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ANGIODYNAMICS INC

ANGIODYNAMICS INC is an American surgical and medical instruments and apparatus company.2 It is headquartered in Wilmington, United States.2 Its shares trade on Nasdaq under the symbol ANGO.2

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Last updated Oct 21, 2026.

Overview

$320.2MRevenue, fiscal 20263
-$36.7MNet income, fiscal 20264

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  • TickerANGO on Nasdaq2
  • IndustrySurgical & Medical Instruments & Apparatus2
  • HeadquartersWilmington, United States2
  • Incorporated inDE5
  • Business address14 Plaza Drive, Latham, Ny 121105
  • Filer categoryAccelerated filer5
  • Legal formCorporation2
  • LEI549300W3VKC5ZKMO8C282
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O The Corporation Trust Company, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 23054162

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AngioDynamics is a dynamic, diversified medical technology company committed to expanding treatment options and improving patient outcomes and quality of life by designing, manufacturing and selling products and technologies which aid clinicians in the treatment of patients with cardiovascular disease and cancer diagnoses. Our execution strategy is built on innovative R&D, clinical and regulatory pathway expansion and customer centric sales performance.7 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 2026

54.6%Gross margin3
-12.5%Operating margin3
-11.5%Net margin4
9.5%Revenue growth, 20263
-21.5%Return on equity3
$508.0KFree cash flow3

What sells

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

Products and services

Med Device brought in 53% of the revenue ANGIODYNAMICS INC broke down this way in fiscal 2026.

  1. Med Device$170.2M353%up 3% from 2025
  2. Med Tech$150.0M347%up 18% from 2025
Products and services by year
Products and services202420252026
Med Device$197.5M$165.8M$170.2M
Med Tech$106.4M$126.7M$150.0M

Business segments

Med Device brought in 53% of the revenue ANGIODYNAMICS INC broke down this way in fiscal 2026.

  1. Med Device$170.2M353%up 3% from 2025
  2. Med Tech$150.0M347%up 18% from 2025
Business segments by year
Business segments202420252026
Med Device$197.5M$165.8M$170.2M
Med Tech$106.4M$126.7M$150.0M

Regions

United States brought in 86% of the revenue ANGIODYNAMICS INC broke down this way in fiscal 2026.

  1. United States$274.9M386%up 10% from 2025
  2. Outside the United States$45.3M314%up 9% from 2025
Regions by year
Regions202420252026
United States$251.5M$251.0M$274.9M
Outside the United States$52.4M$41.5M$45.3M

Where the money goes

Where each dollar of revenue went, fiscal 2026

  • Cost of revenue45¢$145.3M
  • Research and development9¢$29.4M
  • Other costs45¢$145.0M
  • Income tax0¢$442.0K

Out of $320.2M in revenue.34 The company lost money this year.

