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spk01: 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 and technology 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 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 that 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 in this call for a variety of reasons. including those described in the forward-looking statements and risk factors section of the company's form 10K for the year ending December 31st, 2020, which was filed March 31st, 2021, 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 Health 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 growth sales, 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 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. As a reminder, today's conference is being recorded. At this time, it is my pleasure to turn the call over to Lisa Conte, Jaguar Health founder, president, and chief executive officer. Lisa, the floor is yours.
spk03: Thank you very much, and thank you for that comprehensive disclosure here. Welcome all. As you just heard, my name is Lisa Conti. I am the founder, president, and CEO of Jaguar Health and our wholly owned subsidiary, NAPO Pharmaceuticals. And I am a board member, chairman of the board of our majority owned subsidiary in Italy, NAPO EU. And I'm going to begin today with a brief recap of key clinical and product development updates. December is a key month of product development activity for Jaguar. We're so pleased that the results from our phase two or from the phase two, it's not our study, investigator-initiated HALT study of profilamer have been accepted for presentation at the prestigious San Antonio Breast Cancer Symposium. And that takes place from December 7th to December 10th of this year, just next month in San Antonio, Texas. The HALT study was sponsored by Georgetown University and it was funded by Genentech. It was a controlled study of the prevention of diarrhea in breast cancer patients on targeted therapy and a taxane chemotherapy drug. The study is independent from our pivotal phase three on target. That's the name of our study on target, which is profilamer for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy with or without cycle chemotherapy. We initiated our study. on target study in October 2020, and patient enrollment is ongoing. So back to the investigator-initiated HALT study. The poster will be presented at San Antonio by lead author Dr. Paula Polman, who has moved from Georgetown and is now a leading oncologist and associate professor at the University of Texas MD Anderson Cancer Center. And it also includes senior author Dr. Sandy Swain, who is at Georgetown University. And the poster presentation will take place on Friday, December 10th, from 7 to 8.30 a.m. Central Time. And the poster will also be available for virtual participants starting on December 7th. In other important December news, Jaguar is planning for conditional approval and launch of Profelimer, for the treatment of chemotherapy-induced diarrhea in dogs. The drug is called Canilevia, Canilevia CA1, and it will be our first prescription veterinary product. We anticipate conditional approval in late December 2021, likely December 27th. According to the National Cancer Institute, there's roughly 6 million new cancer diagnoses in dogs each year, among the approximately 80 million dogs in the U.S. now. And for the most part, dogs receive human therapeutic agents during treatment and suffer the same side effects as humans. And dogs really are predictive of the human experience. For example, approximately 40% of treated dogs may have their chemotherapy reduced or changed or discontinued due to diarrhea, which can compromise the full benefit of the chemotherapy agent and is a remarkably similar percentage to what's being in human patient treatment as well. Chemotherapy is evolving to become the most widely used oncology treatment modality in veterinary medicine, and there are currently no FDA-approved medications for the symptomatic treatment of CID in dogs, bing-bing in humans. Moreover, the most prevalent and used targeted chemotherapy, tyrosine kinase inhibitors, often referred to as TKIs, which have substantial rates of diarrhea, are widely becoming adopted by small animal practitioners. There are approximately 50 targeted therapies often utilized for chronic management of cancer that have been approved for human use in the past 20 years. Canolevia is a prescription drug product and will be commercialized through the companies Ant Jaguar Animal Health business unit. So turning now to Jaguar's Italian subsidiary, NAPOEU, the merger of NAPOEU and DragonStack has closed, as we announced on November 1st, and is currently effective. Jaguar maintains, the parent company maintains a meaningful majority equity interest in the combined entity, and the combined entity has retained the name NAPOEU. With highly experienced team management for NAPO-EU in place now, we look forward to collaborating with and growing the NAPO-EU team in Italy in support of NAPO-EU's very important mission to