Hello, and welcome to Nuvation Bio's Third Quarter 2025 Financial Results and Corporate Update Call. Today's call is being recorded, and a replay will be available. [Operator Instructions] Now I'd like to turn the call over to JR DeVita, Executive Director of Corporate Development and Investor Relations at Nuvation Bio. Please go ahead.

Thank you, and good afternoon, everyone. Welcome to the Nuvation Bio Third Quarter 2025 Earnings Conference Call. Earlier today, we released financial results for the quarter ending September 30, 2025, and provided a business update. The press release is available on the Investors section of our website at nuvationbio.com, and a recording of this conference call will also be available on our website following its completion. I'd like to remind you that today's call includes forward-looking statements, including statements about the therapeutic and commercial potential of IBTROZI and safusidenib, the components of our anticipated product revenue, expected milestone payments and our cash runway. Because such statements deal with future events and are subject to many risks and uncertainties, actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 10-K and our quarterly reports on Form 10-Q that are filed with the U.S. Securities and Exchange Commission. Joining me on today's call to discuss our quarterly results are our Founder, President and Chief Executive Officer, Dr. David Hung; our Chief Commercial Officer, Colleen Sjogren; and our Chief Financial Officer, Philippe Sauvage. David will provide an overview of our key business updates. Colleen will provide details on the commercial launch of IBTROZI, and Philippe will discuss our financial and operating updates. David will then conclude with closing remarks. Now I'll turn the call over to Dr. David Hung. David?

Thanks, JR. Good afternoon, everyone, and thank you for joining us. I'm pleased to share our third quarter results with you today. As a reminder, our lead product, IBTROZI, received full approval from the U.S. FDA on June 11, making the third quarter our first full quarter as a commercial stage company. We are thrilled to report that momentum from the U.S. launch of IBTROZI continues to build in a meaningful steady manner. On our last earnings call, we announced that 70 new patients had started IBTROZI between FDA approval and the end of July, which represented approximately 10 new patient starts per week. Going forward, we will report key performance indicators and sales on a quarterly basis. This allows for a direct apples-to-apples comparison of quarter-over-quarter growth regardless of when we report our results. Today, we can tell you that 204 new patients started IBTROZI in the third quarter, which represents over 15 new patient starts per week during this period. We are seeing and hearing strong physician appreciation and support for the durable efficacy, robust intracranial activity and excellent tolerability profile we've discussed previously. Importantly, what we're seeing in the field reflects exactly the cadence we were hoping for at this stage, supported by a real-world real-time patient treatment need. While rare disease launches are always complex, we are quite encouraged by the number of patients we have been able to help with IBTROZI at this point in our launch. To put our performance in context, repotrectinib or Augtyro was approved by the FDA on November 15, 2023. For retrospective IQVIA data, just 34 new patients started Augtyro during its first 3 full months after approval. While we realize IQVIA does not capture all patients that start therapy, this represents less than 3 new patient starts per week…

Thank you, David. Today, I am excited to share that due to the efforts of our incredible field team, our launch of IBTROZI continues to build impressive momentum. Since approval on June 11, our team has effectively executed our launch plan across the organization. Specifically, the precise execution of our launch strategy by our sales, marketing and market access team has helped providers quickly identify appropriate patients and ensure these patients have timely access to this important next-generation therapy. In our first full quarter of launch, 204 new patients started treatment with IBTROZI, equivalent to over 15 new patient starts per week. That is 5x greater than the next most recent therapeutic benchmark in this indication. This underscores that a significant medical need in ROS1-positive non-small cell lung cancer still exists. Even in these early days, it is clear to us that IBTROZI's compelling efficacy and safety profile is addressing this need. While ultra-rare disease launches require a multifaceted approach, this early momentum demonstrates that we have the right team, the right plan and strategy and a practice-changing therapy with a differentiated clinical profile in IBTROZI. There is swift adoption from prescribers across the country in all channels, including independent delivery networks, or IDNs, academic centers and large community practices. Through the end of the third quarter, providers across 98% of our 47 sales territories had written prescriptions for IBTROZI, including multiple repeat prescribers. At this point in our launch, we have engaged nearly all of our Tier 1 and Tier 2 target accounts, and our field-facing interactions and results reinforce that physicians are quickly gaining comfort prescribing IBTROZI for their appropriate patients. On the market access front, payer engagement continues to be constructive and effective. As of the end of the quarter, IBTROZI was covered by payers representing more…

