Anika Therapeutics, Inc.

Size: px
Start display at page:

Download "Anika Therapeutics, Inc."

Transcription

1 Anika Therapeutics, Inc. Canaccord Genuity 34th Annual Growth Conference August 14 th, 2014

2 Safe Harbor Statement The statements made in this presentation, which 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 the 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, 2013 and the Company s Quarterly Reports on Form 10-Q, as well as those described in the Company's other press releases and SEC filings. 2

3 Agenda Company Overview and Financial Results Technologies and Products Growth Catalysts Operational Accomplishments & 2014 Outlook 3

4 Company Overview and Financial Results 4

5 World Leader in Hyaluronic Acid (HA) Products and Technology > 20 yrs of R&D, Manufacturing and Commercialization experience with innovative HA products Product approvals worldwide > 400 scientific publications > 50 patents on native and chemically modified HA 5

6 Key Corporate Milestones Company Incorporation Orthovisc U.S. Launch Corporate Headquarters Move Monovisc International Launch Orthovisc Market Leader ₁ in U.S Orthovisc International Launch Elevess FDA Approval Acquisition of Anika S.r.l. New Manufacturing Facility Approval Monovisc FDA Approval ₁ Multi-injection segment 6

7 Successful Business Model Delivering Consistent Growth Business Model Medical Solutions Financial Results Expansive Hyaluronic Acid technologies and products Growing viscosupplementation market Strong Operations and Financial Position State of the art pharmaceutical facility with expanded capacity and efficient manufacturing operations Strong balance sheet position and cash generation ability Growth Through Partnership Experienced network and expanding global reach Diversified product portfolio with extensive opportunities 1.9x Total Revenue Growth 5.4x EBITDA Growth 7

8 Double-digit Growth and Above-average Shareholder Return $40.1 $ % CAGR Total Revenue $64.8 $71.4 $75.1 $ % Total Shareholder Return 08/13/2012 to 08/12/ Net Income 2H 1H $3.7 $ % CAGR $8.5 $11.8 $20.6 $ % +42% +45% H 2014 (Dollars in Millions) Anika Therapeutics Medical Device Peers Russell 2000 Nasdaq Composite 8

9 YTD 2014 Financial Results (# s in 000, except EPS) 1H H 2014 % Δ Total Revenue $36,075 $60, % Net Income $8,963 $24, % EPS, Diluted $0.62 $ % 6/30/2013 6/30/2014 % Δ Cash Balance $54,140 $84, % Working Capital $74,773 $112, % Debt Balance $8,800 $- -100% Continued total revenue growth U.S. Monovisc commercial launch and $22.5 million of milestone and contract revenue Robust bottom line Significant contribution from Monovisc milestone and contract revenue Continued efficiency gains Strong balance sheet Growing cash and working capital Debt free 9

10 Technologies and Products 10

11 Expansive Technology Platform Anika HA Technologies Gels Modified Gels HYAFF Solids Textiles Granules Amvisc Cingal Perforated Membrane Epidisc Epifilm Guide Gauze Sponge Microspheres 11

12 Delivering on Our Technology Vision REGENERATIVE RESTORATIVE PALLIATIVE ENT Products 12

13 Strong Core Business Growth Orthobiologics Product Revenue 2013 Total Revenue (Dollars in Thousands) 13

14 Growing Viscosupplementation Market Joint Health viscosupplementation products treat osteoarthritis pain with hyaluronic acid solutions. Our products represent effective, safe, convenient and non-surgical therapeutic alternatives or adjuncts to physical therapy, medication or surgery. Global Market: Reach: $2 billion Commercialized in 20+ countries US Market: $900 million Growth: 8-11% for , a $1 billion market Users: Orthopedic surgeons, sports medicine physicians, rheumatologists and others Competition: 7 brands, Anika overall #2 14

15 Orthovisc Monovisc Pillars of Viscosupplementation Products #1 in U.S. multiinjection segment Long lasting efficacy Excellent safety profile Superior properties: high HA concentration, ideal molecular weight, optimal dynamic viscosity 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 HA Cingal TM 1st combination HA + steroid in a single injection Rapid and long lasting relief of symptoms Lightly crosslinked, high concentration of non-animal HA 15

16 Growth Catalysts 16

17 Key Growth Drivers Continue to capitalize on strong viscosupplementation market Advance tissue regeneration products Expand market share and geographic presence for key products in U.S., Europe, Latin America and Asia Expand product portfolio via line extensions Continue transformation from biomaterials company to company focusing on advanced tissue healing and regenerative medical solutions 17

18 Capitalize on Strong Viscosupplementation Market 2014 $2 Billion WW Market ROW Japan US Strategic Goal: 15% of WW Market at the end of 2018 Leverage U.S. brand leadership to drive global Monovisc and Orthovisc growth Expand international distribution network Launch two new viscosupplementation products in late 2015 to early Approaching $3 Billion WW Market 18

19 Advancing Regenerative Medicines Product Overview Clinical Positioning Commercial Potential Non-woven hyaluronic acid (HA) based scaffold. 3-D biodegradable support for the entrapment of mesenchymal stem cells for the 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. Clinically proven to support improved clinical scores with follow-up data up to 3 & 4 years on knee 1 and ankle 2 joints respectively. ~4.9M annual incidents globally 3. ~2.0M in the U.S. $500M global market. 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

20 Advancing Regenerative Medicines Product Overview Biologically-derived 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. Clinical Positioning Hyalomatrix PA is indicated 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 wound care biologics global market 1 $550M addressable global market 1. Source: Visiongain AWC Report 20

21 Surgical Product Portfolio ENT Spine WW Anti-adhesion Market >$800M Tendon/Nerve Abdominal Pelvic Orthopedic US & EU Other Japan Anika FY2013 Anti-adhesion portfolio - $5.4M Major Sites of Adhesions Development Clinic Marketed HYAFF Barrier Film & HYAFF Mesh (Abdominal/Pelvic) HYAFF/ACP spray (Pelvic) HYAFF Gel (Orthopedic) Hyalospine Hyalobarrier MeroGel EpiDisc EpiFilm Hyaloglide; Incert-S 21

22 Operational Accomplishments & 2014 Outlook 22

23 Recent Operational Accomplishments Achieved FDA PMA approval and launched Monovisc in the U.S. Successfully resolved Monovisc US patent litigation with Sanofi/Genzyme Completed Cingal TM Phase III clinical trial patient enrollment and treatment Entered into a new commercial partnership agreement with Medline Industries, Inc. for Hyalomatrix TM in the U.S. Achieved planned operating and manufacturing efficiencies 23

24 2014 Outlook Solid top- and bottom-line growth U.S. Monovisc launch Focus on franchises with high potential Expand market share and geographic presence for existing key products Focused R&D advancements Complete Cingal TM Phase III clinical trial Advance tissue regeneration products, including Hyalofast TM Continue transformation from biomaterials company to company focusing on advanced tissue healing and regenerative medical solutions 24

25 Thank You 25