Release Date: August 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Strong financial performance with top and bottom-line growth driven by the cabozantinib franchise.
- CABOMETYX maintained its status as the leading TKI for RCC in the US, with significant revenue growth.
- Global cabozantinib franchise net product revenues grew to $618 million in Q2 2024.
- Exelixis earned a $150 million commercial milestone from Ipsen, highlighting the strength of the Cabo franchise.
- The company announced a new $500 million share repurchase program, reflecting strong financial health.
Negative Points
- Discontinuation of XB002 due to its inability to improve upon existing tissue factor targeting ADCs.
- Gross-to-net for the cabozantinib franchise decreased to 27.6%, primarily due to lower Medicare Part D and other expenses.
- The final overall survival analysis for CONTACT-02 did not reach statistical significance.
- No plans to file COSMIC-313 for label extension due to lack of OS benefit and evolving treatment landscape.
- Increased SG&A expenses due to pre-launch costs for the potential NET indication.
Q & A Highlights
Q: Just for Cabo and thinking about expectations for possible labeling in NET. Looking at the CABINET study, patients have seen around two to three median lines, including somatostatin analogs and other treatments. How are you thinking about how the label might reflect prior lines of therapy in terms of second-line versus third-line plus? And any other thoughts about the label that you could share would be super helpful. Thank you.
A: Thanks, Paul, for the question. I can't really share much in terms of the label. We're deep in the response to the agency. We're very excited about the fact that they've accepted the filing and are marching towards an approval date of April 3 and 2025. We think that this study allows a fairly broad label for NET pancreatic, extrapancreatic, prior SSTR, yes or no, functional yes or no. How that actually pans out in words will remain to be seen.
Q: On the business development opportunities and collaborations that is exploring, does that include the potential acquisition of late-stage assets that fit with the DUGI portfolio that was indicated in the previous quarter? Any color on the collaboration would be helpful. Thank you.
A: Yeah. Thanks for the question. It's Mike. Yes, look, as we mentioned last quarter, we're very interested in looking at late stage assets in the GUGI space. Obviously, I can't go into details right now about that, but it's certainly a prime area of focus for us. Anything we can do to add late-stage compounds to our portfolio would be, I think it will benefit for potentially patients, shareholders, and the company. So that's where our focus is right now and stay tuned as things evolve throughout the second half of the year.
Q: Just want to say congrats on the progress and the beat on travel sales quarter. So I have another question for you. It's unfortunate that contact did not hit on OS, where hopefully it still gets approved. And if it does, what is the level of confidence that not having ORS will not be detrimental to uptake. And if I can squeeze a quick one, a quick side question in here, can you just give us a little bit more color on the update on the recruitment to STELLAR-305. I know you said site activation is going well, but there's just quite a lot of other clinical trials underway in the study. I just want to get a little bit more color from you if you can provide on how patient enrollment is going? Thanks.
A: Yeah. Thanks, Asthika. PJ take that first question on travel commercial for prostate potentially?
A: Yeah. Thanks for the question. We're really excited about the data. And I think there's a significant unmet need out there as we've talked about previously. We certainly wouldn't want to get ahead of ourselves in talking about potential uptake in the market, et cetera. But like I said, we're excited about that data right now. As I mentioned in my remarks, we're really excited about and focused on the near-term neuroendrocrine tumor launch, which is really our top priority in addition to maintaining our current in-line business. So our focus is there at the moment.
Q: For the new 311 study of Zanza in first-line net, can you talk about how you're weighing the use of single-agent Zanza versus combination approach? And would you consider running a head-to-head trial of Zanza versus Cabo? Thank you.
A: Thanks, Jay. Great questions. So at this point in time, we're focusing on the Zanza head-to-head versus Everolimus, which we think is a reasonable therapy to offer patients in this line. We have to maintain Equipoise whenever we design the study so that the physician is okay talking about each option that they have we are interested in combinations. However, at this point in time, it's a little bit early days. We would have to assess the safety, tolerability of any combination before we could initiate a Phase III study. We believe that this is the first of probably multiple trials that will run in this space. So stay tuned. We'll look at combinations as well.
Q: On CONTACT-02, I was just wondering if you will be performing subgroup analyses in patients by high-risk factors similar to what you did for PFS, for example, in liver-met patients. And whether you hope to learn from anything there on the OS separation and what drove the overall OS to not be statistically significant? Thanks.
A: Yeah. Hi. Thanks for the question. So we're looking forward to sharing the data. We did provide subgroup analyses at GU ASCO, both according to PFS and according to OS, which we would intend to update. We're very interested in what subgroups may benefit the most from this combination as well as potential subgroups that may not have as much benefit, right? It's all about risk-benefit when a physician is deciding who to treat. And so we'll -- we look forward to providing an update. Stay tuned for when that happens and looking forward to have more discussion on this in the future.
Q: Could you speak to your launch preparedness for treating neuroendocrine tumors given that it's not overlapping as much with renal, how much of an extra lift does this represent for the team?
A: Yeah, David, thanks for that question. We covered that pretty extensively on the call. PJ, want to give the one-minute summary real fast.
A: Yeah. Thanks, David. I think we've got a good handle on this. It's not much of a significant lift. It's more or less incremental as we've said from a resourcing perspective. We see a strong overlap in net treating physicians with our current customer universe. That we call on because we're calling on GI specialists already with HCC and then we're -- we have a very strong presence in community oncology. So I think there's a couple of things there. One is that it's not a significant incremental resourcing request and the others we're well-positioned to take advantage of it.
Q: For CABINET and neuroendocrine tumors you noted that five-year survival rates trend down when going from GI to lung to pancreatic. Given that, but also given the CABINET was stopped early due to the compelling efficacy, how long into the treatment course do you want to go into with STELLAR-311 to see sort of the competitive landscape? Thanks so much.
A: Hi, Michael. Yeah, thanks for the question. I think we're still refining the study. We hope that Zanza, if the study ultimately is positive, would be -- would effectively be the preferred first oral treatment in patients who have advanced or metastatic neuroendocrine tumors. So in that sense, it's looking pretty early on. In the treatment setting, we know that median progression-free survival in this setting can be up to 22
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
