You prefer. Today we have Seth Lederman, Co-Founder, CEO, and Chairman of Tonix Pharmaceuticals. Let me just start by saying this company accomplished something that is pretty amazing. First company in 15 years to get a drug approved for fibromyalgia, so I think it's really impressive. I'll start there, and then I'll get to a couple questions. You just reported $3.7 million in TONMYA sales, and that was based on 5,400 prescriptions. As we sit here in mid-May, do you see Q1 trends, Q2 trends accelerating, or where do we stand, especially given Medicare coverage, GPOs, those sorts of things?
Thank you very much. First, thank you very much for having us at the conference. It's a big achievement to get approval for a fibromyalgia drug. I was at Columbia University for about 20 years. I was a rheumatologist. I've been interested in fibromyalgia for more than 30 years, probably more than 35 years. It's a big achievement not only to get a drug approved, but ours is first in class, and I would argue a very exciting advance over the existing medicines. It's a difficult condition because the endpoints are subjective.
There's no animal model to guide dosing, the only way to get a drug approved is by clinical research, and fortunately investors have backed us during this difficult period of finding the dose, finding the right formulation, and getting a medicine that, with a new mechanism that I think makes a big difference. Turning to our commercial launch, we launched in November. Q1 was our first full quarter of sales, and I think we laid a very solid foundation for a successful launch. It's still early. Our script numbers are available on Bloomberg. The Symphony number captures it pretty adequately. Nonetheless, I would call Q1 relatively flat with one kind of a curve, the Q2 numbers to me look like there's a new slope, and we're starting to get, you know, some even more solid growth.
We're pretty much on track with our internal estimates of what we thought it would be. One of the things that we highlight in addition to Thanks for mentioning the 5,400 scripts, there are, you know, roughly 3,600 patients on it and, you know, 2,150 new prescribers, a broad base of prescribers, patients. All of the metrics that we're looking at are quite positive. Other things like refills.
Persistence, other things. It's hard early in a launch to get that kind of information.
Sure.
We're very pleased with the parameters of Q1.
Okay. You know what? Since you just mentioned that, can you talk at all about refill persistent rates? Given that it is a sublingual formulation and oral side effects are in the label, is adherence tracking where you'd expect as well?
Thank you.
Yeah
Obviously our persistence data will be better.
Sure
over time. We are satisfied with the refill rates, which is TRX minus NRX is refills.
Yeah.
That, you know, we, you know, continue to grow that, as we, you know, at least as a trend line are growing TRX and NRX. We are satisfied with it. We get indirect information from the, you know, the sales reps getting information from the doctors and all things like that. You know, there's also a lot of information on social media about.
How people are satisfied, for example. I don't go on it 'cause I'm afraid to click the wrong button. From what I hear, you know, in different patient groups and whatever for fibromyalgia, there's, you know, people. You know, in the clinical trials, about 25% of people experienced one of these different oral side effects, and 75% didn't. The oral side effects, you know, do come up, you know.
[tonmiken]
On chat rooms and, you know, talking about it. Generally speaking, I think it's playing out pretty much like it played out in the trials where it's something people notice, but it largely doesn't interrupt their interest in continuing therapy. You know, we're very encouraged when we hear that, you know, the benefits outweigh the, you know, minor problems.
Okay. That's fantastic. This is a differentiated product. How are the non-opioid analgesic and non-DEA scheduled attributes, resonating with patients, with physicians?
Thank you. Our status as a non-opioid analgesic is very important. Fibromyalgia is a chronic pain condition.
Any medicine that treats it is an analgesic, and ours is a non-opioid analgesic. That is very important to patients. It's also important to policymakers and to payers. I think that that differentiation probably played out pretty well with our recent announcement of we got a contract with one of the big three payers. I think that they recognize the importance of this, particularly the payers who are concerned about the overall picture. You know, that are really interested in the economics across the spectrum.
Right
Of different care that patients get. One of the appalling things is that despite what everyone learns in medical school or whatever schools they go to, nurse practitioner school, whatever, all these people are trained not to use opioids for fibromyalgia patients. Yet when we look at the claims data, someone is writing them.
