Clearpoint Neuro Inc

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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 on 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 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, exceptions -- 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-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 these 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.

Thank you very much. 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.

This is an earnings webcast. Again, I'm pleased to say I'm going to steal the thunder of our CFO, Carol Lizak, as we report that our net 2024 revenue increased approximately 20% versus net revenue for the year ended December 31, 2023, approximately $11.7 million for 2024 versus the net revenue of $9.8 million for 2023. The total net Q4 2024 revenue of approximately $3.5 million increased approximately 53% versus net Q4 2023 revenue of $2.3 million and 13% versus the net Q3 2024 revenue of $3.1 million. After I speak, our CFO, Carol Lizak, will provide a more detailed recap of the financial highlights for the fourth quarter of 2024.

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. 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 in 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 and 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 3 other members of the company's Board of Directors, 7 of their 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 crofelemer and believe in crofelemer'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 2025, 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 36th anniversary of our team's focus on crofelemer. In the next weeks and months, there will be a convergence of important catalysts for our 2 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 catalysts. 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 microvillus 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 SBS-IF.

MVID and SBS-IF 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, et cetera. And they're on total parenteral nutrition, TPN, which refers to the delivery of electrolytes and nutrients via IV up to 20 hours a day, 7 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 SBS-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. 10% to 20% is what we're seeking in patients treated with crofelemer. 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 that and illustrate the life journey of patients as described to us by a committed health care professional who specializes in their treatment. Imagine a child born not thriving, putting out cholera levels of stool from the moment they are 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 2 ongoing proof-of-concept investigator-initiated trials, they're called IITs, investigator-initiated trials, and also conducting 2 Phase II studies, placebo-controlled of crofelemer for MVID and SBS-IF 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 2025, 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 Ped-Gi Conference taking place this month, April, in Abu Dhabi. And it's led by Dr. Mohamad Miqdady, the principal investigator for the ongoing pediatric investigator-initiated trial of crofelemer for MVID and SBS-IF, and it's being conducted at the Sheikh Khalifa Medical City, a flagship tertiary hospital in UAE. Napo-Jaguar is a Bronze Sponsor of the Elite Ped-Gi 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 MVID. 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 crofelemer. This may potentially qualify crofelemer for participation in PRIME, a fast track European Medicines Agency, EMA, 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 unmet medical needs.

We've already had preliminary interactions with PRIME officials. PRIME designation could bring crofelemer 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 2026, potentially full approval as early as the end of 2026. 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 8 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 formulation development. These rare disease studies while evaluating crofelemer, which is the active agent in Mytesi, are instead utilizing a distinct, novel, highly concentrated liquid formulation of crofelemer. It's a different product. This is not the commercialized formulation of crofelemer, brand name Mytesi, which is an oral tablet.

Due to the intestinal failure of these patients, an oral tablet formulation of crofelemer 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, teduglutide, which is a GLP-2 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.

I'm going to move now to our second major program, Mytesi, our FDA-approved prescription product for HIV and AIDS-related diarrhea. For those following the story, Jaguar has completed a Phase III OnTarget clinical trial of Mytesi. 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 prespecified OnTarget 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 crofelemer was more than twice as effective as placebo in monthly breast cancer patient responders during the trial's initial 3-months treatment stage, the typical responder rate of the approved crofelemer, again, under the brand name Mytesi.

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 OnTarget study for consideration at the conference, it's referred to as MASCC, Multicentral (sic) [ Multinational ] Association of Supportive Care. And their meeting -- their annual meeting is in June 2025 this year in Seattle.

What's different for Mytesi for breast cancer therapy-related diarrhea? As I announced last week, the FDA has granted us a Type C face-to-face meeting in the second quarter of 2025 to review the OnTarget results in breast cancer patients. Our goal for this meeting is to discuss the most efficient pathway to expand the approved indication of Mytesi 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 further 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, Gelclair, 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 treatment programs, which have an extremely high and predictable rate of mucositis, one of the worst side effects in cancer patients. There is a strategy for future expansion into the general oncology market, hopefully, coincident with Mytesi approval for breast cancer prophylaxis, diarrhea prophylaxis.

And I do want to mention for our dog families out there, Canalevia-CA1, 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 Lizak for her recap of the financial highlights for the fourth quarter of 2024. You're on, Carol.

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 Mytesi, Gelclair and Canalevia-CA1, nonprescription products and license revenue was approximately $11.7 million in the year 2024, representing an increase of approximately 20% versus the total net revenue in the year 2023, which totaled approximately $9.8 million.

The total net revenue for the company's prescription products, nonprescription products and license revenue was approximately $3.5 million in the fourth quarter of 2024, representing an increase of 13% over the total net revenue in the third quarter of 2024, which totaled approximately $3.1 million, and an increase of approximately 53% over the total net revenue in the fourth quarter of 2023, which totaled about $2.3 million.

Mytesi prescription volume increased approximately 3.9% in the year 2024 over 2023. Mytesi prescription volume increased by about 3.4% in the fourth quarter of 2024 over the third quarter of 2023 and increased approximately 9.4% in the fourth quarter of 2024 over the fourth quarter of 2023. 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 $3.5 million from $34.3 million for the year ended December 31, 2023, to $30.8 million during the same period in 2024. Non-GAAP recurring EBITDA for 2024 and 2023 were a net loss of $34.7 million and $34.5 million, respectively. Net loss attributable to common shareholders decreased by approximately $2.8 million from $41.3 million in the year ended December 31, 2023, to $38.5 million 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 Conte.

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 2 programs and our ongoing efforts to identify business development partners, drive investment interest and funding opportunities and enhance value for all our stakeholders. I 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.

Thank you. This does conclude today's webcast. We appreciate your participation. You may disconnect at this time.