UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): October 24, 2018

Anika Therapeutics, Inc.
(Exact name of registrant as specified in its charter)


 

Delaware

000-21326

04-3145961

(State or other jurisdiction of
incorporation or organization)

Commission file number

(I.R.S. Employer
Identification No.)

32 Wiggins Avenue, Bedford, MA 01730

(Address of principal executive offices) (Zip code)


(781)-457-9000
Registrant’s telephone number, including area code:   

Not Applicable
(Former name or former address, if changed since last report)


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company   

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.   

 

Item 2.02.  Results of Operations and Financial Condition.

The following information, including the exhibit attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

On October 24, 2018, Anika Therapeutics, Inc. issued a press release announcing its financial results for the third quarter and nine months ended September 30, 2018. The full text of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

Item 9.01.  Financial Statements and Exhibits.

(d)  Exhibits.

99.1           Press Release of Anika Therapeutics, Inc. dated October 24, 2018.

[Remainder of page left blank intentionally]


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be filed on its behalf by the undersigned hereunto duly authorized.

Anika Therapeutics, Inc.

 

Dated: October 24, 2018

By:

/s/ Sylvia Cheung

 

Sylvia Cheung

 

Chief Financial Officer


Exhibit Index

99.1

Press Release of Anika Therapeutics, Inc. dated October 24, 2018.

Exhibit 99.1

Anika Reports Third Quarter 2018 Financial Results

CINGAL Drives Strong International Viscosupplement Revenue Growth

Achieves Solid Bottom Line Performance with $0.53 Diluted EPS

BEDFORD, Mass.--(BUSINESS WIRE)--October 24, 2018--Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today reported financial results for the third quarter ended September 30, 2018, and provided an update on its business progress in the period.

“Anika delivered solid financial results in the third quarter, while continuing to take important steps to accelerate revenue growth in 2019 and beyond,” said Joseph Darling, President and Chief Executive Officer of Anika Therapeutics. “We are encouraged by the continued advances we are making across our deep pipeline and diverse commercial portfolio. During the quarter, CINGAL end user demand in Canada and Europe remained strong, and we were pleased to add four new distribution partners to further expand our commercial reach in Europe, Asia and South America. Focused international expansion efforts enabled us to realize a 31% year-over-year increase in international Viscosupplement revenue while we continued to generate strong earnings and cash flow. As we prepare to discuss the pathway for U.S. regulatory approval for CINGAL with the U.S. Food and Drug Administration in the first quarter of 2019, we believe Anika is well-positioned to transform into a global commercial company increasingly capable of generating significant value for our patients and shareholders.”

Third Quarter Financial Results


Recent Business Highlights

Full Year 2018 Revised Corporate Outlook
Based on currently available information, the Company anticipates full year product revenue to be approximately 3% below prior year. The Company continues to expect that it will resume the shipment of products that were the subject of the previously-disclosed voluntary recall by the end of this year. Total operating expenses are now expected to be reduced to the high $80 million range for the full year of 2018 as a result of successful cost control initiatives.

Conference Call Information
Anika’s management will hold a conference call and webcast to discuss its financial results and business highlights today, Wednesday, October 24 at 5:00 pm 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 and regenerative medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative tissue repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika's orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.


Forward-Looking Statements
The statements made in the last sentence of the second paragraph of this press release and in the Section captioned “Full Year 2018 Corporate Outlook,” 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 expected meeting with the U.S. Food and Drug Administration during the first quarter of 2019, the Company’s full-year 2018 product revenue and operating expense projections, and the Company’s expectations related to shipment of products previously subject to the voluntary recall. 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
Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
 
For the Three Months Ended September 30, For the Nine Months Ended September 30,
2018 2017 2018 2017
Product revenue $ 26,781 $ 27,178 $ 78,581 $ 78,899
Licensing, milestone and contract revenue   6   6   18   5,133
Total revenue 26,787 27,184 78,599 84,032
 
Operating expenses:
Cost of product revenue 8,282 6,250 24,279 18,648
Research and development 4,232 5,842 14,126 14,521
Selling, general and administrative   5,700   4,823   28,207   14,862
Total operating expenses   18,214   16,915   66,612   48,031
Income from operations 8,573 10,269 11,987 36,001
Interest and other income, net   522   261   907   335
Income before income taxes 9,095 10,530 12,894 36,336
Provision for income taxes   1,496   3,643   1,890   12,587
Net income $ 7,599 $ 6,887 $ 11,004 $ 23,749
 
Basic net income per share:
Net income $ 0.53 $ 0.47 $ 0.76 $ 1.63
Basic weighted average common shares outstanding 14,237 14,579 14,524 14,572
Diluted net income per share:
Net income $ 0.53 $ 0.46 $ 0.74 $ 1.58
Diluted weighted average common shares outstanding 14,377 15,115 14,820 15,065
 
 
Anika Therapeutics, Inc. and Subsidiaries
Consolidated Balance Sheets
(in thousands, except per share data)
(unaudited)
       
ASSETS September 30,
2018
December 31,
2017
Current assets:
Cash, cash equivalents and investments $ 149,011 $ 157,256
Accounts receivable, net 20,771 23,825
Inventories, net 23,828 22,035
Prepaid expenses and other current assets   1,981     3,211  
Total current assets 195,591 206,327
Property and equipment, net 55,041 56,183

Other long-term assets

1,109 1,254
Intangible assets, net 9,564 10,635
Goodwill   7,959     8,218  
Total assets $ 269,264   $ 282,617  
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 2,462 $ 6,747
Accrued expenses and other current liabilities   6,843     6,326  
Total current liabilities   9,305     13,073  
Other long-term liabilities 574 660
Deferred tax liability 4,120 5,393
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.01 par value - -
Common stock, $0.01 par value 142 147
Additional paid-in-capital 49,836 68,617
Accumulated other comprehensive loss (5,228 ) (4,784 )
Retained earnings   210,515     199,511  
Total stockholders’ equity   255,265     263,491  
Total liabilities and stockholders’ equity $ 269,264   $ 282,617  
 

 
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 September 30, For the Nine Months Ended September 30,
Product Line: 2018     % 2017     % 2018     % 2017     %
Orthobiologics $ 24,097 90 % $ 23,990 88 % $ 69,778 88 % $ 68,686 87 %
Surgical 1,191 4 % 1,765 7 % 3,700 5 % 4,395 6 %
Dermal 80 1 % 358 1 % 163 1 % 1,235 2 %
Other   1,413     5 %   1,065     4 %   4,940     6 %   4,583     5 %
Product Revenue $ 26,781     100 % $ 27,178     100 % $ 78,581     100 % $ 78,899     100 %
 
Product Gross Profit $ 18,499 $ 20,928 $ 54,302 $ 60,251
Product Gross Margin 69% 77% 69% 76%
 

Product Revenue by Geographic Region
(in thousands, except percentages)
(unaudited)

 
For the Three Months Ended September 30, For the Nine Months Ended September 30,
2018     % 2017     % 2018     % 2017     %
Geographic Region:
United States $ 21,695 81 % $ 22,227 82 % $ 63,377 81 % $ 63,507 81 %
Europe 3,132 12 % 2,832 10 % 9,021 11 % 9,743 12 %
Other   1,954       7 %   2,119   8 %   6,183   8 %   5,649   7 %
Product Revenue $ 26,781       100 % $ 27,178       100 % $ 78,581       100 % $ 78,899       100 %
 

CONTACT:
Anika Therapeutics, Inc.
Joseph Darling, 781-457-9000
President & CEO
or
Sylvia Cheung, 781-457-9000
CFO