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spk02: 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 product 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 would cause actual results to differ materially from those contemplated from 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 caution not to place undue reliance on those forward-looking statements. The company's actual results may differ materially from those discussed in the calls for a variety of reasons, including those described in forward-looking statements and risk factor sections of the company's Form 10-K for the year ending December 31, 2021, which was filed March 11, 2022. and its other filings with the SEC, which are available in the Investor Relations section of Jaguars website. Except as required by law, Jaguars Health undertakes no obligation to update or revise any forward-looking statements continued in this presentation to reflect on new information, future events, or otherwise. Additionally, please note that the company supplements its consolidated financial statements presented on the GAAP basis by providing gross 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 the company's management assets and operates the business. These non-GAAP financial measures should not be viewed in isolation or as substitutions for GAAP net sales and GAAP net loss and are not substitutes for or superior to measures of financial performance and comparability with GAAP at this time. It is my pleasure to turn the call to Lisa Conti, Jaguars Health Founder, President, and Chief Executive Officer.
spk05: Lisa, the floor is yours. Thank you, Allie. That was quite thorough and I understand a mouthful. Thank you all and welcome. As you just heard, my name is Lisa Conte. I am the founder, president, and CEO of Jaguar Health and our wholly owned subsidiary in the United States, NAPO Pharmaceuticals. I'm also chairman of the board of NAPO Therapeutics, the corporation we established in Milan, Italy last year that focuses on expanding prophyllum access in Europe. Specifically, NAPO Thera is initially pursuing a rare disease business model based on the orphan designation of crofilomer for short bowel syndrome, known as SBS. You'll hear me refer to it as SBS throughout this presentation, and you'll hear more about that in a moment. Also of note, Jaguar is the majority shareholder of NAPO Thera, providing equity interest value to Jaguar as well as parallel product development activities for crofilomer in Europe. I'm going to begin today with a few brief updates and then Carol Isaac Jaguars, Chief Financial Officer, will provide a recap of key financial results for the fourth quarter of 2021. As you'll hear from Carol, we're pleased to report that fourth quarter 2021 Mitessi net revenue was approximately $2.1 million versus approximately $600,000 in the third quarter of 2021. an increase of 230%. This increase largely represents the important realization of financial benefits from Jaguar's recently completed shift to distributing Mitessi through a closed network of specialty pharmacies, specifically, for example, a decrease in distribution costs and an improvement in our gross-to-net ratio. You'll hear more about that transition from Ian Wendt Jaguar's Chief Commercial Officer, who will speak after Carol. As a reminder, profilamer, under the trade name Mitessi, is our plant-based, FDA-approved antidiarrheal drug indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV AIDS on antiretroviral therapy. Profilamer is also the focus of our two core pipeline indications in clinical development each expected to bring transformative value to Jaguar in the next 12 to 18 months. And this includes prophylaxis of cancer therapy-related diarrhea, which I'm going to refer to as CTD throughout this presentation, cancer therapy-related diarrhea, CTD, and SES, short bowel syndrome, which is a catastrophic health situation, which has received orphan drug designation in the United States and Europe. Let me speak to CTD, the cancer indication, first. We are currently in the midst of continued enrollment for the phase three trial for CTD, and that trial is known as the On Target Study. We're aiming to complete 256 patient enrollment by the first half of 2023. We're in the process now of adding additional clinical trial sites both in the United States and outside the United States to help ensure patient enrollment, despite COVID-related restrictions and global unrest, stays on track. The successful completion of this pivotal trial will result in a supplemental new drug application filing for mitesi, profilamer, which, of course, as I mentioned, is already approved for the HIV-related diarrhea indication and which is approved for a chronic use and has a full FDA-compliant supply chain in place from the rainforest to all pharmacies in our U.S. specialty pharmacy network. As a note, safety and manufacturing are the two most common reasons that new drug applications fail. Hence, we spent much care and communication with the FDA in the design and execution of this final clinical and regulatory step to bring profilamer to cancer patients suffering with diarrhea. Diarrhea is the most common side effect of cancer therapy. 