ANIK on Nasdaq

Anika Therapeutics, Inc.

Anika Therapeutics, Inc. is an American surgical and medical instruments and apparatus company.2 It is headquartered in Bedford, United States.2

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Last updated Oct 21, 2026.

Overview

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  • TickerANIK on Nasdaq2
  • IndustrySurgical & Medical Instruments & Apparatus2
  • HeadquartersBedford, United States2
  • Incorporated inDE3
  • Business address32 Wiggins Avenue, Bedford, Ma 017303
  • Filer categoryAccelerated filer3
  • Legal formCorporation2
  • LEI529900R9LS3Z0O6QH4552
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressc/o CORPORATION SERVICE COMPANY, 251 LITTLE FALLS DRIVE, 19808 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 69192342

Founded in 1992, Anika Therapeutics, Inc. (“Anika” or “Company”) is a global leader in the OA Pain Management and regenerative solutions space, focusing on early intervention orthopedics. The Company leverages proprietary hyaluronic acid (“HA”) technology to develop highly differentiated products. Driven by strong partnerships with physicians, Anika is dedicated to pioneering HA-based innovations that redefine orthopedic care. Our mission is to restore active living, empower surgeon choice, and enhance patient outcomes worldwide.5 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

56.6%Gross margin6
-9.8%Operating margin6
-9.6%Net margin6
-5.9%Revenue growth, 20256
-7.6%Return on equity6
$4.4MFree cash flow6

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

OEM Channel brought in 57% of the revenue Anika Therapeutics, Inc. broke down this way in fiscal 2025.

  1. OEM Channel$64.4M657%down 17% from 2024
  2. Commercial Channel$48.4M643%up 15% from 2024
Products and services by year
Products and services202320242025
OEM Channel$84.6M$77.8M$64.4M
Commercial Channel$36.1M$42.1M$48.4M

Regions

United States brought in 62% of the revenue Anika Therapeutics, Inc. broke down this way in fiscal 2025.

  1. United States$70.1M662%down 15% from 2024
  2. Europe$22.2M620%up 14% from 2024
  3. Other Location$20.5M618%up 14% from 2024
Regions by year
Regions202320242025
United States$86.9M$82.4M$70.1M
Europe$17.3M$19.4M$22.2M
Other Location$16.6M$18.1M$20.5M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue39¢$49.0M
  • Research and development21¢$25.8M
  • Selling, general and admin39¢$49.1M
  • Income tax1¢$672.0K

Out of $112.8M in revenue.6 The company lost money this year.

Where each dollar of operating cash went, fiscal 2025

  • Capital spending42¢$6.8M
  • Share buybacks58¢$9.5M

Out of $11.2M of cash from operations. Spending exceeded cash from operations; the rest came from savings or borrowing.6

Financial statements

Revenue789106$112.8M in 2025−2% since 2019
0$50.0M$100.0M$150.0M2019: $114.6M$114.6M20192020: $130.5M$130.5M2020+14%2021: $147.8M$147.8M2021+13%2022: $113.8M$113.8M2022−23%2023: $120.8M$120.8M2023+6%2024: $119.9M$119.9M2024−1%2025: $112.8M$112.8M2025−6%
Gross profit789106$63.8M in 2025−26% since 2019
0$25.0M$50.0M$75.0M$100.0M2019: $85.9M$85.9M20192020: $69.0M$69.0M2020−20%2021: $82.9M$82.9M2021+20%2022: $73.2M$73.2M2022−12%2023: $82.5M$82.5M2023+13%2024: $76.0M$76.0M2024−8%2025: $63.8M$63.8M2025−16%
Operating income789106-$11.1M in 2025
-$40.0M-$20.0M0$20.0M$40.0M2019: $34.2M$34.2M20192020: -$28.3M-$28.3M20202021: $2.6M$2.6M20212022: $3.7M$3.7M2022+40%2023: $844.0K$844.0K2023−77%2024: -$5.1M-$5.1M20242025: -$11.1M-$11.1M2025+117%
Net income789106-$10.9M in 2025
-$100.0M-$50.0M0$50.0M2019: $27.2M$27.2M20192020: -$24.0M-$24.0M20202021: $4.1M$4.1M20212022: -$14.9M-$14.9M20222023: -$82.7M-$82.7M2023+456%2024: -$56.4M-$56.4M2024−32%2025: -$10.9M-$10.9M2025−81%

