Puma Biotechnology Inc

Good afternoon. My name is Darrell and I will 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 would like to ask a question during that time, simply press star key, then the number one on your telephone keypad. If you would like to withdraw your questions, 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 O'Hanessian, Senior Director of IR for PUMA Biotechnology. You may begin your conference.

Thank you, Darrell. Good afternoon and welcome to PUMA's conference call to discuss our earnings results for the fourth quarter of 2024. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board of PUMA Biotechnology, Maximo Noguez, Chief Financial Officer, and Jeff Ludwig, Chief Commercial Officer. After the close date, PUMA issued a news release detailing earnings results for the fourth quarter of 2024. That news release, 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 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, February 27, 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 fourth quarter 2024 earnings release for a reconciliation of our GAAP to non-GAAP results. I will now turn the call over to Alan.

Thank you, Mary Ann, and thank you all for joining our call today. Today, PUMA reported total revenue for the fourth quarter of 2024 of $59.1 million. Total revenue includes product revenue net, which consists entirely of Neuralink sales, as well as royalties from our sub-licensees. Product revenue net was $54.4 million in the fourth quarter of 2024, which declined from $56.1 million reported in Q3 2024 and increased from the 53.2 million reported in Q4 2023. Product revenue for the fourth quarter of 2024 was impacted by approximately 3.7 million of inventory increase at our specialty pharmacies and distributors. Royalty revenue was 4.7 million in the fourth quarter of 2024 compared to 24.4 million in Q3 2024 and 19.0 million in Q4 2023. Royalty revenue in the third quarter of 2024 and fourth quarter of 2023 included the sales to China by our partner Pierre Farb, as we noted in our calls for those quarters. We reported 2,964 bottles of Neerlings sold in the fourth quarter of 2024, an increase of 241 from the 2,723 bottles sold in Q3 2024. In Q4 2024, we estimate that inventory increased by about 205 bottles. In Q4 2024, new prescriptions, NRX, were down approximately 7% compared to Q3 2024, and total prescriptions, TRX, were up approximately 4% compared to Q3 2024. Jeff will provide further details in his comments and slides. I will now provide a clinical review of the quarter, and then Jeff Ludwig will add additional color on Nearlink's commercial activities, and Maximo Noguez will follow with highlights of the key components of our financial statements for the fourth quarter of 2024. There is currently an ongoing phase one trial that is sponsored by the National Cancer Institute to evaluate the combination of neratinib and trastuzumab-duruxtacan, otherwise known as InHER2, in patients with metastatic solid tumors. The phase one trial includes patients with metastatic solid tumors harboring HER2 overexpression, IHC3+, ERB2 amplifications, or activating HER2 mutations. The primary objectives are to assess safety and tolerability of the combination, and the secondary objectives include evaluating pharmacokinetics, preliminary efficacy, and potential biomarkers of response. We anticipate that interim data from this trial will be presented in the first half of 2025. In addition, PUMA currently has two ongoing phase two trials of our investigational drug Alacertib. The first is the ALISCA breast one, which is a phase two of Alacertib in combination with endocrine treatment in patients with chemotherapy naive HER2 negative hormone receptor positive metastatic breast cancer. And the second is the ALISCA lung one trial, which is a Phase II study looking at the efficacy of allocertib monotherapy in patients with small cell lung cancer. As a reminder, the ELISCA Breast 1 trial investigates allocertib in combination with endocrine treatment. The endocrine treatment consists of either anastrozole, exomestane, letrozole fulvestrant, or tamoxifen in patients with chemotherapy-naive HER2-negative, hormone receptor-positive metastatic breast cancer. Patients must have received previous treatment 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 L-acertib at either 30 milligrams, 40 milligrams, or 50 milligrams twice daily 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 that will be given in combination with Alicertib in the trial. The primary efficacy endpoints include overall 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 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 aliceridib in combination with endocrine therapy 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 22 sites that have been activated for the trial and the trial is enrolling ahead of expectations. There are currently 14 patients enrolled in the trial with four additional patients in screening. We look to have interim data from this trial later in 2025. With respect to ALISCA Lung 1, as discussed on the last conference call, the company believes that the data obtained to date from the ALISCA Lung 1 trial is providing a preliminary indication of potentially better activity in patients with biomarkers where the aurora kinase pathway plays a role. The company recently met with members of the steering committee for the trial, and the committee recommended expanding enrollment in the trial to patients that have been treated with additional lines of prior treatment, as the current protocol limits enrollment in the trial to patients with up to two prior lines of therapy. The biomarkers that correlate with aurorokinase activity tend to be acquired as a mechanism of resistance to treatment, so by opening up the protocol to patients with additional lines of treatment, that will allow for enrichment of these biomarkers. The company is in the process of amending the protocol to allow for this. 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 end license that would allow the company to diversify itself and leverage our 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.