OMRIX BIOPHARMACEUTICALS, INC. - 8-K - 20080317 - EXHIBIT_99
Exhibit 99.2
NASDAQ: OMRI
Innovative Solutions for a Healthier World
Cowen and Company 28th Annual Health Care Conference
Robert Taub, Chief Executive Officer
March 17, 2008
SAFE HARBOR STATEMENT
During the course of this presentation the Company or its representatives
may make forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements, including
those relating to future events or the future financial performance of the
Company, are based on management's current expectations and are
subject to certain risks and uncertainties that could cause actual events
or results to differ materially from those in the forward-looking
statements. These documents contain important factors that could cause
actual results to differ materially from those contained in any forward-
looking statement of the Company made in connection with this
presentation. Information on other potential risks and uncertainties not
discussed herein may be found in the Company's filings with the
Securities and Exchange Commission.
COMPANY OVERVIEW
BIOSURGERY CONVERGENCE PRODUCTS
A fully integrated biosurgery company with expertise
in biologic/device combination products
INVESTMENT HIGHLIGHTS
Financial Strength
Revenues from 6 commercialized products (2 in U.S.)
Biosurgery sales grew 91% during 2006 and 44% during 2007
Biosurgery sales are projected to grow 75% in 2008
Immunotherapy sales, other than VIG, are steady at ~$30+ million per year
Profitable since IPO
Successful execution
Two BLA's approved in the last 2 years
Received FDA approval of Evicel and Evithrom with general hemostasis in
surgery indication
Submitted Evicel for general hemostasis in surgery in the EU
Marketing, distribution and development partnership with Ethicon, Inc.
Mature relationship with Ethicon, Inc., a Johnson & Johnson company,
the major player in wound closure and wound management, including
hemostasis
INVESTMENT HIGHLIGHTS
Establishing presence in growing and under-penetrated markets with
our existing biosurgery products
Expanding market share with Evicel following FDA approval of General
Hemostasis in surgery indication (Jan. 2008)
EU approval of Evicel for general hemostasis in surgery expected in 3Q08
Multiple product and market opportunities within and outside of Ethicon
relationship
Visible pipeline of near-term and medium-term biosurgery product
launches
Thrombin-based combination products
Adhexil for post-surgical adhesion prevention (open/minimally invasive)
Fibrin Patch to address unmet medical need
Other product extensions (e.g. Aeris Therapeutics)
GROWTH STRATEGY
Execute and expand Ethicon, Inc. partnership
Introduce hemostasis products in territories not
licensed to Ethicon, including Far East (e.g. Japan)
Develop additional product extensions
Develop new products outside of Ethicon partnership
Achieve continued growth while maintaining financial discipline
ETHICON PARTNERSHIP OVERVIEW
Exclusive supply, distribution and development agreement
OMRIX receives substantial revenue share
Ethicon expands leadership position in hemostasis market
Development funding
Sales & marketing
Development
Regulatory
Manufacturing / Supply
ONE-STOP-SHOP
FOR SURGICAL HEMOSTATS
MARKET OPPORTUNITY - HEMOSTASIS
Source: IMS data, Company Reports and OMRIX Estimates
Note: $ in millions
Fibrin Sealants
&
Thrombin Products
Fibrin Patch
Active Hemostats
The fastest growing segment of the surgical sealant market
Fibrin Sealants
&
Thrombin Products
2006
2011
CAGR = 10%
$700 (WW)
$1,200 (WW)
Gelatin/
Collagen-Based
Cellulose-Based
Price per procedure
~$50 - $100
Passive Hemostats
Action: Mechanical
MARKET SHIFT:
TOWARD ACTIVE AND ADVANCED HEMOSTATS
Advanced Hemostats
Action: Combination of
mechanical and
physiological
Fibrin Patch
Price per procedure
TBD
Active Hemostats
Action: Physiological
Fibrin Sealants
Evicel(tm) / Quixil(tm)
Evithrom / Thrombin
Price per procedure
~$200 - $500
EVICEL: LIQUID FIBRIN SEALANT
EVICEL: LIQUID FIBRIN SEALANT
COMPETITIVE ADVANTAGES
Ease of use, safety & efficacy
