regen biologics, inc. health tech net november 15, 2002 presented by: gerald e. bisbee, jr., ph.d....
TRANSCRIPT
ReGen Biologics, Inc.Health Tech Net
November 15, 2002
Presented by: Gerald E. Bisbee, Jr., Ph.D. Chairman, President and CEO
Brion Umidi, SVP and CFO
Cautionary 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 managements of Aros and 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 Aros' current report on Form 8-K/A, filed with the Securities and Exchange Commission on September 4, 2002. Aros' filings with the SEC are available to the public from commercial document-retrieval services and at the Web site maintained by the SEC at http://www.sec.gov.
Today’s Agenda
• The Orthopedic Marketplace– Hips, knees, spine, sports medicine and more
• ReGen Biologics – The CMI
– The marketplace
– The Company
The Orthopedic Marketplace
Not Just Hips and Knees
• Orthopedics - medical devices addressing joint deterioration, trauma, arthritis, spinal problems and related pain/ mobility issues.
• $12.4 billion market expanded beyond traditional hip and knee replacements to new and developing areas.
• Segments include:– Reconstructive implants – Spine
– Sports medicine – Orthobiologics
– Trauma – Other
– Dental
Segment % of Market
Trauma15% Sports
Medicine12%
Reconstructive Implants
41%
Spine14%
Other10%
Dental6%
Orthobiologics2%
Market Segments - Breakdown
Segment Growth Rates
Orthobiologics27%
Dental15%
Other8%
Trauma9%
Sports Medicine
10%
Reconstructive Implants
8%
Spine23%
Market Segments - Growth
Trends and Innovations
• Key areas of current and future development: – Spinal disc repair and replacement;
– Minimally invasive surgical techniques; and
– Tissue regeneration.
Innovations in the Spine
• Achieve more normal anatomic function, which is lacking in traditional spinal fusion and cage applications.
• Developments are focused primarily on:– Artificial discs and disc repair procedures;
– Using an array of materials and approaches;
– Designs that absorb shock and restore more normal anatomic function.
Minimally Invasive Surgical Technologies
• Minimally invasive hip and knee replacements, requiring less surgical impact and quicker recovery.
• Instrumentation devices in the spinal and orthobiologics areas.
• Nerve guidance systems to more effectively navigate around nerves during surgery.
Tissue Regeneration
• Currently small, but rapidly growing segment, including:– Soft tissue regeneration, such as implants and procedures in
the articular cartilage and meniscus of the knee;
– Growth factors and gene therapy; and
– Bioresorbable fixation devices.
Orthopedic Valuations
• Public company valuations reflect large market with reliable earnings/cash flow, and promising high growth segments.
• Revenue growth of 9% - 13% in 2002.
• Earnings per share growth of 15% - 20%.
• Pricing multiples of 2x forward EPS growth rates.
• Public company pricing multiples of 30x - 40x forward EPS.
ReGen Biologics, Inc.
ReGen Biologics Overview
• ReGen is in the biological remodeling business
– Designs and manufactures proprietary biologically active type I collagen scaffold and delivery devices
– Strong intellectual property position
• Current application is orthopedics – Collagen Meniscus Implant (CMI) is first product
• R&D
– Each product engineered with unique mechanical properties
– Additional orthopedic applications in articular cartilage, spine, ligament, and hand
Scaffold Promotes In-situ Regrowth
• Core technology: Porous Type I bovine collagen scaffold
• Pore size optimized for cellular infiltration and growth
• Promotes in-situ use of patient’s own cells to populate and seed the regrowth
Management
Gerald E. Bisbee, Jr., Ph.D. • Chairman and CEO; CEO Apache Medical & Sequel Corporation;
Director Healthcare Group, Kidder Peabody; Ph.D., Yale; M.B.A., Wharton
John Dichiara • SVP, Clinical and Regulatory Affairs; 15 years of experience at
Howmedica; B.A., Biological Science, Columbia College
William G. Rodkey, DVM • VP, Scientific Affairs; internationally known knee researcher; DVM,
Purdue; board certified
Brion D. Umidi • SVP and CFO; 16 years of experience assisting corporations with
various corporate, financial, development and operational matters; B.A., Accounting and Finance, Loyola College
Board of Directors
• Gerald E. Bisbee, Jr., Ph.D., Chairman, President and CEO, ReGen Biologics
• J. Richard Steadman, Steadman Hawkins Clinic; U.S. Ski Team Hall of Fame; highly published; B.S., Texas A&M; M.D., U. of Texas Southwestern Medical School
• Robert McNeil, Ph.D., General Partner, Sanderling; active and experienced investor and board member; Ph.D., U.C. Irvine
• Richard Fritschi, President, Centerpulse Orthopedic Division; former Sulzer Medica CFO; General Manager, Joint & Traumatology,
• Alan W. Baldwin, CEO, Alcore, Inc.; experienced manager, director and investor; B.S., U.S. Military Academy; M.A., University of Alabama
ReGen Highlights-to-date
• Intellectual Property
– 22 U.S., 29 international & 12 pending patents on products materials and processes
• U.S. Clinical Trial– U.S. Clinical Trial - 288 enrollment complete; surgeries in Q402
– Feasibility study five year results submitted for publication
• R&D– Initial product developed, active R&D pipeline
• Products – Products approved and sales underway
Product Sales Underway
• Product Approvals– CMI approved for sale in Europe and Australia; ex-U.S.
