Key Takeaways Corcept reported Q3 EPS of $0.16, which missed estimates and fell from $0.41 in the prior-year quarter.CORT's revenues grew 14% year over year to $207.6 million in Q3 but missed expectations.CORT cut 2025 revenue guidance to $800-$850 million, prompting a 4.6% after-hours share drop.Corcept Therapeutics (CORT) reported third-quarter 2025 earnings of 16 cents per share, which missed the Zacks Consensus Estimate of 18 cents. The company had reported earnings of 41 cents per share in the year-ago ...

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $207.6 million, up from $182.5 million in the same period last year, reflecting a year-over-year increase of approximately 13% [3] - Net income decreased to $19.7 million from $47.2 million in Q3 2024 [3] - Cash and investments as of September 30, 2025, totaled $524 million, which includes a $50 million stock repurchase [3] Business Line Data and Key Metrics Changes - The hypercortisolism business experienced a 42.5% increase in tablet shipments compared to Q3 2024, driven by record prescriptions for Korlym [7] - The company is transitioning to a new pharmacy vendor due to capacity constraints with the previous vendor, which may affect growth in the short term [7][8] Market Data and Key Metrics Changes - The company reported around 3,250 paying patients at the end of Q3 2025, with expectations for significant market capacity growth as relacorilant is launched [34][35] - The authorized generic accounted for approximately 70% of the business in Q3 2025, with expectations to reach around 75% by year-end [42] Company Strategy and Development Direction - The company is preparing for the launch of relacorilant, with PDUFA dates set for December 30, 2025, for hypercortisolism and July 11, 2026, for ovarian cancer [12] - The oncology program is expanding significantly, with plans for new studies in various solid tumors and a focus on combining treatments with existing therapies [20][21] - The company aims to triple the potential patient base for gynecological cancers from 20,000 to 60,000 annually in the U.S. [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of relacorilant, anticipating it could generate $3-$5 billion in annual revenue in hypercortisolism alone within three to five years [11] - The company is optimistic about the upcoming FDA approvals and the potential impact of its clinical studies on treatment paradigms [28][29] Other Important Information - The company is finalizing a phase 3 trial design for dazcorilant in ALS, expected to start by mid-2026 [14][27] - The CATALYST study revealed that one in four patients with resistant diabetes has hypercortisolism, indicating a significant opportunity for treatment [24] Q&A Session Summary Question: How many patients were on drug at the end of the quarter? - Approximately 3,250 paying patients were reported at the end of Q3 2025 [34] Question: What is the capacity of the new pharmacy compared to the old one? - The new pharmacy has the ability to continually expand and has multiple locations, which is expected to support the business effectively [34] Question: Are there any downward pressures on margins? - No downward pressure on margins has been observed, and the company does not expect any [36] Question: What is the net pricing relative to brand pricing? - The net pricing is about a 30% discount to Korlym's list price, with the authorized generic making up a significant portion of the business [42] Question: Was the lack of priority review for the ovarian cancer NDA surprising? - Management was not surprised by the lack of priority review, acknowledging the FDA's many priorities [44] Question: What are the expectations for R&D and SG&A in 2026? - R&D expenditures are expected to remain stable, while SG&A expenses are anticipated to increase due to preparations for product launches [46]

Core Insights - Corcept Therapeutics Incorporated (NASDAQ:CORT) is identified as a strong investment opportunity with over 50% upside potential, supported by analysts maintaining a Buy rating and setting price targets of $140 and $145 respectively [1][2]. Company Overview - Corcept Therapeutics is a biopharmaceutical company focused on developing therapies that modulate cortisol effects, with its flagship product, Korlym, FDA-approved for treating Cushing's syndrome [5]. Clinical Developments - The company's relacorilant shows promise for treating ovarian cancer, particularly in patients with platinum-resistant ovarian cancer previously treated with PARP inhibitors, as indicated by recent ROSELLA trial data presented at a medical congress [3]. - Despite the typically poorer prognosis of this subgroup, significant progression-free survival benefits were observed with relacorilant in combination with nab-paclitaxel [4]. - Management is optimistic about the broader therapeutic potential of relacorilant, as evidenced by the expansion of the BELLA Phase 2 trial to include additional indications like endometrial cancer and platinum-sensitive ovarian cancer [4].

