Exelixis Announces Preliminary Fiscal Year 2023 Financial Results, Provides 2024 Financial Guidance, and Outlines Key Priorities and Milestones for 2024
– Cabozantinib franchise achieves approximately
– Fiscal year 2024 net product revenues guidance of
– Appointment of two new board members, Mary C. Beckerle, Ph.D., and Gail Eckhardt, M.D., with extensive drug development and corporate governance expertise –
– Implementing corporate restructuring to focus R&D resources on clinical stage and IND-enabling activities to maximize pipeline success and operational efficiency –
– Board of Directors authorized
– Presentation and webcast at 2024 J.P. Morgan Healthcare Conference tomorrow, Monday, January 8th at 4:30 p.m. PT / 7:30 p.m. ET –
Preliminary Fiscal Year 2023 Financial Results & 2024 Financial Guidance
Exelixis is providing the following preliminary unaudited 2023 financial results and financial guidance for 2024:
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Exelixis’ 2024 net product revenues guidance range includes the impact of a |
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Preliminary results not yet available. |
The preliminary 2023 financial information presented in this press release has not been audited and is subject to change. The complete Exelixis Fourth Quarter and Fiscal Year 2023 Financial Results are planned for release after market on Tuesday, February 6, 2024.
“Supported by strong revenues from cabozantinib, our global oncology franchise, Exelixis is advancing an innovative pipeline of differentiated product candidates that can improve standards of care for cancer patients,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. “Our 2024 plans include filing data-driven label expansions for CABOMETYX, accelerating the development of zanzalintinib, XB002, and XL309, and moving three promising preclinical programs into clinical development. The success of our internal drug discovery efforts as highlighted at our recent R&D Day compels a rebalancing of our investment priorities from early-stage research to product development activities. Exelixis will therefore implement a corporate restructuring that will concentrate R&D resources to advance our emerging pipeline, and maintain positive cash flow to support an additional
Corporate Updates
Corporate Restructuring to Rebalance Resources to Drive Pipeline Success: Exelixis will implement a corporate restructuring that will prioritize the advancement of the company’s deep pipeline of clinical and near-clinical programs. As a result, Exelixis is reducing its workforce by approximately 175 employees or 13 percent. Exelixis expects to substantially complete the restructuring in the first quarter of 2024 and recognize a restructuring charge of approximately
Appointment of Two New Board Members: As part of the company’s continued board refreshment plan announced last year, Exelixis is announcing two new appointments to its Board of Directors, effective January 5, 2024:
Mary C. Beckerle, Ph.D., Chief Executive Officer of the Huntsman Cancer Institute and Distinguished Professor of Biological and Oncological Sciences at the University of
Gail Eckhardt, M.D., Associate Dean of Experimental Therapeutics at Baylor College of Medicine and Associate Director of Translational Research at the College’s Dan L. Duncan Comprehensive Cancer Center. Dr. Eckhardt is a recognized leader in translational medicine relative to oncology with a particular emphasis on preclinical and early clinical development of molecularly targeted therapies and combination regimens to treat colorectal and other gastrointestinal cancers. She currently serves on the Board of Syros Pharmaceuticals, and as an academic advisor for eleven NCI-designated Cancer Centers, among other roles.
In addition, current Exelixis board member Alan M. Garber, M.D., Ph.D., has notified the company that he will not stand for reelection at the company’s 2024 Annual Meeting of Stockholders later this spring due to his expanded responsibilities at Harvard University. Having served as Harvard’s provost and chief academic officer since 2011, last week Dr. Garber became the University’s interim president.
Announcement of
Anticipated 2024 Cabozantinib Milestones
Cabozantinib Pivotal Trial Data Readouts and Anticipated
Anticipated Outcome of Cabozantinib Abbreviated New Drug Application (ANDA) Litigation with MSN Pharmaceuticals: The second bench trial for Exelixis’ ongoing ANDA lawsuit against MSN Pharmaceuticals, Inc. concluded in October 2023, and Exelixis anticipates a ruling from the United States District Court for the District of
Upcoming Development Milestones
Zanzalintinib Clinical Progress Anticipated in 2024: Zanzalintinib is a third-generation tyrosine kinase inhibitor (TKI) that Exelixis believes can become the vascular endothelial growth factor receptor TKI of choice as solid tumor therapeutic landscapes continue to evolve. Exelixis is executing on three ongoing pivotal trials of zanzalintinib, STELLAR-303, -304, and -305, in forms of colorectal cancer, non-clear cell renal cell carcinoma, and squamous cell carcinoma of the head and neck, respectively. Zanzalintinib is also the subject of three ongoing earlier-stage trials, STELLAR-001, -002, and -009, intended to evaluate its potential in best-in-class combinations and identify indications for future pivotal trials, with priorities defined by emerging data and potential clinical co-funding opportunities.
