Vericel Corporation · NASDAQ:VCEL
Vericel — Aastrom Biosciences — Investor Presentation (September 2003)
31 slides from Vericel's investor presentation, Sep 15, 2003
Slide 1: Investor Presentation September 2003 – The Cell Therapy Company
Investor Presentation September, 2003 The Cell Therapy Company (Nasdaq: ASTM)
Slide 2: Safe Harbor
This presentation contains forward-looking statements, including, without limitation, statements concerning product-development objectives and anticipated timing, clinical trial results, revenue projections, potential market opportunities, market development plans, anticipated key milestones and pot
Slide 3: Develops proprietary bone marrow stem cell products for regenerative repair
Develops proprietary bone marrow stem cell products for the regenerative repair of damaged human tissues (Nasdaq: ASTM)
Slide 4: Capturing the Therapeutic Potential of Bone Marrow Stem Cells
Capturing the Therapeutic Potential of Bone Marrow Stem Cells Regenerate tissues with stem cells grown from bone marrow collected from the patient... .... for blood, vascular tissue, bone grafts, joint reconstruction, myocardial infarction, Parkinson's, diabetes, and osteoarthritis
Slide 5: What's Unique About Aastrom
What's Unique About Aastrom Unique mixture of stem and progenitor cells Produced ex vivo Proven patient safety Proven functionality Automation Single-pass perfusion 12-day production GMP-compliant Scalable .... enables Prescription Cell Products Proprietary stem cells and industry-unique manufacturi
Slide 6: Aastrom's Tissue Repair Cells (TRCs)
Aastrom's Tissue Repair Cells (TRCs) TRCs regenerate normal human tissues
Slide 7: Prescription Cell Products: How The Process Works
Prescription Cell Products: How The Process Works Small cell sample collected from patient Cells go to production lab TRCs used to generate healthy tissues $ Prescription Cell Products generate revenue just like pharmaceuticals Cell product produced in AastromReplicell System
Slide 8: Prescription Cell Products Business
Prescription Cell Products Business Tissue Repair Cell Program
Slide 9: Aastrom Tissue Repair Cells Established Results
Over 160 patients have safely received TRCs at major U.S. medical centers Loyola, Duke, University of Pennsylvania, MD Anderson, Hackensack Medical Center, University of Michigan Cells have engrafted stably to form healthy tissues Blood cells, immune system cells and bone TRCs shown to produce same
Slide 10: Product Applications and Annual Market Opportunity
Product Applications Annual Market Opportunity Bone Grafting BG-Fracture BG-Dental BG-Spine Aastrom Tissue Repair Cells Active Lead Products Clinical Status $2.4B Vertebral fusion Preclinical (Private) Implants Active (4Q 03) Peripheral Vascular Tissue VT-Ischemia VT-Cardiac $1.0B Non-union fracture
Slide 11: Bone Graft Market: Autograft is the Gold Standard
Bone Graft Market Traditional Autograft is the "Gold Standard" Use of patient's own bone chips and cells to build new bone tissue Autograft usually collected by chiseling material from the hip during a surgical procedure Works well for bone grafting (good efficacy) Very painful and undesired after-e
Slide 12: Bone Graft Product Comparison
Therapy Bone Graft Product Comparison Sources: J Bone Joint Surg Am 83 (Suppl. 2): 98-103, 2001 Aastrom in-house data Autograft (Gold Standard) Aastrom TRCs Cells +++ no no no +++ Stimulation +++ no ++ (variable) +++ ++ Lattice +++ ++ +++ no no Aastrom TRCs + Matrix +++ +++ +++ Alternatives
Slide 13: The Optimized Bone Graft Solution
The Optimized Bone Graft Solution
Slide 14: Strategic Alliance Opportunity
Strategic Alliance Opportunity Matrix + Optimized Bone Graft = Aastrom TRCs TRCs in Bone Grafting The efficacy of Autograft, without the after-effects!