Core Insights - Corcept Therapeutics (CORT) has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its lead candidate, relacorilant, aimed at treating platinum-resistant ovarian cancer [1] - The MAA is supported by positive results from the pivotal phase III ROSELLA study and phase II studies, which demonstrated improved progression-free and overall survival when relacorilant was combined with nab-paclitaxel compared to nab-paclitaxel alone [2] - The FDA has accepted a new drug application (NDA) for relacorilant, with a final decision expected on July 11, 2026 [2] Company Performance - Year-to-date, Corcept's shares have increased by 43.1%, significantly outperforming the industry average rise of 7.4% [3] - The company's sole marketed drug, Korlym (mifepristone), generated sales of $351.6 million in the first half of 2025, reflecting a year-over-year increase of 13.2% [7] Ongoing Development Activities - Corcept is also developing relacorilant for Cushing's syndrome, having submitted an NDA to the FDA in December 2024, with a target action date of December 30, 2025 [5][6] - The company is conducting the phase II BELLA study to evaluate the combination of relacorilant with nab-paclitaxel and Roche's Avastin for platinum-resistant ovarian cancer [6] Market Position - A potential approval of relacorilant could expand Corcept's market reach and reduce its dependence on Korlym for future growth [5][7] - Corcept currently holds a Zacks Rank of 5 (Strong Sell), while other biotech stocks like Chemomab Therapeutics and ANI Pharmaceuticals have better rankings [8]

Core Insights - Corcept Therapeutics' sole-marketed drug, Korlym, is approved for treating Cushing's syndrome, and the company's revenue is entirely dependent on Korlym sales [1][2] Sales Performance - In the first half of 2025, Korlym generated sales of $351.6 million, reflecting a year-over-year increase of approximately 13.2% [1][9] - Full-year 2025 sales for Korlym are estimated to reach $857.1 million, indicating a nearly 26% year-over-year growth [1] Revenue Guidance - Management has revised its total revenue guidance for 2025, now expecting revenues between $850 million and $900 million, down from the previous estimate of $900 million to $950 million [3] Pipeline Development - Corcept is developing relacorilant as a potential alternative to reduce dependence on Korlym, with a new drug application submitted to the FDA for Cushing's syndrome [4][5] - The FDA has set a target action date of December 30, 2025, for the relacorilant application for Cushing's syndrome [4][9] Additional Indications - Corcept is also pursuing relacorilant for other indications, including a combination therapy for platinum-resistant ovarian cancer, with an FDA decision expected on July 11, 2026 [6][9] - The BELLA study is evaluating relacorilant in combination with nab-paclitaxel and Avastin for ovarian cancer treatment [7] - Other studies are assessing relacorilant with Keytruda for adrenal cancer and with Xtandi for early-stage prostate cancer [8]

Core Insights - Corcept Therapeutics Incorporated (NASDAQ:CORT) is recognized as one of the 12 stocks with consistent growth potential for investment [1] - The company reported a strong Q2 performance but subsequently lowered its full-year revenue guidance [2] Financial Performance - In Q2 2025, Corcept achieved an EPS of $0.29, surpassing estimates by 45% compared to the expected $0.20 [2] - Revenue for the quarter was $194.4 million, reflecting an 18.7% year-over-year increase [2] - The company has revised its full-year revenue guidance to a range of $850 million to $900 million [2] Drug Development and Regulatory Updates - The FDA has accepted the New Drug Application (NDA) for Corcept's drug candidate, Relacorilant, aimed at treating platinum-resistant ovarian cancer [3] - A decision date for the NDA has been set for July 11, 2026, which is expected to de-risk a significant portion of the company's pipeline [3] - Corcept plans to present new data from the pivotal Phase 3 ROSELLA trial at the European Society for Medical Oncology (ESMO) annual meeting on October 19, 2025 [3] Company Overview - Corcept Therapeutics has demonstrated a remarkable 10-year performance increase of 1534.68%, indicating a strong market position [4] - Founded in 1998, the company focuses on developing drugs for severe metabolic, psychiatric, and oncologic disorders by modulating cortisol effects [4]