Every line of the income statement as filed: the last 3 fiscal years, latest first.6

Period ending2025-12-312024-12-312023-12-31
Revenue$112.8M$119.9M$120.8M
Cost of revenue$49.0M$43.9M$38.3M
Gross profit$63.8M$76.0M$82.5M
Research & development$25.8M$25.5M$21.8M
Selling, general & administrative$49.1M$55.6M$59.9M
Total operating expenses$74.9M$81.1M$81.7M
(Loss) income from operations-$11.1M-$5.1M$844.0K
Interest and other income, net$1.7M$2.3M$2.3M
(Loss) income before income taxes-$9.3M-$2.8M$3.2M
Provision for income taxes$672.0K$6.1M$6.6M
Loss from continuing operations-$10.0M-$8.8M-$3.4M
Loss from discontinued operations, net of tax-$901.0K-$47.6M-$79.2M
Continuing operations (in dollars per share)-$1-$1-$0
Discontinued operations (in dollars per share)-$0-$3-$5
Earnings Per Share, Basic-$0.76-$3.83-$5.64
Continuing operations (in dollars per share)-$1-$1-$0
Discontinued operations (in dollars per share)-$0-$3-$5
Earnings Per Share, Diluted-$0.76-$3.83-$5.64
Basic (in shares)14.3M shares14.7M shares14.7M shares
Diluted (in shares)14.3M shares14.7M shares14.7M shares
Net loss-$10.9M-$56.4M-$82.7M
Foreign currency translation adjustment$1.8M-$840.0K$500.0K
Comprehensive loss-$9.1M-$57.2M-$82.2M

Compare Anika Therapeutics, Inc. with another company

Corporate structure

Anika Therapeutics, Inc. sits at the top of its group. 3 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Anika Therapeutics, Inc.

  • Anika Therapeutics, Inc. Bedford, Massachusetts, United States
    • Anika Securities, Inc. Subsidiary · Massachusetts, United States
    • Anika Therapeutics S.r.l. Subsidiary · Italy

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Anika Therapeutics, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$91.8M6 Dec 31, 2025$85.3M6 Dec 31, 2024+7.6%
Accumulated depreciation$51.4M6 Dec 31, 2025$46.3M6 Dec 31, 2024+11.1%
Property and equipment, net$40.3M6 Dec 31, 2025$39.0M6 Dec 31, 2024+3.4%
Operating-lease assets (leased space)$25.9M6 Dec 31, 2025$25.7M6 Dec 31, 2024+1.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$57.5M6 Dec 31, 2025$55.6M6 Dec 31, 2024+3.3%
Marketable securities, current$23.7M6 Dec 31, 2025$23.6M6 Dec 31, 2024+0.4%
Marketable securities, non-current$06 Dec 31, 2025$06 Dec 31, 2024
Debt securities available for sale$06 Dec 31, 2025$06 Dec 31, 2024

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$8.1M6 Dec 31, 2025$7.1M6 Dec 31, 2024+13.0%
Intangible assets, net (excluding goodwill)$1.6M6 Dec 31, 2025$2.5M6 Dec 31, 2024−33.7%
Accumulated amortization$10.7M6 Dec 31, 2025$14.7M6 Dec 31, 2024−27.5%

Inventory

ItemLatestA year beforeChange
Inventory, total$18.8M6 Dec 31, 2025$23.8M6 Dec 31, 2024−21.1%
Raw materials$10.7M6 Dec 31, 2025$13.2M6 Dec 31, 2024−18.6%
Work in process$8.1M6 Dec 31, 2025$7.0M6 Dec 31, 2024+15.8%
Finished goods$3.5M6 Dec 31, 2025$8.8M6 Dec 31, 2024−60.0%

Properties, in its own words

We maintain leases on three facilities, including our corporate headquarters location in Bedford, Massachusetts, where we lease approximately 134,000 square feet of administrative, research and development, and manufacturing space. The lease on this facility contains multiple extension options that allow us to extend the term through October 2038. Our other lease locations are in Warsaw, Indiana and Padova, Italy. These additional facilities provide us with an aggregate of over 64,000 square feet of additional space and have terms expiring between 2026 and 2032, subject to certain renewal provisions contained within the lease agreements.

See Note 8, Leases, to the consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional information regarding our specific leaseholds.

