Puma Biotechnology Inc

Good afternoon. My name is Alexandra, 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'd 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, Alex. Good afternoon and welcome to PUMA's conference call to discuss our financial results for the fourth quarter of 2021. Joining me on the call today are Ellen Auerbach, Chief Executive Officer, President and Chairman of the Board of PUMA Biotechnology, Maximo Noguez, Chief Financial Officer, and Jeff Ludwig, Chief Commercial Officer. After market closed today, PUMA issued a news release detailing fourth quarter 2021 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 sessions 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 Securities and Exchange Commission from time to time, including our annual report on Form 10-K for the year ended December 31, 2021. 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, March 3, 2022. 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 2021 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 2021 of $55.4 million. Total revenue includes product revenue net, which consists entirely of near-link sales, as well as licensees and royalties from our sub-licensees. Product revenue net was $51 million in the fourth quarter of 2021, which represents increases from the $43.4 million in product revenue net reported in the third quarter of 2021 and $50 million in product revenue net reported in Q4 of 2020. Product revenue for the fourth quarter included approximately $5 million of inventory bills at our specialty pharmacies and specialty distributors. Royalty revenue was $2.9 million in the fourth quarter of 2021 versus $2.8 million in Q3 2021 and $2.6 million in Q4 2020. License revenue was $1.5 million in Q4 2021. We reported 3,454 bottles of Neuralink sold in the fourth quarter of 2021, an increase from the 2,947 bottles sold in Q3 2021. Bottles sold in the quarter included an estimated 345 bottles representing inventory stocking at our specialty pharmacies and specialty distributors, as mentioned earlier. New prescriptions were down 8% in Q4 compared to Q3, while total prescriptions were down 2.8%. Bottles sold through our specialty distributor network, which we often refer to as our in-office network, were up 2.6% in Q4 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 Ludwig will add additional color on NEARLINK's commercial activities. Maximo Degues will follow with highlights of the key components of our financial statements for the fourth quarter of 2021. As we have mentioned on prior calls, PUMA has an ongoing basket trial of neuratinib and HER2 mutated cancers referred to as the summit trial. In the fourth quarter of 2021, PUMA met with the FDA to discuss the regulatory path for neratinib in patients with hormone receptor-positive HER2-negative breast cancer who have a HER2 mutation. And vessels will remember that based on the meeting with the FDA in the fourth quarter of 2019, this arm of the summit trial was modified such that patients were randomized to receive either fulvestrant alone, fulvestrant plus trastuzumab, or the combination of neratinib plus fulvestrant plus trastuzumab. Under the initial Simon 2 stage design, each of the three arms enrolled seven patients during stage one. And if no patient in a given arm responded, that arm was closed to further enrollment. If in the first stage one or more patients responded, the arm was then expanded up to 18 patients. If less than four patients in the expanded arm respond, that arm was closed to further enrollment. If more than four patients responded, the arm was expanded to 30 patients. As was previously disclosed to investors and was presented at the San Antonio Breast Cancer Symposium in 2021, for the first seven patients who were treated in the fulvestrant alone arm of the trial, no patients achieved a response. In the first seven patients who were treated in the fulvestrant plus trastuzumab arm of the trial, no patients achieved a response. In the first seven patients who were treated in the neratinib plus fulvestrant plus trastuzumab arm of the trial, one or more responses were seen, And therefore, the criteria was met to expand to stage two of the Simon 2 stage design. That arm of the trial was expanded to further enrollment, and an additional 18 patients have been treated with the combination of neratinib plus fulvestrin plus trastuzumab. Enrollment to this arm has been stopped while we analyze the additional data. At the meeting with the FDA in the fourth quarter of 2021, the data from the seven patients were randomized to each of the three arms we shared with the FDA. PUMA also notified the FDA that they had enrolled an additional 18 patients who had been treated with a combination of neratinib plus fulvestrin plus trastuzumab and that the data from these 18 patients could be shared with the FDA in 2022. PUMA plans to submit this data in the first half of 2022 and schedule a meeting to discuss the regulatory path for neratinib in this indication. PUMA anticipates that the FDA will either allow the company to file for accelerated approval based on single-arm data or may require additional data or may require a separate randomized trial for this indication. If a randomized trial is required, the company will make a decision whether or not to proceed based on the time and cost of the trial versus the potential market opportunity. Additional data from this cohort will be presented in the first half of 2022. Puma will continue to update investors on the status of this as it progresses. As investors are also aware, in November 2020, we announced interim results from another cohort of the SUMMIT trial, and more specifically, the cohort of patients with metastatic non-small cell lung cancer with epidermal growth factor, or EGFR, exon 18 mutations, who have previously been treated with an EGFR tyrosine kinase inhibitor. As was shown in the data that was presented, there were four responses out of 11 patients, and therefore the criteria had been met to proceed to stage 2 of the Simon 2 stage design and enroll 30 patients. There are currently 31 patients enrolled in this arm of the trial, and we anticipate that we will have additional data from this cohort to report in the second half of 2022. Once we receive this data, we plan to meet with the FDA to discuss the regulatory path for this indication. PRMA anticipates that the FDA will either allow the company to file for accelerated approval based on single arm data, or may require additional data or a separate randomized trial for this indication. If a randomized trial is required, the company will make a decision whether or not to proceed based on the time and cost of the trial versus the potential market opportunity. Enrollment to this arm of the trial has been halted while we analyze the current data and wait for regulatory guidance. 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.