OSUR on Nasdaq

ORASURE TECHNOLOGIES INC

ORASURE TECHNOLOGIES INC is an American surgical and medical instruments and apparatus company.1 It is headquartered in Bethlehem, Pennsylvania.1 Its shares trade on Nasdaq under the symbol OSUR.1

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Last updated Oct 21, 2026.

Overview

Compare with Anika Therapeutics, Inc., Intersect ENT or Beta Bionics, Inc., or pick any stock.

  • TickerOSUR on Nasdaq1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersBethlehem, Pennsylvania1
  • Incorporated inDE2
  • Business address220 E First St, Bethlehem, Pa 180152
  • Filer categoryAccelerated filer2

OTI transforms health through actionable insight and decentralizes diagnostics to connect people to healthcare wherever they are.4 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

41.9%Gross margin5
-62.6%Operating margin5
-59.8%Net margin5
-38.1%Revenue growth, 20255
-20.2%Return on equity5
-$53.2MFree cash flow5

What sells

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

Products and services

Product And Services brought in 95% of the revenue ORASURE TECHNOLOGIES INC broke down this way in fiscal 2025.

  1. Product And Services$109.1M595%down 41% from 2024
  2. Other Revenues$6.0M55%up 391% from 2024
Products and services by year
Products and services202320242025
Product And Services$402.2M$184.6M$109.1M
Other Revenues$3.2M$1.2M$6.0M

Regions

United States brought in 68% of the revenue ORASURE TECHNOLOGIES INC broke down this way in fiscal 2025.

  1. United States$78.3M568%down 44% from 2024
  2. Africa$24.0M521%down 27% from 2024
  3. Europe$7.4M56%down 12% from 2024
  4. Other Foreign Countries$5.4M55%down 2% from 2024
Regions by year
Regions202320242025
United States$361.7M$139.2M$78.3M
Africa$29.3M$32.7M$24.0M
Europe$8.1M$8.4M$7.4M
Other Foreign Countries$6.4M$5.5M$5.4M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue58¢$66.8M
  • Research and development37¢$42.5M
  • Other costs3¢$3.9M
  • Income tax2¢$1.8M

Out of $115.0M in revenue.5 The company lost money this year.

Financial statements

Revenue67895$115.0M in 2025−26% since 2019
0$200.0M$400.0M$600.0M2019: $154.6M$154.6M20192020: $171.7M$171.7M2020+11%2021: $233.7M$233.7M2021+36%2022: $387.5M$387.5M2022+66%2023: $405.5M$405.5M2023+5%2024: $185.8M$185.8M2024−54%2025: $115.0M$115.0M2025−38%
Gross profit67895$48.2M in 2025−49% since 2019
0$50.0M$100.0M$150.0M$200.0M2019: $94.6M$94.6M20192020: $101.9M$101.9M2020+8%2021: $117.6M$117.6M2021+15%2022: $148.4M$148.4M2022+26%2023: $171.7M$171.7M2023+16%2024: $79.4M$79.4M2024−54%2025: $48.2M$48.2M2025−39%
Operating income67895-$72.0M in 2025
-$100.0M-$50.0M0$50.0M2019: $18.6M$18.6M20192020: -$5.2M-$5.2M20202021: -$10.2M-$10.2M2021+96%2022: -$22.2M-$22.2M2022+118%2023: $32.7M$32.7M20232024: -$28.2M-$28.2M20242025: -$72.0M-$72.0M2025+155%
Net income67895-$68.7M in 2025
-$100.0M-$50.0M0$50.0M$100.0M2019: $16.7M$16.7M20192020: -$14.9M-$14.9M20202021: -$23.0M-$23.0M2021+54%2022: -$17.1M-$17.1M2022−26%2023: $53.7M$53.7M20232024: -$19.5M-$19.5M20242025: -$68.7M-$68.7M2025+252%

Every line of the income statement as filed: the last 3 fiscal years, latest first.5

