cept Therapeutics rporated(US:CORT)2022-05-04 16:00Financial Performance - Net product revenue for the three months ended March 31, 2022, was $93.7 million, an increase from $79.4 million in the comparable period in 2021, with higher sales volumes accounting for 53.6% of the increase [100]. - Cost of sales for Q1 2022 was $1.3 million, representing 1.3% of revenue, a decrease from 1.6% in Q1 2021 due to reduced manufacturing costs [101]. - Research and development expense decreased to $28.1 million in Q1 2022 from $29.0 million in Q1 2021, primarily due to reduced spending on clinical trials [103]. - Selling, general and administrative expense increased to $37.5 million in Q1 2022 from $29.5 million in Q1 2021, driven by higher employee compensation and legal fees [106]. - Net cash provided by operating activities was $35.2 million for Q1 2022, up from $25.4 million in Q1 2021, attributed to higher revenue [115]. - Net cash used in investing activities rose to $50.5 million in Q1 2022 from $3.3 million in Q1 2021, mainly due to investments in marketable securities [116]. - As of March 31, 2022, cash, cash equivalents, and marketable securities totaled $368.1 million, an increase from $335.8 million at the end of 2021 [113]. - Income tax expense for Q1 2022 was $4.1 million, compared to an income tax benefit of $3.6 million in Q1 2021, reflecting increased income before taxes [110]. - Retained earnings as of March 31, 2022, were $217.8 million [118]. - The company expects higher research and development expenses in 2022 compared to 2021 as clinical programs advance [104]. - The company anticipates that selling, general and administrative expenses will increase in 2022 due to expanded commercial activities [108]. Clinical Development - The company has developed and marketed Korlym (mifepristone) since 2012 for treating Cushing's syndrome, with ongoing efforts to educate physicians and patients about the disorder [71][72]. - Two Phase 3 trials of relacorilant for Cushing's syndrome are underway, with planned enrollments of 130 patients each in the GRACE and GRADIENT trials [74][76]. - Relacorilant has been designated as an orphan drug by the FDA and the European Commission, providing potential tax credits and exclusive marketing rights upon approval [78]. - In a Phase 2 trial for advanced ovarian cancer, patients receiving relacorilant intermittently showed a median progression-free survival of 5.6 months compared to 3.8 months for those receiving nab-paclitaxel alone [81]. - The company is conducting two Phase 2 trials of miricorilant for antipsychotic-induced weight gain, with both trials having completed enrollment [90][93]. - The company is studying miricorilant as a potential treatment for nonalcoholic steatohepatitis (NASH) and has suspended a Phase 2a trial due to elevated liver enzymes in patients [94]. - A Phase 1 trial of dazucorilant for amyotrophic lateral sclerosis (ALS) has been completed, with plans to advance to Phase 2 [95]. - The COVID-19 pandemic has impacted revenue and slowed enrollment in clinical trials for non-life-threatening conditions, while trials for life-threatening diseases continued without delays [96][97]. Patient Access and Support - The company utilizes a specialty pharmacy and distributor for Korlym, ensuring no patient is denied access for financial reasons through its support programs [73].