Nuvation Bio (NUVB) Q3 2025 Earnings Transcript

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DATE

Monday, Nov. 3, 2025, at 4:30 p.m. ET

CALL PARTICIPANTS

• Chief Executive Officer — David Hung
• Chief Commercial Officer — Colleen Sjogren
• Chief Financial Officer — Philippe Sauvage

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TAKEAWAYS

• Iptrozi Net Product Revenue -- $7.7 million generated in Q1 2025, with minimal ongoing impact from initial channel stocking.
• Total Revenue -- including collaboration, license, and royalty streams beyond Iptrozi sales.
• New Patient Starts -- 204 new patients began Iptrozi during Q3 2025, equating to over 15 new patient starts per week.
• First-Line Clinical Efficacy -- Pooled data show a confirmed overall response rate (ORR) of 89% and a median duration of response (DOR) for TKI-naive patients rising to 50 months with the August 2025 data cutoff.
• Intracranial Response Rate -- For TKI-pretreated patients with brain metastases, Iptrozi demonstrated a 66% confirmed intracranial response rate in pooled analyses from the TRUST-1 and TRUST-2 studies, using a June 2024 data cutoff.
• Tolerability/Discontinuation -- Out of 337 pivotal-study patients, only one discontinued Iptrozi due to any of the six most common adverse events, equating to a 0.3% discontinuation rate for those AEs.
• Market Access -- By the end of Q3 2025, Iptrozi was covered by payers representing over 80% of U.S. covered lives, up from 58% two months prior.
• Gross to Net -- Gross-to-net adjustments were approximately 20% in Q3 2025, with an expected gradual increase before stabilization, reflecting payer mix and contracting.
• Patient Mix and Prescriber Base -- 75% of new patient starts have come from academic centers or independent delivery networks, covering 98% of the 47 sales territories as of Q3 2025, with increasing first-line adoption noted.
• Japan Approval and Milestone -- Regulatory approval in Japan secured in partnership with Nippon Kayaku; a $25 million milestone payment is expected to be recognized in Q4 2025 upon reimbursement listing.
• Cash Position -- Quarter-end cash, cash equivalents, and marketable securities totaled $549 million at the end of Q3 2025, with an additional $50 million available under a term loan agreement.
• R&D and SG&A Expenses -- R&D spending was $28.8 million in Q3 2025 and SG&A was $37.4 million in Q3 2025, reflecting commercialization and clinical pipeline support.
• Field Team Size -- Commercial field force right-sized at 47 oncology account managers, with no planned expansion.
• Pipeline Developments — Sacucitanib -- Enrollment began in a global randomized trial for high-grade IDH1 mutant glioma, designed for 300 patients, with anticipated completion in 2029 and primary endpoint of progression-free survival.
• Development Strategy Shift -- Decision made not to pursue a costly head-to-head sacucitanib vs. vorasidenib study in grade 2 IDH1 mutant glioma in the U.S, reallocating resources to other segments.
• Supplemental NDA Timing -- Submission planned by the end of the week to update Iptrozi’s label with the new 50-month median duration of response (DOR) statistic.
• Near-Term Catalyst -- Anticipated update from the NUV1511 drug-drug conjugate Phase 1 study in solid tumors to be presented in the near term.

SUMMARY

Nuvation Bio (NYSE:NUVB) reported $7.7 million in net product revenue for Iptrozi’s first full commercial quarter (Q3 2025), driven by 204 new patient starts, with payer coverage expanding rapidly to over 80% of covered lives by the end of the quarter. Management highlighted unprecedented clinical results, with Iptrozi’s median duration of response for TKI-naive patients increasing to 50 months, based on pooled analyses from the TRUST-1 and TRUST-2 studies with an August 2025 data cutoff. The company secured regulatory approval in Japan, triggering an imminent $25 million milestone payment in Q4 2025, and expects to see royalty streams from both Japanese and Chinese partnerships ramping up. Cash and investments of $549 million at the end of Q3 2025 provide runway through profitability, further enabled by disciplined expense management and a strategic decision to reallocate R&D away from a prohibitively expensive head-to-head glioma trial. Future pipeline potential was signaled by first patient dosed in a pivotal IDH1 glioma study and the planned label update to reflect extended Iptrozi durability, with the field team now fully scaled to sustain U.S. commercial execution.

