Jaguar Health, Inc.

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 risk 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 10K for the year ending December 31st, 2020, which was filed March 31st, 2021, 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 growth 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. As a reminder, today's conference is being recorded. At this time, it is my pleasure to turn the call over to Lisa Conte, Jaguar Health founder, president, and chief executive officer. Lisa, the floor is yours.

Thank you very much, and thank you for that comprehensive disclosure here. Welcome all. As you just heard, my name is Lisa Conti. I am the founder, president, and CEO of Jaguar Health and our wholly owned subsidiary, NAPO Pharmaceuticals. And I am a board member, chairman of the board of our majority owned subsidiary in Italy, NAPO EU. And I'm going to begin today with a brief recap of key clinical and product development updates. December is a key month of product development activity for Jaguar. We're so pleased that the results from our phase two or from the phase two, it's not our study, investigator-initiated HALT study of profilamer have been accepted for presentation at the prestigious San Antonio Breast Cancer Symposium. And that takes place from December 7th to December 10th of this year, just next month in San Antonio, Texas. The HALT study was sponsored by Georgetown University and it was funded by Genentech. It was a controlled study of the prevention of diarrhea in breast cancer patients on targeted therapy and a taxane chemotherapy drug. The study is independent from our pivotal phase three on target. That's the name of our study on target, which is profilamer for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy with or without cycle chemotherapy. We initiated our study. on target study in October 2020, and patient enrollment is ongoing. So back to the investigator-initiated HALT study. The poster will be presented at San Antonio by lead author Dr. Paula Polman, who has moved from Georgetown and is now a leading oncologist and associate professor at the University of Texas MD Anderson Cancer Center. And it also includes senior author Dr. Sandy Swain, who is at Georgetown University. And the poster presentation will take place on Friday, December 10th, from 7 to 8.30 a.m. Central Time. And the poster will also be available for virtual participants starting on December 7th. In other important December news, Jaguar is planning for conditional approval and launch of Profelimer, for the treatment of chemotherapy-induced diarrhea in dogs. The drug is called Canilevia, Canilevia CA1, and it will be our first prescription veterinary product. We anticipate conditional approval in late December 2021, likely December 27th. According to the National Cancer Institute, there's roughly 6 million new cancer diagnoses in dogs each year, among the approximately 80 million dogs in the U.S. now. And for the most part, dogs receive human therapeutic agents during treatment and suffer the same side effects as humans. And dogs really are predictive of the human experience. For example, approximately 40% of treated dogs may have their chemotherapy reduced or changed or discontinued due to diarrhea, which can compromise the full benefit of the chemotherapy agent and is a remarkably similar percentage to what's being in human patient treatment as well. Chemotherapy is evolving to become the most widely used oncology treatment modality in veterinary medicine, and there are currently no FDA-approved medications for the symptomatic treatment of CID in dogs, bing-bing in humans. Moreover, the most prevalent and used targeted chemotherapy, tyrosine kinase inhibitors, often referred to as TKIs, which have substantial rates of diarrhea, are widely becoming adopted by small animal practitioners. There are approximately 50 targeted therapies often utilized for chronic management of cancer that have been approved for human use in the past 20 years. Canolevia is a prescription drug product and will be commercialized through the companies Ant Jaguar Animal Health business unit. So turning now to Jaguar's Italian subsidiary, NAPOEU, the merger of NAPOEU and DragonStack has closed, as we announced on November 1st, and is currently effective. Jaguar maintains, the parent company maintains a meaningful majority equity interest in the combined entity, and the combined entity has retained the name NAPOEU. With highly experienced team management for NAPO-EU in place now, we look forward to collaborating with and growing the NAPO-EU team in Italy in support of NAPO-EU's very important mission to expand access to profilamer in Europe, the entire European territory, excluding Russia, for multiple pipeline indications. And beginning with NAPO-EU's initial focus on short bowel syndrome with intestinal failure, a rare disease representing another important potential indication for profilamer in the patient community. NAPO-EU operates under an exclusive license to profilamer from Jaguar with typical license terms including upfront fees, milestone payments, royalties, and collaborative clinical work including sharing of clinical and regulatory data generated by each organization. NAPO-EU is laser-focused initially on orphan indications. Short bowel syndrome is a catastrophic event where patients' guts, normally 20 to 25 feet, may be as short as less than 5 feet, perhaps as short as 30 centimeters. These patients often require TPN, total parenteral nutrition, which can be for 20, 22 hours a day, and at a cost to the healthcare system of potentially over and typically over half a million dollars a year, and that's without complications. And these patients often have complications, serious complications as well. In Europe, with typically single-payer healthcare systems, rare diseases provide an opportunity for a business model for profilamer that represents a different value parameter. Specifically, we believe profilamer will reduce the time and quantity need for parenteral nutrition and hence increase the opportunity for enteral nutrition, enteral directly into the stomach, directly into the intestinal tract. To that end, NAPOEU submitted an orphan drug designation application for clophalomer for the indication of short bowel syndrome for review by the European Medicines Agency, EMA. And EMA is equivalent to the FDA in the U.S. We submitted this in, or NAPOEU submitted this in September. Acceptance of the submission by EMA started the formal review process of the application. So they did accept the submission. And the formal review process is by EMA's Committee for Orphan Medicinal Products. I'm very pleased to report today here that on November 5th, the Committee for Orphan Medical Products provided us with a positive opinion for the orphan drug designation of cofelomer in the EU. for this indication short bowel syndrome. The formal decision and designation for Cofelimer for short bowel syndrome with orphan designation should be received within the next 30 days. And this is a key benchmark in achievement for the NAPO EEG business plan. As a reminder, Cofelimer previously received orphan drug designation in the United States from the Food and Drug Administration for short bowel syndrome. In Europe, however, the orphan designation provides a pathway for accelerated pre-approval patient access because of the catastrophic health situation of many short bowel syndrome patients. And it's part of the reason why it's the initial strategic focus of NAPO-EU. Massimo Mineo, the general manager of NAPO-EU, has extensive, and was announced yesterday, has extensive experience with orphan and rare disease business management in Europe. And it's very exciting right now. I am speaking from a hotel in Boston, and the NAPO EU management team is over here from Italy. Travel was permitted, and they are meeting, and we are meeting with the Jaguar drug development team as I speak, providing a download of all things profilamer. The sharing of data between the two organizations augments the opportunity for multiple clinical shots on goal of profilamer for each organization, and in particular, allows Jaguar to benefit from another shot on goal with non-diluted financing, and that's specifically for a proplemer in pursuit of short bowel syndrome indication. Before I hand the discussion over to Carol Isaac, Jaguar's Chief Financial Officer, who will provide a recap of key financial results for the third quarter of 2021, I want to highlight the fact that my TESI prescription volume, the metric we believe to be the best indicator of patient demand, increased 7.6% in the third quarter of 2021 over the second quarter of 2021, and new Mitessi prescriptions increased 9% during the same comparison period. Mitessi total prescription volume remained the same in the third quarter of 2021 over the third quarter of a year ago, 2020, and new Mitessi prescriptions increased by 10.5% during the same comparison period. you're all aware of course that this has been the pandemic period what's very important and i want to address head-on the fact that we are still in the midst of the process of transitioning a substantial amount of my tesi volume to a closed network of specialty pharmacies rather than the wholesalers that resale the product to retail pharmacies this transition results in an under-representation of Mitessi utilization as revenue-related, the wholesaler inventory has already been recognized by Jaguar as required and in accordance with GAAP. And that inventory is now being bought down. This inventory buy-down is painful to our financial measurements and is expected to be completed in the fourth quarter of this year. So why do we do this? A key component of the company's market access strategy, this initiative to transition to a closed network of specialty pharmacies is intended and is, in fact, helping to remove access barriers for patients receiving Mitessi prescriptions and include services such as a higher level of support for prior authorizations, appeals, adherence counseling, home delivery options, all of which has become even more important during the pandemic, And while patients often visit retail pharmacies for short-term or uncomplicated medical needs, specialty pharmacy focus and specialty pharmacies themselves focus on servicing patients with complex and chronic medical conditions. Financially, the transition to a closed network with specialty pharmacies is expected to result in a meaningful reduction in my PESI distribution costs and strategically prepares the company's U.S. commercial distribution network for future indication expansion of profilamer to other populations of patients with complex medical needs. We'll get through this transition, and we believe, and that's why we did this transition, for the good of the business to be in a better place in 2022 and beyond, with a focus on prescription growth, payer mix, net revenue growth, and getting our reps back into promotional face-to-face post-pandemic office visits. Lastly, I'd like to let all of you participating know that we will have a brief Q&A segment at the end of the webcast to address questions. Some have already come in, and they can be submitted in writing. Questions can be submitted via the webcast link for today's event that appears on the Events and Presentations page of the Investor Relations section of Jaguar's website. The URL for Jaguar's website is jaguar.health. Okay, we'll now move along to the key financial results for the third quarter of 2021. I'm going to hand this over to you, Carol, please.