In the first 18 months after a fibromyalgia diagnosis, there's opioids are commonly written, and not only do they not work, but many experts believe that they can worsen.
the kind of pain syndrome that causes fibromyalgia called nociplastic pain. We hope that we can be an agent of change in this and to provide a very interesting alternative. Another aspect of that is LYRICA, which has the lowest level of DEA schedule. I think for that reason gets much lower prescriptions than gabapentin, which is its cousin, that it's completely off-label for fibromyalgia, but it gets more use. It's probably easier for doctors to write it 'cause they don't have to click as many boxes for the scheduling.
Yeah.
There's a lot of sentiment that there's too much gabapentin around and they, you know, there's even been an article in The Wall Street Journal that maybe gabapentin is heading towards getting scheduled itself. I think that a non-opiate, non-scheduled, medicine for fibromyalgia with good tolerability is a important commercial, differentiator.
Perfect. It does appear that it is resonating because you do have medical, Medicaid coverage, excuse me, in 38 states representing 55 million lives, and a GPO agreement covering 35 commercial lives, 35 million commercial lives. I view that as meaningful progress already. What's the path for the remaining states for Medicaid, and what's the timeline look like for Medicare Part D coverage, et cetera, et cetera?
Yeah, thanks. We have a team of professionals in managed access, and they're at it all the time. We actually started in January of 2025 before approval, doing pre-approval information exchanges, and we've been at it consistently, and we're getting a really good audience and really good interest. As I said, we already have one GPO contract, which is one of the big three, two to go. Can't guide on it, that was just missed the first quarter of commercialization and, you know, we're hoping to get, you know, well, at least one more soon. The commercial is doing well, and commercial we think is about 70% of the market. Medicare is a little bit trickier because the way the Medicare formulary goes is when they open the formulary, it's a two year delay.
It'll be a while. It won't be really till 2028 that we get on the Medicare formulary. Nonetheless, we are quite pleased by the number of prior authorizations in Medicare that are nonetheless getting approved and reimbursed.
We are finding actually good pull-through, and we think that that's about 30% of the market by our analysis of the market before launch. Medicaid is smaller, but as you mentioned, we're pretty successful and we're getting new states all the time.
Yeah.
I don't even know what the current number is. Medicaid, we've been successful with, but all in all, our picture of reimbursement, I think, is a lot of cause for optimism.
Okay. Perfect. It's been out there for a few months now. People are starting to understand the benefits. You had highlighted that you were gonna be starting a digital advertising campaign, I believe, in this quarter. Can you tell us where we stand with respect to that?
Yes. We have a lot going on. We actually had a digital program before launch, a so-called unbranded campaign called Move Fibro Forward. Since then we've a number of digital initiatives ongoing, search engine optimization. We have influencer campaigns on Instagram and Reddit. We recently had a successful program on Reddit called Ask Me, you know, with a key opinion leader. You know, all compliant, but really a lot of interest in these programs. We're doing well on that front and there's a lot of engagement from patients.
I think that one of the interesting things about fibromyalgia, and it may be what drove the success of LYRICA and Cymbalta because LYRICA and Cymbalta are the first and second drugs approved for fibromyalgia, and each of them became a multibillion-dollar blockbuster. We believe, I told you I've been working in fibromyalgia for a long time. We believe that it's really the fibromyalgia patient who is our infantry.
Right.
They are on the web. They are looking about things. They're the ones going to their doctors saying, you know, "I want this. I wanna try it," and this kind of a thing. I think that we're very lucky in that regard because when people don't think about the nature of fibromyalgia and the nature of fibromyalgia patients, they think it might be impossible for a small company to market a product to 10 million American adults. If you know more about the patients, you'll see that, you know, they're really part of it with us.
On that note, what does the sales force look like? Do you think You need to add in certain places or focus in certain areas? Anything that you've learned since the launch?
Thanks. We've learned a lot. First of all, I think looking back, we're very happy with what we did.
Right.
You know, we started with 90, we're up to 100 reps. They're spread out across the country. Roughly 10 are internal reps, and then we have about 90 from a outstanding contract sales organization called Inizio, but they only market TONMYA, they only work for Tonix. They have a phenomenal, you know, HR operation there, and they're a great partner. Nonetheless, A lot of things have been confirmed our predictions about the general number of prescribers, rheumatologists, GPs, pain anesthesia, neurologists. In the granular information, there have been some surprises, that some targets.
