EXEL · 10-K filed 10 Feb 2026 · year to 2 Jan 2026

Exelixis

39 named things its latest annual report says its results depend on, each in the company's own words. 22 of them are also named by other companies we've read.

Read the filing on SEC.gov ↗

Customers

Medicare

earns fromnamed as a risk

Our ability to commercialize our products successfully is highly dependent on the extent to which health insurance coverage and reimbursement is, and will be, available from third-party payers, including foreign and U.S. governmental payers, such as Medicare and Medicaid, and private health insurers.Risk factors (Item 1A)

Also named by ABT, ARWR, AXGN, BAX, BDX, BMY, BSX, CAH and 48 more

Suppliers

Third-party contract manufacturing organizations

depends onnamed as a risk

Instead, we rely on various third-party contract manufacturing organizations to conduct GMP manufacturing operations on our behalf to produce our monoclonal antibodies, linker/payloads, drug substance and drug product.Business (Item 1)

Also named by BIIB

Partners and platforms

Takeda

earns from · $60.3 millionnamed as a risk

As of December 31, 2025, we have earned royalties of $60.3 million on net sales of cabozantinib by Takeda since the inception of the collaboration agreement.Business (Item 1)

Also named by IONS, PFE

Ipsen

earns from · $837.9 millionnamed as a risk

As of December 31, 2025, we have earned royalties of $837.9 million on net sales of cabozantinib by Ipsen since the inception of the collaboration agreement.Business (Item 1)

Insilico Medicine

depends on · $80 million

Under the agreement, Insilico granted us global rights to develop and commercialize XL309 in exchange for an upfront payment to Insilico of $80 million.Business (Item 1)

Merck (MSD)

depends on

Merck will fund one of these phase 3 studies and we will co-fund the phase 1/2 study and the other phase 3 study, as well as supply zanzalintinib and cabozantinib.Business (Item 1)

Also named by LGND, MRNA

Bristol-Myers Squibb (BMS)

depends on

In February 2017, we entered into a clinical trial collaboration agreement with BMS for the purpose of exploring the therapeutic potential of cabozantinib in combination with BMS’s ICIs, nivolumab and/or ipilimumab, to treat a variety of types of cancer.Business (Item 1)

Also named by PFE

Roche

depends on

We are the trial sponsor of COSMIC-021, and Roche is providing atezolizumab free of charge.Business (Item 1)

Also named by IONS

National Cancer Institute Cancer Therapy Evaluation Program (NCI-CTEP)

depends on

The CRADA reflects a commitment by NCI-CTEP to provide funding for the broad exploration of cabozantinib’s potential in a wide variety of cancers, each representing a substantial unmet medical need.Business (Item 1)

Catalent

depends on

XB010 was constructed using Catalent’s SMARTag site-specific bioconjugation platform, and its 5T4-targeting mAb was discovered in collaboration with Invenra.Business (Item 1)

Invenra

depends on

In May 2018, we entered into a collaboration and license agreement with Invenra to discover and develop multispecific antibodies for the treatment of cancer.Business (Item 1)

Other companies

Royalty Pharma

3% royalty

Accordingly, and consistent with our historical agreement with GSK, we are required to pay a 3% royalty to Royalty Pharma on total net sales of any product containing cabozantinib, including net sales by Ipsen.Business (Item 1)

Also named by ARWR, BIIB, IONS

Competitors

Bayer

competes withnamed as a risk

Should the combination of zanzalintinib and atezolizumab be approved for the treatment of these CRC patients, we believe its principal competition may include the following approved therapies or therapies in late-stage development: Bayer’s regorafenib; Taiho Oncology’s trifluridine/tipiracil; the combination of Taiho Oncology’s trifluridine/tipiracil and Roche’s bevacizumab; Takeda’s fruquintinib; and the combination of Agenus’ botensilimab and balstilimab.Business (Item 1)