XB002 Clinical Progress Anticipated in 2024: XB002 is a next-generation tissue factor (TF)-targeting antibody-drug conjugate (ADC) that Exelixis believes has development potential as a monotherapy and in combination regimens. In 2024, Exelixis is focused on advancing JEWEL-101, the phase 1 study of XB002 alone and in combination with immunotherapy in a variety of solid tumor settings with the goal of prioritizing sensitive tumor types for full development.
XL309 Clinical Progress Anticipated in 2024: XL309 is a potentially best-in-class small molecule inhibitor of USP1, which has emerged as a synthetic lethal target in the context of BRCA-mutated tumors. Exelixis in-licensed XL309 from Insilico Medicine in September 2023, and the process of transferring stewardship of the program’s ongoing phase 1 trial to Exelixis was completed in the fourth quarter of 2023. Exelixis’ clinical development priorities for XL309 include accelerating its development as a potential therapy for tumors that have become refractory to PARP inhibitor (PARPi) therapy, including forms of ovarian, breast, and prostate cancers, pursuing potential PARPi combinations, and moving beyond the PARPi market into new areas.
Anticipated Discovery Milestones
Three Potential Investigational New Drug (IND) Applications in 2024: Exelixis anticipates moving three programs into clinical development this year, including two biotherapeutics and one small molecule compound. The company expects to file an IND application for the XB010 5T4-MMAE ADC program in the first half of 2024, and expects to file IND applications for the XB628 PD-L1-NKG2A bispecific antibody and XL495 small molecule PKMYT1 inhibitor programs in the second half of 2024 if preclinical data continue to be supportive.
Current Development Candidate (DC) Programs and New DC Designations expected in 2024: Exelixis has two DC programs that may be the subjects of IND filings in 2025, including the XB371 TF-Topoisomerase I inhibitor ADC and XB064 ILT-2 monoclonal antibody programs, and the XB033 IL13Ra2-Topoisomerase I inhibitor ADC that may be the subject of an IND filing in 2026. In 2024, the company expects to designate two new programs to DC status, including a small molecule PLK4 inhibitor and an additional ADC.
Presentation and Webcast
Exelixis President and Chief Executive Officer Michael M. Morrissey, Ph.D., will provide a corporate overview and discuss the company’s preliminary fiscal year 2023 financial results, 2024 financial guidance, and key priorities and milestones for 2024 during the company’s presentation at the 42nd Annual J.P. Morgan Healthcare Conference beginning at 4:30 p.m. PT / 7:30 p.m. ET on Monday, January 8, 2024.
To access the webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. A replay will also be available at the same location for at least 30 days.
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 and Preliminary Financial Results
This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ expectation that 2024 will be a year of pipeline progress as it advances its portfolio of promising biotherapeutics and small molecule candidates and pursues potential near-term label-expansion opportunities for CABOMETYX; Exelixis’ 2024 financial guidance; Exelixis’ 2024 plans for filing data-driven label expansions for CABOMETYX, accelerating the development of zanzalintinib, XB002 and XL309, and moving three promising preclinical programs into clinical development; Exelixis’ plans and expectations for corporate restructuring in the first quarter of 2024 and for a new
In addition, this press release includes Exelixis’ preliminary financial results for the fiscal year ended December 29, 2023. Exelixis is currently in the process of finalizing its financial results for the quarter and fiscal year ended December 29, 2023, and the preliminary financial results presented in this press release are based only upon preliminary information available to Exelixis as of January 7, 2024. Exelixis’ preliminary financial results should not be viewed as a substitute for audited financial statements prepared in accordance with
Exelixis, the Exelixis logo and CABOMETYX are registered
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Investor Contacts:
Susan Hubbard
EVP, Public Affairs & Investor Relations
Exelixis, Inc.
650-837-8194
shubbard@exelixis.com
Chris Senner
Chief Financial Officer
Exelixis, Inc.
650-837-7240
csenner@exelixis.com
Media Contact:
Hal Mackins
For Exelixis, Inc.
415-994-0040
hal@torchcommunications.com
Source: Exelixis, Inc.