costs and marketing and
selling costs in the respective line items on the consolidated
statements of operations.
A New Drug Application has been submitted to the U.S. Food
and Drug Administration (FDA) for exenatide once weekly. Amylin
is constructing and will operate a manufacturing facility for
exenatide once weekly, and we have entered into a supply
agreement in which Amylin will supply exenatide once weekly
product to us for sales outside the U.S. The estimated
total cost of the facility is approximately $550 million.
In 2008, we paid $125.0 million to Amylin, which we will
amortize to cost of sales over the estimated life of the supply
agreement beginning with product launch. We would be required to
reimburse Amylin for a portion of any future impairment of this
facility, recognized in accordance with GAAP. A portion of the
$125.0 million payment we made to Amylin would be
creditable against any amount we would owe as a result of
impairment. We have also agreed to loan up to
$165.0 million to Amylin at an indexed rate beginning
December 1, 2009; no amounts were loaned in 2009 and any
borrowings have to be repaid by June 30, 2014. We have also
agreed to cooperate with Amylin in the development,
manufacturing, and marketing of exenatide once weekly in a
dual-chamber cartridge pen configuration. We will contribute
60 percent of the total initial capital costs of the
project, our portion of which will be approximately
$130 million, of which we have contributed approximately
$50 million as of December 31, 2009.
Cymbalta
Boehringer
Ingelheim
We are in a collaborative arrangement with Boehringer Ingelheim
(BI) to jointly market and promote Cymbalta, a product for the
treatment of major depressive disorder, diabetic peripheral
neuropathic pain, generalized anxiety disorder, and
fibromyalgia, outside the U.S. Pursuant to the terms of the
agreement, we generally share equally in development, marketing,
and selling expenses, and pay BI a commission on
53
sales in the co-promotion territories. We manufacture the
product for all territories. Reimbursements or payments for the
cost sharing of marketing, selling, and administrative expenses
are recorded in the respective expense line items in the
consolidated statements of operations. The commission paid to BI
is recognized in marketing, selling, and administrative expenses.
Quintiles
We were in a collaborative arrangement with Quintiles
Transnational Corp. (Quintiles) to jointly market and promote
Cymbalta in the U.S. since Cymbaltas launch in 2004.
Pursuant to the terms of the agreement, Quintiles shared in the
costs to co-promote Cymbalta with us and receives a commission
based upon net product sales. According to that agreement,
Quintiles obligation to promote Cymbalta expired during
2009, and we will pay a lower rate on net product sales for
three years after completion of the promotion efforts specified
in that agreement. The commissions paid to Quintiles are
recorded in marketing, selling, and administrative expenses.
Effient
We are in a collaborative arrangement with Daiichi Sankyo
Company, Limited (D-S) to develop, market, and promote Effient,
an antiplatelet agent for the treatment of patients with acute
coronary syndromes (ACS) who are being managed with an
artery-opening procedure known as percutaneous coronary
intervention (PCI). The product was approved for marketing by
the European Commission under the tradename Efient in February
2009, and the initial sales were recorded in the first quarter
of 2009. The product was also approved for marketing by the FDA
under the tradename Effient in July 2009, and the initial sales
in the U.S. were recorded in the third quarter. Within this
arrangement, we and D-S have agreed to co-promote under the same
trademark in certain territories (including the U.S. and
five major European markets), while we have exclusive marketing
rights in certain other territories. D-S has exclusive marketing
rights in Japan. Under the agreement, we paid D-S an upfront
license fee and agreed to pay future success milestones. The
parties share approximately
50/50 in the
profits, as well as in the costs of development and marketing in
the co-promotion territories. A third party manufactures bulk
product, and we produce the finished product for our exclusive
and co-promotion territories. We record product sales in our
exclusive and co-promotion territories. In our exclusive
territories, we will pay D-S a royalty specific to these
territories. Profit share payments made to D-S are recorded as
marketing, selling, and administrative expenses. All royalties
paid to D-S and the third-party manufacturer are recorded in
cost of sales. Worldwide Effient sales were $27.0 million
in 2009. The product is in the early phases of launch in both
the U.S. and Europe.
TPG-Axon
Capital
In 2008, we entered into an agreement with an affiliate of
TPG-Axon Capital (TPG) for the Phase III development of a
gamma-secretase inhibitor and an A-beta antibody, our two lead
molecules for the treatment of mild to moderate Alzheimers
disease. Under the agreement, both we and TPG will provide
funding for the Alzheimers clinical trials. Funding from
TPG will not exceed $325 million and could extend into
2014. In exchange for their funding, TPG may receive
success-based milestones totaling $330 million and mid- to
high-single digit royalties that are contingent upon the
successful development of the Alzheimers treatments. The
royalties will be paid for approximately eight years after
launch of a product. Reimbursements received from TPG for its
portion of research and development costs incurred related to
the Alzheimers treatments are recorded as a reduction to
the research and development expense line item on the
consolidated statements of operations. The reimbursement from
TPG is not expected to be material in any period.
Summary of Collaboration Related Commission and Profit Share
Payments
The aggregate amount of commission and profit share payments
included in marketing, selling, and administrative expense
pursuant to the collaborations described above was
$319.2 million, $307.6 million, and
$217.5 million in 2009, 2008, and 2007, respectively.
Note 5: Asset
Impairments, Restructuring, and Other Special Charges
The components of the charges included in asset impairments,
restructuring, and other special charges in our consolidated
statements of operations are described below.
Asset Impairments
and Related Restructuring and Other Charges
Asset impairments, restructuring, and other special charges of
$37.9 million were recognized in the fourth quarter of 2009
as a result of our announced initiatives to reduce our cost
structure and global workforce. These charges relate to
severance costs which are expected to be paid in the first half
of 2010.
