exel-20250404

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM			10-Q


☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended April 4, 2025


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 000-30235



EXELIXIS, INC.
(Exact name of registrant as specified in its charter)


Delaware						04-3257395
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification Number)

1851 Harbor Bay Parkway

Alameda, CA 94502

(650) 837-7000

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.001 Par Value per Share	EXEL	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days). Yes ý No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ý No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

☐

Non-accelerated filer

☐

Smaller reporting company

☐

Emerging growth company

☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ý

As of May 5, 2025, there were 272,708,280 shares of the registrant’s common stock outstanding.

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EXELIXIS, INC.

QUARTERLY REPORT ON FORM 10-Q

INDEX


		Page
PART I - FINANCIAL INFORMATION
Item 1.	Financial Statements	3
	Condensed Consolidated Balance Sheets (Unaudited)	3
	Condensed Consolidated Statements of Income (Unaudited)	4
	Condensed Consolidated Statements of Comprehensive Income (Unaudited)	4
	Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)	5
	Condensed Consolidated Statements of Cash Flows (Unaudited)	6
	Notes to Condensed Consolidated Financial Statements (Unaudited)	7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	21
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	35
Item 4.	Controls and Procedures	35
PART II - OTHER INFORMATION
Item 1.	Legal Proceedings	36
Item 1A.	Risk Factors	36
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	40
Item 3.	Defaults Upon Senior Securities	41
Item 4.	Mine Safety Disclosures	41
Item 5.	Other Information	41
Item 6.	Exhibits	42
SIGNATURES

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PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

EXELIXIS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except per share data)

(unaudited)


	March 31, 2025		December 31, 2024
ASSETS
Current assets:
Cash and cash equivalents	$	183,752	$	217,374
Marketable securities	847,564		893,902
Trade receivables, net	281,637		265,437
Inventory	24,853		22,388
Prepaid expenses and other current assets	58,696		68,478
Total current assets	1,396,502		1,467,579
Non-current marketable securities	619,441		637,291
Property and equipment, net	115,030		119,391
Deferred tax assets, net	419,045		420,027
Goodwill	63,684		63,684
Right-of-use assets and other non-current assets	223,545		239,718
Total assets	$	2,837,247	$	2,947,690
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	42,840	$	38,191
Accrued compensation and benefits	89,747		109,830
Accrued clinical trial liabilities	57,635		57,976
Rebates and fees due to customers	57,840		62,376
Accrued collaboration liabilities	25,489		40,384
Other current liabilities	125,551		95,012
Total current liabilities	399,102		403,769
Non-current operating lease liabilities	187,125		190,823
Other non-current liabilities	119,996		108,895
Total liabilities	706,223		703,487
Commitments and contingencies (Note 11)
Stockholders’ equity:
Preferred stock, $0.001 par value, 10,000 shares authorized and no shares issued	—		—
Common stock, $0.001 par value; 400,000 shares authorized; issued and outstanding: 275,033 and 281,732 at March 31, 2025, and December 31, 2024, respectively	275		282
Additional paid-in-capital	2,292,033		2,343,915
Accumulated other comprehensive income (loss)	2,010		(1,347)
Accumulated deficit	(163,294)		(98,647)
Total stockholders’ equity	2,131,024		2,244,203
Total liabilities and stockholders’ equity	$	2,837,247	$	2,947,690

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 March 31,
	2025		2024
Revenues:
Net product revenues	$	513,283	$	378,523
Collaboration revenues	42,164		46,703
Total revenues	555,447		425,226
Operating expenses:
Cost of goods sold	19,172		21,256
Research and development	212,233		227,689
Selling, general and administrative	137,183		113,984
Restructuring	—		32,835
Total operating expenses	368,588		395,764
Income from operations	186,859		29,462
Interest income	19,076		19,894
Other expenses, net	(245)		(89)
Income before income taxes	205,690		49,267
Provision for income taxes	46,074		11,950
Net income	$	159,616	$	37,317
Net income per share:
Basic	$	0.57	$	0.12
Diluted	$	0.55	$	0.12
Weighted-average common shares outstanding:
Basic	278,804		300,757
Diluted	288,177		305,530

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 March 31,
	2025		2024
Net income	$	159,616	$	37,317
Other comprehensive income (loss):
Net unrealized gains (losses) on available-for-sale debt securities, net of tax impact of $(983) and $433, respectively	3,357		(1,454)
Comprehensive income	$	162,973	$	35,863

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 March 31, 2025
	Common Stock			Additional Paid-in Capital		Accumulated Other Comprehensive Income (Loss)		Accumulated Deficit		Total Stockholders' Equity
	Shares	Amount
Balance at December 31, 2024	281,732	$	282	$	2,343,915	$	(1,347)	$	(98,647)	$	2,244,203
Net income	—	—		—		—		159,616		159,616
Other comprehensive income	—	—		—		3,357		—		3,357
Issuance of common stock under the equity incentive plans	1,362	1		11,562		—		—		11,563
Stock transactions associated with taxes withheld on equity awards	—	—		(22,506)		—		—		(22,506)
Repurchases of common stock	(8,061)	(8)		(67,055)		—		(224,263)		(291,326)
Stock-based compensation	—	—		26,117		—		—		26,117
Balance at March 31, 2025	275,033	$	275	$	2,292,033	$	2,010	$	(163,294)	$	2,131,024