Yeah
who we thought would be low prescribers or high prescribers, and in some cases, there are people that weren't even on our list who are, you know, who are prescribing. We're learning a lot, and I think that we've always thought that when we started getting managed care contracts, we would look to actually grow the sales force. That's what we're thinking about. We don't have any concrete plans yet, but, you know, you don't wanna grow the sales force too much ahead of access because you don't want frustrated people who then can't get the medicine. Now that-
Of course.
All those pieces are coming together, you know, we think it's getting close to the time where we might expand it. Most of it will be increase the density.
Sure
In the areas where there are good prescribers. To some extent, you know, we can go to prescribers that were outside of our targets or we just couldn't cover with, you know, with 100.
When companies launch the drugs, any type of drug, there is a change in the gross to net, and you have initial headwinds, you get access to the market, et cetera, et cetera, et cetera. You have people try the drugs. What do you see the changes on the gross to net to look like through this year and into next year?
Yeah. Well, thanks. I think at equilibrium, let's say, but equilibrium meaning when a lot of these forces are balanced, but hopefully sales are still growing. I think we're gonna have the gross to net of a traditional pharmaceutical product.
You know, an oral, you know, an oral pill pharmaceutical. In the beginning, as you know, there are two things. One is gross to net tends to be higher, meaning less favorable to us. The other thing is it's bouncy, you know.
Yeah
Different forces pushing in both directions, it's a little bit unpredictable, you know, month by month or quarter by quarter. I think even now, the demand, the pull-through is correlating pretty closely with our factory sales. A lot of, I think, the bugs are getting out of the system. Even with Q1, I think that there's a pretty close alignment with pull through, meaning paid for prescriptions, with factory shipments. I think that we're entering in a, you know, very predictable market. We just have to continue growing demand.
Okay. Before I move on to with Lyme disease, I do wanna close with how you see the total revenue opportunity. You highlighted, you know, a couple billion dollars for previous drugs, et cetera, et cetera. I'm just thinking about has this market changed at all? Is your pricing going to be different? What do we see as the realistic patient population that we're gonna be targeting, realistic, you know, penetration of that, and then ultimately, where you could get to, let's say, over five years?
Yeah. Thank you. We don't guide to peak sales. Some related companies do. We haven't yet. Maybe we will over time. You know, what we do is talk about the total addressable market.
The total addressable market, before the pandemic, the statistics basically said there were 10 million American adults. Now, you know, the pandemic left us with 20 million-30 million Americans with long COVID, and our analysis of claims data suggests half of them may have fibromyalgia. National Academy of Sciences said fibromyalgia is a diagnosable condition in long COVID. This is on label if someone has, you know, can be diagnosed with fibromyalgia. That, that may even double the number of people, so you're talking about an enormous population. The other thing is, ours is an every night bedtime medicine for weeks, months, years.
Maybe even decades. We'll see. You know, one of the things our company's named for Tonix, a gentle, soothing medicine. We think that we have tolerability that would support long-term use. A lot of things have changed since LYRICA and Cymbalta. First of all, we like the term we stand on the shoulders of giants. They really brought fibromyalgia into the mainstream, you know, phenomenally important drugs in their day, but they have real tolerability issues.
The general cost of drugs has increased since that time.
Sure.
Our WAC is higher than their WACs. They came out in 2007 and 2008. I think we have, you know, solid GPO contract with one of the three, and I expect continue that. I think that we could be looking at a really important product. Another thing that has changed is the recognition of fibromyalgia.
In 2007 and 2008, people said, "Wow, Pfizer and Lilly are putting their imprimatur on this vague condition." It's vague no more. I mean, the International Association for the Study of Pain codified it in 2017. There are now three primary types of pain. Nociceptive, neuropathic, and nociplastic. It's like three colors, yellow, red, and blue. Fibromyalgia is the prototype of one of the three types of pain. It's not only out of the shadows, it's the It was the plenary lecture at the last International Association Study of Pain meeting. The science has never been stronger. The acceptance of it has never been stronger, and we think, you know, we're coming in again on that backdraft of all of the knowledge improvements. I think that the total addressable market and the possibilities here are high.
We're gonna have to see what persistence is.
