PBYI - NASDAQ

Good afternoon. My name is Sherry, and I will be your conference call operator today. [Operator Instructions] As a reminder, this call is being recorded. I would now like to turn the conference over to Mariann Ohanesian, Senior Director of Investor Relations for Puma Biotechnology. Thank you. You may begin your conference.

Thank you, Sherry. Good afternoon and welcome to Puma's conference call to discuss our earnings results for the first quarter of 2025. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board of Puma Biotechnology; Maximo Nougues, Chief Financial Officer; Jeff Ludwig, Chief Commercial Officer; Heather Blaber, Vice President of Marketing; and Jeff Storms, Vice President of Sales. After the close today, Puma issued a news release detailing earnings results for first quarter 2025. That news release, the slides that Jeff will refer to and a webcast of this call are accessible via the homepage and investor sections of our website at pumabiotechnology.com. The webcast and presentation slides will be archived on our website and available for replay for the next 90 days. Today's conference call will include statements about Puma's future expectations, plans and prospects that constitute forward-looking statements for purposes of federal securities laws. Such statements are subject to risks and uncertainties, and actual events and results may differ from those expressed in these forward-looking statements. For a full discussion of these risks and uncertainties, please review our periodic and current reports filed with the SEC from time to time, including our annual report on Form 10-K for the period ended December 31, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this live conference call, May 8, 2025. Puma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law. During today's call we may refer to certain non-GAAP financial measures that involve adjustments to our GAAP figures. We believe these non-GAAP metrics may be useful to investors as a supplement to, but not a substitute for our GAAP financial measures. Please refer to our first quarter 2025 earnings release for a reconciliation of our GAAP to non-GAAP results. I will now turn the call over to Alan.

