Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) Q3 2019 Earnings Conference Call - Final Transcript

Nov 05, 2019 • 08:30 am ET


Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) Q3 2019 Earnings Conference Call - Final Transcript


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Good morning, ladies and gentlemen. And welcome to the Intra-Cellular Therapies Third Quarter ended September 30, 2019 Financial Results Conference Call. At this time, all participant lines are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions]

As a reminder, today's conference call is being recorded. I'd now like to turn the conference call over to your host, Dr. Juan Sanchez, Vice President, Corporate Communications and Investor Relations. Please go ahead, sir.

Juan Sanchez

Thank you, operator. Good morning, and thank you all for joining us for today's conference call. Our earnings press release providing a corporate update and details of the company's financial results for the third quarter ended September 30, 2019 crossed the wire a short time ago, and is available on our website at

Joining me on the call today are, Dr. Sharon Mates, Chairman and Chief Executive Officer; Dr. Andrew Satlin, Executive Vice President and Chief Medical Officer; Mark Neumann, Executive Vice President and Chief Commercial Officer; Dr. Kimberly Vanover, Senior Vice President of Early Stage Clinical Development and Translational Medicine; Larry Hineline, Senior Vice President and Chief Financial Officer; and Michael Halstead, Executive Vice President and General Counsel.

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 utilization 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, our ongoing NDA review process with the FDA for lumateperone, future research and development, our plans regarding the commercialization of lumateperone, 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 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 undue reliance on these forward-looking statements and the company disclaims any obligation to update such statements.

I will now turn the call over to Sharon.

Sharon Mates

Thanks, Juan. Good morning, everyone. We are now within two months of the potential approval of lumateperone for the treatment of schizophrenia with a PDUFA action date of December 27th of this year. These are very exciting and transformative times for our company. As such, on today's call, we will be updating you on progress made across the company with particular emphasis on our lumateperone programs and our preparations towards commercialization.

Mark Neumann, our Chief Commercial Officer will elaborate on our commercial activities, and Andy Satlin, our Chief Medical Officer, will provide an overview of our clinical development programs. Lastly, Larry Hineline, our Chief Financial Officer, will review our financial results, and we will open up the line