Earnings call transcript: Jaguar Health sees revenue growth in Q4 2024

Jaguar Health Inc. (JAGX), with a market capitalization of $2.62 million, reported a notable increase in revenue for the fourth quarter of 2024, with net revenue rising 53% compared to the same period in 2023. This growth was driven by increased Mytesi prescription volumes and advancements in their product pipeline. According to InvestingPro analysis, the company maintains a strong gross profit margin of 80.1%, though it faces significant operational challenges. Despite a decrease in losses from operations, the company’s stock experienced a decline in the regular trading session but saw a recovery in premarket trading.

Key Takeaways

• Q4 2024 net revenue increased by 53% year-over-year.
• Full-year 2024 revenue grew by 20% compared to 2023.
• Loss from operations decreased by $3.5 million.
• Stock price fell by 7.06% in regular trading but rose 3.4% in premarket.

Company Performance

Jaguar Health demonstrated strong revenue growth in the fourth quarter of 2024, with net revenue of $3.5 million, marking a 53% increase from Q4 2023. The full-year revenue reached $11.7 million, up 20% from the previous year. The company attributed this growth to the rising demand for its Mytesi product and its ongoing efforts in product development.

Financial Highlights

• Revenue: $11.7 million for 2024, up 20% from 2023.
• Q4 2024 revenue: $3.5 million, up 53% from Q4 2023.
• Loss from operations: $30.8 million, reduced from $34.3 million in 2023.
• Non-GAAP recurring EBITDA: Net loss of $34.7 million in 2024.

Outlook & Guidance

Jaguar Health is optimistic about its future, with key catalysts expected in Q2 2025. The company is looking forward to potential collaborations, business development deals, and licensing opportunities. It also anticipates the first proof of concept trial results in Q2 2025 and hopes for a PRIME designation in the EU by the end of 2026.

Executive Commentary

CEO Lisa Conte highlighted the potential of the company’s pipeline assets, stating, "These catalysts are the hidden variables that can move a pipeline asset to the potential of Blockbuster." She also emphasized the impact of their treatments on patients’ lives, noting, "A reduction in TPN need can allow the child to perhaps attend school for a bit of time, go to a movie, a birthday party."

Risks and Challenges

• Regulatory hurdles: The company is pursuing fast-track regulatory pathways, which can be unpredictable.
• Market competition: As the company targets niche markets, it faces potential competition from larger pharmaceutical companies.
• Financial sustainability: Despite reduced losses, the company continues to operate at a loss, which may affect long-term viability.
• Dependence on key products: Continued reliance on products like Mytesi could pose risks if market dynamics change.

Jaguar Health’s recent performance highlights its growth potential, but the company must navigate several challenges to maintain momentum and achieve its strategic goals.

Full transcript - Jaguar Health Inc (JAGX) Q4 2024:

Unidentified Moderator, Jaguar Health: Greetings, and welcome to the Jaguar Health Investor webcast. 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 can 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 a 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 section of the company’s Form 10 ks for the year 2024, which was filed 03/31/2025, 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 to 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 this 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 Conte, Jaguar Health’s Founder, President and Chief Executive Officer. Lisa, the floor is yours.

Lisa Conte, Founder, President and CEO, Jaguar Health/NAPO Pharmaceuticals: Thank you very much. Hello, and thank you all for joining our investor webcast this morning. As you heard, my name is Lisa Conti. I’m the Founder, President and CEO of Jaguar Health and our wholly owned subsidiary, NAPO Pharmaceuticals, and I’m the Chairman of our Italian subsidiary, NAPO Therapeutics. As usual, I may use the words Jaguar and NAPO interchangeably to refer to our company and our activities.

This is an earnings webcast. Again, I’m pleased to say I’m going to steal the thunder of our CFO, Carol Isaac, as we report that our net 2024 revenue increased approximately 20% versus net revenue for the year ended 12/31/2023, approximately $11,700,000 for 2024 versus the net revenue of $9,800,000 for 2023. The total net Q4 twenty twenty four revenue of approximately $3,500,000 increased approximately 53% versus net Q4 twenty twenty three revenue of $2,300,000 and 13% versus the net Q3 twenty twenty four revenue of $3,100,000 dollars After I speak, our CFO, Carol Isaac will provide a more detailed recap of the financial highlights for the fourth quarter of twenty twenty four. As you’ll hear as I address our ongoing commercial and development efforts, we have multiple near term catalysts in Q2 twenty twenty five and throughout 2025 that we view as significant and value enhancing. These are the reasons for why Jaguar, why now.

