Tricida Inc (NASDAQ:TCDA) Q3 2018 Earnings Conference Call Transcript

Nov 08, 2018 • 05:00 pm ET

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Tricida Inc (NASDAQ:TCDA) Q3 2018 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Good day, ladies and gentleman, thank you for standing by. And welcome to Tricida Third Quarter 2018 Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded. At this time, I would like to turn the conference call over to Jackie Cossmon. You may begin.

Executive
Jackie Cossmon

Thank you, Olivia. Good afternoon, and thank you for joining the Tricida third quarter financial results conference call. In today's call, Gerrit Klaerner, our CEO, President and Founder will discuss our recent achievements, our future plans for the development of TRC101, and our prelaunch disease awareness and commercial spending initiative. Jeff Parker, our CFO will then speak to our financial results for the quarter and provide a brief overview of our financial outlook. We will then open the call for questions. (Forward-looking Cautionary Statements) At this time, I'll turn the call over to Gerrit.

Executive
Gerrit Klaerner

Thank you, Jackie, and thank you all for joining us today. We've made significant progress since our last quarterly conference call, and I'm pleased to update you today on major initiatives that include the upcoming submission of NDA under the Accelerated Approval Program in the second half of 2019, and our successful prelaunch activities for TRC101, including the start of our disease awareness campaign at the 2018 American Society of Nephrology meeting 2 weeks ago.

As many of you know, TRC101 is a non-absorbed once-daily orally dosed polymer designed to treat metabolic acidosis and thereby, potentially slow the progression of CKD. TRC101 works by binding and removing hydrochloric acid from the GI tract and have been shown in clinical trials to safely and effectively increase serum bicarb levels in patients with metabolic acidosis.

With our NDA submission planned for the second half of 2019, we're now engaged in number of activities, including the launch of our non-branded disease awareness campaign and additional analyses related to both, the health economics and payer landscape for TRC101.

Let me now review the key elements of our initial disease awareness campaign, which received strongly positive reception at the ASN meeting. The educational elements of this campaign included a video discussing the link between metabolic acidosis and CKD progression as well as our new mobile app called Neph+.

Our disease awareness video features three prominent nephrologists, Dr. Bushinsky, Wesson and Tangri and provides the company as purview of the clear link between metabolic acidosis and the progression of CKD. This nine minute video is also now available in our new disease awareness website, metabolicacidosisinsight.com.

Our innovative new mobile app Neph+ contains a patient education tool, designed to help nephrologists quantify an individual CKD patient's risk of progression to end-stage renal disease. It uses the eight variable kidney failure risk equations to quantify how a change in a patient's serum bicarb levels among other variables, such as age and eGFR can effect progression to ESRD. The app also features commonly used nephrology equations and a summary of key KDIGO guideline recommendations for the care of patients with CKD. The Neph+ can be downloaded from the