Where each dollar of operating cash went, fiscal 2026

  • Capital spending84¢$2.6M
  • Kept or used elsewhere16¢$508.0K

Out of $3.1M of cash from operations.3

Financial statements

Revenue891011123$320.2M in 2026+18% since 2019
0$100.0M$200.0M$300.0M$400.0M2019: $270.6M$270.6M20192020: $264.2M$264.2M2020−2%2021: $291.0M$291.0M2021+10%2022: $316.2M$316.2M2022+9%2023: $338.8M$338.8M2023+7%2024: $303.9M$303.9M2024−10%2025: $292.5M$292.5M2025−4%2026: $320.2M$320.2M2026+9%
Gross profit891011123$174.9M in 2026+12% since 2019
0$50.0M$100.0M$150.0M$200.0M2019: $156.0M$156.0M20192020: $150.3M$150.3M2020−4%2021: $156.8M$156.8M2021+4%2022: $165.7M$165.7M2022+6%2023: $174.2M$174.2M2023+5%2024: $154.7M$154.7M2024−11%2025: $157.7M$157.7M2025+2%2026: $174.9M$174.9M2026+11%
Operating income891011123-$39.9M in 2026+325% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$9.4M-$9.4M20192020: -$167.1M-$167.1M2020+1678%2021: -$35.3M-$35.3M2021−79%2022: -$28.5M-$28.5M2022−19%2023: -$51.2M-$51.2M2023+80%2024: -$192.4M-$192.4M2024+276%2025: -$40.0M-$40.0M2025−79%2026: -$39.9M-$39.9M2026−0%
Net income894-$36.7M in 2026
-$200.0M-$100.0M0$100.0M2019: $61.3M$61.3M20192020: -$166.8M-$166.8M20202021: -$31.5M-$31.5M2021−81%2022: -$26.5M-$26.5M2022−16%2023: -$52.4M-$52.4M2023+98%2024: -$184.3M-$184.3M2024+252%2025: -$34.0M-$34.0M2025−82%2026: -$36.7M-$36.7M2026+8%

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

Period ending2026-05-312025-05-312024-05-31
Net sales$320.2M$292.5M$303.9M
Cost of sales (exclusive of intangible amortization)$145.3M$134.8M$149.2M
Gross margin$174.9M$157.7M$154.7M
Research and development$29.4M$26.2M$31.5M
Sales and marketing$113.4M$103.1M$102.8M
General and administrative$43.7M$42.1M$41.2M
Amortization of intangibles$10.7M$10.3M$13.0M
Goodwill impairment$0$0$159.5M
Change in fair value of contingent consideration$0$272.0K$432.0K
Acquisition, restructuring and other items, net$17.6M$15.6M$53.2M
Total operating expenses$214.8M$197.7M$401.6M
Gain on sale of assets$0$0$54.5M
Operating loss-$39.9M-$40.0M-$192.4M
Interest income (expense), net-$299.0K$978.0K$1.6M
Other income (expense), net$3.9M$4.9M-$817.0K
Total other income, net$3.6M$5.9M$797.0K
Loss before income tax expense (benefit)-$36.3M-$34.0M-$191.6M
Income tax expense (benefit)$442.0K-$39.0K-$7.3M
Net loss-$36.7M-$34.0M-$184.3M
Basic (usd per share)-$0.88-$0.83-$4.59
Diluted (usd per share)-$0.88-$0.83-$4.59
Basic (in shares)41.5M shares40.9M shares40.2M shares
Diluted (in shares)41.5M shares40.9M shares40.2M shares

Compare ANGIODYNAMICS INC with another company

Corporate structure

ANGIODYNAMICS INC sits at the top of its group. 9 entities, 8 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of ANGIODYNAMICS INC

  • ANGIODYNAMICS INC Wilmington, Delaware, United States
    • AngioDynamics Canada Inc. Subsidiary · Canada
    • AngioDynamics France, SARL Subsidiary · France
    • AngioDynamics Italy S.r.l Subsidiary · Italy
    • AngioDynamics Medical Brasil Servicos de Marketing Ltda. Subsidiary · Brazil
    • AngioDynamics Netherlands B. V. Subsidiary · Netherlands
    • AngioDynamics UK Limited Subsidiary · United Kingdom
    • Eximo Medical, Ltd. Subsidiary · Israel
    • RITA Medical Systems, LLC Subsidiary · Delaware, United States

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 ANGIODYNAMICS 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, net$27.1M3 May 31, 2026$32.3M3 May 31, 2025−16.1%
Operating-lease assets (leased space)$5.1M3 May 31, 2026$3.9M3 May 31, 2025+31.2%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$53.9M3 May 31, 2026$55.9M3 May 31, 2025−3.6%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$67.2M3 May 31, 2026$69.1M3 May 31, 2025−2.8%
Finite-lived intangibles, gross$207.5M3 May 31, 2026$192.4M3 May 31, 2025+7.9%
Accumulated amortization$140.3M3 May 31, 2026$123.2M3 May 31, 2025+13.8%
Finite-lived intangibles, net$67.2M3 May 31, 2026$69.1M3 May 31, 2025−2.8%

