Q1 2025 Jaguar Health Inc Earnings Call

Yahoo

16-05-2025

Lisa Conte; President, Chief Executive Officer, Director; Jaguar Health Inc
Carol Lizak; Chief Financial Officer; Jaguar Health Inc
Operator
Greetings, and welcome to Jaguar Health's May 15, 2025, investor webcast. Before I turn the call over to management, I'd like to remind you that management may look -- 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 product 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 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 2024, which was filed March 31, 2025, 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 items of these non-GAAP measures provide investors with additional information that reflects the basis upon which company management assesses operates the business. These non-GAAP financial measures should not be viewed in isolation or a substitute for GAAP net sales and GAAP net loss and are not substitute 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 your host, Lisa Conte, Jaguar Health's Founder, President and Chief Executive Officer. Lisa, the floor is yours.
Lisa Conte
Thank you very much. Rob, and thank you for the introduction. Again, my name is Lisa Conte. And I -- as usual, I may use the words Jaguar and Nepo interchangeably to refer to our company. After I speak, our CFO, Carol Lizak, will provide a recap of the financial highlights for the first quarter of 2025.While our net revenue decreased in Q1 2025 versus Q4 2024. This was mostly driven by increased sales and higher distribution chain inventory levels in the fourth quarter of 2024, which resulted in fewer purchases in Q1 of 2025. This is in contrast to dispensed prescriptions for Mytesi, crofelemer which I am pleased to announce increased in the first quarter of 2025 versus the first quarter of 2024 by approximately 2%. This is an indication of increased demand and that more patients are receiving treatment for HIV-related diarrhea from Mytesi.To move on to the bigger picture for Jaguar. This is the year of convergence of key catalysts for Jaguar. Catalysts that we feel will be transformational in terms of the value they bring to all the stakeholders in the company. and this includes paradigm-shifting medicines and mechanisms of action to address patient supportive care, comfort, dignity, as well as disease progression modification, ability to stay on life-saving medicines and standard of care and more.To recap our -- both our recent and upcoming catalysts, on April 30, we released initial results from an independent proof-of-concept study in pediatric patients of a novel liquid formulation of crofelemer, a highly concentrated liquid formulation, which is distinct product from Mytesi, and crofelemer, of course, is our first-in-class plant-based prescription drug and this was for intestinal failure associated with MVID, microvillus inclusion disease.I'm going to refer to this as MVID. It's an ultra-rare disease. And also results that we released on that same date April 30 for intestinal failure associated with short bowel syndrome, which I'll refer to SBS-IF, another rare disease.Okay, what is intestinal failure? Intestinal failure is the condition where patients cannot adequately absorb the necessary nutrients of life: carbohydrates, protein, fats, vitamins, electrolytes, et cetera. The necessary absorption to sustain life.Patients with intestinal failure due to MVID and often short bowel syndrome, but with MVID required total parenteral nutrition, TPN, up to 7 days a week for more than 20 hours a day, and also are suffering from devastating diarrhea like everything that goes in, goes right out, the dehydration associated with that, electrolyte imbalance and more complications.TPN, total parenteral nutrition, to be graphic here, it's a medical feeding method where nutrients are delivered directly into a vein through an IV line bypassing the digest system. So chronic TPN has the risk of morbidity and mortality, infections from the lines, metabolic implications, LER and kidney disease problems, neurodevelopment delay, it's a catastrophic chronic situation.And it impacts in addition to all these medical issues, obviously, quality of life of both patients and their caregiver community. These patients are in a highly fragile state and children, in particular, with intestinal failure are off nor curves failing to thrive and MVID patients have a short life. They typically die at age of 11 or 12.For MVID patients, again, TPN is necessary from the first day of birth to survive. If they are not initially diagnosed and not put on TPN, they do not survive. There are no approved drug treatments for MVID or anything that we're aware of in development. The biggest impact we could have on a patient with intestinal failure, is an achievement of reduction in the quality and the time on TPN.The initial proof-of-concept results that we issued on April 30 showed that crofelemer reduced TPN in the first MVID patient to participate in the study by up to 27%, and for the first pediatric SBS patients by up to 12.5%. And I should say so far, there's -- these patients will continue on an open-label basis on crofelemer for some time.These results are groundbreaking. And they have the opportunity to modify disease progression for this catastrophic patient condition internal failure. These initial results are potentially transformative for the patients in their caregiving community, and it's not possible to overstate the significance of reduction in TPN.The results were presented April 26, 2025, at the Annual Elite