Sure.
The persistence of LYRICA and Cymbalta was low.
If we can improve on that, this could be a very significant product.
Okay. Excellent. Let's spend a few minutes then on your Lyme disease product. I understand that you do have a Type C meeting coming up with FDA. How do you believe the Pfizer data is gonna inform conversations that you have with the FDA?
Yeah. Thank you. For the audience who may not know, last year we licensed a preventative monoclonal antibody from UMass Chan. This functions somewhat like a vaccine would function in terms of you. The goal is to administer to people who are at risk but don't have Lyme disease.
That it would protect them through the season.
Sure.
This has become a standard model in, for example, pediatric RSV. It was done in the pandemic for COVID, and there's actually a product out there for COVID now for immunosuppressed people. This is a novel concept in Lyme disease to have a preventative monoclonal antibody, and we're delighted to be working with UMass Chan. It's a really good partnership in the sense that we already have a lot of infectious disease expertise and manufacturing monoclonals and other things that tie in well with this. I think it was a really perfect partnership. In 2026, we're just manufacturing it. When you license from university, they don't always have GMP material. In this case, they didn't have any. In 2026, we're manufacturing it.
As Doug said, we've announced that we're meeting with FDA early in Q3. What we're really asking them is, how large a study can we do in the tick season in 2027? Because we're coming in with a phase I study of 44 patients. I think it was 35 got drug. How can we leverage that safety information? Can we do a 3,000 patient study? You know, can we do it with a rolling safety monitoring situation? I mean, we'd like to get a lot of exposure quickly based on our preclinical work and our phase I work, which showed, in our view, a good tolerability profile. We're gonna have to see, you know, their comfort with what size study.
To get to your question, Pfizer-Valneva just announced disappointing data, where they missed the primary endpoint using a vaccine-
Right
The traditional way of getting antibodies to OspA is to immunize with it, and there was a successful product, at 80% efficacy, in 1998 from SmithKline Beecham, now GSK, called LYMErix, and that had 80% efficacy. Pfizer came along, partnered with Valneva, and created kind of a modern version of it, similar alum-based vaccine. They had one twist to it, where instead of just immunizing with the U.S. version of OspA from Borrelia burgdorferi, they added five OspAs that we think are irrelevant to the U.S. consumer. These are five OspAs from Europe. I used to be an immunologist. I was a professor at Columbia University. If you want strong antibodies to one antigen, you stick with that antigen. I think that adding five others probably hurt them. They came in, and their own numbers say it's 73%.
Basically, if you look at the power calculations, if you're closer to 70 than 80, you need more events. I think that just that slight edge that may have been taken off by the extra OspAs, you know, 'cause otherwise it was an alum-based vaccine, similar immunization schedule. We're coming in. We're revolutionizing this field, 'cause all of the vaccine people talk about titers. Titers from the era of Louis Pasteur in the 1800s.
Yeah.
We're talking about micrograms per ML in the serum. They have a polyclonal response. We have a monoclonal antibody that has picomolar affinity to OspA and, you know, defined characteristics, binds complement, all these kind of things. I think that ours is gonna be, you know, if approved, provide people with a lot more confidence that they're gonna be protected against Lyme than the vague rates of a vaccine. Also, ours doesn't depend on the immune response of the recipient. We're just giving the antibody and letting it work. I think it's gonna be an interesting conversation. I think that, you know, the FDA reports into HHS.
Secretary of HHS, seems like every time he goes in front of the Senate or the House, talks about the importance of Lyme disease to him personally.
Yeah.
Held a special hearing on it in December. I think that the winds are at our back in terms of there's a big need. The other thing is Lyme is spreading.
It's spreading enormously, mostly on the back of the spread of this deer tick, Ixodes scapularis, which just seems to be out-competing all of the other ticks. Like the dog tick that I grew up with as a kid is somehow getting pushed out, and with it, carrying it along.
Yeah
Lyme is spreading like crazy. Connecticut, threefold increase in just a couple of years. I mean, it's really.
Scary
The Lyme thing is really scary.
Well, I've got three seconds left, so you answered basically all the other questions I had on Lyme disease in answering the one question. Thank you very much for coming, this year, and congratulations on that approval.
Thank you very much.
You bet. Okay then.