Announcement no. 14

Summary of Q2 2011

·Revenues (including licensing income) in the first half-year of 2011 increased 46% to DKK 10.1 million (DKK 6.9 million).

·The financial result was a loss of DKK –7.3 million (DKK –6.5 million) for the first 6 months.

·Since launch The NGAL Test™—corresponding to a market value of DKK 3.3 million—has been distributed to hospitals all over the world for the purpose of testing, validating and routine set-up of the test. Sales of The NGAL Test™ generated DKK 355,000 in the first half-year. Sales for routine diagnostics utilization are expected to commence late this year.

·Distribution collaborations with several global diagnostics companies, which market their own analyzers, are currently being negotiated, and the validations of The NGAL Test™ for these companies’ specific analyzers are in progress.

·BioPorto has established agreements with two of the largest diagnostics companies in China. The agreements include the registration, marketing and sale of The NGAL Test™ on the Chinese market. The registration process is expected to be initiated at the SFDA (the Chinese Drug Administration) in Q4 2011.

·BioPorto’s NGAL cut-off patent was issued in Japan and India in Q2. BioPorto’s NGAL triage patent for diagnosing the severity of physical traumas by measuring NGAL was approved for issuance in Europe in July.

·The US Food and Drug Administration (FDA) has commenced the evaluation of BioPorto’s application for approval of The NGAL Test™. The FDA has accepted to evaluate The NGAL Test™ under the 510(k) paradigm, but has requested that the included clinical data is verified by conducting an additional clinical study in the USA. The final study design is currently discussed with the FDA.

·To ensure the access to market The NGAL Test™ in the USA, BioPorto has started preparations to conduct an additional clinical study. In addition BioPorto plans to increase marketing activities in markets where The NGAL Test™ has already been approved for IVD use in order to gain a faster market penetration. BioPorto currently examines the possibilities for external financing to be able to speed up these activities successfully.

Forecast for 2011

·It is still too early for BioPorto to predict the sales revenues generated by The NGAL Test™ in 2011. At present, the assay still is in its introductory phase and is primarily being provided for validation and trial set-ups, which is why BioPorto does not anticipate major sales until Q4 2011. BioPorto expects the sales of the rest of its product portfolio to continue to grow.

·In relation to the Group’s IP rights to the NGAL assay method—and in addition to the agreement with Instrumentation Laboratory—BioPorto expects to conclude agreements concerning other vendors’ use of these rights to develop and market the NGAL assay in other assay formats.

·The most important activities in 2011 are to continue to register and widen the registration of The NGAL Test™ for diagnostic use and to implement the assay in routine diagnostics.