Anika Reports Second Quarter 2016 Financial Results
Total Revenue Increases 16% Year-over-Year

BEDFORD, Mass.--(BUSINESS WIRE)-- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid ("HA") technology, today reported financial results for the second quarter ended June 30, 2016, along with business progress in the period.

"We continued our strong momentum in the second quarter, with total revenue growth of 16% year- over-year for the quarter," said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. "MONOVISC end user demand remained strong, we achieved important milestones in our global expansion with the launch of CINGAL in Canada and Europe, and we continued to advance our deep and differentiated pipeline. We are well-positioned to drive future growth and create significant near- and long-term value for patients and shareholders."

Second Quarter Financial Results

  • Total revenue for the second quarter of 2016 increased 16% to $26.6 million, compared to $22.9 million for the second quarter of 2015.
  • Worldwide Orthobiologics revenue grew 21% year-over-year in the second quarter of 2016. ORTHOVISC and MONOVISC, our lead viscosupplementation products in the Orthobiologics franchise, continued to be the main revenue driver.
  • International Orthobiologics revenue grew 36% year-over-year in the second quarter of 2016 as a result of our global commercial expansion efforts. Domestically, ORTHOVISC maintained its position as the leading multiple-injection product. MONOVISC continued to hold the number two position in the single-injection segment.
  • Total operating expenses for the second quarter of 2016 were $13.1 million, compared to $10.5 million for the second quarter of 2015.
  • Net income for the second quarter of 2016 increased $0.8 million to $8.6 million, or $0.57 per diluted share, compared to $7.8 million, or $0.51 per diluted share, for the second quarter of 2015.

Recent Business Highlights

The Company made key commercial, operational, pipeline, and financial advancements, including:

  • Commercially launching CINGAL, the Company's third generation viscosupplement, in Europe and Canada to treat pain associated with osteoarthritis.
  • Advancing its product pipeline with continued progress on the FastTRACK Phase III HYALOFAST Study, as well as the Phase III MONOVISC study for the treatment of osteoarthritis pain in the hip.
  • Submitting and obtaining approval of an investigational device exemption to conduct a Phase III clinical trial for the treatment of pain associated with lateral epicondylosis, or tennis elbow. The study plans to enroll 185 patients across approximately 20 investigational sites in the U.S. and Europe beginning in the fourth quarter of 2016.
  • Continuing to execute the Company's $25 million accelerated share repurchase program, with completion expected in August 2016.
  • Progressing with the full integration of the Company's global manufacturing operations under one roof in Anika's Bedford, Mass. global headquarters.

 

Conference Call Information

Anika's management will hold a conference call and webcast to discuss its financial results and business highlights tomorrow, Thursday, July 28th at 9:00 am ET. The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or 1-484-756-4332 (international). A live audio webcast will be available in the "Investor Relations" section of Anika's website, www.anikatherapeutics.com. An accompanying slide presentation may also be accessed via the Anika website. A replay of the webcast will be available on Anika's website approximately two hours after the completion of the event.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Mass. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions by providing clinically meaningful therapeutic pain management solutions along the continuum of care, from palliative care to regenerative medicine. The Company has over two decades of expertise developing, manufacturing and commercializing more than 20 products, in markets across the globe, based on its proprietary hyaluronic acid (HA) technology. Anika's orthopedic medicine portfolio is comprised of marketed (ORTHOVISC® and MONOVISC®) and pipeline (CINGAL® and HYALOFAST® in the U.S.) products to alleviate pain and restore joint function by replenishing depleted HA and aiding cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements

The statements made in the third and fourth bullet points in the section captioned "Recent Business Highlights" of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the Company's advancement of its pipeline, the Company's enrollment plans for its lateral epicondylosis clinical trial, and the expected timeline for completion of the Company's accelerated share repurchase program. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties, and other factors. 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, but not limited to, (i) the Company's ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company's ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company's research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company's clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company's ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company's ability to provide an adequate and timely supply of its products to its customers; and (x) the Company's ability to achieve its growth targets. Additional factors and risks are described in the Company's periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC's website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

 
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
                 
   

For the Three Months Ended June 30,

  

For the Six Months Ended June 30,
      2016     2015     2016     2015
Product revenue   $ 26,575   $ 22,898   $ 48,853   $ 38,413
Licensing, milestone and contract revenue     6     6     11     11
Total revenue     26,581     22,904     48,864     38,424
                 
