Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint
preservation company that creates and delivers meaningful
advancements in early intervention orthopedic care, today reported
financial results for the third quarter ended September 30, 2020,
and provided an update on its business progress in the period.
“Anika posted another quarter of top-line growth, while further
expanding our global product portfolio. The transformation enabled
by our new strategic focus and recent acquisitions has provided
revenue diversification leading to the generation of new revenue
streams and growth, even in light of the impact of COVID-19,” said
Cheryl R. Blanchard, Ph.D., President and Chief Executive Officer
of Anika Therapeutics. “We were also delighted to make significant
progress on Anika’s new product development roadmap which is
focused on delivering meaningful solutions in high opportunity
spaces within orthopedics that address the unmet needs of
orthopedic and sports medicine surgeons and their patients.
Additionally, we strengthened our leadership team and our Board of
Directors with the addition of Mike Levitz, our new CFO, and Ben
Joseph, our new Vice President of Sales and Marketing, Americas,
and two new independent directors. Finally, we initiated enrollment
in our CINGAL Pilot Study and resumed enrollment in our HYALOFAST
Phase III clinical trial during the quarter. Our progress executing
on our growth initiatives, combined with the continued recovery of
elective procedures, positions us to drive sustainable growth and
value for all of our stakeholders going forward.”
Third Quarter Financial
Results
- Total revenue for the third
quarter of 2020 increased 7% year-over-year to $31.7 million,
compared to $29.7 million in the prior year. The increase was due
to Orthopedic Joint Preservation and Restoration revenue following
the acquisitions of Parcus Medical, LLC and Arthrosurface, Inc., in
the first quarter of 2020, offset by lower Joint Pain Management
revenue as a result of the COVID environment.
- Net loss was $6.4 million, or
$0.45 loss per diluted share, compared to net income of $9.2
million, or $0.64 per diluted share, in the prior year. Adjusted
net income1 was $0.8 million, or $0.05 per diluted share. Adjusted
EBITDA1 was $4.9 million, compared to $14.9 million for the prior
year. The year-over-year decrease was primarily due to the impact
of COVID and investments for future growth.
- Cash and investments were $124.8
million as of September 30, 2020, compared to $184.9 million as of
December 31, 2019. Anika repaid $25.0 million of its outstanding
credit facility in the third quarter of 2020. The decrease in cash
and investments in the first nine months of 2020 was due mainly to
the $93.0 million of upfront payments for the acquisitions earlier
in the year, offset by $25.0 million, net, drawn on the credit
facility.
1 See description of non-GAAP financial information contained in
this release.
Recent Business
Updates
- Completed launch activities for seven joint preservation
products.
- Received 510(k) clearance in October 2020 for the WristMotion®
Total Arthroplasty System.
- Enrolled the first patient in the CINGAL® Pilot Study and
resumed the HYALOFAST® Phase III trial to advance those therapies
toward regulatory approval in the U.S.
- Advanced new product development roadmap focused on early
intervention orthopedic care, which represents more than an $8
billion addressable market.
- Hired Mike Levitz as EVP, Chief Financial Officer and
Treasurer, and Ben Joseph, VP Sales and Marketing, Americas.
- Appointed Jack Henneman and Steve Richard to the Board of
Directors and Jeffery Thompson succeeded Dr. Joseph Bower as Chair
of the Board of Directors.
Non-GAAP Financial
Information
Adjusted EBITDA
Anika presents adjusted EBITDA because management uses it as a
supplemental measure in assessing the Company’s operating
performance, and the Company believes that it is helpful to
investors, securities analysts and other interested parties as a
measure of comparative operating performance from period to period.
The Company recognizes adjusted EBITDA as a commonly used measure
in determining business value and as such, uses it internally to
report results. It is also one of the performance metrics that
determines management incentive compensation.
