Exelixis EXEL
Exelixis reports $658.7M revenue
- Form
- 10-Q
- Filed
- Importance
- Notable
- Accession
- 0000939767-26-000116
- Revenue: $658.7 million for the three months ended Oct 2, 2026
- Net income: $218.09 million for the three months ended Oct 2, 2026
- Diluted EPS: $0.85 for the three months ended Oct 2, 2026
- Cash and equivalents: $304.77 million at Oct 2, 2026
Written from the 10-Q on EDGAR. AI can make mistakes. Check the filing.
What changed
31 changes since the July 2026 10-Q
Compared with the 10-Q 0000939767-26-000098, filed Aug 5, 2026.
New legal mention
On August 31, 2026, the CAFC issued its opinion, where it affirmed that the asserted claims of the 439, 440, and 015 patents are not invalid, dismissed MSN s appeal as to the asserted claim of the 349 patent, which…
From the filings
Now
On August 31, 2026, the CAFC issued its opinion, where it affirmed that the asserted claims of the 439, 440, and 015 patents are not invalid, dismissed MSN s appeal as to the asserted claim of the 349 patent, which expires on February 10, 2032, and vacated the district court s judgment with respect to the validity of the asserted claim of the 349 patent.New legal mention
Based on the CAFC s opinion, the effective date of any final approval by the FDA of MSN s ANDA shall not be a date earlier than January 15, 2030, the expiration date of each of the 439, 440, and 015 patents, subject to…
From the filings
Now
Based on the CAFC s opinion, the effective date of any final approval by the FDA of MSN s ANDA shall not be a date earlier than January 15, 2030, the expiration date of each of the 439, 440, and 015 patents, subject to any further appellate proceedings, applicable regulatory exclusivity, and the outcome of separate litigation involving the 039 Patent (as defined below), which expires in February 2032 and for which trial is currently scheduled to begin in November 2026.New legal mention
On October 5, 2026, the Delaware District Court denied Azurity s motions for judgment on the pleadings.
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On October 5, 2026, the Delaware District Court denied Azurity s motions for judgment on the pleadings.New legal mention
On October 28, 2026, we entered into a settlement and license agreement with Azurity (the Azurity Settlement Agreement) to resolve the Azurity litigation.
From the filings
Now
On October 28, 2026, we entered into a settlement and license agreement with Azurity (the Azurity Settlement Agreement) to resolve the Azurity litigation.New legal mention
Pursuant to the terms of the Azurity Settlement Agreement, we will grant Azurity a license to market its proposed 505(b)(2) NDA product in the U.S. beginning on December 1, 2030, if approved by the FDA and subject to…
From the filings
Now
Pursuant to the terms of the Azurity Settlement Agreement, we will grant Azurity a license to market its proposed 505(b)(2) NDA product in the U.S. beginning on December 1, 2030, if approved by the FDA and subject to conditions and exceptions customary for agreements of this type.New legal mention
The effective date for the proposed generic cabozantinib products where we have a settlement and license agreement remains January 1, 2031, subject to conditions and exceptions customary for agreements of this type.
From the filings
Now
The effective date for the proposed generic cabozantinib products where we have a settlement and license agreement remains January 1, 2031, subject to conditions and exceptions customary for agreements of this type.New legal mention
In accordance with the Azurity Settlement Agreement, within three (3) business days after the effective date, we and Azurity will jointly file a stipulated dismissal (the Azurity Dismissal) terminating all ongoing…
From the filings
Now
In accordance with the Azurity Settlement Agreement, within three (3) business days after the effective date, we and Azurity will jointly file a stipulated dismissal (the Azurity Dismissal) terminating all ongoing litigation between us and Azurity in the Consolidated Litigation.New legal mention
The Azurity Dismissal will not affect our litigation with MSN, which remains pending in the Consolidated Litigation.
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The Azurity Dismissal will not affect our litigation with MSN, which remains pending in the Consolidated Litigation.New legal mention
On August 31, 2026, the Delaware District Court granted our request to dismiss the July 6, 2026 complaint without prejudice.
From the filings
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On August 31, 2026, the Delaware District Court granted our request to dismiss the July 6, 2026 complaint without prejudice.New legal mention
On September 3, 2026, the FDA responded to our citizen petition denying our requests and, on the same day, granted full approval to Handa s 505(b)(2) NDA.
From the filings
Now
On September 3, 2026, the FDA responded to our citizen petition denying our requests and, on the same day, granted full approval to Handa s 505(b)(2) NDA.Cash up 8.3% from Jul 3
$305M, was $281M.
From the filings
Before
$281MNow
$305MEPS up 3.7% from Jul 3
$0.85, was $0.82.
From the filings
Before
$0.82Now
$0.85Net income up 2.9% from Jul 3
$218M, was $212M.
From the filings
Before
$212MNow
$218MThe FDA first approved CABOMETYX in the U.S. as a monotherapy for previously treated patients with advanced…
Drops "CABOMETYX label was expanded to include first-line advanced RCC in combination with…".
From the filings
Before
The FDA first approved CABOMETYX in the U.S. as a monotherapy for previously treated patients with advanced RCC in April 2016, and then for previously untreated patients with advanced RCC in December 2017. In January 2021, the CABOMETYX label was expanded to include first-line advanced RCC in combination with nivolumab, which was the first CABOMETYX regimen approved for treatment in combination with an immune checkpoint inhibitor (ICI). In addition to RCC, in January 2019, the FDA approved CABOMETYX for the treatment of patients with HCC previously treated with sorafenib, and in September 2021, the FDA approved CABOMETYX for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic DTC that has progressed following prior VEGF receptor-targeted therapy and who are RAI-refractory or ineligible. In March 2025, the FDA approved CABOMETYX for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pNET and epNET.Now
The FDA first approved CABOMETYX in the U.S. as a monotherapy for previously treated patients with advanced RCC in April 2016, and then for previously untreated patients with advanced RCC in December 2017. In January 2021, theMedical Devices Agency for monotherapy CABOMETYX as a treatment of patients with curatively unresectable or…
New paragraph in MD&A.
From the filings
Now
Medical Devices Agency for monotherapy CABOMETYX as a treatment of patients with curatively unresectable or metastatic RCC and as a treatment of patients with unresectable HCC that has progressed after cancer chemotherapy, as well as for CABOMETYX in combination with nivolumab as a treatment for unresectable or metastatic RCC.In October 2026, we also initiated STELLAR-202, a phase 2 trial evaluating zanzalintinib in combination with…
Adds "October"; drops "April".
From the filings
Before
In April 2026, we initiated STELLAR-201, a phase 2 trial evaluating zanzalintinib in patients with recurrent Grade I/II/III meningioma with relapse or progression following radiation and/or surgery or those who are not candidates for these therapies. The primary endpoint of the trial is objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), duration of response (DOR) and OS. Enrollment is currently ongoing.Now
In October 2026, we also initiated STELLAR-202, a phase 2 trial evaluating zanzalintinib in combination with pembrolizumab in the maintenance setting in squamous non-small cell lung cancer (NSCLC). The primary endpoint of the trial is six-month progression-free survival (PFS-6), with secondary endpoints including safety, PFS, OS, ORR, and DOR. The study is currently enrolling.Beyond STELLAR-001, STELLAR-002, STELLAR-201, STELLAR-202, STELLAR-303, STELLAR-304, STELLAR-311, and…
New paragraph in MD&A.
From the filings
Now
Beyond STELLAR-001, STELLAR-002, STELLAR-201, STELLAR-202, STELLAR-303, STELLAR-304, STELLAR-311, and STELLAR-316, we are pursuing additional early-stage and pivotal trials evaluating zanzalintinib across a broad array of potential future indications, including trials evaluating zanzalintinib in combination with established immunotherapies, novel immunotherapies (including in a phase 1 cohort in combination with XB628, our first-in-class bispecific antibody), as well as chemotherapy and other treatment modalities.In August 2026, the United States Court of Appeals for the Federal Circuit (Court of Appeals) affirmed a…
New paragraph in MD&A.
From the filings
Now
In August 2026, the United States Court of Appeals for the Federal Circuit (Court of Appeals) affirmed a favorable district court decision in our patent lawsuit against MSN Laboratories Private Limited et al. (MSN), upholding the validity of U.S. Patent Nos. 11,091,439, 11,091,440 and 11,098,015. As a result, the effective date of any final FDA approval of MSN s Abbreviated New Drug Application (ANDA) shall not be a date earlier than January 15, 2030, subject to any further appellate proceedings, applicable regulatory exclusivity, and the outcome of separate consolidated litigation involving U.S. Patent No. 12,128,039, with a trial scheduled for November 2026. The Court of Appeals also dismissed as moot MSN s appeal relating to the validity of U.S. Patent No. 11,298,349. See Note 11. Commitments and Contingencies of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for additional information.In September 2026, we announced that the FDA notified us that it had extended the review period for our NDA…
New paragraph in MD&A.
From the filings
Now
In September 2026, we announced that the FDA notified us that it had extended the review period for our NDA for zanzalintinib, in combination with atezolizumab, for the treatment of patients with metastatic colorectal cancer by three months. In response to an FDA information request, we had submitted updated safety and efficacy data, which the FDA deemed a major amendment. The updated PDUFA target action date is March 3, 2027.In October 2026, we entered into a settlement and license agreement with Azurity Pharmaceuticals, Inc.
New paragraph in MD&A.
From the filings
Now
In October 2026, we entered into a settlement and license agreement with Azurity Pharmaceuticals, Inc. (Azurity, and such agreement, the Azurity Settlement Agreement) to resolve the Azurity litigation. Pursuant to the terms of the Azurity Settlement Agreement, we will grant Azurity a license to market its proposed 505(b)(2) NDA product in the U.S. beginning on December 1, 2030, if approved by the FDA and subject to conditions and exceptions customary for agreements of this type. The effective date for the proposed generic cabozantinib products where we have a settlement and license agreement remains January 1, 2031, subject to conditions and exceptions customary for agreements of this type.2026.
New paragraph in MD&A.
From the filings
Now
2026. We will continue to engage in pipeline expansion initiatives with the goal of acquiring and in-licensing promising investigational oncology assets and then further characterize and develop them utilizing our established preclinical and clinical development infrastructure.
and 10 more of the same kinds
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Section by section. Added words and removed words against the earlier filing.
Cover page 2 changes
3 unchanged paragraphs
For the quarterly period ended July 3, October 2, 2026
18 unchanged paragraphs
As of July 27, October 19, 2026, there were 247,781,692 244,010,895 shares of the registrant s common stock outstanding.
