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Puma Biotechnology(PBYI) - 2020 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenue for Q4 2020 was reported at $52.6 million, which includes net U.S. NERLYNX sales and royalty fees from sublicensees [9] - Net U.S. NERLYNX sales were $50 million in Q4 2020, a slight increase from $49.3 million in Q3 2020, but a decrease from $58.7 million in Q4 2019 [9] - Royalty revenue for Q4 2020 was $2.6 million, compared to $200,000 in Q4 2019 [9] - The company reported a GAAP net loss of $15 million or $0.38 per share for Q4 2020, an improvement from a GAAP net loss of $31.5 million in Q3 2020 [41] - Non-GAAP net loss for Q4 2020 was $5.5 million or $0.14 per share [42] Business Line Data and Key Metrics Changes - NERLYNX sales gross revenue was $60.1 million in Q4 2020, up from $58.6 million in Q3 2020 [43] - Approximately 79% of NERLYNX sales were through the specialty pharmacy channel, with 21% through the specialty distributor channel [25] - The number of NERLYNX bottles sold in Q4 2020 was 3,585, a slight decrease from 3,611 in Q3 2020 [30] Market Data and Key Metrics Changes - The company anticipates that NERLYNX net sales for fiscal year 2021 will be in the range of $205 million to $210 million [45] - The gross-to-net adjustment for Q4 2020 was approximately 16.8%, an increase from 15.8% in Q3 2020 [44] - The company expects Q1 2021 NERLYNX net sales to be in the range of $42 million to $43 million [47] Company Strategy and Development Direction - The company is focusing on the extended adjuvant setting for NERLYNX, aiming to prevent patients from becoming metastatic, as this market is significantly underpenetrated [24][59] - Puma has extended its licensing agreement with Pierre Fabre to include commercialization rights for NERLYNX in Greater China, with an upfront payment of $50 million and potential milestone payments of up to $240 million [19][21] - The company is adapting to a virtual environment due to the COVID-19 pandemic and is hopeful that changes to its commercial infrastructure will positively impact NERLYNX sales growth [52][53] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges posed by the COVID-19 pandemic on achieving sales growth and emphasized the need for improvement in NERLYNX sales [52] - The company remains committed to addressing the unmet needs of women battling breast cancer and is focused on finding more effective ways to assist these patients [54] - Management expressed optimism about the second half of 2021, anticipating a more favorable commercial promotional environment as vaccination efforts progress [67] Other Important Information - The company reported cash burn of $15.6 million in Q4 2020, which included a $10.1 million milestone payment to Pfizer [50] - As of the end of Q4 2020, the company had $93.4 million in cash, cash equivalents, and marketable securities [51] Q&A Session Summary Question: Next steps on ongoing litigation regarding T790M patent in the EU and feedback on competition in the metastatic setting - Management indicated that the T790M patent is a sensitive legal matter and could not provide much detail. They noted that while the metastatic setting is competitive, their focus remains on the extended adjuvant setting where they see less competition [56][58] Question: Bar for success in EGFR exon 18 lung cancer and guidance assumptions for NERLYNX sales in 2021 - Management stated that the interim data showed a 40% response rate for EGFR exon 18, which compares favorably to existing data. They also noted that guidance for NERLYNX sales in 2021 considers the impact of the pandemic, with expectations for growth in the second half of the year as conditions improve [64][67] Question: Accelerated approval for HER2-mutant hormone receptor positive breast cancer cohort of the SUMMIT trial - Management explained that they are focusing on isolating the contribution of neratinib in combination therapies and are hopeful for a favorable response from the FDA based on the data [70][76] Question: Market for neratinib in Asia and go-to-market strategy for additional geographies - Management expressed optimism about the partnership with Pierre Fabre in Asia, highlighting their existing commercial infrastructure and plans for a launch in China. They also mentioned ongoing partnerships across various regions and potential for further expansions [81][84] Question: Current revenue breakdown from extended adjuvant versus metastatic settings - Management indicated that approximately 6% of new patient starts are in the metastatic setting, with expectations for this to remain consistent as the focus is on the extended adjuvant market [98]