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 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 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 during this webcast 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 2021, which was filed March 11, 2022, 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 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 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. Today's conference is being recorded. At this time, it's my pleasure to turn the call over to Lisa Conti, Jaguar Health's founder, president, and chief executive officer. Lisa, the floor is yours.

Thank you, and thank you for those very comprehensive, forward-looking statements. Welcome all. As you just heard, my name is Lisa Conti, and I am the founder, president, and CEO of Jaguar Health and our wholly-owned subsidiary in the United States NAPO Pharmaceuticals. I'm also the chairman... of the Board of NAPO Therapeutics, the corporation we established in Milan, Italy last year, to which we granted an exclusive license to Crofilomer in the European territory. Specifically, NAPO Thera is initially pursuing a rare disease business model based on the orphan designation of Crofilomer for short bowel syndrome, which I'm going to refer to as SBS throughout this talk. Jaguar is the majority shareholder of NAPO Thera. providing equity interest value to Jaguar, as well as the typical license terms, which we'll talk about in a moment. I'm going to begin today with a few brief updates, and then Carol Isaac, Jaguar's Chief Financial Officer, will provide a recap of key financial results for the first quarter of 2022. As you'll hear from Carol, and I am so pleased to steal her thunder at the moment, We are reporting Mitessi net revenue of approximately $2.6 million in the first quarter of 2022, representing an approximate 24% increase over Mitessi net revenue in the fourth quarter of 2021, which was approximately $2.1 million, and approximately 112% increase over Mitessi net revenue in the first quarter of 2021, which was approximately $1.2 million. These increases largely represent the important and continuing realization of the benefits from both the financial perspective and so importantly from the standpoint of improved patient access of the transition Jaguar completed this past January to distributing Mitessi through a closed network of specialty pharmacies rather than to wholesalers that resell the product to retail pharmacies. A transition that has decreased our distribution costs and improved our gross to net ratio to 76% in this first quarter of 2021, an improvement from approximately 27% in the first quarter of 2021. So having the net and the growth track much more closely together in Q1 2022. After Carol, whose thunder I just stole, we'll hear from Ian Wendt, Jaguar's Chief Commercial Officer, about several new Mitessi-related commercial initiatives that we're very excited about, including a telehealth initiative to continue to educate and serve the HIV community, and about commercial efforts underway for Canalevia CA1, Our prescription drug for the treatment-induced diarrhea, which I'm going to refer to as CID, chemotherapy-induced diarrhea in dogs that received and the product received conditional approval from the FDA this past December and became commercially available to veterinarians and their clients in the U.S. to provide comfort and relief to their canine patients at the end of April 2022, just last month. 9 million dogs were acquired by the U.S. households during the pandemic, according to the American Pet Products Association, bringing the total number of dogs in the United States to 108 million, which is roughly one dog for every three humans in the country. 25% of dogs will deal with a tumor at some point. 50% of dogs over 10 years of age will be diagnosed with cancer. And addressing CID is to canine survivability from cancer, as well as for supporting dog owners in the decision to seek cancer care for their dogs. Dogs are remarkably predictive of, and similar to the human CID situation, as with human cancer patients, dogs go off their disease-modifying chemotherapy approximately 40% of the time due to diarrhea, meaning these dogs cannot complete their therapeutic dose of chemotherapy because of diarrhea. Extremely relevant in the dog market, though, is the comfort factor for the dog, a key factor influencing a dog parent's decision about whether to treat the dog's cancer. And the quality of life for the whole family is a key factor as well. A dog losing control on the rug, bed, couch is an important consideration for the family household. While we do not provide guidance, we do feel the total addressable dog CID market could be about the size of the total addressable market for the human HIV specialty market and provides much greater predictability of this gross to net ratio since dog parents are typically paying out of pocket for treatment and medication, so we don't have the variability in the chargebacks as you have in the human situation. Education about the devastating impact to the patient of diarrhea and cancer therapy builds awareness, regardless of whether the patient is a human or a dog. And while we're on the topic of canine cancer, I want to take a moment to invite all of you to the in-person special media event and performance in New York City on Monday, May 23rd, from 1230 to 230, Eastern Time, to celebrate the launch of the Jaguar Health Canine Cancer Conference. Take Charge Initiative. CHARGE is an acronym for Canine Health and Registry Exchange. The goal is to establish the first-ever U.S. Canine Cancer National Registry and Cancer Care Index to assess the prevalence and incidence of cancer in dogs. The mission is important because protecting dogs from cancer begins with knowing its impact by breed, by type, by age, by gender, and geography, location. We will be revealing data at the event from the first nationwide Gallup survey of pet owners, which is an important media hook, addressing their experience with canine cancer, as well as the registry itself that is based on the analysis of thousands of canine medical records, anonymous canine medical records. The data may also provide insights to help better understand cancer in humans, and the importance of managing side effects in humans in human cancer therapy. You can RSVP online for this