NASDAQ: OMRI

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Merrill Lynch 2007 Global Pharmaceutical, Biotechnology & Medical Device Conference February 6-8, 2007 Robert Taub, President & Chief Executive Officer NASDAQ: OMRI Innovative Solutions for a Healthier World

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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. - PowerPoint PPT Presentation

Transcript of NASDAQ: OMRI

Page 1: NASDAQ: OMRI

Merrill Lynch2007 Global Pharmaceutical, Biotechnology & Medical Device Conference

February 6-8, 2007

Robert Taub, President & Chief Executive Officer

NASDAQ: OMRI

Innovative Solutions for a Healthier World

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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.

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OMRIX Biopharmaceuticals, Inc.

IMMUNOTHERAPYBIOSURGERY

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

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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

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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

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BIOSURGERY

NASDAQ: OMRI

Innovative Solutions for a Healthier World

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MARKET OPPORTUNITY - HEMOSTASIS

Source: IMS data, Company Reports and OMRIX EstimatesNote: $ in millions

Fibrin Sealants&

Thrombin Products

$1,100

Fibrin Patch$400

Active hemostats is fastest growing segment of surgical sealant market

Fibrin Sealants&

Thrombin Products

2006 2015

CAGR = 10%

$650 (WW)

$1,500 (WW)

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Gelatin/Collagen-Based

Cellulose-Based

Price per procedure~$50 - $100

Passive HemostatsAction: Mechanical

MARKET SHIFT:TOWARDS ACTIVE AND ADVANCED HEMOSTATS

Advanced HemostatsAction: Combination of

mechanical and physiological

Fibrin Patch

Price per procedureTBD

Active HemostatsAction: Physiological

Fibrin Sealants Evicel™ / Quixil™

Thrombin

Price per procedure~$200 - $500

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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

1H07 2H07Evicel Approval Timeline

1H06

PV Surgery IndicationKidney Surgery Indication

General Hemostasis IndicationLiver Surgery Indication

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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

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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

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WET LAB DEMONSTRATION OF FIBRIN PATCH

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JOHNSON & JOHNSON PARTNERSHIP OVERVIEW

Exclusive supply, distribution and development agreement OMRIX receives substantial revenue share Johnson & Johnson expands leadership position in hemostasis market

Sales & marketingDevelopment costs

ManufacturingRegulatory submissions

ONE-STOP-SHOP FOR SURGICAL HEMOSTATS

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BEYOND HEMOSTASIS: MARKET OPPORTUNITIES

Internal Wound

Bleeding

Hemostasis

Fibrin Polymer

OMRIX Biopharmaceuticals, Inc.

Ethicon Other Partners

TissueEngineering,

Repair,Regeneration

AdhesionPrevention

Healing

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BIOSURGERY PRODUCT PIPELINE

General Hemostasis in surgery

EvicelTM** (US)

Spine

Adhesion PreventionAdhexil

Phase II Phase IIIPhase IPreclinicalIndicationProgram

Management of brisk bleeding; use on active bleeding sites

Fibrin Patch

General Hemostasis in surgery

Thrombin Stand-Alone*

General Hemostasis in surgery

EvicelTM** (US)

Spine

Adhesion PreventionAdhexil

Phase II Phase IIIPhase IPreclinicalIndicationProgram

Management of brisk bleeding; use on active bleeding sites

Fibrin Patch

General Hemostasis in surgery

Thrombin Stand-Alone*

* Biologics License Application (BLA) submitted on November 6, 2006** Currently approved as adjunct to hemostasis in patients undergoing liver surgery

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IMMUNOTHERAPY

NASDAQ: OMRI

Innovative Solutions for a Healthier World

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THREE MARKETED IMMUNOTHERAPY PRODUCTS

Intravenous Immunoglobulin (IVIG) Currently marketed in Israel Phase 3 study in US by FFF Enterprises

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

HYPERIMMUNES:

Provide ongoing protection, prevention and treatment against viral threats and infectious diseases

POLYVALENT IMMUNOGLOBULIN:

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IMMUNOTHERAPY PRODUCT PIPELINE

Avian InfluenzaInfluenza IG **

Primary Immune Deficiency IVIG (US)

Phase II Phase IIIPhase IPreclinicalIndicationProgram

Treatment of complications related to vaccinia vaccination

HT-VIG *High Titer IG

Treatment of West Nile VirusWNIG *

West Nile IG

Avian InfluenzaInfluenza IG **

Primary Immune Deficiency IVIG (US)

Phase II Phase IIIPhase IPreclinicalIndicationProgram

Treatment of complications related to vaccinia vaccination

HT-VIG *High Titer IG

Treatment of West Nile VirusWNIG *

West Nile IG

* We have received NIH Grants for the development of these product candidates** Cooperative Research and Development Agreement (CRADA) with the NIAID

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UPCOMING MILESTONES

sBLA – Supplemental Biologics License Application

PRODUCT 1H07 2H07 2008 2009

Thrombin US Launch

sBLA FilingKidney

EMEA Filing

US LaunchGeneral

HemostasisEU Launch

Fibrin Patch US IND Filing

US Launch

Adhexil US Launch

WNIG Phase 3

IVIG (US) US Launch

Clinical Development

Clinical Development

Phase 3

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FINANCIAL OVERVIEW

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DELIVERING RESULTS

$0.0

$5.0

$10.0

$15.0

$20.0

Q305 Q405 Q106 Q206 Q306

Pro

du

ct S

ales

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

Gro

ss M

arg

in

Product Sales Gross Margin

$0.0

$5.0

$10.0

$15.0

$20.0

Q305 Q405 Q106 Q206 Q306

Pro

du

ct S

ales

Biosurgery Immunotherapy

Increased Product Volume Drives Margin Expansion

190%

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INCOME STATEMENT & BALANCE SHEET ($ IN THOUSANDS, EXCEPT PER SHARE DATA)

9 Months Ended September 30,

FY 2005 2005 2006* 2006 Guidance

Product Sales $22,478 $16,019 $41,241 $54 - $55M

Total Revenue $27,499 $19,171 $45,721

Operating Income (Loss) ($2,190) ($2,823) $15,415

Net Income (Loss) ($27,712) ($27,805) $16,668

Diluted EPS ($2.45) ($2.48) $1.23 $1.40 - $1.45

As of September 30, 2006Cash and short term investments $40,463*Total debt $1,370 Working capital $47,511Total assets $76,390

* Note: Figures include $15.3 million sales under the UK contract for VIG.

* 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.

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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

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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

Page 25: NASDAQ: OMRI

Merrill Lynch2007 Global Pharmaceutical, Biotechnology & Medical Device Conference

February 6-8, 2007

Robert Taub, President & Chief Executive Officer

NASDAQ: OMRI

Innovative Solutions for a Healthier World

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FIBRINOGEN CROSSLINKING

FIBRINOGEND D domaindomain

E E domaindomain

XIIIXIIIaa

ThrombinThrombin

dimerdimer

D:DD:DD:DD:D

FPAFPA D:D:DDD:D:DD

ThrombinThrombin

(XIII(XIIIaa))

FPAFPA

Crosslinked fibrinCrosslinked fibrin

Crosslinked Crosslinked fibrinogenfibrinogen

D:ED:ED:ED:E

FIBRIN