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- **Revenue Growth**: Q3 2025 revenue $207.6M (+19% YoY); 2025 guidance $800M-$850M
- **FDA Milestones**: relacorilant approvals expected Dec 2025 (hypercortisolism), Jul 2026 (ovarian cancer)
- **Patient Expansion**: 3,250 active Korlym patients (+42% YoY); transitioning to new pharmacy network
- **Oncology Breakthrough**: ROSELLA trial shows relacorilant + nab-paclitaxel improves ovarian cancer survival
- **Future Potential**: $3B-$5B annual target for relacorilant; Phase III ALS trial planned for 2026

**【CFO Financial Remarks】**
- Q3 2025 revenue: $207.6M (19% YoY growth); updated 2025 guidance: $800M-$850M
- Net income: $19.7M (45% YoY decline); cash & investments: $524M (includes $50M stock buyback)
- Gross margin remains stable despite 75% of sales on authorized generic (30% discount to Korlym list price)

**【Patent Litigation Update】**
- Ongoing appeal against Teva's generic Korlym; Federal Circuit decision pending
- If successful, Teva's generic would lose FDA approval until 2037 patent expiry

**【Endocrinology Division Update】**
- Korlym prescriptions up 42% YoY; 3,250 active patients at Q3 end
- Transitioning to new pharmacy (Curant) with 25+ years of orphan drug experience
- Planning to add 2 more pharmacies by Q1 2026 to handle relacorilant launch

**【CEO Strategic Overview】**
- Key FDA dates: relacorilant for hypercortisolism (Dec 30, 2025 PDUFA); ovarian cancer (Jul 11, 2026)
- CATALYST trial shows 25% of diabetic patients have hypercortisolism; Korlym reduces HbA1c by 1.47% vs placebo
- $3B-$5B annual revenue target for relacorilant in hypercortisolism

**【CDO Oncology Pipeline】**
- Ovarian cancer: ROSELLA trial shows relacorilant + nab-paclitaxel improves PFS & OS
- New studies launching: 
  - BELLA trial (relacorilant + bevacizumab in platinum-sensitive ovarian)
  - Phase II in endometrial & cervical cancers
  - Phase Ib with PD-1 inhibitor nivolumab
- ALS Phase III planned for mid-2026 after DAZALS trial showed 84% mortality risk reduction

Corcept Therapeutics Incorporated (CORT) Q3 2025 Earnings Call Transcript

- **Revenue Growth Strong:** Q2 revenue $194.4M (+19% YoY), guided to $850-900M for 2025.
- **Hyper Cortisolism Expansion:** CATALYST trial results driving 49% tablet growth; relacorilant projected to generate $3-5B annually.
- **Ovarian Cancer Breakthrough:** ROSELLA trial shows 30% PFS improvement, NDA filed with PDUFA 12/30/25.
- **Pipeline Momentum:** ALS survival benefit (84% death risk reduction), NASH Phase IIb trial, and prostate cancer combo trials.
- **Key Risk:** Pharmacy capacity constraining near-term growth, resolved by Q4 2025.

**【CFO Financial Remarks】**
- Q2 2025 revenue: $194.4 million (19% YoY growth). Updated 2025 guidance: $850-900 million.
- Net income: $35.1 million (stable YoY). Cash balance: $515 million post $115 million share buyback.
- Key driver: Endocrinology division growth, offset by AG pricing discounts (30% avg vs. Korlym list price).

**【Endocrinology Division Update】**
- Korlym tablets shipped +49% YoY; Q2 revenue growth underperformed due to pharmacy capacity constraints (-$15M impact).
- New prescribers/prescriptions at record highs; CATALYST trial results driving awareness (1 in 4 diabetic patients with hypercortisolism).
- Transitioning to AG: 67% of business now on AG, stabilizing at ~70% by year-end.
- Second pharmacy onboarding Q4 to support relacorilant launch (PDUFA 12/30/25).

**【Patent Litigation Update】**
- Federal Circuit oral argument (7/7/25) on Teva generic Korlym infringement; decision expected Q3-Q4.
- If upheld, Teva approval blocked until 2037 patent expiry.
- Company confident in legal position, prioritizing resolution.

**【CEO Strategic Update】**
- **Hyper Cortisolism:**
  - CATALYST trial shows Korlym reduces HbA1c by 1.47% vs. 0.15% placebo (p<0.001). Relacorilant NDA supported by GRACE/GRADIENT trials.
  - Projected $3-5B annual relacorilant revenue in hypercortisolism by 2030.
- **Ovarian Cancer:**
  - ROSELLA trial: relacorilant + nab-paclitaxel reduces progression risk by 30% (HR 0.7, p=0.008) and extends OS to 16 vs. 11.5 months (p=0.01).
  - NDA filed; targeting $1B+ annual revenue in oncology.
- **Pipeline Expansion:**
  - ALS: DAZALS trial shows 84% reduction in death risk at 12 months (p=0.0009).
  - NASH: Phase IIb MONARCH trial enrolling; miricorilant shows rapid liver fat reduction.
  - Prostate cancer: Phase II trial with enzalutamide evaluating cortisol receptor antagonism.

