C

Corcept Therapeutics Incorporated

40.826.41 %$CORT
NASDAQ
Healthcare
Biotechnology
Price History
-10.67%

Company Overview

Business Model: Corcept Therapeutics Incorporated is a commercial-stage biopharmaceutical company focused on the discovery and development of medications for severe endocrinologic, oncologic, metabolic, and neurologic disorders through the modulation of cortisol effects. The Company's primary revenue is generated from the sale of Korlym (mifepristone) 300 mg Tablets and an authorized generic version of Korlym in the United States for the treatment of hypercortisolism (Cushing's syndrome). Market Position: Corcept Therapeutics Incorporated holds a competitive position in the hypercortisolism market with its marketed product, Korlym, and its authorized generic. The Company is actively developing relacorilant, a proprietary selective cortisol modulator, as a next-generation treatment for hypercortisolism, aiming to offer a superior safety profile by avoiding progesterone receptor (PR)-related side effects. Corcept Therapeutics Incorporated also maintains a robust research and development pipeline with over 1,000 proprietary selective cortisol modulators targeting a wide range of serious disorders. Recent Strategic Developments:

  • Product Launch: In June 2024, Corcept Therapeutics Incorporated made available an authorized generic version of Korlym for the treatment of hypercortisolism.
  • Regulatory Submission: In December 2024, the Company submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for relacorilant as a treatment for endogenous hypercortisolism, supported by positive results from its pivotal GRACE trial, Phase 3 GRADIENT trial, Phase 3 long-term extension study, and Phase 2 study.
  • Clinical Trial Progress:
    • Completed enrollment in the pivotal Phase 3 ROSELLA trial for relacorilant combined with nab-paclitaxel in patients with platinum-resistant ovarian cancer (381 women).
    • Initiated the randomized, double-blind, placebo-controlled Phase 2b MONARCH trial in October 2023 for miricorilant in patients with Metabolic dysfunction-associated steatohepatitis (MASH), with two cohorts totaling 195 patients.
    • The Phase 2 DAZALS trial for dazucorilant in Amyotrophic Lateral Sclerosis (ALS) did not meet its primary endpoint, but an open-label, long-term extension study with 118 patients is continuing, with overall survival to be assessed in March 2025.
  • Market Education: The 2024 CATALYST study demonstrated a 23.8% prevalence of hypercortisolism in patients with difficult-to-control diabetes, with Korlym showing a clinically meaningful and statistically significant improvement in hemoglobin A1c. Geographic Footprint: Corcept Therapeutics Incorporated primarily conducts its commercial operations in the United States. Its clinical development programs and intellectual property portfolio have international reach, with foreign patents issued in Europe, Japan, China, Canada, and Australia. Relacorilant has received orphan drug designation in both the United States and the European Union. The Company has a wholly owned subsidiary, Corcept Therapeutics UK Limited, incorporated in the United Kingdom. Corporate facilities are leased in Redwood City, California.

Financial Performance

Revenue Analysis

MetricCurrent Year (2024)Prior Year (2023)Change
Total Revenue$675.0 million$482.4 million+39.9%
Gross Profit$664.1 million$475.9 million+39.5%
Operating Income$137.0 million$107.3 million+27.7%
Net Income$141.2 million$106.1 million+33.0%

Profitability Metrics (2024):

  • Gross Margin: 98.4%
  • Operating Margin: 20.3%
  • Net Margin: 20.9%

Investment in Growth (2024):

  • R&D Expenditure: $246.9 million (36.6% of revenue)
  • Capital Expenditures: $2.2 million
  • Strategic Investments: Not explicitly detailed beyond R&D expenditures.

Business Segment Analysis

Corcept Therapeutics Incorporated operates as a single operating segment focused on the discovery, development, and commercialization of pharmaceutical products. However, the Company provides a breakdown of its research and development expenses by program, reflecting its strategic focus areas.