	Three Months Ended March 31, 2024
	Common Stock			Additional Paid-in Capital		Accumulated Other Comprehensive Loss		Accumulated Deficit		Total Stockholders' Equity
	Shares	Amount
Balance at December 31, 2023	302,793	$	303	$	2,440,710	$	(3,750)	$	(173,351)	$	2,263,912
Net income	—	—		—		—		37,317		37,317
Other comprehensive loss	—	—		—		(1,454)		—		(1,454)
Issuance of common stock under the equity incentive plans	877	1		8,437		—		—		8,438
Stock transactions associated with taxes withheld on equity awards	—	—		(6,994)		—		—		(6,994)
Repurchases of common stock	(8,638)	(9)		(69,618)		—		(122,914)		(192,541)
Stock-based compensation	—	—		19,330		—		—		19,330
Balance at March 31, 2024	295,032	$	295	$	2,391,865	$	(5,204)	$	(258,948)	$	2,128,008

The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.

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EXELIXIS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)


	Three Months Ended March 31,
	2025		2024
Net income	$	159,616	$	37,317
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization	7,345		6,378
Stock-based compensation	25,930		19,113
Non-cash lease expense	6,096		6,764
Acquired in-process research and development technology	—		19,500
Other, net	(4,786)		9,206
Changes in operating assets and liabilities:
Trade receivables, net	(16,119)		(3,170)
Inventory	(71)		1,715
Prepaid expenses and other assets	20,320		10,075
Accrued collaboration liabilities	4,605		(3,829)
Accounts payable and other liabilities	8,501		(34,247)
Net cash provided by operating activities	211,437		68,822
Cash flows from investing activities:
Purchases of marketable securities	(186,701)		(138,468)
Proceeds from maturities and sales of marketable securities	258,917		268,452
Purchases of property, equipment and other, net	(2,952)		(9,691)
Acquired in-process research and development technology	(19,500)		(8,500)
Net cash provided by investing activities	49,764		111,793
Cash flows from financing activities:
Payments for repurchases of common stock	(283,934)		(185,375)
Proceeds from issuance of common stock under the equity incentive plans	11,627		8,315
Taxes paid related to net share settlement of equity awards	(22,516)		(6,988)
Net cash used in financing activities	(294,823)		(184,048)
Net decrease in cash and cash equivalents	(33,622)		(3,433)
Cash and cash equivalents at beginning of period	217,374		262,994
Cash and cash equivalents at end of period	$	183,752	$	259,561

The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.

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EXELIXIS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

NOTE 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Organization

Exelixis, Inc. (Exelixis, we, our or us) is an oncology company innovating next-generation medicines and combination regimens at the forefront of cancer care. We have produced four marketed pharmaceutical products, two of which are formulations of our flagship molecule, cabozantinib, and we are steadily advancing and evolving our product pipeline portfolio, including our lead asset zanzalintinib, currently the focus of an extensive phase 3 clinical development program. With a rational and disciplined approach to investment, we are leveraging our internal experience and expertise, and the strength of strategic partnerships, to identify and pursue opportunities across the landscape of scientific modalities, including small molecules, biotherapeutics and antibody-drug conjugates.

Sales related to cabozantinib account for the majority of our revenues. Cabozantinib is an inhibitor of multiple tyrosine kinases, including MET, AXL, VEGF receptors and RET and has been approved by the U.S. Food and Drug Administration (FDA) and in other countries as CABOMETYX® (cabozantinib) tablets for: advanced renal cell carcinoma (both alone and in combination with Bristol-Myers Squibb Company’s nivolumab (OPDIVO®)), previously treated hepatocellular carcinoma, previously treated, radioactive iodine-refractory differentiated thyroid cancer, and previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors and extra-pancreatic neuroendocrine tumors; and as COMETRIQ® (cabozantinib) capsules for progressive, metastatic medullary thyroid cancer. For physicians treating these types of cancer, cabozantinib has become or is becoming an important medicine in their selection of effective therapies.

The other two products resulting from our discovery efforts are: COTELLIC® (cobimetinib), an inhibitor of MEK approved as part of multiple combination regimens to treat specific forms of advanced melanoma and marketed under a collaboration with Genentech, Inc. (a member of the Roche Group) (Genentech); and MINNEBRO® (esaxerenone), an oral, non-steroidal, selective blocker of the mineralocorticoid receptor, approved for the treatment of hypertension in Japan and licensed to Daiichi Sankyo Company, Limited.

Basis of Presentation

The accompanying unaudited Condensed Consolidated Financial Statements include the accounts of Exelixis and those of our wholly owned subsidiaries. These entities’ functional currency is the U.S. dollar. All intercompany balances and transactions have been eliminated.