We recognized asset impairments, restructuring, and other
special charges of $424.8 million in the third quarter of
2009 primarily due to the sale of our Tippecanoe Laboratories
manufacturing site to an affiliate
54
of Evonik Industries AG (Evonik) in early 2010. In connection
with the sale of the site, we entered into a nine-year supply
and services agreement, whereby Evonik will manufacture final
and intermediate step active pharmaceutical ingredient (API) for
certain of our human and animal health products. The decision to
sell the site was based upon a projected decline in utilization
of the site due to several factors, including upcoming patent
expirations on certain medicines made at the site; our strategic
decision to purchase, rather than manufacture, many late-stage
chemical intermediates; and the evolution of our pipeline toward
more biotechnology medicines. In addition to the sale of the
Tippecanoe site, in the third quarter of 2009 we announced a
voluntary exit program for certain U.S. sales employees.
Components of the third-quarter restructuring charge include
non-cash asset impairment charges and other charges of
$363.7 million, and $61.1 million in severance related
charges, substantially all of which is expected to be paid in
cash by early 2010. The fair value of assets used in determining
impairment charges was based on contracted sales prices.
We incurred asset impairments, restructuring, and other special
charges of $80.0 million in the fourth quarter of 2008.
These charges were the result of decisions approved by
management in the fourth quarter as well as previously announced
strategic decisions. The primary components of this charge
include non-cash asset impairments of $35.1 million for the
write down of impaired assets, all of which have no future use,
and other charges of $44.9 million, primarily related to
severance and environmental cleanup charges in connection with
previously announced strategic decisions made in prior periods.
Substantially all of these costs were paid during 2009.
Further, in the third quarter of 2008, as a result of our
previously announced agreements with Covance Inc. (Covance),
Quintiles Transnational Corp. (Quintiles), and Ingenix
Pharmaceutical Services, Inc., doing business as i3 Statprobe
(i3), and as part of our efforts to transform into a more
flexible organization, we recognized asset impairments,
restructuring, and other special charges of $182.4 million.
We sold our Greenfield, Indiana site to Covance, a global drug
development services firm, and entered into a
10-year
service agreement under which Covance will provide preclinical
toxicology work and perform additional clinical trials for us as
well as operate the site to meet our needs and those of other
pharmaceutical industry clients. In addition, we signed
agreements with Quintiles for clinical trial monitoring services
and with i3 for clinical data management services. Components of
the third-quarter restructuring charge include non-cash charges
of $148.3 million primarily related to the loss on sale of
assets sold to Covance, severance costs of $27.8 million,
and exit costs of $6.3 million. Substantially all of these
costs were paid in 2008.
In the second quarter of 2008, we recognized restructuring and
other special charges of $88.9 million. In addition, we
recognized non-cash charges of $57.1 million for the write
down of impaired manufacturing assets that had no future use,
which were included in cost of sales. In April 2008, we
announced a voluntary exit program that was offered to employees
primarily in manufacturing. Components of the second-quarter
restructuring charge include total severance costs of
$53.5 million related to these programs and
$35.4 million related to exit costs incurred during the
second quarter in connection with previously announced strategic
decisions made in prior periods. Substantially all of these
costs were paid by the end of July 2008.
In March 2008, we terminated development of our AIR Insulin
program, which was being conducted in collaboration with
Alkermes, Inc. The program had been in Phase III clinical
development as a potential treatment for type 1 and
type 2 diabetes. This decision was not a result of any
observations during AIR Insulin trials relating to the safety of
the product, but rather was a result of increasing uncertainties
in the regulatory environment, and a thorough evaluation of the
evolving commercial and clinical potential of the product
compared to existing medical therapies. As a result of this
decision, we halted our ongoing clinical studies and
transitioned the AIR Insulin patients in these studies to other
appropriate therapies. We implemented a patient program in the
U.S., and other regions of the world where allowed, to provide
clinical trial participants with appropriate financial support
to fund their medications and diagnostic supplies through the
end of 2008.
We recognized asset impairments, restructuring, and other
special charges of $145.7 million in the first quarter of
2008. These charges were primarily related to the decision to
terminate development of AIR Insulin. Components of these
charges included non-cash charges of $40.9 million for the
write down of impaired manufacturing assets that had no use
beyond the AIR Insulin program, as well as charges of
$91.7 million for estimated contractual obligations and
wind-down costs associated with the termination of clinical
trials and certain development activities, and costs associated
with the patient program to transition participants from AIR
Insulin. This amount includes an estimate of Alkermes
wind-down costs for which we were contractually obligated. The
wind-down activities and patient programs were substantially
complete by the end of 2008. The remaining component of these
charges, $13.1 million, is related to exit costs incurred
in the first quarter of 2008 in connection with previously
announced strategic decisions made in prior periods.
55
We incurred asset impairments, restructuring, and other special
charges of $67.6 million in the fourth quarter of 2007.
These charges were a result of decisions approved by management
in the fourth quarter as well as previously announced strategic
decisions. Components of this charge include non-cash charges of
$42.5 million for the write down of impaired assets, all of
which have no future use, and other charges of
$25.1 million, primarily related to additional severance
and environmental cleanup charges related to previously
announced strategic decisions. The impairment charges were
necessary to adjust the carrying value of the assets to fair
value. These restructuring activities were substantially
complete at December 31, 2007.
In connection with previously announced strategic decisions, we
recorded asset impairments, restructuring, and other special
charges of $123.0 million in the first quarter of 2007.
These charges primarily related to a voluntary severance program
at one of our U.S. plants and other costs related to this
action as well as management actions taken in the fourth quarter
of 2006 to close two research and development facilities and one
production facility outside the U.S. The component of these
charges related to the non-cash asset impairment was
$67.6 million, and were necessary to adjust the carrying
value of the assets to fair value. These restructuring
activities were substantially complete at December 31, 2007.
Product Liability
and Other Special Charges
In the second and the third quarters of 2009, we incurred other
special charges of $105.0 million and $125.0 million,
respectively, related to advanced discussions with the attorneys
general for several states that were not part of the Eastern
District of Pennsylvania settlement, seeking to resolve their
Zyprexa-related claims. The charge represents the currently
probable and estimable exposures in connection with the
states claims. Refer to Note 14 for additional
information.
