cept Therapeutics rporated(CORT) - 2025 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS Presents unaudited condensed consolidated financial statements (balance sheets, income, cash flows, equity) and detailed notes on accounting policies and key financial items CONDENSED CONSOLIDATED BALANCE SHEETS | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | | Cash and cash equivalents | $102,745 | $127,665 | | Total current assets | $443,112 | $471,602 | | Total assets | $801,722 | $840,553 | | Total current liabilities | $144,664 | $140,773 | | Total liabilities | $165,929 | $160,964 | | Total stockholders' equity | $635,793 | $679,589 | CONDENSED CONSOLIDATED STATEMENTS OF INCOME | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :------------------------------------------ | :------------------------------------------ | | Product revenue, net | $194,430 | $163,796 | $351,644 | $310,604 | | Total operating expenses | $167,755 | $128,204 | $321,553 | $245,513 | | Income from operations | $26,675 | $35,592 | $30,091 | $65,091 | | Net income | $35,149 | $35,488 | $55,696 | $63,250 | | Basic net income per common share | $0.33 | $0.34 | $0.53 | $0.61 | | Diluted net income per common share | $0.29 | $0.32 | $0.46 | $0.57 | CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------- | :-------------------------------------------- | :-------------------------------------------- | :------------------------------------------ | :------------------------------------------ | | Net income | $35,149 | $35,488 | $55,696 | $63,250 | | Total comprehensive income | $36,748 | $35,314 | $58,204 | $62,725 | CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | Metric | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Net cash provided by operating activities | $49,067 | $64,944 | | Net cash provided by (used in) investing activities | $66,956 | $(69,208) | | Net cash used in financing activities | $(142,737) | $(2,693) | | Net decrease in cash and cash equivalents | $(24,920) | $(6,963) | | Cash and cash equivalents, at end of period | $102,745 | $128,588 | CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY | Metric | Balance at December 31, 2024 (in thousands) | Balance at June 30, 2025 (in thousands) | | :-------------------------------- | :---------------------------------------- | :-------------------------------------- | | Common Stock (Shares) | 105,113 | 105,288 | | Common Stock (Amount) | $136 | $138 | | Additional Paid-in Capital | $832,108 | $900,864 | | Treasury Stock | $(696,173) | $(866,931) | | Accumulated Other Comprehensive (Loss) Income | $(217) | $2,291 | | Retained Earnings | $543,735 | $599,431 | | Total Stockholders' Equity | $679,589 | $635,793 | NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS Details explanations and breakdowns of figures in the condensed consolidated financial statements, covering accounting policies and key financial components 1. Basis of Presentation and Summary of Significant Accounting Policies - Corcept Therapeutics is a commercial-stage biopharmaceutical company focused on the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic, and neurologic disorders by modulating cortisol effects[26] - Korlym® (mifepristone) 300 mg tablets were FDA-approved in 2012 for hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome, with an authorized generic version made available in June 2024[26] - The company operates as one operating segment: discovery, development, and commercialization of biopharmaceutical products[29] - The company adopted ASU No. 2023-09 (disaggregated tax rate reconciliation and income taxes paid) for the fiscal year ending December 31, 2025[31] 2. Composition of Certain Balance Sheet Items | Inventory Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :----------------- | :----------------------------- | :------------------------------- | | Raw materials | $1,745 | $0 | | Work in progress | $11,798 | $7,789 | | Finished goods | $6,724 | $8,206 | | Total inventory | $20,267 | $15,995 | | Less strategic inventory (non-current) | $(7,991) | $(3,583) | | Total current inventory | $12,276 | $12,412 | | Accrued Liabilities Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--------------------------- | :----------------------------- | :------------------------------- | | Government rebates | $50,866 | $41,580 | | Accrued compensation | $26,281 | $41,731 | | Accrued selling and marketing costs | $7,042 | $3,345 | | Other | $6,884 | $4,044 | | Total accrued and other liabilities | $91,073 | $90,700 | 3. Available-for-Sale