expand access to profilamer in Europe, the entire European territory, excluding Russia, for multiple pipeline indications. And beginning with NAPO-EU's initial focus on short bowel syndrome with intestinal failure, a rare disease representing another important potential indication for profilamer in the patient community. NAPO-EU operates under an exclusive license to profilamer from Jaguar with typical license terms including upfront fees, milestone payments, royalties, and collaborative clinical work including sharing of clinical and regulatory data generated by each organization. NAPO-EU is laser-focused initially on orphan indications. Short bowel syndrome is a catastrophic event where patients' guts, normally 20 to 25 feet, may be as short as less than 5 feet, perhaps as short as 30 centimeters. These patients often require TPN, total parenteral nutrition, which can be for 20, 22 hours a day, and at a cost to the healthcare system of potentially over and typically over half a million dollars a year, and that's without complications. And these patients often have complications, serious complications as well. In Europe, with typically single-payer healthcare systems, rare diseases provide an opportunity for a business model for profilamer that represents a different value parameter. Specifically, we believe profilamer will reduce the time and quantity need for parenteral nutrition and hence increase the opportunity for enteral nutrition, enteral directly into the stomach, directly into the intestinal tract. To that end, NAPOEU submitted an orphan drug designation application for clophalomer for the indication of short bowel syndrome for review by the European Medicines Agency, EMA. And EMA is equivalent to the FDA in the U.S. We submitted this in, or NAPOEU submitted this in September. Acceptance of the submission by EMA started the formal review process of the application. So they did accept the submission. And the formal review process is by EMA's Committee for Orphan Medicinal Products. I'm very pleased to report today here that on November 5th, the Committee for Orphan Medical Products provided us with a positive opinion for the orphan drug designation of cofelomer in the EU. for this indication short bowel syndrome. The formal decision and designation for Cofelimer for short bowel syndrome with orphan designation should be received within the next 30 days. And this is a key benchmark in achievement for the NAPO EEG business plan. As a reminder, Cofelimer previously received orphan drug designation in the United States from the Food and Drug Administration for short bowel syndrome. In Europe, however, the orphan designation provides a pathway for accelerated pre-approval patient access because of the catastrophic health situation of many short bowel syndrome patients. And it's part of the reason why it's the initial strategic focus of NAPO-EU. Massimo Mineo, the general manager of NAPO-EU, has extensive, and was announced yesterday, has extensive experience with orphan and rare disease business management in Europe. And it's very exciting right now. I am speaking from a hotel in Boston, and the NAPO EU management team is over here from Italy. Travel was permitted, and they are meeting, and we are meeting with the Jaguar drug development team as I speak, providing a download of all things profilamer. The sharing of data between the two organizations augments the opportunity for multiple clinical shots on goal of profilamer for each organization, and in particular, allows Jaguar to benefit from another shot on goal with non-diluted financing, and that's specifically for a proplemer in pursuit of short bowel syndrome indication. Before I hand the discussion over to Carol Isaac, Jaguar's Chief Financial Officer, who will provide a recap of key financial results for the third quarter of 2021, I want to highlight the fact that my TESI prescription volume, the metric we believe to be the best indicator of patient demand, increased 7.6% in the third quarter of 2021 over the second quarter of 2021, and new Mitessi prescriptions increased 9% during the same comparison period. Mitessi total prescription volume remained the same in the third quarter of 2021 over the third quarter of a year ago, 2020, and new Mitessi prescriptions increased by 10.5% during the same comparison period. you're all aware of course that this has been the pandemic period what's very important and i want to address head-on the fact that we are still in the midst of the process of transitioning a substantial amount of my tesi volume to a closed network of specialty pharmacies rather than the wholesalers that resale the product to retail pharmacies this transition results in an under-representation of Mitessi utilization as revenue-related, the wholesaler inventory has already been recognized by Jaguar as required and in accordance with GAAP. And that inventory is now being bought down. This inventory buy-down is painful to our financial measurements and is expected to be completed in the fourth quarter of this year. So why do we do this? A key component of