Jaguar Health Inc

NASDAQ:JAGX

Earnings Call Transcript 2024-Q1

[Operator]

[Audio Gap] Before I turn the call over to the 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 risks 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 the 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 the 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 2023, which was filed April 1, 2024, 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 non-GAAP EBITDA and non-GAAP recurring EBITDA.

Jaguar believes that the disclosure of items of these non-GAAP measures provide investors with additional information that reflects the basis upon which company and 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 Conte, Jaguar Health's Founder, President and Chief Executive Officer. Lisa, the floor is yours.

[Lisa Conte, executive]

Hello. Thank you all for joining our webcast for the first quarter of 2024. My name is Lisa Conte. I'm the Founder, President and CEO of Jaguar Health and our wholly owned subsidiary, Napo Pharmaceuticals, and I am the Chairman of our Italian subsidiary, Napo Therapeutics.

As usual, I may use the words Jaguar and Napo interchangeably when I'm referring to our company and our company activities. Following my comments this morning, our CFO, Carol Lizak, will provide a recap of the financial highlights for the first quarter of 2024. However, I apologize, Carol, I'm going to steal your thunder somewhat because I am so pleased to report our combined Q1 2024 net revenue of approximately $2.4 million for our prescription and nonprescription products, increased approximately 20% versus Q1 2023 last year and increased approximately 4% versus the fourth quarter of 2023. And you'll hear more financial highlights from Carol shortly.

Now I will once again address what I feel is the burning question that I continue to legitimately hear from shareholders, the timing of the release of results from our OnTarget trial. We are upgrading our timing expectation. We expect the top line results to be imminent, not forthcoming, as I've indicated before, but upgrading to imminent. Until the results are released, we at Jaguar remain blinded to them. As a reminder, the OnTarget trial is our pivotal Phase III trial of crofelemer, which is our novel plant-based prescription drug, trade name Mytesi, and the trial is for the prophylaxis for the prevention of cancer therapy-related diarrhea, which we refer to as CTD in patients with all solid tumor types on targeted therapy with or without cytotoxic chemotherapy. And we have referred to that as a basket trial aiming for a broad label based on the results of the trial.

We thankfully now live in the age of targeted therapies for cancer treatment. And then thanks to these amazing drugs, cancer patients and metastatic cancer patients are now living longer, 5, 10, 20 years. Targeted therapies though can lead to severe side effects. I'd like to describe the shifting paradigm we're experiencing in the cancer care community. Metastatic patients, as I mentioned, for example, are living longer. They're living longer on these targeted therapies that they're taking indefinitely. Hence, the side effects often continue indefinitely. Sometimes these side effects become therapy limiting, meaning the patient must go off or reduce their drug to a subtherapeutic level, a subtherapeutic level of their life-saving treatment or go off their life-saving treatment.

Side effects are graded in severity from 1 to 4. And even side effects of grade 1 or 2, so the least severe 1 or 2 can dramatically decrease patient comfort, dignity, quality of life and critically their ability to adhere to their cancer treatment regimen, as I mentioned. Research publications on these therapies, often referred to grade 1 and 2 side effects, not grade 3 and 4, grade 1 and 2 side effects as tolerable toxicities. And we have to ask ourselves, tolerable to whom -- for example, let's take cancer therapy-related diarrhea.

Grade 2 is 4 to 6 loose watery stools a day with potential incontinence. How is that tolerable? How is that tolerable indefinitely? Oral mucositis, for example, is various levels of pain, resembling broken glass in your mouth with a hotness like a habanero or pepper. Who wants to live like that, who can live like that indefinitely. A prominent cancer patient advocate, a person living with metastatic lung cancer for 15 years now speaks about the 21 distinct side effects of cancer treatment that she has managed throughout her continuing battle with cancer.

Obviously, there is an abundance of unmet medical need in cancer supportive care. And there are no acceptable toxicities. Our goal is to achieve a leadership role and continue a leadership role in oncology supportive care, and we, at Jaguar and Napo are evaluating additional commercial opportunities in this area to supplement our efforts in CTD, cancer therapy-related diarrhea and now oral mucositis.

Oral mucositis. As announced recently, we have expanded Jaguar's commercial footprint beyond HIV, supportive care at this moment, to include cancer-related supportive care with our recent in-license of the FDA-approved oral mucositis prescription product, Gelclair. And for the U.S. market, this is our first building block into this new franchise.

Napo exhibited at the Oncology Nursing Society Congress last month in Washington, D.C. where we drove awareness among the oncology nursing community about our expanding focus on cancer supportive care as nurses play, of course, a vital role in providing integrative supportive care to cancer survivors, cancer patients under treatment to meet the various physical, psychological and social support needs.

The reception to Gelclair at this conference and we had a booth at the ONS conference was fantastic. Numerous oncology nurses told us how pleased they were to learn that this product which was available in the U.S. a number of years ago is coming back. Gelclair is paradigm shifting and fits with our model of paradigm shifting solutions in supportive care in addressing mucositis in that it's [indiscernible], it's calming, it's protective to the patient, it's an adhesion to the patient rooms, not just an attempt to numb the mouth to pain as is the approach with current available treatments.

