| Filed by Regeneration Technologies, Inc. Pursuant to Rule 425 under the Securities Act of 1933 and deemed filed pursuant to Rule 14a-6 under the Securities Exchange Act of 1934 Subject Company: Regeneration Technologies, Inc. Commission File No.:333-148305 |
Forward Looking Statements
This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to statements about the expected benefits of the business combination involving Regeneration Technologies Inc. and Tutogen Medical Inc., including potential synergies and cost savings, future financial and operating results, and the combined company’s plans and objectives. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results, regulatory approvals or changes to agreements with distributors also are forward-looking statements. Forward-looking statements are subject to risks and uncertainties, including the ability of Regeneration Technologies and Tutogen to integrate their businesses successfully and to realize the expected synergies and cost savings from the merger and the risks described in public filings by Regeneration Technologies and Tutogen on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results reflected in these forward-looking statements. Copies of Regeneration Technologies’ SEC filings may be obtained by contacting Regeneration Technologies or the SEC or by visiting Regeneration Technologies’ Web site at www.rtix.com or the SEC’s Web site at www.sec.gov. Copies of Tutogen’s SEC filings may be obtained by contacting Tutogen or the SEC or by visiting Tutogen’s Web site at www.tutogen.com or the SEC’s Web site at www.sec.gov.
Important Additional Information and Where to Find It
The proposed merger will be submitted to the respective stockholders of Regeneration Technologies and Tutogen for their consideration, and Regeneration Technologies and Tutogen have filed a registration statement, a joint proxy statement/prospectus and other relevant documents concerning the proposed transaction with the SEC. Shareholders are urged to read the registration statement and the joint proxy statement/prospectus regarding the proposed merger and any other relevant documents filed with the SEC, as well as any amendments or supplements to those documents, because they contain important information. You can obtain a free copy of the joint proxy statement/prospectus, as well as other filings containing information about Regeneration Technologies and Tutogen, at the SEC’s Internet site (http://www.sec.gov). You will also be able to obtain these documents, free of charge, at RTI’s Web site (http://www.rtix.com) or Tutogen’s Web site (http://www.tutogen.com). Copies of the joint proxy statement/prospectus and the SEC filings that are incorporated by reference in the joint proxy statement/prospectus can also be obtained, without charge, by directing a request to Thomas F. Rose, Vice President and CFO, Regeneration Technologies Inc., PO Box 2650, Alachua, FL 32616 or to L. Robert Johnston, Jr., CFO, Tutogen Medical Inc., 13709 Progress Blvd., Box 19, Alachua, FL 32615 .
Regeneration Technologies and Tutogen, and their respective directors and executive officers, may be deemed to be participants in the solicitation of proxies from the stockholders of Regeneration Technologies and Tutogen in connection with the proposed merger. Information about the directors and executive officers of Regeneration Technologies and their ownership of Regeneration Technologies common stock is set forth in the proxy statement, dated March 30, 2007, for Regeneration Technologies’ annual meeting of stockholders, as filed with the SEC on a Schedule 14A. Information about the directors and executive officers of Tutogen and their ownership of Tutogen common stock is set forth in Tutogen’s Annual Report on Form 10-K for the fiscal year ended September 30, 2007. Additional information regarding the interests of those participants and other persons who may be deemed participants in the merger may be obtained by reading the joint proxy statement /prospectus regarding the proposed merger filed with the SEC on January 23, 2008. You may obtain free copies of these documents as described in the preceding paragraph.
This communication shall not constitute an offer to sell or the solicitation of an offer to buy securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
The following is the presentation for the Roth Growth Stock Conference held on February 19, 2008.
 Roth
Growth Stock Conference Brian K. Hutchison Chairman, President and CEO |
 FORWARD
LOOKING STATEMENT The Private Securities Litigation Reform Act of 1995
provides a “safe harbor” for certain forward-looking
statements. The forward-looking statements contained in this document
are subject to certain risks and uncertainties, such as our ability to
maintain our existing strategic relationships, rapid technological
changes, intense competition, negative publicity concerning our industry and/or
significantly greater regulation by the FDA. Actual results could differ
materially from current expectations. The information contained herein is not a prospectus and does not constitute an offer to sell nor a solicitation of an offer to buy any security.