• CEO Hung said, "We believe that Iptrozi is on track to become the new standard of care in ROS1-positive non-small cell lung cancer."
• Chief Financial Officer Sauvage stated, "We have right-sized our field team with 47 oncology account managers. We do not expect field and commercial team numbers to grow."
• Patient support program conversion times are now measured in weeks, signaling strong payer receptivity and high prescriber conviction for Iptrozi.
• The first clinical candidate from the company’s drug-drug conjugate (DDC) platform, NUV1511, is poised for a Phase 1 data update in solid tumors that may inform future pipeline value.

INDUSTRY GLOSSARY

• ORR: Overall Response Rate; the proportion of patients in a clinical trial whose cancer shrinks or disappears after treatment.
• DOR: Duration of Response; the length of time a tumor continues to respond to treatment without growth.
• R&D Expenses: Research and Development Expenses; funds allocated to product and pipeline clinical development efforts.
• SG&A Expenses: Selling, General, and Administrative Expenses; costs associated with commercial operations, marketing, and support functions.
• DDC Platform: Drug-Drug Conjugate Platform; a technology that links multiple drugs to target cancers more effectively.
• Adjuvant Therapy: Treatment given after the primary therapy to maximize its effectiveness, such as to prevent recurrence after surgery.
• Gross to Net: The amount of gross revenue remaining after deducting discounts, rebates, and other payment-related adjustments, reflecting actual realized sales.
• Pivotal Study: A late-stage clinical trial intended to provide the primary evidence for regulatory approval.
• TKI: Tyrosine Kinase Inhibitor; a type of drug that blocks signals needed for tumors to grow.

Full Conference Call Transcript

David will provide an overview of our key business updates, Colleen will provide details on the commercial launch of Atrozy, 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?

David Hung: Thanks, J.R. 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 Iptrozi received full approval from the US 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 Iptrozi continues to build in a meaningful steady manner. On our last earnings call, we announced that 70 new patients had started Iptrozi between FDA approval and 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 Iptrozi 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 real-world, real-time patient treatment needs.

While rare disease launches are always complex, we are quite encouraged by the number of patients we have been able to help with Iptrozi at this point in our launch. To put our performance in context, repotrectinib was approved by the FDA on November 15, 2023. Per retrospective IQVIA data, just 34 new patients started Oktyro during its first three full months after approval. While we realize IQVIA does not capture all patients that start therapy, this represents less than three new patient starts per week from December 2023 to February 2024.

As evidenced by the volume of new patient starts to date, defining characteristics of its product profile, we believe that Iptrozi is on track to become the new standard of care in ROS1 positive non-small cell lung cancer. This sentiment is already reflected in the practicing physician community as evidenced by a recent article published last month in Cure Today by Dr. Jeffrey Liu, one of the most prominent KOLs in the ROS1 lung cancer space, on the data we recently presented at the 2025 World Conference on Lung Cancer or WCLC. Since its launch, IQVIA data also shows that Oktyro has been unable to displace crizotinib or Xalkori and become the standard of care in this disease.

We believe Xalkori should not be the standard of care because it does not cross the blood-brain barrier. About 36% of newly diagnosed patients with advanced ROS1 positive non-small cell lung cancer have tumors that have already spread to their brain and another 50% of patients previously treated developed brain metastases upon progression. This viewpoint has been echoed by multiple KOLs we have interacted with in the field. Per data published in the Journal of Clinical Oncology or JCO, Iptrozi demonstrated a confirmed overall response rate or ORR of 89% and a median duration of response or DLR of 44 months in TKI naive patients.

And importantly, a 66% confirmed intracranial response rate in patients with brain metastases who were TKI pretreated. Data published in JCO was based on pooled analyses from the TRUST-1 and TRUST-2 studies using a June 2024 data cutoff. And today, we are delighted to report that the median DOR of TKI naive patients treated with Iptrozi in the pooled analyses has now increased to 50 months from 44 months with additional follow-up from a more recent data cutoff date of August 2025. These new data are being prepared in a supplemental NDA to support a label update that we plan to submit in the coming weeks.

And we also plan to provide a more fulsome update from the August 2025 data cutoff at a medical conference in 2026. These long-term data appear to represent the greatest patient benefit to date in ROS1 positive non-small cell lung cancer. It is also important to note that unlike ongoing studies of other ROS1 TKIs, our pivotal studies did not exclude patients with other concomitant oncogenic mutations, making the results with Iptrozi, we believe, representative and applicable to real-world patients. To our knowledge, we have not seen any approved therapies in any solid tumor oncology indication that have shown efficacy data like those of Iptrozi's combined response rates and durability in the first-line setting.