Period ending2025-12-312024-12-312023-12-31
Total revenue$115.0M$185.8M$405.5M
COST OF PRODUCTS AND SERVICES SOLD$66.8M$106.4M$233.8M
Gross profit$48.2M$79.4M$171.7M
Research and development$42.5M$26.0M$33.7M
Sales and marketing$26.1M$31.0M$36.3M
General and administrative$47.7M$46.2M$58.2M
Loss on impairments$0$4.4M$10.8M
Change in the estimated fair value of acquisition-related contingent consideration$4.6M$0-$99.0K
Gain on sale of assets-$725.0K$0$0
Total operating expenses$120.2M$107.6M$139.0M
Operating (loss) income-$72.0M-$28.2M$32.7M
OTHER INCOME$7.4M$12.2M$23.6M
(Loss) income before income taxes and equity investment-$64.6M-$16.0M$56.3M
INCOME TAX EXPENSE$1.8M$1.8M$2.6M
(LOSS) INCOME BEFORE EQUITY INVESTMENT-$66.4M-$17.8M$53.7M
LOSS ON EQUITY INVESTMENT-$2.3M-$1.7M$0
NET (LOSS) INCOME-$68.7M-$19.5M$53.7M
Basic earnings per share (in US dollars per share)-$0.94-$0.26$0.73
Diluted earnings per share (in US dollars per share)-$0.94-$0.26$0.72
Basic weighted average number of shares outstanding (in shares)73.5M shares74.4M shares73.3M shares
Diluted weighted average number of shares outstanding (in shares)73.5M shares74.4M shares74.4M shares

Compare ORASURE TECHNOLOGIES INC with another company

Corporate structure

ORASURE TECHNOLOGIES INC sits at the top of its group. 5 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of ORASURE TECHNOLOGIES INC

  • Islet Management, LP Filed SCHEDULE 13D on ORASURE TECHNOLOGIES INC, latest Sep 17, 2026
  • GAGNON SECURITIES LLC Filed SCHEDULE 13G on ORASURE TECHNOLOGIES INC, latest Aug 12, 2026 (4 filings since Nov 17, 2025)
  • PRIVATE MANAGEMENT GROUP INC Filed SCHEDULE 13G/A on ORASURE TECHNOLOGIES INC, latest Jul 31, 2026 (3 filings since May 5, 2025)
  • VANGUARD CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on ORASURE TECHNOLOGIES INC, latest Apr 30, 2026
  • Altai Capital Management, L.P. Filed SCHEDULE 13D/A on ORASURE TECHNOLOGIES INC, latest Apr 20, 2026 (5 filings since Sep 9, 2025)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on ORASURE TECHNOLOGIES INC, latest Mar 27, 2026 (6 filings since Feb 10, 2022)
  • DIMENSIONAL FUND ADVISORS LP Filed SCHEDULE 13G/A on ORASURE TECHNOLOGIES INC, latest Oct 9, 2025 (2 filings since Feb 9, 2024)
  • EARNEST PARTNERS LLC Filed SCHEDULE 13G/A on ORASURE TECHNOLOGIES INC, latest Sep 3, 2025 (2 filings since Feb 8, 2022)
  • Camber Capital Management LP Filed SCHEDULE 13G/A on ORASURE TECHNOLOGIES INC, latest May 15, 2025 (3 filings since Nov 8, 2021)
  • BlackRock Filed SCHEDULE 13G/A on ORASURE TECHNOLOGIES INC, latest Apr 23, 2025 (6 filings since Jan 28, 2022)
  • Neuberger Berman Filed SCHEDULE 13G on ORASURE TECHNOLOGIES INC, latest Apr 4, 2025 (3 filings since Oct 4, 2024)
  • MANAGED ACCOUNT ADVISORS LLC Filed SC 13G/A on ORASURE TECHNOLOGIES INC, latest Feb 7, 2023 (2 filings since Jan 26, 2022)
  • ORASURE TECHNOLOGIES INC Bethlehem, Pennsylvania
    • BioMedomics, Inc. Subsidiary · Delaware, United States
    • DNA Genotek Inc. Subsidiary · Canada
    • Sense Biodetection Limited Subsidiary · United Kingdom
    • Sherlock Biosciences, Inc Subsidiary · Delaware, United States

Built from 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 ORASURE TECHNOLOGIES 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$102.1M5 Dec 31, 2025$111.0M5 Dec 31, 2024−8.1%
Accumulated depreciation$62.9M5 Dec 31, 2025$65.9M5 Dec 31, 2024−4.6%
Property and equipment, net$39.2M5 Dec 31, 2025$45.1M5 Dec 31, 2024−13.1%
Finance-lease assets$146.0K5 Dec 31, 2025$145.0K5 Dec 31, 2024+0.7%
Operating-lease assets (leased space)$12.0M5 Dec 31, 2025$13.4M5 Dec 31, 2024−10.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$199.3M5 Dec 31, 2025$267.8M5 Dec 31, 2024−25.6%
Debt securities available for sale$05 Dec 31, 2025$05 Dec 31, 2024

