VCYT on Nasdaq

VERACYTE, INC.

American medical laboratories services company based in South San Francisco2

In its 2026 annual report the company says: “We are a global diagnostics company that empowers clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Our high-performing tests enable clinicians to make more confident diagnostic, prognostic and predictive treatment decisions.”6 Its shares trade on Nasdaq under the symbol VCYT.2

$45.27 up 1.76 (4.04%)Price as of Oct 15, 2026 at 17:33 UTC

Last updated Oct 21, 2026.

Overview

Compare with CareDx, Inc, CASTLE BIOSCIENCES INC or Caris Life Sciences (United States), or pick any stock.

  • TickerVCYT on Nasdaq2
  • IndustryServices-Medical Laboratories2
  • HeadquartersSouth San Francisco, United States2
  • Incorporated inDE4
  • Business address6000 Shoreline Court, Suite 300, South San Francisco, Ca 940804
  • Filer categoryLarge accelerated filer4
  • Legal formCorporation2
  • LEI529900ESWZRHXOW27Z372
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressc/o NATIONAL REGISTERED AGENTS, INC., 160 GREENTREE DR STE 101, 19904 Dover, United States2
  • Registered withDivision of Corporations, Department of State, 41989982

At Veracyte, we believe that exceptional cancer care begins with exceptional diagnostics. We are a global diagnostics company that empowers clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Our high-performing tests enable clinicians to make more confident diagnostic, prognostic and predictive treatment decisions. Insights from these tests help patients avoid unnecessary procedures and interventions and accelerate time to appropriate treatment, thereby improving outcomes for patients across our global markets.6 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

70.1%Gross margin7
11.2%Operating margin7
12.8%Net margin7
16.0%Revenue growth, 20257
5.1%Return on equity7
$126.6MFree cash flow7

What sells

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

Products and services

Testing brought in 94% of the revenue VERACYTE, INC. broke down this way in fiscal 2025.

  1. Testing$493.2M794%up 18% from 2024
  2. Product$14.3M73%up 5% from 2024
  3. Biopharmaceutical And Other - Biopharmaceutical Revenue$6.5M71%down 9% from 2024
  4. Testing - Other$6.2M71%down 47% from 2024
  5. Biopharmaceutical And Other - Contract Manufacturing And Testing$3.1M71%down 48% from 2024
Products and services by year
Products and services202320242025
Testing$326.5M$419.0M$493.2M
Product$15.6M$13.7M$14.3M
Biopharmaceutical And Other - Biopharmaceutical Revenue$13.9M$7.1M$6.5M
Testing - Other$7.8M$11.8M$6.2M
Biopharmaceutical And Other - Contract Manufacturing And Testing$5.0M$6.0M$3.1M

Regions

United States brought in 96% of the revenue VERACYTE, INC. broke down this way in fiscal 2025.

  1. United States$496.6M796%up 17% from 2024
  2. Outside the United States$20.5M74%down 8% from 2024
Regions by year
Regions202320242025
United States$334.5M$423.5M$496.6M
Outside the United States$26.5M$22.2M$20.5M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development14¢$70.8M
  • Other costs73¢$378.1M
  • Income tax0¢$1.8M
  • Profit13¢$66.4M

