cept Therapeutics rporated(CORT)

Search documents
cept Therapeutics rporated(CORT) - 2023 Q1 - Quarterly Report
2023-05-02 16:00
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 March 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 CORCEPT THERAPEUTICS ...
cept Therapeutics rporated(CORT) - 2022 Q4 - Earnings Call Transcript
2023-03-01 00:59
Financial Data and Key Metrics Changes - Revenue in Q4 2022 was $103.1 million, up from $98.8 million in Q4 2021, with 2023 revenue guidance of $430 million to $450 million compared to 2022 revenue of $401.9 million [3][28] - Net income for Q4 2022 was $16.6 million, totaling $101.4 million for the full year 2022 [23] Business Line Data and Key Metrics Changes - The Cushing's syndrome business is expected to grow significantly, with substantial investments being made to improve screening and treatment [28] - Clinical development programs for proprietary selective cortisol modulators, including relacorilant, dazucorilant, and miricorilant, are advancing, with multiple trials ongoing [8][10] Market Data and Key Metrics Changes - In-person clinical interactions have returned to about 80% to 90% of pre-COVID levels, which is expected to be the new baseline [80] Company Strategy and Development Direction - The company is focused on expanding its Cushing's syndrome business and enhancing disease awareness among physicians [28][48] - The CATALYST study aims to understand the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes and evaluate the efficacy of Korlym [12][73] Management's Comments on Operating Environment and Future Outlook - Management is optimistic about the growth potential of the Cushing's syndrome business and believes there are more patients to be diagnosed and treated than previously thought [28] - The company remains confident in its legal position regarding ongoing litigation and believes recent settlements will positively influence future cases [5][92] Other Important Information - The company has successfully settled two lawsuits, including a securities class action and a patent infringement case with Hikma Pharmaceuticals [5][6] - The company is conducting a Phase 1b trial for miricorilant in NASH, with promising results expected to be shared by midyear [63] Q&A Session Summary Question: What endpoints are being looked for in the ALS study? - The primary endpoint is a 24-week evaluation using the ALS functional rating scale, which is a validated FDA endpoint [41] Question: What would increase confidence in the NASH program as it enters Phase 2? - The goal is to find the right dosing regimen that achieves progressive fat loss over time without ALT rises, with plans to move to Phase 2 in Q4 [42] Question: What drives the revenue range for 2023? - The revenue range is driven by the number of patients added to the active patient base, with stable pricing and retention rates [47] Question: How are in-person clinical interactions progressing? - In-person interactions are at about 80% to 90% of pre-COVID levels, which is expected to be the new baseline [80] Question: Will the CATALYST study impact new starts on Korlym? - The study is expected to increase awareness among physicians who are currently not treating or diagnosing hypercortisolism, thus not negatively impacting new starts on Korlym [88]
cept Therapeutics rporated(CORT) - 2022 Q4 - Annual Report
2023-02-27 16:00
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, 2022 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 CORCEPT THERAPEUTICS INCORPORATED (Exact Name of Corporation as Specified in Its Charter) Delaware 77-0487658 (State or other jurisdictio ...