Only lorlatinib or Lovrenia for ALK positive non-small cell lung cancer has shown a longer median PFS of greater than five years in its CROWN study. Per its label, Lovrenia's confirmed ORR is 76%. Just as it would be a challenging and significant investment over many years to achieve, much less surpass, the median PFS of Lovrenia in ALK positive non-small cell lung cancer, we feel it will be equally difficult and lengthy an investment to demonstrate durability data close to that of Iptrozi in ROS1 positive non-small cell lung cancer. We also published important new data at both WCLC in September and the European Society of Medical Oncology or ESMO in October.

At WCLC, we shared updated Iptrozi data from both the pivotal TRUST-1 and TRUST-2 studies that support the data in our label. This included both additional details, which emphasized the consistent durability of Iptrozi's efficacy profile and a more thorough characterization of Iptrozi's well-tolerated safety profile. Specifically, while our presentation did not summarize all adverse events detailed in our prescribing information, it instead focused on the six most common adverse events seen in clinical studies of Iptrozi. These were increased aspartate aminotransferase or AST, increased alanine aminotransferase or ALT, followed in order by diarrhea, nausea, vomiting, and dizziness.

Of note, out of the 337 patients with ROS1 positive non-small cell lung cancer treated with Iptrozi in our pivotal studies, the number of patients who discontinued Iptrozi for any of these top six adverse events was one. This represents a discontinuation rate of just 0.3% for the six most common adverse events. In addition, the published data showed that Iptrozi's clinically apparent adverse events—diarrhea, nausea, vomiting, and dizziness—were transient, majority grade one, and resolved in one to three days. Again, the combined efficacy, durability, and tolerability of Iptrozi are unprecedented in this disease. Additionally, at the ESMO conference, we presented data on Iptrozi's efficacy in patients who had failed rozlutrek or entrectinib, the only CNS penetrant first-generation ROS1 TKI.

Iptrozi's confirmed ORR post-entrectinib failure was 80%. We are not aware of any ROS1 agents approved or in development that can match this response rate. Also notably, all 10 patients who failed entrectinib in this study failed for progression, not tolerability. This is an important distinction because showing an 80% confirmed ORR after progression is a much higher bar to achieve than an 80% ORR in patients who failed entrectinib for tolerability, but whose tumors are not progressing on entrectinib.

This data is particularly important because, as I noted earlier, intracranial metastases develop in 50% of patients progressing with ROS1 positive non-small cell lung cancer, and rozlutrek was previously the most tolerable of the currently approved earlier generation brain penetrant ROS1 TKIs. We believe these results following progression on rozlutrek solidify Iptrozi's differentiated profile and activity in the central nervous system. We believe that Iptrozi's robust, durable systemic and intracranial response rates may be due to its unique combination of activities against two important targets, ROS1 and TRK2. As we have previously mentioned, Iptrozi is 11 to 20 fold more selective for ROS1 over TRK B. It is strikingly potent against ROS1 with picomolar level inhibitory activity.

However, we believe that modest and tolerable inhibition of TRK B by Iptrozi may also contribute to intracranial disease control. Per published studies, TRK B signaling has been associated with larger tumor size, higher clinical stage, higher probability of distant metastases, including in the CNS, and worse survival across multiple solid tumor types, including lung cancer. Our view is that Iptrozi strikes the right balance between potent inhibition of ROS1 combined with measured and tolerable TRK B activity. Interestingly, as I just mentioned, the only other approved TKI with a PFS longer than that of Iptrozi is Lovrenia, used in ALK positive non-small cell lung cancer, which also inhibits TRK B to a measured extent.

We do not believe this is a coincidence. ALK positive non-small cell lung cancers also frequently metastasize to the brain, and Lovrenia's TRK B activity may be one of the key features in striking durability. We believe that Iptrozi's ability to hit ROS1 very hard, and TRK B modestly, may drive its unique systemic and intracranial response durability and its tolerability profile. We also continue to execute on the Iptrozi's lifecycle management. We recently dosed the first patient in TRUST-4, a randomized, placebo-controlled Phase 3 study evaluating talotrectinib as adjuvant therapy for patients with resected ROS1 positive early-stage non-small cell lung cancer.

Surgical resection remains the standard of care for early-stage lung cancer, yet recurrence is unfortunately common in patients with ROS1 infusions who have no approved targeted therapy options in the adjuvant setting today. TRUST-4 is designed to address this gap, building on the proven efficacy and safety profile of Iptrozi in advanced disease with the goal of delaying or preventing disease recurrence after surgery. We are the first approved ROS1 therapy to initiate a clinical trial in this setting, providing an important opportunity to address a key unmet need for patients.

