Jaguar Health, Inc.
Q3 2021 Earnings Call Transcript

Published: 17 Nov 2021

[Operator:]

Before I turn the call over to management, I would 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 risks 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 event. While management believes that it's 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 10-K for the year ending December 31, 2020, which was filed March 31, 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's supplements are condensed consolidated financial statements presented on a 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 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.

[Lisa Conte:]

Thank you very much and thank you for that comprehensive disclosure here. Welcome all. As just heard, my name is Lisa Conte. 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 the key month of product development activity for Jaguar. We're so pleased that the results from our Phase 2, or from the Phase 2 that's on our study investigator initiated a HALT-D study of Crofelemer, 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-D study was sponsored by Georgetown University and it was funded by Genentech tech. It was a controlled study of the prevention of diarrhea in breast cancer patients on targeted therapy and a taxane chemotherapy drugs. The study is independent from our pivotal Phase 3 OnTarget, that's the name of our study, OnTarget; which is Crofelemer for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy with or without cycles chemotherapy. We initiated our OnTarget study in October 2020 and patient enrollment is ongoing. So back to the investigator-initiated poll study, the poster will be presented at San Antonio by lead author Dr. Paula Pohlmann 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 Swing ho is at Georgetown University, and the poster presentation will take place on Friday, December 10th, from 7 to 8

[Carol Lizak:]

Thank you, Lisa. And thank you all for joining our webcast today. Key financial highlights for the quarter ended September 30th, 2021 are as follows. As Lisa as stated, Mytesi prescription volumes increased 7.6% in the third quarter of 2021 over the second quarter of 2021. And new Mytesi prescriptions increased 9 % during the same period. Mytesi total prescription volume, remained the same in the third quarter of 2021. Over the third quarter of 2020, our new Mytesi prescriptions increased by 10.5% during the same period. Mytesi 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. Mytesi net revenue decreased like 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 draw-down of approximately 1300 bottles of Mytesi across the Company's third-party logistics warehouse, wholesalers, distributors, and retail stores. The Company expects essentially a full transition to Mytesi prescriptions, being dispensed through Specialty Pharmacies by the end of the fourth quarter of 2021. Mytesi gross revenue, non-GAAP measure was approximately $2.2 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. Mytesi growth revenue 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 draw-down of approximately 1300 bottles of Mytesi across the Company's third-party logistics warehouse, wholesalers, distributors, and retail stores. Sales volumes distributed through the Company's recently established, and expanding, pool of third-party specialty pharmacies through which Mytesi 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 the 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 financial for the third quarter of 2021. I will now hand the discussion back to Lisa.

[Lisa Conte:]

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 Wendt, who is our Chief Commercial Officer. And -- so I'm just going to take the first question and send it right over to Ian here. The question is, why have your office for strategy which delivers you less sales year over year? And so, we have not opted for 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, then 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 move into the Specialty Pharmacy network, please.

[Ian Wendt:]

Thank you, Lisa, and happy to do that, and good morning. Great question and one I think gets straight to the point of what we're trying to communicate on this call. So, I'll try to address this in a couple of 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 Mytesi. And we've already seen evidenced that this is working significantly. Part of that strategy is the transition of Mytesi 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 outcome’s perspective, that are important from patients, we've known for a while that they do better because 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, and that has to do with the adherence counseling, fighting for the PAs and appeals with pairs that the specialty pharmacies do. The days between fills is significantly lower. So ideally, the patients 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 that tells you how good of a job you're doing in managing through the PA appeals process, the barriers that payers put in place. And that's higher in the SP environment we know in the long run, patients do better in this environment. 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 Mytesi in the current indication, but becomes critically important in the future for potential future indications with much larger market opportunities. 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 the -- for Mytesi, 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 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.

