Intra-Cellular Therapies Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the Intracellular Therapy second quarter 2021 earnings conference call. At this time, all participant lines are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star then 1 in your telephone. We ask that you please limit yourself to one question and one follow-up. Please be advised that today's conference is being recorded. If you require any further assistance, please press star then zero. I would now like to hand the conference over to your host today, Juan Sanchez, VP of Corporate Communications and Investor Relations. Please go ahead.

Good morning and thank you all for joining us for today's conference call. Our earnings press release provides a corporate update and details of the company's financial results for the second quarter ended June 30th, 2021. This press release crossed the world a short time ago and is available on our website at intrafellulatherapist.com. Joining me on the call today are Dr. Sharon Mage, Chairman and Chief Executive Officer, Mark Newman, Executive Vice President and Chief Commercial Officer, Dr. Suresh Dorgon, Senior Vice President and Chief Medical Officer, and Larry Heinlein. Senior Vice President and Chief Financial Officer. As a reminder, during today's call, we will be making certain forward-looking statements. These statements may include statements regarding, among other things, the efficacy, safety, and intended use of the company's product development candidates, our clinical and non-clinical plans, our plans to present or report additional data, the anticipated conduct and results of ongoing and future clinical trials, plans regarding regulatory filings, future research and development, our plans and expectations regarding the commercialization of Capita, the potential impact of the COVID pandemic on our business, and possible uses of existing cash and investment resources. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statement. These and other risks are described in our periodic findings made with the Securities and Exchange Commission, including our quarterly and annual reports. Your question is not to place on due reliance on these forward-looking statements, and the company disclaims any obligations to update such statements. I will now turn the call over to Sharon.

Thanks, Juan. Good morning, everyone, and welcome to today's conference call. We are pleased with our strong results in the second quarter. Across all fronts, we are continuing our progress and are excited about what lies ahead, including the potential expansion of our Kaplida label for the treatment of bipolar depression with a BDUFA date for this indication later this year. If approved, this will mark a significant milestone in our plans to move Kaplida beyond its first indication for the treatment of schizophrenia into the much larger bipolar depression market and later into major depressive disorder pending ongoing clinical development results. In addition to our commercial performance, we'll also highlight our progress in Lumetepirone's late stage programs and provide a brief update on the rest of our pipeline, which we will cover extensively at our upcoming R&D day in the fall. I'll start with an update on Keplitis commercial performance where we drove a 22% quarter-over-quarter increase in total prescriptions in Q2, in spite of continuing COVID challenges. Total revenues in Q2 grew to $20 million. Kaplida's growth trajectory continued with second quarter net revenues reaching $19 million compared with $15.6 million in the first quarter of 2021 and $1.9 million in the same period last year. We expect continued growth in the second half of this year. Larry Heinlein and Mark Newman will provide further details in a few minutes. Looking ahead to our potential new indication for Keplida, we're especially encouraged by the significant progress made in the second quarter. The FDA accepted our supplemental new drug applications, or SNDAs, for Keplida for the treatment of bipolar depression and has set a PDUFA action date of December 17th, 2021. Our commercial team is making excellent progress in preparing to launch immediately following FDA approval. This approval would represent an important milestone for ITCI and a major advance for patients. If approved, Keplida will be a promising new medicine for more than 11 million adults in the U.S. living with bipolar I or bipolar II disorder. Bipolar depression is a chronic, serious condition with one of the highest rates of suicide among psychiatric disorders. Keplida is a great product with a compelling clinical profile, having demonstrated efficacy along with a favorable safety and tolerability profile. In our clinical trials, Lumetampirone improved depressive symptoms in patients with bipolar disorder. Results were similar to placebo for changes in weight, fasting glucose, total cholesterol, triglycerides, prolactin, and EPS, including akathisia. Keplida has the potential