Jaguar Health, Inc.
Q3 2020 Earnings Call Transcript

Published: 16 Nov 2020

[Operator:]

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.

[Lisa Conte:]

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.

[Carol Lizak:]

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.

[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.

[Pravin Chaturvedi:]

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 the study is led by our national principal investigator Dr. Pablo Okhuysen who is Professor of Medicine at MD Anderson Cancer Center. According to the Centers for Disease Control and Prevention approximately 650,000 cancer patients in the United States receive chemotherapy in an outpatient oncology clinic each year. Diarrhea is a common adverse event seen with chemotherapy agents typically used for solid tumors such as breast and colon and in particular more recently induced -- introduced top therapeutic classes of epidermal growth factor receptor inhibitors such as EGFR inhibitors and tyrosine kinase inhibitors known as TKIs, so the CDK four and six inhibitors are often used in adjuvant or metastatic settings for the management of chronic diarrhea in cancer patients. Availability of new therapies to address diarrhea in cancer patients receiving targeted therapy with or without standard chemotherapy will likely result in improved tolerability of the cancer regimens at their appropriate approved dosing levels. This would potentially reduce the need for cancer drug dose reductions, drug holidays and/or discontinuations, potentially leading to improved cancer therapy adherence and outcomes. A novel physiologically acting antidiarrheal drug Mytesi thus holds promise for the treatment of secretory diarrhea in cancer patients. In addition to Napo's ongoing Phase III clinical trial, there are some ongoing investigator-initiated studies to evaluate the effects of crofelemer in addressing functional or chronic idiopathic diarrhea, which may also include some IBS patients. A study at The University of Texas in Houston was recently initiated and patients are being screened and enrolled in this trial, although the trial has been affected by restrictions due to COVID-19. Another exploratory trial for functional diarrhea has been initiated at the Beth Israel Deaconess Medical Center, a Harvard medical school institution in Boston. This study will have a four-week double-blind placebo-controlled period followed by another four weeks of open-label treatment period for eligible patients with functional diarrhea. The study is expected to initiate enrollment of patients next month. In addition to these functional diarrhea studies, the investigator-initiated trial in metastatic HER2-positive breast cancer patients at Georgetown University Medical Center is nearing completion of its treatment phase. Napo is also developing a new liquid formulation that will allow the initiation of clinical studies in pediatric patients that have congenital diarrheal disorders that require feeding tubes and total parenteral nutritional support to survive. Napo is in active discussions with clinicians and regulatory experts about this orphan and rare disease population, and is evaluating both United States and Middle Eastern clinical trial sites the latter where the prevalence of these patients is in higher numbers and is developing an appropriate clinical development plan to support our goal of expediting availability of crofelemer to this patient population to address their severe diarrhea. In summary, Napo has an ongoing Phase III clinical trial for crofelemer for cancer therapy-related diarrhea in adult solid tumor patients, as well as investigator-initiated studies for the treatment of functional and pediatric diarrhea in adults with crofelemer. Napo is also developing an appropriate pediatric liquid formulation to support studies in children with congenital diarrheal disorders. I will now turn the discussion over to my colleague Dr. Michael Guy. Michael?

[Michael Guy:]

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 the substantial evidence of effectiveness that is required for full approval. A sponsor that gains conditional approval for a MUMS designated drug receives seven years of marketing exclusivity. According to current estimates, more than 230,000 dogs in the U.S. receive chemotherapy treatment for various cancers each year and roughly one in four, more than 50,000 dogs are estimated to experience diarrhea as a side effect of this treatment. There is currently no FDA-approved anti-secretory prescription product to manage this type of debilitating diarrhea in dogs, which is not only a health and comfort issue for the dog, but also impacts dog owners' peace of mind as well as their home and living environment. Since Jaguar's July 2017 merger with Napo, Napo's human portfolio has been and continues to be our core focus. Our work to develop crofelemer for dogs suffering from debilitating diarrhea provides a helpful model for human medical needs. The site of mechanism of action on crofelemer is highly conserved not only in dogs, but across all mammals. It's important to note that almost all cancer treatment agents provided to dogs are human drugs. And these agents and mechanisms of action often have meaningful rates of diarrhea in both humans and dogs. The cost of cancer therapy in dogs can be $10,000 or more depending on the size of the dog, the extended chemotherapy treatment and the adjunct use of other treatment modalities such as surgery or radiation. I'd like to add my welcome back to Dr. Andre Teixeira as we prepare for commercialization of the prescription drug products for dogs and an overall greater attention to our burgeoning animal health program. That concludes my comments. I will now turn the discussion over to Dr. Steven King to discuss Jaguar's recently launched Mental Health Entheogen Therapeutics Initiative.