Item 2 of the 10-K filed Mar 3, 2026.5

Leadership

Who has led Anika Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (32)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Anika Securities, Inc. Massachusetts4
  • Anika Therapeutics Limited United Kingdom4
  • Anika Therapeutics S.r.l. Italy4

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • ANIKA THERAPEUTICS INCMay 15, 1997 to Mar 13, 20143
  • ANIKA RESEARCH INCJul 24, 1996 to Nov 27, 19963

Timeline

  1. Jul 29, 20268-K Results of operations54
  2. Jul 14, 20268-K Entered a material agreement; New debt or obligation55
  3. Jun 23, 20268-K Executive or director change; Shareholder vote56
  4. Apr 29, 20268-K Results of operations; Executive or director change57
  5. Feb 26, 20268-K Results of operations; Executive or director change58
  6. Feb 3, 2026New chief executive Stephen D. Griffin becomes CEO14
  7. Jan 8, 20268-K Results of operations; Executive or director change59
  8. Nov 5, 20258-K Results of operations; Other events60
  9. Jul 30, 20258-K Regulation FD disclosure61
  10. Jul 30, 20258-K Results of operations62
  11. Jun 24, 20258-K Executive or director change; Shareholder vote63
  12. May 9, 20258-K Results of operations64
  13. Apr 10, 20258-K Executive or director change65
  14. Apr 28, 2020New chief executive Cheryl R. Blanchard becomes CEO15
  15. Mar 13, 2018New chief executive Joseph G. Darling becomes CEO16
  16. Jan 30, 2006New chief executive Charles H. Sherwood becomes CEO17

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.17) a share, on Nov 5, 2025.66

When it reported results

  1. Jul 29, 2026Reported quarterly or annual results54
  2. Apr 29, 2026Reported quarterly or annual results57
  3. Feb 26, 2026Reported quarterly or annual results58
  4. Jan 8, 2026Reported quarterly or annual results59
  5. Nov 5, 2025Reported quarterly or annual results60
  6. Jul 30, 2025Reported quarterly or annual results62
  7. May 9, 2025Reported quarterly or annual results64
  8. Mar 12, 2025Reported quarterly or annual results67

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

253 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 40 major events, 107 insider forms, 43 large holders, 42 other. The latest 20:

  1. Aug 7, 2026144 EDGAR
  2. Aug 5, 20264 EDGAR
  3. Jul 31, 2026SCHEDULE 13G/A EDGAR
  4. Jul 29, 2026S-8 EDGAR
  5. Jul 29, 202610-Q EDGAR
  6. Jul 29, 20268-K EDGAR
  7. Jul 17, 2026SCHEDULE 13G/A EDGAR
  8. Jul 14, 20268-K EDGAR
  9. Jun 23, 20264 EDGAR
  10. Jun 23, 20264 EDGAR
  11. Jun 23, 20264 EDGAR
  12. Jun 23, 20264 EDGAR
  13. Jun 23, 20264 EDGAR
  14. Jun 23, 20268-K EDGAR
  15. Jun 8, 2026DEFA14A EDGAR
  16. Jun 5, 20264 EDGAR
  17. Jun 1, 2026DEFA14A EDGAR
  18. May 4, 20264 EDGAR
  19. Apr 30, 20264 EDGAR
  20. Apr 30, 202610-Q EDGAR

The 253 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

9 open-market trades by officers, directors and large owners since October 2021: 9 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 4, 2026Fischetti Gary PDirectorBuy1,000$20.32$20.3KForm 4
Aug 3, 2026Fischetti Gary PDirectorBuy1,000$20.75$20.8KForm 4
May 1, 2026HENNEMAN JOHN B IIIDirectorBuy5,000$14.66$73.3KForm 4
Apr 30, 2026Griffin Stephen D.President and CEOBuy12,200$12.29$149.9KForm 4
May 11, 2022Colleran DavidEVP, General Counsel, Corp SecBuy1,500$21.37$32.1KForm 4
Mar 14, 2022Colleran DavidEVP, General Counsel, Corp SecBuy1,500$26.65$40.0KForm 4
Mar 11, 2022Thompson Jeffery SDirectorBuy2,000$24.66$49.3KForm 4
Mar 11, 2022Blanchard Cheryl RDirectorBuy8,100$25.57$207.1KForm 4
Mar 11, 2022Levitz Michael LEVP, CFO, TreasurerBuy4,000$24.62$98.5KForm 4

