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..

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 of non-infectious diarrhea in adult patients with HIV being on antiretroviral therapy.

We have an essential product with Mytesi, where an essential business and we’ve anticipated topped [ph] up and taken steps to ensure that patients living with HIV who rely on Mytesi have uninterrupted access to this first of its kind of oral Class A prescription medicine. Mytesi as we said before is a products in the pipeline.

We're actively developing multiple potential follow-on pipeline indications focused on the GI indication, the most advanced being cancer therapy related diarrhea, which we refer to as CTD.

Other potential GI indications include irritable bowel syndrome, inflammatory bowel disease and Crohn's [ph] supportive care, functional diarrhea’s and pediatric rare [ph] gastrointestinal disease indication. There are five primary topics we'll be covering for today’s call, with five participating speakers from the company [indiscernible] speaker.

I'll begin with a status update regarding our ongoing business development efforts and provide an update on COVID-19 related activities.

Next I'll turn the discussion over to our Senior VP of Finance and Chief Accounting Officer, Carol Lizak, who will recap financials for 2019 and provide a comparison to 2018, after Carol we’ll introduce Ian Wendt, our Vice President of Commercial Strategy.

Ian, will discuss the multiple facets of Napo's enhanced market access strategy for Mytesi for the currently approved indications of HIV related death diarrhea, which is an initiative we’re quite excited about in recurring real time. Dr.

Steven King, our Chief of Ethnobotanical Science and also the project leader of our Cholera [ph] development program would provide information regarding recently approved funding support from the National Institute of Allergy and Infectious Diseases in support of the Cholera [ph] program moving forward.

He will also discuss the world that traditional medicine has played and potentially is currently playing in the fight against global pathogenic scourges [ph] And finally Dr.

Pravin Chaturvedi, our Chief Scientific Officer will speak to the regulatory developments related to Crofelemer for the potential CTD indications and potential pediatric rare disease indication for congenital diarrheal disorder in short bowel syndrome. Let's jump right in.

Looking forward, we believe 2020 has the potential to be a transformative year for Jaguar and Napo.

Our core goals for 2020 include initiating the pivotal trial in the second half of this year for Mytesi with CTD cancer therapy related diarrhea and completing the rollout of our enhanced market access strategy which is part of the company's larger strategy to support the health of HIV patients especially during this time of global crisis.

The majority of people living with HIV AIDS in the United States are older. As Tez Anderson, the founder of the non-profit organization Let's Kick ASS-AIDS Survivor Syndrome pointed out to me recently, its not our first pandemic Lisa.

The community is resilient as is Napo and we believe our enhanced patient access plan will help expand Mytesi access among HIV patients which we'll hear more about from Ian.

Key to our business model, this sustainable base commercial business effort supports the company's strategy to become a stable, cash flows positive business supported primarily by growth in Mytesi sales. Simultaneously and as I stated before we are confident that by mid 2020 we’ll forge a regional ex-U.S.

business development deal possibly more than one to bring in non dilutive dollars to support the pivotal trial initiation and or key clinical development activities, the pipeline follow on indication for Mytesi.

[indiscernible] at Napo is pipeline, pipeline, pipeline driven by business development, business development, business development for that pipeline mobilization. We have a remarkable risk mitigated product pipeline – a pipeline within a product, I can't say that enough, which contains multiple novel and important number one indications for Mytesi.

Let me remind you a drug product that is already approved by the FDA for chronic indications and therefore supported by a chronic safety package, GMP commercial manufacturing is in place for Mytesi and several of the follow on indications for Mytesi are strong Phase II and or proof of concept data.

The depth of our pipeline provides potential supportive care solutions for a large patient populations across multiple disease indications around the world and we believe this pipeline will fuel long term value creation for investors and provide non-dilutive funding opportunities for partner collaborations around the world.

Diarrhea related to cancer therapy continues to be the core focus of our pipeline development efforts. A significant portion of patients undergoing cancer treatment experience diarrhea.

Novel targeted cancer therapy agents such as epidermal factor receptor antibodies, herceptin for example and tyrosine kinase inhibitors herceptin – I am sorry, anyway, tyrosine kinase inhibitors, with or without standard chemotherapy agents may activate natural chloride secretion pathways in the gastrointestinal mucosa, potentially leading to secretory diarrhea.

