Corcept Therapeutics Incorporated

Good day and thank you for standing by. Welcome to the Course of Therapeutics conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. And to ask a question during the session, you will need to press star 1 on your telephone keypad. And please be advised that today's conference is being recorded. Should you require further assistance, you may press star 0. And I will now turn the call over to Mr. Atabak Mukari, CFO. Please go ahead.

Good afternoon, and thank you for joining us. I'm Adivac Mukari, Corset's Chief Financial Officer. Today, we issued a press release announcing our financial results for the first quarter and providing a corporate update. The copy is available at corset.com. Our complete financial results will be available when we file our Form 10-Q 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 may cause actual results to differ materially from those such statements express or imply. These forward-looking statements are described in today's press release, and the risks and uncertainties that may affect them are described in the press release and in our annual report on Form 10-K and our quarterly reports on Form 10-Q. Please refer to those documents for additional information. We disclaim any intention or duty to update forward-looking states. Our revenue in the first quarter was $93.7 million, an increase of 18% compared to the first quarter of last year. As a reminder, each year, insurance reauthorization and coverage of our portion of the donor whole gap and Medicare Part D coverage reduce our first quarter revenues. We expect our revenue growth to continue and have reiterated our 2022 revenue guidance of $400 to $430 million. Net income was $22.8 million or 20 cents per share in the first quarter, and our cash and investments increased $32 million in the first quarter to $368.1 million at March 31st. I will now turn the call over to Charlie Robb, our Chief Business Officer, provide an update on our litigation with generic manufacturers Teva and Hicklund Pharmaceuticals. Charlie?

Thanks, Adivac. There's little to report this quarter. As many of you know, Teva is seeking to market a generic version of Coraline in violation of our patents. In March 2018, we sued Teva in federal district court. That litigation is still underway. In the midst of our federal court litigation, TEVA launched a parallel challenge to the validity of one of our patents, the 214 patent, in a procedure before the Patent Trial and Appeals Board, or PTAB, known as a Post-Grant Review, or PGR. In November of 2020, the PTAB rejected TEVA's arguments, upholding the 214 patent in its entirety. TEVA appealed its loss to the Federal Circuit Court of Appeals, where, in December of 2021, it lost again. The matter is closed. Having lost the PGR, TEVA can no longer challenge the 214 patent's validity in our district court case. TEVA can only argue that its proposed product would not infringe a position we believe has no legal or factual support. A year ago, we filed for summary judgment based on TEVA's infringement of the 214 patent. TEVA responded by filing its own summary judgment motion. Summary judgment is a procedure whereby courts can decide a case without holding a trial. We believe the court has all it needs with respect to the 214 patent to decide the case in our favor, in which case Teva would be barred from marketing generic corulum until 2037 when the 214 patent expires. If the court rules in Teva's favor, we will proceed to trial, most probably sometime next year, although it is impossible to say with certainty. There's no timetable for the summary judgment ruling, no trial date, and no schedule for any trial-related activities. All is quiet. which is in some respects unfortunate. This case has gone extremely well for us, and we would like to wrap things up. In March 2021, we sued another antifiler, Hikma Pharmaceuticals, in the same federal district court that is hearing our case against Teva. In this case, the court has set a fact discovery deadline of July 1 this year. Nothing is scheduled after that. With respect to both Teva and Hikma, we are very confident in the strength of our legal position. I will now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Joe?