[Lisa Conte:]

Thanks, Ian. And I do want to say to everyone that 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 remember, Mytesi 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 to follow on indications for Mytesi and for Crofelemer co-founder. And 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 relevant. What is the market potential for chemotherapy-induced diarrhea and exercise-induced diarrhea? This is Canalevia. So, this is the dog product of -- the dog prescription products of Crofelemer. And also, after the potential launches of Canalevia in chemotherapy-induced diarrhea -- exercise-induced diarrhea, do you see any other potential usage of Canalevia 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 the humans react to these drugs and the diarrhea that results from that and therefore, of course, the benefit that we're expecting from crofelemer. We do think that this will be about as important a specialty market opportunity as Mytesi in HIV. But what's also quite interesting, in the United States, it's a self-pay 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 it -- is the different situation and much more straightforward in dog. 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 6 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 pipeline versus our animal pipeline because that's not in the initial labeled targeted indication. Ian, is there anything you would like to add about the plans for the launch for Canalevia?

[Ian Wendt:]

Yeah. Just a couple of points, I think, that might be interesting for folks to understand. We did do the market research on assessing the market potential for CAD. I can't give specific numbers, but what I can say is that our baseline assumptions were more conservative than what's 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, what future indications might Crofelemer potentially have an app -- where it might have an application for a variety of different populations. And 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 any diarrheal for dogs, not just within CID, but in broader diarrhea diagnoses outside of CID. 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 for -- to really get the word out there to pet owners and to providers. We have rather large event plan ned at VMX, which is a veterinary conference that takes place in the middle of January, is 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.

[Lisa Conte:]

Thank you. And I will add, it is 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, again, give their dog chemotherapy or not, and try to extend their life are

[Ian Wendt:]

Happy to and yes. 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 things that we watch quite closely as we look at persistency, 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 to 45 days. Patients don't always fill exactly when they are supposed to. The ideas 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. Those are some of the key metrics we look at. And really, we see it's a pretty stark difference between the retail pharmacies, the type of support and outcomes that they deliver. And remember, the retail pharmacy space is just volume-driven. 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. And specialty pharmacies can do that and the metrics really support the idea that we're getting better outcomes there.

[Lisa Conte:]

Great. Ian, I'm going to give you another one.

[Ian Wendt:]

Yeah.

[Lisa Conte:]

Let me see. Hang on. How do you see Mytesi revenues being impacted further as greater specialty pharmacies continue to offer the product?

[Ian Wendt:]

Well, once we get through the transition period, we know that the patients that we've already -- have already been on Mytesi, I guess we'll start there, are going to do better for the reasons that I just mentioned. Like, they'll stay on the -- we expect them to stay on the product longer, fewer days between refills, all those great things that really demonstrate the patient is getting better support in general. The metric that we were really suffering from, and really this isn't unique to Mytesi, a lot of brands have struggled with this, is the ratio between -- 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 are 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 the patient to be on to actually -- to get filled. So, we see that we are going to -- we already see that we're improving that metric quite significantly for the reasons I mentioned earlier. So that bodes well for new patients -- 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 starting Mytesi and stay on Mytesi. To be able to successfully do that. And really that's supports the underlying long-range vision of the strategy, right? Better support those patients allow more patients to benefit -- appropriate patients to benefit from Mytesi.

[Lisa Conte:]