Also named by COO, CTVA, GEHC, REGN

Novartis

competes withnamed as a risk

CABOMETYX - pNET/epNET: We believe the principal competition for CABOMETYX in previously treated, advanced pNET and epNET includes the following approved therapies or therapies in late-stage development: Novartis’ lutetium Lu177 dotatate; Novartis’s everolimus; Pfizer’s sunitinib; Lantheus Holdings, Inc. and POINT Biopharma’s 177Lu-PNT2003; Curium US LLC’s 177Lu-DOTATATE; ITM Solucin GmbH’s 177Lu-Edotreotide; and the combination of Roche’s capecitabine and Merck & Co.’s temozolomide.Business (Item 1)

Also named by INCY, IONS

Teva

competes withnamed as a risk

For example, we received Paragraph IV certification notice letters from MSN, Teva, Cipla, Sun, and Biocon concerning the respective ANDAs that each had filed with the FDA seeking approval to market generic versions of CABOMETYX tablets.Risk factors (Item 1A)

Also named by LGND

Eisai

competes withnamed as a risk

CABOMETYX - HCC: We believe the principal competition for CABOMETYX in previously treated HCC includes: Bayer’s regorafenib and Eisai’s lenvatinib.Business (Item 1)

Also named by BIIB

Merck & Co.

competes withnamed as a risk

CABOMETYX - RCC: We believe the principal competition for CABOMETYX in advanced RCC includes: the combination of Merck & Co.’s pembrolizumab and Pfizer’s axitinib; the combination of BMS’s ipilimumab and nivolumab; the combination of Merck & Co.’s pembrolizumab and Eisai’s lenvatinib; the combination of Eisai’s lenvatinib and Novartis’ everolimus; and Merck & Co.’s belzutifan.Business (Item 1)

Also named by BMY

MSN Pharmaceuticals

competes withnamed as a risk

For example, other companies, including MSN Pharmaceuticals, Inc. (individually and collectively with certain of its affiliates, including MSN Laboratories Private Limited, referred to as MSN) have applied for or received tentative approval for an ANDA for generic versions of CABOMETYX tablets.Risk factors (Item 1A)

Azurity Pharmaceuticals

competes withnamed as a risk

Azurity Pharmaceuticals, Inc. (Azurity) has received tentative approval for a 505(b)(2) NDA for cabozantinib tablets and Handa Oncology, LLC (Handa) has submitted a 505(b)(2) NDA requesting approval to market cabozantinib capsules (in the form of cabozantinib lauryl sulfate).Risk factors (Item 1A)

Handa Oncology

competes withnamed as a risk

Cipla

competes withnamed as a risk

Sun Pharmaceutical

competes withnamed as a risk

Biocon

competes withnamed as a risk

Places

Japan

earns fromnamed as a risk

Under the collaboration agreement, Takeda has exclusive commercialization rights for current and potential future cabozantinib indications in Japan, and the parties have agreed to collaborate on the clinical development of cabozantinib in Japan.Business (Item 1)

Also named by A, AAPL, AFL, AMKR, ANET, BMY, BSX, CAT and 25 more

Hazards

Russia-Ukraine conflict, Middle East conflicts and Venezuela instability

operates innamed as a risk

The ongoing conflicts between Russia and Ukraine and in the Middle East and the political, economic and social instability in Venezuela have had modest impacts on our clinical development operations and may continue to have adverse impacts on the ability of clinical sites and enrolled patients to adhere to trial protocols for in-office clinical visits and other procedures, our ability to supply clinical sites with cabozantinib, zanzalintinib or other study drugs and to pay clinical sites and investigators for work performed, as well as our ability to collect data and conduct site monitoring visits, all of which could undermine the data quality for patients enrolled at these clinical sites.Risk factors (Item 1A)

Commodities and inputs

Euro

exposed to its price

Royalty revenues and sales-based milestones we receive from our collaboration agreements with Ipsen, Takeda and Genentech are a percentage of the net sales made by those collaboration partners from sales made in countries outside the U.S. and are denominated in currencies in which the product is sold, which is predominantly the Euro or Japanese Yen.Market risk (Item 7A)

Also named by ABBV, ABNB, ABT, ADBE, ADI, AME, AMG, AMGN and 186 more

Regulators

U.S. Food and Drug Administration (FDA)

subject tonamed as a risk

In January 2026, we announced that the FDA had accepted our NDA and assigned a standard review, with a Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026.Business (Item 1)

Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more

Health Resources and Services Administration (HRSA)

subject tonamed as a risk

The petitioners contend that our 340B Program Integrity Initiative caused them to be overcharged for CABOMETYX and COMETRIQ.Risk factors (Item 1A)

Also named by LLY, UTHR

West Virginia Board of Pharmacy

subject tonamed as a risk

On March 17, 2025, April 24, 2025, and May 27, 2025, we received notice letters (collectively, Notices) from the West Virginia Board of Pharmacy (WV Board) of complaints filed against us for purported violations of laws related to distribution of drugs to 340B facilities (West Virginia Code § 60A-8-6a (WV Statute)).Risk factors (Item 1A)

Laws and programs

Inflation Reduction Act of 2022 (Medicare Drug Price Negotiation Program)

subject tonamed as a risk

Over time, the IRA could reduce the revenues we are able to collect from sales of our products or present challenges for payer negotiations and formulary access for our products, as well as increase our government discount and rebate liabilities; however, the degree of impact that the IRA will ultimately have upon our business remains unclear.Risk factors (Item 1A)

Also named by ABBV, APD, ARE, BKH, DD, DHR, ELV, ENPH and 30 more

340B Drug Pricing Program

subject tonamed as a risk

Furthermore, because we participate in the 340B Program to sell a portion of our marketed products, changes in the administration of the program could have a material adverse impact on our revenues.Risk factors (Item 1A)

Also named by ABBV, BAX, BIIB, BMY, CAH, COR, CVS, GILD and 13 more

Medicaid Drug Rebate Program

subject tonamed as a risk

Changes to our obligations under these government pricing programs occur frequently and program requirements are often ambiguous, and we cannot predict how future guidance or rules would affect our profitability (including the potential for increases in our overall Medicaid rebate liability and the obligation to charge greatly reduced prices to covered entities).Business (Item 1)

Also named by BIIB, BMY, HROW, PFE, REGN, VRTX

Drug Supply Chain Security Act (DSCSA)

subject tonamed as a risk

If our third-party contract manufacturers or data service providers fail to support our efforts to continue to comply with DSCSA and its foreign equivalents, as well as any future electronic pedigree requirements, we may face legal penalties or be restricted from selling our products.Risk factors (Item 1A)

Also named by CAH, COR, HSIC, MCK

Most favored nation (MFN) drug pricing

subject tonamed as a risk

The scope of these models and the impact that they could have on Exelixis’ products is unclear at this time.Risk factors (Item 1A)

Also named by MTD, NBIX, VTRS

U.S. tariffs on imports from China, Mexico and Canada

exposed to its pricenamed as a risk

Significant changes in tariffs or other trade barriers, such as the enactment of tariffs on goods imported into the United States, including, but not limited to, tariffs on goods imported from China, Mexico and Canada (including raw materials and components used in our manufacturing processes) or the introduction of additional tariffs or other trade barriers, could also increase the costs of our finished drug product.Risk factors (Item 1A)

Also named by AXON, GNTX, LFUS

U.S. Patent No. 7,579,473 (cabozantinib composition of matter)

named as a risk

This composition of matter patent, with patent term extension, will expire in August 2026.Business (Item 1)

Medicare Part D Manufacturer Discount Program

subject tonamed as a risk

We have since received notice from CMS that we qualify for the "specified small manufacturer” designation and are thereby eligible for a phase-in of the increased manufacturer discounts under the Part D Discount Program, from 2025 to 2031.Business (Item 1)

EU Regulation on Health Technology Assessment

subject tonamed as a risk

Such initiatives, particularly the Regulation on Health Technology Assessment adopted in December 2021 and entered into application in January 2025, may further impact the price and reimbursement status of CABOMETYX and COMETRIQ.Risk factors (Item 1A)

IRA small biotech exception

subject to

As of the date of this Annual Report on Form 10-K, we have qualified for the small biotech exception with respect to our cabozantinib franchise products through 2027.Business (Item 1)