Management Commentary
"Anika made continued progress toward meeting its business goals and delivered solid financial results in the second quarter," said
"Operationally, our key highlight this quarter was the U.S. commercial launch and first domestic sales of Monovisc®," Sherwood said. "Monovisc® has been well-received by the orthopedic physician community, and it is generating results in line with our plans. In addition, we continued to expand our international viscosupplementation distribution network, while making solid progress on our product pipeline with clinical and regulatory advances for Cingal™ and Hyalofast™."
"Anika begins the second half of 2014 with strong momentum. We are successfully executing our strategy to expand our global presence in viscosupplementation. Cingal™ and Hyalofast™ are advancing toward commercialization. We are continuing to add the organizational and operational capabilities the company needs to expand beyond viscosupplementation and to deliver on its growth potential in the years ahead, and our product pipeline continues to be strong. As a result, we believe
Revenue
Anika's total revenue for the second quarter of 2014 was
Product Gross Margin and Operating Expenses
Product gross margin for the second quarter of 2014 improved to 75%, from 69% in the second quarter of 2013. This improvement was driven by a more favorable product mix, increased royalties from the Company's U.S. viscosupplementation products, as well as efficiency gains and a lower raw material cost for a key component. Total operating expenses for the second quarter of 2014 were
Operating and Net Income
Operating income for the second quarter of 2014 was
Cash and Cash Equivalents
Anika's cash and cash equivalents at
Conference Call Information
To listen to the conference call, dial 855-468-0611 (international callers dial 484-756-4332). In addition, the call will be available through a live audio webcast in the "Investor Relations" section of Anika's website, www.anikatherapeutics.com. An accompanying slide presentation also may be accessed via the
About
Headquartered in
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 include, but are not limited to, those relating to (i) the Company and its partner's ability to successfully commercialize Monovisc® in the U.S.; (ii) our ability to capitalize on the strengths of our viscosupplementation portfolio; (iii) our ongoing initiatives to improve performance across the business; (iv) our efforts and ability to strengthen and expand our international orthobiologics distribution network; (v) the Company's plans to continue to drive efficiencies in operations and manufacturing; (vi) the prospects for the Company's product pipeline, including viscosupplementation and regenerative product development; (vii) bringing Cingal™ and Hyalofast™ to market; and (viii) our expectations for future growth and profitability improvement in the quarters ahead. 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 (i) the Company's ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all, obtain pre-clinical or clinical data to support domestic and international pre-market approval applications or 510(k) applications, or timely file and receive
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Condensed Consolidated Statements of Operations |
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(unaudited) |
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Three Months Ended |
Six Months Ended |
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2014 | 2013 | 2014 | 2013 | |||||||||||||||||||
Product revenue | $ | 21,267,156 | $ | 20,067,407 | $ | 35,618,561 | $ | 34,561,896 | ||||||||||||||
Licensing, milestone and contract revenue | 5,007,504 | 760,970 | 24,666,386 | 1,513,492 | ||||||||||||||||||
Total revenue | 26,274,660 | 20,828,377 | 60,284,947 | 36,075,388 | ||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||
Cost of product revenue | 5,332,913 | 6,311,332 | 9,693,932 | 11,152,502 | ||||||||||||||||||
Research & development | 1,873,158 | 1,829,052 | 4,160,873 | 3,411,962 | ||||||||||||||||||
Selling, general & administrative | 3,865,876 | 3,400,679 | 7,356,861 | 7,347,793 | ||||||||||||||||||
Restructuring credits | - | (111,178 | ) | - | (246,785 | ) | ||||||||||||||||
Total operating expenses | 11,071,947 | 11,429,885 | 21,211,666 | 21,665,472 | ||||||||||||||||||
Income from operations | 15,202,713 | 9,398,492 | 39,073,281 | 14,409,916 | ||||||||||||||||||
Interest income (expense), net | 5,935 | (36,381 | ) | 6,402 | (75,939 | ) | ||||||||||||||||
Income before income taxes | 15,208,648 | 9,362,111 | 39,079,683 | 14,333,977 | ||||||||||||||||||
Provision for income taxes | 5,906,298 | 3,467,219 | 14,747,080 | 5,371,083 | ||||||||||||||||||
Net income | $ | 9,302,350 | $ | 5,894,892 | $ | 24,332,603 | $ | 8,962,894 | ||||||||||||||
Basic net income per share: | ||||||||||||||||||||||
Net income | $ | 0.63 | $ | 0.44 | $ | 1.67 | $ | 0.67 | ||||||||||||||
Basic weighted average common shares outstanding | 14,687,747 | 13,510,573 | 14,559,917 | 13,459,049 | ||||||||||||||||||
