EXELIXIS, INC. Q1 FY2025 earnings call

Exelixis had a strong first quarter with significant progress across business components. Executing on strategy to build multi-compound, multi-franchise oncology enterprise. CABOMETYX US business strong with growth in demand, new starts and revenue. US regulatory approval of CABOMETYX in pNET and epNET ahead of PDUFA date. Advancing zanza with key data milestones in 2025. Exelixis' IND pipeline coming into focus with new molecules. Focus on capital allocation, including pipeline priorities, BD activities.

First quarter 2025 US cabo franchise net product revenues grew 36% year-over-year to $513 million compared to $378 million in the first quarter 2024. Global cabo franchise net product revenues generated by Exelixis and its partners were approximately $680 million in the first quarter 2025 compared to $559 million in the first quarter 2024. CABOMETYX net product revenues were $510.9 million and included approximately $12 million in clinical trial sales.

Increasing 2025 full year financial guidance for net product revenues and total revenues by $100 million. Plan to evaluate further updates to 2025 financial guidance as NET launch builds momentum.

Risks and uncertainties related to product commercial success, market competition, regulatory review and approval processes, conducting clinical trials, compliance with regulatory requirements, dependence on collaboration partners, and cost associated with discovery, product development, etc.

Q: Good afternoon. Thanks for taking our questions and congrats on a great first quarter result here. So 1Q sales were obviously very strong in terms of growth over last year. Could you just help us understand a little bit better what's been driving cabo growth at this point? And obviously, neuroendocrine was approved at the end of 1Q. Did you see some contribution from that prior to approval already? And secondly, could you just provide some more color about the launch in neuroendocrine tumors and expectations for the early trajectory there throughout the rest of the year?

A: Thanks, Michael. P.J, why don't you start and then Chris and I can provide some color commentary afterwards as needed. Go ahead. Okay. Thanks for the question, Michael. Yes, as you mentioned, we had a strong quarter of results. We're very pleased with the progress we've made. As you look at the business in terms of demand in TRx, we grew significantly in terms of market share from 40% to 44%. And on absolute level, the volume grew 18% year-over-year. Similarly, NRx, we grew share from 38% to 43% in terms of new prescription share in our TKI market basket and even had a more substantial growth, an absolute terms of 27% and both of those were the only product to grow share, so performing really well relative to the competition. In terms of our business, the majority of this is being driven by RCC and in particular frontline RCC in terms of the combination of cabo with nivo. As I mentioned in my prepared remarks, we had updated data presented at GU ASCO in terms of CheckMate -9ER and the five-year follow-up data that's been resonating really well with physicians and really continues to position us in a way that differentiates us from the competition, which we're pleased with. So now a little bit in terms of NET, what I'll say is we only promote on label. There was a little bit of NET utilization we saw prior to approval. But as I mentioned, the approval came -- our approvals came on March 26th. So very early days in terms of the launch, but what I can tell you is that the feedback we're getting is really positive from prescribers. The team was literally sprinting out of the gate across all tactics and really all channels. So we're really pleased with the momentum there in NET. And we think, as I mentioned, it's a really substantial opportunity, but obviously really early days here and we'll be excited to continue to report updates on that as the launch progresses and we get throughout the year.