MENLO PARK, Calif., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced preliminary results from the prevalence phase of its ongoing CATALYST study of Cushing's syndrome (hypercortisolism) in patients with difficult-to-control type 2 diabetes. With a pl ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 (Exact Name of Corporation as Specified in Its Charter) Delaware 77-0487658 (State or other jurisdiction of incorporation or organization ...

Have you been searching for a stock that might be well-positioned to maintain its earnings-beat streak in its upcoming report? It is worth considering Corcept Therapeutics (CORT) , which belongs to the Zacks Medical - Drugs industry.When looking at the last two reports, this drug developer has recorded a strong streak of surpassing earnings estimates. The company has topped estimates by 46.97%, on average, in the last two quarters.For the last reported quarter, Corcept came out with earnings of $0.28 per sh ...

MENLO PARK, Calif., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced the appointment of Roberto Vieira as President, Oncology. He will report to Joseph K. Belanoff, MD, Corcept's Chief Executive Officer, and join the company's Executive Team. Mr. Vie ...

Financial Data and Key Metrics Changes - The company's revenue for Q3 2023 was $123.6 million, representing a 22% increase compared to the same quarter last year [47] - Net income for the quarter was $31.4 million, or $0.28 per share [47] - Cash and investments as of September 30th totaled $414.8 million, an increase of $51.5 million during the quarter [47] - The revenue guidance for 2023 has been raised to a range of $470 million to $480 million, up from the previous range of $455 million to $470 million [52] Business Line Data and Key Metrics Changes - The growth in revenue was driven by a 12% increase in volume and a 9% increase in price for Korlym [79] - The company is experiencing a mix of new prescribers and repeat prescriptions from existing physicians, contributing to the growth in Korlym sales [82] Market Data and Key Metrics Changes - There is an increasing recognition among physicians that hypercortisolism is more common than previously assumed, leading to more screenings and diagnoses [80] - The CATALYST study is expected to provide further evidence supporting the prevalence of hypercortisolism, which could enhance the treatment landscape for Cushing's syndrome [51] Company Strategy and Development Direction - The company is focused on expanding its sales force and improving the effectiveness of its team, with a target of increasing the sales force from mid-60s to about 75 [18] - The company is advancing multiple clinical development programs, including GRACE, GRADIENT, CATALYST, ROSELLA, and DAZALS studies, with significant milestones expected in 2024 [35][43] - The company is optimistic about the growth potential of its Cushing's syndrome business and the broader applications of cortisol modulation in various diseases [73] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of their case against Teva Pharmaceuticals regarding patent infringement, which is expected to be resolved by mid-2025 [32] - The management anticipates continued growth in the Cushing's syndrome market as more physicians become aware of the condition and its treatment options [51] Other Important Information - The company has robust intellectual property protections for both Korlym and relacorilant, with protections extending through 2037 and beyond 2040, respectively [25][26] - The company introduced a new executive team member, Monica Toledo, who will focus on emerging markets such as ALS and NASH [74] Q&A Session Summary Question: Can you provide specifics on the year-over-year volume growth for Korlym? - The company reported a 22% growth, with 12% driven by volume and 9% by price [79] Question: What does the increase in screening for hypercortisolism mean for future growth? - The recognition that hypercortisolism is more common is expected to sustain growth as more patients are diagnosed and treated [80] Question: Can you elaborate on the GRACE study and its primary endpoint? - The GRACE trial is evaluating dosing escalation and aims to show significant improvement in patients with Cushing's syndrome [85]

Cushing's Syndrome Treatments - Korlym is marketed in the United States for treating Cushing's syndrome, with a focus on patient access through specialty pharmacy and distributor support, alongside patient assistance programs[96] - Relacorilant, a selective cortisol modulator, is in Phase 3 trials (GRACE and GRADIENT) for Cushing's syndrome, with 152 patients enrolled in GRACE and 130 planned for GRADIENT[97][98][99] - The GRADIENT trial aims to study relacorilant's effects on glucose metabolism and hypertension in patients with benign adrenal tumors, with half receiving the drug and half receiving placebo for 22 weeks[99] - Relacorilant has been designated as an orphan drug by the FDA and EC, offering tax credits, reduced fees, and exclusive marketing rights for 7 years in the U.S. and 10 years in the EU[114] - The CATALYST Phase 4 study aims to evaluate the prevalence of Cushing's syndrome in up to 1,000 patients with difficult-to-control diabetes, with potential randomization to Korlym or placebo for 24 weeks[111] Financial Performance and Expenses - Stock-based compensation expense for 2023 totaled $12.9 million for the three months and $36.0 million for the nine months, compared to $10.6 million and $32.1 million in 2022, respectively[103] - Income tax expense for the three and nine months ended September 30, 2023, was $5.0 million and $13.0 million, respectively, compared to a benefit of $1.6 million and expense of $7.1 million in 2022[106] - Research and development expenses for the three and nine months ended September 30, 2023, were $4.0 million and $11.2 million, respectively, compared to $3.1 million and $9.7 million in 2022[103] Stock Options and Compensation - As of September 30, 2023, the company had 23.3 million stock options, 0.1 million RSUs, and 0.7 million RSAs outstanding, compared to 23.5 million, 0.2 million, and 0.2 million in 2022[105] Tax and R&D Regulations - The Tax Cuts and Jobs Act of 2017 requires U.S. and foreign R&D expenditures to be amortized over five and fifteen years, respectively, with no modifications as of September 30, 2023[108]