Hypercortisolism (Cushing’s Syndrome) Program

Financial Performance:

  • R&D Expenditure: $65.2 million (+58.3% YoY from $41.2 million in 2023)
  • Key Growth Drivers: The primary driver is the advancement of relacorilant, a proprietary selective cortisol modulator, as a potential treatment for hypercortisolism. The NDA submission in December 2024 was based on positive results from the GRACE, GRADIENT, Phase 3 long-term extension, and Phase 2 trials, which demonstrated clinically meaningful and statistically significant improvements in hypertension, glucose control, weight, and body composition, with a favorable safety profile (no PR affinity, no hypokalemia, no QT prolongation). The CATALYST study data is expected to aid in identifying undiagnosed patients. Product Portfolio:
  • Korlym (mifepristone) 300 mg Tablets: Marketed in the United States since 2012.
  • Authorized generic version of Korlym: Made available in June 2024.
  • Relacorilant: Proprietary, selective cortisol modulator, NDA submitted to the FDA in December 2024 for endogenous hypercortisolism. It has received orphan drug designation in both the United States and the European Union. Market Dynamics:
  • The market for hypercortisolism treatments is competitive, with established treatments including surgery, radiation, and other medications such as Signifor (pasireotide) Injection, Isturisa (osilodrostat), and Recorlev (levoketoconazole), as well as off-label uses of generic medications like ketoconazole.
  • A significant portion of patients with hypercortisolism remain undiagnosed or inadequately treated. Relacorilant aims to differentiate itself by offering a treatment that avoids the PR-related side effects and other serious adverse events (hypokalemia, QT prolongation) associated with existing therapies.

Oncology Program

Financial Performance:

  • R&D Expenditure: $52.7 million (+27.2% YoY from $41.4 million in 2023)
  • Key Growth Drivers: The program is driven by the potential of cortisol modulation to improve outcomes in various cancers. Enrollment is complete in the pivotal Phase 3 ROSELLA trial for relacorilant combined with nab-paclitaxel in platinum-resistant ovarian cancer. Product Portfolio:
  • Relacorilant: In pivotal Phase 3 ROSELLA trial for platinum-resistant ovarian cancer (combined with nab-paclitaxel).
  • Relacorilant: Completed an open-label Phase 1b trial with pembrolizumab in 14 patients with metastatic or unresectable adrenal cancer with cortisol excess. Patients showed significant improvements in hypercortisolism symptoms, but tumor progression did not slow.
  • Relacorilant: In a randomized, placebo-controlled Phase 2 trial with enzalutamide in patients with prostate cancer, pre-prostatectomy, in collaboration with the University of Chicago. Market Dynamics:
  • Substantial evidence suggests that cortisol activity at the glucocorticoid receptor (GR) can reduce the efficacy of anti-cancer therapies and promote tumor growth. Corcept Therapeutics Incorporated's strategy is to modulate cortisol activity to enhance anti-cancer treatment effects, particularly in solid tumors expressing the GR, such as ovarian, adrenal, and prostate cancer.

Metabolic Diseases Program

Financial Performance:

  • R&D Expenditure: $40.1 million (+11.1% YoY from $36.1 million in 2023)
  • Key Growth Drivers: The program is focused on miricorilant as a potential treatment for Metabolic dysfunction-associated steatohepatitis (MASH), an advanced form of fatty liver disease. A Phase 1b trial identified a dosing regimen that reduced liver fat, improved liver health, and key metabolic and lipid measures, and was well-tolerated. Product Portfolio:
  • Miricorilant: A selective cortisol modulator, currently in a randomized, double-blind, placebo-controlled Phase 2b MONARCH trial for patients with MASH. Cohort A (120 patients) focuses on liver fat reduction, MASH resolution, and fibrosis improvement over 48 weeks. Cohort B (75 patients) focuses on liver fat reduction over 24 weeks. Market Dynamics:
  • MASH affects millions of patients and is a leading cause of liver-related mortality, representing a significant unmet medical need.