40% of patients with CTD discontinue their chemotherapy or targeted therapy, their life-saving treatment, because of diarrhea. And this is not your garden variety traveler's diarrhea. Patients are often hospitalized for dehydration, electrolyte imbalance, and organ failure. And some patients have even died from the impact of their diarrhea during clinical trial investigation by the targeted therapy manufacturers. Our second core development focus for profilomer in 2022 is the Orphan Designated Disease, SBS. An investigator-initiated proof of concept study is expected to be initiated and completed in 2022 at sites in the United States and Middle East and led as a parallel clinical development effort by the skilled, focused, and rare disease experience NAPO Therapeutics management team in Europe. Team leadership including a managing director, a chief medical officer, and a head of regulatory and quality. And let me expand that the investigator initiated proof of concept studies may include sites in Europe as well. This study will be for patients with CDD, congenital diarrheal disorders, a rare inherited disease causing lifelong intestinal failure, and SBS, again, for which the European Medicines Agency, referred to as the EMA, the equivalent of the FDA here in the United States, granted orphan drug designation to Profelimer, as I mentioned, on December 13th, 2021, a key event for the NAPOFERA rare disease business model and business plan. So, why did we establish this company, Napothera, in Europe? In Europe, the EMA is committed to enabling early access to new medicines with orphan drug status, indicating the important unmet medical need. And they do this to patients through an early patient access program. Participation in an early access program would provide patients with access to profilamer as early as 2023, potentially impacting in a positive way their morbidity, mortality, and the cost of care for this chronic indication that has no good therapeutic options, the substantial cost of care. CDD and SPS patients with intestinal failure typically require parenteral nutrition up to 20 hours a day, seven days a week, to survive at tremendous cost and with accompanying medical complications, which adds even more cost. The ability to decrease that by even 20% would provide a huge medical and quality of life improvement. In a typical rare disease business model, these substantial benefits are highly valued for a relatively small patient population. The global SBS market of approximately 40,000 to 60,000 patients worldwide is expected to reach 4.6 billion by 2027, according to a report from Vision Research Reports. NAPOthera operates under an exclusive license to Crofilamer from Jaguar, for which Jaguar receives typical license payments, including an upfront payment, milestone payments, royalties, and transfer pricing of Crofilamer. Jaguar also receives the value of the clinical data generated by NAPOthera. As reciprocally, NAPO Thera receives the value and ability to utilize the CTD, the cancer phase 3 data JAGUAR is developing. Hence, the parallel complementary and geographically focused development efforts of CROFELIMER to these two core indications, CTD and SBS, are progressing simultaneously and collaboratively with dedicated teams respectively. One final advantage of the NAPO-THERA effort to Jaguar is that NAPO-THERA is well over majority owned by Jaguar, providing the equity accretion value to Jaguar shareholders and stakeholders, which we believe is unrecognized at this time. So once again, these are the two core pipeline events transforming profilamer from pipeline to what we believe will be tangible value in the next 12 to 18 months. What else as we look forward to an exciting 2022? For Jaguar, 2022 is the year of the dog. In December 2021, we received conditional approval from the FDA's Center for Veterinary Medicine for Crofilomer for chemotherapy-induced diarrhea. I'm going to refer to that as CID, chemotherapy-induced diarrhea in dogs. This is an exciting and important, and it's important for so many reasons. First and foremost, this is the key to canine survivability from cancer and the dog parent consideration of the cancer care decision process. There are approximately 100 million dogs in the U.S. thanks to the pandemic, post-pandemic dogs, and 25% will deal with a tumor at some point, over 50% of dogs over the age of 10. Dogs are remarkably predictive of and similar to the human CID situation. Forty percent of the time, the dog cannot complete its therapeutic dose of chemotherapy because of diarrhea, as is the case in humans. Extremely relevant in the dog market, though, is the comfort factor for the dog, a key factor influencing the dog parent's decision to treat the dog's cancer. And the quality of life of the whole family. A dog losing control on the rug, the bed, the couch is an important consideration for the family household. But we do not provide financial guidance. We do feel the dog CID market could be about the size of the human HIV specialty market. And the dog market, the veterinary market provides much greater predictability