Anika Therapeutics, Inc.
Transcript of Anika Therapeutics, Inc.
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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 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 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.
Safe Harbor Statement
Company Overview and Financial Results
Technologies and Products
Growth Catalysts
Operational Accomplishments & 2014 Outlook
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Agenda
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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
Key Corporate Milestones
Company Incorporation
Orthovisc® U.S. Launch
Acquisition of Anika S.r.l.
Orthovisc® Market
Leader₁ in U.S.
1992 2004 2007 2009 2012
Elevess™ FDA Approval
New Manufacturing
Facility Approval
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1996
Orthovisc® International
Launch
Corporate Headquarters
Move
₁ Multi-injection segment
Monovisc® International
Launch
2008 2014
Monovisc®
FDA Approval
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Successful Business Model Delivering
Consistent Growth
• Expansive Hyaluronic Acid technologies and products
• Growing viscosupplementation market
Medical Solutions
• State of the art pharmaceutical facility with expanded capacity and efficient manufacturing operations
• Strong balance sheet position and cash generation ability
Strong Operations and Financial Position
• Experienced network and expanding global reach
• Diversified product portfolio with extensive opportunities
Growth Through Partnership
Business Model Financial Results
2009 -2013
1.9x
Total Revenue Growth
5.4x
EBITDA Growth
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Double-digit Growth and Above-average
Shareholder Return
(Dollars in Millions)
2009 2010 2011 2012 2013 2014
Total Revenue
2H
1H
$40.1
$55.6 $64.8 $71.4
$75.1
$60.3
+17% CAGR
$3.7 $4.3 $8.5
$11.8
$20.6 $24.3
2009 2010 2011 2012 2013 1H 2014
Net Income
+54% CAGR
+182%
+25%
+42% +45%
Anika Therapeutics
Medical Device Peers
Russell 2000 Nasdaq Composite
Total Shareholder Return 08/13/2012 to 08/12/2014
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(#’s in ‘000, except EPS) 1H 2013 1H 2014 % Δ
Total Revenue $36,075 $60,285 +67%
Net Income $8,963 $24,333 +171%
EPS, Diluted $0.62 $1.57 +153%
YTD 2014 Financial Results
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
6/30/2013 6/30/2014 % Δ
Cash Balance $54,140 $84,880 +57%
Working Capital $74,773 $112,195 +50%
Debt Balance $8,800 $- -100%
Textiles
Expansive Technology Platform
Granules
Perforated Membrane
Amvisc Cingal
Epifilm
Gels Modified Gels HYAFF Solids
Anika HA Technologies
Epidisc
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Guide
Gauze
Sponge
Microspheres
Strong Core Business Growth
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2013 Total Revenue
(Dollars in Thousands)
Orthobiologics Product Revenue
Growing Viscosupplementation Market
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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: ≈ $2 billion • Reach: Commercialized in 20+ countries
US
• Market: ≈ $900 million • Growth: 8-11% for 2013-2018, a $1 billion market • Users: Orthopedic surgeons, sports medicine
physicians, rheumatologists and others • Competition: 7 brands, Anika overall #2
Pillars of Viscosupplementation Products
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Ort
ho
visc
®
•#1 in U.S. multi-injection segment
•Long lasting efficacy
•Excellent safety profile
•Superior properties: high HA concentration, ideal molecular weight, optimal dynamic viscosity
Mo
no
visc
®
•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
Cin
gal
TM
• 1st combination HA + steroid in a single injection
•Rapid and long lasting relief of symptoms
•Lightly crosslinked, high concentration of non-animal HA
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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
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Capitalize on Strong Viscosupplementation
Market
2014 $2 Billion
WW Market
US
Japan
ROW
2018 Approaching $3 Billion
WW Market 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 2016
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Advancing Regenerative Medicines
Product Overview
•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.
Clinical Positioning
•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 knee1 and ankle2 joints respectively.
Commercial Potential
•~4.9M annual incidents globally3. ~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, 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
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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 market1
• $550M addressable global market
1. Source: Visiongain AWC Report
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Surgical Product Portfolio
WW Anti-adhesion Market >$800M
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
Anika FY2013 Anti-adhesion portfolio - $5.4M
ENT
Abdominal
Tendon/Nerve
Pelvic
Orthopedic
Spine
Major Sites of Adhesions
Other
Japan
US &
EU
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Recent Operational Accomplishments
Achieved FDA PMA approval and launched Monovisc® in the U.S.
Successfully resolved Monovisc® US patent litigation with Sanofi/Genzyme
Completed CingalTM Phase III clinical trial patient enrollment and treatment
Entered into a new commercial partnership agreement with Medline Industries, Inc. for HyalomatrixTM in the U.S.
Achieved planned operating and manufacturing efficiencies
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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 CingalTM Phase III clinical trial
• Advance tissue regeneration products, including HyalofastTM
• Continue transformation from biomaterials company to company focusing on advanced tissue healing and regenerative medical solutions