Intra-Cellular Therapies Inc.

Good morning, ladies and gentlemen, and welcome to Intracellular Therapy's first quarter earnings 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 the session, you will need to press star, then 1 on your telephone keypad. 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. Juan?

Good morning and thank you all for joining us on the call today. Our earnings press release provides a corporate update and details of the company's financial results for the first quarter ended in March 31st, 2022. This press release is available on our website at intracellulartherapist.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 Dorgan, Executive 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 might 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 plan and expectations regarding the commercialization of Kaplaita, 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. Those 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 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're cautioned not to place your reliance on these forward-looking statements, and the company disclaims any obligations to obey such statements. I will now turn the call over to Sharon.

Thanks, Juan. Good morning, everyone, and welcome to today's call. I am pleased to present our first quarter 2022 results and to provide an overview of our strong launch of Keplida in bipolar depression. Additionally, I will share our progress with our Lumetepirone clinical development programs and other pipeline programs. We launched Keplida in bipolar depression immediately following its FDA approval in late December of last year, and we're off to a great start. Following this important label expansion, Keplida's prescription growth has accelerated significantly. In the first quarter, Keplida new prescriptions increased by 63%, and total prescriptions increased by 45% compared to the fourth quarter of 2021. Compared to the first quarter of 2021, in Q1 2022, new prescriptions increased by 154% and total prescriptions increased by 134%. Consistent with this strong demand has been the highly positive feedback we are receiving from physicians regarding Keplitis clinical profile in a broad range of patients with bipolar depression as well as their early experience with patients. Keplita is an important treatment option to help individuals living with bipolar disorder. We are confident in Keplita's continued growth for several reasons. First, Keplita is a novel antipsychotic with a strong clinical profile which is clearly reflected in its broad label. There are only a few approved treatments for bipolar depression which affects more than 11 million U.S. adults. Keplida is the first and only treatment approved for both bipolar I and bipolar II depression in adults, both as monotherapy and as adjunctive therapy with lithium or valproate. Depressive episodes in patients with bipolar I or bipolar II disorder are significantly more common than mania or hypomania and are linked to worse prognosis, greater impairment, decreased quality of life, higher morbidity, and increased suicide rates. The prevalence of Bipolar I and Bipolar II disorder are similar. Bipolar II is often characterized by a higher frequency of depressive episodes that last longer with lower overall functioning than Bipolar I. Prior to Keplitis approval, only one drug was approved for Bipolar II depression. Second, physicians and patients are looking for effective treatments with favorable side effect profiles, and Kaplida has shown consistent efficacy across a broad patient population with a favorable safety and tolerability profile. Bipolar patients consistently identify weight and akathisia as side effects of great concern. Importantly, across our clinical trials, weight gain was similar to placebo and, in fact, In our longer-term open-label studies, patients with bipolar depression had no weight gain from baseline to six months, while patients with schizophrenia lost an average of seven pounds in one year. Additionally, fasting glucose, total cholesterol, triglycerides, and EPS, including akathisia, were also similar to placebo. In recent market research, psychiatrists highly rate keplitis performance on efficacy and safety measures. Third, capillitis administration is simple and straightforward. It is a once-a-day medication that does not require dose titration. The starting dose is a therapeutic dose and can be taken with or without food. To address special populations, we recently received FDA approval for the expansion of the capillita label. This label provides dose adjustment recommendations for patients concomitantly taking strong or moderate CYP3A4 inhibitors and for patients with moderate or severe hepatic impairment. This label expansion allows an even greater patient population to have access to Keplida. Finally, our confidence about Keplida's continued growth is further fueled by our strong commercial team, their launch execution, and the improving market conditions as COVID continues to subside. Mark will provide more details on our launch in a few minutes. We're pleased to report that total revenues were $35 million for the first quarter of 2022, representing 120% increase over the same period of 2021 and a 36% increase quarter over quarter. Larry will provide additional details in our financial performance in his remarks. In addition to our commercialization of Capilita, we have ongoing programs to expand our label to include the treatment of a broad range of mood disorders, including major depressive disorder, or MDD, and mixed features in MDD with bipolar depression. These disorders, which affect millions of patients, have important unmet medical needs. Patient enrollment is ongoing in our registrational MDD studies evaluating Lumetepirone as an adjunctive treatment to antidepressants. We expect to file a supplemental new drug application with the FDA for approval of Lumetepirone as an adjunctive therapy to antidepressants for the treatment of MDD in 2024. In addition, study 403, our study evaluating the antidepressant effects of Lumetepirone, in patients who exhibit mixed features with bipolar depression or MDD is ongoing. We expect to complete clinical conduct of this study in the second half of this year. We are also advancing our Lumateprone long-acting injectable program for the treatment of schizophrenia, which is currently in phase one clinical development, addressing different formulations and additional sites of injection. In addition to Lumatepolone, we continue to expand our robust pipeline with ITI1284 ODTSL, our phosphodiesterase 1 or PDE1 inhibitors, and ITI333. In 2022, we are advancing ITI1284 for the treatment of agitation in patients with probable Alzheimer's disease, followed by studies in dementia-related psychosis and certain depressive disorders in the elderly. We also plan to begin patient enrollment in a phase two clinical study of our lead PDE1 compound lenrospotin for the treatment of Parkinson's disease shortly. In addition, we have successfully completed a phase one single ascending dose study for ITI333 and plan to continue its development with neuroimaging studies to support dose selection for future studies, including a phase one multiple ascending dose study. We ended the first quarter with $773.2 million in cash, cash equivalents, and investment securities. In January, we received $433.7 million in net proceeds from our public offering of common stock. We have no debt. Across all our efforts, our goal remains the same. We're developing effective, innovative treatments to improve the lives of patients with neuropsychiatric and neurologic disorders. We're very proud of our team and the progress we've made towards our goals. We're encouraged by our performance to start off the year and look forward to bringing Keplida to increasing numbers of patients in the months ahead. I'll now turn the call over to Mark, who will provide additional details about our successful launch. Mark?