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$43.4M5 Dec 31, 2025$40.3M5 Dec 31, 2024+7.5%
Intangible assets, net (excluding goodwill)$19.0M5 Dec 31, 2025$17.4M5 Dec 31, 2024+9.2%
Finite-lived intangibles, gross$29.2M5 Dec 31, 2025$32.8M5 Dec 31, 2024−11.0%
Accumulated amortization$27.2M5 Dec 31, 2025$32.4M5 Dec 31, 2024−16.1%
Finite-lived intangibles, net$2.0M5 Dec 31, 2025$435.0K5 Dec 31, 2024+370.3%

Inventory

ItemLatestA year beforeChange
Inventory, total$31.1M5 Dec 31, 2025$34.2M5 Dec 31, 2024−9.2%
Raw materials$14.8M5 Dec 31, 2025$17.0M5 Dec 31, 2024−12.8%
Work in process$56.0K5 Dec 31, 2025$420.0K5 Dec 31, 2024−86.7%
Finished goods$14.2M5 Dec 31, 2025$13.9M5 Dec 31, 2024+2.3%

Properties, in its own words

The Company owns a 31,700 square foot facility that houses its primary corporate office, sales and marketing, research and development, human resources, and regulatory and quality offices. The Company also owns a 48,000 square foot facility and a 33,500 square foot facility which are used for manufacturing activities. The Company also leases a 139,000 square foot manufacturing facility. Each of these facilities is located in Bethlehem, Pennsylvania. The Company's subsidiary, DNAG, also leases a 36,000 square foot facility in Ottawa, Canada, which is used as its primary corporate office and houses sales and marketing, manufacturing, distribution, research and development, and regulatory and quality operations. The Company's subsidiary, Sherlock, leases various facilities in the United Kingdom totaling approximately 37,600 square feet, as well as outside Boston, Massachusetts, totaling approximately 5,000 square feet. These facilities house Sherlock's corporate offices, production, and research and development activities. The Company's subsidiary, BioMedomics, leases a building in North Carolina totaling approximately 2,000 square feet. The facility houses BioMedomics' corporate offices, production, and research and development activities.

The Company believes that the facilities described above are adequate for its current requirements.

Item 2 of the 10-K filed Mar 9, 2026.4

Leadership

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

Board members and other officers (35)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • BioMedomics, Inc. Delaware3
  • DNA Genotek Inc. Canada3
  • Sense Biodetection Limited England and Wales3
  • Sherlock Biosciences, Inc Delaware3

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

Timeline

  1. Aug 5, 20268-K Results of operations54
  2. Jun 11, 20268-K Other events55
  3. Jun 3, 20268-K Executive or director change; Bylaws or fiscal year changed; Shareholder vote56
  4. May 6, 20268-K Results of operations; Regulation FD disclosure57
  5. Apr 17, 20268-K Entered a material agreement; Executive or director change; Regulation FD disclosure58
  6. Mar 30, 20268-K Regulation FD disclosure59
  7. Mar 5, 20268-K Executive or director change60
  8. Feb 25, 20268-K Results of operations; Regulation FD disclosure61
  9. Jan 5, 20268-K Regulation FD disclosure; Other events62
  10. Dec 1, 20258-K Other events63
  11. Nov 5, 20258-K Results of operations; Regulation FD disclosure64
  12. Oct 28, 20258-K Executive or director change65
  13. Jun 6, 2022New chief executive Manner Carrie Eglinton becomes CEO13

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. Aug 5, 2026Reported quarterly or annual results54
  2. May 6, 2026Reported quarterly or annual results57
  3. Feb 25, 2026Reported quarterly or annual results61
  4. Nov 5, 2025Reported quarterly or annual results64
  5. Aug 5, 2025Reported quarterly or annual results67
  6. May 7, 2025Reported quarterly or annual results68
  7. Feb 25, 2025Reported quarterly or annual results69
  8. Nov 6, 2024Reported quarterly or annual results70

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

Filings

315 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 59 major events, 144 insider forms, 38 large holders, 54 other. The latest 20:

