Highlights
Strategic developments in 2012
- BioPorto is in the process of establishing collaborative agreements with major diagnostics companies concerning the registration, distribution and/or marketing of The NGAL Test™. In 2012 an agreement was entered into with Wiener Lab. Group concerning distribution and marketing in Latin America. Both Siemens Diagnostics and Roche Diagnostics have informed about The NGAL Test™ to all their local divisions, directly referring to the technical validation on Siemens’ and Roche’s respective analyzers and providing contact details for BioPorto’s sales team for buying the test. This is expected to be the first step towards more comprehensive collaboration.
- Sales of NGAL products increased by 24% to DKK 6.5 million, of which sales of The NGAL Test™ amounted to DKK 1.8 million. Sales forecasts for The NGAL Test™ have been revised downward due to delays in the test’s qualification for reimbursement in China and registration in Brazil.
- The NGAL Test™ is continuously being developed for existing analyzers; as part of this, application notes have been achieved for Siemens’ ADVIA 1800 and ADVIA 2400.
- The NGAL Test™ was approved for registration in China, Russia and other countries in 2012. The test was also approved for registration in Brazil in March 2013. With a view to being approved for registration in the US, the first required trial to identify the normal range of NGAL levels has begun and the trial protocol for the actual clinical trial has been finalized.
- A decisive factor for implementing The NGAL Test™ into routine diagnostics is to determine the clinical guidelines for the use of NGAL analyses for diagnostic purposes. The initial indications of use comprise diagnosing/monitoring kidney injury resulting from antibiotic treatment and ruling out kidney injury before release from hospital, both of which are used in practice at selected hospitals.
- The NGAL cut-off patent was issued in China in 2012, which is one of BioPorto’s high-priority markets, and the NGAL ratio patent was approved for issuance in the US. In a first instance decision, the European Patent Office rejected the already issued cut-off patent, but the ruling has been appealed and BioPorto expects a favorable outcome. The European patent is fully valid during the appeal. The NGAL ratio patent is BioPorto’s first NGAL patent to be issued in the US. Following a case filed by BioPorto against Phadia’s NGAL patent in Denmark, the patent was declared invalid insofar as principal claims 1 and 2 are concerned. Phadia has appealed this case to Denmark’s Supreme Court.
- Licensing income of DKK 0.6 million has been received for Instrumentation Laboratories’ access to the NGAL IP rights in 2012.
Financial trends in 2012
- The group’s net revenues amounted to DKK 17.9 million in 2012 (2011: DKK 18.3 million). The net revenues are on a par with the most recently announced expectations. Product sales rose 5.5% from DKK 16.4 million to DKK 17.3 million.
- The net loss for the year in 2012 was DKK 13.9 million (2011: DKK -12.9 million). The loss is in line with the most recently announced expectations.
- A private placement cash issue was carried out and generated proceeds of DKK 9.6 million.
- By December 31, 2012, the group’s equity amounted to DKK -1,2 million.
Forecast for 2013
- BioPorto expects its 2013 revenues to be on a par with 2012.
- A loss is expected in 2013 and is expected to be slightly greater than in 2012 due to the initiation of clinical trials.
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The most important task in 2013 is to ensure wider routine use and implementation of The NGAL Test™:
- by continuing the registration process, focusing on the US market;
- by collaborating with distributors and hospitals concerning the implementation of trials aimed at establishing clinical guidelines and preparing health-economic analyses;
- by continuing to enter into partnerships with distributors of analyzers.
- It is expected that further resources will be earmarked to protect the group’s technologies by obtaining patent rights and to defend, optimize and expand these rights.
- At the end of February, 2013, cash in the form of bank deposits totaled DKK 5.2 million, which is expected to finance BioPorto’s activities until June 2013. The management estimates the funding needs by the end of May 2013 to be DKK 5-10 million and by third quarter at the latest an additional DKK 15-20 million in order to finance the activities of the group in 2013 and settle the convertible debt due in September 2013. After considering the options available, management has decided to attempt to carry out a rights issue to existing shareholders. The issue, planned for third quarter, is expected to provide BioPorto with funds in the range of DKK 60-70 million.
See the full report in the attached pdf
For further information, please contact:
Thea Olesen, CEO
Christina Thomsen, Investor Relations
Telephone +45 4529 0000, e-mail investor@bioporto.com