Out of $517.1M in revenue.7

Where each dollar of operating cash went, fiscal 2025

  • Capital spending7¢$9.7M
  • Kept or used elsewhere93¢$126.6M

Out of $136.3M of cash from operations.7

Financial statements

Revenue8910117$517.1M in 2025+330% since 2019
0$200.0M$400.0M$600.0M2019: $120.4M$120.4M20192020: $117.5M$117.5M2020−2%2021: $219.5M$219.5M2021+87%2022: $296.5M$296.5M2022+35%2023: $361.1M$361.1M2023+22%2024: $445.8M$445.8M2024+23%2025: $517.1M$517.1M2025+16%
Gross profit117$362.5M in 2025+106% since 2022
0$100.0M$200.0M$300.0M$400.0M2022: $175.7M$175.7M20222023: $229.7M$229.7M2023+31%2024: $298.1M$298.1M2024+30%2025: $362.5M$362.5M2025+22%
Operating income8910117$57.8M in 2025
-$100.0M-$50.0M0$50.0M$100.0M2019: -$15.1M-$15.1M20192020: -$35.4M-$35.4M2020+134%2021: -$81.9M-$81.9M2021+131%2022: -$41.1M-$41.1M2022−50%2023: -$85.8M-$85.8M2023+109%2024: $16.1M$16.1M20242025: $57.8M$57.8M2025+258%
Net income8910117$66.4M in 2025
-$100.0M-$50.0M0$50.0M$100.0M2019: -$12.6M-$12.6M20192020: -$34.9M-$34.9M2020+177%2021: -$75.6M-$75.6M2021+116%2022: -$36.6M-$36.6M2022−52%2023: -$74.4M-$74.4M2023+104%2024: $24.1M$24.1M20242025: $66.4M$66.4M2025+175%

Every line of the income statement as filed: the last 3 fiscal years, latest first.7

Period ending2025-12-312024-12-312023-12-31
Total revenue$517.1M$445.8M$361.1M
Intangible asset amortization - cost of revenue$10.7M$11.6M$18.5M
Total cost of revenue$154.6M$147.6M$131.4M
Gross profit$362.5M$298.1M$229.7M
Research and development$70.8M$69.3M$57.3M
Selling and marketing$100.2M$95.4M$101.5M
General and administrative$110.8M$110.6M$86.2M
Impairment of assets$20.5M$3.4M$68.3M
Total operating expenses$304.8M$282.0M$315.5M
Income (loss) from operations$57.8M$16.1M-$85.8M
Other income, net$10.4M$9.6M$9.2M
Income (loss) before income taxes$68.2M$25.7M-$76.6M
Income tax provision (benefit)$1.8M$1.6M-$2.2M
Net income (loss)$66.4M$24.1M-$74.4M
Basic (in USD per share)$0.84$0.32-$1.02
Diluted (in USD per share)$0.82$0.31-$1.02
Basic (in shares)78.6M shares76.5M shares72.6M shares
Diluted (in shares)80.6M shares78.2M shares72.6M shares

Compare VERACYTE, INC. with another company

Corporate structure

VERACYTE, INC. sits at the top of its group. 8 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of VERACYTE, INC.

  • VERACYTE, INC. South San Francisco, California, United States
    • C2i Genomics Ltd Subsidiary · Israel
    • Veracyte Diagnostics, LLC Subsidiary · Delaware, United States
    • Veracyte Global, B.V. Subsidiary · Netherlands
    • Veracyte International Corp. Subsidiary · Delaware, United States
    • Veracyte Labs SD Corporation Subsidiary · Delaware, United States
    • Veracyte Labs VA Corporation Subsidiary · Delaware, United States
    • Veracyte SD, Inc. 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 VERACYTE, 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
Operating-lease assets (leased space)$36.6M7 Dec 31, 2025$48.2M7 Dec 31, 2024−24.1%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$362.6M7 Dec 31, 2025$239.1M7 Dec 31, 2024+51.7%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$767.2M7 Dec 31, 2025$745.8M7 Dec 31, 2024+2.9%
Intangible assets, net (excluding goodwill)$89.1M7 Dec 31, 2025$102.3M7 Dec 31, 2024−12.9%
Indefinite-lived intangibles (excluding goodwill)$13.5M11 Dec 31, 2024$7.3M11 Dec 31, 2023+84.9%
Finite-lived intangibles, gross$146.7M7 Dec 31, 2025$139.4M7 Dec 31, 2024+5.2%
Accumulated amortization$63.8M7 Dec 31, 2025$50.6M7 Dec 31, 2024+26.0%
Finite-lived intangibles, net$82.9M7 Dec 31, 2025$88.8M7 Dec 31, 2024−6.6%

Inventory

ItemLatestA year beforeChange
Inventory, total$20.5M7 Dec 31, 2025$21.8M7 Dec 31, 2024−5.5%
Finished goods$07 Dec 31, 2025$3.9M7 Dec 31, 2024−100.0%
Supplies$20.5M7 Dec 31, 2025$17.9M7 Dec 31, 2024+14.9%

Properties, in its own words

We lease office and laboratory facilities in South San Francisco (approximately 65,700 square feet) and San Diego (approximately 50,900 square feet), California; and Austin, Texas (approximately 10,400 square feet). We believe our facilities are in good condition and adequate for their current use. We may expand or improve our current facilities or add additional facilities as appropriate to meet the needs of our operations.

