Biovitrum Full Year Report 2009
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(TM) (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.
For more information please visitwww.biovitrum.com <http://www.biovitrum.com/>