[Steven King:]

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 team, which is scheduled to take place early next month. According to the World Health Organization one in four people in the world will be affected by mental or neurological disorders at some point in their lives. Around 450 million people currently suffer from such conditions facing mental health disorders among the leading case -- causes of ill health and disability worldwide. As announced last month, the ETI program is targeting the plant-based compound alstonine for possible indications related to schizophrenia and other psychosis and for development with potential corporate partners. Alstonine is a heteroyohimbine-type alkaloid that occurs naturally in a variety of plant species including a species of West African plant contained in our library. Neuropsychopharmacology profile analysis of alstonine shows that the compound demonstrates antipsychotic activity and has a mechanism of action distinct from existing FDA-approved therapies for schizophrenia and other mental health conditions that present psychotic symptoms. Schizophrenia the most serious form of psychosis is a chronic disabling mental illness that affects approximately 1% of the U.S. population and it's estimated that up to 34% of patients with schizophrenia fail to respond to currently available treatments. While we remain steadfastly focused on the commercial success of Mytesi and on the development of the crofelemer follow-on indications in the area of GI health, we are thrilled to be leading this effort to potentially uncover a pipeline of novel psychoactive plant-based compounds, engage with recognized leaders in this space and share our findings with potential corporate partners with the goal of developing plant-based compounds into possible medical breakthroughs. For decades, the Jaguar and Napo team has recognized the unique and powerful traditional knowledge and business -- that business people have about plants, ecosystems, interrelationships, and healing compounds. And we continue to be extremely grateful to the traditional healers, who have taught our field, teams and research scientists about the medical applications of plants to treat and help people in their communities and the world. That concludes my comments, and I will now turn the discussion back over to Lisa Conte.

[Lisa Conte:]

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 populations across multiple disease indications and around the globe. And we believe this pipeline will fuel long-term value creation for investors and non-dilutive funding opportunities for potential partner collaborations. Beyond CTD, pipeline explorations for crofelemer include, potential indications previously mentioned on this call such as, congenital diarrheal disorders, which is a rare indication for infants and children, supportive care for inflammatory bowel disease, irritable bowel syndrome and functional diarrhea and an orphan indication for short bowel syndrome. Napo pipeline explorations are also underway for a second-generation antisecretory agent, lechlemer for a potential indication in cholera-related diarrhea. And Napo continues to receive preclinical services from the National Institute of Allergy and Infectious Diseases to support lechlemer development preclinical development ongoing right now. We continue of course to be concerned about the impact of COVID, not only here in the United States but also on our rainforest partners, the local and indigenous communities of the Peruvian Amazon. They are showing resilience and are managing their families, forests and communities with great care as always. The collection of red bark sap from Croton lechleri trees, a latex material from which Mytesi is extracted and purified, is continuing in a satisfactory manner, as it is essential reforestation work Napo funds in various regions. We rely very strongly on our relationships with indigenous and local communities in Peru. And on the ancient and powerful knowledge, these traditional people have about plant, ecosystems and natural healing compounds in plants. Ongoing sources of income continue to be critical in these regions of Peru. And we remain as always fully committed to supporting our local and indigenous partners, as we continue to operate in accordance with both, the regional and national government COVID guidelines and safety measures. We are also focused of course on value recognition of Jaguar and Napo's tremendous achievements and assets. A micro stock NASDAQ environment is a tough place to generate that recognition. We are dedicated to continuing to perform, and continuing to drive value recognition for the company, and also committed to focusing only on non-dilutive, non-structured financing transactions as we move forward. As the holiday season and the end of what has indeed been a unique and challenging year to the world, approaches I am grateful and pleased to be able to say that 2020 has without questions, lived up to our vision that it would be a transformative period for Jaguar and Napo. I am very pleased with all of our achievements thus far this year. And continue to be grateful for the ongoing support and dedication of our employees, our stockholders, our local and indigenous partners and crews, and all of our stakeholders, as we continue to grow sales and progress multiple possible follow-on indications for crofelemer and Mytesi and an unwavering focus on patients in need. This concludes our call for today. Thank you all for joining. Please be safe and be well. And Peter Hodge, do we have any questions that have been submitted?

[A - Peter Hodge:]

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

[Lisa Conte:]

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?

[Peter Hodge:]

That's it for that today, Lisa.

[Lisa Conte:]

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.

[Operator:]

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