Anika Therapeutics, Inc.

Transcription

1 Anika Therapeutics, Inc. Jefferies Global Healthcare Conference June 4, 2015

2 Safe Harbor Statement The statements made in this presentation that are not statements of historical fact 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, 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 including the results of its research and development efforts and timing of regulatory approvals. Certain other factors that might cause the Company's actual results to differ materially from those in the forward-looking statements include those set forth under the headings Business, Risk Factors, and Management's Discussion and Analysis of Financial Condition and Results of Operations in the Company's Annual Report on Form 10-K for the year ended December 31, 2014, as well as those described in the Company's other press releases and SEC filings. 2

3 Meet Anika : Delivering therapies covering the full continuum of patient care A global, commercial-stage, orthopedic focused company with proprietary lines of hyaluronic acid (HA)-based products for orthopedic pain management, tissue regeneration, and wound healing. Worldwide product approvals for our expansive HA product portfolio Over 25 million procedures performed globally utilizing our safe and innovative products 50+ patents on native and chemically modified HA 400+ scientific publications 3

4 Business Model Delivering Innovation and Strong Growth Robust Technology Base Expansive HA technologies and premier product portfolio Growing osteoarthritis viscosupplementation market as foundation for success Strong Operations and Financial Position Modern pharmaceutical facility with expansion capacity and efficient manufacturing operations Strong balance sheet position and cash generation ability Partnership Growth and Other Opportunities Experienced network and expanding global reach via appropriate sales channels Diverse product and development portfolio with extensive opportunities for continued growth Growth 90% Total Revenue Growth 467% EBITDA Growth 4

5 Journey to Become a Leading Regenerative Medicine Company PAST HA Biomaterials Company Core Ophthalmic viscoelastic business Dispersed R&D spend <20% operating margin PRESENT Strong and growing viscosupplementation franchise Building momentum with robust regenerative medicine pipeline Double digit revenue growth >30% operating margin FUTURE Leading regenerative medicine and surgical company with an Orthopedic focus Direct sales network Sustained double-digit growth Innovative pipeline sourced internally and externally 5

6 Therapeutic Areas and Commercial Product Portfolio REGENERATIVE RESTORATIVE PALLIATIVE PALLIATIVE RESTORATIVE REGENERATIVE Orthobiologics ($62.0M) ORTHOVISC ORTHOVISC mini MONOVISC HYALONECT HYALOSS MATRIX HYALOFAST Dermal ($1.3M) HYALOGRAN HYALOFILL HYALOSAFE ELEVESS HYALOMATRIX Surgical ($5.9M) ($5.9M) Other (6.3M) ($6.3M) HYVISC HYALOBARRIER HYALOGLIDE ENT Products ANIKAVISC ANIKAVISC Plus INCERT Other Ophthalmic products Numbers in millions represent FY2014 product revenue. 6

7 Strong and Growing Viscosupplementation Franchise $2 Billion worldwide market Orthovisc Long lasting efficacy Excellent safety profile Superior properties: high HA concentration, ideal molecular weight, optimal dynamic viscosity Monovisc Highest dose of ultra-pure HA in a single injection Long lasting efficacy Excellent safety profile 1st FDA approved single injection product with non-animal sourced HA Cingal 1 st combination HA + steroid in a single injection Rapid and long lasting relief of symptoms Lightly crosslinked, high concentration of non-animal HA Excellent safety profile in clinical trials $900 Million U.S. market Orthovisc is the #1 brand in the multi-injection segment with growing market share Monovisc launched in 2014 and experiencing significant share growth Cingal is our 3 rd generation innovative product under regulatory review with strong phase III study outcome Target overall U.S. market leadership position in

8 Extending the HA Power: Hyaluronic Acid and Tissue Regeneration HA affects cell migration, angiogenesis, and cell proliferation Directs tissue development and remodeling Modulates inflammation Anika has developed long lasting hyaluronic acid scaffolds Matrices for cell migration and proliferation, and for tissue development Persistent release of HA over time Modulates inflammatory cytokines, catabolic factors, and stem cell homing (Lisignoli 2006) 8

