The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Silvan Tuerkcan - Citizens JMP Securities LLC - Analyst
: Congratulations on all the progress. Maybe if you could just summarize the post-ESMO feedback that you had on the zanzalintinib
results and how they match up with those points that you unveiled today regarding how you plan to position this product in the
market.
Question: Karishma Misra - Goldman Sachs & Co LLC - Analyst
: This is Karishma on for Paul. Congrats on the quarter. So given the performance in the STELLAR-303 initial cut of data from ESMO,
can you help us level set expectations for the NLM cut coming out early next year? And particularly, we were interested in the idea
of powering with relation to the study given that Lonsurf-bev had approximately 500 patients in their Phase III study. Can you speak
to your decision to enroll roughly 900 patients in STELLAR-303 and the overall implications?
Question: Asthika Goonewardene - Suntrust Robinson Humphrey Capital Markets - Analyst
: I want to offer my congratulations on both the top- and bottom-line growth here, which are really impressive. So I have a question
on this: Merck announced LITESPARK-011 was positive, and one could assume that they'll be putting effort into marketing belzu
plus lenvatinib combination in second-line RCC patients.
We all know that zanza is a better drug than lenvatinib, but there could be a lot of population overlap between LITESPARK-011 and
the belz and zanza cohort in KEYMAKER-U03. So does that reduce the probability that Merck will want to pursue a pivotal second-line
study with belz and zanza? And then if I can sneak one in an extra in here, what was the clinical trial contribution for cabo sales in
3Q?
Question: Anastasia Parafestas - Jefferies LLC - Analyst
: This is Anastasia on for Akash. So do you see any risk to your STELLAR-303 trial approval given that Vinay was publicly apprehensive
about the usefulness of CABINET?
Question: Anastasia Parafestas - Jefferies LLC - Analyst
: Yes, for sure. So do you see any risk to your STELLAR-303 trial, specifically its approval, given that Vinay has been publicly apprehensive
about the usefulness of CABINET?
Question: Michael Schmidt - Guggenheim Securities LLC - Analyst
: I had one on zanza, specifically the opportunity based on the STELLAR-304 study. Just help us understand the size of this commercial
opportunity in non-clear cell RCC. And how much CAP use is driven in non-clear cell right now? And then lastly, just the minor delay
to mid-2026 from the first half, is that based on event rate slowdown? Or is there something else going on there?
Question: Jason Gerberry - BofA Securities Inc - Analyst
: Susan, you'll be missed. My question is on the NET cabo launch. Just wondering, a pretty impressive share of -second-line oral
therapies, I was just curious, are orals getting a greater share relative to Lutathera? Or is the dynamic between orals and Luta in
second line relatively stable? And if I could just squeeze one in, the MSN patent appeal, is there a timeline on that?
Question: Cheng Li - Oppenheimer & Co Inc - Analyst
: This is Cheng on the line for Jay. Congrats on the quarter. Also want to thank Susan for all the help in the past years, and congrats
on the retirement. As we are seeing several bispecific programs are now actually being developed in the first-line CRC, so how are
you thinking about the potential impact of those novel agents? And how will that impact the later line uptake of the atezo plus
zanza? And if I could sneak in one clarification question, for the STELLAR-303 trial based on ITT population, just wondering why
couldn't you file earlier because the top-line results were a few months ago?
Question: Ashwani Verma - UBS AG - Analyst
: So I just wanted to come back on the CRC market dynamic that you mentioned that zanza plus beva is roughly one-third of this
third-line market right now. But just the physician feedback that we've been getting is that is a growing part, so by the time that you
get to the market with zanza-atezo, what is your assumption with how much would that share will be? And then yes, there is some
sort of difference in the SUNLIGHT study based on the prior beva exposure but has that been slowing down the adoption of that
regimen?
Question: Christopher Liu - Lucid Capital Markets LLC - Analyst
: Maybe one that is more around capital allocation and financial strategy. With the share buybacks that have already been done and
that are planned, going forward, how are you thinking about incremental buybacks versus things like business development or
clinical investment opportunities? And do you feel like there's going to be a point where share buybacks would be less favored for
some of these other potential value generators?
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