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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Anika Therapeutics Inc | NASDAQ:ANIK | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.07 | -0.25% | 28.29 | 28.19 | 28.26 | 28.69 | 27.8124 | 28.25 | 37,412 | 20:38:01 |
Delivers Strong Bottom Line Performance with $0.67 Diluted EPS
CINGAL Revenue Drives International Viscosupplement Revenue Growth of 28% Year-over-Year
Announces Decision to Advance CINGAL Program Towards U.S. Regulatory Approval
Raises Full Year 2019 Revenue and Adjusted EBITDA Guidance
Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today reported financial results for the second quarter ended June 30, 2019, and provided an update on its business progress in the period.
“Anika delivered strong earnings and cash flow in the second quarter, while we continued our transformation into a global commercial company,” said Joseph Darling, President and Chief Executive Officer of Anika Therapeutics. “With an ongoing commitment to our people, products and performance, during the quarter we further strengthened our executive leadership team, continued to realize the benefits of our international expansion efforts and prepared for the launch of our first surgically-delivered therapy for bone repair procedures in the U.S. under our hybrid commercial model in the third quarter of 2019. Additionally, based on extensive analysis and discussions, and building on the strength of our international viscosupplement results, we have decided to move forward with our efforts to obtain regulatory approval for CINGAL in the U.S. Anika remains well positioned to deliver a continuum of orthopedic and regenerative medicine therapies and create sustained value for patients and shareholders.”
Second Quarter Financial Results
Recent Business Highlights
Full Year 2019 Revised Corporate Outlook Based on currently available information, the Company expects total revenue growth to be in the range of 1% to 4% for the full year of 2019. Total operating expenses are now anticipated to be in the high $70 million range, as a result of internal cost control initiatives. Adjusted EBITDA is now expected to be in the high $30 million to low $40 million range, which is based on anticipated U.S. GAAP net income around the mid $20 million range.
Non-GAAP Information To supplement the financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company is reporting Adjusted EBITDA, which is a non-GAAP financial measure and should not be considered an alternative to net income or other measurements under GAAP. The Company believes that Adjusted EBITDA provides additional useful information to investors in their assessment of its operating performance as it is a metric routinely used by management to evaluate the Company’s performance. Adjusted EBITDA is not calculated identically by all companies, and therefore the Company’s measurements of Adjusted EBITDA may not be comparable to similarly titled measures reported by other companies. Adjusted EBITDA is defined by the Company as GAAP net income excluding depreciation and amortization, interest and other income (expense), income taxes and stock-based compensation expense. A reconciliation of Adjusted EBITDA to net income, the most directly comparable financial measure calculated and presented in accordance with GAAP, is shown in the table below for the three- and six-month periods ended June 30, 2019 and 2018 (in thousands).
For the Three Months Ended June 30, For the Six Months Ended June 30,2019
2018
2019
2018
Net income$
9,435
$
10,092
$
13,942
$
3,405
Interest and other income, net
(533
)
(290
)
(1,031
)
(385
)
Provision for income taxes
3,013
1,444
4,486
394
Depreciation and amortization
1,466
1,447
2,943
2,920
Stock-based compensation expense
1,443
1,322
2,829
8,887
Adjusted EBITDA
$
14,824
$
14,015
$
23,169
$
15,221