to safely treat a broad range of patients with bipolar depression in a large patient population that remains underserved. We have advanced our Lumotepirone program in major depressive disorder, or MDD, We are very pleased to announce that patient enrollment has initiated in study 501, evaluating Lumetepirone for the treatment of MDD. Patient enrollment in our second phase three trial, study 502, is anticipated to begin shortly. These phase three double-blind global studies evaluate Lumetepirone 42 milligrams versus placebo as adjunctive treatment with antidepressants to treat The primary endpoint for these trials is change from baseline at week six on the Montgomery Asperg Depression Rating Scale, or MADRIS, total score versus placebo. More than 17 million adults experience at least one major depressive episode, and about half of patients have an inadequate response following initial therapy, with only one-third achieving remission. Our goal is to provide a new treatment option to meet the needs of these patients. We're very enthusiastic about the prospects of this program and the possibility to substantially expand the opportunity for Keplida. Lumetepirone has already shown efficacy in the treatment of major depressive episodes in patients with bipolar disorder and in the treatment of depressive symptoms in patients with schizophrenia with comorbid depression. Additionally, we're expanding our efforts in depressive disorders with our ongoing monotherapy study 403 in patients with major depression or bipolar depression who exhibit mixed features. An estimated one-third of these patients exhibit mixed features during their depressive episodes. These patients typically respond poorly to antidepressants, suffer greater symptom severity, have a higher risk of suicide attempts, and experience severe illness with many comorbidities. A significant unmet need remains for effective, safe, and well-tolerated medicines. We anticipate results from Study 403 in the second half of 2022. To complete this Lumetepirone update, we have an ongoing Phase I safety and pharmacokinetic study with our Lumetepirone long-acting injectable formulation and anticipate initial results in the second half of this year. Finally, I'd like to provide highlights on our additional pipeline programs, which we will further expand upon in our upcoming R&D day in the fall. We are advancing ITI1284-ODTSL, a deuterated form of Lumetepirone. This is an orally disintegrating tablet delivered sublingually. We plan to initiate our program for the development of ITI1284-ODTSL for the treatment of behavioral disturbances in dementia in the second half of 2021 and plan additional studies in dementia-related psychosis and certain depressive disorders in the elderly in 2022. Our phosphodiesterase 1 or PDE1 inhibitor program is focused on investigating the therapeutic potential of this mechanism of action across a variety of diseases, including neurological and cardiovascular diseases, as well as cancer. We plan to initiate a phase two clinical trial in Parkinson's disease this year, and we will share with you the trial design details in the upcoming months. Our objective for the program is to study the drug's ability to improve motor symptoms without causing troublesome dyskinesia, improve cognition, and preserve and restore neuronal function, which may lead to disease modification. In Q2, we presented preclinical data at the American Association for Cancer Research annual meeting describing the anti-tumor effects of our PDE1 inhibitors when administered in conjunction with checkpoint inhibitor immunotherapy. We are currently evaluating our PDE1 inhibitors in other cancer models and are developing potential biomarkers that may assist in the translation of these data to the treatment of human cancers. Lastly, ITI-333 is a promising asset in our pipeline being developed for the treatment of opioid use disorder. ITI-333 acts as a modulator of serotonin and new opioid receptors and has shown efficacy in animal models in both opioid use disorder and acute and chronic pain. Our phase one single ascending dose study evaluating the safety, tolerability, and pharmacokinetics of ITI-333 in healthy volunteers is underway. Initial results from this study are anticipated in the second half of this year. We ended the quarter in a strong financial position with $556.2 million in cash, cash equivalents, and restricted cash. In summary, our continued commercial performance and growing portfolio confirm the strength of our team as well as our long-term commitment to developing and commercializing innovative therapeutics to improve the lives of patients, with neuropsychiatric and neurological disorders. I am proud of what our team has accomplished during this time. Mark will now share details of our ongoing commercial activities in schizophrenia and future plans in bipolar depression. Following his remarks, Larry will provide additional details on our Q2 financial performance. Mark.