Hello, and welcome to the Life Sciences Investor Forum. On behalf of OTC Markets and our co-host, Zacks Small Cap Research, we're very pleased you've joined us. Our next presentation is from Tonix Pharmaceuticals. Their session will be moderated by David Bautz, Senior Analyst with Zacks Small Cap Research. Please note you can submit questions for the presenter, and you can view a company's availability for one-on-one meetings by clicking Book a Meeting. At this point, I'm very pleased to welcome Dr. Seth Lederman. He's the Co-founder, Chief Executive Officer, and Chairman of Tonix Pharmaceuticals, which trades on Nasdaq under the symbol TNXP. Welcome back, Seth and David.
Thanks, Jason. Seth, how are you doing?
I'm well. Thank you very much for having me on, John and David.
Yeah. Glad we could do this today. All right, let's get started. Obviously Tonix has gone through a major transformation over the past year, culminating with the commercial launch of Tonmya for fibromyalgia. Obviously investors are really focused on how the launch is progressing, but also on the broader pipeline, so including your Lyme disease program. I'm kind of excited to dive into both of those things today. Before we get into specifics, how would you describe the company's transition so far to becoming a commercial stage organization?
Thank you very much, David. We're very excited about the launch of Tonmya, which is sublingual cyclobenzaprine, and indicated for the treatment of fibromyalgia in adults. It's the first new treatment for fibromyalgia in more than 15 years. We've been working on this from the beginning of the company, so we've been working on Tonmya for 15 years. It's the reason our company was founded, and we feel very special to be one of those companies that can take a drug from concept to FDA approval to launch. We've been preparing for the launch for more than two years. As a matter of fact, two and a half years ago, we acquired two marketed migraine products in order to set up our commercial infrastructure.
Those products are Zembrace, which is an injectable, subcutaneous, device to inject sumatriptan for the acute treatment of migraine, and the other is Tosymra, which is an intranasal sumatriptan spray, also indicated for the acute treatment of migraine. The objectives of acquiring those products was to stand up our commercial organization, and that was a very big success. I don't think we could have been as successful as we are now in doing a launch if we were at the same time setting up commercial infrastructure. We launched Tonmya on November seventeenth last year. We have about 90 representatives in the field, and we have extensive, ongoing efforts in what's called omnichannel, which is digital and other means of connecting with healthcare providers, and to a smaller extent, direct to consumer in the launch.
We're generally pleased. Fortunately for us, we really began our transition to being commercial two and a half years ago.
Yeah. Kinda, to extend that a little bit, what would you say were the most important things that the company had to get right going into the launch?
Well, one of the things that was facilitated, that facilitated our launch is that we already had preexisting contracts with, a number of different elements in the supply chain, distributors, PBMs, specialty pharmacies, things like this. We already were very much in the mix. Probably more than just talking about capabilities, we have a really wonderful team of dedicated professionals who understand how to market and launch prescription pharmaceuticals. It took a while to acquire those people and those capabilities. There haven't been many surprises in the launch. As a matter of fact, it's been more a case of things happening according to a plan.
All right. Sounds good. Let's, I wanna ask you a little bit about early physician reaction, and I kinda wanna ask this in three parts. First, what kind of feedback are you hearing from physicians who are prescribing Tonmya? Are you seeing adoption primarily among, is it pain specialists, rheumatologists, or primary care physicians? How do you think physicians are positioning Tonmya relative to therapies that have already been available?
Great. Thank you. The first is physician feedback. The next is who's prescribing. The third is how is it being positioned among existing therapies. The first is, you know, I'm the CEO. I'm getting information thirdhand in terms of the feedback, and it's not really coming back in a systematic way. I'll say that the feedback I'm getting is anecdotal. But generally speaking, the patients are reporting positive results, generally speaking. There hasn't been anything surprising on the downside. You know, we're just at the beginning of the timing of the launch where we can start seeing patterns of patients refilling and things like that. All of that I think is generally positive. All of that is encouraging.
