| Filed by Tutogen Medical, 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 Tutogen Medical, Inc.’s presentation for the ROTH Growth Stock Conference held on February 19, 2008.
 Tutogen
Medical, Inc. ROTH Growth Stock Conference February 2008 AMEX: TTG |
 2
FORWARD LOOKING STATEMENT 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 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' S.E.C. filings may be obtained by contacting Regeneration Technologies or the S.E.C. or by visiting Regeneration Technologies' Web site at www.rtix.com or the S.E.C.'s Web site at www.sec.gov. |
 3
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 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, 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. Informati on 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 10K 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. MORE INFORMATION |
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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. |
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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 |
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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 |
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IMPLANT SEGMENTS Int'l 6% Spine 43% Other 26% Sports Med 25% Int'l 28% Dent. 48% Spine 10% Other 14% Other 6% Spine 32% Dental 17% Int'l 14% Surgical Spec 5% BGS 10% Sports Med 16% + RTI Tutogen Combined Company |
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COMBINED IMPLANT SEGMENTS RTI Tutogen Combined Spine Sports Medicine Bone Graft Substitutes General Orthopedic Other Dental Urology Hernia Ophthalmology Breast Reconstruction ENT International |
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COMBINED FINANCIAL HIGHLIGHTS >$30 million in cash at Dec. 31, 2007 and generate positive operating cash
flow Strong balance sheet with very little debt Accretive to RTI’s 2008 GAAP earnings per share $5-6MM of identified 2008 cost savings when fully implemented Significant revenue enhancement opportunities |
 10 COMBINED REVENUE Tutogen and RTI Revenue Comparison Calendar Year 2007 vs. 2006 31.4% 32.4% 34.7% 30.8% 27.2% Revenue Growth $36,172 $9,902 $10,035 $8,743 $7,492 Revenue Growth $115,346 $30,554 $28,909 $28,343 $2,750 2006 $151,518 $40,456 $38,944 $37,086 $3,502 Combined Revenue: 2007 Total Q4 Q3 Q2 Q1 Calendar Year |
 11 Tutogen is a leading worldwide manufacturer and supplier of sterile biological implants made from human (allograft) and animal (xenograft) soft tissue and bone The Company is the only biologics manufacturer worldwide able to claim a 100% sterile full product complement using the Company’s Tutoplast process Operates in a more than $1 billion market 21% 5-Year Revenue Compound Annual Growth Rate Strong leading distribution partners: Zimmer Dental, Zimmer Spine, Davol, Mentor, Coloplast and IOP Company Overview $20.7 $30.3 $29.3 $31.9 $37.9 $53.8 $0 $10 $20 $30 $40 $50 $60 2002 2003 2004 2005 2006 2007 Fiscal Year Ending 9/30 Revenue |
 12 Tutoplast ® Process Production Flow DELIPIDIZATION OSMOTIC TREATMENT OXIDATIVE TREATMENT DEHYDRATION TISSUE DONATION PRECISION MACHINING STERILIZATION INCOMING INSPECTION PACKAGING Multi-step Process Substantially eliminates all types of pathogens More than 1.5 million grafts implanted With an unblemished 30 year safety record |
 13 Advantages of Tutoplast Process Inactivates and removes bacteria Removes lipids Inactivates prion activity Removes antigenicity Eliminates viral infectivity by a safety margin of 5 log (100,000 times) Breaks down RNA and DNA into fragments not capable of replication and disease transmission Preserves biological and mechanical properties Meets and exceeds regulatory requirements Terminally sterilized and packaged in double pouch Stores at room temperature |
 14 U.S. Market Size: $1.25 Billion* Addressable Markets Spine, $656 Hernia $150 Dental, $174 Surgical Specialty, $279 Urology Obstetrics/Gynecology Breast Reconstruction Ophthalmology Ear Nose & Throat (ENT) *Source: Internal Estimates and Orthopedic Network News, October 2005 |
 15 Partnership – Zimmer Dental, Inc. - subsidiary of Zimmer Holdings (NYSE: ZMH) – Valued partner since Sept. 2000 – Worldwide – New Agreement Completed August 2007 Products and Applications – Puros Block Allograft increases bone volume for surgical ridge augmentation – Puros Cortical Particulate Allograft provides the necessary bony structure needed to support subsequent dental implants – Puros Cancellous Particulate Allograft provides complete and effective bone regeneration – Puros Pericardium for guided bone regeneration in ridge augmentation – Puros Dermis used for vertical and horizontal soft tissue augmentation Initiatives – Expansion into International Markets – New Products – Single Tooth Block, Bovine Pericardium Markets – Global market $350 million / U.S. market is $174 million – Expected to grow 15.3% annually thru 2014 Dental Market |
 16 U.S. Quarterly Dental Sales (Jan. 2002 to December 2007) Quarterly Dental Sales $0 $1,000 $2,000 $3,000 $4,000 $5,000 $6,000 $7,000 $8,000 Good market growth – Puros Bone at about a 20% market share • Strong brand recognition • Good clinical outcomes • Zimmer educational forums • Support from opinion leaders Continued growth – New Products Released in Past Year • Puros Dermis • Puros Pericardium – Addition of xenograft (bovine) pericardium for U.S. Market – early 2008 |
 17 Dental Accounts Growth – Past 18 Months 0 50 100 150 200 250 300 |
 18 International Dental Opportunity Total Market-$180 million Several regulatory approvals already in place Exclusive Distributorship in over 30 countries including Germany-large dental implant market-large potential Full line of allograft and xenograft products to promote bone growth for dental implants Zimmer became our stocking Distributor effective August 2007 International Dental Revenues grew by 87% during our 1 st quarter. |
 19 Spine Market Estimated 2005 U.S. Machined Bone Market – $321 Million, 18% growth* Estimated percent of time bone is used in Spinal fusion procedures – ALIF – 12% – Cervical – 68% – PLIF – 72% – TLIF – 9% Current Focus on Machined Bone – New Products shipped to Zimmer • Puros C for Cervical procedures • Puros A for ALIF procedures • Puros P for PLIF procedures Bone Graft Substitute Market Machined Bone 49% Allograft Bone 19% Demineralized Bone Matrix 32% *Source: Orthopedic Network News, October 2005
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 20 Partnership – Zimmer Spine, Inc. - subsidiary of Zimmer Holdings (NYSE: ZMH) – Valued partner since Sept. 2000 – U.S. & Canada Products and Applications – Puros Bone for enhancing interbody fusion • Traditional bone • Specialty Machined grafts – Cervical Grafts, ALIF and PLIF Initiatives – First new products designed and manufactured in the U.S. shipped in H2 2006 • Puros C, for cervical applications • Puros A, new ALIF • Puros P, new PLIF – Two to three new products by mid 2008 Markets – Worldwide market $1,200 million – U.S. market is $656 million* – Expected to grow at a 16% CAGR* Spine Market *Source: Orthopedic Network News, October 2005
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 21 NEW Partnership – Davol Inc. – subsidiary of CR Bard, Inc. (NYSE: BCR) – Market leader (60%) in estimated $500 million worldwide market Products and Applications – Repair of hernias and reconstruction of the chest and abdominal walls – AlloMax-human dermis product Initiatives – Training sales force – Product released in 2 nd Quarter 2007 – Clinical Case Studies on-going Markets – Worldwide market $500 million – U.S. Market $150 million – Expected to grow at a 18% CAGR Hernia Market |
 22 Breast Reconstruction NEW Partnership – Mentor Corporation (NYSE: MNT) – Market leader in Breast Implants Applications and Products – Breast Reconstruction following Mastectomy – NeoForm™ Human Dermis Initiatives – Training sales force – Product introduced in 2 nd Quarter to clinical sites – Product launched July 2007 Markets – Currently a $50 Million market with the potential of $100 Million |
 23 International Business Projected Sales Mix, by specialty Membranes 36% Orthopaedic 35% Sports Medicine 3% Tissue Service 10% Dental 16% Distributor Based Sales – 60% Membranes / 40% Bone – 65% Human / 35% Bovine Strategy Driving Global Agreements – Davol Hernia Repair Signed January 2006 – Coloplast Agreement in Urology/Gynecology Signed May 2007 – Zimmer Dental Agreement Signed August 2007 - $1.0M initial stocking order Aug 2007 Sales increased 27% in 2007 compared to 2006; 32% for FY1Q 2008 compared to FY1Q
2007 |
 24 Bovine Initiatives 30%-35% of international sales are bovine products Tutogen to introduce bovine pericardium product to U.S. marketplace through Zimmer Dental-January 2008 Tutogen to introduce bovine pericardium product for hernia repair in U.S. to initial clinical sites over the next 12 months Coloplast distribution agreement expanded to international markets to include bovine products Zimmer Dental distribution agreement expanded to international to include bovine products |
 25 Revenues for Years Ended September 30, 2007 and 2006 (in 000’s) Years Ended September 30, % 2007 2006 Change Dental $24,329 $17,616 38% Spine $5,516 $2,877 92% Surgical Specialties $8,139 $4,937 65% Total U.S. Revenues $37,984 $25,430 49% International Revenues $15,835 $12,517 27% Total Consolidated Revenues $53,819 $37,947 42% |
 26 Revenues for Quarters Ended December 31, 2007 and 2006 (in 000’s) Quarters Ended December 31, % 2007 2006 Change Dental $6,720 $5,286 27% Spine $1,150 $1,293 -11% Surgical Specialties $2,683 $1,554 73% Total U.S. Revenues $10,553 $8,133 30% International Revenues $4,402 $3,330 32% Total Consolidated Revenues $14,955 $11,463 30% |
 27 Quarterly Financials $11.5 $13.0 $14.2 $15.2 $15.0 $0 $2 $4 $6 $8 $10 $12 $14 $16 Dec. '06 Mar. '07 June '07 Sep. '07 Dec. '07 Revenue Net Income * Includes $1.6million in costs related to the proposed merger. Excluding these costs, the company would have generated a $343K profit or a $.02 per share. $0.4 $0.9 $0.9 -$0.4 -$1.3 Dec. '06 Mar. '07 June '07 Sep. '07 Dec. '07 |
 28 Balance Sheet as of December 31, 2007 Cash $11.1M Accounts Receivable $7.5M Inventory $19.0M Other $4.3M Total Current Assets $41.9M Total Assets $59.8M Total Current Liabilities $13.8M Long Term Debt $3.2M Other $2.5M Total Liabilities $19.5M Total Shareholders' Equity $40.3M Total Liabilities & Shareholders' Equity $59.8M |
 Tutogen
Medical, Inc. ROTH Growth Stock Conference February 2008 AMEX: TTG |