Deutsche Bank Health Care Conference

Transcription

1 Deutsche Bank Health Care Conference May 8, 2018 NASDAQ: ANIK0

2 Safe Harbor Statement The statements made in, and during the course of, this presentation that are not statements of historical fact, including those related to the Company s expanded commercial capabilities, product pipeline and associated timelines, upcoming corporate milestones, and growth strategy and projections, are forward looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of Forward-looking statements involve known and unknown risks, uncertainties, and other factors. The words potential, develop, promising, believe, will, would, expect, anticipate, intend, estimate, plan, likely, and other expressions, which are predictions of, or indicate future events and trends, and which do not constitute historical matters, identify forward-looking statements, including, without limitation, those statements related to the Company s product pipeline, the regulatory status, including plans for expanded indications, of the Company s products, the market potential of the Company s products, and management s discussion of the Company s growth and strategic plans. The Company's actual results could differ materially from any anticipated future results, performance or achievements described in the forward-looking statements as a result of a number of factors, both known and unknown, including, without limitation, future strategic decisions made by the Company, the results of its research and development efforts and the timing of regulatory approvals. 1

3 Innovating Orthopedic Medicine A global medicines company delivering innovative solutions for pain management, tissue regeneration, and wound healing Over 25 year track record of growth Over 20 commercialized products across five therapeutic areas Commercial presence in over 65 countries Deep and innovative product pipeline 2

4 Leader in Hyaluronic Acid-Based Therapies Broad Portfolio and Applications of Proprietary Hyaluronic Acid (HA) Technologies Existing and Potential Applications Natural component of the body vital to healthy joint and tissue function Versatile applications leading to broad potential product candidates Textiles Woven Liquid HA Gel Textiles Non-woven Strong efficacy and safety profile Anika s HA-based therapies used in over 30 million treatments worldwide Robust HA technology platform with 50+ patents owned and accessible In-situ Forming Devices Drug Delivery Perforated Membrane Time Release Applications Guide 3

5 Over A Global, Growing Need Innovating Orthopedic Medicine ~30M People affected by Osteoarthritis (OA) in U.S. ~$2B Knee OA global market opportunity Advancing Regenerative Medicine ~4M Annual sports related injuries in U.S. & EU ~$2B Cartilage repair market opportunity in U.S. $185B in annual U.S. healthcare costs spent on OA More 5% than of global population affected by knee OA ~1.2M Knee arthroscopies in U.S. annually ~$300M Burn market opportunity in U.S. Aging Joint Injury Repetitive Joint Stress Heredity Muscle Weakness 4

6 Innovative Product Pipeline Product Candidate Indication Research Phase III Clinical Trial Development Existing Approvals Market Opportunity Knee Osteoarthritis Phase III (Drug): Complete 2 nd clinical trial in 2018 Approved in E.U. & Canada Hip Osteoarthritis Phase III (Device): Complete patient enrollment 2H 2019 Approved in E.U. & Other Intl. Countries Lateral Epicondylosis Tennis Elbow Post-Market Clinical Follow-up Study (Device): Commence in 2018 Approved in E.U. Cartilage Regeneration Phase III (Biologic): Complete patient enrollment 2H 2018 Approved in E.U. & Other Intl. Countries 5 Bone Repair Commercialization in (k) Clearance in U.S. Rotator Cuff Repair Prototype development in 2018 Product Road Map Extension into synovial joints, including hip, shoulder, ankle, and others University Collaborations Drug delivery system and stem cell research = $500M 5

7 Our Solutions Innovating Orthopedic Medicine 6

8 ORTHOVISC: First Generation OA Therapy Market leading product in multi-injection treatment for OA* Long-lasting results through 26 weeks, with a strong safety profile Superior properties: high HA concentration, ideal molecular weight, optimal dynamic viscosity Available in over 20 countries, including the U.S., Canada, and Europe * Knee in U.S., all Synovial Joints in International Markets 7

9 MONOVISC: Second Generation OA Therapy Single-injection treatment for OA* Long-lasting results through 26 weeks, with a strong safety profile Highest dose of ultra-pure HA, and lowest volume in a single injection treatment Potential to be first therapy to market for hip OA indication Available in over 25 countries, including the U.S., Canada, and Europe * Knee in U.S and Canada., all Synovial Joints in International Markets 8

10 CINGAL: Strong Driver of our Growth Strategy First-in-class single-injection treatment combining FDAapproved HA and steroid for pain associated with Osteoarthritis (OA) Rapid and long-lasting pain relief through 6 months, with a strong safety profile; Potential for 9-month efficacy claim Strong CINGAL commercial growth in key international markets outpacing MONOVISC during the same period following its launch Continued strong CINGAL commercial growth in key international markets, with close to 280% year-over-year revenue growth in Q Completed Phase III trial 6-month follow up activities in April 2018; On track for potential FDA approval around mid-year

