Anika Therapeutics, Inc.

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

Transcript of Anika Therapeutics, Inc.

Anika Therapeutics, Inc. Canaccord Genuity 34th Annual

Growth Conference

August 14th, 2014

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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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Company Overview and Financial Results

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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%

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Technologies and Products

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

Delivering on Our Technology Vision

PALLIATIVE

RESTORATIVE

REGENERATIVE

ENT Products

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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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Growth Catalysts

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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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Operational Accomplishments

&

2014 Outlook

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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

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Thank You