|
| The proposed merger will be submitted to the respective stockholders of
Regeneration Technologies and Tutogen for their consideration, and
Regeneration Technologies and Tutogen have filed a registration statement, a joint proxy statement/prospectus and other relevant documents concerning the proposed
transaction with the SEC. Shareholders are urged to read the
registration statement and the joint proxy statement/prospectus regarding the proposed merger and any other relevant documents filed with the SEC, as well as any
amendments or supplements to those documents, because they contain important
information. You can obtain a free copy of the joint proxy statement/prospectus, as well as other filings containing information about Regeneration
Technologies and Tutogen, at the SEC's Internet site
(http://www.sec.gov). You will also be able to obtain these documents, free of charge, at RTI’s website (http://www.rtix.com) or Tutogen’s website
(http://www.tutogen.com). Copies of the joint proxy statement/prospectus
and the SEC filings are incorporated by reference in the joint proxy statement/prospectus can also be obtained, without charge, by directing a request to
Thomas F. Rose, Vice President and CFO, Regeneration Technologies Inc., PO Box
2650, Alachua, FL 32616 or to L. Robert Johnston, CFO, Tutogen Medical Inc.,
13709 Progress Blvd., Box 19, Alachua, FL 32615. Regeneration Technologies and
Tutogen, and their respective directors and executive officers, may be deemed to be participants in the solicitation of proxies from the stockholders of Regeneration
Technologies and Tutogen in connection with the proposed merger.
Information about the directors and executive officers of Regeneration Technologies and their ownership of Regeneration Technologies common stock is set forth in
the proxy statement, dated March 30, 2007, for Regeneration
Technologies’ annual meeting of stockholders, as filed with the SEC on a
Schedule 14A. Information about the directors and executive officers of
Tutogen and their ownership of Tutogen common stock is set forth in the proxy
statement, dated February 5, 2007, for Tutogen's annual meeting of stockholders, as filed with the SEC on a Schedule 14A. Additional information
regarding the interests of those participants and other persons who may be
deemed participants in the merger may be obtained by reading the joint
proxy statement /prospectus regarding the proposed merger. You may obtain free
copies of these documents as described in the preceding paragraph. MORE INFORMATION |
 MERGER
ANNOUNCEMENT On November 13, 2007, Regeneration Technologies, Inc. and Tutogen Medical, Inc. announced a merger to create the leading provider of sterile biologic solutions for patients around the world, reaching a broad range of markets and medical specialties with a diversified mix of implants through established distribution channels. |
 ABOUT THE
TRANSACTION Terms of the deal: • Tax-free, stock-for-stock exchange • Tutogen shareholders will receive 1.22 shares of newly issued RTI common stock in exchange for each share of Tutogen common stock they own • Expect to close in Q1 2008, subject to regulatory and other customary conditions Pro forma ownership of the combined company*: • ~ 55% RTI shareholders • ~ 45% TTG shareholders *Ownership of the company on a diluted basis • 56 million shares outstanding |
 COMBINED
LEADERSHIP Executive Leadership: • Brian Hutchison, Chairman and CEO • Guy Mayer, President – focused on international activities and sales and marketing • Tom Rose, VP, CFO and Secretary • Bob Johnston, VP Finance Board of Directors: • Total of 12 directors – Seven directors from RTI board, including Hutchison – Five members of Tutogen board, including Mayer |
 SIGNIFICANT MARKET OPPORTUNITY EXPANSION Regeneration Technologies Tutogen* Both companies are aligned with the increasing trends of biologic devices Biologics SPINE SPORTS MEDICINE HIPS/ KNEES CRANIO- MAXILLOFACIAL DENTAL DENTAL HERNIA REPAIR SURGICAL SPECIALTY $900 million addressable market $1.5 billion addressable market ~$2.5 billion market opportunity; No overlap; spine is completely complementary * Tutogen’s spine franchise is considered in the RTI Spine market SPINE |
 Tissue Processing Allograft: Human Recovery Xenograft Animal Recovery • Well defined market • Steady demand • Industry leader in procurement • RTI continues to innovate • Increased tissue supply • Predictable supply • Increased targeted procedures • Expands international markets • BioCleanse • Tutoplast • Highest safety profiles • Exclusive supply source • Supported by clinical studies • Significant margin expansion CORNERING THE MARKET |
 IMPLANT