Pre-clinical and Early-stage Selective Cortisol Modulators and ALS Program

Financial Performance:

  • R&D Expenditure: $41.0 million (+33.0% YoY from $30.9 million in 2023)
  • Key Growth Drivers: Continued discovery and advancement of new selective cortisol modulators (over 1,000 compounds in four distinct series). The ongoing open-label, long-term extension study for dazucorilant in ALS patients. Product Portfolio:
  • Dazucorilant: A selective cortisol modulator that improved motor performance and reduced neuroinflammation and muscular atrophy in an animal model of ALS. The Phase 2 DAZALS trial in 249 patients did not meet its primary endpoint (change from baseline in ALS Functional Rating Scale-Revised). However, an open-label, long-term extension study with 118 patients is continuing, with overall survival to be assessed in March 2025. Dazucorilant has Fast Track Designation and orphan drug status for ALS in the United States.
  • Over 1,000 proprietary selective cortisol modulators: These compounds potently bind to the GR but not the progesterone, estrogen, or androgen receptors, offering a broad pipeline for future development across various disorders. Market Dynamics:
  • ALS is a devastating neuromuscular illness with a high unmet need for effective treatments. The Company's broad portfolio of selective cortisol modulators provides a foundation for addressing a wide range of serious disorders.

Capital Allocation Strategy

Shareholder Returns:

  • Share Repurchases: In 2024, Corcept Therapeutics Incorporated purchased 0.5 million shares of common stock for $15.7 million under its Stock Repurchase Program. Additionally, $22.3 million was used to satisfy tax withholding requirements for net settlement of cashless option exercises and vesting of restricted stock grants.
  • Dividend Payments: Corcept Therapeutics Incorporated has never declared or paid cash dividends and does not anticipate doing so in the foreseeable future.
  • Future Capital Return Commitments: In January 2024, the Board of Directors authorized the repurchase of up to $200 million of common stock under the Stock Repurchase Program.

Balance Sheet Position (as of December 31, 2024):

  • Cash and Equivalents: $127.7 million
  • Total Debt: No traditional long-term debt is disclosed. Current liabilities totaled $140.8 million, and a long-term operating lease liability was $6.1 million.
  • Net Cash Position: $603.2 million (comprising cash, cash equivalents, and marketable securities).
  • Credit Rating: Not disclosed.
  • Debt Maturity Profile: Not applicable as no traditional debt is disclosed. Marketable securities are limited to maturities of less than three years, with a weighted-average maturity of nine months.

Cash Flow Generation (2024):

  • Operating Cash Flow: $198.1 million
  • Free Cash Flow: Approximately $195.9 million (Operating Cash Flow of $198.1 million minus Capital Expenditures of $2.2 million).
  • Cash Conversion Metrics: Not explicitly detailed in the filing.

Operational Excellence

Production & Service Model: Corcept Therapeutics Incorporated relies on a network of contract manufacturers for the production of its active pharmaceutical ingredients (API), tablet manufacturing, and bottling of its products and product candidates. For commercial distribution in the United States, the Company utilizes a single specialty pharmacy and a specialty distributor.

Supply Chain Architecture: Key Suppliers & Partners:

  • API Manufacturers: Agreements are in place for the supply of mifepristone, the active ingredient in Korlym. Corcept Therapeutics Incorporated maintains significant quantities of API in its inventory.
  • Tablet Manufacturers: Contracted for the production and bottling of tablets.
  • Specialty Pharmacy: Optime Care, Inc. - serves as the exclusive specialty pharmacy distributor for Corcept Therapeutics Incorporated's products in the United States, providing comprehensive pharmacy operations, patient intake, access and reimbursement services, patient support, claims management, and accounts receivable. The agreement with Optime Care, Inc. was extended through March 31, 2027, with automatic three-year renewals.
  • Specialty Distributor: Used for product distribution.
  • Clinical Research Organizations (CROs): Syneos Health assists with the ROSELLA trial, and Medpace Research assists with the MONARCH trial.

Facility Network:

  • Manufacturing: The Company does not own manufacturing facilities, relying entirely on contract manufacturers.
  • Research & Development: No specific R&D centers are detailed beyond general R&D activities.
  • Distribution: Handled through the specialty pharmacy (Optime Care, Inc.) and a specialty distributor.
  • Corporate Facilities: Corcept Therapeutics Incorporated leases 50,632 square feet of office space in Redwood City, California, which became its new headquarters effective August 1, 2024. The current lease expires in June 2030.

Operational Metrics:

  • Cost of sales as a percentage of revenue increased to 1.6% in 2024, up from 1.3% in 2023, primarily driven by increased manufacturing and distribution costs.

