On July 15, 2016 (Sobi) reported its results for the second quarter 2016 (Press release, Swedish Orphan Biovitrum, JUL 15, 2016, View Source;Media/News/RSS/?RSS=View Source [SID:1234513892]). Revenue for the quarter totalled SEK 1,469 M (764), an increase of 92 per cent compared to previous year. All parts of the business contributed to the result with Haemophilia, Inflammation and Partner Products delivering strong performance.

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Business Summary Q2 2016

Alprolix approved in the EU with first sales reported in Germany in early June
Elocta approved in Switzerland
European patent granted on new formulation of Kineret
Signed licensing agreement with Affibody for IL-1
Signed two manufacturing agreements with Pfizer
Orfadin Oral Suspension and 20 mg capsule approved in the US
Entered into new credit facility and redeemed SEK 800 M bond loan 2012/2017 prior to final maturity
Financial Summary Q2 2016 (Q2 2015)

Total revenue was SEK 1,469 M (764), an increase of 92 per cent (95 per cent at CER)
Product revenue was SEK 1,288 M (593), an increase of >100 per cent (>100 per cent at CER)
Revenues include a SEK 386 M one-time credit from Biogen triggered by first commercial sales of Alprolix
Gross margin was 72 per cent (63)
EBITA was SEK 550 M (74)
Earning per share 0.99 SEK (-0.01)
"The highlight of the first half of 2016 has been the launch of our long-acting Haemophilia franchise in Europe, with supporting achievements seen in the solid growth across the commercial portfolio, and in several milestones including two significant new manufacturing agreements with Pfizer, two Orfadin approvals and the granting of a European patent for a new citrate free formulation of Kineret", said Geoffrey McDonough, CEO and Pesident at Sobi.

"During the quarter, we have continued to build momentum for the launch of Elocta and we now have patients using the product in Germany, UK, Ireland, Sweden and in the Middle East. It has also been an exciting quarter for Alprolix with the approval by the European Commission in May. We are very pleased that Alprolix is now commercially available in Germany, and continue to work to make this innovative treatment available as quickly as possible in more countries in Europe in a similar launch sequence as for Elocta."

Financial Summary
Q2 Q2 H1 H1 Full year
Amounts in SEK M 2016 2015 Change 2016 2015 Change 2015
Total revenues1 1,469 764 92% 2,742 1,629 68% 3,228
Gross profit 1,065 482 >100% 2,009 1,001 >100% 2,007
Gross margin 72% 63% 73% 61% 62%
EBITA 550 74 >100% 1,052 247 >100% 433
EBIT (Operating profit/loss) 453 3 >100% 862 105 >100% 146
Profit/loss for the period 265 -2 >100% 567 73 >100% 68
1 Q2 2016 revenues include a one time credit of SEK 386 M relating to first commercial sales of Alprolix. H1 2016 revenues also include the one time credit received in Q1 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. Revenues include one time credits for Elocta of SEK 322 M and for Alprolix SEK 386 M, which do 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.