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8-K - ANIKA THERAPEUTICS, INC. 8-K - Anika Therapeutics, Inc. | a51842915.htm |
Exhibit 99.1
Anika Reports Second Quarter 2018 Financial Results
Solid Top and Bottom Line Performance with 8% Product Revenue Growth and $0.68 Diluted EPS
New Leadership Added to Optimize Commercial Reach and Operating Efficiency
Multiple Initiatives Ongoing to Gain U.S. Regulatory Approval of CINGAL
BEDFORD, Mass.--(BUSINESS WIRE)--July 25, 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 second quarter ended June 30, 2018, along with business progress in the period.
“Anika’s strategic initiatives in the second quarter were focused on opportunities to accelerate revenue growth in 2019 and beyond,” said Joseph Darling, President and Chief Executive Officer of Anika Therapeutics. “We strengthened our senior leadership team, increased our focus on strategic M&A, and began executing on multiple strategies to gain U.S. regulatory approval of CINGAL. Bringing CINGAL to U.S. patients and physicians remains one of Anika’s top strategic priorities. We are committed to both maximizing our current business opportunities and pursuing new growth initiatives to create near- and long-term value for shareholders.”
Second Quarter Financial Results
- Product revenue increased 8% year-over-year in the second quarter of 2018, due primarily to higher MONOVISC revenue in the U.S. Global MONOVISC revenue increased 26% year-over-year in the second quarter of 2018.
- U.S. Viscosupplementation revenue increased $2.3 million year-over-year for the second quarter of 2018. International Viscosupplementation revenue decreased $0.7 million year-over-year for the second quarter of 2018, due primarily to the timing of orders. Domestically, ORTHOVISC and MONOVISC maintained the number one position in the combined multi- and single-injection segments in the second quarter of 2018.
- Total revenue for the second quarter of 2018 was $30.5 million, compared to $33.5 million for the second quarter of 2017. The year-over-year decline was due to the achievement of $5.0 million of milestone revenue in the second quarter of 2017, as a result of MONOVISC reaching $100 million in U.S. end-user sales within a consecutive 12-month period.
- Total operating expenses for the second quarter of 2018 were $19.3 million, compared to $15.7 million for the second quarter of 2017. The increase in total operating expenses was due primarily to product revenue growth, increased personnel costs, and expanded worldwide commercial initiatives.
- Net income for the second quarter of 2018 was $10.1 million, or $0.68 per diluted share, compared to $11.4 million, or $0.76 per diluted share, for the second quarter of 2017. The decline in net income was due primarily to the increase in operating expenses previously discussed.
Recent Business Highlights
- Announced that initial top-line results for the CINGAL 16-02 clinical trial, an active-comparator Phase III study conducted to support U.S. approval, did not reach statistical significance, although it did maintain the durability of strong pain relief throughout the 26 weeks, consistently demonstrating the long-term benefits of CINGAL. The magnitude of pain reduction demonstrated incremental improvement compared to the previous CINGAL Phase III study, and the duration of patient improvement after CINGAL injection was maintained near peak levels throughout the 26-week study. Anika has engaged external regulatory and legal experts to assist in the strategic approach for seeking CINGAL approval in the U.S. market. Anika remains fully committed to working closely with regulators to gain U.S. approval of CINGAL.
- Strengthened the senior leadership management team with the newly created position of Vice President of International Sales based in Europe to maximize sales impact and optimize the Company’s commercial reach in our foreign markets.
- Added a new Vice President of Operations to senior leadership team to focus on operation efficiency and margin improvements.
- Redirected internal efforts of Chief Technology and Strategy Officer with spear-heading the assessment of strategic M&A opportunities.
- Completed the Company’s $30 million accelerated share repurchase program in July, under which Anika repurchased approximately 800,000 shares of its outstanding common stock.
Full Year 2018 Revised Corporate Outlook
Based on currently
available information, the Company revised its guidance for the full
year of 2018. Anika currently does not expect licensing, milestone and
contract revenue of $5.0 million in 2018. The Company continues to
anticipate product revenue to be flat for the full year of 2018. 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 in
the low $90 million range for the full year of 2018, adjusted for the
reduction of CINGAL pre-launch marketing expenses.