The fact that we and the dedicated investigators participating in our adjuvant study believe Iptrozi's safety profile is well-tolerated to the point that we can help patients earlier in the disease is a particularly positive reflection of this program. Finally, in partnership with Nippon Kayaku, we were pleased to receive regulatory approval of Iptrozi in Japan, further expanding access to patients with ROS1 non-small cell lung cancer outside the U.S. We view this milestone as an important step in bringing Iptrozi to patients and providers around the globe following its approval in China earlier this year.

In short, we believe our launch performance, the latest updates reconfirming efficacy and tolerability profile, and the additional development regulatory achievements all show why Iptrozi is poised to be the new standard of care for patients with ROS1 positive non-small cell lung cancer. We also made important progress on the rest of our pipeline. Allow me to turn briefly to sacucitanib. Sacucitanib is a mutant IDH1 inhibitor being developed for diffuse IDH1 mutant glioma, a devastating brain cancer for which there are very few treatment options available today. Each year, there are approximately 2,400 new cases of IDH1 mutant glioma in the U.S., split almost evenly between low grade, including grade two, and high grade, including grades three and four.

An important difference from ROS1 positive non-small cell lung cancer is that patients newly diagnosed with low grade and high grade IDH mutant glioma live approximately 10 to 15 and three to seven years, respectively. Therefore, patients may benefit from an approved therapy for many years. As a result, the market opportunity is materially larger. The only treatment option available for patients with IDH1 mutant glioma is vorasidenib, which was approved by the U.S. FDA in August 2024 for only grade two patients. In its pivotal INDIGO study, which again included only grade two patients with non-enhancing disease, vorasidenib demonstrated a median PFS of 27.7 months and an ORR of 11%.

Strikingly, the launch of vorasidenib has greatly surpassed analysts' expectations by approximately 20 fold. For background, vorasidenib is commercialized by Servier, a private company who acquired the program from Agios. Although Servier does not report sales of vorasidenib, they can be gleaned from the royalties received and reported by Royalty Pharma, who in May 2024 paid Agios $95 million for a 15% royalty on net sales of vorasidenib in the U.S. Royalty Pharma recently disclosed in an investor update that U.S. net sales of vorasidenib were over $550 million since launch, compared to analyst projections of approximately $30 million over the same timeframe, including $223 million in net revenue in 2025 alone.

Based on this, vorasidenib is quickly approaching an annual run rate of $1 billion in U.S. net sales. We believe this is consistent with what we have said is a significant commercial opportunity for our IDH1 inhibitor, sacucitanib. As a reminder, vorasidenib is approved in grade two IDH1 mutant glioma, and there are no therapies approved in the IDH1 mutant high grade, or high risk lower grade settings. While we acknowledge the complexity of cross-trial comparisons, in a clinical study run by our partner Daiichi Sankyo, sacucitanib showed an ORR of 33% in patients with recurrent low grade IDH1 mutant glioma, which is three times the ORR vorasidenib showed in its pivotal INDIGO study.

More importantly, sacucitanib demonstrated a 17% ORR in high grade IDH1 glioma, including two complete responses lasting multiple years. These complete responses include a GBM or glioblastoma multiforme, the worst of all gliomas, which is now referred to as grade four astrocytoma. To our knowledge, no other IDH1 inhibitors have demonstrated responses of this kind in high grade IDH1 mutant glioma. We believe this speaks to the emerging and promising clinical profile of sacucitanib. Based on data generated to date, we have begun dosing patients in a global randomized study evaluating the efficacy and safety of sacucitanib versus placebo for the maintenance treatment of high grade IDH1 mutant glioma following standard of care treatment.

Specifically, we define the population as patients with newly diagnosed IDH1 mutant grade three astrocytoma with certain high risk features or grade four disease. Following a successful meeting with the US FDA, we're actively preparing a protocol amendment to modify the trial into a pivotal Phase III study by increasing the size to approximately 300 patients, which should support potential regulatory approvals. Please refer to clinicaltrials.gov for additional details on the study design.

Other important elements coming from the FDA meeting include agreement on PFS as the primary endpoint, which could support full approval, agreement on the dose of 250 milligrams BID without further need for dose optimization in this setting, and agreement on the defined patient population with the potential to also include patients with IDH1 mutant high risk grade two or low grade gliomas, a patient group that might not be best served by vorasidenib given its pivotal INDIGO study design. For example, the INDIGO study excluded grade two patients with enhancing disease. Enhancing disease is known for having a higher risk of progression.

