Santhera Announces Financial Results for the First Half-Year 2018 and Updates on Operational Progress and Growth Strategy

Santhera Pharmaceuticals (SIX: SANN) reports first half-year results as of June 30, 2018, outlines the Company's vision and strategy as it moves through the second half of 2018, and positions itself for future growth.

Thomas Meier, PhD, Chief Executive Officer of Santhera, said: "Our vision is to be a leader in the development and commercialization of rare disease therapies for neuro-ophthalmology, neuromuscular and pulmonary indications. Our strategy to achieve this vision focuses on three distinct pillars: One, we continue to expand our commercial reach and grow sales of our revenue generating product Raxone® for the treatment of LHON. Turnover during the first half-year has been above expectation and we are on track to exceed our 2018 guidance. Two, we are progressing our pipeline assets towards regulatory approval in the EU and the U.S. and, with the inclusion of new data, intend to submit marketing authorization applications for idebenone in DMD in 2019. Three, we are pursuing an active in-licensing strategy for high quality, late-stage rare disease assets with a short time to market."

"We see multiple business development opportunities to leverage our existing development, regulatory and commercial capabilities and our recent in-licensing for POL6014 to treat cystic fibrosis is the first example of Santhera advancing this strategy. With this vision and strategy in mind, we believe Santhera is optimally positioned to create value with its existing and future product portfolio opportunities."

Financial highlights:

• 1H 2018 sales of CHF 16.0 million, increase of 48% compared to 1H 2017
• Operating expenses of CHF 39.9 million (1H 2017: CHF 30.5 million)
• Operating result of CHF -26.3 million (1H 2017: CHF -21.4 million) leading to a net result of
• CHF -27.4 million (1H 2017: CHF -22.7 million)
• Cash, cash equivalents and short-term financial assets of CHF 34.8 million (June 30, 2018)
• Full year sales guidance raised to CHF 30-32 million

Operational highlights:

• Acquisition of worldwide exclusive license to develop and commercialize clinical stage candidate POL6014 for cystic fibrosis (CF) and other pulmonary diseases
• Renewal of the Early Access to Medicines Scheme (EAMS) Scientific Opinion by UK's Medicines and Healthcare products Regulatory Agency (MHRA) for idebenone for patients with Duchenne muscular dystrophy (DMD) in the UK
• Launch of Expanded Access Program with idebenone for patients with DMD in the U.S.
• Submissions of regulatory dossiers for Raxone in Leber's hereditary optic neuropathy (LHON) in South Korea and Serbia
• Analysis of new data linking study findings with idebenone in DMD to clinically relevant patient benefits for inclusion in regulatory submissions in Europe and the U.S. (planned for 2019)
• Progress with clinical development candidates having successfully completed first clinical trial with omigapil in patients with congenital muscular dystrophy (CMD) and advanced preparations for multiple-ascending dose trial for POL6014 in CF

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