  1. Oct 1, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  2. Sep 17, 2026SCHEDULE 13D EDGAR
  3. Sep 9, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  4. Aug 12, 2026SCHEDULE 13G EDGAR
  5. Aug 7, 2026S-8 EDGAR
  6. Aug 7, 202610-Q EDGAR
  7. Aug 5, 20268-K EDGAR
  8. Jul 31, 2026SCHEDULE 13G/A EDGAR
  9. Jun 30, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  10. Jun 11, 20268-K EDGAR
  11. Jun 5, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  12. Jun 5, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  13. Jun 5, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  14. Jun 5, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  15. Jun 5, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  16. Jun 5, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  17. Jun 3, 20268-K EDGAR
  18. May 14, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  19. May 14, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
  20. May 14, 20263 INITIAL STATEMENT OF BENEFICIAL OWNERSHIP OF SECURITIES EDGAR

The 315 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

21 open-market trades by officers, directors and large owners since October 2021: 19 buys and 2 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 14, 2026Boyd Steven KyleDirectorBuy25,000$2.99$74.8KForm 4
May 13, 2026Boyd Steven KyleDirectorBuy25,000$3.02$75.5KForm 4
May 12, 2026Boyd Steven KyleDirectorBuy25,000$2.98$74.5KForm 4
Mar 20, 2026McGrath Kenneth JChief Financial OfficerBuy32,300$2.93$94.6KForm 4
Mar 20, 2026EGLINTON MANNER CARRIEPresident & CEOBuy32,300$2.93$94.6KForm 4
Mar 13, 2026McGrath Kenneth JChief Financial OfficerBuy22,021$3.00$66.1KForm 4
Mar 13, 2026EGLINTON MANNER CARRIEPresident & CEOBuy22,022$3.00$66.1KForm 4
Nov 28, 2025Gagliano Nancy JDirectorBuy2,100$2.37$5.0KForm 4
Feb 28, 2025EGLINTON MANNER CARRIEPresident & CEOBuy28,670$3.49$100.1KForm 4
Feb 27, 2025Gagliano Nancy JDirectorBuy12,750$3.08$39.3KForm 4
Feb 27, 2025EGLINTON MANNER CARRIEPresident & CEOBuy78,625$3.15$247.7KForm 4
Feb 27, 2025Kenny John P.DirectorBuy47,659$3.17$151.1KForm 4
Feb 27, 2025McGrath Kenneth JChief Financial OfficerBuy64,000$3.15$201.6KForm 4
Feb 27, 2025Marmora LelioDirectorBuy7,000$3.06$21.4KForm 4
Dec 19, 2023Weber Kathleen GallagherChief Product OfficerSale24,129$8.05$194.2KForm 4
Aug 15, 2023Anthony Michele MarieSVP Finance & CAOSale1,758$6.50$11.4KForm 4
May 30, 2023McGrath Kenneth JChief Financial OfficerBuy100,000$4.93$493.0KForm 4
Aug 26, 2022LANCASTER RONNY BDirectorBuy50,000$4.00$200.0KForm 4
Aug 25, 2022Aspinall Mara G.DirectorBuy6,000$4.19$25.1KForm 4
Aug 17, 2022Gagliano Nancy JDirectorBuy2,200$4.39$9.7KForm 4

All 21 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
2025Carrie Eglinton Manner52$721.0K$4.3M83
2025Kathleen G. Weber$421.1K$1.8M83
2025Kenneth McGrath54$512.0K$1.3M83
2024President and Chief Executive Officer$721.0K$5.6M83
2024Chief Financial Officer$497.5K$1.7M83
2024Former Chief Product Officer$488.0K$1.4M83
2023President and Chief Executive Officer$721.0K$6.7M83
2023Former Chief Product Officer$473.8K$1.7M83
2023Chief Financial Officer$483.0K$1.5M83

