Catalyst Pharmaceuticals(CPRX) - 2019 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - In 2019, Catalyst Pharmaceuticals achieved GAAP net income of $32 million, or $0.31 per basic share, compared to a GAAP net loss of $34 million in 2018 [58] - For Q4 2019, GAAP net income was $7.9 million, or $0.08 per basic share, compared to a GAAP net loss of $14.5 million in Q4 2018 [60] - Full-year 2019 net revenues from Firdapse were $102 million, with Q4 2019 net revenues of $30 million [9][60] Business Line Data and Key Metrics Changes - Firdapse launch exceeded expectations, with 532 patients prescribed by the end of Q4 2019, up from 490 at the end of Q3 2019 [25] - The average co-pay for patients decreased to $1.08 per month, with 94% of patients having zero out-of-pocket costs [27] - The discontinuation rate for newly enrolled patients decreased to under 25% in Q4, down from over 35% in the first three quarters [28] Market Data and Key Metrics Changes - Approximately 35% of diagnosed adult LEMS patients have received a Firdapse prescription since its launch [24] - The company is expanding its global footprint, with a New Drug Submission for Firdapse in Canada and ongoing discussions for approval in Japan [18][51] Company Strategy and Development Direction - Catalyst aims to establish Firdapse as the standard of care for adult LEMS patients and expand its label to include other indications [69] - The company is focusing on business development in rare diseases and has hired a new Vice President of Business Development [17] - Plans for additional proof-of-concept studies for neuromuscular conditions are underway, including Kennedy's disease and hereditary neuropathy [53] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the impact of COVID-19 on business operations, emphasizing the robustness of the supply chain [10][55] - The company anticipates continued growth in patient enrollments and revenue, with guidance for 2020 net product revenues expected to be between $135 million and $155 million [9][75] Other Important Information - Catalyst has a strong balance sheet with approximately $95 million in cash and no funded debt [20] - The company is pursuing a lawsuit against the FDA regarding the approval of a competing product, Ruzurgi, with expected decisions in Q2 or Q3 2020 [21][22] Q&A Session Summary Question: Current tone of business and guidance for 2020 - Management indicated that the guidance of $135 million to $155 million does not include global expansion and is driven by new patient starts and maintaining current patients [72][75] Question: Impact of COVID-19 on patient follow-up and prescriptions - All prescriptions are delivered directly to patients by mail, and the company is ensuring that patients are informed about product availability [87][88] Question: Discontinuation rates and reasons for patient drop-off - Discontinuations were primarily due to patients switching to a competitor's product, but trends are improving with new patient enrollments increasing [92][94] Question: MuSK-MG trial optimism - Management remains cautiously optimistic about the MuSK-MG trial due to the homogeneous patient population and previous positive outcomes [82][84] Question: Market dynamics regarding competitor share - The share of the competitor's product has leveled off, and efforts are focused on supporting existing patients and generating awareness among new patients [103][104]