Item 2 of the 10-K filed Feb 26, 2026.6

Leadership

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

Board members and other officers (25)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • C2i Genomics Ltd Israel5
  • Veracyte Diagnostics, LLC Delaware5
  • Veracyte Global, B.V. Netherlands5
  • Veracyte International Corp. Delaware5
  • Veracyte Labs SD Corporation Delaware5
  • Veracyte Labs VA Corporation Delaware5
  • Veracyte SAS France5
  • Veracyte SD, Inc. Delaware5

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

Former names

  • CALDEROME INCDec 6, 2006 to Feb 27, 20084

Timeline

  1. Sep 14, 20268-K Entered a material agreement; Completed an acquisition or sale; Regulation FD disclosure45
  2. Jul 30, 20268-K Results of operations46
  3. Jun 11, 20268-K Executive or director change; Shareholder vote47
  4. May 5, 20268-K Results of operations48
  5. Mar 16, 20268-K Executive or director change49
  6. Feb 25, 20268-K Results of operations50
  7. Jan 12, 20268-K Results of operations51
  8. Nov 4, 20258-K Results of operations52
  9. Aug 6, 20258-K Results of operations53
  10. Jun 18, 20258-K Executive or director change; Shareholder vote54
  11. May 7, 20258-K Results of operations55
  12. Feb 24, 20258-K Results of operations56
  13. Jun 3, 2021New chief executive Marc Stapley becomes CEO15
  14. Oct 29, 2013New chief executive Bonnie H. Anderson becomes CEO16

Calendar

Coming up

  1. Nov 4, 2026 · After the closeReports results for the quarter ending Sep/2026 A year earlier it reported $0.38 a share, on Nov 4, 2025.57

When it reported results

  1. Jul 30, 2026Reported quarterly or annual results46
  2. May 5, 2026Reported quarterly or annual results48
  3. Feb 25, 2026Reported quarterly or annual results50
  4. Jan 12, 2026Reported quarterly or annual results51
  5. Nov 4, 2025Reported quarterly or annual results52
  6. Aug 6, 2025Reported quarterly or annual results53
  7. May 7, 2025Reported quarterly or annual results55
  8. Feb 24, 2025Reported quarterly or annual results56

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

Filings

504 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 40 major events, 277 insider forms, 55 large holders, 112 other. The latest 20:

  1. Sep 24, 2026144 EDGAR
  2. Sep 22, 20264 EDGAR
  3. Sep 21, 2026144 EDGAR
  4. Sep 16, 20264 EDGAR
  5. Sep 14, 2026144 EDGAR
  6. Sep 14, 20268-K EDGAR
  7. Sep 4, 20264 EDGAR
  8. Sep 4, 2026144 EDGAR
  9. Sep 4, 2026144 EDGAR
  10. Sep 4, 2026144 EDGAR
  11. Sep 4, 20264 EDGAR
  12. Sep 4, 20264 EDGAR
  13. Sep 4, 20264 EDGAR
  14. Sep 4, 20264 EDGAR
  15. Sep 4, 20264 EDGAR
  16. Sep 3, 20264 EDGAR
  17. Sep 1, 2026144 EDGAR
  18. Jul 31, 202610-Q EDGAR
  19. Jul 30, 20268-K EDGAR
  20. Jun 22, 20264 EDGAR