2 unchanged paragraphs
Financial statements 165 changes
2 unchanged paragraphs
Marketable securities 557,937 576,603
Inventory 28,729 21,686
June September 30, 2026 December 31, 2025
Cash and cash equivalents $ 281,448 304,774 $ 482,488
Marketable securities 587,244 576,603
Trade receivables, net 322,213 328,466 286,916
Inventory 29,871 21,686
Prepaid expenses and other current assets 60,495 71,267 75,596
Total current assets 1,250,822 1,321,622 1,443,289
Non-current marketable securities 544,930 507,759 603,603
Property and equipment, net 92,665 87,276 98,960
Deferred tax assets, net 294,205 295,561 292,582
1 unchanged paragraph
Right-of-use assets and other non-current assets 247,928 237,587 342,305
Total assets $ 2,494,234 2,513,489 $ 2,844,423
2 unchanged paragraphs
Accounts payable $ 39,062 $ 29,623
Total liabilities 650,472 683,104
Accounts payable $ 30,833 $ 29,623
Accrued compensation and benefits 68,629 100,493 102,218
Accrued clinical trial liabilities 59,767 70,316 65,742
Rebates and fees due to customers 66,711 70,767 59,896
Accrued collaboration liabilities 25,096 24,627 22,783
Other current liabilities 102,662 114,841 125,382
Total current liabilities 361,927 411,877 405,644
Non-current operating lease liabilities 165,929 162,201 173,038
Other non-current liabilities 122,616 105,579 104,422
Total liabilities 679,657 683,104
3 unchanged paragraphs
Accumulated deficit ( 262,533 ) ( 76,830 )
Common stock, $ 0.001 par value; 400,000 shares authorized; issued and outstanding: 248,885 244,678 and 262,483 at June September 30, 2026, and December 31, 2025, respectively
Additional paid-in-capital 2,108,059 2,098,978 2,234,411
Accumulated other comprehensive income (loss) ( 2,013 6,589 ) 3,476
Accumulated deficit ( 258,802 ) ( 76,830 )
Total stockholders equity 1,843,762 1,833,832 2,161,319
Total liabilities and stockholders equity $ 2,494,234 2,513,489 $ 2,844,423
3 unchanged paragraphs
Three Months Ended June 30, Six Months Ended June 30,
Net product revenues $ 573,025 $ 520,014 $ 1,128,002 $ 1,033,297
Collaboration revenues 55,665 48,247 111,500 90,411
Total revenues 628,690 568,261 1,239,502 1,123,708
Cost of goods sold 20,657 19,470 40,610 38,642
Research and development 211,987 200,356 411,903 412,589
Selling, general and administrative 147,632 134,859 287,234 272,042
Total operating expenses 380,276 354,685 739,747 723,273
Income from operations 248,414 213,576 499,755 400,435
Interest income 14,210 16,789 30,337 35,865
Other income (expenses), net 54 50 273 ( 195 )
Income before income taxes 262,678 230,415 530,365 436,105
Provision for income taxes 50,628 45,567 107,848 91,641
Net income $ 212,050 $ 184,848 $ 422,517 $ 344,464
Three Months Ended September 30, Nine Months Ended September 30,
Net product revenues $ 604,924 $ 542,930 $ 1,732,926 $ 1,576,227
Collaboration revenues 53,772 54,825 165,272 145,236
Total revenues 658,696 597,755 1,898,198 1,721,463
Cost of goods sold 26,233 18,574 66,843 57,216
Research and development 209,481 199,164 621,384 611,753
Selling, general and administrative 154,559 123,661 441,793 395,703
Restructuring 19,816 19,816
Total operating expenses 390,273 361,215 1,130,020 1,084,488
Income from operations 268,423 236,540 768,178 636,975
Interest income 14,315 15,922 44,652 51,787
Other income (expenses), net 47 ( 49 ) 320 ( 244 )
Income before income taxes 282,785 252,413 813,150 688,518
Provision for income taxes 64,690 58,835 172,538 150,476
Net income $ 218,095 $ 193,578 $ 640,612 $ 538,042
1 unchanged paragraph
Basic $ 0.85 $ 0.68 $ 1.66 $ 1.25
Diluted $ 0.82 $ 0.65 $ 1.60 $ 1.20
Basic $ 0.88 $ 0.72 $ 2.54 $ 1.97
Diluted $ 0.85 $ 0.69 $ 2.46 $ 1.90
1 unchanged paragraph
Basic 250,808 272,583 254,568 275,693
Diluted 259,675 284,393 263,499 286,285
Basic 246,756 268,421 251,964 273,269
Diluted 255,754 278,535 260,917 283,701
2 unchanged paragraphs
Three Months Ended June 30, Six Months Ended June 30,
Net income $ 212,050 $ 184,848 $ 422,517 $ 344,464
Three Months Ended September 30, Nine Months Ended September 30,
Net income $ 218,095 $ 193,578 $ 640,612 $ 538,042
1 unchanged paragraph
Comprehensive income $ 210,452 $ 184,187 $ 417,028 $ 347,160
Net unrealized gains (losses) on available-for-sale debt securities, net of tax impact of $ 475 1,357 , $( 197 659 ), $ 1,622 2,979 and $( 786 1,445 ), respectively ( 1,598 ) ( 661 4,576 ) 2,216 ( 5,489 10,065 ) 2,696 4,912
Comprehensive income $ 213,519 $ 195,794 $ 630,547 $ 542,954
2 unchanged paragraphs
Three Months Ended June September 30, 2026
2 unchanged paragraphs
Balance at March 31, 2026
Net income 212,050 212,050
1 unchanged paragraph
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and 85 more changes in the filing
Note 1: ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES 4 changes
5 unchanged paragraphs
We have adopted use a 52- or 53-week fiscal year policy that generally ends on the Friday closest to December 31. Fiscal year 2026, which is a 52-week fiscal year, will end on January 1, 2027 and fiscal year 2025, which was a 52-week fiscal year, ended on January 2, 2026. For convenience, references in this report as of and for the fiscal periods ended July 3, October 2, 2026, July 4, October 3, 2025, April July 3, 2026 and April July 4, 2025, and as of and for the fiscal year ending January 1, 2027 and the fiscal years ended January 2, 2026 and January 3, 2025, are indicated as being as of and for the periods ended June September 30, 2026, June September 30, 2025, March 31, June 30, 2026 and March 31, June 30, 2025, and the year ending December 31, 2026, and the years ended December 31, 2025, and December 31, 2024, respectively.
The accompanying Condensed Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the U.S. for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In our opinion, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of our financial statements for the periods presented have been included. Operating results for the six nine months ended June September 30, 2026 are not necessarily indicative of the results that may be expected for the year ending December 31, 2026 or for any future period. The accompanying Condensed Consolidated Financial Statements and Notes thereto should be read in conjunction with our Consolidated Financial Statements and Notes thereto for the fiscal year ended December 31, 2025, included in Part II, Item 8 of our Annual Report on Form 10-K, filed with the SEC on February 10, 2026 (Fiscal 2025 Form 10-K).
2 unchanged paragraphs
There have been no material changes to our significant accounting policies during the six nine months ended June September 30, 2026, as compared to the significant accounting policies disclosed in Note 1. Organization and Summary of Significant Accounting Policies of the Notes to Consolidated Financial Statements included in Part II, Item 8 of our Fiscal 2025 Form 10-K.
6 unchanged paragraphs
In December 2025, the FASB issued ASU 2025-12, Codification Improvements (ASU 2025-12), which addresses thirty-three 33 issues, representing amendments to Accounting Standards Codification (ASC) topics that clarify, correct errors or make minor improvements. ASU 2025-12 makes the ASC topics easier to understand and apply. ASU 2025-12 is effective for us in our annual reporting for fiscal year 2027, and in our interim periods beginning in fiscal year 2027. Early adoption and retrospective application are permitted on an issue-by-issue basis. We are currently evaluating the impact of ASU 2025-12 on our Consolidated Financial Statements.
Note 2: SEGMENT REPORTING 17 changes
3 unchanged paragraphs
Three Months Ended June 30, Six Months Ended June 30,
Revenues $ 628,690 $ 568,261 $ 1,239,502 $ 1,123,708
Cost of goods sold 20,657 19,470 40,610 38,642
Drug discovery 18,252 21,357 37,728 39,610
Development 150,522 134,159 286,237 287,376
Selling, general, and administrative 127,413 112,931 250,283 233,706
Three Months Ended September 30, Nine Months Ended September 30,
Revenues $ 658,696 $ 597,755 $ 1,898,198 $ 1,721,463
Cost of goods sold 26,233 18,574 66,843 57,216
Drug discovery 17,144 23,838 54,872 63,448
Development 147,739 133,645 433,976 421,021
Selling, general, and administrative 136,910 103,129 387,193 336,835
1 unchanged paragraph
Interest income ( 14,210 ) ( 16,789 ) ( 30,337 ) ( 35,865 )
Provision for income taxes 50,628 45,567 107,848 91,641
Interest income ( 14,315 ) ( 15,922 ) ( 44,652 ) ( 51,787 )
Provision for income taxes 64,690 58,835 172,538 150,476
Segment and consolidated net income $ 212,050 218,095 $ 184,848 193,578 $ 422,517 640,612 $ 344,464 538,042 (1) Other segment items include stock-based compensation, restructuring expenses, other research and development expenses, including the allocation of general corporate costs to research and development services and development cost reimbursements in connection with certain of our collaboration arrangements, and other income (expenses), net.
1 unchanged paragraph
Note 3: REVENUES 57 changes
1 unchanged paragraph
Three Months Ended June 30, Six Months Ended June 30,
Gross product revenues $ 812,782 $ 745,280 $ 1,608,136 $ 1,466,991
Discounts and allowances ( 239,757 ) ( 225,266 ) ( 480,134 ) ( 433,694 )
Net product revenues 573,025 520,014 1,128,002 1,033,297
Three Months Ended September 30, Nine Months Ended September 30,
Gross product revenues $ 853,716 $ 780,272 $ 2,461,852 $ 2,247,263
Discounts and allowances ( 248,792 ) ( 237,342 ) ( 728,926 ) ( 671,036 )
Net product revenues 604,924 542,930 1,732,926 1,576,227
1 unchanged paragraph
License revenues 59,810 49,301 116,758 91,781
Collaboration services revenues ( 4,145 ) ( 1,054 ) ( 5,258 ) ( 1,370 )
License revenues 58,408 56,236 175,166 148,017
Collaboration services revenues ( 4,636 ) ( 1,411 ) ( 9,894 ) ( 2,781 )
1 unchanged paragraph
Total revenues $ 628,690 $ 568,261 $ 1,239,502 $ 1,123,708
Total revenues $ 658,696 $ 597,755 $ 1,898,198 $ 1,721,463
1 unchanged paragraph
Three Months Ended June 30, Six Months Ended June 30,
Three Months Ended September 30, Nine Months Ended September 30,
Affiliates of Cencora, Inc. 20 % 20 % 21 % 22 %
Affiliates of McKesson Corporation 21 20 % 18 20 % 20 % 18 19 %
Affiliates of CVS Health Corporation 15 % 16 % 15 % 15 % 15 %
Affiliates of Optum Specialty Pharmacy 11 % * 10 % *
Accredo Health Group, Inc. 10 % 12 * 11 % 10 % 12 %
1 unchanged paragraph
Affiliates of Optum Specialty Pharmacy * * * 10 %
2 unchanged paragraphs
June September 30, 2026 December 31, 2025
Affiliates of McKesson Corporation 26 25 % 25 %
Affiliates of Cencora, Inc. 23 24 % 23 %
Ipsen Pharma SAS 17 15 % 19 %
1 unchanged paragraph
Cardinal Health, Inc. 11 12 % 12 %
1 unchanged paragraph
Three Months Ended June 30, Six Months Ended June 30,
Europe 46,007 37,033 85,575 69,739
Japan 4,322 6,460 17,020 12,017
Total revenues $ 628,690 $ 568,261 $ 1,239,502 $ 1,123,708
Three Months Ended September 30, Nine Months Ended September 30,
Europe 44,298 44,966 129,873 114,705
Japan 5,299 6,328 22,319 18,345
Total revenues $ 658,696 $ 597,755 $ 1,898,198 $ 1,721,463
3 unchanged paragraphs
Three Months Ended June 30, Six Months Ended June 30,
CABOMETYX $ 570,648 $ 517,890 $ 1,123,421 $ 1,028,762
COMETRIQ 2,377 2,124 4,581 4,535
Net product revenues $ 573,025 $ 520,014 $ 1,128,002 $ 1,033,297
Three Months Ended September 30, Nine Months Ended September 30,
CABOMETYX $ 603,154 $ 539,878 $ 1,726,575 $ 1,568,640
COMETRIQ 1,770 3,052 6,351 7,587
Net product revenues $ 604,924 $ 542,930 $ 1,732,926 $ 1,576,227
6 unchanged paragraphs
Current period 316,366 37,604 126,249 480,219
Prior periods 502 ( 402 ) ( 185 ) ( 85 )
Payments and customer credits issued ( 318,885 ) ( 39,750 ) ( 116,701 ) ( 475,336 )
Current period 492,111 55,155 192,295 739,561
Prior periods ( 10,015 ) ( 402 ) ( 218 ) ( 10,635 )
Payments and customer credits issued ( 485,149 ) ( 56,113 ) ( 179,846 ) ( 721,108 )
Balance at June September 30, 2026
2 unchanged paragraphs
We receive payments from our collaboration partners based on billing schedules established in each contract. Amounts are recorded as accounts receivable when our right to consideration is unconditional. We may also recognize revenue in advance of the contractual billing schedule and such amounts are recorded as a contract asset when recognized. We may be required to defer recognition of revenue for upfront and milestone payments until we perform our obligations under these arrangements, and such amounts are recorded as deferred revenue upon receipt or when due. For those contracts that have multiple performance obligations, contract assets and liabilities are reported on a net basis at the contract level. There were no contract assets as of June September 30, 2026 and December 31, 2025. Contract liabilities are primarily related to deferred revenues from Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Company Limited (Takeda).