As discussed further in Note 14, in the third quarter of
2008, we recorded a charge of $1.48 billion related to the
Zyprexa investigations led by the U.S. Attorney for the
Eastern District of Pennsylvania, as well as the resolution of a
multi-state investigation regarding Zyprexa involving
32 states and the District of Columbia.
As a result of our product liability exposures, the substantial
majority of which were related to Zyprexa, we recorded net
pretax charges of $111.9 million in 2007. These charges,
which are net of anticipated insurance recoveries, include the
costs of product liability settlements and related defense
costs, reserves for product liability exposures and defense
costs regarding known product liability claims, and expected
future claims to the extent we could formulate a reasonable
estimate of the probable number and cost of the claims. See
Note 14 for further discussion.
Note 6: Financial
Instruments and Investments
Financial instruments that potentially subject us to credit risk
consist principally of trade receivables and interest-bearing
investments. Wholesale distributors of life-sciences products
account for a substantial portion of trade receivables;
collateral is generally not required. The risk associated with
this concentration is mitigated by our ongoing credit review
procedures and insurance. Major financial institutions represent
the largest component of our investments in corporate debt
securities. In accordance with documented corporate policies, we
limit the amount of credit exposure to any one financial
institution or corporate issuer. We are exposed to
credit-related losses in the event of nonperformance by
counterparties to risk-management instruments but do not expect
any counterparties to fail to meet their obligations given their
high credit ratings.
At December 31, 2009, we had outstanding foreign currency
forward commitments to purchase 518 million British pounds
and sell 578 million euro, commitments to purchase
194 million U.S. dollars and sell 131 million
euro, and commitments to buy 151 million euro and sell
218 million U.S. dollars, which will settle within
35 days.
At December 31, 2009, approximately 97 percent of our
total debt is at a fixed rate. We have converted approximately
65 percent of our fixed-rate debt to floating rates through
the use of interest rate swaps.
The Effect of
Risk-Management Instruments on the Statement of
Operations
Both the gains on the hedged fixed-rate debt and the offsetting
losses on the related interest rate swaps for 2009 were
$369.5 million. All of these amounts net to zero and are
included in
other-net,
expense (income).
We expect to reclassify $12.0 million of pretax net losses
on cash flow hedges of the variability in expected future
interest payments on floating rate debt from accumulated other
comprehensive loss to earnings during the next 12 months.
56
Other-net,
expense (income) for 2009 includes the effective portion of
losses on interest rate contracts in designated cash flow
hedging relationships reclassified from accumulated other
comprehensive loss into income of $10.2 million, and the
net gains on foreign exchange contracts not designated as
hedging instruments recognized in income of $43.4 million.
The effective portions of net gains on interest rate contracts
in designated cash flow hedging relationships recorded in other
comprehensive income (loss) for 2009 was $38.0 million.
During the years ended December 31, 2009, 2008, and 2007,
net losses related to ineffectiveness and net losses related to
the portion of our risk-management hedging instruments, fair
value and cash flow hedges excluded from the assessment of
effectiveness were not material.
57
Fair Value of
Financial Instruments
The following tables summarize certain fair value information at
December 31 for assets and liabilities measured at fair value on
a recurring basis, as well as the carrying amount and amortized
cost of certain other investments:
|
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|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prices in
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
Active
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Markets
|
|
|
Significant
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
for
|
|
|
Other
|
|
|
Significant
|
|
|
|
|
|
|
|
|
|
|
|
|
Identical
|
|
|
Observable
|
|
|
Unobservable
|
|
|
|
|
|
|
Carrying
|
|
|
Amortized
|
|
|
Assets
|
|
|
Inputs
|
|
|
Inputs
|
|
|
Fair
|
|
Description
|
|
Amount
|
|
|
Cost
|
|
|
(Level 1)
|
|
|
(Level 2)
|
|
|
(Level 3)
|
|
|
Value
|
|
|
|
|
December 31, 2009
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities
|
|
$
|
15.8
|
|
|
$
|
16.1
|
|
|
$
|
|
|
|
$
|
15.8
|
|
|
$
|
|
|
|
$
|
15.8
|
|
U.S. government and agencies
|
|
|
18.5
|
|
|
|
18.8
|
|
|
|
18.5
|
|
|
|
|
|
|
|
|
|
|
|
18.5
|
|
Other securities
|
|
|
0.4
|
|
|
|
0.4
|
|
|
|
|
|
|
|
0.4
|
|
|
|
|
|
|
|
0.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
34.7
|
|
|
$
|
35.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Noncurrent investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities
|
|
$
|
185.9
|
|
|
$
|
195.4
|
|
|
$
|
|
|
|
$
|
185.9
|
|
|
$
|
|
|
|
$
|
185.9
|
|
Mortgage-backed
|
|
|
240.3
|
|
|
|
310.0
|
|
|
|
|
|
|
|
240.3
|
|
|
|
|
|
|
|
240.3
|
|
Asset-backed
|
|
|
78.7
|
|
|
|
94.1
|
|
|
|
|
|
|
|
78.7
|
|
|
|
|
|
|
|
78.7
|
|
U.S. government and agencies
|
|
|
81.3
|
|
|
|
81.7
|
|
|
|
81.3
|
|
|
|
|
|
|
|
|
|
|
|
81.3