Marketable Securities and Fair Value Measurements | Asset Type | June 30, 2025 Fair Value (in thousands) | December 31, 2024 Fair Value (in thousands) | | :------------------------ | :------------------------------------ | :------------------------------------ | | Corporate bonds | $325,441 | $373,244 | | Commercial paper | $6,902 | $9,775 | | U.S. government agency securities | $34,970 | $7,997 | | U.S. Treasury securities | $44,943 | $84,484 | | Money market funds | $72,303 | $98,436 | | Total marketable securities | $484,559 | $573,936 | - The company's investments, including those with unrealized losses due to interest rate fluctuations, are not impaired[37] - As of June 30, 2025, all long-term marketable securities had original maturities of no more than 24 months, and short-term securities had maturities of less than one year, with a weighted-average maturity of nine months[39] 4. Commitments and Contingencies - No material changes in contractual obligations described in the Annual Report on Form 10-K for the year ended December 31, 2024[40] - The Melucci litigation was settled for a one-time payment of $14.0 million, which was fully reimbursed by insurers. This matter is now closed[43] - No losses or provisions for loss contingencies have been recorded for any matter to date[44] 5. Leases - Entered into a six-year sublease for new headquarters (50,632 rentable square feet) at 101 Redwood Shores Parkway, Redwood City, CA, effective July 1, 2024, with base rent averaging $1.5 million annually[45] - Operating lease expense for the three months ended June 30, 2025, was $0.6 million (vs. $0.8 million in 2024), and for the six months ended June 30, 2025, was $1.3 million (vs. $1.4 million in 2024)[47] | Future Minimum Lease Payments (in thousands) | Amount | | :----------------------------------- | :----- | | 2025 (remainder) | $764 | | 2026 | $1,551 | | 2027 | $1,598 | | 2028 | $1,646 | | 2029 | $1,695 | | 2030 | $860 | | Total operating lease payments | $8,114 | | Less imputed interest | $(1,509) | | Present value of operating lease liabilities | $6,605 | 6. Stockholders' Equity - The Board authorized a Stock Repurchase Program of up to $200 million in January 2024. The company purchased 1.5 million shares for $103.0 million in Q2 2025 and 2.0 million shares for $130.5 million in H1 2025. $53.9 million remained available as of June 30, 2025[49][50] - Issued 0.8 million shares (Q2 2025) and 2.0 million shares (H1 2025) upon stock option exercise. Purchased 0.2 million shares (Q2 2025) and 0.5 million shares (H1 2025) for net exercises, paying $7.6 million (Q2 2025) and $20.5 million (H1 2025) for tax withholding[53] - Granted 0.3 million RSAs (Q2 2025) and 0.8 million RSAs (H1 2025) to employees, with weighted-average grant date fair values of $73.53/share and $64.95/share, respectively[55] - The Employee Stock Purchase Plan (ESPP) allows employees to purchase common stock and receive a matching RSA that vests after one year. A liability of $3.6 million (June 30, 2025) vs. $3.2 million (December 31, 2024) is recorded for ESPP-related RSAs[56][57][58] Expense Category | Expense Category | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------- | :-------------------------------------------- | :-------------------------------------------- | :------------------------------------------ | :------------------------------------------ | | Capitalized | $107 | $83 | $251 | $128 | | Cost of sales | $27 | $14 | $63 | $25 | | Research and development | $5,397 | $4,437 | $11,718 | $8,358 | | Selling, general and administrative | $13,599 | $10,756 | $29,072 | $20,073 | | Total stock-based compensation | $19,130 | $15,290 | $41,104 | $28,584 | 7. Net Income Per Share | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Basic net income per common share | $0.33 | $0.34 | $0.53 | $0.61 | | Diluted net income per common share | $0.29 | $0.32 | $0.46 | $0.57 | | Weighted-average shares (Basic) | 104,111 | 103,118 | 104,108 | 102,954 | | Dilutive effect of employee stock options and unvested RSUs | 16,374 | 8,126 | 16,119 | 7,596 | | Weighted-average shares (Diluted) | 120,485 | 111,244 | 120,227 | 110,550 | - Excluded 2.7 million (Q2 2025) and 2.0 million (H1 2025) stock options from diluted EPS computation because they would have reduced dilution[62] 8. Income Taxes | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------- | :-------------------------------------------- | :-------------------------------------------- | :------------------------------------------ | :------------------------------------------ | | Income tax benefit (expense) | $3,457 | $(6,108) | $14,386 | $(13,339) | - The decrease in income tax expense (benefit) was primarily due to increased stock compensation deductions and decreases in year-to-date pretax income[63] - Unrecognized tax benefits increased by $1.8 million (Q2 2025) and $1.9 million (H1 2025)[64] - The recently enacted One Big Beautiful Bill Act (OBBBA) is expected to decrease current income taxes payable and deferred tax asset balances in Q3 and Q4 2025 by allowing immediate expensing of domestic R&D expenses[66] ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Management's discussion and analysis of financial condition and results, covering business, product performance, R&D, liquidity, and accounting policies Overview - Corcept Therapeutics is a commercial-stage biopharmaceutical company focused on the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic, and neurologic disorders by modulating the effects of the hormone cortisol[69] - The company markets Korlym and an authorized generic version in the United States for the treatment of hypercortisolism (Cushing's syndrome)[69][70] - The CATALYST study met its primary endpoint, demonstrating a clinically meaningful and statistically significant decrease in HbA1c (1.47% vs 0.15% for placebo, p<0.0001) in patients receiving Korlym for difficult-to-control diabetes with hypercortisolism. Secondary endpoints for body weight and waist circumference reduction were also met[71] - The MOMENTUM trial was initiated in March 2025 to determine the prevalence of hypercortisolism in patients with resistant hypertension, with a planned enrollment of 1,000 patients[73] - A New Drug Application (NDA) for relacorilant as a treatment for endogenous hypercortisolism was submitted to the FDA in December 2024 and accepted in March 2025, with a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025[77] - The GRACE trial met its primary endpoint, showing that patients with hypertension switched to placebo were significantly more likely to lose blood pressure control than those who continued to receive relacorilant (odds ratio: 0.17; p-value: 0.02). The trial also demonstrated clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight, body composition, cognition, and Cushing's Quality of Life score[79][80][81] - The GRADIENT study showed that patients receiving relacorilant exhibited clinically meaningful improvements in hypertension, hyperglycemia, weight, and body composition. Statistically significant improvements were observed in fasting glucose (placebo-adjusted reduction of 22.2 mg/dL; p-value 0.002), AUCglucose (p-value 0.046), HbA1c (p-value 0.019), body weight (p-value: 0.0001), and visceral adipose fat mass and volume[83][84][86] - Relacorilant received Orphan Drug Designation from both the FDA and the European Commission (EC) for the treatment of hypercortisolism, providing tax credits, reduced regulatory fees, and 7-10 years of exclusive marketing rights upon approval[89] - An NDA for relacorilant plus nab-paclitaxel as a treatment for platinum-resistant ovarian cancer was submitted to the FDA in July 2025[91] - The Phase 3 ROSELLA trial met its PFS endpoint, demonstrating a clinically and statistically significant 30% reduction in the risk of disease progression (hazard ratio: 0.70; p-value: 0.008) for patients treated with relacorilant plus nab-paclitaxel. An interim analysis of OS data showed a meaningful 31% reduction in the risk of death (hazard ratio: 0.69; p-value: 0.012), with a median OS of 16.0 months compared to 11.5 months for nab-paclitaxel alone[93][94] - The Phase 2 trial of relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer showed that intermittent relacorilant significantly improved median PFS (5.6 months vs 3.8 months, HR: 0.66; p-value: 0.038) and longer median duration of response (5.6 months vs 3.7 months, HR: 0.36; p-value: 0.006)[97] - The DAZALS Phase 2 trial for dazucorilant in ALS did not meet its primary endpoint (ALSFRS-R change). However, a statistically significant reduction in early death was observed at week 24, continuing at one year (84% reduction in risk of death for 300 mg dose, HR: 0.16; p-value: 0.0009)[104] - The FDA has granted dazucorilant Fast Track Designation and orphan drug status for the treatment of ALS in the United States[106] - The randomized, double-blind, placebo-controlled Phase 2b MONARCH trial of miricorilant in patients with MASH was initiated in October 2023. Cohort A (biopsy-confirmed MASH) screening has closed, and Cohort B (presumed MASH) has completed enrollment of 93 patients. The primary endpoint for both cohorts is reduction in liver fat[107] - The Inflation Reduction Act of 2022 (IRA) is anticipated to limit revenue from Medicare patients and materially reduce profits in 2026 and beyond due to provisions requiring manufacturers to pay rebates if drug prices increase faster than inflation and allowing Medicare to negotiate drug prices[109][174] - The One Big Beautiful Bill Act (OBBBA) enacted in July 2025 is expected to decrease current income taxes payable and deferred tax asset balances in Q3 and Q4 2025 by allowing immediate expensing of domestic research and development expenses[66] Results of Operations Net Product Revenue | Period | 2025 (in millions) | 2024 (in millions) | Change | | :-------------------------- | :----------------- | :----------------- | :----- | | Three Months Ended June 30, | $194.4 | $163.8 | +$30.6 (+18.7%) | | Six Months Ended June 30, | $351.6 | $310.6 | +$41.0 (+13.2%) | - Net product revenue increases were driven by 49.0% (Q2) and 36.8% (H1) increases in sales volume, partially offset by 20.3% (Q2) and 17.3% (H1) decreases in average price due to higher sales volume from the authorized generic version of Korlym[113] Cost of Sales | Period | 2025 (in millions) | 2024 (in millions) | Change | % of Revenue (2025) | % of Revenue (2024) | | :-------------------------- | :----------------- | :----------------- | :----- | :------------------ | :------------------ | | Three Months Ended June 30, | $3.4 | $2.5 | +$0.9 (+36.0%) | 1.8% | 1.5% | | Six Months Ended June 30, | $5.8 | $5.1 | +$0.7 (+13.7%) | 1.7% | 1.6% | - The increase in cost of sales as a percentage of revenue for Q2 2025 was primarily due to increased manufacturing and distribution costs. For H1 2025, the increase was due to increased manufacturing and distribution costs, offset by a one-time $0.5 million API write-off in Q1 2024 that did not recur[115] Research and Development Expense | Period | 2025 (in millions) | 2024 (in millions) | Change | | :-------------------------- | :----------------- | :----------------- | :----- | | Three Months Ended June 30, | $60.5 | $58.7 | +$1.8 (+3.1%) | | Six Months Ended June 30, | $121.2 | $117.3 | +$3.9 (+3.3%) | - R&D expense increases were primarily due to increased employee compensation expenses and the advancement of development programs, partially offset by decreased expenses related to programs nearing completion[117] R&D Expense by Program (Six Months Ended June 30) | Program Category | 2025 (in thousands) | 2024 (in thousands) | Change | | :------------------------------------------ | :------------------ | :------------------ | :----- | | Oncology | $19,360 | $29,230 | -$9,870 | | Hypercortisolism (Cushing's syndrome) | $38,307 | $25,657 | +$12,650 | | Metabolic diseases | $22,731 | $19,508 | +$3,223 | | Pre-clinical and early-stage selective cortisol modulators and ALS | $13,654 | $20,445 | -$6,791 | | Unallocated activities, including manufacturing and regulatory | $15,436 | $14,053 | +$1,383 | | Stock-based compensation | $11,718 | $8,358 | +$3,360 | | Total R&D Expense | $121,206 | $117,251 | +$3,955 | Selling, General and Administrative Expense | Period | 2025 (in millions) | 2024 (in millions) | Change | | :-------------------------- | :----------------- | :----------------- | :----- | | Three Months Ended June 30, | $103.9 | $66.9 | +$37.0 (+55.3%) | | Six Months Ended June 30, | $194.5 | $123.2 | +$71.3 (+57.9%) | - SG&A expense increases were primarily due to increased employee compensation expenses and sales and marketing activities to support commercialization of existing and potential future products[120] Interest and Other Income | Period | 2025 (in millions) | 2024 (in millions) | Change | | :-------------------------- | :----------------- | :----------------- | :----- | | Three Months Ended June 30, | $5.0 | $6.0 | -$1.0 (-16.7%) | | Six Months Ended June 30, | $11.2 | $11.5 | -$0.3 (-2.6%) | - Decreases in interest and other income were due to market-wide decreases in interest rates[122] Income Tax Benefit (Expense) | Period | 2025 (in millions) | 2024 (in millions) | Change | | :-------------------------- | :----------------- | :----------------- | :----- | | Three Months Ended June 30, | $3.5 (benefit) | $(6.1) (expense) | +$9.6 | | Six Months Ended June 30, | $14.4 (benefit) | $(13.3) (expense) | +$27.7 | - The shift to an income tax benefit (from expense) was primarily due to increased stock compensation deductions and decreases in year-to-date