of the gross to net ratio since dog parents are typically paying out of pocket for treatment and medications. You can expect many PR, IR, educational and promotional events around CID in dogs throughout 2022. Education as to the devastating impact to the patient of diarrhea in cancer therapy builds awareness, regardless of whether the patient is a human or a dog. And there's more Canalivia news. We completed the filing of the major sections with the CVM, Center of Veterinary Medicine, for Canalivia, for a proposed exercise-induced diarrhea. I'm gonna refer to that as EID, exercise-induced diarrhea indication. And we hope that in the fourth quarter of this year, Canalevia will be available for all working dogs suffering from EID, which includes, for example, Iditarod dogs. And this will be known as Canalevia CA2. Our team is as tenacious and dedicated as the mushers and the teams of dogs currently competing in the Iditarod Trail sled dog race, which officially kicked off March 6 in Willow, Alaska. This is the 50th anniversary of this rugged, world-renowned 1,000-mile race. Interestingly, last year, Brenda Mackey, a well-known musher, had to withdraw when her dog experienced EID. And just two days ago, In the race this year, Musher U. Neff withdrew halfway into the race after his dog's developed diarrhea. Neff said he was upset. He had to call it quits. He planned to take his dogs to a friend's house in Ruby to decide what to do next. Imagine in the future what he could do next is treat the dogs with canolevia for EID once we have it approved by the CVM. Other exciting plans for 2022 include continuing efforts to forge license and business development relationships in key markets around the globe for pro polymer pipeline within a product. Also, multiple investigator initiated trials that are ongoing that may come to conclusion for other chronic situations, such as functional diarrhea and irritable bowel syndrome. And several new initiatives in the commercialization of ITESI for people living with HIV AIDS to address new behaviors during the pandemic, such as adopting a telehealth option for patients. And you'll hear more from Ian on that topic. Finally, a third key clinical milestone for 2022 is the filing of an investigational new drug application with the FDA in the middle of this year for the symptomatic relief of diarrhea from cholera with Lequimer. Lequimer is a different chemical collection of proanthocyanidins, different from profilamer, extracted from the Croton-Lechlery tree, the same tree from which we get profilamer, and which we believe defines Lequimer as a distinct product from profilamer under FDA botanical guidance, which is the guidance upon which profilamer is approved. And Lequimer, has a lower manufacturing cost than Krelthelmer, and works by the same novel anti-secretory mechanism of action. We are planning to initiate phase one clinical trials, the Lechlemer study, in the second half of 2022, as I mentioned, for the symptomatic release of diarrhea from cholera, which is what kills patients with cholera. It's not the cholera infection. It's the dehydration from the massive diarrhea. In support of this clinical activity, we received comprehensive animal toxicity pre-clinical services supported by NIAID for four pre-clinical studies. We plan to pursue a tropical disease priority review voucher for Leucomere under the FDA's financial incentive program to develop drugs for tropical diseases, such as cholera, which provides for an immediate return on investment upon the approval of the product for the cholera indication. On a financial note, before I hand the conversation over to Carol Lysak, I want to highlight the fact that as of March 11th, this past Friday, the company's cash position was approximately $18.5 million, and Jaguar had a public float exceeding $75 million. Therefore, the company remains shelf eligible. and SEC designation that provides continuing flexibility to issue registered shares quickly and opportunistically, including in connection with potential future business transactions, such as potential asset acquisitions, purchases of product, payments for services, license deal, and an at-the-market financing program we've had in place and currently have in place. Additionally, as announced, Jaguar received a letter from NASDAQ's listing qualification staff on February 17, 2022, indicating that the big prize for the company's common stock for the last 30 consecutive business days had closed below the minimum $1 per share required for continued listing. We have a six-month compliance period and plan to meet the requirements for continued listing on NASDAQ through value recognition of our various milestones and pipeline progress as I've discussed. At this time, there are no plans for Jaguar to conduct a reverse split. Lastly, I'd like to let all of you participating today know that we will have a brief Q&A segment at the end of this webcast to address questions, if any, 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. And the URL for Jaguar's website is jaguar.health. We'll now move along to key financial results for the fourth quarter of 2021. Carol, you are on.