Considering the high unmet need and the exciting profile of sacucitanib, we are optimistic about the speed of recruitment in this trial. That said, we want to be transparent on the length of this study. Given the agreed-upon PFS endpoint and natural history of disease, this study will take years to complete. In addition, I'd reiterate that the blinded protocol will prevent us from disclosing public updates until enough events have occurred. We estimate that the study will be completed in 2029. Finally, we want to share an update on our discussions with the FDA regarding the development of sacucitanib in grade two IDH1 mutant glioma where vorasidenib is approved. These discussions were incredibly collaborative.

But it was clear that to receive approval, we would need to demonstrate a PFS benefit of sacucitanib in a single randomized study with sufficient representation of U.S. patients. This would naturally result in including vorasidenib as the control arm given any other control arm in the U.S. would be considered unethical. While vorasidenib may be approved or achieving approvals in ex-U.S. regions, accessibility and reimbursement is highly variable, and it would take too long to enroll a study supported by a PFS endpoint solely in the U.S. An alternative is for us to supply vorasidenib, but the cost would easily exceed $100 million, which is simply not a financially prudent business decision.

Therefore, we've decided not to pursue a head-to-head low grade glioma study on our own at this time and to instead focus our resources and efforts on the high grade maintenance study. However, as we've alluded to above, some grade II subsets were excluded from the vorasidenib INDIGO pivotal study, such as high risk grade two patients, which are still low grade gliomas. We will therefore likely enroll grade two or low grade subsets with high risk features, which still represents an unmet need with no approved therapy.

We will continue to explore whether there are other pathways to pursue development in a portion of the low grade population or other IDH1 glioma patient subsets that could potentially benefit from sacucitanib. And also remain flexible around further partnerships in the development of this program. Lastly, NUV1511 is the first clinical candidate from our drug-drug conjugate or DDC platform and represents a new modality in targeted cancer therapy. We plan to provide an update from our Phase one dose escalation study in difficult-to-treat solid tumors in the near term. We remain confident that we have the team, strategy, and mindset to execute our program successfully, build lasting value, and most importantly, help patients.

With that, I'll turn it over to Colleen.

Colleen Sjogren: Thank you, David. Today, I am excited to share that due to the efforts of our incredible field team, our launch of Iptrozi 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 Iptrozi, equivalent to over 15 new patient starts per week. That is five times 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 Iptrozi'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 Iptrozi. 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 Iptrozi, including multiple repeat prescribers.

At this point in our launch, we have engaged nearly all of our tier one and tier two target accounts. And our field-facing interactions and results reinforce that physicians are quickly gaining comfort prescribing Iptrozi for their appropriate patients. On the market access front, payer engagement continues to be constructive and effective. As of the end of the quarter, Iptrozi was covered by payers representing more than 80% of covered lives, up from 58% just two months prior. The incredible effort of our Market Access team is reflected in the truly phenomenal growth in coverage. Our patient support program, Nuvation Connect, continues to play a critical role supporting patients beginning treatment quickly while reimbursement is being secured.

We are encouraged that while our free trial program was intended to last up to one month, we continue to convert patients in a matter of weeks, highlighting both payer receptivity and prescriber conviction. Now let's look at some of the backgrounds of key segments of who have been prescribed Iptrozi, as they highlight the broad potential of this therapy. First, we are seeing use from providers in both academic and community settings nationwide. To date, nearly 75% of our new patient starts have come from academic centers or independent delivery networks.

This is to be expected as these centers are typically quicker to adopt new and innovative products, while community centers, where the majority of ROS1 patients are located, are just now starting to come online. Over time, we expect the majority of new patient starts to come from the community setting, in turn supporting prescription growth and continued momentum. In addition, Iptrozi is being prescribed across both TKI naive and TKI pretreated patient populations. We have limited visibility into the characteristics of all patients on our therapy, but we do have insight into patients that come through our support program Nuvation Connect. And our data shows encouraging signs that the percentage of TKI naive patients prescribed Iptrozi is increasing.

We were expecting a higher proportion of TKI pretreated patients to make up the majority of new patients at launch, but the greatest opportunity for long-term patient impact and treatment with Iptrozi remains in the first-line setting, which is further bolstered by the latest data cut providing for a 50-month median duration of response based on pooled data from TRUST-1 and TRUST-2 studies. In the second-line setting, consistent with what we reported on our last earnings call, we continue to see switches from all three of the other therapies approved for this indication. Reasons for this have included disease progression, toxicity, brain penetrance, or HCP preference.