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Cheryl R. Blanchard, Ph.D.Executive Chair; Former President and Chief Executive Officer$750.4K$4.9M80
2025Stephen D. GriffinPresident and Chief Executive Officer; Former EVP, Chief Financial Officer and Chief Operating Officer40$500.0K$2.0M80
2025David B. Colleran EVPGeneral Counsel and Secretary$486.4K$1.6M80
2025Anne M. NunesFormer SVP, Chief Operations Officer$157.6K$946.6K80
2025Ian W. McLeodSVP, Chief Accounting Officer and Treasurer60$345.4K$765.5K80
2024Cheryl R. Blanchard, Ph.D.Executive Chair; Former President and Chief Executive Officer$743.9K$5.1M80
2024Stephen D. GriffinPresident and Chief Executive Officer; Former EVP, Chief Financial Officer and Chief Operating Officer40$1.0M$2.6M80
2024David B. Colleran EVPGeneral Counsel and Secretary$482.0K$1.7M80
2024Anne M. NunesFormer SVP, Chief Operations Officer$451.3K$1.1M80
2023Cheryl R. Blanchard, Ph.D.Executive Chair; Former President and Chief Executive Officer$726.0K$4.5M80
2023David B. Colleran EVPGeneral Counsel and Secretary$469.9K$1.6M80
2023Anne M. NunesFormer SVP, Chief Operations Officer$440.0K$1.0M80

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.1,449,671$21.2M0.0%−145,222
Caligan Partners LP1,435,130$21.0M1.0%No change
Morgan Stanley614,320$9.0M0.0%−257,746
Vanguard Capital Management LLC572,113$8.4M0.0%−33,664
Aqr Capital Management LLC559,846$8.2M0.0%+287,577
Boothbay Fund Management, LLC529,640$7.7M0.1%+137
Renaissance Technologies LLC481,417$7.0M0.0%−20,800
Dimensional Fund Advisors LP451,095$6.6M0.0%−7,752
Capital Management Corp /va448,474$6.6M1.0%+753
Deutsche Bank Ag\353,552$5.2M0.0%+378
Geode Capital Management, LLC331,577$4.9M0.0%+1,526
State Street Corp311,896$4.6M0.0%−34,196
Two Sigma Investments, LP252,964$3.7M0.0%+16,844
D. E. Shaw & Co., Inc.245,066$3.6M0.0%+15,270
Goldman Sachs Group Inc237,722$3.5M0.0%+19,844
Jacobs Levy Equity Management, Inc217,530$3.2M0.0%−48,097
Nuveen, LLC156,538$2.3M0.0%+35,821
Quantinno Capital Management LP155,257$2.3M0.0%+29,431
UBS Group AG145,816$2.1M0.0%+12,742
Man Group plc140,712$2.1M0.0%+16,419
Hillsdale Investment Management Inc.138,821$2.0M0.0%+113,421
Assenagon Asset Management S.A.126,032$1.8M0.0%+79,446
Charles Schwab Investment Management Inc113,374$1.7M0.0%−1,025
Arrowstreet Capital, Limited Partnership106,644$1.6M0.0%+75,290
American Century Companies Inc103,559$1.5M0.0%−34,025

13F reports cover disclosed long positions in U.S. stocks only.

Members of Congress who traded it

7 trades disclosed by members of Congress. “Vs S&P since” is the stock’s change since the trade minus the S&P 500’s.

DateMemberTradeAmountVs S&P sinceFiling
Mar 2, 2020Tom MalinowskiDemocratic, HouseBuy$1,001 - $15,000−202.8%Report
Feb 28, 2020Tom MalinowskiDemocratic, HouseBuy$1,001 - $15,000−212.7%Report
Feb 27, 2020Tom MalinowskiDemocratic, HouseBuy$1,001 - $15,000−210.8%Report
Jan 28, 2020Tom MalinowskiDemocratic, HousePartial sale$1,001 - $15,000+191.9%Report
Oct 29, 2019Tom MalinowskiDemocratic, HousePartial sale$1,001 - $15,000+224.9%Report
Aug 1, 2019Tom MalinowskiDemocratic, HouseBuy$50,001 - $100,000−225.3%Report
Jul 29, 2019Tom MalinowskiDemocratic, HousePartial sale$1,001 - $15,000+218.6%Report

Members report amounts as ranges, not exact figures. Returns are price-only (no dividends).

