管理層發言
Good morning, and welcome to the Tonix Pharmaceuticals Second Quarter 2026 Financial Results and Business Update Conference Call. The operator provided instructions. As a reminder, this call is being recorded. I would now like to turn the call over to Deborah Elson, Head of Investor Relations at Tonix Pharmaceuticals. Please go ahead.
Thank you, Operator, and good morning, everyone. We appreciate you joining us today to discuss Tonix Pharmaceuticals' second quarter 2026 financial results and operational highlights. Before we begin, I would like to remind everyone of the disclaimers on Slide 2 that any statements made on today's call that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These risks are described more fully in our filing with the Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2025, and our subsequent periodic reports. Tonix undertakes no obligation to update or revise any forward statements, except as required by law. Joining me on today's call are Dr. Seth Lederman, Chief Executive Officer; Thomas Englese, Executive Vice President of Commercial Operations; and Bradley Saenger, Chief Financial Officer. With that, I will turn the call over to Seth. Seth?
Thank you, Deborah, and good morning, everyone. We're pleased to welcome you to Tonix's earnings call. Today we're reporting second quarter financial results and operational highlights that reflect strong execution in both our commercial business and advancing our development pipeline. We are focused on improving the care for patients with debilitating conditions or preventing illness before it happens. We believe each of the commercial products and the development candidates target major unmet medical needs. As you can see on Slide 2, the launch of TONMYA is progressing well, supported by growing sales, improvement across launch metrics, and patient access wins. TONMYA was invented, developed, tested, and launched in-house by the Tonix team. TONMYA is the first medicine for the treatment of fibromyalgia in adults approved by the FDA in over 15 years. More than 10 million adults in the U.S. suffer from fibromyalgia. We are initially targeting nearly 3 million patients who are currently diagnosed and treated. The second quarter of 2026 was the second full quarter of TONMYA sales. We believe our second quarter and cumulative launch performance underscored TONMYA's compelling value proposition and differentiated profile. Historically, fibromyalgia patients and their healthcare providers, or HCPs, have been dissatisfied with limited treatment options. We are pleased to offer TONMYA as an effective and generally well-tolerated treatment option. TONMYA is a non-opioid analgesic that improves fibromyalgia pain, the core symptom of the disease. TONMYA is a once-daily medicine taken at bedtime and indicated for long-term use by fibromyalgia patients. Commercially, Tonix has 100% share of voice as the only branded and marketed product for fibromyalgia. We are set to improve the lives of patients and simultaneously create long-term value for shareholders. In the second quarter of 2026, we achieved approximately $11 million in net sales for TONMYA, representing 197% quarter-over-quarter growth. That is approximately triple the net sales of the first quarter. Additionally, we saw increases across other key metrics. We attribute these results to patient and prescriber recognition of TONMYA's value and to our strategic focus and execution. We also had early wins in managed access. We do not believe these wins contributed significantly to TONMYA sales in Q2. However, we are beginning to see their effects in Q3. Currently, TONMYA coverage across commercial, managed Medicare, and Medicaid channels represents approximately 136 million covered lives, or 43% of the approximately 314 million covered lives in the United States. On January 1, 2027, when our managed Medicare GPO coverage agreement becomes effective, TONMYA coverage will represent approximately 145 million covered lives or approximately 46% of the covered lives in the United States. We believe this broad coverage lays the foundation for growth in patient access and net sales for the rest of the year and beyond. This coverage led us to activate our planned sales force expansion, which will be fully implemented by September. Tom will dive deeper into the field dynamics and expectations for the rest of the year. As we execute on our commercial launch, we are also strategically advancing certain development stage programs. Tonix's pipeline includes a carefully selected group of therapeutic and preventative development stage candidates targeting large therapeutic or preventative areas of unmet need. Each of these agents is potentially first-in-class or best-in-class. In 2026, we have focused our resources primarily on TNX-102 SL, which is cyclobenzaprine sublingual tablets, a potential new indication for TONMYA for the treatment of Major Depressive Disorder, or MDD, and TNX-4800, a long-acting monoclonal antibody for the prevention of Lyme disease. In the second quarter and early third quarter, we made substantial headway on both programs. For TNX-102 SL and MDD, we randomized the first patient in the second quarter. For TNX-4800 and Lyme disease prevention, we held a constructive Type C FDA meeting and received positive final minutes on our planned adaptive Phase II study, which we expect to begin enrolling in the first quarter of 2027. I will now turn the call over to Tom Englese, EVP Commercial Operations, to discuss the TONMYA launch. Tom?
