cept Therapeutics rporated(US:CORT)2020-02-21 01:42Financial Data and Key Metrics Changes - Revenue for Q4 2019 was $87.9 million, a 32% increase from Q4 2018, and for the full year, revenue was $306.5 million, a 22% increase from 2018 [7][8] - GAAP net income for the year was $94.2 million and $29.4 million for Q4 2019, compared to $75.4 million and $22 million for the same periods in 2018 [8] - Non-GAAP net income was $133.3 million for the year and $40.3 million for Q4 2019, compared to $108.2 million and $30.4 million in 2018 [8] - Cash and investments increased by $48.4 million in Q4 to a total of $315.3 million at year-end [9] Business Line Data and Key Metrics Changes - The commercial team successfully increased the number of patients receiving Korlym each quarter, contributing to revenue growth [16] - The company expects continued growth in 2020, reaffirming revenue guidance of $355 million to $375 million [16][39] Market Data and Key Metrics Changes - The company is actively enrolling patients in the Phase III trial of relacorilant, with 54 sites opened across the U.S., Europe, and Israel [18] - The GRACE trial aims to demonstrate the efficacy and safety of relacorilant, with expected enrollment of 130 patients [18][20] Company Strategy and Development Direction - Corcept is focused on the development of proprietary selective cortisol modulators for various conditions, including Cushing's syndrome, solid tumors, and metabolic disorders [16][39] - The company plans to submit an NDA for relacorilant in Cushing's syndrome in Q4 2021 [18][40] - The GRADIENT trial will study relacorilant in patients with Cushing's syndrome caused by adrenal adenomas, aiming to improve care for this understudied group [19][40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong financial position, which allows for the funding of development programs [16][39] - The management highlighted the importance of relacorilant's safety profile compared to Korlym, which has significant side effects [21][22] - The company anticipates that relacorilant will replace Korlym if it continues to demonstrate superior efficacy and safety [48] Other Important Information - The company is involved in ongoing patent litigation against Teva and Sun Pharmaceuticals regarding Korlym, with updates on legal proceedings expected [10][12] - The PTAB recently ruled in favor of Corcept regarding the validity of the '348 patent, which strengthens its position in ongoing litigation [14][15] Q&A Session Summary Question: What are the key triggers for revenue guidance? - Management indicated that pricing adjustments and the addition of new patients and prescribers will influence revenue guidance [44][46] Question: Will Korlym continue to be marketed if relacorilant is approved? - Management believes relacorilant will likely replace Korlym due to its superior profile if it replicates current results [47][48] Question: How should costs be expected to change in 2020? - Management expects a marginal increase in SG&A spending and a significant increase in R&D spending due to expanding trials [51][53] Question: What is the enrollment pace for the GRACE study? - Management noted that enrollment is dependent on the number of patients with the disease and the number of sites open for treatment [70][71] Question: What is the mechanism of action for miricorilant in treating NASH? - Management explained that cortisol modulation may help treat fatty liver disease, which is often a precursor to NASH [73] Question: What is the design of the pancreatic cancer trial? - The trial will have a single-arm phase followed by a randomized phase, focusing on patients in need of effective treatments [76][77]