Core Insights - Corcept Therapeutics' sole-marketed drug, Korlym, has shown strong sales performance, with $351.6 million in sales for the first half of 2025, reflecting a year-over-year increase of approximately 13.2% [1][9] - The company anticipates full-year 2025 Korlym sales to reach $857.1 million, indicating a nearly 27% increase year-over-year [1][3] - Management expects a significant rise in Korlym prescriptions in the second half of 2025 as vendor issues are resolved [2][3] Sales and Revenue Expectations - Korlym sales were impacted by vendor capacity issues in Q1 2025 but improved in Q2, with expectations for continued growth in H2 2025 [2][3] - Corcept projects total revenues for 2025 to be between $850 million and $900 million [3] Pipeline Developments - Corcept is developing relacorilant for Cushing's syndrome, with a new drug application submitted to the FDA, and a decision expected by December 30, 2025 [4][9] - Approval of relacorilant is anticipated to broaden the patient base and reduce reliance on Korlym for future growth [5] Additional Indications and Studies - The company is also pursuing relacorilant for other indications, including a combination therapy for platinum-resistant ovarian cancer and adrenal cancer [6][7] - The BELLA study is evaluating the efficacy of relacorilant combined with nab-paclitaxel and Avastin for ovarian cancer treatment [7] Market Performance and Valuation - Corcept's stock has increased by 38.3% year-to-date, outperforming the industry average of 8.3% [8] - The company's shares are trading at a premium, with a price-to-sales ratio of 11.73 compared to the industry average of 2.38 [10] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share has decreased from $1.39 to $1.15, and for 2026, it has decreased from $2.08 to $1.71 [11]

Core Insights - Corcept Therapeutics (CORT) has shown a strong performance in 2025, with shares increasing by 39.6%, significantly outperforming the industry average of 10.2% [1][7] - The company's lead pipeline candidate, relacorilant, is progressing towards potential FDA approval for Cushing's syndrome by December 2025, which is expected to enhance growth prospects [2][3] Pipeline Developments - Corcept submitted a new drug application (NDA) for relacorilant to the FDA for treating hypercortisolism in December 2024, which was accepted in March 2025 [3][7] - The NDA is supported by positive data from the GRACE study and phase III GRADIENT study, indicating strong efficacy for relacorilant [4] - A second NDA was submitted for relacorilant in combination with nab-paclitaxel for platinum-resistant ovarian cancer, based on positive phase III ROSELLA study results [5][8] Financial Performance - Korlym, the only marketed product, generated sales of $351.6 million in the first half of 2025, reflecting a year-over-year increase of approximately 13.2% [12] - Full-year 2025 sales for Korlym are estimated at $857.1 million, indicating a nearly 27% increase year-over-year [12] - The company has lowered its total revenue guidance for 2025 to a range of $850-$900 million, down from the previous estimate of $900-$950 million [13] Valuation Metrics - Corcept's shares are trading at a price-to-sales (P/S) ratio of 11.83, which is significantly higher than the industry average of 2.42 and above its five-year mean of 7.52 [14] - The Zacks Consensus Estimate for 2025 earnings per share (EPS) has decreased from $1.39 to $1.21, with 2026 EPS estimates also declining from $2.08 to $1.84 [16] Future Outlook - The potential approval of relacorilant is anticipated to broaden the patient base and positively impact stock performance in future quarters [17] - However, the reliance on Korlym for revenue remains a concern, and any regulatory or developmental setbacks could adversely affect the company's growth prospects [17][18]