SEC filer profile

How Anika Therapeutics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARAnika Therapeutics, Inc.1
  • CIK0000898437
  • Employer ID (EIN)04-31459615
  • Filer statusAccelerated filer not an emerging growth company; not a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address32 Wiggins Avenue, Bedford, MA 017301
  • Phone(781) 457-90001
  • Shares outstanding13,382,966 as of Jul 24, 202612
  • Public float$147.3M as of Jun 30, 20255
  • AuditorDeloitte & Touche LLP, Boston, Massachusetts PCAOB ID 34; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceFeb 22, 19961
  • Filings1,096 in all: 4 (435), 8-K (219), SC 13G/A (96), 10-Q (84), 3 (37), DEF 14A (31), SC 13G (28), 10-K (27)1
    All 46 form types

    DEFA14A (25), S-8 (20), 10QSB (8), SCHEDULE 13G/A (8), 8-K/A (7), 11-K (6), UPLOAD (6), SC 13D/A (5), ARS (4), PRE 14A (4), 10-K/A (3), 10-Q/A (3), 4/A (3), CORRESP (3), 8-A12B (2), DEFR14A (2), POS AM (2), PREC14A (2), PRER14A (2), SB-2/A (2), SC 13D (2), SCHEDULE 13D/A (2), SCHEDULE 13G (2), SEC STAFF LETTER (2), 10-K405 (1), 10KSB (1), 10KSB40 (1), 11-K/A (1), 144 (1), 3/A (1), 424B1 (1), 424B3 (1), CT ORDER (1), DFAN14A (1), PRRN14A (1), S-3 (1), S-8 POS (1), SB-2 (1)

  • Latest filingsAnnual report (10-K) Mar 3, 2026
    Quarterly report (10-Q) Jul 29, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Jul 29, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.01 per shareANIKNASDAQ

From the cover page of the 10-K filed Mar 3, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Anika Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 3, 2026: 45 risks under these headings, as written.5