9 Advancing Regenerative Medicine In Cartilage Repair Product Overview Clinical Positioning Commercial Potential Non-woven HA based scaffold 3-D biodegradable support for the entrapment of mesenchymal stem cells used to repair of chondral & osteochondral lesions Cost effective single-step procedure for the repair of articular cartilage defects A single-layered HA-based scaffold supporting mesenchymal stem cell adhesion for hyaline-like cartilage regeneration Published evidence supports improved clinical scores with follow-up data of up to 3 & 4 years on knee 1 and ankle 2 joints, respectively ~4.9M annual incidence globally 3 ; ~2.0M in the U.S. $2.0B market opportunity >6,000 patients treated with Hyalofast internationally 1. Buda R. et al., One-step arthroscopic technique for the treatment of osteochondral lesions of the knee with bone-marrow-derived cells: three years results, Giannini S. et al., One-Step Repair in Talar Osteochondral Lesions 4-year Clinical Results and t2-mapping Capability in Outcome Prediction, Source: McCormick F. et al., Trends in the Surgical Treatment of Articular Cartilage Lesions in the United States: An Analysis of a Large Private-Payer Database Over a Period of 8 Years, 2014; Hjelle K. et al., Articular cartilage defects in 1,000 knee arthroscopies. 2002; online database CIA World Fact book, August

10 A biodegradable support for human bone marrow mesenchymal stem cells used for cartilage regeneration and as an adjunct for microfracture surgery Cartilage defect Minimally-invasive arthroscopic surgery Use with microfracture or BMAC Mesenchymal stem cells mobilized Cells adhere, proliferate, differentiate Hyaline-like cartilage regenerated [Hyalofast is not available in the United States] 10

11 Advancing Regenerative Medicine In Wound Care Product Overview HA matrix for in-growing cells Wound contact layer is made of a HA based scaffold for ordered reconstruction Outer layer is comprised of a protective silicone membrane layer that controls water vapor loss, provides a flexible anti-infection covering, and allows easy inspection of the wound site Clinical Positioning Hyalomatrix PA is reimbursed as a dermal substitute Indicated for management of wounds including but not limited to: Partial & full-thickness wounds; Deep burns; Ulcers (pressure, venous, diabetic, chronic vascular); Surgical wounds (donor sites, post-mohs surgery, podiatric, wound dehiscence) Commercial Potential $1.1B skin substitute global market 1 Growing at a double-digit rate annually 1. Source: Visiongain AWC Report 11

12 Hyalomatrix PA is a bi-layered, sterile, flexible, and conformable dermal substitute designed to provide immediate wound closure and to promote the permanent regeneration of dermis Targted to treat partial or full-thickness acute and chronic lesions of the skin covered by Burn centers / pediatric burn centers Trauma centers Emergency rooms Diabetology Dermatology / plastic surgery Vascular surgery Orthopaedics surgery 12

13 Product Development Portfolio Regenerative 3 rd Gen. OA Tissue Repair Hyalofast (US) Orthobiologics development focus Strong IP platform for a wide array of applications 1. Short Term Protect Damaged Tissue 2. Medium Term Relief Pain and Restore Function 3. Long Term Regenerate Damaged Tissue Restorative Hyalobarrier (expanded applications) Palliative Cingal (Europe and US) Development Clinical 13

14 Financial Performance Growth Profitability $MM Total Revenue CAGR: 17% Orthobiologics CAGR: 19% Operating Margin 14

15 Executing Strategy to Deliver Sustainable Results INNOVATION Cingal Regenerative medicine: Hyalofast, Hyalomatrix Robust internal pipeline and external collaboration GROWTH Strong and growing viscosupplementation franchise Targeted international expansion Direct sales channel PROFITABILITY Proven track record Focused investments Expense profile that supports earnings growth 15

16 Thank You 16