Exelixis Announces Fourth Quarter and Fiscal Year 2024 Financial Results and Provides Corporate Update
- Total Revenues of
- Cabozantinib Franchise Achieved
- GAAP Diluted EPS of
- Non-GAAP Diluted EPS of
- Conference Call and Webcast Today at 5:00 PM Eastern Time -
“Exelixis delivered a strong fourth quarter of 2024, positioning us well to maximize success in 2025,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. “Due to the continued outsized performance of the cabozantinib franchise, we generated net product revenues of
Dr. Morrissey continued: “We expect zanzalintinib to take center stage in 2025 as our next franchise opportunity that could improve standards of care for patients with cancer. Our anticipated zanzalintinib pivotal data milestones include top-line results from STELLAR-303 in colorectal cancer and STELLAR-304 in non-clear cell renal cell carcinoma, and a decision to advance to the phase 3 portion of STELLAR-305 in head and neck cancer, all in the second half of the year pending event rates for each trial. We are also excited to deliver on our plan to initiate the STELLAR-311 trial of zanzalintinib in neuroendocrine tumors in the first half of 2025 and anticipate Merck to initiate two renal cell carcinoma studies evaluating zanzalintinib plus belzutifan this year. With so much in store for 2025, the entire Exelixis team has a singular focus on achieving our mission to help cancer patients recover stronger and live longer.”
Fourth Quarter and Fiscal Year 2024 Financial Results
Total revenues for the quarter and year ended December 31, 2024 were
Total revenues for the quarter and year ended December 31, 2024 included net product revenues of
Collaboration revenues, composed of license revenues and collaboration services revenues, were
Research and development expenses for the quarter ended December 31, 2024 were
Selling, general and administrative expenses for the quarter ended December 31, 2024 were
Provision for income taxes for the quarter and year ended December 31, 2024 was
GAAP net income for the quarter ended December 31, 2024 was
Non-GAAP net income for the quarter ended December 31, 2024 was
Non-GAAP Financial Measures
To supplement Exelixis’ financial results presented in accordance with
Exelixis believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Exelixis believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Exelixis’ results from period to period, and to identify operating trends in Exelixis’ business. Exelixis has excluded stock-based compensation expense, adjusted for the related income tax effect, because it is a non-cash item that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. Exelixis also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.
These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Exelixis encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations, to more fully understand Exelixis’ business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.
2025 Financial Guidance
Exelixis is maintaining the previously provided financial guidance for fiscal year 2025. Net product and total revenues guidance do not currently reflect any revenues resulting from a potential
Total revenues |
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Net product revenues |
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Cost of goods sold |
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Research and development expenses |
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Selling, general and administrative expenses |
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Effective tax rate |
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(1) |
Exelixis’ 2025 net product revenues guidance range includes the impact of a |
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(2) |
Includes |
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(3) |
Includes |
Cabozantinib Highlights
Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the
Detailed Results from Subgroup Analysis of Phase 3 CABINET Pivotal Study Evaluating Cabozantinib in Advanced Gastrointestinal (GI) NET Presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2025). In January 2025, results from a subgroup analysis of the CABINET study of patients with extra-pancreatic neuroendocrine tumors (epNET) arising in the GI tract were featured in a poster session at ASCO GI 2025. The analysis showed cabozantinib was associated with an improvement in progression-free survival (PFS) compared with placebo in patients with advanced GI NET, which was a subgroup of the epNET cohort. Earlier in January, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Neuroendocrine and Adrenal Tumors were updated to include cabozantinib as category 1 for certain types of NET following specific treatments, and as a category 2A preferred regimen for several other forms of advanced NET, depending on site of origin and grade.
Cabozantinib Data Presentations at the American Society of Clinical Oncology 2025 Genitourinary Cancers Symposium (ASCO GU). In February 2025, cabozantinib will be the subject of 16 presentations and poster sessions at this year’s ASCO GU, which is being held from February 13-15 in
Pipeline Highlights
Encouraging Results from Phase 1b/2 STELLAR-001 Trial Evaluating Zanzalintinib Alone or in Combination with Atezolizumab (Tecentriq®) in Metastatic Colorectal Cancer (CRC) Presented at ASCO GI 2025. In January 2025, results from an expansion cohort of the phase 1b/2 STELLAR-001 trial evaluating zanzalintinib alone or in combination with atezolizumab in patients with previously treated metastatic CRC were presented during a poster session at ASCO GI 2025. This cohort of the STELLAR-001 trial included 107 patients randomized 1:1 to receive single-agent zanzalintinib or zanzalintinib in combination with atezolizumab. Patients had unresectable, locally advanced or metastatic RAS wild-type CRC that is non-microsatellite instability-high or non-mismatch repair-deficient. Results from the presentation demonstrated that all efficacy parameters, including objective response rate, PFS and overall survival (OS) favored the combination of zanzalintinib plus atezolizumab versus zanzalintinib monotherapy in the overall population, as well as in a subgroup of patients without liver metastases. These data provide insights into the contribution of components for the zanzalintinib plus atezolizumab combination and support zanzalintinib’s ongoing pivotal development in metastatic CRC. Exelixis anticipates disclosing additional data from zanzalintinib’s phase 1b/2 studies in the first half of 2025.