Ped-Gi Conference, which was hosted by Dr. Mohamad Miqdady, he also presented the results, and he is a recognized leader in pediatric gastroenterology. This is conference, his brain trial that he established over 12 years ago. I think this was the 13, 14, 15 annual, and he serves as the Chief of Pediatric Gastroenterology, Hepatology and Nutrition at the Sheikh Khalifa Medical City in Abu Dhabi.He is the principal investigator for this ongoing exploratory single-arm, open-label, nonrandomized study for MVID and pediatric SBS patients and he's a member of our Scientific Advisory Board. This conference was a major international event, there were over 150 health care professionals participating.Right after his presentation on April 26, Dr. Miqdady and his colleague, (inaudible) took part in an extemporaneous fireside chat to discuss the initial findings of this study. And in a few minutes, we're going to replay the recording for you of that fireside chat in case anyone participating today did not take part or did not get a chance to hear this fireside chat in our April 30 Investor Webcast.The fireside chat was moderated by my longtime colleague in Jaguar's long term colleague, Dr. Province Davidi, the Chief Scientific Officer of Jaguar and Napo and the Chair of our Scientific Advisory Board. (inaudible) is the founder of the Pediatric Gastrointestinal Department at (inaudible), Children's Specialty Hospital in Dubai.And an Adjunct Clinical Assistant Professor at Mohamad Bin Rashid University of Medicine and Health in Dubai. He is also an investigator and key opinion leader in another trial of -- and as I said, you're going to see the real time medical reaction to these extraordinary results.This fireside chat was just moments after those results were presented.Our rare disease programs have been in the works at Jaguar for close to 8 years. And we have been developing close working relationships with KOLs, principal investigators around the world conducting regulatory interactions, developing protocols and endpoint definition, formulation development. These first proof-of-concept results are also catalyst to enhance potential business development plans for partnering with a goal of achieving funding through access and license fees for the extraordinary based development and success Jaguar has achieved over the years.These important results put us in a position to close collaboration -- potentially close collaborations with receipt of nondilutive dollars, as I mentioned, access fees and license fees. And there are many large deal precedents in the orphan drug space and several with much less clinical data, even preclinical opportunities at the time of deal closing.Well, short bowel syndrome affects approximately 10,000 to 20,000 people in Europe and roughly the same in the United States. MVID in that is an orphan designation, and we do have orphan designation for short bowel syndrome. MVID for which we also have orphan designation is an ultra-rare condition with an estimated prevalence of just a couple of hundred patients globally.Given this situation, initial results in a very small number of MVID patients showing benefit with crofelemer may allow us to lower pathways for expedited regulatory approval for this indication including the FDA of Europe, European Medicine Agency's program for expedited and assisted regulatory approval, full approval in the 27 countries of the EU and FDA's Breakthrough Therapy program for expedited regulatory approval in the United States, and we've already had preliminary interactions with PRIME officials at the EMA.In Jaguar in collaboration with Napo Therapeutics in Italy is currently supporting 2 ongoing proof-of-concept investigator-initiated trials in addition to the one that we've mentioned with Dr. Miqdady and also conducting 2 levo-controlled Phase II trials with crofelemer, one for MVID and one for adult short bowel syndrome intestinal failure, these trials are global in the U.S., Europe and MENA region, as you typically do with orphan-designated indications.So in addition to Dr. Miqdady, there is an investigator-initiated trial in adult patients with short bowel syndrome intestinal failure at Cleveland Clinic. And between these 2 studies, we expect to have proof of concept results from these investigator-initiated trials throughout 2025 and potentially even into 2026. At the same time, simultaneously running are the placebo-controlled Phase II trials for MVID and SBS, and they are expected to conclude and have results in the first half of 2026. So a lot, a lot, a lot of news associated with our rare disease program.And again, a convergence of results and important news based on almost 8 years of planning and development work on the part of the company.So moving on to our other core crofelemer development program, which also has a convergence of catalyst happening right now. OnTarget, was a global Phase III prophylactic clinical trial conducted by Jaguar, again, prophylaxis for diarrhea in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy. It was a big (inaudible) study, a big hug around the cancer community, including all solid tumor types, 24 different targeted agents again, with or without cytotoxic chemotherapy.What are targeted agents? Those are those agents that targeted [ CDK4/6 ] epidermal growth factor receptor antibodies, tyrosine kinase inhibitors, taken chronically, by metastatic patients and often 9 to 18 months in a cure the situation to keep the cancer at bay. We did not achieve statistical significance in this big bold