Vericel Corporation · NASDAQ:VCEL
Vericel — Investor Presentation (April 2016)
36 slides from Vericel's investor presentation, Apr 12, 2016
Slide 1: Company Presentation
Company Presentation April 12, 2016
Slide 2: Safe Harbor
Safe Harbor This presentation contains forward-looking statements, including, without limitation, statements concerning anticipated progress, objectives and expectations regarding profitability, growth in revenue and earnings per share, cash payments, the commercial potential of our products, intend
Slide 3: Vericel Investment Highlights
Vericel Investment Highlights Vericel Investment Highlights • Acquired Sanofi’s global Cell Therapy and Regenerative Medicine business in 2014 Robust Commercial – U.S. revenues of $42 million in 2013 Biologics Business • Total Carticel® and Epicel® revenues of $50.4 million in 2015 – 14% growth vs.
Slide 4: Robust Product Portfolio
Robust Product Portfolio PHASE 2 PHASE 3 Approved Products ©@Carticel w (autologous cultured chondrocytes) Epicel OS) (cultured epidermal autografts) Clinical/Regulatory Programs matrixapplied Lace fone sy PDUFA Date: January 3, 2017 jutologous cultured chondrocytes Ixmyelocel-T . . ixCELLIDCM FDA O
Slide 5: Carticel Overview
Carticel Overview Carticel is a 1st generation autologous chondrocyte implant (ACI) for the treatment of cartilage defects in the knee • First and only FDA-approved autologous cartilage repair product1 • Therapeutic advantage: produces natural hyaline-like cartilage vs. fibrocartilage • STAR study d
Slide 6: Carticel Commercial Highlights
Carticel Commercial Highlights • Target patient population is younger, active patients with larger cartilage defects • Dedicated physician customer base – Core physicians drive the majority of implants in the U.S. • Widespread reimbursement coverage – 15 largest payers, representing 132 million (98%
Slide 7: Stable Carticel Net Revenue Base
Stable Carticel Net Revenue Base Carticel Net Revenue $40 $35 +1% $30 $25 $ Millions $20 $15 $10 -1% +9% $5 -8% +4% $- Q1 Q2 Q3 Q4 Total 2014 2015 • 2015 revenue = $35.2 million • Net revenue growth of 1% vs. 2014 7
Slide 8: Large Addressable Cartilage Repair Market for MACI
Large Addressable Cartilage Repair Market for MACI Estimated U.S. Cartilage Repair Procedures 818,000 Cartilage Surgical Surgical Procedures5 Procedures1 ACI (6%) 44,000 Osteochondral Large (>2 cm2) Allograft (13%) Chondroplasty/ Full-Thickness Microfracture Focal Chondral (38%) Defects2 Juvenile Al
Slide 9: Large Addressable Cartilage Repair Market for MACI
Large Addressable Cartilage Repair Market for MACI Estimated U.S. Cartilage Repair Procedures 818,000 Cartilage Surgical Product Revenues5 Procedures1 Allograft- Derived 44,000 (14%) Large (>2 cm2) Full-Thickness Carticel (37%) Juvenile Focal Chondral Allograft Defects2 (19%) 29,000 Insured Osteocho
Slide 10: MACI Overview
MACI Overview MACI is an investigational 3rd generation ACI intended for the treatment of cartilage defects in the knee Implantation Procedure • First tissue-engineered product approved as an Advanced Therapy Medicinal Product by the EC (June 2013)1 Mini-Arthrotomy Technique • Biologics License Appl
Slide 11: MACI Potential Therapeutic Advantages
MACI Potential Therapeutic Advantages CARTICEL MACI Effective in a challenging patient population 3rd generation ACI – Moderate to large sized chronic, symptomatic – Less invasive ACI lesions that have failed a primary treatment – Easier administration – Eliminates periosteal harvest and sutures Lim
Slide 12: MACI SUMMIT Study (EU) – Significant Improvement in Pain and Function Scores
MACI SUMMIT Study (EU) – Significant Improvement in Pain and Function Scores vs. Microfracture at Year 21 SUMMIT (Demonstrate the Superiority of MACI Implant to Microfracture Treatment) Study KOOS Pain and Function Endpoints at Year 2 P <.001 50 45.5 46 45 Improvement in Score 40 (Estimated Mean) 35
