Good day and welcome to the Jaguar Health Investor Conference 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 current 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 on 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 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 reoccurring EBITDA. Jaguar believes the disclosure items on these non-GAAP measures provide investors with additional information that reflects the basis upon which the company's management assesses and operates the business. These non-GAAP financial measures should not be viewed in isolation or as subsidies for GAAP net sales and GAAP net loss and are not substitutes for or superior to measures of financial performance and conformity with GAAP. And now at this time, it's my pleasure to turn the call over to Lisa Conte, Jaguar Health's President and Chief Executive Officer. Lisa, the floor is now yours.

Terrific. Thank you. Thank you very much and thank you all for joining our call today. My name is Lisa Conte. I'm the Founder and CEO of Jaguar Health and our wholly owned subsidiary Napo Pharmaceuticals. I may use those names interchangeably Jaguar and Napo. As always, I want to begin today's call by giving my heartfelt thanks to our dedicated team, many of whom who have been working with me over many years with one goal in mind, providing responsible 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 third quarter of 2020. And I am filled with gratitude and pride again this quarter, as the Jaguar Napo team has been able to maintain the substantial growth achieved in the second quarter of 2020, with the initiation of our patient access program, NapoCares, as we and all in the United States and beyond have endured the modified working environment of the continued pandemic. Mytesi net sales for the third quarter of 2020 were approximately $2.8 million. Third quarter 2019 sales were $1 million. The third quarter 2020 results represents approximately 280% of the same period in 2019 or an increase of $1.8 million quarter-over-quarter. Mytesi gross sales for the third quarter of 2020 were approximately $6.3 million. Third quarter 2019 sales were approximately $1 million. This Q3, 2020, result represents approximately 332% of the same period in 2019 or an increase of $4.4 million quarter-over-quarter. The sales increase was accompanied by a reduction in cost of product revenue. Cost of product revenue in the third quarter of 2020 was 28% compared with the cost of product revenue of 97% in the third quarter of 2019. This reduction was primarily due to improved management of…

Thank you, Lisa, and thank you all for joining our call today. The key financial highlights for the quarter ended September 30, 2020 are as follows. Mytesi net sales during the third quarter of 2020 were approximately $2.8 million and $1 million in the third quarter of 2019. This third quarter of 2020 result represents approximately 280% of the same period in 2019 or an increase of $1.8 million quarter-over-quarter. Mytesi gross sales during the third quarter of 2020 were approximately $6.3 million and $1.9 million in the third quarter of 2019. This third quarter 2020 result represents approximately 332% of the same period in 2019 or an increase of $4.4 million quarter-over-quarter. The increase in sales coincided with enhancements to Napo's Mytesi patient access program known as NapoCares in the beginning of April 2020. Total Mytesi prescription volume which is the combination of new prescriptions and refills has maintained an essentially consistent level of activity in the third quarter of 2020 over the third quarter of 2019 according to data from IQVIA, a provider of life sciences industry analytics. The total operating expense for the third quarter of 2020 was approximately $8.1 million as compared to $7.7 million for the same period last year, a 5.8% or $0.4 million increase quarter-over-quarter. The increase in total operating expenses was due to an increase in R&D expense by $0.2 million, general and administrative expense of $1.2 million, primarily due to the net impact of a one-time trial delay fee related to the patent purchase and license-back arrangement with Atlas Sciences LLC for Napo's NP-500 drug candidate. The company made the decision not to initiate the Phase II study and terminated its performance obligation. These were offset by a decrease of $0.2 million in cost of revenues, $0.2 million decrease in sales and marketing expenses, and a decrease of settlement of the Tempesta royalty license agreement of $0.6 million in the third quarter of 2019. The net loss for the third quarter of 2020 was $7.9 million compared to the net loss of $7.6 million in the third quarter of 2019, a 4% or approximately $0.3 million increase over -- quarter-over-quarter. The increase in net loss was primarily due to an increase in the fair value of financial instruments of $2.9 million, offset by a decrease in interest expense of $0.8 million, a decrease in loss from operations of $1.4 million, a decrease of other income of $0.1 million, and a decrease of $0.3 million of loss of extinguishment of debt. That concludes my recap of high-level financials for the third quarter of 2020. I will now hand the discussion over to our next speaker Ian Wendt.

