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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) |
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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 |
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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 |
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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
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Anika Therapeutics, Inc. provided additional information to their SEC Filing as exhibits
Ticker: ANIKEvents:
CIK: 898437
Form Type: 8-K Corporate News
Accession Number: 0001157523-18-002129
Submitted to the SEC: Wed Oct 24 2018 4:06:07 PM EST
Accepted by the SEC: Wed Oct 24 2018
Period: Wednesday, October 24, 2018
Industry: Surgical And Medical Instruments And Apparatus