Puma Biotechnology(PBYI) - 2022 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenue for Q3 2022 was reported at $57.1 million, with product revenue net of$ 54.3 million, an increase from $51.3 million in Q2 2022 and$ 43.4 million in Q3 2021 [7][8] - Net loss based on GAAP for Q3 2022 was $0.4 million or$ 0.01 per share, compared to a net income of $9.4 million or$ 0.21 per share in Q2 2022 [28] - Non-GAAP net income for Q3 2022 was $2.5 million or$ 0.05 per share [29] - Gross to net adjustment in Q3 2022 was about 14.3%, down from 19% in Q2 2022 [30] Business Line Data and Key Metrics Changes - NERLYNX sales included approximately $0.5 million of inventory build in Q3 2022 [8] - New prescriptions (NRx) increased by approximately 17% compared to Q2 2022, while total prescriptions (TRx) were up about 5% [9][22] - Enrollments grew 7% quarter-over-quarter and 12% year-over-year [22] Market Data and Key Metrics Changes - Approximately 80% of NERLYNX business flowed through the specialty pharmacy channel in Q3 2022 [18] - NERLYNX received regulatory approval for metastatic breast cancer in Ecuador and Singapore, and was launched in Brazil and Spain [24] Company Strategy and Development Direction - The company continues to focus on increasing the adoption of NERLYNX through three strategic areas: communicating clinical data, engaging patients, and enhancing field force execution [16] - Puma is evaluating several drugs for potential in-licensing to diversify its portfolio [15] Management Comments on Operating Environment and Future Outlook - Management noted that increased face-to-face interactions with healthcare providers (HCPs) have contributed to improved commercial results [37] - The company anticipates a seasonal decline in new patient starts in Q4 2022 due to the side effect profile of NERLYNX [32] Other Important Information - The company expects net NERLYNX product revenue for fiscal year 2022 to be in the range of$ 194 million to $196 million [31] - Cash burn for Q3 2022 was approximately$ 17.4 million, compared to $14 million in Q2 2022 [35] Q&A Session Summary Question: Change in timing for FDA meeting - The timing for the FDA meeting was moved to the first half of 2023 due to delays in submitting the packages [41] Question: Size of the sales team - The current size of the field force is deemed appropriate, with adjustments possible if access continues to improve [42][43] Question: Drivers of good commercial quarter - Increased live interactions with clinicians and improved access due to reduced COVID restrictions contributed to the positive commercial quarter [47][48] Question: Payer split and patient compliance - The payer split is approximately 65% commercial and 25% government, with dose escalation showing a 5% to 7% benefit in decreased discontinuations [54] Question: FDA discussion regarding alisertib - The company plans to proceed with the FDA discussions regardless of the availability of biomarker data [55]