spk04: Thank you, Lisa. And thank you all for joining our webcast today. I'll begin my review of our 2021 financial results with our main focus being on the fourth quarter gap over the third quarter of 2021 and year-over-year performance. My testing and prescription volume, an indicator of growth in patient demand, increased 10.4% in the fourth quarter of 2021 as compared to the prior quarter. and increased 2.1% in the year 2021 over the year 2020. Prescription volume differs from invoice sales volume, which reflects, among other factors, varying buying patterns among wholesalers in the retail channel and specialty pharmacies in the closed network as they manage their inventory levels. My TESI net revenue during the fourth quarter of 2021 was approximately $2.1 million and approximately $600,000 in the third quarter of 2021, an increase of $1.5 million, or 230% quarter over quarter. The transition to a closed network of specialty pharmacies has resulted in a meaningful reduction in my TESI distribution costs and higher average net price. My TESI net revenue for the year 2021 was approximately $4.3 million and approximately 9.4 million for the year 2020, a decrease of approximately $5.1 million year on year. As part of the process of transitioning to the closed specialty pharmacy network, the third and fourth quarters of 2021 were significantly impacted by the inventory drawdown of approximately 1,300 bottles of My Tessie across the company's third-party logistics warehouse, wholesalers, distributors, and retail stores. My Tessie gross revenues a non-GOP measure, was approximately $3 million and $3.2 million during the fourth and third quarters of 2021, respectively, representing a decrease of $200,000 quarter over quarter. My TESI gross revenue for the year 2021 was approximately $15.7 million and and approximately $20.4 million for the year 2020, a decrease of $4.7 million year-over-year. As mentioned, the third and fourth quarters of 2021 were significantly impacted by the inventory drawdown of approximately 1,300 bottles by Tessie, and the transition to distribution through the closed specialty pharmacies network improved the Mitessi gross to net revenue ratio. Mitessi sales volume distributed through the recently established and expanding closed network of third party specialty pharmacies was 100% of total sales in the fourth quarter of 2021 compared to approximately 38% in the third quarter of 2021. Lossful operations was approximately $10.8 million and $9.5 million during the fourth and third quarters of 2021, respectively, an increase of $1.3 million, largely from increased R&D expenses of approximately $2.2 million due to our clinical trial costs from CTD and other indications. increased GMA expenses of approximately $700,000, mostly from the annual shareholder meeting and offset by the increased net revenue in the fourth quarter of 2021, as previously stated. For the year 2021, the loss from operations was $40.7 million, compared to a loss of $26.6 million for the year 2020, an increase of $14.1 million year-over-year. The increase was attributable to the $8.7 million increase in R&D expenses. This reflects the important R&D activities associated with, for example, the conduct of the pivotal Phase III trial for CTDs, including increased personal related expenses, manufacturing expenses, and contract manufacturing costs in anticipation of a potential launch upon successful clinical trial results. Sales and marketing expenses increased by $2.3 million related to the expanding market access through specialty pharmacy channels, and G&A expenses increased by $2.7 million largely from the shareholder meetings non-cash stock-based compensation, audit, and accounting services. For the year 2021, the net loss was $52.6 million compared to a net loss of $38.6 million for the year 2020, an increase of $14 million year over year. In addition to the loss from operations, Interest expense increased by $5.6 million from $2.8 million for the year 2020 to $8.4 million for the year 2021, primarily due to the royalty interest agreement. A non-cash change in fair value of financial instruments and hybrid instruments designated at fair value option, or FVO, losses decreased 800,000 from a loss of 2.7 million for the year 2020 to 1.9 million for the year 2021 designated as FVO. The non-GAAP recurring IDCA for the year ended December 31, 2021 was at a loss of $37.5 million as compared to $24.3 million for the year 2020. That concludes my recap of high-level financials for the fourth quarter and year-to-date 2021. I will now hand the discussion over to Ian Wendt, Jaguar's Chief Commercial Officer.