study. However, the analysis in adult breast cancer patient indicates that crofelemer achieved significant results, statistically significant results in this prespecified subgroup the patients with breast cancer accounted for approximately 65% or 183 of the 287 participants in this study.The results in breast cancer patients were the subject of an accepted poster presentation in December 2024 at the acclaimed San Antonio Breast Cancer Symposium, an additional significant results in adult breast cancer patients from this OnTarget study have been accepted for presentation at the Multinational Association of Supportive Care and Conference, MASCC annual meeting next month in Seattle.The FDA has granted Jaguar, Jaguar-Napo again, we use those were named interchangeably -- a Type C meeting now the second quarter of 2025. To discuss the responder analysis, the statistical analysis in this prespecified subgroup of patients with breast cancer with prophylaxis with crofelemer for diarrhea, targeted therapy in the OnTarget trial. Our goal for the meeting is to discuss the most efficient pathway to make crofelemer available this patient population for cancer therapy-related diarrhea in the United States. And this is for the formulation currently known as Mytesi.And I want to contrast this with what we were talking about in the rare disease program, which is a new formulation, a new product into a different business model. This is literally the same formulation of crofelemer as Mytesi currently on the market.Diarrhea is a unfortunately, a very common side effect of targeted cancer therapies. There's about 21 unmet needs in supportive care area for cancer treatment. And adjusting this supportive care is important not only for patient comfort and dignity as important as this are, but also diarrhea can lead to dose changes, treatment delays or often even cancellation, cessation of treatment altogether, which now is having an impact on the outcome of the patient's cancer treatment.I will now hand the over to Carol Lizak, our Chief Financial Officer for her recap of the financial highlights for the first quarter 2025. Carol, take it away.
Carol Lizak
Good afternoon, Lisa, and thank you to all of you who have joined our webcast today. I'll begin my review of our financials for the first quarter of 2025. The total net revenue for the company's prescription products, Mytesi, Gelclair and Canalevia-CA1, nonprescription products and license revenue was approximately $2.2 million in the first quarter of 2025 a decrease of approximately 6% versus the first quarter of 2024. Revenue of $2.4 million and 37% versus net fourth quarter 2024 revenue of $3.5 million.Mytesi prescription volume increased by approximately 1.8% in the first quarter of 2025 over the first quarter of 2024 and decreased by approximately 13.5% in the first quarter of 2025 and over the fourth quarter of '24. 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.Loss from operations increased by $1.2 million from $8.2 million in the quarter ended March 31, 2024 to $9.4 million during the same period in 2025. Non-GAAP recurring EBITDA for the first quarter of 2025 and 2024, were a net loss of $9.7 million and $8.8 million, respectively. Net loss attributable to common shareholders increased by approximately $1.2 million from $9.2 million in the quarter ended March 31, 2024 to $10.4 million in the same period in 2025.That concludes my recap of high-level financials for the first quarter of 2025 and I will now hand the discussion back to Lisa Conte.
Lisa Conte
Thanks, Carol. So all members of Jaguar, Napo Pharmaceuticals, Napo Therapeutics in Italy, all of us in this family are energized and excited about the multiple expected near-term and recently completed catalysts throughout 2025 and beginning of 2026, all of which we view as important value-enhancing and potentially transformative for all our stakeholders, including, first and foremost, our patients.These catalysts, as I said, represent the convergence of key potential inflection points in our two major programs that have been in development for years, and we expect these catalysts to lead to important collaborations, business development and license deals and the opportunity to bring in nondilutive dollars to support these late-stage products and programs and get them to regulatory approval and reimbursed patient access.There's also another potential business development opportunity that I do want to mention. Our crofelemer product approved for chemotherapy-induced diarrhea in dogs use Canalevia-CA1 conditionally approved for chemotherapy-induced diarrhea in dogs the subject of business development conversations as well to support bringing the approval to include all noninfectious acute diarrhea in dogs. And it's really a very interesting situation at this time. If you are a patient in the United States with cancer and diarrhea, and you have 4 legs, we can educate and promote crofelemer as a dog, but not to a human, but not yet, and we're committed to make that happen.So we'll now play the recording for you of the fireside chat from the Elite Ped-Gi conference, which was the first of the really important catalysts for this year. It's about 12 minutes long. After the replay finishes, it will be the end of today's webcast. I will say my goodbyes and thank you and my gratitude for your participation at this time.Peter, I'll let you take it away and play the webcast.
Operator
This concludes today's conference. You may disconnect your lines at this time, and we thank you for your participation.