Tonix Pharmaceuticals Holding Corp. 2026 Q2 Earnings Call
Review the key takeaways and the transcript of this earnings call.
- Tonix Pharmaceuticals reported second quarter 2026 net sales of approximately $11 million for Tanmaya, representing 197% quarter-over-quarter growth and nearly triple the first quarter sales.
- Total net product revenue for Q2 2026 was approximately $13.5 million, including $2.5 million from migraine products Zembrace-symtouch and Tosymra, compared to $2 million in Q2 2025.
- Cost of sales decreased to approximately $0.7 million in Q2 2026 from $3.3 million in Q2 2025 due to product mix changes and write-offs of migraine products.
- Research and development expenses increased to approximately $19.4 million in Q2 2026 from $10.8 million in Q2 2025, driven by higher manufacturing, clinical expenses, and headcount.
- Selling, general and administrative expenses rose to approximately $36 million in Q2 2026 from $16.2 million in Q2 2025 due to sales and marketing investments for Tanmaya and migraine products, and higher employee and professional costs.
- Tonix ended Q2 2026 with approximately $176.2 million in cash and equivalents, down from $207.6 million at year-end 2025, with cash expected to fund operations into early Q2 2027.
- Tanmaya is the first FDA-approved fibromyalgia treatment in over 15 years, targeting nearly 3 million diagnosed and treated U.S. patients.
- Tanmaya coverage currently represents approximately 136 million covered lives (43% of U.S. covered lives), expected to increase to 145 million (46%) on January 1, 2027, after managed Medicare GPO coverage agreement takes effect.
- Tonix is expanding its sales force by 50 reps by September 2026 to increase geographic coverage and depth, totaling roughly 150 reps primarily through a contract partner.
- Key prescription metrics for Tanmaya in Q2 2026 included 12,592 prescriptions (100% quarter-over-quarter increase), 36% increase in new patient starts, and 207% increase in refills.
- Tonix is advancing two mid-stage clinical programs: TNX 102 SL for major depressive disorder (MDD) and TNX 4800, a long-acting monoclonal antibody for Lyme disease prevention.
- TNX 102 SL is being evaluated in a potentially pivotal phase 2 study enrolling approximately 360 U.S. adults with moderate to severe MDD, with primary endpoint at 6 weeks.
- TNX 4800 phase 2 adaptive field study is planned to start in Q1 2027, enrolling approximately 3,300 adults in Lyme endemic U.S. areas over two seasons, with primary endpoint of Lyme disease prevention through 6 months.
- Tonix believes the TNX 4800 phase 2 study could provide pivotal evidence of efficacy and support product approval.
- Management highlighted positive early clinical feedback on Tanmaya's efficacy and tolerability, reflected in encouraging refill dynamics and prescriber acceptance.
- Gross-to-net for Tanmaya has fluctuated due to channel mix and prior authorization approvals; similar fluctuations are expected in Q3 and Q4 2026.
- No significant inventory build at wholesalers was observed during Q2 2026 despite increased demand.
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Transcript
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Welcome to Tonix Pharmaceuticals' second quarter 2026 financial results and business update conference call. At this time, all participants are in listen-only mode. Following management's prepared remarks, we will hold a question-and-answer session. As a reminder, this call is being recorded. I would like to turn the call over to Deborah Elson, Head of Investor Relations at Tonix Pharmaceuticals.
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.
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