Financial Data and Key Metrics Changes - Revenue for the second quarter of 2023 was $117.7 million, a 14% increase compared to the same period last year [8] - Net income was $27.5 million or $0.25 per share, compared to $27.4 million or $0.24 per share in the same period last year [8] - Cash and investments totaled $363.3 million as of June 30, reflecting the purchase of 6.6 million shares for $145.4 million during the quarter [8] - The company raised its 2023 revenue guidance to a range of $455 million to $470 million, up from $435 million to $455 million [8] Business Line Data and Key Metrics Changes - The Cushing's Syndrome business is experiencing growth, with more patients receiving Korlym and an increase in the number of prescribing physicians [120] - The CATALYST study is expected to provide further evidence of the prevalence of hypercortisolism in patients with type 2 diabetes, which may lead to increased treatment rates [122] Market Data and Key Metrics Changes - The prevalence of hypercortisolism in patients with type 2 diabetes is estimated to be significantly higher than in the general population, with studies indicating rates of 10% to 20% [129] - The updated European Society of Endocrinology guidelines encourage physicians to look harder for hypercortisolism, which is expected to increase screening and diagnosis [131] Company Strategy and Development Direction - The company is focused on cortisol modulation as a therapeutic mechanism for various serious disorders, with proprietary compounds being developed for conditions like Cushing's Syndrome, NASH, and various cancers [124] - The company plans to submit an NDA for relacorilant in Cushing's Syndrome in the second quarter of 2024 and is advancing multiple clinical trials [10][12][124] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of the Cushing's Syndrome business and the impact of ongoing clinical development programs [22][124] - The company anticipates continued growth in revenue and patient treatment rates, driven by increased disease awareness and improved field execution [126] Other Important Information - The CATALYST study is a landmark study evaluating the prevalence of hypercortisolism in difficult-to-treat type 2 diabetes patients, with enrollment expected to complete ahead of schedule [122][129] - The company is also conducting a Phase 1b trial of miricorilant for NASH, with promising results from previous studies [11][124] Q&A Session Summary Question: What drove the revenues in the second quarter and confidence in increasing guidance? - Management attributed revenue growth to improved access and field execution, with more patients and prescribers for Korlym [126] Question: What are the implications of the updated European Society of Endocrinology guidelines? - The guidelines encourage increased screening for hypercortisolism, which is expected to enhance diagnosis and treatment rates [131] Question: What are the dynamics of miricorilant in terms of efficacy and safety? - Management highlighted the rapid reduction in liver fat and improvements in liver enzymes observed in previous studies, supporting the advancement to Phase IIb [88]

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) Corcept Therapeutics reported net product revenue of $117.7 million for Q2 2023, a 14% increase year-over-year, and $223.4 million for the first six months of 2023, with net income for the quarter at $27.5 million and a strong financial position of $363.3 million in cash, cash equivalents, and marketable securities [Condensed Consolidated Statements of Income](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20INCOME) For the three months ended June 30, 2023, net product revenue increased to $117.7 million, but income from operations decreased to $29.6 million due to higher operating expenses, while net income remained relatively flat at $27.5 million Condensed Consolidated Statements of Income (Three Months Ended June 30) | Metric | 2023 (in thousands) | 2022 (in thousands) | Change | | :--- | :--- | :--- | :--- | | Product revenue, net | $117,715 | $103,386 | +13.9% | | Total operating expenses | $88,132 | $71,954 | +22.5% | | Income from operations | $29,583 | $31,432 | -5.9% | | Net income | $27,528 | $27,412 | +0.4% | | Diluted net income per common share | $0.25 | $0.24 | +4.2% | Condensed Consolidated Statements of Income (Six Months Ended June 30) | Metric | 2023 (in thousands) | 2022 (in thousands) | Change | | :--- | :--- | :--- | :--- | | Product revenue, net | $223,369 | $197,074 | +13.3% | | Total operating expenses | $178,933 | $138,873 | +28.8% | | Income from operations | $44,436 | $58,201 | -23.6% | | Net income | $43,407 | $50,209 | -13.5% | | Diluted net income per common share | $0.38 | $0.44 | -13.6% | [Condensed Consolidated Balance Sheets](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of June 30, 2023, total assets decreased to $524.6 million from $583.4 million at year-end 2022, primarily due to reduced marketable securities and increased treasury stock, while total liabilities rose to $103.0 million and stockholders' equity declined to $421.6 million Key Balance Sheet Items (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $172,377 | $66,329 | | Total current assets | $432,588 | $499,253 | | Total assets | $524,625 | $583,430 | | Total liabilities | $103,011 | $81,588 | | Total stockholders' equity | $421,614 | $501,842 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) For the six months ended June 30, 2023, net cash from operating activities increased to $68.2 million, investing activities provided $183.4 million due to a shift from marketable securities, and financing activities used $145.6 million primarily for common stock repurchases Cash Flow Summary (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash provided by operating activities | $68,243 | $53,287 | | Net cash provided by (used in) investing activities | $183,378 | $(92,296) | | Net cash used in financing activities | $(145,573) | $(3,262) | | **Net increase (decrease) in cash** | **$106,048** | **$(42,271)** | - The company repurchased common stock for **$145.4 million** in connection with a Tender Offer during the first six months of 2023[32](index=32&type=chunk) [Notes to Condensed Financial Statements](index=9&type=section&id=NOTES%20TO%20CONDENSED%20FINANCIAL%20STATEMENTS) The notes detail key accounting policies and events, including a **$14.0 million** Melucci litigation settlement fully covered by insurance, a March 2023 tender offer repurchasing **6.6 million shares** for **$145.4 million**, and **$23.1 million** in stock-based compensation expense for the first six months of 2023 - The company reached an agreement in principle to settle the Melucci litigation for a one-time payment of **$14.0 million**, which will be fully covered by insurers[45](index=45&type=chunk) - In March 2023, the company commenced a tender offer and subsequently purchased **6.6 million shares** of its common stock for an aggregate price of **$145.4 million**[49](index=49&type=chunk) Stock-Based Compensation Expense (in thousands) | Period | 2023 | 2022 | | :--- | :--- | :--- | | Three Months Ended June 30 | $11,892 | $10,662 | | Six Months Ended June 30 | $23,125 | $21,487 | [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=17&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management attributes the **14% year-over-year revenue growth** in Q2 2023 to higher sales volumes and a price increase, while advancing its clinical pipeline with multiple Phase 3 and Phase 2 trials, expecting higher R&D expenses in 2023, and confirming sufficient capital for at least the next 12 months - The company is a commercial-stage pharmaceutical firm focused on modulating the hormone cortisol to treat severe disorders, with its main product being Korlym®, approved for Cushing's syndrome[35](index=35&type=chunk)[87](index=87&type=chunk) - Key clinical development programs include: - **Relacorilant:** Two Phase 3 trials (GRACE and GRADIENT) for Cushing's syndrome and a pivotal Phase 3 trial (ROSELLA) for ovarian cancer - **Dazucorilant:** A Phase 2 trial (DAZALS) for Amyotrophic Lateral Sclerosis (ALS) - **Miricorilant:** A planned Phase 2b trial for Nonalcoholic steatohepatitis (NASH) and a planned Phase 1 trial for preventing antipsychotic-induced weight gain[89](index=89&type=chunk)[120](index=120&type=chunk)[123](index=123&type=chunk) Results of Operations Highlights (Three Months Ended June 30) | Metric (in millions) | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Net product revenue | $117.7 | $103.4 | +13.8% | | Research and development | $43.3 | $32.8 | +32.0% | | Selling, general and administrative | $43.3 | $37.8 | +14.6% | - The company expects to fund its operations and planned R&D activities for the next 12 months and beyond without needing to raise additional funds, based on current plans and expectations[199](index=199&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=22&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company states that its market risks as of June 30, 2023, primarily associated with cash, cash equivalents, and marketable securities, have not materially changed from those disclosed in its 2022 Annual Report on Form 10-K - There were no material changes in the company's market risks during the six months ended June 30, 2023[243](index=243&type=chunk) [Controls and Procedures](index=22&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2023, with no material changes to internal control over financial reporting identified during the quarter - The CEO and CFO concluded that as of June 30, 2023, the company's disclosure controls and procedures were effective[203](index=203&type=chunk) - No material changes to internal control over financial reporting were identified during the quarter ended June 30, 2023[244](index=244&type=chunk) [PART II. OTHER INFORMATION](index=23&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=23&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company is involved in ongoing patent infringement litigation with Teva Pharmaceuticals regarding a generic Korlym, settled a similar suit with Hikma, reached an agreement to settle the Melucci securities class action for **$14.0 million** fully covered by insurance, and is cooperating with a subpoena from the U.S. Attorney's Office - The company is in ongoing patent litigation with Teva Pharmaceuticals over its ANDA for a generic version of Korlym, with a trial scheduled for September 27, 2023[245](index=245&type=chunk)[184](index=184&type=chunk) - Litigation with Hikma Pharmaceuticals was resolved via a settlement agreement in December 2022, granting Hikma the right to sell a generic version of Korlym beginning October 1, 2034, or earlier under certain circumstances[188](index=188&type=chunk) - The Melucci securities class action lawsuit has been resolved in principle with a proposed settlement of **$14.0 million**, which will be paid in full by the company's insurers[141](index=141&type=chunk) - The company received a subpoena from the U.S. Attorney's Office for the District of New Jersey in November 2021 seeking information on the sale and promotion of Korlym and is cooperating with the investigation[191](index=191&type=chunk)[261](index=261&type=chunk) [Risk Factors](index=24&type=page&id=ITEM%201A.