distribution agreement with Centerpulse (NYSE: CEP)
– SharpShooter OK for sale in U.S., Canada, Europe, Australia, and Japan; Linvatec WW agreement (NASDAQ: CNMD)
– Marketing to begin in Chile Q402, distribution through Centerpulse
• Canadian approval underway Q402, distribution through Centerpulse
The First Application -- CMI
• The market: 775,000 U.S. partial meniscectomies in 2002; ROW = 310,000
• Unmet need: – Surgeons and patients have no current option to regrow
meniscus tissue
– Result is to prevent or delay long term degenerative arthritis which can cause:
» Changed or lost lifestyle
» Interrupted or lost employment
Remodeling is Successful Over Time
38%62%
Gain: double amount of tissue
75%
Remaining MeniscusRemoved
meniscus
Post Partial Meniscectomy
Post CMI (1 & 5 years)
100% Tissue Regeneration
Surgery
One Year Post Surgery
Before
The Patient Clinical Benefit
2.5
3
3.5
4
4.5
5
5.5
6
6.5
7
7.5
Before Injury Before Index
Surgery
12 Months 24 Months 36 Months 48 Months 5+ years
MCT CMI
MCT Control
30% increase from
Control to CMI groups
Tegner Activity Level
The Patient Clinical Benefit
Tegner Activity Level
2.5
3
3.5
4
4.5
5
5.5
6
6.5
7
7.5
Before Injury Before Index
Surgery
12 Months 24 Months 36 Months 48 Months 5+ years
MCT CMI
FeasibilityPatients
MCT Control
U.S. Multicenter Clinical Trial Results
• Prior surgery patients double amount of tissue
• CMI patients achieve a significantly higher activity level at two years than controls
– Activity levels for feasibility study patients have steadily grown
• Safety (adverse events) – no apparent safety issues
• Histology – no immune reactions or infections
• Ratio of pain, function, and self assessment per unit of activity higher for CMI patients
Disease Progression - 775,000 P.M. in 2002
$9,500+
$9,500
MeniscusTear
Preserve Meniscus
RegenerateMeniscus
CMICollagen Meniscus
Implant
Remove Meniscus
RepairMeniscus
MeniscusRepair
Partial Meniscectomy
Cost:$16,000
Cost: up to
$49,500+
Cost: $12,500
Add’l Surgeries
Allograft
Joint Replacement
$15,000
$40,000
Meniscal Repair – 140,000 in 2002
$9,500+
$9,500
MeniscusTear
Preserve Meniscus
RegenerateMeniscus
CMICollagen Meniscus
Implant
Remove Meniscus
RepairMeniscus
MeniscusRepair
Partial Meniscectomy
Cost:$16,000
Cost: up to
$49,500+
Cost: $12,500
Add’l Surgeries
Allograft
Joint Replacement
$15,000
$40,000
CMI – Clinical and Financial Benefits
$9,500+
$9,500
MeniscusTear
Preserve Meniscus
RegenerateMeniscus
CMICollagen Meniscus
Implant
Remove Meniscus
RepairMeniscus
MeniscusRepair
Partial Meniscectomy
Cost:$16,000
Cost: up to
$49,500+
Cost: $12,500
Add’l Surgeries
Allograft
Joint Replacement
$15,000
$40,000
CMI Advantage – Affects Lifestyle and Costs
$9,500+
$9,500
MeniscusTear
Preserve Meniscus
RegenerateMeniscus
CMICollagen Meniscus
Implant
Remove Meniscus
RepairMeniscus
MeniscusRepair
Partial Meniscectomy
Cost:$16,000
Cost: up to
$49,500+
Cost: $12,500
Add’l Surgeries
Allograft
Joint Replacement
$15,000
$40,000
CMI Market Penetration Comparables
• Spinal fusion cage = 35% in five years
• Radiofrequency (RF) Ablation = 40% in five years
• Meniscal Repair Arrow = 50% in five years
• CMI = estimated 31% market penetration in five years post approval
CMI Projected $500 Million Market
0
100,000
200,000
300,000
400,000
500,000
600,000
2006 2007 2008 2009 2010
YEARS
PR
OC
ED
UR
ES
(un
its)
0
100
200
300
400
500
600
SA
LE
S P
OT
EN
TIA
L
($ m
illio
ns) CMI Eligible Market
(units)
CMI Sales (units)
CMI Sales Potential($ mil.)