pretax income[123] Liquidity and Capital Resources - The company relies on revenues from product sales to fund its operations and expects to fund operations and planned R&D activities for the next 12 months and beyond without needing to raise additional funds[124][125] Cash, Cash Equivalents, and Marketable Securities | Metric | June 30, 2025 (in millions) | December 31, 2024 (in millions) | Change | | :------------------------------------------ | :-------------------------- | :------------------------------ | :----- | | Cash and cash equivalents | $102.7 | $127.7 | -$25.0 | | Marketable securities | $412.3 | $475.5 | -$63.2 | | Total | $515.0 | $603.2 | -$88.2 | - Net cash provided by operating activities decreased to $49.1 million for the six months ended June 30, 2025, from $64.9 million in the comparable period of 2024, primarily due to lower net income resulting from higher operating expenses[128] - Net cash provided by investing activities was $67.0 million for the six months ended June 30, 2025, a significant increase from net cash used of $69.2 million in the comparable period of 2024, primarily due to a higher allocation of cash proceeds from marketable securities maturities towards cash equivalents for stock repurchases[129] - Net cash used in financing activities increased significantly to $142.7 million for the six months ended June 30, 2025, from $2.7 million in 2024, mainly due to $158.7 million spent acquiring common stock (including $130.5 million for the Stock Repurchase Program)[130] - Retained earnings as of June 30, 2025, were $599.4 million[131] Contractual Obligations and Commitments - There were no material changes in contractual payment obligations and purchase commitments during the six months ended June 30, 2025, compared to those disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024[132] Critical Accounting Policies and Estimates - No material changes occurred during the fiscal quarter ended June 30, 2025, that affected the company's critical accounting policies and estimates[133] ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Confirms no material changes in market risks for cash, cash equivalents, and marketable securities during the period - The market risks associated with the company's cash, cash equivalents, and marketable securities (consisting entirely of debt instruments with original maturities of less than 24 months) did not change materially during the six months ended June 30, 2025[134] ITEM 4. CONTROLS AND PROCEDURES Reports on the effectiveness of disclosure controls and procedures, confirming no material changes in internal control over financial reporting - Management, including the Chief Executive Officer and Chief Financial Officer, concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, providing reasonable assurance for timely and accurate reporting[135] - There were no material changes in internal control over financial reporting during the quarter ended June 30, 2025[136] PART II. OTHER INFORMATION ITEM 1. LEGAL PROCEEDINGS Details ongoing legal proceedings, including patent litigation, antitrust complaints, shareholder derivative suits, and a records subpoena from the NJ USAO - The company has appealed the District Court's December 2023 ruling that Teva's proposed generic Korlym product would not infringe its patents. Oral argument was heard by the United States Court of Appeals for the Federal Circuit on July 7, 2025, with the outcome pending[139] - Teva Pharmaceuticals USA, Inc. filed an antitrust complaint in June 2024 against Corcept and Optime Care, Inc., alleging violations of federal and state antitrust and unfair business practices laws. Additionally, Aetna Inc. and other plaintiffs filed a similar complaint in February 2025, which is now pending in federal court, with a motion to remand to state court scheduled for August 20, 2025[141][142] - The Melucci Litigation, a securities class action, was finalized and settled in 2024 with a $14 million payment, fully reimbursed by insurers, and is now closed. Shareholder derivative complaints (Williams, Jeweltex, Ritchie) alleging breach of fiduciary duty are ongoing; the Ritchie case was dismissed by the Delaware Court of Chancery on July 22, 2025, with Federal Court proceedings stayed pending this outcome[143][144][146][147] - The company received a HIPAA records subpoena from the United States Attorney's Office for the District of New Jersey (NJ USAO) in November 2021, seeking information related to the sale and promotion of Korlym, relationships with healthcare