%20RISK%20FACTORS) The company identifies several key risks, including high dependence on Korlym revenue and threats from generic competition and the Inflation Reduction Act, inherent uncertainties in clinical trials, intellectual property protection, reliance on third-party manufacturers, and potential stock price volatility - **Commercial Risk:** The company's financial results are highly dependent on the sale of Korlym, and the successful commercialization of a generic version would adversely affect business[149](index=149&type=chunk)[170](index=170&type=chunk) - **Regulatory and Pricing Risk:** The Inflation Reduction Act of 2022 (IRA) is expected to significantly limit revenue from Medicare patients through inflation rebates and future price negotiations, potentially reducing profits[153](index=153&type=chunk)[157](index=157&type=chunk)[159](index=159&type=chunk) - **Competition Risk:** Other approved medications for Cushing's syndrome, such as Isturisa® and Recorlev®, compete with Korlym and could reduce its market share[139](index=139&type=chunk)[152](index=152&type=chunk) - **Development Risk:** The company's efforts to develop and commercialize new product candidates are lengthy, expensive, and may not succeed, as failure can occur at any stage of clinical development[174](index=174&type=chunk)[261](index=261&type=chunk) - **Supply Chain Risk:** The company relies on a single third-party manufacturer for Korlym's active pharmaceutical ingredient (API), and any disruption could harm the business[164](index=164&type=chunk)[165](index=165&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=38&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) The company reported no unregistered sales of equity securities, but repurchased **6.6 million shares** for **$145.4 million** through a tender offer in April 2023, and acquired **202,040 shares** for approximately **$4.8 million** via cashless net exercises of stock options Issuer Purchases of Equity Securities (Tender Offer) | Period | Total Shares Purchased | Average Price Per Share | Total Cost (in thousands) | | :--- | :--- | :--- | :--- | | April 2023 | 6,610,000 | $22.00 | $145,428 | | May 2023 | 0 | N/A | $0 | | June 2023 | 0 | N/A | $0 | | **Total** | **6,610,000** | **$22.00** | **$145,428** | Issuer Purchases of Equity Securities (Cashless Exercises) | Period | Total Shares Purchased | Average Price Per Share | Total Cost (in thousands) | | :--- | :--- | :--- | :--- | | April 2023 | 13,461 | $22.58 | $304 | | May 2023 | 166,673 | $24.03 | $4,005 | | June 2023 | 21,906 | $23.44 | $514 | | **Total** | **202,040** | **$23.87** | **$4,823** |

Call Start: 17:00 January 1, 0000 5:41 PM ET Corcept Therapeutics Incorporated (NASDAQ:CORT) Q1 2023 Earnings Conference Call May 3, 2023 17:00 ET Company Participants Atabak Mokari - Chief Financial Officer Charlie Robb - Chief Business Officer Joseph Belanoff - Chief Executive Officer Bill Guyer - Chief Development Officer Conference Call Participants Matt Kaplan - Ladenburg Thalmann David Amsellem - Piper Sandler Edward Nash - Canaccord Genuity Roanna Ruiz - SVB Securities Greg Fraser - Truist Operator G ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) Presents Corcept Therapeutics' unaudited condensed consolidated financial statements and notes for Q1 2023 and 2022 [ITEM 1. FINANCIAL STATEMENTS](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) Details Corcept Therapeutics' unaudited condensed consolidated financial statements and related notes for the first quarter of 2023 and 2022 [CONDENSED CONSOLIDATED BALANCE SHEETS](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) Presents the company's financial position, including assets, liabilities, and equity, as of March 31, 2023, and December 31, 2022 CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) | (In thousands) | March 31, 2023 | December 31, 2022 | | :----------------------------------- | :------------- | :---------------- | | **ASSETS** | | | | Cash and cash equivalents | $299,942 | $66,329 | | Short-term marketable securities | 165,115 | 365,343 | | Total current assets | 533,893 | 499,253 | | Total assets | $617,848 | $583,430 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | 78,865 | 72,491 | | Total liabilities | 88,264 | 81,588 | | Total stockholders' equity | 529,584 | 501,842 | | Total liabilities and stockholders' equity | $617,848 | $583,430 | - Cash and cash equivalents significantly increased from **$66.3 million** at December 31, 2022, to **$299.9 million** at March 31, 2023, while short-term marketable securities decreased from **$365.3 million** to **$165.1 million**[11](index=11&type=chunk) [CONDENSED CONSOLIDATED STATEMENTS OF INCOME](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20INCOME) Outlines the company's revenues, expenses, and net income for the three months ended March 31, 2023, and 2022 CONDENSED CONSOLIDATED STATEMENTS OF INCOME (In thousands, except per share data) | (In thousands, except per share data) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Product revenue, net | $105,654 | $93,688 | | Total operating expenses | 90,801 | 66,919 | | Income from operations | 14,853 | 26,769 | | Net income | $15,879 | $22,797 | | Basic net income per common share | $0.15 | $0.22 | | Diluted net income per common share | $0.14 | $0.20 | - Net product revenue increased by **12.8%** year-over-year, from **$93.7 million** in Q1 2022 to **$105.7 million** in Q1 2023. However, net income decreased by **30.4%** from **$22.8 million** to **$15.9 million**, primarily due to a significant increase in total operating expenses[13](index=13&type=chunk) [CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20COMPREHENSIVE%20INCOME) Details net income and other comprehensive income components for the three months ended March 31, 2023, and 2022 CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (In thousands) | (In thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------- | :-------------------------------- | :-------------------------------- | | Net income | $15,879 | $22,797 | | Other comprehensive income (loss): | | | | Unrealized gain (loss) on available-for-sale investments, net of tax effect | 605 | (1,019) | | Foreign currency translation gain (loss), net of tax | 111 | (105) | | Total comprehensive income | $16,595 | $21,673 | - Total comprehensive income decreased from **$21.7 million** in Q1 2022 to **$16.6 million** in Q1 2023, despite a positive shift in unrealized gains on available-for-sale investments[16](index=16&type=chunk) [CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) Summarizes