in-person outdoor event on the events and presentations page of the investor section of Jaguar's website, or you can RSVP by sending an email to takechargerSVP at togorun.com, T-O-G-O-R-U-N.com. If you're not able to join us in person in New York on May 23rd, virtual access will, of course, be available. This is an event for all interested parties, dog owners, veterinarians, veterinary oncologists, investors, the media, anyone who is concerned about addressing and managing cancer and our four-legged best friends. And the event is taking place on the first annual National Canine Careness Canine Cancer Awareness Day, National Canine Cancer Awareness Day. Human and doggy treats will be served and the event will feature presentations by Jaguar, by a collaborating partner, Togo Run, our wonderful PR firm that is supporting this effort, by Gallup, the leading survey organization that conducted our national poll of dog owners about canine cancer, and from Dr. Suh, the famous cancer vet who has enormous online and offline following. And very excitingly, the Take Charge launch event will also feature performances by a truly amazing lineup of Broadway stars who are also dog lovers and want to bring awareness to this activity. A lineup that we expect to include Academy Award-nominated actor and playwright Chaz Palmateri, actress and producer Gianna Palmateri, his wife, actor, director, and producer Richard Blake, Grammy-winning and Tony-nominated actress Jen Colella, recently Tony-nominated actress as of yesterday Shoshana Bean, Broadway actor and singer Bobby Conti, who happens to be my son, Tony-nominated actress, singer, and songwriter Ofra, her husband, Tony-nominated actor and singer Andy Carle, and Broadway actor, singer, and film producer Manu Narayan. We're very excited about this event. It'll be educational, it'll be entertaining, and we would be thrilled to have you attend. 2022 is Jaguars Year of the Dog, and we're praying for good weather on the 23rd. As a reminder, Crofellimer, under the trade name Mitessi, is our plant-based, FDA-approved, anti-diarrheal drug, indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV-AIDS on antiretroviral therapy. This is the current indication. Profilamer is also the focus for human pipeline indications on the clinical development front, each expected to create transformative value for JAGUAR in the next 12 to 15 months. And this includes prophylaxis of cancer therapy-related diarrhea, and short bowel syndrome, SPS, which is a catastrophic health situation for which profilamere has received orphan drug designation in the U.S. and the European Union. Profilamere is also the active ingredient, by the way, in canalivia CA1, the dog product. Enrollment is continuing for the on-target study, our phase three trial of profilamere for CTD, cancer therapy-related diarrhea, in humans. We're aiming to complete 256 patient enrollments by the first half of 2023. As I mentioned during the last webcast on March 14th, we're in the process of adding additional clinical trial sites both in the United States and outside the U.S. to help ensure patient enrollment despite COVID-related restrictions and global unrest and the diversity of the tumor types in the patients. The successful completion of this pivotal trial will result in a supplemental new drug application filing for the same formulation as the currently commercialized crofilomer Mitessi. Mitessi is, of course, already approved for chronic use in people with HIV AIDS and has a full FDA-compliant supply chain in place from the rainforest to our specialty pharmacy distribution network across the U.S. And as a reminder, safety and manufacturing are the two most common reasons why new drug applications fail. Hence, we spent much care and communication with the FDA in the design and execution of this final clinical and regulatory step to bring profilamide to cancer patients suffering with diarrhea. Diarrhea is the most common side effect of cancer patients. As mentioned, an estimated 40% of patients with CTD continue their chemotherapy or their targeted therapy, their life-saving cancer treatment, because of diarrhea. And this is not your garden variety traveler's diarrhea. Patients are often hospitalized, CTD, for dehydration, electrolyte imbalance, and organ failure. And some patients have even died from the impact of their diarrhea during clinical investigation by targeted therapy manufacturers. Our second core development focus for crofilomer in 2022 is the orphan-designated disease, SBS. We expect investigator-initiated proof-of-concept studies for crofilomer for SBS and congenital diarrheal disorders, CDD, a rare inherited disease causing lifelong intestinal failure, and we expect these investigative proof of concept studies to be completed in 2022 and others continuing into 2023 at sites in the Middle East and Europe, supporting the potential for expanded patient access in 2023 through programs in Europe for these devastating and catastrophic diseases and health situations for these patients. Expanded patient access is a reimbursed program throughout Europe. SPS and CDD clinical development efforts are being led by the skilled, focused, and rare disease experienced NAPRO Therapeutics Management Team in Italy, a leadership team comprised of a managing director, chief medical officer, and a head of regulatory and quality. As another reminder, we established NAPO Therapeutics in Europe, because the European Medicines Agency, the EMA, equivalent to the FDA in the United States, is committed to enabling reimbursed early access to new medicines with orphan drug status, underscoring the important medical needs to patients through early access programs. Participation in an early access program would potentially provide patients with access to profilameric as early as 2023, and thereby potentially impacting in a positive way their morbidity, mortality, and the cost of care for this chronic indication, SPS, that has no good therapeutic options. Both CDD and SPS patients with intestinal failure typically require parenteral nutrition up to 20 hours a day, seven days a week. to survive at tremendous cost with tremendous accompanying medical complications, huge impact on any sort of quality of life. Ability to decrease the parental nutrition requirement by even 20% would provide a huge medical and quality of life improvement. In a typical