1 unchanged paragraph
June September 30, 2026 December 31, 2025
2 unchanged paragraphs
Total contract liabilities $ 5,699 5,122 $ 7,227
2 unchanged paragraphs
During the three and six months ended June 30, 2026, we recognized $ 1.0 million and $ 2.1 million, respectively, in revenues that were included in the beginning deferred revenues balance for those periods, as compared to $ 1.2 million and $ 2.4 million, respectively, for the corresponding prior year periods.
During each of the three and nine months ended September 30, 2026, and 2025, we recognized $ 1.0 million and $ 3.1 million, respectively, of revenues that were included in the deferred revenues balance at the beginning of the respective periods.
During the three and six nine months ended June September 30, 2026, we recognized $ 59.9 58.0 million and $ 119.8 177.9 million, respectively, in revenues for performance obligations satisfied in previous periods, as compared to $ 51.2 57.6 million and $ 93.7 151.3 million, respectively, for the corresponding prior year periods. During the three and nine months ended September 30, 2026, such revenues were primarily related to royalty payments allocated to our license performance obligations for our collaborations with Ipsen and Takeda and the recognition of revenues for the achievement of milestones, including a commercial milestone achieved during the first quarter of 2026. During the three and nine months ended September 30, 2025, such revenues were primarily related to royalty payments allocated to our license performance obligations for our collaborations with Ipsen and Takeda and the recognition of revenues for the achievement of milestones, including a regulatory milestone achieved during the third quarter of 2025.
As of June September 30, 2026, $ 17.8 16.0 million of t he co mbined transaction prices for our Ipsen a nd Takeda collaborations were allocated to research and development services performance obligations that had not yet been satisfied. See Note 4. Collaboration Agreements and Business Development Activities of the Notes to Consolidated Financial Statements included in Part II, Item 8 of our Fiscal 2025 Form 10-K for additional information about the expected timing to satisfy these performance obligations.
Note 4: COLLABORATION AGREEMENTS AND BUSINESS DEVELOPMENT ACTIVITIES 24 changes
We have established multiple collaborations with leading biopharmaceutical companies for the commercialization and further development of our cabozantinib franchise. Additionally, we have made considerable progress under our existing research collaboration and in-licensing arrangements to further enhance our early-stage pipeline and expand our ability to discover, develop and commercialize novel therapies with the goal of providing new treatment options for cancer patients. Historically, we also entered into other collaborations with leading biopharmaceutical companies pursuant to which we out-licensed other compounds and programs in our portfolio.
4 unchanged paragraphs
Three Months Ended June 30, Six Months Ended June 30,
License revenues $ 50,539 $ 39,540 $ 94,071 $ 73,519
Collaboration services revenues ( 4,532 ) ( 2,507 ) ( 8,496 ) ( 3,780 )
Total collaboration revenues $ 46,007 $ 37,033 $ 85,575 $ 69,739
Three Months Ended September 30, Nine Months Ended September 30,
License revenues $ 49,071 $ 47,313 $ 143,142 $ 120,832
Collaboration services revenues ( 4,773 ) ( 2,347 ) ( 13,269 ) ( 6,127 )
Total collaboration revenues $ 44,298 $ 44,966 $ 129,873 $ 114,705
During the three and nine months ended September 30, 2025, we recognized $ 4.3 million in license revenues and $ 0.4 million in collaboration services revenues in connection with a $ 5.0 million regulatory milestone payment, upon approval by the European Commission for the treatment of patients with either advanced pancreatic neuroendocrine tumors or advanced extra-pancreatic neuroendocrine tumors.
3 unchanged paragraphs
Three Months Ended June 30, Six Months Ended June 30,
License revenues $ 2,659 $ 3,833 $ 10,312 $ 6,592
Collaboration services revenues 387 1,453 3,238 2,410
Total collaboration revenues $ 3,046 $ 5,286 $ 13,550 $ 9,002
Three Months Ended September 30, Nine Months Ended September 30,
License revenues $ 2,691 $ 3,299 $ 13,003 $ 9,891
Collaboration services revenues 136 936 3,375 3,346
Total collaboration revenues $ 2,827 $ 4,235 $ 16,378 $ 13,237
During the six nine months ended June September 30, 2026, we recognized $ 7.8 million in revenues in connection with an $ 8.0 million commercial milestone payment from Takeda, which was earned upon their achievement of $ 300.0 million of cumulative net sales of cabozantinib in Japan. Of the revenues recognized from this milestone, $ 5.3 million was allocated to license revenues and $ 2.5 million was allocated to collaboration services revenues. Upon the achievement of this commercial milestone, the tiered royalty rate on annual net sales reset to 20% and will reset each calendar year, thereafter.
Royalty Pharma and GSK
In October 2002, we established a product development and commercialization collaboration agreement with GlaxoSmithKline (now GSK plc, or GSK), that required us to pay a 3 % royalty to GSK on the worldwide net sales of any product containing cabozantinib sold by us and our collaboration partners. Effective January 1, 2021, Royalty Pharma plc (Royalty Pharma) acquired from GSK all rights, title and interest in royalties on net product sales containing cabozantinib for non-U.S. markets for the full term of the royalty and for the U.S. market through September 2026, after which time U.S. royalties will revert reverted back to GSK. Royalty fees earned by Royalty Pharma in connection with our sales of cabozantinib sales are included recognized in cost of goods sold for our sales and as a reduction of collaboration services revenues for sales made by our collaboration partners. Such royalty fees earned by Royalty Pharma were $ 24.1 24.5 million and $ 47.0 71.6 million during the three and six nine months ended June September 30, 2026, respectively, as compared to $ 21.4 22.2 million and $ 41.7 63.9 million, respectively, for the corresponding prior year periods.
1 unchanged paragraph
We enter into collaborative arrangements with other pharmaceutical or biotechnology companies to develop and commercialize oncology assets or other intellectual property. Our research collaborations and in-licensing arrangements are intended to enhance our early-stage pipeline and expand our ability to discover, develop and commercialize novel therapies with the goal of providing new treatment options for cancer patients. Our research collaborations, in-licensing arrangements and other strategic transactions generally include upfront payments for the purchase or in-licensing of intellectual property, development, regulatory and commercial milestone payments and royalty payments, in each case contingent upon the occurrence of certain future events linked to the success of the asset in development. Certain of our research collaborations provide us exclusive options that give us the right to license programs or acquire the intellectual property developed under the research collaborations for further discovery and development. When we decide to exercise the options, we are required to pay an exercise fee and then assume the responsibilities for all subsequent development, manufacturing and commercialization.
During the three and six nine months ended June September 30, 2026, we recognized $ 9.3 3.2 million and $ 17.1 20.3 million, respectively, as compared to $ 5.7 8.4 million and $ 10.9 19.3 million, respectively, for the corresponding prior year periods, within research and development expenses on the Condensed Consolidated Statements of Income, primarily related to development milestone payments for the cost of intellectual property that have not yet achieved technological feasibility, research and development funding and other fees.
As of June September 30, 2026, in conjunction with the active collaborative in-licensing arrangements and asset purchase agreements, we are subject to potential future development milestone payments of up to $ 441.5 million, regulatory milestone payments of up to $ 278.0 million and commercial milestone payments of up to $ 2.5 billion, each in the aggregate per product or target, as well as royalties on future net sales of products.
Note 5: CASH AND MARKETABLE SECURITIES 28 changes
5 unchanged paragraphs
Commercial paper $ 158,312 $ $ $ 158,312
Corporate bonds 824,595 740 ( 2,424 ) 822,911
Municipal bonds 8,715 4 ( 14 ) 8,705
Total debt securities available-for-sale 1,158,264 798 ( 3,060 ) 1,156,002
Money market funds 171,852 171,852
Certificates of deposit 55,886 55,886
Commercial paper $ 257,765 $ $ ( 3 ) $ 257,762
Corporate bonds 792,197 84 ( 6,780 ) 785,501
U.S. Treasury and government-sponsored enterprises 166,642 54 165,033 3 ( 622 1,457 ) 166,074 163,579
Municipal bonds 6,835 ( 42 ) 6,793
Total debt securities available-for-sale 1,221,830 87 ( 8,282 ) 1,213,635
Money market funds 139,503 139,503
Certificates of deposit 46,639 46,639
Total cash, cash equivalents and marketable securities $ 1,386,577 1,407,972 $ 798 87 $ ( 3,060 8,282 ) $ 1,384,315 1,399,777
11 unchanged paragraphs
Interest receivable was $ 9.8 million and $ 12.4 million as of both June September 30, 2026 and December 31, 2025, respectively, and is included in prepaid expenses and other current assets in the accompanying Condensed Consolidated Balance Sheets.
Realized gains and losses on the sales of marketable securities were immaterial during the three and six nine months ended June September 30, 2026 and 2025.