cash flows from operating, investing, and financing activities for the three months ended March 31, 2023, and 2022 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) | (In thousands) | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Net cash provided by operating activities | $25,957 | $35,247 | | Net cash provided by (used in) investing activities | $207,475 | $(50,496) | | Net cash provided by (used in) financing activities | $181 | $(506) | | Net increase (decrease) in cash and cash equivalents | $233,613 | $(15,755) | | Cash and cash equivalents, at end of period | $299,942 | $61,862 | - Net cash provided by operating activities decreased by **26.4%** year-over-year[19](index=19&type=chunk) - Net cash from investing activities saw a significant positive swing, from a net outflow of **$50.5 million** in Q1 2022 to a net inflow of **$207.5 million** in Q1 2023, primarily due to proceeds from maturities of marketable securities[19](index=19&type=chunk) [CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY](index=8&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20STOCKHOLDERS%27%20EQUITY) Presents changes in stockholders' equity, including common stock, additional paid-in capital, and retained earnings CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (In thousands) | (In thousands) | Balance at Dec 31, 2022 | Balance at Mar 31, 2023 | | :------------- | :---------------------- | :---------------------- | | Common Stock (Shares) | 107,835 | 108,156 | | Common Stock (Amount) | $131 | $131 | | Additional Paid-in Capital | $662,342 | $679,848 | | Treasury Stock | $(456,148) | $(462,507) | | Retained Earnings | $296,386 | $312,265 | | Total Stockholders' Equity | $501,842 | $529,584 | - Total stockholders' equity increased from **$501.8 million** at December 31, 2022, to **$529.6 million** at March 31, 2023, driven by net income and stock-based compensation, partially offset by treasury stock purchases[21](index=21&type=chunk) [NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS](index=9&type=section&id=NOTES%20TO%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) Provides detailed explanations of accounting policies, balance sheet items, commitments, and subsequent events - Corcept Therapeutics Incorporated is a commercial-stage pharmaceutical company focused on discovering and developing medications by modulating cortisol effects, with Korlym approved for Cushing's syndrome since 2012[22](index=22&type=chunk) - The company relies on a single manufacturer for Korlym's active pharmaceutical ingredient (API) and classifies inventory not expected to be sold within 12 months as 'Strategic inventory' (long-term asset)[26](index=26&type=chunk) - The company reached a proposed settlement of **$14.0 million** for the Melucci litigation, fully covered by insurers, with an accrued liability and corresponding insurance recovery receivable recorded as of March 31, 2023[40](index=40&type=chunk) - In April 2023, the company amended its office lease, extending it through June 30, 2024, and leased additional space, expecting to record a **$0.3 million** right-of-use asset and corresponding lease liability[66](index=66&type=chunk) - A tender offer to repurchase up to **7.5 million shares** of common stock commenced on March 6, 2023, and expired on March 31, 2023, resulting in the repurchase of **6.6 million shares** for **$145.4 million** on April 5, 2023[67](index=67&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=16&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management's analysis of Corcept's financial condition, operational results, and key business drivers for Q1 2023 [Overview](index=16&type=section&id=Overview) Introduces Corcept Therapeutics as a commercial-stage pharmaceutical company focused on cortisol modulation - Corcept Therapeutics is a commercial-stage pharmaceutical company focused on discovering and developing medications for severe endocrine, oncologic, metabolic, and neurological disorders by modulating cortisol effects[71](index=71&type=chunk) - The company has marketed Korlym (mifepristone) for Cushing's syndrome since 2012 and possesses a portfolio of over **1,000** proprietary selective cortisol modulators[71](index=71&type=chunk) [Cushing's Syndrome](index=16&type=section&id=Cushing%27s%20Syndrome) Discusses Korlym sales and ongoing Phase 3 trials for relacorilant in Cushing's syndrome treatment - Corcept sells Korlym in the U.S. for endogenous Cushing's syndrome, utilizing sales representatives and patient support programs to address underdiagnosis and ensure patient access[72](index=72&type=chunk)[73](index=73&type=chunk) - The company is conducting two Phase 3 trials (GRACE and GRADIENT) for relacorilant, a selective cortisol modulator for Cushing's syndrome, which, unlike Korlym, lacks affinity for the progesterone receptor and does not cause hypokalemia[74](index=74&type=chunk)[75](index=75&type=chunk)[76](index=76&type=chunk) - Relacorilant has received orphan drug designation from the FDA and EC, providing tax credits, reduced regulatory fees, and exclusive marketing rights (**seven years** in the U.S., **ten years** in the EU) upon approval[77](index=77&type=chunk) [Oncology](index=17&type=section&id=Oncology) Outlines clinical trials for relacorilant in ovarian, adrenal, and prostate cancers, leveraging cortisol modulation - Cortisol modulation may enhance anti-cancer therapies by reducing cortisol activity at the GR, which can otherwise reduce efficacy, promote tumor growth, or suppress immune response[78](index=78&type=chunk) - A Phase 2 trial of relacorilant combined with nab-paclitaxel in platinum-resistant ovarian cancer showed statistically significant improvement in median progression-free survival (PFS) for patients receiving intermittent higher doses (**5.6 months** vs. **3.8 months**, p=0.038)[79](index=79&type=chunk)[80](index=80&type=chunk) - A pivotal Phase 3 trial (ROSELLA) was initiated in June 2022 to replicate these positive results in **360 women** with recurrent, platinum-resistant