Corcept Therapeutics Incorporated · NASDAQ:CORT
Corcept Therapeutics — Q1 2025 Earnings Presentation
37 slides from Corcept Therapeutics's earnings presentation, May 5, 2025
Slide 1: May 2025
May 2025 PROPRIETARY – Do not republish, redistribute or modify without Corcept’s express written permission
Slide 2: Safe Harbor
Safe Harbor Statements in this presentation, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or
Slide 3: Discovering, developing and commercializing medications modulating cortisol
Discovering, developing and commercializing medications that treat severe diseases by modulating the effects of the stress hormone CORTISOL 3 May 2025 – PROPRIETARY – Do not republish, redistribute or modify without Corcept’s express written permission
Slide 4: Cortisol – The Stress Hormone
Cortisol – The Stress Hormone • Essential for life o Produced by the adrenal glands o Diurnal rhythm o Binds to receptors found in nearly every tissue type • Excess cortisol activity causes and exacerbates serious diseases • Korlym and our proprietary next-generation selective cortisol modulators co
Slide 5: Corcept's Model for Growth
Corcept’s Model for Growth Cash Generating c Operating Model Rich Collaborative Therapeutic Research & c c Platform Development 5 May 2025 – PROPRIETARY – Do not republish, redistribute or modify without Corcept’s express written permission
Slide 6: Cash Generating Operating Model
Cash Generating Operating Model In millions Revenue EBITDA1 $1,000 2025 guidance: $925 $900 - 950 Cash as of 3/31/25: $570.8M $800 $675 $600 $482 $402 $400 $354 $366 $307 $251 $199 $200 $159 $162 $169 $156 $157 $142 $113 $81 $66 $50 $10 $27 $17 $3 $3 $- $(31) $(36) $(22) $(200) 2012 (A) 2013 (A) 201
Slide 7: Rich Therapeutic Platform
Rich Therapeutic Platform Program Compound Stage of Development / Status Hypercortisolism (Cushing’s Syndrome) Pivotal Phase 3 / PDUFA target date of December 30, 2025 GRACE (all etiologies of hypercortisolism) Relacorilant Results presented at ENDO annual meeting and HiD conference in June 2024 GRA
Slide 8: Hypercortisolism (Cushing's Syndrome)
Hypercortisolism (Cushing’s Syndrome) • Highly morbid orphan disease • Hypercortisolism is caused by a tumor that produces cortisol or ACTH • Patients suffer a wide array of complications including: o Diabetes o Osteoporosis o Hypertension o Immune suppression o Central obesity o Altered mood o Musc
Slide 9: Hypercortisolism: Significant Unmet Need
Hypercortisolism: Significant Unmet Need • Nonspecific signs and symptoms can hinder screening and diagnosis • Surgery is the first-line treatment; 50% success rate; tumors not always found • Associated with substantial cardiometabolic morbidity, 4–5x increased mortality1–3, and 5–7x increased healt
Slide 10: Screening and Treatment of Patients with Hypercortisolism and Difficult-to-Control Type 2 Diabetes
Screening and Treatment of Patients with Hypercortisolism and Difficult-to-Control Type 2 Diabetes CATALYST • Randomized, double-blind, placebo-controlled, Phase 4 trial o Part 1: examining the prevalence of hypercortisolism in patients with _______difficult-to-control type 2 diabetes o Part 2: pati
Slide 11: Screening and Treatment of Patients with Hypercortisolism and Resistant Hypertension
Screening and Treatment of Patients with Hypercortisolism and Resistant Hypertension MOMENTUM • Examining the prevalence of hypercortisolism in patients with resistant hypertension • Planned enrollment: 1,000 patients • Results expected by year-end 2025 11 May 2025 – PROPRIETARY – Do not republish,
Slide 12: Commercial Capabilities Drive Hypercortisolism Business
Commercial Capabilities Drive Hypercortisolism Business • Deep understanding of hypercortisolism • A highly-skilled, experienced field organization o Focused on endocrinologists and diabetologists o Clinical specialists o Medical science liaisons • Support for patients o Corcept patient advocates o
Slide 13: Intellectual Property for Hypercortisolism
Intellectual Property for Hypercortisolism Korlym: • Method of use patents extending to 2038 • ANDAs submitted by Teva, Sun and Hikma o On December 29, 2023, the Federal District Court ruled that Teva's proposed product would not infringe Corcept patents o Corcept has appealed this decision to the F