Inventory

ItemLatestA year beforeChange
Inventory, total$52.4M3 May 31, 2026$62.0M3 May 31, 2025−15.4%
Raw materials$19.3M3 May 31, 2026$27.5M3 May 31, 2025−29.8%
Work in process$5.7M3 May 31, 2026$7.5M3 May 31, 2025−23.9%
Finished goods$27.4M3 May 31, 2026$27.0M3 May 31, 2025+1.5%

Properties, in its own words

During the year ended May 31, 2026, we operated in the following locations:

Location · Purpose · Approx.Sq. Ft. · PropertyType

The rest of Item 2

Latham, NY · Corporate headquarters · 18,600 · Leased

Glens Falls, NY · Manufacturing · 21,000 · Leased

Queensbury, NY · Manufacturing · 135,000 · Leased

Queensbury, NY · Distribution · 58,000 · Leased

Marlborough, MA · Research and development · 17,200 · Leased

Rehovot, IL · Research and development · 4,300 · Leased

In addition, we lease sales offices in various other jurisdictions.

Item 2 of the 10-K filed Jul 14, 2026.7

Leadership

Who has led ANGIODYNAMICS INC, and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Eamonn P. Hobbs2006–2009
  2. Jan Keltjens2009–2011
  3. Scott J. Solano2011
  4. Joseph Devivo2011–2015
  5. James C. Clemmer2016–now

President

  1. Eamonn P. Hobbs2006–2009
  2. William M. Appling2006–2010
  3. Jan Keltjens2009–2011
  4. Joseph Devivo2011–2015
  5. James C. Clemmer2016–now

Chief financial officer

  1. Joseph G. Gerardi2006–2007
  2. D. Joseph Gersuk2007–2012
  3. Mark T. Frost2013–2015
  4. Michael Greiner2016–2019
  5. Stephen A. Trowbridge2020–now

Chief operating officer

  1. Robert D. Mitchell2006–2007
  2. George W. Bourne Iv.2013–2014
2010201520202025
Board members and other officers (47)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • AngioDynamics Canada Inc. Canada6
  • AngioDynamics France, SARL France6
  • AngioDynamics Italy S.r.l Italy6
  • AngioDynamics Medical Brasil Servicos de Marketing Ltda. Brazil6
  • AngioDynamics Netherlands B. V. Netherlands6
  • AngioDynamics UK Limited United Kingdom6
  • Eximo Medical, Ltd. Israel6
  • RITA Medical Systems, LLC Delaware6

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

Timeline

  1. Oct 8, 20268-K Entered a material agreement; Executive or director change76
  2. Oct 8, 20268-K Results of operations; Regulation FD disclosure77
  3. Jul 14, 20268-K Results of operations; Regulation FD disclosure78
  4. Apr 23, 20268-K Other events79
  5. Apr 2, 20268-K Results of operations; Regulation FD disclosure80
  6. Feb 3, 20268-K Executive or director change81
  7. Jan 14, 20268-K Regulation FD disclosure82
  8. Jan 6, 20268-K Results of operations; Regulation FD disclosure83
  9. Nov 12, 20258-K Shareholder vote84
  10. Oct 2, 20258-K Results of operations; Regulation FD disclosure85
  11. Jul 15, 20258-K Results of operations; Regulation FD disclosure86
  12. May 28, 20258-K Entered a material agreement; New debt or obligation87
  13. Apr 5, 2016New chief executive James C. Clemmer becomes CEO18
  14. Sep 9, 2011New chief executive Joseph Devivo becomes CEO20
  15. Aug 5, 2011New chief executive Scott J. Solano becomes CEO19
  16. Mar 3, 2009New chief executive Jan Keltjens becomes CEO21
  17. Jan 5, 2006New chief executive Eamonn P. Hobbs becomes CEO22

Calendar

Coming up

  1. Around Jan 2, 2027Next results, estimated About a quarter after its last report. The company hasn't announced the date.

