20: Interim Financial Report for Q3 2011 for the BioPorto Group
November 24 2011
Announcement no. 20
Summary of Q3 2011
• Revenues (including licensing income) increased 37% to DKK 14.3 million (DKK 10.5 million) in the first three quarters of 2011.
• The financial result for the first 9 months was a loss of DKK -10.7 million (DKK -9.8 million).
• 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 of The NGAL Test™ generated DKK 584,300 in Q3, which is a 138% increase from Q2. The first sales for routine use in hospitals will begin in the months ahead.
• In Q3, BioPorto focused on establishing distribution collaborations in the BRIC countries (Brazil, Russia, India and China), as a result of which distribution agreements have now been entered into in all four.
• Distribution collaborations with a number of the global diagnostics companies marketing their own analyzers are the object of continued negotiation. It is anticipated that the first agreement will be entered into in first half year of 2012.
• Sales of The NGAL Test™ for diagnostic use have obtained official certification in South Korea and India in Q3. As regards to registration in the US, BioPorto is awaiting a response from the FDA concerning the preparation of the protocol for the initiation of a clinical study.
• BioPorto’s NGAL cut-off patent, which has been issued in Europe, is being assessed in an opposition case before the European Patent Office (EPO). The EPO has issued a provisional opinion which provisionally concedes to the opponents that the patent may have been issued too broadly or on an incorrect basis. Høiberg, BioPorto’s patent attorneys, has evaluated this opinion in detail. Høiberg expects it will be possible to mitigate the objections submitted and expects BioPorto will still hold a relevantly adequate NGAL cut-off patent in Europe after the opposition case.
• BioPorto’s patent concerning the diagnostic use of the APC-PCI marker for selecting patients with severe sepsis for special treatment has been approved for issue in the US.
• In Q3, BioPorto increased the share capital by the nominal amount of DKK 8.1 million, as a result of carrying out a cash issue, private placement. The new stocks were subscribed at a price of DKK 5.00. The total net proceeds from the placement amount to DKK 12.75 million.
Forecast for 2011
• The revenues for the year are estimated to be DKK 18–19 million, approximately 10% of which are expected to constitute sales of The NGAL Test™. The test is still in the introductory phase and for this reason tests will still have to be distributed for trials and validation. Sales for diagnostic use are expected to begin in the months ahead with continued strong revenue growth from one quarter to the next. Based on the estimated revenues, the financial result is expected to be negative at DKK -14 to -15 million.
• Negotiations are being conducted with two additional licensees concerning access to BioPorto’s IP rights to the NGAL measuring method for developing and marketing the a NGAL test in other testing formats. These negotiations may continue into 2012.
• The most important tasks in 2011 have been and will continue to be a broader registration of The NGAL Test™ for diagnostic use and the implementation of the test in routine diagnostics.