According to data appearing in treatment guidelines with DID, which stands for chemotherapy induced diarrhea, a component of CTD and this was in the April 2004 issue [ph] of gastroenterology and endoscopy news. Diarrhea is the most common adverse events reported in chemotherapy patients.

Diarrhea in this patient population has the potential to cause dehydration, OTC [ph] and [indiscernible] agents which is the opioids Imodium, Loperamide causes constipation and lethargy [ph] and many cancer patients with diarrhea require drug holiday or dose reductions in their life saving cancer therapy.

Better management of diarrhea allows for better - it potentially allows for better compliance with the therapeutic dosing of targeted treatments for cancer. And as we've shown in relevant animal models, potentially leading better clinical outcomes for cancer patients and in particular for cancer patients on long term adjuvant therapy.

To continue in one mentioned, our efforts to make Mytesi available for supportive care related to COVID-19, we submitted an emergency use authorization request on March 21, 2020. The request was based on and accompanied by a letter of endorsement submitted to Dr.

Janet Woodcock, Director of the FDA Center for Drug Evaluation of Research and CC to FDA Commissioner Dr. Stephen Han, from a world leader in the field of infectious diseases and epidemiologist.

The letter of endorsement is based on information and publications with key opinion leaders has been reviewing real time which indicates that there is adequate information to document that diarrhea and other gastrointestinal symptoms are early symptoms of COVID-19 prior to the pulmonary symptoms.

This review of data also supports dependence that the virus can be shed from the blood [ph] and is less potentially transmissible via the people all group [ph] decreasing sequel volumes by changing the store [ph] consistency from watery deformed [indiscernible] key to the mechanism of action and the results of Mytesi would not only support patients here but could thus also reduce the contagion risk to health care providers.

As we've heard from the FDA they expect to get back to us in days with respect to this potential off label use of Mytesi. We’re so pleased to have the FDA's attention for a request to provide possible supports to COVID-19 patients and potentially reduce contagion among patients and healthcare workers.

And we're grateful to and proud of the many Napo stakeholders that have taken the initiative and perseverance in a time of chaos to play a meaningful role in seeking to address release during this pandemic. Back to our major core business, we’ll now move along to the 2019 financial result.

The company filed its 2019 10-K on Friday, April 3rd with the SEC, the 10-KL can of course be viewed on the SECs website and on the Investor Relations section of the Jaguar website.

I'll now turn the call over to Carol Lizak, Jaguar’s Senior Vice President and Chief Accounting Officer to review topline financial results for the year ended December 31st 2019.

Carol?.

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..

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 drugs for uninsured patients has increased from two times the Federal Poverty Limit to five times the Federal Poverty Limit, a 150% increase.

In the Mytesi co-pay benefit for commercially insured patients has an increased amount from of an annual maximum of $1200 to $600,000, which is a 400% increase. Most eligible patients will now pay no more than $25 dollars for their Mytesi prescription.

Additionally, patients can now use their co-pay cards if they refill Mytesi prescriptions earlier and every 30 days. Fast-start prescriptions will soon be available to provide immediate access to Mytesi for patients facing reimbursement challenges, and a bridge drug program will soon be available for patients who have a lapse in insurance coverage.

To support providers, patients with – the patients with access services from reimbursements in prior authorization support to appeals and patient assistance dispensing for Mytesi, Napo is working with Florida-based AssistRx to design and implement a comprehensive patient support services program.

AssistRx has extensive experience supporting HIV patients and has developed an industry leading technology platform called iAssist to streamline therapy initiation. Our new market access strategy is also designed to significantly increase the number of specialty pharmacy involved in Mytesi’s distribution.

Specialty pharmacies offer a high such patient engagement model to help ensure appropriate use of drugs of Mytesi in optimal patient outcomes. The fact that our expanded patient support program is launching during the COVID-19 pandemic should especially benefit Mytesi patients who may have lost jobs or health insurance during the crisis.

We are removing barriers for patients to access Mytesi and the changes we've instituted should help ensure patients can employ good social distancing practices while still obtaining their medication.

Diarrhea is a chronic, life-altering condition in HIV patients on ART and it's our goal to remove Mytesi access for all patients who need regardless of their income level, as well as for their provider, especially during this national crisis. That concludes my comments for today. Steve, I'll now turn the discussion over to you..

