On December 12, 2018 Santhera Pharmaceuticals (SIX: SANN) reported its financial results for the nine months ended September 30, 2018, and confirms its guidance and positive outlook (Press release, Santhera Pharmaceuticals, DEC 12, 2018, View Source [SID1234532027]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Santhera is on track to meet its strategic and financial goals for 2018. The Company further delivered on its active in-licensing strategy for high quality, late-stage rare disease assets by acquiring an exclusive sub-license option to vamorolone, the first-in-class dissociative steroid currently in development for the treatment of Duchenne muscular dystrophy (DMD). On the commercial side, the Company has further grown sales of the revenue-generating product Raxone for the treatment of Leber’s hereditary optic neuropathy (LHON) and expects to meet its 2018 full-year sales guidance in the range of CHF 30-32 million.

Santhera continued its business expansion and grew sales to CHF 23.6 million in the first nine months of 2018 which corresponds to a 45% growth rate (compared to the same period in the previous year). Development expenses increased by 49% compared to the same prior-year period, primarily driven by clinical development activities for POL6014 for the treatment of cystic fibrosis (CF) and regulatory work in preparation of filings for idebenone in the indication DMD. Efficient use of resources resulted in lower marketing and sales expenses (-6%) and a slower rise in general and administrative expenses (+18%). Taken together, this contributed to an increase of operating expenses by 20% compared to the same period of last year. In summary, Santhera closed the nine-month period under review with a net result of CHF -39.9 million (Jan.-Sept. 2017: CHF -33.3 million).

Financial highlights:

Sales of CHF 23.6 million (Jan.-Sept. 2018), reflecting an increase by 45% compared to same period last year (Jan.-Sept. 2017: CHF 16.3 million)
Operating expenses of CHF 57.2 million (Jan.-Sept. 2017: CHF 47.7 million)
Operating result of CHF -37.2 million (Jan.-Sept. 2017: CHF -34.2 million), leading to a net result of CHF -39.9 million (Jan.-Sept. 2017: CHF -33.3 million)
Cash, cash equivalents and short-term financial assets of CHF 25.4 million (as of September 30, 2018)
2018 full-year sales guidance of CHF 30-32 million confirmed
Corporate highlights:

Agreement with Idorsia Ltd under which Santhera is to acquire the option to an exclusive sub-license of the first-in-class dissociative steroid vamorolone in all indications and all countries worldwide except Japan and South Korea (November 20, 2018)
Idorsia became largest shareholder in Santhera
Extraordinary General Meeting (EGM) approval of the capital increase in connection with the vamorolone sub-license agreement (December 11, 2018)
Operational highlights (July 2018 to present day):

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.
Positive opinion on orphan drug designation received from European regulators for POL6014 for the treatment of CF
Start of a Phase Ib/IIa multiple ascending dose (MAD) trial with POL6014 in patients with CF
Revenue Guidance:
Santhera will continue to grow its international business, advance its pipeline programs and actively proceed with business development initiatives to expand its late stage product portfolio. Based on its sales performance to date this year, the Company confirms its previous guidance and expects to reach a full-year sales for Raxone in the range of CHF 30-32 million in 2018.

Note
The financial statements as of and for the nine months ended September 30, 2018 have been prepared and are being published exceptionally on the occasion of and in connection with the capital increase proposed to and approved by the EGM held on December 11, 2018. Santhera publishes results in line with the disclosure requirements of the SIX Swiss Exchange. Santhera does not plan on publishing quarterly reports in the future.