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 21, 2019
Anika
Therapeutics, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
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) |
(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 February 21, 2019, Anika Therapeutics, Inc. issued a press release announcing its financial results for the fourth quarter and twelve months ended December 31, 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 February 21, 2019.
[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: February 21, 2019 |
By: |
/s/ Sylvia Cheung |
|
|
Sylvia Cheung |
||
|
Chief Financial Officer |
Exhibit Index
Exhibit 99.1
Anika Reports Fourth Quarter and Full Year 2018 Financial Results
Strong Bottom Line Performance with $0.54 Diluted EPS for Fourth Quarter of 2018
MONOVISC and CINGAL Global Revenue Increased 14% for Full Year of 2018
BEDFORD, Mass.--(BUSINESS WIRE)--February 21, 2019--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 fourth quarter and full year ended December 31, 2018, and provided an update on its business progress in the periods.
“Anika continued to deliver strong earnings and cash flow in the fourth quarter, entering 2019 well-positioned to further build on the foundation that will drive the Company’s next phase of growth,” said Joseph Darling, President and Chief Executive Officer of Anika Therapeutics. “During the quarter, MONOVISC and CINGAL end user demand remained strong. We also successfully expanded the reach of our orthobiologics business in Europe, Asia, Africa and South America with the addition of eight new international distributors during the year. We were pleased to resume global production and distribution of HYALOFAST, HYALOGRAFT-C and HYALOMATRIX, and look forward to benefitting from our full complement of products in 2019. We believe 2019 will be a transformational year for Anika and we will continue to take advantage of the multiple levers available to advance our long-term goal of returning to annual double-digit revenue growth. We are focused on solid execution and increasing efficiency and productivity, as we address our challenges and continue to expand our commercial reach, advance our pipeline and drive value for our shareholders.”
Fourth Quarter and Full Year Financial Results
Recent Business Highlights
CINGAL FDA Update
Anika recently met with the U.S. Food and
Drug Administration (FDA) to discuss the totality of available CINGAL
data, including information from the 17-02 extension study and real
world evidence from physicians in Canada and Europe, to gain additional
guidance on the pathway for CINGAL approval in the U.S. Based on that
meeting, it has become clear that Anika will need to conduct another
Phase III clinical trial before it can obtain approval for CINGAL in the
U.S. The Company plans to continue to work with the FDA and pursue the
most expeditious path to FDA approval for CINGAL. The Company will
provide updates on its progress on this initiative at appropriate
intervals moving forward.
Full Year 2019 Corporate Outlook
For the full year of 2019,
the Company expects total revenue to be approximately 3% to 6% below the
prior year level due primarily to continued pricing pressures on its
U.S. viscosupplement business. Licensing, milestone and contract revenue
is expected to be flat for the year. Total operating expenses are
anticipated to be in the high $70 million to $80 million range. Adjusted
EBITDA is expected to be in the low $30 million range, which is based on
anticipated U.S. GAAP net income in the mid-teen to around $20 million
range. Capital expenditures are expected to be between $5 million and $8
million. In 2019, the Company plans to continue advancing key ongoing
initiatives, including:
Non-GAAP Outlook
The Company is stating its expectations
regarding, and will report, its 2019 financial results with respect to
Adjusted EBITDA, which is a non-GAAP financial measure and should not be
considered an alternative to net income or other measurements under
generally accepted accounting principles (GAAP). The Company believes
that Adjusted EBITDA provides additional useful information to investors
in their assessment of its operating performance as it is a metric used
by management to evaluate the Company's performance. Adjusted EBITDA is
not calculated identically by all companies, and therefore the Company’s
measurements of Adjusted EBITDA may not be comparable to similarly
titled measures reported by other companies.
