Earnings Labs

Jaguar Health, Inc. (JAGX)

Q4 2019 Earnings Call· Mon, Apr 6, 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 impacts 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 subjects 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 assumption, 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 sections of the company's Form 10-K for the year ending December 31, 2019, which was filed April 3rd, 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, the company's supplement 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 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. At this time, it's my pleasure to turn the call over to Lisa Conte, Jaguar’s Health President and Chief Executive Officer. Lisa, the floor is yours.

Lisa Conte

Operator

Thank you. Thank you very much. And thank you all who are on the phone, very much for joining our call today. My name is Lisa Conte. I'm the Founder and CEO of Jaguar Health and are wholly-owned subsidiary Napo Pharmaceuticals. I may use the names Napo and Jaguar interchangeably throughout this call. First, I of course, understand [ph] my warmest wishes to everyone as we all navigate through these unprecedented times, we feel grateful to report that everyone at Jaguar - Jaguar and Napo are fine. We're all stoked at home doing this call remotely and as such we would not be taking Q&A today. Third of the company has been together for over 10 to 25 years. Three of us have been working together for over 30 years. That trusted familiarity and continuity allow us to work well together even when working remotely. Now we literally finished each other's doing [ph] the sentences. 30 years ago we were in the middle of another pandemic HIV AIDS and for Napo we were on a mission to find natural resource, plant-based medicines to meet urgent global health needs. We successfully brought Mytesi from a tree that we responsibly harvest in the Amazon Rainforest to the first and only oral plant-based prescription medicines approved under botanical guidance by the FDA. Today we find ourselves in the middle of the COVID-19 pandemic, working with the FDA to determine if Mytesi may be appropriate for emergency use authorization for symptomatic relief of diarrhea in patients with COVID-19. Nearly 38 million people with HIV globally and nearly 25 million people use antiretroviral therapy, based on data from [indiscernible] at the end of June 2019. As a reminder, Mytesi is a first in class anti-secretory agent, currently FDA approved for the indication of symptomatic relief…

Carol Lizak

Analyst

Thank you, Lisa. And thank you all for joining our call today. Key financial highlights for the year ended December 31, 2019 are as follows, 2019 Mytesi net sales were approximately $5.7 million, an increase of 36% in year-over-year. The Mytesi total prescription volume increased to 62% in the year 2019 and over the year 2018. The total operating expense for the year 2019 was $34.7 million as compared to $35.2 million for the year 2018, a 1%, or 500,000 decrease year-over-year. The decrease in total operating expenses was primarily due to the write-off of goodwill of $5.2 million in the year 2018, offset by an impairment of long-lived intangible assets of $4 million and 600,000 in the settlement of the royalty license agreement. That concludes my recap of high level financials for 2019. I’ll now hand the discussion over to our next speaker, Ian Wendt.

Ian Wendt

Analyst

Good morning, all. As Lisa stated in her opening comments and as the company announced last week, Napo is expanding NapoCares our patient support program for Mytesi, the company's FDA approved plant-based prescription drug indicated for the symptomatic relief of non-infectious diarrhea in adult patients living with HIV on anti-retroviral therapy. The changes to the NapoCares program are intended to increase by its healthy patient access, uptake and persistency. HIV Enteropathy, which has chronic diarrhea due to the direct or indirect effects of HIV on the GI tract is a problem for many HIV positive patients. Unlike certain antidiarrheal products that are only approved for acute use, Mytesi is a non-opiate derivative and has a very low risk of causing constipation. Mytesi is approved for chronic use and its unique mechanism of action helps ensure that diarrhea does not have to become the new normal for adult patients living with HIV on anti-retroviral therapy. Our field team's efforts remain focused primarily on physicians who are already writing my Mytesi prescriptions, on alleviating access issues faced by patients and on increasing the duration of Mytesi therapy in HIV patients with clinically appropriate, while also reducing Mytesi related cost burdens in non-government supported better payer channel. The expansions to the NapoCares program raises income limits on patients eligible for Napo’s uninsured free drug program, significantly increases co-pay support for commercially insured patients and allows the co-pay amounts to remain the same whether a patient fills a 30 day or 90 day prescription of Mytesi. These changes became effective on April 1st. A key component of the NapoCares market access program involves offering significantly expanded support for eligible patients to reduce out-of-pocket costs as a barrier to obtaining Mytesi in the US. The income limit for the patient assistance program which offers free…

