Corcept Therapeutics Q1 2025: Unpacking Key Contradictions on Korlym Demand, Relacorilant NDA, and Clinical Strategies
Generado por agente de IAAinvest Earnings Call Digest
martes, 6 de mayo de 2025, 7:34 pm ET1 min de lectura
CORT--
Pharmacy operations and Korlym demand, Relacorilant NDA acceptance and AdCom expectations, ROSELLA study endpoints and strategy, Relacorilant's pivotal study and approval pathPATH--, and impact of CATALYST results on Korlym's performance, are the key contradictions discussed in Corcept Therapeutics' latest 2025Q1 earnings call.
Revenue and Financial Performance:
- Corcept TherapeuticsCORT-- reported revenue of $157.2 million for Q1 2025, compared to $146.8 million in Q1 2024, with a reiterated 2025 revenue guidance of $900 million to $950 million.
- The increase in revenue was driven by increased patient growth and screening for hypercortisolism.
Patent Litigation and Legal Status:
- Corcept is appealing a decision against its lawsuit to block Teva's generic version of Korlym, with the Federal Circuit Court of Appeals yet to schedule oral arguments.
- If Corcept prevails, Teva would lose FDA approval for its product until 2037.
Oncology Program and Clinical Results:
- The ROSELLA trial in platinum-resistant ovarian cancer met primary endpoints, showing a 30% reduction in disease progression risk with relacorilant, with an expected NDA submission in Q4 2025.
- The positive results support cortisol modulation's role in cancer treatment and expand Corcept's oncology portfolio.
Endocrinology Business and Market Growth:
- The number of Korlym prescriptions in Q1 2025 was nearly double compared to the same period in 2024, driven by increased screening and treatment of hypercortisolism.
- Growth is expected to continue, driven by the CATALYST study's results and the expansion of the sales force.
Pharmacy Operations and Business Impact:
- The first quarter results were affected by insufficient capacity at the pharmacy vendor, leading to delayed drug shipments to patients.
- The issue has been resolved, with March and April seeing record tablet dispenses, and Corcept is exploring a broader distribution network for relacorilant.
Revenue and Financial Performance:
- Corcept TherapeuticsCORT-- reported revenue of $157.2 million for Q1 2025, compared to $146.8 million in Q1 2024, with a reiterated 2025 revenue guidance of $900 million to $950 million.
- The increase in revenue was driven by increased patient growth and screening for hypercortisolism.
Patent Litigation and Legal Status:
- Corcept is appealing a decision against its lawsuit to block Teva's generic version of Korlym, with the Federal Circuit Court of Appeals yet to schedule oral arguments.
- If Corcept prevails, Teva would lose FDA approval for its product until 2037.
Oncology Program and Clinical Results:
- The ROSELLA trial in platinum-resistant ovarian cancer met primary endpoints, showing a 30% reduction in disease progression risk with relacorilant, with an expected NDA submission in Q4 2025.
- The positive results support cortisol modulation's role in cancer treatment and expand Corcept's oncology portfolio.
Endocrinology Business and Market Growth:
- The number of Korlym prescriptions in Q1 2025 was nearly double compared to the same period in 2024, driven by increased screening and treatment of hypercortisolism.
- Growth is expected to continue, driven by the CATALYST study's results and the expansion of the sales force.
Pharmacy Operations and Business Impact:
- The first quarter results were affected by insufficient capacity at the pharmacy vendor, leading to delayed drug shipments to patients.
- The issue has been resolved, with March and April seeing record tablet dispenses, and Corcept is exploring a broader distribution network for relacorilant.
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