|
|
Other debt securities
|
|
|
34.4
|
|
|
|
12.8
|
|
|
|
|
|
|
|
3.6
|
|
|
|
30.8
|
|
|
|
34.4
|
|
Marketable equity
|
|
|
378.7
|
|
|
|
184.0
|
|
|
|
378.7
|
|
|
|
|
|
|
|
|
|
|
|
378.7
|
|
Equity method and other investments
|
|
|
156.5
|
|
|
|
156.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,155.8
|
|
|
$
|
1,034.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt, including current portion
|
|
$
|
(6,655.0
|
)
|
|
|
NA
|
|
|
$
|
|
|
|
$
|
(6,827.8
|
)
|
|
$
|
|
|
|
$
|
(6,827.8
|
)
|
Risk-management instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts designated as hedging instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sundry
|
|
$
|
134.9
|
|
|
|
NA
|
|
|
$
|
|
|
|
$
|
134.9
|
|
|
$
|
|
|
|
$
|
134.9
|
|
Other noncurrent liabilities
|
|
|
(6.2
|
)
|
|
|
NA
|
|
|
|
|
|
|
|
(6.2
|
)
|
|
|
|
|
|
|
(6.2
|
)
|
Foreign exchange contracts not designated as hedging instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses
|
|
|
8.8
|
|
|
|
NA
|
|
|
|
|
|
|
|
8.8
|
|
|
|
|
|
|
|
8.8
|
|
Other current liabilities
|
|
|
(10.7
|
)
|
|
|
NA
|
|
|
|
|
|
|
|
(10.7
|
)
|
|
|
|
|
|
|
(10.7
|
)
|
December 31, 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities
|
|
$
|
172.4
|
|
|
$
|
180.1
|
|
|
$
|
|
|
|
$
|
172.4
|
|
|
$
|
|
|
|
$
|
172.4
|
|
U.S. government and agencies
|
|
|
212.3
|
|
|
|
212.0
|
|
|
|
212.3
|
|
|
|
|
|
|
|
|
|
|
|
212.3
|
|
Other securities
|
|
|
44.7
|
|
|
|
41.8
|
|
|
|
|
|
|
|
44.7
|
|
|
|
|
|
|
|
44.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
429.4
|
|
|
$
|
433.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
58
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prices in
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Active
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Markets
|
|
|
Significant
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
for
|
|
|
Other
|
|
|
Significant
|
|
|
|
|
|
|
|
|
|
|
|
|
Identical
|
|
|
Observable
|
|
|
Unobservable
|
|
|
|
|
|
|
Carrying
|
|
|
Amortized
|
|
|
Assets
|
|
|
Inputs
|
|
|
Inputs
|
|
|
Fair
|
|
Description
|
|
Amount
|
|
|
Cost
|
|
|
(Level 1)
|
|
|
(Level 2)
|
|
|
(Level 3)
|
|
|
Value
|
|
|
|
|
Noncurrent investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities
|
|
$
|
466.4
|
|
|
$
|
542.2
|
|
|
$
|
|
|
|
$
|
466.4
|
|
|
$
|
|
|
|
$
|
466.4
|
|
Mortgage-backed
|
|
|
330.6
|
|
|
|
436.6
|
|
|
|
|
|
|
|
330.6
|
|
|
|
|
|
|
|
330.6
|
|
Asset-backed
|
|
|
204.0
|
|
|
|
240.1
|
|
|
|
|
|
|
|
204.0
|
|
|
|
|
|
|
|
204.0
|
|
U.S. government and agencies
|
|
|
179.2
|
|
|
|
176.8
|
|
|
|
179.2
|
|
|
|
|
|
|
|
|
|
|
|
179.2
|
|
Other debt securities
|
|
|
14.7
|
|
|
|
10.6
|
|
|
|
|
|
|
|
3.6
|
|
|
|
11.1
|
|
|
|
14.7
|
|
Marketable equity
|
|
|
221.9
|
|
|
|
175.1
|
|
|
|
221.9
|
|
|
|
|
|
|
|
|
|
|
|
221.9
|
|
Equity methods and other investments
|
|
|
127.8
|
|
|
|
127.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,544.6
|
|
|
$
|
1,709.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt, including current portion
|
|
$
|
(5,036.1
|
)
|
|
|
NA
|
|
|
$
|
|
|
|
$
|
(5,180.1
|
)
|
|
$
|
|
|
|
$
|
(5,180.1
|
)
|
Risk-management instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate contracts designated as hedging instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sundry
|
|
$
|
500.3
|
|
|
|
NA
|
|
|
$
|
|
|
|
$
|
500.3
|
|
|
$
|
|
|
|
$
|
500.3
|
|
Foreign exchange contracts not designated as hedging instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses
|
|
|
12.0
|
|
|
|
NA
|
|
|
|
|
|
|
|
12.0
|
|
|
|
|
|
|
|
12.0
|
|
Other current liabilities
|
|
|
(57.3
|
)
|
|
|
NA
|
|
|
|
|
|
|
|
(57.3
|
)
|
|
|
|
|
|
|
(57.3
|
)
|
NANot applicable
We determine fair values based on a market approach using quoted
market values, significant other observable inputs for identical
or comparable assets or liabilities, or discounted cash flow
analyses. The fair value of equity method and other investments
is not readily available. Approximately $235 million of our
investments in debt securities, measured at fair value, mature
within five years.
A summary of the fair value of
available-for-sale
securities in an unrealized gain or loss position and the amount
of unrealized gains and losses (pretax) in accumulated other
comprehensive loss at December 31 follows:
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
Unrealized gross gains
|
|
$
|
222.4
|
|
|
$
|
69.9
|
|
Unrealized gross losses
|
|
|
101.7
|
|
|
|
239.0
|
|
Fair value of securities in an unrealized gain position
|
|
|
579.8
|
|
|
|
767.5
|
|
Fair value of securities in an unrealized loss position
|
|
|
449.4
|
|
|
|
1,046.1
|
|
As discussed further in Note 2, a new accounting
pronouncement effective in 2009 changed the accounting for
other-than-temporary
impairment losses for debt securities, providing that the amount
of the
other-than-temporary
losses recorded in earnings is limited to the portion attributed
to credit losses, with the remaining portion recorded in other
comprehensive income (loss). A summary of
other-than-temporary
losses on our investments in debt securities follows:
|
|
|
|
|
|
|
2009
|
|
|
|
|
Losses recognized in the statement of operations
|
|
$
|
22.4
|
|
Losses recognized in other comprehensive income (loss)
|
|
|
9.6
|
|
|
|
|
|
|
Total
other-than-temporary
impairment losses
|
|
$
|
32.0
|
|
|
|
|
|
|
59
The
other-than-temporary
losses recognized in the statement of operations primarily
relate to credit losses on certain mortgage-backed securities.