Market Access & Customer Relationships

Go-to-Market Strategy: Distribution Channels:

  • Direct Sales: Utilizes sales representatives to engage with physicians who care for patients with hypercortisolism.
  • Channel Partners: Employs a field-based force of medical science liaisons. Relies on Optime Care, Inc. as its exclusive specialty pharmacy and a specialty distributor for product distribution and logistical support in the United States.
  • Digital Platforms: Not explicitly detailed as a primary sales channel.

Customer Portfolio: Enterprise Customers:

  • Tier 1 Clients: Focuses on physicians and healthcare providers treating patients with hypercortisolism.
  • Strategic Partnerships: Has licensed patents from the University of Chicago for the use of cortisol modulators in certain cancer treatments.
  • Customer Concentration: Revenue collection is highly concentrated with Optime Care, Inc., which collects payments from insurers representing over 99% of Corcept Therapeutics Incorporated's revenue. Receivables risk is diversified across various third-party payers, including pharmacy benefit managers, insurance companies, government programs, and private charities.

Geographic Revenue Distribution:

  • United States: Primary market for product sales.
  • Growth Markets: Not explicitly detailed in the filing.

Competitive Intelligence

Market Structure & Dynamics

Industry Characteristics: The Company operates in the biopharmaceutical sector, focusing on severe endocrinologic, oncologic, metabolic, and neurologic disorders. The hypercortisolism market, where Corcept Therapeutics Incorporated's primary product competes, is characterized by a significant number of undiagnosed or inadequately treated patients. Drug development and commercialization in this sector are subject to extensive regulatory oversight and high costs.

Competitive Positioning Matrix:

Competitive FactorCompany PositionKey Differentiators
Technology LeadershipStrongProprietary portfolio of over 1,000 selective cortisol modulators that bind to the glucocorticoid receptor (GR) but not the progesterone receptor (PR), aiming to avoid PR-related side effects.
Market ShareCompetitiveKorlym (and its authorized generic) competes with established and newer treatments for hypercortisolism. Relacorilant is positioned to capture market share with an improved safety profile.
Cost PositionNot explicitly statedThe Company has introduced an authorized generic version of Korlym. No specific cost advantages over competitors are detailed.
Customer RelationshipsStrong/DevelopingPatient support programs and donations to independent charitable foundations ensure patient access to hypercortisolism care, regardless of financial ability. Educational programs for physicians and patients are in place to improve diagnosis and treatment.

Direct Competitors

Primary Competitors (for hypercortisolism):

  • Recordati S.p.A.: Markets Signifor (pasireotide) Injection and Isturisa (osilodrostat) tablets for Cushing's disease and hypercortisolism.
  • Xeris Biopharma Holdings, Inc.: Markets Recorlev (levoketoconazole) for hypercortisolism.
  • Generic Manufacturers: Teva Pharmaceuticals USA, Inc. launched a generic version of Korlym in January 2024. Litigation settlements with Sun and Hikma allow them to sell generic mifepristone under certain conditions.
  • Off-label treatments: Generic medications such as ketoconazole are prescribed off-label for hypercortisolism.

Emerging Competitive Threats:

  • The entry of generic versions of Korlym poses a significant competitive threat, potentially reducing revenue and market share.

Competitive Response Strategy:

  • Corcept Therapeutics Incorporated is developing relacorilant, a selective cortisol modulator, to offer a differentiated product with a superior safety profile compared to Korlym and other existing treatments.
  • The Company vigorously enforces its intellectual property rights, as evidenced by ongoing patent litigation against Teva Pharmaceuticals USA, Inc.
  • Corcept Therapeutics Incorporated launched its own authorized generic version of Korlym to compete in the generic market.

Risk Assessment Framework

Strategic & Market Risks

Market Dynamics:

  • Competition: The availability of generic versions of Korlym, including from Teva Pharmaceuticals USA, Inc., Sun, and Hikma, and competition from other approved and off-label treatments for hypercortisolism, could adversely affect revenue and financial results.
  • Pricing and Reimbursement: New laws, government regulations (e.g., Inflation Reduction Act of 2022), or changes to existing laws could make it difficult to obtain acceptable prices or adequate insurance coverage and reimbursement for products, potentially limiting revenue.
  • Public Perception of Mifepristone: Public perception of mifepristone, the active ingredient in Korlym, due to its use in pregnancy termination, or legislation restricting its distribution, could limit the ability to sell products.
  • Customer Concentration: Dependence on a single specialty pharmacy, Optime Care, Inc., for product dispensing and collection of over 99% of revenue, poses a risk if Optime Care, Inc. fails to perform its obligations or meet regulatory requirements.

