Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

24
Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal Conference February 7, 2012

Transcript of Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Page 2: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Safe Harbor Statement

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 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, 2010 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.

Page 3: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

The Anika Story

Four near-term investment catalysts

Monovisc pending approval in

U.S.

Product

Revenue

Growth

1.

3.

2.

Breakeven for Anika S.r.l.

Earnings

Growth

Manufacturing facilities

consolidation

Growing demand for currently

marketed products

4.

Page 4: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Anika at a Glance

Products for tissue protection, healing, repair and regeneration

Leader

• Domain expertise in

hyaluronic acid technology

Market Leader

• Orthobiologics franchise driving growth

Up 26% 9Mo

• Eight consecutive years of profitability EPS up 86% 9Mo

• Healthy operating cash flow and strong cash position $29M at 9/30/11

Page 5: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Current Business Highlights

• Strong top-line growth and successful Anika S.r.l. integration

• Strong and expanding demand for Orthovisc® in U.S. and

international markets (up 19%)

• Monovisc® performing well in Europe; optimistic for U.S. approval;

DePuy Mitek selected as distribution partner

• Anika S.r.l. positioned to be breakeven in Q4 2011; S.r.l. products

gaining traction in U.S., Europe and Asia (up 22%)

• Expect to complete Bedford manufacturing consolidation in 2012

achieve significant cost reduction

Page 6: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Anika Business by Segment (2011)

Ophthalmic, 17%

Surgical, 4%

Aesthetic, 1%

Orthobiologics,

65%ENT, 4%

Animal Health,

4%

Wound Care, 5%

Anika’s business is broadly diversified,

dominated by the Orthobiologics portfolio

Page 7: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Product Portfolio

S.r.l. products significantly expand Anika’s portfolio and pipeline

Anika, Inc. Anika S.r.l.

Orthobiologics Orthovisc

Orthovisc Mini

Monovisc

Hyalograft C Autograft

Hyalofast Hyalonect

Hyaloss Hyaloglide

Dermal Hydrelle

Elevess

Hyalograft 3D Laserskin

Hyalomatrix Hyalogran

Hyalofill Jaloskin

Ophthalmic Anikavisc, Anikavisc Plus

Amvisc, Amvisc Plus

Staarvisc-II

Shellgel

Surgical Incert-S Hyalobarrier

Hyalobarrier Endo

Merogel & other ENT products

Veterinary Hyvisc

Page 8: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Market Share Distribution Sales Growth

Grew to 12% of US market in 2010

Tracking higher in 2011

20% sales growth past four years

Strong demand in U.S. and globally

Distributed by DePuy Mitek to most physician specialties

Orthovisc® – Flagship Orthobiologics Product

20%

Page 9: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

New Opportunity: Single-Injection Monovisc®

Performing well in Europe

Distributed in 18 countries

Ongoing dialogue with FDA on PMA application

DePuy Mitek recently selected as partner for U.S.

$783M U.S. Viscosupplementation market in 2012; $915M in Japan, Europe & ROW Single injection represents 40% of U.S. market

Page 10: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

15 % up

Product Revenue Growth

Orthobiologics

Sales Orthobiologics Growth

28.2 $ 26

up

Orthobiologics Sales Driving Strong Growth

%

9 Month 2011 Results

million

Page 11: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Industrial Services

Oil & Gas Production Services

Regenerating Damaged Tissue

Protecting Damaged Tissue

Relieving Pain

Palliative Regenerative

HyaloGraft C/Hyalofast Orthovisc/Monovisc

Delivering on Our Vision

Restorative

Hyalonect/Hyaloglide/Hyalobarrier

Page 12: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Product Development Anika HA Technologies

Gel • Orthovisc

• Amvisc

• Hyvisc

Modified

Gels

• Monovisc

• Hyalobarrier

• Hyaloglide

• Elevess

Solids

• Granules • Hyalogran

• Sponge • Meropak

• Mesh/textiles • Hyalofll

• Hyalonect

Hyaluronic

Acid

Page 13: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal
Page 14: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Hyalograft C: Cartilage Regeneration Product

First bioengineered cartilage regeneration product for minimally

invasive surgery – adding new EU and ROW distributors

Global Market over $100M

Day 0

Cartilage biopsy

In vitro chondrocyte

culture

Day 14

Seeding on HA matrix

Day 28

Cartilage formation

Day 30

Grafting on patient

Page 15: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Advanced Wound Care Portfolio