Adjusted EBITDA is defined by the Company as GAAP net income excluding depreciation and amortization, interest and other income (expense), income taxes, and share-based compensation expense. The Company is not providing a quantitative reconciliation of projected Adjusted EBITDA to the corresponding GAAP information because the GAAP measures that the Company excludes from its projected Adjusted EBITDA are not available without unreasonable effort on a forward-looking basis due to their unpredictability, high variability, complexity, and low visibility. These excluded GAAP measures include interest and other income, income taxes, and other charges. Because these charges may vary materially, they will have an unpredictable, and potentially significant, impact on our future GAAP results.
Conference Call Information
Anika’s management will hold a
conference call and webcast to discuss its financial results and
business highlights today, Thursday, February 21 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 fifth
and sixth sentences of the second paragraph, the fourth bullet point in
the section captioned “Recent Business Highlights,” the third sentence
in the section captioned “CINGAL FDA Update,” and those made in the
section captioned “Full Year 2019 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 long-term strategies and
growth plans, the status and completion of the Company’s 5-year
strategic plan, the Company’s expectations with respect to its 2019
financial performance, the Company’s U.S. and international commercial
efforts, the Company’s plans related to, and the development and
finalization of a regulatory pathway for, CINGAL, and the Company’s
pursuit of strategic acquisitions and partnerships. 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) quarterly sales
volume variation experienced by the Company, which can make future
results difficult to predict and period-to-period comparisons
potentially less meaningful; (x) the Company’s ability to provide an
adequate and timely supply of its products to its customers; and (xi)
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 December 31, | For the Twelve Months Ended December 31, | |||||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||||
Product revenue | $ | 26,950 | $ | 28,884 | $ | 105,531 | $ | 107,783 | ||||||||||
Licensing, milestone and contract revenue | 6 | 504 | 24 | 5,637 | ||||||||||||||
Total revenue | 26,956 | 29,388 | 105,555 | 113,420 | ||||||||||||||
Operating expenses: | ||||||||||||||||||
Cost of product revenue | 7,001 | 8,716 | 31,280 |
27,364 |
||||||||||||||
Research & development | 4,064 | 4,266 | 18,190 |
18,787 |
||||||||||||||
Selling, general & administrative | 6,129 | 6,678 | 34,336 | 21,540 | ||||||||||||||
Total operating expenses | 17,194 | 19,660 | 83,806 | 67,691 | ||||||||||||||
Income from operations | 9,762 | 9,728 | 21,749 | 45,729 | ||||||||||||||
Interest and other income, net | 551 | 138 | 1,458 | 473 | ||||||||||||||
Income before income taxes | 10,313 | 9,866 | 23,207 | 46,202 | ||||||||||||||
Provision for income taxes | 2,596 | 1,799 | 4,485 | 14,386 | ||||||||||||||
Net income | $ | 7,717 | $ | 8,067 | $ | 18,722 | $ | 31,816 | ||||||||||
Basic net income per share: | ||||||||||||||||||
Net income | $ | 0.54 | $ | 0.55 | $ | 1.30 | $ | 2.18 | ||||||||||
Basic weighted average common shares outstanding | 14,168 | 14,596 | 14,442 | 14,575 | ||||||||||||||
Diluted net income per share: | ||||||||||||||||||
Net income | $ | 0.54 | $ | 0.53 | $ | 1.27 | $ | 2.11 | ||||||||||
