Puma Biotechnology Inc

Good afternoon. My name is Alicia 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 would like to ask a question during that time, simply press star then the number 1 on your telephone keypad. If you would like to withdraw your question, please press star 2. And 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'Hanison, Senior Director of IR for PUMA Biotechnology. You may begin your conference. Thank you, Alicia.

Good afternoon and welcome to PUMA's conference call to discuss our financial results for the fourth quarter of 2023. Joining me on the call today are Ellen 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 market closed today, PUMA issued a news release detailing fourth quarter and full year 2023 financial results. That news release, the slides that Jeff will refer to, and a webcast of this call are accessible via the homepage and investor sessions 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 the company'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, 2023. 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 29, 2024. The company 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 also 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 2023 news release for a 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 fourth quarter of $72.2 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 $53.2 million in the fourth quarter of 2023, which was an increase from the Q3 2023 and slightly below 53.7 million reported in Q4 2022. Product revenue for the fourth quarter of 2023 was impacted by approximately 2.1 million of inventory increase at all specialty pharmacies and specialty distributors. Royalty revenue was 19 million in the fourth quarter of 2023 compared to 4.5 million in Q3 of 2023 and 12 million in Q4 of 2022. We reported 2,881 bottles of Neuralink sold in the fourth quarter of 2023, essentially unchanged from the 2,874 bottles sold in Q3 of 2023. In Q4 of 23, we estimate that inventory increased by about 127 bottles. In Q4 of 2023, new prescriptions, or NRX, were down approximately 9% compared to Q3 of 2023, and total prescriptions, TRX, were down approximately 7% compared to Q3 23. Jeff will provide further details in his comments and slides. Near-link sales were negatively impacted by the decline in enrollments that we mentioned in our third quarter earnings call, a lower than anticipated rate of conversion from enrollment to commercial new patient starts, and a higher than expected gross to net. Jeff and Maximo will discuss these two topics further in their comments. We have continued to reduce our internal expenses to account for these factors as we recognize our fiscal responsibility to the shareholders and continue to be net income positive in 2024. I will now provide a clinical review of the quarter, then Jeff Ludwig will add additional color on Neerlink's commercial activities, and Maximo Noguez will follow with highlights of the key components of our financial statements for the fourth quarter of 2023. In February, we were pleased to announce that we initiated the Allocertib in Cancer, or ALISCA Lung 1 trial, a phase two clinical trial of allocertib monotherapy for the treatment of patients with extensive stage small cell lung cancer. This trial was previously referred to as study PUMA-ALI-4201. The trial will enroll up to 60 patients with extensive stage small cell lung cancer who have progressed after first-line platinum-based chemotherapy and immunotherapy. Patients must provide tissue-based biopsies so that biomarkers can be analyzed. Alacerdib will be dosed at 50 milligrams BID on days one to seven of every 21 day cycles. PUMA plans to perform an initial interim analysis for the evaluation of the biomarkers as well as an evaluation of efficacy. As we discussed in our last earnings call, The goal of this Phase II study will be to confirm the efficacy of allosterative monotherapy in patients with small cell lung cancer with biomarkers where the aurora kinase pathway plays a role. The goal would be to correlate the efficacy of these biomarkers 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 allosterative versus paclitaxel plus placebo That was previously published in the Journal of Thoracic Oncology in 2020. If the efficacy and biomarker data are comparable from the two studies, the company believes it would represent a potential accelerated approval strategy and would engage FDA to discuss this further. We currently have four sites open for enrollment and expect to have 10 to 15 sites open within the next 30 to 60 days. We anticipate that we will be able to share interim data from this trial with investors in the second half of 2024. We also anticipate the initiation of ALISCA Breast 1, a phase two trial of Alacertib in combination with endocrine treatment in patients with chemotherapy and IAs, HER2 negative hormone receptor positive breast cancer in Q4 of 2024. We additionally anticipate two clinical data presentations on Alacertib in the first half of 2024. Investors will remember that the Phase II trial referred to as TBCRC41, which was a Phase II trial of allocertib monotherapy versus allocertib plus endocrine therapy in patients with HER2 negative hormone receptor positive metastatic breast cancer, was published in JAMA Oncology in 2023. As part of this trial, an analysis of biomarkers was performed in order to determine if the efficacy of allocertib in patients with HER2 negative hormone receptor positive metastatic breast cancer correlates with any biomarkers. We anticipate that the biomarker data from this trial will be presented in the first half of 2024. In addition, there is an ongoing investigator-sponsored trial of aliceridib given in combination with osimertinib in patients with metastatic EGFR mutant non-small cell lung cancer. More specifically, Patients with metastatic EGFR mutant non-small cell lung cancer are treated with osimertinib, and then at the time of progression, aliceridib is added to osimertinib in order to see if aliceridib can overcome osimertinib resistance. Interim data on this trial was previously presented at ASCO prior to PUMA licensing the drug. We anticipate that updated data from this trial will be presented in the first half of 2024. Most notably, a recent biomarker analysis from this trial has demonstrated a subgroup of patients with a biomarker where the rorokinase pathway plays a role, where aliceridib appears to have much greater efficacy when added to osomertinib at the time of progression on osomertinib. This biomarker occurs in about half of the patients in the trial, which is consistent with the published literature on this biomarker in this patient population. Based on this biomarker data, the trial is being amended to limit enrollment in the trial to only continue enrolling patients who have this biomarker. We believe that this might represent another potential indication for L-acertib, and we look forward to discussing this data with investors once it has been presented publicly. As mentioned on previous earnings calls and in response to investor questions, PUMA continues to evaluate several drugs to potentially in-license 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.