Submission of application to the FDA and successful rights issue
- In September, following satisfactory clinical studies at leading hospitals in the US, BioPorto submitted a registration application to the FDA, regarding NGAL Test™. Approval is expected early 2016, and is a prerequisite for deployment of the test for clinical use in the US.
- The company's antibodies and assays for research use in the US are currently sold through distributors. With the anticipated FDA approval of The NGAL Test™, BioPorto has however initiated a significantly aggressive US sales and support strategy, which involves building a business base in the US for direct sales.
- In August, BioPorto completed a successful increase of the share capital through a fully subscribed private placement with gross proceeds of DKK 28.1 million. The proceeds will partly be used to finance the more aggressive US strategy, partly to an acceleration of the development and marketing of new products.
- In the third quarter of 2015, four new NGAL routine users were initiated, bringing the total number of routine users to 23.
- Negotiations with potential partners for the distribution and licensing agreements continue. If entered, the agreements will have financial effect no sooner than 2016 and not, as expected, in 2015.
Continued improvement in results despite the focus on US preparations
- The sale of The NGAL Test™ has not progressed as expected in 2015, largely due to preparations for market entry in the US. It is partly offset by an increase in sales of human NGAL ELISA kits, which underlines the interest for NGAL. In the first nine months of 2015, BioPorto’s turnover amounts to DKK 14.6 million against DKK 13.8 millio. last year, corresponding to a moderate growth of 6%. Q3 revenue was DKK 4.7 million (2014: DKK 4.6 million), which is slightly lower than expected.
- The Group's cost focus is maintained and therefore EBIT totaled DKK -10.6 million (2014: DKK -12.4 million) with a net profit of DKK 8.9 million (2014: DKK -10.7 million).
Guidance for 2015 adjusted
- In 2015, revenue is expected to be DKK 21-22 million, representing a growth of 12-18% compared to 2014, against previous guidance of DKK 22-23 million.
- In 2015, an EBIT of DKK -13 million and a net result of DKK -11m is expected against previous guidance of EBIT of DKK -12 million. and net profit of DKK 10 million.
Peter Morch Eriksen, CEO comments: "We have come far in the preparations for the launch of The NGAL Test™ in the US with the submission of the application to the FDA and a fully subscribed rights issue, which allows us to plan and implement a new, targeted US strategy. Growth in sales of The NGAL Test™ in Europe and of other products shows progress, but did not quite live up to expectations. The reason is in part due to resources focused on the strategic objectives. Beginning next year, the company will get the full effect of NGAL routine users and inlicensed antibodies. We have managed to keep costs at a minimum which means we can maintain our earnings expectations, apart from accelerated US investments."
Read the full report in the enclosed PDF
For further information, please contact: Peter Mørch Eriksen, CEO Christina Thomsen, Investor Relations Manager Tel: +45 4529 0000 E-mail: investor@bioporto.com
