Jaguar Health, Inc.
Q1 2022 Earnings Call Transcript

Published: 10 May 2022

[Operator:]

Before I turn the call over to management, I'd like to remind you that the -- 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 the 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 11th, 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's 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 - non-GAAP financial measures should not be viewed in isolation or as substitutes for GAAP net sales and GAAP net loss and are not substitute for or superior to measures of financial performance and conformity with GAAP. Today's conference is being recorded. At this time, it's my pleasure to turn the call over to Lisa Conte, Jaguar Health's Founder, President, and Chief Executive Officer. Lisa, the floor is yours.

[Lisa Conte:]

Thank you for those very comprehensive forward-looking statements. Welcome all, and as you just heard, my name is Lisa Conte, and I'm 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 Crofelemer in the European territory. Specifically, Napo Thera is initially pursuing a rare disease business model based on the orphan designation of Crofelemer 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 Lizak, 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'm so pleased to steal her thunder at the moment, we are reporting Mytesi net revenue of approximately $2.6 million in the first quarter of 2022, representing an approximate 24% increase over Mytesi net revenue in the fourth quarter of 2021, which was approximately $2.1 million and approximately a 112% increase over Mytesi net revenue in the first quarter of 2021, which was approximately $1.2 million. These increases largely represents 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 Mytesi 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 all -- 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 Mytesi related commercial initiatives that we're very excited about, including a tele-health initiative to continue to educate and serve the HIV community and about commercial efforts underway for Canalevia CA1, our prescription drug, [Indiscernible] 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. An estimated nine 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 key to canine survivability from cancer, as well as for supporting dog owners in the decision to seek cancer care for the 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 the 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 adjustable dog CID market, could be about the size of the total addressable markets for the human HIV specialty markets, and provides much greater predictability, of this gross to net ratio, since dog parents are typically paying out of pocket for treatment and medications. So we don't have the variability in the charge backs as you have in human situation. Education about the devastating impact to the patient of diarrhea in 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 23, from 12

[Carol Lizak:]

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. Mytesi net revenue during the first quarter of 2022 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 Mytesi 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 Mytesi distribution costs, and a higher average net price. As part of the process of transitioning to a closed specialty pharmacy network, the third and fourth quarters of 2021, were significantly impacted by the inventory draw down of approximately 1,300 bottles of Mytesi, across the company's third-party logistics warehouse, wholesalers, distributors and retail stores. Mytesi, 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 but buying patterns among specialty pharmacies in the closed network as they manage their inventory levels. Mytesi 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 Mytesi revenue, gross revenue that is, in the first quarter of 2021, which was approximately $4.6 million. The increase in Mytesi 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 Mytesi sales personnel to visit more healthcare providers. The decrease in Mytesi 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 Mytesi through a closed network of specialty pharmacies instead helps 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 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 ONTARGET Phase 3 off crofelemer for prophylaxis of cancer therapy-related diarrhea or what we call CTV, 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 $753000 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 at fair value option or FVO, losses decreased, $400,000 from a loss of $600,000, industry months ended March 31, 2021, to $200,000 for the same period in 2022, designated as FOV 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 Wendt, Chief Commercial Officer. Ian?

[Ian Wendt:]