Thank you, Mariann, and thank you all for joining our call today. Today, Puma reported total revenue for the first quarter of 2025 of $46.0 million. Total revenue includes products revenue net, which consists entirely of NERLYNX sales as well as royalties from our sub-licensees. Product revenue net was $43.1 million in the first quarter of 2025, a decline from the $54.4 million reported in Q4 2024 and an increase from the $40.3 million reported in Q1 of 2024. Product revenue for the first quarter of 2025 was impacted by approximately $4.7 million of inventory decrease at our specialty pharmacies and specialty distributors. Royalty revenue was $2.9 million in the first quarter of 2025 compared to $4.7 million in Q4 2024 and $3.5 million in Q1 2024. We reported 2,338 bottles of NERLYNX sold in the first quarter of 2025, a decrease of 626 from the 2,964 bottles sold in Q4 2024. In Q1 '25, we estimate that inventory decreased by 251 bottles. In Q1 2025, new prescriptions, or NRx, were up approximately 6% compared to Q4 2024. And total prescriptions were down approximately 9% compared to Q4 2024. Jeff will provide further details in his comments and slides. I will now provide a clinical review of the quarter. Then Jeff Ludwig as well as Heather Blaber and Roger Storms will add additional color on NERLYNX's commercial activities. Maximo Nougues will follow with highlights of the key components of our financial statements for the first quarter of 2025. At the recent American Association for Cancer Research or AACR Annual Meeting, interim data from an ongoing Phase I trial, which is NCT-05372 that is sponsored by the National Cancer Institute, evaluating the combination of neratinib and Fam-trastuzumab deruxtecan or Enhertu, in patients with metastatic solid tumors was presented. The Phase I data includes patients with metastatic solid tumors harboring HER2 overexpression, IHC3+, HERB2 amplifications or activating HER2 mutations. In the poster presentation, 20 patients received study treatment. Dose level 1 had 7 patients, dose level 2 had 4 patients; dose level 3 had 9 patients. The most common treatment-emergent adverse events of any grade included nausea N=15 or 75%, diarrhea N=15 or 75%, fatigue N=13 or 65%, and hypokalemia N=11 or 55%. Grade 3 treatment-emergent adverse events that incurred in more than 2 patients included anemia N=6 or 30%, diarrhea N=4 or 20%, and hypokalemia N=3 or 15%. The only Grade 4 treatment-related adverse event was neutropenia that incurred 1 patient, which was 5%, 1 DLT, which was acute kidney injury was observed at dose level 1. No DLTs were observed at dose level 2 and 1 DLT was observed, which was, fatigue leading to early discontinuation at dose level 3. Three patients developed Grade 1 pneumonitis or interstitial lung disease, ILD, 2 patients at dose level 1 and 1 at dose level 3. The proportion of reported treatment-emergent adverse events was lower at higher doses. Of the 15 response evaluable patients by RECIST, 4 patients had a partial response, including patients with gastroesophageal, which was N=2. And it was 1 HER2-positive IHC3+ and 1 HER2 mutated. Pancreatic, which was 1 patient who was an IHC3+, and ovarian, which was 1 patient who was also a 3+ and the ovarian was a confirmed response. Most notably, 3 of 5 patients with advanced pancreatic cancer were observed to have tumor regression, 1 PR for 13 cycles, which is ongoing and 2 with stable disease, consisting of 1 patient with a 29.4% tumor regression for 9 cycles and 1 patient with a 13.3% regression for 8 cycles. Dose level 3, which consisted of trastuzumab deruxtecan at 5.4 mgs per kg, and neratinib at 120 mgs in week 1, 160 in week 2 and 240 in week 3 and onward, was selected as the recommended Phase II dose. Part 2 of the study, which consists of a pharmacodynamic evaluation of trastuzumab deruxtecan with neratinib in 12 patients opened to enrollment in March of 2025. Patients with advanced solid tumor and HER2 amplification or overexpression or HER2 mutation will be enrolled. We look forward to updated data from this trial to be presented likely in 2026. In addition, Puma currently has 2 ongoing Phase II studies of our investigational drug, alisertib, the ALISCA-Breast1 trial, which is a Phase II trial of alisertib in combination with endocrine treatment in patients with HER2-negative hormone receptor positive, metastatic breast cancer and ALISCA-Lung1, which is a Phase II study looking at the efficacy of alisertib monotherapy in patients with small cell lung cancer. As a reminder, the ALISCA-Breast1 trial investigates alisertib in combination with endocrine treatment, which consists of anastrozole exemestane, letrozole, fulvestrant or tamoxifen in patients with HER2-negative hormone receptor-positive metastatic breast cancer. Patients must be chemotherapy naive, have been previously treated with CDK4/6 inhibitors and received at least 2 prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial. Patients are being dosed with alisertib given at either 30 mgs, 40 mgs or 50 mgs twice daily BID, on days 1 to 3, 8 to 10 and 15 to 17 on a 28-day cycle in combination with the endocrine therapy of the investigator's choice. Patients must not have been previously treated with the endocrine treatment in the metastatic setting that is being given in combination with alisertib in the trial. Primary efficacy endpoints will include objective response rate, duration of response, disease control rate and progression-free survival. As a secondary objective, the company will be evaluating each of these efficacy endpoints within biomarker subgroups in order to determine whether any biomarker subgroup correlates with better efficacy as has been seen in the preclinical and clinical studies in other cancers, including breast cancer and small cell lung cancer. The company will then look to focus the future clinical development of alisertib in combination with endocrine for patients with HER2-negative hormone receptor-positive breast cancer in patients with these biomarkers. The trial was initiated in late November 2024. There are currently 26 sites in the U.S. and 12 sites in Europe that have been activated for the trial. And the trial is enrolling ahead of expectations. There are currently 28 patients enrolled in the trial, one expected to be enrolled this week and 6 additional patients in screening. We are looking to have interim data from this trial later in 2025. With respect to the ALISCA-Lung study, as discussed on the last conference call, the company believes that the data obtained to date from the ALISCA-Lung1 trial is providing a preliminary indication of potentially better activity in patients with biomarkers where the Aurora kinase pathway plays a role. The most recent analysis of the pharmacokinetic data from the ALISCA-Lung1 trial suggests that we are seeing a lower PK of alisertib in the ALISCA-Lung trial compared to the previous Phase II study of alisertib monotherapy in small cell lung cancer patients that was published in Lancet Oncology. The company is in the process of amending the protocol to increase the dose of alisertib from 50 mgs to 60 mgs, which the company believes will increase the PK of the drug to levels closer to what was seen in the prior Phase II trial. The company looks to have additional interim data from this trial later in 2025. As mentioned on prior earnings calls and in response to investor questions, Puma continues to evaluate several drugs to potentially in-license or acquire. That would allow the company to diversify itself and leverage Puma's existing R&D, regulatory and commercial infrastructure. The company will keep investors updated on this as it progresses. I will now turn the call over to Jeff Ludwig, Puma's Chief Commercial Officer, for a review of our commercial performance during the quarter.

