Today Medigene released its FY18 results, confirming that the company’s core business revenues related to immunotherapies increased from €4.9m to €6.0m. Total sales stood at €7.7m (FY17: €8.9m) and EBITDA reached negative €16.3m (negative €14.6m), in line with the company’s guidance of a €16-18m loss.
Medigene expects that FY19 sales will drop to €5.5-6.5m due to a decrease in sales of its non-core product, Veregen. According to the company, the year-on-year decline in revenues will also result from non-recurring effects related to the extended cooperation with bluebird bio (a clinical-stage company) in 2018.
For 2019, Medigene anticipates an increase in R&D expenses to €24-29m. This will be backed by the progress of preclinical and clinical development programs in the core area of immunotherapies. Consequently, the company guides to FY19 EBITDA loss at €23-28m.
The company also, in Q119, launched patient treatment in the phase I/II clinical trial of its T cell receptor-modified T cell (TCR-T) therapy MDG1011 for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM).
Dr. Kai Pinkernell, Medigene’s CMO and CDO, explained that “We plan to build on this momentum and will open up to five additional treatment centres over the coming months so we can potentially accelerate dosing and conduct the first dose cohorts of the trial in the course of this year.”
Medigene is also evaluating new TCR candidates (targeting HA-1 antigen) and continues its collaboration with bluebird bio. In addition, Medigene will pursue its ongoing Phase I/II dendritic cell vaccine clinical trial for the treatment of acute myeloid leukemia (AML), whose interim data will be available in H119.