Tonix Pharmaceuticals Holding Corp. 2026 Q2 Earnings Call

Please go ahead. Thank you, operator.

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 two 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 filings 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-looking 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. Good morning, everyone.

We are 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 two, 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 underscore TONMYA's compelling value proposition and differentiated profile. Historically, fibromyalgia patients and their healthcare providers, or HCPs, have been dissatisfied with limited treatment options. Now, 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 striving to improve the lives of patients and simultaneously creating 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 the patient and prescriber recognition of the value of TONMYA 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 U.S.

On January 1st, 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 U.S. 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, each targeting large therapeutic or preventative areas of unmet need. Each of these agents are potentially first in class or best in class.

In 2026, we have focused our resources primarily on TNX-102 SL, which is sublingual cyclobenzaprine tablets, which is 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 in MDD, we randomized the first patient in the second quarter. For TNX-4800 in 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 Thomas 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. I will cover our launch strategy. We are pleased to offer TONMYA as a treatment to adults fibromyalgia patients. Looking at slide four, 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. First, we are seeing proactive patient and prescriber hand raisers interested in TONMYA. 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 buydowns related to stronger than expected prior authorization approvals.

We have 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. 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. 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 walk you through our strategy regarding market access, sales, and marketing on slide five. We've already reached major market access coverage milestones, which we believe speaks to the value of TONMYA.

We signed commercial pay agreements with two leading GPOs. These agreements, which went into effect on May 1st and June 1st, 2026, cover 52 million lives. We also signed a major managed Medicare agreement, which will cover approximately nine million Medicare lives beginning January 1st, 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.