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Jaguar Health, Inc. (JAGX)

Q2 2020 Earnings Call· Thu, Aug 13, 2020

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Transcript

Operator

Operator

Good day, and welcome to the Jaguar Health Investor Call. Today's conference is being recorded. 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 continued growth prospects for the company; uncertainties regarding market acceptance of products, the impact of competitive products and pricing, industry trends and product and technology initiatives, including products in the development stage, which may not achieve scientific objectives or meet stringent regulatory requirements. Forward-looking statements are subject to risks 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 about future events. While management believes that 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 in this call for a variety of reasons, including those described in the forward-looking statements and Risk Factors section of the company's Form 10-K for the year ending December 31, 2019, which was filed on April 3, 2020; 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 Health 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 gross sales, 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 a substitute for GAAP's net sales and GAAP net loss and are not substitutes for, or superior to, measures of financial performance in conformity with GAAP. At this time, it is my pleasure to turn the call over to Lisa Conte, Jaguar Health's President and Chief Executive Officer. Lisa, the floor is yours.

Lisa Conte

Management

Thank you, and thank you all who are on the phone very much for joining our call today. My name is Lisa Conte. I am the founder and CEO of Jaguar Health and our wholly owned subsidiary, Napo Pharmaceuticals. I may use Jaguar and Napo interchangeably. I want to start today's call by giving my heartfelt thanks to our dedicated team, many of whom have been working with me over the last 30 years, some now persevering with shelter-at-home with one goal in mind: providing responsibly and sustainably harvested plant-based prescription medicines to people in need around the world. I'm going to start with the key financial results for the second quarter of 2020. I am filled with gratitude and pride as the Jaguar-Napo team has adapted and thrived during the modified working environment of the pandemic with, for example, several tools and techniques that we've adopted to support education and expanded access to Mytesi, while our dedicated sales reps are, for the most part, sheltered at home. Mytesi net product revenue during the second quarter of 2020 was approximately $3.2 million compared with net sales during the first quarter of 2020 of approximately $830,000. Net sales for the second quarter of 2020 represented 378% of the first quarter of 2020 or an increase of $2.3 million quarter-over-quarter. Mytesi gross product revenue, this is a non-GAAP number, during the second quarter of 2020 was approximately $6.3 million compared with gross sales during the first quarter of 2020, which was approximately $1.3 million. Gross sales for the second quarter of 2020 represented 482% of the first quarter of 2020, or an increase of approximately $5 million quarter-over-quarter. In the second quarter of 2020, we sold 3,030 bottles of Mytesi, and in the second quarter of 2020, we sold 1,950 bottles, a…

Carol Lizak

Management

Yes. Thank you, Lisa, and thank you all for joining our call today. The key financial highlights for the quarter ended June 30, 2020, are as follows. Net sales during the second quarter of 2020 were approximately $3.2 million and $1.7 million in the second quarter of 2019. This second quarter 2020 result represents 186% of the same period in 2019, or an increase of $1.5 million quarter-over-quarter. Total Mytesi bottles sold for the second quarter of 2020 represented 104% of the bottles sold in the same period in 2019. The total operating expense for the second quarter of 2020 was approximately $11.6 million as compared to $12.3 million for the same period last year, a 6% or $700,000 decrease quarter-over-quarter (sic) [ year-over-year ]. The decrease in total operating expenses was due to a $4 million impairment charge in the second quarter of 2019 and none in the same period this year, an approximately $1 million decrease in cost of product revenue, research and development and sales and marketing expenses, offset by a warrant inducement expense of $3.7 million and an increase in general and administrative expense of $600,000. The net loss for the second quarter of 2020 was $9.2 million compared to a net loss of $16.7 million in the second quarter of 2019, a 45% or approximately $7.5 million decrease quarter-over-quarter. The decrease in net loss was due to the increase of Mytesi list price, a decrease in operating loss of $2.2 million, and interest expense was lower by $3.2 million. A $2.7 million loss on extinguishment of debt was recorded during the 3 months ended June 30, 2019, and none in the same period this year. That concludes my recap of high-level financials for the second quarter of 2020. I'll now hand the discussion over to our next speaker, Ian Wendt.

