Exelixis, Inc. EXEL announced its preliminary financial results for fiscal 2024 and provided guidance for fiscal 2025.
Revenues, on a preliminary basis, for 2024 were approximately $2.165 billion, while net product revenues were $1.8 billion. The preliminary number for total revenues marginally beat the Zacks Consensus Estimate of $2.16 billion.
The company also updated on its anticipated pipeline and regulatory milestones.
Shares of Exelixis have surged 58.7% in a year against the industry’s decline of 16.3%.
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EXEL’s Outlook for 2025
Revenues for 2025 are expected between $2.15 billion and $2.25 billion. Net product revenues are estimated in the range of $1.95-$2.05 billion. This net product revenues guidance includes the impact of a wholesale acquisition cost increase of 2.8% for Cabometyx effective Jan. 1, 2025.
Research and Development expenses are expected in the range of $925-$975 million. Selling, General & Administrative expenses are targeted around $475-$525 million.
EXEL’s Focus on Cabometyx Label Expansion
EXEL’s lead drug Cabometyx maintained its status as the leading tyrosine kinase inhibitor (“TKI”) for the treatment of renal cell carcinoma (“RCC”) in 2024. This was mainly due to its use in combination with Bristol Myers’ BMY Opdivo in the first-line setting. The drug also maintained growth in the hepatocellular carcinoma indication.
BMY’s Opdivo is one of the leading immuno-oncology drugs, approved for various oncology indications.
Management is also focused on the label expansion of Cabometyx. The FDA accepted EXEL’s supplemental new drug application (sNDA) for cabozantinib for patients with previously treated advanced pancreatic neuroendocrine tumors (pNET) and those with previously treated advanced extra-pancreatic NET (epNET). It assigned a standard review with a target action date of April 3, 2025. The FDA also granted the orphan drug designation to cabozantinib for the treatment of pNET.
The net product and total revenues guidance do not currently indicate any revenues resulting from a potential approval of Cabometyx for the treatment of patients with previously treated advanced neuroendocrine tumors.
Exelixis had also planned to submit an sNDA with the FDA for cabozantinib in combination with Tecentriq (atezolizumab) for metastatic castration-resistant prostate cancer. The company is currently evaluating the timing of the same.
Update on EXEL’s Stock Repurchase Program
In August 2024, its board of directors authorized the repurchase of up to $500 million of the company’s common stock through the end of 2025. This is the third stock repurchase program undertaken by Exelixis since March 2023. Under this program, Exelixis repurchased $205.6 million of its common stock at an average price of $33.62 by the end of fiscal 2024.
Exelixis, Inc. Price, Consensus and EPS Surprise
Exelixis, Inc. price-consensus-eps-surprise-chart | Exelixis, Inc. Quote
EXEL Strives to Develop Other Pipeline Candidates
The pipeline progress has also been impressive as Exelixis looks to expand its oncology portfolio beyond Cabometyx.
Another promising candidate in Exelixis’ pipeline is zanzalintinib, a next-generation oral TKI. Enrollment has been completed in the late-stage STELLAR-303 study evaluating zanzalintinib in combination with Tecentriq compared with regorafenib in patients with metastatic refractory colorectal cancer that is not microsatellite instability-high or mismatch repair-deficient.
Preliminary results are expected in the second half of 2025, dependent on study event rates.
Another study, STELLAR-304 is evaluating zanzalintinib in combination with Opdivo versus sunitinib in previously untreated patients with advanced non-clear cell RCC. Based on the current enrollment status in the trial, the primary endpoint of progression-free survival is expected to be available in the second half of 2025, dependent on study event rates.
Exelixis recently collaborated with pharma giant Merck MRK to evaluate zanzalintinib in combination with its blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) in a late-stage study for treating patients with head and neck squamous cell carcinoma (“HNSCC”).
Per the terms of the agreement, Merck will supply Keytruda for the ongoing, Exelixis-sponsored phase III STELLAR-305 study in previously untreated PD-L1 positive recurrent or metastatic HNSCC.
Data from the phase II portion is expected to be available in the second half of 2025.
Exelixis also expects to initiate a late-stage study, STELLAR-311, evaluating zanzalintinib compared with everolimus as a first oral therapy in patients with advanced NET, regardless of site of origin, in the first half of 2025.
Per the collaboration with Merck, two RCC studies are also planned for 2025. Updates on the same will be provided later.
Exelixis is also evaluating XL309, a potentially best-in-class small molecule inhibitor of USP1, in a phase I study as a single agent and in combination with olaparib, a PARP1/2 inhibitor, in patients with advanced solid tumors.
Enrollment is ongoing in the dose escalation cohorts for XL309 monotherapy and olaparib combination. Data from the XL309 program will be presented at a scientific meeting in 2025.
Exelixis initiated the development of two other pipeline candidates in 2024, XB010 and XL495. The company plans to rapidly profile each compound to determine if early clinical data support further advancement toward full development.
In addition, three biotherapeutics programs are targeted for clinical development in 2025, XB628 PD-L1-NKG2A bispecific antibody, XB064 ILT-2 monoclonal antibody and XB371 TF-topoisomerase I inhibitor ADC. Exelixis plans to file the investigational new drug applications for these compounds in 2025 if preclinical data continue to be supportive.
The successful development of additional drugs should broaden the company’s portfolio and reduce dependence on its lead drug, Cabometyx.
EXEL’s Zacks Rank & Another Key Pick
EXEL currently carries a Zacks Rank #2 (Buy). Another top-ranked stock in the biotech sector is Immunocore Holdings plc IMCR, which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.18 to 94 cents. Loss per share estimates for 2025 have narrowed from $1.70 to $1.57 during the same time frame.
IMCR’s earnings beat estimates in two of the trailing four quarters and missed the same on the remaining two occasions, the average surprise being 25.57%.
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