EXEL on Nasdaq

Exelixis

Logo: Exelixis, Public domain, via Wikimedia Commons5

American biotechnology company

Exelixis, Inc. is a genomics-based drug discovery company located in Alameda, California, and the producer of Cometriq, a treatment approved by the U.S. Food and Drug Administration (FDA) for medullary thyroid cancer with clinical activity in several other types of metastatic cancer.3 Wikipedia text CC BY-SA 4.0

Price unavailable

Last updated Oct 21, 2026.

Overview

$2.3BRevenue, fiscal 20266
$782.6MNet income, fiscal 20266
1994Founded1

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  • TickerEXEL on Nasdaq1
  • Industrybiotechnology1
  • HeadquartersSouth San Francisco1
  • Websitewww.exelixis.com
  • Legal formDelaware corporation1
  • Incorporated inDE7
  • Business address1851 Harbor Bay Parkway, Alameda, Ca 945027
  • Filer categoryLarge accelerated filer7
  • LEI254900PJQB59O2O95R374
  • StatusActive4
  • LEI statusLapsed (not renewed)4
  • Registered addressc/o Corporation Service Company, 19808 Wilmington, United States4
  • Registered withDivision of Corporations, Department of State, 24528194

Exelixis, Inc. is a genomics-based drug discovery company located in Alameda, California, and the producer of Cometriq, a treatment approved by the U.S. Food and Drug Administration (FDA) for medullary thyroid cancer with clinical activity in several other types of metastatic cancer.3

Financials

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

Key numbers, fiscal 2026

37.6%Operating margin6
33.7%Net margin6
7.0%Revenue growth, 20266
36.2%Return on equity6
$875.8MFree cash flow6

What sells

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

Products and services

Product, Gross brought in 54% of the revenue Exelixis broke down this way in fiscal 2025.

  1. Product, Gross$3.0B654%up 20% from 2024
  2. Cabometyx$2.1B638%up 18% from 2024
  3. License$214.4M64%down 39% from 2024
  4. Collaboration$197.3M64%down 45% from 2024
  5. Cometriq$9.4M60%down 15% from 2024
Products and services by year
Products and services202320242025
Product, Gross$2.3B$2.5B$3.0B
Cabometyx$1.6B$1.8B$2.1B
License$178.6M$349.2M$214.4M
Collaboration$201.3M$359.3M$197.3M
Cometriq$13.9M$11.2M$9.4M

Regions

United States brought in 92% of the revenue Exelixis broke down this way in fiscal 2025.

  1. United States$2.1B692%up 17% from 2024
  2. Europe$154.2M67%down 52% from 2024
  3. Japan$25.6M61%down 5% from 2024
Regions by year
Regions202320242025
United States$1.6B$1.8B$2.1B
Europe$145.0M$318.6M$154.2M
Japan$39.5M$27.1M$25.6M

Where the money goes

Where each dollar of revenue went, fiscal 2026

  • Cost of revenue4¢$83.7M
  • Research and development35¢$825.0M
  • Selling, general and admin22¢$518.7M
  • Income tax7¢$158.6M
  • Profit33¢$782.6M

Out of $2.3B in revenue.6

Where each dollar of operating cash went, fiscal 2026

  • Capital spending1¢$8.4M
  • Share buybacks99¢$947.5M

Out of $884.3M of cash from operations. Spending exceeded cash from operations; the rest came from savings or borrowing.6

