Key Takeaways CORT's only drug Korlym generated $351.6M in H1 2025 sales, up 13.2% year over year.Corcept filed an NDA for relacorilant in Cushing's syndrome, with an FDA decision due on Dec. 30, 2025.An NDA for relacorilant with nab-paclitaxel in ovarian cancer has an FDA decision date of July 11, 2026.Corcept Therapeutics’ (CORT) sole-marketed drug, Korlym (mifepristone), is approved for treating Cushing's syndrome or endogenous hypercortisolism. The company’s top line solely comprises product sales from ...

Corcept Therapeutics Incorporated (NASDAQ:CORT) is one of the 12 Stocks with Consistent Growth to Invest In. Following a strong positive second quarter, the company lowers its full-year guidance and announces the NDA acceptance for a new drug by the FDA. Corcept Therapeutics Beats Q2 Estimates, Cuts Guidance and Advances NDA for New Cancer Drug Corcept Therapeutics Incorporated (NASDAQ:CORT) reported its Q2 2025 earnings on July 31, 2025, in which it highlighted a 45% EPS beat, achieving $0.29 per share ...

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]

Financial Performance and Guidance - Corcept achieved significant revenue growth, increasing from $3 million in 2012 to $482 million in 2024 [13] - The company's 2025 revenue guidance is between $900 million and $950 million [13] - As of March 31, 2025, Corcept had $570.8 million in cash [13] Clinical Trial Results and Drug Development - The GRACE trial showed that 63% of patients with hypertension met the study's response criteria, with a mean improvement of 12.6 mm Hg in SBP and 8.3 mm Hg in DBP [29] - In the GRACE trial, 50% of patients with hyperglycemia met the study's response criteria, showing a mean improvement of 0.7% in HbA1c, 25.2 mg/dL in fasting glucose, and 85.0 mg/dL in 2-hour oGTT [33] - The ROSELLA trial in platinum-resistant ovarian cancer met its primary endpoint, with relacorilant + nab-paclitaxel reducing disease progression risk by 30% (HR=0.70; p=0.008) and mortality risk by 31% (HR=0.69; p=0.01) [62] - In the CATALYST trial, 23.8% of 1,057 patients with difficult-to-control type 2 diabetes were found to have hypercortisolism [21] - Patients who received Korlym in the CATALYST trial experienced a 1.47% reduction in HbA1c compared to a 0.15% reduction in patients who received placebo (p<0.0001) [21] Regulatory and Intellectual Property - Relacorilant's NDA has a PDUFA target date of December 30, 2025 [15, 24] - Corcept holds method of use patents for Korlym extending to 2038 [24] - Corcept holds composition of matter patents for Relacorilant extending to 2038 and method of use, formulation and manufacturing patents extending to 2040 [25]