3 unchanged paragraphs
Corporate bonds $ 469,752 $ ( 2,422 ) $ 2,988 $ ( 2 ) $ 472,740 $ ( 2,424 )
U.S. Treasury and government-sponsored enterprises 113,845 ( 582 ) 4,958 ( 40 ) 118,803 ( 622 )
Municipal Bonds 5,711 ( 14 ) 5,711 ( 14 )
Commercial Paper $ 26,354 $ ( 3 ) $ $ $ 26,354 $ ( 3 )
Corporate bonds 680,392 ( 6,780 ) 680,392 ( 6,780 )
U.S. Treasury and government-sponsored enterprises 147,881 ( 1,407 ) 4,948 ( 50 ) 152,829 ( 1,457 )
Municipal Bonds 6,793 ( 42 ) 6,793 ( 42 )
6 unchanged paragraphs
There were 262 356 and 35 debt securities available-for-sale in an unrealized loss position as of June September 30, 2026 and December 31, 2025, respectively. During the three and six nine months ended June September 30, 2026, we did no t record an allowance for credit losses or other impairment charges on our marketable securities. Based upon our quarterly impairment review, we determined that the unrealized losses were not attributed to credit risk but were primarily associated with changes in interest rates and market liquidity. Based on the scheduled maturities of our marketable securities, we determined that it was more likely than not that we will hold these marketable securities for a period of time sufficient for a recovery of our cost basis.
1 unchanged paragraph
June September 30, 2026 December 31, 2025
Maturing in one year or less $ 611,072 705,875 $ 691,409
Maturing after one year through five years 544,930 507,760 600,433
Total debt securities available-for-sale $ 1,156,002 1,213,635 $ 1,291,842
Note 6: FAIR VALUE MEASUREMENTS 15 changes
6 unchanged paragraphs
Commercial paper $ $ 158,312 $ 158,312
Corporate bonds 822,911 822,911
Municipal bonds 8,705 8,705
Money market funds 171,852 171,852
Certificates of deposit 55,886 55,886
Total financial assets carried at fair value $ 171,852 $ 1,211,888 $ 1,383,740
Commercial paper $ $ 257,762 $ 257,762
Corporate bonds 785,501 785,501
U.S. Treasury and government-sponsored enterprises 166,074 166,074 163,579 163,579
Municipal bonds 6,793 6,793
Total debt securities available-for-sale 1,156,002 1,156,002 1,213,635 1,213,635
Money market funds 139,503 139,503
Certificates of deposit 46,639 46,639
Total financial assets carried at fair value $ 139,503 $ 1,260,274 $ 1,399,777
13 unchanged paragraphs
As of June September 30, 2026 , we had one forward contract outstanding to sell 3.5 2.2 million. The forward contract with a maturity of three months is recorded at fair value and is included in other current liabilities in the accompanying Condensed Consolidated Balance Sheets. The unrealized loss gain on the forward contract was immaterial as of June September 30, 2026. T he forward contract is considered a Level 2 in the fair value hierarchy of our fair value measurements. The net realized gains and losses we recognized on the upon maturity of forward contracts were immaterial for each of the three and six nine months ended June September 30, 2026 and 2025, and are included in other income (expenses), net in the accompanying Condensed Consolidated Statements of Income.
Note 7: INVENTORY 9 changes
1 unchanged paragraph
Raw materials $ 916 $ 894
Finished goods 14,373 5,942
June September 30, 2026 December 31, 2025
Raw materials $ 798 $ 894
Work in process 48,801 45,803 53,531
Finished goods 17,917 5,942
Total $ 64,090 64,518 $ 60,367
1 unchanged paragraph
Current portion included in inventory $ 28,729 29,871 $ 21,686
Non-current portion included in other non-current assets 35,361 34,647 38,681
Note 8: STOCKHOLDERS EQUITY 20 changes
1 unchanged paragraph
We have an equity incentive plan under which we grant stock options and restricted stock units (RSUs), including market condition-based RSUs and performance-based RSUs (PSUs) to employees and directors. On May 26, 2026, at the 2026 Annual Meeting of Stockholders, our stockholders approved the amendment and restatement of the Exelixis, Inc. 2017 Equity Incentive Plan (as amended and restated, the 2017 Plan). The amendment and restatement increased the share reserve, under the 2017 Plan, by 2,000,000 shares. As of June September 30, 2026, 16.0 17.0 million sh ares were available for grant under the 2017 Plan. The share reserve is reduced by 1 share for each share issued pursuant to any award granted on or after May 26, 2026, including stock options, RSUs and PSUs. In addition, for each share that becomes available again for issuance under the terms of the 2017 Plan on or after May 26, 2026, the share reserve will be increased by the same number of shares by which the share reserve was reduced at the time the applicable award was granted.
1 unchanged paragraph
Three Months Ended June 30, Six Months Ended June 30,
Research and development $ 12,344 $ 14,143 $ 24,662 $ 23,665
Selling, general and administrative 20,219 21,928 36,951 38,336
Total stock-based compensation $ 32,563 $ 36,071 $ 61,613 $ 62,001
Three Months Ended September 30, Nine Months Ended September 30,
Research and development $ 11,069 $ 10,353 $ 35,731 $ 34,018
Selling, general and administrative 17,649 20,532 54,600 58,868
Total stock-based compensation $ 28,718 $ 30,885 $ 90,331 $ 92,886
1 unchanged paragraph
Three Months Ended June 30, Six Months Ended June 30,
Stock options $ 214 $ 671 $ 467 $ 1,731
Restricted stock units 31,644 34,626 58,703 57,728
Three Months Ended September 30, Nine Months Ended September 30,
Stock options $ 206 $ 493 $ 673 $ 2,224
Restricted stock units 27,830 29,660 86,533 87,388
2 unchanged paragraphs
Total stock-based compensation $ 32,563 $ 36,071 $ 61,613 $ 62,001
Total stock-based compensation $ 28,718 $ 30,885 $ 90,331 $ 92,886
As of June September 30, 2026 , there were 1.3 1.1 million stock options outstanding and $ 0.8 0.6 million of related unrecognized stock-based compensation.
5 unchanged paragraphs
During the six nine months ended June September 30, 2026, we granted 1.9 2.0 million service-based RSUs with a weighted- average grant date fair value of $ 44.69 45.38 per share. As of June September 30, 2026 , there were 16.4 15.8 million RSUs outstanding, including RSUs that are subject to market conditions, and $ 342.9 307.3 million of related unrecognized stock-based compensation. Service-based RSUs granted to employees during the six nine months ended June September 30, 2026, have vesting conditions and contractual lives of a similar nature to those described in Note 9. Stockholders Equity of the Notes to Consolidated Financial Statements included in Part II, Item 8 of our Fiscal 2025 Form 10-K.
1 unchanged paragraph
In October 2025, our Board of Directors authorized a stock repurchase program (SRP) to acquire up to $ 750.0 million of our outstanding common stock before December 31, 2026 (the October 2025 SRP). As of June 30, 2026, we completed the repurchase of 17.2 million shares of outstanding common stock for an aggregate purchase price of $ 750.0 million pursuant to the October 2025 SRP. In May 2026, our Board of Directors authorized the repurchase of up to an additional $ 750.0 million of our outstanding common stock before December 31, 2027 (the May 2026 SRP). Under these SRPs, the May 2026 SRP, as of June September 30, 2026, we have repurchased 20.2 7.4 million shares of common stock for an aggregate purchase price of $ 902.2 402.1 million. and have completed the October 2025 SRP. As of June September 30, 2026, approximately $ 597.8 347.9 million remained available under the May 2026 SRP for future stock repurchases before December 31, 2027. Stock repurchases under these SRPs the May 2026 SRP may be made from time to time through a variety of methods, which may include open market purchases, in block trades, Rule 10b5-1 trading plans, accelerated share repurchase transactions, exchange transactions, or any combination of such methods. The timing and amount of any stock repurchases under the SRPs SRP will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of our common stock and general market conditions. The SRPs do SRP does not obligate us to acquire any amount of our common stock, and the SRPs SRP may be modified, suspended or discontinued at any time without prior notice.
Note 9: PROVISION FOR INCOME TAXES 1 change
The effective tax rates for the three and six nine months ended June September 30, 2026 were 19.3 22.9 % and 20.3 21.2 %, respectively, as compared to 19.8 23.3 % and 21.0 21.9 % for the corresponding prior year periods. in 2025. The effective tax rates for the three and six months ended June September 30, 2026, differed from the U.S. federal statutory tax rate of 21%, primarily due to excess tax benefits related to certain stock grants and state taxes, partially offset by the Foreign-Derived Intangible Income (FDII) deduction. partially offset by state taxes. The effective tax rate for the three nine months ended June September 30, 2025, 2026, differed from the U.S. federal statutory tax rate of 21% primarily due to state taxes, offset by excess tax benefits related to certain stock grants and the generation of federal tax credits, partially offset by state taxes. FDII deduction. The effective tax rate rates for the six three and nine months ended June September 30, 2025, differed from the U.S. federal statutory tax rate of 21%, primarily due to state taxes, offset by excess tax benefits related to certain stock grants. and the generation of federal tax credits.
Note 10: NET INCOME PER SHARE 17 changes
1 unchanged paragraph
Three Months Ended June 30, Six Months Ended June 30,
Net income $ 212,050 $ 184,848 $ 422,517 $ 344,464
Weighted-average common shares outstanding basic 250,808 272,583 254,568 275,693
Dilutive securities 8,867 11,810 8,931 10,592
Weighted-average common shares outstanding diluted 259,675 284,393 263,499 286,285
Net income per share basic $ 0.85 $ 0.68 $ 1.66 $ 1.25
Net income per share diluted $ 0.82 $ 0.65 $ 1.60 $ 1.20
Three Months Ended September 30, Nine Months Ended September 30,
Net income $ 218,095 $ 193,578 $ 640,612 $ 538,042
Weighted-average common shares outstanding basic 246,756 268,421 251,964 273,269
Dilutive securities 8,998 10,114 8,953 10,432
Weighted-average common shares outstanding diluted 255,754 278,535 260,917 283,701
Net income per share basic $ 0.88 $ 0.72 $ 2.54 $ 1.97
Net income per share diluted $ 0.85 $ 0.69 $ 2.46 $ 1.90
3 unchanged paragraphs
Three Months Ended June 30, Six Months Ended June 30,
Three Months Ended September 30, Nine Months Ended September 30,
Anti-dilutive securities and contingently issuable shares excluded 2,820 1,890 2,881 1,718 2,017 2,133 2,593 1,856
Legal proceedings 9 changes
4 unchanged paragraphs
On November 22, 2024, MSN noticed an appeal to the Court of Appeals for the Federal Circuit (CAFC) and we noticed a cross-appeal on November 26, 2024. On April 1, 2025, MSN filed its Opening Brief arguing that the asserted claims of the 439, 440, 015, and 349 Patents are invalid. On June 10, 2025, the CAFC granted our request to dismiss our cross-appeal. On June 11, 2025, we filed our Response Brief. On August 1, 2025, MSN filed its Reply Brief. Oral argument in this matter was held on June 4, 2026. On August 31, 2026, the CAFC issued its opinion, where it affirmed that the asserted claims of the 439, 440, and 015 patents are not invalid, dismissed MSN s appeal as to the asserted claim of the 349 patent, which expires on February 10, 2032, and vacated the district court s judgment with respect to the validity of the asserted claim of the 349 patent. Based on the CAFC s opinion, the effective date of any final approval by the FDA of MSN s ANDA shall not be a date earlier than January 15, 2030, the expiration date of each of the 439, 440, and 015 patents, subject to any further appellate proceedings, applicable regulatory exclusivity, and the outcome of separate litigation involving the 039 Patent (as defined below), which expires in February 2032 and for which trial is currently scheduled to begin in November 2026. MSN has until October 30, 2026 to seek rehearing at the CAFC.