Operating expenses:                
Cost of product revenue     6,065     5,275     11,490     9,588
Research & development     2,792     1,812     4,951     3,910
Selling, general & administrative     4,255     3,388     8,245     6,993
Total operating expenses     13,112     10,475     24,686     20,491
Income from operations     13,469     12,429     24,178     17,933
Interest income, net     49     24     121     48
Income before income taxes     13,518     12,453     24,299     17,981
Provision for income taxes     4,903     4,634     8,789     6,646
Net income   $ 8,615   $ 7,819   $ 15,510   $ 11,335
                 
Basic net income per share:                
Net income   $ 0.59   $ 0.52   $ 1.05   $ 0.76
Basic weighted average common shares outstanding     14,679     14,961     14,778     14,934
Diluted net income per share:                
Net income   $ 0.57   $ 0.51   $ 1.02   $ 0.74
Diluted weighted average common shares outstanding     15,111     15,336     15,210     15,332
                 
 
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except share data and per share data)
(unaudited)
         
   

June 30,

  

December 31,
ASSETS     2016       2015  
Current assets:        
Cash and cash equivalents   $ 89,125     $ 110,707  
Investments     22,500       27,751  
Accounts receivable, net of reserves of $220 and $167 at June 30, 2016 and December 31, 2015, respectively     24,597       21,652  
Inventories     17,264       14,938  
Prepaid expenses and other current assets     1,158       1,385  
Total current assets     154,644       176,433  
Property and equipment, net     49,198       40,108  
Long-term deposits and other     69       69  
Intangible assets, net     11,259       11,656  
Goodwill     7,568       7,482  
Total Assets   $ 222,738     $ 235,748  
         
LIABILITIES AND STOCKHOLDERS' EQUITY        
Current liabilities:        
Accounts payable   $ 3,294     $ 8,302  
Accrued expenses and other current liabilities     6,638       4,778  
Income taxes payable     591       4,198  
Total current liabilities     10,523       17,278  
Other long-term liabilities     1,173       781  
Long-term deferred revenue     56       66  
Deferred tax liability     6,570       6,775  
Commitments and contingencies        
Stockholders' equity:        
Preferred stock, $.01 par value; 1,250,000 shares authorized, no shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively     -       -  
Common stock, $.01 par value; 60,000,000 and 30,000,000 shares authorized, 14,777,663 and 15,036,808 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively     148       150  
Additional paid-in-capital     59,506       81,685  
Accumulated other comprehensive loss     (6,410 )     (6,649 )
Retained earnings     151,172       135,662  
Total stockholders' equity     204,416       210,848  
Total Liabilities and Stockholders' Equity   $ 222,738     $ 235,748  
                 

 

 
Anika Therapeutics, Inc. and Subsidiaries
Supplemental Financial Data
 
 
Revenue by Product Line and Product Gross Margin
(in thousands, except percentages)
(unaudited)
 
   

For the Three Months Ended June 30,

  

For the Six Months Ended June 30,
      2016   %       2015   %       2016   %       2015   %  
Orthobiologics   $ 23,304   88 %   $ 19,283   84 %   $ 42,891   88 %   $ 31,255   81 %
Surgical     1,433   5 %     1,647   7 %     2,751   5 %     3,037   8 %
Dermal     582   2 %     303   1 %     963   2 %     719   2 %
Other     1,256   5 %     1,665   8 %     2,248   5 %     3,402   9 %
Product Revenue   $ 26,575   100 %   $ 22,898   100 %   $ 48,853   100 %   $ 38,413   100 %
                                 
Product Gross Profit   $ 20,510       $ 17,623       $ 37,363       $ 28,825    
Product Gross Margin     77%         77%         77%         75%    
                                 
                                 
Product Revenue by Geographic Region
(in thousands, except percentages)
(unaudited)
 
   

For the Three Months Ended June 30,

   For the Six Months Ended June 30,
      2016   %       2015   %       2016   %       2015   %  
Geographic Location:                                
United States   $ 21,895   82 %   $ 19,218   84 %   $ 39,906   82 %   $ 31,809   83 %
Europe     2,971   11 %     2,325   10 %     5,531   11 %     4,306   11 %
Other     1,709   7 %     1,355   6 %     3,416   7 %     2,298   6 %
Product Revenue   $ 26,575   100 %   $ 22,898   100 %   $ 48,853   100 %   $ 38,413   100 %

 

Anika Therapeutics, Inc.
Charles H. Sherwood, Ph.D., President and CEO
or
Sylvia Cheung, CFO
781-457-9000

Source: Anika Therapeutics, Inc.

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