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.6,256,762$27.9M0.0%−259,454
Neuberger Berman Group LLC4,685,432$20.9M0.0%+323,531
Private Management Group Inc3,797,682$16.9M0.4%−1,624,447
Vanguard Capital Management LLC3,018,907$13.5M0.0%−11,981
Systematic Financial Management LP2,857,974$12.7M0.3%+377,491
Dimensional Fund Advisors LP2,340,901$10.4M0.0%−479,929
First Eagle Investment Management, LLC2,125,500$9.5M0.0%New
Renaissance Technologies LLC2,014,903$9.0M0.0%−68,400
Geode Capital Management, LLC1,807,889$8.1M0.0%−12,130
State Street Corp1,686,609$7.5M0.0%−18,171
Gagnon Securities LLC1,592,147$7.1M1.4%−122,244
Cannell Capital LLC1,427,419$6.4M4.4%−575,852
Gagnon Advisors, LLC1,207,440$5.4M3.4%No change
Peapod Lane Capital LLC993,875$4.4M3.0%−24,601
Wells Fargo & Company/mn924,030$4.1M0.0%+24,189
Jacobs Levy Equity Management, Inc844,935$3.8M0.0%−154,658
D. E. Shaw & Co., Inc.827,187$3.7M0.0%−555,201
Archon Capital Management LLC747,909$3.3M1.4%No change
Vanguard Portfolio Management LLC623,664$2.8M0.0%+33,466
Jpmorgan Chase & Co589,177$2.7M0.0%+228,653
Northern Trust Corp587,408$2.6M0.0%−7,764
Charles Schwab Investment Management Inc579,583$2.6M0.0%−6,254
Goldman Sachs Group Inc561,650$2.5M0.0%+150,124
Vanguard Fiduciary Trust Co458,067$2.0M0.0%+3,292
Tudor Investment Corp Et Al400,829$1.8M0.0%+288,073

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

SEC filer profile

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

  • Name on EDGARORASURE TECHNOLOGIES INC1
  • CIK0001116463
  • Employer ID (EIN)36-43709664
  • Filer statusAccelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • 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 address220 E First St, Bethlehem, PA 180151
  • Phone50364161151
  • Shares outstanding68,968,627 as of Jul 31, 202611
  • Public float$218.5M as of Jun 30, 20254
  • AuditorGRANT THORNTON LLP, Philadelphia, PA PCAOB ID 248; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceJun 14, 20001
  • Filings1,482 in all: 4 (686), 8-K (315), SC 13G/A (85), 10-Q (78), SC 13G (34), 3 (32), DEFA14A (31), 10-K (26)1
    All 43 form types

    DEF 14A (26), UPLOAD (19), ARS (18), CORRESP (16), S-8 (16), S-3 (9), SCHEDULE 13G/A (9), S-3/A (8), 424B5 (6), 8-K/A (6), EFFECT (6), SCHEDULE 13G (6), CT ORDER (5), S-4/A (5), SC 13D (4), SCHEDULE 13D/A (4), 144 (3), 4/A (3), S-8 POS (3), 10-K/A (2), 10-Q/A (2), 5 (2), DFAN14A (2), PRE 14A (2), SC 13D/A (2), SCHEDULE 13D (2), 10-QT (1), 424B3 (1), 425 (1), 8-A12B (1), FWP (1), PX14A6G (1), S-4 (1), S-4 POS (1), SD (1)

  • Latest filingsAnnual report (10-K) Mar 9, 2026
    Quarterly report (10-Q) Aug 7, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Aug 5, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.000001 par value per shareOSURThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 9, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks ORASURE TECHNOLOGIES INC names in Item 1A of its 10-K filed Mar 9, 2026: 68 risks under these headings, as written.4