the company's market access strategy, this initiative to transition to a closed network of specialty pharmacies is intended and is, in fact, helping to remove access barriers for patients receiving Mitessi prescriptions and include services such as a higher level of support for prior authorizations, appeals, adherence counseling, home delivery options, all of which has become even more important during the pandemic, And while patients often visit retail pharmacies for short-term or uncomplicated medical needs, specialty pharmacy focus and specialty pharmacies themselves focus on servicing patients with complex and chronic medical conditions. Financially, the transition to a closed network with specialty pharmacies is expected to result in a meaningful reduction in my PESI distribution costs and strategically prepares the company's U.S. commercial distribution network for future indication expansion of profilamer to other populations of patients with complex medical needs. We'll get through this transition, and we believe, and that's why we did this transition, for the good of the business to be in a better place in 2022 and beyond, with a focus on prescription growth, payer mix, net revenue growth, and getting our reps back into promotional face-to-face post-pandemic office visits. Lastly, I'd like to let all of you participating know that we will have a brief Q&A segment at the end of the webcast to address questions. Some have already come in, and they can be submitted in writing. Questions can be submitted via the webcast link for today's event that appears on the Events and Presentations page of the Investor Relations section of Jaguar's website. The URL for Jaguar's website is jaguar.health. Okay, we'll now move along to the key financial results for the third quarter of 2021. I'm going to hand this over to you, Carol, please.
spk02: Thank you, Lisa, and thank you all for joining our webcast today. Key financial highlights for the quarter ended September 30, 2021 are as follows. As Lisa stated, my tested prescription volume increased 7.6% in the third quarter of 2021 over the second quarter of 2021, and new my tested prescription increased 9% during the same period. My tested total prescription volume remained the same in the third quarter of 2021 over the third quarter of 2020, and new my tested prescriptions increased by 10.5% during the same period. My testing net revenue during the third quarter of 2021 was approximately $600,000 and approximately $400,000 in the second quarter of 2021, an increase of $200,000 quarter over quarter. Mitessi net revenues decreased by $2.2 million in the third quarter of 2021 versus the third quarter of 2020. As part of the process of transitioning to the closed specialty pharmacy network, the third quarter of 2021 was significantly impacted by the one-time inventory drawdown of approximately 1,300 bottles of Mitessi across the company's third-party logistics warehouse, wholesalers, distributors, and retail stores. The company expects essentially a full transition to my Tessie prescriptions being dispensed through specialty pharmacies by the end of the fourth quarter of 2021. My Tessie gross revenue, a non-GAAP measure, was approximately $3.2 million during the third quarter of 2021 and approximately 4.9 million in the second quarter of 2021, a decrease of 1.7 million quarter over quarter. My TESI gross revenues decreased by 3.1 million in the third quarter of 2021 versus the third quarter of 2020. As mentioned, the third quarter of 2021 was significantly impacted by the one-time inventory drawdown of approximately 1,300 bottles of MyTessy across the company's third-party logistics warehouse, wholesalers, distributors, and retail stores. Sales volume distributed through the company's recently established and expanding pool of third-party specialty pharmacies through which my test is distributed was approximately 38% of total sales volume in the third quarter of 2021 compared to approximately 17% in the second quarter of 2021. For the third quarter of 2021, the net loss was 12.2 million compared to a net loss of 7.9 million in the third quarter of 2020. an increase of $4.3 million quarter over quarter. That concludes my recap of high-level financials for the third quarter of 2021. I will now hand the discussion back to Lisa.
spk03: Thank you, Carol. Okay, so we have some written questions, and this time I've got them. And we also have on the phone Ian Wentz, who is our Chief Commercial Officer. And so, you know, I'm just going to take this first question and send it right over to Ian here. The question is, why have you opted for a strategy which delivers you less sales year on year? And so we have not opted for a strategy for less sales. I'm going to turn this over to Ian, but I just want to repeat what I said and add, first and foremost, we're patient community focused. And we focus on the patient and everything else will fall into place here. But Ian, why don't you talk about what the key financial and strategic catalysts are for the movement to the specialty pharmacy network, please?
