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Innovative Solutions for a Healthier World. Merrill Lynch 2007 Global Pharmaceutical, Biotechnology & Medical Device Conference February 6-8, 2007 Robert Taub, President & Chief Executive Officer. NASDAQ: OMRI. SAFE HARBOR STATEMENT.
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Innovative Solutions for a Healthier World Merrill Lynch2007 Global Pharmaceutical, Biotechnology & Medical Device Conference February 6-8, 2007Robert Taub, President & Chief Executive Officer NASDAQ: OMRI
SAFE HARBOR STATEMENT • This presentation contains forward-looking statements. Forward-looking statements provide the company's current expectations or forecasts of future events. Forward-looking statements include statements about the company's expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘ongoing,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project’’ or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. • Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. The company's actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the company’s filings with the SEC, including sections entitled ‘‘Risk Factors’’ and "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in the company's prospectus as filed with the Securities and Exchange Commission on December 15, 2006 and the company’s most recent quarterly reports on Form 10-Q and its current reports on Form 8-K. Accordingly, you should not unduly rely on these forward-looking statements, which speak only as of the date of this press release. • Unless required by law, the company undertakes no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events. You should, however, review the factors and risks we describe in the reports the company will file from time to time with the Securities and Exchange Commission after the date of this presentation.
OMRIX Biopharmaceuticals, Inc. • Biopharmaceutical player in protein-based biosurgery and passive immunotherapy • Diversified and synergistic business platforms • Hemostasis in surgery backed by Johnson & Johnson • Hyperimmunes provide upside potential BIOSURGERY IMMUNOTHERAPY
INVESTMENT HIGHLIGHTS • Establishing presence in growing and underpenetrated markets • Expanding market share with commercialized biosurgery product, Evicel; indication expansion expected in 2H07 • 2H07 Thrombin launch is anticipated to capture market share • Continued growth and profitability • 157% product sales growth ($41.2M YTD Q306 vs. $16.0M YTD Q305)* • $16.7M net income in Q306 vs. net loss of $27.8M in Q305 • Visible pipeline of near-term and medium-term product launches • Breakthrough biosurgery product in development addressing brisk bleeding: The Fibrin Patch • Three immunotherapy product candidates to address emerging viral threats • Long-term development, marketing & distribution partnership with Ethicon, a Johnson & Johnson company and dominant player in surgical closure and wound management, including hemostasis • Differentiated business model • Manufacturing commonalities and economies of scale between two business lines • Development costs financed by third parties * Total revenues: $45.7M YTD Q306, $19.2M YTD Q305
OUR STRATEGY BIOSURGERY • Execute and expand Ethicon partnership • Develop new products outside of Ethicon relationship • Commercialize hemostasis products in new territories IMMUNOTHERAPY • Three tiered strategy: • Launch current products in new territories • Commercialize product candidates • Rapidly respond to emerging viral threats Achieve continued growth while maintaining financial discipline
Innovative Solutions for a Healthier World BIOSURGERY NASDAQ: OMRI
MARKET OPPORTUNITY - HEMOSTASIS Active hemostats is fastest growing segment of surgical sealant market $1,500 (WW) Fibrin Sealants & Thrombin Products CAGR = 10% $650 (WW) $1,100 Fibrin Sealants & Thrombin Products Fibrin Patch $400 2006 2015 Note: $ in millions Source: IMS data, Company Reports and OMRIX Estimates
MARKET SHIFT:TOWARDS ACTIVE AND ADVANCED HEMOSTATS • Passive Hemostats • Action: Mechanical • Active Hemostats • Action: Physiological • Advanced Hemostats • Action: Combination of mechanical and physiological Fibrin SealantsEvicel™ / Quixil™ Gelatin/Collagen-Based Fibrin Patch Thrombin Cellulose-Based Price per procedure~$200 - $500 Price per procedureTBD Price per procedure~$50 - $100
EVICEL (US) / QUIXIL (EU): LIQUID FIBRIN SEALANTS Competitive Advantages • Ease of use • Ready to use in less than one minute (refrigerated) • No mixing or reconstitution required • Sprays or drips with same device tip • Safety • Human only, no bovine • Needle-free device • Product Overview • Used as adjunct to hemostasis in surgery • Only commercially available bovine-free fibrin sealant • Indicated for liver surgery in US; General hemostasis in EU • 2006 US Market: ~$100M, Growing 15% annually Evicel Approval Timeline 2H07 1H07 1H06 Kidney Surgery Indication PV Surgery Indication Liver Surgery Indication General Hemostasis Indication