Thank you, Carol. And good morning to all. As Carol stated, Mytesi total prescription volume, the metric we believe to be the best indicator of patient demand, increased 14.6% in the first quarter of 2022, over the fourth quarter of 2021. As previously announced, the transition to a closed network of specialty pharmacies, has resulted in a meaningful reduction in Mytesi distribution costs as well as a higher average net price. In fact, I'm very pleased to report that we significantly outperformed the industry gross-to-net average in the first quarter of 2022, and the fourth quarter of 2021 for sales of our human prescription product as a result of our transition to the closed network of specialty pharmacies. A key component of the company's market access strategy, the initiative to transition to a closed network of specialty pharmacies, is intended to help remove access barriers for patients prescribed Mytesi, and include services such as a higher level of support for prior authorizations, appeals, adherence counseling, and home delivery options. While patients often visit retail pharmacies for short term or uncomplicated medical needs, specialty pharmacies focused primarily on serving patients with complex and chronic medical conditions like HIV. Importantly, this transition has also allowed us to begin utilizing sales and prescription data directly provided by our network of specialty pharmacies to more accurately track prescription volume and the patient journey rather than relying on a third-party provider of estimated data for these important performance metrics. And assists in the preparation of our U.S. commercial distribution network for potential future indication expansion of crofelemer to other populations of patients with complex medical needs, such as CTD and SBS. I'm also pleased to report that we have rolled out new innovative programs that further support identifying appropriate Mytesi patients and connecting them to care and medication access services. The first program is a tele -health initiative, which went live just this past Friday that enables patients seeking help with our HIV related diarrhea to be linked immediately to a provider for assistance with their medical needs. This new capability prevents patients from having to wait until their next scheduled doctor visit to get help with an urgent problem. Our second new program delivers digital Mytesi and disease state education directly into a provider's electronic health record or EHR system so that they learn about Mytesi at the moment they are seeing their HIV patients. This technology allows us to intelligently deliver ads to a provider based on the profile of the patient they are seeing in their exam room. I know this is strictly a one-way communication. We do not actually receive any protected health information around this program. Both of these programs are designed to drive incremental brand awareness, among prescribers who have not written for Mytesi previously, and among patients who have not been able to receive immediate care for their HIV related Diarrhea. Now, turning to the animal health side of our business, we are thrilled, as Lisa mentioned, that Canalevia CA1, our FDA conditionally approved treatment for chemotherapy-induced Diarrhea or CID in dogs, became commercially available to veterinarians across the United States at the end of last month. Canalevia CA1 is an important prescription drug introduction for the veterinary community and the thousands of dogs experiencing CID. As Lisa commented, dogs as with humans, go off their disease modifying chemotherapy approximately 40% of the time due to diarrhea. Canalevia CA1 can help support the comfort and quality of life of dogs while being treated with chemotherapy, which may help them remain compliant with their life-saving treatment. The reception of Canalevia CA1, among general practice vets and veterinarians oncologists who have learned about the product has been extremely positive. Launch activities for Canalevia CA1 remain underway. The product was a focus of Jaguar animal health exhibit booth at the recent in April, veterinary cancer society, mid-year conference, which took place in Port of VAR to Mexico. The company also held a well-attended dinner event. Veterinary oncologists about CID in dogs at this conference, Jaguar animal health will be also be exhibiting at the 2022 American College of Veterinary Internal Medicine or ACVIM forum in Austin from June 22nd to the 25th. As announced, we expect that Canalevia could additionally receive FDA conditional approval under the name Canalevia CA2 for the treatment of exercise-induced diarrhea, what is termed EID, in dogs in the fourth quarter of 2022, which will be a very fitting way to finish up what we're referring to as Jaguar’s year of the dog. That concludes my comments. Thank you for your time today. I'll now pass the conversation back to Lisa.

[A - Lisa Conte:]

Thank you, Ian. Thank you, Carol. Nicely done. We at Jaguar, Napo and Napo Thera are energized about all of the important initiatives underway in 2022, and in particular, the expectation for what we feel will be transformative value creation in the next 12 to 15 months as we focus on supporting the realization of the value of our crofelemer pipeline. We now open the floor to written questions that have come in, and I will start to pull them up right now. Okay. My connection to the questions just disappeared, but it's coming back. Peter, if you are online, can you see the questions? Can you read them out to me?

[Peter Hodge:]

Yes, I can read them out to you. The first question is --

[Lisa Conte:]

Okay. Why don't we do that?

[Peter Hodge:]

Is there a plan for an upcoming IPO?

[Lisa Conte:]

So of course, we're a public company. That must be referring to Napo Therapeutics. And Napo Therapeutics has indicated that it would seek liquidity in after what we're looking for and they're looking for the value transformative event of completing the proof-of-concept studies that are published, that could support expanded patient access. So that liquidity event could take many different forms. But of course, Jaguar is already public, and well over the majority of Napo Thera is held in equity in Jaguar.

