Exelixis (EXEL) Q2 FY26 earnings call: guidance and Q&A

Can you provide more precise timing for STELLAR-304 data readout and if it might be presented at a major medical meeting this year?

Management reiterated that top-line results are expected in the second half of 2026, but declined to speculate on exact timing or medical meeting presentations, stating they would message at the appropriate time.

“As I said in my prior remarks, we are expecting to achieve the planned number of events in the second half of this year. Beyond that, it wouldn't really be appropriate for me to speculate on when exactly that's going to happen or even when the data will be available at a medical meeting.”

asked by Kyuwon Choi · answered by Dana Aftab

How does the LITESPARK-022 study (pembro + HIF-2 alpha) impact the estimated 15,000 patient population for your first-line post-adjuvant study, and could it reduce the patient pool?

Management noted it's very early days for LITESPARK-022. They estimate 20-25% of first-line patients come off previously treated adjuvant therapy. They believe physicians will be cautious about adding toxicity in the adjuvant setting, especially given the high bar set by pembrolizumab monotherapy for overall survival.

“I wouldn't want to speculate with regards to how much utilization the combination will be used in the adjuvant setting. But I will say, historically, that setting is one that's very sensitive to toxicity.”

asked by Anastasia Parafestas · answered by P. Haley

Could the ongoing STELLAR-311 study for zanzalintinib in NET be cannibalizing cabozantinib sales, contributing to the slower ramp in the NET indication?

Management acknowledged that any recruiting study can draw patients from the commercial pool, especially in smaller tumor types, potentially having a small impact. However, the primary driving factor for the slower ramp is the unique, more indolent patient kinetics of NET, allowing patients more time before subsequent therapy.

“Any time you do have a study that is recruiting, it does draw potential patients from the commercial patient pool, so to speak. And it can be a bit exacerbated in a smaller tumor type, for example. So we think that could be having a small impact.”

asked by Andy Hsieh · answered by P. Haley

What progress has been made towards the $5 billion revenue vision for zanzalintinib by 2033, and how has the makeup of that projection evolved?

Management stated that the $5 billion figure was an aspirational view from late 2024. They highlighted the progress with 7 pivotal trials launched or imminent, and a second wave of trials planned, demonstrating the depth and breadth of the opportunity. They are committed to making the franchise as valuable as possible.

“The fact that we have launched or are about to launch or one is imminent of the 7 pivotal trials with the next wave on the way, I think, speaks to the depth and breadth of the opportunity going forward.”

asked by Joshua Werman · answered by Michael Morrissey

How quickly can data be generated for STELLAR-201 in meningioma, given single-arm Phase II studies can lead to approval? Also, can a new 505(b)(2) salt get NCCN guideline placement without clinical data?

For STELLAR-201, management noted it's a high unmet need with no standard of care, and enrollment is exceeding projections. They intend to bring appropriate data to regulators and are designing a confirmatory Phase III. For 505(b)(2), they highlighted differences from ANDA, emphasizing that NCCN considers lack of clinical data and patient safety, contrasting with successful 505(b)(2) examples based on large Phase III trials.

“Our intention is to bring the appropriate data to regulatory authorities at the appropriate time. But in the meantime, we're also in the process of designing a confirmatory Phase III trial.”

asked by Yaron Werber · answered by Dana Aftab

What drove the non-liver met subgroup in STELLAR-303 not achieving statistical OS benefit, and has this been discussed with the agency?

Management explained that the non-liver met subgroup is a very small subpopulation, and while the treatment effect was similar to interim ITT results, the data did not evolve to statistical significance over time. They emphasized that the ITT population, which includes both liver and non-liver met patients, is the subject of the NDA.

“The most important thing to us is that the ITT population is the overall population, the entire population of the study, it includes both liver mets patients and non-liver mets patients. And those are the data that were the subject of the NDA that we submitted to the regulatory agency.”

asked by Ashwani Verma · answered by Dana Aftab