Diluted net income per share: | ||||||||||||||||||||||
Net income | $ | 0.60 | $ | 0.40 | $ | 1.57 | $ | 0.62 | ||||||||||||||
Diluted weighted average common shares outstanding | 15,492,732 | 14,578,927 | 15,487,432 | 14,484,978 | ||||||||||||||||||
Net income | $ | 9,302,350 | $ | 5,894,892 | $ | 24,332,603 | $ | 8,962,894 | ||||||||||||||
Other comprehensive income (loss) | ||||||||||||||||||||||
Foreign currency translation adjustment | (190,739 | ) | 340,095 | (216,855 | ) | (409,355 | ) | |||||||||||||||
Comprehensive income | $ | 9,111,611 | $ | 6,234,987 | $ | 24,115,748 | $ | 8,553,539 | ||||||||||||||
Condensed Consolidated Balance Sheets |
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(unaudited) |
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2014 | 2013 | |||||||||||
ASSETS | ||||||||||||
Current assets: | ||||||||||||
Cash and cash equivalents | $ | 84,879,562 | $ | 63,333,160 | ||||||||
Accounts receivable, net of reserves of |
19,235,039 | 18,736,845 | ||||||||||
Inventories | 13,864,165 | 10,996,785 | ||||||||||
Current portion deferred income taxes | 659,040 | 659,040 | ||||||||||
Prepaid expenses and other | 878,929 | 865,957 | ||||||||||
Total current assets | 119,516,735 | 94,591,787 | ||||||||||
Property and equipment, at cost | 53,142,322 | 52,413,423 | ||||||||||
Less: accumulated depreciation | (20,754,596 | ) | (19,474,712 | ) | ||||||||
32,387,726 | 32,938,711 | |||||||||||
Long-term deposits and other | 69,077 | 69,080 | ||||||||||
Intangible assets, net | 17,762,272 | 18,998,409 | ||||||||||
Goodwill | 9,360,884 | 9,443,894 | ||||||||||
Total assets | $ | 179,096,694 | $ | 156,041,881 | ||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||||
Current liabilities: | ||||||||||||
Accounts payable | $ | 2,198,070 | $ | 2,793,911 | ||||||||
Accrued expenses | 4,875,167 | 5,537,881 | ||||||||||
Deferred revenue | 15,463 | 180,433 | ||||||||||
Income taxes payable | 232,704 | 770,276 | ||||||||||
Total current liabilities | 7,321,404 | 9,282,501 | ||||||||||
Other long-term liabilities | 1,031,414 | 1,133,544 | ||||||||||
Long-term deferred revenue | 71,446 | 2,054,941 | ||||||||||
Deferred tax liability | 8,278,135 | 7,936,864 | ||||||||||
Commitments and contingencies | ||||||||||||
Stockholders' equity: | ||||||||||||
Preferred stock, |
- | - | ||||||||||
Common stock, |
147,981 | 142,893 | ||||||||||
Additional paid-in-capital | 73,245,459 | 70,606,031 | ||||||||||
Accumulated currency translation adjustment | (1,915,950 | ) | (1,699,095 | ) | ||||||||
Retained earnings | 90,916,805 | 66,584,202 | ||||||||||
Total stockholders' equity | 162,394,295 | 135,634,031 | ||||||||||
Total liabilities and stockholders' equity | $ | 179,096,694 | $ | 156,041,881 | ||||||||
Supplemental Financial Data |
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Revenue by Product Line and Product Gross Margin |
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(unaudited) |
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Three Months Ended |
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2014 |
|
2013 |
% Change | |||||||||||
Orthobiologics | $ | 18,278,254 | $ | 16,506,226 | 11% | |||||||||
Dermal | 348,961 | 557,059 | (37%) | |||||||||||
Surgical | 1,376,530 | 1,830,022 | (25%) | |||||||||||
Ophthalmic | 363,411 | 464,340 | (22%) | |||||||||||
Veterinary | 900,000 | 709,760 | 27% | |||||||||||
Total Product Revenue | $ | 21,267,156 | $ | 20,067,407 | 6% | |||||||||
Product gross profit | $ | 15,934,243 | $ | 13,756,075 | ||||||||||
Product gross margin | 75% | 69% | ||||||||||||
Six Months Ended |
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2014 |
|
2013 |
% Change | |||||||||||
Orthobiologics | $ | 29,850,404 | $ | 27,789,773 | 7% | |||||||||
Dermal | 537,612 | 798,643 | (33%) | |||||||||||
Surgical | 3,128,549 | 2,818,886 | 11% | |||||||||||
Ophthalmic | 571,996 | 1,392,798 | (59%) | |||||||||||
Veterinary | 1,530,000 | 1,761,796 | (13%) | |||||||||||
Total Product Revenue | $ | 35,618,561 | $ | 34,561,896 | 3% | |||||||||
Product gross profit | $ | 25,924,629 | $ | 23,409,394 | ||||||||||
Product gross margin | 73% | 68% | ||||||||||||
Supplemental Financial Data |
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Total Revenue by |
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(unaudited) |
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Three Months Ended |
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2014 | 2013 | % Change | ||||||||||||
$ | 22,946,738 | $ | 15,482,068 | 48% | ||||||||||
1,793,841 | 1,986,195 | (10%) | ||||||||||||
Other | 1,534,081 | 3,360,114 | (54%) | |||||||||||
Total | $ | 26,274,660 | $ | 20,828,377 | 26% | |||||||||
Six Months Ended |
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2014 | 2013 | % Change | ||||||||||||
$ | 54,480,556 | $ | 27,765,515 | 96% | ||||||||||
3,489,656 | 3,569,963 | (2%) | ||||||||||||
Other | 2,314,735 | 4,739,910 | (51%) | |||||||||||
Total | $ | 60,284,947 | $ | 36,075,388 | 67% | |||||||||
or
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