2 unchanged paragraphs
In March 2025, we received a notice letter regarding a 505(b)(2) New Drug Application (NDA) submitted to the FDA by Azurity, requesting approval to market cabozantinib tablets. Azurity s notice letter included a Paragraph IV certification with respect to the 776 Patent, the 342 Patent, the 873 Patent, the 757 Patent, the 439 Patent, the 440 Patent, the 015 Patent, the 349 Patent, and the 039 Patent, which are listed in the Orange Book, for CABOMETYX. On April 18, 2025, we filed a complaint in the Delaware District Court for patent infringement against Azurity asserting infringement of the 776, 439, 440, 015, 349, and 039 Patents. On April 24, 2025, we filed our First Amended Complaint alleging infringement of the same patents. On June 11, 2025, Azurity filed its response to the complaint, alleging that the asserted claims of the patents at issue are not infringed and/or invalid. On July 2, 2025, we filed our answer to Azurity s counterclaims. On July 28, 2025, Azurity filed motions for judgment on the pleadings regarding the non-infringement of the 776, 439, 440, 015, 349, and 039 Patents. On August 25, 2025, we filed our answering briefs to Azurity s motions for judgment on the pleadings. On September 15, 2025, Azurity filed its reply briefs. On October 5, 2026, the Delaware District Court denied Azurity s motions for judgment on the pleadings. On October 22, 2026, pursuant to a stipulation between us and Azurity, the Delaware District Court entered an order that (i) Azurity s submission of its 505(b)(2) NDA constitutes infringement of certain claims relating to the 349 and 039 Patents, if those claims are not found to be invalid, and (ii) upon approval, Azurity s commercial manufacture, use, sale or offer for sale within the U.S., and importation into the U.S., of Azurity s proposed 505(b)(2) NDA product prior to the expiration of the 349 and 039 Patents would also infringe certain claims of those patents, if those claims are not found to be invalid. This Azurity litigation was consolidated in the Consolidated Litigation. On October 28, 2026, we entered into a settlement and license agreement with Azurity (the Azurity Settlement Agreement) to resolve the Azurity litigation. Pursuant to the terms of the Azurity Settlement Agreement, we will grant Azurity a license to market its proposed 505(b)(2) NDA product in the U.S. beginning on December 1, 2030, if approved by the FDA and subject to conditions and exceptions customary for agreements of this type. The effective date for the proposed generic cabozantinib products where we have a settlement and license agreement remains January 1, 2031, subject to conditions and exceptions customary for agreements of this type.
1 unchanged paragraph
On August 8, 2025, the Delaware District Court ordered that the then-pending abovementioned MSN and Azurity district court litigations be consolidated with the trial scheduled for November 2, 2026. In accordance with the Azurity Settlement Agreement, within three (3) business days after the effective date, we and Azurity will jointly file a stipulated dismissal (the Azurity Dismissal) terminating all ongoing litigation between us and Azurity in the Consolidated Litigation. The Azurity Dismissal will not affect our litigation with MSN, which remains pending in the Consolidated Litigation.
1 unchanged paragraph
In November 2025, we received a notice letter regarding a 505(b)(2) NDA submitted to the FDA by Handa Oncology, LLC (Handa), requesting approval to market cabozantinib capsules (in the form of cabozantinib lauryl sulfate). Handa s notice letter included a Paragraph IV certification with respect to the 776 Patent, the 342 Patent, the 873 Patent, the 757 Patent, the 439 Patent, the 440 Patent, the 015 Patent, the 349 Patent, and the 039 Patent, which are listed in the Orange Book, for CABOMETYX. Handa s notice letter also included a Paragraph III certification with respect to the 473 Patent. In April 2026, we filed a citizen petition with the FDA pursuant to section 505(q) of the Food, Drug, and Cosmetic Act notifying the FDA that Handa s application raises new questions of safety and effectiveness requiring clinical data to support approval. On April 13, 2026, the FDA issued a letter acknowledging the petition. On July 6, 2026, we filed a complaint in the Delaware District Court for patent infringement against Handa asserting infringement of U.S. Patent Nos. 9,174,947, method of use and process for preparing compounds, 9,365,516, process for preparing compounds, 9,969,692, process for preparing compounds, 10,123,999, process for preparing compounds, and 10,736,886, method of use and process for preparing compounds arising from Handa s 505(b)(2) NDA filing with the FDA. On August 31, 2026, the Delaware District Court granted our request to dismiss the July 29, 6, 2026 complaint without prejudice. On September 3, 2026, the FDA responded to our citizen petition denying our requests and, on the same day, granted tentative full approval to Handa s 505(b)(2) NDA. In its response, the FDA stated that it had carefully considered the issues raised in the petition and concluded, based on its review of the data submitted in support of Handa s NDA, that Handa was not required to submit additional data to support the safety and effectiveness of its product. We continue to evaluate all legal and strategic options with respect to Handa s approved product.
1 unchanged paragraph
In May 2026, we received a notice letter regarding an ANDA submitted to the FDA by Intas Pharmaceuticals Ltd. and Accord Healthcare, Inc. (collectively, Accord), requesting approval to market cabozantinib tablets. Accord s notice letter included a Paragraph IV certification with respect to the 776 Patent, the 342 Patent, the 873 Patent, the 757 Patent, the 439 Patent, the 440 Patent, the 015 Patent, the 349 Patent, and the 039 Patent, which are listed in the Orange Book, for CABOMETYX. On July 6, 2026, we filed a complaint in the Delaware District Court for patent infringement against Accord asserting infringement of the 776, 439, 440, 015, and 039 Patents arising from Accord s ANDA filing with the FDA. On September 22, 2026, Accord filed its response to the complaint, alleging that the asserted claims of the patents at issue are not infringed, invalid, and/or unenforceable. On October 20, 2026, we filed our answer to Accord s counterclaims.
In May 2026, we received a notice letter regarding a 505(b)(2) NDA submitted to the FDA by Almatica Pharma, LLC (Almatica), requesting approval to market cabozantinib tablets (in the form of cabozantinib fumarate). Almatica s notice letter included a Paragraph IV certification with respect to the 776 Patent, the 342 Patent, the 873 Patent, the 757 Patent, the 439 Patent, the 440 Patent, the 015 Patent, the 349 Patent, and the 039 Patent, which are listed in the Orange Book, for CABOMETYX. The company continues We continue to evaluate all legal and strategic options with respect to Almatica s product.
In September 2026, we received a notice letter regarding a 505(b)(2) NDA submitted to the FDA by MSN Pharmaceuticals, Inc. and MSN Private Laboratories Limited (the September 2026 Notice Letter), requesting approval to market cabozantinib tablets (in the form of cabozantinib fumarate). The September 2026 Notice Letter included a Paragraph IV certification with respect to the 776 Patent, the 342 Patent, the 873 Patent, the 757 Patent, the 439 Patent, the 440 Patent, the 015 Patent, the 349 Patent, and the 039 Patent, which are listed in the Orange Book, for CABOMETYX. We continue to evaluate all legal and strategic options with respect to the fumarate product of MSN Pharmaceuticals, Inc. and MSN Private Laboratories Limited.
2 unchanged paragraphs
NOTE 12. RESTRUCTURING
In the third quarter of fiscal year 2025, our Board of Directors authorized, and we implemented, a corporate reorganization plan (the 2025 Plan) to reorganize our workforce and close our office located in King of Prussia, Pennsylvania. Restructuring expenses incurred under the 2025 Plan were primarily severance and employee-related costs. During the three and nine months ended September 30, 2025, we recognized $ 19.8 million in expenses associated with the 2025 Plan, which are presented in restructuring in the accompanying Condensed Consolidated Statements of Income. We incurred the majority of the charges related to the 2025 Plan during the third quarter of 2025 and substantially completed the 2025 Plan by the end of the fiscal year 2025. For more information about our restructuring expenses, see Note 13. Restructuring of the Notes to Consolidated Financial Statements included in Part II, Item 8 of our Fiscal 2025 Form 10-K.
MD&A 175 changes
6 unchanged paragraphs
The FDA first approved CABOMETYX in the U.S. as a monotherapy for previously treated patients with advanced RCC in April 2016, and then for previously untreated patients with advanced RCC in December 2017. In January 2021, the
The FDA first approved CABOMETYX in the U.S. as a monotherapy for previously treated patients with advanced RCC in April 2016, and then for previously untreated patients with advanced RCC in December 2017. In January 2021, the CABOMETYX label was expanded to include first-line advanced RCC in combination with nivolumab, which was the first CABOMETYX regimen approved for treatment in combination with an immune checkpoint inhibitor (ICI). In addition to RCC, in January 2019, the FDA approved CABOMETYX for the treatment of patients with HCC previously treated with sorafenib, and in September 2021, the FDA approved CABOMETYX for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic DTC that has progressed following prior VEGF receptor-targeted therapy and who are RAI-refractory or ineligible. In March 2025, the FDA approved CABOMETYX for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pNET and epNET.
2 unchanged paragraphs
To develop and commercialize cabozantinib outside the U.S., we have entered into license agreements with Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Company Limited (Takeda). To Ipsen, we granted the rights to develop and commercialize cabozantinib outside of the U.S. and Japan, and to Takeda we granted such rights in Japan. Both Ipsen and
To develop and commercialize cabozantinib outside the U.S., we have entered into license agreements with Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Company Limited (Takeda). To Ipsen, we granted the rights to develop and commercialize cabozantinib outside of the U.S. and Japan, and to Takeda we granted such rights in Japan. Both Ipsen and Takeda also contribute financially and operationally to the further global development and commercialization of the cabozantinib franchise, and we work closely with them on these activities. Utilizing its regulatory expertise and established international oncology marketing network, Ipsen has continued to execute on its commercialization plans for CABOMETYX, having received regulatory approvals and launched in multiple territories outside of the U.S., including in the European Economic Area (EEA), which covers all 27 member states of the European Union and Norway, Liechtenstein and Iceland, the United Kingdom and Canada, as a treatment for advanced RCC (both as a monotherapy and in combination with nivolumab) and for previously treated HCC and DTC indications. In July 2025, Ipsen received approval for CABOMETYX as a treatment for previously treated, well-differentiated/unresectable, locally advanced, or metastatic pNET or epNET (with local labeling variations) from the European Commission (EC) for the EEA, and health regulatory authorities in Brazil and Australia, and from health regulatory authorities in Switzerland in October 2025 and Singapore in December 2025. With respect to the Japanese market, Takeda received Manufacturing and Marketing Approvals from the Japanese Pharmaceuticals and Medical Devices Agency for monotherapy CABOMETYX as a treatment of patients with curatively unresectable or metastatic RCC and as a treatment of patients with unresectable HCC that has progressed after cancer chemotherapy, as well as for CABOMETYX in combination with nivolumab as a treatment for unresectable or metastatic RCC.
Medical Devices Agency for monotherapy CABOMETYX as a treatment of patients with curatively unresectable or metastatic RCC and as a treatment of patients with unresectable HCC that has progressed after cancer chemotherapy, as well as for CABOMETYX in combination with nivolumab as a treatment for unresectable or metastatic RCC.
