Catalyst Pharmaceuticals(CPRX)2022-08-10 18:00Financial Data and Key Metrics Changes - Catalyst Pharmaceuticals reported an all-time high in total FIRDAPSE net revenue of 28.2 million, a 77.6% increase compared to 21.6 million, or 0.20 per diluted share, reflecting a 77.5% increase year-over-year [49] - The company ended Q2 2022 with 53 million, showing a 23.3% growth quarter-over-quarter and a 57.7% growth year-over-year [22] - The company successfully transitioned nearly 100% of adult LEMS patients from Ruzurgi to FIRDAPSE without a lapse in therapy [23] - Payer approval rates for adult LEMS patients transitioning from Ruzurgi were greater than 90% [24] Market Data and Key Metrics Changes - The company expects steady organic growth in the second half of 2022, primarily driven by new patient enrollments of already diagnosed LEMS patients not yet on FIRDAPSE [26] - Leading indicators for Q3 are positive, with July net new patients ahead of forecast due to low discontinuation rates and consistent new enrollments [27] Company Strategy and Development Direction - Catalyst Pharmaceuticals aims to broaden and diversify its product portfolio through collaborative partnerships and acquisitions of commercial stage assets [17] - The company is actively engaged in advanced stages of due diligence for several acquisition opportunities [18] - The company has made significant progress in building its ESG program, publishing its inaugural set of industry-specific disclosures [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, believing the company is well-positioned to execute its growth strategy and deliver long-term value for stakeholders [21] - The company anticipates that 2022 will continue to be a transformative year with increased momentum to diversify and invest in innovative opportunities for rare diseases [60] Other Important Information - The company resolved issues with Jacobus Pharmaceuticals, acquiring certain intellectual property rights, including U.S. and Mexico rights for Ruzurgi [12] - A supplemental new drug application for FIRDAPSE to support its use in pediatric LEMS patients has been accepted by the FDA for review [15] Q&A Session Summary Question: What are the key factors to achieve the upper end of revenue guidance? - Management indicated that strong new patient enrollments and low discontinuation rates are crucial for achieving the upper end of revenue guidance [64] Question: What information was provided to the FDA regarding the pediatric LEMS supplemental application? - The company submitted pediatric safety data and simulations on how adult data translates to pediatric patients [67] Question: Will potential business development activities be accretive to revenue opportunities next year? - Management expects that any potential business development activities would be accretive to revenues next year, leveraging established commercial infrastructure [68] Question: What is the expected pace of naïve new patient enrollments in the second half of the year? - Management expects the pace of growth to continue, with strong new enrollments and steady discontinuation rates [74] Question: What does the newly acquired patent cover? - The patent contains claims for a new and novel previously unknown impurity that appears in all products containing amifampridine [78]