Thanks, Colleen, and good afternoon, everyone. For detailed first quarter 2025 financials, please refer to our earnings press release, which is available on our website. Now, let's go over some important highlights from the quarter. We are so proud that this is our first full quarter reporting as a commercial stage company. And I'm pleased to inform you that in the first quarter, we generated $13.1 million in total revenue, which includes $7.7 million in net product revenue from IBTROZI. While there was some channel stocking at the start of the launch, growth is now purely driven by treating new patients with IBTROZI as our limited distribution model keeps inventory proportionally in line with new levels of prescription. Today, stocking no longer makes up a material amount of our product revenue, and we expect that to be the case from here on out. This is important when comparing the launch of IBTROZI to other medicines on the market where channel stocking and not new patient starts did make up a material part of revenue in the first few quarters post approval. Lastly, while some patients have been enrolled in our free trial program, we will expect nearly all patients on this program to generate full commercial revenue in their second month on IBTROZI at the latest. Our approach to access has been extremely successful with a very high level of coverage this soon post approval. Our level of gross to net has naturally increased based on contracting in the vicinity of 20%. We expect this level to slightly increase over time and then stabilize based on our balance of business with commercial, Medicare, Medicaid and 340B plans and the limited amount of free medicine provided to date. As of the end of the quarter, more than 80% of lives are…

Thank you, Philippe. Before we move to Q&A, I want to emphasize how proud I am of our team and the progress they have made. We are encouraged by the strong early adoption of IBTROZI across patients with advanced ROS1-positive non-small cell lung cancer, the feedback we're hearing from physicians and patients and the momentum we are building as a commercial company. This is only the beginning. With IBTROZI’s differentiated profile and growing adoption, coupled with the breadth of our pipeline and a robust cash balance, I believe we are well positioned to create meaningful impact for patients and long-term value for shareholders. With that, I'll ask the operator to open the line for questions.

[Operator Instructions] Our first question comes from the line of Kaveri Pohlman of Clear Street.

Congratulations on the progress. Maybe just a couple on IBTROZI. With more clarity and experience, curious if you would be able to provide any guidance on sales for this year? Also, how do you see the current and future trends in usage between treatment-naive or first-line and second-line settings relative to your expectations? And what key factors or strategies could influence greater uptake in first line? And I have a follow-up.

Kaveri, thanks for listening to us. As we said in the past, we are not going to provide any guidance on our numbers, but we are very comfortable with the level of consensus today. And we think that what we accomplished in Q3 with $7.7 million in net sales in the U.S. is a very, very strong number for Q3 and therefore, for year.

And Kaveri, to answer your second question, clearly, we're seeing an uptake in all lines of patients. But because the PFS of patients in the second line is going to be shorter than the PFS in the first line, over time, as we get turnover of patients, we are going to see increasing proportion of first-line patients. So we would anticipate that to grow. And we're capturing a significant number of patients at this stage of our launch, and we would expect that to continue to grow and accelerate.

Got it. And for expanded access program, first, can you tell us how many patients were on that program? And could you provide insight into overall impact and future direction of EAP and the fast access program or the free trial program, specifically how you see these initiatives evolving? And what potential do they have to support adoption as physicians gain more experience with the commercialized drug?

Thank you, Kaveri. So for expanded access program, you might remember, we told you in the last quarter that we had only 6 patients on these EAPs that were converted to commercial IBTROZI, only 6 of them. We didn't convert any patients from our clinical trials because they're still on trial. As David pointed out, with a very, very long duration. We expect them to stay on trial for a very long time. So it's only 6 patients that convert to EAP. And I wanted to come back to another point I was making back to your question about consensus. Obviously, as we said, if patients were to stay for the full year on IBTROZI, you're looking at roughly $55 million. So that should help us and help you to document the kind of sales for next year.

Our next question comes from the line of Farzin Haque of Jefferies.

Congrats on the quarter. Can you provide some color on the gross to net and payer mix and then timeline for submitting the supplemental NDA to update the label for IBTROZI?

Thank you, Farzin, for your question. I'll start by the gross to net and the payer mix. So we communicated about our gross to net of roughly 20% so far because we are starting to see the various payers coming online. We believe that we would have something in the vicinity of 40% coming from Medicare, a little bit less than 10% from Medicaid and maybe 20% additional from 340B, it's slightly lower right now. And obviously, all of those payer mix, Medicare, Medicaid, 340Bs are taking the rebates to certain levels. Some of them are being, as you know, legal, like 23.1% in Medicaid. So all of this to say that with the collection of payer mix that we see and we expect looking ahead and the contracting that we've done, we have for the quarter about 20%. We think it's still going to go a little bit higher over the next few quarters, and then it will stabilize.

And Farzin, to answer your question on the timing of the sNDA, we anticipate submitting that by the end of the week.

Got it. And then on the IDH1 program, are you saying more on the powering assumptions? And then like I know the prespecified stratification, but perhaps something on the crossover provisions for the high-grade glioma study.

I'm not sure I captured the second part of your question, but we haven't given detail on the powering assumptions except to say that we anticipate a trial size at [ 150 ] per arm will enable us to get registration.

