cept Therapeutics rporated(CORT)
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Corcept Therapeutics (CORT) Tops Q3 Earnings and Revenue Estimates
ZACKS· 2024-10-30 23:01
Corcept Therapeutics (CORT) came out with quarterly earnings of $0.41 per share, beating the Zacks Consensus Estimate of $0.27 per share. This compares to earnings of $0.28 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 51.85%. A quarter ago, it was expected that this drug developer would post earnings of $0.23 per share when it actually produced earnings of $0.32, delivering a surprise of 39.13%. Over the last four quarters ...
cept Therapeutics rporated(CORT) - 2024 Q3 - Quarterly Report
2024-10-30 20:12
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________________________________________________ FORM 10-Q _______________________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 000-50679 ________________ ...
cept Therapeutics rporated(CORT) - 2024 Q3 - Quarterly Results
2024-10-30 20:09
[Corcept Therapeutics Third Quarter 2024 Results](index=1&type=section&id=Corcept%20Therapeutics%20Third%20Quarter%202024%20Results) Corcept Therapeutics reported strong financial performance in Q3 2024 and provided significant updates on its clinical development pipeline [Financial Highlights and Corporate Update](index=1&type=section&id=Financial%20Highlights%20and%20Corporate%20Update) Corcept Therapeutics reported strong Q3 2024 results with a **48%** year-over-year revenue **increase** to **$182.5 million** and raised its full-year 2024 revenue guidance to **$675–$700 million**. Diluted net income per share **grew** to **$0.41**. The company also announced **Positive results** from its Phase 3 GRADIENT trial, which will support the New Drug Application (NDA) for relacorilant, planned for submission this quarter | Metric | Q3 2024 | Q3 2023 | % Change | | :--- | :--- | :--- | :--- | | Revenue | $182.5 million | $123.6 million | +48% | | Diluted EPS | $0.41 | $0.28 | +46% | | Cash & Investments (as of Sep 30, 2024) | $547.6 million | N/A | N/A | - The company **increased** its 2024 revenue guidance from **$640–$670 million** to **$675–$700 million**[1](index=1&type=chunk)[3](index=3&type=chunk) - **Positive results** from the Phase 3 GRADIENT trial will support the New Drug Application (NDA) for relacorilant, which is scheduled for submission this quarter[1](index=1&type=chunk) [Financial Results](index=1&type=section&id=Financial%20Results) In Q3 2024, revenue growth was driven by a record number of Korlym® prescribers and patients. Operating expenses rose to **$135.9 million** from **$92.4 million** in Q3 2023. The company's cash and investments balance **increased** to **$547.6 million**, even after repurchasing **$23.4 million** of its common stock during the quarter - Revenue growth was attributed to an **increase** in Korlym® prescribers and patients, with physicians becoming more aware of hypercortisolism's prevalence[2](index=2&type=chunk) | Financial Item | Q3 2024 | Q3 2023 | | :--- | :--- | :--- | | Revenue | $182.5 million | $123.6 million | | Operating Expenses | $135.9 million | $92.4 million | | Net Income | $47.2 million | $31.4 million | - Cash and investments **grew** to **$547.6 million** at September 30, 2024, from **$492.5 million** at June 30, 2024. This was after acquiring **$23.4 million** of common stock (870,000 shares) through the company's repurchase program[3](index=3&type=chunk) [Clinical Development](index=1&type=section&id=Clinical%20Development) Corcept is poised for significant clinical milestones in Q4 2024, including the NDA submission for relacorilant for Cushing's syndrome. The company also expects to release pivotal data from its ROSELLA trial in ovarian cancer, the CATALYST study in Cushing's syndrome, and the DAZALS study in ALS by year-end - **Key data readouts expected by year-end include:** - CATALYST