Thank you, Seth, and good morning, everyone. Today, I will review our second quarter sales performance for TONMYA, and then I will cover our launch strategy. We are pleased to offer TONMYA as a treatment to adult fibromyalgia patients. Looking at Slide 4, we are encouraged to see net sales of $11 million for TONMYA in the second quarter, representing 197% quarter-over-quarter growth or nearly triple the first quarter. There are a few contributing factors to note. We are seeing proactive patient and prescriber interest in TONMYA, and we're gaining traction with our HCP target list. Second, gross-to-net in both Q1 and Q2 have been driven by a favorable mix between the retail and specialty distribution channels and lower co-pay buy-downs related to stronger-than-expected prior authorization approvals. We've historically shared that we expect fluctuations quarter-over-quarter, as is common early in commercial launches. We expect continued fluctuations for gross-to-net in both Q3 and Q4. Now, we'll look at our key performance indicators for TONMYA. In the second quarter, we saw positive trends across prescriptions, new patient starts, and refills. Prescriptions for the quarter totaled 12,592, increasing 100% quarter-over-quarter. New patient prescriptions increased 36% quarter-over-quarter and refills increased 207% quarter-over-quarter. We continue to see increases in the number of prescriptions per patient, which we attribute to the benefits and tolerability of TONMYA and our patient support program. We will now walk you through our strategy regarding market access, sales, and marketing on Slide 5. First, we've already reached major market access coverage milestones, which we believe speaks to the value of TONMYA. We signed commercial payer agreements with two leading GPOs. These agreements, which went into effect on May 1 and June 1, 2026, cover 52 million lives. We also signed a major managed Medicare agreement, which will cover approximately 9 million Medicare lives beginning January 1, 2027. TONMYA is also available under Medicaid in most states. We expect downstream pull-through from these agreements to begin to materialize in the third and fourth quarters of 2026. Our strategy has been to secure market access as early as possible so that the availability of insurance reimbursement could match patient demand. As our team brings these coverage agreements online, we expect patient access to become more robust. We have seen favorable rates of prior authorization submissions and approvals across commercial payers and Medicare and strong usage of our co-pay assistance and savings programs in the commercial population. Altogether, we expect these trends to serve as the catalyst to unlock the next stages of the launch, which is sales and targeting. We've been planning to expand our sales force after securing coverage. Following the access wins, we are adding 50 sales reps who will be in the field by September. This expansion will enable us to increase our presence in previously uncovered geographies and increase our breadth and depth in existing dense geographies. By September, our field force will be roughly 150 reps, primarily engaged through our contract partner. Each of these contract reps is exclusively dedicated to TONMYA and does not support any other company or product. Over time, we expect to bring high-performing reps in-house to Tonix. The entire sales force management team has recently been brought in-house at Tonix. We are committed to quality and consistency of tactical execution. As a reminder, we are initially targeting the 25,000 HCPs who write approximately 70% of the fibromyalgia treatment prescriptions. We continue to focus on engaging priority HCPs and supporting prescribing for appropriate patients consistent with approved labeling. We are hearing supportive feedback from prescribers that TONMYA is a welcome new treatment option for their patients. Moving to marketing, our efforts have focused on an unbranded digital disease awareness campaign called Move Fibro Forward, DTC social advertising, influencer programs, and peer-to-peer KOL speaker programs. Highlights in Q2 include programs such as our KOL speaker bureau, a Reddit Ask Me Anything program, influencer ads, and a digital HCP webcast. Looking ahead, we are excited to further advance the launch of TONMYA. I will now turn the call back to Seth to discuss medical affairs. Seth?