Financial statements

Revenue1011126$2.3B in 2026+140% since 2020
0$1.0B$2.0B$3.0B2020: $967.8M$967.8M20202021: $1.4B$1.4B2021+48%2022: $1.6B$1.6B2022+12%2023: $1.8B$1.8B2023+14%2025: $2.2B$2.2B2025+18%2026: $2.3B$2.3B2026+7%
Operating income1011126$872.2M in 2026+136% since 2020
0$250.0M$500.0M$750.0M$1.0B2020: $369.5M$369.5M20202021: $286.7M$286.7M2021−22%2022: $201.5M$201.5M2022−30%2023: $170.9M$170.9M2023−15%2025: $604.6M$604.6M2025+254%2026: $872.2M$872.2M2026+44%
Net income1011126$782.6M in 2026+144% since 2020
0$200.0M$400.0M$600.0M$800.0M2020: $321.0M$321.0M20202021: $231.1M$231.1M2021−28%2022: $182.3M$182.3M2022−21%2023: $207.8M$207.8M2023+14%2025: $521.3M$521.3M2025+151%2026: $782.6M$782.6M2026+50%

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

Period ending2025-12-312024-12-312023-12-31
Total revenues$2.3B$2.2B$1.8B
Cost of goods sold$83.7M$76.2M$72.5M
Research and development$825.0M$910.4M$1.0B
Selling, general and administrative$518.7M$492.1M$542.7M
Impairment of long-lived assets$0$51.7M$0
Restructuring$20.5M$33.7M$0
Total operating expenses$1.4B$1.6B$1.7B
Income from operations$872.2M$604.6M$170.9M
Interest income$69.2M$77.2M$86.5M
Other income (expenses), net-$198.0K-$133.0K$93.0K
Income before income taxes$941.2M$681.6M$257.5M
Provision for income taxes$158.6M$160.4M$49.8M
Net income$782.6M$521.3M$207.8M
Basic (in dollars per share)$2.88$1.80$0.65
Diluted (in dollars per share)$2.78$1.76$0.65
Basic (in shares)271.6M shares290.0M shares318.2M shares
Diluted (in shares)281.9M shares296.1M shares321.5M shares

Compare Exelixis with another company

Corporate structure

Exelixis sits at the top of its group. 4 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Exelixis

  • Exelixis Alameda, California, United States
    • Exelixis Patent Company LLC Subsidiary · Delaware, United States
    • Exelixis Plant Sciences, Inc. Subsidiary · Delaware, United States
    • Exelixis U.S., 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 Exelixis 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$231.2M6 Jan 2, 2026$220.1M6 Jan 3, 2025+5.0%
Accumulated depreciation$132.2M6 Jan 2, 2026$100.7M6 Jan 3, 2025+31.3%
Property and equipment, net$99.0M6 Jan 2, 2026$119.4M6 Jan 3, 2025−17.1%
Operating-lease assets (leased space)$159.0M6 Jan 2, 2026$172.6M6 Jan 3, 2025−7.8%

Real estate and locations

ItemLatestA year beforeChange
Area of real estate215.0 million sq ft6 Jan 3, 2025

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$482.5M6 Jan 2, 2026$217.4M6 Jan 3, 2025+122.0%
Marketable securities, current$576.6M6 Jan 2, 2026$893.9M6 Jan 3, 2025−35.5%
Marketable securities, non-current$603.6M6 Jan 2, 2026$637.3M6 Jan 3, 2025−5.3%
Debt securities available for sale$1.3B6 Jan 2, 2026$1.5B6 Jan 3, 2025−15.3%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$63.7M6 Jan 2, 2026$63.7M6 Jan 3, 20250%

Inventory

ItemLatestA year beforeChange
Inventory, total$21.7M6 Jan 2, 2026$22.4M6 Jan 3, 2025−3.1%
Raw materials$894.0K6 Jan 2, 2026$2.8M6 Jan 3, 2025−67.9%
Work in process$53.5M6 Jan 2, 2026$60.3M6 Jan 3, 2025−11.2%
Finished goods$5.9M6 Jan 2, 2026$8.6M6 Jan 3, 2025−31.1%

Properties, in its own words

Our corporate headquarters is located in Alameda, California, where we lease approximately 610,000 square feet of office and laboratory space under multiple leases. In 2025, we exited approximately 40,000 square feet of our office and laboratory space in the Greater Philadelphia area as part of our 2024 corporate restructuring plan. We believe these leased facilities are sufficient to accommodate our current and near-term needs.