Fast (ready to use in less than one minute after thawing)
Only commercially available bovine-free and aprotinin-free,
fibrin sealant
Forms clear, stable clot that anchors firmly to bleeding site
New laparoscopic device
EVICEL SALES ARE GROWING RAPIDLY
EVITHROM
EVITHROM
COMPETITIVE ADVANTAGES
Safety
Human only (no bovine)
Ease of use
Ready to use in less than one
minute (refrigerated)
No mixing or reconstitution
required
Kitted product
(Thrombin plus gelatin)
BIOSURGERY PRODUCT PIPELINE
General Hemostasis
in surgery
Thrombin**
Adhesion Prevention
Adhexil
Phase II
Phase III
Phase I
Preclinical
Indication
Program
Management of brisk bleeding;
use on active bleeding sites
Fibrin Patch
General Hemostasis
in surgery
Evicel
TM
* (US)
General Hemostasis
in surgery
Evithrom
Adhesion Prevention
Adhexil
Phase II
Phase III
Phase I
Preclinical
Indication
Program
Management of brisk bleeding;
use on active bleeding sites
Fibrin Patch
General Hemostasis
in surgery
Evicel
TM
* (US)
General Hemostasis
in surgery
Thrombin**
Adhesion Prevention
Adhexil
Phase II
Phase III
Phase I
Preclinical
Indication
Program
Management of brisk bleeding;
use on active bleeding sites
Fibrin Patch
General Hemostasis
in surgery
Evicel
TM
* (US)
Adhesion prevention
Adhexil
Phase II
Phase III
Phase I
Preclinical
Indication
Program
Mgmt of mild, moderate and
severe bleeding; use on
active bleeding sites
Fibrin Patch
General Hemostasis
in surgery
Evicel
TM
(EU)
Spine / Orthopedic
"CAPITALIZING ON CONVERGENCE"
"Still another example is an exciting ETHICON, Inc. solution in development
for heavy bleeding, the world's leading cause of death due to injury.
Scientists from ETHICON have teamed up with Omrix Biopharmaceuticals and
our biologics manufacturing team at Centocor, Inc. to create an absorbable
patch that can manage the entire spectrum of bleeding. Proprietary biologics
embedded in the patch form an instant clot when they come in contact with
the wound. This product, which is in early phases of clinical testing, is just
one of many product and technology convergence projects across the
Company."
William C. Weldon
Chairman, Board of Directors, and Chief Executive Officer
March 12, 2008
Johnson & Johnson 2007 Annual Report
FIBRIN PATCH: BREAKTHROUGH
CONVERGENCE PRODUCT
Product Overview
Addressing unmet medical need
Convergence of Johnson &
Johnson's matrix with OMRIX's
biologicals
Global Market Opportunity
$400M+ Annually
Competitive Advantages
Multiple barriers to entry
Lack of comparable product on
market or in development
"#1 project in Ethicon pipeline"
Dan Wildman, President Johnson & Johnson Wound Management
FIBRIN PATCH: TECHNOLOGY
Oxidized Regenerated
Cellulose (ORC)
Ease of handling
Stable material
Known material
Non Woven Fibers
Increased surface
area for application of
biologic powders
Known material
BAC and
Thrombin Powder
Combination of mechanical
and physiological
Strong adherence
characteristics
Known ingredients
FIBRIN PATCH: BREAKTHROUGH
CONVERGENCE PRODUCT
Severe
Oozing
FIBRIN PATCH: THE PROBLEM
The Human Body
Contains:
50 miles of blood vessels
5 Liters of blood
FIBRIN PATCH: THE PROBLEM
FIBRIN PATCH: THE PROBLEM
FIBRIN PATCH: THE PROBLEM
DEMONSTRATION OF FIBRIN PATCH
FIBRIN PATCH STUDY
A randomized, controlled clinical study evaluating the superiority of
Fibrin Patch compared to SURGICEL
Soft Tissue (Retroperitoneal/Intra-Abdominal/Thoracic/Pelvic)
Pancreatic resection, peri-aortic node dissection, pulmonary resection, esophageal
resection, partial nephrectomy, radical hysterectomy, tumor de-bulking,
prostatectomy, Low Anterior Colon resection, Anterior/Posterior Colon resections
Efficacy Endpoint
Primary endpoint: Time to hemostasis at 4 min. with no re-bleeding during a
subsequent 6 min. observation period
Sample Size:
Minimal: 90 subjects for safety and efficacy
Maximal: 210 subjects
At least 100 subjects on Fibrin Patch
Randomization 2:1 Fibrin Patch: SURGICEL
Group sequential for statistical design
Interim analysis at 90 subjects with additional enrollment to satisfy FDA requirements
FIBRIN PATCH
Trauma Burden
160,000 deaths/year (U.S.)
