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Interim Report, Second Quarter 2018, BioPorto Group
August 16, 2018
Announcement no. 14
BioPorto submits application to the FDA for clinical use of The NGAL Test™ in the US
BioPorto completed the clinical studies for The NGAL Test™ in the second quarter of 2018 and has in July submitted the final application to the US Food and Drug Administration, (“FDA”), for regulatory clearance of The NGAL Test™.
Submitting the application based on comprehensive clinical studies and data, which in BioPorto’s and its partners’ view supports the case of using NGAL in relation to acute kidney injury (“AKI”) in ICU populations to rule out and support prediction of AKI, is a major milestone for the company.
Assuming a standard review process from the FDA, a decision regarding clearance of the application could be expected in the second half of 2018. If successful, BioPorto will commercialize The NGAL Test™ by late-2018 or early 2019.
Growth in second quarter based on solid performance by The NGAL Test™
BioPorto’s revenue in the second quarter of 2018 was DKK 7.1 million, an increase of 8% over the second quarter 2017, driven by solid growth of 38% in sales of The NGAL Test™ and an uptake in the sales of the MBL ELISA product. Revenue from antibodies remains affected by the postponement of recurring bulk orders from the first half of 2018 to the second half of the year.
BioPorto’s operating loss before interest and tax (EBIT) for the second quarter of 2018 was DKK 10.0 million compared to DKK 8.4 million in second quarter 2017. For the first six months of 2018, BioPorto reported an EBIT loss of DKK 22.4 million compared to a loss of DKK 17.7 million last year in the same period. The development is primarily driven by higher research and development costs associated with the US clinical study.
Establishing awareness of NGAL through practitioners and leading organizations within kidney disease
BioPorto spent significant time and resources on increasing knowledge and awareness around NGAL through various means such as Grand Round presentations by physicians in the US, meetings with the US National Kidney Foundation, and working with KDIGO, an organization developing and implementing evidence-based clinical practice guidelines in kidney disease, with the intent of getting NGAL into future guidelines. These activities will continue.
Strategic and financial review
BioPorto has initiated a strategic review to assess the potential of the company’s technology platform, market reach and clinical development. This process includes an evaluation of organizational and capital resources required to secure strong momentum in sales and expansion into other indications to broaden the product portfolio.
Outlook for 2018 revised
Based on the results of the first 6 months of 2018, BioPorto is changing its revenue guidance for the financial year 2018 to approximately DKK 30 million. The revised revenue guidance corresponds to a revenue growth of 19% over 2017.
EBIT guidance for the financial year 2018 is maintained and forecasted to be a loss in the range DKK 32-37 million.
Peter M. Eriksen, CEO comments: “Resources and efforts in the second quarter have strongly focused on finalizing and submitting the US application for The NGAL Test™ to the FDA. We succeeded with this important milestone in July after thoroughly testing and analyzing the clinical data obtained from more than 500 patient cases conducted by 17 leading US hospitals. We also spent considerable resources establishing awareness for the test in the US by engaging with leading health care practitioners and important public and private organizations. It has been very encouraging to witness the strong support for NGAL as a biomarker for acute kidney injury, and I expect that the continued efforts in these areas together with our strategic sales initiatives will provide a solid commercial foundation for The NGAL Test™, subject to clearance from the FDA.”
In connection with the release of the interim report for the first half of 2018, BioPorto will host an investor meeting on August 16, 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.
Peter M. Eriksen, CEO
Gry Husby Larsen, GC
Tel. no. (+45) 45 29 00 00, e-mail email@example.com
See full report below: