Highlights
- In early 2011, BioPorto’s kidney injury test, The NGAL Test™, was CE-marked and, thus, launched for diagnostic use in Europe. Registration processes have also been initiated in the US, China and other countries.
- Since its launch, The NGAL Test™ has been distributed to hospitals all over the world for the purpose of testing, validation and routine set-up of the test. Sales for routine use at the first hospitals have gradually commenced, and sales of the test comprised DKK 1.5 million in 2011.
- Twenty-four agreements for the distribution of The NGAL Test™ have been entered into, including distribution partnerships in the four BRIC countries. Distribution collaborations with a number of the global diagnostics companies marketing their own analyzers are the object of negotiation.
- The NGAL Test™ is continuously being developed for existing analyzers, and application notes have been drawn up for some of the most widely used devices.
- An NGAL cut-off patent for the protection of NGAL as a method of measuring acute kidney injury has been issued in Japan and India. The patent was rejected by means of an opposition case in Europe, but BioPorto is appealing this decision. The patent is still valid during the appeal. In addition, the NGAL triage patent has been approved for issuance in Europe.
- In March 2011, BioPorto concluded a non-exclusive agreement with Instrumentation Laboratory concerning access to BioPorto’s NGAL IP rights. The agreement does not include the homogeneous test format.
- BioPorto’s patent concerning the diagnostic use of the APC-PCI marker for selecting patients with severe septicemia for special treatment has been issued in the US.
- The group’s net revenues increased 35% in 2011 to a total of DKK 18.6 million, from DKK 13.8 million in 2010. The revenues are on a par with the most recently announced expectations.
- 2011 saw a loss of DKK 14.8 million, compared to a loss of DKK 14.2 million in 2010. The loss is in line with the most recently announced expectations.
- A private placement cash issue was carried out and generated proceeds of DKK 12.75 million.
Forecast for 2012
- In 2012, BioPorto expects product sales to grow to revenues around DKK 25–30 million, and sales of The NGAL Test™ are expected to exceed DKK 10 million.
- A net loss of around DKK 10–12 million is expected for 2012.
-
The most important task in 2012 will be to ensure the increased use and implementation of The NGAL Test™ for routine use:
- by establishing a distribution agreement with one or more global diagnostics companies;
- by continuing the registration process, focusing on the US and Chinese markets;
- by preparing more application notes.
- Further resources will be provided to protect the group’s technologies by obtaining patent rights and to defend, optimize and expand these rights, including the appeal of the rejection of the European NGAL cutoff patent.
For further information please contact:
Frank Harder, CFO
Thea Olesen, CEO
Telefon 45 29 00 00, mail investor@bioporto.com
