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 second quarter ended June 30, 2016, along with business progress in the period.
“We continued our strong momentum in the second quarter, with total revenue growth of 16% year- over-year for the quarter,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. “MONOVISC end user demand remained strong, we achieved important milestones in our global expansion with the launch of CINGAL in Canada and Europe, and we continued to advance our deep and differentiated pipeline. We are well-positioned to drive future growth and create significant near- and long-term value for patients and shareholders.”
Second Quarter Financial Results
- Total revenue for the second quarter of 2016 increased 16% to $26.6 million, compared to $22.9 million for the second quarter of 2015.
- Worldwide Orthobiologics revenue grew 21% year-over-year in the second quarter of 2016. ORTHOVISC and MONOVISC, our lead viscosupplementation products in the Orthobiologics franchise, continued to be the main revenue driver.
- International Orthobiologics revenue grew 36% year-over-year in the second quarter of 2016 as a result of our global commercial expansion efforts. Domestically, ORTHOVISC maintained its position as the leading multiple-injection product. MONOVISC continued to hold the number two position in the single-injection segment.
- Total operating expenses for the second quarter of 2016 were $13.1 million, compared to $10.5 million for the second quarter of 2015.
- Net income for the second quarter of 2016 increased $0.8 million to $8.6 million, or $0.57 per diluted share, compared to $7.8 million, or $0.51 per diluted share, for the second quarter of 2015.
Recent Business Highlights
The Company made key commercial, operational, pipeline, and financial advancements, including:
- Commercially launching CINGAL, the Company’s third generation viscosupplement, in Europe and Canada to treat pain associated with osteoarthritis.
- Advancing its product pipeline with continued progress on the FastTRACK Phase III HYALOFAST Study, as well as the Phase III MONOVISC study for the treatment of osteoarthritis pain in the hip.
- Submitting and obtaining approval of an investigational device exemption to conduct a Phase III clinical trial for the treatment of pain associated with lateral epicondylosis, or tennis elbow. The study plans to enroll 185 patients across approximately 20 investigational sites in the U.S. and Europe beginning in the fourth quarter of 2016.
- Continuing to execute the Company’s $25 million accelerated share repurchase program, with completion expected in August 2016.
- Progressing with the full integration of the Company’s global manufacturing operations under one roof in 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, July 28th 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, Mass. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions by providing clinically meaningful therapeutic pain management solutions along the continuum of care, from palliative care to regenerative medicine. The Company has over two decades of expertise developing, manufacturing and commercializing more than 20 products, in markets across the globe, based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio is comprised of marketed (ORTHOVISC® and MONOVISC®) and pipeline (CINGAL® and HYALOFAST® in the U.S.) products to alleviate pain and restore joint function by replenishing depleted HA and aiding 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 bullet points in the section captioned “Recent Business Highlights” 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 advancement of its pipeline, the Company’s enrollment plans for its lateral epicondylosis clinical trial, and the expected timeline for completion of the Company’s accelerated share repurchase program. 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 June 30, | For the Six Months Ended June 30, | |||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||
| Product revenue | $ | 26,575 | $ | 22,898 | $ | 48,853 | $ | 38,413 | ||||
| Licensing, milestone and contract revenue | 6 | 6 | 11 | 11 | ||||||||
| Total revenue | 26,581 | 22,904 | 48,864 | 38,424 | ||||||||
| Operating expenses: | ||||||||||||
| Cost of product revenue | 6,065 | 5,275 | 11,490 | 9,588 | ||||||||
| Research & development | 2,792 | 1,812 | 4,951 | 3,910 | ||||||||
| Selling, general & administrative | 4,255 | 3,388 | 8,245 | 6,993 | ||||||||
| Total operating expenses | 13,112 | 10,475 | 24,686 | 20,491 | ||||||||