  • Risks Relating to Products, Marketing and Sales
  • Risks Relating to the Company's Industry, Business and Strategy
  • Risks Relating to the Company's Reliance on Third Parties
  • Risks Relating to Intellectual Property
  • Regulatory Risks
  • Risks Relating to the Economy, Company Financial Results, Investments, Credit Facilities and Need for Financing
  • Risks Relating to the Company's Common Stock
  • General Risk Factors
  • Changes in the Genomics Market May Adversely Affect the Company's Business.
  • The Company's Future Success Depends Upon Market Acceptance of its Existing and Future Products and Service Offerings.
  • If Acceptance and Adoption of Oral Fluid Testing and Collection Products Does Not Continue, the Company's Future Results May Suffer.
  • The Company Expects to Face Increasing Competition From Other Providers of Diagnostic Tests and Sample Collection Products.
The other 63 risks
  • The Company's Product Sales Cycles Can be Lengthy, and May Depend on Public Funding, Which Can Cause Variability and Unpredictability in the Company's Operating Results.
  • The Company's Inability To Expand International Sales Could Adversely Affect its Business and Results of Operations.
  • The Company's International Presence May Increase Its Risks and Expose Its Business to Regulatory, Cultural or Other Restraints.
  • The Company's U.S. Government Contracts Require Compliance With Numerous Laws and Increases Its Risk and Liability.
  • The Company's Inability to Manufacture Products in Accordance with Applicable Specifications, Performance Standards or Quality Requirements Could Adversely Affect Its Business.
  • The Company's Business Will Suffer if It Does Not Effectively Manage Challenges to Its Manufacturing Processes and It May be Unable to Successfully Scale-Up Manufacturing of Its Products in Sufficient Quality and Quantity to Meet Demand, Which Would Negatively Impact Revenue Expectations.
  • The Company's Business Results Depend on Its Ability to Manage Disruptions in Its Domestic and Global Supply Chains and Distribution Channels.
  • Certain of the Company's Products Depend on Components From a Sole-Source Supplier, the Loss of Which Would Cause the Company to be Unable to Deliver Such Products.
  • The Company's U.S. Government Contracts May Affect Its Intellectual Property Rights.
  • The Company's U.S. Government Contracts and Related Administrative Processes Are Subject to Audits and Cost Adjustments by the Federal Government.
  • The Company Expects Revenue Levels From its InteliSwab® COVID-19 Rapid Test to Continue to Decline.
  • Marketing of the Company's COVID-19 Tests and Collection Kits Under EUAs from the FDA Is Subject To Certain Limitations and the Company Is Required To Maintain Compliance with the Terms of the EUA, Among Other Things, and the Continuance of the EUAs Is Subject To Government Discretion.
  • Consolidation in the Healthcare Industry Could Adversely Affect the Company's Future Revenues and Operating Results.
  • The Company's Research, Development and Commercialization Efforts May Not Succeed and Its Competitors May Develop and Commercialize More Effective or Successful Offerings.
  • Customer Concentration Creates Risk for the Company's Business.
  • The Company is Subject to Risks Related to Government Funding and Customer Ordering.
  • Acquisitions or Investments May Not Generate the Expected Benefits and Could Disrupt the Company's Ongoing Business, Distract Its Management, Increase Its Expenses and Adversely Affect Its Business.
  • The Company's Revenues Could be Affected by Third-Party Reimbursement Policies and Potential Cost Constraints.
  • Changes in Healthcare Regulation Could Affect the Company's Revenues, Costs and Financial Condition.
  • New or Changed Testing Guidelines Could Affect Sales of the Company's Diagnostic Products.
  • Reductions in Government Funding and Research Budgets Could Adversely Affect the Company's Business and Financial Results.
  • The Company's Failure to Maintain Existing Distribution Channels, or Develop New Distribution Channels, May Result in Lower Revenues.
  • The Company May Need Strategic Partners to Assist in Developing and Commercializing Some of Its Products.
  • The Company's Success Depends on Its Ability to Protect Its Proprietary Technology.
  • The Company May Become Involved in Intellectual Property Disputes, Which Could Increase Its Costs and Limit or Eliminate Its Ability to Sell Products, Provide Services or Use Certain Technologies.
  • The Need to Obtain Regulatory Approvals, Clearances, Authorizations or Certifications Could Increase the Company's Costs and Adversely Affect Its Financial Performance.
  • Failure to Comply With FDA or Other Regulatory Requirements May Require the Company to Suspend Production or Sale of Its Products or Institute a Recall Which Could Result in Higher Costs and a Loss of Revenues.
  • The Company's Inability to Respond to Changes in Regulatory Requirements Could Adversely Affect Its Business.
  • The Company Is Subject to Numerous Government Regulations in Addition to FDA Requirements, Which Could Increase the Company's Costs and Affect Its Operations.
  • Disruptions at the FDA and Other Government Agencies, Including Staffing Constraints, and Funding Uncertainty, Could Delay or Prevent the Development, Review, Approval, or Commercialization of Our Products and Adversely Affect Our Business.
  • Failure to Comply With Privacy, Security and Breach Notification Regulations May Increase the Company's Costs.