THROMBIN STAND-ALONE • Product Overview • BLA submitted on November 6, 2006 • Designed for gradual onset of clotting • Component of Evicel registered as stand-alone product 2006 US Thrombin Products Market • >300M • Competitive Advantages • Ease of use • Ready to use in less than one minute (refrigerated) • No mixing or reconstitution required • Safety • Human only, no bovine • Partnered with Ethicon • Launch, marketing to be powered by Ethicon leadership
FIBRIN PATCH:BREAKTHROUGH CONVERGENCE PRODUCT • Product Overview • Phase 1 clinical trial commenced on December 6, 2006 • Addressing unmet medical need – Hemostasis in severe bleeding scenarios • Convergence of Johnson & Johnson’s matrix with OMRIX’s biologicals • Global Market Opportunity • $400M • Competitive Advantages • Multiple development barriers to entry • Lack of comparable product on market or in development “#1 project in Ethicon pipeline” • Dan Wildman, President Johnson & Johnson Wound Management Biodegradable matrix Embedded fibrin sealant biologics
JOHNSON & JOHNSON PARTNERSHIP OVERVIEW • Exclusive supply, distribution and development agreement • OMRIX receives substantial revenue share • Johnson & Johnson expands leadership position in hemostasis market • Sales & marketing • Development costs • Manufacturing • Regulatory submissions • ONE-STOP-SHOP FOR SURGICAL HEMOSTATS
BEYOND HEMOSTASIS: MARKET OPPORTUNITIES OMRIX Biopharmaceuticals, Inc. Ethicon Other Partners Healing Fibrin Polymer Internal Wound Tissue Engineering, Repair, Regeneration Adhesion Prevention Bleeding Hemostasis
Innovative Solutions for a Healthier World IMMUNOTHERAPY NASDAQ: OMRI
THREE MARKETED IMMUNOTHERAPY PRODUCTS • Intravenous Immunoglobulin (IVIG) • Currently marketed in Israel • Phase 3 study in US by FFF Enterprises • HYPERIMMUNES: • Provide ongoing protection, prevention and treatment against viral threats and infectious diseases • Vaccinia Immunoglobulin (VIG) • Biodefense stockpile • Treatment of smallpox vaccine related complications • Hepatitis B Immunoglobulin (HBIG) • For the prevention of post liver transplant Hepatitis B re-infection • POLYVALENT IMMUNOGLOBULIN:
UPCOMING MILESTONES Clinical Development Clinical Development Phase 3 sBLA – Supplemental Biologics License Application
DELIVERING RESULTS 190% Increased Product Volume Drives Margin Expansion
INCOME STATEMENT& BALANCE SHEET ($ IN THOUSANDS, EXCEPT PER SHARE DATA) * Note: Figures include $15.3 million sales under the UK contract for VIG. • As of September 30, 2006 • Cash and short term investments $40,463* • Total debt $1,370 • Working capital $47,511 Total assets $76,390 * Note: Figure does not include $51.4 million in net proceeds raised from follow-on offering and exercise of over-allotment completed on December 14, 2006 and January 12, 2007, respectively.
MANAGEMENT TEAM • Robert Taub, Founder, President and CEO • 30+ years pharmaceutical experience; serial entrepreneur • Co-Founder of Octapharma AG, a privately-held plasma fractionator • Monsanto; Revlon Health Care Group;Baxter International Inc. • Michael Burshtine, Executive Vice President, Chief Financial Officer • Former PricewaterhouseCoopers partner • Joined in 2004, has worked with OMRIX since 1995 • Nissim Mashiach, Executive Vice President, Chief Operating Officer • 20 years device and biological experience • Joined 1998, prior management experience in leading Israeli pharmaceutical and biotech companies • Orgad Laub, Ph.D., Vice President, R&D Immunotherapy • 25 years of biotechnology experience • Chiron, Ares Serono and The Weizmann Institute of Science • Israel Nur, Ph.D., Vice President, R&D Biosurgery • 15 years of biosurgery experience at Octapharma and OMRIX • Hank Safferstein, Ph.D., JD, Vice President, Business Development • 15 years biotechnology and pharmaceutical experience • Bristol-Myers Squibb; The National Institutes of Health; Acorda Therapeutics
INVESTMENT HIGHLIGHTS • Establishing presence in growing and underpenetrated markets • Expanding market share with commercialized biosurgery product, Evicel; indication expansion expected in 2H07 • 2H07 Thrombin launch is anticipated to capture market share • Continued growth and profitability • 157% product sales growth ($41.2M YTD Q306 vs. $16.0M YTD Q305)* • $16.7M net income in Q306 vs. net loss of $27.8M in Q305 • Visible pipeline of near-term and medium-term product launches • Breakthrough biosurgery product in development addressing brisk bleeding: The Fibrin Patch • Three immunotherapy product candidates to address emerging viral threats • Long-term development, marketing & distribution partnership with Ethicon, a Johnson & Johnson company and dominant player in surgical closure and wound management, including hemostasis • Differentiated business model • Manufacturing commonalities and economies of scale between two business lines • Development costs financed by third parties * Total revenues: $45.7M YTD Q306, $19.2M YTD Q305
Innovative Solutions for a Healthier World Merrill Lynch2007 Global Pharmaceutical, Biotechnology & Medical Device Conference February 6-8, 2007Robert Taub, President & Chief Executive Officer NASDAQ: OMRI
FIBRINOGEN CROSSLINKING FIBRINOGEN D:D D domain E domain Thrombin FPA D:D XIIIa g dimer (XIIIa) D:E Crosslinked fibrinogen Crosslinked fibrin Thrombin FPA FIBRIN