rare disease business model, these substantial benefits are highly valued for a relatively small patient population. The global SPS market of an estimated 40,000 to 60,000 patients worldwide is expected to reach $4.6 billion by 2027, according to a third-party report from Vision Research Reports. NapoSara operates under an exclusive license to profilamer from Jaguar, for which Jaguar receives typical license payments, including an upfront payment, milestone payments, royalties, and transfer pricing of Crofilamer. Jaguar also receives the value of the clinical data generated by NAPO Thera, in this case for SPS, as reciprocally, NAPO Thera receives the value and the ability to utilize the CTE, the cancer phase three data Jaguar is developing. Hence, the parallel, complementary, and geographically focused development efforts of profilamer for these two core indications, CTD cancer and SPS short bowel syndrome, are progressing simultaneously and collaboratively with dedicated teams, respectively. And again, a key advantage of the NAPO Thera effort to JAGUAR. is that NAPO Thera is well over majority owned by Jaguar, providing potential equity accretion value to Jaguar shareholders and stakeholders, which we believe is unrecognized at this time. So once again, these are the two core pipeline events transforming Crow Felimer from pipeline to what we believe will be tangible value in the next 12 to 15 months. An additional key clinical milestone for 2022 is the filing of an investigational new drug, IND, investigational new drug application with the FDA in the mid-year of 2022 this year for symptomatic relief of diarrhea from cholera. And this is for our second-generation anti-secretory called Leuclamir. Leclamer is a different chemical collection of proanthocyanidins extracted from the croton lechleria tree, which is the same tree from which we get profilamer, and which we believe defines leclamer as a distinct product from profilamer under FDA botanical guidance. And by the way, leclamer has a lower manufacturing cost than profilamer. Luxembourg works by the same novel anti secretory mechanism of action as we're planning to initiate a phase 1 study in the 2nd, half of 2022. for, as I mentioned, the symptomatic release of diarrhea from cholera. In support of this clinical activity, we received comprehensive animal toxicity, pre, clinical services supported by the National Institute of allergy and infectious diseases and basically, for four preclinical studies, which have been completed. We plan to pursue a tropical disease priority review voucher for Lequimer under the FDA's financial incentive program to develop drugs for tropical diseases such as cholera. Priority review vouchers are transferable and in past transactions by other companies have sold for prices ranging from $67 million to $350 million. And this, therefore, provides a potential immediate return on investment upon approval of the product, Leclamer, for the symptomatic release of diarrhea from cholera. On the business development front, as previously announced, this year we entered an agreement at the end of Q1 with Quadri Pharma that grants Quadri Pharma exclusive promotional commercialization and distribution rights for specified human indications of crofilomer in Bahrain, Kuwait, Qatar, Saudi Arabia, and UAE, and Oman, following regulatory approval to market crofilomer in these countries for the specified indications, including the indication currently approved in the United States for HIV-related diarrhea and cancer therapy-related diarrhea. for which Profilamer is currently, as I mentioned, in the pivotal Phase III trial. In addition, the agreement grants Quadri Pharma exclusive rights to distribute Profilamer in these countries in the immediate future under named patient programs. Quadri has knowledge and experience in the distribution of pharmaceutical products throughout the Middle East, including the servicing of requests for a particular medicine in markets where that medicine does not yet have marketing approval, such as requests related to a named patient program, which provides revenue generating products approved in a major market country, such as the United States, to individual named patients through physician requests in a country where marketing approval has not yet been granted. According to UNAIDS 2020 global report, the HIV epidemic is growing in the Middle East and North Africa, referred to as the MENA region, with an estimated 20,000 new infections in 2019, a 25% increase over infections in 2010, and an estimated 170,000 to 400,000 adults and children in the region who lived with HIV in 2019. This is a revenue-sharing relationship for HIV-related diarrhea in Bahrain, Kuwait, Qatar, Saudi Arabia, UAE, and Oman. And the agreement terms provide Jaguar with an increase in the revenue-sharing percentage for sales in these countries of newly approved indications, which will apply to the CTD and ultimately inflammatory bowel disease indications for profilamer upon marketing approval. Dr. Karen Bronke-Jag was very experienced and capable executive vice president of corporate and business development, orchestrated our relationship with Quadri Pharma, and this collaboration is a welcome and important step towards making Crofellimer's novel mechanism of action available to patients in need in global markets. Karen is hard at work, continuing hard at work, pursuing additional business development opportunities for Crofellimer. which, again, we consider a pipeline within a product for multiple potential indications in other key markets outside the United States. Lastly, I'd like to let you all participating today know that we will have a brief Q&A segment at the end of this webcast to address questions, if any, submitted in writing as we normally do. 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. I'd also like to point out that the list of analysts that cover Jaguar can also be found on the investor relations section of Jaguar's website and includes a new edition this week. We are now being covered, and initiation is expected this week. Well, we're now being covered by Lattenberg Cantor Fitzgerald, and just this week, the initiation is expected from CWIC Equity Solutions in conjunction with TAG, TAG Investment Bankers. We'll now move along to key financial results for the first quarter of 2022, and I'll turn it over to Carol.