Operational & Execution Risks

Supply Chain Vulnerabilities:

  • Supplier Dependency: Reliance on contract manufacturers for API and finished product manufacturing, and on Optime Care, Inc. for distribution, creates dependency risks. Failure of these vendors to perform or comply with regulations (cGMPs) could disrupt supply and clinical trials.
  • Geographic Concentration: Not explicitly detailed as a specific risk beyond general natural disaster exposure.
  • Capacity Constraints: Not explicitly detailed.

Financial & Regulatory Risks

Market & Financial Risks:

  • Capital Needs: The Company may require additional capital to fund operations or for strategic reasons, and such funding may not be available on acceptable terms or at all.
  • Stock Price Volatility: The price of common stock fluctuates widely due to factors such as operating results, clinical trial outcomes, regulatory approvals, intellectual property disputes, and general market conditions.
  • Tax Law Changes: Changes in federal, state, and local tax laws, such as the Tax Cuts and Jobs Act of 2017's R&D amortization requirement, may increase tax payments and reduce net earnings. Regulatory & Compliance Risks:
  • Regulatory Approval & Compliance: Failure to obtain or maintain regulatory approvals for product candidates, or non-compliance with extensive pre- and post-approval regulations (FDA, EMA, MHRA, cGMPs, GCPs), could prevent commercialization or lead to penalties.
  • Marketing & Promotion: Risk of civil or criminal penalties if marketing of products violates FDA regulations (e.g., off-label promotion) or healthcare fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA).
  • Legal Proceedings: Ongoing patent litigation with Teva Pharmaceuticals USA, Inc., antitrust litigation, shareholder derivative complaints, and a records subpoena from the United States Attorney’s Office for the District of New Jersey, pose risks of significant costs, adverse outcomes, and reputational harm.
  • Data Privacy: Compliance with numerous and evolving state, federal, and foreign data privacy and security laws (e.g., HIPAA, CCPA, GDPR, UK GDPR) is complex and costly. Failure to comply or data breaches could result in significant penalties, litigation, and reputational damage.

Geopolitical & External Risks

Geopolitical Exposure:

  • Geographic Dependencies: Not explicitly detailed beyond general international regulatory approvals.
  • Trade Relations: Potential impact of tariffs on materials used in operations.
  • Sanctions & Export Controls: Not explicitly detailed. Natural Disasters: Vulnerability to natural disasters (e.g., earthquakes, fires, extreme weather, pandemics like COVID-19) which could disrupt commercial and clinical activities, damage facilities, or impact vendors and employees.

Innovation & Technology Leadership

Research & Development Focus: Core Technology Areas:

  • Selective Cortisol Modulators: Corcept Therapeutics Incorporated's core focus is the discovery and development of proprietary selective cortisol modulators. These compounds are designed to potently bind to the glucocorticoid receptor (GR) but not the progesterone receptor (PR), thereby avoiding PR-related side effects.
  • Investment Level: Research and development expenditure was $246.9 million in 2024, representing 36.6% of total revenue, indicating a significant commitment to innovation. Innovation Pipeline:
  • Relacorilant: Lead compound in late-stage development for hypercortisolism (NDA submitted) and platinum-resistant ovarian cancer (Phase 3). Also in Phase 2 for prostate cancer.
  • Miricorilant: In Phase 2b for Metabolic dysfunction-associated steatohepatitis (MASH).
  • Dazucorilant: In an open-label, long-term extension study for Amyotrophic Lateral Sclerosis (ALS).
  • Early-stage Compounds: The Company has discovered over 1,000 proprietary selective cortisol modulators across four structurally distinct series, with promising compounds continually advanced towards clinical development.

