Exelixis (NASDAQ:EXEL) Chief Executive Officer Mike Morrissey said the company will continue to balance internal investment, clinical development and share repurchases with a data-driven approach as it manages the later stages of CABO’s exclusivity and advances zanza through multiple studies.
Speaking at a BofA investor event hosted by pharma and biotech analyst Jason Gerberry, Morrissey framed the company’s strategy around building “franchise molecules” that can improve standards of care for patients while creating shareholder value. He said Exelixis has been profitable on an annual basis since its success with CABO and continues to generate cash that can be deployed across research, development, commercialization and buybacks.
Capital allocation remains flexible
Morrissey said zanza is currently viewed internally as the company’s “next big drug” and suggested it may be undervalued by investors. He said Exelixis is investing in zanza in a controlled way, including through collaborations where appropriate, while maintaining flexibility within its research and development budget.
On whether zanza’s move into more pivotal trials could drive a significant increase in R&D spending, Morrissey said he would not characterize the situation that way. He noted that not all trials begin at the same time and that Exelixis evaluates whether to run studies alone or with partners. He said the company models clinical and commercial success scenarios and retains flexibility to make difficult prioritization decisions.
Exelixis says it will not ease off CABO
Gerberry asked whether Exelixis would alter its CABO commercial strategy as zanza approaches a potential approval and CABO moves later in its lifecycle. Morrissey said the company does not plan to “take our foot off the gas on CABO,” adding that Exelixis is focused on maximizing CABO’s value without allowing zanza to cannibalize it unnecessarily.
He said the company’s goal is not to choose between CABO and zanza, but to “run fast both ways” and expand the opportunity set across the portfolio. Morrissey pointed to a previously discussed metric of CABO gaining three share points, saying that level of performance at the current stage of the product’s launch was notable.
On competitive dynamics in renal cell carcinoma, including LITESPARK-011, Morrissey said Exelixis has heard a narrative from key opinion leaders that any potential share loss in the second-line setting could be offset by opportunities in the first-line setting. However, he said the company remains focused on maintaining share in the second line and noted that oncology remains highly competitive.
Zanza studies span renal cell carcinoma and combinations
Morrissey discussed the rationale for STELLAR-304 in non-clear-cell renal cell carcinoma, calling the setting an area without level-one evidence and a clear unmet need. He said Exelixis expects top-line data from the study in the second half of the year.
Asked whether progression-free survival would be sufficient to support clinical success in non-clear-cell disease, Morrissey said an overall survival signal is always valuable, especially for commercial differentiation. He referenced the company’s earlier experience with METEOR, saying survival data helped differentiate CABO. He added that survival may not be required for approval, but it can help build a stronger commercial position.
In clear-cell renal cell carcinoma, Morrissey said Exelixis is evaluating zanza combinations and is particularly interested in pairing zanza with mechanisms of action that are orthogonal to checkpoint inhibition. He said the company is in advanced discussions around frontline de novo metastatic opportunities involving zanza, a checkpoint inhibitor and a potential additional mechanism that could improve efficacy while limiting safety and tolerability issues.
Morrissey said Exelixis has learned from prior combination efforts, including COSMIC-313, and is being careful in selecting partners. He described the company’s longer-term ambition as translating CABO’s success into a larger opportunity for zanza in the next decade.
CRC strategy leans on GI sales presence and MRD selection
Morrissey also discussed Exelixis’ colorectal cancer strategy, including STELLAR-303 and STELLAR-316. He said the company’s experience with CABOMETYX in community oncology settings could help as it builds awareness for zanza in gastrointestinal oncology. He added that many representatives have oncology experience from other companies and products, which Exelixis expects to be useful in a potential colorectal cancer launch.
Gerberry asked whether later-line colorectal cancer would be more academically focused, but Morrissey said the setting is “truly a community setting,” making commercial coverage in GI oncology important.
For STELLAR-316, Morrissey said the high-risk post-adjuvant colorectal cancer population has limited options, with some patients progressing within months after adjuvant chemotherapy. He said Exelixis sees Natera’s minimal residual disease technology as useful for identifying patients at risk and selecting them for the study.
Morrissey said STELLAR-316 will be conducted only in the United States because that is where the technology is used. He described the trial as a three-arm study of zanza monotherapy, zanza plus a checkpoint inhibitor that the company will discuss later, and best supportive care. He said treatment with zanza plus a PD-1 therapy would not be cycle-limited.
He said the rationale is based more on metastatic zanza/checkpoint inhibitor data than on earlier competitor studies, arguing that if the combination can improve survival in patients with radiographically visible tumors, it is reasonable to test the same approach against micrometastatic disease. Morrissey said Exelixis is “super excited” to begin the trial soon.
About Exelixis (NASDAQ:EXEL)
Exelixis, Inc is a biotechnology company specializing in the discovery, development and commercialization of small molecule therapies primarily for the treatment of cancer. Building on a platform that leverages model organism genetics and high-throughput screening, the company focuses its research on kinase inhibitors that modulate critical signaling pathways involved in tumor growth and metastasis. Exelixis’s translational research approach aims to advance novel compounds from early-stage discovery through clinical development and regulatory approval.
The company’s most recognized products include CABOMETYX® (cabozantinib), approved for the treatment of advanced renal cell carcinoma and hepatocellular carcinoma, and COMETRIQ® (cabozantinib) for metastatic medullary thyroid cancer.