Item 2 of the 10-K filed Feb 10, 2026.17

The story

Exelixis was founded in 1994; the scientific founders were Spyridon Artavanis–Tsakonas, at Yale at that time, and Corey Goodman and Gerry Rubin who were then at the University of California, Berkeley. George Scangos joined the company as CEO in 1996. The business plan was to use model organisms (fruit flies, nematodes, and zebrafish) and functional genomics to identify pathways and biological targets that could be exploited in the fields of agriculture and medicine. It eventually set up a subsidiary, Exelixis Plant Sciences, for the agricultural work.

By 2000, Exelixis had left the radical exploratory phase behind and became focused on drug discovery and had a chemical library of 4 million compounds. The company went public that year, after withdrawing its offering the week before; it raised $118 million in a down market.

In 2002, the company signed a broad alliance with GSK to discover new drugs in the fields of cancer, inflammatory diseases, and vascular conditions; GSK paid it $30 million in cash, bought $14 million in stock at twice the market rate, and committed to providing Exelixis with $90 million in research funding; it also offered loan financing of up to $85 million. By 2002, the company had limited its internal efforts to cancer, and had settled its strategy on discovering and developing drugs that could inhibit targeted small sets of tyrosine kinases that are needed for cancer formation, growth, and metastasis. The sets of TKs had been identified by means of its prior functional genomics work. This approach was controversial at the time; most companies try to selectively target just one protein in their discovery efforts.

In 2006, Exelixis partnered with Daiichi Sankyo on compounds that targeted mineralocorticoid receptors; esaxerenone was part of this collaboration. In 2007, the company partnered its MEK inhibitor program with Genentech; cobimetinib (at that time XL-518) was part of this collaboration. Exelixis had filed an IND on XL-518 prior to the partnership, committed to funding and running the Phase I trial, and retained rights to co-market it in the US.

In 2008, the company partnered its lead cancer drug candidate, XL-184 (which would become called cabozantinib) and another cancer candidate, XL-281, with Bristol Myers Squibb; BMS returned the rights to XL-184 to Exelixis in 2010 and returned the rights to other drug candidate in 2011.

In 2010, Scangos departed as CEO to take over at Biogen and the company appointed Michael M. Morrissey as president and CEO; Morrissey had joined the company in 2000 as Vice President of Discovery Research. At that time the company had eight drugs in clinical trials. Exelixis' first drug approval came in 2012, when cabozantinib was approved for medullary thyroid cancer, an orphan indication. It was approved in Europe in 2014. Exelixis invested heavily in exploring cabozantinib in other cancers, betting the future of the company on the drug. In 2014 the drug failed a Phase III trial in prostate cancer, and the company laid off 70% of its employees. In 2015, Genentech and Exelixis won FDA approval for cobimetinib for certain forms of melanoma.

In March 2016, Exelixis licensed to Ipsen worldwide rights (outside the US, Canada, and Japan) to market cabozantinib. In April 2016, the FDA granted approval for marketing the tablet formulation as a second line treatment for kidney cancer and the same was approved in Europe in October of that year.

In December 2017, the FDA granted approval for the use of cabozantinib for first line treatment of kidney cancer and in 2018 approval for first-line treatment was approved in Europe.