Got it. So it just 2029 data best expectations. So number of events, you're not saying how many number of events to accumulate to get to that?

That's correct.

Our next question comes from the line of Soumit Roy of Jones Research.

Congratulations again on the quarter. On the projection of the -- so right now, you are getting almost 15 patients every week, so 60 a month. Could you give us some guidance on -- is that a fair number for next couple of quarters to go with? Or following the initial excitement, we should trim the total number of patients -- new patients a little bit? And any color on the TRX number or refilling of the prescription, if you can provide?

Soumit, thanks for your question. I mean, as we said, there is no bolus. So we expect this is going to be a continuous growth for us. There was no bolus of patients. There are new cancer patients, unfortunately, every day. And for ROS1 positive lung cancer patients, we believe IBTROZI is the best drug out there. So this will continue to increase. This is a rhythm. As we discussed in the past, unfortunately, the number you can get from IQVIA today are still not accurate for us. We expect this is going to get better probably in the next quarter, maybe sometime in February, March. That's what they told us. But today, obviously, you cannot get those numbers in a very good manner from IQVIA, which is why we're communicating about it. In terms of growth, as Colleen was saying, there is still a lot of potential for us to grow because the majority of the patients are in the community setting where we are doing a lot of efforts to promote IBTROZI because today, despite the majority of patients out there, we still get a majority of patients from university center, like very, very academic centers, specialized centers. So there is still a lot of patients out there for us to put on IBTROZI or to help them with our drug, and that's what we're trying to do right now.

And I would also emphasize that growth is going to come from several areas. Number one, as Philippe said, we're going to organically grow as we penetrate the market more and more. But also, we are making efforts to increase our testing awareness, and I think that should also increase the commercial opportunity. But finally, as you know, given the durability of IBTROZI, after a year, the patients who continue on IBTROZI are going to start to get revenue stacking. So independent of new patients just having patients past the 1-year mark, continue to stack revenues and with our median now DOR of 50 months, now we're talking about stacking into the fifth year, not just the fourth year as we had previously discussed. So I think there are a number of avenues for growth.

Got it. And you mentioned briefly on the -- you are in the final stages for a European partnership. If you -- is that something we should expect in fourth quarter, finalization of the deal? Any nature you are looking at co-partnership cost revenue share? Or is it going to be completely out-licensed royalty-based with the upfront payment?

So we are in very advanced conversation. And honestly, we are very advanced in our conversation right now. So I would expect that we could give you all the details you need sometimes in Q4.

Okay. And one last one. The Nippon, the $25 million milestone, is that something we should include in the fourth quarter or more in the first quarter?

No, this is a fourth quarter event because this is not the approval from a regulatory perspective, but the reimbursement list. So this is imminent considering the typical time line to negotiate price in Japan.

Our next question comes from the line of Leonid Timashev of RBC Capital Markets.

I wanted to drill down a little bit more on the first-line versus second and later line use. I guess in the real world, I guess, practically, how many patients are truly treatment naive? And I guess what I'm asking are, are there patients that are switching early and that might be somewhere in between what you would consider a first-line and a second-line patient and sort of how you think that might impact the real-world duration of response that you might have? And then maybe from a commercial perspective as well, if competitors come on the market later with later-line labels, how effectively you might be able to corner off the market by being in first line? Or is there some wiggle room in what is truly a second-line versus a first-line patient?

So first of all, if you just look at DNA testing, based on DNA testing alone, there's an incidence of 3,000 new patients per year in the U.S. alone. By definition, a new diagnosis means they are treatment naive. So -- but that's what's already out there. We would expect -- given our data that we would expect to become the treatment of choice for those patients. For the prevalence pool of ROS1 patients that are already out there who have been diagnosed in previous years and who have taken other therapies, other TKIs, as you've heard from Colleen, we're already seeing patients -- those patients being switched to IBTROZI either for progression or for tolerability and in some cases, for nothing just because our data are better. So we will eventually capture -- we believe we will capture the vast majority of all TKI experienced patients. But as we completely capture that pool, then we will continue to grow the market by new patients, which we think will be -- if the standard of care just remains DNA testing, that will be 3,000 new patients a year in the U.S., we think the standard of care is going to change to RNA testing, and that's going to go to about 4,000 new patients per year, and we would expect to capture the majority of that.

Our next question comes from the line of Yaron Werber of TD Cowen.

Congrats on a really nice start. So also a couple of questions. So we're kind of backing into, let's say, 108 patients sort of on average on therapy, and you started 208 -- I'm sorry, 204. So it almost seems like we're in a pretty good run rate. You can actually grow fairly substantially in Q4. And it sounds like you're comfortable with consensus for next year. I don't know if you can share with us what you think consensus is next year? And then secondly, it looks like you're doing $4 million to $5 million, $5.5 million in collaboration license revs quarterly. Is that sort of a good run rate to take into the next quarter and next year?