Conference Call Information Anika’s management will hold a conference call and webcast to discuss its financial results and business highlights today, Wednesday, July 24 at 5:00 pm 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 and regenerative 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 tissue 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®, viscosupplements 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 Statements The statements made in the second and third sentences of the second paragraph, the first, third, and fourth bullet points in the section captioned “Recent Business Highlights,” as well as the section captioned “Full Year 2019 Revised Corporate Outlook” 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 plans for the launch of its surgically-delivered therapy for bone repair, the Company’s plans to advance CINGAL for approval in the United States initially via a pilot study, the timing associated with the Company’s ongoing ASR program, and the Company’s revised expectations with respect to its 2019 financial performance. 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) quarterly sales volume variation experienced by the Company, which can make future results difficult to predict and period-to-period comparisons potentially less meaningful; (x) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (xi) 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 Consolidated Statements of Operations (in thousands, except per share data) (unaudited) For the Three Months Ended June 30, For the Six Months Ended June 30,2019
2018
2019
2018
Product revenue$
30,413
$
30,542
$
55,130
$
51,800
Licensing, milestone and contract revenue
5
6
11
12
Total revenue
30,418
30,548
55,141
51,812
Operating expenses: Cost of product revenue
6,836
8,152
14,147
15,996
Research and development
4,165
4,733
8,423
9,895
Selling, general and administrative
7,502
6,417
15,174
22,507
Total operating expenses
18,503
19,302
37,744
48,398
Income from operations
11,915
11,246
17,397
3,414
Interest and other income, net
533
290
1,031
385
Income before income taxes
12,448
11,536
18,428
3,799
Provision for income taxes
3,013
1,444
4,486
394
Net income
$
9,435
$
10,092
$
13,942
$
3,405
Basic net income per share: Net income
$
0.68
$
0.69
$
0.99
$
0.23
Basic weighted average common shares outstanding
13,916
14,652
14,054
14,666
Diluted net income per share: Net income
$
0.67
$
0.68
$
0.98
$
0.23
Diluted weighted average common shares outstanding
14,088
14,915
14,203
15,045
Anika Therapeutics, Inc. and Subsidiaries Consolidated Balance Sheets (in thousands, except per share data) (unaudited) June 30, December 31, ASSETS
2019
2018
Current assets: Cash, cash equivalents and investments$
141,452
$
159,014
Accounts receivable, net
23,073
20,775
Inventories, net
22,986
21,300
Prepaid expenses and other current assets
2,413
1,854
Total current assets
189,924
202,943
Property and equipment, net
52,960
54,111
Operating lease right-of-use assets
23,495
-
Other long-term assets
4,884
4,897
Intangible assets, net
8,303
9,191
Goodwill
7,798
7,851
Total assets
$
287,364
$
278,993
LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable
$
2,287
$
3,143
Accrued expenses and other current liabilities
8,101
8,146
Total current liabilities
10,388
11,289
Other long-term liabilities
373
550
Deferred tax liability
3,683
3,542
Operating lease liabilities
21,974
-
Commitments and contingencies Stockholders’ equity: Preferred stock, $0.01 par value
-
-
Common stock, $0.01 par value
138
142
Additional paid-in-capital
24,329
50,763
Accumulated other comprehensive loss
(5,696
)
(5,526
)
Retained earnings
232,175
218,233
Total stockholders’ equity
250,946
263,612
Total liabilities and stockholders’ equity
$
287,364
$
278,993
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, Product Line:
2019
%
2018
%
2019
%
2018
%
Orthobiologics$
26,462
87
%
$
26,192
86
%
$
48,210
88
%
$
45,681
88
%
Surgical
2,101
7
%
1,263
4
%
3,493
6
%
2,509
5
%
Dermal
444
1
%
623
2
%
573
1
%
83
0
%
Other
1,406
5
%
2,464
8
%
2,854
5
%
3,527
7
%
Product Revenue$
30,413
100
%
$
30,542
100
%
$
55,130
100
%
$
51,800
100
%
Product Gross Profit$
23,577
$
22,390
$
40,983
$
35,804
Product Gross Margin
78%
73%
74%
69%
Product Revenue by Geographic Region (in thousands, except percentages) (unaudited) For the Three Months Ended June 30, For the Six Months Ended June 30, Geographic Region:
2019
%
2018
%
2019
%
2018
%
United States$
22,937
76
%
$
24,773
81
%
$
43,026
78
%
$
41,682
81
%
Europe
4,927
16
%
3,498
11
%
7,454
14
%
5,889
11
%
Other
2,549
8
%
2,271
8
%
4,650
8
%
4,229
8
%
Product Revenue$
30,413
100
%
$
30,542
100
%
$
55,130
100
%
$
51,800
100
%
View source version on businesswire.com: https://www.businesswire.com/news/home/20190724005750/en/
Anika Therapeutics, Inc. Joseph Darling, President & CEO Sylvia Cheung, CFO Tel: 781-457-9000
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