On October 27, 2016 Swedish Orphan Biovitrum AB (publ) (Sobi) reported its results for the third quarter 2016 (Press release, Swedish Orphan Biovitrum, OCT 27, 2016, View Source;Media/News/RSS/?RSS=View Source [SID1234516046]). Revenue for the quarter totalled SEK 1,171 M (786), an increase of 49 per cent compared to previous year. Based on strong performance across the portfolio and an earlier launch for Alprolix, the company has raised guidance for the full year.

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!

Business highlights Q3 2016

Elocta reimbursed in the UK, Italy, France and Spain
Alprolix reimbursed in the UK
Long term Elocta and Alprolix data presented at WHF 2016 World Congress
Orfadin capsule filing validated by Health Canada
Milan Zdravkovic appointed as SVP, Head of R&D
Financial highlights Q3 2016 (Q3 2015)

Total revenue of SEK 1,171 M (786), an increase of 49 per cent
Product revenue of SEK 1,009 M (645), an increase of 56 per cent (57 per cent at CER)
Gross margin of 67 per cent (62)
EBITA of SEK 282 M (97)
Ended the quarter with a cash position of SEK 824 M
Earnings per share 0.53 SEK (0.02)
"Results in the third quarter had a positive contribution from the ongoing launch of Elocta, from an earlier than anticipated launch for Alprolix and from Kineret. We continue to lay the foundation for a sustainable haemophilia business in Europe with both Elocta and Alprolix gaining several important reimbursement approvals in major markets", said Geoffrey McDonough, CEO and President at Sobi.

"A significant milestone after the quarter was the orphan designation approval by the European Commission for our development candidate SOBI003 – a chemically modified human recombinant sulfamidase for the treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome). MPS IIIA is a severe and debilitating disease with devastating consequences for patients, and there is presently no treatment available."

Financial Summary
Q3 Q3 Jan-Sep Jan-Sep Full year
Amounts in SEK M 2016 2015 Change 2016 2015 Change 2015
Total revenues1 1 171 786 49% 3 913 2 414 62% 3 228
Gross profit 782 486 61% 2 791 1 486 88% 2 007
Gross margin 67% 62% 71% 62% 62%
EBITA 282 97 >100% 1 334 343 >100% 433
EBIT (Operating profit/loss) 171 25 >100% 1 034 129 >100% 146
Profit/loss for the period 143 5 >100% 710 77 >100% 68
1Jan-Sep 2016 revenues include a one-time credit in Q1 of SEK 322 M relating to the first commercial sales of Elocta, and a one-time credit in Q2 of SEK 386 M relating to first commercial sales of Alprolix.
Outlook 2016 – guidance raised

For the full-year 2016, Sobi now expects revenues of SEK 5,125—5,200 M (4,800-5,000). Revenues include one-time credits for Elocta of SEK 322 M and for Alprolix of SEK 386 M which do not impact cash. Gross margin is now expected to be 70 per cent (68-70) and EBITA for the full-year in the range of SEK 1,475–1,525 M (1,200-1,300).

The original outlook was published 29 February 2016.

—

Sobi’s report for the third quarter 2016 can be found on View Source;Media/Financial-Reports/