The amount of credit losses represents the difference between
the present value of cash flows expected to be collected on
these securities and the amortized cost. Factors considered in
assessing the credit loss were the position in the capital
structure, vintage and amount of collateral, delinquency rates,
current credit support, and geographic concentration.
The securities in an unrealized loss position are comprised of
fixed-rate debt securities of varying maturities. The value of
fixed income securities is sensitive to changes to the yield
curve and other market conditions which led to the decline in
value during 2008. Approximately 50 percent of the
securities in a loss position are investment-grade debt
securities. The majority of these securities first moved into an
unrealized loss position during 2008. At this time, there is no
indication of default on interest or principal payments for debt
securities other than those for which an
other-than-temporary
impairment charge has been recorded. We do not intend to sell
and it is not more likely than not we will be required to sell
the securities in a loss position before the market values
recover or the underlying cash flows have been received, and we
have concluded that no additional
other-than-temporary
loss is required to be charged to earnings as of
December 31, 2009. The fair values of our auction rate
securities and collateralized debt obligations held at
December 31, 2009 were determined using Level 3
inputs. We do not hold securities issued by structured
investment vehicles at December 31, 2009.
The net adjustment to unrealized gains and losses (net of tax)
on
available-for-sale
securities increased (decreased) other comprehensive income
(loss) by $186.6 million, $(125.8) million, and
$(5.4) million in 2009, 2008, and 2007, respectively.
Activity related to our
available-for-sale
investment portfolio was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
|
|
Proceeds from sales
|
|
$
|
1,227.4
|
|
|
$
|
1,876.4
|
|
|
$
|
1,212.1
|
|
Realized gross gains on sales
|
|
|
68.9
|
|
|
|
45.7
|
|
|
|
21.4
|
|
Realized gross losses on sales
|
|
|
6.8
|
|
|
|
8.7
|
|
|
|
6.1
|
|
Note 7: Borrowings
Long-term debt at December 31 consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
3.55 to 7.13 percent notes (due
2012-2037)
|
|
$
|
6,387.4
|
|
|
$
|
3,987.4
|
|
Floating rate bonds (due 2037)
|
|
|
|
|
|
|
400.0
|
|
Other, including capitalized leases
|
|
|
105.3
|
|
|
|
116.8
|
|
Fair value adjustment
|
|
|
162.3
|
|
|
|
531.9
|
|
|
|
|
|
|
|
|
|
|
6,655.0
|
|
|
|
5,036.1
|
|
Less current portion
|
|
|
(20.3
|
)
|
|
|
(420.4
|
)
|
|
|
|
|
|
|
|
|
$
|
6,634.7
|
|
|
$
|
4,615.7
|
|
|
|
|
|
|
|
In March 2009, we issued $2.40 billion of fixed-rate notes
with interest to be paid semi-annually. The $400.0 million
of floating rate bonds outstanding at December 31, 2008
were repaid with proceeds from this issuance.
The 6.55 percent Employee Stock Ownership Plan (ESOP)
debentures are obligations of the ESOP but are shown on the
consolidated balance sheet because we guarantee them. The
principal and interest on the debt are funded by contributions
from us and by dividends received on certain shares held by the
ESOP. Because of the amortizing feature of the ESOP debt,
bondholders will receive both interest and principal payments
each quarter. The balance was $72.8 million and
$81.9 million at December 31, 2009 and 2008,
respectively, and is included in Other in the table above.
The aggregate amounts of maturities on long-term debt for the
next five years are as follows: 2010, $20.3 million; 2011,
$15.8 million; 2012, $1.51 billion; 2013,
$13.9 million; and 2014, $1.01 billion.
At December 31, 2009 and 2008, short-term borrowings
included $7.1 million and $5.43 billion, respectively,
of notes payable to banks and commercial paper. Commercial paper
was issued in late 2008 for the acquisition of ImClone. At
December 31, 2009, we have $1.24 billion of unused
committed bank credit facilities, $1.20 billion of which
backs our commercial paper program and matures in May, 2011.
Compensating balances and commitment fees are not material, and
there are no conditions that are probable of occurring under
which the lines may be withdrawn.
60
We have converted approximately 65 percent of all
fixed-rate debt to floating rates through the use of interest
rate swaps. The weighted-average effective borrowing rates based
on debt obligations and interest rates at December 31, 2009
and 2008, including the effects of interest rate swaps for
hedged debt obligations, were 3.07 percent and
4.77 percent, respectively.
In 2009, 2008, and 2007, cash payments of interest on borrowings
totaled $205.9 million, $203.1 million, and
$159.2 million, respectively, net of capitalized interest.
In accordance with the requirements of derivatives and hedging
guidance, the portion of our fixed-rate debt obligations that is
hedged is reflected in the consolidated balance sheets as an
amount equal to the sum of the debts carrying value plus
the fair value adjustment representing changes in fair value of
the hedged debt attributable to movements in market interest
rates subsequent to the inception of the hedge.
Note 8: Stock-Based
Compensation
Stock-based compensation expense in the amount of
$368.5 million, $255.3 million, and
$282.0 million was recognized in 2009, 2008, and 2007,
respectively, as well as related tax benefits of
$128.9 million, $88.6 million, and $96.4 million,
respectively. Our stock-based compensation expense consists
primarily of performance awards (PAs), and shareholder value
awards (SVAs). We recognize the stock-based compensation expense
over the requisite service period of the individual grantees,
which generally equals the vesting period. We provide newly
issued shares and treasury stock to satisfy stock option
exercises and for the issuance of PA and SVA shares. We classify
tax benefits resulting from tax deductions in excess of the
compensation cost recognized for exercised stock options as a
financing cash flow in the consolidated statements of cash flows.
