SOURCE: Biovitrum

February 18, 2010 03:03 ET

Biovitrum Full Year Report 2009

STOCKHOLM, SWEDEN--(Marketwire - February 18, 2010) -

Strong revenue growth and profit turn around.

This full year report refers to the Biovitrum group before acquisition of Swedish Orphan. A financial pro forma statement for Swedish Orphan Biovitrum 2009 is shown on page 8 in this report.

January - December

* Total revenues before licensing and milestone revenues increased by 22 percent and amounted to SEK 1,234.4 M (1,008.1) mainly driven by Kineret® and Kepivance®. Profit for the period amounted to SEK 32.5 M (- 335.5). This corresponds to a reported earnings per share[1] of SEK 0.32 (- 3.66).

* Core EPS[2] was SEK 0.84 (0.18).

* Cash flow from operations was SEK 58.8 M (-506.6). Cash and cash equivalents and short-term investments as of December 31 amounted to SEK 306.6 M (460.1).

* Positive progressions were seen in late stage clinical programmes and successful out-licensing and divestments of non core R&D projects and operations were made.

October - December

* Total revenues amounted to SEK 347.7 M (314.3).

* Fourth quarter combined sales of Kineret® and Kepivance® were the highest since Biovitrum acquired the products in December 2008. ReFacto® co-promotion revenues were up 25 percent compared to Q4 2008.

* Operating result was SEK 51.4 M (-290.2). Profit for the period amounted to SEK 31.5 M (-246.6). This corresponds to a reported earnings per share(1)) of SEK 0.31 (-2.64).

* Core EPS(2)) was SEK 0.44 (-0.20).

* Cash flow from operations was SEK 149.3 M (-382.6).

* The first patient was dosed in a phase I/IIa study with the long-acting rFVIIIFc, a programme partnered with Biogen Idec.

* Results were positive in one of two clinical phase II studies with Kiobrina™ (rhBSSL). A statistically significant improvement of growth velocity in preterm infants was observed. The safety profile was comparable to placebo.

* An agreement to expand Biovitrums's Kineret® license to include certain additional orphan indications was signed with Amgen. Cambridge Biotechnology Ltd (CBT) was divested to Proximagen Neuroscience plc. Astra Zeneca acquired all of Biovitrum's rights to its preclinical leptin modulator program aimed at treating obesity. Upfront payments amounted to EUR 6 M. Biovitrum will receive future milestone payments contingent on development progress and sales, as well as single digit percentage royalties on future sales.

Events after the period

* Biovitrum announced on November 5, 2009 the acquisition of Swedish Orphan. The transaction was closed on January 14, 2010 and was financed by a rights issue, an issue in kind and bank financing.

* Biovitrum and Biogen Idec reconstructed the collaboration agreement for the companies' long-acting, recombinant Factor VIII Fc and Factor IX Fc fusion proteins for treatment of hemophilia A and B respectively.

* Biovitrum and Biogen Idec enrolled the first patients in the registrational, open-label, multicenter trial designed to evaluate the efficacy, pharmacokinetics and safety of the long-acting rFIXFc protein in hemophilia B patients (the B-LONG study).

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[1] Adjusted for new share issue completed in January 2010, after which total number of shares are 151,704,533.

[2] Core EPS is calculated from P/L for the period excluding amortizations and restructuring and other one-time expenses and based on average number of shares.

CEO comments:

"2009 was a very successful and active year for Biovitrum. Our revenues before licensing revenues grew strongly and I am pleased that the operating profit was in line with our guidance, demonstrating a turn around into a profitable business. The positive progression of our clinical projects is also exciting as well as the fact that we were successful in out-licensing and divestment of the remaining non core R&D projects and operations. Finally, the acquisition of Swedish Orphan was a significant achievement. The new company, Swedish Orphan Biovitrum, will have a diverse product portfolio and an interesting late stage project pipe-line within rare diseases. I am personally committed to deliver future profitable growth reaching our 2015 business target of more than SEK 5 B in revenues and an EBITA margin of at least 30% based on the existing product/project range but also by adding new business opportunities to the company," says CEO Martin Nicklasson.

For further information, please contact:
Erik Kinnman, Investor Relations  phone +46 73 422 15 40
Martin Nicklasson, CEO phone +46 8 697 20 00
Göran Arvidson, CFO phone +46 8 697 23 68

About Swedish Orphan Biovitrum

On January 14, 2010, Biovitrum AB (publ) completed the acquisition of Swedish Orphan International Holding AB and created Swedish Orphan Biovitrum - a leading company focused on treatment of rare diseases.

Swedish Orphan Biovitrum is a Swedish based specialty pharmaceutical company with an international market presence. The company is focused on providing and developing orphan and niche specialist pharmaceuticals to patients with high medical needs. The portfolio consists of about 60 marketed products and an emerging late stage clinical development pipe-line within rare diseases. Swedish Orphan Biovitrum has pro-forma revenues 2009e of about 2 BSEK and approximately 500 employees. The head office is located in Sweden and the share (STO: BVT) is listed on NASDAQ OMX Stockholm.

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