ovarian cancer, with PFS as the primary endpoint[82](index=82&type=chunk) - The company is also conducting a Phase 1b trial of relacorilant plus pembrolizumab for metastatic or unresectable adrenal cancer with cortisol excess and plans a Phase 2 trial of relacorilant plus enzalutamide for prostate cancer[84](index=84&type=chunk)[85](index=85&type=chunk)[86](index=86&type=chunk) [Amyotrophic Lateral Sclerosis ("ALS")](index=18&type=section&id=Amyotrophic%20Lateral%20Sclerosis%20%28%22ALS%22%29) Details the Phase 2 DAZALS trial for dazucorilant in ALS patients, following promising preclinical results - Corcept initiated a Phase 2 trial (DAZALS) in October 2022 for dazucorilant, a selective cortisol modulator, in **198 ALS patients**, following promising preclinical results that showed improved motor performance and reduced neuroinflammation[87](index=87&type=chunk) [Metabolic Diseases](index=18&type=section&id=Metabolic%20Diseases) Reviews miricorilant's development for NASH and Antipsychotic-Induced Weight Gain, including trial updates - The Phase 2a trial of miricorilant for NASH was suspended in April 2021 due to elevated liver enzymes, but an ongoing Phase 1b dose-finding trial has identified doses that reduce liver fat without excessive irritation, with a Phase 2 trial planned for Q4 2023[88](index=88&type=chunk) - Miricorilant is also being studied for Antipsychotic-Induced Weight Gain (AIWG), with plans for further study despite previous Phase 2 trials not showing reversal of AIWG, based on preclinical and published trial results suggesting potential to prevent weight gain[89](index=89&type=chunk) [COVID-19 Pandemic](index=18&type=section&id=COVID-19%20Pandemic) Assesses the ongoing negative impact of the COVID-19 pandemic on Korlym revenue and clinical trial enrollment - The COVID-19 pandemic has negatively impacted Korlym's revenue growth and slowed enrollment in some clinical development programs, particularly for non-life-threatening indications like Cushing's syndrome[90](index=90&type=chunk)[91](index=91&type=chunk) [Inflation Reduction Act of 2022](index=18&type=section&id=Inflation%20Reduction%20Act%20of%202022) Examines the implications of the IRA on share repurchases, corporate taxes, and drug pricing for the company - The Inflation Reduction Act of 2022 (IRA) introduces a **1%** excise tax on share repurchases (effective 2023) and a **15%** corporate alternative minimum tax (CAMT) (effective 2024), though CAMT is not expected to significantly affect consolidated financial statements[92](index=92&type=chunk) - The IRA also allows CMS to negotiate prices for certain Medicare Part B/D drugs and requires manufacturers to pay rebates if prices increase faster than inflation, which is anticipated to significantly limit revenue from Medicare patients and reduce profits starting in 2025[92](index=92&type=chunk)[93](index=93&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Analyzes product revenue, operating expenses, and other financial items for the three months ended March 31, 2023 Net Product Revenue (in thousands) | Period | 2023 | 2022 | Change (%) | | :----- | :--- | :--- | :--------- | | Q1 | $105,654 | $93,688 | 12.8% | - The increase in net product revenue was driven by **42.9%** higher sales volumes and a price increase effective January 1, 2023[95](index=95&type=chunk) Operating Expenses (in thousands) | Expense Category | Q1 2023 | Q1 2022 | Change ($) | Change (%) | | :--------------- | :------ | :------ | :--------- | :--------- | | Cost of sales | $1,386 | $1,250 | $136 | 10.9% | | R&D | $40,851 | $28,120 | $12,731 | 45.3% | | SG&A | $48,564 | $37,549 | $11,015 | 29.3% | | Total Operating Expenses | $90,801 | $66,919 | $23,882 | 35.7% | - Research and development expense increased significantly by **45.3%** to **$40.9 million**, primarily due to increased spending on development programs (Oncology, Cushing's syndrome, Metabolic diseases, Pre-clinical/ALS) and employee compensation[98](index=98&type=chunk)[99](index=99&type=chunk) - Selling, general and administrative expense rose by **29.3%** to **$48.6 million**, mainly due to increased sales and marketing activities and employee compensation[101](index=101&type=chunk) Other Financial Items (in thousands) | Item | Q1 2023 | Q1 2022 | Change ($) | | :--- | :------ | :------ | :--------- | | Interest and other income | $3,581 | $80 | $3,501 | | Income tax expense | $2,555 | $4,052 | $(1,497) | - Interest and other income increased substantially due to higher cash and investment balances and market-wide increases in interest rates[103](index=103&type=chunk) [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) Evaluates the company's cash position, operating cash flow, and funding strategy for future operations - Corcept relies on Korlym sales revenue to fund operations and expects to continue doing so without needing additional funds for the next **12 months** and beyond, though it may choose to raise funds for strategic reasons[104](index=104&type=chunk)[105](index=105&type=chunk) Cash, Cash Equivalents, and Marketable Securities (in millions) | Item | March 31, 2023 | December 31, 2022 | | :--- | :------------- | :---------------- | | Cash, cash equivalents, and marketable securities | $465.1 | $436.6 | | Cash and cash equivalents | $299.9 | $66.3 | | Marketable securities | $165.1 | $370.3 | - Net cash provided by operating activities decreased to **$26.0 million** in Q1 2023 from **$35.2 million** in Q1 2022, primarily due to increased operating expenses[108](index=108&type=chunk) - Net cash provided by investing activities significantly increased to **$207.5 million** in Q1 2023 from a net use of **$50.5 million** in Q1 2022, mainly due to reallocating cash from marketable securities maturities to cash equivalents in anticipation of a tender offer[109](index=109&type=chunk) [Contractual Obligations and Commitments](index=20&type=section&id=Contractual%20Obligations%20and%20Commitments) Confirms no material changes to contractual payment obligations and purchase commitments during Q1 2023 - Contractual payment obligations and purchase commitments did not materially change during the three months ended March 31, 2023, as disclosed in the Annual Report on Form 10-K for December 31, 2022[112](index=112&type=chunk) [Off-Balance Sheet Arrangements](index=20&type=section&id=Off-Balance%20Sheet%20Arrangements) States that the company has no off-balance sheet arrangements to report - The company has no off-balance sheet arrangements[113](index=113&type=chunk) [Critical Accounting Policies and Estimates](index=20&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Confirms no material changes to critical accounting policies and estimates during the fiscal quarter - There were no material changes to the company's critical accounting policies and estimates during the fiscal quarter ended March 31, 2023[115](index=115&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=21&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) Confirms no material changes to market risks, primarily related to cash, cash equivalents, and marketable securities - Market risks related to cash, cash equivalents, and marketable securities (debt instruments with maturities under **24 months**) did not materially change during Q1 2023[116](index=116&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=21&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management confirms effective disclosure controls and no material changes in internal control over financial reporting - Management concluded that disclosure controls and procedures were effective as of March 31, 2023, providing reasonable assurance that required information is recorded, processed, summarized, and reported timely[117](index=117&type=chunk) - There were no material changes in internal control over financial reporting during the quarter ended March 31, 2023[118](index=118&type=chunk) [PART II. OTHER INFORMATION](index=22&type=section&id=PART%20II.%20OTHER%20INFORMATION) Presents other required information, including legal proceedings, risk factors, equity sales, and exhibits [ITEM 1. LEGAL PROCEEDINGS](index=22&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) Details ongoing legal proceedings, including patent litigation, a securities class action settlement, and a government subpoena [Teva Litigation](index=22&type=section&id=Teva%20Litigation) Outlines patent infringement lawsuits against Teva Pharmaceuticals regarding generic Korlym, with ongoing trial dates - Corcept filed a lawsuit against Teva Pharmaceuticals in March 2018 for infringement of Korlym patents ('214 and '216) after Teva submitted an ANDA for a generic version[121](index=121&type=chunk) - The PTAB upheld the validity of the '214 patent in November 2020, a decision affirmed by the Federal Circuit Court of Appeals in December 2021, closing that specific matter[122](index=122&type=chunk) - A new lawsuit was filed against Teva on March 17, 2023, for infringement of U.S. patents 10,842,800 and 10,842,801, with a trial date set for September 27, 2023, for both pending matters[123](index=123&type=chunk)[124](index=124&type=chunk) [Hikma ANDA Litigation and Settlement](index=22&type=section&id=Hikma%20ANDA%20Litigation%20and%20Settlement) Describes the patent infringement litigation and subsequent settlement with Hikma Pharmaceuticals for generic Korlym - Corcept sued Hikma Pharmaceuticals in March 2021 for patent infringement related to Korlym after Hikma submitted an ANDA for a generic version[126](index=126&type=chunk)[127](index=127&type=chunk) - The litigation was resolved on December 7, 2022, granting Hikma the right to sell a generic Korlym version in the U.S. starting October 1, 2034, or earlier under customary settlement terms[128](index=128&type=chunk) [Other Matters](index=22&type=section&id=Other%20Matters) Covers the Melucci securities class action settlement, shareholder derivative complaints, and a USAO subpoena - A proposed settlement of **$14.0 million** was reached on February 8, 2023, to resolve the Melucci securities class action litigation, fully covered by insurers and awaiting court approval[130](index=130&type=chunk) - Multiple shareholder derivative complaints (Lauren Williams, Jeweltex Pension Plan, Joel B. Ritchie) alleging breach of fiduciary duty and other claims have been stayed pending resolution of the Melucci litigation[131](index=131&type=chunk)[132](index=132&type=chunk)[133](index=133&type=chunk) - The company received a records subpoena from the NJ USAO in November 2021, investigating potential criminal or civil violations related to Korlym's sale, promotion, and relationships with healthcare professionals, with Corcept cooperating as an entity whose conduct is within scope[135](index=135&type=chunk) [ITEM 1A. RISK FACTORS](index=23&type=section&id=ITEM%201A.%20RISK%20FACTORS) Outlines significant risks to Corcept's business, including commercial, R&D, intellectual property, and regulatory factors [Summary of Principal Risks](index=23&type=section&id=Summary%20of%20Principal%20Risks) Summarizes key risks such as revenue generation, generic competition, regulatory changes, and intellectual property - Principal risks include failure to generate sufficient Korlym revenue, adverse effects from the COVID-19 pandemic, impact of generic Korlym versions, and new government regulations (e.g., IRA) on pricing and reimbursement[148](index=148&type=chunk) - Research and development risks involve potential failure of product candidates, lengthy and expensive clinical trials, and delays caused by the COVID-19 pandemic or vendor performance[148](index=148&type=chunk) - Intellectual property risks center on securing and maintaining adequate patent protection for proprietary compounds and Korlym[142](index=142&type=chunk) - Stock-related risks include wide price fluctuations, potential decline if financial performance misses guidance, and limited opportunities for investors to sell shares[143](index=143&type=chunk)[148](index=148&type=chunk) - General risks encompass reliance on information technology, potential breakdowns or breaches, and the