[Peter Hodge:]

Next question. Congrats on the quarter. We saw the statement on the 10-Q regarding your current capital runway. We are interested to know more about your strategy, and extending your runway, can you provide more color here?

[Lisa Conte:]

That's from Karvi. Hi, Karvi. Okay. I can see the questions now, Peter. So we -- money is fungible, money is money, but we do our best to match the expense of our clinical initiatives to non - dilutive dollars. For example, the SBS, of course, is being run by the funds that are in Napo Thera. And Napo Thera has additional fundraising activities going on now. And our cancer program, we match to the royalty deal that we have where we have royalties based on the revenues that are coming in from Mytesi for HIV a royalty funding program. And with some of the business activities that we're planning in 2022 that are initiatives and discussions that have started months, if not years ago, we're looking to continue to bring in non - dilutive dollars to fund our clinical programs. At this moment, there are no plans to do an equity raise or a structured raise at this stock price. Okay. Will we see a big PO for Canalevia for Mars pet company this year? Mars, which, for people who don't know, Mars -- the Mars company, the candy bar company, they own VCA and a couple of other major -- they have corporate ownership of many clinics. Ian, you probably know what the number of clinics are throughout the United States and even outside the United States. I want you to jump in in a moment here. So they are absolutely a customer, and many of the veterinarians who work and do clinical trials in that network has participated in the presentations that we have done with the education and promotion of Canalevia. So yeah, we expect that there will be sales into the Mars network. And Ian, do you know what that number of vet clinics is in the Mars network is?

[Ian Wendt:]

I know in the specialty clinics space, I think they have about 90 to a 100, and those would be clinics that include oncology care. The primary care clinics, or general practice clinics, number into the many hundreds. In fact, I think it might even be approaching a thousand, especially with all the recent acquisitions that they've made, they bought up a number of large clinic chains, or medium to large clinic chains, so they are a huge customer of ours. They actually reached out to us, to kick off the commercial discussions, because they were very interested in stocking Canalevia and adding into their formulary, and we're certainly expecting them to be a large customer.

[Lisa Conte:]

Perfect. And these days, more and more dogs are being treated for cancer at their general veterinary practitioner, not just at specialty clinics although the specialty research and awareness and education in their oncology specialty clinics really are the organizations that are cutting edge and are a focus of our initial efforts for Canalevia education and promotion. I do want to just want to go back one question to Karvi. Also, I believe everyone's aware that we do have an ATM in place and so that does provide great flexibility for a company like ours if at some point we feel concerned about cash because of excess time or excess expense, for example, in our clinical trials. We can always utilize the ATM. Could you talk a bit more about the name patient program? So how does it work? What's the impact it can have on top line in the near medium-term? Name patient program is terrific. It's fantastic for patients around the world in countries where there is not FDA approval -- I'm sorry, where there's not clinical approval, regulatory approval in their particular country, but where a major country like the United States has FDA approval. Obviously for us, it's for the HIV indications. Physicians who become aware of Mytesi can specifically name a patient for which the product can be imported and prescribed and paid for. So it is at our WAC price and in the case of Quadri, it's based on the revenue sharing model that we talked about and so it can provide immediate release to these patients, as of physicians become aware of Mytesi and the need in certain patients, well, the regulatory process is continuing in different countries in the [ME](ph) region. And I don't see any other questions. Peter, do you see any other questions?

[Peter Hodge:]

I do not Lisa. I think we’re good on that front.

[Lisa Conte:]

Okay. I think we're good. Thank you all for participating and we're very excited about this quarter's results and we're very excited about the continual performance of Mytesi, Canalevia in 2022. And of course, the SBS and the CTD in the future. Have a wonderful day. Thank you all.

[Operator:]

And this concludes today's webcast. We thank you again for your participation. You may now disconnect.