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): February 15, 2017
Anika Therapeutics, Inc. |
(Exact name of registrant as specified in its charter) |
Massachusetts |
000-21326 |
04-3145961 |
(State or other jurisdiction of |
(Commission file number) |
(I.R.S. Employer |
32 Wiggins Avenue, Bedford, MA 01730 |
(Address of principal executive offices) (Zip code) |
Registrant's telephone number, including area code: (781) 457-9000
(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 obligations 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))
Section 2--Financial Information
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 February 15, 2017, Anika Therapeutics, Inc. issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2016. The full text of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.
Section 9--Financial Statements and Exhibits
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
99.1 | Press Release of Anika Therapeutics, Inc. dated February 15, 2017. |
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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. |
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|
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February 15, 2017 |
By: |
/s/ Sylvia Cheung |
|
Sylvia Cheung |
|
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Chief Financial Officer |
Exhibit Index
99.1 |
Press Release of Anika Therapeutics, Inc. dated February 15, 2017. |
Exhibit 99.1
Anika Reports Fourth Quarter and Full Year 2016 Financial Results
Worldwide Orthobiologics Revenue Increases 13% Year-over-Year for Fourth Quarter of 2016
Product Revenue Grows 17% for Full Year of 2016
BEDFORD, Mass.--(BUSINESS WIRE)--February 15, 2017--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 fourth quarter and full year ended December 31, 2016, along with business progress in the periods.
“Anika delivered another year of very strong growth, with 17% product revenue growth for the full year of 2016,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. “We also submitted an IND application to the FDA to initiate an additional Phase III clinical trial of CINGAL, and we received CE Mark approval for ORTHOVISC-T in the fourth quarter, paving the way for our next generation of growth drivers. We expect to commence the CINGAL Phase III trial and launch ORTHOVISC-T in Europe in the first half of 2017. Our strategic objectives in 2017 are focused on global commercial expansion, pipeline advancement, infrastructure enhancements and strategic M&A to drive sustained growth and create value for patients and shareholders.”
Fourth Quarter and Full Year Financial Results
Recent Business Highlights
The Company made key commercial,
operational, pipeline, and financial advancements, including:
Full Year 2017 Corporate Outlook
Looking forward to 2017, the
Company expects total revenue growth to be in the mid-teen percentage
range for the full year of 2017. Licensing, milestone and contract
revenue is expected to be $5 million for the year. The Company also
anticipates continued headway on several key initiatives including:
Conference Call Information
Anika’s management will hold a
conference call and webcast to discuss its financial results and
business highlights tomorrow, Thursday, February 16th 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, 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 cartilage 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 third
and fourth sentences of the second paragraph, as well as all of the
information in the section captioned “Full Year 2017 Corporate Outlook”
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 expectations regarding 2017
revenue growth, 2017 contractual milestone revenue, total 2017 operating
expenses, product launches and territorial expansion for existing
products, commencement of the CINGAL clinical trial, strategic
objectives, including the Company’s focus on strategic M&A, progression
of the HYALOFAST FastTRACK clinical trial enrollment, consolidation of
manufacturing operations, and progress in the development of its direct
commercialization capability. 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 December 31, |
For the Year Ended December 31, | |||||||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||||||
Product revenue | $ | 28,296 | $ | 25,607 | $ | 102,932 | $ | 87,696 | ||||||||||||
Licensing, milestone and contract revenue | 430 | 5,287 | 447 | 5,303 | ||||||||||||||||
Total revenue |
28,726 | 30,894 | 103,379 | 92,999 | ||||||||||||||||
Operating expenses: | ||||||||||||||||||||
Cost of product revenue | 7,539 | 6,290 | 24,027 | 21,053 | ||||||||||||||||
Research & development | 2,959 | 3,016 | 10,732 | 8,987 | ||||||||||||||||
Selling, general & administrative | 5,488 | 4,524 | 18,013 | 14,825 | ||||||||||||||||
Total operating expenses | 15,986 | 13,830 | 52,772 | 44,865 | ||||||||||||||||
Income from operations | 12,740 | 17,064 | 50,607 | 48,134 | ||||||||||||||||
Interest income, net | 49 | 39 | 263 | 120 | ||||||||||||||||