From Wikipedia’s article on Exelixis, shared under CC BY-SA 4.0.8

Leadership

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

Board members and other officers (32)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Exelixis Patent Company LLC Delaware9
  • Exelixis Plant Sciences, Inc. Delaware9
  • Exelixis U.S., LLC Delaware9

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

Former names

  • EXELIXIS INCSep 15, 2000 to Sep 12, 20127

Timeline

  1. Sep 11, 20268-K Other events53
  2. Aug 31, 20268-K Other events54
  3. Aug 5, 20268-K Results of operations55
  4. May 29, 20268-K Executive or director change; Shareholder vote56
  5. May 5, 20268-K Results of operations; Other events57
  6. Feb 10, 20268-K Results of operations58
  7. Jan 12, 20268-K Results of operations59
  8. Nov 7, 20258-K Executive or director change; Other events60
  9. Nov 4, 20258-K Results of operations; Other events61
  10. Aug 29, 20258-K Executive or director change62
  11. Jul 28, 20258-K Results of operations63
  12. Jun 2, 20258-K Shareholder vote64
  13. Aug 17, 2010New chief executive Michael M. Morrissey becomes CEO18
  14. Jan 6, 2006New chief executive George Scangos becomes CEO19
  15. 1994Founded Founded1

Calendar

Coming up

  1. Oct 29, 2026 · After the closeReports results for the quarter ending Sep/2026 A year earlier it reported $0.67 a share, on Nov 4, 2025.65

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results55
  2. May 5, 2026Reported quarterly or annual results57
  3. Feb 10, 2026Reported quarterly or annual results58
  4. Jan 12, 2026Reported quarterly or annual results59
  5. Nov 4, 2025Reported quarterly or annual results61
  6. Jul 28, 2025Reported quarterly or annual results63
  7. May 13, 2025Reported quarterly or annual results66
  8. Feb 11, 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

555 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 55 major events, 319 insider forms, 32 large holders, 129 other. The latest 20:

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

The 555 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

122 open-market trades by officers, directors and large owners since October 2021: 5 buys and 117 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 10, 2026Beckerle Mary CDirectorSale9,812$53.66$526.5KForm 4
Jun 1, 2026WYSZOMIERSKI JACK LDirectorSale3,925$50.55$198.4KForm 4
Jun 1, 2026Eckhardt Sue GailDirectorSale9,812$50.14$492.0KForm 4
May 26, 2026Aftab DanaEVP, Research and DevelopmentSale43,451$50.35$2.2MForm 4
May 20, 2026Haley Patrick J.EVP, CommercialSale32,110$49.81$1.6MForm 4
May 18, 2026Senner Christopher J.EVP and CFOSale34,901$50.00$1.7MForm 4
May 18, 2026Hefti BrendaSVP and General CounselSale6,625$50.21$332.6KForm 4
May 7, 2026Beckerle Mary CDirectorSale7,712$48.45$373.6KForm 4
May 7, 2026Freire Maria CDirectorSale20,634$46.00$949.2KForm 4
May 7, 2026POSTE GEORGEDirectorSale60,000$45.71$2.7MForm 4
Feb 24, 2026Aftab DanaEVP, Research and DevelopmentSale47,918$44.50$2.1MForm 4
Feb 19, 2026Aftab DanaEVP, Research and DevelopmentSale29,873$44.35$1.3MForm 4
Feb 18, 2026WYSZOMIERSKI JACK LDirectorSale99,574$44.01$4.4MForm 4
Feb 18, 2026Smith JulieDirectorSale64,117$44.44$2.8MForm 4
Feb 18, 2026Hefti BrendaSVP and General CounselSale18,669$44.01$821.6KForm 4
Feb 17, 2026Smith JulieDirectorSale42,422$43.33$1.8MForm 4
Feb 17, 2026Senner Christopher J.EVP and CFOSale30,617$43.67$1.3MForm 4
Feb 17, 2026Haley Patrick J.EVP, CommercialSale67,814$43.52$3.0MForm 4
Feb 13, 2026Senner Christopher J.EVP and CFOSale34,278$43.00$1.5MForm 4
Feb 13, 2026Eckhardt Sue GailDirectorSale3,856$43.79$168.9KForm 4