Thanks, Alan. Appreciate it, and thanks to everyone for joining our first quarter earnings call. Before I move into the commercial review, just a reminder that I will be making forward-looking statements. The commercial team remains focused on expanding the utilization of NERLYNX with a primary emphasis on patients who are at increased risk of reoccurrence. The marketing team has recently revised the core sales aligned with this strategy. In addition, the team has continued their emphasis on improving clinical education and engagement through nonpersonal promotion and developed a new patient resource brochure designed to improve persistence and compliance throughout a patient's NERLYNX therapy. The sales team is working very hard on expanding overall HCP reach and frequency with an emphasis on increasing engagement when treatment decisions are being made. In Q1 of 2025, call activity was flat year-over-year and down about 2% quarter-over-quarter, driven by an increased number of vacancies. We expect that trend to improve as these vacancies are filled. Heather Blaber, our VP of Marketing; and Roger Storms, our VP of Sales, have joined us during this call and will add some additional details in a few moments. Let me now transition to some of the commercial slides where I will provide some additional specifics around performance. Slide 3 is an illustration of our distribution model, which is broken out into the specialty pharmacy channel and the specialty distributor or in-office dispensing channel. In regards to the overall distribution of our business, in Q1 of '25, about 67% of our business was purchased through the SP channel and the remaining 33% was purchased through the SD channel. We are seeing some stronger growth in the SD channel driven by 2 main factors: number one, increased sales in the GPO segment; and two, some increasing 340B purchasing. Turning to Slide 4. NERLYNX net revenue in Q1 of 2025 was $43.1 million, which represents a decline of about $11.3 million from the $54.4 million we reported in Q4 of 2024 and an increase of $2.8 million from the $40.3 million we reported in Q1 of 2024. The significant change in quarterly revenue was driven largely by anticipated seasonal inventory changes and higher gross to net expenses in the prior quarter. I will provide some more details around inventory changes. And Maximo will provide some additional specifics around gross to net expenses during his update. In Q1 of 2025, we estimate that inventory decreased by about $4.7 million. As a comparator, we estimate that inventory increased by about $3.7 million in Q4 of '24 and decreased by about $2 million in Q1 of '24. On Slide 5, Slide 5 shows Q1 2025 ex-factory bottle sales and also provides a year-over-year and a quarter-over-quarter comparison. In Q1 of 2025, NERLYNX ex-factory bottle sales were 2,338, which represents an approximate 21% decrease quarter-over-quarter and a 3% decrease year-over-year. It is typical for us to see inventory increase in Q4 and then subsequently decline in Q1. Similar to the prior slide, let me specifically call out the inventory changes from a bottle perspective. In Q1 of 2025, we estimate that inventory decreased by 251 bottles. As a comparator, we estimate that inventory increased by 204 bottles in Q4 of '24 and decreased by 120 bottles in Q1 of 2024. Let me take a moment to provide some additional metrics regarding our first quarter performance and then I'll turn the call over to Heather and Roger to share their insights into sales and marketing. In Q1, we saw enrollments increased about 6% quarter-over-quarter, but declined about 8% year-over-year. We have seen some continued enrollment softness in April, which we are monitoring very closely. New patient starts or NRx followed a similar pattern, growing about 6% quarter-over-quarter, but declining about 7% year-over-year. Turning to total prescriptions or TRx, we saw a TRx decline of about 9% quarter-over-quarter and a decline of about 3% year-over-year. Finally, let me share some specifics around demand. In Q1, we saw demand declined about 6% quarter-over-quarter, but increased about 2% year-over-year. As mentioned earlier, we have seen stronger demand growth in the SD channel, where we saw SD demand grow about 4% quarter-over-quarter and about 14% year-over-year. Let me now turn the call over to Heather and Roger for some additional insights. Why don't we start with Heather Blaber, our VP of Marketing? Heather, the floor is yours.