Intellectual Property Portfolio:

  • Patent Strategy: Corcept Therapeutics Incorporated owns U.S. composition of matter patents for its next-generation cortisol modulators, with expiration dates ranging from 2025 to 2041. Foreign counterparts exist in Europe, Japan, China, Canada, and Australia. The Company also holds U.S. and foreign method of use patents for its selective cortisol modulators in various disorders, including hypercortisolism and cancers. U.S. method of use patents for Korlym expire between 2028 and 2038.
  • Licensing Programs: The Company has exclusively licensed U.S. patents from the University of Chicago for the use of cortisol modulators in treating triple-negative breast cancer and castration-resistant prostate cancer, with these licenses expiring in 2031 and 2033, respectively.
  • IP Litigation: Corcept Therapeutics Incorporated is actively involved in an appeal against Teva Pharmaceuticals USA, Inc. regarding the infringement of its Korlym patents.

Technology Partnerships:

  • Strategic Alliances: Collaborates with independent academic investigators and institutions, such as the University of Chicago, to advance the understanding and potential utility of cortisol modulation in a wide range of disorders.

Leadership & Governance

Executive Leadership Team

PositionExecutiveTenurePrior Experience
Chief Executive OfficerJoseph K. Belanoff, M.D.Not explicitly disclosedSigned 2008 Severance and Change in Control Agreement
Chief Financial OfficerAtabak MokariNot explicitly disclosedEmployment offer letter dated March 1, 2021
Chief Development OfficerWilliam GuyerNot explicitly disclosedEmployment offer letter dated July 2, 2021
Chief Accounting and Technology OfficerJoseph Douglas LyonNot explicitly disclosedSigned 2020 Severance and Change in Control Agreement
President of Corcept EndocrinologySean MaduckNot explicitly disclosedSigned 2020 Severance and Change in Control Agreement
Chief Business OfficerJames N. WilsonNot explicitly disclosedSigned 2008 Severance and Change in Control Agreement
Chief Legal OfficerHazel HuntNot explicitly disclosedSigned 2020 Severance and Change in Control Agreement

Leadership Continuity: Corcept Therapeutics Incorporated emphasizes hiring, retaining, and motivating skilled managerial, scientific, sales, marketing, and financial personnel. The Company offers competitive compensation, performance bonuses, and equity grants to align employee goals with corporate objectives.

Board Composition: The Corporate Governance and Nominating Committee of the Board of Directors oversees management of risks associated with corporate governance, including cybersecurity, and reports to the full Board.

Human Capital Strategy

Workforce Composition:

  • Total Employees: 500 as of December 31, 2024.
  • Geographic Distribution: Not explicitly detailed, but corporate headquarters are in Redwood City, California.
  • Skill Mix: The Company is managed by experienced pharmaceutical executives and relies on skilled managerial, scientific, sales, marketing, and financial personnel.

Talent Management: Acquisition & Retention:

  • Hiring Strategy: The Company seeks to hire, retain, and motivate smart, ethical, hard-working employees, officers, and directors.
  • Retention Metrics: Not explicitly disclosed.
  • Employee Value Proposition: Offers a collegial work environment that encourages creativity, collaboration, and initiative. Provides competitive salaries, performance bonuses, equity grants, and industry-leading health, retirement, and other benefits. Diversity & Development:
  • Diversity Metrics: Not explicitly disclosed.
  • Development Programs: Not explicitly detailed beyond general talent management efforts.
  • Culture & Engagement: Fosters a collegial work environment where creativity, collaboration, and initiative are encouraged.

Environmental & Social Impact

Environmental Commitments: Climate Strategy: Not explicitly detailed in the filing. Carbon Neutrality: Not explicitly detailed in the filing. Renewable Energy: Not explicitly detailed in the filing.

Supply Chain Sustainability:

  • Supplier Engagement: Not explicitly detailed in the filing.
  • Responsible Sourcing: Not explicitly detailed in the filing.

Social Impact Initiatives:

  • Community Investment: Corcept Therapeutics Incorporated has patient support programs and donates money to independent charitable foundations to help financially needy patients pay for all aspects of their hypercortisolism care, regardless of whether it includes the Company's products.
  • Product Impact: The Company's policy ensures that no patient with hypercortisolism will be denied access to its products for financial reasons, providing products at no cost to uninsured patients who do not qualify for charitable support.

Business Cyclicality & Seasonality

Demand Patterns:

  • Seasonal Trends: Not explicitly detailed in the filing.
  • Economic Sensitivity: Not explicitly detailed in the filing.
  • Industry Cycles: Not explicitly detailed in the filing.

