Puma Biotechnology Inc

Good afternoon. My name is Julian and I'll be your conference call operator today. At this time, all participants are in a listen-only mode. After the speaker's formal remarks, there will be a question and answer session. If you'd like to ask a question during that time, simply press the star key, then the number one on your telephone keypad. If you'd like to withdraw your question, please press star two. If you should require operator assistance during the conference, please press star zero. As a reminder, this call is being recorded. I would now like to turn the conference call over to Marianne Ohanesian, Senior Director of IR for PUMA Biotechnology. Thank you. You may begin.

Thank you, Julian. Good afternoon and welcome to PUMA's conference call to discuss our earnings results for the third 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 Niguez, 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 third quarter 2025. That news release, the slides that Roger 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 year 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, November 6, 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 third quarter 2025 earnings release for reconciliation of our GAAP to non-GAAP results. I will now turn the call over to Alan.

Thank you, Marianne, and thank you all for joining our call today. Today, PUMA reported total revenue for the third quarter of 2025 of $54.5 million. Total revenue includes product revenue net, which consists entirely of near-link sales, as well as royalties from our sub-licensees. Product revenue net was $51.9 million in the third quarter of 2025, an increase from $49.2 million reported in Q2 2025, and a decrease from $56.1 million reported in Q3 2024. As a reminder to investors, PUMA reported Nearlink sales includes both U.S. net sales of Nearlink's and product supply revenues of Neuralinks to Pumas ex-U.S. partners. Please note that in Q3 2024, we reported product supply revenue to our international partners of about 7.4 million versus 0.1 million in Q3 2025. Therefore, U.S. net sales of Neuralinks in Q3 2025 were 51.8 million versus $48.8 million in Q3 2024. Product revenue for the third quarter of 2025 was impacted by approximately $3.1 million of inventory billed in our specialty pharmacies and specialty distributors. Royalty revenue was $2.6 million in the third quarter of 2025 compared to $3.2 million in Q2 2025 and $24.4 million in Q3 2024. Q3 2024 royalty revenue included sales to China by our offshore partner, Pierrefarm. We reported 2,949 bottles of Neerlings sold in the third quarter of 2025, an increase of 341 from the 2,608 bottles sold in Q2 2025. In Q3 2025, we estimate that inventory increased by 172 bottles. In Q3 2025, new prescriptions were down approximately 3% compared to Q2 2025, and total prescriptions were down approximately 1% compared to Q2 2025. Roger will provide further details in his comments and slides. I will now provide a clinical review of the quarter, then Heather Blaber and Roger Storms will add additional color on Nearlink's commercial activities. Maximo Noguez will follow with highlights of the key components of our financial statements for the third quarter of 2025. As investors are aware, PUMA currently has two ongoing Phase II trials of our investigational drug, Alacertib, Aliska Breast 1, which is a Phase II trial of Alacertib in combination with endocrine treatment in patients with HER2-negative hormone receptor-positive breast cancer, and Aliska Lung 1, a Phase II trial looking at the efficacy of Alacertib monotherapy in and patients with small cell lung cancer. As a reminder, the ELISCA breast one trial investigates alicerib in combination with endocrine treatment, which consists of either anastrozole, exomestine, letrozole, fulvestrant, or tamoxifen, and patients with HER2 negative, hormone receptor positive, metastatic breast cancer. Patients must be chemotherapy naive, have been previously treated with a CDK4-6 inhibitor, and received at least two prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial. Patients are being dosed with Allocertib given at either 30 milligrams, 40 milligrams, or 50 milligrams twice daily BID on days 1 to 3, 8 to 10, and 15 to 17 in 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 a metastatic setting that will be given in combination with Allocertib in the trial. The primary efficacy endpoints include BID. objective response rate, duration of response, disease control rate, and progressions for each survival. As a secondary objective, the company will be evaluating each of these efficacy biomarkers within biomarker subgroups in order to determine whether any biomarker subgroup correlates with better efficacy and has been seen in 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 Alicerta in combination with endocrine therapy for patients with HER2-negative hormone receptor-positive breast cancer with these biomarkers. The trial was initiated in late November 2024. There are currently 34 sites in the U.S. and 18 sites in Europe that have been activated for the trial, and the trial is rolling ahead of expectations. There are currently 98 patients enrolled in the trial and 14 additional patients in screenings. Due to the faster-than-expected enrollment in the trial, the former interim analysis was triggered sooner than expected. We anticipate that the formal interim analysis will be completed in the first half of 2026 and look forward to sharing this with investors at that time. With respect to the Illisca Lung study, the Illisca Lung is a Phase II study of our investigational drug, allicertib. to investigate the efficacy of allocertib monotherapy in patients with small cell lung cancer, and to specifically look at the efficacy of the drug in patients with biomarkers where the rorokinase pathway plays a role. The goal is to correlate the efficacy in these biomarker subgroups in the ELISCA LUNG-1 study to the efficacy that was previously seen in the biomarker subgroups from the randomized trial of paclitaxel plus allocertib 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 benefits were seen in patients with biomarkers which correlate with the aurora kinase pathway. If the efficacy and biomarker data are comparable from the two 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 the data obtained to date from the ALISCA Lung 1 is providing a preliminary indication of potentially better activity in patients with biomarkers where the Rurikonase plays a role. The most recent analysis of the PK data from the ALISCA Lung suggests that we're seeing lower PK of Alacertib in the ALISCA 1 study compared to the previous Phase 2 of Alacertib monotherapy in small cell lung cancer patients that was published in Lancet Oncology. The company has amended the protocol for the trial to increase the dose of Alcertib from 50 milligrams BID to 60 milligrams BID, which the company believes will increase the PK of the drug to levels closer to what was seen in the prior phase two. The company is currently enrolling patients at the 60 milligram dose, 60 milligram BID dose. There are currently 61 patients in the trial, with nine of these patients enrolled at the 60 milligram BID dose and an additional two patients in screening. Assuming the safety at the 60 milligram dose is acceptable, the company plans to meet with the FDA in order to amend the protocol to continue to dose escalate to 70 milligrams BID. The company looks to have additional interim data from this trial in the first half of 2026. 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 Heather Blaber for an update on our marketing initiatives. Roger Storms will follow with a review of our commercial performance during the quarter.