When it reported results

  1. Oct 8, 2026Reported quarterly or annual results77
  2. Jul 14, 2026Reported quarterly or annual results78
  3. Apr 2, 2026Reported quarterly or annual results80
  4. Jan 6, 2026Reported quarterly or annual results83
  5. Oct 2, 2025Reported quarterly or annual results85
  6. Jul 15, 2025Reported quarterly or annual results86
  7. Apr 2, 2025Reported quarterly or annual results88
  8. Jan 8, 2025Reported quarterly or annual results89

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

Filings

302 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 53 major events, 166 insider forms, 42 large holders, 19 other. The latest 20:

  1. Oct 8, 202610-Q EDGAR
  2. Oct 8, 2026DEFA14A EDGAR
  3. Oct 8, 2026DEF 14A EDGAR
  4. Oct 8, 20268-K EDGAR
  5. Oct 8, 20268-K EDGAR
  6. Sep 29, 202610-K/A EDGAR
  7. Sep 29, 202610-K/A EDGAR
  8. Jul 31, 20264 EDGAR
  9. Jul 30, 2026144 EDGAR
  10. Jul 24, 20264 EDGAR
  11. Jul 24, 20264 EDGAR
  12. Jul 24, 20264 EDGAR
  13. Jul 24, 20264 EDGAR
  14. Jul 24, 20264 EDGAR
  15. Jul 22, 20264 EDGAR
  16. Jul 22, 20264 EDGAR
  17. Jul 22, 20264 EDGAR
  18. Jul 22, 20264 EDGAR
  19. Jul 22, 20264 EDGAR
  20. Jul 22, 20264 EDGAR

The 302 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

22 open-market trades by officers, directors and large owners since October 2021: 12 buys and 10 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jul 30, 2026Nighan Warren JRSVP Quality and RegulatorySale23,370$14.72$344.0KForm 4
Oct 21, 2025Weiss Lawrence TSVP, Chief Legal OfficerBuy10,000$11.81$118.1KForm 4
Oct 13, 2025Trowbridge Stephen AEVP and CFOBuy890$11.16$9.9KForm 4
Oct 9, 2025Clemmer James CPresident and CEOBuy10,000$11.15$111.5KForm 4
Jan 16, 2025Nighan Warren JRSVP Quality and RegulatorySale4,060$12.31$50.0KForm 4
Oct 10, 2024Nighan Warren JRSVP Quality and RegulatoryBuy100$6.08$608Form 4
Oct 8, 2024Trowbridge Stephen AEVP and CFOBuy1,700$5.86$10.0KForm 4
Oct 7, 2024Nighan Warren JRSVP Quality and RegulatoryBuy768$6.09$4.7KForm 4
Oct 7, 2024Clemmer James CPresident and CEOBuy20,000$6.03$120.6KForm 4
Apr 8, 2024Clemmer James CPresident and CEOBuy10,000$6.70$67.0KForm 4
Jan 31, 2023Helsel DaveSVP Global Operations and R&DSale4,633$12.95$60.0KForm 4
Oct 12, 2022Trowbridge Stephen AEVP and CFOBuy1,083$13.82$15.0KForm 4
Oct 10, 2022Clemmer James CPresident and CEOBuy10,000$15.00$150.0KForm 4
Jul 29, 2022Helsel DaveSVP Global Operations and R&DSale5,000$22.44$112.2KForm 4
Apr 28, 2022Helsel DaveSVP Global Operations and R&DSale3,513$22.44$78.8KForm 4
Apr 12, 2022JOHNSON WESLEYDirectorSale1,299$23.26$30.2KForm 4
Apr 11, 2022JOHNSON WESLEYDirectorSale6,201$23.00$142.6KForm 4
Jan 12, 2022Trowbridge Stephen AEVP and CFOBuy1,000$22.64$22.6KForm 4
Jan 11, 2022Clemmer James CPresident and CEOBuy10,000$22.84$228.4KForm 4
Oct 20, 2021Helsel DaveSVP Global Operations and R&DSale3,494$27.97$97.7KForm 4

All 22 trades can be filtered by person here when JavaScript is on.