Surgeon and Patient Incentives Match
• Surgeon’s View
– Quality of life: happy patient attracts more patients
– Meniscus --“the more the merrier”
– CMI delays or prevents osteoarthritis
– CMI adds important treatment option
» Expand revenue source
– New “standard of care” requires surgeon to perform procedure
Surgeon and Patient Incentives Match
• Surgeon’s View
– Quality of life: happy patients lead to referrals
– Literature shows that in terms of the meniscus --“the more the merrier”
– CMI delays or prevents osteoarthritis
– CMI adds important treatment option
» Expand revenue source
– New “standard of care” requires surgeon to perform procedure
• Patient’s View
– Quality of life: increased activity is key
– Internet search shows that in terms of meniscus, “the more the merrier,”
– CMI delays or prevents osteoarthritis
– New treatment option demanded
» Decreases total costs
– New “standard of care” demanded by patients and defined in literature
Reimbursement Follows Clinical Benefit
• Tissue regrowth and activity levels show positive results in the 12-18 month timeframe desired by managed care companies
• Patients and surgeons will define CMI as new “standard of care”
• CMI procedure ($16,000) is attractive alternative to very expensive joint replacement procedure ($40,000+)
• Reimbursement in U.S. will include the following steps:– Obtain CPT code– Develop economic model – Establish Relative Value Units (RVU)– Present economic model and clinical benefits to major
insurance and managed care companies
The SharpShooter® Application
PICTURE
Selected ReGen Milestones Through 2004
• Product Sales– Annual sales goals established - Distribution agreements
accelerating sales, for both CMI and SharpShooter • FDA Submissions
– CMI U.S. submission planned in Q404, when two year follow-up for all patients is complete
– U.S. Feasibility study on Grade IV patients in Q103– Two 510k applications
• R&D– One significant product development partnership – Four additional patents
• Financings– One round of financing in next 12 months
Research & Development Pipeline
Approved for sale in Europe and Australia.
Clinical trial enrollment currently complete
Prototype developed; cadaver testing initiated
Patents issued; large animal model testing complete
Patent issued; primate testing complete; 510(k) submission expected
Prototype development; large animal model testing initiated
Prototype developed; animal studies initiated
Patent filed; lab testing
Prototype development
Patents issued; prototype development
ResearchIn-VitroTesting
Pre-Clinical Clinical Market Comments
Medial Meniscus Implant:
Europe & Australia
U.S.
Lateral Meniscus Implant
Intervertebral Disc Repair
Hand Bone Augmentation Device
Ligament Augmentation Devices
CMI + Growth Factors
CMI Improvements
Rotator Cuff Repair Device
Articular Cartilage Repair
September 2002
Recent Financing Transactions
Multi-Stage Financing Completed June 21, 2002:
• Private Placement of $4 million into ReGen Biologics, Inc., in addition to conversion of approximately $2.6 million bridge financing provided by Sanderling companies and other existing ReGen shareholders
• Merger with Aros Corporation, resulted in net liquid assets of approximately $3 million, and instant public company status
• Shareholders of ReGen own approximately 80% of post merged company
Key Scientific Advisors
• Kenneth E. DeHaven, M.D., Professor, Department of Orthopedics, University of Rochester
• Charles P. Ho, M.D., Director, National Orthopedic Imaging Associates
• Steven Arnoczky, D.V.M., Endowed Professor of Orthopedic Surgery, Michigan State Veterinary School
• Mininder S. Kocher, M.D., Instructor of Orthopedic Surgery, Harvard Medical School
• Paolo Bulgheroni, M.D., Clinical Professor, Institute of Orthopedics and Traumatology, Varese, Italy
• Juan Carlos Monllau, M.D., Clinical Professor, Orthopedic Surgery, Barcelona, Spain
• Shu-Tung Li, Ph.D., Founder and President, Collagen Matrix, Inc.
ReGen Biologics, Inc.
www.regenbio.com