spk01: Thank you, Carol, and good morning to all. As Lisa stated, the 230% increase in fourth quarter 2021 Mitessi net revenue over the third quarter of 2021 largely represents the realization of the benefits from the company's shift to distributing Mitessi through a closed network of specialty pharmacies, rather than to wholesalers that resell the product to retail pharmacies. The process of transitioning to a closed network of specialty pharmacies resulted in a one-time, short-term underrepresentation of Mitessi utilization. As anticipated, Mitessi revenue, primarily in the third quarter of 2021, was impacted by this transition as wholesalers in the retail distribution channel drew down their inventory of typically more than two months' volume. Our closed network of specialty pharmacies typically orders on a just-in-time inventory business model. We are pleased to report that the company completed the process of transitioning its Mitessi volume to a closed network of specialty pharmacies this past January. As a result of this transition, no significant Mitessi inventory remains in the retail distribution channel. As Carol stated, Mitessi new prescription volume, an indicator of growth in patient demand, increased 10.4% in the fourth quarter of 2021 over the third quarter of 2021 and increased by 2.1% in the year 2021 over the year 2020. The transition to a closed network of specialty pharmacies has resulted in a meaningful reduction in Mitessi distribution costs and a higher average net price and assists in the preparation of our U.S. commercial distribution network for potential future indication expansion of Grofellimer to other populations of patients with complex medical needs, such as CTD and SBS. A key component of the company's market access strategy, the initiative to transition to a closed network of specialty pharmacies is intended to help remove access barriers for patients prescribed Mitessi and includes services such as a higher level of support for prior authorizations, appeals, adherence counseling, and home delivery options. While patients often visit retail pharmacies for short-term or uncomplicated medical needs, specialty pharmacies focus primarily on serving patients with complex and chronic medical conditions like HIV. Additionally, in early 2022, We are rolling out new innovative programs that further support identifying appropriate Mitessi patients and connecting them to care and medication access services. The first program delivers digital Mitessi and disease state education directly into a provider's EHR or electronic health record system so that they learn about Mitessi at the moment they are seeing their HIV patients. This technology allows us to intelligently deliver ads to a provider based on the profile of the patient they are seeing in their exam room. This is strictly a one-way communication. We did not receive any protected health information related to this program. The next program is a telehealth initiative that will enable patients seeking help with their HIV-related diarrhea to be linked immediately to a provider for assistance with their medical needs. This will prevent patients from having to wait until their next scheduled doctor visit to get help with an urgent problem. Both of these programs are designed to drive incremental brand awareness among prescribers who have not written for Mitessi previously and among patients who have not been able to receive immediate care for their HIV-related diarrhea. Turning to the animal health side of our business, we're referring to 2022 as Jaguar's Year of the Dog. Launch activities remain underway for cantilevius CA1 in the U.S. veterinary market for the treatment of chemotherapy-induced diarrhea, also known as CID. in dogs. This included CID treatment forums on January 16th and March 6th for veterinarians, veterinary oncologists, and members of the media during two well-attended national gatherings, the Veterinary Meeting and Expo, also called BMX, that conference was in Orlando, and the Western Veterinary Conference, WVC, in Las Vegas. Dogs, as with humans, discontinue their disease-modifying chemotherapy in approximately 40% of the time due to diarrhea. And the reception of cantilevia CA1 among general practice vets and veterinary oncologists who have learned about the product has been extremely positive. Later in 2022, we're looking forward to the expected addition of another dog-focused product to the animal health portfolio, cantilevia being conditionally approved for exercise-induced diarrhea, another rare mums indication. That concludes my comments. Thank you all for your time today. And I'll now pass the conversation back to Lisa.