At December 31, 2009, additional stock-based compensation
awards may be granted under the 2002 Lilly Stock Plan for not
more than 84.6 million shares.
Performance Award
Program
PAs are granted to officers and management and are payable in
shares of our common stock. The number of PA shares actually
issued, if any, varies depending on the achievement of certain
pre-established
earnings-per-share
targets. In 2009, we granted both a one-year and a two-year
award to all global management as a transition to a two-year
performance period for all PAs granted beginning in 2010. PA
shares are accounted for at fair value based upon the closing
stock price on the date of grant and fully vest at the end of
the fiscal year of the grant. The fair values of performance
awards granted in 2009 were $36.17 for the one-year award and
$34.12 for the two-year award. The fair values of PAs granted in
2008 and 2007 were $51.22 and $54.23, respectively. The number
of shares ultimately issued for the performance award program is
dependent upon the earnings achieved during the vesting period.
Pursuant to this plan, approximately 2.8 million shares,
2.5 million shares, and 2.3 million shares were issued
in 2009, 2008, and 2007, respectively. Approximately
4.4 million shares are expected to be issued in 2010. As of
December 31, 2009, the total remaining unrecognized
compensation cost related to nonvested PAs amounted to
$88.8 million, which will be amortized over the
weighted-average remaining requisite service period of
12.0 months.
Shareholder Value
Award Program
In 2007, we implemented a SVA program, which replaced our stock
option program. SVAs are granted to officers and management and
are payable in shares of common stock at the end of a three-year
period. The number of shares actually issued varies depending on
our stock price at the end of the three-year vesting period
compared to pre-established target stock prices. We measure the
fair value of the SVA unit on the grant date using a Monte Carlo
simulation model. The Monte Carlo simulation model utilizes
multiple input variables that determine the probability of
satisfying the market condition stipulated in the award grant
and calculates the fair value of the award. Expected
volatilities utilized in the model are based on implied
volatilities from traded options on our stock, historical
volatility of our stock price, and other factors. Similarly, the
dividend yield is based on historical experience and our
estimate of future dividend yields. The risk-free interest rate
is derived from the U.S. Treasury yield curve in effect at
the time of grant. The weighted-average fair values of the SVA
units granted during 2009, 2008, and 2007 were $33.97, $43.46,
and $49.85, respectively, determined using the following
assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
|
|
Expected dividend yield
|
|
|
4.00%
|
|
|
|
3.00%
|
|
|
|
2.75%
|
|
Risk-free interest rate
|
|
|
.44% - 1.48%
|
|
|
|
2.05% - 2.29%
|
|
|
|
4.81% - 5.16%
|
|
Range of volatilities
|
|
|
24.34% - 24.92%
|
|
|
|
20.48% - 21.48%
|
|
|
|
22.54% - 23.90%
|
|
61
A summary of the SVA activity is presented below:
|
|
|
|
|
|
|
Units
|
|
|
|
Attributable to SVAs
|
|
|
|
(in thousands)
|
|
|
|
|
Outstanding at January 1, 2007
|
|
|
|
|
Granted
|
|
|
969
|
|
Forfeited or expired
|
|
|
(47
|
)
|
|
|
|
|
|
Outstanding at December 31, 2007
|
|
|
922
|
|
Granted
|
|
|
1,282
|
|
Forfeited or expired
|
|
|
(301
|
)
|
|
|
|
|
|
Outstanding at December 31, 2008
|
|
|
1,903
|
|
Granted
|
|
|
1,416
|
|
Forfeited or expired
|
|
|
(559
|
)
|
|
|
|
|
|
Outstanding at December 31, 2009
|
|
|
2,760
|
|
|
|
|
|
|
The maximum number of shares that could ultimately be issued
upon vesting of the SVA units outstanding at December 31,
2009, is 3.7 million. Approximately 0.4 million shares
are expected to be issued in 2010. As of December 31, 2009,
the total remaining unrecognized compensation cost related to
nonvested SVAs amounted to $48.1 million, which will be
amortized over the weighted-average remaining requisite service
period of 20.7 months.
Stock Option
Program
Stock options were granted prior to 2007 to officers and
management at exercise prices equal to the fair market value of
our stock price at the date of grant. No stock options were
granted subsequent to 2007. Options fully vest three years from
the grant date and have a term of 10 years.
Stock option activity during 2009 is summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares of
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
|
|
|
|
Weighted-Average
|
|
|
|
|
|
|
Attributable to
|
|
|
Weighted-Average
|
|
|
Remaining
|
|
|
Aggregate
|
|
|
|
Options
|
|
|
Exercise
|
|
|
Contractual Term
|
|
|
Intrinsic
|
|
|
|
(in thousands)
|
|
|
Price of Options
|
|
|
(in years)
|
|
|
Value
|
|
|
|
|
Outstanding at January 1, 2009
|
|
|
72,025
|
|
|
$
|
69.35
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(14
|
)
|
|
|
15.08
|
|
|
|
|
|
|
|
|
|
Forfeited or expired
|
|
|
(12,562
|
)
|
|
|
69.51
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2009
|
|
|
59,449
|
|
|
|
69.36
|
|
|
|
3.0
|
|
|
$
|
1.2
|
|
Exercisable at December 31, 2009
|
|
|
59,449
|
|
|
|
69.36
|
|
|
|
3.0
|
|
|
|
1.2
|
|
A summary of the status of nonvested options as of
December 31, 2009, and changes during the year then ended,
is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average
|
|
|
|
Shares
|
|
|
Grant Date
|
|
|
|
(in thousands)
|
|
|
Fair Value
|
|
|
|
|
Nonvested at January 1, 2009
|
|
|
3,992
|
|
|
$
|
15.26
|
|
Vested
|
|
|
(3,918
|
)
|
|
|
17.49
|
|
Forfeited
|
|
|
(74
|
)
|
|
|
16.06
|
|
|
|
|
|
|
|
|
|
|
Nonvested at December 31, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The intrinsic value of options exercised during 2009, 2008, and
2007 amounted to $0.3 million, $4.8 million, and
$1.5 million, respectively. The total grant date fair value
of options vested during 2009, 2008, and 2007 amounted to
$68.5 million, $84.1 million, and $381.8 million,
respectively. We received cash of $0.2 million,
$2.9 million, and $15.2 million from exercises of
stock options during 2009, 2008, and 2007, respectively. The
recognized related tax benefits for all three years were not
material.