spk00: Yeah, thank you, Lisa, and happy to do that, and good morning. Great question, and one I think gets right to the point of what we're trying to communicate on this call. So I'll try to address this in a couple different ways, but first, this is really part of this overarching strategy that we've been implementing for about a year and a half. which internally we call our market access strategy, really designed to better support patients in their ability to start and stay on Mitessi. And we've already seen evidence that this is working significantly. Part of that strategy is the transition of Mitessi patients to receive their prescriptions in specialty pharmacies. And we've known for a while now that patients do better if they're serviced by a specialty pharmacy that just have the capacity and capabilities to provide these enhanced set of services for these patients. So when we look at some of these key metrics that we believe are important from an outcomes perspective that are important from patients, we've known for a while that they do better. So we always had a subset of our patients that were in the specialty space. The vast majority of the patients were in the retail space. And so we could see that difference. Just as an example, patients in specialty pharmacies tend to stay on the drug longer, significantly longer, which is great. That has to do with the adherence counseling fighting for the PAs and appeals with payers that specialty pharmacies do. The days between fills is significantly lower. So ideally, the patient should be filling their script every 30 days. And those that are in the SP environment get closer to that number than those in the retail number. The prescription to fill ratio, which is really critical, that basically measures out of 100 prescriptions that are written, what percentage of them are actually filled. It tells you how good of a job you're doing in managing through the PA and appeals process and other barriers that payers put in place. And that's higher in the SP environment. So we know in the long run, patients do better in this environment. So it's really important for us to have all patients benefit from what the SPs can offer. Not just today, and it's certainly important for Mitessi in the current indication, but becomes critically important in the future for patients potential future indications with much larger market opportunities. So the long-term strategy is to set us up to better support these patients, and that will result in greater year-on-year sales growth in our belief. And we're already seeing those key metrics represent that. Ultimately, this will help support a more favorable payer mix and higher net price for Mitessi, which is something we watch quite closely. getting through this period, as Lisa talked about earlier and Carol mentioned earlier as well, we really had to get through this inventory buy down that sat out in the retail channel and there were about 1300 bottles out there. So on a gross sales basis, that's about $2.8 million. We had to let that flow through the inventory channel and be dispensed out to patients. And then once the inventory pipeline essentially is empty, once the wholesalers don't have any more product, once the retailers don't have any more product, then those patients have been moving over to the SP channel and buying directly, which has resulted in the benefits we've talked about, including the dramatic reduction in distribution fees associated with those pharmacies buying directly from us.
spk03: Thanks, Ian. And I do want to say to everyone, we own this and we recognize that this is a painful transition for everyone financially, and hopefully we've explained the benefits to the company, to the patients of doing that. And, you know, remember, my TESI for HIV is the first commercialized indication, and it is a gift in setting up the strategy and the distribution for the product for what we believe is going to be really important follow-on indications for mitesb and for profilamer that will have the benefit of having this network already set up. So we do acknowledge that this has been painful for everyone. Okay, next question. I'm going to get to all the questions, but I'm going to just skip to a third question right now because it's sort of relevant. And what is the market potential for chemotherapy-induced diarrhea and exercise-induced diarrhea. This is cantilever. So this is the dog product, the dog prescription product of profilamer. And also, after the potential launches of cantilever in chemotherapy-induced diarrhea, exercise-induced diarrhea, do you see any other potential usage of cantilever in dogs? So Ian, again, get ready to comment on this, but I'm going to put in a few comments first. First of all, we don't give out financial guidance, as you know, but we do think that the dog indications first are certainly chemotherapy-induced diarrhea is remarkably predictive health situation of the human situation. In dogs, it's predictive of how humans react to these drugs and the diarrhea that results from that, and therefore, of course, the benefit that we're expecting from profilamate. We do think that this will be about as important a specialty market opportunity as Mitessi and HIV. But what's also quite interesting, in the United States, it's a self-paced situation for veterinary medicine. And so therefore, the difference between the gross and the net is much more predictive than we've had in the human situation. And so, for example, the strategy of moving to specialty pharmacy to address patients, to address the net, to address the health of the business is a different situation and much more straightforward in dogs. We will expect the approval and the launch. As I said, at the very end of December specifically, we're looking at a date of December 27th for chemotherapy-induced diarrhea approval and launch. Exercise-induced. diarrhea is a conditional approval that is probably about six months away, so in the midst of 2022. Other potential uses of canalevia, we'd obviously like to have the product studied and approved in all diarrhea in dogs, and that is a strategy that is being discussed internally right now, weighing the resources and the attention that we give to our human pipelines versus our animal pipeline, because that's not in the initial label targeted indication. And Ian, is there anything you would like to add about the plans for the launch for Canolevia?
