Vericel Corporation · NASDAQ:VCEL
Vericel — Aastrom Biosciences — Investor Presentation (March 2005)
31 slides from Vericel's investor presentation, Mar 15, 2005
Slide 1: Proprietary Cell Products for Tissue Regeneration
Proprietary Cell Products for Tissue Regeneration Investor Presentation March, 2005 (Nasdaq:ASTM)
Slide 2: Safe Harbor
SAFE HARBOR z This presentation contains forward-looking statements, including, without limitation, statements concerning product-development objectives and anticipated timing, clinical trial timing and results, potential market opportunities and revenue models, market development plans, anticipated
Slide 3: Summary
Summary z Emerging as a leading tissue regeneration company z Proprietary bone marrow stem cell products: Tissue Repair Cells z Business model based on clinical experience and ability to apply TRCs to multiple markets z Phase II-level trials now active for two bone graft indications, with third plan
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...
Slide 5: What's Unique About Aastrom
What’s Unique About Aastrom Proprietary adult stem cells and industry-unique manufacturing capability ... Proprietary AastromReplicell System Tissue Repair Cells z Bone marrow-derived adult stem & progenitor cells z Cell production automation with (non-embryonic) GMP compliance z Bone, vascular, blo
Slide 6: Tissue Repair Cells: Maximizing Regenerative Capability
Tissue Repair Cells Maximizing Regenerative Capability Early Stem Multi-Lineage Precursor Mature Late Stage Cells Progenitor Cells Cells Cells Stage Bone Marrow Aastrom’s TRCs Typical Cultured Cells Best Regeneration Effectiveness Least
Slide 7: Aastrom Tissue Repair Cell Product
Aastrom Tissue Repair Cell Product New Capability in Tissue Regeneration Natural Tissue Bone Marrow Regeneration Derived Cells Process TRCs Multi-Lineage z Bone Stem/Progenitor z Vascular Cells z Others z BMPs Growth Factor z VEGF Production z SCGF z Others
Slide 8: Tissue Repair Cells: How The Process Works
Tissue Repair Cells: How The Process Works Small aspirate Cells go to TRCs produced in TRCs used to generate collected from patient production lab AastromReplicell System healthy tissues TRC products are designed to generate revenue just like pharmaceuticals $
Slide 9: Aastrom's Business Model
Aastrom’s Business Model Transforming Cells into Products Bone Grafting · Fractures · Jaw Reconstruction · Spine Fusion TRCs Limb Ischemia Future Tissue Repair Cell Patient-Specific Cell Products Developed for Manufacturing and Percutaneous Bone Treatments Multiple Indications Distribution · Cardiac
Slide 10: Development Pipeline
Development Pipeline Research Preclinical Clinical Market Comments Bone Grafting Long bone fractures U.S. Phase I/II Trial enrolling at 4 sites Europe Enrolling –Spain & Germany Jaw reconstruction Enrolling –Spain (Sinus lift for dental implants) Spine fusions Clinical protocol in development Vascul
Slide 11: Aastrom Tissue Repair Cells Lead Product Indications
Aastrom Tissue Repair Cells Active Lead Product Indications Applicable Market Product Applications Clinical Status Size (Patients) * Bone Grafting • Fracture Long bone fractures 120,000 U.S./EU: Active • Jaw Sinus lift 205,000 EU: Active • Spine Spine fusions 330,000 Preclinical Vascular Tissue • Is
Slide 12: Potential for TRCs in Bone Grafting
Potential for TRCs in Bone Grafting 12
Slide 13: Bone Graft Product Comparison
Bone Graft Product Comparison Conceptual Model for Severe Indications Therapy Effectiveness Morbidity Cells Autograft +++ high ++ (Gold Standard) Synthetic low to no Matrix high Allograft/DBM + low to no Alternatives Matrix (variable) high BMP ++ n/a no Aastrom TRCs low +++ +++ (+) (+ Matrix) DBM =
Slide 14: Bone Graft Market
Bone Graft Market Conceptual Product Use Model Bone Injury Scale Non-Union Fracture Basic or Fracture Low Range of Severity High Multi-Level Spine Fixation Fusion Lead Matrix Products Treatment BMPs Approach Autograft Aastrom TRCs 14
Slide 15: Bone Graft Market Opportunity