Planning & Forecasting: Not explicitly detailed in the filing.

Regulatory Environment & Compliance

Regulatory Framework: Industry-Specific Regulations:

  • Drug Development and Commercialization: Corcept Therapeutics Incorporated's products and product candidates are subject to extensive pre- and post-approval regulation by the FDA and comparable foreign regulatory authorities (e.g., European Medicines Agency, Medicines and Healthcare products Regulatory Agency). This includes compliance with the Federal Food, Drug and Cosmetic Act, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and current Good Manufacturing Practices (cGMP) regulations.
  • Orphan Drug Designation: Relacorilant has received orphan drug designation for hypercortisolism in the United States (seven years of exclusive marketing rights upon approval) and the European Union (ten years of exclusive marketing rights upon approval). Dazucorilant has orphan drug status for ALS in the United States.
  • Fast Track Designation: Dazucorilant has received Fast Track Designation for ALS in the United States. Trade & Export Controls:
  • Export Restrictions: Not explicitly detailed in the filing.
  • Sanctions Compliance: Not explicitly detailed in the filing.

Legal Proceedings:

  • Teva Patent Litigation: Corcept Therapeutics Incorporated is appealing a December 29, 2023, federal district court ruling that Teva Pharmaceuticals USA, Inc.'s proposed generic version of Korlym would not infringe two of Corcept Therapeutics Incorporated's patents. The appeal is pending before the United States Court of Appeals for the Federal Circuit.
  • Antitrust Litigation: Teva Pharmaceuticals USA, Inc. filed an antitrust complaint against Corcept Therapeutics Incorporated and Optime Care, Inc. in June 2024. Separately, Aetna Inc., Health Care Service Corporation, Humana Inc., and Molina Healthcare Inc. filed a similar complaint against Corcept Therapeutics Incorporated in February 2025.
  • Shareholder Derivative Complaints: Multiple shareholder derivative complaints (Lauren Williams v. G. Leonard Baker, et al., Jeweltex Pension Plan v. James N. Wilson, et al., Joel B. Ritchie v. G. Leonard Baker, et al.) are ongoing, alleging breach of fiduciary duty, violation of Section 14(a) of the Exchange Act, insider selling, misappropriation of insider information, and waste of corporate assets.
  • Records Subpoena: In November 2021, Corcept Therapeutics Incorporated received a records subpoena from the United States Attorney’s Office for the District of New Jersey regarding the sale and promotion of Korlym, relationships with healthcare professionals, and prior authorizations and reimbursement. The Company is cooperating with the investigation.

Tax Strategy & Considerations

Tax Profile:

  • Effective Tax Rate: The reconciliation from the U.S. federal statutory income tax rate to the effective rate shows various adjustments, including R&D and other credits, state income taxes, non-deductible compensation, and stock-based compensation.
  • Geographic Tax Planning: Not explicitly detailed in the filing.
  • Tax Reform Impact: The Tax Cuts and Jobs Act of 2017 eliminated the immediate deduction of research and development expenditures, requiring amortization over five to fifteen years for tax purposes, which has resulted in higher cash taxes paid. The Inflation Reduction Act of 2022 introduced a 1% excise tax on certain share repurchases and a 15% corporate alternative minimum tax (effective January 1, 2024), neither of which is expected to significantly affect consolidated financial statements.

Net Operating Loss Carryforwards:

  • As of December 31, 2024, Corcept Therapeutics Incorporated had California net operating loss carryforwards of $49.4 million, which will begin to expire in 2035.
  • The Company also had California research and development credits of $19.3 million, which have no expiration date.

Insurance & Risk Transfer

Risk Management Framework: Corcept Therapeutics Incorporated utilizes managed detection and response services to monitor its network infrastructure for cybersecurity threats, employs multi-factor authentication, performs penetration testing, and engages third parties to assess cybersecurity effectiveness. The Corporate Governance and Nominating Committee oversees cybersecurity risk management.

  • Insurance Coverage: Insurers fully reimbursed Corcept Therapeutics Incorporated for the $14.0 million Melucci litigation settlement. The Company notes that insurance for losses resulting from disasters or other business interruptions may be insufficient.
  • Risk Transfer Mechanisms: Not explicitly detailed in the filing.