Puma Biotechnology Inc

Good afternoon. My name is Camilla, and I will be your conference call operator today. At this time, all participants are in 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 the star key, then the number 1 on your telephone keypad. If you would like to withdraw your question, please press star 2. If you should require operator assistance during the conference, please press star 0. As a reminder, this conference call is being recorded. I would now like to turn the conference call over to Marianne Ohannesson, Senior Director of IR for PUMA Biotechnology. You may begin your conference.

Thank you, Camilla. Good afternoon and welcome to PUMA's conference call to discuss our financial results for the first 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 Ledwick, Chief Commercial Officer. After market closed today, PUMA issued a news release detailing first quarter 2024 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 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, 2023. Your caution not to place undue reliance on these forward-looking statements would speak only as of the date of this live conference call, May 2, 2024. PUMA undertakes no obligation to revise or update any forward-looking statements to reflect the 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 2024 news 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 first quarter of 2024 of $43.8 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 $40.3 million in the first quarter of 2024, which was a decrease from the $53.2 million reported in Q4 2023 and below the $46.8 million reported in Q1 of 2023. Product revenue for the first quarter of 2024 was impacted by approximately $2 million of inventory drawdown at our specialty pharmacies and specialty distributors. Royalty revenue was $3.5 million in the first quarter of 2024 compared to $19 million in Q4 of 2023 and $6 million in Q1 of 2023. We reported 2,410 bottles of Nearlinks sold in the first quarter of 2024 A decrease of 471 bottles from the 2,881 bottles sold in Q4 2023. In Q1 2024, we estimate that inventory decreased by about 120 bottles. In Q1 2024, new prescriptions were up approximately 27% compared to Q4 2023, and total prescriptions were down approximately 3% compared to Q4 2023. Jeff will provide further details in his comments and slides. Near-link sales were negatively impacted by the decline in enrollments that we mentioned previously in our third and fourth quarter earnings calls. Jeff will discuss this further in his comments. We have continued to reduce our internal expenses to account for these factors as we recognize our fiscal responsibility to shareholders to continue to be net income positive for 2024. I will now provide a clinical review of the quarter Then Jeff Ludwig will address color on near-links commercial activities. Maximo Noguez will follow with highlights of the key components of our financial statement for the first quarter of 2024. In February, we were pleased to announce that we initiated the Allocertib in Cancer or ALISCA Lung 1 trial, a Phase II 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. Alicerta will be dosed at 50 milligrams BID on days 1 through 7 of every 21-day cycle. PUMA plans to reform an interim analysis for the evaluation of the biomarkers as well as an evaluation of efficacy. As we discussed on 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 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 alicerib versus paclitaxel plus placebo that was 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 approximately 16 sites open for enrollment and we expect to have a total of approximately 25 sites contributing to enrollment in the study. 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 2 trial of aliceridin in combination with endocrine treatment in patients with chemotherapy-naive HER2-negative hormone receptor-positive metastatic breast cancer, in Q4, 2024. We additionally anticipate two clinical data presentations on L-acertib at the 2024 ASCO Annual Meeting in early June. Investors will remember that the Phase II trial referred to as TBCRC41, which was a Phase II trial of L-acertib monotherapy versus the L-acertib 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 Alacertib in patients with HER2-negative hormone receptor-positive metastatic breast cancer correlates with any biomarkers. The biomarker data from this trial will be presented in a poster presentation at the 2024 ASCO Annual Meeting. In addition, there is an ongoing investigator-sponsored trial of allocertib given in combination with osomertinib 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 osomertinib, and then at the time of progression, allocertib is added to osomertinib in order to see if allocertib can overcome osomertinib resistance. Interim data on this trial was previously presented at ASCO prior to PUMA licensing the drug. Updated data on this trial will also be presented as opposed to presentation at the 2024 ASCO annual meeting. As we mentioned on our last earnings call, a recent biomarker analysis from this trial has demonstrated a subgroup of patients with a biomarker where the Aurora kinase 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 has been 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-assertive, and we look forward to discussing this data with investors once it has been presented publicly. Of note, the biomarker data is not contained in the ASCO abstract, but will be presented in the ASCO poster. As mentioned on prior earnings calls and in response to investor questions, PUMA continues to evaluate several drugs to potentially unlicense 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.