spk00: Yeah, just a couple points I think that might be interesting for folks to understand. You know, we did do the market research on assessing the market potential for CID, and, you know, I can't give specific numbers, but what I can say is that our baseline assumptions were more conservative than what the market research returned to us in terms of how we size this market. That was really encouraging for us to see. As we continue to engage in conversations with key opinion leaders and potential prescribers as part of that market research effort, we get a lot of great questions around the CID indication. And then one of the questions that comes up quite often is, you know, what future indications might profilamer potentially have, where it might have an application for a variety of different populations. I think where that comes from, and I think this is a good thing to understand about the market, is there's no currently approved antidiarrheal for dogs, not just within CID, but in broader diarrhea, you know, diagnoses outside of CID. So, You know, there is this unmet medical need. There is this sense of certainly enthusiasm among KOLs looking for a new solution, a new tool to use for these patients. So we're quite excited about the launch. As Lisa indicated, we anticipate our approval letter coming back on December 27th. And we are certainly preparing to really get the word out there to pet owners and to providers. We have a rather large event planned at BMX, which is a veterinary conference that takes place in the middle of January. It's kind of a kickoff for a lot of our launch activities. So we have a lot planned around that and more to come on execution as we get through that conference.
spk03: Thanks, Ian. And I will add, it's very exciting to have a drug approval. The patient happens to be a dog versus a human. It's very exciting and it's a big deal to have a product approval. And in this particular patient population, obviously the patient is the dog, the decision maker is the dog owner, is the human. And so there will be, the launch will be augmented by a consumer outreach effort as well. And the factors that a dog owner thinks about when they are deciding to give their dog chemotherapy or not and try to extend their life are, first of all, it's going to be out of pocket. It's going to be expensive. It could be $10,000, $12,000, $15,000. Secondly, you want to manage the side effects that if you're going to do this, that you're in fact going to be able to keep the dog on the therapeutic dose, as we talked about, about 40% have to go on a sub-therapeutic dose or stop therapy because of diarrhea. Also, then the patient's comfort, the dog's comfort does consistently come back as such an important factor in the decision process because you can't talk to the dog and say, just suck it up. You're going to feel terrible. It's going to be awful for two, three months, but things will be better. So, you know, the patient comfort is very important in this decision process. And then the last thing is the practicality of really the home and the quality of life for everybody involved. if a dog has lost control and what that means for your rug, your carpet, your household, really the experience for the whole family. So it's really interesting dynamics. It's a situation where I certainly have found over the 30 years of working with profilamere and diarrhea, there's always a bit of human reticence to talking about human bowel function and diarrhea. But dog owners have no problem. It's all about poop. Anybody who has a dog in an apartment has no problem talking about poop. So we really think there can be some halo effect in terms of education into the human situation as well. So there will be some consumer outreach that you will see, which will be very exciting. Okay, an easy question. When do you expect completion of enrollments? in the phase three cancer indication. This is cancer therapy-related diarrhea. This is the human indication. Cancer therapy-related diarrhea, the prophylaxis study that is ongoing right now, with targeted therapy, with or without underlying chemotherapy, and we are planning on the last patient enrollment by the end of 2022. This is Mitessi. This is the exact formulation of Mitessi that is currently commercialized, so supply chain is in place, FDA approved GMP supply chain. My testing for HIV is a chronic indication, so chronic safety has been completed, for example, two-year