cept Therapeutics rporated(CORT) - 2024 Q1 - Quarterly Report

Part I. Financial Information Item 1. Financial Statements The company's Q1 2024 financial statements reflect significant growth in revenue, net income, and total assets Condensed Consolidated Balance Sheets Total assets grew to $655.9 million as of March 31, 2024, with a decrease in total liabilities Balance Sheet Summary (in thousands) | Balance Sheet Item | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $149,750 | $135,551 | | Total current assets | $503,367 | $458,636 | | Total assets | $655,935 | $621,517 | | Total current liabilities | $97,202 | $104,505 | | Total liabilities | $108,071 | $114,812 | | Total stockholders' equity | $547,864 | $506,705 | Condensed Consolidated Statements of Income Net product revenue grew 39% year-over-year to $146.8 million, driving net income to $27.8 million Q1 2024 vs Q1 2023 Income Statement (in thousands, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Product revenue, net | $146,808 | $105,654 | | Research and development | $58,505 | $40,851 | | Selling, general and administrative | $56,268 | $48,564 | | Income from operations | $29,500 | $14,853 | | Net income | $27,762 | $15,879 | | Diluted net income per common share | $0.25 | $0.14 | Condensed Consolidated Statements of Cash Flows Net cash from operations was $23.8 million, and cash and cash equivalents increased by $14.2 million Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash provided by operating activities | $23,756 | $25,957 | | Net cash (used in) provided by investing activities | $(9,014) | $207,475 | | Net cash (used in) provided by financing activities | $(543) | $181 | | Net increase in cash and cash equivalents | $14,199 | $233,613 | Notes to Condensed Financial Statements Notes detail key events including a $14.0 million litigation settlement and a new $200 million stock repurchase program - The company is a commercial-stage pharmaceutical firm focused on medications that modulate cortisol, with its primary product being Korlym® for Cushing's syndrome[22] - The Melucci securities class action lawsuit was settled for a one-time payment of $14.0 million, which was fully covered by the company's insurers[40] - In January 2024, the Board of Directors authorized a new stock repurchase program for up to $200 million of common stock, with $199.5 million available as of March 31, 2024[47][48] - Subsequent to quarter-end, the company extended its pharmaceutical manufacturer services agreement with Optime Care, Inc, to March 31, 2027[65] - On April 12, 2024, the company entered into a six-year sublease for a new headquarters in Redwood City, CA, with lease obligations of approximately $9.6 million[67] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses strong Q1 2024 performance driven by Korlym sales and progress in the clinical pipeline Overview The company markets Korlym® for Cushing's syndrome and advances its pipeline, including positive relacorilant trial data - The company's lead product, Korlym, is marketed for the treatment of Cushing's syndrome[71][72] - In April 2024, preliminary results from the GRACE Phase 3 trial of relacorilant showed clinically meaningful and statistically significant improvements in hypertension and hyperglycemia[77] - Enrollment is complete for the ROSELLA Phase 3 trial in ovarian cancer and the DAZALS Phase 2 trial in ALS[88][91] - The MONARCH Phase 2b trial of miricorilant in patients with NASH was initiated in October 2023[92] Results of Operations Q1 2024 net product revenue rose 39% to $146.8 million, while operating expenses increased due to clinical program costs Q1 2024 vs Q1 2023 Operating Results (in millions) | Line Item | Q1 2024 | Q1 2023 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Net Product Revenue | $146.8 | $105.7 | +38.9% | Higher sales volume (67.6%) and price increase (32.4%) | | Cost of Sales | $2.5 | $1.4 | +78.6% | $0.5M write-off of API | | R&D Expense | $58.5 | $40.9 | +43.0% | Increased spending on development programs | | SG&A Expense | $56.3 | $48.6 | +15.8% | Increased employee compensation and marketing activities | Liquidity and Capital Resources The company maintains strong liquidity with $451.0 million in cash and investments, sufficient for future operations - As of March 31, 2024, the company held $451.0 million in cash, cash equivalents, and marketable securities[111] - The company relies on revenues from the sale of Korlym to fund its operations and expects to do so for the next 12 months and beyond[109][110] - Net cash provided by operating activities was $23.8 million for the three months ended March 31, 2024[113] Item 3. Quantitative and Qualitative Disclosures About Market Risk Market risks associated with cash and investments have not materially changed from the prior annual report - Market risks associated with cash, cash equivalents, and marketable securities did not change materially during the three months ended March 31, 2024[119] Item 4. Controls and Procedures Management concluded that disclosure controls and procedures were effective with no material changes in internal controls - The CEO and CFO concluded that as of March 31, 2024, the company's disclosure controls and procedures were effective[120] - No changes during the quarter materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[121] Part II. Other Information Item 1. Legal Proceedings The company faces significant legal matters including patent litigation, a settled class action, and a government inquiry - Teva Litigation: A court ruled Teva's proposed generic Korlym would not infringe Corcept's patents; Corcept has appealed, and Teva has launched its generic product[124] - Hikma Litigation: The company settled with Hikma, granting it the right to sell a generic version of Korlym beginning October 1, 2034, or earlier under certain circumstances[127] - Melucci Litigation: A securities class action was settled for $14.0 million, to be paid in full by insurers, pending final court approval[129] - The company received a subpoena from the U.S. Attorney's Office for the District of New Jersey regarding the sale and promotion of Korlym and is cooperating[134] Item 1A. Risk Factors Key risks include reliance on Korlym, generic competition, regulatory pricing pressures, and clinical development uncertainty - Commercial risk: The company's financial results depend heavily on Korlym, which is now threatened by the launch of a generic version by Teva[138][150] - Regulatory risk: The Inflation Reduction Act of 2022 (IRA) could significantly limit revenue from Medicare patients through price negotiation and inflation rebates[139][157][159] - Development risk: Efforts to develop new product candidates are lengthy, expensive, and may not succeed, with failure possible at any stage[148][179] - Intellectual Property risk: The company must secure and defend its patent protection for its products, which involves complex, costly, and uncertain litigation[142][192] - Operational risk: The company relies on a single specialty pharmacy (Optime) to dispense Korlym and on other vendors for manufacturing[162][163] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company repurchased $0.5 million of its common stock under a new $200 million repurchase program Issuer Purchases of Equity Securities (Q1 2024) | Program | Total Shares Repurchased | Average Price Paid Per Share | Total Cost (in thousands) | | :--- | :--- | :--- | :--- | | Stock Repurchase Program | 20,000 | $23.82 | $524 | | Cashless Exercises/Vesting | 143,000 | $24.75 | $3,555 | - On January 8, 2024, the Board of Directors authorized a new stock repurchase program for up to $200 million of common stock, with $199.5 million remaining available as of March 31, 2024[224] Item 5. Other Information The company's Chief Business Officer adopted a Rule 10b5-1 trading plan for the potential sale of company stock - Charles Robb, Chief Business Officer, adopted a Rule 10b5-1 trading plan on February 22, 2024, to sell up to 44,000 shares of common stock[231] Item 6. Exhibits This section lists exhibits filed with the Form 10-Q, including agreements and required officer certifications