In 2020, adjusted EBITDA is defined by the Company as GAAP net
income excluding depreciation and amortization, interest and other
income (expense), income taxes, stock-based compensation expense,
acquisition related costs, non-cash charges related to goodwill
impairment and changes in the fair value of contingent
consideration associated with the Company’s recent acquisitions as
a result of the COVID-19 pandemic, and product rationalization
charges associated with certain non-core legacy products.
Non-GAAP financial measures should be considered supplemental
to, and not a substitute for, the Company’s reported financial
results prepared in accordance with GAAP. Furthermore, the
Company’s definition of non-GAAP measures may differ from similarly
titled measures used by others. Because non-GAAP financial measures
exclude the effect of items that will increase or decrease the
Company’s reported results of operations, Anika strongly encourages
investors to review the Company’s consolidated financial statements
and publicly filed reports in their entirety.
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 nine-month periods ended September 30, 2020 and 2019.
Anika Therapeutics, Inc. and Subsidiaries |
Reconciliation of GAAP Net Income to Adjusted
EBITDA |
(in thousands, except per share data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
For the Nine Months Ended September 30, |
in thousands, except per share
data |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Net income (loss) |
|
$ |
(6,411 |
) |
|
$ |
9,200 |
|
|
$ |
(8,326 |
) |
|
$ |
23,142 |
|
Interest and other income (expense), net |
|
228 |
|
|
(482 |
) |
|
118 |
|
|
(1,513 |
) |
Income taxes |
|
(1,744 |
) |
|
3,331 |
|
|
(2,161 |
) |
|
7,817 |
|
Depreciation and amortization |
|
1,718 |
|
|
1,516 |
|
|
5,130 |
|
|
4,459 |
|
Stock-based compensation |
|
1,920 |
|
|
1,311 |
|
|
3,953 |
|
|
4,140 |
|
Product rationalization related charges |
|
- |
|
|
- |
|
|
2,892 |
|
|
- |
|
Acquisition related expenses |
|
5,033 |
|
|
- |
|
|
16,384 |
|
|
- |
|
Goodwill impairment |
|
- |
|
|
- |
|
|
18,144 |
|
|
- |
|
Change in fair value of contingent consideration (benefit) |
|
4,150 |
|
|
- |
|
|
(16,176 |
) |
|
- |
|
Adjusted EBITDA |
|
$ |
4,894 |
|
|
$ |
14,876 |
|
|
$ |
19,958 |
|
|
$ |
38,045 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted Net Income and Adjusted EPS
In addition to adjusted EBITDA, the Company is reporting its
third quarter 2020 results with respect to adjusted net income (net
loss) and adjusted diluted Earnings (loss) per Share (EPS) with
respect to adjusted net income. The Company believes that adjusted
net income and adjusted diluted EPS also provide additional useful
information for investors as they assess the Company’s operating
performance, as they are measures that the Company evaluates
regularly when assessing its own performance. Adjusted net income
and adjusted diluted EPS are not calculated identically by all
companies, and therefore the Company’s measurements of adjusted net
income and adjusted diluted EPS may not be comparable to similarly
titled measures reported by other companies. Adjusted net income is
defined by the Company as GAAP net income excluding acquisition
related expenses, inclusive of the impact of purchase accounting,
on a tax effected basis, as well as the non-cash product
rationalization charges associated with certain non-core legacy
products. In the context of adjusted net income, the impact of
purchase accounting includes amortization of inventory step up and
intangible assets recorded as part of purchase accounting for
acquisition transactions. The amortized assets contribute to
revenue generation, and the amortization of such assets will recur
in future periods until such assets are fully amortized. These
assets include the estimated fair value of certain identified
assets acquired in acquisitions in 2020 and beyond, including
in-process research and development, developed technology, customer
relationships and acquired tradenames. As a result of COVID-19, the
Company is also specifically excluding the impacts of goodwill
impairment charges and changes in the fair value in contingent
consideration associated with the acquisition transactions, each on
a tax effected basis. Adjusted diluted EPS is defined by the
Company as GAAP diluted EPS excluding acquisition related expenses
and the impact of purchase accounting, each on a tax-adjusted per
share basis, as well as the non-cash product rationalization
charges associated with certain non-core legacy products. Again,
the Company is also specifically excluding the impacts of goodwill
impairment charges and changes in the fair value in contingent
consideration associated with the acquisition transactions, each on
a tax effected basis if applicable. The Company is reporting this
financial measure to the Board of Directors in order to facilitate
an appropriate assessment of the Company’s performance and the
impact of the COVID-19 pandemic. A reconciliation of adjusted net
income to net income and adjusted diluted EPS to diluted EPS, the
most directly comparable financial measures calculated and
presented in accordance with GAAP, is shown in the tables below for
the three- and nine-month periods ended September 30, 2020 and
2019.