Thank you, Tom. Medical affairs is making headway with KOL engagements and education through conference symposia and data presentations. A key focus of our efforts has been raising awareness among HCPs for the current fibromyalgia diagnostic criteria that state fibromyalgia is not a diagnosis of exclusion. The outdated conception that fibromyalgia was a diagnosis of exclusion created a barrier to diagnosis for two reasons. First, a diagnosis of exclusion was an unreasonable standard because no amount of lab tests or imaging can prove a negative. Second, the medical community now recognizes that fibromyalgia commonly occurs in the context of other conditions, including long COVID, chronic Lyme, systemic lupus, rheumatoid arthritis, and cancer. This means that these other diagnoses should not exclude the diagnosis of fibromyalgia. We believe broader understanding of the current diagnostic criteria could meaningfully grow the addressable fibromyalgia patient population and help patients get diagnosed and treated earlier in the course of their condition. It currently takes on average over 6 years for patients to be diagnosed with fibromyalgia. Moving on from medical affairs, I now want to update you on the pipeline. We are advancing our development pipeline. Today, I will focus on TNX-102 SL and TNX-4800. Moving to Slide 6, TNX-102 SL for the treatment of MDD could potentially serve as a label expansion for TONMYA. In June, we randomized the first patient in HORIZON, a potentially pivotal Phase II study evaluating TNX-102 SL as first-line monotherapy in adults with MDD. We are targeting the enrollment of approximately 360 patients in the U.S. Eligible participants must be 18 years of age or older, currently experiencing a moderate to severe major depressive episode. Participants are being randomized to receive TNX-102 SL 5.6 milligrams taken sublingually at bedtime or matching placebo. The primary endpoint of the study is the change from baseline in MADRS total score at week 6. Secondary endpoints include global impression scores, anxiety ratings, and measures of sleep quality. We are evaluating TNX-102 SL for MDD based on initial signals observed in previous Tonix Phase II and III studies in which TNX-102 SL nominally improved depression symptoms in fibromyalgia patients and PTSD patients. TNX-102 SL was designed to target the disturbed sleep in fibromyalgia. If TNX-102 SL has effects on depression, then we believe targeting sleep would be a novel mechanism. Use of SSRIs and SNRIs for depression are frequently associated with treatment-emergent insomnia. Another TONMYA label extension is acute stress disorder and acute stress reaction. An investigator-initiated Phase II study called OASIS is enrolling at the University of North Carolina, funded by a United States Department of Defense grant to University of North Carolina, and for which we expect to report top-line data in mid-2027. Now, I'll move to Slide 7 to discuss TNX-4800, our long-acting monoclonal antibody for the prevention of Lyme disease. Positive FDA meeting minutes demonstrate alignment on the key elements of our adaptive Phase II study design and support study start in the first quarter of 2027. Currently, no FDA-approved vaccines or prophylactics for Lyme disease are available. We believe TNX-4800 could potentially change the prevention paradigm. It targets the outer surface protein A, or OspA, on the Lyme-causing Borrelia bacteria. One type of Borrelia, Borrelia burgdorferi, causes 99.9% of Lyme disease cases in the United States. TNX-4800 is designed to act in the midgut of the Borrelia-infected deer tick. If someone is treated with TNX-4800 before getting bitten by the tick, then the tick ingests TNX-4800-containing blood into its midgut. TNX-4800 either kills or blocks the maturation of Borrelia burgdorferi in the midgut of infected deer ticks while they are feeding. This mechanism blocks transmission and infection. OspA is a validated target for antibodies. TNX-4800 is engineered for an extended half-life to provide a longer duration of protection after dosing relative to standard monoclonals. As a monoclonal antibody, we believe TNX-4800 has important advantages over vaccines, namely that it provides protection within 2 days after 1 dose, compared to a prior vaccine or a vaccine in development that takes 3 or 4 separate immunizations over at least 6 months to provide protection. Also, TNX-4800 does not require a host immune response like vaccines. That means it does not depend on the host's immune system, which is known to be less active in older people and people with certain conditions. After reporting Phase I data earlier this year and meeting with