Income before income taxes | 12,789 | 17,103 | 50,870 | 48,254 | ||||||||||||||||
Provision for income taxes | 4,704 | 6,061 | 18,323 | 17,496 | ||||||||||||||||
Net income | $ | 8,085 | $ | 11,042 | $ | 32,547 | $ | 30,758 | ||||||||||||
Basic net income per share: | ||||||||||||||||||||
Net income | $ | 0.56 | $ | 0.74 | $ | 2.22 | $ | 2.06 | ||||||||||||
Basic weighted average common shares outstanding | 14,538 | 14,965 | 14,682 | 14,934 | ||||||||||||||||
Diluted net income per share: | ||||||||||||||||||||
Net income | $ | 0.54 | $ | 0.72 | $ | 2.15 | $ | 2.01 | ||||||||||||
Diluted weighted average common shares outstanding | 14,979 | 15,353 | 15,116 | 15,321 | ||||||||||||||||
Anika Therapeutics, Inc. and Subsidiaries | ||||||||||||
Condensed Consolidated Balance Sheets | ||||||||||||
(in thousands, except per share data) |
||||||||||||
(unaudited) | ||||||||||||
December 31, | December 31, | |||||||||||
ASSETS | 2016 | 2015 | ||||||||||
Current assets: | ||||||||||||
Cash and cash equivalents | $ | 104,261 | $ | 110,707 | ||||||||
Investments | 20,500 | 27,751 | ||||||||||
Accounts receivable, net of reserves of $194 and $167 at December 31, 2016 and December 31, 2015, respectively | 27,598 | 21,652 | ||||||||||
Inventories | 15,983 | 14,938 | ||||||||||
Prepaid expenses and other current assets | 2,098 | 1,385 | ||||||||||
Total current assets | 170,440 | 176,433 | ||||||||||
Property and equipment, at cost |
79,079 |
64,648 | ||||||||||
Less: accumulated depreciation |
(26,783 |
) | (24,540 | ) | ||||||||
Property and equipment, net | 52,296 | 40,108 | ||||||||||
Long-term deposits and other | 69 | 69 | ||||||||||
Intangible assets, net | 10,227 | 11,656 | ||||||||||
Goodwill | 7,214 | 7,482 | ||||||||||
Total Assets | $ | 240,246 | $ | 235,748 | ||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||||
Current liabilities: | ||||||||||||
Accounts payable | $ | 2,303 | $ | 8,302 | ||||||||
Accrued expenses and other current liabilities | 6,496 | 4,778 | ||||||||||
Current portion of long-term debt | ||||||||||||
Income taxes payable | - | 4,198 | ||||||||||
Total current liabilities | 8,799 | 17,278 | ||||||||||
Other long-term liabilities | 2,078 | 781 | ||||||||||
Long-term deferred revenue | 48 | 66 | ||||||||||
Deferred tax liability | 6,548 | 6,775 | ||||||||||
Commitments and contingencies | ||||||||||||
Stockholders’ equity: | ||||||||||||
Preferred stock, $.01 par value; 1,250 shares authorized, no shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively | - | - | ||||||||||
Common stock, $.01 par value; 60,000 and 30,000 shares authorized, 14,627 and 15,037 shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively | 146 | 150 | ||||||||||
Additional paid-in-capital | 61,735 | 81,685 | ||||||||||
Accumulated other comprehensive loss | (7,317 | ) | (6,649 | ) | ||||||||
Retained earnings | 168,209 | 135,662 | ||||||||||
Total stockholders’ equity | 222,773 | 210,848 | ||||||||||
Total Liabilities and Stockholders’ Equity | $ | 240,246 | $ | 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 December 31, | For the Year Ended December 31, | |||||||||||||||||||||||||||||||||||
2016 | % | 2015 | % | 2016 | % | 2015 | % | |||||||||||||||||||||||||||||
Orthobiologics | $ | 24,376 | 86 | % | $ | 21,530 | 84 | % | $ | 89,695 | 87 | % | $ | 73,247 | 84 | % | ||||||||||||||||||||
Surgical | 1,590 | 6 | % | 1,363 | 5 | % | 5,427 | 5 | % | 5,812 |
7 |
% | ||||||||||||||||||||||||
Dermal | 1,114 | 4 | % | 1,134 | 5 | % | 2,759 | 3 | % | 2,266 |
2 |
% | ||||||||||||||||||||||||
Other | 1,216 | 4 | % | 1,580 | 6 | % | 5,051 | 5 | % | 6,371 | 7 | % | ||||||||||||||||||||||||
Product Revenue | $ | 28,296 | 100 | % | $ | 25,607 | 100 | % | $ | 102,932 | 100 | % | $ | 87,696 | 100 | % | ||||||||||||||||||||
Product Gross Profit | $ | 20,757 | $ | 19,317 | $ | 78,905 | $ | 66,643 | ||||||||||||||||||||||||||||
Product Gross Margin | 73 |
% |
|
75 |
% |
|
77 |
% |
|
76 |
% |
|
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Product Revenue by Geographic Region | ||||||||||||||||||||||||||||||||||||
(in thousands, except percentages) | ||||||||||||||||||||||||||||||||||||
(unaudited) | ||||||||||||||||||||||||||||||||||||
For the Three Months Ended December 31, | For the Year Ended December 31, | |||||||||||||||||||||||||||||||||||
2016 | % | 2015 | % | 2016 | % | 2015 | % | |||||||||||||||||||||||||||||
Geographic Region: |
||||||||||||||||||||||||||||||||||||
United States | $ | 22,940 | 81 | % | $ | 20,574 | 80 | % | $ | 83,972 | 82 | % | $ | 71,621 | 82 | % | ||||||||||||||||||||
Europe | 2,696 | 10 | % | 2,462 | 10 | % | 10,953 | 10 | % | 8,756 | 10 | % | ||||||||||||||||||||||||
Other | 2,660 | 9 | % | 2,571 | 10 | % | 8,007 | 8 | % | 7,319 | 8 | % | ||||||||||||||||||||||||
Product Revenue | $ | 28,296 | 100 | % | $ | 25,607 | 100 | % | $ | 102,932 | 100 | % | $ | 87,696 | 100 | % | ||||||||||||||||||||
CONTACT:
Anika Therapeutics, Inc.
Charles H. Sherwood, Ph.D.,
781-457-9000
President and CEO
or
Sylvia Cheung, 781-457-9000
CFO