Exelixis, Inc. (NASDAQ:EXEL) Q2 2023 Earnings Call Transcript

Michael Morrissey: Right. Jay, thanks. Why don’t we start with the second part of that question first. P.J. can talk about the market dynamics in the RCC space, and then Chris can briefly comment on guidance.

P.J. Haley: Yeah, thanks for the question. So with regards to the market, as I mentioned, we are now the market leaders in first line TKI plus IO combinations for the third quarter in a row. So a lot of strength there and in the TRx market, in the market basket we’re 39% share. And that market increased quarter-over quarter. So I think we have strong momentum. As I mentioned, we’re seeing growth in both demand and new patient starts and I think what we’re really seeing is that the our data, particularly the long-term follow-up data from CheckMate -9ER, now at 44 months follow-up and the strong balance of data, but particularly the overall survival data — we were 14 months in the combination beyond sunitinib which is really differentiating from the combination, continues to really drive positive perceptions for the data. So we feel good about our sort of continued momentum and opportunity for growth in the marketplace. Chris?

Christopher Senner: Thanks, P.J. So from a guidance perspective, as you just heard from P.J., we had a strong quarter. We continue to have strong growth and based on that strong growth that we’ve seen in the first half of the year, we think we’re confident that cabo has the ability to grow into the second half of the year and that’s why we reiterated the guidance range we did today.

Jay Olson: Okay, great, thank you. And if I could squeeze in a pipeline question, congrats on the CBX-12 data at ASCO. Can you just comment on whether or not you’ll be starting a Q3W dosing cohort and how far away do you think you are from recommending a Phase II dose?

Vicki Goodman: Yeah, so, thanks for the question. We are moving into every three weekly dosing actually, Cybrexa has that cohort ongoing now. Ultimately in terms of selection of a dose, I think there are multiple factors here in terms of doses, different schedule, and we have to consider the requirements of FDA’s Project Optimus and dose optimization. So we’re in discussions now with Cybrexa on exactly what that might look like, but making sure that we have a solid foundation for selecting a dose to go forward with.

Jay Olson: Great. Thanks for taking the questions.

Vicki Goodman: Of course, Jay. Thank you.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Silvan Tuerkcan with JMP Securities. Your line is open.

Silvan Tuerkcan: Thank you for taking my questions and congrats on the great quarter. I have a question about, if you can please outline the scenarios for COSMIC-313 with the data upcoming in the second half of the year? What are kind of the scenarios and how do we get from this data to supplemental NDA? And then I have a follow-up question.

Vicki Goodman: Yeah, so COSMIC-313, of course, we reported top-line results for the progression-free survival endpoints just about a year ago in which we showed an improvement in progression-free survival for the combination of cabozantinib with nivolumab and ipilimumab versus nivo and Ipi alone in-patients with poor and intermediate-risk renal cell carcinoma. At that time, the OS data were immature and in conversations with FDA, they made it clear that they wanted to see overall survival data prior to considering any filing. So with respect to 313, this is the next interim analysis of overall survival and data dependent, if the data seem to support a favorable benefit risk and we could — can consider a filing. We have that discussion with FDA.

Silvan Tuerkcan: Is there a way that you could file only on a subset of patients that the — I recall that was a differential in benefit between the low-risk versus medium-to-high-risk patients?