Interim report, second quarter of 2017

US Clinical study commencing according to announced plan

BioPorto commenced the recruitment of 530 patients for its US clinical study of The NGAL Test™ in April 2017 and concluded the enrolment of 19 participating hospitals and clinics in second quarter 2017. By early August 2017, more than 25 % of all patients have been recruited to the study which will form the data leading to BioPorto's FDA application for registration of The NGAL Test™ in the US. The recruitment is progressing per the announced plan.

In an article published in 'The open British Medical Journal', data collected from BioPorto's multicentre prospective US study in 2015 demonstrated high specificity and very high accuracy. For EDTA plasma the sensitivity was 84% and specificity was 73.5% with a cut-off of 148.3 ng/mL. The data, which confirmed that NGAL with great confidence can predict moderate to severe Acute Kidney Imjury (AKI), has provided a very strong basis for BioPorto's new study underway to support the FDA registration application for The NGAL Test™.

Improved clinical and economic outcomes with the use of NGAL

Furthermore, in an article submitted to POS Medical Journal in May 2017 by a group of international experts, it was concluded that the combination of NGAL and serum creatinine for the diagnosis of AKI reduced overall treatment cost per patient by 10-15% compared to only using serum creatinine. A conclusion, which supports both the clinical and the economical argument of incorporating NGAL in diagnosis and treatment of AKI.

Strong sales development for The NGAL Test™ in second quarter 2017

BioPorto has experienced record high revenue in the first half of 2017 driven by strong performance of The NGAL Test™.

BioPorto's total revenue grew 42% in the second quarter 2017 to DKK 6.6 million and totalled DKK 12.4 million for the first six months of 2017.  This was the best half year result in BioPorto's history, corresponding to a growth of 26% year-over-year. Growth was primarily driven by strong performance by The NGAL Test™, both in the US and rest of the world, followed by a hike in revenues from antibodies.

Strong sales of The NGAL Test™ in the first quarter 2017 was further accelerated in the second quarter of 2017 and reached a record high of DKK 2.0 million - a year-over-year increase of 115% and quarter-over-quarter increase of 64%. In total, sales of the The NGAL Test™ in the first half of 2017 reached DKK 3.3 million corresponding to a growth of 80% year-over-year, driven by increased Research Use Only sales in the US, which was up more than 250% compared to same period last year.

In first half of 2017 BioPorto's operating loss before interest and tax (EBIT) amounted to DKK 17.7 million compared to a loss of DKK 13.2 million the previous year. Costs have increased substantially due to higher spending on US clinical studies and operating costs for the US subsidiary.

Options on future financing being evaluated

Based on the current strong momentum in sales and the on-track pending FDA approval process for The NGAL Test™, BioPorto has initiated a process of evaluating options for raising additional capital to support the uptrend in sales and prepare for a commercial US roll-out after FDA approval has been obtained as expected in 2018.

Sales guidance for 2017 adjusted after strong first half of 2017. EBIT guidance adjusted

Revenue in 2017 is adjusted from DKK 25-28 million to DKK 26-28 million, equivalent to a growth rate of 25-35%.

EBIT forecast for the financial year 2017 is adjusted from a loss between DKK 26-29 million to a loss of DKK 28 - 35 million, including non-liquidity constraining cost for a recently established warrant program. The adjustment is mainly due to timing of recognition of cost in connection with the on-going FDA-study, as cost will be brought forward from 2018 to 2017.

Peter M. Eriksen, CEO comments: "I am very pleased with our performance in the first half of 2017, which is the best sales performance in BioPorto's history. A strong sales execution of The NGAL Test™ in the first quarter of 2017 was followed by an even stronger second quarter, where growth in the US was +300% and growth in rest of the world was 60%. We are encouraged to see the clinical and economic evidence build for the importance of NGAL in diagnosing and treating Acute Kidney Injury while we have commenced recruitment of patients for our clinical study in the US. We continue to be on-track for all strategic key parameters planned for the year. Indeed, a very satisfactory mid-term status confirming our direction and focus for BioPorto."

Investor meeting

In connection with the release of the interim report for the first half of 2017, BioPorto will host an investor meeting on August 10, 2017 at 3 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.  

Further details from:

Peter Mørch Eriksen, CEO

Gry Husby Larsen, General Counsel

Phone 45 29 00 00, mail investor@bioporto.com

The kidney biomarker NGAL

Every year about 13 million people are struck by acute kidney injury worldwide, of whom about 4 million die. Nevertheless, there has been no real progress in methods of diagnosing kidney injury over the last half century. Existing methods, such as serum creatinine determination, only signal kidney failure 24-72 hours after the injury has taken place. In contrast, NGAL rises to diagnostic levels within a few hours of kidney injury and thus enables the physician to make vital clinical decisions before the damage progresses to potentially fatal renal shutdown. In addition to helping the patient, cost-benefit analyses show that implementing NGAL testing will contribute to reducing hospital costs in the management of kidney injury and its consequences.

About BioPorto

BioPorto Diagnostics A/S is an in-vitro diagnostics company that provides healthcare professionals in clinical and research settings a range of diagnostic tests and antibodies. Our pioneering product portfolio includes assays for underserved disease states such as NGAL for acute kidney injury. We sell our products in more than 80 countries through diverse sales channels and partners. BioPorto has its headquarters in Copenhagen, Denmark and is listed on the NASDAQ Copenhagen stock exchange.

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10 announcement - 2017 08 10.pdf