MeiraGTx reports 2023 EPS ($1.49), consensus ($1.77)

Reports revenue $14M, consensus $40.4M. “We are very pleased with the progress made at MeiraGTx in the past year across every area of the company, as well as the two transactions that we executed in the fourth quarter of 2023, bolstering our balance sheet. We advanced each of our three lead clinical programs, and we now have three studies in late-stage clinical development. For our program for radiation-induced xerostomia, we presented unprecedented positive data from our Phase 1 AQUAx study in June 2023; we opened the Phase 2 AQUAx2 study mid-year 2023, a randomized, double-blind placebo-controlled study of AAV-hAQP1, and last month we aligned with the FDA on the requirements for this Phase 2 study to be pivotal supporting a potential BLA. This is a completely transformative treatment for this large addressable patient population, and we are excited to have the opportunity to expedite the development of this therapy for these patients who currently have no options for treatment. In addition, the data from our Phase 1 AQUAx study will be presented at an oral session at AAOM next month,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “In the area of ophthalmology, in the third quarter of 2023, we completed enrollment in the large multi-center Phase 3 study of bota-vec for XLRP-RPGR in collaboration with Janssen. Data from this global pivotal study is expected after the third quarter of 2024. Additionally, in the retinal disease space, we recently received data from our ongoing compassionate use program under a Specials License for children with LCA4 due to mutations in the AIPL1 gene. MeiraGTx developed and optimized the AAV-AIPL1 vector and manufactured it in-house at our London facility, which we believe is the only viral vector manufacturing facility with a Specials License under the UK Medicines and Healthcare products Regulatory Agency regulations. Manufacturing at our site under the Specials License allows this material to be supplied and delivered to patients at UK hospitals, with 8 LCA4 children ages 1 to 3 years old having been treated to date. The responses seen in each of these children have been remarkable, and we are now moving forward with regulators to expedite access to this transformative treatment to patients globally.”