Exelixis Announces Preliminary Fiscal Year 2024 Financial Results, Provides 2025 Financial Guidance and Outlines Key Priorities and Milestones for 2025

-- Cabozantinib franchise achieves approximately $1.805 billion in preliminary U.S. net product revenues for fiscal year 2024 --

-- Fiscal year 2025 net product revenues guidance of $1.95 billion - $2.05 billion --

-- Presentation and webcast at 43(rd) Annual J.P. Morgan Healthcare Conference tomorrow, Monday, January 13(th) at 5:15 p.m. PT / 8:15 p.m. ET --

ALAMEDA, Calif.--(BUSINESS WIRE)--January 12, 2025-- 

Exelixis, Inc. (Nasdaq: EXEL) today announced its preliminary unaudited financial results for the fiscal year 2024, provided financial guidance for fiscal year 2025 and delivered an update on its business. Exelixis anticipates 2025 will be a year of clinical and regulatory execution and continued growth for its cabozantinib franchise, as well as multiple data readouts for zanzalintinib and across its diversified pipeline of small molecules and biotherapeutics with the potential to improve standards of care for patients with cancer.

Preliminary Fiscal Year 2024 Financial Results & 2025 Financial Guidance

Exelixis is providing the following preliminary unaudited 2024 financial results and financial guidance for 2025. Net product and total revenues guidance do not currently reflect any revenues resulting from a potential U.S. regulatory approval and commercial launch of CABOMETYX$(R)$ (cabozantinib) for the treatment of patients with previously treated advanced neuroendocrine tumors $(NET)$. The U.S. Food and Drug Administration (FDA) is currently reviewing Exelixis' supplemental New Drug Application (sNDA) for this proposed indication, with a Prescription Drug User Fee Act (PDUFA) target action date of April 3, 2025.

 
                               Fiscal Year 2024    Fiscal Year 2025 Guidance 
----------------------------  ------------------  ---------------------------- 
                                                     $2.15 billion - $2.25 
Total revenues                  $2.165 billion             billion 
----------------------------  ------------------  ---------------------------- 
                                                     $1.95 billion - $2.05 
Net product revenues            $1.805 billion            billion(1) 
----------------------------  ------------------  ---------------------------- 
                                                     4% - 5% of net product 
Cost of goods sold                   4.2%                  revenues 
----------------------------  ------------------  ---------------------------- 
Research and development                              $925 million - $975 
expenses                       $910 million(2)            million(3) 
----------------------------  ------------------  ---------------------------- 
Selling, general and                                  $475 million - $525 
administrative expenses        $495 million(4)            million(5) 
----------------------------  ------------------  ---------------------------- 
Effective tax rate                  n/a(6)                 21% - 23% 
----------------------------  ------------------  ---------------------------- 
Ending cash and marketable      $1.75 billion                n/p 
 securities(7) 
----------------------------  ------------------  ---------------------------- 
 
 
(1)    Exelixis' 2025 net product revenues guidance range includes impact of a 
       U.S. wholesale acquisition cost increase of 2.8% for CABOMETYX 
       effective Jan. 1, 2025. 
(2)    Includes $30.7 million of non-cash stock-based compensation expense. 
(3)    Includes $40.0 million of non-cash stock-based compensation expense. 
(4)    Includes $63.2 million of non-cash stock-based compensation expense. 
(5)    Includes $60.0 million of non-cash stock-based compensation expense. 
(6)    Preliminary results not yet available. 
(7)    Cash and marketable securities are composed of cash, cash equivalents 
       and marketable securities. Fiscal year 2025 guidance not provided 
       (n/p). 
 

The preliminary 2024 financial information presented in this press release has not been audited and is subject to change. The complete Exelixis Fourth Quarter and Fiscal Year 2024 Financial Results are planned for release after market on Tuesday, February 11, 2025.

"Entering 2025, Exelixis stands at an inflection point as we work toward our goal of building a multi-product, multi-franchise oncology business, " said Michael M. Morrissey, Ph.D., President & CEO, Exelixis. "Exelixis had a very successful 2024 highlighted by strong commercial and financial performance, the favorable ruling on our cabozantinib patent litigation, accelerating progress with the zanzalintinib pivotal trial program and establishing our zanzalintinib clinical development collaboration with Merck. We're carrying that momentum into the new year as we seek to grow cabozantinib franchise revenues, accelerate and expand our zanzalintinib pivotal development program, and advance our diversified therapeutic pipeline of small molecules and biotherapeutics."

