PBYI - NASDAQ

Good morning -- good afternoon, ladies and gentlemen. 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 IR for Puma Biotechnology. You may begin your conference.

Thank you, Sherry. Good afternoon, and welcome to Puma's conference call to discuss our earnings results for the fourth quarter and full-year 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; Heather Blaber, Senior Vice President of Marketing; and Roger Storms, Senior Vice President of Sales. After the close today, Puma issued a news release detailing earnings results for fourth quarter 2025. That news release, the slides that Roger will refer to and a webcast of this call are accessible via the homepage and Investors 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 law. 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 year ended December 31, 2025. 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, February 26, 2026. 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 fourth 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. PUMA reported total revenue for the fourth quarter of 2025 of $75.5 million. Total revenue includes product revenue net, which consists entirely of NERLYNX sales as well as royalties from our sub-licensees. Product revenue net was $59.9 million in the fourth quarter of 2025, an increase from the $51.9 million reported in Q3 2025 and an increase from the $54.4 million reported in Q4 2024. As a reminder to investors, Puma's reported NERLYNX sales include both U.S. net sales of NERLYNX and product supply revenues of NERLYNX to Puma's ex-U.S. partners. Product revenue for the fourth quarter of 2025 was impacted by approximately $5.7 million of inventory build at our specialty pharmacies and specialty distributors. Royalty revenue was $15.6 million in the fourth quarter of 2025 compared to $2.6 million in Q3 2025 and $4.7 million in Q4 2024. We reported 3,298 bottles of NERLYNX sold in the fourth quarter of 2025, an increase of 349 from the 2,949 bottles sold in Q3 2025. In Q4 2025, we estimate that inventory increased by approximately 343 bottles. In Q4 2025, new prescriptions were down approximately 11.4% compared to Q3 2025 and total prescriptions were up approximately 1.4% compared to Q3 2025. Roger will provide additional details in his comments and slides. I will now provide a clinical review of the quarter, and then Heather Blaber and Roger Storms will add additional color on NERLYNX commercial activities. Maximo Nougues will follow with highlights of the key components of our financial statements for the fourth quarter of 2025. And as investors are aware, Puma currently has 2 ongoing Phase II trials of alisertib. One is the ALISCA-Breast1 trial, a Phase II trial of alisertib in combination with endocrine treatment in patients with HER2-negative, hormone receptor positive recurrent or metastatic breast cancer; and number two, ALISCA-Lung1, a Phase II trial 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, consisting of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen in patients with HER2-negative, hormone receptor positive recurrent or metastatic breast cancer. Patients must be chemotherapy naive in the recurrent or metastatic setting, have had prior treatment with a CDK4/6 inhibitor 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 at either 30, 40 or 50 milligrams 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 will be given in combination with alisertib in the trial. The primary endpoint for the trial includes 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 activity as has been seen in pre-clinical and clinical studies in other cancers, including breast and small cell lung cancer. Depending on the outcome of the data, the company will then look to focus the future clinical development of alisertib in combination with endocrine therapy for patients with HER2-negative, hormone receptor-positive breast cancer in these biomarker-specific patient population or in the broader population of interest. The trial was initiated in late November 2024. There are currently 35 sites in the U.S. and 18 sites in Europe that have been activated for the trial, and the trial is enrolling ahead of expectations. The trial was originally designed to enroll 150 patients and was originally anticipated to achieve full enrollment in December 2026. As we have previously reported, enrollment in the trial has occurred faster than expected, and we, therefore, reached 150 patients enrolled in February 2026. There are currently 164 patients enrolled in the trial and 15 additional patients in screening. Screening in the study is now closed. We anticipate that the interim data from this trial will be available in Q2 of 2026. Per the study protocol, the interim safety and efficacy analysis will be done after approximately 75 patients have been randomized and have completed at least 2 tumor assessments or have documented disease progression or death. With respect to ALISCA-Lung1, as investors are aware, Puma has ongoing Phase II of our investigational drug, alisertib, to investigate the efficacy of alisertib monotherapy in patients with small cell lung cancer and to specifically look at the efficacy of the drug in patients with biomarkers where the Aurora Kinase pathway plays a role. The goal is to correlate the efficacy in these biomarker subgroups in the ALISCA-Lung1 study to the efficacy that was previously seen in the biomarker subgroups from the randomized trial of paclitaxel plus alisertib versus paclitaxel plus placebo that was published in the Journal of Thoracic Oncology in 2020. In that randomized trial, a progression-free survival benefit and overall survival benefit was seen in patients with biomarkers that correlate with Aurora Kinase pathway. If the efficacy and biomarker data are comparable from the 2 studies, the company would look to engage the FDA to discuss the regulatory path further. As discussed on the recent earnings call, the company believes that the data obtained to date in the ALISCA-Lung1 study 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 pharmacokinetic data from ALISCA-Lung1 suggests that we are seeing lower PK of alisertib in the ALISCA-Lung1 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 amended the protocol for the trial to increase the dose of alisertib from 50-milligram BID to 60-milligram BID, which the company believes will increase the PK of the drug to levels closer to what was seen in the prior Phase II. The company is currently enrolling patients at the 60-milligram dose. There are currently 79 patients enrolled in the trial, with 27 of these enrolled at the 60-milligram BID dose and additional 3 patients in screening. Based on a preliminary review of the data from the 60-milligram cohort, the company believes that the safety of the 60-milligram dose is acceptable, and the company is in the process of submitting a protocol amendment to the FDA to increase the dose to 70 milligrams in the trial. Separately, Puma also plans to initiate a second trial of alisertib in small cell lung cancer, where the drug will be given in combination with paclitaxel, similar to the previously mentioned trial that was published in the Journal of Thoracic Oncology. The company will provide investors with further information on this trial in the future. The company anticipates that it will have additional interim data from the ALISCA-Lung1 study in the second quarter of 2026. As per the trial protocol, this interim analysis will include safety and efficacy data from approximately 60 patients that have been enrolled in the trial and have completed at least 2 tumor assessments or have documented disease progression or death. 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 the company'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 Heather Blaber for an update on our marketing initiatives. Roger Storms will follow with a review of our commercial performance during the quarter.