The 504 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

109 open-market trades by officers, directors and large owners since October 2021: 1 buys and 108 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 21, 2026Leite JohnGlobal Chief Commercial OffSale4,015$40.00$160.6KForm 4
Sep 14, 2026Holstein JensDirectorSale5,000$40.95$204.8KForm 4
Sep 4, 2026McGuire AnnieEVP, General CounselSale3,254$43.09$140.2KForm 4
Sep 4, 2026Chambers RebeccaChief Financial OfficerSale3,652$43.10$157.4KForm 4
Sep 4, 2026Febbo Phillip G.Chief Scientific & Med OfficerSale13,110$43.05$564.4KForm 4
Sep 1, 2026Bhanji MunaDirectorSale1,864$42.97$80.1KForm 4
Jun 18, 2026EASTHAM KARINDirectorSale3,729$52.89$197.2KForm 4
Jun 4, 2026Leite JohnGlobal Chief Commercial OffSale13,975$50.07$699.7KForm 4
Jun 4, 2026McGuire AnnieEVP, General CounselSale3,176$49.76$158.0KForm 4
Jun 4, 2026Chambers RebeccaChief Financial OfficerSale3,561$49.73$177.1KForm 4
Jun 4, 2026Stapley MarcChief Executive OfficerSale138,051$50.12$6.9MForm 4
May 22, 2026Wygant JonathanVP, Chief Accounting OfficerSale24,000$45.40$1.1MForm 4
May 20, 2026EPSTEIN ROBERT SDirectorSale10,000$44.01$440.1KForm 4
May 6, 2026McGuire AnnieEVP, General CounselSale10,204$39.02$398.2KForm 4
Mar 4, 2026Leite JohnGlobal Chief Commercial OffSale5,260$35.19$185.1KForm 4
Mar 4, 2026McGuire AnnieEVP, General CounselSale6,658$35.55$236.7KForm 4
Mar 4, 2026Chambers RebeccaChief Financial OfficerSale18,341$36.14$662.9KForm 4
Mar 4, 2026Stapley MarcChief Executive OfficerSale45,523$35.98$1.6MForm 4
Mar 2, 2026Febbo Phillip G.Chief Scientific & Med OfficerSale13,425$36.16$485.4KForm 4
Dec 16, 2025McGuire AnnieEVP, General CounselSale10,739$43.14$463.2KForm 4

All 109 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
2025Marc StapleyChief Executive Officer56$700.0K$7.4M71
2025John LeiteGlobal Chief Commercial Officer54$510.3K$3.2M71
2025Rebecca ChambersChief Financial Officer48$550.0K$2.9M71
2025Annie McGuireGeneral Counsel and Head of Market Access46$500.0K$2.8M71
2025Phillip FebboChief Scientific Officer and Chief Medical Officer59$561.0K$2.5M71
2024Marc StapleyChief Executive Officer56$675.0K$6.8M71
2024Rebecca ChambersChief Financial Officer48$530.4K$3.6M71
2024John LeiteGlobal Chief Commercial Officer54$472.5K$3.1M71
2024Annie McGuireGeneral Counsel and Head of Market Access46$470.8K$3.1M71
2024Phillip FebboChief Scientific Officer and Chief Medical Officer59$550.0K$2.8M71
2023Marc StapleyChief Executive Officer56$650.0K$7.2M71
2023Phillip FebboChief Scientific Officer and Chief Medical Officer59$137.5K$3.8M71
2023Rebecca ChambersChief Financial Officer48$510.0K$2.8M71
2023Annie McGuireGeneral Counsel and Head of Market Access46$440.0K$2.5M71
2023John LeiteGlobal Chief Commercial Officer54$421.1K$1.9M71

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.13,486,437$792.1M0.0%+313,819
Fmr LLC7,702,746$452.4M0.0%−61,103
Artisan Partners Limited Partnership5,538,404$325.3M0.5%+42,034
Vanguard Portfolio Management LLC4,716,191$277.0M0.0%+271,461
State Street Corp4,698,128$276.0M0.0%−345,462
Vanguard Capital Management LLC3,593,922$211.1M0.0%+61,690
Dimensional Fund Advisors LP2,826,524$166.0M0.0%−54,566
First Trust Advisors LP2,507,902$147.3M0.1%+390,856
ARK Investment Management LLC2,295,951$134.8M0.9%−757,867
Wellington Management Group Llp2,274,160$133.6M0.0%−284,125
Geode Capital Management, LLC2,104,000$123.6M0.0%+146,904
Goldman Sachs Group Inc1,642,911$96.5M0.0%+366,651
Fuller & Thaler Asset Management, Inc.1,509,749$88.7M0.2%+95,387
William Blair Investment Management, LLC1,431,596$84.1M0.3%+441,909
Morgan Stanley1,191,790$70.0M0.0%+393,988
Bank Of America Corp /de/1,102,279$64.7M0.0%−346,618
Driehaus Capital Management LLC1,045,826$61.4M0.4%New
Northern Trust Corp996,154$58.5M0.0%+66,654
Charles Schwab Investment Management Inc939,983$55.2M0.0%+16,410
Oberweis Asset Management Inc/877,734$51.5M1.1%+37,900
Legal & General Group Plc858,136$50.4M0.0%−39,035
Sumitomo Mitsui Trust Group, Inc.768,949$45.2M0.0%−286,707
Amova Asset Management Americas, Inc.768,949$45.1M0.6%−276,098
Point72 Asset Management, L.P.737,804$43.3M0.1%+253,900
Fisher Asset Management, LLC700,592$41.1M0.0%−35,678