Diluted weighted average common shares outstanding | 14,299 | 15,141 | 14,689 | 15,068 | ||||||||||||||
Anika Therapeutics, Inc. and Subsidiaries | ||||||||||||||||||
Consolidated Balance Sheets | ||||||||||||||||||
(in thousands, except per share data) | ||||||||||||||||||
(unaudited) | ||||||||||||||||||
December 31, | December 31, | |||||||||||||||||
ASSETS | 2018 | 2017 | ||||||||||||||||
Current assets: | ||||||||||||||||||
Cash, cash equivalents and investments | $ | 159,014 | $ | 157,256 | ||||||||||||||
Accounts receivable, net | 20,775 | 23,825 | ||||||||||||||||
Inventories, net | 21,300 | 22,035 | ||||||||||||||||
Prepaid expenses and other current assets | 1,854 | 3,211 | ||||||||||||||||
Total current assets | 202,943 | 206,327 | ||||||||||||||||
Property and equipment, net | 54,111 | 56,183 | ||||||||||||||||
Other long-term assets | 4,897 | 1,254 | ||||||||||||||||
Intangible assets, net | 9,191 | 10,635 | ||||||||||||||||
Goodwill | 7,851 | 8,218 | ||||||||||||||||
Total assets | $ | 278,993 | $ | 282,617 | ||||||||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||||||||||
Current liabilities: | ||||||||||||||||||
Accounts payable | $ | 3,143 | $ | 6,747 | ||||||||||||||
Accrued expenses and other current liabilities | 8,146 | 6,326 | ||||||||||||||||
Total current liabilities | 11,289 | 13,073 | ||||||||||||||||
Other long-term liabilities | 550 | 660 | ||||||||||||||||
Deferred tax liability | 3,542 | 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 | 50,763 | 68,617 | ||||||||||||||||
Accumulated other comprehensive loss | (5,526 | ) | (4,784 | ) | ||||||||||||||
Retained earnings | 218,233 | 199,511 | ||||||||||||||||
Total stockholders’ equity | 263,612 | 263,491 | ||||||||||||||||
Total liabilities and stockholders’ equity | $ | 278,993 | $ | 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 December 31, | For the Twelve Months Ended December 31, | |||||||||||||||||||||||||||||||
Product Line: | 2018 | % | 2017 | % | 2018 | % | 2017 | % | ||||||||||||||||||||||||
Orthobiologics | $ | 23,778 | 88 | % | $ | 25,131 | 87 | % | $ | 93,556 | 89 | % | $ | 93,816 | 87 | % | ||||||||||||||||
Surgical | 1,814 | 7 | % | 867 | 3 | % | 5,514 | 5 | % | 5,262 | 5 | % | ||||||||||||||||||||
Dermal | 233 | 1 | % | 1,519 | 5 | % | 396 | 0 | % | 2,755 | 3 | % | ||||||||||||||||||||
Other | 1,125 | 4 | % | 1,367 | 5 | % | 6,065 | 6 | % | 5,950 | 5 | % | ||||||||||||||||||||
Product Revenue | $ | 26,950 | 100 | % | $ | 28,884 | 100 | % | $ | 105,531 | 100 | % | $ | 107,783 | 100 | % | ||||||||||||||||
Product Gross Profit | $ | 19,949 | $ | 20,168 | $ | 74,251 | $ | 80,419 | ||||||||||||||||||||||||
Product Gross Margin |
74% |
70% | 70% | 75% | ||||||||||||||||||||||||||||
Product Revenue by Geographic Region | ||||||||||||||||||||||||||||||||
(in thousands, except percentages) | ||||||||||||||||||||||||||||||||
(unaudited) | ||||||||||||||||||||||||||||||||
For the Three Months Ended December 31, | For the Twelve Months Ended December 31, | |||||||||||||||||||||||||||||||
Geographic Region: | 2018 | % | 2017 | % | 2018 | % | 2017 | % | ||||||||||||||||||||||||
United States | $ | 21,974 | 82 | % | $ | 23,783 | 82 | % | $ | 85,351 | 81 | % | $ | 87,290 | 81 | % | ||||||||||||||||
Europe | 2,709 | 10 | % | 2,692 | 9 | % | 11,730 | 11 | % | 12,435 | 12 | % | ||||||||||||||||||||
Other | 2,267 | 8 | % | 2,409 | 9 | % | 8,450 | 8 | % | 8,058 | 7 | % | ||||||||||||||||||||
Product Revenue | $ | 26,950 | 100 | % | $ | 28,884 | 100 | % | $ | 105,531 | 100 | % | $ | 107,783 | 100 | % |
CONTACT:
Anika Therapeutics, Inc.
Joseph Darling, President & CEO
Sylvia
Cheung, CFO
Tel: 781-457-9000