Thanks, Alan. I appreciate the opportunity to share some additional insights into our marketing strategy. The marketing team is focused on creating awareness of both clinical data for NERLYNX, as well as reinforcing the continued unmet need in HER2-positive early-stage breast cancer after adjuvant therapy. We continue to invest in market research to help us better understand and validate the most effective ways to communicate this data with health care professionals through both personal and non-personal promotion. Our strategy is focused on increasing awareness of our dual-indication in HER2-positive breast cancer. We believe NERLYNX plays an important role in the early stage by reducing the risk of recurrence and in the metastatic setting by helping protect against progression. Not only do physicians who have experience with NERLYNX continue to identify appropriate patients, but we continue to adopt new prescribers year-over-year who recognize the unmet need and how NERLYNX can help their patients. In summary, we are excited about the potential to engage with more oncologists and support their patients diagnosed with HER2-positive breast cancer. I will now turn the call over to Roger Storms to provide an overview on the commercial performance for the fourth quarter.

Thank you, Heather, and thanks to everyone for joining our fourth quarter earnings call. Before I move into the commercial review, just a reminder that I'll be making forward-looking statements. Sales team remains focused on expanding overall HCP reach and frequency, with a strong emphasis on driving engagements when treatment decisions are being made. Q4 2025 call activity increased 23% year-over-year and decreased 13% quarter-over-quarter. The year-over-year increase is a direct result of continued emphasis put on executional excellence and increased field accountability and the quarter-over-quarter decrease was due to increased number of vacant territories as well as fewer opportunities with HCPs due to the holidays in Q4. I expect call activity to continue to improve as we fill vacancies. The commercial team continues to prioritize increasing the use of NERLYNX, with a main focus on patients at higher risk of recurrence. They are also dedicated to enhancing clinical education and engaging through non-personal promotional efforts as well as utilizing patient resources to support persistence and compliance during NERLYNX therapy. Let me now transition to some of the commercial slides where I'll 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 Q4 2025, about 63% of our business was purchased through the SP channel and the remaining 37% was purchased through the SD channel. We continue to see stronger growth in the SD channel driven by 2 main factors: one, increased sales in the group purchasing organizations, or GPO segment; and two, increasing 340B purchasing. Turning to Slide 4. NERLYNX net product revenue in Q4 2025 was $59.9 million, which represents an increase of $8 million from the $51.9 million we reported in Q3 2025 and an increase of $5.5 million from the $54.4 million we reported in Q4 of 2024. As a reminder to investors, Puma's reported NERLYNX sales include both U.S. net sales of NERLYNX and product supply revenues of NERLYNX to Puma's ex-U.S. partners. Please note that in Q4 2024, we reported product supply revenue to our international partners of about $840,000 versus the $4.7 million in Q4 of 2025. Therefore, U.S. net sales of NERLYNX in Q4 2025 were $55.2 million versus $53.5 million in Q4 of 2024. 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 Q4 2025, we estimate that inventory increased by about $5.7 million. As a comparator, we estimate that inventory increased by about $3.1 million in Q3 of 2025 and increased by about $3.7 million in Q4 of 2024. Slide 5 shows Q4 2025 ex-factory bottle sales and also provides a year-over-year and quarter-over-quarter comparison. In Q4 2025, NERLYNX ex-factory bottle sales were 3,298, which represents an approximate 12% increase quarter-over-quarter and an 11% increase year-over-year. Inventory declined for the first 2 quarters, but increased in Q3 of 2025 and Q4 of 2025. Similar to the prior slide, let me specifically call out the inventory changes from a bottle perspective. In Q4 2025, we estimate that inventory increased by 343 bottles. As a comparator, we estimate that inventory increased by 182 bottles in Q3 of 2025 and increased by 205 bottles in Q4 of 2024. Let me take a moment to provide some additional metrics regarding our fourth quarter performance. In Q4, we saw enrollments declined by about 5% quarter-over-quarter and declined by about 3% year-over-year. New patient starts or NRxs followed a similar pattern, declining approximately 11% quarter-over-quarter and declining about 6% year-over-year. Turning to total prescriptions or TRxs. We saw TRx increase about 2% quarter-over-quarter and decline about 6% year-over-year. Finally, let me share some specifics around demand. In Q4 2025, we saw demand increase by about 7% quarter-over-quarter and about 7% year-over-year. As mentioned earlier, we have seen stronger demand growth in the SD channel, where we saw SD grow by about 17% quarter-over-quarter and about 46% year-over-year. Slide 6 highlights the quarterly adoption of dose escalation since the launch of NERLYNX. In Q4 2025, approximately 75% of patients started NERLYNX at a reduced dose. This is lower compared to the 77% we reported in Q3 of 2025. Continued messaging and adoption of dose escalation remains an important commercial priority. Patients who start on NERLYNX utilizing dose escalation have better persistence and compliance. We believe dose escalation, coupled with patient education resources will give patients better support throughout their NERLYNX therapy and ultimately, help them reduce the risk of recurrence. Slide 7 highlights the strategic collaborations we have formed across the globe. In Q4 of 2025, NERLYNX was launched in Algeria in the extended adjuvant setting. Most recently, in Q1 of 2026, NERLYNX was launched in Thailand also in the extended adjuvant setting. We really appreciate the excellent work being done by our partners around the world and look forward to supporting their continued success moving forward. I'll close by sharing my sincere appreciation for the entire Puma team and their steadfast commitment to supporting patients and families affected by breast cancer. This disease is truly devastating. And while meaningful progress has been made, we know there is still important work ahead and even more we can accomplish together. I will now turn the call over to Maximo for a review of our financial results.