The next thing about who's prescribing it, from the beginning, we had a strategy, a very data-driven strategy, to look at people at HCPs, healthcare providers, who diagnose and treat fibromyalgia. We were really looking in a way that was agnostic to what the subspecialties were. That's turned out to be spot on. When we looked at the deciling of high prescribers, the highest prescribers broke out into roughly 30% rheumatologists, 30% primary care, then came pain anesthesia, then neurology, and then a variety of things. Pretty much that's what we're seeing, you know, now that prescriptions are coming in. Let me also remind you, it's early. I think it's about week 12, and you know, we're still hopefully at the very bottom of a adoption curve.
There's noise at the bottom, and there are a number of other things. I'm giving you very early impressions. I'll tell you some of the surprises that we have seen so far is that some of the high-prescribing physicians were on our list, our initial target list, as being prescribers, but low prescribers, and some reasonably active prescribers were not on our list at all. I think that, taken together with a lot of other information, suggests to us that patients came to their providers and had somehow learned about the availability of Tonmya and asked them, you know, to look to it to get a to try it. I think that is all very encouraging.
One of the things that is a very encouraging sign that we're seeing is the large number of different prescribers who are writing and it's a large number, and it's also geographically dispersed across the country. I think that the way that these sales regions were determined seems to be panning out and things like that. Our whole plan is to be dynamic and reactive. If we see someone who's suddenly a high prescriber and we didn't even know about them or weren't targeting them with field force visits in the beginning, you know, we will be targeting them now. The last point you mentioned was how are they positioning it in the treatment of fibromyalgia? Again, the information I'm gonna provide you is anecdotal, not systematic.
You know, generally speaking, I think it's being used according to the label, that it is monotherapy, can be first line. You know, fibromyalgia patients often cycle between different medicines, mostly because of the limited benefits of the existing drugs and also tolerability issues. We view the market as something like a merry-go-round, a carousel, I guess you'd call it. You know, each patient will jump on a different drug journey at different points of their disease cycles. The fact that there are already three approved drugs out there, we don't see as so limiting because people have relatively low persistence on each of those drugs. There are periods where fibromyalgia patients are not taking any drugs.
We think that there is not a significant limitation to people trying our medicine. Let me just answer a question you didn't ask. We have a robust patient access program up and running. Doctors can get samples, and, you know, those are shipping out. That's a 14-count bottle, which is 2 weeks of one tablet a night. We have between prescription cards and other kind of electronic resources, for adults, for non-Medicare patients, we have I think industry standard co-pay support and other programs to improve access.
Okay. To kind of follow up on the patient profile, so either in your opinion or if you are hearing any feedback, which patients do you think are the best candidates for Tonmya, or is there a best candidate for Tonmya?
Yeah. Again, we're early in the launch, so I don't have anything systematic to return to you, but I think Tonmya is for all comers. I think that's one of the differences between Tonmya and the previously approved three drugs. The previously approved drugs, Lyrica from Pfizer, Cymbalta from Lilly, and Savella, which is now sold by AbbVie, they were all approved based on studies that enrolled patients with the 1990 criteria, the American College of Rheumatology 1990 criteria. The criteria were updated in 2010 and 2016. Our studies enrolled people with the 2016 ACR criteria, which is the more modern criteria. I think generally we enrolled and studied patients with milder forms of fibromyalgia than the earlier ones.
The 1990 criteria required 11 tender points, which are where the physician or the healthcare provider applies pressure at different points of the body and elicits pain, which is called tenderness. The tender points were eliminated from the diagnostic criteria of 2016. We did not routinely measure whether they had tender points. I think generally speaking, tender points are indicative of a more severe form. I think another important thing that was that, you know, primary fibromyalgia and secondary fibromyalgia, you know, those words are used a lot, but it's all fibromyalgia. The 2016 criteria made it very clear that fibromyalgia is not a diagnosis of exclusion.
The 2016 criteria actually have two sentences to make that point, that fibromyalgia can be diagnosed in the context of other diseases and that another diagnosis does not preclude the diagnosis of fibromyalgia. Many cases of fibromyalgia exist in the context of other conditions. I think that those are indications that we address the way fibromyalgia is really diagnosed today, and those other drugs from 15 years ago are using a diagnostic criteria from 35 years ago. I think that we're really much more relevant to how fibromyalgia is treated today, both in terms of that it's a bigger tent, let's say, and also that it's clear that it is not a diagnosis of exclusion.