Thanks Carol and good morning all. As a reminder, we launched our NapoCares patient access program in the second quarter of 2020, unknown to us that we'd be launching in the midst of the first COVID wave and shelter-in-place. As the pandemic continues to dominate daily life, the timing of the NapoCares' launch has proven to be invaluable and critical to helping Mytesi patients easily start and stay on the Mytesi medication given the COVID-related challenges patients face in accessing care, filling prescriptions and instability of employment, and insurance status. Mytesi is indicated for a chronic condition so adherence and patient persistency are critical success metrics for both patients and our commercial business. As part of our market access strategy, we are expanding our efforts by now increasingly distributing Mytesi through specialty pharmacy channels due to their capabilities to help support patient success on chronic medications. The first step in this initiative is our agreement with a large national specialty pharmacy chain which launched on October 5th, 2020. This chain will now support all of their Mytesi patients through their specialty services which includes mail order of medications, prior authorization and appeal support, adherence reminder calls, and triaging patients to the NapoCares patient hub. This program represents a significant improvement in support for Mytesi patients to help them more easily start and stay on their medication. A 2020 AMA survey showed that 91% of physician respondents stated that prior authorizations or PAs resulted in a treatment delay and 86% of respondents stated that PA burdens have increased over the last five years. Perhaps most concerning is that 74% of physicians surveyed stated that a PA can at least sometimes lead to treatment abandonment. NapoCares is a key initiative to help support patient access to Mytesi. And our specialty pharmacy services are positioned to help patients successfully navigate prior authorization requirements and gain access to Mytesi. In addition to the suite of patient support services, the specialty pharmacies will provide, this will also reduce our distribution fees by an estimated 45% from approximately 11% of WAC to now 6% of WAC significantly improving our gross to net revenue performance. We are also excited to announce the addition earlier this month of Andre Teixeira, a doctor of veterinary medicine to our commercial team as Senior Director of Animal Health. Andre brings an important blend of clinical, academic and commercial experience to help build and lead our animal health business. This includes the Neonorm line of products, Equilevia and the pending new animal drug applications supporting registration of Canalevia for sale next year for chemotherapy-induced diarrhea and exercise-induced diarrhea. Andre's role represents an important investment in the Jaguar animal health division to develop another revenue stream for the commercial organization. That concludes my comments for today. I will now turn the discussion over to Dr. Chaturvedi to discuss crofelemer development activities.

Thank you Ian and good morning to all. As Lisa mentioned and as announced last month, Napo has initiated its pivotal Phase III multicenter clinical trial for crofelemer Mytesi for the prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. We refer internally to this proposed indication as CTD standing for cancer therapy-related diarrhea. The initiation of this pivotal multicenter randomized double-blind placebo-controlled Phase III trial is a key milestone for Mytesi as we evaluate its potential to prevent and/or mitigate the intensity and severity of diarrhea experienced by adult cancer patients receiving targeted cancer therapy regimens which may also include combinations with standard chemotherapy regimens. The protocol and endpoint definitions for the study were discussed and agreed to with the FDA after collaborative discussions based on the success of crofelemer's pivotal trial that is supporting its currently approved indication of Mytesi for the symptomatic relief of HIV-related diarrhea. The CTD trial is a 24-week study comprised of two 12-week stages which will evaluate the currently approved formulation of Mytesi at the same dosing regimen that is used for the symptomatic relief of noninfectious area in adult HIV patients receiving an antiretroviral therapy. Crofelemer or placebo treatment will start concurrently with targeted cancer therapy regimens. The primary endpoint will be assessed at the end of the initial 12-week double-blind placebo-controlled period referred to as stage 1. After completing the stage one treatment phase the subjects will have the option to remain on their assigned treatment arm and re-consent to enter the second 12-week stage two extension phase. The assessment of reduction of diarrhea will be measured by the comparison of average number of weekly loose or watery stools for the stage one treatment period for the placebo or crofelemer arms. Multiple oncology clinics are participating in this study. And…

Thank you, Pravin, and good morning, everyone. As Lisa stated, Canalevia is crofelemer for two proposed animal use indications. Specifically, Canalevia is Jaguar's oral plant-based prescription drug candidate for the treatment of chemotherapy-induced diarrhea in dogs or CID as well as exercise-induced diarrhea or EID in dogs. Jaguar is in the process of seeking conditional approval of Canalevia for CID and EID in dogs, under the Minor Use Minor Species Animal Health Act of 2004 typically referred to as MUMS or M-U-M-S which is modeled on the orphan drug designation for human drug development. To obtain approval of an animal health prescription drug product in contrast to the filing of a new drug application for a human indication the company must submit major technical sections that govern chemistry manufacturing and control data, environmental impact data, and target animal safety data. This part of the process is identical for either a MUMS or full approval of an animal health drug. In addition for the MUMS' pathway, a chemical section that demonstrates reasonable expectation of effectiveness for the new drug must also be submitted. Each of these four major technical sections requires a six-month review, at which point, if the FDA has deemed all four sections complete, administratively the new animal drug application is filed, which then leads to approval to sell the product two months later. We plan to submit the new animal drug application or the NADA in the second quarter of next year for Canalevia for both the CID and EID indications. Once the NADA is accepted for filing, the statutory review period is 60 days and Canalevia will be conditionally approved for both the CID and EID indications in Q3 of next year. This conditional approval allows for commercialization of the product, while the sponsor continues to collect…