**【Q&A Highlights】**
- **Supply Chain:**
  - Q2 pharmacy capacity improved but still lagging demand. Second pharmacy to contribute Q4.
  - Prescribe-to-fill gap narrowed but remains significant (~$15M Q2 impact).
- **Litigation Risk:**
  - No material impact on $3-5B hypercortisolism forecast if Teva appeal fails.
- **Oncology Expansion:**
  - BELLA trial enrolling for platinum-sensitive ovarian cancer. Exploring combinations with immunotherapy/ADCs.
- **ALS Regulatory Path:**
  - FDA meeting scheduled for August to discuss potential accelerated approval or confirmatory trial design.

Corcept Therapeutics Incorporated (CORT) Q2 2025 Earnings Call Transcript

- **Revenue growth acceleration**: Q1 2025 revenue up 12.7% YoY to $157.2M, guided to $900-950M for 2025.
- **Korlym momentum**: Prescriptions up 97% YoY, CATALYST study shows 25% of diabetics have hypercortisolism.
- **Oncology breakthrough**: Relacorilant improves PFS by 30% and OS by 40% in ovarian cancer, NDA expected Q4 2025.
- **Pipeline expansion**: 5+ Phase 2+ programs in ALS, liver disease, and solid tumors.
- **Operational fix**: Pharmacy capacity issues resolved, tablets dispensed up 200% QoQ in Q1.

**【CFO Financial Summary】**
- Q1 2025 revenue: $157.2M (12.7% YoY growth), reiterating 2025 guidance of $900-950M.
- Net income: $20.5M (26.3% YoY decline), driven by higher R&D expenses.
- Cash & investments: $570.8M, with $43M in share buybacks.

**【Endocrinology Division Update】**
- Korlym prescriptions +97% YoY, new prescribers +108% YoY.
- CATALYST study: 25% of poorly controlled diabetics have hypercortisolism; Korlym reduced HbA1c by 1.47% vs. 0.15% placebo (p<0.0001).
- Pharmacy vendor capacity issues resolved in March/April, tablets dispensed up 200% QoQ.

**【Oncology Pipeline Highlights】**
- Relacorilant (ovarian cancer): Phase 3 ROSELLA showed 30% PFS improvement (HR 0.70, p=0.008) and 40% OS improvement (HR 0.69, p=0.01).
- Phase 2b BELLA trial combining with bevacizumab underway.
- ALS program: Dazucorilant showed 6x survival benefit in 300mg arm (HR 0.16, p=0.0009).
- MASH program: Miricorilant reduced liver fat 30% in Phase 1b, Phase 2b MONARCH enrolling.

**【Key Q&A Takeaways】**
- Pharmacy vendor scaled staffing to handle +150% QoQ volume; no bolus expected, growth will be steady.
- Relacorilant positioned as first-line for platinum-resistant ovarian cancer, ahead of Elahere.
- FDA advisory committee unlikely for hypercortisolism NDA; oncology NDA expected Q4 2025.
- ALS program seeking regulatory feedback on accelerated approval path.


Corcept Therapeutics (CORT)-5 May 25-2025 Q1 Earnings call transcript

- **Revenue surge**: 40% YoY growth to $675M, 2025 guided to $900-950M
- **Relacorilant breakthrough**: Phase III shows 6x better BP control, 6-year durability
- **Ovarian cancer hope**: ROSELLA trial dual endpoints with 20% survival benefit
- **Market expansion**: $3-5B market by 2030 as 1/4 diabetics diagnosed with hypercortisolism

**【CFO Financial Summary】**
- 2024 revenue: $675 million (40% YoY growth)
- 2025 revenue guidance: $900-950 million
- Net income: $141 million (33% YoY growth)
- Cash and investments: $603 million (up from $425 million)
- Stock buybacks: $38 million in 2024

**【Legal Update】**
- Ongoing patent litigation against Teva
- Federal Circuit appeal pending
- Oral argument expected May 2025, decision 3-4 months later
- If successful, Teva product would lose FDA approval until 2037

**【CEO Business Overview】**
- Korlym: Record Q4 prescribers and patients
- Relacorilant NDA submitted Dec 2024
  - GRACE Phase III: 152 patients, 6x better BP control vs placebo
  - Long-term extension: 6-year durability of cardiometabolic benefits
- Ovarian cancer trial (ROSELLA): 381 pts, PFS endpoint expected Q2
- ALS trial: 249 pts, 300mg dose showed 20% survival benefit
- MASH trial (miricorilant): 30% liver fat reduction, no GI side effects

**【Clinical Trial Updates】**
- ROSELLA: Dual primary endpoints (PFS & OS) with 0.04/0.01 p-values
- CATALYST: 1/4 diabetics have hypercortisolism, Korlym reduced HbA1c by 1.47%
- MOMENTUM study launching Q2 to assess hypertension prevalence

**【Analyst Q&A Highlights】**
- NDA timeline: FDA 60-day review period ending soon
- ROSELLA statistical design: 2 shots on goal (PFS/OS), alpha recycling
- Market growth: $3-5 billion by 2030 driven by hypercortisolism awareness
- Korlym supply chain issues resolved for 2025 growth

Corcept Therapeutics (CORT)-26 Feb 25-2024 Q4 Earnings call transcript

Corcept Therapeutics (CORT)-30 Oct 24-2024 Q3 Earnings call transcript

Corcept Therapeutics (CORT)-29 Jul 24-2024 Q2 Earnings call transcript

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