Catalyst Pharmaceuticals(CPRX) - 2022 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Catalyst Pharmaceuticals reported a record quarterly net product revenue of $57.2 million for Q3 2022, representing a 59.3% increase compared to Q3 2021 [5][44] - GAAP net income for Q3 2022 was$ 22.7 million, or $0.22 per basic share, reflecting a 120.2% increase year-over-year [6][45] - Non-GAAP net income for Q3 2022 was$ 28.6 million, or $0.28 per basic share, which is an 83.3% increase compared to Q3 2021 [7][48] - The company ended Q3 2022 with$ 256 million in cash and short-term investments, marking a $35.3 million increase from the previous quarter [9][55] Business Line Data and Key Metrics Changes - Firdapse net sales for Q3 2022 were$ 57.2 million, showing an 8% growth quarter-over-quarter and a 59.3% growth year-over-year [22] - The discontinuation rate of reimbursed patients in Q3 was 35% lower than in Q2, indicating improved patient retention [23] - Average co-pay for patients enrolled in Catalyst Pathways was less than $2 per month, facilitating access to treatment [24] Market Data and Key Metrics Changes - Approximately 50% of LEMS patients have a comorbidity of small cell lung cancer, representing a significant market opportunity for Catalyst [11] - The company estimates that there are about 1,500 small cell lung cancer LEMS patients in the U.S., with over 80% currently undiagnosed [27] Company Strategy and Development Direction - Catalyst aims to broaden and diversify its product portfolio through acquisitions and partnerships, with ongoing due diligence for potential commercial stage products [15][42] - The company has launched a marketing initiative targeting thoracic oncologists to educate them about LEMS and Firdapse, expected to ramp up in early 2023 [11][28] - Catalyst is focused on expanding access to Firdapse for all LEMS patients, including pediatric patients aged six and older, following recent FDA approval [14][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 2022 objectives, revising Firdapse revenue guidance upward to$ 205 million to $210 million [8] - The company anticipates continued organic growth driven by new patient enrollments and improved diagnostic efforts [24][80] - Management acknowledged the potential for challenges to their patent position but indicated preparedness for such events [80] Other Important Information - Catalyst was named Company of the Year by BioFlorida and ranked 39th in Fortune Magazine's 2022 Top 100 Fastest Growing Companies [17][18] - The company was added to the S&P SmallCap 600 Index on September 15, 2022, reflecting its market capitalization and growth [19] Q&A Session Summary Question: How many patients are currently offered Firdapse, and how many are small cell lung cancer patients? - Management indicated that about 30% of new enrollments are small cell lung cancer LEMS patients, with expectations for growth in this area [60] Question: What is the target for small cell lung cancer patients in 2023? - The company expects to increase the percentage of small cell lung cancer patients among new enrollments from 30% to about 35% to 40% in 2023 [61] Question: Is the patient growth from breadth or depth in the prescriber base? - The prescriber base is broad, with 75% of prescribers treating only one patient, indicating potential for future growth as physicians gain experience [66] Question: Are there differences in persistence between treatment naïve patients and those switching from Ruzurgi? - No significant differences in persistence were observed between the two groups, with both groups showing similar treatment adherence [68] Question: What is the current status of patients on Ruzurgi for other indications? - Approximately 100 patients with congenital myasthenic syndromes are being treated with Ruzurgi under INDs, but no specific plans to pursue this indication currently exist [72]