spk05: Thanks, Ian. Thanks, Carol. I'm going to pause here for a moment to acknowledge that as we in the Jaguar, NAPO Pharmaceuticals, and NAPO TheraFamily are well aware, diarrhea is not always a topic that people outside of the company are comfortable discussing, although we have found it's not as much of an issue with dogs. Nevertheless, we're going to play a short video clip now that I hope you will all enjoy. A video on the topic of diarrhea is mentioned in a refreshingly public and candid manner. Peter, can you do that?
spk03: Yeah, we'll launch the video now, Lisa. Okay.
spk00: I get really peed off when I read or hear about actors being maligned as a group. It's so easy, isn't it? That lazy and false assumption of vanity. When in my experience, which by now is considerable, the opposite is true. We love and admire each other's work. Together we laugh, we weep, we worry, we change clothes, we throw up and we suffer diarrhea. Don't you? I mean, I do.
spk03: All right.
spk05: We have heard from many of our patients that it's okay to bring humor to the topic. And the love Dame Helen Mirren and love acting in theater. I have a son in the business, so thank you, Dane Murin, for helping to de-stigmatize the subject of diarrhea. I am extremely pleased with all of our achievements as a company in 2021, and we at Jaguar are energized about all of our important initiatives underway for 2022, and in particular, the expectation for transformative value creation in the next 12 to 18 months as the value of the CROFELIMER pipeline can be realized. I continue to be grateful for the ongoing support and dedication of our employees, our partners in the Amazon, our stockholders, and all of our other stakeholders. And we'll now open the floor for written questions that have come in, which I can access right here. And I'm going to, so hang on. Okay, I'm just going to take these in the order in which they've come in here. Question number one, are there Canolevia purchase orders yet? Yes, there are open purchase orders, and there are a list being accumulated of veterinarians who have learned about the product, for example, from the two conferences that Ian spoke about, who want to know about Canolevia and place orders when the product is available. And then there's another question. When will cantilever sales to the public begin? We expect that to begin in the second quarter. So we're just around the corner from that. Let's see. There are many investors who say that you are not confident in investing money in your company. How can you reassure the investors in order to restore confidence? So, first of all, I should let you know there are many, many blackout periods for buying or selling stock in the company for the CEO and the key officers in the company. Nevertheless, during one of those open windows last quarter, both myself and the CFO, Carol, invested at a substantial premium, restricted stock, so we couldn't sell it, no warrants, nothing special. at about five times where the price is now, and we're happy to do that, to show our confidence in where the stock price needs to be. And this was after the reverse split that we had done last year. I also can tell you that there is not one company or board member who has options that are in the money. So we're all rowing in the same direction with the shareholders to get the value recognition in the company. Could you discuss the endpoints for the cancer-related diary indication, enrollment criteria, and sample size? Yes, I can. So what is very important is the learning that came into play to define the primary endpoint for the cancer study. So Mitessi, crofilomer, is a first-in-class mechanism of action. It's an anti-secretory. And what it does is it normalizes stool formation. It takes the water out of the watery stools, Helen Mirren would appreciate this discussion, and makes it a formed stool. And therefore, the appropriate endpoint is looking at stool formation. And in the trial, which is called the ADVENT study, which got Mitessi approved or Felimer approved for the HIV indication, the definition of the endpoint was a responder endpoint. the patient responding and moving from watery stool to formed stools, not eliminating stools as you would have