01: Annual Report 2009
March 12 2010
2009 fiscal year
·The Group’s net revenues increased in 2009 by 11% to a total of DKK 11.01 mill., from DKK 9.88 mill. in 2008. The net revenues are on a par with the most recently announced expectations.
·2009 saw a loss of DKK 15.95 mill., compared to a loss of DKK 14.74 mill. in 2008. The loss is in line with the most recently announced expectations.
·The Group achieved successful results during the development of a new NGAL immunoassay (diagnostic renal injury assay, i.e. The NGAL Test), which was developed in a format targeting existing instruments at central hospital laboratories. This assay format paves the way for rapid access to the NGAL market for most major vendors of diagnostic tests and assay instruments.
·After the completion of ownership litigation, BioPorto’s NGAL cutoff patent for protecting NGAL as a measurement method for acute renal injury was issued in Europe on 11 November 2009. In the beginning of 2010, the patent has been validated in the individual countries. By this means, BioPorto has bolstered its position in ongoing licensing-access negotiations for the utilization of the patent by other players in developing the NGAL immunoassay in other formats besides the homogeneous assay, for which the Group retains the rights to market The NGAL Test.
·The Group has launched an APC-PCI ELISA Kit. Studies in this area have spurred positive expectations for a new utilization of APC-PCI as a biomarker for sepsis patients with a view to qualifying them for treatment using activated protein C (Xigris, a drug marketed by Eli Lilly).
·A Mouse NGAL Kit and a Dog NGAL Kit were launched under the animal NGAL portfolio. One effect of this enlarged and comprehensive portfolio of animal NGAL products is that it has been possible to establish distribution collaboration with ALPCO Diagnostics in the US.
·A private placement was carried out by issuing 3.83 million new shares at a price of DKK 3.97 per share, equating to net proceeds of DKK 14.7 million. The capital infusion is expected to ensure operations for the launch of The NGAL Test (beginning of 2011).
·In 2009, BioPorto completed a quality-assurance certification audit and achieved ISO 13485:2003 certification in February 2010.
Expectations for 2010
·In 2010, BioPorto anticipates that product sales will continue to grow by around 15-25% and revenues are expected to be around DKK 12.5-14 mill., not including income from the sales of licenses.
·Without licensing income, a net loss of around DKK 14-15 mill. is expected for 2010.
·The most important task for 2010 will be the completion and marketing of The NGAL Test.
·In terms of the Group’s IP rights to the NGAL measurement method, BioPorto expects to enter into agreements concerning other vendors’ use of these for developing and marketing the NGAL immunoassay in other assay formats, and expects to achieve licensing income in 2010 in the form of one or more down payments.
The Group expects to launch two more animal NGAL ELISA Kits and four to six new unique antibodies, developed in-house.