Slide 13: Epicel Overview
Epicel Overview Epicel is a permanent skin replacement for full thickness burns ≥ 30% of total body surface area • Important treatment option for severe burn patients where little skin is available for autografts • Only FDA-approved autologous epidermal product available for large total body surface
Slide 14: Revised Epicel Label Will Enable Continued Growth
Revised Epicel Label Will Enable Continued Growth Epicel Epicel may now be sold for (cultured epidermal autografts) profit on up to 360,400 HDE# BH990200 grafts per year (>50X 2015 volume) Directions for Use HUMANITARIAN DEVICE: Authorized by Federal law for use in adult and pediatric patients who
Slide 15: Large Addressable Burn Therapy Market for Epicel
Large Addressable Burn Therapy Market for Epicel Estimated U.S. Burn Patients1 500,000 Annual Burns (U.S.) 40,000 $120 Million Hospitalized Patients Addressable Market in the 1,500 Epicel- U.S.2 Indicated (>30% TBSA) Patients 600 Surviving >40% TBSA Patients 1 2012 National Burn Repository Report Ve
Slide 16: Strong Epicel Revenue Growth
Strong Epicel Revenue Growth Epicel Revenue $18 $16 $14 +60% $12 $ Million $10 $8 $6 $4 +127% +24% +40% +83% $2 $- Q1 Q2 Q3 Q4 Total 2014 2015 • 2015 revenues = $15.2 million • Net revenue growth of 60% vs. 2014 16
Slide 17: Strong Total Revenue Growth In the Core Commercial Business
Strong Total Revenue Growth In the Core Commercial Business Total Carticel & Epicel Revenue $60 $50 +14% $40 $ Millions $30 $20 +5% $10 +31% +4% +19% $- Q1 Q2 Q3 Q4 Total 2014 2015 • 2015 Carticel and Epicel revenue = $50.4 million • Total Carticel and Epicel revenue growth of 14% vs. 2014 17
Slide 18: Robust Financial Results Post-Acquisition
Robust Financial Results Post-Acquisition Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015 31-Dec-15 Revenues $ 9,658 $ 14,706 $ 10,849 $ 13,590 $ 11,309 $ 15,420 Cash $ 14,581 Cost of Product Sales 5,532 6,752 5,568 6,901 6,772 7,229 Total Current Assets $ 27,343 Gross Profit 4,126 7,954 5,281 6,689
Slide 19: Ixmyelocel-T is a Highly Differentiated Multicellular Therapy
Ixmyelocel-T is a Highly Differentiated Multicellular Therapy Expanded populations of M2-like macrophages and MSCs have multiple biological activities that promote tissue repair and regeneration 19
Slide 20: Ixmyelocel-T for the Treatment of Advanced Heart Failure Due to Ischemic DCM
Ixmyelocel-T for the Treatment of Advanced Heart Failure Due to Ischemic DCM Patient Profile • Majority of patients that are refractory to medical therapy have ischemic dilated cardiomyopathy (DCM) ( 1̴ 50,000 patients) • Generally have maximized Rx and device therapy • Typically no longer candidate
Slide 21: Heart Failure Represents a Large Unmet Need
Heart Failure Represents a Large Unmet Need Incidence of Heart Failure Unmet Need Hospitalizations • Over one million first time hospitalizations due to heart 1.1M1 failure per year1 • 50% of the patients in NYHA III/IV are ischemic2,3 Ischemic HF [Addressable patient population for all ischemic HF]
Slide 22: Fewer Ischemic DCM Patients Treated with Ixmyelocel-T Experienced a MACE
Fewer Ischemic DCM Patients Treated with Ixmyelocel- T Experienced a Major Adverse Cardiovascular Event1 75% fewer patients treated with ixmyelocel-T experienced a MACE (* p < 0.05) IMPACT-DCM Catheter-DCM Both Studies (6 Months) (1 Year) Control Ixmyelocel-T Control Ixmyelocel-T Control Ixmyelocel-
Slide 23: Phase 2b ixCELL-DCM Clinical Study
Phase 2b ixCELL-DCM Clinical Study Phase 2b ixCELL-DCM Study Design Objectives • To evaluate the efficacy, safety and tolerability of ixmyelocel-T compared to placebo in patients with heart failure due to ischemic DCM Patients • Males and females, age 30-86 • Diagnosis of ischemic DCM according to W