In addition, multiple key opinion leaders have shared that Iptrozi's efficacy profile, specifically the prolonged durability in TKI naive patients, is best in class, and they have elected to switch their TKI pretreated patients as a result, even if they had not progressed or had toxicity issues. Since launch, we are learning that the clinical efficacy profile is resonating strongly with physicians, and they also appreciate that Iptrozi's safety profile is well-defined, manageable, and most importantly, allows patients the possibility to remain on therapy for years and stay ahead of their disease. Looking ahead, we are focused on deepening adoption in the U.S. and continuing to raise awareness of the importance of oncogenic driver testing.

Today, DNA-based testing identifies roughly 3,000 advanced ROS1 positive non-small cell lung cancer patients annually in the U.S. And as the field shifts towards RNA-based testing, which publications suggest may detect approximately 30% more ROS1 fusions, the annual addressable population could potentially expand to roughly 4,000 patients in the U.S. alone. So given Iptrozi's median duration of response of 50 months, we would expect the theoretical maximum number of patients treated with Iptrozi to potentially be over 16,000 patients early in the fifth year post-approval. Iptrozi's unprecedented durability in ROS1 positive non-small cell lung cancer turns a small incidence population into a substantial prevalence population, generating an opportunity to help a much larger patient population than we had previously articulated.

This example is based on first-line patients only and does not count any patients in the pretreated population, which further increases the addressable population over this time frame. As David noted, we recently initiated the TRUST-4 study to evaluate Iptrozi as an adjuvant therapy for patients with resected ROS1 positive early-stage non-small cell lung cancer. From my standpoint, this is important for three reasons. First, thoracic thought leaders have encouraged us to pursue approval in early-stage non-small cell lung cancer. This speaks to the efficacy and importantly the safety profile of Iptrozi, as taking a medicine for many years requires that it be tolerable.

Second, potential approval in the adjuvant setting can further expand the number of patients we can support with Iptrozi. And third, success in this study can solidify Iptrozi as the leader in ROS1 positive non-small cell lung cancer, as we are the only company to have pursued an adjuvant study in the ROS1 patient population. To give you an example in this field, I would point you to osimertinib, or Tagrisso, in EGFR positive non-small cell lung cancer. Following its approval in the adjuvant setting, there was an exponential increase in prescriptions of the medicine. In fact, it became one of the most widely prescribed lung cancer treatments globally.

Finally, I want to highlight the efforts of our remarkable field team. Their deep experience in rare disease and dedication to oncology, coupled with Iptrozi's outstanding efficacy and safety profile, have led to the fastest ROS1 launch in history. We believe this early adoption supports our conviction that it is quickly emerging as the new standard of care in ROS1 positive non-small cell lung cancer, delivering meaningful benefit for patients. Now I'll turn it over to Philippe.

Philippe Sauvage: 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 I'll 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 Iptrozi. While there was some channel stocking at the start of the launch, growth is now purely driven by treating new patients with Iptrozi 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. Comparing the launch of Iptrozi 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 after approval. Lastly, while some patients have been enrolled in our free trial program, we expect nearly all patients on this program to generate full commercial revenue in their second month of Iptrozi 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 amounts of free medicine provided to date. As of the end of the quarter, more than 80% of lives are covered across the U.S. payer label, an outstanding number this early in the launch, which gives providers strong confidence in coverage for Iptrozi. Adding that, with Iptrozi's very favorable profile, we have everything we need for continued prescription growth and success.

The remaining revenue comes from our collaboration and license agreements, including product supply, royalty revenue, and research and development services. While our current royalty revenue comes from our commercialization partner in China, Innopharma Biologics, we expect to begin receiving additional royalty revenue from our partner in Japan, Nippon Kayaku, following approval in September. Notably, we expect Iptrozi to be approved for reimbursement within the fourth quarter, which will result in a $25 million milestone payment from Nippon Kayaku to Nuvation Bio Inc. and the start of our royalty payments. We are also in late-stage discussions with potential Iptrozi commercialization partners in Europe and other ex-U.S. territories. This will further reinforce our revenue and cash position.

