Puma Biotechnology Inc

Good afternoon. My name is Rob, and I'll 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'd like to ask a question during that time, simply press the star key, then the number 1 on your telephone keypad. If you'd 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 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. You may now begin your conference.

Thank you, Rob. Good afternoon and welcome to PUMA's conference call to discuss our financial results for the first 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 Noguez, Chief Financial Officer, and Jeff Ledwood, Chief Commercial Officer. After market closed today, PUMA issued a news release detailing first quarter 2023 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 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, 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, May 4, 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 first 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 first quarter of 2023 of $52.8 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 46.8 million in the first quarter of 2023, which represents a decline as expected from 53.7 million reported in Q4 2022, and it represents a 15% increase from 40.7 million reported in Q1 of 22. Product revenue for the first quarter of 2023 was impacted by approximately 3.8 million of inventory drawdown at our specialty pharmacies and specialty distributors. Royalty revenue was $6 million in the first quarter of 2023, compared to $12 million in Q4 of 2022 and $5 million in Q1 of 2022. We reported 2,849 bottles of Neuralinks sold in the first quarter of 2023, compared to 3,323 bottles sold in Q4 of 2022. As we noted on last quarter's call, we estimate that the Q4 inventory build amounted to approximately 164 bottles. In Q1 2023, new prescriptions, or NRX, were up approximately 11% compared to Q4 22, and total prescriptions were down approximately 4% compared to Q4 22. 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 Noguez will then follow with highlights of the key components of our financial statements for the fourth quarter of 2022. As investors are aware, in September 2022, PUMA was pleased to announce that we had in-licensed the anti-cancer drug Alacertib from Takeda. In clinical trials to date, Alicertib has shown single-agent activity and activity in combination with other anti-cancer drugs in the treatment of various cancers, including homoreceptor-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 Alicertib 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. We are currently anticipating that we will be meeting with the FDA late in the second quarter of 2023 to discuss the registration pathway for L-acertib in small cell lung cancer and would substantially, I'm sorry, subsequently anticipate initiating clinical trials of L-acertib in small cell lung cancer in the fourth quarter of 2023. In March, we are pleased to announce the publication of clinical trial results from TBCRC41 in JAMA Oncology. This was a randomized trial that tested allocertib monotherapy versus allocertib plus fulvestrins in patients with homoerceptor-positive HER2-negative breast cancer. We are pleased to see the activity of allocertib in this patient population, as well as the resulting biomarker analysis in the publication. As investors are also aware, in April 2021, Data was published in JAMA Network Open from a randomized phase 2 trial of paclitaxel plus alicerib versus paclitaxel in patients with metastatic breast cancer. In patients with hormone receptor positive HER2 negative breast cancer, the data showed a statistically significant benefit in progression-free survival for patients who received alicerib plus paclitaxel compared to patients who received paclitaxel alone. We anticipate that the biomarker data from this trial will be presented as a poster at the American Society of Clinical Oncology, or ASCO, annual meeting in June. We further anticipate meeting with the FDA in the second half of 2023 to discuss the registration pathway for allocertib in homoreceptor-positive HER2-negative breast cancer and subsequently initiating clinical trials of allocertib in homoreceptor-positive HER2-negative breast cancer in the first half of 2024. We continue to anticipate that there will be several clinical milestones for the Allocerta program in the coming months. This includes the previously mentioned biomarker data from the randomized trial of Allocerta plus paclitaxel versus paclitaxel alone in homoreceptor-positive HER2-negative breast cancer, which, as I mentioned, will be presented at ASCO in June. Also, data from an ongoing investigator-sponsored Phase I-II trial of Allocerta plus pembrolizumab in the treatment of patients with RB deficiency head and neck squamous cell cancer, which is anticipated sometime in 2023, conducting a meeting with the FDA to discuss the registration pathway for allocertib and small cell lung cancer, which we anticipate in late Q2 of 2023, and conducting a meeting with the FDA to discuss the registration pathway for allocertib and homoreceptor-positive HER2-negative breast cancer, which we anticipate 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 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.