Anika Therapeutics Inc. · NASDAQ:ANIK
Anika Therapeutics — Q4 2016 Earnings Presentation
10 slides from Anika Therapeutics's earnings presentation, Feb 16, 2017
Slide 1: Fourth Quarter 2016 Earnings Call Presentation
ANIKA THERAPEUTICS, INC. Fourth Quarter 2016 Earnings Call Presentation February 16, 2017
Slide 2: Safe Harbor Statement
SAFE HARBOR STATEMENT The statements made in this presentation that 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 a
Slide 3: Update on Discussions with FDA on CINGAL
UPDATE ON DISCUSSIONS WITH FDA ON CINGAL • Achieved Alignment on an Overall Approval Framework • Submitted CINGAL IND Application in December 2016 • Commencement of a CINGAL Phase III Clinical Trial Expected in Q1 2017 with the first patient treated in Q2 2017 3
Slide 4: Advancing Pipeline
ADVANCING PIPELINE * • Non-woven HA Biodegradable 3D Scaffold for Cartilage * In Pipeline in the U.S.; Approved in E.U. 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
Slide 5: Expanding Globally
EXPANDING GLOBALLY • Commercial Launch of CINGAL in Canada and Europe Continues • Currently Available in Approximately Ten Countries • Finalizing CINGAL Regulatory Packages for India and Australia • Received FDA Approval for IDE to Conduct Phase III Trial for Lateral Epicondylosis (Tennis Elbow) ORT
Slide 6: Strengthening Infrastructure
STRENGTHENING INFRASTRUCTURE • Integration of Solid HA Manufacturing Operations is Progressing as Planned Build-out of the Bedford Facility has been Completed Solid HA Product Packaging Operations Online Producing Enhanced Finished Goods Fully Operational with Regulatory Approvals for Contract
Slide 7: 2017 Business Objectives
2017 BUSINESS OBJECTIVES Advance CINGAL, HYALOFAST and Other Development Programs for U.S. Approval Expand MONOVISC and CINGAL into New International Markets Commercially Launch ORTHOVISC-T in Europe Complete Consolidation of Global Manufacturing Operations Complete Build-out of New Europe
Slide 8: Delivering Strong Growth
DELIVERING STRONG GROWTH Q4 & FY 2016 Financial Highlights Q4 Q4 FY FY • Product revenue increased 11% year- 2015 2016 2015 2016 over-year for quarter; 17% for year • Orthobiologics revenue grew 13% year- Total Revenue $30.9 $28.7 $93.0 $103.4 over-year for quarter; 22% for year • Net income of $8.1
Slide 9: FY 2017 Guidance
FY 2017 GUIDANCE FY 2017 Guidance Total Revenue Growth Mid-Teen Percentage Growth Increased R&D Spending to Advance Pipeline Operating Expenses Investments to Strengthen Infrastructure Capital Expenditures $8M - $12M 9
Slide 10: Q&A
Q&A Anika Therapeutics, Inc. Fourth Quarter 2016 Earnings Call Presentation February 16, 2017