Corcept anticipates $3B–$5B annual hypercortisolism revenue with relacorilant as FDA decisions near

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Corcept anticipates $3B–$5B annual hypercortisolism revenue with relacorilant as FDA decisions near
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Earnings Call Insights: Corcept Therapeutics (CORT) Q3 2025

MANAGEMENT VIEW

* Joseph K. Belanoff, CEO, stated that “we are on the cusp of a new era at Corcept,” highlighting the company’s two New Drug Applications (NDAs) approaching FDA target action dates for relacorilant in hypercortisolism (December 30, 2025) and platinum-resistant ovarian cancer (July 11, 2026). He also noted the submission of a marketing authorization application to the European Medicines Agency for ovarian cancer, with a regulatory decision expected by year-end 2026.
* Sean Maduck, President of Endocrinology, described another quarter of “robust growth,” with shipments of tablets to patients up 42.5% year-over-year and a substantially expanded base of prescribers. He explained that “the underlying strength of our business continues to build,” but noted that “the financial results don't fully reflect the surge in demand” due to pharmacy capacity constraints, which are being addressed by transitioning to a new pharmacy and plans to add two more specialty pharmacies by early 2026.
* Maduck emphasized confidence in future growth, projecting, “In the next 3 to 5 years, I believe relacorilant will generate $3 billion to $5 billion in annual revenue in hypercortisolism alone.”
* Atabak Mokari, CFO, stated, “Our revenue in the third quarter of 2025 was $207.6 million compared to $182.5 million in the prior year period. We have modified our 2025 revenue guidance to $800 million to $850 million. Net income was $19.7 million compared to $47.2 million in the third quarter of last year. Our cash and investments at September 30 were $524 million, which reflects our acquisition of $50 million of our common stock in the third quarter pursuant to our stock repurchase program.”
* William Guyer, Chief Development Officer, detailed the expansion of the oncology pipeline, including new trials in ovarian, endometrial, cervical, and pancreatic cancer, as well as studies combining proprietary GR antagonists with immunotherapy.

OUTLOOK

* Management modified 2025 revenue guidance to $800 million to $850 million.
* Maduck expects “almost all patients who are receiving Korlym will choose to transition to relacorilant and our growth will accelerate.”
* Belanoff reiterated expectations for relacorilant's approval in hypercortisolism by December 30, 2025, and in ovarian cancer by mid-2026, with a European regulatory decision by year-end 2026.
* Guyer announced that “all of these studies will begin enrollment in the coming weeks and should enroll very quickly like all of our past studies have done.”

FINANCIAL RESULTS

* Revenue for Q3 2025 was $207.6 million.
* Net income for Q3 2025 was $19.7 million.
* Cash and investments at September 30 were $524 million.
* Mokari reported a $50 million stock repurchase in the quarter.
* The company cited robust growth in patient volume, with Maduck noting “we shipped more tablets to patients than ever before, 42.5% higher than the third quarter of last year.”
* The transition to new and additional specialty pharmacies is expected to alleviate recent capacity-related constraints.

Q&A

* Edward Nash, Canaccord Genuity: Asked about patient counts and pharmacy capacity expansion; Maduck responded, “We had around 3,250 paying patients at the end of the third quarter,” and noted the new pharmacy has “the ability to continually expand with our business.”
* Nash inquired about gross margins; Mokari answered, “No, we have not seen that, and we don't expect that.”
* David Amsellem, Piper Sandler: Queried about net pricing and business mix; Maduck explained, “in the third quarter, it ended in the low 70s” for business on the authorized generic, with a “30% discount to Korlym's list price.”
* Asim Rana, Truist Securities: Sought details on pharmacy readiness and the relacorilant NDA review; Maduck confirmed, “Curant is fully online,” while Robb added, “we've had both” mid- and late-cycle reviews with the FDA, and “things have moved per schedule.”
* Swayampakula Ramakanth, H.C. Wainwright: Questioned guidance achievability and new molecule differentiation; Maduck clarified both pharmacies are active, supporting a strong Q4, and Guyer described nenocorilant’s unique properties for oncology combinations, with plans to publish preclinical data next year.

SENTIMENT ANALYSIS

* Analysts posed questions about capacity constraints, pricing dynamics, guidance achievability, and regulatory timelines, with a tone that was neutral to slightly positive, focusing on operational execution and pipeline progress.
* Management’s tone was confident throughout both prepared remarks and Q&A, repeatedly expressing confidence in growth, regulatory outcomes, and commercial launches, using phrases like “we are very confident” and “I've never been more confident.”
* Compared to the previous quarter, management maintained a strong level of optimism, while analysts’ questions shifted toward near-term execution risks and pharmacy transitions rather than skepticism of the market opportunity.

QUARTER-OVER-QUARTER COMPARISON

* Q3 revenue increased compared to Q2 ($207.6 million vs. $194.4 million), while net income decreased ($19.7 million vs. $35.1 million).
* 2025 revenue guidance was adjusted downward to $800 million–$850 million from the prior quarter’s $850 million–$900 million.
* Pharmacy capacity issues persisted into Q3, but management took steps to resolve them by transitioning to a new specialty pharmacy and planning for further expansion, compared to the previous quarter when only the onboarding of a second pharmacy was mentioned.
* The number of clinical specialists increased from 145 to 150 since Q2, with further expansion planned.
* Management’s confidence in relacorilant’s commercial prospects and the scale of future revenue opportunities remained strong, with explicit projections for $3 billion–$5 billion in annual hypercortisolism revenue.
* Analysts’ focus shifted from the timing of pharmacy onboarding and fulfillment issues to the execution of transition and ability to meet guidance.

RISKS AND CONCERNS

* Ongoing patent litigation with Teva remains unresolved, with management awaiting an appellate decision.
* Pharmacy capacity constraints impacted financial results, with management transitioning to new partners and planning to further expand the network to address future demand.
* Analysts questioned the company’s ability to meet guidance amid operational transitions and holiday periods, as well as potential pricing and margin pressures due to business mix shifts.

FINAL TAKEAWAY

Corcept Therapeutics presented a quarter marked by continued growth in patient demand and preparations for key regulatory milestones, including anticipated FDA decisions for relacorilant in both hypercortisolism and ovarian cancer. Management highlighted robust prescription growth, ongoing pharmacy network expansion, and confidence in relacorilant’s potential to drive $3 billion to $5 billion in annual revenue within three to five years. Operational challenges, particularly around pharmacy capacity, were addressed with concrete steps, while the pipeline continues to broaden across oncology and other therapeutic areas. Investors received clear signals of confidence in the company’s growth trajectory and commercial readiness for upcoming product launches.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/cort/earnings/transcripts]

MORE ON CORCEPT THERAPEUTICS

* Corcept Therapeutics Incorporated (CORT) Q3 2025 Earnings Call Transcript [https://seekingalpha.com/article/4837837-corcept-therapeutics-incorporated-cort-q3-2025-earnings-call-transcript]
* Corcept: Transition To New Specialty Pharmacy Well Underway [https://seekingalpha.com/article/4830087-corcept-transition-to-new-specialty-pharmacy-well-underway]
* Corcept Primed For An Upside EPS Surprise [https://seekingalpha.com/article/4826215-corcept-primed-for-an-upside-eps-surprise]
* Corcept Therapeutics Q3 2025 Earnings Preview [https://seekingalpha.com/news/4513450-corcept-therapeutics-q3-2025-earnings-preview]
* Corcept's ovarian cancer treatment under FDA review [https://seekingalpha.com/news/4493684-corcepts-ovarian-cancer-treatment-under-fda-review]