Upload
others
View
4
Download
0
Embed Size (px)
Citation preview
2
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 1934. 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.
Safe Harbor Statement
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
Meet Anika : Delivering therapies covering the full continuum of patient care
3
4
Business Model Delivering Innovation and Strong Growth
•Expansive HA technologies and premier product portfolio •Growing osteoarthritis viscosupplementation market as foundation
for success
Robust Technology Base
•Modern pharmaceutical facility with expansion capacity and efficient manufacturing operations
•Strong balance sheet position and cash generation ability
Strong Operations and Financial Position
•Experienced network and expanding global reach via appropriate sales channels
•Diverse product and development portfolio with extensive opportunities for continued growth
Partnership Growth and Other Opportunities
90% Total
Revenue Growth
467% EBITDA Growth
2010 – 2014 Growth
5
Journey to Become a Leading Regenerative Medicine Company
•HA Biomaterials Company •Core Ophthalmic viscoelastic business •Dispersed R&D spend •<20% operating margin
PAST
•Strong and growing viscosupplementation franchise •Building momentum with robust regenerative medicine pipeline •Double digit revenue growth •>30% operating margin
PRESENT
•Leading regenerative medicine and surgical company with an Orthopedic focus •Direct sales network •Sustained double-digit growth •Innovative pipeline sourced internally and externally
FUTURE
Therapeutic Areas and Commercial Product Portfolio
6
($62.0M)
($1.3M)
($5.9M)
($6.3M)
Numbers in millions represent FY2014 product revenue.
PALLIATIVE RESTORATIVE REGENERATIVE
Orthobiologics
($62.0M)
Dermal ($1.3M)
Surgical
($5.9M)
Other (6.3M)
ORTHOVISC®
ORTHOVISC® mini MONOVISC®
HYALONECT®
HYALOSS MATRIX®
HYALOFAST®
HYALOGRAN®
HYALOFILL®
HYALOSAFE®
ELEVESS®
HYALOMATRIX®
HYALOBARRIER®
HYALOGLIDE®
ENT Products
HYVISC®
ANIKAVISC®
ANIKAVISC® Plus INCERT
Other Ophthalmic products
PALLIATIVE
RESTORATIVE REGENERATIVE
Strong and Growing Viscosupplementation Franchise
7
Ort
hovi
sc®
•Long lasting efficacy
•Excellent safety profile
•Superior properties: high HA concentration, ideal molecular weight, optimal dynamic viscosity
Mon
ovis
c®
•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
Cing
al®
•1st 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
• $2 Billion worldwide market
• $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 3rd generation innovative product under regulatory review with strong phase III study outcome
• Target overall U.S. market leadership position in 2017
Extending the HA Power: Hyaluronic Acid and Tissue Regeneration
8
• 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)
9
Advancing Regenerative Medicine
Product Overview
•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
Clinical Positioning
•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 knee1 and ankle2 joints, respectively
Commercial Potential
•~4.9M annual incidence globally3; ~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, 2013 2. Giannini S. et al., One-Step Repair in Talar Osteochondral Lesions 4-year Clinical Results and t2-Mapping Capability in Outcome Prediction, 2012 3. 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 2014
In Cartilage Repair
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
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 market1
• Growing at a double-digit rate annually
1. Source: Visiongain AWC Report
In Wound Care
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
12
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
13
Product Development Portfolio
• 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
Hyalofast (US)
Development Clinical
Palliative
Restorative
Regenerative
Cingal (Europe and US)
3rd Gen. OA
Hyalobarrier (expanded applications)
Tissue Repair
14
Financial Performance 2010 – 2014
Growth
$MM
Total Revenue CAGR: 17% Orthobiologics CAGR: 19%
Profitability
Operating Margin
15
Executing Strategy to Deliver Sustainable Results
• Cingal®
• Regenerative medicine: Hyalofast®, Hyalomatrix®
• Robust internal pipeline and external collaboration
INNOVATION
• Strong and growing viscosupplementation franchise • Targeted international expansion • Direct sales channel
GROWTH
• Proven track record • Focused investments • Expense profile that supports earnings growth
PROFITABILITY