the FDA in early Q3, we now have a clear view of our planned Phase II study. Pending FDA agreement on the final study protocol, we plan to conduct a randomized, placebo-controlled, adaptive field study. We expect to enroll approximately 3,300 adult participants. These volunteers, age 18 and older, will be recruited from Lyme endemic areas in the U.S. and selected for their engagement in activities that increase their risk of deer tick bites. We expect this to be a 2-season study and expect to enroll the majority of participants in 2028. If the attack rate is lower than planned, enrollment could potentially extend into 2029. The primary efficacy endpoint will be Lyme disease prevention through 6 months after the first dose, and a key secondary efficacy endpoint will be prevention through 3 months. Although it is a Phase II study, we believe it has the potential to demonstrate efficacy. The primary safety objective will be to evaluate the safety and tolerability of TNX-4800 over a 52-week period after dosing. Participants in the planned adaptive Phase II field study will be randomized 1-to-1 to receive either placebo or TNX-4800 dosing 450 milligrams subcutaneously in the spring, and another dose approximately 3 months later. Our focus in 2026 has been on manufacturing investigational product for TNX-4800, which is on track for delivery to study sites in the first quarter of 2027. With that, I will turn the call over to Bradley Saenger, our Chief Financial Officer, to review our financial results. Bradley?
Thank you, Seth. And good morning, everyone. On Slide 8, I will review financial results for the second quarter ended June 30, 2026. Net product revenue for the second quarter of 2026 was approximately $13.5 million, which consists of approximately $11 million from TONMYA and $2.5 million from ZEMBRACE SymTouch and TOSYMRA, which are our migraine products. This compares to $2 million for the same period in 2025, which consisted only of ZEMBRACE and TOSYMRA. TONMYA was approved last August and launched in November, and the second quarter of 2026 was TONMYA's second full quarter of sales after launch. Cost of sales was approximately $0.7 million compared to $3.3 million for the same period in 2025. The decrease in the cost of sales was predominantly driven by a change in product mix and a write-off of migraine products in 2025. Research and development expenses were approximately $19.4 million compared to $10.8 million for the same period in 2025. The increase was primarily driven by higher manufacturing and clinical expenses reflecting pipeline prioritization along with increased employee-related costs from higher headcount. Selling, general, and administrative expenses were approximately $36 million, compared to $16.2 million for the same period in 2025. The increase was primarily driven by sales and marketing investment behind the launch of TONMYA and our migraine products, together with higher employee-related and professional expenses. Turning to the balance sheet, we ended the quarter with approximately $176.2 million in cash and cash equivalents as of June 30, 2026, compared to approximately $207.6 million as of December 31, 2025. We expect our cash resources as of June 30, 2026, together with net proceeds from equity offerings subsequent to June 30, 2026, to fund our planned operating and capital expenditure requirements into the early second quarter of 2027. With that, I will turn the call back to Seth for closing remarks. Bradley?
Thank you, Bradley. We'll move to Slide 9. In the second quarter, we delivered progress on the launch of TONMYA and on the development of two of our mid-stage clinical development programs, TNX-102 SL for the treatment of MDD and TNX-4800 to prevent Lyme disease in the United States. We entered the second half of 2026 with meaningful momentum. Our strategic priorities are clear. Deliver on the promise of TONMYA, advance the development of our mid-stage clinical programs, and drive sustainable growth to create value for all shareholders. Patients remain at the forefront of our work and our team is dedicated to supporting them. For TONMYA, we remain focused on driving growth across net sales and KPIs, working to secure patient access and deploying our expanded sales force. For TNX-102 SL, we will continue to execute on the enrollment of the potentially pivotal Phase II study in MDD. For TNX-4800, we are manufacturing the investigational product in 2026 to begin the adaptive Phase II field study in preventing Lyme disease in the first quarter of 2027. With that, we will now open the call for questions. Operator?
分析師問答
Our first question comes from Stacy Ku with TD Cowen. Your line is open.