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
2026James C. ClemmerPresident, CEO$828.2K$6.1M102
2026Stephen A. TrowbridgeEVP, CFO$471.3K$2.7M102
2026Laura PiccininiSVP & GM, Cardiovascular and International$470.6K$1.6M102
2026Lawrence T. WeissSVP, Chief Legal Officer & Corporate Secretary$439.4K$1.5M102
2026Warren NighanSVP & GM, Global Supply Chain, Quality and Regulatory Affairs$416.3K$1.4M102
2025James C. ClemmerPresident, CEO$803.0K$5.5M102
2025Stephen A. TrowbridgeEVP, CFO$455.8K$2.2M102
2025Laura PiccininiSVP & GM, Cardiovascular and International$410.1K$1.4M102
2025Lawrence T. WeissSVP, Chief Legal Officer & Corporate Secretary$206.7K$1.2M102
2025Warren NighanSVP & GM, Global Supply Chain, Quality and Regulatory Affairs$401.3K$1.2M102
2024James C. ClemmerPresident, CEO$783.0K$5.0M102
2024Stephen A. TrowbridgeEVP, CFO$441.3K$1.8M102
2024Laura PiccininiSVP & GM, Cardiovascular and International$401.3K$1.2M102
2024Warren NighanSVP & GM, Global Supply Chain, Quality and Regulatory Affairs$392.7K$995.1K102

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.3,803,232$49.5M0.0%+117,328
Point72 Asset Management, L.P.3,062,517$39.8M0.1%−119,312
Systematic Financial Management LP2,640,214$34.3M0.7%+186,513
Armistice Capital, LLC2,198,000$28.6M0.8%+329,000
Royce & Associates LP1,969,835$25.6M0.2%+440,884
Broadfin Holdings LLC1,818,533$23.7M100.0%−250,800
Vanguard Capital Management LLC1,694,716$22.0M0.0%−32,104
Weber Capital Management LLC /adv1,356,602$17.6M15.0%−16,547
Nuveen, LLC1,199,358$15.6M0.0%−16,807
Geode Capital Management, LLC1,020,658$13.3M0.0%+35,235
Dimensional Fund Advisors LP969,497$12.6M0.0%+20,682
State Street Corp958,167$12.5M0.0%−375,691
Segall Bryant & Hamill, LLC926,711$12.1M0.1%−39,254
Bastion Asset Management Inc.923,270$10.8M3.7%−389,732
Pier Capital, LLC806,678$10.5M1.4%+9,982
Millennium Management LLC783,125$10.2M0.0%+138,448
Renaissance Technologies LLC733,883$9.5M0.0%−69,400
Arrowstreet Capital, Limited Partnership692,534$9.0M0.0%−65,916
Paradigm Capital Management Inc/ny671,200$8.7M0.2%−47,000
Aqr Capital Management LLC589,157$7.7M0.0%+337,643
First Eagle Investment Management, LLC552,870$7.2M0.0%+277,135
Vanguard Portfolio Management LLC440,844$5.7M0.0%+4,359
Marshall Wace, Llp420,378$5.5M0.0%−65,126
Western Standard LLC387,188$5.0M1.7%New
Goldman Sachs Group Inc382,917$5.0M0.0%+68,828

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

Members of Congress who traded it

3 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
Oct 20, 2025Debbie Wasserman SchultzDemocratic, HouseSale$2,000+19.9%Report
Jul 16, 2025Debbie Wasserman SchultzDemocratic, HouseSale$1,001 - $15,000−7.1%Report
Jun 27, 2025Debbie Wasserman SchultzDemocratic, HouseBuy$1,001 - $15,000−10.6%Report