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 this drug candidate makes port efforts to receive a priority review voucher from the FDA for cholera indication. Early review vouchers are granted by the FDA to drug developers as an incentive to develop treatment for neglected diseases and rare pediatric diseases.

But many of you are no doubt aware, Napo’s mission dating back to company’s founding is to discover and develop novel safe and effective plant-based prescription medicines that can be possibly harvested to be urgent global healthcare needs.

For crofelemer, the active ingredient in Mytesi of our FDA approved non-opiate subscription drug indicated for the symptomatic disease of non-infectious diarrhea and of those patients living with HIV and anti-retroviral therapy was extracted and purified in the Amazon Rainforest tree Croton lechleri.

[indiscernible] has a rich history of the maximum use and business people in South America.. At present as a result of the COVID-19 pandemic there's a great deal of information that global media related to another plant based medicine one that changed the world a long time ago.

The medicine I'm referring to is Quinine, discovered originally by the petro [ph] people of Ecuador of Bolivia. We used the bulk of the Amazon increase and sona efficient [ph] out to treat, [indiscernible] inflammation and pain. To explore results [indiscernible] Quinine in the beginning of the 17th [ph] century.

Quinine [indiscernible] almost 400 years after effectiveness was first documented. Quinine and quinidine are still as a approved drug new secret cardiac disorders, digestive problems and muscle spasm. Quinidine [ph] came to the world as a royal treatment that allowed U.S.

nations to develop and explore acrossa the regions that have been devastated by uncontrolled malaria. The [indiscernible] derivatives of Quinine, activin and chloroquine were developed between 1931 and 1934 to prevent and treat malaria before and after World War II.

Chloroquine and another synthetic derivative hydroxychloroquine are also used today to treat rheumatoid arthritis and lupus [ph] There is now medical research focusing on the potential to use these recent derivative to Quinine to combat COVID-19.

It's not clear if these drugs will prove to be safe and or effective for COVID-19, but I believe it's worth remembering that the medical practice and discovery of new therapeutics has used methods of medical knowledge and disease people and an anticipated percent as part of the additional medicine.

In fact the interesting historical footnote in intertial reportedly once declared [indiscernible] more investment wise and mind than all the doctors in the empire, with so called [indiscernible] was Quinine.

I'm very proud of the fact that Mytesi also has its huge and traditional medicine and I'm proud that Mytesi as a pipeline and a product at terms recently employed by Lisa is being developed for multiple possible follow up indications.

With Napo's maturing commitment to developments and commercializing traditional current based medicine, we expect that it won't be another 100 years before they once again made aware of the reason of conserving and leveraging additional medical knowledge. Pravin, on to you..

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 refers to as Mass [ph] We are supporting our efforts to set some guidelines for the treatment and management of diarrhea cancer patient.

We are at all level sponsor for the Mass conference which was to be held in Spain at June this year. However it has been postponed for obvious reasons at this time. However, we will continue to work with the leadership team of Mass and provide the requisite support. While we all work through the challenges of the global pandemic.

For the pediatric clinical study in the orphan indication of short bowl syndrome, we prepared a dossier that support pre-IND discussion with the FDA. We’ve submitted it and we expect the FDA to revert to in approximately 30 days with their input on the pre-IND package.

This pre-IND treating document from Napo outlined the planned 30 [ph] clinical trial in short bowl syndrome and congenital diarrheal disorders, as well as the provide the rational for addressing diarrhea to reduce in additional requirements with children with either short bowl syndrome or congenital diarrheal disorders.

SBS and CTD, short bowel syndrome and congenital diarrheal disorders are much more prevalent in region as we believe, North Africa region, [indiscernible] region, where there are [indiscernible] and we are pleased to actually have support of the key opinion leaders in the regions of Mohammed Miqdady, from the Sheikh Khalifa Medical Center in Abu Dhabi, who's providing us with the leadership and guidance to conduct appropriate clinical studies in that region.

As I mentioned earlier, reduction of central and/or parental nutrional requirements to these children [indiscernible] congenital diarrheal disorders would improve both the quality of their life, as well as improve the onset survival.

Hence we are planning to substantially to improve pediatric clinical studies that would provide evidence of safety of Mytesi, as well as proof of efficacy [indiscernible] CTD patients. I will now pass the microphone back on to Lisa for her comments – closing comments. Thank you. Over to you, Lisa..

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..

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