Thanks, Jeff. I appreciate the opportunity to be on this call and share some more insights into the marketing strategy and execution. As Jeff mentioned earlier, the marketing team is focused on increasing the utilization of NERLYNX with a focus on patients who are at continued risk of recurrence. We recently conducted several focus groups with community oncologists to better understand patient risk factors that are most concerning to physicians and to garner feedback on some more recent publications regarding the overall risk of recurrence. We have utilized those insights to update and revised our core sales aid and messaging with the goal of engaging physicians on a broader set of patients where the risk of recurrence is high and where we believe that NERLYNX can play an important role in helping to reduce that risk. In addition to revising the core sales aid and messaging, we have also recently rolled out a new patient education resource designed to better support our patients throughout their recommended course of NERLYNX therapy. This educational resource will be provided to patients on a monthly basis as they receive their refills. Lastly, I know Jeff mentioned our goal of expanding the overall share of voice. The marketing team works very closely with our field leadership team to increase the engagement with oncologists through our nonpersonal promotion, both branded and unbranded messaging. Our nonpersonal promotion efforts target a very broad group of oncologists. And we are continually evaluating new partners and new approaches that will enhance these efforts. I know our sales team is also heavily focused on increasing engagements with health care providers. So now I would like to take the opportunity to turn it over to our Vice President of Sales, Roger Storms, to provide some additional insights and perspective. Roger?

Thanks, Heather. I also appreciate the opportunity to participate on the call and share my perspective. I joined Puma in December of last year, so I'm still relatively new. But I'm very excited to be here and passionate about finding ways to better support HER2-positive breast cancer patients. My focus is on executional excellence and expanding overall share of voice. As previously mentioned, our Q1 call activity was flat year-over-year and down about 2% quarter-over-quarter, driven by a higher vacancy rate. My expectation is that we will see an increase in our overall reach and frequency driven by a reduction in these vacancies as well as better overall execution. I'm happy to say that we've made good progress on our openings and have brought in strong talent with both breast cancer experience and established relationships with key customers. In regards to executional excellence, we are focused on helping our sales reps get in front of more customers with the goal of increasing engagement when clinical decisions are being made. We're utilizing claims data, nonpersonal promotion feedback and piloting predictive analytics to help our teams prioritize their time and maximize their impact. Early feedback on the new marketing core sales aid has been positive and allows my team to discuss a broad group of patients, which is aligned with our goal of increasing the utilization of NERLYNX.

Thanks, Roger, and thanks, Heather, for providing additional specifics and insights. Let me wrap up with just a few more slides. Then, I'll turn the call over to Maximo for a more detailed financial review. Turning to Slide 6. Slide 6 highlights the quarterly adoption of dose escalation since NERLYNX launch. In Q1, approximately 72% of patients started NERLYNX at a reduced dose. This is similar to the 74% we reported in Q4 of 2024. Continued messaging and adoption of dose escalation remains an important commercial priority. Patients who are started on NERLYNX utilizing dose escalation have better persistence and compliance. We believe dose escalation, coupled with the new patient education resource Heather discussed, will give patients better support throughout their NERLYNX therapy and ultimately help them reduce the risk of reoccurrence. Slide 7 highlights the strategic collaborations we have formed across the globe. In Q1 of 2025, NERLYNX was launched in Libya in the extended adjuvant setting. And we signed a distribution agreement with Er-Kim for select countries in Eastern Europe and Central Asia. We really appreciate the excellent work being done by our partners around the globe and look forward to supporting their continued success moving forward. Let me wrap up by thanking the entire Puma team once again for their continued passion and commitment for helping patients and their families battling breast cancer. This disease can have devastating effects. And we know more can be done and more needs to be done. I'll now turn the call over to Maximo for a review of our full financial results. Maximo?