All 122 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
2025Michael M. MorrisseyPh.D.$1.3M$33.2M78
2025Amy C. PetersonM.D.$614.5K$11.1M78
2025Christopher J. Senner58$822.8K$10.6M78
2025Dana T. AftabPh.D.$659.1K$10.5M78
2025Patrick J. HaleyExecutive Vice President, Commercial50$621.3K$9.0M78
2025Jeffrey J. HessekielJ.D.$672.4K$9.0M78
2025Brenda J. Hefti, J.D., Ph.D.Senior Vice President and General Counsel52$454.5K$4.2M78
2024President and Chief$1.3M$12.7M78
2024Executive VicePresident$788.3K$4.7M78
2024Former Executive VicePresident, General Counsel$685.9K$3.7M78
2023Executive Officer$1.2M$16.4M78
2023Research andDevelopment$577.9K$5.7M78
2023and Chief Financial Officer$746.7K$4.9M78
2023Former Executive VicePresident, General Counsel$657.2K$4.6M78

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.29,075,377$1.6B0.0%−1,740,932
Farallon Capital Management, L.l.c.13,468,010$732.8M4.3%+357,000
Renaissance Technologies LLC13,427,993$730.6M1.0%−299,000
Vanguard Portfolio Management LLC12,043,122$655.3M0.0%−42,151
Aqr Capital Management LLC11,023,943$598.6M0.2%−2,071,798
Vanguard Capital Management LLC10,950,997$595.8M0.0%−307,987
State Street Corp9,970,071$542.5M0.0%−328,368
Fuller & Thaler Asset Management, Inc.8,929,389$485.8M1.3%+387,153
Geode Capital Management, LLC7,650,316$416.3M0.0%−145,294
D. E. Shaw & Co., Inc.5,551,747$302.1M0.2%+1,948,684
Morgan Stanley4,519,684$245.9M0.0%+341,448
Invesco Ltd.4,495,697$244.6M0.0%+181,316
Dimensional Fund Advisors LP4,426,620$240.9M0.0%+127,023
Arrowstreet Capital, Limited Partnership4,365,926$237.6M0.1%−468,699
Two Sigma Investments, LP4,209,861$229.1M0.2%+2,003,649
Assetmark, Inc3,433,824$186.8M0.3%+44,904
Nuveen, LLC3,276,984$178.3M0.0%−505,750
UBS Group AG3,167,890$172.4M0.0%+774,377
Stephens Investment Management Group LLC2,710,011$147.5M1.6%+185,511
Goldman Sachs Group Inc2,690,489$146.4M0.0%+571,915
Norges Bank2,688,866$146.3M0.0%New
First Trust Advisors LP2,543,353$138.4M0.1%+8,361
Charles Schwab Investment Management Inc2,261,816$123.1M0.0%−56,420
Bank Of America Corp /de/2,149,397$116.9M0.0%+504,660
Northern Trust Corp2,126,094$115.7M0.0%−69,001

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

Members of Congress who traded it

4 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
Jun 4, 2019Donna Shalala, HouseSale$1,001 - $15,000−28.4%Report
Apr 16, 2019Donna Shalala, HousePartial sale$1,001 - $15,000−6.4%Report
Feb 6, 2019Donna Shalala, HouseBuy$1,001 - $15,000−7.6%Report
Jan 9, 2019Donna Shalala, HouseBuy$1,001 - $15,000−36.3%Report

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

SEC filer profile

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

  • Name on EDGAREXELIXIS, INC.2
  • CIK0000939767
  • Employer ID (EIN)04-325739517
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company17
  • Incorporated inDelaware17
  • Fiscal year endsJanuary 12
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address1851 Harbor Bay Parkway, Alameda, CA 945022
  • Phone65083770002
  • Shares outstanding247,781,692 as of Jul 27, 202614
  • Public float$9.4B as of Jul 4, 202517
  • AuditorErnst & Young LLP, San Mateo, California PCAOB ID 42; it also attests to the company’s internal control over financial reporting17
  • On EDGAR sinceFeb 7, 20002
  • Filings2,513 in all: 4 (1,407), 8-K (338), SC 13G/A (116), 144 (86), 10-Q (80), CT ORDER (70), S-8 POS (41), 3 (31)2
    All 60 form types