We have adopted a 52- or 53-week fiscal year policy that generally ends on the Friday closest to December 31. Fiscal year 2025, which is a 52-week fiscal year, will end on January 2, 2026 and fiscal year 2024, which was a 53-week fiscal year, ended on January 3, 2025. For convenience, references in this report as of and for the fiscal periods ended April 4, 2025 and March 29, 2024, and as of and for the fiscal years ending January 2, 2026 and ended January 3, 2025, are indicated as being as of and for the periods ended March 31, 2025 and March 31, 2024, and the years ending December 31, 2025 and ended 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 three months ended March 31, 2025 are not necessarily indicative of the results that may be expected for the year ending December 31, 2025 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, 2024, included in Part II, Item 8 of our Annual Report on Form 10-K, filed with the SEC on February 11, 2025 (Fiscal 2024 Form 10-K).

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Use of Estimates

The preparation of the accompanying Condensed Consolidated Financial Statements conforms to accounting principles generally accepted in the U.S., which requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosures. On an ongoing basis, we evaluate our significant estimates. We base our estimates on historical experience and on various other market-specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates.

Reclassifications

Certain prior period amounts in the accompanying Condensed Consolidated Financial Statements have been reclassified to conform to the current period presentation. Such reclassifications did not impact previously reported total revenues, income from operations, net income, total assets, total liabilities or total stockholders’ equity.

Significant Accounting Policies

There have been no material changes to our significant accounting policies during the three months ended March 31, 2025, 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 2024 Form 10-K.

Recently Adopted Accounting Pronouncements

There were no new accounting pronouncements adopted by us since our filing of the Fiscal 2024 Form 10-K, which could have a significant effect on our Condensed Consolidated Financial Statements.

Recent Accounting Pronouncements Not Yet Adopted

In December 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 2023-09), which enhances the disclosures required for income taxes in our annual consolidated financial statements. ASU 2023-09 is effective for us in our annual reporting for fiscal 2025 on a prospective basis. Early adoption and retrospective reporting are permitted. We are currently evaluating the impact of ASU 2023-09 on our Consolidated Financial Statements.

In November 2024, the FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (ASU 2024-03), which enhances the disclosures required for expense disaggregation in our annual and interim consolidated financial statements. In January 2025, the FASB issued ASU 2025-01, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40) – Clarifying the effective Date (ASU 2025-01), which clarifies the effective date of ASU 2024-03 for companies with a non-calendar year end. ASU 2024-03 is effective for us in our annual reporting for fiscal year 2027, and in our interim periods beginning in fiscal year 2028. Early adoption and retrospective application are permitted. We are currently evaluating the impact of ASU 2024-03 on our Consolidated Financial Statements.

NOTE 2. SEGMENT REPORTING

We operate in one business segment that focuses on the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Our President and Chief Executive Officer, as the chief operating decision-maker, manages and allocates resources to our operations on a total consolidated basis. Consistent with this decision-making process, our President and Chief Executive Officer uses net income to monitor budget versus actual results for purposes of evaluating performance and to make decisions about the allocation of resources.

Our significant segment expenses that are regularly provided to our President and Chief Executive Officer and included in the measure of segment net income consist of consolidated expenses for our operational departments: drug discovery, development, and selling, general and administrative and other segment items.

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The segment and consolidated net income, including significant segment expenses were as follows (in thousands):


	Three Months Ended March 31,
	2025		2024
Revenues	$	555,447	$	425,226
Less:
Cost of goods sold	19,172		21,256
Drug discovery	18,253		22,490
Development	153,217		172,887
Selling, general, and administrative	120,775		98,763
Other segment items(1)	57,416		80,457
Interest income	(19,076)		(19,894)
Provision for income taxes	46,074		11,950
Segment and consolidated net income	$	159,616	$	37,317

_________________

(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 expenses, net.

All of our long-lived assets are located in the U.S. See “Note 3. Revenues” for enterprise-wide disclosures about product sales, revenues from major customers and revenues by geographic region.

NOTE 3. REVENUES

Revenues consisted of the following (in thousands):


	Three Months Ended March 31,
	2025		2024
Product revenues:
Gross product revenues	$	721,711	$	563,785
Discounts and allowances	(208,428)		(185,262)
Net product revenues	513,283		378,523
Collaboration revenues:
License revenues	42,480		44,676
Collaboration services revenues	(316)		2,027
Collaboration revenues	42,164		46,703
Total revenues	$	555,447	$	425,226

The percentage of total revenues by customer who individually accounted for 10% or more of our total revenues were as follows:


	Three Months Ended March 31,
	2025		2024
Affiliates of Cencora, Inc.	23	%	19	%
Affiliates of McKesson Corporation	18	%	18	%
Affiliates of CVS Health Corporation	14	%	17	%
Accredo Health, Incorporated	12	%	12	%
Affiliates of Optum Specialty Pharmacy	10	%	10	%

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The percentage of trade receivables by customer who individually accounted for 10% or more of our trade receivables were as follows:


	March 31, 2025		December 31, 2024
Affiliates of Cencora, Inc.	26	%	17	%
Affili

SEC Form 10-Q filed by Exelixis Inc.