anika therapeutics, inc. (nasdaq: anik)

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ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK) Rodman & Renshaw Global Investment Conference September 13, 2016

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Page 1: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

ANIKA THERAPEUTICS, INC.(Nasdaq: ANIK)

Rodman & Renshaw Global

Investment Conference

September 13, 2016

Page 2: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

SAFE HARBOR STATEMENT

The statements made in, and during the course of, this presentation that are not statements of

historical fact, including those related to the Company’s expanded commercial capabilities, product

pipeline and associated timelines, upcoming corporate milestones, and growth strategy and

projections, 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, those

statements related to the Company’s product pipeline, the regulatory status, including plans for

expanded indications, of the Company’s products, the market potential of the Company’s products,

and 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, both known and

unknown, including, without limitation, future strategic decisions made by the Company, the results of

its research and development efforts and the timing of regulatory approvals.

2

Page 3: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

A GLOBAL, INTEGRATED ORTHOPEDIC MEDICINES COMPANY

3

Committed to improving the lives of patients with degenerative orthopedic diseases by providing innovative and

differentiated therapeutic solutions along the continuum of care, from palliative care to regenerative medicine.

Experience in Product

Development, Manufacturing and Commercialization

Proprietary Hyaluronic Acid

TechnologyPlatform

Worldwide Product Approvals

25 Million+ Procedures

Performed Globally

Page 4: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

4

HYALURONIC ACID (HA) TECHNOLOGY PLATFORM:INSPIRED BY NATURE, PERFECTED BY SCIENCE

Hyaluronic Acid is a Naturally-Occurring Biopolymer • Vital to Healthy Joint and Tissue Function

• Affects Cell Migration, Angiogenesis, and Cell Proliferation

Anika’s HA Technology Platform• Modification of HA to Address Range of

Palliative, Restorative, and

Regenerative Indications

• Basis for Current Commercialized

Products and Future Innovative

Therapies Yet to be Conceptualized

• Over 20 Commercialized Products

Across 5 Therapeutics Areas and a

Robust Pipeline

Page 5: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

5

2015 + BEYOND

2004-2015

1992-2004

Building ViscosupplementationFranchise

Delivering Innovation & Growth

• Company Incorporated 1992• Primarily HA Biomaterials

• Direct Product Commercialization• Launch of CINGAL and HYALOFAST• Continued Pipeline Growth

Focus on Manufacturing

• Focused Development• Launch of U.S. Visco Business• ORTHOVISC and MONOVISC Achieve

Strong Market Positioning

REMARKABLE HISTORY AND EXCITING FUTURE

Page 6: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

STRONG FOUNDATION DRIVING FUTURE GROWTH:PRODUCT REVENUE

6

₁ Multi-injection segment

$52.7M

$62.0M$68.0M $71.8M

$75.5M

$87.7M

ORTHOVISC® Market Leader

in U.S.1

MONOVISC® U.S. Launch

MONOVISC® #2 in U.S. Single-Injection Market

2010 2011 2012 2013 2014 2015 Beyond

Growing Visco. Franchise

Pipeline based on HA Technology Platform

Direct Commercial Capability and Other Investments

Strategic M&A

Page 7: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

Q2 2016 FINANCIAL & BUSINESS HIGHLIGHTS

7

$26.6M

$112M

Total revenue, 16%

growth year-over-year

$8.6M Net income, 10% growth

year-over-year

Cash and investments

Commercially launched CINGAL in Canada and Europe

Advanced HYALOFAST FastTRACK and MONOVISC hip OA Phase III trials

Received FDA approval of IDE for tendinopathy Phase III trial

Continued $25M ASR program

Build-out of manufacturing operations on track

Page 8: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

LONG-TERM GROWTH STRATEGY

8

Expanding Globally

Advancing Pipeline

Strengthening Infrastructure

Strategic M&A

Page 9: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

VISCOSUPPLEMENTATION FRANCHISE WITH FORMIDABLE MARKET POSITIONING

• Superior properties: high HA concentration, ideal molecular weight, optimal dynamic viscosity

• #1 Multi-Injection Product in U.S.

• Performance Driven by Strong End-User Demand

• Growing Market Share

• Poised to be Leader of U.S. Viscosupplementation Market

• Highest dose of ultra-pure HA, and lowest volume in a single injection

• 1st and only FDA-approved single injection product with non-animal HA

• #2 Single-Injection Product in U.S.