    SC 13G (30), S-8 (28), 10-K (26), DEF 14A (26), DEFA14A (23), 424B5 (18), ARS (15), CORRESP (15), UPLOAD (14), 424B3 (10), 4/A (8), 5 (8), DFAN14A (8), 425 (7), S-1/A (7), 10-Q/A (6), 8-K/A (6), S-3 (6), SC 13D/A (6), REGDEX (5), SC TO-T/A (5), 3/A (4), 424B7 (4), PRE 14A (4), S-3ASR (4), S-4/A (4), SC 13D (4), SCHEDULE 13D/A (4), EFFECT (3), POS AM (3), SC TO-C (3), SCHEDULE 13G/A (3), DEFC14A (2), PREC14A (2), S-1 (2), S-3/A (2), S-4 (2), SC TO-I/A (2), SCHEDULE 13G (2), 10-K/A (1), 305B2 (1), 424B4 (1), 8-A12G (1), AW (1), D (1), FWP (1), POS EX (1), POSASR (1), PRRN14A (1), S-3MEF (1), SC TO-I (1), SC TO-T (1)

  • Latest filingsAnnual report (10-K) Feb 10, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 15, 2026
    Latest 8-K (8-K) Sep 11, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock $0.001 Par Value per ShareEXELThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Feb 10, 2026 (Section 12(b) of the Exchange Act).17

Risk factors and legal proceedings

The risks Exelixis names in Item 1A of its 10-K filed Feb 10, 2026: 31 risks under these headings, as written.17