Congratulations on a great quarter and thanks so much for taking our questions. We do have a few. First one is for Tom and Seth. Given that TONMYA launch is going pretty well, can you talk about your current learnings and what strategies you're using to drive patient adoption in fibromyalgia? What has been the early clinical feedback on TONMYA's efficacy and the early durability signals, given encouraging refill dynamics? That's the first on TONMYA. And then as we look to 4800 and Lyme, it's been great to get the FDA interaction minutes. So first, can you discuss in more detail why you believe the majority of infections will be collected in the first season? Maybe discuss how you're identifying the right sites. And then second, do you believe the Phase II has the potential to be pivotal in Lyme given the patient study size of around 3,300? And then actually before you guys answer the questions, just some really quick quarterly clarifications for TONMYA. One, what gross-to-net range would you expect for Q3 and Q4 given the favorable mix we saw in Q2? And kind of the same question, but what kind of inventory nuances we should consider for Q2?
So there are three parts to your question. Let me ask Tom: would you please address the question about TONMYA's launch and the clinical feedback?
Yes, absolutely. The early feedback we have received from HCPs is that TONMYA is a welcome addition to the space. There hasn't been anything for 15 years. The durability thus far has been very good. We have seen, as you mentioned, a high rate of refills. I attribute that to the effectiveness and tolerability of the product. The feedback has been positive. We'll continue to target over time with our sales force those key writers, as I mentioned. We're excited for the additional reps because we can increase our breadth and depth. All in all, signs have been very positive and the durability and refill signals have been encouraging.
Great. Thank you, Tom. And Stacy, to follow up on your question about Lyme. First of all, now that we have the final FDA minutes, we've gone back to the CROs in the process of bid defense and the rest of it. We're actively working on identifying sites and characteristics of people at risk for deer ticks and Lyme disease. With respect to your question about whether we think it could provide evidence of efficacy, we have stated that in a press release and in our comments today. We do believe that this Phase II study can provide evidence of efficacy, and if positive, could be a pivotal study supporting approval of the product. The study will be conducted as a potential registrational study. The key question will be whether we accumulate enough events, which is mostly driven by Lyme disease cases in the placebo group in our observation period. Now let me turn the third part over about the quarterly gross-to-net back to Tom, this quarterly gross-to-net and also about inventory on TONMYA to Tom.
Great. Thanks again. So, as we mentioned, we don't disclose specifics about our gross-to-net. What I can say is that we've seen favorable dynamics that impacted gross-to-net in Q2. It is going to fluctuate, as I mentioned, especially as the coverage comes online from the two commercial contracts and the downstreams come online. Moving forward, I would anticipate gross-to-net in the range similar to what we've seen in Q1 and Q2. In terms of inventory — assuming we're talking about inventory at the wholesalers — we track that, and we have seen consistent days on hand as demand has increased. So there's been no incremental inventory build at our wholesaler and distributor partners.
Stacy, are there follow-up questions?
No, I think we're all set.
Our next question comes from Tiago Fauth with Raymond James.
Great. Thanks for the good question and congrats on the progress. I have one for TONMYA, one for the 4800. For the 4800, just to hone in on the sample size and to your comment related to infection rates on the placebo arm. If you look at the older studies, you see a slightly higher rate. We've seen a surprisingly low rate of infections in VALOR. So can I just talk about that dynamic as we're thinking about both powering of the study and also the site selection enrichment to ensure that you can accrue enough events? And also I just wanted to understand a little bit better how to characterize the access and ease of access of the policies that are in place relative to step edits, how cumbersome is the paperwork, how is that evolving over time?
I'll take the first part about 4800 then I'm going to ask Tom to answer the question about step edits. So with the TNX-4800 Lyme preventative program, the study that most people use as a reference is the study that was behind the approval of the LYMErix vaccine in 1998, which has subsequently been withdrawn. In that study, they had an attack rate of 0.8% in one group and 1.2% in another group that was the main efficacy group. Since then, Lyme has increased significantly in the United States, at least a threefold increase in Lyme endemic areas. We think that the epidemiology supports that we could get enough events with 3,300 participants that we've announced we're targeting. How we're targeting them and the specifics of the clinical trial are to some extent proprietary, but we're certainly working with experts in the field and clinical experts in areas where Lyme is growing rapidly to select patients who are at risk for getting deer tick bites and in areas where the deer ticks have a significant rate of Borrelia infection. So let me turn it over to Tom for the discussion about step edits on TONMYA.
