Full Press Release Details
Anika. Restore Active Living. SIDOTI SMALL CAP INVESTOR CONFERENCE INVESTOR OVERVIEW SEPTEMBER 21, 2023
6+ NEW PRODUCT LAUNCHES in Fastest Growing Segments of Joint Preservation SIGNIFICANT & ONGOING CASH FLOW GENERATION STRONG HYALURONIC ACID (HA) FRANCHISE Leading osteoarthritis (OA) pain management franchise with Monovisc and Orthovisc and Cingal OUS Newly launched products are expected to generate accelerating double - digit topline growth Anika: A Well - Positioned Company With A Compelling Future Strong base business generates resilient cash flow that is funding new product launches in large, growing markets X - Twist TM Fixation System Integrity TM Patch System Tactoset Expansion Hyalofast (US) Cartilage Repair Cingal (US) Next - Gen OA RevoMotion TM Reverse Shoulder 3
Multiple New Product Launches in Fast Growing Joint Preservation Markets to Accelerate Growth 63% 32% 5% 90% 2% 8% REVENUE GROWTH & DIVERSIFICATION $115M $156M 2019 2022 In 2023 and early 2024, we are launching innovative products in the largest and fastest growing markets that compete with existing high value players ~11% CAGR OA Pain Management Integrity Patch System* RevoMotion Reverse Shoulder System X - Twist Fixation System $150M+ annual market opportunity $1B+ annual market opportunity $600M+ annual market opportunity Significant Investments in Pipeline Have Vastly Expanded Anika's Market Opportunity Joint Preservation and Restoration Non - Orthopedic * Integrity rotator cuff patch system received clearance of final 510(k) in August 2023, planned launch in Q1 - 2024 4
Versatile Suture Eyelet Strong Fixation Open Design Supports Healing Fast and Easy to Insert (X - Spline ) Successful Full Market Launch in 2023 of X - Twist Fixation System X - Twist Fixation System is a feature - rich suture anchor platform for soft tissue repairs in the shoulder and other extremities Easy - to - use and highly effective competitor to the market leading offerings Growth to be amplified in 2024 with recently 510(k) - cleared biocomposite to accompany the PEEK version introduced in 2023 The X - Twist is a new addition to the Anika sports medicine portfolio that brings their anchor options to the highest standard in orthopedics in the market. The instrumentation is easy to use and intuitive, and fixation is robust. The X - Twist can easily be used for nearly any soft tissue repair within the shoulder and throughout the body . " Dr . Christopher E . Baker, M . D . Florida Orthopedics Institute, Tampa, FL X - Twist Biocomposite Cleared Sept. 19, 2023 5
Bone Preserving Design Smallest Diameter Threaded Baseplate Personalized Options Anatomic Mid - Lay Humeral Enhanced Facility Efficiency Two Instrument Tray Design Limited Market Launch of RevoMotion Reverse Shoulder Arthroplasty System Moves to Full Market Launch in September 2023 So far, early into my experience with using RevoMotion reverse total shoulder arthroplasty, my patients have had universally exceptional outcomes and reviews. I am already booking patients for their contralateral shoulder RevoMotion as their first has performed so well." Dr. Christopher Baker, M.D. Florida Orthopeadic Institute, Tampa, FL Accelerated full market launch to September at OSET annual meeting Positive feedback from limited market launch 6
Strong Hybrid*, multifilament structure provides superior implant handling and strength vs. collagen - based products Versatile Differentiated lateral - to - medial fixation and technique via tacks and darts, provides confidence across continuum of tears Proven Higher regenerative capacity vs. first generation collagen patches 1 . Composed of 80% HYAFF material with 15 years of safe clinical use Easy to Use Pliable, soft matrix supports arthroscopic insertion * 80% Hyaff / 20% PET v/v Cleared Integrity Regenerative Rotator Cuff Patch System Launches Q1 - 2024 Differentiated, regenerative, arthroscopic, HA - based; Superior to collagen patches Leveraged our hyaluronic acid (HA) and joint preservation expertise to design a better, easier to use delivery system for our second - generation HA - based product competing against market leader Regeneten (Smith & Nephew), as well as Embody and BioRez products, all of whom use collagen Integrity is generating substantial initial surgeon interest, even before market launch, as existing collagen technology is not easy to work with and lacks proper fixation Integrity's instrumentation and technique are a game changer. Securing the implant laterally helps ensure proper coverage across the repair site and the rolling deployment tool provides consistent and repeatable implant placement." Dr. Timothy P. Codd, M.D. University of Maryland Medical System 1 Clinical data on file 7
Integrity Patch System Highly Differentiated Compared to Collagen Patches Greater mechanical integrity for easier insertion Greater regenerative capacity of HA - based patch vs. collagen through 26 weeks 1 Histology showing greater regenerative capacity with Integrity vs. collagen INTEGRITY 8 COMPETITIVE COLLAGEN 26 weeks 12 weeks 6 weeks Bars at 6, 12, & 26 weeks show difference in regenerative capability Both devices ~1mm thick at t=0 Collagen competition - collagen layer doesn't increase in thickness Integrity becomes a cellular collagen construct ~3x thicker than competition, significantly augmenting rotator cuff 26 weeks 12 weeks 6 weeks 1 Clinical data on file
Advancing Hyalofast and Cingal Towards FDA Approval Expecting final PMA module filing with FDA in 2025 for Hyalofast US Launch in 2026 Single - stage, off - the - shelf, resorbable, HA - based scaffold for cartilage repair Provides entry into $1 billion U.S. knee cartilage repair market Recently completed enrollment of pivotal phase III study in U.S. Designated as breakthrough device by FDA allowing prioritized interaction and review Already selling in more than 30 countries OUS Highly competitive with Vericel's market - leading MACI based on clinical data 1 Engaging with FDA regarding Next Steps for Cingal Cingal is poised to be a game - changing OA pain product in the U.S., as demonstrated by its consistent double - digit international growth with a >$1 billion U.S. market opportunity Highly differentiated next generation OA pain product with significant clinical and real - world advantages vs. existing therapies as demonstrated by continued growth in over 35 countries OUS Evaluating significant interest from potential partners in Asia, as well as the US Engaging with FDA for next steps toward potential approval Highly competitive with Pacira Biosciences' Zilretta based on clinical data 1 1 Clinical data on file 9
Driving Commercial Focus While Actively Managing Costs to Enhance Margins and Profitability Actively managing OpEx spend, while preparing to support significant growth in coming years Significant progress in both launching breakthrough products and addressing Medical Device Regulations (MDR) enables savings and improved operating leverage Continue to deploy cost - conscious hybrid sales model but enhancing to drive focus - Executing on a targeted approach utilizing key direct sales resources to penetrate accounts not currently a priority for existing distributors - Addition of direct sales resources will not increase overall OpEx spend Confident in margin expansion as Anika pivots to accelerated top and bottom - line growth Targeting double digit Joint Preservation and Restoration (JPR) growth with RevoMotion, Tactoset, and X - Twist in the market and Integrity launching in early 2024 Committed to driving operating leverage as growth accelerates and costs remain stable 10
