Santhera Pharmaceuticals Holding AG reported revenue results for the year 2019. For the year, the company reported net revenues of CHF 27.9 million against CHF 31.7 million a year ago.

Pipeline and Regulatory Update: Anticipated near-term inflection points towards approval for both DMD pipeline candidates Puldysa (idebenone) and vamorolone: Puldysa first launch in Europe in 2020 subject to positive opinion and approval from CHMP/EMA: The review of Santhera's application for conditional marketing authorization (CMA) for Puldysa in the treatment of respiratory dysfunction in patients with DMD who are not using glucocorticoids is ongoing and the Company expects an opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) around mid-2020. Subject to a positive opinion and subsequent EU approval, Santhera expects to launch Puldysa in the first European markets in late 2020. SIDEROS DMD trial enrollment with idebenone nearing completion: Patient enrollment in Santhera's randomized, double-blind, placebo-controlled Phase 3 SIDEROS trial is expected to complete in Q2-2020 (clinicaltrials.gov: NCT02814019). With a study duration of 18 months, the last patient's last visit is scheduled for Q4-2021. If positive, the study data will allow for regulatory submissions supporting the use of Puldysa in all DMD patients experiencing respiratory decline, irrespective of their glucocorticoid use, in Europe and the US. Vamorolone pivotal VISION-DMD study progressing as cornerstone for US/European regulatory filings: ReveraGen BioPharma is currently enrolling the Phase 2b VISION-DMD study with vamorolone, designed as a pivotal efficacy and safety trial (VBP15-004; clinicaltrials.gov: NCT03439670). Read-out of topline 6-month data from the randomized placebo-controlled treatment period is expected by Q4-2020 followed by an NDA submission in the US by first quarter of 2021. Under the agreements between the parties and upon exercising its option, Santhera would receive the sub-license to ReveraGen's vamorolone from Idorsia Ltd. for all indications and all countries worldwide except Japan and South Korea. The marketing authorization application in Europe will require inclusion of 12-month data expected for second quarter of 2021. Neuromuscular franchise a top priority for 2020: Santhera's strategic priorities for 2020 are its neuromuscular franchise: Puldysa and vamorolone in DMD. For Puldysa, the focus is on the preparation for European market entry in DMD later in the year and the completion of enrollment into the SIDEROS trial to support planned regulatory submissions, particularly in the US. For vamorolone, the key milestone will be the VISION-DMD topline data readout, which if positive would allow for preparation of the NDA filing and pave the way for Santhera's option exercise. In parallel, the Company is advancing its clinical stage candidate POL6014 for cystic fibrosis and is evaluating further diversification of its platform type pipeline products, including development of additional indications in collaboration with partners.