Q4 2024 Jaguar Health Inc Earnings Call
and Certaintees Regarding Market
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Conference Host/Operator: Today's conference is being recorded. At this time, it's my pleasure to turn the call over to Lisa Conte. Jaguar for Health's founder, president and chief executive officer, Lisa, the floor is yours.
Thank you very much.
Conference Host/Operator: Hello, and thank you all for joining our Investor Webcast this morning. As you heard, my name is Lisa Conte. 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.
Conference Host/Operator: This is an earnings webcast. Again, I'm pleased to say I'm going to steal the thunder of our CFO , Carol Lizak.
Conference Host/Operator: versus Net Revenue for the Year and December 31, 2023. Approximately $11.7 million for 2024 versus the Net Revenue of $9.8 million for 2023.
Conference Host/Operator: Acrease to possibly 53% versus NetQ4 2023 Revenue of $2.3 million and 13% versus the NetQ3 2024 Revenue of $3.1 million.
Conference Host/Operator: As you'll hear, as I address our ongoing commercial and development efforts, we have multiple near-term catalysts in Q2 2025 and throughout 2025 that we view as significant and value-enhancing.
These are the reasons for why Jaguar why now.
Conference Host/Operator: 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.
Conference Host/Operator: 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 lock
Conference Host/Operator: Qualify a pipeline assets for a paradigm shifting regulatory pathways with both the FDA and the ENA of Europe and lead to an approved drug.
Conference Host/Operator: Blockbuster is first and foremost for the modification of disease progression for patients. It all starts with patient needs and outcomes.
Conference Host/Operator: 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.
Conference Host/Operator: So, beyond living with these diseases, and I do emphasize living versus just existing also addressing quality of life for patients and their community of caregivers.
Conference Host/Operator: 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, the bridge financing.
Conference Host/Operator: The participants who invested in this offering in addition to myself
Includes three other members of the company's Board of Directors.
Conference Host/Operator: 7. Other C-suite and senior executives of Jaguar, along with selected institutional and accredited investors, including predominantly long-term holders, investors in some cases, who have invested for decades in Crophelomer, and believe in Crophelomer's paradigm-shifting mechanism-vaccine and our shared commitment to bring this novel, plant-based prescription and drug to patients in need around the world.
Conference Host/Operator: <unk> for short bowel syndrome within kits and I'll tell you I'll refer to that as SBS I F.
Conference Host/Operator: N V I D and S. P. S. I S are situations, where the intestines to these patients children in many cases are failing.
Conference Host/Operator: So theyre not able to absorb the nutrients of life protein car vitamins et cetera, and there.
Conference Host/Operator: On total parenteral nutrition TPN.
Conference Host/Operator: Which refers to the delivery of electric lights, and nutrients via IV up to 20 hours a day seven days a week.
Conference Host/Operator: It's a catastrophic chronic situation for these patients.
Conference Host/Operator: Patients are in a fragile state and children in particular or off normal growth curves.
Conference Host/Operator: Failing to thrive.
Conference Host/Operator: N V I D N S. P. S. I S has severe morbidity and mortality implications metabolic complications liver problems devastating diarrhea, and dehydration the risk of series T. P N remediate infections and impact the quality of life, obviously a book patients.
Conference Host/Operator: In their caregivers the entire family.
Speaker Change: The brass ring opportunity.
Speaker Change: Is to be able to meaningfully reduce the need for T. P. M, 10% to 20% is what we're seeking in patients treated with kusama chronic treatment. This is not a transient effect. The goal is to modify the disease progression associated with intestinal failure with better nutrient absorbed.
Speaker Change: And reduction in T P and need.
Speaker Change: The highlight in that and illustrate the life journey of patients as described to us by our committed health care professionals, who specializes in their treatment.
Speaker Change: Imagine a child born.
Speaker Change: Not thriving.
Speaker Change: Putting out holleran levels, a stool from the moment their board and immediate risk of severe dehydration.
Speaker Change: And then the parents finding out and N V I D diagnosis and that their child will be on night IV nutrition for the rest of their life.
Speaker Change: The parent is informed that the typical life expectancies in the early teens.
Speaker Change: 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.
Speaker Change: This is life changing for the entire family.
Speaker Change: A reduction in T. P N need can allow the child to perhaps attend school for a bit of time go to a movie 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 I D.
Speaker Change: The company Jaguar is currently supporting two ongoing proof of concept of investigator initiated trials you called the <unk> investigator initiated trials.
Speaker Change: Also conducting two phase two studies placebo controlled of quick Palomar for N V. I D. N S. P. S. I F in the U S Europe and Mena regions.
Speaker Change: Ts are.
Speaker Change: Blinded proof of concept trials, which allow data to be obtained quickly from real world experience.
Speaker Change: The first proof of concept I I T results are expected to be available in Q2 2025, just around the corner with additional proof of concept I I T.
Speaker Change: T results expected throughout the years.
Speaker Change: The first patients are already who.
Speaker Change: This is an important.