SEGMENTS Int'l 6% Spine 43% Other 26% Sports Med 25% Int'l 28% Dental 48% Spine 10% Other 14% Other 6% Dental 17% Spine 32% Int'l 14% Surgical Spec 5% BGS 10% Sports Med 16% RTI Tutogen Combined Company |
 COMBINED
IMPLANT SEGMENTS International ENT Breast Reconstruction Ophthalmology Hernia Urology Dental Other General Orthopedic Bone Graft Substitutes Sports Medicine Spine Combined Tutogen RTI |
 KEY
DISTRIBUTORS MSD 37% Other 27% ZMH 22% Int'l 14% Int'l 6% MSD 60% Other 34% Int'l 28% Other 14% ZMH 58% RTI Tutogen Combined Company Significantly reducing dependency on single distributors |
 31.4% 32.4% 34.7% 30.8% 27.2% Y/Y Growth $36,172 $9,902 $10,035 $8,743 $7,492 Y/Y $ increase $115,346 $30,554 $28,909 $28,343 $27,540 2006 $151,518 $40,456 $38,944 $37,086 $35,032 2007 Total Q4 Q3 Q2 Q1 Pro Forma Combined Company Revenues Calendar Year $ in thousands POSITIVE TRENDS FOR BOTH COMPANIES $27.54 $28.34 $28.90 $30.55 $35.03 $37.08 $38.94 $40.46 $0 $5 $10 $15 $20 $25 $30 $35 $40 $45 Q1-06 Q2-06 Q3-06 Q4-06 Q1-07 Q2-07 Q3-07 Q4-07 TTG RTIX • RTI Biologics will bring together the diversification of products and distribution networks superior to any other company serving the industry • Opportunity for synergies that should translate into further growth in revenue, margins and profitability |
 WHO WE
ARE Began operations in 1998 – University of Florida technology transfer Leading provider of biologic tissue repair implants for the orthopedic industry Our portfolio of products serves all orthopedic applications Two-tier technology platform in orthobiologicals: Allograft – donor tissue Xenograft – bovine based tissue Extensive tissue recovery program – currently #2 in donor recoveries Access to largest xenograft (bovine) tissue source with exclusivity BioCleanse ® sterilization process differentiates our platform; proprietary, patented, FDA reviewed and noted in peer-reviewed journal |
 We are
Biologics for Orthopedic Tissue Repair; We are positioned in all major
orthopedic markets Spine Sports Medicine Reconstructive/ Revision Surgery Oral/ Maxillofacial Trauma RTI $1.5 Billion Orthobiologics Market $25 Billion Orthopedic Device Industry WHO WE ARE |
 REVENUE
CATEGORIES SPINE SPORTS MEDICINE BONE GRAFT SUBSTITUTES GENERAL ORTHOPEDICS TOTAL CORE BUSINESS CARDIOVASCULAR (exiting) OTHER TOTAL REVENUES 12 Months Ended December 31, 2007 12 Months Ended December 31, 2006 $41.06 27.69 17.01 1.00 86.76 1.95 5.50 $94.21 $35.09 14.96 13.50 .97 64.53 5.64 3.81 $73.97 (in thousands) % Inc/Dec 17% 85% 26% 3% 34% -65% 44% 27% |
 Bone
Graft Substitutes: 56% Machined/Tooled Spine: 17% Sports Med Cartilage/Ligament Repair: 2% (excluding Autograft) Biologics Product Landscape – Industry Wide RTI is present in 75% of the biologics market WHO WE ARE Hyaluranic Injections, 22% Stem Cell, 1% Platelet Concentration, 2% |
 Our
Biologics Competitive landscape WHERE WE ARE Sports Medicine* (Cartilage/Ligament Repair) Allograft tissue Autologous cultured chondrocytes Hyaluronic injections Bone Graft Substitutes* Growth factors: Protein based Platelet derived Allograft tissue Biomaterials: Hydroxyapatites Ceramic Calcium phosphates Bone cements PMMA (plastics) Cell based: Stem cell Machined Tooled Spine Metal Allograft tissue Biomaterials: PMMA (plastics/acrylic) * Excludes Autograft
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 BIOCLEANSE ® : Scientifically Undisputed, Safe, Sterile, Clinically Effective The New England Journal of Medicine - June 17, 2004 Third Party Validated, FDA Reviewed; Broad Industry Study by CDC Over Half Million Sterilized Allografts Distributed; No Reported Disease BioCleanse ® differentiates our platform; Proprietary, patented, FDA reviewed and noted in peer-reviewed journal WHAT MAKES US DIFFERENT? Maintain Clinical Utility of Implant |
 Cryolife Agreement Dec 2006 Tutogen Agreement Nov 2006 Move to Non- Exclusive with Medtronic Sep 2006 Orthofix/Blackstone Spine Agreement Dec 2006 1 st new spine partner in 9 years Wright Medical Xenograft Agreement Feb 2007 Stryker Spine Agreement Jun 2007 Bone Graft Substitute Agreement May 2007 2006:Prepared for New Business Model 2007: Met Key Objectives; Grew Revenues 35% (Q4:06) (Q2:07) (Q1:07) WHAT WE’VE BEEN DOING Favorable execution of seven key agreements; provides further visibility and predictability |
 Diversified Group of Distribution Partners Extremely Effective Direct Sales in Sports Medicine Growing Tissue Supply & New Product Introductions -Better pricing -Better visibility -Increased utilization -More predictive model -High revenue/margin per unit -85% 2007 Y/Y growth -96% Q4:07 growth -More predictive model -Increase in tissue supply -Decrease in rejections -New xenograft products -New sports medicine (BTB) products WHERE WE ARE Better Business Model; predictability, sustainability & profitability |
