Santhera Reports Net Revenues 2019 and Highlights Pipeline Progress

Pratteln, Switzerland, January 27, 2020 – Santhera Pharmaceuticals (SIX: SANN) generated net revenues of CHF 27.9 million in 2019 from sales of Raxone for the treatment of Leber’s hereditary optic neuropathy (LHON), which was out-licensed to Chiesi Group from August 2019. The Company made strong progress in advancing its lead neuromuscular compounds Puldysa (idebenone) and vamorolone towards market entry and regulatory submission, respectively.

“We are pleased about Santhera’s strong progress in 2019 and are excited about the prospects 2020 holds,” said Dario Eklund, CEO of Santhera. “Our late-stage neuromuscular assets targeting the high value Duchenne muscular dystrophy (DMD) market are nearing key inflection points. With Puldysa (idebenone), we anticipate offering the first drug for the treatment of respiratory dysfunction for non-ambulant DMD patients who are not taking glucocorticoids. Vamorolone, a first-in-class anti-inflammatory drug candidate shown in studies to improve muscle and motor function with a favorable clinical safety profile, is being developed to replace glucocorticoids as standard of care in ambulant DMD patients. We will continue working with clinical experts, patient advocacy groups and regulators in order to bring these promising treatments to patients with currently few alternative treatment options as soon as possible.”

2019 Turnover

• Net revenues CHF 27.9 million
• Gross income of CHF 49.3 million from Raxone out-licensing agreement
• Freely available liquid funds of CHF 31.4 million (December 31, 2019)
  

2019 full-year net revenues slightly above guidance
In 2019, Santhera reported net revenues of CHF 27.9 million (2018: CHF 31.7 million), slightly surpassing the Company’s full-year guidance. This includes sales of Raxone in the approved indication Leber’s hereditary optic neuropathy (LHON) in the first seven months of 2019. From August 2019, after the closing of the licensing transaction and the transfer of the Raxone-business to Chiesi Group, Santhera is commercializing Raxone for LHON in France in a transitional phase.

Upfront payment from Chiesi Group following closing of licensing agreement
In August 2019, Santhera recognized an initial gross income of CHF 49.3 million (EUR 44 million) from the licensing agreement with Chiesi Group. As previously announced per the agreement, Chiesi Group has in-licensed Raxone for LHON and all other ophthalmologic indications for all territories worldwide except the US and Canada for a total consideration of up to EUR 93 million.