carcinogenicity studies. And just as an aside, the two most common reasons why new drug applications fail are safety and manufacturing. So those have been completed. When we file the data from the pivotal phase three trial, It should be a six-month supplemental review for the approval, and we're planning for the launch at some point in 2023 in terms of manufacturing supplies. Okay. When is the merge? I assume this is the NAPOEU merger with staff. The long, painstaking process completed. It's over. It completed in November. I believe we announced it on November 1st. It is effective. NAPO-EU is merged with Dragon SPAC. The resulting name is NAPO-EU, so you will no longer hear Dragon SPAC. The combined organization is NAPO-EU and has the resources that came from the investment that went into Dragon SPAC, and as I said, is allowing that company to operate under license from Jaguar and is providing another clinical shot on goal in the pipeline of profilamer development with non-diluted resources from Jaguar Health. And that's where I am in Boston right now, meeting with that team and making those plans. Let's see. What countries do you believe are the biggest markets for profilamer in Europe? I can answer that very effectively. The biggest markets and the markets that provide the earliest Pre-approval, those are key words, pre-approval of standard patient access in Europe for an orphan designation because of the catastrophic nature of these patients and different than the U.S., I assume, I believe, because of the single-payer health care system and anything that can be done that can reduce the cost of taking care of these patients as well as provide benefit to them, are Italy and and that happens to be where NAPA EU is located in Milano, Italy, France, and Germany. But there are all the European countries, with the exception of Russia, as we call Russia in Europe, are part of the license. But those three countries in particular are not only very large markets, but provide the opportunity for pre-approval accelerated patient access for an orphan product, which means revenue generation, which is very exciting. Could you talk about, let's see, Ian, I'm going to give this to you again. Are you noticing additional patient stickiness through the specialty pharmacies? Do you want to take that, Ian?
spk00: Yeah, happy to. And yeah, the short answer is yes, we are. And I mentioned, I think, some of those key metrics a little bit earlier, but just to review them really quickly, because these are the things that we watch quite closely is we look at So that's how long the patient remains on drug. We look at a metric called MPR, which is medication possession ratio. So out of those X number of days that they're on the drug, how many of those days that they have drug in hand? And so that kind of gets at some patients fill every 30 days. Some patients fill every 40, 45 days. Patients don't always fill exactly when they're supposed to. So the idea is that we want to get the days between fills lower, closer to 30. And we're seeing improvements in that metric as well. We also look at the time it takes from a patient when they receive their prescription from the doctor to when they actually get the fill dispensed. And that can be longer than you might expect sometimes, right? Patients, they have to get to the pharmacy. There has to be a PA maybe that has to be managed by the pharmacy and provider. Sometimes in the retail sector, that doesn't happen at all, unfortunately. People just don't have time to do it. maybe the follow-up isn't there. In the specialty space, they're much better at doing that, and they can get through that in just a handful of days versus weeks. So those are some of the key metrics we look at, and really we see it's a pretty stark difference between what the retail pharmacies, the type of support and outcomes that they deliver. And remember, the retail pharmacy space is just volume-driven. I mean, they're filling prescriptions all day, every day, and they're checking folks out with some of their groceries in the front store, purchases the patient makes, and they have a lot of things going on. They can't really devote extra time, nor is it very cost-effective for them to do that, the extra time needed for some of these specialty products that just require more support. The specialty pharmacies can do that, and the metrics really support the idea that we're getting better outcomes there.