Thanks, Roger. I will begin with a brief summary of our financial results for the fourth quarter of 2025. Please note that I will make comparisons to Q3 2025, which we believe is a better indication of our progress as a commercial company and year-over-year comparisons. For more information, I recommend that you refer to our 2025 10-K, which will be filed today and includes our consolidated financial statements. For the fourth quarter of 2025, we reported net income based on GAAP of $13.4 million, or $0.20 (sic) [ $0.27 ] per share -- basic share and $0.26 per diluted share. This compares to net income in Q3 2025 of $8.8 million, or $0.18 per basic share and $0.17 per diluted share. The fourth quarter of 2025 included a net change in valuation allowance that unfavorably impacted net income by $3.2 million. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $15.1 million, or $0.30 per basic share and $0.29 per diluted share for the fourth quarter of 2025. Gross revenue from NERLYNX sales was $82.9 million in Q4 2025 and $70 million in Q3 2025. As Alan mentioned, net product revenue from NERLYNX sales was $59.9 million, an increase from the $51.9 million reported in Q3 2025 and an increase versus the $54.4 million reported in Q4 2024. As a reminder to investors, Puma's reported NERLYNX sales include both U.S. net sales of NERLYNX and product supply revenue of NERLYNX to Puma's ex-U.S. partners. Please note that in Q4 2025, we reported product supply revenue to our international partners of about $4.7 million. Therefore, U.S. net sales of NERLYNX in Q4 2025 were $55.2 million versus $51.8 million in Q3 2025. The increase in Q4 2025 net revenue versus Q3 2025 was driven primarily by an increase in NERLYNX demand and inventory build of $5.7 million, offset by higher gross to net expense. Royalty revenue totaled $15.6 million in the fourth quarter of 2025 compared to $2.6 million in Q3 2025. The increase in royalty was driven by the shipment to our partner in China. Our gross to net adjustment in Q4 2025 was about 27.8% and 25.9% in Q3 2025. The increase on gross to net was driven mostly by higher Medicare and Medicaid share and higher government chargebacks. Cost of sales for Q4 2025 was $23.2 million and includes $2.4 million for the amortization of intangible assets related to our neratinib license. Cost of sales for Q3 2025 was $12.2 million. Going forward, we will continue to recognize amortization of milestones to the licensor about $2.4 million per quarter as cost of sales. For fiscal year 2026, Puma anticipates that net NERLYNX product revenue will be in the range of $194 million to $198 million. We also anticipate that our gross to net adjustment for the full-year 2026 will be between 27.5% and 28.5%, significantly higher than 2025 as we expect high government chargebacks and Medicare and Medicaid share to maintain in the same levels we saw in the last quarters of 2025. In addition, for fiscal year 2025, we anticipate receiving royalties from our partners around the world in the range of $20 million to $23 million. We don't expect any license revenue in 2025. We also expect that net income for the full year will be in the range of $10 million to $13 million. The current guidance does not include any potential release of any additional tax asset valuation allowance in our net income estimate. The company is reviewing its deferred tax assets as part of its ongoing tax valuation analysis and has not yet determined whether any adjustments will be required or if so, the potential timing or size of such an adjustment. We will continue to keep investors updated 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, shift in 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 costs account for a mid- to high single-digit percentage of our total cost of goods sold. We anticipate that for Q1 2026, NERLYNX product revenue, net, will be in the range of $36 million to $39 million. Please note that the Q1 net product revenue is usually the lowest quarter of the year as we often see inventory burn off from our distribution channel. We expect Q1 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 Q1 2026 will be approximately 29.5% to 30.5%. Puma anticipates a Q1 net loss of $8 million -- between -- sorry, between $8 