failure to protect confidential information[144](index=144&type=chunk) [Risk Factors – Discussion](index=24&type=section&id=Risk%20Factors%20%E2%80%93%20Discussion) Provides a detailed discussion of various risks impacting Korlym revenue, clinical development, and operational stability - Failure to generate sufficient Korlym revenue due to physician preferences for competing treatments, generic versions, or lack of insurance coverage would harm financial results and stock price[147](index=147&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk) - The COVID-19 pandemic continues to adversely affect business by reducing patient office visits, hindering physician identification of eligible patients, and slowing clinical trial enrollment[150](index=150&type=chunk)[151](index=151&type=chunk)[152](index=152&type=chunk) - Successful commercialization of generic Korlym versions, despite ongoing patent litigation, could rapidly and significantly reduce Korlym sales and price, materially harming financial position[153](index=153&type=chunk)[154](index=154&type=chunk) - New laws like the Inflation Reduction Act (IRA) could make it difficult to obtain acceptable prices or adequate reimbursement for Korlym, potentially reducing revenue and profits, especially from Medicare patients[158](index=158&type=chunk)[159](index=159&type=chunk)[161](index=161&type=chunk) - Dependence on single third-party manufacturers for Korlym's API and specialty pharmacies for distribution poses risks of supply chain disruptions and delays if vendors fail to perform or comply with regulations[164](index=164&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk) - The unfavorable public perception of mifepristone (Korlym's active ingredient) due to its use in abortion, exacerbated by recent legal decisions, may limit Korlym sales and draw hostile attention, even though it's not approved for pregnancy termination[167](index=167&type=chunk)[168](index=168&type=chunk) - Clinical drug development is lengthy, expensive, and unpredictable; product candidates may fail to show efficacy or acceptable safety, or trials may be delayed or terminated due to various factors, including slow patient enrollment or unforeseen safety issues[182](index=182&type=chunk)[183](index=183&type=chunk)[184](index=184&type=chunk) - The company may need additional capital if Korlym revenue declines or for strategic reasons, and such funding may not be available on acceptable terms, potentially leading to delays or elimination of development programs[197](index=197&type=chunk) - The price of common stock fluctuates widely due to factors like operating results, clinical trial outcomes, intellectual property disputes, and market conditions, and may decline if financial performance does not meet public guidance or analyst estimates[201](index=201&type=chunk)[202](index=202&type=chunk) - Reliance on information technology means breakdowns or breaches of systems, or failure to protect confidential information, could interrupt business operations and lead to liability, especially with increased remote work and cyber threats[213](index=213&type=chunk)[215](index=215&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=37&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) Reports no unregistered equity sales and details issuer purchases of common stock through cashless option exercises [Issuer Purchases of Equity Securities](index=39&type=section&id=Issuer%20Purchases%20of%20Equity%20Securities) Details the company's common stock repurchases, including shares acquired through cashless net exercises of options - No unregistered sales of equity securities occurred during the reporting period[226](index=226&type=chunk) Issuer Purchases of Equity Securities (Q1 2023) | Fiscal Period | Total Number of Shares Purchased (1) | Average Price Per Share (in dollars) | Total Purchase Price of Shares (2, in dollars) | | :------------ | :----------------------------------- | :---------------------- | :--------------------------------- | | Jan 1 - Jan 31, 2023 | 40 | $22.10 | $887 | | Feb 1 - Feb 28, 2023 | 11 | $23.03 | $244 | | Mar 1 - Mar 31, 2023 | 246 | $21.21 | $5,228 | | Total | 297 | $21.40 | $6,359 | - The company paid **$1.1 million** to satisfy tax withholding obligations associated with the net-share settlement of cashless option exercises[228](index=228&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=39&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) Confirms no defaults upon senior securities to report for the period - Not applicable; there were no defaults upon senior securities[229](index=229&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=39&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) States that mine safety disclosures are not applicable to the company's operations - Not applicable; there are no mine safety disclosures[230](index=230&type=chunk) [ITEM 5. OTHER INFORMATION](index=39&type=section&id=ITEM%205.%20OTHER%20INFORMATION) Indicates that no other information is reported in this section - No other information is reported in this section[231](index=231&type=chunk) [ITEM 6. EXHIBITS](index=40&type=section&id=ITEM%206.%20EXHIBITS) Lists exhibits filed with the Form 10-Q, including corporate documents, lease amendments, and certifications - Exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, an Eighth Amendment to Office Lease Agreement, Rule 13a-14(a)/15d-14(a) Certifications, 18 U.S.C. Section 1350 Certifications, and XBRL formatted financial statements[233](index=233&type=chunk) [SIGNATURES](index=41&type=section&id=SIGNATURES) Contains the official signatures of Corcept Therapeutics' executive officers, certifying the report's submission [SIGNATURES](index=41&type=section&id=SIGNATURES) Presents the official signatures of Corcept Therapeutics' executive officers, certifying the report's submission - The report is duly signed by Joseph K. Belanoff, M.D. (Chief Executive Officer), Atabak Mokari (Chief Financial Officer), and Joseph D. Lyon (Chief Accounting Officer) on May 3, 2023[237](index=237&type=chunk)