study (Cushing's syndrome) - ROSELLA pivotal study (platinum-resistant ovarian cancer) - DAZALS study (amyotrophic lateral sclerosis - ALS)[4](index=4&type=chunk) [Cushing's Syndrome](index=1&type=section&id=Cushing%27s%20Syndrome) The NDA for relacorilant is on track for submission this quarter, supported by **positive data** from the pivotal Phase 3 GRACE trial and the supportive Phase 3 GRADIENT trial. Both studies demonstrated that relacorilant provided clinically meaningful improvements in hypercortisolism symptoms with a favorable safety profile, notably lacking side effects like hypokalemia. The GRADIENT trial showed **statistically significant improvements** in hyperglycemia, weight, and body composition compared to placebo - The pivotal Phase 3 GRACE trial **met its primary endpoint**, demonstrating that relacorilant maintained improvements in hypertension and hyperglycemia[5](index=5&type=chunk)[6](index=6&type=chunk) - The supportive Phase 3 GRADIENT trial confirmed relacorilant's efficacy, showing **statistically significant improvements** versus placebo in glucose metabolism, body weight, and visceral adipose fat[7](index=7&type=chunk)[9](index=9&type=chunk)[10](index=10&type=chunk) - Relacorilant was **well-tolerated** in both GRACE and GRADIENT trials, with no induced instances of hypokalemia, endometrial hypertrophy, adrenal insufficiency, or QT prolongation[5](index=5&type=chunk)[6](index=6&type=chunk)[11](index=11&type=chunk) - Results from the CATALYST study, the largest study of hypercortisolism in patients with difficult-to-control diabetes, are **expected by year-end**[6](index=6&type=chunk)[13](index=13&type=chunk) [Oncology](index=3&type=section&id=Oncology) Enrollment is **complete** in the pivotal Phase 3 ROSELLA trial, which evaluates relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer. Data on the primary endpoint, progression-free survival, is expected this quarter and could form the basis for relacorilant's next NDA. A Phase 2 trial in early-stage prostate cancer is also ongoing - The pivotal Phase 3 ROSELLA trial in 381 patients with platinum-resistant ovarian cancer has **completed enrollment**[14](index=14&type=chunk) - Progression-free survival data, the primary endpoint for ROSELLA, is expected by the end of the current quarter[14](index=14&type=chunk) [Amyotrophic Lateral Sclerosis (ALS)](index=3&type=section&id=Amyotrophic%20Lateral%20Sclerosis%20(ALS)) The Phase 2 DAZALS trial of dazucorilant in 249 patients with ALS has **completed enrollment**. Following promising results in animal models, data on the trial's primary endpoint—improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R) score—is **expected by the end of the year** - Enrollment is **complete** for the Phase 2 DAZALS trial of dazucorilant in 249 patients with ALS[15](index=15&type=chunk) - Data for the primary endpoint (ALSFRS-R score) is **expected by year-end**[15](index=15&type=chunk) [Metabolic Dysfunction-Associated Steatohepatitis (MASH)](index=3&type=section&id=Metabolic%20Dysfunction-Associated%20Steatohepatitis%20(MASH)) Enrollment is **ongoing** for the Phase 2b MONARCH trial of miricorilant in patients with MASH. This study builds on promising Phase 1b results where miricorilant **rapidly reduced liver fat** and improved key metabolic measures - The Phase 2b MONARCH trial of miricorilant in patients with MASH is **currently enrolling**[16](index=16&type=chunk) - Previous Phase 1b results showed miricorilant **rapidly reduced liver fat**, improved liver health, and was **well-tolerated**[16](index=16&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) This section provides a detailed overview of Corcept's financial position and performance through its condensed consolidated balance sheets and income statements [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2024, Corcept's total assets **increased** to **$784.3 million** from **$621.5 million** at the end of 2023. This growth was primarily driven by a rise in cash and investments to **$547.6 million**. Stockholders' equity also saw substantial growth, reaching **$638.8 million** | (In thousands) | Sep 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Cash and investments** | **$547,646** | **$425,397** | | Total assets | $784,257 | $621,517 | | Total liabilities | $145,422 | $114,812 | | **Stockholders' equity** | **$638,835** | **$506,705** | [Condensed Consolidated Statements of Income](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Income) For the third quarter of 2024, Corcept generated net product revenue of **$182.5 million**, a significant **increase** from **$123.6 million** in the same period last year. Net income for the quarter rose to **$47.2 million** (**$0.41 per diluted share**) from **$31.4 million** (**$0.28 per diluted share**) in Q3 2023. Operating expenses **increased**, driven by higher R&D and SG&A costs Three Months Ended September 30 (in thousands, except per share data) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Product revenue, net | $182,546 | $123,601 | | Total operating expenses | $135,948 | $92,424 | | Income from operations | $46,598 | $31,177 | | **Net income** | **$47,213** | **$31,378** | | **Diluted net income per common share** | **$0.41** | **$0.28** | Nine Months Ended September 30 (in thousands) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Product revenue, net | $493,150 | $346,970 | | Total operating expenses | $381,461 | $271,357 | | **Net income** | **$110,463** | **$74,785** | [Corporate Information and Forward-Looking Statements](index=3&type=section&id=Corporate%20Information%20and%20Forward-Looking%20Statements) This section outlines Corcept's long-standing focus on cortisol modulation and provides cautionary statements regarding future projections and clinical outcomes [About Corcept Therapeutics](index=4&type=section&id=About%20Corcept%20Therapeutics) Corcept Therapeutics has focused on cortisol modulation for over 25 years, discovering **over 1,000 proprietary selective cortisol modulators**. The company commercialized Korlym for Cushing's syndrome in 2012 and is advancing clinical trials in hypercortisolism, solid tumors, ALS, and liver disease - The company's focus on cortisol modulation has led to the discovery of **over 1,000 proprietary selective cortisol modulators**[18](index=18&type=chunk) - Corcept introduced Korlym, its **first FDA-approved medication** for Cushing's syndrome, in February 2012[18](index=18&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section cautions that statements in the press release regarding future events are subject to risks and uncertainties. Key forward-looking statements include the 2024 revenue guidance, the timing and outcome of the relacorilant NDA submission, and the expected data releases and potential approvals for its clinical programs, including CATALYST, ROSELLA, and DAZALS - Forward-looking statements cover topics such as 2024 revenue guidance, clinical development timelines for relacorilant, dazucorilant, and miricorilant, and the timing of regulatory submissions and data readouts[20](index=20&type=chunk)
Strength Seen in Corcept (CORT): Can Its 5.5% Jump Turn into More Strength?
ZACKS· 2024-10-21 08:46
Corcept Therapeutics (CORT) shares soared 5.5% in the last trading session to close at $49.75. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 15.3% gain over the past four weeks.The company’s sole marketed drug, Korlym, approved for treating Cushing's syndrome, is witnessing strong demand and driving growth. Also, a new drug application for the lead candidate, relacorilant, to treat Cushing’s syndrome is expected to be filed lat ...
Wall Street Analysts See a 43.01% Upside in Corcept (CORT): Can the Stock Really Move This High?