Initiation of Phase 1 Clinical Trial Evaluating XL495 in Patients with Advanced Solid Tumors. In November 2024, Exelixis announced the initiation of the dose-escalation stage of the first-in-human phase 1 clinical trial of XL495 in patients with advanced solid tumors. XL495 is a novel, potent, small molecule inhibitor of PKMYT1. The dose-escalation stage of this phase 1 study is designed to determine the maximum tolerated dose of XL495. The expansion cohorts are designed to further assess the tolerability and activity of XL495 both as monotherapy and in combination with select cytotoxic agents in tumor-specific indications. Exelixis plans to present data from the XL495 program, as well as XL309 (potentially best-in-class small molecule inhibitor of USP1) and XB010 (5T4-targeting antibody-drug conjugate), at a scientific meeting in 2025.
Corporate Highlights
Clinical Development Collaboration with Merck to Evaluate Zanzalintinib in Combination with KEYTRUDA® (pembrolizumab) in Head and Neck Cancer and with WELIREG® (belzutifan) in Renal Cell Carcinoma (RCC). In October 2024, Exelixis and Merck (known as MSD outside of the
Favorable Ruling in Second Cabozantinib Abbreviated New Drug Application (ANDA) Litigation Against MSN Pharmaceuticals, Inc. (MSN). In October 2024, the
Stock Repurchase Program. Under the ongoing 2024-25
Announcement of Key Priorities and Anticipated Milestones for 2025. In January 2025, Exelixis announced its key priorities and anticipated milestones for 2025, including: the potential commercial launch of CABOMETYX for the treatment of patients with previously treated advanced NET following completion of the FDA’s review of Exelixis’ sNDA, which has a PDUFA action date of April 3, 2025; expansion of zanzalintinib’s pivotal development program with six ongoing or planned pivotal trials, including two pivotal RCC studies with Merck and additional studies to be announced in 2025, as well as initial clinical data readouts from the phase 1b/2 STELLAR-001 and STELLAR-002 clinical studies in the first half of the year and clinical updates from the pivotal STELLAR-303, -304 and -305 trials in the second half of 2025; accelerating the phase 1 development of XL309 as a potential therapy for tumors that have become refractory to PARP inhibitor (PARPi) therapy, as well as in combination with PARPi agents to deepen and prolong responses; continued progress of phase 1 clinical trials for XB010 and XL495; potentially filing three Investigational New Drug applications for the XB628 PD-L1-NKG2A bispecific antibody, XB064 ILT-2 monoclonal antibody and XB371 TF-topoisomerase I inhibitor antibody-drug conjugate. Exelixis presented the details of its key priorities and anticipated milestones at the 43rd Annual J.P. Morgan Healthcare Conference.
Basis of Presentation
Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31. For convenience, references in this press release as of and for the fiscal periods ended January 3, 2025 and December 29, 2023, are indicated as being as of and for the periods ended December 31, 2024 and 2023, respectively.
Conference Call and Webcast
Exelixis management will discuss the company’s financial results for the fourth quarter and fiscal year 2024 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Tuesday, February 11, 2025.
To access the conference call, please register using this link. Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. A webcast replay of the conference call will also be archived on www.exelixis.com for one year.
About Exelixis
Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules, antibody-drug conjugates and other biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ ability to maximize success in 2025; Exelixis’ 2025 financial guidance, which does not include any impact from a potential
Exelixis, the Exelixis logo, CABOMETYX and COMETRIQ are registered trademarks of Exelixis, Inc.
