Corcept Therapeutics, Inc. (NASDAQ:CORT) Q4 2024 Earnings Conference Call February 26, 2025 5:00 PM ET Company Participants Atabak Mokari - CFO & Treasurer Gary Robb - Chief Business Officer & Secretary Joe Belanoff - Co-Founder, President, CEO & Director Bill Guyer - Chief Development Officer Sean Maduck - President, Endocrinology Conference Call Participants David Amsellem - Piper Sandler Swayampakula Ramakanth - H.C. Wainwright Asim Rana - Truist Operator Thank you for standing by, and welcome to Corcept ...

Core Insights - Corcept Therapeutics reported quarterly earnings of $0.26 per share, missing the Zacks Consensus Estimate of $0.37 per share, and showing a decrease from $0.28 per share a year ago, resulting in an earnings surprise of -29.73% [1] - The company posted revenues of $181.89 million for the quarter ended December 2024, which was 7.08% below the Zacks Consensus Estimate, but an increase from $135.41 million year-over-year [2] - Corcept has surpassed consensus EPS estimates three times over the last four quarters, indicating a mixed trend in estimate revisions ahead of the earnings release [2][6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is $0.39 on revenues of $189.08 million, and for the current fiscal year, it is $1.85 on revenues of $811.91 million [7] - The stock has outperformed the S&P 500, gaining about 21.5% since the beginning of the year compared to the S&P 500's gain of 1.3% [3] - The Zacks Industry Rank for Medical - Drugs is in the top 50% of over 250 Zacks industries, suggesting that the industry outlook can significantly impact stock performance [8] Industry Context - Recursion Pharmaceuticals, another company in the same industry, is expected to report a quarterly loss of $0.36 per share, with revenues projected at $28.73 million, reflecting a year-over-year increase of 163.9% [9][10]