| Income from operations | 13,469 | 12,429 | 24,178 | 17,933 | ||||||||
| Interest income, net | 49 | 24 | 121 | 48 | ||||||||
| Income before income taxes | 13,518 | 12,453 | 24,299 | 17,981 | ||||||||
| Provision for income taxes | 4,903 | 4,634 | 8,789 | 6,646 | ||||||||
| Net income | $ | 8,615 | $ | 7,819 | $ | 15,510 | $ | 11,335 | ||||
| Basic net income per share: | ||||||||||||
| Net income | $ | 0.59 | $ | 0.52 | $ | 1.05 | $ | 0.76 | ||||
| Basic weighted average common shares outstanding | 14,679 | 14,961 | 14,778 | 14,934 | ||||||||
| Diluted net income per share: | ||||||||||||
| Net income | $ | 0.57 | $ | 0.51 | $ | 1.02 | $ | 0.74 | ||||
| Diluted weighted average common shares outstanding | 15,111 | 15,336 | 15,210 | 15,332 | ||||||||
| Anika Therapeutics, Inc. and Subsidiaries | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (in thousands, except share data and per share data) | ||||||||
| (unaudited) | ||||||||
| June 30, | December 31, | |||||||
| ASSETS | 2016 | 2015 | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 89,125 | $ | 110,707 | ||||
| Investments | 22,500 | 27,751 | ||||||
| Accounts receivable, net of reserves of $220 and $167 at June 30, 2016 and December 31, 2015, respectively | 24,597 | 21,652 | ||||||
| Inventories | 17,264 | 14,938 | ||||||
| Prepaid expenses and other current assets | 1,158 | 1,385 | ||||||
| Total current assets | 154,644 | 176,433 | ||||||
| Property and equipment, net | 49,198 | 40,108 | ||||||
| Long-term deposits and other | 69 | 69 | ||||||
| Intangible assets, net | 11,259 | 11,656 | ||||||
| Goodwill | 7,568 | 7,482 | ||||||
| Total Assets | $ | 222,738 | $ | 235,748 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,294 | $ | 8,302 | ||||
| Accrued expenses and other current liabilities | 6,638 | 4,778 | ||||||
| Income taxes payable | 591 | 4,198 | ||||||
| Total current liabilities | 10,523 | 17,278 | ||||||
| Other long-term liabilities | 1,173 | 781 | ||||||
| Long-term deferred revenue | 56 | 66 | ||||||
| Deferred tax liability | 6,570 | 6,775 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $.01 par value; 1,250,000 shares authorized, no shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively | – | – | ||||||
| Common stock, $.01 par value; 60,000,000 and 30,000,000 shares authorized, 14,777,663 and 15,036,808 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively | 148 | 150 | ||||||
| Additional paid-in-capital | 59,506 | 81,685 | ||||||
| Accumulated other comprehensive loss | (6,410 | ) | (6,649 | ) | ||||
| Retained earnings | 151,172 | 135,662 | ||||||
| Total stockholders’ equity | 204,416 | 210,848 | ||||||
| Total Liabilities and Stockholders’ Equity | $ | 222,738 | $ | 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 June 30, | For the Six Months Ended June 30, | |||||||||||||||||||||||
| 2016 | % | 2015 | % | 2016 | % | 2015 | % | |||||||||||||||||
| Orthobiologics | $ | 23,304 | 88 | % | $ | 19,283 | 84 | % | $ | 42,891 | 88 | % | $ | 31,255 | 81 | % | ||||||||
| Surgical | 1,433 | 5 | % | 1,647 | 7 | % | 2,751 | 5 | % | 3,037 | 8 | % | ||||||||||||
| Dermal | 582 | 2 | % | 303 | 1 | % | 963 | 2 | % | 719 | 2 | % | ||||||||||||
| Other | 1,256 | 5 | % | 1,665 | 8 | % | 2,248 | 5 | % | 3,402 | 9 | % | ||||||||||||
| Product Revenue | $ | 26,575 | 100 | % | $ | 22,898 | 100 | % | $ | 48,853 | 100 | % | $ | 38,413 | 100 | % | ||||||||
| Product Gross Profit | $ | 20,510 | $ | 17,623 | $ | 37,363 | $ | 28,825 | ||||||||||||||||
| Product Gross Margin | 77% | 77% | 77% | 75% | ||||||||||||||||||||
| Product Revenue by Geographic Region | ||||||||||||||||||||||||
| (in thousands, except percentages) | ||||||||||||||||||||||||
| (unaudited) | ||||||||||||||||||||||||
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||||||||||
| 2016 | % | 2015 | % | 2016 | % | 2015 | % | |||||||||||||||||
| Geographic Location: | ||||||||||||||||||||||||
| United States | $ | 21,895 | 82 | % | $ | 19,218 | 84 | % | $ | 39,906 | 82 | % | $ | 31,809 | 83 | % | ||||||||
| Europe | 2,971 | 11 | % | 2,325 | 10 | % | 5,531 | 11 | % | 4,306 | 11 | % | ||||||||||||
| Other | 1,709 | 7 | % | 1,355 | 6 | % | 3,416 | 7 | % | 2,298 | 6 | % | ||||||||||||
| Product Revenue | $ | 26,575 | 100 | % | $ | 22,898 | 100 | % | $ | 48,853 | 100 | % | $ | 38,413 | 100 | % | ||||||||
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Anika Therapeutics, Inc.
Charles H. Sherwood, Ph.D., President and CEO
or
Sylvia Cheung, CFO
781-457-9000
Source: Anika Therapeutics, Inc.
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