Conference Call Information
Anika’s management will hold a
conference call and webcast to discuss its financial results and
business highlights tomorrow, Thursday, July 26 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 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
section captioned “Full Year 2018 Revised 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 2018 revenue and total
operating expense expectations and to the Company’s timeline to resume
shipping of products that were the subject of the previously-disclosed
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 June 30, |
For the Six Months Ended June 30, |
|||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||
Product revenue | $ | 30,542 | $ | 28,340 | $ | 51,800 | $ | 51,721 | ||||||
Licensing, milestone and contract revenue |
6 | 5,122 | 12 | 5,127 | ||||||||||
Total revenue | 30,548 | 33,462 | 51,812 | 56,848 | ||||||||||
Operating expenses: | ||||||||||||||
Cost of product revenue |
8,152 |
6,315 | 15,996 | 12,398 | ||||||||||
Research and development |
4,733 |
4,449 | 9,895 | 8,679 | ||||||||||
Selling, general and administrative | 6,417 | 4,972 | 22,507 | 10,039 | ||||||||||
Total operating expenses | 19,302 | 15,736 | 48,398 | 31,116 | ||||||||||
Income from operations | 11,246 | 17,726 | 3,414 | 25,732 | ||||||||||
Interest and other income, net | 290 | 16 | 385 | 74 | ||||||||||
Income before income taxes | 11,536 | 17,742 | 3,799 | 25,806 | ||||||||||
Provision for income taxes | 1,445 | 6,373 | 394 | 8,944 | ||||||||||
Net income | $ | 10,091 | $ | 11,369 | $ | 3,405 | $ | 16,862 | ||||||
Basic net income per share: | ||||||||||||||
Net income | $ | 0.69 | $ | 0.78 | $ | 0.23 | $ | 1.16 | ||||||
Basic weighted average common shares outstanding |
14,652 | 14,588 | 14,666 | 14,582 | ||||||||||
Diluted net income per share: | ||||||||||||||
Net income | $ | 0.68 | $ | 0.76 | $ | 0.23 | $ | 1.12 | ||||||
Diluted weighted average common shares outstanding | 14,915 | 15,044 | 15,045 | 15,046 | ||||||||||
Anika Therapeutics, Inc. and Subsidiaries | ||||||||||||||
Consolidated Balance Sheets | ||||||||||||||
(in thousands, except per share data) | ||||||||||||||
(unaudited) | ||||||||||||||
June 30, | December 31, | |||||||||||||
ASSETS | 2018 | 2017 | ||||||||||||
Current assets: | ||||||||||||||
Cash and cash equivalents | $ | 126,047 | $ | 133,256 | ||||||||||
Investments | 13,250 | 24,000 | ||||||||||||
Accounts receivable |
23,389 |
23,825 | ||||||||||||
Inventories, net | 24,060 | 22,035 | ||||||||||||
Prepaid expenses and other current assets |
4,245 | 3,211 | ||||||||||||
Total current assets |
190,991 |
206,327 | ||||||||||||
Property and equipment, net | 55,377 | 56,183 | ||||||||||||
Other long-term assets | 1,157 | 1,254 | ||||||||||||
Intangible assets, net | 9,876 | 10,635 | ||||||||||||
Goodwill | 8,013 | 8,218 | ||||||||||||
Total assets | $ |
265,414 |
$ | 282,617 | ||||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||||||
Current liabilities: | ||||||||||||||
Accounts payable | $ |
5,074 |
$ | 6,747 | ||||||||||
Accrued expenses and other current liabilities |
7,459 |
6,326 | ||||||||||||
Total current liabilities |
12,533 |
13,073 | ||||||||||||
Other long-term liabilities | 882 | 660 | ||||||||||||
Deferred tax liability | 5,396 | 5,393 | ||||||||||||
Commitments and contingencies | ||||||||||||||
Stockholders’ equity: | ||||||||||||||
Preferred stock, $0.01 par value; 1,250 shares authorized, no shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively |
- | - | ||||||||||||
Common stock, $0.01 par value; 90,000 shares authorized, 14,584 and 14,688 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively | 146 | 147 | ||||||||||||
Additional paid-in-capital | 48,656 | 68,617 | ||||||||||||
Accumulated other comprehensive loss | (5,115 | ) | (4,784 | ) | ||||||||||
Retained earnings | 202,916 | 199,511 | ||||||||||||
Total stockholders’ equity | 246,603 | 263,491 | ||||||||||||
Total liabilities and stockholders’ equity | $ |
265,414 |
$ | 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 June 30, | For the Six Months Ended June 30, | ||||||||||||||||||||
Product Line: | 2018 | % | 2017 | % | 2018 | % | 2017 | % | |||||||||||||
Orthobiologics | $ | 26,192 | 86% | $ | 24,468 | 86% | $ | 45,681 | 88% | $ | 44,695 | 86% | |||||||||
Surgical | 1,263 | 4% | 1,335 | 5% | 2,509 | 5% | 2,631 | 5% | |||||||||||||
Dermal | 623 | 2% | 453 | 2% | 83 | 0% | 878 | 2% | |||||||||||||
Other |
2,464 | 8% | 2,084 | 7% | 3,527 | 7% | 3,517 | 7% | |||||||||||||
Product Revenue | $ | 30,542 | 100% | $ | 28,340 | 100% | $ | 51,800 | 100% | $ | 51,721 | 100% | |||||||||
Product Gross Profit | $ |
22,390 |
$ | 22,025 | $ |
35,803 |
$ | 39,323 | |||||||||||||
Product Gross Margin | 73% | 78% | 69% | 76% | |||||||||||||||||
Product Revenue by Geographic Region | |||||||||||||||||||||
(in thousands, except percentages) | |||||||||||||||||||||
(unaudited) | |||||||||||||||||||||
For the Three Months Ended June 30, |
For the Six Months Ended June 30, | ||||||||||||||||||||
2018 | % | 2017 | % | 2018 | % | 2017 | % | ||||||||||||||
Geographic Region: | |||||||||||||||||||||
United States | $ | 24,773 | 81% | $ | 22,331 | 79% | $ | 41,682 | 81% | $ | 41,261 | 80% | |||||||||
Europe | 3,498 | 11% | 4,060 | 14% | 5,889 | 11% | 6,889 | 13% | |||||||||||||
Other | 2,271 | 8% | 1,949 | 7% | 4,229 | 8% | 3,571 | 7% | |||||||||||||
Product Revenue | $ | 30,542 | 100% | $ | 28,340 | 100% | $ | 51,800 | 100% | $ | 51,721 | 100% |
CONTACT:
Anika Therapeutics, Inc.
Joseph Darling, President & CEO
Sylvia
Cheung, CFO
Tel: 781-457-9000