cept Therapeutics rporated(CORT) - 2022 Q3 - Earnings Call Transcript
2022-11-04 03:11
Financial Data and Key Metrics Changes - Revenue for Q3 2022 was $101.7 million, an increase from $96.1 million in Q3 2021, representing a growth of approximately 6% [6] - Net income for Q3 2022 was $34.6 million, or $0.30 per share, compared to $30.5 million, or $0.24 per share, in the same period last year [6] - Cash and investments as of September 30, 2022, totaled $401.2 million, an increase of $19 million during the quarter [6] - The company tightened its 2022 revenue guidance to a range of $400 million to $410 million [6][12] Business Line Data and Key Metrics Changes - The Cushing's Syndrome business experienced revenue impacts due to fewer in-person interactions with physicians, which have not returned to pre-pandemic levels [11][12] - The company is optimistic about the potential growth in the Cushing's Syndrome market, with leading endocrinologists believing there are more patients than previously assumed [12] Market Data and Key Metrics Changes - The company is focusing on increasing physician interactions and awareness of hypercortisolism, which is believed to be more prevalent than previously thought [67] - The company aims to improve screening and referral rates by targeting specialties that may have undiagnosed patients [70] Company Strategy and Development Direction - The company is making substantial investments to enhance the screening and treatment of Cushing's Syndrome patients [12][52] - Clinical development programs are advancing, with ongoing trials in various therapeutic areas including ovarian cancer, ALS, and metabolic diseases [14][34][42] - The company is exploring the potential of cortisol modulation in treating a wide range of diseases, indicating a broadening of therapeutic interests [53][54] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges posed by the ongoing changes in physician practices post-pandemic, emphasizing the need for innovative approaches to maintain education and outreach [61][62] - The company remains confident in its growth trajectory and the potential of its clinical programs to contribute positively to future results [52][53] Other Important Information - The company is involved in ongoing litigation with generic manufacturers Teva and Hikma Pharmaceuticals regarding patent infringements related to its product Korlym [7][10] - The company is preparing for the NDA submission for its new product Relacorilant in the second half of 2023 [50][81] Q&A Session Summary Question: What is causing the limited interactions in doctor's offices? - Management explained that while many practices have returned to normal, some have not, and they are working on innovative ways to educate physicians about hypercortisolism [58][60] Question: What is the growth outlook for 2023? - Management expressed confidence in achieving a double-digit growth profile, focusing on increasing physician interactions and awareness [65][67] Question: What data will be available from the anti-psychotic induced weight gain trial? - The company expects to have data by the end of the year, focusing on weight loss and other metabolic factors [72][74] Question: How is the competitive environment affecting the company? - Management indicated that they have not seen a negative impact from competitors and are pleased that more companies are raising awareness about hypercortisolism [80] Question: What is the status of patient enrollment for clinical trials? - Management stated that they are focused on submitting the NDA and are actively working with investigators to ensure successful enrollment [81]
cept Therapeutics rporated(CORT) - 2022 Q3 - Quarterly Report
2022-11-02 16:00
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) Unaudited condensed consolidated financial statements for Q3 and nine months ended September 30, 2022, are presented [Condensed Consolidated Balance Sheets](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) Total assets grew to $533.3 million by Sep 30, 2022, driven by marketable securities, with liabilities and equity increasing Condensed Consolidated Balance Sheets (in thousands) | Account | September 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Total current assets** | $452,402 | $266,463 | | **Total assets** | $533,255 | $423,756 | | **Total current liabilities** | $53,068 | $47,541 | | **Total liabilities** | $59,891 | $47,950 | | **Total stockholders' equity** | $473,364 | $375,806 | [Condensed Consolidated Statements of Income](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20INCOME) Q3 2022 net income was $34.6 million on $101.7 million revenue, showing overall growth Financial Performance (in thousands, except per share data) | Metric | Q3 2022 | Q3 2021 | Nine Months 2022 | Nine Months 2021 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $101,728 | $96,131 | $298,802 | $267,156 | | Income from operations | $31,934 | $36,232 | $90,135 | $87,813 | | Net income | $34,608 | $30,471 | $84,817 | $80,459 | | Diluted net income per share | $0.30 | $0.24 | $0.73 | $0.63 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) Net cash from operations decreased to $86.9 million, with investing activities using $97.1 million Cash Flow Summary for Nine Months Ended Sep 30 (in thousands) | Cash Flow Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash provided by operating activities | $86,935 | $118,465 | | Net cash used in investing activities | ($97,086) | ($4,345) | | Net cash used in financing activities | ($17,223) | ($95,622) | | Net (decrease) increase in cash | ($27,374) | $18,498 | [Notes to Condensed Financial Statements](index=10&type=section&id=NOTES%20TO%20CONDENSED%20FINANCIAL%20STATEMENTS) Notes detail the company's cortisol modulator business, strategic inventory, and R&D tax impact - Corcept is a commercial-stage pharmaceutical company focused on discovering and developing medications that modulate the effects of cortisol for severe endocrine, oncologic, metabolic, and neurological disorders. Its primary commercial product is Korlym, approved in 2012 for treating hyperglycemia in certain patients with endogenous Cushing's syndrome[26](index=26&type=chunk) - The company holds significant quantities of Korlym's active pharmaceutical ingredient (API) from a single manufacturer, classifying inventory not expected to be sold within 12 months as a long-term asset called "Strategic inventory"[30](index=30&type=chunk) - Beginning in 2022, the Tax Cuts and Jobs Act of 2017 requires the company to capitalize and amortize R&D expenditures for tax purposes (over 5 years for U.S. and 15 for foreign), resulting in higher cash paid for taxes compared to prior years[68](index=68&type=chunk)[70](index=70&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=17&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses financial performance, Korlym revenue, clinical trials, COVID-19 impacts, and liquidity [Overview](index=17&type=section&id=Overview) Corcept markets Korlym and advances cortisol modulators, with clinical trials ongoing and COVID-19 impacts - The company is conducting two Phase 3 trials for relacorilant in Cushing's syndrome (GRACE and GRADIENT) and initiated a pivotal Phase 3 trial (ROSELLA) for relacorilant combined with nab-paclitaxel in platinum-resistant ovarian cancer[77](index=77&type=chunk)[78](index=78&type=chunk)[87](index=87&type=chunk) - The company is studying miricorilant for antipsychotic-induced weight gain (AIWG) in two Phase 2 trials (GRATITUDE and GRATITUDE II), with data expected by the end of 2022[93](index=93&type=chunk)[95](index=95&type=chunk)[98](index=98&type=chunk) - The COVID-19 pandemic has reduced Korlym revenue by making it harder for physicians to see patients and has slowed enrollment in clinical trials for conditions not considered immediately life-threatening[101](index=101&type=chunk)[102](index=102&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20Operations) Net product revenue grew in Q3 and YTD 2022 due to Korlym sales, with R&D and SG&A expenses rising Revenue Growth Analysis (YTD ended Sep 30) | Metric | Nine Months 2022 | Nine Months 2021 | Change | | :--- | :--- | :--- | :--- | | Net product revenue | $298.8M | $267.2M | +11.8% | - Sales volume accounted for **60.7%** of the increase - Price increases accounted for the remaining growth[106](index=106&type=chunk) Research & Development Expense by Program (in thousands) | Program | Nine Months 2022 | Nine Months 2021 | | :--- | :--- | :--- | | Oncology | $13,000 | $12,549 | | Cushing's syndrome | $23,082 | $21,893 | | Metabolic diseases | $17,734 | $16,129 | | **Total R&D Expense** | **$94,237** | **$85,345** | - Selling, general and administrative (SG&A) expenses increased to **$110.5 million** for the nine months ended Sep 30, 2022, from **$90.1 million** in the prior year, due to higher employee compensation, sales and marketing activities, and legal fees[115](index=115&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) The company funds operations via Korlym sales, holding $401.2 million in cash, despite decreased operating cash flow - As of September 30, 2022, the company had **$401.2 million** in cash, cash equivalents, and marketable securities, up from **$335.8 million** at year-end 2021[121](index=121&type=chunk) - Net cash from operating activities decreased to **$86.9 million** for the first nine months of 2022 from **$118.5 million** in 2021, primarily due to higher deferred income