| November 8, 2018 Announcement no. 18 Highlights FDA clearance of The NGAL Test™ expected by mid-2019 In the beginning of October 2018, the U.S. Food and Drug Administration (“FDA”) requested additional data from BioPorto to continue the clearance process for The NGAL Test™ in adults. To further support the application, BioPorto plans to initiate a clinical study with 150-200 additional patients from a group of the U.S. hospitals and clinics already participating in the clinical trial program. Therefore, BioPorto has updated the anticipated clearance timeline and expects FDA clearance of The NGAL Test ™ by mid-2019. Study initiated to support separate FDA submission for The NGAL Test™ in children BioPorto has initiated a pivotal retrospective clinical pediatric NGAL study for AKI. The study will form the basis for a new and separate application for regulatory clearance of The NGAL Test™ in the U.S. based on urine NGAL and dedicated clinical use in children. The application is expected to be submitted to FDA in the first half of 2019. Seeking two separate FDA clearances of The NGAL Test™ is an important step in BioPorto’s strategy of establishing and expanding the product portfolio both vertically and at a later stage, horizontally. Strong interest for NGAL as a bio-marker for Acute Kidney Injury BioPorto has allocated significant resources to increase knowledge and awareness of NGAL through discussions with leading experts as well as presentations and participations at conferences. In October, BioPorto participated at the 2018 International Symposium on AKI in Children in Cincinnati, Ohio, where The NGAL Test™ encountered strong interest from the more than 100 participating physicians. In addition, the U.S. sales organization has recently been strengthened with two sales people to cover strategic territories in the South East and Western U.S. Revenue from The NGAL Test™ up 139% in third quarter 2018 Sales of The NGAL Test™ grew 139% in the third quarter of 2018 compared to same quarter last year due to strong performance in research use only sales in the U.S. However, antibodies and ELISA kits sales were below budget, causing overall revenue in the third quarter of 2018 to decrease to DKK 5.4 million from DKK 6.0 million in the same quarter of last year. BioPorto’s operating loss before interest and tax (EBIT) for the third quarter of 2018 was DKK 11.6 million. For the first nine months of 2018, BioPorto reported an EBIT loss of DKK 34.0 million. Proceeds from share issue to drive strategic execution BioPorto’s board expects to complete a private placement of new shares at market price in November of 2018. This will strengthen the company’s financial position and support the execution of its strategy to secure strong momentum in sales of The NGAL Test™ and expand into other indications to broaden the NGAL product portfolio. Outlook for 2018 maintained Based on the results of the first nine months of 2018, BioPorto maintains its latest guidance for the financial year 2018. Revenue in 2018 is expected to total approximately DKK 30 million, corresponding to a growth rate of 19% over 2017. EBIT for the financial year 2018 is forecasted to be a loss in the range DKK 32-37 million. Peter M. Eriksen, CEO comments: “In the third quarter of 2018, we have successfully continued activities to boost awareness of The NGAL Test™ among leading healthcare practitioners and important industry organizations. We now expect clearance of The NGAL Test™ in mid-2019, following the FDA’s request for additional data to support the application process. The postponement was undoubtedly a disappointment but nevertheless, we remain completely dedicated to bringing the test to the U.S. market. We are encouraged by the positive and ongoing dialogue with the FDA, the performance of research use only sales and strong interest in our NGAL platform from U.S. hospitals and clinics. Our focus in the next period will be on collecting the additional data for the FDA application for The NGAL Test™, and very importantly, taking the first steps in the execution of our vertical strategy as we initiate the separate urinary studies for The NGAL Test™ for children, and hence will have U.S. applications for NGAL in both urine and plasma in 2019. While doing so, we will continue the buildup of the commercial foundation for the test with a strong focus on research use only sales.” Investor meeting In connection with the release of the interim report for the first nine months of 2018, BioPorto will host an investor meeting on November 8, 2018 at 3 pm. The meeting will be held at Tuborg Havnevej 15 st., 2900 Hellerup, Denmark. To attend the meeting, please sign up at investor@bioporto.com Further information: Peter M. Eriksen, CEO Gry Husby Larsen, GC Tel. no. (+45) 45 29 00 00, e-mail investor@bioporto.com About BioPorto BioPorto is an in-vitro diagnostics company that provides healthcare professionals in clinical and research settings a range of diagnostic tests and antibodies. BioPorto has its headquarters in Hellerup, Denmark and is listed on the NASDAQ Copenhagen stock exchange. |
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