Yes. Our target patient population is around 3 million patients who were previously diagnosed and treated for fibromyalgia. It's important to understand that roughly 80% of these patients have already been on or are on multiple therapies for fibromyalgia. In our discussions with payers, both pre-approval and post-launch, we've seen a tendency to require a step or two through one of multiple products, but no mandatory steps through any specific product. Based on what we've already seen with our prior authorization submissions and approvals early in launch, we're comfortable that this is a very manageable approach for both patients and HCPs.
All right, fantastic.
Thank you. Our next question comes from James Molloy with AGP. Your line is open.
I know that looking at the TONMYA launch the gross-to-net came down quite a bit in the quarter. I know you suggested it's going to fluctuate. It seems like we see different numbers than you guys see when we look at our Symphony data. Is this lower level, do you anticipate this lower level being more typical, or do you think it's more likely to fluctuate back towards sort of the second quarter of launch, where it's almost a 50% gross-to-net discount?
Thank you very much for the question, Jim. Let me turn that over to Tom.
So, in Q2 we had favorable dynamics that attributed to gross-to-net. It is going to fluctuate, especially as the coverage comes online from the two commercial contracts we have recently signed and the downstreams come online. Moving forward, I would expect continued fluctuations in the range of what we've seen thus far for Q1 and Q2. Then, once we get coverage largely locked down, we should see more stabilization.
Okay, great. And then stay with TONMYA on the launch. You had some anecdotal comments already. I saw the launch is going well. Could you walk through sort of on the sales reps, what percentage of the reps or what number of the reps are sort of covering their own costs currently? When do you sort of anticipate them getting to that point? And also looking at the overall gross margin was quite good, 5% cost of goods in the quarter. Is that a number we should anticipate going forward now that sort of you've got production up to a scale and running at a higher level?
Tom?
We're excited about the performance of the reps so far. In launch you're in a focused ramp period and targeting specific doctors who treat most of those patients, for which we have strong data. Over time, as we add the 50 incremental reps who will be boots on the ground in September, they're already in training, and we'll expand geographies and depth. I would anticipate that over the course of 2027 we'll see a good portion of those reps covering the cost of the reps and continue to drive new patients, prescriptions, and refills. We're looking forward to getting even more doctors and patients on TONMYA.
Bradley on the gross margin question?
Thanks for the question. As we mentioned, we do have a product mix that's shifting over time. We don't guide to exact numbers, but I would expect some fluctuation as we solidify various levels. I think that's where we will be for at least the next quarter or two. Hopefully once things have stabilized, we'll be able to have a more regular gross-to-net and margins.
Okay, final question, if I may. The 4800 study is starting up. Could you compare and contrast any learnings you took from Pfizer's VALOR study, which just missed significance? I believe they didn't have quite enough infections, so how can you best work around that in the 4800 study?
Thank you, Jim. I'll take that. The Pfizer study was very different from the study that we're planning. They had a significant proportion of their patients enrolled from Europe and they evaluated a vaccine product that took multiple immunizations over several months to produce immunity, whereas our product is designed to provide protection within 2 days of the first dose. So our product is easier to administer and for volunteers to understand. The U.S.-only focus, the product characteristics, and our engagement with experts and clinicians who see a lot of Lyme in the United States give us confidence that we can better identify people at higher risk of Lyme. Our ability to understand all details of that study is limited, but we believe these differences are material.
I'm showing no further questions at this time. I'd like to turn the call over to Seth Lederman for closing remarks.
Well, we're very grateful to everyone who participated, and particularly those who asked questions. We are excited about the success of TONMYA so far and our clinical programs. We look forward to keeping our investors and stakeholders engaged and updated as we make progress in 2026 and beyond. So with that I want to thank everyone on the call, particularly the management team. And thank you very much. This is the end of the call.
Thank you for your participation. You may now disconnect. Good day.