Product Development and Clinical Trials - Korlym (mifepristone) has been marketed in the U.S. since 2012 for treating hypercortisolism, with an authorized generic version launched in June 2024[19]. - In the CATALYST study, 23.8% of 1,057 patients with difficult-to-control diabetes were found to have hypercortisolism, with Korlym showing a significant HbA1c reduction of 1.47% compared to 0.15% in the placebo group (p-value: < 0.0001)[25]. - Relacorilant, a proprietary cortisol modulator, was submitted for FDA approval in December 2024, based on positive results from multiple clinical trials[28]. - In the GRACE trial, patients receiving relacorilant showed a mean systolic blood pressure reduction of 7.9 mm Hg and diastolic blood pressure reduction of 5.4 mm Hg at 22 weeks (p-values: <0.0001)[30]. - GRADIENT study patients receiving relacorilant experienced a placebo-adjusted reduction in fasting glucose of 22.2 mg/dL (p-value: 0.002) and a reduction in body weight of 3.9 kg (p-value: 0.0001)[37][38]. - The pivotal Phase 3 trial "ROSELLA" for relacorilant combined with nab-paclitaxel has completed enrollment with 381 women randomized 1:1[43]. - In the Phase 2 trial, patients receiving 150 mg of relacorilant intermittently had a median progression-free survival (PFS) of 5.6 months compared to 3.8 months for nab-paclitaxel alone, with a hazard ratio of 0.66[46]. - The Phase 2 trial also showed that patients receiving relacorilant intermittently had a median overall survival (OS) of 13.9 months versus 12.2 months for nab-paclitaxel alone, with a hazard ratio of 0.67[46]. - The Phase 1b trial of relacorilant plus pembrolizumab in adrenal cancer patients showed significant symptom improvement but did not slow tumor progression[48]. - A Phase 2 trial of dazucorilant in ALS did not meet its primary endpoint, but the 300 mg dazucorilant arm had 0 deaths compared to 5 deaths in the placebo group[50]. - The Phase 2b trial "MONARCH" for miricorilant in patients with metabolic dysfunction-associated steatohepatitis (MASH) has a planned enrollment of 120 patients[51]. Regulatory and Compliance Issues - Regulatory approval from the FDA is required for all product candidates, involving significant time and expense for compliance with pre- and post-approval regulations[69][70]. - The FDA's review process for a New Drug Application (NDA) aims for a response within ten months for standard review and six months for priority review[74]. - The Orphan Drug Act provides exclusivity for seven years for drugs that receive FDA approval for rare diseases, along with tax credits and waivers for certain fees[75]. - The company is subject to various healthcare regulations, including anti-kickback and false claims laws, which could result in significant penalties for violations[82][84]. - The company is subject to the Physician Payments Sunshine Act, requiring reporting of payments and transfers of value to healthcare providers, with penalties for non-compliance[88]. - The company faces significant risks related to compliance with various healthcare regulations, which could lead to penalties and affect financial results[94]. - The company is under investigation by the United States Attorney's Office for the District of New Jersey regarding the sale and promotion of Korlym, with a focus on relationships and payments to healthcare professionals[139]. - Potential violations of federal healthcare laws could lead to civil and criminal penalties, including fines and exclusion from government healthcare programs, adversely affecting financial results[140]. - Regulatory compliance is critical, as failure to maintain approvals or comply with regulations could lead to significant penalties and loss of revenue[135]. - The company is subject to increased scrutiny regarding patient assistance programs, which may reduce the financial support available to patients needing treatment for hypercortisolism[123]. Financial Performance and Revenue - Research and development expenses were $246.9 million, $184.4 million, and $131.0 million for the years ended December 31, 2024, 2023, and 2022, respectively, accounting for 46%, 49%, and 45% of total operating expenses[57]. - The company’s ability to generate revenue is heavily dependent on the sales of its products for treating hypercortisolism[111]. - The commercial success of the company's products is highly dependent on acceptable pricing and adequate insurance coverage, with government and private payers increasingly limiting reimbursement for medicines[119]. - The Inflation Reduction Act (IRA) requires the Secretary of HHS to negotiate Medicare prices for selected drugs, which may significantly reduce revenue from sales of those drugs[120]. - Beginning in 2025, the IRA will shift a significant portion of Medicare beneficiary costs from the government to manufacturers, potentially limiting revenue and profits[122]. - The company faces potential revenue limitations due to government health care programs and third-party payers increasingly restricting coverage and reimbursement[80]. - The launch of a generic version of Korlym by Teva in January 2024 could adversely affect the company's business and financial position[114]. - The court ruling on December 29, 2023, found that Teva's generic product would not infringe the company's patents, leading to an appeal by the company[114]. - The availability of generic versions of Korlym from other companies like Sun and Hikma could further harm the company's financial results, even if the appeal against Teva is successful[115]. - The company has made its own generic version of Korlym available, which may impact revenue[114]. - The company may need additional capital to fund operations, and if revenue declines significantly, it may have to curtail operations or raise funds under unfavorable terms[154]. - The company faces competition from other medications for hypercortisolism, including FDA-approved drugs like Isturisa® and Recorlev®, which could materially reduce revenue[125][126]. Intellectual Property and Patents - The company holds U.S. and foreign patents for selective cortisol modulators with expiration dates ranging from 2025 to 2041[61]. - The company holds U.S. and international patents for relacorilant, including its use in treating ovarian and pancreatic cancer, with orphan drug designation in both the U.S. and EU for pancreatic cancer treatment[67]. - The company owns patents for cortisol modulators applicable to various conditions, with expiration dates ranging from 2025 to 2039[68]. - Patent protection for the company's products may be challenged, and failure to secure adequate intellectual property rights could erode competitive advantage[156]. Employee and Operational Matters - The company employs 500 individuals as of December 31, 2024, and maintains good employee relations[96]. - The company offers competitive salaries, performance bonuses, and equity grants to attract and retain talent[97]. - The company is subject to significant political and regulatory uncertainties that may adversely affect its business operations and financial condition[184]. - The company faces significant challenges in managing growth due to limited administrative and operational resources, which could impact financial performance and competitiveness[165]. - The company is subject to complex and costly regulations related to drug development and commercialization, which may divert management's attention from revenue-generating activities[167]. Data Privacy and Cybersecurity - The company is subject to stringent data protection regulations, including HIPAA and GDPR, which could impose additional compliance costs[95]. - The company has experienced data breaches and cybersecurity threats, which could result in material costs and reputational damage[178]. - The company utilizes managed detection and response services and multi-factor authentication to protect sensitive information from cybersecurity threats[186]. - Compliance with evolving data privacy regulations, such as HIPAA and GDPR, is expected to increase operational costs and complexity for the company[173]. - The company may incur significant penalties and litigation risks due to non-compliance with privacy laws, including the California Consumer Privacy Act, which could adversely affect financial condition[172]. - The company must adapt to stringent data protection requirements in the EU, which could lead to increased costs and operational challenges[174]. Stock Performance and Market Conditions - The company’s stock price may decline if performance does not meet public guidance or analyst expectations[116]. - The average daily trading volume of the company's common stock was approximately 970,395 shares during the 52-week period ended February 18, 2025[160]. - The intra-day sales prices per share of the company's common stock ranged from $20.84 to $74.61 during the same period[160]. - Approximately 21 percent of the company's common stock is beneficially owned by officers, directors, and principal stockholders as of February 18, 2025[160]. - The company faces risks related to stock performance, which could be influenced by the outcomes of ongoing investigations and regulatory compliance[159]. - The Board of Directors authorized a stock repurchase program of up to $200 million in January 2024, which may reduce cash reserves and impact future capital requirements[181]. - As of February 18, 2025, officers and directors beneficially owned approximately 21% of the common stock, potentially influencing corporate actions significantly[183]. Legal Matters - The company faces ongoing litigation, including antitrust claims from Teva Pharmaceuticals, which could impact financial conditions and operations[194]. - The company has faced a securities class action lawsuit that resulted in a settlement requiring a one-time payment of $14 million, fully reimbursed by insurers[197].