Thanks, Yaron. I'll start with the collaboration point. So a large chunk of our collaboration revenue from the quarter comes from our deferred revenue with Nippon Kayaku. So when we did the deal, we got basically deferred revenue that we recognize now because we have executed everything that we needed to do because basically they are approved, right? So that's as simple as that. So this collaboration revenue from that part of purely R&D collaboration revenue will go down. But on the other hand, as you pointed out, we will start to get more and more collaboration revenue driven by royalties. So far, royalty have been only coming from China with Innovent. And as I pointed out in previous calls, because they were not on the NRDL list or if you prefer not reimbursed, those royalty revenues were typically small. Now they're going to increase if they get NRDL list. At the same time, on royalty revenues coming from Nippon Kayaku will increase as well because it will be on the market. And finally, if we conclude during Q4, our partnership in Europe, we will have other collaboration revenues potentially coming from that. So this part of our collaboration revenue from this quarter will disappear, but we'll have a lot of other things coming up in the terms of royalties. I think to your point about consensus, what we have for consensus in 2026 is about $115 million. And as I pointed out, if we were to keep all the patients that we have seen starting on IBTROZI in Q3, so 204, this is an annual revenue of $55 million already. So considering a very, very long duration of response that even typically our second-line patients will be on therapy for more than a year, the fact that our therapy is so tolerable that we don't believe that people will just go on this and then go to something else. All of this accumulates revenue for next year. $55 million is just patients that have started in Q3 staying on therapy for a full year. So that's all the reasons why we're very comfortable with consensus next year.

Our next question comes from the line of David Nierengarten of Wedbush.

Just a couple from me. First off, as you know, there's a competitor around the corner who will be filing for approval. And I was just wondering how you're preparing marketplace and your sales force for that? And then on the sales force also, is it fair to assume that your sales force and marketing efforts are fully built out at this point with incremental adds over the next year? Or do you continue to plan on building out sales and marketing efforts?

So David, I will respond to your first question by saying that there actually are no data from any drug either approved or in development that have been able to match our metrics. A 50-month DOR is unprecedented in the space. As I said, in the history of oncology, there's only one other drug that has a PFS or DOR that long, and that drug has a response rate that's 76%. You might recall, our first-line response rate was 89%. So I would say that we feel extremely confident. If you look at the rate of our launch, we're capturing all lines of therapy, but we would anticipate by next year, we will have captured a very sizable chunk of the second-line market. And next year, there are no new competitors in the first-line setting. So our only competitors in the first-line setting will be agents that are not being currently actively promoted and at which we have data that I would just say there's really no match on any metric. Our sales force is built up. We don't anticipate any increase.

Our next question comes from the line of Silvan Tuerkcan of Citizens.

Congrats also from me on the quarter. Just maybe to Colleen, what will be the added benefit of the marketing basically the day after you get the new label with this new long DOR that you're showing? And maybe could you characterize also today with these 15 patients -- new patients per week that you're adding, what is that in terms of market share versus the competitors that are approved out there right now?

Yes. Thanks for your question. Well, the new label gives you opportunity, as you know, to be in front of your health care providers again with new information. And it's just going to solidify the story of IBTROZI and what we're hearing anecdotally from many of the HCPs already, and that really is becoming the new standard of care in these ROS1-positive patients. So for us, it just adds to the collection of positive data we already have and the efficacy and safety profile. But with such a durable response now, as David mentioned, we don't know of any other oral oncolytic in any space with this type of DOR. So it's just the opportunity to continue to make sure that the HCPs are updated on this data. It's really exciting for us, and it's great to have something new for the OEMs, the oncology account managers go in on. Secondly, you asked about market share. So I'm going to turn that to you Philippe, for you to take that one.

Yes, it's difficult to compare market share right now for all the reasons we said about the limitation of IQVIA. So this is something that over time will get better once we are really on a comparable basis with the other guys. What is clear is that when you look at our launch and our history of launch, we are doing much better and much faster than any other drug launch in that space. We -- after just 3 complete months, again, 2 or 4 patients starting in pre-complete launch, that's 5 or 6x better than the latest launch in the space. So this is increasingly really the dominant player in terms of new patients.

Great. And maybe one follow-up, if I may. On Nuvation -- NUV-1511, your Drug-Drug Conjugate, the data that we expect by year-end, do you -- how insightful will that be? How needle moving for the company? And what will you be able to tell us with that data?

And we'll just present the data we've accumulated to date in our clinical trial.

There seem to be no questions waiting at this time. So I'll pass it back over to the management team for any closing or further remarks.

I want to thank you all for dialing in. We really look forward to keeping you apprised of our progress, and we'll report again next quarter. Thanks so much.

Thank you. That will conclude today's call. Thank you for your participation. You may now disconnect your lines.