Slide 15: Alliance between leaders in stem cells and orthopedic tissue matrix
Alliance between leaders in stem cells and orthopedic tissue matrix Largest market provider of allograft tissue matrix (>$220 million revenue) Direct sales force as well as active marketing relationships with Synthes Spine, Osteotech, and others Gives Aastrom access to allograft matrix supply, the p
Slide 16: Bone Graft Market Opportunity
Bone Graft Market Opportunity Autograft Bone Chips Demineralized Bone Matrix Synthetics East 0.52 0.2 0.19 0.09 United States - 2000 $700M 20% 10% $175M 5% 5 10 20
Slide 17: Bone Graft Market Strategy: Market Entry Plan
Bone Graft Market Strategy Target the Autograft market Provide efficacy of Autograft without the painful after-effects No need to compete with bone graft substitutes Enter European market first Enables commercialization 3 to 5 years before U.S. Simpler regulatory pathway for autologous cells Market
Slide 18: European Market Development Plan
Bone Graft Market Strategy Target small marketing clinical trials at major European orthopedic centers Centers become customers after successful use of TRCs In Europe, cells from the patient are not regulated as drugs, but the manufacturing process is controlled Need license to manufacture cells CE
Slide 19: U.S. Clinical Trial Plan
Bone Graft Clinical Strategy Initial multi-center trial for non-union tibial fracture FDA approved IND for Phase I/II trial in August 2003 Target start date = 4Q/03 Lead sites selected Up to 20 patients at up to three centers Approximately one year to complete accrual Begin with three long term non-
Slide 20: European Clinical Trial Plan
Bone Graft Clinical Strategy Two lead trials to start in Germany Non-union tibial fracture Dental implant bone grafting Trial designs Up to 20 patients Single center studies Target start dates = 4Q/03 Approximately one year to complete accrual Plan to file for CE Mark approval with successful data f
Slide 21: Peripheral Vascular Disease
Peripheral Vascular Disease Degenerated vascular tissue in limbs 400,000+ patients in U.S. and Europe No current effective treatment available Often results in amputation Recent clinical data suggests large volumes of bone marrow can regenerate effective vascular tissue in these patients Major clini
Slide 22: Peripheral Vascular Disease: Effect of Bone Marrow Stem Cells
Peripheral Vascular Disease Effect of Bone Marrow Stem Cells Lancet 360: 427-435, 2002 Can TRCs substitute for large volume bone marrow and produce the same clinical result?
Slide 23: Peripheral Vascular Product Strategy
Peripheral Vascular Product Strategy Further establish TRC capability to generate endothelial cells Develop external funding support First NIH grant in process Initiate clinical trials to determine feasibility of VC-I cells First trial targeted for 2-3Q/04 In Europe, target small marketing trials at
Slide 24: Aastrom TRC Products Development Summary
Aastrom TRC Products Principal focus on bone graft products Large, multi-application market in bone grafting Most clinical endpoints are short-term Completed preclinical studies provide strong rationale Next step: complete phase I/II patient data and secure CE Mark for non-U.S. markets Determine cap
Slide 25: Other Business Development Areas
Other Business Development Areas Tissue Repair Cells Osteoporosis Phase I/II trial collaboration Osteoarthritis (bone and cartilage) Being explored with matrix combinations Therapeutic Cells Dendritic cell vaccines - Dendricell(tm) - for cancer Grant funded clinical trials planned with collaborators
Slide 26: Cell Production Products Business
Cell Production Products Business
Slide 27: Business Strategy: AastromReplicell System Platform
Business Strategy AastromReplicell(tm) System Platform Patented human cell production from "single-pass perfusion" Industry-unique automation and GMP compliance Instruments and single-use kits Target Market Clinical research market Third-party therapeutic cell developers Cell Production Products Bus
Slide 28: Cell Production Products Market Strategy
Cell Production Products Incorporate AastromReplicell(tm) System in as many cell therapy programs as possible Near-term revenue from customers in early clinical trials Large long-term revenue from customers with successful cell therapy Recurring revenue from consumable kit sales following initial sa
Slide 29: Zellera AG: Expanding Aastrom's Business in Europe
Zellera AG Wholly owned subsidiary in Berlin, Germany Establishes relationships for clinical trials Directs product marketing Manages sub-distributor relationships in Italy, Switzerland and Turkey Coordinates installation and servicing with NovaMed GMBH Completes customer training and support Expand
Slide 30: Aastrom's Key 12-Month Milestones
Aastrom's Key 12-Month Milestones Initiate and complete Phase I / II trials for bone graft products Tibial non-union fracture trial planned in Europe and U.S. If results positive, complete CE Mark Possible next indication trials (e.g., dental and spinal fusion) Determine capability of TRCs for vascu
Slide 31: September 2003 – The Cell Therapy Company
Investor Presentation September, 2003 The Cell Therapy Company (Nasdaq: ASTM)
Aastrom Biosciences — Investor Presentation (September 2003) on 6ix