Puma Biotechnology Inc

Good afternoon. My name is Diego, 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 the star key, then the number 1 on your telephone keypad. If you would like to withdraw your questions, please press star 2. If you should require operator assistance during the conference, please press star zero as a reminder this conference is being recorded. I would now like to turn the call over to Marianne Ohannesson, Senior Director of IR for PUMA Biotechnology. You may begin your conference.

Thank you, Diego. Good afternoon and welcome to PUMA's conference call to discuss our financial results for the second 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 second 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. 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, August 1, 2024. 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 second 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 second quarter of 2024 of $47.1 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 $44.4 million in the second quarter of 2024, which was an increase from the $40.3 million reported in Q1 of 2024 and below the $51.6 million reported in Q2 of 2023. Product revenue for the second quarter of 2024 was impacted by approximately 2.3 million of inventory drawdown in our specialty pharmacies and specialty distributors. Royalty revenue was 2.7 million in the second quarter of 2024 compared to 3.5 million in Q1 of 2024 and 3.0 million in Q2 of 2023. We reported 2,515 bottles of Neuralink sold in the second quarter of 2024, an increase of 105 bottles from the 24 2,410 bottles sold in Q1 2024. In Q2 2024, we estimate that inventory decreased by about 132 bottles. In Q2 2024, new prescriptions were down approximately 9% compared to Q1 2024, and total prescriptions were up approximately 3% compared to Q1 of 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. Maximo Nuguez will follow with highlights of the key components of our financial statements for the first quarter of 2024. As we have previously discussed, PUMA has initiated a Phase II study of our investigational drug, Alacertib, to confirm the efficacy of Alacertib monotherapy in patients with small cell lung cancer with biomarkers where aurora kinase pathway plays a role. The goal is to correlate the efficacy in these biomarker subgroups in the ALISCA Lung 1 study to the efficacy that was previously seen in the biomarker subgroups from the randomized trial of paclitaxel plus aliceridib 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 could represent a potential accelerated approval strategy and would engage FDA to discuss this further. As investors will remember, Alicertib was previously tested as a monotherapy in patients with small cell lung cancer, and the results of this trial were published in Lancet Oncology in 2015. In this trial, Alicertib was administered as a monotherapy to 48 patients with small cell lung cancer. The safety results from the study showed that 37% of the patients experienced grade 3-4 neutropenia, 17% experienced grade 3-4 anemia, 13% experienced grade 3-4 leukopenia, and 10% experienced grade 3-4 thrombocytopenia, and 13 patients discontinued treatment due to adverse events. It is believed that these adverse events are due to the allocertive mechanism of action as a cell cycle inhibitor. The efficacy results from the trial showed that for the 36 chemotherapy-sensitive patients, the objective response rate was 19%, and the PFS was 2.8 months. And for the 12 chemotherapy-resistant or relapsed patients, the objective response rate was 25%, with a PFS of 1.4 months. When PUMA licensed Allocertib, we stated that one of the focuses was to try to reduce the adverse event profile of the drug, and more specifically, the grade 3.4 neutropenia, by giving prophylactic GCSF with the administration of Alacertib. This is being instituted in the ALISCA Lung 1 trial, and we look forward to seeing the results of this trial to better assess whether or not the prophylactic use of GCSF improved the adverse event profile of the drug. We'll also be looking at the efficacy of Alacertib in the ALISCA Lung 1 trial, and more specifically, we'll be looking at response rate and PFS both by type of relapse after treatment, sensitive versus resistant refractory, and by small cell lung cancer molecular subtype, ASCL1, NeuroD1, POU2, F3, and YAP1. As mentioned previously, we will also be performing a biomarker analysis on the patients in the ELISCA-1 study, Lung-1 study, in order to see if the efficacy of allocerted monotherapy in patients with small cell lung cancer correlates with biomarkers where the aurora kinase pathway plays a role. There are currently 12 patients enrolled in the ALISCA Lung 1 trial, with several in screening and prescreening. We anticipate that we will be able to share interim data from this trial with investors in late 2024. In addition, two clinical presentations on alicerib were made 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 allocertib monotherapy versus allocertib plus endocrine therapy in patients with HER2-negative hormone receptor-positive metastatic breast cancer, which 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. Some of the biomarker data from this trial was presented on a poster at the 2024 ASCO Annual Meeting. We anticipate the initiation of the ELISCA Breast 1 study, a Phase 2 trial of Alacertib in combination with endocrine treatment in patients with chemotherapy-naive HER2-negative hormone receptor-positive metastatic breast cancer in Q4 of 2024. In addition, there is an ongoing investigator-sponsored trial of alacertib 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, alacertib is added to osomertinib in order to see if alacertib can overcome osomertinib resistance. Interim data on this trial was previously presented at ASCO prior to PUMA licensing this drug. Updated data from this trial was presented as a poster presentation at the 2024 ASCO Annual Meeting. For the 21 evaluable patients, the investigator-assessed overall response rate was 9.5%, and the disease control rate was 81%. The median PFS for all patients was 5.5 months, while the median OS was 23.5 months. For patients with TP53 mutations, N equals nine, the overall response rate was 0%, and the disease control rate was 66.7%. For the patients who were T53 wild type, which was eight patients, the overall response rate was 25%, and the disease control rate was 87.5%. For patients with TP53 mutations, progression fee survival was 3.7 months, and for patients who were T53 wild type, The progression-free survival was eight months. The hazard ratio for PFS was 0.42 with a p-value of 0.05. Based on these interim results, the trial has been amended such that it will limit future enrollment in the trial to patients who are TP53 wild type. We look forward to updating investors on this data in the future. As previously mentioned, on prior 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.