Steven King

Analyst

Thank you, Ian and thanks to for those of you on the phone to make time to join us this morning. My name Steven King, I'm the Chief Sustainable Supply, Ethnobotanical Research and Intellectual Property officer for Jaguar and Napo. To begin, I'm happy to report that Napo was informed last week on April 1st, [indiscernible] received additional preclinical services from the National Institute of Allergy and Infectious Diseases to support the development of crofelemer, Napo’s growth products candidate for a cholera [ph] indication. Under NIAID's suite of preclinical services, NIAID-funded contractors will conduct toxicology testing for a 28-day rat study. NIAID is part of the National Institutes of Health. As previously announced, under NIAID’s suite of preclinical services these NIAID-funded contractors conducted toxicology testing for 70 day rat and dog study. Cholera is an acute diarrhoeal - caused by infection of intestine [ph] with the bacterium Vibrio cholerae. According to the Centers for Disease Control and Prevention of the US Department of Health and Human Services, an estimated 3 to 5 million cholera cases and more than 100,000 cholera related test each year around the world. Advanced [ph] due to dehydration knock the cholera affect death [ph] itself [indiscernible] occurs in the first 2 to 18 hours after infection. Lechlemer, which we also refer to as SB-300 has the same mechanism of acting as crofelemer and is less cost to produce. We have previously presented Phase II data on crofelemer for the treatment of devastating diarrhea in cholera patients from the renowned International Center on Disease and Research in Dhaka, Bangladesh. Under permitted, we plan to follow the same study design for Lechlemer following the same protocol, using the same principal investigator, and using the same clinical trial sites in Bangladesh for the development of Lechlemer. Additionally, we believed…

Pravin Chaturvedi

Analyst

Thank you, Steve. Good morning, everybody. Thanks for joining. My name is Pravin Chaturvedi and I am the Chair of Napo Scientific Advisory Board and also serve as the Chief Scientific Officer of Napo Pharmaceuticals [indiscernible] As Lisa mentioned earlier, Napo is planning the initiation of preclinical trials for Crofelemer in the second half of 2010, a pivotal trial for indication of prevention and treatment of cancer therapy related or BTP [ph] in adult cancer patient, a target indication we refer to as CTD and two pediatiric [indiscernible] orphan gastrointestinal short bowel syndrome, I also refer to FDA. For the adult CTD study there is an active discussion with the FDA and with key opinion leaders and we have received their input on the clinical trial and statistical analysis plan. We are revising the clinical protocol to accommodate their input and after getting the requisite documents including the statistical analysis plans based on consent and other requirement. We initiating the pivotal adult CTD trial under a new IND. The principal investigator for the CTD trial [indiscernible] in the United States. Our goal is to ensure that the protocols [indiscernible] the unmet medical need for the treatment of CTD. Combined with the practicality of patient enrolment and trial design, but we are also ensuring that satisfaction from both Napo Pharmaceuticals and the FDA agree on the endpoint that are relevant to crofelemer unique physiological mechanism of action. Our planned study for CTD's analogous with successful pivotal trial for Mytesi – and as a part of our risk mitigation strategy we intend to use the same formulation and dosing as the currently commercialized Mytesi. In addition to working with the key opinion leaders on clinical strategy and trial design, we've been coordinating with the Multinational Association of the Broad Cancer Care, also…

Lisa Conte

Operator

Thanks, Pravin. Thank you to all speakers and thank you to all the listeners. In closing, I'm proud to announce this past February the non-profit American Botanical Council has given the 2019 Varro E. Tyler Commercial Investment in Phytomedicinal Research Award to Napo in recognition of Napo’s ongoing commitment to the sustainable development and production of natural therapeutic preparation, we had a [indiscernible] their money for obvious reasons as well. Specifically this award acknowledges the successful development and approval of crofelemer, which is derived as Steve said, some of additional Croton lechleri tree in the Amazon Rainforest. The development in crofelemer has been the key mission of Napo’s four core team members for more than 30 years and we remain firmly committed to expanding the crofelemer access to all patients in need throughout the world. Previous recipients of this board include our partner Italian based in Dana, one of the world's largest producers of clinically-tested [ph] botanical extracts for the pharmaceutical market. As a reminder, Mytesi is the first and only oral plant-based prescription medicine drug approved under FDA’s botanical extracts guidance and there's no pathway by which the generic product can be developed for a drug approved under botanical guide. I'm extremely pleased with all our key achievements in 2019 and continue to be grateful for the ongoing support and dedication of our employees, stockholders and all of our stakeholders as we continue efforts in 2020 to grow sales, bring on more partners, address multiple possible follow on indicators of Mytesi and drive this company to breakeven and cash flow positive situation. I'm also very proud to be working with a team with high integrity and values which have been displayed privately very time this global crisis. I'll repeat the words of Ted's Anderson. This is not our first pandemic Lisa and we are grateful to be working together to make a difference in the lives of people living with chronic life altering GI conditions. As I said earlier, we believe 2020 has the potential to be a transformative year for Jaguar and Napo. With that, we conclude our comments. Thank you all once again for joining today’s call. Please be safe, be well and stay home. Thank you.

Operator

Operator

And that does conclude today's conference. Again, tank you for your participation.