Thanks, Jeff. I will begin with a brief summary of our financial results for the first quarter of 2025. Please note that I will make comparisons to Q4 2024, which we believe is a better indication of our progress as a commercial company than year-over-year comparisons. For more information, I recommend that you refer to our first quarter 2025 10-Q, which will be filed today and includes our consolidated financial statements. For the first quarter of 2025, we reported net income based on GAAP of $3 million or $0.06 per share. This compares to net income in Q4 2024 of $19.3 million or $0.39 per share. In the fourth quarter of 2024, we released a portion of our valuation allowance, resulting in a noncash deferred income tax benefit of $7.1 million. The valuation allowance was established to offset our deferred tax assets, which are primarily related to our historical losses. This significantly increased our net income for the fourth quarter. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $5 million or $0.10 per basic and diluted share for the first quarter of 2025. Gross revenue from NERLYNX sales was $54.4 million in Q1 2025 and $66.5 million in Q4 2024. As Alan mentioned it, net product revenue from NERLYNX sales was $43.1 million, a decrease from the $54.4 million reported in Q4 2024. The lower net revenue was driven mostly by seasonality of inventory fluctuation and higher gross to net expenses than prior quarter. Inventory drawdown by our distributors was approximately $4.7 million in Q1 versus an increase of approximately $3.7 million in Q4 2024. Royalty revenue totaled $2.9 million in the first quarter of 2025 compared to $4.7 million in Q4 2024. Our gross to net adjustment in Q1 2025 was about 20.8% compared to the 18.2% gross to net adjustment reported in Q4 2024. Cost of sales for Q1 2025 declined to $10.6 million and includes $2.4 million for amortization of intangible assets related to our neratinib license. Cost of sales for Q4 2024 was $13.9 million. Going forward, we will continue to recognize amortization of our milestones to the license source about $2.4 million per quarter as cost of sales. For fiscal year 2025, Puma anticipates that net NERLYNX product revenue will be in the range of $192 million to $198 million. We also anticipate that our gross to net adjustment for the full year 2025 will be between 20.5% and 21.5%. In addition, for fiscal year 2025, we anticipate receiving royalties from our partners around the world in the range of $20 million to $24 million, lower than 2024 due to fewer shipments expected to China as our partner works through regulatory transitions during the first several quarters of 2025. We don't expect license revenue in 2025. We also expect that net income for the full year will be in the range of $23 million to $28 million. We are not forecasting any potential release of any additional tax asset valuation allowance in our net income estimate at this time. However, this will be evaluated on an ongoing basis. We will continue to keep investors updated on this as it progresses. At this time, we do not believe that tariffs imposed or proposed to be imposed by the United States, particularly with other countries, will have a material impact on our product cost or results of operations. However, shifting trade policies in the United States and other countries have been rapidly evolving and are difficult to predict. As a point of reference, our manufacturing product cost accounts for a mid to high single-digit percentage of our total cost of goods sold. We anticipate that for Q2 2025, NERLYNX product revenue net will be in the range of $48 million to $50 million. Also, we expect Q2 royalty revenue will be in the range of $2 million to $3 million and no license revenue. We further estimate that the gross to net adjustment in Q2 2025 will be approximately 20% to 21.5%. Puma anticipates Q2 net income between $4 million and $6 million. SG&A expenses were $17.6 million in the first quarter of 2025 compared to $16.6 million in the fourth quarter of 2024. SG&A expenses included noncash charges for stock-based compensation of $1.2 million for Q1 and $1.3 million for Q4 2024. Research and development expenses were $13.8 million in the first quarter of 2025, a decrease from $15.2 million in the fourth quarter of 2024. R&D expenses included noncash charges for stock-based compensation of $0.8 million in the first quarter of 2025 compared to $0.5 million in the fourth quarter of 2024. On the expense side, Puma anticipates flat to slightly lower total operating expenses in 2025 compared to 2024. More specifically, we anticipate SG&A expenses to decrease by 5% to 10% and R&D expenses to increase by 10% to 15% year-over-year. In the first quarter of 2025, Puma reported cash burn of approximately $7.8 million. This compares to cash earned of approximately $4.3 million in Q4 2024. Please note that during Q1, we made our fourth principal loan payment of $11.1 million related to our obligation with Athyrium. As a result of this, our total outstanding principal debt balance decreased to approximately $56 million. At March 31, 2025, we had approximately $93 million in cash, cash equivalents and marketable securities versus about $101 million at year-end in 2024. Our accounts receivable balance was $24.2 million. Our accounts receivables terms range between 10 and 68 days, while our days sales outstanding are about 50 days. We estimate that as of March 31, 2025, our distribution network maintained approximately 3 weeks of inventory. Overall, we continue to deploy our financial resources to focus on the commercialization of NERLYNX, the development of alisertib and controlling our expenses.

Thanks, Maximo. Puma's senior management in cooperation with the Board of Directors continues to remain focused on NERLYNX sales trends in 2025 and beyond and recognizes its fiscal responsibility to the shareholders to continue to maintain positive net income. We believe that the positive net income that was seen in fiscal years 2023 and 2024 resulted from the financial discipline across the company over the last 3 years. The expense reductions that we have previously performed and continue to perform are also a major contributor to the positive net income that the company achieved in Q1 2025 and the company is guiding to for full year 2025. The company remains committed to continuing to achieve this positive net income. And we will continue to reduce expenses if needed to achieve this. We look forward to updating investors on this in the future. There continues to remain a significant unmet medical need for patients battling breast cancer, lung cancer and other solid tumors. We at Puma are committed and passionate about finding more effective ways at helping these patients during their journey. And we will continue to strive to achieve that goal. This concludes today's presentation. We will now turn the floor back to the operator for Q&A. Operator?

