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FibroGen(FGEN) - 2023 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q1 2023, total revenue was $36.2 million, a decrease from $60.8 million in the same period of 2022, primarily due to a one-time $25 million payment received in the prior year for regulatory approval of roxadustat in Russia [51] - The company reported a net loss of $76.7 million or $0.81 per share, compared to a net loss of $63.2 million or $0.68 per share in Q1 2022 [69] - Operating costs decreased to $112.3 million from $123.8 million year-over-year, with R&D expenses down to $74.5 million from $89 million [67] Business Line Data and Key Metrics Changes - Roxadustat sales in China generated $24.2 million in net product revenue for Q1 2023, up from $18.9 million in Q1 2022, representing a 28% increase [31] - Total roxadustat net sales in China reached $64.1 million, a 47% increase from $43.5 million in Q1 2022, driven by over 50% increase in volume [28][65] Market Data and Key Metrics Changes - The company highlighted a significant unmet medical need in the idiopathic pulmonary fibrosis (IPF) market, with approximately 120,000 patients in the US and only about one-third receiving treatment [21][22] - The diagnosed prevalence of IPF across the US, EU, China, and Japan is approximately 330,000 patients, with current therapies generating over $4 billion in global net revenue in 2022 [41] Company Strategy and Development Direction - The company aims to deliver pivotal Phase 3 pamrevlumab data in three high-value indications: IPF, Duchenne muscular dystrophy (DMD), and locally advanced unresectable pancreatic cancer [34] - FibroGen is focused on advancing its early-stage pipeline and expects to file up to two INDs by the end of 2023 [48][55] - The company has entered into an exclusive license with Fortis Therapeutics for FOR46, targeting a novel epitope on CD46 present in certain cancers [27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming top-line data from four Phase 3 trials through Q3 2023 and two more by mid-2024 [13][30] - The CEO emphasized the importance of maintaining a strong financial position and discipline while progressing through 2023 [29][54] Other Important Information - The company reported $373.6 million in cash, cash equivalents, investments, and accounts receivable as of March 31, 2023, sufficient to fund operations through 2024 [52] - FibroGen completed a structured loan agreement with Morgan Stanley for up to $150 million, with the first tranche of $75 million already funded [70] Q&A Session Summary Question: Can you characterize the 25 patients who dropped out of the PRAISE study? - Management confirmed that the study was analyzed by intention to treat, meaning all available data from patients who dropped out were included in the analysis [57][79] Question: What proportion of patients do you think will be eligible for treatment with FOR46? - The company estimates that over 50% of patients will be eligible based on biomarker imaging, although this is based on a small data set [82] Question: Can you provide insights on the combination of pamrevlumab with standard of care? - Management indicated that while pamrevlumab can be used in combination with standard care, the trial design does not formally test this combination [96][100] Question: What are the projected discontinuation rates for ZEPHYRUS-1? - The company has not disclosed specific rates but is making efforts to keep patients on study, anticipating a robust data set [100] Question: Can you remind us about regulatory discussions regarding filing based on ZEPHYRUS-1 and PRAISE results? - Management stated that they believe they will be in a good position to file if ZEPHYRUS-1 results replicate PRAISE [117]