Title: Company Overview
1- Company Overview
- May 2009
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2Cautionary Note on Forward Looking Statements
- This presentation contains forward-looking
statements within the meaning of the Safe Harbor
Provisions of the Private Securities Litigation
Reform Act of 1995. Such statements are based on
the current expectations and beliefs of the
management of ReGen, and are subject to a number
of factors and uncertainties that could cause
actual results to differ materially from those
described in the forward-looking statements,
including those discussed in the Risk Factors
section of ReGens 2008 annual report on Form
10-K and other filings with the Securities and
Exchange Commission. ReGens filings with the SEC
are available to the public from the Companys
web site at http//www.regenbio.com, commercial
document-retrieval services and at the web site
maintained by the SEC at http//www.sec.gov.
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3Investment Highlights
- FDA cleared / CE marked orthobiologic device
- Knee market largest among orthopaedic procedures
- 1.4 million partial meniscectomies (PM) worldwide
in 2009E - gt2x hip / knee replacement procedures
- 1.6 billion WW opportunity
- Only randomized multicenter clinical trial (MCT)
on arthroscopic meniscus procedure - Strong and comprehensive clinical trial outcomes
- Attractive reimbursement profile
- Company focused on execution of Menaflex
commercialization - 45 surgeons trained in Q1 2009 exceeded
training budget of 30
4Preservation is the New Replacement
- Unmet clinical need in PM
- Progression of osteoarthritis in post-PM patient
- Little or no competition
- Growing consensus / trends
- Preservation of meniscus tissue
- Use of orthobiologic implants
- Extension of patient active lifestyle
- Evidence based medicine
- Proprietary, arthroscopic, biologic,
off-the-shelf implant - Strong and documented clinical results
- Clinical data defines new standard of care
5What is Menaflex?
- An off-the-shelf collagen meniscus implant
- Type I bovine collagen no immunological
reactions - Collagen most common protein in human body
- Resorbable scaffold facilitating bodys own
healing process largely resorbed during first
year
- Menaflex procedures target irreparable meniscus
tears where surgical intervention is required - Arthroscopic procedure typically performed in
30-60 minutes in outpatient setting
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61.6 Billion Market Opportunity
Worldwide Meniscectomy Procedures
Current Menaflex Eligible Market
Partial Meniscectomies 1.4 million
- Initial target of approximately 50 of PM
procedures - Eligible market of 700,000 WW / 350,000 U.S.
annual procedures - Market opportunity of 1.6 billion WW / 900
million U.S.
7Patient Profile
- The Menaflex implant represents a much needed
new treatment option for patients with meniscus
deficiency Dr. David Caborn, Jewish Hospital
St. Marys HealthCare, Louisville, KY - ACL Repair
- Patient presents for ACL repair with meniscus
damage Menaflex performed simultaneously - Young Acute
- Patient with significant meniscus injury goal is
to delay damage to articular surface and
eliminate or delay future need for more tissue
removal - Chronic Patient
- Has had one or more previous procedures Menaflex
facilitates tissue growth, allowing for increased
activity and decreased future operations
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8Menaflex Unique U.S. MCT
- Average patient follow-up of 5 years
- Only randomized MCT of arthroscopic meniscus
procedure - Singular and extensive database
- Randomized and controlled clinical trial vs. PM
- 311 patients analyzed
- Ages 18-60
- 50 control (PM)
- 50 Menaflex implant
- 16 surgical sites, 25 surgeons across the U.S.
- Menaflex patient re-look surgery biopsy at 1
year
9Menaflex Outperforms Clinically
- Tissue nearly doubles at one year from 37 at
surgery to 73 at one year arthroscopic re-look - Patients gain greater portion of pre-injury
activity - Patients undergo nearly 3x fewer reoperation
procedures
Chronic patient data from Journal of Bone
Joint Surgery July 2008. Activity and
Reoperations measured through approximately 5
years post surgery.
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10Proven Success Over Time
- 11 years experience with 8 Feasibility Study
patients - Re-looks conducted at 1 and 6 years
- Published in major journal
- One patient returned for ACL procedure at 11 years
11 Year Re-Look
Menaflex Tissue
11Menaflex Supported by Key Publications
- Journal of Bone Joint Surgery - July 2008
- Multicenter clinical trial results, co-authored
by Drs. Rodkey, Steadman, DeHaven, et.al. - Lead article
- JBJS / AAOS authored video introduced at AAOS
2009 - Journal of Arthroscopy - 2005
- 5.8 year re-look surgeries of 8 feasibility study
patients volume retained through 6 years - Full bibliography including additional
publications available at www.regenbio.com
12Favorable Reimbursement Pathway
- ReGen has been working to establish reimbursement
since 2003 - Regulatory consultant
- Targeting largest commercial carriers first
- Aetna, Cigna, Anthem, United, Humana
- Attractive payment proposition for surgeon skill,
time and training - Support Services
- 800 help desk for surgeons and facilities
- Regional reimbursement specialists
- Payer information packets and educational programs
13Established Manufacturing Capabilities
- Proprietary collagen scaffold production
- In-house collagen purification and molding
expertise - 10 years manufacturing experience
- Capacity available for planned growth
- Ample production capacity with 15,000 square foot
facility - 2009 production secured with incremental
personnel - Current facility capable of planned 3-5 year
output - Experienced manufacturing management
- Product available for sale in the U.S. as of
March 2009
14Focused Business Execution
- Training and distribution are key to adoption
- Target 200 trained surgeons by end of 2009
- Develop independent sales network 10
distributors by YE 2009 - Target 100 trained reps by YE 2009
- Additional filing of lateral Menaflex 510(k)
- Execute towards 5-year plan
- 50,000 unit sales in year 5 (less than 10
penetration) - 100 million revenue
- 85 gross margin
- 20 operating margin
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15Successful U.S. Launch Q1 2009
- Recruiting surgeon mentors thought leaders
- Trained 45 practicing surgeons during Q1 2009 vs.
budget of 30 - First U.S. procedure performed 4/15/09
- High level of surgeons trained
- Professional/Olympic teams Buffalo Bills, New
York Giants, Denver Broncos, San Diego Padres,
U.S. Ski and Snow Board, U.S. Swim - Division I universities USC, Michigan,
Louisville, Northwestern, Columbia - Societies President AANA, AOSSM board member
AAOS - Distributor network
- 3 distributors with 30 sales representatives
trained
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16Financial Summary
- Recent financial data
- Menaflex unit sales of 583 in FY 2008 up 65 over
FY 2007 - Q1 2009 Menaflex unit sales of 125
- 1.4 million total revenue in FY 2008 up 51 over
FY 2007 - Q1 2009 total revenue 297,000
- Cash burn of 7 million in FY 2008
- Q1 2009 average burn rate 1 million / month
- 8.75 million private placement completed Q1 2009
- March 31, 2009 capitalization
- 15.6 million fully diluted common share
equivalents - 9.9 million voting shares outstanding
- 5.6 million options, warrants avg. exercise of
4.75 / share
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17Management Team
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18Investment Summary
- Menaflex addresses a large underserved market
opportunity - Need is well documented and understood
- Little or no competition
- Early-stage medical device execution risks are
reduced - Extensive clinical data document safety and
clinical benefit (5 year follow-up) - Peer reviewed journal articles published
- Manufacturing has been in place for several years
- Favorable reimbursement pathway
- International market is already being developed
- Menaflex benefits from favorable industry trends
- Preservation of meniscus tissue
- Orthobiologic implants
- Evidence-based medicine
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