Thank you, Lisa, and thank you all for joining our webcast today. Key financial highlights for the quarter ended September 30, 2021 are as follows. As Lisa stated, my tested prescription volume increased 7.6% in the third quarter of 2021 over the second quarter of 2021, and new my tested prescription increased 9% during the same period. My tested total prescription volume remained the same in the third quarter of 2021 over the third quarter of 2020, and new my tested prescriptions increased by 10.5% during the same period. My testing net revenue during the third quarter of 2021 was approximately $600,000 and approximately $400,000 in the second quarter of 2021, an increase of $200,000 quarter over quarter. Mitessi net revenues decreased by $2.2 million in the third quarter of 2021 versus the third quarter of 2020. As part of the process of transitioning to the closed specialty pharmacy network, the third quarter of 2021 was significantly impacted by the one-time inventory drawdown of approximately 1,300 bottles of Mitessi across the company's third-party logistics warehouse, wholesalers, distributors, and retail stores. The company expects essentially a full transition to my Tessie prescriptions being dispensed through specialty pharmacies by the end of the fourth quarter of 2021. My Tessie gross revenue, a non-GAAP measure, was approximately $3.2 million during the third quarter of 2021 and approximately 4.9 million in the second quarter of 2021, a decrease of 1.7 million quarter over quarter. My TESI gross revenues decreased by 3.1 million in the third quarter of 2021 versus the third quarter of 2020. As mentioned, the third quarter of 2021 was significantly impacted by the one-time inventory drawdown of approximately 1,300 bottles of MyTessy across the company's third-party logistics warehouse, wholesalers, distributors, and retail stores. Sales volume distributed through the company's recently established and expanding pool of third-party specialty pharmacies through which my test is distributed was approximately 38% of total sales volume in the third quarter of 2021 compared to approximately 17% in the second quarter of 2021. For the third quarter of 2021, the net loss was 12.2 million compared to a net loss of 7.9 million in the third quarter of 2020. an increase of $4.3 million quarter over quarter. That concludes my recap of high-level financials for the third quarter of 2021. I will now hand the discussion back to Lisa.