BEDFORD, Mass.--(BUSINESS WIRE)--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 third quarter ended September 30, 2016, along with business progress in the period.
“We continued to deliver solid financial results in the third quarter, while expanding globally and advancing our deep and differentiated pipeline to drive sustained growth,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. “Last quarter, we had a productive meeting with the FDA regarding the CINGAL regulatory submission and continue to gain alignment on additional clinical and non-clinical work required to bring this important treatment to the U.S. Our confidence in the future success of CINGAL in the U.S. has been reaffirmed by how well CINGAL has been received by physicians in Canada and Europe, where we recently launched. We are well-positioned to achieve our operational and financial objectives for 2016 and to create significant near- and long-term value for patients and shareholders.”
Third Quarter Financial Results
- Total revenue for the third quarter of 2016 increased 9% to $25.8 million, compared to $23.7 million for the third quarter of 2015.
- Worldwide Orthobiologics revenue grew 10% year-over-year in the third quarter of 2016. MONOVISC revenue increased 33% year-over-year in the third quarter of 2016, and it was the Company’s main revenue growth driver during the period.
- International Orthobiologics revenue grew 27% year-over-year in the first nine months of 2016 as a result of the Company’s global commercial expansion efforts. Domestically, we believe ORTHOVISC maintained its position as the leading multiple-injection product while MONOVISC continued to hold the number two position in the single-injection segment.
- Total operating expenses for the third quarter of 2016 were $12.1 million, compared to $10.5 million for the third quarter of 2015, commensurate with the Company’s growth in revenue, increased commercial efforts, and active pipeline.
- Net income for the third quarter of 2016 increased $0.6 million to $9.0 million, or $0.59 per diluted share, compared to $8.4 million, or $0.55 per diluted share, for the third quarter of 2015.
Recent Business Highlights
The Company made key commercial,
operational, pipeline, and financial advancements, including:
- Meeting with the U.S. Food and Drug Administration (FDA) in late September about the New Drug Application (NDA) for CINGAL, during which the Company and FDA aligned on one additional Phase III clinical trial to supplement the strong stable of existing pivotal data.
- Advancing its product pipeline with continued progress on enrolling patients in the FastTRACK Phase III HYALOFAST Study for cartilage repair, as well as the Phase III MONOVISC study for the treatment of osteoarthritis pain in the hip.
- Showcasing data from four recent studies evaluating the clinical utility of our HA-based bioscaffold, HYALOFAST, at the 13th World Congress of the International Cartilage Repair Society (ICRS).
- Completing the Company’s $25 million accelerated share repurchase program, with a total of 531,067 shares repurchased by Anika.
- Progressing with the consolidation of the Company’s global manufacturing operations at Anika’s Bedford, Mass. global headquarters.
Conference Call Information
Anika’s management will hold a
conference call and webcast to discuss its financial results and
business highlights tomorrow, Thursday, October 27th 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
last sentence of the second paragraph 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 future growth and creation of value, and the Company’s ability
and positioning to meet its 2016 financial and operational goals. 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 (SEC), 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 September 30, | For the Nine Months Ended September 30, | |||||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||||
| Product revenue | $ | 25,783 | $ | 23,676 | $ | 74,636 | $ | 62,089 | ||||||||||
| Licensing, milestone and contract revenue | 6 | 5 | 17 | 16 | ||||||||||||||
| Total revenue | 25,789 | 23,681 | 74,653 | 62,105 | ||||||||||||||
| Operating expenses: | ||||||||||||||||||
| Cost of product revenue | 4,998 | 5,176 | 16,488 | 14,764 | ||||||||||||||
| Research & development | 2,822 | 2,061 | 7,773 | 5,971 | ||||||||||||||
| Selling, general & administrative | 4,280 | 3,309 | 12,525 | 10,302 | ||||||||||||||
| Total operating expenses | 12,100 | 10,546 | 36,786 | 31,037 | ||||||||||||||