with an opioid like Imodium or Loperamide, but moving to formed normalized stool function. And this is a prophylaxis study, the cancer study. So the enrollment criteria is the patient needs to be on targeted therapy, which is typically chronic therapy, which has a secretory-mediated diarrhea associated with it, with or without traditional chemotherapy. And it's in solid tumors. And as I said, it's prophylaxis before the patient starts the targeted therapy. And it's looking at the ratio for the responder analysis, essentially the area under the curve comparing the treated patient to the placebo patient. And it's 256 patients. Same dose of Mitessi that is currently commercialized. So it's the single dose of Mitessi compared to placebo. Let's see. On profilamer in CID, is the study enrollment impacted by COVID-19? Will there be any early reads like interim analysis before reporting the top line results? So as everybody who was in clinical trials in the United States, Yes, definitely study enrollment was impacted by by coven and it's part of the reason to stay on schedule. If you may have heard me mentioned that we are opening new sites, not only in the United States, but outside of the United States as well to put as much geographical diversification in place and make sure that we stay on target, which is the name of the study on target for completing patient enrollment. In the beginning of 2023. And there's a question, can you give more color on the closed network specialty pharmacy strategy? How much spending does that enable you to save on an annual basis? Ian, I'm going to turn that question over to you, please.
spk01: Sure, yeah, thank you. And a great question, Louise. Yeah, essentially, there's two pieces to the value of the SP pharmacy, and some of those are related to cost savings and improvement in gross net and payer mix. And just as an example, we save approximately, our distribution fees are about half of what they were prior to the transition to the SP pharmacy. So instead of paying through the title model and through all the wholesalers, we sale, again, we cut that cost in about half going directly to the SPs. But the other piece of the value really is in terms of kind of the market access components for patients. And really, the metrics we look at there are time to first fill, so how long from when the patient gets the prescription written until they actually get the drug in their hand. SPs can do that much more quickly. The time between fills, so theoretically every patient should fill every 30 days. Often patients don't. In the retail sector, that was retail channel, that was up to 45 days in between fills. Now we have it down to in the low 30s across most of the SPs. And then patient persistency, how long do they stay on the drug is also longer which benefits the patients in the SP model because they just provide better support and kind of access services related to kind of working with the payers that the SPs are just much better equipped to be able to provide.
spk05: And Dean, I'm going to give you two other questions here. Specialty pharmacy revenue was 100% of Q4 of my test revenue. How may that look throughout 2022?
spk01: So the SP model is working quite well by many metrics that we originally kind of modeled around this transition that's outperforming many of those metrics. So we're very happy with the SP relationships that we have in place and envision that continuing through 2022 with no significant changes. So we anticipate the vast majority of the volume of Mitessi continuing to be distributed through SPs, just like as we reported in Q4.
spk05: Okay, and then another question for you, Ian. Will you be creating your own, our own telehealth platform or leveraging an existing platform?
spk01: Yeah, great question. So there are a number of vendors out there who provide this technology and connectivity specifically for pharmaceutical brands. It actually is pretty complicated in order to be able to build a platform like this. So we have partnered with some of the leading industry providers in this space. We anticipate launching this in Q2, but we have some great vendors supporting this rather than trying to build it on our own, which I think would be quite difficult.