  • Risks Related to Our Business and Industry
  • Our financial performance depends on sales growth and increasing demand for our product portfolios, and we may not be able to successfully manage the current, and future, expansion of our operations.
  • Substantial competition could materially affect our financial performance.
  • Our business may be adversely affected if consolidation in the healthcare industry leads to demand for price concessions or if we are excluded from being a supplier by a group purchasing organization or similar entity.
  • A significant portion of our OA Pain Management revenues are derived from a small number of customers, the loss of which could materially adversely affect our business, financial condition and results of operations.
  • We experience quarterly sales volume variation, which makes our future results difficult to predict and makes period-to-period comparisons potentially not meaningful.
  • We rely on a small number of suppliers for certain key raw materials and components for the manufacturing and delivery of our products, and disruption could materially adversely affect our business, financial condition, and results of operations.
  • Our manufacturing processes involve inherent risks, and disruption could materially adversely affect our business, financial condition, and results of operations.
  • We could become subject to product liability claims, which, if successful, could materially adversely affect our business, financial condition, and results of operations.
  • Failure to comply with current or future national, international, federal or state laws and regulations, regulatory guidance and industry standards relating to data protection, privacy and information security, including restrictive European regulations, could lead to government enforcement actions (which could include civil or criminal penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.
  • The use of new and evolving technologies, such as artificial intelligence, in our business may result in spending material resources and presents risks and challenges that can impact our business including by posing security and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
  • We are increasingly dependent on sophisticated information technology and if we fail to effectively maintain or protect our information systems or data, including from data security incidents or breaches, our business could be adversely affected.
The other 34 risks
  • We may face circumstances in the future that will result in impairment charges, including, but not limited to, goodwill impairment, intangible assets impairment and in-process research and development charges.
  • Our business is dependent upon hiring and retaining qualified management, operations and technical personnel.
  • We may require additional capital in the future. We cannot give any assurance that such capital will be available at all or on terms acceptable to us, and if it is available, additional capital raised by us could dilute your ownership interest or the value of your shares.
  • Changes in tax law could adversely affect our business and financial condition.
  • Substantial changes to U.S. tax law may adversely affect our business.
  • Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect the Company’s current and projected business operations and its financial condition and results of operations.
  • The impact of the ongoing conflict between Russia and Ukraine and the conflict in the Middle East on the global economy, energy supplies and raw materials is uncertain, but may prove to negatively impact our business and operations.
  • Significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations.
  • Risks Related to Our Commercialization Activities
  • Our license agreements with J&J MedTech provide substantial control of Monovisc and Orthovisc in the United States to J&J MedTech and J&J MedTech’s actions could have a material impact on our business, financial condition and results of operations.
  • We may not succeed in our buildout of our direct sales channel in the United States, and our failure to do so could negatively impact our business and financial results.
  • We are dependent upon marketing and distribution partners and the failure to maintain strategic alliances on acceptable terms will have a material adverse effect on our business, financial condition, and results of operations.
  • Sales of our products are largely dependent upon third-party health insurance coverage and reimbursement and our performance may be harmed by health care cost containment initiatives or decisions of individual third-party payers.
  • Risks Related to Our Product Development and Regulatory Compliance
  • We are facing a longer than expected pathway to commercialize our Cingal product in the United States, and we may face other unforeseen difficulties in achieving regulatory approval for Cingal and Hyalofast, which could affect our business and financial results.
  • We may experience difficulties or delays in securing regulatory approval for Hyalofast, which could negatively affect our business and financial results.
  • Failure to obtain, or any delay in obtaining, FDA or other U.S. and foreign governmental clearances or approvals for our products may have a material adverse effect on our business, financial condition, and results of operations.
  • Once obtained, we cannot guarantee that the FDA or international product clearances or approvals will not be withdrawn or that relevant agencies will not require other corrective action, and any withdrawal or corrective action could materially affect our business and financial results.
  • Our operations and products are subject to extensive regulation, compliance with which is costly and time consuming, and our failure to comply may result in substantial penalties, including recalls of our products.
  • Any changes in the FDA or international regulations related to product approval or approval renewal, including those currently under consideration by the FDA or those that apply retroactively, could adversely affect our competitive position and materially affect our business and financial results.
  • Notices of inspectional observations or deficiencies from the FDA or other regulatory bodies require us to undertake corrective and preventive actions or other actions to address the FDA’s or other regulatory bodies' concerns. These actions could be expensive and time-consuming to complete and could impose an additional burden on us.
  • We may rely on third parties to support certain aspects of our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory clearance or approval or commercialize our products, and our business could be substantially harmed.
  • If we are found to have improperly promoted our products for off label uses, we may become subject to significant fines and other liability.
  • We are subject to various healthcare laws and regulations, and any failure to comply with applicable laws could subject us to significant liability and harm our business.
  • We are subject to environmental regulations and any failure to comply with applicable laws could subject us to significant liabilities and harm our business.
  • Risks Related to Our Growth Initiatives
  • We may have difficulty managing our growth.
  • We may not generate the expected benefits of our acquisitions, and the actions associated with the divestiture of those acquisitions could disrupt our ongoing business, distract our management and increase our expenses.
  • We expect to continue to actively explore inorganic growth as a part of our future growth strategy, which exposes us to a variety of risks that could adversely affect our business operations.
  • Customer and employee uncertainty about the effects of any acquisitions or divestitures could harm us.
  • As our international sales and operations grow, we could become increasingly subject to additional economic, political, and other risks that could harm our business.
  • Risks Related to Our Intellectual Property
  • We may be unable to adequately protect our intellectual property rights, which could have a material impact on our business and future financial results.
  • There can be no assurance that we will not infringe upon the intellectual property rights of others, which could have a significant impact on our business and financial results.
  • Risks Related to Ownership of Our Common Stock
  • Our stock price may be highly volatile, and we cannot assure you that market making in our common stock will continue.
  • Our charter documents contain anti-takeover provisions that may prevent or delay an acquisition of our company.
  • If securities or industry analysts do not publish or cease publishing research or reports about us, our business, or our market, or if they adversely change their recommendations regarding our stock, our stock price and trading volume could decline.
  • We have been, and may continue to be, subject to the actions of activist stockholders, which could cause us to incur substantial costs, divert management’s and the board’s attention and resources, and have an adverse effect on our business and stock price.

Legal proceedings

We are involved from time to time in various legal proceedings arising in the normal course of business. Although the outcomes of these legal proceedings are inherently difficult to predict, we do not expect the resolution of these proceedings to have a material adverse effect on our financial position, results of operations, or cash flows.

The opening of Item 3, Legal Proceedings.5

Sources

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