Tonix Pharmaceuticals (TNXP) 3rd Annual Guggenheim Healthcare Innovation Conference summary

TONMYA launch

• Q3 net sales were $15M vs. over $11M in Q2, up 37%; TRx grew 27%, with NRx, refills, NBRx and MBRx also increasing.

• Launch described as on track; the fibromyalgia category had gone more than 15 years without a new product, while recent science and interest are supportive.

• Gross-to-net is fluctuating early; steady-state gross-to-net is expected to be 50% or better, potentially in year two or three.

• Sales force grew from 100 to 150 reps, with 50 new representatives in the field from Sept. 1; current focus is prescribing breadth and depth.

• Fibromyalgia awareness efforts included an unbranded segment sponsored on Good Morning America.

Access and prescribing

• Coverage reached 53% of U.S. covered lives, or 166M; two of the top three commercial payers were secured in Q2 and two of the top three managed Medicare payers in Q3.

• One top-three payer remains in each of commercial and managed Medicare; discussions continue with other plans and subplans.

• Typical contracts have one or two prior-authorization steps; approvals have been strong, and many diagnosed patients have already tried and failed existing therapies.

• Rheumatologists are the largest writer group; growing recognition links fibromyalgia with conditions including rheumatoid and psoriatic arthritis.

Depression program

• TNX-102 SL is in an ongoing potential pivotal Phase II MDD study; sleep-quality improvement is the proposed differentiator, with MADRS as the primary endpoint.

• Prior fibromyalgia and PTSD studies showed nominal improvements in depression measures; these findings are viewed as a signal supporting development in MDD.

• HORIZON enrollment began in June; top-line timing may be guided once enrollment reaches steady state. The study follows a conventional six-week depression protocol.

• Poor sleep is viewed as a potential therapeutic target across indications, with fibromyalgia and depression described as initial opportunities.