May 9, 2019
Announcement no. 6
Q1 2019 Report
Highlights
FDA application processes for The NGAL Test™ on schedule
In the first quarter of 2019 BioPorto focused intensively on driving our clinical studies and preparation of U.S. regulatory applications for two indications for The NGAL Test™ with the U.S. Food and Drug Administration (FDA); one for risk prediction of AKI in children using a urine sample, and one for use in adults based on plasma.
The pediatric application (for children under the age of 21) based on a retrospective set of urine samples, is expected to be finalized and submitted before end of June 2019 – in alignment with our plan.
Also in accordance to plan, BioPorto has in first quarter 2019 commenced the enrollment of additional patients in the clinical study for the FDA application for The NGAL Test for use in adults. The final application for this indication is expected to be submitted to the FDA later in 2019, with clearance - subject to timing of the FDA process - expected in the second half of 2019.
U.S. organization further strengthened
In the first quarter of 2019 BioPorto has expanded its U.S. sales force to broaden its customer base among cardiac and kidney transplant centers and accelerate the momentum of awareness building of the NGAL biomarker and of Research Use Only (RUO) sales. Furthermore, Amy Winslow has been engaged as President for the U.S. subsidiary BioPorto Diagnostics Inc. to strengthen management and sales focus in the organization.
Revenue affected by strong focus on strategic execution in beginning of 2019
In the first quarter of 2019 BioPorto grew revenue by 20% to DKK 5.5 million compared to DKK 4.6 million last year. Continued focus on RUO sales has doubled revenues from The NGAL Test in the U.S. and sales of antibodies are positively affected by higher bulk orders.
BioPorto’s operating loss before interest and tax (EBIT) for the first three months of 2019 was DKK 17.1 million compared to a loss of DKK 12.5 million last year in the same period. The increase in the loss is primarily related to the full year effect of 2018 hires as well as increased spend on external consultants and lawyers.
Sales and EBIT guidance for 2019 maintained
Based on the results of the three months of 2019, BioPorto maintains its latest guidance for the financial year 2019. Revenue in 2019 is expected to total approximately DKK 40 million, corresponding to a growth rate of 50% over 2018. BioPorto expects to incur an operating loss (EBIT) of approximately DKK 45 million with a cash impact of DKK 41 million.
Peter M. Eriksen, CEO comments: “BioPorto is off to a good start in 2019. We have maintained the U.S. growth momentum in the Research Use Only sales of The NGAL Test, increasing revenues of the test in the leading global market more than 100% year-on-year. We have expanded our U.S. sales organization and attracted important competencies which will become very valuable as we continue to build awareness of the test prior to FDA clearance. Additionally, we are on-track with both the urinary study for the FDA application in children under 21 and enrollment of patients for the adult study in plasma. I am optimistic about the progress and status made thus far and look forward to advancing these programs during the remainder of the year – a year that will be pivotal for the prospects of AKI patients, health care systems and BioPorto as we move towards submissions and hopefully clearance of the U.S. NGAL applications.”
Investor meeting
In connection with the release of the interim report for the first three months of 2019, BioPorto will host an investor meeting on May 9, 2019 at 3:00 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.
For further information, please contact:
Ole Larsen, CFO
Telephone +45 4529 0000, 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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