Speaker Change: There is an important pediatric gastroenterology conference the annual elite TGI conference taking place this month.
Speaker Change:
Speaker Change: You know Abu Dhabi, and it's led by Dr. Mohammed Mcatee, the principal investigator for the ongoing pediatric investigator initiated trials of <unk>, where N V. I D. N S. P. S I S.
Speaker Change: Is being conducted at the shake loose and medical city, a flag ship tertiary hospital in UAE.
Speaker Change: Nappo Jaguar is the bronze sponsor of the lead Pgi event again this year in.
Speaker Change: And potentially initial proof of concept data.
Speaker Change: The AVO dog study will be presented at this conference.
Speaker Change: There are currently no approved drug treatments for N V. I D. The standard of care is P. P M.
Speaker Change: The fact that no approved treatments exist for N V. I D opens up several important opportunities for the company and the patients we studied.
Speaker Change: We expect did even just a very small number of N V. I D patients show proof of concept benefit book, how cross selling there.
Speaker Change: This may potentially qualify from selling or for participation in right.
Speaker Change: Fast track European Medicines agency, DNA, which is the equivalent of the FDA for European countries.
Speaker Change: The prime program, providing enhanced interaction and early death.
Speaker Change: Dialogue with drug developers of novel medicines targeting unmet medical needs. We've already had preliminary interactions with prime officials prime designation could bring cross selling or four N V. I G to full approval in the 'twenty seven European countries EU countries.
Speaker Change: With a single digit number of patients showing benefit.
Speaker Change: As early as the end of 2026 potentially full approval as early as the end of 2026.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: These programs exist.
Speaker Change: Because these agencies genuinely want to help patients with rare disorders.
Speaker Change: Of course, a safe.
Speaker Change: The expedited manner.
Speaker Change: We're a company rare disease programs can significantly reduce both the time and cost with bringing a drug to market full approval reimbursement.
Speaker Change: Huge.
Speaker Change: 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.
Speaker Change: Principal investigators around the world regulatory interactions and protocol development endpoint definition and formulation development.
Speaker Change: These rare disease studies, while evaluating <unk>, which is the active agent in my Tessie are instead utilizing a distinct novel highly concentrated liquid formulation of cross selling or it's a different product. This is not the commercialized formulation of my of cross selling there.
Speaker Change: Brand name my chassis, which is an oral tablet.
Speaker Change: Two the intestinal failure. These patients an oral tablet formulation of <unk> is not viable in most cases it would land in the toilet.
Speaker Change: Our team has developed a novel proprietary highly concentrated lyophilize pant crowder.
Speaker Change: For oral solution.
Speaker Change: Which is again a different product.
Speaker Change: Supporting a different business model of small populations for orphan indications with high morbidity and mortality high patient advocacy and high expense.
Speaker Change: As an example to nucleotide which is a G. L. P to analog approved and short bowel syndrome patients, though it's not standard of care and has limited utility. Nevertheless is reimbursed at the rate of approximately $500000 a year in the United States and several hundred thousands of dollars a year in Europe.
Speaker Change: Yeah.
Speaker Change: When you move now to our second major program.
Speaker Change: Kasey are FDA approved prescription products for HIV and AIDS related diarrhea.
Speaker Change: For those following the story Jaguar has completed a phase III on target clinical trial of my Tessie, 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.
Speaker Change: Bold.
Speaker Change: Hub for the cancer community.
Speaker Change: We did not hit the primary endpoint for all tumor types.
Speaker Change: As I mentioned it was a big Bowl Global study however, in the pre specified on target subgroup of adult patients with breast cancer.
Speaker Change: We have statistically significant data in a responder analysis, which was presented.
Speaker Change: At the acclaimed San Antonio breast cancer Symposium this past December.
Speaker Change: Results presented at San Antonio demonstrate that cross selling or it was more than twice as effective as placebo.
Speaker Change: In monthly breast cancer patient responders during the trials initial three months treatment stage.
Speaker Change: Typical responder rate of the approved profiling or again under the brand name My Tessie.
Speaker Change: As we were pleased to announce this past Thursday, Nappo Jaguar recently submitted a late breaker abstract.
Speaker Change: To another conference the multinational association of supportive care in cancer.
Speaker Change: Additional significant results in adult breast cancer patients from the on target study.
Speaker Change: For consideration.
Speaker Change: At the conference, it's referred to as mass multi Central Association of supportive care and they're meeting their annual.
Speaker Change: Meeting is in June.
Speaker Change: 2025, this year in Seattle.
Speaker Change: What's different for my testing for breast cancer therapy related diarrhea.
Speaker Change: As I announced last week.
Speaker Change: The FDA has granted us a type C face to face meeting in the second quarter of 2025 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 my test seem to include.
Speaker Change: The prophylaxis of cancer therapy related diarrhea, and adult breast cancer patients.
Speaker Change: Supplemental approval would provide patient access and reimbursement.
Speaker Change: I'm pleased to say.
Speaker Change: That patient advocates.
Speaker Change: Who are former members of our scientific Advisory Board and also part of the Jaguar community.
Speaker Change: Through our unbranded patient Ambassador program make cancer a shitty.
Speaker Change: Our participants in our regulatory approach.
Speaker Change: Their participation highlights not just statistical analysis of this study.
Speaker Change: Also the impact on patient dignity.
Speaker Change: Quality of life.
Speaker Change: And the ability to stay on therapeutic doses of their lifesaving cancer medication.
Speaker Change: As further commitment to cancer supportive care and there are 21 unmet needs associated with supportive care in cancer treatment.
Speaker Change: We are continuing with our first commercial launch of the FDA approved oral mucositis prescription product gel clear our third commercialize prescription product in the United States.
Speaker Change: This is a focused and deliberate launch into bone marrow transplant centers and head and neck radiation treatments programs, which have been extremely high and predictable rate of Mucositis one of the worst.
Speaker Change: <unk> cancer pain.
Speaker Change: There is a strategy for future expansion into the general oncology market, hopefully coincident with my tsetse approval for breast cancer prophylaxis diarrhea prophylaxis.
Speaker Change: And I do want to mention for dumped families out there.
Speaker Change: D C. A one conditionally approved for chemotherapy induced diarrhea is available for patients who have cancer and chemo therapy induced diarrhea.
Speaker Change: <unk> are a dog.
Speaker Change: An important quality of life issue to address for both the dog and the entire household when a dog has loss control.
Speaker Change: Those are also an extremely relevant and predictive model for the human situation.
Speaker Change: I will now hand, the discussion over to characterize that for her recap of the financial highlights for the fourth quarter 2020 for Euro and Carol.
Speaker Change: Good morning, Lisa and thank you to all of you who have joined our webcast today.
Speaker Change: I'll begin my review of our financials for the year 2024.
Speaker Change: The total net revenue for the Companys prescription products. Those are my tsetse gel Claire and cannot leave you'll see a one.
Speaker Change: Nonprescription products and license revenue was approximately $11.7 million from the year 2024.
Speaker Change: Representing an increase of approximately 20% versus the total net revenue in the year 2023, which totaled approximately $9.8 million.
Speaker Change: The total net revenue for the Companys prescription products non.
Speaker Change: Nonprescription products and license revenue was approximately three and a half a million in the fourth quarter of 2024.
Speaker Change: Representing an increase of 13%.
Speaker Change: Over the total net revenue in the third quarter of 'twenty 'twenty four.
Speaker Change: Which totaled approximately 3.1 million and an increase of approximately 53% over the total net revenue.
Speaker Change: In the fourth quarter of 2023.
Speaker Change: Which totaled about $2 $3 million.
Speaker Change: My tested prescription volume increased approximately three 9% in the year 'twenty 'twenty four.
Speaker Change: 2023.
Speaker Change: Mike chassis prescription volume.
Speaker Change: Increased by about 3.4 percents in the fourth quarter of 2024.
Speaker Change: For the third quarter of 2023 and increased approximately 9.4% in the fourth quarter of 2024 over the fourth quarter of 2023.
Speaker Change: Prescription volume differs from Invoiced sales volume.
Speaker Change: Which reflects among other factors varying buying patterns among specialty pharmacies in the closed network as they manage their inventory levels.
Speaker Change: Yeah.
Speaker Change: Loss from operations.
Speaker Change: Decreased by three and a half a million dollars from $34 3 million for the year ended December 31, 2000 $23 million to $38 million during the same period in 2024.
Speaker Change: non-GAAP recurring EBITDA for 2024, and 22 123, where in that loss of $34 7 million and 34 and a half million dollars respectively.
Speaker Change: Net loss attributable to common shareholders.
Speaker Change: Kris by approximately 2.8 million from $41 3 million in the year ended December 31 2023.
Speaker Change: The 38 and a half million dollars in the same period in 2024.
Speaker Change: That concludes my recap of high level financials for the year 2024.
Louisa Coffee: I will now hand, the discussion back to Louisa coffee.
Louisa Coffee: Thank you Carol.
Louisa Coffee: Thank you all once again for joining our webcast today all members of the Jaguar in Napa and Napa Therapeutics family are energized and excited about the multiple expected near term catalysts in the second quarter of this year and throughout 2025.
Louisa Coffee: All of which we view as significant.
Louisa Coffee: In value enhancing and the variables that make this a different time for Jaguar and that though.
Louisa Coffee: These catalysts represents the convergence of key potential inflection points in your major two programs and our ongoing efforts to identify business development partners drive investment interest in funding opportunities enhanced value for all our stakeholders I really look forward to our next quarterly update as these catalysts are in full.
Louisa Coffee: All the best to you and the entire Jaguar community, including especially our patient focus.
Louisa Coffee: Have a good day.
Speaker Change: Thank you. This does conclude today's webcast. We appreciate your participation you may disconnect at this time.
Louisa Coffee: Okay.
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Louisa Coffee: Thank you.
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Louisa Coffee: Thanks.
Louisa Coffee: [music].
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