Commercialized in Europe, Middle East, Korea, U.S. W

ound c

om

ple

xity

# patients

Moist wound dressings

Antimicrobial dressings

Advanced therapies

Skin

substitute

• Hyalograft3D autograft

• Laserskin autograft

• Hyalomatrix

• Hyalofill

• Cronofill

Debridment agents • Jaloskin

• Hyalogran

Film dressings

Skin substitutes

Advanced therapies

Traditional Dressings

(Films,fleece,hydrogels)

Basic wound care

Tissue regeneration

Page 16: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Product Development Programs

• Monovisc-Knee

• Orthovisc-Shoulder

• Cingal-(HA plus drug)

• Hyalofast scaffold-Cartilage repair

Orthopedic

• Modified Elevess

• Aesthetic follow on products

• Wound care dressings (HA plus additives)

• Antioxidant,

Dermal

• Chondroitin based viscoelastic Ophthalmic

Page 17: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Financial Overview and

Operating Leverage Initiatives

Page 18: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Income Statement Highlights

• Revenues up due to

Orthobiologics and Surgical

franchise growth

• GM post 2009 reflects

addition of Anika S.r.l. products

and climbing back

• Operating expenses remain tightly

controlled

• 2011 estimated tax rate 38.0%

versus 41.2% in 2010

2009 2010 9 Mo.

2010

9 Mo.

2011

Total Revenue $40.1 $55.6 $40.8 $46.3

Product Gross

Margin

63% 55% 56% 56%

Operating

Expenses*

$20.9 $24.2 $18.7 $17.6

Operating

Income

$5.6 $7.5 $5.1 $9.1

Net Income $3.7 $4.3 $3.0 $5.6

EPS (diluted) $0.32 $0.32 $0.22 $0.41

Top- and bottom-line trends remain favorable

(Dollars in millions, except per-share amounts) * Excluding cost of product revenue

Key Dynamics

Page 19: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Balance Sheet Highlights

• Total assets of $129.8 million

• Healthy cash flow from

operations -- $2.9 million in 9M

(In millions) 12/31/09 12/31/10 9/30/11

Cash & Cash

Equivalents

$24.4 $28.2 $29.0

Net Working

Capital

$33.3 $37.0 $43.5

Net Property

& Equipment

$35.7 $37.0 $36.7

Long-Term

Debt

$12.8 $11.2 $10.0

Stockholders’

Equity

$82.1 $85.2 $92.8

Continued strong cash and working capital position

Key Dynamics

Page 20: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Key Business Targets

Focused on solid strategic execution over the long term

2009 2010 9 Mo.

2011

Target

3-5 Years

Product

Revenue –

Organic

Growth

13% 18% 15% >20%

Product Gross

Margin

63% 55% 56% >60%

SG&A

26% 31% 28% 20–30%

R&D

20% 12% 10% 10–15%

Operating

Margin

14% 14% 19% >20%

Page 21: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Successful Integration of Anika S.r.l.

Reduced Anika S.r.l. operating loss and positioned the business to

be breakeven in Q4 2011

Revenue growth (+19%)

• Hyalobarrier surgical products shipping in Korea and Taiwan

• Advanced wound care: international distribution & U.S. launch

• Tissue engineered orthopedic products: seek increased EU/ROW penetration

Cost reduction synergies

• SG&A

• R&D

• Manufacturing

Page 22: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Manufacturing Efficiency Initiatives

Consolidating and improving quality across all of Anika’s operation

Consolidating GMP Manufacturing in Bedford, MA USA

• CE-Mark approval received for all products

• FDA-validated for cross-linked product line

• Aseptic products validated and FDA-inspected

• Awaiting FDA approval in Q1 2012

Totally Revamped Anika’s Quality Organization

• Enhanced manufacturing quality

• Achieved exemplary level of FDA compliance

S.r.l. Product Manufacturing in

Bedford

• Products made by S.r.l.’s former parent

• Targeting significant cost savings

Page 23: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Anika Outlook

Strongly positioned for profitable growth

• Growing demand for currently commercialized

products

• Potential FDA approval of Monovisc

• Anika S.r.l – approaching breakeven; products

gaining traction in U.S., Europe and Korea

• Expect to complete Bedford manufacturing

consolidation in Q1 2012

• Capitalizing on technology assets with new product

introductions

Page 24: Anika Therapeutics, Inc. Cannacord Genuity Musculoskeletal

Thank You