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

Members of Congress who traded it

14 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 3, 2026Gilbert Ray Cisneros, Jr.Democratic, HouseBuy$1,001 - $15,000+14.6%Report
Nov 12, 2025Gilbert Ray Cisneros, Jr.Democratic, HousePartial sale$1,001 - $15,000+6.7%Report
Jun 16, 2025Gilbert Ray Cisneros, Jr.Democratic, HouseBuy$1,001 - $15,000+40.6%Report
Oct 16, 2023Josh GottheimerDemocratic, HouseBuy$1,001 - $15,000+34.2%Report
Sep 15, 2023Josh GottheimerDemocratic, HousePartial sale$1,001 - $15,000−5.3%Report
Apr 10, 2023Daniel S. GoldmanDemocratic, HousePartial sale$1,001 - $15,000−22.5%Report
Dec 23, 2020Gilbert Ray Cisneros, Jr.Democratic, HousePartial sale$1,001 - $15,000+131.1%Report
Dec 10, 2020Gilbert Ray Cisneros, Jr.Democratic, HousePartial sale$1,001 - $15,000+131.8%Report
Dec 8, 2020Josh GottheimerDemocratic, HousePartial sale$1,001 - $15,000+134.0%Report
Oct 29, 2020Gilbert Ray Cisneros, Jr.Democratic, HousePartial sale$1,001 - $15,000+111.8%Report
Jan 17, 2020Gilbert Ray Cisneros, Jr.Democratic, HouseBuy$1,001 - $15,000−83.5%Report
Dec 24, 2019Gilbert Ray Cisneros, Jr.Democratic, HouseBuy$1,001 - $15,000−88.5%Report
Dec 12, 2019Gilbert Ray Cisneros, Jr.Democratic, HouseBuy$1,001 - $15,000−86.4%Report
Dec 6, 2019Josh GottheimerDemocratic, HouseBuy$1,001 - $15,000−91.1%Report

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

SEC filer profile

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

  • Name on EDGARVERACYTE, INC.1
  • CIK0001384101
  • Employer ID (EIN)20-54553986
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company6
  • Incorporated inDelaware6
  • Fiscal year endsDecember 311
  • Industry code (SIC)8071 Services-Medical Laboratories1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address6000 Shoreline Court, Suite 300, South San Francisco, CA 940801
  • Phone(650) 243-63001
  • Shares outstanding80,390,731 as of Jul 27, 202613
  • Public float$1.7B as of Jun 30, 20256
  • AuditorErnst & Young LLP, San Diego, California PCAOB ID 42; it also attests to the company’s internal control over financial reporting6
  • On EDGAR sinceDec 6, 20061
  • Filings1,170 in all: 4 (571), 8-K (145), 144 (74), SC 13G/A (58), 3 (45), 10-Q (39), SC 13G (24), SCHEDULE 13G/A (19)1
    All 47 form types

    CORRESP (17), S-8 (16), UPLOAD (14), 10-K (13), DEF 14A (13), DEFA14A (12), S-8 POS (10), 424B5 (9), 424B3 (7), 8-K/A (7), SCHEDULE 13G (7), 425 (6), ARS (6), EFFECT (6), CT ORDER (5), 4/A (4), 424B7 (4), S-1/A (4), S-3 (4), SEC STAFF LETTER (4), REGDEX/A (3), S-3ASR (3), 10-Q/A (2), D (2), DRS/A (2), POS AM (2), 10-K/A (1), 3/A (1), 424B4 (1), 5 (1), 8-A12B (1), CERTNAS (1), DRS (1), FWP (1), PRE 14A (1), REGDEX (1), RW (1), S-1 (1), S-1MEF (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Jul 31, 2026
    Proxy statement (DEF 14A) Apr 22, 2026
    Latest 8-K (8-K) Sep 14, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value, $0.001 per shareVCYTThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).6

