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 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 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 fourth quarter and full year 2022. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board of PUMA, Maximo Noguez, Chief Financial Officer, and Jeff Ludwig, Chief Commercial Officer. After market closed today, PUMA issued a news release detailing fourth 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 31st, 2022. You are cautioned not to place undue reliance on these forward-looking statements. We speak only as of the date of this live conference call, March 2nd, 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 fourth quarter 2022 news release for 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 fourth quarter of 2022 of $65.7 million. Total revenue includes product revenue net, which consists entirely of Neuralink sales, as well as license fees and royalties from our sub-licensees. Product revenues net was $53.7 million in the fourth quarter of 2022 compared to $54.3 million reported in Q3 2022 and $51.0 million reported in Q4 of 2021. Product revenue for the fourth quarter of 2022 included approximately $2.6 million of inventory billed at our specialty pharmacies and specialty distributors. Royalty revenue was 12 million in the fourth quarter of 2022, an increase from 2.8 million in Q3 of 2022, and an increase from 2.9 million in Q4 of 2021. We reported no license revenue in 2022. We reported 3,323 bottles of Neuralink sold in the fourth quarter of 2022 compared to 3,197 bottles sold in Q3 of 2022. We estimate that Q4 inventory build amounted to approximately 164 bottles. In Q4 2022, new prescriptions were down approximately 16% compared to Q3, and total prescriptions were flat compared to Q3. Jeff will provide further details in his comments and slides. I will now provide a clinical review of the quarter, and then Jeff Ludwood will address additional color on Nearly's commercial activities, Maximo Nuguez will then follow with highlights of the key components of our financial statements for the fourth quarter of 2022. As investors are aware, PUMA had an ongoing basket trial of neratinib, referred to as the SUMMIT trial, which was testing neratinib in patients with metastatic HER2-negative hormone receptor-positive breast cancer that has a HER2 mutation, and in patients with metastatic non-small cell lung cancer that has an exon 18 mutation. As we mentioned to investors in the past, we believe that it was unlikely that FDA would grant accelerated approval for neratinib based on the summit data and would instead require us to either, one, do a head-to-head trial against standard of care in these indications, or two, study neratinib in patient populations that do not overlap with other drugs in the rapidly changing treatment landscape. Based on recent precedents and interactions with the FDA, which suggested that regulatory approval in these indications would require a randomized trial, the company will not be further pursuing the development of neratinib in these indications. Due to the rarity of these mutations, enrollment in randomized studies would be challenging, and it is not clear that this would be able to be accomplished in a timeframe that would result in a positive return for PUMA shareholders based on the time and cost of the trial versus the potential market opportunity. The summit trial is therefore being discontinued, which results in a cost reduction from this trial in 2023 versus 2022. In September, PUMA was pleased to announce that we in-licensed the anti-cancer drug Alacertib from Takeda. In clinical trials to date, L-acertib has shown single-agent activity and activity in combination with other cancer drugs in the treatment of various cancers, including homoerceptor-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. Takeda's previous clinical development program with L-acertib was extensive, And due to this, there is a large, well-characterized clinical safety database with over 1,300 patients who were treated across 22 company-sponsored trials. As mentioned in our last earnings call, PUMA was in the process of transitioning the Allocertib program from Cicada to PUMA. This has now been successfully completed, and the IND is currently being held by PUMA. We are currently anticipating that we will be meeting with the FDA in the first half of 2023 to discuss the registration path for L-assertive in small cell lung cancer and would subsequently anticipate initiating clinical trials of L-assertive in small cell lung cancer in the second half of 2023. We further anticipate meeting with the FDA in the second half of 23 to discuss the registration pathway for L-assertive in hormone receptor positive HER2 negative breast cancer and subsequently initiating clinical trials of L-assertive in hormone receptor positive HER2 negative breast cancer in the first half of 2024. We continue to anticipate that there will be several clinical milestones for the Allocertib program in the coming months. This includes the publication of the biomarker studies from the randomized trial of Allocertib plus Fulvestrin versus Allocertib alone in home receptor-positive HER2-negative breast cancer, which we anticipate in the first half of 2023, biomarker data from the randomized trial of Allocertib plus Paclitaxel versus Paclitaxel alone and homoreceptor-positive HER2-negative breast cancer, anticipated in the first half of 23. Data from an ongoing investigator-sponsored Phase 1-2 trial of allocertib plus PEMBRO for the treatment of patients with RB-deficient head and neck squamous cell cancer, which is anticipated sometime in 23. Conducting the meeting with the FDA to discuss the registration path for allocertib and small cell lung cancer, which is expected in the first half of 2023. and conducting the meeting with the FDA to discuss the registration path for L-acertib and homoreceptor-positive HER2-negative breast cancer, which is anticipated in the second half of 2023. 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 its 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.