 Sports
Medicine; positive trends; significant growth opportunity $0.00 $1.00 $2.00 $3.00 $4.00 $5.00 $6.00 $7.00 $8.00 $9.00 $10.00 Qtr 1 Qtr 2 Qtr 3 Qtr 4 2005 2006 2007 +69% +80.5% +90% We have full control over sports medicine distribution Direct sales force and independent reps gaining traction Excellent position for continued growth over next several years $ in millions WHERE WE’RE GOING: SPORTS MED +96% |
 6% $733 $693 $656 $620 $586 Total Tendons & Ligaments 10% $88 $81 $74 $67 $61 Soft Tissue implants 10% $96 $87 $79 $72 $65 Bone Tendon Bone (BTB) 10% $184 $168 $153 $139 $126 Allograft: 5% $549 $525 $503 $481 $460 Autograft CAGR 2010E 2009E 2008E 2007E 2006 Segment (in $ millions) Market is constrained by shortage of allograft BTB Surgeons use alternative tendons BTB tendons provide optimal outcomes over alternatives Sports Medicine; We are addressing an unmet clinical need WHERE WE’RE GOING: SPORTS MED |
 Bone
Graft Substitutes; This is RTI turf; Take back share BMP continues to
see price/use resistance; many surgeons moving back to more cost effective materials (DBM) in spine Surgeons continue to be mixed Introduce new one- step paste to address demand; expand distribution In store for 2008 $893 $731 Growth Factors $143 $127 Synthetics $221 $205 DBM (RTI) Market 2007E Market 2006 Product $ in millions Largest distributor lost share due to focus on Growth Factor (BMP) RTI confined to 2-step process; introducing new 1-step product; demand is
high We have the right products and a large user base WHERE WE’RE GOING: BGS |
 Zimmer
Agreement – May 2007 Exclusive 10-year distribution agreement; $5 million in exclusivity payments
New allograft bone paste; next generation, one-step delivery system - Flowable and moldable formulations derived solely from human tissue - Offers surgeons better performance and ease of use for a variety of applications Initial shipments are expected in Q1:08 Agreement is a base with a potentially more extensive relationship focused more
broadly in orthopedics Zimmer is among many companies looking to increase orthobiologicals presence RTI bone paste provides Zimmer with further access in well established market Provides RTI with significant market share expansion potential RECENT ACTIVITIES: BGS |
 Allograft, $855 Autograft, $797 Metals & Synthetics, $648 $2.3 billion market for biologics Biologics are preferred in the surgical community – patients are following; large ortho companies are positioning Limited supply of donor tissue limits allograft’s market opportunity Xenograft will contribute significantly to growth of tissue-based biologics
segment $ in millions Xenograft supply allows further penetration into autograft market Xenograft; Facilitates steady growth in tissue market WHERE WE’RE GOING: XENOGRAFT |
 Image
slices of a CT scan of one patient’s knee at seven month follow-up examination. The femoral interference screw is visible in the right-hand image. Be the leader in Xenograft; BioCleanse ® adds clinical benefit WHERE WE’RE GOING: XENOGRAFT Research indicates the Sterling® Interference Screw combines the fixation strength of metal and bioabsorbable materials with the proven incorporation characteristics of bone materials. |
 Agreement to develop advanced xenograft implants for use in foot and ankle surgeries with Wright Medical – Feb. 12, 2007 New implants marketed by Wright under the CANCELLO-PURE™ brand A multi-purpose wedge version of product shipped 2Q07; indication-specific product configurations shipped in Q7:07; 2 new implant families slated for 2008 Wright has allocated significant resources to foot/ankle segment with several recent acquisitions and distribution agreements, expanding sales force and product focus Xenograft; Wright Medical validates xeno opportunity WHAT WE’VE BEEN DOING: XENOGRAFT |
 Positive
changes; Excellent outlook New business model gives us opportunity to
leverage our technology & grow our business – recent results illustrate execution We are in the most dynamic segment of the $25 billion orthopedic device industry Merger positions us in worldwide biologics industry; ortho & other surgical
Tissue repair/regeneration is main focus of surgeons, patients, corporations
Tissue industry driven by trusted clinical results and surgeon acceptance
Our developments in xenograft will facilitate further growth in tissue repair
We expect continued accomplishments in FY:2007 and FY:2008: Continued increases in revenue Introduce new products Continued increases in profitability Increases in cash flow INVESTMENT SUMMARY |
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