taxes from the capitalization of R&D costs[123](index=123&type=chunk) - Net cash used in financing activities was **$17.2 million** in the first nine months of 2022, compared to **$95.6 million** in the same period of 2021. The decrease was mainly because the company did not repurchase stock under its program in 2022, whereas it spent **$88.5 million** on repurchases in 2021[125](index=125&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=22&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) Market risks from debt investments did not materially change during the nine months ended September 30, 2022 - Market risks associated with cash, cash equivalents, and marketable securities did not change materially during the nine months ended September 30, 2022[131](index=131&type=chunk) [Controls and Procedures](index=22&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded disclosure controls were effective as of September 30, 2022, with no material internal control changes - Management, including the CEO and CFO, concluded that as of September 30, 2022, the company's disclosure controls and procedures were effective[132](index=132&type=chunk) - There were no changes during the quarter ended September 30, 2022, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[133](index=133&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) Corcept faces patent infringement lawsuits, a settled generic suit, securities class action, and a U.S. Attorney's investigation - The company is in ongoing patent infringement litigation against Teva and Hikma regarding their attempts to market generic versions of Korlym. A trial date has not been set in the Teva case, and discovery in the Hikma case is set to close in April 2023[139](index=139&type=chunk)[145](index=145&type=chunk) - In June 2021, the company settled its patent litigation with Sun Pharma, granting Sun the right to sell a generic version of Korlym beginning October 1, 2034, or earlier under certain circumstances[143](index=143&type=chunk) - In November 2021, the company received a subpoena from the U.S. Attorney's Office for the District of New Jersey investigating potential criminal or civil violations related to the sale and promotion of Korlym. The company is cooperating with the investigation[157](index=157&type=chunk)[158](index=158&type=chunk) - The company is defending against a securities class action lawsuit (Melucci v. Corcept) and several related shareholder derivative complaints, which are currently stayed pending resolution of the Melucci litigation[148](index=148&type=chunk)[152](index=152&type=chunk)[154](index=154&type=chunk) [Risk Factors](index=25&type=section&id=ITEM%201A.%20RISK%20FACTORS) This section details significant business risks, including Korlym reliance, generic competition, R&D uncertainty, and IP litigation [Risks Related to Commercial Activities](index=26&type=section&id=Risks%20Related%20to%20our%20Commercial%20Activities) Korlym sales face risks from generic competition, COVID-19, price controls, and single-source vendor reliance - The company's financial results depend on revenue from its single commercial product, Korlym. Failure to generate sufficient revenue would harm financial results[176](index=176&type=chunk)[177](index=177&type=chunk) - The commercialization of generic versions of Korlym would adversely affect business. The company is in active litigation with Teva and Hikma to defend its patents[184](index=184&type=chunk)[185](index=185&type=chunk)[186](index=186&type=chunk) - The company relies on a single third-party manufacturer (PCAS) for Korlym's API and a single specialty pharmacy (Optime) for distribution, creating significant vendor dependency risk[204](index=204&type=chunk)[205](index=205&type=chunk) [Risks Related to Research and Development Activities](index=31&type=section&id=Risks%20Related%20to%20our%20Research%20and%20Development%20Activities) Drug development is long, expensive, and uncertain, with COVID-19 causing trial delays and CRO reliance posing risks - Clinical drug development is a lengthy, expensive, and often unsuccessful process. Early positive results are not predictive of later trial success, and failure can occur at any time[223](index=223&type=chunk)[224](index=224&type=chunk) - The COVID-19 pandemic has slowed the pace of clinical trials, particularly for non-life-threatening conditions like Cushing's syndrome, by delaying patient enrollment and site initiation[229](index=229&type=chunk)[230](index=230&type=chunk)[231](index=231&type=chunk) - The company relies on third-party vendors like CROs to manage trials. Failure of these vendors to perform their duties, meet timelines, or adhere to GCPs can delay or prevent the approval of product