ANIKA THERAPEUTICS, INC.
(Nasdaq: ANIK)
Canaccord Genuity
Musculoskeletal Conference
March 14, 2017
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.
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A GLOBAL, INTEGRATED
ORTHOPEDIC MEDICINES COMPANY
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
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Proprietary
Hyaluronic Acid
Technology
Platform
Worldwide Product
Approvals
~30 Million
Procedures
Performed Globally
HYALURONIC ACID TECHNOLOGY PLATFORM:
INSPIRED BY NATURE, PERFECTED BY SCIENCE
Hyaluronic Acid (HA) 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 Applications
• 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
4
REMARKABLE HISTORY AND EXCITING FUTURE
2015 + BEYOND
2004-2015
Delivering Innovation
& Growth
• Direct Product Commercialization
• Launch of CINGAL and HYALOFAST
• Continued Pipeline Growth
Building
Viscosupplementation
Franchise
• Focused Development
• Launch of U.S. Visco Business
• ORTHOVISC and MONOVISC Achieve
Strong Market Positioning
Focus on
Manufacturing
• Company Incorporated 1992
• Primarily HA Biomaterials
1992-2004
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STRONG FOUNDATION DRIVING FUTURE GROWTH:
PRODUCT REVENUE
CINGAL® OUS
Approvals
MONOVISC® #2 in U.S.
Single-Injection Market
ORTHOVISC®
Market Leader
in U.S.1
$62.0M
2011
₁
6
MONOVISC®
U.S. Launch
Expansive Technology
Platform
$102.9M
Direct Commercial
Capability and Other
Investments
$87.7M
$68.0M
$71.8M
2012
2013
Multi-injection segment
Growing Orthobiologics
Franchise
$75.5M
2014
Strategic M&A
2015
2016
Beyond
FY 2016 FINANCIAL & BUSINESS HIGHLIGHTS
$103M
Product revenue, 17%
growth over FY 2015
Commercially launched CINGAL in
Canada and Europe
Submitted IND application to FDA for
additional CINGAL Phase III trial
$33M
Net income, $1.8M
increase over FY 2015
Received CE Mark approval for
ORTHOVISC-T
Advanced HYALOFAST FastTRACK and
MONOVISC hip OA Phase III trials
$125M
7
Cash and investments
as of December 31, 2016
Completed $25M ASR program
LONG-TERM GROWTH STRATEGY
Expanding
Globally
8
Advancing
Pipeline
Strengthening
Infrastructure
Strategic
M&A
VISCOSUPPLEMENTATION FRANCHISE WITH
FORMIDABLE MARKET POSITIONING
• Superior properties: high HA
concentration, ideal molecular weight,
optimal dynamic viscosity
• #1 Multi-Injection product in U.S.
• 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.
• Performance Driven by Strong End-User Demand
• Growing Market Share
• Poised to be Leader of U.S. Viscosupplementation Market
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DEEP & DIFFERENTIATED PIPELINE
Product
Candidate
Indication
Research
Collaboration
10
Market
Opportunity
(For U.S. Approval)
Ex-U.S. Approvals
Phase III
Approved in
Canada & E.U.
~$2 B
Hip
Osteoarthritis
Phase III
Approved in
Canada, E.U. &
Other Intl. Countries
~$600 M
Cartilage
Regeneration
Phase III
Approved in E.U. &
Other Intl. Countries
$500+ M
Lateral Epicondylosis
“Tennis Elbow”
Phase III to Commence
Approved in E.U.
~$700 M
Rheumatoid
Arthritis
Research
Knee
Osteoarthritis
Tendinopathy
Stage of Development
~$16 B
CINGAL AS NEXT GENERATION OA DRUG THERAPY
• 1st Combination HA and Steroid
in a Single Injection for Pain
Associated with OA
• Rapid and Long Lasting Relief of
Pain Symptoms
• Approved in Canada and EU; 2nd
Phase III Study to Commence in
Q1 2017 for U.S. Approval
Market Opportunity: ~$2 Billion
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CINGAL AS NEXT GENERATION
OA DRUG THERAPY
Mean
Improvement
from Baseline (%)
shows a high level of statistical improvement compared to saline
at all endpoints at 26 weeks
73%
67%
58%
53%
49%
Patient Global
Assessment
Evaluator Global
Assessment
1 day
68%
52%
50%
Total WOMAC
1 month
WOMAC
Stiffness
6 months
Rapid pain relief that lasts
Steroids
Starts working within
days post injection
12
67%
66%
Intra-Articular
Viscosupplements
Lasts through 6 months
post injection
WOMAC Physical
Function
*Western Ontario and McMaster
Universities Arthritis Index (WOMAC)
CINGAL AS NEXT GENERATION
OA DRUG THERAPY
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
ACETAMINOPHEN
NSAIDs
STEROIDS
VISCOSUPPLEMENTATION
OPIOIDS
TKA
0
1
2
3
4
No Radiographic
Evidence of OA
No Joint Space Narrowing
(JSN) but Possible
Osteophytic Lipping
Definite JSN
and Definite
Osteophytes
Moderate & Multiple
Osteophytes, Definite
JSN, Sclerosis, Possible
Bony Deformity
Large Osteophytes,
Marked JSN, Severe
Sclerosis, & Definite Bony
Deformity
Kellgren & Lawrence Classification System of Knee Osteoarthritis Severity
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EXPANDING INDICATION FOR MONOVISC
• Expanding Product Indication for
Treatment of Hip OA Pain
• Clinical Trial Sponsored by U.S.
Commercial Partner DePuy Synthes
• Potential to be First Therapy to
Market for Hip OA Indication
• Phase III Trial Ongoing for U.S.
Approval
Market Opportunity: ~$600M
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ADVANCING REGENERATIVE MEDICINE WITH
HYALOFAST FOR CARTILAGE REPAIR
*
*
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+
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LEVERAGING HA TECHNOLOGY PLATFORM
Tendinopathy: Repetitive Overuse Injuries to Soft and Connective
Tissue Components of the Joint
• New Program Leveraging Injectable HA Technology
• Received FDA Approval for IDE to Conduct Phase III Trial for
Lateral Epicondylosis (Tennis Elbow)
• Received CE Mark Approval for ORTHOVISC-T in Q4 2016
• Commercial Launch in Europe Expected in 1H 2017
Market Opportunity: ~$700 Million
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KEY CORPORATE MILESTONES
17
Commercial
Developments
•
Operational
Developments
• Relocation of Expanded European Hub in Padova, Italy
Product
Developments
• CINGAL NDA Submission to FDA
Commercialization of CINGAL and ORTHOVISC-T internationally
• Development of Direct Commercial Strategy
• Integration of Manufacturing Operations
• HYALOFAST U.S. Study Patient Enrollment Completion
TRACK RECORD OF SUCCESS
42%
$106M
$93M
3-Year Total
Shareholder Return
$103M
FY 2016
Total Revenue
(as of 2/21/2017)
17%
FY 2016 Product
Revenue Growth
Overall Position in
U.S. Visco. Market
#2
Commercial Presence in
55+ Countries
$103M
FY 2014
FY 2015
Product Revenue
FY 2016
Milestone Revenue
Strong Balance Sheet*
$125M in Cash & Investments
No Debt
Solid HA Tech Platform with 50+
Patents Owned and Accessible
* As of 12/31/2016
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ANIKA THERAPEUTICS, INC.
(Nasdaq: ANIK)
Canaccord Genuity
Musculoskeletal Conference
March 14, 2017