  • Risks Related to the Commercialization of Our Marketed Products
  • Our ability to grow our company is dependent upon the commercial success of CABOMETYX in its approved indications and, to a lesser degree, the continued clinical development, regulatory approval, clinical acceptance and commercial success of the cabozantinib franchise.
  • Our ability to grow revenues from sales of CABOMETYX depends upon the degree of market acceptance among physicians, patients, healthcare payers, and the medical community.
  • Our competitors may develop products and technologies that impair the relative value of our marketed products and any current and future product candidates.
  • If we are unable to maintain or increase our sales, marketing, market access and product distribution capabilities for our products, we may be unable to maximize product revenues, which could have a material adverse impact on our business, financial condition and results of operations.
  • If we are unable to obtain or maintain coverage and reimbursement for our products from government and other third-party payers, our business will suffer.
  • Current healthcare laws, policies, and regulations in the U.S. and future legislative or regulatory reforms to the U.S. healthcare system, including those related to drug pricing, may affect our ability to commercialize our marketed products profitably. Pricing for pharmaceutical products in the U.S. has come under increasing attention and scrutiny by federal and state governments, legislative bodies and enforcement agencies. Initiatives arising from this scrutiny may result in changes that have the effect of reducing our revenue or harming our business or reputation.
  • Lengthy regulatory pricing and reimbursement procedures and cost control initiatives imposed by governments outside the U.S. could delay the marketing of and/or result in downward pressure on the price of our approved products, resulting in a decrease in revenue.
  • The timing of the entrance of generic competitors to CABOMETYX and legislative and regulatory action designed to reduce barriers to the development, approval and adoption of generic drugs in the U.S. could limit the revenue we derive from our products, most notably CABOMETYX, which could have a material adverse impact on our business, financial condition and results of operations.
  • Risks Related to Growth of Our Product Portfolio and Research and Development
  • We may be unable to expand our discovery and development pipeline, which could limit our growth and revenue potential.
  • Clinical testing of our product candidates is a lengthy, costly, complex and uncertain process that may ultimately fail to demonstrate sufficiently differentiated safety and efficacy data for those products to compete in our highly competitive market environment.
The other 21 risks
  • The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, uncertain and subject to change, and may not result in regulatory approvals for additional cabozantinib indications or for our other product candidates, such as zanzalintinib, which could have a material adverse impact on our business, financial condition and results of operations.
  • Risks Related to Financial Matters
  • Our profitability could be negatively impacted if expenses associated with our drug discovery, clinical development, business development and commercialization activities grow more quickly than the revenues we generate.
  • Risks related to recent U.S. tariff announcements
  • Risks Related to Our Relationships with Third Parties
  • We rely on Ipsen and Takeda for the commercial success of CABOMETYX in its approved indications outside of the U.S., and we are unable to control the amount or timing of resources expended by these collaboration partners in the commercialization of CABOMETYX in its approved indications outside of the U.S.
  • Our clinical, regulatory and commercial collaborations with major companies make us reliant on those companies for their continued performance and investments, which subjects us to a number of risks.
  • Our growth potential is dependent in part upon companies with which we have entered into research collaborations, in-licensing arrangements and similar business development relationships.
  • If third parties, upon which we rely to perform clinical trials for cabozantinib in new indications and for other new product candidates, do not perform as contractually required or expected, additional regulatory approvals may be delayed or may not be possible.
  • If third-party advisors we rely on to assist with our drug discovery and development efforts do not perform as expected, the expansion of our product pipeline may be delayed.
  • We lack our own manufacturing and distribution capabilities necessary for us to produce materials required for certain preclinical activities and to produce and distribute our products for clinical development or for commercial sale, and our reliance on third parties for these services subjects us to various risks.
  • Risks Related to Healthcare Regulatory and Other Legal Compliance Matters
  • We are subject to healthcare laws, regulations and enforcement; our failure to comply with those laws could have a material adverse impact on our business, financial condition and results of operations.
  • Enhanced governmental and private scrutiny over, or investigations or litigation involving, pharmaceutical manufacturer patient assistance programs and donations to patient assistance foundations created by charitable organizations could negatively impact our business practices, harm our reputation, divert the attention of management and increase our expenses.
  • We are subject to laws and regulations relating to privacy, data protection and the collection and processing of personal data. Failure to maintain compliance with these regulations could create additional liabilities for us.
  • Risks Related to Our Information Technology and Intellectual Property
  • Data breaches and other cybersecurity incidents impacting our information technology operations and infrastructure could compromise our intellectual property or other sensitive information, damage our operations and cause significant harm to our business and reputation.
  • If we are unable to adequately protect our intellectual property, third parties may be able to use our technology, which could adversely affect our ability to compete in the market.
  • Litigation or third-party claims of intellectual property infringement could require us to spend substantial time and money and adversely affect our ability to develop and commercialize products.
  • Risks Related to Our Operations, Managing Our Growth and Employee Matters
  • If we are unable to manage our human capital needs, there could be a material adverse impact on our business, financial condition and results of operations, and our prospects may be adversely affected.
  • The loss of key personnel or the inability to retain or attract additional personnel could impair our ability to operate successfully.
  • Risks Related to Environmental and Product Liability
  • We use hazardous chemicals and biological materials in our business. Any claims relating to improper handling, storage or disposal of these materials could be time consuming and costly.
  • We face potential product liability exposure far in excess of our limited insurance coverage.
  • Risks Related to Our Common Stock
  • Our stock price has been and may in the future be highly volatile.
  • Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent or deter attempts by our stockholders to replace or remove our current management, which could cause the market price of our common stock to decline.
  • Our disclosures related to environmental, social and governance matters subjects us to risks, including risks to our market perception and stock price.

Legal proceedings

The information required to be set forth under this Item 3 is incorporated by reference to “Note 12. Commitments and Contingencies – Legal Proceedings” of the “Notes to Consolidated Financial Statements” in Part II, Item 8 of this Annual Report on Form 10-K.

The opening of Item 3, Legal Proceedings.17

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