11 CINGAL: Potential First-in-Class Therapy with 9-Month Extended Pain Relief First CINGAL Phase III Study First Phase III study results: Reduced WOMAC Pain by 70% at 12 weeks and 72% at 26 weeks Demonstrated rapid pain relief following administration (a 59% improvement in WOMAC Pain at 1 week and 68% at 3 weeks) Over 320 patients from our 2 nd Phase III trial have consented to enroll into the 3-month extension study for CINGAL to collect 9- month efficacy data 9-month efficacy claim is a potential game changer with positive effects on overall market size, reimbursement, and adoption rates CINGAL 13-01, a randomized, double-blind, placebo-controlled, active comparator Phase III study. Anika Therapeutics, Inc.: study sponsor, Dr. Laszlo Hangody: global principal investigator. No impact on NDA filing timeline 10

12 Building U.S. Commercialization Infrastructure Debut appearance at the 2018 AAOS annual meeting Conducted in-depth interviews with approximately 50 U.S. orthopedic surgeons >50% of surgeons surveyed indicated CINGAL would be 1 st line choice based solely on product profile Upcoming key initiatives: Market sizing research Sales force sizing & alignment Physician segmentation Pre-launch Commercial Infrastructure Activities Meetings with Members of the Academy of Managed Care Pharmacy In-depth Orthopedic Surgeon Interviews Payer Market Research & Segmentation Analysis Improved Physician Access, Physician Relationships, Physician Segmentation 11

13 Advancing Regenerative Medicine 12

14 Transforming Regenerative Care through HYAFF Acquired HYAFF regenerative technology in 2009 Expanding Orthobiologics Franchise into Regenerative Medicine Onshored manufacturing of HYAFF-based products to Bedford, MA ( ) HYALOFAST Phase III trial ongoing for U.S. approval (2015-Ongoing) PHASE III New European headquarters and training center in Padova, Italy established in

15 HYALOFAST: The Future of Regenerative Medicine Only HA-Based Scaffold Material Single-Step, Off the Shelf, and Cost Effective Solution HA promotes cell migration and proliferation Proven to repair cartilage tissue in ankle and knee lesions Commercially available in over 15 countries outside the U.S. Over 14,000 patients successfully treated internationally Versatile A chondroprotective coverage after microfracture, or in combination with bone marrow aspirate concentrate Flexible Application Via arthroscopy or mini-arthrotomy not requiring additional fixation Adaptive Fit Soft texture, easy to conform, cover and fill regular and irregular lesions Phase III trial ongoing for U.S. approval 14

16 Injectable HA-Based Bone Repair Treatment Sets and cures in situ to support the formation of new bone Offers a minimally invasive approach to treatment of e.g., tibial plateau fractures Osteoconductive, self-setting, injectable treatment indicated to fill bone voids or gaps through minimally invasive application, which is ultimately resorbed to assist in bone regeneration during the healing process 510(k) Application submitted Q3 2017, with clearance received in Q4 2017; Completing clinical & commercial strategy in 2018 Complements growing regenerative medicine franchise and provides another option to delay arthroplasty 15

17 Accelerating Growth and Execution 16

18 $ in Millions Steady Product Revenue Growth in 2017 $53 $76 $72 $68 $62 $88 $108 $ % CAGR for Orthobiologics franchise over the last 3 years Recently launched 2 new products as part of our Orthobiologics franchise: CINGAL and ORTHOVISC-T Lead products ORTHOVISC and MONOVISC achieved the U.S. market leader position in Q Commercial presence in 65+ countries 17

19 Q Financial Summary Top-line impacted by voluntary recall US Viscosupplement franchise became the market leader in Q1 ORTHOVISC softness partially offset by strong single-injection MONOVISC and CINGAL revenue growth 29% worldwide MONOVISC growth; Close to 280% international CINGAL growth One-time charge of $8.4 million related to CEO transition Q TOTAL REVENUE $21.3M 9% DECLINE OVER Q PRODUCT GROSS MARGIN Q % DILUTED EPS ($0.46) Q $163M CASH & INVESTMENTS AT MARCH 31, 2018; NO DEBT 18

20 Key Milestones Complete consolidation of global manufacturing operations in Bedford, MA and 2017 international expansion Phase III trial completion for U.S. approval CINGAL NDA submission to FDA Approval and commercial launch in U.S. Bone Repair Commercial Launch Clinical study Tendinopathy approvals and commercial launches in U.S. Continued global expansion with new line extensions and innovative new treatments 19

21 Positioned for Long-Term Growth & Success Deep and expansive technology platforms Innovative and robust product pipeline Management experience Large commercial opportunities Strong financial position 20

22 Deutsche Bank Health Care Conference May 8, 2018 NASDAQ: ANIK21