What Tonix Pharmaceuticals (TNXP) Said on Its Q3 Earnings Call

Key Points

• TONMYA sales grew rapidly: Third-quarter sales reached about $15 million, up 37% from the prior quarter, while prescriptions rose 28% and U.S. coverage expanded to approximately 53% of covered lives.
• Growth came with higher costs and a patent challenge: R&D expenses climbed to $25.8 million and SG&A to $45.6 million. Tonix said cash and post-quarter equity offering proceeds are expected to fund operations into early Q3 2027, and it plans to defend its patents against Dr. Reddy’s generic application.
• Clinical programs are moving forward: Tonix is enrolling a Phase II depression study and plans to start studies of its Lyme disease prevention and kidney transplant rejection candidates in Q1 2027; development of its cocaine-intoxication candidate remains on hold pending FDA alignment.

Tonix Pharmaceuticals NASDAQ: TNXP reported approximately $15 million in third-quarter sales of its fibromyalgia drug TONMYA, up 37% from the previous quarter, as insurance coverage expanded and prescriptions increased.

Total net product revenue rose to approximately $17.2 million from $3.3 million a year earlier. The prior-year figure consisted entirely of revenue from the company’s migraine products, Zembrace SymTouch and TOSYMRA; TONMYA launched in November 2025.

Chief Executive Officer Seth Lederman said previously signed payer agreements contributed to TONMYA sales, and that performance improved after the company expanded its sales force on Sept. 1. Management also discussed a generic challenge to the drug and plans for clinical studies in depression, Lyme disease prevention and kidney transplant rejection.

Prescriptions and coverage expand

TONMYA prescriptions totaled 16,375 in the third quarter, up 28% from the second quarter, Chief Commercial Officer Thomas Englese said. New prescriptions rose 17%, while refills increased 56%.

Englese attributed revenue growth to factors including payer agreements signed in May and June, more favorable gross-to-net adjustments than expected and execution of the launch strategy. He said the company expects gross-to-net fluctuations early in the launch. A shift toward 60-count bottles from 30-count bottles also contributed to higher average prices, he said.

TONMYA coverage now reaches approximately 53% of covered lives in the U.S., according to Englese. The company signed two managed Medicare agreements during the third quarter and is pursuing additional payer contracts.

Bridge prescriptions through digital specialty pharmacy BlinkRx declined as a share of total prescriptions as coverage expanded, Englese said. He did not provide the percentage of third-quarter prescriptions that were bridge prescriptions.

Following the expansion to 150 sales representatives, Tonix is targeting roughly 70% of an estimated 25,000 healthcare providers who diagnose and treat fibromyalgia, compared with about 40% before the expansion, Englese said. He reported increases in both new and total prescribers after Sept. 1 but did not provide counts.

Generic challenge and spending

Lederman said Tonix received notice on Oct. 1 that Dr. Reddy’s Laboratories had filed an abbreviated new drug application with a Paragraph IV patent certification for TONMYA. He said Tonix would vigorously defend its intellectual property and that its core patents, as currently granted, provide protection into 2034. He declined to provide detailed litigation updates.

Third-quarter research and development expenses rose to approximately $25.8 million from $9.3 million a year earlier, primarily because of higher manufacturing, clinical, non-clinical and employee-related costs, Chief Financial Officer Bradley Saenger said. Selling, general and administrative expenses increased to approximately $45.6 million from $25.7 million, driven largely by sales and marketing, employee and professional expenses associated with the TONMYA launch.

Tonix ended September with approximately $162.8 million in cash and cash equivalents, compared with $207.6 million at the end of 2025. Saenger said that cash, together with net proceeds from an equity offering after quarter-end, is expected to fund operating and capital expenditure requirements into early in the third quarter of 2027.

Clinical programs advance

Tonix is enrolling participants in HORIZON, a potentially pivotal Phase II study of TNX-102 SL as a first-line monotherapy for adults with major depressive disorder. Lederman said a successful program could support an expansion of TONMYA’s label. He said it was too early to guide on enrollment completion or top-line results.

The company also plans to start TRAIL, an adaptive Phase II field study of its Lyme disease prevention candidate TNX-4800, in the first quarter of 2027. The planned study would enroll approximately 3,300 adults over two Lyme seasons, beginning with a roughly 500-person cohort focused primarily on safety, as well as efficacy.

Lederman said the company received favorable FDA meeting minutes on the study design and submitted a protocol for review. He said Tonix did not expect significant changes but could not provide a timeline for a finalized protocol. After a safety review, the company expects to enroll the balance of the efficacy cohort during the 2028 Lyme season.

An investigator-initiated Phase II study of TNX-1500, an antibody being developed to prevent kidney transplant rejection, is expected to begin at Massachusetts General Hospital in the first quarter of 2027 and enroll five patients. Lederman said the study has an 18-month primary endpoint, with interim assessments at earlier points.

On TNX-1300, which Tonix is developing for cocaine intoxication, Lederman said the company has met with the FDA and is awaiting a response on a proposed path to approval based on laboratory studies. He said clinical development remains at an impasse until the parties reach agreement on a path forward.

About Tonix Pharmaceuticals (NASDAQ:TNXP)

Tonix Pharmaceuticals Holding Corp. is a clinical-stage biopharmaceutical company focused on developing therapies for conditions involving the central nervous system, immunology and infectious diseases. The company's research programs are designed to address disorders with significant unmet medical needs, including chronic pain, neuropsychiatric conditions and infectious diseases.

Tonix's pipeline has included TNX-102 SL, an investigational sublingual formulation of cyclobenzaprine being studied for fibromyalgia and other pain-related conditions.

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