million and $10 million. SG&A expenses were $18.4 million in the fourth quarter of 2025 compared to $16.8 million in the third quarter. SG&A expenses included non-cash charges for stock-based compensation of $1 million for Q4 and $1.1 million for Q3 2025. Research and development expenses were $16.8 million in the fourth quarter of 2025 and $15.9 million in the third quarter. R&D expenses included non-cash charges for stock-based compensation of $0.7 million in the fourth quarter of 2025, unchanged from the third quarter. On the expense side, Puma anticipates higher than operating expenses in 2026 compared to 2025. More specifically, we anticipate SG&A expenses to increase by 3% to 5%, and R&D expenses to increase by 30% to 35% year-over-year. The higher increase in R&D is driven by the progress of our clinical trials. In the fourth quarter of 2025, Puma reported cash burn of approximately $3.1 million. This compares to cash burn of approximately $1.6 million in Q3. Please note that during Q4, we made our seventh quarterly 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 $22 million. At December 31, 2025, we had approximately $97.5 million in cash, cash equivalents and marketable securities versus about $101 million at year-end in 2024. Our accounts receivables balance was $53.7 million. Our accounts receivable terms range between 10 and 68 days, while our days sales outstandings are about 48 days. We estimate that as of December 31, 2025, our distribution network maintained approximately 4.5 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. On past earnings calls, we have stressed that Puma's senior management in cooperation with the Board of Directors continues to remain focused on NERLYNX sales trends and recognizes its fiscal responsibility to shareholders to continue to maintain positive net income. We are pleased to achieve positive net income for the full-year 2025, which marks the third consecutive year of profitability for the company. We believe that the positive net income that the company is guiding to for the full-year 2026 is resulting from the continued financial discipline across the company over the last few years. The company remains committed to continuing to achieve this positive net income, and we'll 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 need for patients battling breast cancer, lung cancer and other solid tumors. We at Puma are committed and passionate about finding more effective ways of 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 call back to the operator for Q&A.

[Operator Instructions] Our first question is from Salvatore Caruso with TD Cowen.

This is Salvatore Caruso on behalf of Marc Frahm over at TD Cowen. Great presentation. Just one quick question. Can you maybe speak to some of the dynamics around the inventory build this fourth quarter as well as how it relates to build in previous quarters? Is there any sort of overall trend that you're starting to see, and kind of what can we expect going forward?

So, Salvatore, this is Alan. We tend to always see an inventory build at the end of the quarter -- at the end of the year, especially in the fourth quarter. This has been since launch. A lot of the reason for that is that there's an assumption that you're going to take a price increase at the beginning of the year. So, we perceive the reason they're doing that is to get in on that to buy before you do the price increase. Maximo, if you want to speak to a little more on the logistics there?

Yes. As Alan mentioned, we usually see that in Q4, and that's what we called out in terms of the increase that we saw in terms of the number of units and the net product sales in the U.S. We also -- when we provided guidance for Q1, we usually see a decrease or the burn off of that inventory. Thus, our Q1 guidance is usually on the lower end in terms of the quarter-by-quarter comparison.

Yes. So, Salvatore, what you usually see is the -- we see the -- and again, we're near 9 of launch here. So, we've got a lot of history. We saw the inventory burn off -- we see the inventory buildup in Q4, and it burns off in the first quarter.

This concludes our question-and-answer session. I would like to turn the conference 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.