We will report key performance indicators related to Iptrozi and corresponding net revenue on a quarterly basis from now on. To us, the real metric of success is the number of patients we can help with our differentiated therapy, and this is what we will focus on in the near term. We are not yet providing net revenue guidance, but plan to at the appropriate time. Still, it is important to note that if we consider our new patient starts in the quarter, we are already at a level of annualized net revenue of more than $55 million if these patients were to remain on Iptrozi just for the next twelve months.

However, given Iptrozi's 50-month median DOR, we believe there is a considerably larger commercial opportunity ahead of us. On the expense side, R&D expenses for the quarter were $28.8 million as we continued investment in Iptrozi and in our clinical stage pipeline. SG&A expenses were $37.4 million, primarily driven by support for commercialization. This includes personnel-related expenses tied to commercial operations, as well as strategic investments in medical education, payer engagement, patient support programs, and marketing. We have right-sized our field team with 47 oncology account managers. We do not expect field and commercial team numbers to grow. Turning to the balance sheet, we ended the quarter with $549 million in cash, cash equivalents, and marketable securities.

An additional $50 million is available to us under our term loan agreement with Sagard Healthcare Partners until June 30, 2026. As we have stated previously, we believe our cash balance is sufficient to fund operations through profitability. Our previous projections included the cost of a head-to-head study of tafasitamab against vorasidenib. After discussion with the FDA, we decided to not conduct this study and instead focus on executing a registration-enabling study in the high-grade IDH mutant glioma setting while also including patients who have high-risk low-grade tumors.

This was a prudent financial decision based on a careful evaluation of the cost and time needed to complete a fully powered head-to-head study to support U.S. approval and generates significant flexibility for us to allocate these saved funds elsewhere. Given the substantial cost of the head-to-head study against vorasidenib that was previously in our budget, this should lower operating expenses and further support our ability to reach profitability. This expanded runway gives us further flexibility as we continue to pursue additional attractive, underappreciated, and undervalued assets that can make an impact on patients' lives.

Operationally, we remain an agile organization with the flexibility to redirect resources as insights emerge into both commercial launch development of our pipeline and evaluation of other exciting external opportunities. That discipline, combined with our early Iptrozi performance and robust cash balance, positions us to execute on our 2025 objectives while we plan for 2026 and beyond. We have one of the sector's best teams, especially for a product like Iptrozi, with more to come, combined with the right structure, resources, flexibility, and agility to continue to grow and make an impact. I'll now hand it back to David.

David Hung: 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 Iptrozi 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 Iptrozi'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: Thank you so much. We'll now begin our Q&A session. So if you'd like to ask a question, please press star one on your telephone keypad. As a reminder, if you are using a speakerphone, please remember to pick up your handset before asking your question. Our first question comes from the line of Kaveri Pohlman of Clear Street. Your line is now open.

Kaveri Pohlman: Great. Good afternoon. Thanks for taking my question and congratulations on the progress. Maybe just a couple on Iptrozi. With more clarity and experience, curious if you would be able to provide any guidance on sales for this year. Also, 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.

Philippe Sauvage: Hi, 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, $7.7 million in net sales in the U.S., is a very, very strong number for Q3 and therefore for the year.

David Hung: And Kaveri, to answer your second question, clearly, we're seeing an uptick 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 an 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. We would expect that to continue to grow and accelerate.

Kaveri Pohlman: Got it. Thank you. And for the expanded access program, first, can you tell us how many patients were on that program? And could you provide insight into the overall impact and future direction of the EAP and the fast access program or the free trial program? Specifically, how do 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.

Philippe Sauvage: Thank you, Kaveri. So for the expanded access program, if you might remember, we told you in the last quarter that we had only six patients on these EAPs that were converted to commercial Iptrozi. Only six of them. We didn't convert any patients from our clinical trials because they're still on trial. 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 six patients that converted 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 Iptrozi, you're looking at roughly $55 million. So that should help us and help you document the kind of sales for next year.

Operator: Thank you. Our next question comes from the line of Farzan Haik of Jefferies. Your line is now open.

Farzan Haik: Hi everyone. Congrats on the quarter and thank you for taking my question. 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 the 50-month DOR?

Philippe Sauvage: Thank you, Farzan, for your question. I'll start with the gross to net and the payer mix. So we communicated about our gross to net of roughly 20% so far because we're 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, slightly lower right now. And obviously, all of those payer mixes, Medicare, Medicaid, 340B, are taking the rebates to certain levels. Some of them are being, as you know, legal, like 23.1% in Medicaid.

So all of these 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.

David Hung: And Farzan, to answer your question on the timing of the S NDA, we anticipate submitting that by the end of the week.

