"We made important progress executing our long-term growth strategy in the first quarter of 2017," said
First Quarter Financial Results
- Total revenue for the first quarter of 2017 increased 5% to
$23.4 million , compared to$22.3 million for the first quarter of 2016. - Worldwide Orthobiologics revenue grew 3% year-over-year in the first quarter of 2017. MONOVISC revenue increased 24% year-over-year in the first quarter of 2017, and it was the main revenue growth driver in the period.
- International Orthobiologics revenue increased 12% for the first quarter of 2017, due primarily to the global expansion of MONOVISC, as well as the growth of CINGAL in
Europe andCanada . Domestically, ORTHOVISC and MONOVISC continue to maintain a combined market leading position. - Total operating expenses for the first quarter of 2017 were
$15.4 million , compared to$11.6 million for the first quarter of 2016. The increase in total operating expenses was due primarily to higher research and development spending required to advance the Company's product pipeline, expanded operational efforts, and increased professional service fees. - Net income for the first quarter of 2017 was
$5.5 million , or$0.37 per diluted share, compared to$6.9 million , or$0.45 per diluted share, for the first quarter of 2016. The decline in net income was due primarily to the planned increase in operating expenses previously discussed.
Recent Business Highlights
The Company made key commercial, operational, pipeline, and financial advancements, including:
- Finalizing the clinical study design for an additional Phase III clinical trial of CINGAL, and commencing site initiation activities for the trial. The trial is a randomized, double-blind, active comparator controlled, multi-center study of CINGAL to demonstrate that CINGAL provides symptomatic relief of osteoarthritis of the knee in patients who have not responded to conservative treatment.
- Launching ORTHOVISC-T in
Europe to relieve pain and restore function in tendons affected by chronic lateral epicondylosis. - 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.
- Progressing the consolidation of the Company's global manufacturing operations at Anika's
Bedford, Massachusetts corporate headquarters. - Completing the build-out of the Company's new European headquarters and training center in
Padova, Italy .
Conference Call Information
Anika's management will hold a conference call and webcast to discuss its financial results and business highlights tomorrow,
About
Forward-Looking Statements
The statements made in 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 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
| Condensed Consolidated Statements of Operations | ||||||||
| (in thousands, except per share data) | ||||||||
| (unaudited) | ||||||||
| For the Three Months Ended |
||||||||
| 2017 | 2016 | |||||||
| Product revenue | $ | 23,381 | $ | 22,278 | ||||
| Licensing, milestone and contract revenue | 5 | 5 | ||||||
| Total revenue | 23,386 | 22,283 | ||||||
| Operating expenses: | ||||||||
| Cost of product revenue | 6,083 | 5,425 | ||||||
| Research & development | 4,230 | 2,159 | ||||||
| Selling, general & administrative | 5,067 | 3,990 | ||||||
| Total operating expenses | 15,380 | 11,574 | ||||||
| Income from operations | 8,006 | 10,709 | ||||||
| Interest income, net | 58 | 72 | ||||||
| Income before income taxes | 8,064 | 10,781 | ||||||
| Provision for income taxes | 2,571 | 3,886 | ||||||
| Net income | $ | 5,493 | $ | 6,895 | ||||
| Basic net income per share: | ||||||||
| Net income | $ | 0.38 | $ | 0.46 | ||||
| Basic weighted average common shares outstanding | 14,576 | 14,875 | ||||||
| Diluted net income per share: | ||||||||
| Net income | $ | 0.37 | $ | 0.45 | ||||
| Diluted weighted average common shares outstanding | 15,043 | 15,307 | ||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (in thousands, except per share data) | ||||||||
| (unaudited) | ||||||||
| ASSETS | 2017 | 2016 | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 119,368 | $ | 104,261 | ||||
| Investments | 19,250 | 20,500 | ||||||
| Accounts receivable, net of reserves of 2017 and |
21,079 | 27,598 | ||||||
| Inventories | 16,180 | 15,983 | ||||||
| Prepaid expenses and other current assets | 1,173 | 2,098 | ||||||
| Total current assets | 177,050 | 170,440 | ||||||
| Property and equipment, net | 51,593 | 52,296 | ||||||
| Long-term deposits and other | 1,234 | 69 | ||||||
| Intangible assets, net | 10,162 | 10,227 | ||||||
| 7,328 | 7,214 | |||||||
| Total assets | $ | 247,367 | $ | 240,246 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,050 | $ | 2,303 | ||||
| Accrued expenses and other current liabilities | 4,167 | 6,496 | ||||||
| Total current liabilities | 10,217 | 8,799 | ||||||
| Other long-term liabilities | 400 | 2,126 | ||||||
| Deferred tax liability | 6,722 | 6,548 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, issued and outstanding at 2015, respectively |
- | - | ||||||
| Common stock, authorized, 14,655 and 14,627 shares issued and outstanding at |
146 | 146 | ||||||
| Additional paid-in-capital | 63,719 | 61,735 | ||||||
| Accumulated other comprehensive loss | (7,025 | ) | (7,317 | ) | ||||
| Retained earnings | 173,188 | 168,209 | ||||||
| Total stockholders' equity | 230,028 | 222,773 | ||||||
| Total liabilities and stockholders' equity | $ | 247,367 | $ | 240,246 | ||||
| Supplemental Financial Data | ||||||||||||
| Revenue by Product Line and Product Gross Margin | ||||||||||||
| (in thousands, except percentages) | ||||||||||||
| (unaudited) | ||||||||||||
| For the Three Months Ended |
||||||||||||
| Product Line: | 2017 | % | 2016 | % | ||||||||
| Orthobiologics | $ | 20,227 | 87 | % | $ | 19,587 | 88 | % | ||||
| Surgical | 1,296 | 5 | % | 1,318 | 6 | % | ||||||
| Dermal | 425 | 2 | % | 381 | 2 | % | ||||||
| Other | 1,433 | 6 | % | 992 | 4 | % | ||||||
| Product Revenue | $ | 23,381 | 100 | % | $ | 22,278 | 100 | % | ||||
| Product Gross Profit | $ | 17,298 | $ | 16,853 | ||||||||
| Product Gross Margin | 74% | 76% | ||||||||||
| Product Revenue by |
||||||||||||
| (in thousands, except percentages) | ||||||||||||
| (unaudited) | ||||||||||||
| For the Three Months Ended |
||||||||||||
| 2017 | % | 2016 | % | |||||||||
| $ | 18,930 | 81 | % | $ | 18,011 | 81 | % | |||||
| 2,829 | 12 | % | 2,565 | 11 | % | |||||||
| Other | 1,622 | 7 | % | 1,702 | 8 | % | ||||||
| Product Revenue | $ | 23,381 | 100 | % | $ | 22,278 | 100 | % | ||||
CONTACT:
Tel: 781-457-9000
Source: Anika Therapeutics, Inc.
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