Thank you, Lisa. and thank you all for joining our webcast today. I'll begin my review of our financials for the first quarter of 2022. My TESI net revenue during the first quarter of 22 was approximately $2.6 million and approximately $2.1 million in the fourth quarter of 2021, an increase of approximately $500,000 or approximately 24% quarter over quarter, and an increase of approximately 112% over my TESI net revenue in the first quarter of 2021, which totaled approximately 1.2 million. The transition to a closed network of specialty pharmacies, which was completed this past January, resulted in a meaningful reduction in Mitessi distribution costs and a higher average net price. As part of the process of transitioning to the closed specialty pharmacy network, the third and fourth quarters of 2021 were significantly impacted by the inventory drawdown of approximately 1,300 bottles of Mitessi across the company's third-party logistics warehouse, wholesalers, distributors, and retail stores. Mitessi prescription volume, the metric the company believes to be the best indicator of growth in patient demand, increased 14.6% in the first quarter of 2022 over the fourth quarter of 2021. Prescription volume, differs from invoice sales volume, which reflects, among other factors, varying buying patterns among specialty pharmacies in the closed network as they manage their inventory levels. My TESI gross revenue, a non-GAAP measure, was approximately $3.4 million in the first quarter of 2022 and $3 million in the fourth quarter of 2021, representing an increase of approximately 400,000 or 13.4% quarter over quarter, a decrease of approximately 25.5% over my TESI revenue, gross revenue that is, in the first quarter of 2021, which was approximately 4.6 million. The increase in my TESI gross revenue in the first quarter of 2022 over the fourth quarter of 2021 is due largely to the fact that infrastructure required to complete the transition to a closed network of specialty pharmacies was not fully in place in the fourth quarter of 2021. And the loosening of COVID-related travel restrictions in the first quarter of 2022 allowed my testy sales personnel to visit more healthcare providers. The decrease in Mitessi gross revenue in the first quarter of 2022, as compared to the same quarter in the prior year, was due to the process of transitioning to distributing Mitessi through a closed network of specialty pharmacies instead of through wholesalers that resell the product to retail pharmacies. For the first quarter of 2022, the loss from operations was $11.8 million, compared to a loss of $8.8 million in the first quarter of 2021, an increase of $3 million quarter-over-quarter, largely due to the increased clinical trial activities related to the company's on-target Phase III of Covelmer for prophylaxis of cancer therapy-related diarrhea, or what we call CTD, as well as development efforts for other indications. For the first quarter of 2022, the net loss attributable to common shareholders was approximately $18 million, compared to a loss of 12 million in the first quarter of 2021, an increase of $6 million quarter over quarter. In addition to the loss from operations, Interest expense increased 2.3 million from 1.9 million in the three months ended March 31, 2021, to 4.2 million for the same period in 2022, primarily due to interest from the royalty and note agreement. The increase in the loss and extinguishment of debt from 753,000 in the three months ended March 31, 2021, to 2.8 million in the same period in 2022 is due to the 2.8 million extinguishment loss from the exchange of the outstanding balance of one of the royalty agreements for shares of the company's common stock. Also, change in fair value of financial instruments and hybrid instruments designated a fair value option or FVO losses decreased 400,000 from a loss of 600,000 in the three months ended March 31, 2021 to 200,000 for the same period in 2022 designated as FOB or FVO, I should say. Other income increased by 800,000 from 10,000 in the three months ended March 31, 2021 to 800,000 for the same period in 2022 due to the foreign currency transactions. Non-GAAP EBITDA for the first quarter of 2022 and the first quarter of 2021 was a net loss of $9.4 million and $6.8 million respectively. That concludes my recap of high-level financials for the first quarter of 2022. I will now hand the discussion over to Ian Wentz, Chief Commercial Officer. Ian?