Farzan Haik: Got it. And then on the IDH1 program, are you saying more on the powering assumptions and then like, I know the pre-specified stratification, so perhaps something on the crossover provisions for these high-grade glioma studies?

David Hung: 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 350 per arm will enable us to get registration.

Farzan Haik: Got it. So just 2029 data best expectation. Number of events, you're not saying how many number of events to accumulate to get to that.

David Hung: That's correct.

Farzan Haik: Okay. Thank you so much.

Operator: Thank you. Our next question comes from the line of Soumit Roy of Jones Research. Your line is now open.

Soumit Roy: Hi everyone and 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 the next couple of quarters to go with or following the initial excitement we should trim the total number of new patients a little bit? And any color on the TRx number or the refilling of the prescription if you can provide?

Philippe Sauvage: Hi, Soumit. Thanks for your question. I mean, 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 Iptrozi 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 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 Iptrozi because today, despite the majority of patients out there, we still get a majority of patients from university centers, like very, very academic centers, specialized. So there are still a lot of patients out there for us to put on Iptrozi or to help them with our drug. And that's what we're trying to do right now.

David Hung: 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, you know, we are making efforts to increase testing awareness and I think that should also increase the commercial opportunity. But finally, as you know, given the durability of Iptrozi, after a year, the patients who continue on Iptrozi are going to start to get revenue stacking.

So independent of new patients, just having patients past the one-year mark continue to stack revenues and with our median now, DOR of 50 months, now we're talking about stacking to the fifth year, not just the fourth year as we had previously discussed. So I think there are a number of avenues for growth.

Soumit Roy: Got it. And you mentioned briefly on the you are in the final stages for a European partnership. Is that something we should expect in the 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 option payment?

Philippe Sauvage: 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 sometime in Q4.

Soumit Roy: 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?

Philippe Sauvage: 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 timeline to negotiate price in Japan.

Soumit Roy: Great. Thank you again for taking all the questions and congrats.

Operator: Thank you. Our next question comes from the line of Yaron Werber of Cowen. Your line is now open.

Yaron Werber: Great. Thanks so much and 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 204. It almost seems like we're in a pretty good run rate. We can actually, you know, 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 four to five, $5.5 million in collaboration, the license revs quarterly. Is that sort of a good run rate to take the next quarter next year?

Thank you.

Philippe Sauvage: 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 recognized now we have executed everything that we needed to do because by the case, they are approved. Right? So that's as simple as that. So these collaboration revenues from that part of purely air and collaboration revenue will go up down. But on the other hand, as you pointed out, we will start to get more and more collaboration revenue driven by royalty.

So far, have been only coming from China within events as I pointed out in previous calls, because they were not in the NLDL list, so if you prefer not to reimburse, those royalty revenues were typically small. Now they're going to increase if they get an RTR list. At the same time, 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 workings potentially coming from that. So this part of our collaboration revenue from this quarter will disappear but we'll have lots of other things coming up in 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 Iptrozi 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, so 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 these accumulate revenue for next year.

Euros 55,000,000 is just patients that have started in Q3, staying on therapy for a full year. So that's all the reason why we're very comfortable with consensus year.

Operator: Thank you. Our next question comes from the line of David Gretchen of Wedbush. Your line is now open.

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

David Hung: 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 DLR 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 of response rate was 89%. So I would say that we feel extremely confident.

If you look at the rate of our launch, what we're capturing, 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. As which we have data that I would just say there's really no match on any metric. Our Salesforce is built up. We don't anticipate any increase.

David Gretchen: Okay. Great. Thanks. Nice quarter, guys.

Operator: Thank you. Our next question comes from the line of Silvan Turkin of Citizens. Your line is now open.

Silvan Turkin: Yes. Thank you. And yes, congrats all 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? Thank you.

Colleen Sjogren: Yeah. Thanks for your questions. Well, the new label gives you an 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 Iptrozi 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 in 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. It's great to have something new for the OEMs, the oncology account managers going on. Secondly, you asked about market share. So I'm gonna turn that to you, Philippe, for you to take that one.

Philippe Sauvage: Yeah. It's typical to compel 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 three complete months, again, 204 patients starting in three complete months, that's five or six times better than the latest launch in the space. So this is increasingly really the dominant player in terms of new patients.

Silvan Turkin: Great. Thank you. And maybe one follow-up, if I may. On NUV1511, your 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 about data? Thank you.

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

Silvan Turkin: Great. Thanks.

Operator: 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.

David Hung: 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.

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

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