candidates[235](index=235&type=chunk)[236](index=236&type=chunk) [Risks Relating to Intellectual Property](index=34&type=section&id=Risks%20Relating%20to%20our%20Intellectual%20Property) Success depends on securing and defending patent protection for products, as patent litigation is complex and uncertain - The company's success depends on its ability to secure and defend adequate patent protection for its products and product candidates. Patent litigation is uncertain, complex, and expensive[248](index=248&type=chunk)[249](index=249&type=chunk) [General Risks](index=36&type=section&id=General%20Risks) General risks include managing growth, data privacy compliance, cybersecurity threats, and insider stock influence - The company is subject to complex and evolving federal, state, and foreign laws regarding data privacy and security (e.g., HIPAA, GDPR, CCPA), and failure to comply could result in significant penalties and harm the business[263](index=263&type=chunk)[264](index=264&type=chunk)[270](index=270&type=chunk) - The company relies heavily on information technology and is at risk of cybersecurity breaches, malware, and phishing attacks, which could result in the misuse of confidential data and disrupt operations[272](index=272&type=chunk)[273](index=273&type=chunk) - As of October 26, 2022, officers and directors beneficially owned approximately **18%** of the company's common stock, allowing them to significantly influence corporate actions[288](index=288&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECU%20RITIES%20AND%20USE%20OF%20PROCEEDS) No unregistered equity sales occurred, but 981,000 shares were repurchased for $26.2 million in Q3 2022 - There were no unregistered sales of equity securities during the period covered by this report[289](index=289&type=chunk) Issuer Purchases of Equity Securities (Q3 2022) | Period | Total Shares Purchased (thousands) | Average Price Per Share | Total Purchase Price (thousands) | | :--- | :--- | :--- | :--- | | July 2022 | 563 | $26.35 | $14,834 | | August 2022 | 327 | $27.51 | $8,988 | | September 2022 | 91 | $25.87 | $2,365 | | **Total** | **981** | **$26.69** | **$26,187** | [Other Disclosures](index=40&type=section&id=Other%20Disclosures) This section confirms no defaults on senior securities, no mine safety disclosures, and no other Item 5 information - The report indicates no defaults upon senior securities, no mine safety disclosures, and no other information to be reported for the period[292](index=292&type=chunk)[293](index=293&type=chunk)[294](index=294&type=chunk)
cept Therapeutics rporated(CORT) - 2022 Q2 - Earnings Call Transcript
2022-08-04 02:23
Corcept Therapeutics Incorporated (NASDAQ:CORT) Q2 2022 Earnings Conference Call August 3, 2022 5:00 PM ET Company Participants Joseph Belanoff - Chief Executive Officer, President, and Director Atabak Mokari - Chief Financial Officer Bill Guyer - Chief Development Officer Charlie Robb - Chief Business Officer Sean Maduck - President, Corcept Endocrinology Conference Call Participants Matt Kaplan - Ladenburg Thalmann & Co. Inc. Dennis Ding - Jefferies Greg Fraser - Truist Securities Arthur He - H.C. Wainwr ...
cept Therapeutics rporated(CORT) - 2022 Q2 - Quarterly Report
2022-08-03 16:00
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 June 30, 2022 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) - 2022 Q1 - Earnings Call Presentation
2022-05-13 18:48
May 2022 Safe Harbor This presentation contains forward-looking statements within the meaning of the Securities Exchange Act of 1934, as amended, and the Securities Act of 1933, as amended. All statements contained in this presentation other than statements of historical fact are forward-looking statements. When used in this presentation or elsewhere by management from time to time, the words "believe," "anticipate," "intend," "plan," "estimate," "expect," "may," "will," "should," "seeks" and similar expres ...
cept Therapeutics rporated(CORT) - 2022 Q1 - Earnings Call Transcript
2022-05-06 02:48
Corcept Therapeutics Incorporated. (NASDAQ:CORT) Q1 2022 Earnings Conference Call May 5, 2022 5:00 PM ET Company Participants Atabak Mokari - Chief Financial Officer Charlie Robb - Chief Business Officer Joseph Belanoff - Chief Executive Officer Sean Maduck - Chief Commercial Officer Bill Guyer - Chief Development Officer Conference Call Participants Matt Kaplan - Ladenburg Chris Howerton - Jefferies Edward Nash - Canaccord Genuity Gregory Fraser - Truist Securities Arthur He - H.C. Wainwright Alan Leong - ...
cept Therapeutics rporated(CORT) - 2022 Q1 - Quarterly Report
2022-05-04 16:00
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 March 31, 2022 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 ____________________ ...