Intra-Cellular Therapies Inc.

Good day, and thank you for standing by. Welcome to the Intracellular Therapies 3Q 2024 Earnings 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 the session, you will need to press star 11 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the call over to Juan Sanchez, Head of Investor Relations. Please go ahead.

Good morning, and thank you all for joining us on our third quarter 2024 earnings call. Joining me on the call today are Dr. Sharon Mates, Chairman and Chief Executive Officer, Mark Newman, Chief Commercial Officer, Dr. Suresh Dorgan, Chief Medical Officer, and Sanjeev Narula, Chief Financial Officer. A slide deck to complement today's call is available under the Investors Events section of our corporate website. During today's call, we will be making certain forward-looking statements. These forward-looking statements are based on current information, assumptions, and expectations. The statements 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. Your caution not to pay on your reliance on these forward-looking statements. These statements are made only as of the day of this conference call, and the company disclaims any obligation to update such statements. I will now turn the call over to Sharon.

Thanks, Juan. Good morning, and welcome to our third quarter earnings call. We are pleased to share our Q3 results and to describe the exciting progress we have made across the company. Keplita's growth trajectory continues to reflect a compelling product profile and our successful commercial execution with net sales of $175.2 million in the third quarter, representing a 39% increase over the third quarter of 2023. Based on this continued strong performance, we are raising our 2024 full year net sales guidance range to $665 million to $685 million. We look forward to building on our positive momentum for the rest of 2024 and beyond. In addition, we continue to advance our broad pipeline, and we are on track to submit our supplemental NDA for the Adjunctive Treatment of Major Depressive Disorder, or MDD, this quarter. Looking at the big picture, our objective has always been to help the greatest number of patients. We believe that the recent unprecedented efficacy and safety data for Keplida in our MVD phase three studies profoundly expands the impact Keplida will have in the treatment of mood disorders. As we approach this major MVD approval milestone, we wanted to give you our perspective on the tremendous market opportunity that we see for Keplida across the mood disorder spectrum and provide the rationale for our confidence. First, as I noted, Keplitis efficacy results in studies 501 and 502 for the adjunctive treatment of MDD are truly exceptional. This efficacy was confirmed in both studies, not only by the primary endpoint, the MAGIS total score, but also by the strong results in the clinician-rated CGIS scale and the patient-reported QIDS scale. This data further builds on the consistently strong efficacy data we have seen in our pivotal studies throughout our Kaplida development programs. Kaplida's robust efficacy is complemented with a favorable safety and tolerability profile, including a favorable metabolic weight and movement disorder profile. Metabolic disturbances, weight gain, and motor adverse events are major reasons why patients discontinue their treatment and often result in poor clinical outcomes. Another important feature of Keplida is its convenient dosing. Keplida is dosed once a day with no need for titration, with or without food, making it an attractive option for prescribers and patients. These are important attributes that become more critical as the medicine is used by broader patient populations. With this compelling profile, we are excited about Keplida's potential for the treatment of MDD, a large market with unmet medical needs. There are over 21 million patients with MDD, and current antidepressant therapies do not adequately address depressive symptoms in more than half the patients currently using them. There are few drugs approved for the adjunctive treatment of MDD, and there is still a significant unmet need for efficacious, safe, and well-tolerated medicines for these patients. As a result, we believe Keplida is well-positioned to become a drug of choice across the spectrum of major mood disorders. Starting with bipolar depression, Keplida has the broadest label in this indication, which includes bipolar I and bipolar II patients, and as monotherapy and as adjunctive therapy. In patients with mixed features and anxious distress, difficult-to-treat patient phenotypes, we have also reported robust positive clinical results. The potential addition of the adjunctive MDD indication not only adds a large patient population that can benefit from Keplida, but also gives prescribers additional confidence about the efficacy, safety, and tolerability of the drug across multiple patient populations. In our view, this positions Keplida as a top-of-mind choice for prescribers when treating a broad spectrum of patients, including patients with a diagnosis of bipolar I or bipolar II disorder or MDD. We've demonstrated our commercial expertise and have the financial resources we anticipate will be necessary to maximize Keplida's full potential. Taking all this together, we believe Keplida represents at least a $5 billion opportunity within the next 10 years. This reflects our expectation that Keplida will become a leading treatment across the spectrum of mood disorders and is primarily driven by contributions from bipolar depression and MDD, and to a lesser extent, schizophrenia. In addition to Keplida, we have a very rich pipeline, which includes additional Lumatepolone programs, as well as other novel programs. This will result in significant clinical milestones in the near and medium term. In terms of our Lumateprone long-acting injectable program, we commenced clinical conduct in our Phase I single ACE ending dose study, evaluating four different formulations. Our objective is to develop formulations with treatment durations of one month or longer, and over the next year, we will be prioritizing the formulations with the best profile as we proceed with this Phase I study. Let me now touch on our ITI1284 development programs, which we are very excited about. Patient enrollment is ongoing in our phase two clinical trial evaluating 1284 in patients with generalized anxiety disorder, or GAD, as an adjunctive therapy to generalized anxiety medications. We believe GAD represents at least a $1 billion opportunity for ITI1284. Currently, there are only five drugs approved for the treatment of GAD and only as a monotherapy. Anxiety prevalence and severity is on the rise, and recent reports suggest a prevalence of 20 million patients in the U.S. with 13 million patients being treated. About half of patients who receive treatment do not respond adequately to initial therapy. If approved, ITI-1284 would represent a new mechanism of action in the treatment of GAD and be the only drug approved for patients who have failed prior medications. We believe ITI-1284 is well-suited for this patient population and may offer an effective, safe, and well-tolerated treatment. Patient enrollment is ongoing in our ITI-1284 Phase II clinical study evaluating patients with psychosis associated with Alzheimer's disease. We are pleased to announce that we recently commenced patient enrollment in our phase two program in patients with agitation and Alzheimer's disease. All of our ongoing phase two studies with ITI1284 are large and designed as potential registration studies. Continuing with our pipeline, our Lenris-Poten phase two clinical trial in Parkinson's disease is progressing and we expect to complete this study by the end of 2025. ITI1020, our second molecule in our PDE1 platform, is being developed for certain cancers and cancer-related comorbidities. ITI1020 is currently advancing through a phase one single ascending dose study. Lastly, we are very excited about our 1500 program, exemplified by ITI1549, a non-hucinogenic neuroplastogen. We believe that ITI 1549 holds great promise as a treatment of mood, anxiety, and other disorders. ITI 1549 may offer a safe, effective medicine with a novel mechanism of action that can be conveniently administered without the risks associated with psychedelic hallucinogens. Earlier this year, at the Society of Biological Psychiatry annual meeting and the recent Society for Neuroscience meeting, We presented results from our clinical work showing that ITI1549 is non-hallucinogenic, provides improved social interactions, reverses anhedonia, and decreases anxiety-like behaviors in animal models. Preclinically, ITI1549 has also been shown to enhance neuroplasticity by stimulating the mTOR signaling pathway in the prefrontal cortex and to increase neurite growth and complexity. ITI 1549 is completing IND enabling studies and expected to enter human testing in 2025. In summary, we are very excited about our bright future. We are confident in our ability to capitalize on the substantial growth opportunities ahead. We have experienced high performing teams and we are in a strong financial position. I am proud of our accomplishments and look forward to building on this success. I'll now turn the call over to Mark to provide details on Kaplita's performance and commercial plans. Mark?