professionals, and prior authorizations/reimbursement. The NJ USAO does not currently consider the company a defendant[149] ITEM 1A. RISK FACTORS Outlines significant risks that could adversely affect business, operations, and financial results, categorized by commercial, R&D, IP, capital, stock, and general operational factors Summary of Principal Risks - Principal risks include failure to generate sufficient revenue from product sales, the availability of generic versions of Korlym, public perception of mifepristone, and new laws or government regulations affecting pricing and reimbursement[154] - Risks related to research and development activities include the potential for product candidates to fail in clinical trials, the lengthy and expensive nature of drug development, and the uncertainty of regulatory approvals[162] - Intellectual property risks involve challenges in securing, maintaining, or asserting patent protection for proprietary compounds and products, with litigation being slow, expensive, and uncertain[157] - Stock-related risks include wide fluctuations in common stock price, potential decline if performance does not meet guidance or analyst estimates, and the impact of short-selling strategies[162] - General risk factors encompass legal, governmental, regulatory, and economic uncertainties from federal government actions, reliance on information technology systems, challenges in managing organizational growth, and the potential loss of key personnel[162] Risk Factors – Discussion Provides detailed discussion of principal risks, offering more context and implications for commercial, R&D, IP, capital, stock, and general operational risks Risks Related to our Commercial Activities - The ability to generate revenue is dependent on Korlym sales, which can be limited by physician/payor preference for competing treatments (including generic Korlym and off-label use), lack of insurance coverage, government price controls (e.g., Inflation Reduction Act of 2022, One Big Beautiful Bill Act of 2025), supply chain disruptions, and the inability of the specialty pharmacy to dispense products[161][163] - Teva launched a generic version of Korlym in January 2024, and ongoing litigation against Teva is under appeal. Settlements with Sun Pharmaceutical Industries Limited and Hikma Pharmaceuticals USA Inc. allow them to sell generic mifepristone under certain conditions, which could materially harm the company's revenue and financial condition[165][166][167] - Public perception of mifepristone as an abortifacient, especially following the Dobbs v. Jackson Women's Health Organization decision and ongoing legal challenges, may limit the ability to sell Korlym, despite its different approved use[169] - New laws and government regulations, such as the Inflation Reduction Act of 2022 (IRA), are anticipated to limit revenue from Medicare patients and materially reduce profits in 2026 and beyond due to price negotiation and inflation rebate provisions. The One Big Beautiful Bill Act (OBBBA) of 2025 will also reduce Medicaid funding significantly[163][170][172][173][174] - The company depends on third-party vendors for manufacturing API, tableting, packaging, and distribution, and on Optime, its single specialty pharmacy, for dispensing products and collecting payments. Failure of these vendors to perform or comply with regulations could disrupt operations and harm the business[177][179][181] - Competition from other approved medications for hypercortisolism (e.g., pasireotide, osilodrostat, levoketoconazole) and off-label use of generic medications like ketoconazole could materially reduce revenue and harm financial results[182][183][184] - Natural disasters (e.g., earthquakes, fires, extreme weather) or widespread outbreaks of deadly diseases (e.g., COVID-19) could disrupt commercial and clinical activities, damage facilities, and make it difficult to conduct operations[185][186][187] - Failure to maintain regulatory approval of products or comply with FDA and other regulatory requirements (e.g., cGMPs, GCPs) could lead to substantial civil and criminal penalties, injunctions, product recalls, or withdrawal of approvals[189] - The company may be subject to civil or criminal penalties if its 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, Physician Payment Sunshine Act, state laws). An ongoing records subpoena from the NJ USAO is investigating potential violations[190][191][192][194][195] Risks Related to our Research and Development Activities - The company relies heavily on third-party