Note 9: Other
Assets and Other Liabilities
Our other receivables include receivables from our collaboration
partners, tax receivables, interest receivable for our interest
rate swaps, and a variety of other items. The decrease in other
receivables is
62
primarily attributable to a decrease in receivables from our
collaboration partners and a decrease in tax receivables, offset
by an increase in interest rate swap receivables.
Our prepaid expenses include prepaid income taxes and other
global prepaid expenses. The increase in prepaid expenses is
primarily attributable to income taxes paid on prepaid
intercompany royalties.
Our sundry assets primarily include our capitalized computer
software, deferred tax assets (Note 12), receivables from
our collaboration partners, and the fair value of our interest
rate swaps. The decrease in sundry assets is primarily
attributable to a decrease in deferred tax assets and a decrease
in the fair value of our interest rate swaps.
Our other current liabilities include product litigation, tax
liabilities, deferred income from our collaboration
arrangements, and a variety of other items. The decrease in
other current liabilities is caused primarily by a decrease in
product litigation liabilities, specifically, the
$1.42 billion related to the EDPA settlements which was
paid in 2009 as discussed in Note 14, and a decrease in
current deferred taxes.
Our other noncurrent liabilities include deferred income from
our collaboration and out-licensing arrangements, the long-term
portion of our estimated product return liabilities, product
litigation, and a variety of other items. The decrease in other
noncurrent liabilities is primarily due to a decrease in
deferred income and a decrease in product litigation reserves.
Note 10: Shareholders
Equity
Changes in certain components of shareholders equity were
as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
|
|
|
Deferred
|
|
|
Common Stock in Treasury
|
|
|
|
Paid-in
|
|
|
Retained
|
|
|
Costs -
|
|
|
Shares
|
|
|
|
|
|
|
Capital
|
|
|
Earnings
|
|
|
ESOP
|
|
|
(in thousands)
|
|
|
Amount
|
|
|
|
|
Balance at January 1, 2007
|
|
$
|
3,571.9
|
|
|
$
|
10,766.2
|
|
|
$
|
(100.7
|
)
|
|
|
910
|
|
|
$
|
101.4
|
|
Net income
|
|
|
|
|
|
|
2,953.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividends declared per share: $1.75
|
|
|
|
|
|
|
(1,903.9
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Retirement of treasury shares
|
|
|
(3.9
|
)
|
|
|
|
|
|
|
|
|
|
|
(76
|
)
|
|
|
(3.9
|
)
|
Issuance of stock under employee stock
plans-net
|
|
|
(55.2
|
)
|
|
|
|
|
|
|
|
|
|
|
65
|
|
|
|
3.0
|
|
Stock-based compensation
|
|
|
282.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ESOP transactions
|
|
|
10.4
|
|
|
|
|
|
|
|
5.5
|
|
|
|
|
|
|
|
|
|
FIN 48 implementation (Note 12)
|
|
|
|
|
|
|
(8.6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007
|
|
|
3,805.2
|
|
|
|
11,806.7
|
|
|
|
(95.2
|
)
|
|
|
899
|
|
|
|
100.5
|
|
Net loss
|
|
|
|
|
|
|
(2,071.9
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividends declared per share: $1.90
|
|
|
|
|
|
|
(2,079.9
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Retirement of treasury shares
|
|
|
(10.9
|
)
|
|
|
|
|
|
|
|
|
|
|
(170
|
)
|
|
|
(11.1
|
)
|
Issuance of stock under employee stock
plans-net
|
|
|
(84.9
|
)
|
|
|
|
|
|
|
|
|
|
|
160
|
|
|
|
9.8
|
|
Stock-based compensation
|
|
|
255.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ESOP transactions
|
|
|
11.9
|
|
|
|
|
|
|
|
8.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008
|
|
|
3,976.6
|
|
|
|
7,654.9
|
|
|
|
(86.3
|
)
|
|
|
889
|
|
|
|
99.2
|
|
Net income
|
|
|
|
|
|
|
4,328.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividends declared per share: $1.96
|
|
|
|
|
|
|
(2,153.3
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Retirement of treasury shares
|
|
|
(3.3
|
)
|
|
|
|
|
|
|
|
|
|
|
(132
|
)
|
|
|
(3.3
|
)
|
Issuance of stock under employee stock
plans-net
|
|
|
(85.0
|
)
|
|
|
|
|
|
|
|
|
|
|
125
|
|
|
|
2.6
|
|
Stock-based compensation
|
|
|
368.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ESOP transactions
|
|
|
6.9
|
|
|
|
|
|
|
|
8.9
|
|
|
|
|
|
|
|
|
|
Employee benefit trust contribution
|
|
|
371.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009
|
|
$
|
4,635.6
|
|
|
$
|
9,830.4
|
|
|
$
|
(77.4
|
)
|
|
|
882
|
|
|
$
|
98.5
|
|
|
|
|
|
|
|
63
As of December 31, 2009, we have purchased
$2.58 billion of our announced $3.0 billion share
repurchase program. No shares were repurchased in 2009, 2008, or
2007.
