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 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 0. As a reminder, this call is being recorded. I would now like to turn the conference call over to Marianne Ohannesson, Senior Director of Investor Relations for PUMA Biotechnology. Thank you. You may begin.

Thank you, Camilla. Good afternoon and welcome to PUMA's conference call to discuss our financial results for the third quarter of 2023. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board of PUMA Biotechnology, Maximo Núñez, Chief Financial Officer, and Jeff Ledwig, Chief Commercial Officer. After market closed today, PUMA issued a news release detailing third quarter 2023's 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 the company's future expectations, plans, and prospects that constitute forward-looking statements for purposes of federal securities law. 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 Securities and Exchange Commission from time to time, including our annual report on Form 10-K for the year ended December 31, 2022. 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 2, 2023. 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 third 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, Mary Ann, and thank you all for joining our call today. Today, PUMA reported total revenue for the third quarter of 2023 of $56.1 million. Total revenue includes product revenue net, which consists entirely of Neuralink sales, as well as royalties from our sub-licies. Product revenue net was $51.6 million in the third quarter of 2023, which was unchanged from Q2 2023, and $2.7 million below $54.3 million reported in Q3 of 2022. Product revenue for the third quarter of 2023 was impacted by approximately $0.6 million of inventory increase at our specialty pharmacies and specialty distributors. Royalty revenue was $4.5 million in the third quarter of 2023 compared to $3 million in Q2 of 2023 and $2.8 million in Q3 of 2022. We reported 2,874 bottles of Neuralink sold in the second quarter of 2023, a decrease of 148 bottles from the 3,022 bottles sold in Q2 of 2023. In Q3 2023, we estimate that inventory increased by about 32 bottles. In Q3 2023, new prescriptions, or NRX, were down approximately 15% compared to Q2 2023, and total prescriptions, or TRX, We're down approximately 7% compared to Q2 of 2023. 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 NEARLY's commercial activities. Maximo Noguez will follow with highlights of the key components of our financial statements for the third quarter of 2023. As we mentioned on our last earnings call, in Q3, PUMA filed its IND with the FDA for a phase two study of allosterative monotherapy in patients with small cell lung cancer known 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. Allocertib will be dosed at 50 milligrams BID on days one through seven of every 21-day cycle. Provo plans to perform an initial interim analysis for the evaluation of the biomarkers as well as an evaluation of the efficacy. As we discussed in our last earnings call, the goal of this phase two study will be to confirm the efficacy of allocertib 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 PUMA ALI 4201 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 2021. If the efficacy and biomarker data are comparable from the two studies, the company believes it could represent a potential accelerated approval strategy. In August, we announced that the FDA had determined that the Phase II PUMA ALA 4201 study was safe to proceed. We expect to have multiple sites open for enrollment between now and the end of the year, and we are hopeful that we will be able to enroll patients by year-end, although we recognize the challenges of trying to enroll patients during the November and December holidays. We continue to anticipate that there will be several clinical milestones for the Alicerta program in the coming months. This includes initiating a phase two clinical trial of allocertib in small cell lung cancer before the end of the year, conducting a meeting with the FDA to discuss the clinical development and registration path for allocertib in hormone receptor positive HER2 negative breast cancer in the fourth quarter of 2023, and then initiating the phase two trial of allocertib in this patient population in 2024. 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 PUMA's existing R&D, regulatory, and commercial infrastructure. The company will continue to 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.