  • Failure to Comply With Data Protection Requirements or Privacy Laws Could Increase the Company's Costs.
  • Changes In Tax Laws Or In Their Implementation Or Interpretation May Adversely Affect Us Or Our Investors.
  • The Use of New And Evolving Technologies, Such As Artificial Intelligence (“AI”), In Our Offerings May Present Risks And Challenges That Can Impact Our Business Including by Posing Security Risks to Our Confidential Information, Proprietary Information, and Personal Data.
  • FDA Regulation of Laboratory-Developed Tests and Genetic Testing Could Affect Demand For the Company's Products.
  • The Company's International Sales Create Potential Exposure Under Anti-Corruption Laws.
  • Risks Relating to the Economy, the Company's Financial Results, Investments, and Need for Financing
  • The Company Has Experienced Losses in the Past and May Not Be Able to Again Achieve and Maintain Profitable Operations.
  • Recent Volatility In Capital Markets and Lower Market Prices For the Company's Securities May Affect Its Ability to Access New Capital Through Sales of Shares of Its Common Stock or Issuance Of Indebtedness, Which May Materially Harm Its Liquidity, Limit Its Ability to Grow Its Business, Pursue Acquisitions or Improve Its Operating Infrastructure and Restrict Its Ability to Compete in Its Markets.
  • Rising Inflation Rates Could Negatively Impact the Company's Revenues and Profitability if Increases in the Prices of Its Products or a Decrease in Consumer Spending Results in Lower Sales. In Addition, if the Company's Costs Increase and the Company Is Not Able to Pass Along These Price Increases to Its Customers, Its Net Income Would Be Adversely Affected, and the Adverse Impact May Be Material.
  • Increasing Geopolitical and Economic Risk and Tariffs Could Negatively Affect Our Ability to Maintain Sales at Existing Levels
  • An Impairment of Goodwill and Intangible Assets Could Reduce the Company's Earnings.
  • Changes in Foreign Currency Exchange Rates Could Negatively Affect the Company's Operating Results.
  • The Company's Stock Price Could Continue to be Volatile.
  • Share Repurchases Could Increase the Volatility of the Trading Price of Our Common Stock and Diminish Our Cash Reserves, and We Cannot Guarantee That Our Stock Repurchase Program Will Enhance Long-Term Stockholder Value.
  • Future Sales of the Company's Common Stock by Existing Stockholders, Executive Officers or Directors Could Depress the Market Price of Its Common Stock and Make It More Difficult for the Company to Sell Stock in the Future.
  • Because the Company Does Not Intend to Pay Cash Dividends on Its Common Stock, an Investor in the Company's Common Stock Will Benefit Only if the Its Common Stock Appreciates in Value.
  • Certain Provisions in the Company's Certificate of Incorporation and Bylaws and Under Delaware Law Could Make a Third-Party Acquisition of the Company Difficult.
  • Our Business Could be Negatively Affected as a Result of Actions of Activist Stockholders.
  • The Company May Face Product Liability Claims for Injuries Resulting From the Use of Its Products.
  • Performance of the Company's Products May Affect Its Revenues, Stock Price and Reputation.
  • Failure to Achieve the Company's Financial and Strategic Objectives Could Have a Material Adverse Impact on Its Business Prospects.
  • If the Company Fails To Establish and Maintain Proper And Effective Internal Control Over Financial Reporting, Its Operating Results and Its Ability to Operate Its Business Could Be Harmed.
  • If the Company Loses Key Personnel or Is Unable to Attract and Retain Qualified Personnel as Necessary, Its Business Could be Harmed.
  • Increases in Demand for the Company's Products and Services Could Require It to Expend Considerable Resources or Harm Its Customer Relationships if It Is Unable to Meet That Demand.
  • The Company Relies on Information Technology in Its Operations and Any Material Failure, Inadequacy, Interruption or Security Breach of that Technology Could Harm Its Ability to Efficiently Operate Its Business.
  • Cybersecurity Incidents and Other Disruptions Could Compromise the Company's Information, Expose It to Liability and Harm Its Reputation and Business.
  • Federal and State Laws Pertaining to Healthcare Fraud and Abuse Could Adversely Affect the Company's Business, Financial Condition and Results of Operations.
  • The Company May Experience Fluctuations in Its Financial Results or Fail to Meet Its Financial Projections.
  • The Company May Require Future Additional Capital.
  • Conditions in the Banking System and Financial Markets, Including the Failure of Banks and Financial Institutions, Could Have an Adverse Effect on the Company's Operations and Financial Results.
  • Terrorist Attacks, Natural Disasters, Public Health Crises, Political Unrest or Other Catastrophic Events Outside of the Company's Control May Adversely Affect Its Business.
  • Future Sales of Shares of the Company's Common Stock Could Adversely Affect the Trading Price of Its Common Stock and Its Ability to Raise Funds in New Equity Offerings.

Legal proceedings

Discussion of legal matters is incorporated by reference from Note 14, Commitments and Contingencies, to the Consolidated Financial Statements included in this Annual Report on Form 10-K.

The opening of Item 3, Legal Proceedings.4

Sources

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