Corcept Therapeutics Incorporated (CORT) SEC Filings & Earnings Calls

Transition risk in key division leadership.

“Departure of President of Endocrinology; consulting agreement in place for transition.”

Reliance on Lifyorli launch success; competitive and regulatory risks in oncology.

“Lifyorli revenue dependent on continued adoption; PDUFA date for relacorilant in Cushing's syndrome pending.”

Operating expenses increased significantly due to launch and R&D investments.

“Operating expenses $214.8M vs $167.8M, up 28%.”

Generic Competition for Korlym

“In January 2024, Teva launched a generic version of Korlym. We appealed the District Court’s decision... In February 2026, the appellate court affirmed the District Court’s ruling.” · word for word

Regulatory Risk for Relacorilant

“On December 30, 2025, the FDA issued a Complete Response Letter ("CRL") declining to approve relacorilant.” · word for word

Drug Pricing / IRA Risk

“The IRA shifts a portion of the Medicare beneficiary costs... to manufacturers in the form of limitations on price increases and rebates paid to the government. We anticipate that this provision will limit the revenue we receive from Medicare patients and may materially reduce our revenue and profits in 2026 and beyond.” · word for word

Litigation Risk

“A purported securities class action complaint was filed... The complaint asserts a putative class period from October 31, 2024, to December 30, 2025” · word for word

Regulatory approval risk remains; FDA may require additional data or reject the application.

“NDA resubmission does not guarantee approval; FDA review outcome uncertain.”

Litigation risk: Ongoing qui tam action despite DOJ declination; potential financial and reputational exposure if Relator succeeds

“Relator served amended complaint; company intends to vigorously defend”

Potential dilution from increased share authorization for incentive awards.

“increase the number of shares available thereunder by 8,000,000 shares” · word for word

Net loss due to increased spending for Lifyorli launch and Cushing's syndrome business investments.

“Operating expenses increased to $214.5M from $153.8M due to launch costs.”

Regulatory risk for relacorilant in Cushing's syndrome

“On December 30, 2025, the FDA issued a Complete Response Letter (“CRL”) declining to approve relacorilant. ... the FDA stated that additional evidence of efficacy would be required for approval.” · word for word

IRA pricing pressure

“We anticipate this provision will limit the revenue we receive from Medicare patients and may materially reduce our profits in 2026 and beyond.” · word for word

Commercial execution risk for Lifyorli

“In April 2026, we began selling and distributing Lifyorli in the United States.” · word for word

FDA CRL for relacorilant in Cushing's

“On December 30, 2025, the FDA issued a Complete Response Letter ("CRL") declining to approve relacorilant.” · word for word

Patent litigation loss to Teva

“On February 19, 2026, the appellate court affirmed the District Court's ruling, finding no infringement of either patent.” · word for word

Government funding cuts and tariff uncertainty

“The federal government of the United States has recently significantly reduced funding for scientific research conducted by the federal government and universities, terminated large numbers of employees at government agencies that support health care research and regulation, including the FDA, Centers for Disease Control and National Institutes of Health, an” · word for word

Capacity constraints at previous specialty pharmacy vendor limited growth; transition complete but execution risk remains.

“We should have achieved higher growth but were not able to fully meet demand because of capacity constraints at our previous specialty pharmacy vendor. There were also operational disruptions in the fourth quarter as we transitioned our business to our new specialty pharmacy.” · word for word

Relacorilant NDA for Cushing's syndrome received Complete Response Letter; path to approval uncertain.

“Engaged with FDA to determine best path forward to approval following Complete Response Letter for relacorilant in patients with Cushing’s syndrome” · word for word

Patent invalidation/non-infringement ruling opens door to generic competition for Korlym, threatening revenue stream.

“Federal Circuit found Teva's generic does not infringe two patents; Teva can market generic Korlym.”

FDA rejection of relacorilant NDA could significantly impact revenue expectations and pipeline value.

“FDA issued a Complete Response Letter for relacorilant NDA, indicating the application cannot be approved in its current form.”

IRA pricing pressure on Medicare revenue

“We anticipate this provision will limit the revenue we receive from Medicare patients and may materially reduce our profits in 2026 and beyond.” · word for word

Clinical trial failure in ALS

“Although DAZALS did not meet its primary endpoint – change from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R) in patients who received dazucorilant compared to those who received placebo” · word for word

Regulatory approval risk for relacorilant

“NDA for relacorilant in Cushing's syndrome has PDUFA date of December 30, 2025; NDA for ovarian cancer has PDUFA date of July 11, 2026.”

Revenue guidance cut due to pharmacy capacity constraints; net income decline.

“Guidance cut to $800-850M; net income -58.3% YoY.”

Operating expenses rising faster than revenue for launch preparations.

“Operating expenses +45.2% YoY vs revenue +13.8%.”