Corcept Therapeutics Incorporated

Thank you for standing by, and welcome to CourseUp Therapeutics' fourth quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. To remove yourself from the queue, you may press star 1-1 again. I would now like to hand the call over to Adaba Makari, CFO, please. Go ahead.

Hello, everyone. Good afternoon, and thank you for joining us. Today, we issued a press release announcing our financial results for the full year and providing a corporate update. A copy is available at courseup.com. Our complete financial results will be available when we file our Form 10-K with the SEC. Today's call is being recorded. A replay will be available at the Investors Past Events tab of our website. Statements during this call, other than statements of historical fact, are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties which might cause actual results to be materially different from those such statements express or imply. The risks and uncertainties that may affect our forward-looking statements are described in our annual report on Form 10-K and our quarterly reports on Form 10-Q, which are available at the SEC's website. Please refer to those documents for more information. We disclaim any intention or duty to update forward-looking statements. Our 2025 revenue with $761 million compared to $675 million in the prior year. We expect our revenue growth to continue and are providing full-year 2026 revenue guidance of $900 million to $1 billion. Net income was $99.7 million for the full year 2025 compared to $141.2 million in the prior year. Cash and investments at December 31, 2025 were $532 million, which reflects our acquisition in 2025 of $245 million worth of our common stock pursuant to our stock repurchase program, as well as shares acquired upon the exercise of course of stock options and the vesting of restricted stock grants. I will now turn the call over to Charlie Robb, our Chief Business Officer. Charlie?

Thanks, Adibak. As many of you know, last Thursday, the Federal Circuit Court of Appeals ruled against us in our lawsuit to stop Teva Pharmaceuticals from marketing a generic version of Corlum in violation of our patents. We believe the court made a mistake. Patents we have asserted, as included in Corlum's label and Teva's copy of Corlum's label, instruct physicians how to administer Corlum safely with drugs many patients with Cushing syndrome require for optimal health, such as widely prescribed antifungal and antiviral medications. We know there are physicians who follow these instructions. The expensive, risky research we undertook to make this important medical advance available is exactly what the patent system is meant to encourage and protect. We plan to appeal. I'll now turn to the FDA's failure to approve reliquorlin as a treatment for patients with Cushing syndrome. We were surprised by the FDA's decision. Why? Because reliquorlin benefits patients with Cushing syndrome, and we strongly believe the data we submitted with our NDA shows that. There are many reasons we were so optimistic about reliquorlin's prospects. Most importantly, as the FDA has acknowledged, our pivotal GRACE trial met its primary endpoint with a p-value of 0.02. The primary evidence we submitted to confirm this positive result came from patients in our double-blind, placebo-controlled gradient trial whom the FDA had identified prior to data unblinding as being of particular importance to its review. Further, GRACE's primary endpoint, improvement in hypertension, secondary to Cushing's syndrome, addresses a serious unmet medical need. It was also agreed to by the FDA, and for good reason. Cardiometabolic complications are the leading cause of death in patients with Cushing syndrome. Existing hypertension medications are often partially or wholly ineffective in treating this condition. 76% of the patients with hypertension who enrolled in GRACE, for example, were already taking one or more blood pressure lowering medications. Of these patients, 39% were taking three or more. These patients needed a blood pressure treatment that worked for them. Reliquorlin's demonstrated benefit addressing an unmet need in patients with a serious condition by itself would be ample reason to expect its approval, but we had additional causes for optimism. Throughout Reliquorlin's development program, patients exhibited meaningful improvements in other signs and symptoms of Cushing syndrome, not just hypertension. For example, In the open-label phase of GRACE, patients had a robust and consistent response to treatment. They lost weight without losing muscle mass, their waist circumference shrank, and their glucose control improved, all without a worsening in their other signs and symptoms. Patients with Cushing's syndrome do not improve without treatment. They get worse. Another important quality of relic correlates that gave cause for optimism is that relic correlates confers its benefit without giving rise to serious adverse events and off-target effects associated with the currently approved treatments, including QT interval prolongation, adrenal insufficiency, hypokalemia, endometrial thickening, irregular vaginal bleeding, and termination of pregnancy. Reliquorlin would provide a treatment option for patients who find one or more of these risks disqualifying. The liver enzyme elevation cited in the FDA's complete response letter can be managed, as the complete response letter implies, through appropriate label instructions and post-marketing surveillance, and did not give us reason to doubt. In addition to the efficacy and safety benefits I just described, there was still another reason for us to expect reliquarone's approval. Our clinical development program writ large, by which I mean the design of our trials, the number of patients studied, and the amount of data included in our NDA, compare favorably to the development programs that led to the approval of other Cushing syndrome medications. For example, our Pivotal Grace trial employed the same design as the trials that led to the approval of Isterisa and Recurlab, the two most recently approved Cushing syndrome medications. Our primary source of confirmatory evidence for GRACE's positive result was drawn from patients in a placebo-controlled double-blind study, making it more compelling in our view than the open-label evidence that supported other approvals. The number of patients we studied in GRACE, their trial completion rate, and the amount of data they contributed to our MDA exceeded that of most recently improved medication. In sum, Our review of FDA precedent, just as much as our scientific evaluation of reliquarolin's clinical data, gave us ample reason for optimism. I'll close with a final reason. We worked with the FDA for years to bring reliquarolin to the point of NDA submission. During that time, the FDA made recommendations regarding various aspects of our program, as is the case with all development programs, and we accommodated those recommendations. By the time we submitted our NDA, we had tailored our development program to the FDA's guidance in all material respects. The FDA tells sponsors when it does not think they should submit an NDA. They did not tell us that. Nor did the FDA tell us we would face significant review issues or a possible refusal to file a letter if we did submit. Following the filing of an NDA, FDA's internal guidance calls for the agency to inform drug sponsors as quickly as possible There are deficiencies in the form or substance of the NDA package that would preclude approval. We heard nothing of the sort to the very end of the process, and neither the mid- nor late-cycle meetings that are part of every NDA review was the word deficiencies used. To reiterate my original point, we were surprised, and for good reason, that Reliquorlin was not approved. Where do we go from here? Our priority is to make Reliquorlin available to patients as quickly as possible. We will meet with the FDA in April to better understand its thinking. Outcomes from that meeting range from resubmission of our NDA, perhaps including additional analyses from our NDA's rich data set, to a filing of a formal appeal with the FDA's Office of New Drugs to deciding we need to conduct a new study. I'll now turn the call over to Sean Madduke, President of our Endocrinology Division.