1 unchanged paragraph
0.66 1.05; P=0.1185), with median OS values of 15.9 months with zanzalintinib in combination with atezolizumab, and 12.7 months with regorafenib. We intend to present detailed findings at a future medical conference.
Zanzalintinib is a novel oral inhibitor of kinases including the TAM kinases (TYRO3, AXL, MER), MET and VEGF receptors, which are implicated in cancer s growth and spread. We are evaluating zanzalintinib in a robust and growing development program that builds on our prior experience with cabozantinib and targets indications with high unmet need. We have established collaborations and will continue to explore additional opportunities for novel combinations with zanzalintinib. To date, we have initiated two large phase 1b/2 clinical trials and one two phase 2 clinical trial trials studying zanzalintinib as a monotherapy and/or in combination with other therapies, including ICIs (STELLAR-001, STELLAR-002, and STELLAR-201, and STELLAR-202). Patient enrollment into STELLAR-001 was completed in 2023 and preliminary results from a randomized expansion cohort of patients with metastatic CRC were presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in January 2025 . In May 2025, preliminary results from an expansion cohort of patients with previously untreated advanced ccRCC from STELLAR-002 were presented at the 2025 ASCO Annual Meeting, along with data from multiple dose-escalation cohorts. In May 2026, we announced an expansion cohort for STELLAR-002 evaluating zanzalintinib in combination with docetaxel in metastatic castration-resistant prostate cancer (mCRPC) patients with measurable disease. In August 2026, we announced an additional expansion cohort for STELLAR-002 evaluating zanzalintinib monotherapy in patients with metastatic bladder cancer who have progressed following treatment with enfortumab vedotin and pembrolizumab. Both the bladder cancer and mCRPC expansion cohorts for STELLAR-002 have been initiated and enrollment is ongoing.
In April 2026, we initiated STELLAR-201, a phase 2 trial evaluating zanzalintinib in patients with recurrent Grade I/II/III meningioma with relapse or progression following radiation and/or surgery or those who are not candidates for these therapies. The primary endpoint of the trial is objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), duration of response (DOR) and overall survival (OS). Enrollment is currently ongoing.
In October 2026, we also initiated STELLAR-202, a phase 2 trial evaluating zanzalintinib in combination with pembrolizumab in the maintenance setting in squamous non-small cell lung cancer (NSCLC). The primary endpoint of the trial is six-month progression-free survival (PFS-6), with secondary endpoints including safety, PFS, OS, ORR, and DOR. The study is currently enrolling.
We also have three four ongoing phase 3 pivotal trials two evaluating zanzalintinib as a monotherapy and in combination with other therapies, including ICIs. and one evaluating zanzalintinib as a monotherapy. Our first such trial, STELLAR-303, was initiated in June 2022 and is evaluating zanzalintinib in combination with atezolizumab versus regorafenib in patients with metastatic, refractory non-microsatellite instability high or non-mismatch repair-deficient CRC. In June 2025, we announced positive top-line results in the first dual primary endpoint, demonstrating a statistically significant improvement in overall survival OS versus regorafenib in the intention-to-treat (ITT) population, and in October 2025, announced that the study demonstrated a 20% reduction in the risk of death versus regorafenib in the ITT population at the final analysis (stratified hazard ratio [HR]: 0.80; 95% confidence interval [CI]: 0.69-0.93; P=0.0045). Detailed findings from the study, including OS and PFS in the ITT population and in the subset of patients without active liver metastases (non-liver metastases, NLM), were presented at the 2025 European Society for Medical Oncology Congress in October 2025 and simultaneously published in The Lancet. . In December 2025, we submitted a New Drug Application (NDA) to the FDA for zanzalintinib in combination with atezolizumab for the treatment of previously treated metastatic colorectal cancer. In February 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. In June 2026, we announced results from the final analysis of the other dual primary endpoint of OS in the NLM subpopulation, showing a non-statistically significant trend in OS favoring the combination in the NLM subpopulation (stratified HR: 0.83; 95% CI: 0.66 1.05; P=0.1185), with median OS values of 15.9 months with zanzalintinib in combination with atezolizumab, and 12.7 months with regorafenib. We intend to present detailed findings at a future medical conference. In September 2026, we announced that the FDA notified us that it had extended the review period for our NDA by three months. In response to an FDA information request, we had submitted updated safety and efficacy data, which the FDA deemed a major amendment. The updated PDUFA target action date is March 3, 2027.
The second pivotal trial, STELLAR-304, was initiated in December 2022 and is evaluating zanzalintinib in combination with nivolumab versus sunitinib in previously untreated patients with advanced nccRCC. The primary efficacy endpoints for STELLAR-304 are blinded independent radiology committee-assessed PFS and ORR per RECIST 1.1. The secondary efficacy endpoint is OS. We expect top-line results in the second half first quarter of 2026, depending on event rates. 2027.
Our third pivotal trial, STELLAR-311, was initiated in June 2025 we initiated STELLAR-311, and is a phase 2/3 pivotal trial evaluating zanzalintinib versus everolimus in patients with advanced NET, regardless of site of origin, who had received up to one prior line of therapy. The primary endpoint of the trial is PFS per RECIST 1.1 as assessed by blinded independent central review. Enrollment is currently ongoing.
Beyond STELLAR-001, STELLAR-002, STELLAR-201, STELLAR-303, STELLAR-304 and STELLAR-311, In August 2026, we intend to initiate additional early-stage and pivotal trials evaluating zanzalintinib across a broad array of potential future indications, including initiated STELLAR-316, a planned our fourth phase 3 pivotal trial in collaboration with Natera, Inc. (Natera) and Merck (known as MSD outside of the United States and Canada), which we anticipate will commence in mid-2026. STELLAR-316 will evaluate evaluating zanzalintinib, with and without KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), (KEYTRUDA QLEX is marketed outside the U.S. as KEYTRUDA SC ), in patients with resected stage II/III CRC who, following completion of definitive therapy, have tested positive for molecular residual disease (MRD+) and have no radiographic evidence of disease. The primary endpoint of the trial is disease-free survival, with key secondary endpoints, including circulating tumor DNA clearance. We are conducting STELLAR-316 in collaboration with Natera, Inc. (Natera) and Merck will supply (known as MSD outside of the U.S. and Canada), with Merck supplying KEYTRUDA QLEX and Natera will provide providing its Signatera assay to identify MRD+ patients for trial enrollment. Also, in May 2026, we announced STELLAR-202, a planned phase 2 trial evaluating zanzalintinib in combination with pembrolizumab in The maintenance setting in squamous non-small cell lung cancer, which we expect to initiate in the second half of 2026. study is currently enrolling.
Beyond STELLAR-001, STELLAR-002, STELLAR-201, STELLAR-202, STELLAR-303, STELLAR-304, STELLAR-311, and STELLAR-316, we are pursuing additional early-stage and pivotal trials evaluating zanzalintinib across a broad array of potential future indications, including trials evaluating zanzalintinib in combination with established immunotherapies, novel immunotherapies (including in a phase 1 cohort in combination with XB628, our first-in-class bispecific antibody), as well as chemotherapy and other treatment modalities.
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The knowledge and experience gained through our efforts to discover cabozantinib, cobimetinib, and esaxerenone, each of which were approved by regulatory authorities and are commercially distributed, informs our current strategy for discovering and developing additional small molecules with the potential to treat cancer, including XL309, a potentially best-in-class small molecule inhibitor of USP1, a synthetic lethal target in the context of BRCA-mutated tumors. XL309 is currently being evaluated in a phase 1 clinical trial as monotherapy and in combination with PARP1/2 inhibition in patients with advanced solid tumors and enrollment is ongoing. XL309 has potential in patients whose tumors are no longer responsive to PARPi, including ovarian, breast and prostate cancers. XL309 also has potential in combination with PARPi agents to deepen and prolong the response seen to PARPi, as well as to broaden the activity beyond that observed in patients with tumors that harbor a BRCA1/2 mutation. We also expect to progress XL558, a development candidate from our somatostatin receptor subtype 2 agonist program, toward a potential investigational new drug (IND) filing in 2026 .
Beyond these small molecule assets, we continue to make progress on multiple lead optimization programs for molecules that address a variety of targets, and that we believe have significant potential for clinical differentiation. We anticipate that some of these other programs could reach development candidate status in 2026 2027 and beyond.
Part of our drug discovery activity focuses on discovering and advancing various biotherapeutics that have the potential to become anti-cancer therapies, such as bispecific antibodies, ADCs and other innovative treatments. ADCs in particular present a unique opportunity for new cancer treatments, given their capabilities to target the delivery of deliver anti-cancer drug payloads to specific cells expressing the target- this expressing cells with increased precision should minimize while minimizing collateral impact on healthy tissues. that do not express the target. To facilitate the growth of our various biotherapeutics programs, we have established multiple research collaborations and in-licensing arrangements and entered into other strategic transactions, aimed at conserving capital and managing risks, that provide us with access to antibodies, binders, payloads, and conjugation technologies, which are the components employed to generate next-generation ADCs or multispecific antibodies. We have also established laboratories for discovery of novel biologics with capabilities in antibody engineering, ADC chemistry, bioanalysis, and preclinical testing.
As part of our strategy to access clinical- or near-clinical-stage assets, we executed an exclusive option and license agreement and clinical development collaboration with Sairopa B.V. (Sairopa) to develop ADU-1805. ADU-1805 is currently being evaluated in a phase 1 clinical trial in patients with advanced or metastatic refractory solid tumors, as a monotherapy and in combination with pembrolizumab. Enrollment is ongoing.
We have made significant progress under our other research collaborations and in-licensing arrangements and believe we will continue to do so in 2026 and in future years. For example, in April 2025, we initiated the phase 1 study of XB628, a first-in-class bispecific antibody, and in August 2025, we initiated a phase 1 study of XB371, a next-generation TF-targeting ADC with a topoisomerase inhibitor payload. We also expect to progress XB773, an ADC targeting the tumor antigen DLL3, toward and XB404, a masked ROR1/2-targeting ADC with a topoisomerase inhibitor payload, toward potential IND filing filings in 2026 and 2027, respectively. Each of these biotherapeutics was discovered, in part, in connection with our research collaborations and in-licensing agreements.
Beyond these biotherapeutics assets, we continue to make progress on multiple preclinical programs for molecules that address a variety of targets, and that we believe have significant potential for clinical differentiation. We anticipate that some of these other programs could reach development candidate status in 2027 and beyond. over the next several years.
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In April 2026, we initiated STELLAR-201, a phase 2 trial evaluating zanzalintinib in patients with recurrent Grade I/II/III meningioma with relapse or progression following radiation and/or surgery or those who are not candidates for radiation and/or surgery. The primary endpoint of the trial is ORR, with secondary endpoints including PFS, DOR and OS.
In May 2026, we announced two additional zanzalintinib studies: STELLAR-202, a planned phase 2 trial evaluating zanzalintinib in combination with pembrolizumab in the maintenance setting in squamous non-small cell lung cancer, and an additional expansion cohort in the ongoing phase 1b/2 STELLAR-002 study evaluating zanzalintinib in combination with docetaxel in mCRPC patients with measurable disease. In August 2026, we announced an additional expansion cohort for STELLAR-002 evaluating zanzalintinib monotherapy in patients with metastatic bladder cancer who have progressed following treatment with enfortumab vedotin and pembrolizumab. Both the bladder cancer and mCRPC expansion cohorts for STELLAR-002 have been initiated and enrollment is ongoing. We expect to initiate STELLAR-202 in the second half of 2026.