With long development cycles of drug development, large investments with blinded studies, it can feel a bit insane to expect a different outcome for the company’s valuation. Catalysts are what’s different. These are the hidden variables. These are the transformative events that can move a pipeline asset to the potential of Blockbuster qualify a pipeline asset for paradigm shifting regulatory pathways with both the FDA and the EMA of Europe and lead to an approved drug. Blockbuster is first and foremost for the modification of disease progression for patients.

It all starts with patient needs and outcomes. We are a supportive care focused company and that addresses not only patient outcomes and for Jaguar these patient populations are cancer patients and people living with HIV AIDS and rare disease situations such as intestinal failure associated with short bowel syndrome and congenital diarrheal diseases. So beyond living with these diseases and I do emphasize living versus just existing, also addressing quality of life for patients in their community of caregivers, patient dignity and patient comfort. Blockbuster indications have the potential to benefit all our stakeholders and that includes of course the investment community and our shareholders. That brings me to the bridge financing that Jaguar announced just last week.

The participants who invested in this offering, in addition to myself, include three other members of the company’s Board of Directors, seven other c suite and senior executives at Jaguar, along with selected institutional and accredited investors including predominantly long term holders, investors in some cases who have invested for decades in Cofelamer and believe in Cofelamer’s paradigm shifting mechanism of action and our shared commitment to bring this novel plant based prescription drug to patients in need around the world. This is a bridge financing, a bridge to what? The participating investors understand that a number of key catalysts are expected to occur in the second quarter of twenty twenty five and the whole Jaguar NAPO team is pleased and honored that they participated in this offering and about the confidence that their participation reflects. This is our opportunity for a catalyst driven different outcome. We just passed, believe it or not, the thirty sixth anniversary of our team’s focus on Crofilmer.

In the next weeks and months, there will be a convergence of important catalyst for our two major programs, rare orphan diseases of intestinal failure and cancer therapy related diarrhea. And what’s the manifestation of that? We are working towards and expect these catalysts to lead to significant collaborations, business development, licensing deals, the opportunity to bring in non dilutive dollars to support bringing these late stage products and programs to regulatory approval and reimbursed patient access. Let’s get to the definition of the catalyst. First, I’m going to talk about our intestinal failure rare disease program, particularly the intestinal failure associated with an ultra rare congenital diarrheal disease called microvillous inclusion disease.

I’m going to refer to that to MVID, and for short bowel syndrome with intestinal failure. I’ll refer to that as SBSIF. MVID and SBSIF are situations where the intestines of these patients, children in many cases, are failing. So they’re not able to absorb the nutrients of life, protein, carbs, vitamins, etcetera. And they’re on total parenteral nutrition, TPN, which refers to the delivery of electrolytes and nutrients via IV up to twenty hours a day, seven days a week.

It’s a catastrophic chronic situation for these patients. These patients are in a fragile state and children in particular are off normal growth curves failing to thrive. MVID and SPS IF have severe morbidity and mortality implications, metabolic complications, liver problems, devastating diarrhea and dehydration, the risk of serious TPN related infections and impact the quality of life obviously of both patients and their caregivers, the entire family. The brass ring opportunity is to be able to meaningfully reduce the need for TPN. Ten percent to twenty percent is what we’re seeking in patients treated with Cofelmar.

Chronic treatment, this is not a transient effect. The goal is to modify the disease progression associated with intestinal failure with better nutrient absorption and reduction in TPN need. I want to highlight in that and illustrate the life journey of patients as described to us by a committed healthcare professional who specializes in their treatment. Imagine a child born not thriving, putting out cholera levels of stool from the moment they’re born, an immediate risk of severe dehydration, and then a parent finding out an MVID diagnosis and that their child will be on IV nutrition for the rest of their life. The parent is informed that the typical life expectancy is in the early teens.

In some cases, the child doesn’t leave the hospital for months or years. In other cases, the child, for the most part, is tethered to home care. This is life changing for the entire family. A reduction in TPN need can allow the child to perhaps attend school for a bit of time, go to a movie, a birthday party. In one case, we heard of a child whose goal was to be able to, for the first time, join in a Ramadan fasting for a day.