[Operator Instructions] Our first question is from Divya Rao with Cowen and Company.

This is Divya on for Mark. I just had 2 questions on alisertib. One, I guess, could you talk about where the alisertib IP is held? Is it in Ireland? Is it in the U.S.? And then also manufacturing? The comments that you made, was that just related to NERLYNX manufacturing? Or is that similar for alisertib as well? And then I have a second question.

Hi, Divya, thank you for the question. So in terms of the IP, we actually have a license to the IP from Takeda. I need to get back to you on where it is physically located. The origin of alisertib is that it was originally developed by Millennium, which is here in the United States. I'm assuming that's where it is, but I don't have that information in front of me. So let me get back to you on that. It's a great question. I just don't have the information in front of me. Now, on the manufacturing, I believe it is mostly done in the U.S., if I'm remembering this correctly, currently. Now obviously, we're not at commercial scale. And we obviously will take into account tariffs and future tariffs and things like that in the future. But I believe right now, my remembrance of this is that we're doing it all in the U.S. Do you have another question on the IP? I kind of cut you off there. I apologize.

Our next question is from Gena Wang with Barclays.

This is [Kun Wang] on behalf of Gena Wang from Barclays, we have a few questions. For alisertib, lung cancer Phase II trial, you just mentioned the protocol amendment for dose increase. Could you confirm whether the interim data readout will still be later this year? And in addition to the PK data, how did the response data looks like based on the current dose? Second question is for the NERLYNX Phase I data presented at SECR25. So some tumor types like pancreatic cancer showed a better response than others. How would you select the tumor type moving forward? And what the magnitude of PFS improvement expected based on the response data? And lastly, we would like to ask your view on the impact from the Medicare Part D redesign and also the new CBR director and the potential impact on the drug approval path.

Let me handle the first 2. With regard to the small cell lung cancer, so we are amending the protocol to go from 50 to 60 milligrams. In the prior monotherapy trials of alisertib, if I remember correctly, they went up as high as 100 milligrams. So I think we're assuming we're going to be okay to go up to 60. I don't have the data in front of me in terms of what we would expect in terms -- obviously, we haven't dosed the patients at that level yet. So I don't have the data in front of me in terms of what we'd expect in terms of changes in response rates and things like that. In terms of the biomarkers, again, I don't have the data in front of me. We did definitely see better activity in the patients where the Aurora kinase pathway played a role. We would expect we would probably see something similar to that at the higher doses as well. We still are planning to have data later this year. Obviously, the quicker we can get the amendment done and enroll patients, the more patients at 60 milligrams we could have. So I can't really speculate on that right now. With regard to the NERLYNX Phase I, you are correct that we did tend to see more activity in the combination of neratinib with in HER2. The reason for that is mechanistically based, which is, that neratinib being an irreversible HER2 inhibitor, it internalizes the HER2 receptor. So because of that, if you have an ADC, the perception is what you're doing is you're bringing more of the ADC into the cell that may be why we are seeing in tumor types where you historically have not seen much activity with in HER2 like pancreatic. We're seeing the better activity with the combination. Not clear what we would expect. I think we need more data to be able to say what we expect in terms of ORR, PFS, et cetera. But there's no question. We are extremely encouraged by it. My understanding is that they've had quite a lot of interest in enrollment since we've opened the new cohorts. So I think we'll probably have some more data on that to talk about later this year. And I think my understanding is they're looking to present it publicly at a scientific conference probably in the first half of '26 is my recollection. In terms of your commentary on the FDA, that's CBER, we go through CDER. So not a whole lot we can really add in value. And if you repeat your question on the Medicare, please?

Yes. So your view on the impact from Medicare Part D redesign in 2026 to '27.

So in terms of -- you're talking about the Medicare redesign, it was part of the IRA. Is that what you're asking about?

Yes.

Yes. So yes, great question. So we've been paying attention to that. What we've seen from the IRA portion is that co-pay for patients have actually declined somewhat in '25. And we expect them to decline in '26 as well. So we've actually seen an increase in the percent of our business going through Medicare and a subsequent slight decrease in that going to free goods. So it's actually been helpful to us. And it's made it slightly more affordable for patients to get on and stay on NERLYNX. Does that answer your question?

This concludes our question-and-answer session. I would like to turn the conference call back over to Mariann for closing remarks.

Thank you all for joining us today. As a reminder, this call may be accessed via replay of the webcast at pumabiotechnology.com beginning later today. Have a good evening.