Worldwide Orthobiologics Revenue Increases 10%
Year-over-Year
Diluted Earnings Per Share Increases to
$0.59
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 HighlightsThe 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 InformationAnika’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 StatementsThe 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 %
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version on businesswire.com: http://www.businesswire.com/news/home/20161026006717/en/
Anika Therapeutics, Inc.Charles H. Sherwood, Ph.D., President
and CEOorSylvia Cheung, CFO781-457-9000
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