EXHIBIT 99.1 Financial Results "Once again, we had a record number of new Korlym® prescribers and a record number of patients receiving Korlym in the quarter. Physicians are increasingly aware of hypercortisolism's true prevalence and the poor health outcomes for patients who go untreated. Screening is becoming more common and the number of patients receiving appropriate care continues to increase. We are confident that our Cushing's syndrome business will grow for many years," said Joseph K. Belanoff, M.D. ...

Company Overview - Corcept Therapeutics (CORT) shares increased by 13.6% to close at $69.90, with trading volume significantly higher than usual, contributing to a total gain of 22.1% over the past four weeks [1][2] Drug Development and Market Position - The company submitted a new drug application (NDA) for relacorilant, a selective cortisol modulator aimed at treating endogenous hypercortisolism (Cushing's syndrome), which could expand its market reach beyond the existing treatment Korlym (mifepristone) [2] - Korlym has seen strong demand in recent quarters, indicating a solid market position for Corcept [2] Financial Performance Expectations - Corcept is projected to report quarterly earnings of $0.37 per share, reflecting a year-over-year increase of 32.1%, with revenues expected to reach $195.88 million, up 44.7% from the previous year [3] - The consensus EPS estimate for Corcept has remained stable over the last 30 days, suggesting that the stock's price movement may not sustain without changes in earnings estimate revisions [4] Industry Context - Corcept is classified under the Zacks Medical - Drugs industry, where Aurinia Pharmaceuticals (AUPH) is another player, having closed 1.7% lower at $8, with a return of -9.4% over the past month [4] - Aurinia's consensus EPS estimate has also remained unchanged, projected at $0.05, which represents a significant year-over-year increase of 126.3% [5]

Core Viewpoint - Corcept Therapeutics (CORT) has received an upgrade to a Zacks Rank 1 (Strong Buy), indicating a positive outlook for its stock price driven by an upward trend in earnings estimates [1][3]. Earnings Estimates and Stock Price Correlation - The Zacks rating system emphasizes the importance of changing earnings estimates, which are strongly correlated with stock price movements, particularly influenced by institutional investors [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations for stocks, prompting institutional buying or selling actions that affect stock prices [4]. Recent Performance and Projections - For the fiscal year ending December 2024, Corcept is projected to earn $1.35 per share, reflecting a 43.6% increase from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for Corcept has risen by 14.5%, indicating a positive trend in earnings expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - The upgrade of Corcept to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Core Viewpoint - The content emphasizes the importance of conducting personal due diligence and consulting competent advisors before making any financial decisions, particularly in the context of investments in complex instruments like cryptocurrencies and CFDs [1]. Group 1 - The website provides general news, personal analysis, and third-party content intended for educational and research purposes [1]. - It explicitly states that the information does not constitute any recommendation or advice for investment actions [1]. - Users are advised to perform their own research and consider their financial situation before making decisions [1]. Group 2 - The website includes information about high-risk financial instruments, including cryptocurrencies and CFDs, which are complex and can lead to significant financial losses [1]. - It highlights the necessity for users to understand how these instruments work and the associated risks before investing [1]. - The content warns that the information may not be real-time or accurate, and prices may be provided by market makers rather than exchanges [1].