spk03: Great. And Ian, I'm going to give you another one. Yeah. Let me see. Hang on. How do you see Mitessi revenues being impacted further as greater specialty pharmacies continue to offer the product?
spk00: Well, once we get through the transition period, we know that the patients that have already been on Mitessi, just to start there, are going to do better for the reasons that I just mentioned. We expect them to stay on the product longer. fewer days between refills, all those great things that really demonstrates the patient's just getting better support in general. The metric that we were really suffering from, and really this isn't unique to Mitessi, a lot of brands struggle with this, is the prescription-to-fill ratio. Again, just to review that, it's for every 100 prescriptions written, what percentage of them actually get filled, because different plans have them tiered. There's, you know, co-pays, there's step edits, there's different things that the payers put in place that can make it difficult for the medication that the prescriber wants that patient to be on to actually to get filled. So we see that we're going to, we already see that we're improving that metric quite significantly, you know, for the reasons I mentioned earlier. So that bodes well for new patients. I mean, it bodes well for the existing patients, but it bodes well for new patients too. we're going to have a higher ratio of those folks that the physician would like to have start Mitessi and stay on Mitessi to be able to successfully do that. And really that supports the underlying long range vision of this strategy, right? Better support those patients, allow more patients to benefit, appropriate patients to benefit from Mitessi.
spk03: Great. Thank you. Okay. So there's a question here about veterinarians. And so in, in, Just so that everybody has the same basis of understanding here. So prescriptions in veterinarian offices, for the most part, are a profit center. So if anybody who has an animal, you go to the vet, often you just walk out right with your prescription there and they do a markup from the price that they get from the veterinary wholesalers. And as we've also said, and I'll just underscore this again, because of the self-pay situation, one of the strategies, financial strategies, of moving to specialty pharmacy in addition to the better patient service is to just have a more predictive situation on that growth to net ratio, whereas it's quite predictive in the animal health area. So there was a question about pricing of Canalivia. And we are finalizing that right now and have done a great bit of research looking at other situations where there is a human active ingredient and an animal active ingredient and what is the typical pricing ratio right there. So that's how we're going about that situation. So there's a question about the amount of things that I'm juggling between Jaguar and NAPO-EU. And would you give over the work to another CEO for NAPOEU? Let me tell you, the nomenclature is different in Italy. So a general manager, Massimo Mineo, is the CEO responsibilities. He is essentially the president and CEO in terms of the activities, the responsibilities, what he is managing. And I am a board member of NAPOEU. So my full attention and responsibility, of course, is on the business of Jaguar. However, remember that NAPOEU is providing another clinical shot on gold for ProPhelomir, all that clinical data, which will likely, that clinical trial will likely be conducted on a global basis, which is typically done for rare diseases because you have a small number of patients that will be available for the United States for regulatory filings in the United States. And We are a very large shareholder of NAPOEU and the financial benefit that we would expect to come from that. As NAPOEU achieves its Chatham goal, follow-on indications, will it eventually file for an IPO at AIM Italia in the future? NAPOEU absolutely has its eyes on a public offering and You know, a key transformative event in value enhancement is, of course, proof of concept data in humans versus revenue generation. And remember, as I've said, for an orphan designation in Europe, there can be reimbursed preapproval patient access for an orphan designation. And that would be a strong value enhancing moment to seek a public listing. I can also tell you that quite likely it would not be an AIM listing in Italy. It would be a larger exchange. Let's see. Are you working on any new business deals? What we haven't spoken about is our early stage discovery program, which takes very little resources. It's mobilizing assets that we have in the company for a theogen therapeutics initiative. That's an initiative within the company looking at psychoactive and psychedelic agents, plants, all the way to some pure compounds that are already in our 2300 plant library from firsthand field investigations that this company has conducted with Western trained physicians, ethnobotanists and shamans and healers in the field over a 32 year period of time. It's a fascinating field of research, looking at ways of curing and treating, um, mood disorders, all sorts of mental health disorders. There's a great deal of funding that has gone into this area in general. But almost all of it is focused on the same seven