Ian Wendt

Management

Good morning all. The second quarter marked significant commercial achievements in financial terms, as described by Carol, by one of the most successful initiatives to acquire new patients and to increase time on therapy with the launch of the NapoCares patient support program. At Jaguar and Napo, we remain fully committed to expanding access to Mytesi to all patients in need with the goal of ensuring that no patient is denied access to Mytesi due to cost. The NapoCares initiative helps remove access barriers for patients regardless of their income or health insurance status. NapoCares has proven critical in the era of COVID to offset high out-of-pocket costs imposed by insurers, to provide free drug for the uninsured who cannot afford Mytesi, and to advocate on the behalf of patients with insurers who require prior authorizations prior to paying for a patient's medicine. In particular, the improvements that were made to the copay program showed significant increases in the number of months commercially insured patients stay on Mytesi, which aligns to our commercial imperative of increasing patient persistency. These services could not have been implemented at a more important time to help support patients' ability to easily start and stay on Mytesi once it has been prescribed by the provider. A field team has been delivering sales calls, educational programs and customer support virtually. While we look forward to returning to live sales interactions, we have effectively leveraged technology to stay connected with customers and drive our commercial outcomes. There have also been some interesting efficiencies realized for a small team of 9 reps, since they can now reach their customers across many states using Zoom versus having to fly or drive to each of these sales calls. As a result of these efforts, our commercial-payer patients have now increased from 45% in 2019 to 55% in quarter -- in the second quarter of 2020. This is a very important metric to understand the strength of Mytesi brand and has significantly supported our net sales results. That concludes my comments for today. I will now turn the discussion over to Dr. Chaturvedi to discuss crofelemer development activities.

Pravin Chaturvedi

Management

Thanks, Ian, and good morning to all. As Lisa mentioned, we now have an active IND for the evaluation of Mytesi, which is crofelemer 125-milligram delayed release tablets for the prophylaxis and symptomatic relief of diarrhea in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy. It is an important milestone for Mytesi, as the clinical study will evaluate the currently approved formulation of Mytesi at the same dosing regimen as used for the symptomatic relief of noninfectious diarrhea in adult HIV/AIDS patients receiving an antiretroviral therapy. Given the same formulation and dosing, we will be able to continue the -- to use the currently established infrastructure for manufacturing, testing and release of Mytesi. Furthermore, we'll be able to cross-reference our existing data for clinical pharmacology as well as nonclinical studies for the approved indication in HIV, which is a significant cost and time benefit for the development of Mytesi for cancer-related diarrhea. The unmet medical need for addressing diarrhea in cancer patients receiving therapy remains high as there are currently no physiologically acting antidiarrheal drugs that are approved for cancer therapy-related diarrhea. According to the Centers for Disease Control and Prevention, CDC, approximately 650,000 cancer patients in the U.S. receive chemotherapy in an outpatient oncology clinic each year. Diarrhea is a common adverse event seen with chemotherapy agents, typically used in breast and colon cancers. And in particular, in the more recently introduced therapeutic classes of epidermal growth factor receptor monoclonal antibodies or EGFR inhibitors as well as tyrosine kinase inhibitors or TKIs, which are often used in adjuvant or metastatic settings for the management of cancer as chronic therapy. For instance, diarrhea has been reported as one of the most common side effects with TKIs. Severe diarrhea has been reported in up to 81%…

Lisa Conte

Management

Thank you, Pravin. Thank you, Ian. Thank you, Carol. Looking ahead to this fall, I'm excited to announce that Jaguar is planning to host a virtual CTD, cancer therapy diarrhea, focused disease education event for investors and business development contacts that we're calling Diarrhea Dialogues. This will be virtual. Leading key opinion leader oncologists, patient advocates and supportive care experts will address the importance of supportive care for people experiencing chronic lower GI tract distress, specifically with regard to debilitating diarrhea experienced as a result of cancer therapy. We hope all investors and business development contacts taking part in today's call can join for this event. And we'll be issuing further details regarding the event, along with information about how to register, to participate as we get closer to the October 20 date. So save the date, please. At Jaguar and Napo, we remain committed to our dual strategy of forging regional ex U.S. business development deals to bring in nondilutive dollars to fund efforts to move key potential Mytesi pipeline indications to clinical trials to support our goal of expanding crofelemer access to all patients in need throughout the world, where we simultaneously work to become a stable, cash flow positive business, supported primarily by growth in Mytesi sales for its approved indications. While the pandemic and travel restrictions have elongated those business discussions, there's no doubt of the need for Mytesi globally, and we remain confident that collaborations will be forged. Transitioning over to the legacy animal side of Jaguar's business for a moment, I'd like to comment regarding our efforts to gain FDA approval to market Canalevia, our oral plant-based prescription drug candidate for the treatment of cancer-induced diarrhea, referred to as CID, in dogs. As we announced last month, Jaguar has submitted to the FDA's Center…

Operator

Operator

This concludes today's conference call. Thank you all for your participation. You may now disconnect.