9

Page 10: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

DEEP & DIFFERENTIATED PIPELINE

10

Phase III

Phase III

In U.S. Regulatory Process

Product Candidate

Phase III to CommenceTendinopathy

IndicationStage of Development

(For U.S. Approval)

Market Opportunity

~$2 B

~$600 M

$500+ M

~$700 M

Knee Osteoarthritis

Hip Osteoarthritis

Cartilage Regeneration

Lateral Epicondylosis“Tennis Elbow”

Ex-U.S. Approvals

Approved in Canada & EU

Approved in Canada, EU &

Other Intl. Countries

Approved in EU & Other Intl. Countries

Research ~$16 BRheumatoid Arthritis

Research Collaboration

Page 11: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

CINGAL AS NEXT GENERATION OA DRUG THERAPY

11

•1st Combination HA and Steroid in a Single Injection for Pain Associated with Knee OA

•Rapid and Long Lasting Relief of Pain Symptoms

•Approved in Canada and EU; In U.S. Regulatory Process

Market Opportunity: ~$2 Billion

Page 12: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

CINGAL AS NEXT GENERATION OA DRUG THERAPY

CINGAL® shows highly statistical improvement compared to saline at all endpoints at 26 weeks

49%

Patient Global Assessment

67%58%

Evaluator Global Assessment

73%

53%

Total WOMAC

68%

50%

WOMAC Stiffness

66%

52%

WOMAC Physical Function

67%

Mea

nIm

pro

vem

en

t fr

om

Bas

elin

e (%

)

1 day 1 month 6 months

Rapid pain relief that lasts

SteroidsIntra-Articular

Viscosupplements

Lasts through 6 monthspost injection

Starts working withindays post injection

*Western Ontario and McMaster Universities Arthritis Index (WOMAC)

12

Page 13: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

CINGAL AS NEXT GENERATION OA DRUG THERAPY

CINGAL® extends the proven benefits of Anika’s proprietary high concentration cross-linked hyaluronic acid formulation to a broader range of

patients across the spectrum of osteoarthritis management

0No Radiographic Evidence of OA

1No Joint Space Narrowing

(JSN) but Possible Osteophytic Lipping

2Definite JSN and Definite Osteophytes

3Moderate & Multiple Osteophytes, Definite JSN, Sclerosis, Possible

Bony Deformity

4Large Osteophytes, Marked JSN, Severe

Sclerosis, & Definite Bony Deformity

ACETAMINOPHEN

NSAIDs

STEROIDS

VISCOSUPPLEMENTATION

OPIOIDS

TKA

Kellgren & Lawrence Classification System of Knee Osteoarthritis Severity

13

Page 14: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

EXPANDING INDICATION FOR MONOVISC

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• Expanding Product Indication for Treatment of Hip OA Pain

• IDE Sponsored by U.S. Commercial Partner DePuy Synthes

• Potential to be First Therapy to Market for Hip OA Indication

• Phase III Trial Ongoing

Market Opportunity: ~$600M

Page 15: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

ADVANCING REGENERATIVE MEDICINE WITH HYALOFAST FOR CARTILAGE REPAIR

15

* In Pipeline in the U.S.; Approved in E.U.

* • Non-woven HA Biodegradable 3D Scaffold for Cartilage Repair

• Cost-effective Single-step Procedure for the Repair of Articular Cartilage Defects

• Over 7,000 Treated with HYALOFAST Internationally

• FastTRACK Phase III Trial Ongoing for U.S. Approval

Market Opportunity: $500M+

Page 16: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

LEVERAGING HA TECHNOLOGY PLATFORM

16

• New Program Leveraging Injectable HA Technology

• Received FDA Approval for IDE to Conduct Phase III Trial for Lateral Epicondylosis “Tennis Elbow”

• Patient Enrollment to Commence in Q4 2016

• Submitted CE Mark Application in Q1 2016

Market Opportunity: ~$700 Million

Tendinopathy: Repetitive Overuse Injuries to Soft and Connective Tissue Components of the Joint

Page 17: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

KEY CORPORATE MILESTONES

17

• CINGAL FDA NDA Submission

• HYALOFAST U.S. Study Patient Enrollment Completion

• Relocation of Expanded European Hub in Padova, Italy

• Integration of Manufacturing Operations

Launch of CINGAL in Canada and EuropeCompleted

• Development of Direct Commercial Strategy

Product Developments

Operational Developments

Commercial Developments

Page 18: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

TRACK RECORD OF SUCCESS

18

~280%3-Year Total

Shareholder Return

16% FY 2015 Product Revenue Growth

Strong Balance Sheet*

$112M in Cash & Investments No Debt

Solid HA Tech Platform with 50+ Patents Owned and Accessible

#2Overall Position in U.S. Visco. Market

$93MFY 2015

Total Revenue

55+ CountriesCommercial Presence in

FY 2013 FY 2014 FY 2015

Product Revenue Milestone Revenue

$75M

$106M$93M

* As of 6/30/2016

Page 19: ANIKA THERAPEUTICS, INC. (Nasdaq: ANIK)

ANIKA THERAPEUTICS, INC.(Nasdaq: ANIK)

Rodman & Renshaw Global

Investment Conference

September 13, 2016