compounds, psilocybin, MDNA, ketamine. And what we're providing is an opportunity for what is the next generation of these psychoactive and psychedelic agents that can present new ways not constrained by known mechanisms of action to treat and potentially cure these mental disorders. And it's exactly the pathway of what we successfully did with profilamere. So followed a plan that's been utilized by Shaman for symptoms in the field, bringing it back home, finding a totally new mechanism of action because what we were watching was the symptoms in a whole organism, not doing high throughput screening against a known target or a known mechanism of action that likely already has candidates that are on the market or in clinical development, taking it through as the first oral product approved by the FDA as a drug, drug approval by the FDA under botanical guidance, which provides a very, very important exclusivity advantage since there is no pathway by which a generic can be produced. So these are all skill sets that have been proven and are within this company, take very, very little resources for us to mobilize and then What we're looking to do, as I said before, is collaborate with a company that is focused on the regulatory, the clinical development, the commercialization of these new potential agents. And we're having really, really exciting discussions. We have an amazing scientific strategy team that is almost identical to the scientific strategy team of world-class ethnobotanists, ethnopharmacologists who study pathogens how plants are being used as medicines in tropical areas that was in place when we started the company 32 years ago and has been brought back together in the past year to specifically focus now on our library and new plant collections in this area. The other area where we would, and I've said this publicly as well, we have a sales force. We have our first product. It's, you know, can you put another product in the bag? And so we're always on the lookout for something that could fully utilize the resource that we have up and out there, our sales force, our commercial effort, while we are waiting for the pipeline indications of MyTESI to get developed and approved. And it's got to be the right fit and not take resources away. It has to be something that's additive to the company. So that's something that we're always looking for. And... Let's see if I've nailed all the questions here. I think I have gotten to, oh, where do you see the company in three years? In three years, it will be very exciting. We believe that we will have completed the pivotal clinical investigation and the approvals Two more indications. That's where I would expect it to be. Remember all the forward-looking statements that were previously discussed here. But that would be the timing for CTD, cancer therapy-related diarrhea. That's a MITESI indication in the United States. And then short bowel syndrome, a full approval or a conditional approval, full access to all patients in multiple European countries, And again, that data is available in the United States. So we're already looking at, would there need to be any additional work to support the approval in the United States where we already have orphan designation? That's cofelomer in a highly concentrated liquid formulation. So that's not my testy. Different products, different value propositions, different business model of very, very high valued chronic medicine for small populations. That's very expensive to take care of with very, very large mortality and morbidity situations. So that's very exciting business. And then, of course, cantilever and thinking about ways to get cantilever to all animals that are dealing with diarrhea. And then the last piece is the whole profilamer story is how do we get profilamer to all patients in need, all channels, all countries? And that's the business development efforts that we have going on right now. So we recently brought on an executive VP of business development with whom we have been, who has been consulting with the company for the past six months. So based on her work and how discussions have been progressing on the business development side, specifically focused on getting Quill Salomer out licensed to all the countries in the world, we would expect to have those deals completed. cut in the next year or so, which lays the groundwork then for, gee, where will the product be in terms of bringing in licensed compensation to the company, royalties, et cetera, profit sharing in other parts of the world. And that certainly would be done, our expectation in a three-year period of time. And then hopefully, of course, the collaboration will have been completed and there will be some novel molecules coming out in the psychoactive and the psychedelic area. And I believe that concludes all the questions that I see here. Let me just go down one more time. Yep. So thank you very much for your attention, and we got you off five minutes before the market opened. And I'm glad I was able to access the questions this time, and this was fun to do, and we'll be doing that in the future. Thank you very much.
spk01: Thank you. Ladies and gentlemen, that will now conclude today's conference call. Thank you for your participation. You may now disconnect.
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