Intra-Cellular Therapies Inc.

Good morning, ladies and gentlemen. Welcome to our intro, cellular therapies, third quarter financial results conference call. As a reminder, today's conference call is being recorded. I'd now like to turn the conference over to Dr. Juan Sanchez, Vice President, Corporate Communications and Investor Relations. Please go ahead.

Good morning and thank you all for joining us today. Our earnings press release provides a corporate update and details of the company's financial results for the third quarter, which ended September 30, 2021. This press release crossed the border a short time ago and is available on our website at intracellulotherapies.com. Joining me on the call today are Dr. Sharon Mates, Chairman and Chief Executive Officer, Mark Newman, Executive Vice President and Chief Commercial Officer, Dr. Suresh Dorgam, 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 Catalyta, potential impact of the COVID-19 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 might cause actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. You are cautioned 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 call. We're excited to share our third quarter progress, update you on our programs, and describe our upcoming plans. In the third quarter, we continue to successfully execute our commercial plan for Kaplida our FDA approved medicine for the treatment of schizophrenia in adults. Kaplitis prescription growth trajectory continued quarter over quarter. We have an upcoming milestone rapidly approaching with our FDA of December 17th for Kaplitis label expansion into bipolar depression in adults. We also continue to advance several other promising development programs. Before I provide further details on our programs, let me first provide an overview of our financial and commercial performance. Total revenues for the third quarter grew to $22.2 million. Cap Lida net product revenues were $21.6 million compared to $19 million in Q2 2021 and $7.4 million in the same quarter last year. Total prescriptions increased 15% quarter over quarter, and approximately 200% versus Q3 of 2020. We achieved this sequential growth in spite of disruptions due to the latest surge of COVID-19 during Q3. Keplida has a compelling clinical profile having demonstrated efficacy coupled with favorable safety and tolerability with no dose titration required. In our clinical trials in schizophrenia, Keplida results were similar to placebo for changes in weight, fasting glucose, total cholesterol, triglycerides, and extrapyramidal symptoms, including akathisia. Market research and feedback from the field continues to indicate that patient and physician real-life experiences with teplita are consistent with what was demonstrated in clinical trials. We're very excited about teplita's potential as an important treatment option for patients with bipolar depression. This label expansion would significantly extend the patient opportunity for Capilita to more than 11 million Americans living with bipolar disorder. There are only a few approved treatment options for bipolar depression, the most common and debilitating manifestation of this disorder. If approved, Capilita could help fill an existing need for effective treatment with a favorable safety and tolerability profile. The FDA is currently reviewing our SNDA for the treatment of bipolar depression in adults. Our applications are supported by robust positive results from two Phase III studies that evaluated the effects of Lumotepirone in patients with either bipolar I or bipolar II disorder. In both studies, treatment with Lumotepirone substantially reduced depressive symptoms on both primary and key secondary endpoints. Importantly, The favorable safety and tolerability profile in our bipolar depression program is consistent with that of our schizophrenia program. During the quarter, results from study 404, our monotherapy study, were published in the American Journal of Psychiatry, a highly respected psychiatric journal. Upon approval, we expect to launch this important new option for patients with bipolar depression. Our Salesforce expansion is substantially complete, and Mark will provide further details in a few moments. Our longer-term vision is to establish Lumotepirone as the treatment of choice across a broad range of depressive disorders. Bipolar depression is the first indication in this strategy. This is followed by our Phase III studies in MDD, which are double-blind, placebo-controlled, six-week studies evaluating Lumotepirone 42 milligrams as adjunctive treatment to antidepressants for patients who have an inadequate response to antidepressant therapy. In addition, we have an ongoing program evaluating Lumotepirone in patients who exhibit mixed features. Study 403 is a double-blind, placebo-controlled, six-week study evaluating Lumotepirone 42 milligrams as monotherapy for patients with MDD or bipolar depression exhibiting mixed features. Patients with mixed features who make up roughly one-third of those with bipolar depression and MDD have greater symptom severity, a higher risk of suicide attempts, and higher comorbidities. They also respond poorly to antidepressants. We expect to complete our ongoing 403 study in the second half of 2022. We recently held our first Research and Development Day where we had the opportunity to hear from a group of prominent experts in psychiatry who shared their perspectives on the therapeutic needs in major psychiatric conditions, including schizophrenia and mood disorders, with an emphasis on bipolar depression. They provided insights into Lumateparone's potential to address these needs, which was consistent with feedback we have received. We are confident that Lumateparone addresses an unmet medical need and, if approved, Lumateparone will have broad utility across a range of depressive disorders, with bipolar depression being the first approval within this category. During the event, we provided an overview of molecules in our robust pipeline, including the lumotepirone long-acting injectable formulations and ITI1284 OGTSL programs. We have initiated our program for the development of ITI1284 for the treatment of agitation in patients with probable Alzheimer's. Clinical conduct in this program is expected to begin early next year. Studies in dementia-related psychosis and certain depressive disorders in the elderly are planned for the first half of next year. We also presented important aspects of the mechanistic underpinning, our existing data, and our clinical development plans for our PDE1 inhibitors and ITI 333 platforms. We discussed the features that make PDE1 enzyme unique among the large family of phosphodiesterases. We also discussed PDE1's unique tissue distribution and the selective pathway regulation that allows for a broad therapeutic opportunity for our portfolio of PDE1 inhibitors. We presented preclinical and early stage clinical results in Parkinson's disease, supporting the recent advancement of lenrospodin into phase two clinical development. Our external expert explained the therapeutic needs for treating motor symptoms and non-motor symptoms, including cognition in this patient population. Our goal for this program is to study Lenris-Poten's potential to improve motor and non-motor symptoms, including cognition, by enhancing or restoring neuronal function in affected brain regions. We also highlighted ITI-333, a promising drug candidate to address important unmet therapeutic needs in opioid use disorder and pain. ITI-333 is a novel compound that acts as a partial agonist at mu opioid receptors and as an antagonist at the serotonin 5-HT2A receptors. At mu opioid receptors, it acts as a partial agonist signaling through G protein coupled pathways, but acts as an antagonist at the beta arrestin pathway. Our external expert explained the current opioid use crisis in the U.S. and outlined the unmet therapeutic needs. Results from an ongoing phase one single ascending dose study are anticipated in the fourth quarter of 2021. We ended the third quarter in a strong financial position with $478.7 million in cash, cash equivalents, and restricted cash. We're very proud of our performance and our team's efforts over the last quarter. As we continue to grow and expand, we remain committed to fulfilling our mission to develop innovative treatments to improve the lives of individuals with neuropsychiatric and neurologic disorders. Mark will now share details of our ongoing commercial activities, including our plans for bipolar depression. Following his remarks, Larry will provide additional details on our financial performance. Mark?