Slide 14: Relacorilant: Pivotal Phase 3 GRACE Trial Met Primary Endpoint
Relacorilant: Pivotal Phase 3 GRACE Trial Met Primary Endpoint GRACE • Randomized withdrawal design o Open-label phase: 152 patients with hypercortisolism and either hypertension, hyperglycemia or both received relacorilant for 22 weeks o Randomized, double-blind withdrawal phase: patients who exhib
Slide 15: Open-label GRACE Results: Improvement in Hypertension
Open-label GRACE Results: Improvement in Hypertension • 63% of patients with hypertension met the study’s response criteria • Patients with hypertension who entered randomized withdrawal phase: mean improvement of 12.6 mm Hg in SBP and 8.3 mm Hg in DBP (p<0.0001) Rapid and Sustained Improvements in
Slide 16: Open-label GRACE Results: Improvement in Glucose Control
Open-label GRACE Results: Improvement in Glucose Control • 50% of patients with hyperglycemia met the study’s response criteria o Includes patients with diabetes and impaired glucose tolerance (or pre-diabetes) • Patients with hyperglycemia who entered randomized withdrawal phase: mean improvement o
Slide 17: Open-label GRACE Results: Body Composition, Quality of Life and Cognitive Assessments
Open-label GRACE Results: Significant Improvements in Body Composition, Quality of Life and Cognitive Assessments • Significant improvements in body composition with relacorilant • Significant improvements in quality of life and cognitive assessments with relacorilant BL: baseline; DXA: Dual Energy
Slide 18: Randomized Withdrawal GRACE Results: Primary Endpoint Met
Randomized Withdrawal GRACE Results: Primary Endpoint Met • Significantly more patients receiving placebo lost hypertension control compared to those who continued to receive relacorilant o Odds ratio = 0.17 for relacorilant vs. placebo (p=0.02) o Patients receiving relacorilant were 5.9x more likel
Slide 19: Relacorilant: Phase 3 GRADIENT Trial Design
Relacorilant: Phase 3 GRADIENT Trial Design GRADIENT • Multi-center, randomized, double-blind, placebo-controlled, 22-week study • 137 patients with hypercortisolism caused by adrenal adenomas • Primary endpoint: improvement compared to placebo in systolic blood pressure • Secondary endpoints: impro
Slide 20: GRADIENT Results Support Findings from Pivotal GRACE Trial
GRADIENT Results Support Findings from Pivotal GRACE Trial • Relacorilant arm: clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight and body composition compared to baseline o Placebo arm: neither clinically meaningful nor statistically significant
Slide 21: Phase 3 Long-Term Extension Study Demonstrates Durable Cardiometabolic Benefits
Phase 3 Long-Term Extension Study of Relacorilant Demonstrates Durable Cardiometabolic Benefits • Enrolled 116 patients from GRACE, GRADIENT or Phase 2 study of relacorilant in hypercortisolism • Relacorilant was well-tolerated; treatment duration of more than six years • Patients in the extension s
Slide 22: Relacorilant Safety Results
Relacorilant Safety Results • In all its studies, relacorilant has been well-tolerated, consistent with its known safety profile • No progesterone related side effects (including endometrial hypertrophy and drug-induced vaginal bleeding) • No relacorilant-induced: o Hypokalemia o Adrenal insufficien
Slide 23: Corcept: What's Next? Cortisol Modulation is a Rich Therapeutic Platform
Corcept: What’s Next? Cortisol Modulation is a Rich Therapeutic Platform 23 May 2025 – PROPRIETARY – Do not republish, redistribute or modify without Corcept’s express written permission
Slide 24: Cortisol Modulation's Therapeutic Potential
Cortisol Modulation’s Therapeutic Potential HYPERCORTISOLISM POST TRAUMATIC STRESS DISORDER Fleseriu (2012); Pivonello (2021); Buse (2025) Pitman (2010) OVARIAN CANCER ALCOHOL DEPENDENCE Colombo (2023) Higley (2011) PROSTATE CANCER ALZHEIMER’S DISEASE Kapoor (2012); Ligr (2012) Huang (2009); Canet (
Slide 25: Corcept Oncology Program: Mechanisms of Action
Corcept Oncology Program: Mechanisms of Action Combining a cortisol receptor antagonist with an anti-cancer agent makes it more difficult for tumor cells to survive Apoptosis Growth Pathway Immunosuppression Cortisol is Cortisol provides a Cortisol suppresses the anti-apoptotic growth pathway for im