In May 2026, we presented results from a subgroup analysis of the phase 3 CABINET pivotal trial at the 2026 ASCO Annual Meeting. Several presentations highlighting ongoing studies evaluating CABOMETYX or zanzalintinib in diverse tumor types were also the subject of presentation at the meeting.
In June 2026, we announced results from the final analysis of the dual primary endpoint of OS in the NLM subpopulation in the phase 3 STELLAR-303 pivotal trial, showing a non-statistically significant trend in OS favoring the combination of zanzalintinib and atezolizumab in the NLM subpopulation. Detailed results are expected to be presented at a future medical conference.
Increasing the number of novel anti-cancer agents in our pipeline is essential to our overall strategy and business goals. We are working to expand our oncology product pipeline through drug discovery efforts, which encompass our diverse biotherapeutics and small molecule programs exploring multiple modalities and mechanisms of action. This approach provides a high degree of flexibility with respect to target selection and modality of treatment and allows us to prioritize those programs that we believe have the greatest chance of producing impactful therapeutics. As part of our strategy, our drug discovery activities have and will continue to include internal research, as well as external research collaborations, in-licensing arrangements and other strategic transactions that collectively leverage a wide range of technology platforms and assets and increase our probability of success. As of the date of this Quarterly Report on Form 10-Q, we expect to progress up to two have progressed one new development candidates candidate into preclinical development during 2026. We will continue to engage in pipeline expansion initiatives with the goal of discovering, acquiring and/or in-licensing promising investigational oncology assets and then further characterizing and developing them utilizing our established preclinical and clinical development infrastructure.
Second Third Quarter 2026 Business Updates and Financial Highlights
During the second third quarter of 2026, we continued to execute on our business objectives, generating significant revenues from operations and enabling us to continue to seek to maximize the clinical and commercial potential of our products and expand our product pipeline. Significant business updates and financial highlights for the quarter and subsequent to quarter-end include:
In August 2026, the United States Court of Appeals for the Federal Circuit (Court of Appeals) affirmed a favorable district court decision in our patent lawsuit against MSN Laboratories Private Limited et al. (MSN), upholding the validity of U.S. Patent Nos. 11,091,439, 11,091,440 and 11,098,015. As a result, the effective date of any final FDA approval of MSN s Abbreviated New Drug Application (ANDA) shall not be a date earlier than January 15, 2030, subject to any further appellate proceedings, applicable regulatory exclusivity, and the outcome of separate consolidated litigation involving U.S. Patent No. 12,128,039, with a trial scheduled for November 2026. The Court of Appeals also dismissed as moot MSN s appeal relating to the validity of U.S. Patent No. 11,298,349. See Note 11. Commitments and Contingencies of the Notes to Condensed Consolidated Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for additional information.
In May August 2026, we announced a clinical development collaboration with Merck for the supply of KEYTRUDA QLEX for initiated STELLAR-316, a planned phase 3 pivotal trial which will evaluate in collaboration with Natera and Merck, evaluating zanzalintinib, with and without KEYTRUDA QLEX, in patients with resected stage II/III CRC who, following completion of definitive therapy, have tested positive for MRD+ and have no radiographic evidence of disease. Merck supplies KEYTRUDA QLEX and Natera provides its Signatera assay to identify MRD+ patients for trial enrollment. The primary endpoint of the trial is disease-free survival, with key secondary endpoints, including circulating tumor DNA clearance.
In September 2026, we announced that the FDA notified us that it had extended the review period for our NDA for zanzalintinib, in combination with atezolizumab, for the treatment of patients with metastatic colorectal cancer by three months. In response to an FDA information request, we had submitted updated safety and efficacy data, which the FDA deemed a major amendment. The updated PDUFA target action date is March 3, 2027.
In October 2026, we initiated STELLAR-202, a phase 2 trial evaluating zanzalintinib in combination with pembrolizumab in the maintenance setting in squamous NSCLC. The primary endpoint of the trial is PFS-6, with secondary endpoints including safety, PFS, OS, ORR, and DOR.
In October 2026, we entered into a settlement and license agreement with Azurity Pharmaceuticals, Inc. (Azurity, and such agreement, the Azurity Settlement Agreement) to resolve the Azurity litigation. Pursuant to the terms of the Azurity Settlement Agreement, we will grant Azurity a license to market its proposed 505(b)(2) NDA product in the U.S. beginning on December 1, 2030, if approved by the FDA and subject to conditions and exceptions customary for agreements of this type. The effective date for the proposed generic cabozantinib products where we have a settlement and license agreement remains January 1, 2031, subject to conditions and exceptions customary for agreements of this type.
In October 2025, our Board of Directors authorized a stock repurchase program (SRP) for the repurchase of up to $750 million of our outstanding common stock before December 31, 2026 (the October 2025 SRP). In May 2026, our Board of Directors authorized the repurchase of up to an additional $750 million of our outstanding common stock before December 31, 2027 (the May 2026 SRP). Under these SRPs, this May 2026 SRP, as of June September 30, 2026, we have repurchased $902.2 an aggregate of $402.1 million of our outstanding common stock at an average price of $44.66 $54.03 per share. and have completed the October 2025 SRP.
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Net product revenues for the second third quarter of 2026 were $573.0 $604.9 million, as compared to $520.0 $542.9 million for the second third quarter of 2025.
Total revenues for the second third quarter of 2026 were $628.7 $658.7 million, as compared to $568.3 $597.8 million for the second third quarter of 2025.
Research and development expenses for the second third quarter of 2026 were $212.0 $209.5 million, as compared to $200.4 $199.2 million for the second third quarter of 2025.
Selling, general and administrative expenses for the second third quarter of 2026 were $147.6 $154.6 million, as compared to $134.9 $123.7 million for the second third quarter of 2025.
Provision for income taxes for the second third quarter of 2026 was $50.6 $64.7 million, as compared to $45.6 $58.8 million for the second third quarter of 2025.
Net income for the second third quarter of 2026 was $212.1 $218.1 million, or $0.85 $0.88 per share, basic and $0.82 $0.85 per share, diluted, as compared to net income of $184.8 $193.6 million, or $0.68 $0.72 per share, basic and $0.65 $0.69 per share, diluted, for the second third quarter of 2025.
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We will continue to face numerous challenges and risks that may impact our ability to execute on our business objectives. In particular, for the foreseeable future, we expect our ability to generate sufficient cash flow to fund our business operations and growth will depend upon the continued commercial success of CABOMETYX, both alone and in combination with other therapies, as a treatment for the highly competitive indications for which it is approved. In addition, CABOMETYX will only continue to be commercially successful if private third-party and government payers continue to provide coverage and reimbursement. As is the case for all innovative pharmaceutical therapies, obtaining and maintaining coverage and reimbursement for CABOMETYX is becoming increasingly difficult, both within the U.S. and in foreign markets. Further, healthcare policymakers in the U.S. continue to express concern over healthcare costs, and corresponding legislative and policy initiatives and activities have been launched aimed at increasing the healthcare cost burdens borne by pharmaceutical manufacturers, as well as expanding access to, and restricting the prices and growth in prices of, pharmaceuticals. Furthermore, the current U.S. administration has proposed a scheme taken actions and continues to impose tariffs on consider additional measures relating to imported pharmaceuticals and pharmaceutical ingredients, including tariffs.
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In the longer term, We may eventually face competition from potential manufacturers of generic or follow-on versions of our marketed products, including the proposed generic versions of CABOMETYX tablets that are the subject of ANDAs submitted to the FDA by MSN, Teva, Cipla, Biocon, Sun, and Accord, as well as cabozantinib products that are the subject of 505(b)(2) NDAs submitted by MSN, Azurity, Handa, and Almatica, and Handa s recently approved 505(b)(2) NDA. The commercial launch of Handa s approved product, or the approval and subsequent launch of any of these the other follow-on products, and their subsequent launch could significantly decrease our revenues derived from the U.S. sales of CABOMETYX and thereby materially harm our business, financial condition and results of operations.
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Some of these challenges and risks are specific to our business, others are common to companies in the biopharmaceutical industry with development and commercial operations, and an additional category are is macroeconomic, affecting all companies. For a more detailed discussion of challenges and risks we face, see Risk Factors in Part I, Item 1A of our Fiscal 2025 Form 10-K, as supplemented and, to the extent inconsistent, or superseded in Part II, Item 1A of our subsequent Quarterly Reports on Form 10-Q.
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We have adopted use a 52- or 53-week fiscal year policy that generally ends on the Friday closest to December 31. Fiscal year 2026, which is a 52-week fiscal year, will end on January 1, 2027 and fiscal year 2025, which was a 52-week fiscal year, ended on January 2, 2026. For convenience, references in this report as of and for the fiscal periods ended July 3, October 2, 2026 and July 4, October 3, 2025, and as of and for the fiscal year ending January 1, 2027 and fiscal year ended January 2, 2026, are indicated as being as of and for the periods ended June September 30, 2026 and June September 30, 2025, and the year ending December 31, 2026 and the year ended December 31, 2025, respectively.
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Net product revenues $ 573,025 $ 520,014 10 % $ 1,128,002 $ 1,033,297 9 %
License revenues 59,810 49,301 21 % 116,758 91,781 27 %
Collaboration services revenues (4,145) (1,054) 293 % (5,258) (1,370) 284 %
Total collaboration revenues 55,665 48,247 15 % 111,500 90,411 23 %
Total revenues $ 628,690 $ 568,261 11 % $ 1,239,502 $ 1,123,708 10 %
Three Months Ended June September 30, Percent Change
Six Nine Months Ended June September 30, Percent Change
Net product revenues $ 604,924 $ 542,930 11 % $ 1,732,926 $ 1,576,227 10 %
License revenues 58,408 56,236 4 % 175,166 148,017 18 %
Collaboration services revenues (4,636) (1,411) 229 % (9,894) (2,781) 256 %
Total collaboration revenues 53,772 54,825 -2 % 165,272 145,236 14 %
Total revenues $ 658,696 $ 597,755 10 % $ 1,898,198 $ 1,721,463 10 %
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Gross product revenues $ 812,782 $ 745,280 9 % $ 1,608,136 $ 1,466,991 10 %
Discounts and allowances (239,757) (225,266) 6 % (480,134) (433,694) 11 %
Net product revenues $ 573,025 $ 520,014 10 % $ 1,128,002 $ 1,033,297 9 %
Three Months Ended June September 30, Percent Change
Six Nine Months Ended June September 30, Percent Change
Gross product revenues $ 853,716 $ 780,272 9 % $ 2,461,852 $ 2,247,263 10 %
Discounts and allowances (248,792) (237,342) 5 % (728,926) (671,036) 9 %
Net product revenues $ 604,924 $ 542,930 11 % $ 1,732,926 $ 1,576,227 10 %
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CABOMETYX $ 570,648 $ 517,890 10 % $ 1,123,421 $ 1,028,762 9 %
COMETRIQ 2,377 2,124 12 % 4,581 4,535 1 %
Net product revenues $ 573,025 $ 520,014 10 % $ 1,128,002 $ 1,033,297 9 %
Three Months Ended June September 30, Percent Change
Six Nine Months Ended June September 30, Percent Change
CABOMETYX $ 603,154 $ 539,878 12 % $ 1,726,575 $ 1,568,640 10 %
COMETRIQ 1,770 3,052 -42 % 6,351 7,587 -16 %
Net product revenues $ 604,924 $ 542,930 11 % $ 1,732,926 $ 1,576,227 10 %
The increases in net product revenues for the three and six nine months ended June September 30, 2026, as compared to the corresponding prior year periods, were primarily related to an increase of 6% in the number of CABOMETYX units sold, for each period, reflecting continuing demand for CABOMETYX in combination with nivolumab as a first-line treatment of patients with advanced RCC, and demand for previously treated advanced NET and, to a lesser extent, increases of 4% 5% and 3%, 4%, respectively, in the average net selling price of CABOMETYX. The increases in sales volume were largely driven by refills, reflecting the longer duration of therapy for the combination of CABOMETYX with nivolumab, and increases in related market share reflecting the continued evolution of the metastatic RCC and NET treatment landscapes.