vendors, clinical investigators, sites, and CROs to carry out clinical trials, including drug product distribution, trial management, data collection, and analysis. Failure of these vendors to perform their duties, meet timelines, or adhere to GCPs could prevent or delay approval of product candidates[197][199] - Clinical drug development is costly, time-consuming, and unpredictable. Positive data from early trials are often not predictive of later results, and product candidates can fail at any stage due to lack of efficacy, unanticipated adverse events, or regulatory disagreement, potentially delaying or preventing commercialization[200][201][202] - Obtaining and maintaining regulatory approvals from the FDA and comparable foreign authorities is difficult, uncertain, lengthy, and expensive. Disruptions at government agencies or failure to comply with ongoing requirements could lead to delays, denials, or withdrawal of product approvals[205][206] - Products and product candidates may cause undesirable side effects that could halt clinical development, prevent regulatory approval, limit commercial potential, or lead to significant liability, including regulatory actions like warnings, Risk Evaluation and Mitigation Strategies (REMS), or product recalls[207][208][209] Risks Related to our Capital Needs and Financial Results - The company is dependent on revenue from product sales and cash reserves to fund operations. A significant decline in revenue could necessitate curtailing operations or raising additional funds, which may not be available on acceptable terms[212] - Potential funding options, such as equity financing, would cause dilution, while debt financing could involve restrictive covenants. Collaborations with other companies might require relinquishing rights to product candidates[212] Risks Related to our Intellectual Property - The company may not be able to secure, maintain, or effectively assert patent protection for its proprietary selective cortisol modulators and for the use of its products to treat hypercortisolism. Patents are uncertain, involve complex legal and factual questions, and are frequently subject to litigation[214][215] - Intellectual property litigation is lengthy, expensive, and requires significant management attention, with uncertain outcomes. Failure to protect intellectual property could allow competitors to erode the company's competitive advantage[214] Risks Related to our Stock - The price of the company's common stock fluctuates widely and is subject to extreme price and volume fluctuations that may be unrelated or disproportionate to operating performance or prospects. Factors include variations in operating results, timing and results of clinical trials, regulatory approvals, intellectual property disputes, market manipulation, and general economic conditions[217][218][221] - The stock price may decline if the company's financial performance does not meet public guidance or estimates published by research analysts[219] - The company has been, and may in the future be, subject to short-selling strategies and negative publications, which can drive down the market price of its common stock and increase its volatility, potentially leading to shareholder suits[220][222] - Acquisitions of shares through the stock repurchase program or cashless option exercises reduce cash reserves, which could hamper the company's ability to execute plans, meet financial obligations, or access financing[243] General Risk Factors - Actions by the U.S. federal government, such as reduced funding for scientific research, employee terminations at government agencies (e.g., FDA), significant cuts to Medicaid funding (OBBBA), and the imposition of trade tariffs, create unprecedented legal, governmental, regulatory, and economic uncertainty that may adversely affect the business by increasing costs and delaying R&D and commercial efforts[224][225][226][227] - The company needs to increase the size of its organization and may experience difficulties in managing growth, requiring the addition of talented personnel, effective management of R&D and manufacturing, and development of administrative systems[228][230] - The company's ability to operate successfully depends on hiring and retaining skilled managerial, scientific, sales, marketing, and financial personnel. The loss of key individuals or inability to attract new talent could delay research, development, and commercialization efforts[229] - Compliance with evolving federal, state, and foreign laws and regulations (e.g., taxes, drug development/marketing/pricing, Sarbanes-Oxley, Dodd Frank, data privacy laws like HIPAA, GDPR, CCPA) is complex and costly. Failure to comply could materially harm the business through fines, penalties, litigation, and reputational damage[231][232][233][234][235][236][237] - Reliance on information technology systems and networks (including those of vendors) for confidential business, patient, and employee information exposes the company to risks of breaches, malware, data theft, and other cyberattacks, which could result in liability, operational disruptions, and reputational damage[238][239][240] - Changes in federal, state, and local tax laws could materially increase the amounts the company pays in taxes, thereby reducing net earnings[241] - Anti-takeover provisions in the company's charter and bylaws, as well as under Delaware law, may make an acquisition or change in management more expensive or difficult, potentially reducing the price investors would be willing to pay for common stock[244] - Officers, directors, and principal stockholders beneficially owned approximately 21% of the common stock as of July 24, 2025, allowing them to significantly influence corporate actions and potentially affecting the trading price of the common stock[245] ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS Reports no unregistered equity sales and details common stock repurchases, including shares purchased for cashless net exercises and restricted stock vesting - There were no unregistered sales of equity securities during the period covered by this report[247] Issuer Purchases of Equity Securities (Three Months Ended June 30, 2025) | Fiscal Period | Total Number of Shares Repurchased (in thousands) | Average Price Paid Per Share | Dollar Amount of Shares That May Yet be Purchased Under the Program (in thousands) | | :------------------------------ | :---------------------------------------------- | :--------------------------- | :------------------------------------------------------------------------------- | | April 1, 2025 to April 30, 2025 | 0 | $0 | $156,896 | | May 1, 2025 to May 31, 2025 | 275 | $70.10 | $137,656 | | June 1, 2025 to June 30, 2025 | 1,207 | $69.40 | $53,887 | | Total | 1,482 | $69.53 | $53,887 | Shares Purchased for Cashless Net Exercises & Restricted Stock Vesting (Three Months Ended June 30, 2025) | Fiscal Period | Total Number of Shares Purchased (in thousands) | Average Price Per Share | Total Purchase Price of Shares (in thousands) | | :------------------------------ | :-------------------------------------------- | :---------------------- | :------------------------------------------ | | April 1, 2025 to April 30, 2025 | 44 | $75.65 | $3,293 | | May 1, 2025 to May 31, 2025 | 65 | $73.66 | $4,800 | | June 1, 2025 to June 30, 2025 | 153 | $72.78 | $11,128 | | Total | 262 | $73.48 | $19,221 | - The company paid $12.4 million to satisfy the tax withholding obligations associated with the net-share settlement of cashless option exercises and vesting of restricted stock[251] ITEM 3. DEFAULTS UPON SENIOR SECURITIES This item states that it is not applicable to the company - Not applicable[252] ITEM 4. MINE SAFETY DISCLOSURES This item states that it is not applicable to the company - Not applicable[253] ITEM 5. OTHER INFORMATION This section discloses that no directors or officers adopted, terminated, or modified insider trading arrangements during the reported quarter - During the three months ended June 30, 2025, no directors and officers adopted, terminated, or modified any contract, instruction, or written plan for the purchase or sales of the company's securities intended to satisfy the affirmative defense of Rule 10b5-1(c) of the Exchange Act or any 'non-Rule 10b5-1 trading arrangement'[254] ITEM 6. EXHIBITS Lists all exhibits filed as part of the 10-Q report, including corporate governance documents, executive certifications, and XBRL financial data - Exhibits include the Restated Certificate of Incorporation, Amended and Restated Bylaws, Rule 13a-14(a)/15d-14(a) Certifications (CEO, CFO), 18 U.S.C. Section 1350 Certifications (CEO, CFO), XBRL financial data, and the Cover Page Interactive Data File[256] SIGNATURES Contains required signatures of the CEO, CFO, and Chief Accounting & Technology Officer, certifying report accuracy and completeness - The report was signed on July 31, 2025, by Joseph K. Belanoff, M.D. (Chief Executive Officer), Atabak Mokari (Chief Financial Officer), and Joseph D. Lyon (Chief Accounting & Technology Officer)[260]