Core Insights - Corcept Therapeutics reported first-quarter 2025 earnings of 17 cents per share, matching the Zacks Consensus Estimate, but down from 25 cents per share in the same quarter last year [1] - Revenues for the first quarter increased by 7.1% year over year to $157.2 million, but fell short of the Zacks Consensus Estimate of $178 million, primarily driven by sales of the Cushing's syndrome drug, Korlym [2][5] - Year-to-date, Corcept's shares have increased by 46.8%, contrasting with a 0.4% decline in the industry [4] Financial Performance - Korlym sales were impacted by the inability of a specialty pharmacy vendor to meet the surge in demand, leading to lower-than-expected sales and a 7.5% drop in shares during after-hours trading following the earnings announcement [5] - Research and development expenses rose by 3.8% year over year to $60.7 million, while selling, general, and administrative expenses surged by approximately 61.1% to $90.7 million, resulting in total operating expenses increasing by 31.1% to $153.8 million [6] - As of March 31, 2025, cash and investments totaled $570.8 million, down from $603.2 million as of December 31, 2024 [6] 2025 Guidance - Corcept reiterated its total revenue guidance for 2025, expecting revenues in the range of $900-$950 million, with the Zacks Consensus Estimate at $905.7 million [7] Pipeline Developments - Corcept is advancing its lead candidate, relacorilant, for Cushing's syndrome, with a new drug application submitted to the FDA in December 2024 based on positive data from the GRACE study and other trials [8] - The FDA accepted the NDA in March 2025, with a target action date of December 30, 2025 [9] - Corcept is also exploring relacorilant in combination studies for various cancer indications, with the phase III ROSELLA study meeting its primary endpoint for patients with platinum-resistant ovarian cancer [9] Additional Studies - Corcept initiated the phase II BELLA study to evaluate relacorilant in combination with nab-paclitaxel and Avastin for treating platinum-resistant ovarian cancer [10] - The company is also assessing relacorilant plus Xtandi in early-stage prostate cancer patients in collaboration with the University of Chicago [11] - Data from the phase II DAZALS study for dazucorilant in ALS did not meet its primary endpoint, but exploratory analysis showed improved overall survival for treated patients [12][13] Market Position - Corcept currently holds a Zacks Rank 3 (Hold), with better-ranked biotech stocks including ADMA Biologics and Immunocore Holdings, both carrying a Zacks Rank 2 (Buy) [14]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $157.2 million, an increase from $146.8 million in Q1 2024, representing a year-over-year growth of approximately 9% [5] - Net income decreased to $20.5 million in Q1 2025 from $27.8 million in Q1 2024 [5] - Cash and investments as of March 31, 2025, totaled $570.8 million [5] - The company reiterated its 2025 revenue guidance of $900 million to $950 million [5] Business Line Data and Key Metrics Changes - The prescriber base for hypercortisolism treatments has grown at a record rate for five consecutive quarters, with the number of prescriptions nearly doubling compared to the same period last year [7] - The average price per tablet decreased by 13% due to a transition from branded Korlym to an authorized generic, which has a lower net price [10] Market Data and Key Metrics Changes - The company has seen a substantial improvement in pharmacy operations in March and April 2025, leading to a record number of tablets dispensed [10] - The transition to authorized generic tablets is expected to continue, but the decrease in price will be offset by an increase in the number of tablets shipped [11] Company Strategy and Development Direction - The company is focused on increasing physician awareness and understanding of hypercortisolism, with plans to expand its sales force from 125 to 175 clinical specialists by year-end [8] - The new drug application for relacorilant in hypercortisolism is under FDA review, with an action date set for December 30, 2025 [15] - The company is also exploring the use of relacorilant in combination with other therapies for various cancers, including ovarian and prostate cancers [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth prospects for hypercortisolism treatments, citing the CATALYST study's findings that one in four patients with difficult-to-control diabetes has hypercortisolism [18] - The company anticipates that the publication of full CATALYST treatment results will stimulate further growth in the second half of the year [43] - Management emphasized the potential for relacorilant to become the new standard of care for hypercortisolism patients [33] Other Important Information - The company is actively pursuing regulatory discussions regarding the next steps for its ALS treatment program following mixed results in a Phase II trial [27][66] - The company is preparing to submit relacorilant's NDA for platinum-resistant ovarian cancer in the next quarter [24] Q&A Session Summary Question: How does relacorilant fit into the treatment paradigm compared to Elaher? - Management indicated that relacorilant plus nab-paclitaxel is poised to become a new standard of care in platinum-resistant ovarian cancer, with potential use in multiple lines of therapy [40] Question: What is the expected revenue impact from the recent pharmacy operational improvements? - Management expects growth to continue through the second quarter and accelerate in the second half of the year, driven by strong fundamentals and initiatives [43][44] Question: Can you clarify the mix between brand and authorized generic for Korlym? - Currently, a little over half of patients are on the authorized generic, which is expected to increase, but volume growth is anticipated to outweigh any price changes [50][74] Question: Will there be an advisory committee for the December PDUFA? - Management does not expect an advisory committee for relacorilant, similar to previous approvals in hypercortisolism [51] Question: What are the next steps for relacorilant in solid tumors? - The company plans to rapidly expand studies for relacorilant in combination with other therapies in solid tumors, with a focus on earlier lines of therapy [53]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $157.2 million, an increase from $146.8 million in Q1 2024, with a revenue guidance for 2025 set between $900 million and $950 million [5] - Net income decreased to $20.5 million in Q1 2025 from $27.8 million in Q1 2024 [5] - Cash and investments as of March 31, 2025, totaled $570.8 million [5] Business Line Data and Key Metrics Changes - The prescriber base and patient base for hypercortisolism treatments are growing rapidly, with new prescriber growth at a record rate for five consecutive quarters [7] - The number of prescriptions for Korlym in Q1 2025 was nearly double that of the same period last year [7] - The average price per tablet decreased by 13% due to a transition from branded Korlym to an authorized generic [11] Market Data and Key Metrics Changes - The increase in screening for hypercortisolism is driving rapid patient growth, with expectations for continued acceleration [8] - The transition to authorized generic tablets is expected to grow, but the decrease in price will be offset by an increase in the number of tablets shipped [12] Company Strategy and Development Direction - The company is focused on increasing physician awareness of hypercortisolism and expanding its sales force to support growth [8] - The new drug application for relacorilant in hypercortisolism is under FDA review, with an action date set for December 30, 2025 [16] - The company is exploring the use of cortisol modulation in various cancers, including ovarian and prostate cancers, and is preparing for potential regulatory submissions [22][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth prospects for hypercortisolism treatments, citing the CATALYST study's findings as a catalyst for increased screening and treatment [21] - The company anticipates that the operational improvements at the pharmacy vendor will support continued growth throughout 2025 [61] - Management emphasized the potential for relacorilant to become the new standard of care for hypercortisolism patients [33] Other Important Information - The company has made substantial progress in its oncology portfolio, with positive results from the ROSELA trial indicating potential for broader applications of cortisol modulation [22][33] - The company is actively exploring the potential of proprietary compounds for treating neurologic and hepatic diseases [28][30] Q&A Session Summary Question: Clarification on oncology program and treatment paradigm - Management indicated that relacorilant plus nab-paclitaxel is poised to become a new standard of care in platinum-resistant ovarian cancer, with potential positioning before or after biomarker-driven agents [40][41] Question: Revenue expectations for upcoming quarters - Management expects growth to continue through the second quarter and accelerate in the second half of the year, driven by strong fundamentals and the publication of full CATALYST data [45][46] Question: Mix between brand and authorized generic for Korlym - Currently, a little over half of patients are on the authorized generic, which is expected to increase, but volume growth is anticipated to outweigh any price changes [51][75] Question: Nature of corrective measures taken by pharmacy vendor - The pharmacy vendor has improved staffing and operations to meet increased demand, with March and April showing record dispensing numbers [60][61] Question: Expectations for ALS data and potential approval - Management plans to discuss further studies with regulatory authorities to determine the next steps for the ALS program [66]