Puma Biotechnology Inc

Good afternoon. My name is Melinda, and I'll be your conference operator today. At this time, all participants are in a listen-only mode. After the speaker's formal remarks, there'll 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 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, Melinda. Good afternoon and welcome to PUMA's conference call to discuss our financial results for the third 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 Núñez, Chief Financial Officer, and Jeff Ludwood, Chief Commercial Officer. After market closed today, PUMA issued a news release detailing third 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 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 Securities and Exchange Commission from time to time, including our annual report on Form 10-K for the year ended December 31, 2020. 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 4th, 2021. 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 2021 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 2021 of $46.2 million. Total revenue includes product revenue net, which consists entirely of U.S. near-link sales, as well as license fees and royalties from our sub-licensees. Product revenue net was $43.4 million in the third quarter of 2021, representing declines from the $48.9 million in product revenue net reported in the second quarter of 2021 and $49.3 million in product revenue reported in Q3 of 2020. Product revenue for the quarter was negatively impacted by approximately $3.5 billion due to inventory reduction at our specialty pharmacies and specialty distributors. Royalty revenue was $2.8 million in the third quarter of 2021 versus $4.3 million in Q2 of 2021 and $1.5 million in Q3 of 2020. During the third quarter of 2021, we continued to experience challenges brought on as a result of the COVID-19 pandemic and the Delta variant. As Jeff will show in his presentation, we reported 2,947 bottles of Nearlinks sold in the third quarter versus the 3,354 bottles sold in Q2 of 2021. Bottles sold in the quarter were negatively impacted by the inventory reduction at our specialty pharmacies and specialty distributors mentioned earlier. Jeff will provide further details in his comments and slides. Due to the access limitations presented by COVID-19, call activity to physicians declined approximately 10.5% in Q3 compared to Q2. New prescriptions were up 2.9% in Q3 compared to Q2, while total prescriptions were down 3.1%. Bottles sold through our specialty distributor network, which we also refer to as our in-office network, were down 11.9% in Q3 compared to Q2. I will now provide a clinical review of the quarter, and then Jeff Ludwig will add additional color on the near-length commercial activities. Maximo Noguez will follow with highlights of the key components of our financial statements for the third quarter of 2021. As we have mentioned on our 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 2019, 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. The purpose of the meeting in 2019 was to discuss the potential defile for accelerated approval on the data from the summit trial on the patients treated with a combination of neratinib plus fulvestrin plus trastuzumab. At that meeting, the FDA suggested that PUMA modify the summit trial in order to better isolate the contribution of neratinib to the efficacy seen in the summit trial for the patients treated with a combination of neratinib plus fulvestrin plus trastuzumab. In early 2020, the summit trial was amended such that ER-positive HER2-negative breast cancer patients who have a HER2 mutation were randomized to receive either fulvestrin alone, fulvestrin plus trastuzumab, or the combination of neratinib plus fulvestrin plus trastuzumab. The randomized portion of the trial was designed using assignments two-stage designed. Each arm of the study initially enrolled seven patients during stage one. If no patient in the given arm responds, that arm will be closed to further enrollment. If in the first stage one or more patients respond, the arm will then be expanded up to 18 patients. If less than four patients in the expanded arm respond, that arm will be closed to further enrollment. If four or more patients respond, the arm will be open to enroll additional patients. As was discussed on the second quarter earnings conference call, for the first seven patients who were treated in the fulvestrant alone arm of the trial, no patients received a response. In the seven patients who were treated in the fulvestrant plus trastuzumab arm of the trial, no patients achieved a response. Enrollment to the fulvestrant alone and fulvestrant plus trastuzumab arms of the trial were therefore paused. During the third quarter, PUMA convened the study's Independent Data Monitoring Committee, or IDMC, to review the data from both the singlet and the doublet cohorts. The IDMC recommended closing both the singlet and the doublet cohorts. In the first seven patients who were treated in the neratinib plus polvestrin 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 two-stage design. This arm of the trial has been expanded to further enrollment. Currently, patients with ER-positive HER2-negative breast cancer who have a HER2 mutation are only being rolled into this triplet arm in SUMMIT, which treats patients with neratinib plus fulvestrin plus trastuzumab. We anticipate that additional data on this will be presented at the San Antonio Breast Cancer Symposium in the fourth quarter of 2021. PUMA believes that the data from the randomized portion of the trial has addressed the FDA's request to isolate the contribution of neratinib to the efficacy seen in the summit trial in the patients treated with the combination of neratinib plus filvestrin plus trastuzumab. PUMA has therefore scheduled a meeting with the FDA this quarter to discuss the data from the randomized portion of the trial and to discuss the potential pathway to follow for accelerated approval for the combination of enratinib plus rovestrin plus trastuzumab on the data in patients with ER-positive HER2-negative breast cancer who have a HER2 mutation and have been treated in the summit trial. At the FDA meeting in 2019, the FDA agreed that patients treated with the triplet of Neuratinib plus Provestrit plus Stratuzumab, who were enrolled both prior to the amendment in 2020 as well as those enrolled after the amendment, would be eligible for inclusion in the efficacy database used to support approval. CUMA will continue to update investors on the status of this as it progresses. As investors are also aware, last November, we announced interim data from another cohort and summit, and more specifically, the cohort with metastatic non-small-cell lung cancer with epidermal growth factor, or EGFR, exon 18 mutations who've been previously treated with an EGFR tyrosine kinase inhibitor. We are continuing to enroll this cohort of patients and anticipate we will have additional data from this cohort to report in the first half of 2022. 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.