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

SEC filer profile

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

  • Name on EDGARANGIODYNAMICS INC1
  • CIK0001275187
  • Employer ID (EIN)11-31464607
  • Filer statusAccelerated filer not an emerging growth company; not a smaller reporting company; not a shell company7
  • Incorporated inDelaware7
  • Fiscal year endsMay 311
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address14 Plaza Drive, Latham, NY 121101
  • Phone51879812151
  • Shares outstanding42,054,450 as of Oct 7, 202615
  • Public float$436.3M as of Nov 30, 20257
  • AuditorDeloitte & Touche LLP, Boston, Massachusetts PCAOB ID 34; it also attests to the company’s internal control over financial reporting7
  • On EDGAR sinceMar 5, 20041
  • Filings1,681 in all: 4 (939), 8-K (266), SC 13G/A (88), 10-Q (67), 3 (65), DEFA14A (31), SC 13G (27), 4/A (24)1
    All 41 form types

    10-K (23), DEF 14A (23), S-8 (13), SCHEDULE 13G/A (11), SC 13D/A (10), UPLOAD (10), 3/A (8), 10-Q/A (7), SCHEDULE 13G (7), 10-K/A (6), 424B7 (6), 8-K/A (6), CORRESP (5), ARS (4), SC 13D (4), 425 (3), EFFECT (3), S-1/A (3), S-3/A (3), 144 (2), 424B4 (2), 8-A12G (2), DEFR14A (2), S-3 (2), 424A (1), 8-A12G/A (1), DEFM14A (1), NT 10-Q (1), PRE 14A (1), PREM14A (1), S-1 (1), S-4 (1), S-4/A (1)

  • Latest filingsAnnual report (10-K) Jul 14, 2026
    Quarterly report (10-Q) Oct 8, 2026
    Proxy statement (DEF 14A) Oct 8, 2026
    Latest 8-K (8-K) Oct 8, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $.01 per shareANGONASDAQ Global Select Market

From the cover page of the 10-K filed Jul 14, 2026 (Section 12(b) of the Exchange Act).7

Risk factors and legal proceedings

The risks ANGIODYNAMICS INC names in Item 1A of its 10-K filed Jul 14, 2026: 34 risks under these headings, as written.7