That actually is a good segue into my next question about how much of the commercial strategy would you say involves educating physicians, say, about the importance of sleep disturbance in treating fibromyalgia?
Yeah. Well, you know, there are two main elements of commercializing a product and educating physicians, and one is the sales force, which sticks very exactly to the label and the label claims. That would not come up in a typical sales call. The medical affairs team, you know, is chartered to respond to questions from HCPs about the literature and the details of the study and those kinds of things. In response to a question in the medical affairs context, something like sleep might come up.
Okay. Access and reimbursement are, you know, a couple of key factors for any launch. How is payer coverage evolving for Tonmya?
Yes, they are. I think that's gonna be hopefully, you know, the next big announcement. I'm not guiding on it, but, you know, we're working very hard on it. You know, we started interacting with the payers a long time ago, more than a year ago, through a process called pre-approval information exchange. We've been going back and forth with payers for over a year. Obviously, after we got approval, the discussions intensify and take on a different character. I can't guide to when we'll get coverage, but it's very important to us and, you know, an area of our focus.
I think that one of the issues with payer interactions is, we have to keep the rebates to a reasonable level so that, you know, Tonix can profit from it and, you know, our shareholders can win. There's a trade-off between getting rapid coverage and big rebates. You know, we're in a period where in order to keep the rebates to a reasonable level, we're gonna have to wait and just show that there's enough pull-through, meaning prescriptions without coverage, that at some point it will make sense to the payers that it would be timely and relevant for them to bring us on formulary. It's a process, and, you know, there are three big payers, I'm sure everyone knows.
They control more than 90% of the market, but they don't act that way. In fact, there are many, you know, groups within the three big players that are dealt with, you know, somewhat independently. We're very engaged with it, and we're hopeful that payers will see the value proposition of a non-opioid analgesic, very important, non-opioid analgesic for a chronic pain situation. Certainly, fibromyalgia is something that has been notoriously mistreated with opiates over the years. We're hoping that the availability of our product, you know, will change that part of the care model, and over time, save the healthcare system because hopefully we will be, you know, decreasing all of the chronic problems that opiates bring on, particularly since opiates should not be used in fibromyalgia.
Right. Okay. There's obviously a lot of info coming in, too, about the launch. I'm curious what two or three key metrics are you keeping tabs on, as you know, look to see whether the launch is progressing successfully?
Sure. Thanks. First of all, most of our prescriptions are visible to investors on Bloomberg, which get data from, you know, the typical sources. Symphony, IQVIA, you know, capture the bulk of our prescriptions. Depending on the level of subscription to these services an investor has, you know, they can pretty much see what we're seeing. There's some sales metrics that are invisible, and that is through the specialty pharmacies. You know, over time, that will be a smaller and smaller piece. The key things that we're looking at are things that are available to investors, which is total prescriptions and new prescriptions. The other metric that we're excited to follow is new and unique writers, prescribers.
I think in all those cases, we're doing well. I would loosely describe us as still on a linear growth pattern. It's not exponential. You know, we're just gonna keep working and working and working to see if we can bring it to, you know, some kind of an exponential growth. You know, we're not seeing that yet. You know, again, at the bottom of the curve where we are, there's still a lot of noise in it, variations. Anyone who lives in America knows that we've had a couple of snowstorms this year, and you know, that's not good for sales. You know, as I said, we launched on November seventeenth, and that was followed by Thanksgiving, Christmas, and New Year.
You know, it's a bumpy road, but I would say generally speaking, you know, the path is on the right track. Definitely, you know, NRxs, TRxs, number of prescribers, and now increasingly, refill rate. That's a very early number because obviously you have to finish your first prescription to get a refill.
Right. Okay. Sounds good. I thought we'd spend a couple minutes now, talking about the Lyme disease program because I think investors are pretty interested in that program. I wonder if you could just give us a quick overview of how that whole program works. What the approach that you're taking to Lyme disease prevention versus, say, what else is being developed.
