Tonix Pharmaceuticals Holding Corp. (TNXP) Earnings

Management highlights

### Commercial Launch of TONMYA - TONMYA is the first FDA-approved new fibromyalgia treatment for adults in over 15 years, targeting an initial addressable population of nearly 3 million diagnosed and treated U.S. patients out of the over 10 million total U.S. fibromyalgia patients. It is a non-opioid, once-daily bedtime analgesic with a generally well-tolerated profile, and Tonix holds 100% share of voice as the only branded marketed fibromyalgia product. - Q2 2026 net sales hit $11 million, representing 197% quarter-over-quarter growth (triple Q1 2026 net sales). Key performance metrics grew substantially: total prescriptions rose 100% QoQ to 12,592, new patient prescriptions rose 36% QoQ, and refills rose 207% QoQ, with increasing prescriptions per patient driven by product efficacy and tolerability. - As of Q2 2026, TONMYA has coverage for approximately 136 million covered U.S. lives (43% of total U.S. covered lives). A new managed Medicare GPO agreement effective January 1, 2027 will expand coverage to 145 million covered lives (46% of total U.S. covered lives), and the company has already signed new commercial GPO agreements covering 52 million lives that went into effect in May and June 2026. Downstream revenue from new coverage agreements is expected to begin materializing in Q3 and Q4 2026. - Following recent coverage wins, the company is adding 50 dedicated TONMYA sales reps, expanding the total field force to ~150 reps by September 2026, to increase geographic coverage and depth. Initial sales targeting focuses on 25,000 HCPs who write ~70% of all U.S. fibromyalgia prescriptions. Marketing efforts include unbranded disease awareness campaigns, DTC advertising, influencer programs, and peer-to-peer KOL engagement. ### Pipeline Development - **TNX-102 SL (TONMYA label expansion for Major Depressive Disorder):** The first patient was randomized in the potentially pivotal Phase II HORIZON study in Q2 2026. The trial will enroll ~360 patients with moderate to severe MDD to test 5.6mg nightly sublingual dosing against placebo, with a primary endpoint of change in MADRS depression scores at week 6. This program is based on observed nominal depression symptom improvements in prior fibromyalgia and PTSD studies, targeting a novel mechanism of action by improving sleep, a common contributor to depression. - **TNX-4800 (long-acting monoclonal antibody for Lyme disease prevention):** The company completed a constructive Type C meeting with the FDA and received aligned final minutes for the planned adaptive Phase II study. Enrollment is expected to begin in Q1 2027. TNX-4800 is the first prophylactic for Lyme disease in development with no currently FDA-approved options, and works by blocking Borrelia burgdorferi transmission from infected ticks during bites, with an extended half-life for long-duration protection, and advantages over vaccines including rapid protection (within 2 days of one dose) and no reliance on host immune response. The planned 1:1 randomized placebo-controlled study will enroll ~3,300 at-risk adults in U.S. Lyme endemic areas, with study product delivery to sites on track for Q1 2027. - An investigator-initiated Phase II study of TNX-102 SL for acute stress disorder, funded by a DoD grant, is enrolling and expects top-line data in mid-2027. ### Medical Affairs - A core medical education focus is updating HCP knowledge of current fibromyalgia diagnostic criteria, which no longer classify fibromyalgia as a diagnosis of exclusion. This change can expand the addressable patient population and reduce the current average 6-year diagnostic delay for patients.

Guidance

- The company expects cash on hand as of June 30, 2026 plus post-Q2 equity offering proceeds to fund all planned operating and capital expenditure requirements into the early second quarter of 2027. - Gross-to-net retention for TONMYA is expected to continue fluctuating in the range seen in Q1 and Q2 2026 through the end of 2026, before stabilizing once most coverage agreements are finalized. - The expanded TONMYA sales force is expected to reach cost recovery for most or all reps over the course of 2027. - The Phase II study for TNX-4800 is designed as a potential registrational (pivotal) study. Enrollment of the 3,300 planned participants is expected to be mostly completed in 2028, with potential extension to 2029 if observed Lyme attack rates are lower than projected. - Downstream revenue impact from recently secured payer coverage agreements is expected to begin materializing in the second half of 2026.

Segment performance

Tonix Pharmaceuticals had total net product revenue of $13.5 million in Q2 2026, up from $2 million in the year-ago period. TONMYA, the company's fibromyalgia treatment, accounted for $11 million in net sales, representing 81.5% of total Q2 2026 net product revenue. ZEMBRACE SymTouch and TOSYMRA, the company's legacy migraine products, contributed $2.5 million in net revenue, equal to 18.5% of total Q2 2026 net product revenue. Cost of sales for Q2 2026 was $0.7 million, down from $3.3 million in Q2 2025, driven by a 2025 product write-off for migraine products and a favorable shift in product mix. Research and development expenses were $19.4 million, up from $10.8 million in Q2 2025, and selling, general, and administrative expenses were $36 million, up from $16.2 million in Q2 2025.

Risks & headwinds

- All forward-looking statements regarding development timelines, study outcomes, sales growth, and funding duration are subject to inherent uncertainties that could cause actual results to differ materially from projections, with detailed risks disclosed in the company's SEC filings. - Lower-than-projected Lyme disease attack rates in the TNX-4800 Phase II study could require extending enrollment into 2029 and delay potential approval. - Early launch gross-to-net retention for TONMYA will continue to fluctuate as new coverage comes online, which could create variability in quarterly net sales results. - Clinical trial outcomes are inherently uncertain; even positive preliminary signals do not guarantee successful trial completion or regulatory approval for new indications or products.

Analyst Q&A

• Q: Stacy Ku (TD Cowen) asked for early launch learnings, clinical feedback on TONMYA's efficacy and refill durability, clarification on Q3/Q4 gross-to-net expectations, and details on wholesaler inventory. /

  A: Management reported positive early feedback from HCPs, with strong refill durability attributed to TONMYA's efficacy and good tolerability, which aligns with the strong observed refill growth. Gross-to-net is expected to stay in the range seen in Q1 and Q2, with no unexpected incremental wholesaler inventory build as demand has increased alongside distribution.

• Q: Tiago Fauth (Raymond James) asked how Tonix will ensure enough Lyme infections are accrued for the TNX-4800 study, and asked about the burden of TONMYA step edit requirements for payers. /

  A: Management noted that U.S. Lyme incidence has tripled since the 1998 LYMErix study, so the 3,300-patient size is sufficient to accrue enough events, with site selection focused on high-incidence endemic areas recruiting patients with elevated tick bite risk. For TONMYA, payers typically require 1-2 general steps through existing generic products (no mandatory step against a specific product), and the current approval process is manageable for patients and HCPs.

• Q: James Molloy (AGP) asked when the expanded TONMYA sales force will reach cost neutrality, what gross margin range to expect going forward, and what differences exist between Tonix's TNX-4800 study and Pfizer's missed VALOR trial. /

  A: Management expects most or all of the expanded sales force to cover their costs by 2027. Gross margins will likely fluctuate for the next 1-2 quarters before stabilizing as product mix and coverage mature. Unlike Pfizer's European-enrolled vaccine trial with slow immunity development, Tonix's U.S.-only monoclonal antibody program provides protection within 2 days, improving patient engagement, and the company is focusing on recruiting higher-risk patients to avoid the low event rate issue Pfizer encountered.