Slide 24: Deaths and Cardiovascular Hospitalizations Reduced with Ixmyelocel-T
Deaths and Cardiovascular Hospitalizations Reduced for Patients Treated with Ixmyelocel-T 100 90 Placebo Event s/Per 100 Patient Years 80 Ixmyelocel-T P=0.0344 Rate Ratio [95% CI]: 0.63 [0.42-0.97] 70 60 50 40 30 20 10 0 Deaths Surviving CV Hospitalization ED Visits LVAD/Transplant Patients treated
Slide 25: Adverse Events: Modified ITT Population (n=114)
Adverse Events: Modified ITT Population (n=114) Overall, there were fewer adverse events, including serious adverse events, in the ixmyelocel-T treated group and a 50% reduction in deaths 25
Slide 26: Time to First Event: Per Protocol (n=109)
Time to First Event: Per Protocol (n=109) The time to first event was longer in the ixmyelocel-T treated group compared to placebo, but was not statistically significant 26
Slide 27: Left Ventricular Ejection Fraction and Volumes
Left Ventricular Ejection Fraction and Volumes There were no significant structural changes in left ventricle volumes or left ventricular ejection fraction as measured by echocardiogram in either group 27
Slide 28: Six-Minute Walk Test and NYHA Class
Six-Minute Walk Test and NYHA Class Both treatment groups had an improvement in the six-minute walk test and NYHA class, with no statistical difference between the groups at month 12 28
Slide 29: ixCELL-DCM Trial Results Published in The Lancet
ixCELL-DCM Trial Results Published in The Lancet 29
Slide 30: Highly Automated and Scalable GMP Manufacturing Platform
Highly Automated and Scalable GMP Manufacturing Platform • Automated, Fully-Closed GMP Manufacturing System – Single-use disposable bioreactor cassette – Application key automates/tracks process – Incubator – Processor – System manager – Cassette used to manufacture over 400 patient products – GMP p
Slide 31: Vericel Has Attracted a Strong Fundamental Healthcare Investor Base
Vericel Has Attracted a Strong Fundamental Healthcare Investor Base % Common Stock Holder (>1%) Position Outstanding Consonance Capital Management 2,352,940 9.89% Great Point Partners 2,086,028 8.77% Visium Asset Management 1,662,670 6.99% Stonepine Capital Management* 1,376,887 5.79% venBio Select
Slide 32: Several Near-Term Potential Value-Creating Commercial and Clinical Milestones
Several Near-Term Potential Value-Creating Commercial and Clinical Milestones 2015 2016 2017 U.S. Commercial Operations Quarterly U.S. Operating Results Increasing cash flow from Carticel and Epicel business Clinical/Regulatory Programs MACI PDUFA Date MACI BLA MACI BLA Submitted Accepted HDE Supple
Slide 33: Vericel Investment Highlights
Vericel Investment Highlights Vericel Investment Highlights • Acquired Sanofi’s global Cell Therapy and Regenerative Medicine business in 2014 Robust Commercial – U.S. revenues of $42 million in 2013 Biologics Business • Total Carticel® and Epicel® revenues of $50.4 million in 2015 – 14% growth vs.
Slide 34: Appendix
Appendix a4 ™ VERICEL
Slide 35: Management Team with Deep Operations and Commercialization Experience
Management Team with Deep Operations and Commercialization Experience Management Team Nick Colangelo – President & CEO (March 2013) • More than 20 years of executive management and corporate development experience • Nearly a decade with Eli Lilly, including serving as Director of Strategy and Busine
Slide 36: Vericel Capitalization Table
Vericel Capitalization Table Capitalization (as of March 10, 2016) Shares Common Stock 22,602,412 Series A Preferred Stock Common Equivalents1 1,250,000 Series B Preferred Stock Common Equivalents & Dividends2 1,093,892 Warrants and Options 3,699,430 Fully Diluted Shares 28,645,734 1. Common equival