Thank you, Mike and thanks to all of you for joining us this morning. As announced this past September, Jaguar has launched the Mental Health Entheogen Therapeutics Initiative, a program we're referring to as ETI that aims to discover and develop groundbreaking novel, natural medicines derived from psychoactive plants for treatment of mood disorders, neurodegenerative diseases, addiction as well as schizophrenia and other mental health conditions that present psychotic symptoms. Core members of the Jaguar Napo team began searching for new drug candidates in 1989 by working with indigenous healers in rainforest areas around the world. In the Amazon basin traditional healers taught our research teams about a diversity of plants used to treat a number of diseases. And today, we have a library of approximately 2300 plants with medicinal properties including Croton lechleri tree the source of crofelemer the active ingredient in Mytesi, which is the first and only natural fair trade plant-based oral drug approved under FDA botanical guidance. The ETI program will initially focus on plants contained in this proprietary library as well as an initial selection of plant leads generated by our scientific strategy team. Our newly appointed scientific strategy team for ETI consists of leading and globally renowned ethnobotanists, physicians, pharmacologists as well as experts in the fields of natural product chemistry and neuropharmacology. We believe the wealth of expertise experience and commitment of our team, which is comprised of multiple members of the original scientific strategy team that contributed to the development of Napo's plant library, will play an instrumental role in advancing our shared goal of identifying plants in our library that may have the potential to treat specific mental health conditions. I'm excited to report that the ETI scientific strategy team is gearing up for the first planning meeting involving the whole…

So, with this, thanks very much, Steve and thank you Mike, Pravin, Ian, and Carol for participating. Okay. Looking back to the last month, I'm very pleased with the virtual CTD-focused diarrhea dialogue, a disease education event Jaguar hosted on October 20. This was just for investors and business development contacts. This was really a terrific event and focused on leading key opinion leader oncologists, patients, advocates and supportive care, experts, addressing the importance of supportive care for people experiencing chronic lower GI tract -- specifically with regard to debilitating diarrhea experienced as a result of cancer therapy. And we look forward to hosting additional diarrhea dialogue events for investors and business development content in the future. We set up an online form for investors who would like to request access to view the full video replay a 90-minute event. And to view the form, please visit tinyurl.com/jaguarwebinar or you can find it on our website. At Jaguar Napo, we remain committed to our dual strategy of forging regional ex-U.S. business development deals to bring in non-dilutive dollars to fund the efforts to move key potential crofelemer pipeline indications to clinical trials, where we simultaneously are working to become a sustainable commercial business, supported primarily by the growth that we're seeing in Mytesi sales for the current approved indication. While the pandemic and travel restrictions have elongated those business discussions, there's no doubt of the need for Mytesi globally and we continue to be confident that collaborations will be forged. I'm happy to report that the employee headcount of both Jaguar and Napo has remained stable throughout the course of the COVID crisis. And Napo's national team of highly experienced HIV sales professionals, remain fully in place. The depth of our pipeline provides potential supportive care solutions for large patient…

Yeah Lisa, we have one question from Sam Sali at Reeds [ph]. What is your plan to regain the $1 minimum price before December 23, 2020 to comply with NASDAQ?

Great. Thank you. And thank you for the question. As I mentioned just a short moment ago, it's a really challenging environment in the micro-cap world to get value recognition. Our plan as always is to continue to build value, continue to focus on sales of Mytesi, to continue to progress the pipeline to follow indications, to continue our business development conversations to bring in meaningful non-dilutive deals. We have no plan to do any dilutive financings no structured financing. That's the best we can do to support the value of the company. We trade at a below the low-end of company value to net sales, if we look at comparable companies in the industry. If that doesn't get us over $1 in the time frame that we need to be there. And I believe it's 10 days that we need to trade over $1, we have filed for a shareholder approval to allow us to do a necessary reverse split to get us there, as we are committed to remain listed on NASDAQ which is very important for the goal of getting value recognition in the company. Are there any other questions, Peter?

That's it for that today, Lisa.

Okay, terrific, all right. Well thank you all, who have joined this call. Thank you all for your interest in Napo, Jaguar, Mytesi, crofelemer. Thank you to the company and the participants on this call. And we are going to get back to work, but that's the most important thing that we can do right now.

Thank you. That does conclude today's conference. Thank you for your participation.