On April 27, 2016 Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) reported its results for the first quarter 2016 (Press release, Swedish Orphan Biovitrum, APR 27, 2016, View Source;Media/News/RSS/?RSS=View Source [SID:1234511481]). Revenue for the quarter totalled SEK 1,273 M (865), an increase of 47 per cent compared to previous year. All parts of the business contributed to the result with Orfadin and Kineret delivering strong performance.

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Business Summary Q1 2016

Initiated commercial launch of Elocta in the first European countries; revenue in the quarter derived almost exclusively from Germany
European Commission approved transfer of marketing authorisation for Elocta to Sobi
Sobi and Biogen received recommendation from CHMP that marketing authorisation be granted for Alprolix for the treatment of haemophilia B
Received commercialisation rights to three products from PharmaSwiss
European patent granted for Orfadin oral suspension
Initiated clinical pipeline programmes for acute gout and Still’s disease, and a patent granted for a new formulation of Kineret
Financial Summary Q1 2016 (Q1 2015)

Total revenue was SEK 1,273 M (865), an increase of 47 per cent (48 per cent at CER)
Product revenue was SEK 1,108 M (632), an increase of 75 per cent (76 per cent at CER)
Revenues include a one-time credit from Biogen of SEK 322 M triggered by the first commercial sales of Elocta
Gross margin was 74 per cent (60)
EBITA was SEK 502 M (172)
Earning per share 1.13 SEK (0.28)
"2016 is off to a strong start with excellent financial results, new products added to our Partner Products portfolio, development of two new programmes for Kineret, the launch of Elocta in Europe, and positive opinions regarding Alprolix from the CHMP recommending that marketing authorisation be granted, and from the COMP recommending that the orphan designation be maintained," said Geoffrey McDonough, CEO and Pesident at Sobi. "In January we began the launch of Elocta in the first European countries, enabling people with haemophilia A in the region access to the first extended half-life factor treatment. Revenue from the quarter derives almost exclusively from Germany, the only market in the EU where pharmaceuticals are immediately reimbursed upon EU approval. We received positive reimbursement decisions late in the quarter in both the Netherlands and Ireland, and continue to advance discussions in Denmark, Sweden and the UK."

Financial Summary
Q1 Q1 Full year
Amounts in SEK M 2016 2015 Change 2015
Total revenues1 1,273 865 47% 3,228
Gross profit 944 519 82% 2,007
Gross margin 74% 60% 62%
EBITA 502 172 >100% 433
EBIT (Operating profit/loss) 410 102 >100% 146
Profit/loss for the period 301 75 >100% 68
1 Q1 2016 revenues include a one time credit of SEK 322 M relating to first commercial sales of Elocta.

Outlook 2016 unchanged
Sobi continues to expect total revenue for the full year to be in the range of SEK 4,800 to 5,000 M. Revenue will include one-time credits for Elocta of SEK 300 to 325 M and for Alprolix of SEK 300 to 325 M, which will not impact cash. Gross margin is expected be in the range of 68 to 70 per cent.

Sobi will continue to invest in the launches of Elocta and Alprolix, and will also take on incremental costs of SEK 250 – 300 M reflecting its 50 per cent share of Biogen’s ongoing development costs for the products. Sobi will assume these costs when it becomes marketing authorisation holder for Elocta, which occurred 24 March 2016; and for Alprolix expected in the second half of the year. These incremental costs are included in this outlook.

Sobi expects EBITA for the full year to be in the range of SEK 1,200 to 1,300 M.

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Sobi’s report for the first quarter 2016 can be found on View Source;Media/Reports/.