Swedish Orphan Biovitrum Full Year Report 2010
Successes in the clinical project portfolio create foundation for future growth.
rFIXFc and rFVIIIFc hemophilia projects and Kiobrina® progressing according to
plan.
January - December
* Net revenues declined by 7.7% to SEK 1,906.7 M (pro forma[1] 2,065.6).
Sales, excluding Tracleer® and milestone revenues, increased 3% at constant
exchange rate (CER)
* Operating income (EBITA) increased by 36% to SEK 371.9 M (273.6).
Profit/loss for the period totaled SEK -104.4 M (32.6), which corresponds to
earnings per share of SEK -0.53 (0.32).
* Core EPS [2] was SEK 1.87 (0.84).
* Marketing, distribution and medical support of Xagrid®, Fosrenol® and
Equasym® will terminate when the agreements with Shire expire in 2011.
* An international hemophilia B (rFIXFc) registration trial (phase II/III) was
initiated in January.
* Decision was taken to advance Kiobrina® into phase III development.
October - December
* Net revenues declined 15% to SEK 465.0 M (pro forma 546.1).
* Sales, excluding Tracleer® and milestone revenues, increased 3% at constant
exchange rate (CER) and dropped 2% in SEK.
* Operating result (EBITA) was SEK 192.2 M (pro forma 103.5). Net income and
EPS amounted to SEK -13.2 M (31.6) and SEK -0.06 (0.31).
* Core EPS [2] was SEK 0.60 (0.44).
* An international hemophilia A (rFVIIIFc) registration trial (phase II/III)
was initiated.
* rFVIIIFc received orphan drug designation (ODD) from the FDA in the US.
* Development rights for Sym001 were returned to Symphogen for strategic
reasons.
* Sales rights for Mimpara® were sold back to Amgen.
Significant events after the reporting period
* January 11, 2011 Swedish Orphan Biovitrum signed an agreement with BL&H Co.
Ltd for distribution of Orfadin® and Kepivance® in South Korea.
* January 27, 2011 Swedish Orphan Biovitrum signed an agreement with Fresenius
Biotech for distribution of Removab® in 15 European countries over seven
years.
* Executive Management Team was reorganized and the Business Development
functions were strengthened
CEO's comments
"2010 was a challenging year for our new company. Several external factors had a
major impact on our financial performance this year, including the strong
Swedish krona in relation to the US dollar and the euro, increased parallel
trade as well as government budget problems in several European countries. At
the same time, the new company was quickly and successfully integrated, and we
signed new commercial agreements. Also decisions have been taken to advance our
three most important projects, Kiobrina®, rFVIIIFc and rFIXFc into phace III.
These successes in the late project portfolio lay the foundation for profitable
growth. Conditions on the European pharmaceutical market are however expected to
remain unchanged in 2011 with limited growth.," says CEO Kennet Rooth.
[1] All comparative figures for 2009 are pro forma figures for the merged
companies Biovitrum AB and Swedish Orphan International.
[2] Core EPS is calculated from P/L for the period excluding amortization of
intangible assets and restructuring and other extra ordinary items and
calculated on average number of shares.
For further information, please contact:
Kennet Rooth, CEO phone +46 8 697 38 82
Göran Arvidson phone +46 70 633 30 42
Conference call details
The Interim Report for the fourth quarter 2010 will be presented by Swedish
Orphan Biovitrum's CEO Kennet Rooth at a media and analyst telephone conference.
The presentation will be held in English and can also be followed, direct or
retrospectively, by a web cast via internet.
Time: Wednesday, February 23, 2010 at 3.00 p.m. (CET)
Venue: Grand Hôtel, Stockholm Sweden (room "New York")
To participate in the Telephone Conference please call:
UK: +44 (0)20 3043 2436, SE: +46 (0)8 505 598 53, US: +1 866 458 40 87
To follow the Telephone conference via web cast, direct or retrospectively by
Internet you will find the link on our web site, please visit: www.sobi.com.
About Swedish Orphan Biovitrum (Sobi)
Sobi is a Swedish based niche specialty pharmaceutical company with an
international market presence. The company is focused on providing and
developing specialist pharmaceuticals for rare disease patients with high
medical needs. The portfolio consists of about 60 marketed products and an
emerging late stage clinical development pipe-line. Our focus areas are:
hemophilia, inflammation/autoimmune diseases, fat malabsorption, cancer
supportive care and inherited metabolic disorders. In 2010 Sobi had revenues of
about SEK 1.9 B and approximately 500 employees. Headquarters is located in
Sweden and the share (STO: SOBI) is listed on NASDAQ OMX Stockholm. For more
information please visit www.sobi.com.
Swedish Orphan Biovitrum may be required to disclose the information provided
herein pursuant to the Swedish Securities Markets Act. The information was
provided for public release on February 23, 2011 at 8:30 a.m. CET.