Jaguar Health, Inc. (NASDAQ:JAGX) Q3 2023 Earnings Conference Call November 14, 2023 8:30 AM ET

Company Participants

Lisa Conte - President & CEO

Carol Lizak - CFO

Operator

Good morning. Before I turn the call over to management, I'd like to remind you that management may make forward-looking statements relating to such matters as Contenued growth prospects for the company, uncertainties regarding market acceptance of products, the impact of competitive products and pricing, industry trends, and product initiatives, including products in the development stage which may not achieve scientific objectives or meet stringent regulatory requirements. Forward-looking statements are subject to risk and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These statements are based on currently available information and management's current assumptions, expectations, and projections of future events. While management believes its assumptions, expectations, and projections are reasonable in view of currently available information, you are cautioned not to place undue reliance on these forward-looking statements. The company's actual results may differ materially from those discussed during this webcast for a variety of reasons, including those described in the forward-looking statements and Risk Factors sections of the company's Form 10-K for the year of 2022, which was filed March 24, 2023, and its other filings with the SEC, which are available on the Investor Relations section of Jaguar's website. Except as required by law, Jaguar undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events, or otherwise. Additionally, please note that the Company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon which Company management assesses and operates the business. These non-GAAP financial measures should not be viewed in isolation or as substitutes for GAAP net sales and GAAP net loss, and are not substitutes for or superior to measures of financial performance in conformity with GAAP.

Today's conference is being recorded. At this time, it's my pleasure to turn the call over to Lisa Conte, Jaguar Health's Founder, President and Chief Executive Officer. Lisa, the floor is yours.

Lisa Conte

Thank you very much. I'm glad we didn't miss that opportunity to hear the very important forward-looking statements. Thank you all for joining. My name is Lisa Conte, and following my comments this morning, Carol Lizak, our Chief Financial Officer, will provide a detailed recap of the key financial results for the third quarter of 2023. Although I will preempt Carol to say that we're pleased to report that net revenue increased 5% in the third quarter of 2023 versus the second quarter of 2023. However, this is a momentous time for Jaguar and hopefully a momentum time. The most important takeaway from today's webcast is regarding the potential opportunity to expand the current indication of our FDA-approved product Crofelemer, under the trade name Mytesi, from the current specialty indication of non-infectious diarrhea in adults living with HIV/AIDS on antiretroviral therapy, specialty is a very important indication. It was fast tracked priority reviewed by the FDA, though it's a relatively small indication in the United States. And we're looking to potentially expand it to the much more profound and frankly much larger neglected need for the preventative treatment of diarrhea in adult cancer patients with solid tumors receiving targeted therapy with or without standard chemotherapy. Topline results from our pivotal Phase 3 trial, referred to as the OnTarget trial, which is investigating safety and efficacy for this indication of Crofelemer, are expected to be out before Thanksgiving 2023, so literally around the corner. This trial is studying an indication we also refer to as preventative treatment of chemotherapy-induced overactive bowel. If you've ever heard the terms chemotherapy-induced nausea and vomiting, chemotherapy-induced pain and neuropathy, chemotherapy-induced overactive bowel, which includes symptoms such as unpredictable and/or chronic debilitating diarrhea, looser watery stools, and urgency.