Corcept Therapeutics Incorporated

Good day, thank you for standing by, and welcome to CORE-CEP 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. To ask a question during that session, you will need to press star 1 on your telephone keypad. If you require any further assistance, please press star 0. Thank you. I would now like to hand the conference over to your speaker today, Mr. Adubak Makkari. The floor is yours.

Thank you. Good afternoon, and thank you for joining us. I'm Adubak Makkari, Corsup's Chief Financial Officer. Today, we issued a press release announcing our financial results for the second quarter and providing a corporate update. A copy of it is available at Corsup.com. Our complete financial results will be available when we file our Form 10-Q with 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 differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals during the COVID-19 pandemic and thereafter, and including our ability to generate revenue and cash reserves sufficient to fund our commercial operations and development programs, the availability of competing treatments, including generic versions of Coraline, the initiation or outcome of litigation, our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Coraline, and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversights, and other requirements, and the impact of the COVID-19 pandemic on our employees, consultants, and vendors, well as on our physicians, patients, insurers, regulators, and the practice of medicine generally. 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, exacoralin, miracoralin, cort113176, and our other selective cortisol modulators for the treatment of patients with solid tumors, liver disease, hypercortisolism, 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, our stock repurchase program and its intended funding sources, the impact of the COVID-19 pandemic on our commercial operations, financial performance, clinical development programs, physicians, payers, and patients, and expectations regarding our financial performance and clinical development programs after the COVID-19 pandemic is controlled. The timing, cost, and outcome of the litigation, including our lawsuits against Teva and Hikma Pharmaceuticals, Teva's appeal of its defeat in the post-grant review I brought before the Patent, Trial, and Appeals Board, known as PTAT, and our settlement of litigation with Sun Pharmaceuticals, as well as the scope and protective power of our intellectual property and the benefits of orphan drug designation. We disclaim any intention or duty to update forward-looking statements. Our revenue in the second quarter was $91.6 million compared to $88.6 million in the second quarter of 2020 and $79.4 million in the first quarter of 2021. Second quarter 2021 cap net income was $26.5 million compared to $28.3 million in the same period last year. Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets together with related income tax effects, Non-GAAP net income in the second quarter was $38.2 million compared to $39.7 million in the second quarter of 2020. We have reiterated our revenue guidance of $355 to $385 million, which assumes that pandemic-related restrictions will continue to ease in the second half of this year. Our cash and investments totaled $471.6 million at June 30th, an increase of $16.8 million from March 31st. In the second quarter of this year, we repurchased 1.5 million shares of our common stock, 1.4 million shares pursuant to our stock repurchase program, and about 150,000 shares in connection with the net exercise of employee stock options. The total cost of these repurchases was $30.8 million. Under the current terms of our stock repurchase program, $127.6 million remains available for the repurchase of shares. We will determine the timing and size of future repurchases our stock price, and other factors. And now, Charlie Robb, our Chief Business Officer, will provide a legal update. Charlie?

Thanks, Out-of-Act. I'll briefly review our litigation against generic manufacturers Teva, Hikma, and Sun Pharmaceuticals. In March 2018, we sued Teva and Federal District Court to prevent it from marketing a generic version of Corlum in violation of our patents. Originally, trial was set to start in February of this year. Last quarter, the court vacated this date in order for the parties to be ready for trial in March. That trial-ready date was also vacated. A new trial date has not been set. In April, we asked the court's permission to file for summary judgment based on Teva's alleged infringement of our 214 patent. The court granted permission, and 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, 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. Briefing in this matter is complete. We await the court's decision. If the court grants our motion, we will have won the case. Teva would be barred from marketing generic corlum until 2037 when the 214 patent expires. Teva could appeal, of course, although the district court's bar would remain in place until the appeal is resolved, a process that usually takes 12 to 18 months. If the court rules in Teva's favor, we will proceed to trial late this year or sometime next year. There is at present no timetable for the court's summary judgment ruling, no trial date, and no schedule for any trial-related activities. In parallel with the district court action, TEVA has, as expected, petitioned the Federal Circuit Court of Appeals to reverse its PTAB loss. Briefing in this matter is also complete. A Federal Circuit decision is likely in the first or second quarter of 2022. Earlier this year, we received notice of another antifiler, HICMA Pharmaceuticals. On March 12th, we sued HICMA in the same federal district court that is adjudicating our case against TEVA. The court has entered a schedule for the case that sets a fact discovery deadline of July 1, 2022, next year. Finally, Sun Pharmaceuticals is also seeking to market generic coralline. In June 2019, we sued Sun to prevent it from doing so. As we announced a few weeks ago, we have settled this case. The settlement agreement allows Sun to begin selling a generic version of coralline beginning October 1, 2034, more than 14 years from now, or earlier. under circumstances customary for settlements of this type. I will now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Joe?