Leading cause of life-years lost
Exceeds cancer and heart disease
Leading cause of death in ages 1-44 (U.S.)
Societal cost ~$260 billion annually
5 million deaths/year globally
By 2020, traumatic injuries are projected to be the 3rd leading
cause of death worldwide, surpassing communicable diseases as
the leading cause of disability-adjusted life years lost
ADHEXIL
Anti-Adhesion Product Candidate
Kit containing a human, fibrin-based, absorbable adhesion barrier
Made from plasma proteins
Indication
Prevention of post-operative adhesions
Development Status
Initiated Phase I/II safety and efficacy study (10/07)
Will enroll 25 patients with bilateral ovarian disease and identified
adhesions undergoing gynecological surgery
Three centers in the U.S. & EU
Primary Endpoint: Preventing and/or reducing post-operative adhesions
Upcoming Milestones
Initiate Phase III: 3Q08
Regulatory Filing: Mid-09
Launch: 2Q10
ADHEXIL
Large and Growing Market
Initial target market: laparoscopic gynecology ($150-200M)
In gynecological surgeries, pelvic adhesions have been found in 56-100% of
patients undergoing "second look" laparoscopy
Other potential markets: abdominal, cardiac
Partnership Status
Seeking partner in 2008
Significant competitive advantages
Easy to use vs. other anti-adhesion products and product candidates
Spray is applied using a laparoscope
No other product or product candidate works as well in a wet environment
Large and growing market opportunity
Clinical and business development, regulatory, and commercialization
milestones in 2008, 2009 and 2010, respectively
Low clinical development risk
AERIS PARTNERSHIP
Manufacturing and supply agreement
Supply fibrin sealant for pre-clinical, clinical and commercial use
worldwide in Biologic Lung Volume Reduction (BLVR) System for
treatment of severe emphysema
Aeris' product candidate combines OMRIX's fibrin sealant with other
therapeutic components
Administered in minimally invasive procedure to the most damaged over-
inflated regions of lung to improve breathing function by gradually shrinking
treated areas.
3.8 million patients in the U.S. alone have been diagnosed with
emphysema*
Status: Phase II (U.S.)
*National Center for Health Statistics
UPCOMING MILESTONES
PRODUCT 2008 2009
Evicel
US Launch and EU Approval
for General Hemostasis
Launch in EU
Fibrin Patch Initiate Clinical Trial BLA Filing
Adhexil
Completion of Phase I/II
Initiate Phase III BLA Filing
IVIG (U.S.) Complete Phase III
File BLA US Approval
HEP B Approval in Sweden
FINANCIAL OVERVIEW
FINANCIAL HIGHLIGHTS
($ IN MILLIONS, EXCEPT PER SHARE DATA)
FY 2006 FY 2007
OPERATING RESULTS OPERATING RESULTS OPERATING RESULTS OPERATING RESULTS
Product Sales $56.9 $51.9 FY08 Guidance $64-67
Total Revenue $63.8 $61.7
Operating Income $20.9 $5.9
Net Income $23.0 $11.9
Diluted EPS $1.65 $0.69
FINANCIAL POSITION FINANCIAL POSITION FINANCIAL POSITION FINANCIAL POSITION
Cash & Short-term Investments $80.8 $80.9
Working Capital $94.9 $110.4
Total Assets $121.6 $145.3
Stockholder's Equity $96.1 $118.6
*Note; 2006 figures include $21.2 million in non-recurring sales under the UK contract for VIG.
INVESTMENT HIGHLIGHTS
An industry leader in biosurgery convergence products
75% growth target for biosurgery product sales in 2008 vs. 2007
Approved and marketed products addressing large,
under-served markets in the U.S. and EU
Experienced management and product development teams
Profitable since IPO
NASDAQ: OMRI
Innovative Solutions for a Healthier World
Cowen and Company 28th Annual Health Care Conference
Robert Taub, Chief Executive Officer
March 17, 2008
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