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We recognize product revenues net of discounts and allowances that are described in Note 1. Organization and Summary of Significant Accounting Policies of the Notes to Consolidated Financial Statements included in Part II, Item 8 of our Fiscal 2025 Form 10-K. Discounts and allowances have generally increased over time as the number of patients participating in government programs has increased and as the discounts given and rebates paid to government payers have also increased. The increases in the amount of discounts and allowances for the three and six nine months ended June September 30, 2026 , as compared to the corresponding prior year periods, were primarily the result of increases in the volume of units sold, higher utilization and dollar amount of chargebacks under the Federal Supply Schedule program, and higher discounts associated with the Part D Discount Program, partially offset by lower utilization and dollar amount of chargebacks under the 340B Drug Pricing Program.
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Milestone revenues, which are allocated between license revenues and collaboration services revenues, were $0.7 $0.9 million and $9.5 $10.4 million, respectively, for the three and six nine months ended June September 30, 2026, as compared to $1.6 $5.8 million and $2.5 $8.2 million for the corresponding prior year periods. During the six nine months ended June September 30, 2026, we recognized $7.8 million in revenues in connection with an $8.0 million commercial milestone payment from Takeda, which was earned upon their achievement of $300.0 million of cumulative net sales of cabozantinib in Japan. For the three and nine months ended September 30, 2025, $4.7 million in revenues was recognized, in connection with a $5.0 million regulatory milestone payment from Ipsen, upon approval by the EC for the treatment of patients with either advanced pNET or advanced epNET.
Royalty revenues for the three and six nine months ended June September 30, 2026 increased, as compared to the corresponding prior year periods, primarily as a result of increases in Ipsen s net sales of cabozantinib outside of the U.S and Japan. Ipsen royalties were $50.5 $49.1 million and $94.1 $143.1 million, respectively, for the three and six nine months ended June September 30, 2026, as compared to $39.5 $43.0 million and $73.5 $116.5 million for the corresponding prior year periods. Royalty revenues related to Takeda s net sales of cabozantinib were $2.7 million and $5.1 $7.7 million, respectively, for the three and six nine months ended June September 30, 2026, as compared to $3.8 $3.3 million and $6.6 $9.9 million for the corresponding prior year periods. CABOMETYX is approved and is commercially available in 69 countries outside the U.S.
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Collaboration services revenues include: (a) the development cost reimbursements earned under our collaboration agreements and product supply revenues, net of product supply costs; (b) the recognition of deferred revenues for the portion of upfront and milestone payments that have been allocated to research and development services performance obligations; offset by (c) the royalties royalty fees we pay to Royalty Pharma plc (Royalty Pharma) on sales by Ipsen and Takeda of products containing cabozantinib.
Development cost reimbursements for the three and six nine months ended June September 30, 2026 decreased, as compared to the corresponding prior year periods, due to decreases in spending on studies evaluating cabozantinib that are subject to reimbursement.
Recognition of deferred revenues for the portion of upfront and milestone payments that have been allocated to research and development services performance obligations were not material in each of the three and six nine months ended June September 30, 2026 and 2025.
Collaboration services revenues are reduced by the 3% royalty fees we are required to pay to Royalty Pharma on the net sales by Ipsen and Takeda of any products containing cabozantinib. The royalty payments due to Royalty Pharma increased in the three and six nine months ended June September 30, 2026, as compared to the corresponding prior year periods, as a result of increases in the royalty generating sales of cabozantinib by Ipsen.
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Cost of goods sold $ 20,657 $ 19,470 6 % $ 40,610 $ 38,642 5 %
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and 95 more changes in the filing
Market risk 1 change
Our market risks, as of June September 30, 2026, have not changed significantly from those described in Part II, Item 7A of our Fiscal 2025 Form 10-K.
Unregistered sales of stock 10 changes
April 4, 2026 - May 1, 2026
May 2, 2026 - May 29, 2026
May 30, 2026 - July 3, 2026 1,705 $ 52.59 1,705 $ 597,778
In October 2025, our Board of Directors authorized a stock repurchase program (SRP) to acquire up to $750.0 million of our outstanding common stock before December 31, 2026 (the October 2025 SRP). In May 2026, our Board of Directors authorized the repurchase of up to an additional $750.0 million of our outstanding common stock before December 31, 2027 (the May 2026 SRP). Under these SRPs, the May 2026 SRP, as of June September 30, 2026, we have repurchased 20.2 7.4 million shares of common stock for an aggregate purchase price of $902.2 $402.1 million. and have completed the October 2025 SRP. As of June September 30, 2026, approximately $597.8 $347.9 million remained available under the May 2026 SRP for future stock repurchases before December 31, 2027.
The following table summarizes the stock repurchase activity for the three months ended June September 30, 2026 and the approximate dollar value of shares that may yet be purchased pursuant to our SRPs SRP (in thousands, except per share data):
Total Number of Shares Purchased Average Price Paid per Share Total Number of Shares Purchased as Part of Publicly Announced Programs Program Approximate Dollar Value of Shares That May Yet Be Purchased Under the Programs Program
July 4, 2026 - July 31, 2026 1,401 $ 55.78 1,401 $ 519,653
August 1, 2026 - August 28, 2026 1,453 $ 53.71 1,453 $ 441,627
August 29, 2026 - October 2, 2026 1,627 $ 57.62 1,627 $ 347,880
Stock repurchases under these SRPs the May 2026 SRP may be made from time to time through a variety of methods, which may include open market purchases, in block trades, Rule 10b5-1 trading plans, accelerated share repurchase transactions, exchange transactions, or any combination of such methods. The timing and amount of any stock repurchases under the SRPs SRP will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of our common stock and general market conditions. The SRPs do SRP does not obligate us to acquire any amount of our common stock, and the SRPs SRP may be modified, suspended or discontinued at any time without prior notice.
Other information 2 changes
Mary C. Beckerle , a member of our Board of Directors , entered into a pre-arranged stock trading plan on May 8, 2026 . Dr. Beckerle's trading plan provides for the sale of up to 22,035 shares of our common stock between August 7, 2026 and June 18, 2027 . This trading plan is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act and Exelixis policies regarding transactions in Exelixis securities.
During the three months ended June September 30, 2026, no other directors or Section 16 officers of the company adopted , modified or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement, as each term is defined in Item 408 of Regulation S-K.
Exhibits 4 changes
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Exelixis, Inc. 2017 Equity Incentive Plan
Non-Employee Director Equity Compensation Policy
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Management contract or compensatory plan.
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August 5, October 29, 2026 By: /s/ Christopher J. Senner
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Unchanged: Notes to the financial statements, Controls and procedures, Risk factors, Defaults on senior securities, Mine Safety Disclosures
Compared by code from the two filings' text and XBRL. Not advice.
The reading, claim by claim
- For the quarter ended October 2, 2026, its financial statements show revenue of $658.7 million and net income of $218.1 million.
- In the statements of income for the three months ended September 30, 2026, total revenues were $658,696 thousand, against $597,755 thousand a year earlier.
- Net product revenues were $604,924 thousand and collaboration revenues were $53,772 thousand.
- Diluted net income per share was $0.85, compared with $0.69.
- Net income was $640,612 thousand, against $538,042 thousand.
- The balance sheet shows cash and cash equivalents of $304,774 thousand at September 30, 2026, against $482,488 thousand at December 31, 2025.
- Total assets were $2,513,489 thousand and total stockholders' equity was $1,833,832 thousand.
- The statement of stockholders' equity shows repurchases of common stock of $252,313 thousand in the three months ended September 30, 2026, against $99,891 thousand a year earlier.
- Shares issued and outstanding were 244,678 thousand at September 30, 2026, against 262,483 thousand at December 31, 2025.
9 of 11 claims matched the filing text.
Not found in the filing text
- For the nine months ended September 30, 2026, total revenues were $1,898,198 thousand, against $1,721,463 thousand in the same period of 2025.
- Diluted net income per share was $2.46, compared with $1.90.
From the filing's financial data, not stated in its text
From this 10-Q's financial data (XBRL) for the quarter ended October 2, 2026
- Revenue change from a year earlier was +10.2%.
From the filing
Item 1. Financial Statements.
Item 1. Financial Statements.
EXELIXIS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except per share data) (unaudited)
September 30, 2026 December 31, 2025
ASSETS
Current assets:
Prepaid expenses and other current assets 71,267 75,596
Right-of-use assets and other non-current assets 237,587 342,305
Total assets $ 2,513,489 $ 2,844,4237
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Rebates and fees due to customers 70,767 59,896
Non-current operating lease liabilities 162,201 173,038
Commitments and contingencies (Note 11)
Stockholders' equity:
Preferred stock, $ 0.001 par value, 10,000 shares authorized and no shares issued
— —
Accumulated other comprehensive income (loss) ( 6,589 ) 3,476
Total liabilities and stockholders' equity $ 2,513,489 $ 2,844,423
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.
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EXELIXIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(in thousands, except per share data) (unaudited)
Three Months Ended September 30, Nine Months Ended September 30,
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.
EXELIXIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(in thousands) (unaudited)
Three Months Ended September 30, Nine Months Ended September 30,
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.
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EXELIXIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(in thousands) (unaudited)
Three Months Ended September 30, 2026
Common Stock Additional
Paid-in Capital Accumulated Other Comprehensive Loss Accumulated Deficit Total Stockholders' Equity
Shares Amount
Stock transactions associated with taxes withheld on equity awards — — ( 3,357 ) — — ( 3,357 )
Common Stock Additional
Paid-in Capital Accumulated Other Comprehensive Income Accumulated Deficit Total Stockholders' Equity
Shares Amount
Stock transactions associated with taxes withheld on equity awards — — ( 3,363 ) — — ( 3,363 )
Continued on next page
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EXELIXIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(in thousands) (unaudited)
Nine Months Ended September 30, 2026
Common Stock Additional
Paid-in Capital Accumulated Other Comprehensive Income (loss) Accumulated Deficit Total Stockholders' Equity
Shares Amount
Issuance of common stock under the equity incentive plan and stock purchase plan 3,210 4
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