| Income from operations | 13,689 | 13,135 | 37,867 | 31,068 | ||||||||||||||
| Interest income, net | 93 | 34 | 214 | 82 | ||||||||||||||
| Income before income taxes | 13,782 | 13,169 | 38,081 | 31,150 | ||||||||||||||
| Provision for income taxes | 4,830 | 4,789 | 13,619 | 11,435 | ||||||||||||||
| Net income | $ | 8,952 | $ | 8,380 | $ | 24,462 | $ | 19,715 | ||||||||||
| Basic net income per share: | ||||||||||||||||||
| Net income | $ | 0.61 | $ | 0.56 | $ | 1.66 | $ | 1.32 | ||||||||||
| Basic weighted average common shares outstanding | 14,625 | 14,967 | 14,726 | 14,945 | ||||||||||||||
| Diluted net income per share: | ||||||||||||||||||
| Net income | $ | 0.59 | $ | 0.55 | $ | 1.61 | $ | 1.29 | ||||||||||
| Diluted weighted average common shares outstanding | 15,077 | 15,316 | 15,163 | 15,311 | ||||||||||||||
| Anika Therapeutics, Inc. and Subsidiaries | ||||||||||
| Condensed Consolidated Balance Sheets | ||||||||||
| (in thousands, except share data and per share data) | ||||||||||
| (unaudited) | ||||||||||
| September 30, | December 31, | |||||||||
| ASSETS | 2016 | 2015 | ||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | $ | 98,047 | $ | 110,707 | ||||||
| Investments | 22,250 | 27,751 | ||||||||
| Accounts receivable, net of reserves of $224 and $167 at September 30, 2016 and December 31, 2015, respectively | 21,833 | 21,652 | ||||||||
| Inventories | 18,020 | 14,938 | ||||||||
| Prepaid expenses and other current assets | 924 | 1,385 | ||||||||
| Total current assets | 161,074 | 176,433 | ||||||||
| Property and equipment, net | 51,058 | 40,108 | ||||||||
| Long-term deposits and other | 69 | 69 | ||||||||
| Intangible assets, net | 11,171 | 11,656 | ||||||||
| Goodwill | 7,690 | 7,482 | ||||||||
| Total Assets | $ | 231,062 | $ | 235,748 | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable | $ | 1,949 | $ | 8,302 | ||||||
| Accrued expenses and other current liabilities | 5,423 | 4,778 | ||||||||
| Income taxes payable | 217 | 4,198 | ||||||||
| Total current liabilities | 7,589 | 17,278 | ||||||||
| Other long-term liabilities | 2,556 | 781 | ||||||||
| Long-term deferred revenue | 59 | 66 | ||||||||
| Deferred tax liability | 6,315 | 6,775 | ||||||||
| Commitments and contingencies | ||||||||||
| Stockholders’ equity: | ||||||||||
| Preferred stock, $.01 par value; 1,250,000 shares authorized, no shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively | - | - | ||||||||
| Common stock, $.01 par value; 60,000,000 and 30,000,000 shares authorized, 14,623,225 and 15,036,808 shares issued and outstanding at September30, 2016 and December 31, 2015, respectively | 146 | 150 | ||||||||
| Additional paid-in-capital | 60,374 | 81,685 | ||||||||
| Accumulated other comprehensive loss | (6,101 | ) | (6,649 | ) | ||||||
| Retained earnings | 160,124 | 135,662 | ||||||||
| Total stockholders’ equity | 214,543 | 210,848 | ||||||||
| Total Liabilities and Stockholders’ Equity | $ | 231,062 | $ | 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 September 30, | For the Nine Months Ended September 30, | ||||||||||||||||||||||||||||||
| 2016 | % | 2015 | % | 2016 | % | 2015 | % | ||||||||||||||||||||||||
| Orthobiologics | $ | 22,428 | 87 | % | $ | 20,461 | 86 | % | $ | 65,319 | 88 | % | $ | 51,717 | 83 | % | |||||||||||||||
| Surgical | 1,173 | 5 | % | 1,413 | 6 | % | 3,924 | 5 | % | 4,450 | 7 | % | |||||||||||||||||||
| Dermal | 594 | 2 | % | 412 | 2 | % | 1,558 | 2 | % | 1,132 | 2 | % | |||||||||||||||||||
| Other | 1,588 | 6 | % | 1,390 | 6 | % | 3,835 | 5 | % | 4,790 | 8 | % | |||||||||||||||||||
| Product Revenue | $ | 25,783 | 100 | % | $ | 23,676 | 100 | % | $ | 74,636 | 100 | % | $ | 62,089 | 100 | % | |||||||||||||||
| Product Gross Profit | $ | 20,785 | $ | 18,500 | $ | 58,148 | $ | 47,325 | |||||||||||||||||||||||
| Product Gross Margin |
81% |
|
78% |
|
78% |
|
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, | |||||||||||||||||||||||||||||||
| 2016 | % | 2015 |
% |
2016 |
% |
2015 |
% |
|||||||||||||||||||||||||
| Geographic Location: | ||||||||||||||||||||||||||||||||
| United States | $ | 21,126 | 82 | % | $ | 19,239 | 82 | % | $ | 61,032 | 82 | % | $ | 51,048 | 82 | % | ||||||||||||||||
| Europe | 2,703 | 10 | % | 1,977 | 8 | % | 8,240 | 11 | % | 6,294 | 10 | % | ||||||||||||||||||||
| Other | 1,954 | 8 | % | 2,460 | 10 | % | 5,364 | 7 | % | 4,747 | 8 | % | ||||||||||||||||||||
| Product Revenue | $ | 25,783 | 100 | % | $ | 23,676 | 100 | % | $ | 74,636 | 100 | % | $ | 62,089 | 100 | % | ||||||||||||||||
