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Biovitrum AB A busy half-year with focus on specialist care pharmaceuticals and restructuring of R&D
April - June
* Net revenues amounted to SEK 287.9 M (404.2). The profit for the quarter, before restructuring costs, was SEK 23.4 M (59.8). After restructuring costs the result was SEK -96.6 M (59.8), corresponding to earnings per share of SEK -2.12 (1.31).
* Cash flow from operations was SEK -75.6 M (-16.4). Cash and cash equivalents and short-term investments as of June 30 amounted to SEK 635.6 M (876.8)
* Revenues from ReFacto® amounted to SEK 203.9 M (310.2) in the second quarter. Revenues from other products increased by 18 percent to SEK 25.1 M (21.3).
* Biovitrum implemented the strategic restructuring of the research organization as announced. The profit was charged with a one-off restructuring cost of SEK 120 M. Of this amount, SEK 68 M relates to costs associated with staff cuts. Other costs consist of write-downs of fixed assets. Savings in fixed R&D expenses are estimated to approx. SEK 115 M on a rolling twelve months basis.
* Strong advancement of the clinical portfolio
- The first patients were recruited for a clinical phase II study of Kiobrina(TM), resulting in a milestone payment.
- In preparation of the clinical phase III clinical within Anti-RhD prophylaxis, a second clinical study was initiated to show that Sym001 eliminates RhD positive red blood cells from the circulation of RhD negative healthy men.
- A clinical phase I/II study started in the US of a new long-acting factor IXFc protein with the potential to substantially improve treatment of hemophilia B patients.
- A clinical phase II study of Sym001 was initiated to study safety, efficacy and dosage in patients with idiopathic thrombocytopenia purpura (ITP).
* The results from the clinical phase II study within the A2A project were reported and showed that the candidate drug was very safe and provided a positive therapeutic effect that increases over time in patients with neuropathic pain.
* Mimpara® was the first treatment to be approved by the European Commission for the treatment of primary hyperparathyroidism (PHPT). Biovitrum will market Mimpara® in the Nordic Region.
* In line with its strategy to focus on specialist care pharmaceuticals, Biovitrum has decided to return the DPP-IV project to the Swiss company Santhera A/G from which the project was licensed. This resulted in a write-down of fixed assets.
* The outlook for 2008 remains unchanged.
January - June
* Net revenues amounted to SEK 532.1 M (757.1). The result for the first half-year before restructuring costs was SEK 21.3 M (103.9). Result after restructuring costs was SEK -98.7 M (103.9), corresponding to earnings per share of SEK -2.16 (2.28).
* The cash flow from operations was SEK -98.5 M (31.6).
CEO's Comments:
"It has been an intense and eventful first half year with focus on delivery of our strategy. We are especially satisfied that we have initiated four clinical phase II programs in our specialist care projects. The ReFacto® revenues were lower than the first half year 2007. As previously communicated, this is due to quarterly fluctuations in deliveries of ReFacto® protein to Wyeth as well as revenue in 2007 in the form of a one-off payment for validation batches of the new ReFacto®. We have reason to expect a slightly stronger second half year. Sales of ReFacto® in the Nordic market are doing very well and increased by 14 percent during the period. Sales of other products are also growing and increased by 18 percent," says Biovitrum's CEO Martin Nicklasson and continues: "The key to success is our focus on specialist pharmaceuticals. There are good reasons for a company such as ours to concentrate its resources on products that target small patient groups with great medical needs. The competence, size and flexibility of our R&D organization make us well-equipped to efficiently deliver current and future specialist care pharmaceutical projects all the way to the market."
For more information please contact:
Biovitrum AB (publ) Martin Nicklasson, CEO Phone: +46 8 697 20 00 martin.nicklasson@biovitrum.com
About Biovitrum Biovitrum is a specialty pharmaceutical company with operations in Sweden and in the UK. Biovitrum markets a range of specialist pharmaceuticals primarily in the Nordic countries. The company has a research portfolio with several projects in clinical and preclinical phases for a number of well defined specialist indications. Biovitrum has the expertise and experience to take its projects all the way to the market. Biovitrum develops and produces protein-based drugs and also has small molecule research expertise and capabilities. Biovitrum has revenues of approximately SEK 1.2 billion and around 500 employees. Biovitrum's share is listed on the OMX Nordic Exchange in Stockholm. For more information see www.biovitrum.com
