Puma Biotechnology Inc

Good afternoon. My name is Paul, 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 question, please press star 2. If you 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 over to Marianne Mulhanneson, Senior Director of IR for PUMA Biotechnology. You may begin your conference.

Thank you, Paul. Good afternoon and welcome to PUMA's conference call to discuss our financial results for the third quarter of 2022. Joining me on the call today are Ellen Auerbach, Chief Executive Officer, President and Chairman of the Board of PUMA Biotechnology, Maximo Niguez, Chief Financial Officer, and Jeff Ledwick, Chief Commercial Officer. After market closed today, PUMA issued a news release detailing the third quarter 2022 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 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, 2021, and our quarterly report on Form 10-Q for the period ended September 30, 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 3, 2022. The company undertakes no obligation to revise or update any forward-looking statements to reflect events and 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 terms as a supplement to, but not a substitute for our GAAP financial measures. Please refer to our third quarter 2022 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, PRUMA reported total revenue for the third quarter of 2022 of $57.1 million. Total revenue includes product revenue net, which consists entirely of Neuralink sales, as well as licensees and royalties from our sub-licensees. Product revenue net was 54.3 million in the third quarter of 2022, which represents an increase from the 51.3 million in product revenue net reported in the second quarter of 2022 and 43.4 million in product revenue reported in Q3 2021. Product revenue for the third quarter of 2022 included approximately 0.5 million of inventory bill that our specialty pharmacies and specialty distributors. Royalty revenue was 2.8 million in the second quarter of 2022, a decrease from 8.2 million in Q2 2022, and equal to the 2.8 million recorded in Q3 of 2021. We recorded no license revenue in the latest quarter. We reported 3,197 bottles of Neuralink sold in the third quarter, compared to 3,200 bottles sold in Q2 of 2022. We estimate that the Q3 inventory build amounted to approximately 31 bottles. In Q3 2022, new prescriptions, NRX, were up approximately 17% compared to Q2, and total prescriptions, TRX, were up about 5%. 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 address additional color on near-links commercial activities. Maxim Noguez will follow with highlights of the key components of our financial statements for the third quarter of 2022. As investors are aware, there is an ongoing clinical trial of neratinib that is being run by the Translational Breast Cancer Research Consortium, TBCRC, known as TBCRC22, that is testing neratinib in patients with HER2-positive metastatic breast cancer that are metastasized to the brain. The results from the prior cohort of the trial, which tested neratinib plus capecitabine in patients with brain metastasis, resulted in neratinib being listed in the NCCN guidelines for the treatment of breast cancer that has metastasized to the brain. The current cohort of the trial is testing the combination of neratinib plus Cadsila in patients with HER2-positive breast cancer that has metastasized to the brain. The results from two cohorts of this trial which tested the combination in patients who have not previously been treated with Capsyla and in patients who have previously been treated with Capsyla, will be presented at the San Antonio Breast Cancer Symposium in December. As investors are also aware, PUMA has an ongoing basket trial of neratinib and HER2-mutated cancers with HER2 as the summit trial. PUMA plans to meet with the FDA in the first half of 2023 to discuss the potential regulatory path for neratinib for two arms of this trial. patients with hormone receptor-positive HER2-negative breast cancer who have a HER2 mutation, and patients with metastatic non-small cell lung cancer with epidermal growth factor, or EGFR, exon 18 mutations who've previously been treated with an EGFR tyrosine kinase inhibitor. In September, PUMA was pleased to announce that we in-licensed the anti-cancer drug Alacerdib from Takeda. In clinical trials to date, Allocertib has shown single agent activity and activity in combination with other cancer drugs in the treatment of many different types of cancers, including whole-interceptor positive breast cancer, triple negative breast cancer, small cell lung cancer, and head and neck cancer. The drug has also shown activity in previous clinical trials in peripheral T-cell lymphoma and non-Hodgkin's lymphoma. Decatur's previous clinical development program with Allocertib was extensive, and due to this, There is a large, well-characterized clinical safety database with over 1,300 patients who are treated across 22 company-sponsored trials. PUMA is currently in the process of transitioning the Allocerta program from Takeda to PUMA. We anticipate that the majority of this will be completed by the end of the year. We continue to anticipate that there will be several clinical milestones for the Allocerta program in the coming months. This includes the publication of the biomarker studies from the randomized trial of alacertib plus fulvestrant versus alacertib alone in homoreceptor-positive HER2-negative breast cancer, which is expected in Q4 2022, biomarker data from the randomized trial of alacertib plus paclitaxel versus paclitaxel alone in homoreceptor-positive HER2-negative breast cancer, which is anticipated in the first half of 2023, and data from the ongoing investigator-sponsored Phase I-II trial of alacertib plus pembrolizumab for the treatment of patients with RB-deficient head and neck squamous cell cancer, which is also anticipated in 2023. As mentioned on prior earnings calls and in response to investor questions, PUMA continues to evaluate several drugs, 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, Chief Commercial Officer, for a review of our commercial performance during the quarter.