"We are off to a strong start in 2016, with total revenue growth of 44% year-over-year for the first quarter and advancement of our long-term growth strategy," said
First Quarter Financial Results
- Total revenue for the first quarter of 2016 increased 44% to
$22.3 million, compared to $15.5 millionfor the first quarter of 2015. The increase was driven primarily by domestic ORTHOVISC and MONOVISC revenue.
- Orthobiologics revenue grew 64% year-over-year in the first quarter of 2016. ORTHOVISC maintained its position as the leading multiple-injection product. MONOVISC continued to hold the number two position in the single-injection segment.
- ORTHOVISC and MONOVISC
U.S.end user revenue increased 11% year-over-year in the first quarter of 2016. Product sales to the Company's U.S.commercial partner increased by $5.8 millionas compared to the first quarter of 2015, which was heavily impacted by our commercial partner's inventory rebalancing activities.
- Total operating expenses for the first quarter of 2016 were
$11.6 million, compared to $10.0 millionfor the first quarter of 2015.
- Net income for the first quarter of 2016 increased
$3.4 millionto $6.9 million, or $0.45per diluted share, compared to $3.5 million, or $0.23per diluted share, for the first quarter of 2015.
Recent Business Highlights
The Company made key commercial, operational, pipeline, and financial advancements, including:
- Achieving CE Mark approval for CINGAL to treat pain associated with osteoarthritis of human joints.
- Advancing its product pipeline with continued progress on the FastTRACK Phase III HYALOFAST study and on the Phase III MONOVISC study for the treatment of osteoarthritis pain in the hip.
- Entering into an accelerated share repurchase program to repurchase
$25 millionof its outstanding common stock. The Company initially received approximately 377,000 shares, which represents approximately 70% of the total shares to be repurchased under the program through its expected conclusion in August 2016.
- Strengthening its executive leadership team and expanding its corporate capabilities with the appointments of
Stephen R. Mascioli, M.D., MPH, as Chief Medical Officer and Dana M. Alexanderas Chief Operations Officer.
- Continuing to progress 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,
The statements made in the first sentence of the second paragraph and the third bullet point 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 future growth prospects, the Company's advancement of its long-term growth strategy, 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, including for HYALOFAST, 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)|
|Three Months Ended
|Licensing, milestone and contract revenue||5||5|
|Cost of product revenue||5,425||4,313|
|Research & development||2,159||2,098|
|Selling, general & administrative||3,990||3,605|
|Total operating expenses||11,574||10,016|
|Income from operations||10,709||5,504|
|Interest income, net||72||24|
|Income before income taxes||10,781||5,528|
|Provision for income taxes||3,886||2,012|
|Basic net income per share:|
|Basic weighted average common shares outstanding||14,875||14,905|
|Diluted net income per share:|
|Diluted weighted average common shares outstanding||15,307||15,330|
|Condensed Consolidated Balance Sheets|
|(in thousands, except share data and per share data)|
|Cash and cash equivalents||$||92,837||$||110,707|
|Accounts receivable, net of reserves of
|Prepaid expenses and other current assets||1,500||1,385|
|Total current assets||147,900||176,433|
|Property and equipment, net||46,839||40,108|
|Long-term deposits and other||69||69|
|Intangible assets, net||11,859||11,656|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued expenses and other current liabilities||5,999||4,778|
|Income taxes payable||1,603||4,198|
|Total current liabilities||10,865||17,278|
|Other long-term liabilities||739||781|
|Long-term deferred revenue||63||66|
|Deferred tax liability||7,422||6,775|
|Commitments and contingencies|
|Accumulated other comprehensive loss||(5,873)||(6,649)|
|Total stockholders' equity||195,368||210,848|
|Total Liabilities and Stockholders' Equity||$||214,457||$||235,748|
|Supplemental Financial Data|
|Revenue by Product Line and Product Gross Margin|
|(in thousands, except percentages)|
|Product Gross Profit||$||16,853||$||11,202|
|Product Gross Margin||76%||72%|
|Total Product Revenue by
|(in thousands, except percentages)|
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