It's clear from the conversations we had at the ONS conference with nurses from around the country that Gelclair is beloved by the training community and patients. And we're so pleased to say, it's back. The next large oncology event at which we will exhibit is the American Society of Clinical Oncology, ASCO. It's the annual meeting, which always takes place in Chicago this year, May 31 to June 4. It's the largest cancer gathering each year attended by more than 40,000 oncology professionals and from around the world.

So I'll now turn to our second shot on goal or other shot on goal and that's for crofelemer. And that is our focus on rare disease indications of crofelemer. This is a distinct formulation of our crofelemer, distinct from Mytesi, and therefore, a distinct product. It's highly [indiscernible] to be a highly concentrated liquid administered. Jaguar has 5 clinical efforts across the globe, North America, Europe and the Middle East, including multiple FDA and international regulatory filings to support clinical testing of crofelemer for intestinal failure associated with short bowel syndrome and the ultrarare pediatric indication of congenital diarrheal diseases and very specifically, you'll hear MVID, microvillus inclusion disease, which is a very specific congenital diarrheal disorder.

I just returned yesterday from -- or actually last week from an overseas trip to meet with professionals and their patients, several of our clinical investigators. And I have to say the humble nature and devotion of these health care professionals to their patients. And their patients are frequently on parenteral nutrition for as long as 20 hours a day, 7 days a week, some of them don't leave hospital care for years at a time. This is catastrophic for the patient. Yet, as I mentioned, the nature of the health care providers was absolutely heartwarming.

The entire Jaguar Napo team that I was with couldn't help feeling that these health care professionals are doing God's work. And I mean that in the colloquial sense, not the religious sense, though it is interesting because one of the hospitals that we were visiting was right next to the Vatican.

Our goal, our near-term clinical benchmark for intestinal failure is to generate clinical proof of concept in both the MVID and the short bowel syndrome patients. In support of potential reimbursed early patient access generation in 2024 for crofelemer for these rare diseases, and we do have orphan designation for both [indiscernible] syndrome and MVID in the U.S. and Europe. But to generate the early patient access in Europe, which is a program that does not exist in the United States.

So to wrap this up through the process of sustainably bringing crofelemer from the tree in the rainforest to a product, Mytesi, in endopharmacy, we want across the United States. Currently, for the supportive care indication of adults living with HIV who have noninfectious diarrhea, we at Jaguar have gained a great deal of experience about educating health care professionals and patients and payers about the paradigm shifting mechanism of action.

We learned too from the veterinarian parent response to our crofelemer prescription product Canalevia, which is -- conditions Canalevia C1, which is conditionally approved by the center of veterinary medicine of the FDA for chemotherapy-induced diarrhea of dogs. We have a deep, deep dedication to patient supportive care. Now is the time, and we look forward to continuing to develop and commercialize prescription pharmaceuticals for essential supportive care and management of neglected symptoms across multiple complicated disease states for patients in need all around the world.

We will now hear from our CFO, Carol Lizak, regarding the financial highlights from the first quarter of 2024, and then I will be back.

[Carol Lizak, executive]

Thank you, Lisa. Thank you all for joining our webcast today. Thank you. I'll begin my review of our financials for the first quarter of 2024. The combined net revenue for the company's crofelemer prescription products, Mytesi, Canalevia-CA1 and $4 million in the first quarter of 2024, representing an increase of approximately 20% over the combined net revenue in the first quarter of 2023, which totaled approximately $2 million and an increase of approximately 4% over the combined net revenue in the fourth quarter of 2023 which totaled about $2.3 million.

Mytesi prescription volume decreased in the first quarter of 2024 compared to the fourth quarter of 2023 by 7%, which occurs every year as commercial and Medicare insurance deductibles reset and result in higher co-pays for patients in Q1. Prescriptions decreased slightly by 2.5% in the first quarter of 2024 compared to the first quarter of 2023. Prescription volume differs from the invoiced sales volume, which reflects, among other factors, varying buying patterns among specialty pharmacies in the closed network as they manage their inventory levels.

Loss from operations decreased by $1.6 million from $9.9 million in the quarter ended March 31, 2023, to $8.2 million during the same period in 2024. Non-GAAP recurring EBITDA for the first quarter of 2024 and the first quarter of 2023 were a net loss of $7.5 million and $9 million, respectively. Net loss attributable to common shareholders decreased by approximately $2.9 million from $12.2 million in the quarter ended March 31, 2023, to $9.2 million in the same period in 2024.

That concludes my recap of high-level financials for the first quarter of 2024. I will now hand the discussion back to Lisa.

[Lisa Conte, executive]

I do want to just clarify something that I said earlier, and that's regarding early patient access for crofelemer for intestinal failure in Europe. So I mentioned that it's based on proof-of-concept results. Those results may start coming in 2024 and 2025, we would expect the early patient access reimbursed program, therefore, based on those results to occur in 2025.

And with that, I want to thank you all again. We're highly, highly energized about all the important near-term initiatives, including newly the launch of upcoming launch of Gelclair. And what is now imminent results from OnTarget cancer therapy-related diarrhea. Our Phase III clinical trial for crofelemer and this is a formulation that we currently have on the market, Mytesi. Thank you all for the support to develop and commercialize prescription pharmaceuticals, plant-based for essential supportive care and management and neglected symptoms across multiple complicated disease states with a very strong focus right now on cancer patients in need around the world. And that's the conclusion of our call for today. Have a good day.

[Operator]

And this concludes today's call.