We have 5 million authorized shares of preferred stock. As
of December 31, 2009 and 2008, no preferred stock has been
issued.
We have funded an employee benefit trust with 50 million
and 40 million shares of our common stock at
December 31, 2009 and 2008, respectively, to provide a
source of funds to assist us in meeting our obligations under
various employee benefit plans. In February 2009, we contributed
an additional 10 million shares to the employee benefit
trust, which resulted in a reclassification within equity from
additional
paid-in
capital of $371.9 million and common stock of
$6.3 million to the employee benefit trust of
$378.2 million. The funding had no net impact on
shareholders equity as we consolidate the employee benefit
trust. The cost basis of the shares held in the trust was
$3.01 billion and $2.64 billion at December 31,
2009 and 2008, respectively, and is shown as a reduction in
shareholders equity, which offsets the resulting increases
of $2.98 billion and $2.61 billion in additional
paid-in capital and $31.3 million and $25.0 million in
common stock at December 31, 2009 and 2008, respectively.
Any dividend transactions between us and the trust are
eliminated. Stock held by the trust is not considered
outstanding in the computation of earnings per share. The assets
of the trust were not used to fund any of our obligations under
these employee benefit plans in 2009, 2008, or 2007.
We have an ESOP as a funding vehicle for the existing employee
savings plan. The ESOP used the proceeds of a loan from us to
purchase shares of common stock from the treasury. The ESOP
issued $200.0 million of third-party debt, repayment of
which was guaranteed by us (see Note 7). The proceeds were
used to purchase shares of our common stock on the open market.
Shares of common stock held by the ESOP will be allocated to
participating employees annually through 2017 as part of our
savings plan contribution. The fair value of shares allocated
each period is recognized as compensation expense.
Note 11: Earnings
(Loss) Per Share
Following is a reconciliation of the denominators used in
computing earnings (loss) per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
|
(Shares in thousands)
|
|
|
|
|
Income (loss) available to common shareholders
|
|
$
|
4,328.8
|
|
|
$
|
(2,071.9
|
)
|
|
$
|
2,953.0
|
|
|
|
|
|
|
|
Basic earnings (loss) per share
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares outstanding, including
incremental shares
|
|
|
1,098,338
|
|
|
|
1,094,499
|
|
|
|
1,090,430
|
|
|
|
|
|
|
|
Basic earnings (loss) per share
|
|
$
|
3.94
|
|
|
$
|
(1.89
|
)
|
|
$
|
2.71
|
|
|
|
|
|
|
|
Diluted earnings (loss) per share
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares outstanding
|
|
|
1,094,623
|
|
|
|
1,092,041
|
|
|
|
1,088,929
|
|
Stock options and other incremental shares
|
|
|
3,744
|
|
|
|
2,458
|
|
|
|
1,821
|
|
|
|
|
|
|
|
Weighted-average number of common shares outstandingdiluted
|
|
|
1,098,367
|
|
|
|
1,094,499
|
|
|
|
1,090,750
|
|
|
|
|
|
|
|
Diluted earnings (loss) per share
|
|
$
|
3.94
|
|
|
$
|
(1.89
|
)
|
|
$
|
2.71
|
|
|
|
|
|
|
|
64
Note 12: Income
Taxes
Following is the composition of income tax expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
|
|
Current
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
$
|
45.7
|
|
|
$
|
(207.6
|
)
|
|
$
|
489.5
|
|
Foreign
|
|
|
772.2
|
|
|
|
623.6
|
|
|
|
412.1
|
|
State
|
|
|
49.2
|
|
|
|
(44.6
|
)
|
|
|
27.7
|
|
|
|
|
|
|
|
|
|
|
867.1
|
|
|
|
371.4
|
|
|
|
929.3
|
|
Deferred
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
|
82.5
|
|
|
|
363.0
|
|
|
|
53.0
|
|
Foreign
|
|
|
79.8
|
|
|
|
23.7
|
|
|
|
(27.9
|
)
|
State
|
|
|
(0.4
|
)
|
|
|
6.2
|
|
|
|
(30.6
|
)
|
|
|
|
|
|
|
|
|
|
161.9
|
|
|
|
392.9
|
|
|
|
(5.5
|
)
|
|
|
|
|
|
|
Income taxes
|
|
$
|
1,029.0
|
|
|
$
|
764.3
|
|
|
$
|
923.8
|
|
|
|
|
|
|
|
Significant components of our deferred tax assets and
liabilities as of December 31 are as follows:
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
|
|
Deferred tax assets
|
|
|
|
|
|
|
|
|
Compensation and benefits
|
|
$
|
1,153.2
|
|
|
$
|
1,154.6
|
|
Tax credit carryforwards and carrybacks
|
|
|
738.2
|
|
|
|
755.0
|
|
Tax loss carryforwards and carrybacks
|
|
|
458.2
|
|
|
|
562.3
|
|
Intercompany profit in inventories
|
|
|
270.6
|
|
|
|
473.9
|
|
Asset purchases
|
|
|
253.4
|
|
|
|
251.5
|
|
Asset disposals
|
|
|
173.6
|
|
|
|
3.2
|
|
Contingencies
|
|
|
162.0
|
|
|
|
345.2
|
|
Sale of intangibles
|
|
|
122.6
|
|
|
|
117.9
|
|
Product return reserves
|
|
|
85.0
|
|
|
|
100.8
|
|
Debt
|
|
|
45.9
|
|
|
|
211.6
|
|
Other
|
|
|
510.2
|
|
|
|
310.4
|
|
|
|
|
|
|
|
|
|
|
3,972.9
|
|
|
|
4,286.4
|
|
Valuation allowances
|
|
|
(836.8
|
)
|
|
|
(845.4
|
)
|
|
|
|
|
|
|
Total deferred tax assets
|
|
|
3,136.1
|
|
|
|
3,441.0
|
|
Deferred tax liabilities
|
|
|
|
|
|
|
|
|
Intangibles
|
|
|
|