Bone Graft Market Opportunity Global Market: 2 Million Bone Grafts Annually TRC s 5% of Autograft > $200 Million Synthetics Opportunity 16% BMPs 9% Autograft 48% Allograft & DBM 27% Source: Millennium Research Group CY2009 projections (U.S., Europe and Japan) BMP = Bone MorphogenicProteins DBM = Dem
Slide 16: Bone Graft Clinical Plan: Bone Fracture Indications
Bone Graft Clinical Plan Bone Fracture Indications z EU – Lead studies underway in Spain and Germany – First phase (6 treatments) completed in Barcelona; trial expanding based on progressive healing and safety results – Process logistics working well z United States – Phase I/II multi-center trial;
Slide 17: TRCs and Matrix
TRCs and Matrix Combining TRCs and Matrix Micrograph of TRCs in Matrix 200ƒÊ m 18
Slide 18: Non-Union Fracture Trial: Candidate Patient X-Rays
Non-Union Fracture Trial Candidate Patient X-Rays * Point of Fracture * Clinical Situation: Non-union fracture of humerus which failed fixation and autograft (> 8 months) 19
Slide 19: Non-Union Fracture Trial: Fracture Site with Previous Fixation Removed
Non-Union Fracture Trial Fracture Site with Previous Fixation Removed 20
Slide 20: Non-Union Fracture Trial: New Fixation Applied
Non-Union Fracture Trial Fracture Site with New Fixation Applied 21
Slide 21: Non-Union Fracture Trial: TRCs and Matrix Applied
Non-Union Fracture Trial TRCs and Matrix Applied at Fracture Site TRCs and Matrix 22
Slide 22: Non-Union Fracture Trial: Post-Treatment Recovery
Non-Union Fracture Trial Post-Treatment Patient Recovery (4 Months) Fracture Site 23
Slide 23: TRCs for Bone Grafting: Jaw Reconstruction Indication
TRCs for Bone Grafting Jaw Reconstruction Indication 24
Slide 24: Bone Graft Clinical Plan: Jaw Reconstruction Indication
Bone Graft Clinical Plan Jaw Reconstruction Indication z EU – Lead trial for dental implant (sinus lift) initiated in Spain – 5 patient study; enrollment complete – Bone formation measured by biopsy/histology and compared to standard bone graft approach in same patient – Expect results by end of 2Q
Slide 25: TRCs for Vascular Tissue: Limb Ischemia Indication
TRCs for Vascular Tissue Limb Ischemia Indication 26
Slide 26: Limb Ischemia: Rationale for TRC Development
Limb Ischemia (Veins and Arteries) Rationale for TRC Development z Large market opportunity, with limited therapeutic competition – Diabetic and Buerger’s disease patients – Targeted 2 million patients in need of surgery for severe limb ischemia – Reimbursement levels are high for interventional tre
Slide 27: Limb Ischemia: Effect of Large Volume Bone Marrow
Limb Ischemia Effect of Large Volume Bone Marrow Sources: Lancet 360: 427-435, 2002 (left panel) Eur J. Vasc Endovasc Surg 00, 1-3, 2002 (right panel) 28
Slide 28: Vascular Tissue Clinical Plan: Limb Ischemia Indication
Vascular Tissue Clinical Plan Limb Ischemia Indication z EU – Clinical trial agreement with HDZ in Bad Oeynhausen, Germany – Cell manufacturing license process initiated – Patient accrual expected to begin mid-CY2005 z United States – Phase I NIH grant supported circulation ischemia research – Vascu
Slide 29: Partnering
Partnering z 2003 alliance with – Largest provider of allograft tissue matrix (>$250 million revenue) – Companies both contribute to development and clinical expenses for products that combine TRCs and MTF matrix – Companies sell their own products and coordinate marketing z Targeting other relation
Slide 30: Aastrom Balance Sheet Data (December 2004 Proforma)
Aastrom Balance Sheet Data (December 2004 –Proforma *) z Cash and Investments $37,500,000 z Total Assets $39,400,000 z Shareholders’Equity $38,800,000 z Average Cash Usage Per Month $1,000,000 * Includes $12 million gross proceeds from an equity transaction in January 2005, and $2.9 million gross pr
Slide 31: Proprietary Cell Products for Tissue Regeneration
Proprietary Cell Products for Tissue Regeneration Investor Presentation March, 2005 (Nasdaq:ASTM)
Aastrom Biosciences — Investor Presentation (March 2005) on 6ix