Dr. Morrissey continued: "We expect 2025 to be a year of regulatory, clinical and commercial execution as we work toward a potential regulatory approval and launch for cabozantinib in neuroendocrine tumors and prepare for multiple zanzalintinib and pipeline data readouts throughout the year. As cabozantinib's commercial success drives the business forward in the near-term, we're excited by zanzalintinib's potential to surpass cabozantinib's scope and scale in the coming years and to become an important component of our mid- and long-term revenue growth. We're also optimizing our earlier stage pipeline, rapidly profiling compounds and advancing only those with the highest probability of success into full development. We look forward to providing more detailed updates on our pipeline progress at an R&D Day later this year. Finally, we'll maintain our balanced approach to capital allocation, leveraging our strong balance sheet to execute on business development opportunities within the GU and GI oncology space, while using free cash flows to fund our stock repurchase program and return capital to shareholders."

Corporate Updates

Stock Repurchase Program Update. In August 2024, Exelixis announced that the company's Board of Directors authorized the repurchase of up to $500 million of the company's common stock through the end of 2025, the third stock repurchase program undertaken by Exelixis since March 2023. Under this program, as of the end of fiscal year 2024, Exelixis has repurchased $205.6 million of the company's common stock, at an average price of $33.62 per share.

Anticipated Cabozantinib Milestones

Potential Label Expansion and Commercial Launch into NET. Exelixis is preparing for the potential commercial launch of CABOMETYX for the treatment of patients with previously treated advanced NET following the FDA's acceptance of its sNDA and assignment of a PDUFA target action date of April 3, 2025. In January 2025, the FDA notified Exelixis that its sNDA will no longer be the subject of discussion at an Oncologic Drugs Advisory Committee meeting. The regulatory filing was based on positive results from the phase 3 CABINET pivotal trial sponsored by the National Cancer Institute $(NCI)$, part of the National Institutes of Health, and led by the NCI-funded Alliance for Clinical Trials in Oncology. CABINET met its primary endpoint, demonstrating statistically significant and clinically meaningful improvements in progression-free survival $(PFS)$ for patients treated with cabozantinib as compared to placebo in both its pancreatic NET (pNET) and extra-pancreatic NET (epNET) cohorts. Final results from the trial were subsequently presented at the 2024 European Society for Medical Oncology (ESMO) Congress and published in The New England Journal of Medicine. In January 2025, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for NET 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. A subgroup analysis from CABINET detailing the experience of patients with advanced gastrointestinal (GI) NET will also be presented at the American Society of Clinical Oncology GI Cancers Symposium (ASCO GI 2025) later this month. Exelixis' partner Ipsen anticipates a decision from the European Medicines Agency on its Marketing Authorization Application for its own proposed NET label expansion in the EU for cabozantinib in 2025. While Exelixis prioritizes supporting the FDA's ongoing review of its proposed NET indication, the company will continue to evaluate the timing of its potential regulatory filing for cabozantinib in metastatic castration-resistant prostate cancer based on the phase 3 CONTACT-02 pivotal study.

Anticipated Development Milestones

Expansion and Acceleration of the Zanzalintinib Pivotal Trial Program. Zanzalintinib is a third-generation tyrosine kinase inhibitor (TKI) that Exelixis believes can become the vascular endothelial growth factor receptor TKI of choice as the solid tumor therapeutic landscapes continue to evolve. The zanzalintinib pivotal development program currently consists of six ongoing or planned pivotal trials, with additional studies to be announced in 2025 and beyond:

   -- 
 STELLAR-303 is evaluating zanzalintinib in combination with 
      atezolizumab compared with regorafenib in patients with metastatic, 
      refractory non-microsatellite instability-high or non-mismatch 
      repair-deficient colorectal cancer $(CRC)$. The primary endpoint in the 
      study is overall survival (OS) in the patients without liver metastases 
      (NLM). If OS is positive in the NLM population, the study will evaluate 
      OS in the intent-to-treat population that includes patients with and 

(MORE TO FOLLOW) Dow Jones Newswires

January 12, 2025 16:00 ET (21:00 GMT)