The company Jaguar is currently supporting two ongoing proof of concept investigator initiated trials. They’re called IITs, investigator initiated trials and also conducting two Phase two studies placebo controlled of crepelimer for MVID and SBSIF in The U. S, Europe and MENA regions. IITs are unblinded proof of concept trials which allow data to be obtained quickly from real world experience. The first proof of concept IIT results are expected to be available in Q2 twenty twenty five, just around the corner with additional proof of concept IIT results expected throughout the years.

The first patients are already enrolled. This is an important there is an important pediatric gastroenterology conference, the annual Elite PGI conference taking place this month, April in Abu Dhabi and it’s led by Doctor. Mohammad McDaddy, the principal investigator for the ongoing pediatric investigator initiated trial of Crophelamer for MVID and SDSIF and it’s being conducted at the Sheikh Khalifa Medical City, a flagship tertiary hospital in UAE. NAPO, Jaguar, is the bronze sponsor of the Elite PGI event again this year and potentially initial proof of concept data from the Abu Dhabi study will be presented at this conference. There are currently no approved drug treatments for MZID.

The standard of care is TPN. The fact that no approved treatments exist for MVID opens up several important opportunities for the company and the patients we study. We expect that even just a very small number of MVID patients show proof of concept benefit for prophylamer. This may potentially qualify prophylamer for participation in PRIME, a fast track European Medicines Agency, TMA, which is the equivalent of the FDA for European countries. The PRIME program providing enhanced interaction and early dialogue with drug developers of novel medicines targeting medical needs.

We’ve already had preliminary interactions with prime officials. Prime designation to bring CresselaMer for MVID to full approval in the 27 European countries, EU countries with a single digit number of patients showing benefit as early as the end of twenty twenty six, potentially full approval as early as the end of twenty twenty six. The analog to PRIME in The United States is the FDA’s breakthrough therapies program. If a drug is designated by the FDA as breakthrough therapy, the FDA will expedite the development and review of the drug. Both PRIME and the breakthrough therapies programs are all about getting extra resources at these agencies that are dedicated to this process creating internal champions at the regulatory agencies to help us.

These programs exist because these agencies genuinely want to help patients with rare disorders in of course a safe and expedited manner. For a company rare disease programs can significantly reduce both the time and cost with bringing a drug to market full approval reimbursement. It’s huge. This is an extremely exciting time for the company. These rare disease programs have been in the works at Jaguar for close to eight years as we have been developing close working relationships with the key opinion leaders, the principal investigators around the world, regulatory interactions and protocol development, endpoint definition and and development.

These rare disease studies while evaluating Crefelemer, which is the active agent in mitessi are instead utilizing a distinct novel highly concentrated liquid formulation of Cofelamer. It’s a different product. This is not the commercialized formulation of Cofelamer brand name Mitesse, which is an oral tablet. Due to the intestinal failure of these patients, an oral tablet formulation of Crefilamer is not viable. In most cases, it would land in the toilet.

Our team has developed a novel proprietary highly concentrated lyophilized powder for oral solution, which is again a different product supporting a different business model of small populations for orphan indications with high morbidity, high mortality, high patient advocacy and high expense. As an example, taneuglutide, which is a GLP2 analog approved in short bowel syndrome patients, though it’s not standard of care and has limited utility, nevertheless is reimbursed at the rate of approximately 500,000 a year in The United States and several hundred thousands of dollars a year in Europe. We’re going to move now to our second major program, MYKESI, our FDA approved prescription product for HIV and AIDS related diarrhea. For those following the story, Jaguar has completed a Phase three on target clinical trial of MiTESI. We completed that last year for the prophylaxis of diarrhea in cancer patients with 10 types of solid tumors on targeted therapy with or without cytotoxic chemotherapy, a big bold hug for the cancer community.

We did not hit the primary endpoint for all tumor types. As I mentioned, it was a big bold global study. However, in the pre specified on target subgroup of adult patients with breast cancer, We have statistically significant data in a responder analysis, which was presented at the acclaimed San Antonio Breast Cancer Symposium this past December. The results presented at San Antonio demonstrate that Cofelamer was more than twice as effective as placebo in monthly breast cancer patient responders during the trials initial three months treatment stage. The typical responder rate of the approved Crotellamer again under the brand name Mytesse.