  • RISKS RELATED TO OUR BUSINESS AND INDUSTRY
  • We face intense competition in the medical device industry which continues to experience consolidation. We may be unable to compete effectively with respect to technological innovation and price which may have a material adverse effect on our revenues, financial condition, results of operations and/or liquidity.
  • Our inability to continue to effectively develop, acquire and/or market new products and technologies could have a material adverse effect on our business, financial condition and/or results of operations.
  • If we do not maintain our reputation with interventional physicians, interventional and surgical oncologists, and critical care nurses, our growth will be limited and our business could be harmed.
  • Our business and prospects rely heavily upon our ability to successfully complete clinical trials, including, but not limited to, our Ambition BTK clinical study. We may choose to, or may be required to, suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the trials are not well designed.
  • We are dependent on single and limited source suppliers which subjects our business and results of operations to risks of supplier business interruptions.
  • We rely on third-party manufacturers to manufacture some of our products today, and we have announced a plan to move to a partially outsourced model for manufacturing in various parts of the world, which exposes us to additional risks, including reduced control over manufacturing, delivery timing, product quality issues, potential price fluctuations, regulatory, environmental, labor or other operational disruptions, which would result in a loss of revenue or reduced profitability.
  • We are heavily dependent on third-party distributors to generate a substantial portion of our international revenues and are at the risk of these distributors also selling for our competitors, failing to be financially viable and failing to effectively distribute our products in compliance with applicable laws.
  • We face currency and other risks associated with international sales.
  • If we are unable to convince customers that our products can improve the cost structure of their business, or to secure adequate reimbursement for our products our revenue growth and profitability may be materially and adversely impacted.
  • Pending or future product liability claims brought against us, especially if our product liability insurance coverage is inadequate, could adversely impact our business, operations and financial results.
  • We may be exposed to risks associated with product line divestitures as we may never realize the expected benefits and could cause operational disruptions with personnel, systems and infrastructure changes.
The other 23 risks
  • International and national economic and industry conditions constantly change, and could materially and adversely affect our business, financial condition and results of operations.
  • Our business could be harmed if we cannot hire or retain qualified personnel or fail to successfully manage the transition to a new Chief Executive Officer.
  • If we are unable to manage our growth profitably, our business, financial results and stock price could suffer.
  • We may fail to attract additional capital necessary to expand our business or may incur indebtedness which could impose operating and financial restrictions on us as a result of debt service obligations which could significantly limit our ability to execute our business strategy or curtail our growth.
  • Inflationary pressure and unfavorable economic conditions could negatively affect our operations and business.
  • Our intangible assets and fixed assets are subject to potential impairment; we have historically recorded significant impairment charges and may be required to record additional charges to future earnings if our assets become impaired.
  • We may be limited in our ability to utilize, or may not be able to utilize, net operating loss carryforwards to reduce our future tax liability.
  • A cyber-attack or other breach of our, our distributors, or our supply chain partners' information technology systems could have a material adverse effect on our business, financial condition and/or results of operations.
  • Artificial intelligence based platforms present new risks and challenges to our business.
  • Any disaster at our manufacturing facilities or those of our suppliers could disrupt our ability to manufacture our products for a substantial amount of time.
  • Anti-takeover provisions in our organizational documents and Delaware law may discourage or prevent a change of control, even if an acquisition would be beneficial to our stockholders, which could cause our stock price to decline and prevent attempts by our stockholders to replace or remove our current management.
  • Global health crises, pandemics, epidemics or other outbreaks could adversely impact our business, operations and financial results.
  • We could be negatively impacted by Environmental, Social and Governance (ESG), climate change and other sustainability-related matters.
  • RISKS RELATED TO THE REGULATORY ENVIRONMENT
  • We are subject to a comprehensive system of federal, state and international laws and regulations, and we could be the subject of investigations, enforcement actions or face lawsuits and monetary or equitable judgments.
  • If we or some of our suppliers fail to comply with the FDA’s Quality System Regulation, or QSR, and other applicable post-market requirements, our manufacturing operations could be disrupted, our product sales and profitability could suffer, and we may be subject to a wide variety of FDA enforcement actions.
  • If we cannot obtain and maintain marketing clearance or approval from governmental agencies, we will not be able to sell our products.
  • Our products may be subject to product recalls, which may harm our reputation and divert managerial and financial resources.
  • We may be subject to fines, penalties, injunctions or costly investigations if we are determined to be promoting the use of our products for unapproved or “off-label” uses.
  • Laws and regulations governing the export of our products could adversely impact our business. If the U.S. government imposes strict sanctions on certain countries, our revenue could be impacted.
  • RISKS RELATED TO INTELLECTUAL PROPERTY
  • If we fail to adequately protect our intellectual property rights, we may not be able to generate revenues from new or existing products and our business may suffer.
  • If third parties claim that our products infringe their intellectual property rights, we may be forced to expend significant financial resources and management time defending against such actions and our financial condition and our results of operations could suffer.
  • RISKS RELATED TO OUR STOCK PRICE
  • Our future operating results are difficult to predict and may vary significantly from quarter to quarter, which may adversely affect the price of our common stock.
  • Our stock price may be volatile, which may cause the value of our stock to decline or subject us to a securities class action litigation.

Legal proceedings

Information regarding legal proceedings is included in Note 17 to our consolidated financial statements in this Annual Report on Form 10-K.

The opening of Item 3, Legal Proceedings.7

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