Risk factors and legal proceedings

The risks VERACYTE, INC. names in Item 1A of its 10-K filed Feb 26, 2026: 57 risks under these headings, as written.6

  • Risks Related to Our Business
  • Risks Related to Being a Public Company
  • Risks Related to Our Common Stock
  • Our financial results currently depend mainly on sales of our Decipher Prostate and Afirma laboratory developed tests (LDTs), and we may not generate sufficient revenue from these and our other diagnostic tests to grow our business.
  • If we are unable to grow sales of our tests or products, or we are unable to launch or commercialize our new tests or products, our business may suffer.
  • We have incurred losses in the past, we could incur net losses in the future and we may not sustain our level of profitability in the future.
  • We depend on a few payers for a significant portion of our revenue; if one or more significant payers stops providing reimbursement or decreases the amount of reimbursement for our tests, our revenue could decline.
  • If payers do not provide reimbursement, rescind or modify their reimbursement policies, delay payments for our tests, recoup past payments, or if we are unable to successfully negotiate additional reimbursement contracts, our commercial success could be compromised.
  • We may experience limits on our revenue if physicians decide not to order our tests.
  • We may experience limits on our revenue if patients decide not to use our tests as a result of increased costs, fees or changing payer policies.
  • If we fail to comply with federal and state licensing requirements, we could lose the ability to perform our tests or experience disruptions to our business.
  • We have engaged, and may continue to engage, in acquisitions, dispositions or other strategic transactions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources. If our general strategy of seeking
The other 48 risks
  • incremental growth through acquisitions and collaborations is not successful, or if we do not successfully integrate companies or assets that we acquire into our business, our prospects and financial condition may suffer.
  • We must successfully integrate our acquired businesses, such as C2i, to realize the strategic or financial goals that we currently anticipate.
  • Our future success and international growth depend, in part, on our ability to adapt, manufacture and distribute our tests as IVD tests.
  • If we do not manage inventory in an effective and efficient manner, it could adversely affect our results of operations.
  • We rely on sole suppliers for some of the reagents, equipment and other materials used to perform our tests, as well as certain sole source providers for kit components, instruments and associated services. We may not be able to find replacements or transition to alternative suppliers or service providers, which may materially impact our ability to generate revenue.
  • We may be unable to manage our future growth effectively, which could make it difficult to execute our business strategy.
  • If we are unable to support demand for our tests, products or services, our business could suffer.
  • Changes in healthcare policy, including legislation reforming the U.S. healthcare system, recent U.S. judicial decisions and potential changes in the regulatory environment, may have a material adverse effect on our financial condition and operations.
  • Because of Medicare billing rules, we may not receive reimbursement for all tests provided to Medicare patients.
  • If the FDA or foreign authorities regulate those of our tests that they do not currently regulate, we could incur substantial costs and delays associated with trying to obtain premarket clearance, approval or certification.
  • Obtaining marketing authorization or certification by the FDA and foreign regulatory authorities or notifying regulatory bodies for our diagnostic tests will take significant time and require significant research, development and clinical study expenditures and ultimately may not succeed.
  • If we are unable to obtain marketing authorizations or certifications, approvals, clearances or certifications to market Prosigna or our other IVD assays or if regulatory limitations are placed on our diagnostic kit products, our business and growth will be harmed.
  • We are subject to ongoing and increasingly extensive regulatory requirements, which may be subject to change, and our failure to comply with these requirements could substantially harm our business.
  • If we are unable to compete successfully, we may be unable to increase or sustain our revenue and profitability.
  • We depend on our senior management team, and the loss of one or more of our executive officers, or any inability to attract and retain highly skilled employees and other key personnel in our highly competitive industry, could adversely affect our business.
  • Billing for our diagnostic tests is complex, and we must dedicate substantial time and resources to the billing process in order to collect cash and be paid.
  • We rely on third-party providers to transmit claims to payers, and any delay in transmitting claims could have an adverse effect on our revenue.
  • If our internal sales force is less successful than anticipated, our business expansion plans could suffer and our ability to generate revenue could be diminished.