Slide 26: Anti-Tumor Activity Observed in Relacorilant Phase 1 Trial in Ovarian Cancer
Anti-Tumor Activity Observed in Relacorilant Phase 1 Trial in Ovarian Cancer and Other Solid Tumors Ovarian Cancer Other Solid Tumors 380 388 396 Munster et al. Clin Cancer Res. 2022. Munster et al. Clin Cancer Res. 2022. * Patient with vulvar SCC transitioned to a Single Patient Expanded Access stu
Slide 27: Significant Unmet Need in Platinum-Resistant Ovarian Cancer
Significant Unmet Need in Platinum-Resistant Ovarian Cancer ~21,000 newly diagnosed cases of ovarian cancer annually in the United States1 Diagnosis • Approximately 20,000 1L Ovarian Cancer women with Carboplatin + taxane +/- bevacizumab +/- maintenance with bevacizumab and/or PARP inhibitor platinu
Slide 28: Pivotal ROSELLA Trial in Platinum-Resistant Ovarian Cancer Met Primary Endpoint
Pivotal ROSELLA Trial in Platinum-Resistant Ovarian Cancer Met Primary Endpoint • 381 patients enrolled in sites across the US, Europe, South Korea, Brazil, Argentina, Canada and Australia o Patients were randomized 1:1 to relacorilant + nab-paclitaxel or nab-paclitaxel alone • Primary endpoint of i
Slide 29: BELLA: Phase 2 Trial in Platinum-Resistant Ovarian Cancer
BELLA: Phase 2 Trial in Platinum-Resistant Ovarian Cancer BELLA • Single-arm, open-label trial in platinum-resistant ovarian cancer o BELLA will assess if relacorilant + nab-paclitaxel + bevacizumab offers another potent treatment option for patients with platinum-resistant ovarian cancer • Planned
Slide 30: Amyotrophic Lateral Sclerosis (ALS): Significant Unmet Need
Amyotrophic Lateral Sclerosis (ALS): Significant Unmet Need • ~25,000 people living with ALS in the United States; more than 30,000 in Europe o More than 10,000 newly diagnosed each year in the United States and Europe • Mean survival time of 2-5 years after diagnosis • Few treatment options Dazucor
Slide 31: MASH: Significant Unmet Need
Metabolic Dysfunction-Associated Steatohepatitis (MASH): Significant Unmet Need • MASH is a severe liver disorder that afflicts many millions of patients globally and increases the risk of liver-related morbidity and mortality • Heterogeneous disease with few treatment options 31 May 2025 – PROPRIET
Slide 32: Miricorilant: Prevents and Treats Fatty Liver Disease in Animal Models
Miricorilant: Prevents and Treats Fatty Liver Disease in Animal Models Mouse model of fatty liver prevention: • Control mice: high fat diet and no drug for 21 days • Miricorilant treated mice: high fat diet and miricorilant for 21 days Control mice Miricorilant treated mice Liver lipids, % control 1
Slide 33: Miricorilant: Prevents and Treats Fatty Liver Disease in Animal Models
Miricorilant: Prevents and Treats Fatty Liver Disease in Animal Models 200 p<0.01* 180 160 TG (nm ol/mg protein) 140 p<0.05* 120 100 80 p<0.01** 60 40 20 0 CHOW HF-3wks HF-6wks HF-miricorilant rev * vs. CHOW ** vs. HF – 6 weeks Miricorilant reverses lipid accumulation in the liver Koorneef et al. En
Slide 34: Miricorilant: Promising Phase 1b Results, Phase 2b Trial Underway
Miricorilant: Promising Phase 1b Results, Phase 2b Trial Underway • Phase 1b results (100 mg miricorilant taken orally twice weekly for 12 weeks): o ~30% reduction in liver fat o Improved liver health as well as key metabolic and lipid measures o Very well-tolerated • MONARCH Phase 2b trial enrollin
Slide 35: Academic Collaborations Inform and Augment Our Development Efforts
Academic Collaborations Inform and Augment Our Development Efforts ONCOLOGIC CARDIOVASCULAR METABOLIC PSYCHIATRIC Mifepristone Clinical Research: Mifepristone and/or New Chemical Entity Mifepristone Clinical Research: Mifepristone Clinical Research: • Triple-negative breast cancer Basic Science Rese
Slide 36: Corcept's Model for Growth
Corcept’s Model for Growth Cash Generating c Operating Model Rich Collaborative Therapeutic Research & c c Platform Development 36 May 2025 – PROPRIETARY – Do not republish, redistribute or modify without Corcept’s express written permission
Slide 37: Thank You
THANK YOU 37 May 2025 – PROPRIETARY – Do not republish, redistribute or modify without Corcept’s express written permission