Key Value Drivers RevoMotion fully launched in September 2023 on very positive surgeon feedback from limited release Executing market launch of Integrity in Q1 - 2024 expanding opportunities in fast growing rotator cuff augmentation market Driving double - digit joint preservation growth with new launches underway (RevoMotion, X - Twist, Tactoset fully launched; Integrity launch in Q1 - 2024) Implementation of focused direct sales effort to augment existing hybrid commercial structure Beginning modular PMA filing for Hyalofast in 2024, with final module in 2025 Focused efforts to securing US and OUS Cingal partnerships Continue to engage FDA on solidifying pathway to approval in the U.S. Focused cost control with stable OpEx Driving operating leverage as growth accelerates and costs remain stable 11 11
HIGHLY DIFFERENTIATED PIPELINE SOLVES UNMET NEEDS IN EARLY INTERVENTION ORTHOPEDICS $3B+ MARKET OPPORTUNITY OPENED BY SUCCESSIVE PRODUCT LAUNCH CADENCE Note: Last Patient Out (LPO) 1 SmartTRAK 2023 and internal estimates 2 Overall timing is unknown, largely dependent upon nonclinical testing plan and FDA's willingness to accept scientific bridging study 3 SmartTRAK 2023 and internal estimates for market size by 2027 2 - 23 - 23 1 - 23 1 - 24 Est. U.S. Market Size ($) 1 $1B+ 3 $600M+ $100M+ $150M+ $1B+ To Market FDA Development/Clinical Category Product with FDA to inform nex Actively engaging 3 rd Phase III study achieved primary endpoint - 10/2022 OA Pain Mgmt. Cingal 2025 Est. PMA filing complete Pivotal enrolled; LPO early 2025 Regenerative Hyalofast Cartilage Repair Est. Launch in Q 0(k)s cleared by Q3 - 23 All 51 Regenerative Integrity TM Rotator Cuff Patch System 023 BMA Launched Q ntrast) 510(k) filed in 2 Final (Co Regenerative Tactoset Expansion - 23 PEEK Launched Q ite 510(k) cleared in Q3 Biocompos Sports Medicine X - Twist TM Fixation System Launched Q3 Arthrosurface Joint Solutions RevoMotion TM Reverse Shoulder 13 $1B+ 3 t steps
Joint Preservation Pre - treatment, Conservative Treatment Traditional Total Joint Replacements OVO & OVOMotion Tactoset SpeedSpiral CMC PF Wave / WaveKahuna Hyalofast (OUS) Total WristMotion Monovisc Orthovisc Cingal (OUS) Synd - EZ Syndesmosis 1 st Metatarsal (Hemi & Total) Glenojet Draw Tight X - Twist Fixation System Actiflip Biceps RevoMotion Reverse Shoulder OA Pain Management Arthrosurface Joint Solutions Sports Medicine Regenerative Solutions ATLAS CMC ANIKA'S SOLUTIONS ACROSS THE ORTHOPEDIC CONTINUUM OF CARE Integrity Patch System 1
EXPANDING MARKET OPPORTUNITY IN JOINT PRESERVATION 1 Combination of iData, SmartTRAK, and internal estimates; 2 SmartTRAK and Anika internal estimates. CAGR 2021 - 2026 3 Received 510(k) clearance from FDA in Q3 - 2023; planned launch in Q1 - 2024 Extremities >$4B HA/Visco >$1B Regen >$1B Soft Tissue >$2B ANIKA PORTFOLIO OA Pain Management (HA/Visco) Monovisc Orthovisc Cingal (International) Cingal (U.S.) Regenerative Solutions Tactoset Hyalofast (International) Integrity TM Rotator Cuff Patch System 3 Hyalofast (U.S.) Sports Medicine (Soft Tissue) X. Twist TM Fixation System Suture Anchors Biocomposite Anchors 3 Implants, Instruments and Kits Arthrosurface Joint Solutions (Extremities) OVOMotion Shoulder RevoMotion TM Reverse Shoulder WristMotion Arthroplasty Upper and Lower Extremity Implants Shoulder, Foot and Ankle Implants Denotes Product Development Roadmap MARKET GROWTH RATES 2 FROM $1B IN 2019 TO $8B+ TODAY IN GLOBAL MARKET OPPORTUNITY 1 ~7% CAGR ~1% CAGR ~5 % CAGR ~8 % CAGR 15
SEASONED LEADERSHIP TEAM DRIVING GROWTH STRATEGY DECADES OF EXPERIENCE LEADING ORTHOPEDIC, REGENERATIVE MEDICINE, AND MEDICAL DEVICE COMPANIES Mike Levitz EVP, CFO & Treasurer 2020 David Colleran EVP, General Counsel & Corporate Secretary 2020 James Chase SVP, International Sales & Marketing 2018 Dawn Wilson VP, Research & Development 2020 Lisa Funiciello VP, Human Resources 2022 Mira Leiwant VP, Regulatory, Quality & Clinical Affairs 2019 Ben Joseph VP, Commercial & Corporate Development 2020 Cheryl R. Blanchard, Ph.D. President & CEO Joined: 2020 Anne Nunes SVP, Chief Operations Officer 2021 Robert Delp VP, U.S. Sales 2022 16