  • Developing, commercializing and gaining reimbursement for new products involves a lengthy and complex process, and if we do not achieve our projected development, commercialization and reimbursement goals in the timeframes we announce and expect, our business may suffer, and our stock price may decline.
  • If we are unable to develop products to keep pace with rapid technological, medical and scientific change, our operating results and competitive position could be harmed.
  • Complying with numerous statutes and regulations pertaining to our business is an expensive and time-consuming process, and any failure to comply could result in substantial penalties.
  • If we use hazardous materials in a manner that causes contamination, infection or injury, we could be liable for resulting damages.
  • Aspects of our international business expose us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.
  • We have operations located in Israel, and conflict in the Middle East and any additional escalations of hostilities may cause interruption or suspension of this site without warning, or otherwise negatively impact the global economy or our business.
  • Our reliance on distributors for sales of our products outside of the United States, and on clinical laboratories for delivery of Prosigna testing services, could limit or prevent us from selling our products and impact our revenue.
  • Errors or defects in our products or services could harm our reputation, decrease market acceptance of our products or services or expose us to product liability claims, and we could face substantial liabilities that exceed our resources.
  • Issues relating to the use of AI and machine learning in our offerings could adversely affect our business and operating results.
  • Security breaches, loss of data and other disruptions to our or our third-party service providers' data systems could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
  • Risks associated with data privacy issues, including evolving laws, regulations and associated compliance efforts, may adversely impact our business and financial results.
  • If we are unable to protect our intellectual property effectively, our business may be harmed.
  • If we are unable to enforce or defend our intellectual property effectively, our business may be harmed.
  • If we cannot license or maintain rights to use technologies on reasonable terms, our business may suffer.
  • We may be involved in litigation related to third party intellectual property, which may be time-intensive and costly and may adversely affect our business, operating results or financial condition.
  • Our ability to use our net operating loss carryforwards may be limited and may result in increased future tax liability to us.
  • If we are unable to maintain effective internal control over financial reporting, investors may lose confidence in the accuracy and completeness of our reported financial information and the market price of our common stock may be negatively affected.
  • Our stock price may be volatile, and you may not be able to sell shares of our common stock at or above the price you paid.
  • Anti-takeover provisions in our charter documents and under Delaware law could discourage, delay or prevent a change in control and may affect the trading price of our common stock.
  • We have never paid dividends on our capital stock, and we do not anticipate paying dividends in the foreseeable future.
  • Our quarterly operating results may fluctuate significantly or may fall below our guidance or the expectations of investors or securities analysts for various reasons, including in response to the way we recognize revenue, our level of profitability and/or the amount of cash we generate, which may cause our stock price to fluctuate or decline.
  • General Risk Factors
  • Our operating results may be adversely affected by unfavorable macroeconomic and market conditions.
  • Our business and the operations of our laboratories and manufacturing sites are subject to the risk of disruptions caused by pandemics, political events, war, terrorism, earthquakes, fire, power outages, severe weather, floods, and other catastrophic events.
  • We are exposed to risks associated with transactions denominated in foreign currency.
  • We may be unable to raise additional capital on acceptable terms in the future, which could limit our ability to develop and commercialize new solutions and technologies and expand our operations, organically or inorganically.
  • Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of amounts that have been accrued.
  • Impairment in the value of our goodwill or other intangible assets could have a material adverse effect on our operating results and financial condition.
  • Changes in financial accounting standards or practices may cause adverse, unexpected financial reporting fluctuations and affect our reported operating results.
  • Our consolidated financial statements are subject to change and if our estimates or judgments relating to our critical accounting policies prove to be incorrect, our operating results could be adversely affected.
  • Investors’ expectations of our performance relating to environmental, social and governance factors may impose additional costs and expose us to new risks.

Legal proceedings

We are not currently a party to any material legal proceedings. We may from time to time become involved in legal proceedings arising in the ordinary course of business.

The opening of Item 3, Legal Proceedings.6

Sources

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