As we were pleased to announce this past Thursday, NAPO Jaguar recently submitted a late breaker abstract to another conference, the Multinational Association of Supportive Care in Cancer on additional significant results in adult breast cancer patients from the on target study. For consideration at the conference, it’s referred to as MAS, Multicentral Association of Supportive Care. And their meeting, their annual meeting is in June 2025 this year in Seattle. What’s different for my test for breast cancer therapy related diarrhea? As I announced last week, the FDA has granted us a Type C Phase two Phase meeting in the second quarter of twenty twenty five to review the on target results in breast cancer patients.

Our goal for this meeting is to discuss the most efficient pathway to expand the approved indication of mitesi to include the prophylaxis of cancer therapy related diarrhea in adult breast cancer patients. A supplemental approval would provide patient access and reimbursement. I’m pleased to say that patient advocates who are formal members of our Scientific Advisory Board and also part of the Jaguar community through our unbranded patient ambassador program Make Cancer Less Shitty are participants in our regulatory approach. Their participation highlights not just statistical analysis of the study, also the impact on patient dignity, quality of life and the ability to stay on therapeutic doses of their life saving cancer medication. As for the commitment to cancer supportive care and there are 21 unmet needs associated with supportive care in cancer treatment, we are continuing with our first commercial launch of the FDA approved oral mucositis prescription product, GELCLARE, our third commercialized prescription product in The United States.

This is a focused and deliberate launch into bone marrow transplant centers and head and neck radiation treatments programs, which have an extremely high and predictable rate of mucoidosis, one of the worst side effects cancer pain. There is a strategy for future expansion into the general oncology market, hopefully, coincident with my TESI approval for breast cancer prophylaxis diarrhea prophylaxis. And I do wanna mention for dog families out there, PANELIVIA CA one, conditionally approved for chemotherapy induced diarrhea, is available for patients who have cancer and chemotherapy induced diarrhea and are a dog. An important quality of life issue to address for both the dog and the entire household when a dog has lost control. Dogs are also an extremely relevant and predictive model for the human situation.

I will now hand the discussion over to Carol Isaac for her recap of the financial highlights for the fourth quarter of twenty twenty four. You’re on, Carol.

Carol Isaac, CFO, Jaguar Health: Good morning, Lisa, and thank you to all of you who have joined our webcast today. I’ll begin my review of our financials for the year 2024. The total net revenue for the company’s prescription products, those are Mitesse, GELClare and CANALUVIA CA1, non prescription products and license revenue was approximately $11,700,000 in the year 2024, representing an increase of approximately 20% versus the total net revenue in the year 2023, which totaled approximately $9,800,000 The total net revenue for the company’s prescription products, non prescription products and license revenue was approximately $3,500,000 in the fourth quarter of twenty twenty four, representing an increase of 13% over the total net revenue in the third quarter of twenty twenty four, which totaled approximately $3,100,000 and an increase of approximately 53% over the total net revenue in the fourth quarter of twenty twenty three, which totaled about $2,300,000 My tested prescription volume increased approximately 3.9% in the year 2024 over 2023. My testy prescription volume increased by about 3.4% in fourth quarter of twenty twenty four over the third quarter of twenty twenty three and increased approximately 9.4% in the fourth quarter of twenty twenty four over the fourth quarter of twenty twenty three.

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 decreased by $3,500,000 from $34,300,000 for the year ended 12/31/2023 to $30,800,000 during the same period in 2024. Non GAAP recurring EBITDA for 2024 and 2023 were a net loss of $34,700,000 and $34,500,000 respectively. Net loss attributable to common shareholders decreased by approximately $2,800,000 from $41,300,000 in the year ended 12/31/2023 to $38,500,000 in the same period in 2024. That concludes my recap of High Level Financials for the year 2024.

I will now hand the discussion back to Lisa Conti.

Lisa Conte, Founder, President and CEO, Jaguar Health/NAPO Pharmaceuticals: Thank you, Carol. Thank you all once again for joining our webcast today. All members of the Jaguar, NAPO and NAPO Therapeutics family are energized and excited about the multiple expected near term catalysts in the second quarter of this year and throughout 2025, all of which we view as significant and value enhancing and the variables that make this a different time for Jaguar and Napo. These catalysts represent the convergence of key potential inflection points in our major two programs and our ongoing efforts to identify business development partners, drive investment interests and funding opportunities, enhance value for all our stakeholders. I’d really look forward to our next quarterly update as these catalysts unfold.

All the best to you and the entire Jaguar community, including especially our patient focus. Have a good day.

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