SOURCE: Swedish Orphan Biovitrum AB (publ)

February 23, 2011 02:41 ET

Swedish Orphan Biovitrum Full Year Report 2010

STOCKHOLM, SWEDEN--(Marketwire - February 23, 2011) -

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.

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:

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

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.

Full Year Report 2010:

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(i) the releases contained herein are protected by copyright and other applicable laws; and

(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE


Contact Information

  • For further information, please contact:
    Kennet Rooth
    phone +46 8 697 38 82

    Goran Arvidson
    phone +46 70 633 30 42