Core Viewpoint - U.S. stock markets are experiencing significant volatility due to concerns over inflation, interest rates, and elevated treasury yields [1][2] Market Conditions - The Trump administration's protectionist tariff policies are causing investor anxiety [2] - A strong U.S. economy, resilient labor market, and persistent inflation are raising doubts about potential interest rate cuts this year [2] Stock Performance - A selection of stocks has demonstrated price strength, particularly those on a recent bull run, indicating potential for continued momentum [3] - Five highlighted stocks include OppFi Inc. (OPFI), Corcept Therapeutics Inc. (CORT), DXP Enterprises Inc. (DXPE), Perpetua Resources Corp. (PPTA), and Graham Corp. (GHM) [3] Stock Screening Criteria - Stocks must show a percentage change in price greater than zero over the last four weeks [5] - Stocks must have a percentage change in price greater than 10% over the last twelve weeks [5] - Zacks Rank 1 (Strong Buy) is a key indicator of potential outperformance [6] - Average broker rating of 1 indicates strong future performance expectations [6] - Stocks must be trading at a minimum price of $5 [6] - Current price must be more than 85% of the 52-week high-low range [7] Individual Stock Analysis - **OppFi Inc. (OPFI)**: Stock price increased by 81.2% in the past four weeks, with expected earnings growth of 16.3% for the current year [10] - **Corcept Therapeutics Inc. (CORT)**: Stock price rose by 20.4% in the past four weeks, with an expected earnings growth rate of 36.4% for the current year [13] - **DXP Enterprises Inc. (DXPE)**: Stock price climbed by 19.8% in the past four weeks, with expected earnings growth of 5.9% for the current year [15] - **Perpetua Resources Corp. (PPTA)**: Stock price advanced by 6.7% in the past four weeks, with expected earnings growth of 25.4% for the current year [16] - **Graham Corp. (GHM)**: Stock price increased by 0.5% in the past four weeks, with expected earnings growth of over 100% for the current year [18]

Core Insights - Growth investors seek stocks with above-average financial growth, but identifying such stocks is challenging due to inherent risks and volatility [1] - The Zacks Growth Style Score simplifies the identification of promising growth stocks, with Corcept Therapeutics (CORT) currently recommended due to its favorable Growth Score and top Zacks Rank [2] Earnings Growth - Earnings growth is crucial for investors, with double-digit growth preferred as an indicator of strong prospects [4] - Corcept's projected EPS growth is 36.4% this year, significantly higher than the industry average of 16.6% [5] Asset Utilization - The asset utilization ratio, or sales-to-total-assets (S/TA) ratio, is an important metric for growth investing [6] - Corcept's S/TA ratio is 0.91, indicating it generates $0.91 in sales for every dollar in assets, compared to the industry average of 0.42, showcasing superior efficiency [6] Sales Growth - Sales growth is another critical factor, with Corcept expected to achieve a sales growth of 12.8% this year, outpacing the industry average of 9.5% [7] Earnings Estimate Revisions - Trends in earnings estimate revisions correlate strongly with near-term stock price movements [8] - Corcept's current-year earnings estimates have been revised upward, with the Zacks Consensus Estimate increasing by 0.1% over the past month [9] Conclusion - Corcept has achieved a Growth Score of A and a Zacks Rank 2, positioning it well for potential outperformance, making it an attractive option for growth investors [11]

Core Viewpoint - Kuehn Law, PLLC is investigating potential breaches of fiduciary duties by officers and directors of Corcept Therapeutics Inc. related to self-dealing, which may entitle shareholders to damages and corporate governance reforms [1]. Group 1 - The investigation focuses on whether certain officers and directors of Corcept Therapeutics Inc. have engaged in self-dealing that could harm shareholder interests [1]. - Shareholders are encouraged to contact Kuehn Law for a free consultation regarding their rights and potential claims [2]. - The law firm emphasizes the importance of shareholder participation in maintaining the integrity of financial markets [3].