Great, thank you. There's a question here about -- let me read it just so that everybody has the same basis of understanding here. Prescriptions in veterinarian offices, for the most part are profit-centered. If anybody with an animal, you go to the vet, often you just walk out right with your prescription there and they do a mark up from the price that they get from the veterinary wholesalers. And as we've also said, not just to underscore this again, because of the self-pay situation, one of the strategy -- financial strategies of moving to Specialty Pharmacy in addition to the better patient service, is to just have a more predictive situation on that gross to net ratio, whereas it's quite predictive in the animal health area. So, there was a question about pricing of Canalevia. And we are finalizing that right now in doing -- and have done a great bit of research to looking at other situations where there is a human active ingredient and animal active ingredient, and what is the typical pricing ratio right there. So that's how we're going about that situation. There's a question about the number of things that I'm juggling between Jaguar and Napo EU, and would you give a with the work to another CEO for Napo EU. Let me tell you the nomenclature is different in Italy. So, a General Manager, Massimo Mineo, is the CEO responsibility. 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 Napo EU. So, my full attention and responsibility, of course, is on the business of Jaguar. However, remember that Napo EU is providing another clinical shot on - goal for Crofelemer, 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 Napo EU and the financial benefit that we would expect to come from that. As Napo EU achieved its Chatham goal follow-on indications, will it eventually have filed for an IPO at aim Italia (ph) in the future? Napo EU absolutely has its eyes on a public offering. And a key transformative event in value enhancement is, of course, proof-of-concept data in humans first revenue generation. Remember, as I've said, for an orphan designation, in Europe, there can be reimbursed pre -approval 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 in 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 Entheogen Therapeutics Initiative. That's an initiative within the Company looking at psychoactive and psychedelic agent plants, all the way to some pure compounds that are already in our 2,300-plant library from first-hand field investigations that this Company has conducted with western-trained physicians as and shamans when he was in the field over a 32-year period of time. The fascinating field of research, looking at ways of curing and treating mood disorders offer to 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 7 compounds. So , and DNA, And what we're providing is an opportunity for what is the next generation of the psycho active and psychedelic agents that can prevent 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 Crofelemer. So followed a plan that has been utilized by chime in 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 products approved by the FDA, as the drug -- drug approval by the FDA. Under botanical gardens 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 are on our -- within this Company, take very, very little resources for us to mobilize. And then what we're looking to do, as I've 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 pharmacologists who study 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 just said this publicly as well, we have a sales force. We have our first product. It's -- 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 efforts, while we are waiting for the pipeline indications of Mytesi to get developed and approved, and it's got to be the right fit, does not resource 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 have nailed all the questions here. Looking into nothing in the public. I think I have gotten to -- what where do you see the Company in 3 years. In 3 years, it will be very exciting. We believe that we will have completed, the pivotal clinical investigation and the approvals for 2 more indications. That's why I would expect it to be. Remember all the forward-looking statements that were previously discussed here. But that would be the timing for CTV cancer therapy related diarrhea. That's the Mytesi indication in the United States. And then short bowel syndrome, a full approval in -- or a conditional approval, full access to all patients in multiple European countries. Again, that data is available in the United States. So, we are already looking at, would there need to do any additional work to support the approval in the United States, where we already have orphan designation, that's Crofelemer in a highly concentrated liquid formulation. So that's not Mytesi. Different products, different value propositions, different business model of very, very high-valued chronic medicine for small population. That's very expensive to take care of with very, very large mortality and morbidity situation. So that's very exciting business. And then of course, Canalevia, and thinking about ways to get Canalevia to all animals that are dealing with diarrhea. And then the last piece is the whole Crofelemer story is, how do we get crofelemer 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 consulting with the Company for the past 6 months. So based on per work and how discussions have been progressing on the business development side, specifically focused on getting crofelemer out-licensed to all the countries in the world, we would expect to have those yields cut in the next year or so, which lays the groundwork then for where will the product be in terms of bringing in licensed compensation to the Company royalties, etc., profit sharing in other parts of the world and that certainly would be done, our expectation in the three-year period of time. And then hopefully, of course, the collaboration will have been completed and there will be some novel models’ drugs coming out in the psychoactive and the psychedelic area. And I believe that concludes all the questions that I see here. I'm just going to disclosing on one more time, yes. So, thank you very much for your attention and we got you off five minutes before the market opens. And I'm glad I was able to access the questions this time. And this was something good, we'll be doing that in the future. Thank you very much.

[End of Q&A:]

Thank you. Ladies and gentlemen, that will now conclude today's conference call. Thank you for your participation. You may now disconnect.