Anika Therapeutics, Inc. and Subsidiaries |
Reconciliation of GAAP Net Income to Adjusted Net
Income |
(in thousands, except per share data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
For the Nine Months Ended September 30, |
in thousands, except per share
data |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Net income (loss) |
|
$ |
(6,411 |
) |
|
$ |
9,200 |
|
$ |
(8,326 |
) |
|
$ |
23,142 |
Product rationalization related charges, tax effected |
|
- |
|
|
- |
|
2,377 |
|
|
- |
Acquisition related expenses, tax effected |
|
3,832 |
|
|
- |
|
12,508 |
|
|
- |
Goodwill impairment, tax effected |
|
- |
|
|
- |
|
15,773 |
|
|
- |
Change in fair value of contingent consideration, tax effected
(benefit) |
|
3,336 |
|
|
- |
|
(13,873 |
) |
|
- |
Adjusted net income |
|
$ |
757 |
|
|
$ |
9,200 |
|
$ |
8,459 |
|
|
$ |
23,142 |
|
|
|
|
|
|
|
|
|
|
|
Anika Therapeutics, Inc. and Subsidiaries |
Reconciliation of GAAP Diluted Earnings Per Share to
Adjusted Diluted Earnings Per Share |
(per share data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
For the Nine Months Ended September 30, |
in thousands, except per share
data |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Diluted earnings (loss) per share (EPS) |
|
$ |
(0.45 |
) |
|
$ |
0.64 |
|
$ |
(0.59 |
) |
|
$ |
1.62 |
Product rationalization related charges, tax effected |
|
- |
|
|
- |
|
0.17 |
|
|
- |
Acquisition related expenses per share, tax effected |
|
0.27 |
|
|
- |
|
0.88 |
|
|
- |
Goodwill impairment, tax effected |
|
- |
|
|
- |
|
1.11 |
|
|
- |
Change in fair value of contingent consideration, tax effected
(benefit) |
|
0.23 |
|
|
- |
|
(0.98 |
) |
|
- |
Adjusted diluted EPS |
|
$ |
0.05 |
|
|
$ |
0.64 |
|
$ |
0.59 |
|
|
$ |
1.62 |
|
|
|
|
|
|
|
|
|
|
|
Conference Call Information
Anika’s management will hold a conference call and webcast to
discuss its financial results and business highlights today,
Wednesday, November 4th at 5:00 pm ET. The conference call can be
accessed by dialing 1-855-327-6837 (toll-free domestic) or
1-631-891-4304 (international) and providing the conference ID
number 10011177. A live audio webcast will be available in the
"Investor Relations" section of Anika’s website, www.anika.com. A
slide presentation with highlights from the conference call will be
available in the Investor Relations section of 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 joint
preservation company that creates and delivers meaningful
advancements in early intervention orthopedic care. We partner with
physicians to understand what they need most to treat their
patients and we develop minimally invasive products that restore
active living for people around the world. We are committed to
leading in high opportunity spaces within orthopedics, including
osteoarthritis pain management, regenerative solutions, soft tissue
repair and bone preserving joint technologies. For more information
about Anika, please visit www.anika.com.
