Corcept Therapeutics Incorporated

Good afternoon, ladies and gentlemen, and welcome to CORSEP Therapeutics Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. If you would like to ask a question, you may press star, then the number 1 on your touchtone telephone. And if anyone should require assistance during the conference, please press star 0. Thank you. I would now like to turn the conference over to your host today, Mr. Adibak Mukari, Chief Financial Officer. Sir, the floor is yours.

Thank you. Good afternoon, and thank you for joining us. I'm Adhavak Mukhari, Corset's Chief Financial Officer. Today, we issued a press release announcing our financial results for the third 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 10Q with the SEC. Today's call is being recorded. A replay will be available of the investor's 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 that statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals and conduct our clinical trials during the COVID-19 pandemic and to generate sufficient revenues to fund our commercial operations and development program. the availability of competing treatments, including generic versions of Quorum, our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Quorum, risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, and other requirements, and the scope and protective power of our intellectual property. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. On this call, forward-looking statements include those concerning the safety, efficacy, and other clinical and commercial attributes of relacoralin, hexacoralin, miracoralin, CORIC-113-176, and our other selective cortisol modulators for the treatment of patients with solid tumors, liver disease, hypercortisone, antipsychotic-induced weight gain, amyotrophic lateral sclerosis, or ALS, and other disorders. the progress, enrollment, timing, design, and results of our clinical trials, our revenue guidance, cash flow, and expected growth, the impact of the COVID-19 pandemic on our commercial operations, financial performance, clinical development programs, as well as on physicians, payers, and patients, and on our anticipated financial performance and clinical development activities after the COVID-19 pandemic is controlled. The timing, cost, and outcome of litigation, including our lawsuits against Teva and Hikma Pharmaceuticals, have its appeal of its defeat in the Post-Grant Review, or PGR, before the Patent and Trial and Appeals Board, or PTAB, and may include other forward-looking statements during the course of the call. We disclaim any intention or duty to update forward-looking statements. Our revenue in the third quarter of 2021 was $96.1 million compared to $86.3 million in the third quarter of 2020, an increase of 11%. Third quarter 2021 GAAP net income was $30.5 million compared to $21.6 million in the same period last year. Non-GAAP net income, which excludes non-cash expenses related to stock-based compensation and the utilization of deferred tax assets together with related income tax effects, was $37 million in the third quarter compared to $30 million in the same period last year. We have tightened our 2021 revenue guidance of $365 to $375 million compared to previous guidance of $355 to $385 million. Our cash and investments totaled $495.2 million on September 30th, an increase of $23.6 million from June 30th. The balance of September 30th reflects the repurchase of $28 million per common stock in the third quarter. 1.2 million shares pursuant to our share repurchase program, and about 200,000 shares in connection with the net exercise of employees.com. Over the term of the share repurchase program, we purchased 4.3 million shares of our common stock at a cost of $98.2 million. And now, Charlie Roth, our Chief Business Officer, will provide a legal effort.

Charlie? Thanks, Adam Ackham. In March 2018, we sued Teva and Federal District Court to prevent it from marketing a generic version of Coralim in violation of our patents. The trial was originally scheduled to start in February of this year, although that date was vacated by the court. A new trial date has not been set. In April, the court granted us permission to file for summary judgment regarding Teva's infringement of our 214 patent. Teva responded by filing its own summary judgment motion with respect to the same patent. 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. Having lost its action before the PTAB, which I will talk about more in a minute, TEVA can no longer challenge the 214 patent's validity in the district court case. TEVA can only argue that its proposed product would not infringe a position we believe has no legal or factual support. If the court grants our motion, we will have won the case. TEVA would be banned from marketing generic corlum until 2037, when the 214 patent expires. If the court rules in TEVA's favor, we will proceed trial sometime next year. There is at present no timetable for the court summary judgment ruling, no trial date, and no schedule for any trial-related activities. In parallel with the district court action, TEVA petitioned Federal Circuit Court of Appeals to reverse its PTAB loss, which I referred to earlier. The request, we believe, has no merit. Briefing is complete and the court heard oral argument on October 5th. We expect a decision in the next quarter or two. On March 12th, we sued another antifiler, Hikma Pharmaceuticals, in the same federal district court that is adjudicating our case against Teva. In the Hikma case, the court has set a fact discovery deadline of July 1st, 2022, next year. Nothing is scheduled after that. With respect to both Teva and Hikma, we are confident in the strength of our legal position. I'll now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Joe?