Core Insights - Corcept Therapeutics (CORT) reported Q2 2025 earnings of $0.29 per share, exceeding the Zacks Consensus Estimate of $0.23, but down from $0.32 in the same quarter last year [1][7] - Revenues for the second quarter increased by 18.7% year over year to $194.4 million, although this figure fell short of the Zacks Consensus Estimate of $204 million [1][4] - The revenue was solely derived from product sales of the Cushing's syndrome drug, Korlym [1] Financial Performance - Revenue from Korlym missed the model estimate of $211.7 million [4] - Research and development expenses rose by 3.1% year over year to $60.5 million [4] - Selling, general, and administrative expenses surged by approximately 55.1% year over year to $103.8 million [4] - Total operating expenses increased by 30.8% year over year to $167.8 million in Q2 [4] - Cash and investments as of June 30, 2025, totaled $515 million, down from $570.8 million as of March 31, 2025 [5] Guidance and Market Reaction - Corcept lowered its total revenue guidance for 2025 to a range of $850-$900 million from the previous $900-$950 million [6][8] - This revision may have negatively impacted investor sentiment, leading to a 4.7% decline in stock price during pre-market trading on August 1 [8] Pipeline Developments - Corcept submitted a new drug application (NDA) to the FDA for its lead pipeline candidate, relacorilant, in combination with nab-paclitaxel for treating platinum-resistant ovarian cancer [9] - The NDA submission was based on data from the pivotal phase III ROSELLA study, which met its primary endpoint of improved progression-free survival [10] - The company is also evaluating relacorilant in combination with nab-paclitaxel and Avastin in the phase II BELLA study for the same indication [11][12] - Additional studies are ongoing for relacorilant in early-stage prostate cancer and for other pipeline candidates targeting various conditions [13] Market Performance - Year-to-date, Corcept's shares have increased by 33.3%, significantly outperforming the industry average rise of 4.5% [2]

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $194.4 million, up from $163.8 million in the same period last year, reflecting a significant increase [5][6] - Net income was $35.1 million compared to $35.5 million in Q2 2024, indicating a slight decrease [5] - Cash and investments as of June 30, 2025, totaled $515 million, which includes $115 million spent on stock repurchase [5] Business Line Data and Key Metrics Changes - The Endocrinology Division reported a record number of new prescribers and prescriptions, with a 49% increase in tablets shipped compared to Q2 2024 [6][7] - Despite substantial quarterly revenue growth, fulfillment issues limited the potential revenue increase, with a $37 million increase over Q1 2025 [7][8] Market Data and Key Metrics Changes - The CATALYST study revealed that one in four patients with difficult-to-control diabetes has hypercortisolism, leading to increased screening and treatment [9][19] - The company is expanding its sales force significantly, increasing from 60 to 145 clinical specialists, with plans to reach 175 by year-end [10] Company Strategy and Development Direction - The company is focused on expanding its product offerings in hypercortisolism and oncology, with two new drug applications in progress [16][22] - Relacorilant is expected to become a new standard of care for hypercortisolism, with projected annual revenues of $3 billion to $5 billion in the next three to five years [10][19] - The company is also exploring the use of cortisol receptor antagonism in various cancers and neurological disorders [29][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of relacorilant and the overall business, anticipating significant market expansion due to increased physician awareness [10][19] - The company acknowledged challenges with pharmacy capacity but expects improvements in the second half of the year [7][53] Other Important Information - The company is involved in ongoing patent litigation with Teva regarding Korlym, with a decision expected in the next two to three months [12][15] - The company is preparing to launch a second pharmacy to support its growth and improve fulfillment capabilities [7][53] Q&A Session Summary Question: What portion of your business came from the authorized generic during the quarter relative to Q1? - Approximately two-thirds of the business has transitioned to the authorized generic, with an average discount of about 30% to Korlym's list price [43][44] Question: Can you talk about the disconnect between prescriptions written and filled? - The pharmacy did not meet expectations, impacting Q2 results by approximately $15 million, but improvements are expected in Q3 and Q4 [52][53] Question: How much of the $3 billion to $5 billion peak sales opportunity for hypercortisolism comes from Korlym? - Relacorilant is expected to replace Korlym, and the market for hypercortisolism is larger than previously estimated [56][62] Question: When will the second pharmacy come online? - The second pharmacy is expected to contribute in Q4 2025, with plans to expand the distribution network for relacorilant [63][64] Question: What is the timeline for the BELLA study? - Enrollment for the BELLA trial is progressing rapidly, with results expected about a year after enrollment completion [80][81] Question: What is the strategy regarding ALS discussions with the FDA? - A meeting with the FDA is scheduled for later in August to discuss the path forward, including the possibility of approval based on existing data [82][84]