Forward-Looking Statements
This press release may contain 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, concerning the Company's expectations, anticipations,
intentions, beliefs or strategies regarding the future which are
not statements of historical fact. 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, 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 September 30, |
|
For the Nine Months Ended September 30, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Product revenue |
|
$ |
31,694 |
|
|
$ |
29,615 |
|
$ |
97,769 |
|
|
$ |
84,745 |
|
Licensing, milestone and contract revenue |
|
- |
|
|
82 |
|
- |
|
|
93 |
|
Total revenue |
|
31,694 |
|
|
29,697 |
|
97,769 |
|
|
84,838 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenue |
|
14,351 |
|
|
5,951 |
|
45,487 |
|
|
20,098 |
|
Research and development |
|
5,217 |
|
|
4,158 |
|
15,799 |
|
|
12,581 |
|
Selling, general and administrative |
|
15,903 |
|
|
7,539 |
|
44,884 |
|
|
22,713 |
|
Goodwill impairment |
|
- |
|
|
- |
|
18,144 |
|
|
- |
|
Change in fair value of contingent consideration |
|
4,150 |
|
|
- |
|
(16,176 |
) |
|
- |
|
Total operating expenses |
|
39,621 |
|
|
17,648 |
|
108,138 |
|
|
55,392 |
|
Income (loss) from operations |
|
(7,927 |
) |
|
12,049 |
|
(10,369 |
) |
|
29,446 |
|
Interest and other income (expense), net |
|
(228 |
) |
|
482 |
|
(118 |
) |
|
1,513 |
|
Income (loss) before income taxes |
|
(8,155 |
) |
|
12,531 |
|
(10,487 |
) |
|
30,959 |
|
Income taxes |
|
(1,744 |
) |
|
3,331 |
|
(2,161 |
) |
|
7,817 |
|
Net income (loss) |
|
$ |
(6,411 |
) |
|
$ |
9,200 |
|
$ |
(8,326 |
) |
|
$ |
23,142 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share: |
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
(0.45 |
) |
|
$ |
0.65 |
|
$ |
(0.59 |
) |
|
$ |
1.65 |
|
Basic weighted average common shares outstanding |
|
14,205 |
|
|
14,070 |
|
14,202 |
|
|
14,065 |
|
Diluted net income per share: |
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
(0.45 |
) |
|
$ |
0.64 |
|
$ |
(0.59 |
) |
|
$ |
1.62 |
|
Diluted weighted average common shares outstanding |
|
14,205 |
|
|
14,387 |
|
14,202 |
|
|
14,266 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anika Therapeutics, Inc. and Subsidiaries |
Consolidated Balance Sheets |
(in thousands, except per share data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
ASSETS |
|
|
|
|
|
|
2020 |
|
2019 |
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and investments |
|
|
|
|
|
|
$ |
124,758 |
|
|
$ |
184,943 |
|
Accounts receivable, net |
|
|
|
|
|
|
23,009 |
|
|
23,079 |
|
Inventories, net |
|
|
|
|
|
|
47,882 |
|
|
21,995 |
|
Prepaid expenses and other current assets |
|
|
|
|
|
|
6,226 |
|
|
4,289 |
|
Total current assets |
|
|
|
|
|
|
201,875 |
|
|
234,306 |
|
Property and equipment, net |
|
|
|
|
|
|
51,629 |
|
|
50,783 |
|
Right-of-use assets |
|
|
|
|
|
|
22,898 |
|
|
22,864 |
|
Other long-term assets |
|
|
|
|
|
|
13,226 |
|
|
7,478 |
|
Intangible assets, net |
|
|
|
|
|
|
94,291 |
|
|
7,585 |
|
Goodwill |
|
|
|
|
|
|