spk05: Terrific. And then, thank you, there's another question about, can Alevia, do we expect Mitessi sales to increase? We would not be investing in all these additional companies. initiatives for patient access if we didn't feel that it was going to impact patient access, which therefore would translate to increased prescriptions and increased sales. So, the increased activities is a representation of our confidence. Let's see. How do you anticipate the Lechlamyr in cholera study could look in terms of number of patients, endpoints, and timing? enrollment and completion. So, cholera is very interesting because we have already completed and published studies in cholera with crofilomer that were quite important in terms of the impact on the dehydration. Specifically, if you could decrease the dehydration by about 30% in the first 6 to 18 hours, that's considered sort of the death zone. for patients with cholera. And again, it's not the cholera that kills them, it's the dehydration. And 30% is considered a life-saving impact. And that was achieved, again, these are published posters with Profelimer. Profelimer does not qualify for the Tropical Disease Priority Review Voucher Financial Incentive Program because that program only exists for a drug for their very first indication. And of course, Profelimer is already approved for HIV. Leclerc, as I mentioned, is a second-generation antisecretory, works by the same mechanism of action, comes from the same tree that we, and where we sustainably harvest croton lechlery, but is a distinct product, we believe, under botanical guidance because it's a different collection of proanthocyanidin chemical collection. So, the reason why I'm saying all that is we would imagine the study design would look remarkably similar to the successful trial design that we had with profilomer. There may be a larger number of patients as for a pivotal trial, whereas the profilomer study was a proof-of-concept trial. But we're talking patients under 100. And really rapid enrollment, which was done in Bangladesh at the International Center for Diarrheal Disease Research, which is a beautiful center. It was initially established by John Hopkins' leadership now runs on its own and completely devoted to cholera and cholera patients. So there's patients there all year long. So that study is expected to start, as I mentioned, in the second half. That will be a phase one study. And then we'll go into the phase two and the pivotal trials thereafter. And this is an acute study, so these are much shorter studies, smaller number of patients in three days of treatment, so much shorter than the HIV and the cancer trials. Let's see. How do we explain the loss from last year? The financial loss from last year is because we are a commercial stage company, but we are primarily a development stage company. So we have significant expense going into research and development. To expand the indications of from a specialty market indication, very important patients. This was fast tracked by the FDA. But, you know, another definition of specialty market is a relatively. Small market versus where we're looking to go with the cancer indication and the short bowel indication and future pipeline indication, such as irritable bowel syndrome. There after we talked about short bowel syndrome, 3rd party projections for that global market are. in the $5 billion range. There's no other agents that are out there for cancer therapy-related diarrhea. However, there is a supportive care market for chemotherapy-induced nausea and vomiting. And those agents typically are used just for the first three days of a chemo cycle, yet that market is projected at about $3 billion for this year. So this can give you some idea of the size of the markets that we're going after. and the justification for the investment, not only in clinical trials research and development, but the preparation for the commercial supply and all the manufacturing related expenses. Once the product is approved, it's all about manufacturing and making sure you have product available. Okay, this is an interesting question. As a Native American herbalist and an investor, we have many plans that could change the scope of healing. Jaguar Health is the only corporation I could find, and we believe we have probably the only corporation I could find that is looking at prescription development of traditional medicines. How can I bring the plants to the table? We're probably the only company that has a department and a chief of ethnobotanical supply and investigation. So through the website, you can send information to the company, and we will make sure it gets to our chief ethnobotanist. and my co-founder, Dr. Stephen King. I've been working with him for 33 years and I know he will be very interested in responding to you.
spk03: Let's see, I think the last question.
spk05: I think the last question is, are you going to have a reverse split again? That would be the worst idea. I'm in complete agreement with you. There have been no discussions about doing reverse split. All the energy and efforts are focused on what we talked about, what we expect to see in 2022 near term from not only continued efforts for Mitessi, but Canalivia, and then the ongoing support of the clinical investigation for CTD and SBS, which we feel will be transformative in value creation. the equity that we also have in NAPO Thera besides the licensed opportunity there. Pursuing, and I would expect to have a license agreement in another geography of the world as this year as Crofilamer continues to progress. And a lot, a lot of effort on PR and IR around the importance of managing diarrhea in a patient with cancer therapy, regardless of whether the education is for that patient who is a dog or a human. And I will conclude with that. I think I got all the questions. That concludes our webcast. Thank you for being up early. Thank you for listening. Thank you for your questions. And thank you very much for being a supporter of Jaguar. We are very committed to this business pursuit and we're very committed to all our stakeholders. Thank you.
spk02: And with that, that does conclude today's call. Thank you for your participation. You may now disconnect.
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