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Puma Biotechnology(PBYI) - 2022 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Puma reported total revenue for Q2 2022 of 59.5million,whichincludesproductrevenuenetof59.5 million, which includes product revenue net of 51.3 million, an increase from 40.7millioninQ12022and40.7 million in Q1 2022 and 48.9 million in Q2 2021 [9][10] - Net income based on GAAP for Q2 2022 was 9.4millionor9.4 million or 0.21 per share, compared to a net loss of 3.4millionor3.4 million or 0.08 per share in Q1 2022 [45] - Gross revenue from NERLYNX sales was 63.4millioninQ22022,upfrom63.4 million in Q2 2022, up from 51.5 million in Q1 2022 [46] Business Line Data and Key Metrics Changes - NERLYNX sales included approximately 2.7milliononinventorybuildatspecialtypharmaciesanddistributorsinQ22022[9]Thecompanysold3,200bottlesofNERLYNXinQ22022,anincreaseof520fromQ12022[11][32]Newprescriptions(NRx)weredownapproximately82.7 million on inventory build at specialty pharmacies and distributors in Q2 2022 [9] - The company sold 3,200 bottles of NERLYNX in Q2 2022, an increase of 520 from Q1 2022 [11][32] - New prescriptions (NRx) were down approximately 8% compared to Q1, while total prescriptions (TRX) were up about 1.6% [11] Market Data and Key Metrics Changes - Approximately 79% of NERLYNX business went through the specialty pharmacy channel in Q2 2022, slightly down from 81% in Q1 2022 [29] - The extended adjuvant breast cancer market remains significantly under-penetrated, indicating potential growth opportunities [27] Company Strategy and Development Direction - The company remains focused on leveraging positive clinical data for NERLYNX, engaging patients, and enhancing field force execution [25] - Puma is evaluating several drugs for potential in-licensing to diversify its portfolio and leverage existing infrastructure [21] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the uncertainty regarding the impact of COVID-19 on sales and revenue, but noted a positive trend in face-to-face interactions with healthcare providers [59] - The company anticipates Q3 2022 NERLYNX net sales in the range of 44 million to 47million,withanetlossexpectedbetween47 million, with a net loss expected between 1 million and 2million[50][52]OtherImportantInformationThecompanyplanstosubmitfinaldatafromtheSUMMITtrialtotheFDAlaterthisyear[17]CashburnforQ22022wasapproximately2 million [50][52] Other Important Information - The company plans to submit final data from the SUMMIT trial to the FDA later this year [17] - Cash burn for Q2 2022 was approximately 14 million, down from $17 million in Q1 2022 [54] Q&A Session Summary Question: Changes in sales force structure due to increased live interactions - Management believes that a combination of live and virtual interactions will be the new normal, and they are currently satisfied with the size of the sales force [63][65] Question: Presentation of updated HER2-mutated breast cancer data - Management anticipates presenting updated data at the San Antonio Breast Cancer meeting, but the timing of FDA disclosures is uncertain [68] Question: Long-term profitability and cost management - Management reiterated the commitment to being net income positive and cash flow positive, with potential further cost cuts if necessary [77]