32,419 |
|
|
7,694 |
|
Total assets |
|
|
|
|
|
|
$ |
416,338 |
|
|
$ |
330,710 |
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
|
|
|
|
$ |
6,800 |
|
|
$ |
3,832 |
|
Accrued expenses and other current liabilities |
|
|
|
|
|
|
24,339 |
|
|
12,445 |
|
Total current liabilities |
|
|
|
|
|
|
31,139 |
|
|
16,277 |
|
Other long-term liabilities |
|
|
|
|
|
|
987 |
|
|
357 |
|
Contingent consideration |
|
|
|
|
|
|
41,045 |
|
|
- |
|
Long-term debt |
|
|
|
|
|
|
25,000 |
|
|
- |
|
Deferred tax liability |
|
|
|
|
|
|
12,584 |
|
|
4,331 |
|
Lease liabilities |
|
|
|
|
|
|
21,132 |
|
|
21,367 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, $0.01 par value |
|
|
|
|
|
|
- |
|
|
- |
|
Common stock, $0.01 par value |
|
|
|
|
|
|
142 |
|
|
143 |
|
Additional paid-in-capital |
|
|
|
|
|
|
52,505 |
|
|
48,707 |
|
Accumulated other comprehensive loss |
|
|
|
|
|
|
(5,296 |
) |
|
(5,898 |
) |
Retained earnings |
|
|
|
|
|
|
237,100 |
|
|
245,426 |
|
Total stockholders’ equity |
|
|
|
|
|
|
284,451 |
|
|
288,378 |
|
Total liabilities and stockholders’ equity |
|
|
|
|
|
|
$ |
416,338 |
|
|
$ |
330,710 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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, |
Product
Family: |
|
2020 |
% |
|
2019 |
% |
|
2020 |
% |
|
2019 |
% |
Joint Pain Management |
|
$ |
18,439 |
|
58 |
% |
|
$ |
27,581 |
|
93 |
% |
|
$ |
66,168 |
|
68 |
% |
|
$ |
77,063 |
|
91 |
% |
Orthopedic Joint Preservation and Restoration |
|
11,715 |
|
37 |
% |
|
544 |
|
2 |
% |
|
26,233 |
|
27 |
% |
|
1,510 |
|
2 |
% |
Other |
|
1,540 |
|
5 |
% |
|
1,490 |
|
5 |
% |
|
5,368 |
|
5 |
% |
|
6,172 |
|
7 |
% |
Product Revenue |
|
$ |
31,694 |
|
100 |
% |
|
$ |
29,615 |
|
100 |
% |
|
$ |
97,769 |
|
100 |
% |
|
$ |
84,745 |
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product Gross Profit |
|
$ |
17,343 |
|
|
|
|
$ |
23,664 |
|
|
|
|
$ |
52,282 |
|
|
|
|
$ |
64,647 |
|
|
|
Product Gross Margin |
|
55 |
% |
|
|
|
80 |
% |
|
|
|
53 |
% |
|
|
|
76 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Revenue by Geographic Region |
(in thousands, except percentages) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September
30, |
|
For the Nine Months Ended September 30, |
Geographic
Region: |
|
2020 |
% |
|
2019 |
% |
|
2020 |
% |
|
2019 |
% |
United States |
|
$ |
26,409 |
|
84 |
% |
|
$ |
23,512 |
|
79 |
% |
|
$ |
77,848 |
|
80 |
% |
|
$ |
66,538 |
|
78 |
% |
Europe |
|
2,954 |
|
9 |
% |
|
3,943 |
|
13 |
% |
|
11,140 |
|
11 |
% |
|
11,396 |
|
14 |
% |
Other |
|
2,331 |
|
7 |
% |
|
2,242 |
|
8 |
% |
|
8,781 |
|
9 |
% |
|
6,904 |
|
8 |
% |
Total Revenue |
|
$ |
31,694 |
|
100 |
% |
|
$ |
29,697 |
|
100 |
% |
|
$ |
97,769 |
|
100 |
% |
|
$ |
84,838 |
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For Investor Inquiries:Anika Therapeutics, Inc.Kristen Galfetti,
781-457-9000Executive Director, Investor Relations
investorrelations@anika.com |
For Media Inquiries:W2O GroupRachel Girard, 617-379-6760
rgirard@w2ogroup.com |
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