ZACKS· 2024-10-17 14:55
Core Viewpoint - Corcept Therapeutics (CORT) has seen an 11.8% increase in share price over the past four weeks, closing at $47.27, with analysts suggesting a potential upside of 43% based on a mean price target of $67.60 [1] Price Targets and Analyst Consensus - The average price target for CORT ranges from a low of $45 to a high of $78, with a standard deviation of $13.32, indicating variability in analyst estimates [1] - A low standard deviation suggests a high degree of agreement among analysts regarding the stock's price movement direction, which can serve as a starting point for further research [4] Earnings Estimates and Market Sentiment - Analysts have shown growing optimism regarding CORT's earnings prospects, as indicated by a positive trend in earnings estimate revisions, with a 1.3% increase in the Zacks Consensus Estimate for the current year [5] - CORT holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate factors, which supports the stock's potential upside [5] Limitations of Price Targets - Solely relying on consensus price targets for investment decisions may not be wise, as analysts' price targets can often be overly optimistic due to business incentives [3][4] - Empirical research indicates that price targets set by analysts rarely reflect actual stock price movements, suggesting that investors should approach these targets with skepticism [3][4]
Corcept (CORT) Is a Great Choice for 'Trend' Investors, Here's Why
ZACKS· 2024-10-17 13:50
Core Viewpoint - The article emphasizes the importance of identifying sustainable trends in short-term investing, highlighting that while price momentum can be profitable, ensuring its longevity is crucial for success [1][2]. Group 1: Stock Performance - Corcept Therapeutics (CORT) has shown a solid price increase of 37.1% over the past 12 weeks, indicating strong investor interest [4]. - The stock has also increased by 11.8% in the last four weeks, suggesting that the upward trend is still intact [5]. - CORT is currently trading at 98.4% of its 52-week high-low range, indicating a potential breakout [5]. Group 2: Fundamental Strength - CORT holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises [6]. - The stock has an Average Broker Recommendation of 1 (Strong Buy), reflecting high optimism from the brokerage community regarding its near-term price performance [7]. - Historically, Zacks Rank 1 stocks have generated an average annual return of +25% since 1988, showcasing the effectiveness of this ranking system [7]. Group 3: Investment Strategy - The "Recent Price Strength" screen is a useful tool for identifying stocks with sufficient fundamental strength to maintain their upward momentum [3]. - In addition to CORT, there are other stocks that meet the criteria of the "Recent Price Strength" screen, suggesting further investment opportunities [8].
Corcept: Key Announcements Coming Soon
Seeking Alpha· 2024-10-15 13:43
Our initiation report " "Corcept Therapeutics - Three Dynamic Catalysts To Reaccelerate Growth" on September 15, 2024 became so long we had to save some content for this new report which focuses on the important near term news flow for Brown University Ab.ScB Civil Engineering/Urban Studies, Stanford University MBA, Morgan Guaranty Trust, Fiduciary Trust International ,Tanaka Capital Mgmt., Author "Digital Deflation" McGraw-Hill 2004. Appeared on CNBC and Bloomberg TV 40+ times. Manages the TANAKA Growth Fu ...
Here's Why Investors Should Consider Buying Corcept Stock Now
ZACKS· 2024-10-02 13:50
Corcept Therapeutics' (CORT) sole-marketed drug, Korlym (mifepristone), which is approved for treating Cushing's syndrome, has been performing well. The drug has been witnessing strong demand in the past couple of quarters. The company is also making good progress with its promising set of pipeline candidates. The successful development and commercialization of its pipeline candidates will be an added boost to the company. Let's dig deeper. Reasons to Invest in CORT Stock Good Rank and Rising Estimates: Cor ...
Wall Street Analysts Think Corcept (CORT) Could Surge 41.31%: Read This Before Placing a Bet
ZACKS· 2024-10-01 14:56
Shares of Corcept Therapeutics (CORT) have gained 31.1% over the past four weeks to close the last trading session at $46.28, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $65.40 indicates a potential upside of 41.3%. The average comprises five short-term price targets ranging from a low of $45 to a high of $78, with a standard deviation of $12.46. While the lowest estimate in ...
Here's Why Momentum in Corcept (CORT) Should Keep going
ZACKS· 2024-10-01 13:50
Most of us have heard the dictum "the trend is your friend." And this is undeniably the key to success when it comes to short-term investing or trading. But it isn't easy to ensure the sustainability of a trend and profit from it. The trend often reverses before exiting the trade, leading to a short-term capital loss for investors. So, for a profitable trade, one should confirm factors such as sound fundamentals, positive earnings estimate revisions, etc. that could keep the momentum in the stock alive. Our ...