Interim Report, First Quarter 2018, BioPorto Group
May 3, 2018
Announcement no. 10
Important milestones in global roll-out of The NGAL Test™ secured in first quarter 2018
In the first quarter of 2018, BioPorto secured multiple important milestones in the effort to commence a global roll-out of The NGAL Test™.
Firstly, the last patient was enrolled in the US clinical study for The NGAL Test™, and the analysis and preparations for the FDA application has entered into its final phase. This will lead to the US registration application for The NGAL Test™ being submitted to the FDA in second quarter of 2018 as planned.
Secondly, BioPorto and Roche Diagnostics entered into an agreement for exclusive global distribution of a customized version of The NGAL Test™ on Roche equipment. This agreement, together with the existing distribution agreement with Siemens Healthcare, will have significant importance going forward for the global awareness and availability of NGAL as a diagnostic biomarker for acute kidney injury.
Revenue affected by strong focus on strategic execution in beginning of 2018
The strong focus on the execution of the important strategic FDA clinical milestones in the first quarter of 2018 impacted BioPorto’s revenue which was down DKK 1.1 million to DKK 4.6 million, primarily due to sales being pushed from first to the quarters to come, for antibodies and the NGAL Test™.
BioPorto’s operating loss before interest and tax (EBIT) for the first three months of 2018 was DKK 12.6 million compared to a loss of DKK 9.3 million last year in the same period. The increase in the loss is primarily related to lower revenue and higher research and development costs associated with the US clinical study.
Sales and EBIT guidance for 2018 maintained
After first quarter 2018 management reiterates its guidance for revenue in 2018 of approximately DKK 35 million, corresponding to a minimum growth of 35% over 2017, and an EBIT loss of DKK 32 - 37 million for the financial year 2018.
Peter M. Eriksen, CEO comments: “First quarter 2018 was focused on establishing the foundation for BioPorto’s future growth with NGAL. A very important global distribution agreement with one of the largest diagnostic companies in the world, Roche Diagnostics, was signed; we finalized the enrollment of patients for the US clinical study of The NGAL Test™ and are now moving into the final phase of preparing our FDA application which will be submitted shortly. In addition, we took steps to strengthen our team with the addition of Britt Meelby Jensen to the Board of directors, and Ole Larsen as our new CFO – which strengthens our leadership and assures stability and strategic focus for years to come. Allocation of most of BioPortos resources to concluding the FDA trial, establishing a key distribution relationship with Roche and strengthening the BioPorto team did have an adverse effect on our topline this quarter, but we are confident that growth will increase in the quarters to come, as we finalize the FDA application and shift our focus to sales and preparation for the US launch of the approved The NGAL Test™ later this year.”
In connection with the release of the interim report for the first quarter of 2018, BioPorto will host an investor meeting on May 3, 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 firstname.lastname@example.org.