US clinical trials for The NGAL Test™ initiated and sales of The NGAL Test™ has grown 42%
In early 2017, following three months of dialog with the authorities, BioPorto finalized the protocol that forms the basis for the regulatory submission of The NGAL Test™ to the Federal Drug Administration (FDA) in the US. The important step was in alignment with the new submission strategy, which was initiated in Summer 2016.
After finalizing the protocol, BioPorto has initiated the clinical trials to generate the data that will support the FDA application for The NGAL Test™.
Clinical trials will be conducted at approximately 20 clinics and hospitals in the US and will involve the recruitment of 530 patients, the first of which was enrolled in the beginning of April 2017.
In cooperation with Siemens, a customized NGAL test was tested and approved for use on the Siemens BN Platforms in February 2017 and launched internally by Siemens in April 2017. This was in accordance with the exclusive, global distribution agreement which was entered into in 2016 between the parties. Siemens has placed their first order and has commenced distribution of the NGAL product.
Sales performance for The NGAL Test™ has grown 42% in first quarter of 2017, driven by a sharp growth of 173% to US clients using the test for Research Use Only purposes, and a 20% growth in the rest of the world, primarily driven by sales to Siemens.
Sales growth of 11% and increased activities related to FDA approval process
BioPorto generated first quarter revenue 2017 of DKK 5.7 million compared to DKK 5.2 million last year, corresponding to a year-over-year growth of 11%. This growth is primarily related to the uptake in sales of The NGAL Test™, but is also positively impacted by the performance of antibody sales and ELISA kits. In the first quarter of 2017, The NGAL Test™ generated revenue of DKK 1.2 million, which is 42% higher than sales in the first quarter of 2016.
In first quarter 2017 BioPorto’s operating loss before interest and tax (EBIT) amounted to DKK 9.3 million compared to a loss of DKK 5.4 million the previous year. Costs have increased substantially due to higher spending on items related to the FDA approval process, establishing a subsidiary in the US in Q1 2016 and introduction of a warrant program. The restructuring effort which BioPorto initiated in the fall of 2016 is still being implemented and will reduce capacity cost by DKK 3.0 million in 2017 and DKK 4.0 million in 2018, once all initiatives are fully implemented.
Guidance for 2017 maintained
Revenue in 2017 is expected to be DKK 25-28 million, equivalent to a growth rate of 20-35%.
EBIT forecast for the financial year 2017 is a loss between DKK 26-29 million, including non-liquidity constraining cost for a recently established warrant program.
Peter M. Eriksen, CEO comments: “In the beginning of 2017, we successfully executed on our new FDA submission plan by completing the pre-submission document and recruiting the first patient into the clinical study for The NGAL Test™ in the US. Furthermore, and very importantly, we have had a strong uptake in the sales of The NGAL Test™, primarily driven by very strong growth in Research Use Only sales in the US, but also a solid increase in the rest of the world. We are well on our way to reaching important strategic milestones set out for 2017, which will bring us closer to the goal of an FDA approval for The NGAL Test™ in 2018, and hence realizing the future value-creation potential of BioPorto."
Investor meeting
In connection with the release of the first quarter results, BioPorto will host an investor meeting on May 4, 2017 at 3 pm. The meeting will be held at Hedeager 2, 8200 Aarhus N, plan 1, north wing, room 22-26. To attend the meeting, please sign up at investor@bioporto.com.