Certainly. Thank you very much. Yeah. We have a very new program that has attracted a lot of attention. We call it forty-eight hundred, and it is a long-acting monoclonal antibody that prevents Lyme disease. Well, it's in development to prevent Lyme disease. Let me unpack that. Long-acting means that it's designed to be administered in the spring, in the early spring, and to protect people to the fall. Let's say an April injection of our preventative would last, have an effective concentration until October and November, 'cause in the United States, in the continental United States, that's the Lyme season. The monoclonal antibody, by the way, was developed by UMass Chan Medical School, and we are very grateful to UMass Chan for selecting us as their development partner.
I believe it's because we've shown that we can take a product from concept to approval, and that we had expertise in manufacturing monoclonal antibodies, and that we love new technology. This technology that they developed is exciting. We found a good fit for us and with great potential. The target of the monoclonal antibody is a protein on Borrelia called OspA, and Osp, O-S-P, stands for outer surface protein A. This target has been identified as the Achilles' heel of Borrelia. Borrelia is the bacteria that causes Lyme. This was the target of the SmithKline Beecham vaccine from 10 years or so ago that was withdrawn from the market, but had about an 80% protection rate.
It's also the target of a program from Pfizer, who's partnered with Valneva in a vaccine against OspA. Finally, Moderna has two mRNA vaccines, one that's designed for the U.S., and one's designed for the European market. All of those that I've just mentioned are vaccines, meaning they are used to elicit an immune response in the body. Ours is different. Ours is an antibody, so instead of needing to elicit the immune response, we simply provide the antibody, and the body doesn't have to do any work, which is important because it means that someone who doesn't have a perfect immune system or is immunodeficient can still benefit from ours.
We're gonna study it in healthy adults initially, but over time we plan to study children and people with less perfect immune systems. The big difference is vaccines are active immunity, and ours is passive immunity. There are key differences also in some of the target product profile. Ours is expected to provide protection within two days, whereas the vaccines require more than six months to get protection. You know, that's a big advantage for us. Both vaccines and our product, our long-acting antibody, are designed for annual boosters. In both cases, they just last, you know, a season of protection. I think there's another difference that our program is designed just for the United States, and that's true of one of Moderna's programs.
The Pfizer program is designed to be a U.S. and European vaccine. It has six different OspA types, but only one of those is relevant to the United States. It's very exciting. You know, Pfizer's guided that they'll have top line in the first six months of this year, so the people are anxiously awaiting that data. We hope they're successful and welcome them as a competitor in the sense that the target product profiles are so different, between us, you know, with a long-acting antibody and them with a vaccine requiring, you know, three shots to get the first protection.
Lyme disease obviously continues to expand the incidence in this country. How do you think about the potential demand for preventative therapy like yours?
I think the demand is great. We estimate, and other people have stated this, that about 70 million Americans live, work, or vacation in Lyme endemic areas. While the number of Lyme cases in the United States is low, the consequences, meaning not low, it's 500,000 a year, but out of that 70 million. The consequences can be so devastating, you know, chronic Lyme, all sorts of severe medical problems from untreated Lyme or Lyme that becomes chronic, that we believe the risk-reward strongly favors annual prophylaxis with a long-acting antibody like ours.
Yeah, absolutely. Okay. For the closing question, I'll give you the final word, and I'm curious what you think investors underestimate most about your company today?
Thank you. I think that the fact that our launch is on track and that our product, again, the first new product in fibromyalgia in 15 years, first in class with a new mechanism to treat fibromyalgia, that fibromyalgia is a population approximately 10 million American adults, and it's right now underserved. I think that people have not yet woken up to that. I believe professional institutional investors probably wanna see 2 full quarters of launch. You know, we're just nearing the end of the first full quarter, so I guess they'll be on the sidelines watching. It's a very interesting opportunity, and I think that at the very least, investors are not paying attention to that.
Considering the fact we December thirtieth, we had, we've announced we had $208 million in cash and a runway of a year with fully funding our launch effort. I think that that's one thing. I think our pipeline is also underappreciated. We just talked about the Lyme program, but again, that could be a very significant product, you know, after approval, when we start addressing the risk of Lyme for all these people who live, work, and vacation in Lyme-infected areas.
Yeah. Absolutely. All right. Well, thank you, Seth, for joining us today. Really appreciate the overview.
Thank you very much, David, and I appreciate you following us and the care and attention you give to our announcements.
Sure thing. Have a good day.
Thank you.