KEYTRUDA® and WELIREG® are registered trademarks of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.,
TECENTRIQ (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
EXELIXIS, INC. |
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CONDENSED CONSOLIDATED STATEMENTS OF INCOME |
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(in thousands, except per share amounts) |
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(unaudited) |
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Three Months Ended December 31, |
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Year Ended December 31, |
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2024 |
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2023 |
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2024 |
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2023 |
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Revenues: |
|
|
|
|
|
|
|
|||||||
Net product revenues |
$ |
515,232 |
|
$ |
429,336 |
|
|
$ |
1,809,395 |
|
|
$ |
1,628,879 |
|
License revenues |
|
49,343 |
|
|
45,229 |
|
|
|
349,244 |
|
|
|
178,635 |
|
Collaboration services revenues |
|
2,180 |
|
|
5,087 |
|
|
|
10,062 |
|
|
|
22,694 |
|
Total revenues |
|
566,755 |
|
|
479,652 |
|
|
|
2,168,701 |
|
|
|
1,830,208 |
|
Operating expenses: |
|
|
|
|
|
|
|
|||||||
Cost of goods sold |
|
19,965 |
|
|
21,753 |
|
|
|
76,216 |
|
|
|
72,547 |
|
Research and development |
|
249,002 |
|
|
244,670 |
|
|
|
910,408 |
|
|
|
1,044,071 |
|
Selling, general and administrative |
|
134,328 |
|
|
131,441 |
|
|
|
492,128 |
|
|
|
542,705 |
|
Impairment of long-lived assets |
|
— |
|
|
— |
|
|
|
51,672 |
|
|
|
— |
|
Restructuring |
|
254 |
|
|
— |
|
|
|
33,660 |
|
|
|
— |
|
Total operating expenses |
|
403,549 |
|
|
397,864 |
|
|
|
1,564,084 |
|
|
|
1,659,323 |
|
Income from operations |
|
163,206 |
|
|
81,788 |
|
|
|
604,617 |
|
|
|
170,885 |
|
Interest income |
|
21,295 |
|
|
21,388 |
|
|
|
77,156 |
|
|
|
86,543 |
|
Other income (expense), net |
|
272 |
|
|
(137 |
) |
|
|
(133 |
) |
|
|
93 |
|
Income before income taxes |
|
184,773 |
|
|
103,039 |
|
|
|
681,640 |
|
|
|
257,521 |
|
Provision for income taxes |
|
44,912 |
|
|
17,521 |
|
|
|
160,373 |
|
|
|
49,756 |
|
Net income |
$ |
139,861 |
|
$ |
85,518 |
|
|
$ |
521,267 |
|
|
$ |
207,765 |
|
Net income per share: |
|
|
|
|
|
|
|
|||||||
Basic |
$ |
0.49 |
|
$ |
0.28 |
|
|
$ |
1.80 |
|
|
$ |
0.65 |
|
Diluted |
$ |
0.48 |
|
$ |
0.27 |
|
|
$ |
1.76 |
|
|
$ |
0.65 |
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|||||||
Basic |
|
284,527 |
|
|
308,482 |
|
|
|
290,030 |
|
|
|
318,151 |
|
Diluted |
|
293,546 |
|
|
313,023 |
|
|
|
296,132 |
|
|
|
321,464 |
|
EXELIXIS, INC. |
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RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME |
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(in thousands, except per share amounts) |
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(unaudited) |
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|
Three Months Ended December 31, |
|
Year Ended December 31, |
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|
2024 |
|
2023 |
|
2024 |
|
2023 |
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GAAP net income |
$ |
139,861 |
|
|
$ |
85,518 |
|
|
$ |
521,267 |
|
|
$ |
207,765 |
|
|
Adjustments: |
|
|
|
|
|
|
|
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Stock-based compensation - research and development expenses (1) |
|
8,836 |
|
|
|
9,041 |
|
|
|
30,670 |
|
|
|
34,320 |
|
|
Stock-based compensation - selling, general and administrative expenses (1) |
|
17,510 |
|
|
|
15,265 |
|
|
|
63,166 |
|
|
|
72,025 |
|
|
Income tax effect of the above adjustments |
|
(5,896 |
) |
|
|
(5,629 |
) |
|
|
(21,520 |
) |
|
|
(24,691 |
) |
|
Non-GAAP net income |
$ |
160,311 |
|
|
$ |
104,195 |
|
|
$ |
593,583 |
|
|
$ |
289,419 |
|
|
GAAP net income per share: |
|
|
|
|
|
|
|
|||||||||
Basic |
$ |
0.49 |
|
|
$ |
0.28 |
|
|
$ |
1.80 |
|
|
$ |
0.65 |
|
|
Diluted |
$ |
0.48 |
|
|
$ |
0.27 |
|
|
$ |
1.76 |
|
|
$ |
0.65 |
|
|
Non-GAAP net income per share: |
|
|
|
|
|
|
|
|||||||||
Basic |
$ |
0.56 |
|
|
$ |
0.34 |
|
|
$ |
2.05 |
|
|
$ |
0.91 |
|
|
Diluted |
$ |
0.55 |
|
|
$ |
0.33 |
|
|
$ |
2.00 |
|
|
$ |
0.90 |
|
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|||||||||
Basic |
|
284,527 |
|
|
|
308,482 |
|
|
|
290,030 |
|
|
|
318,151 |
|
|
Diluted |
|
293,546 |
|
|
|
313,023 |
|
|
|
296,132 |
|
|
|
321,464 |
|
____________________ | ||
(1) |
Non-cash stock-based compensation expense used for GAAP reporting in accordance with Accounting Standards Codification Topic 718, Compensation—Stock Compensation. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20250211666637/en/
Chris Senner
Chief Financial Officer
Exelixis, Inc.
650-837-7240
csenner@exelixis.com
Susan Hubbard
EVP, Public Affairs & Investor Relations
Exelixis, Inc.
650-837-8194
shubbard@exelixis.com
Source: Exelixis, Inc.