BioPorto is currently conducting a clinical study to get The NGAL Test™ for diagnosis of Acute Kidney Injury approved in the USA.
60% of patients enrolled for U.S. clinical study by end of October
BioPorto Diagnostics A/S is currently conducting a clinical study to get The NGAL Test™ for diagnosis of Acute Kidney Injury (AKI) approved in the USA.
Since commencement of the clinical study in April 2017, BioPorto has enrolled more than 60% of the 530 patients that will make up the total number of patients in the study and generate the data for BioPorto’s US registration application for The NGAL Test™.
BioPorto is on schedule for establishing the data for its US registration application for The NGAL Test™.
BioPorto expects to conclude the enrolment of patients late-2017 or early- 2018, and submit its registration application to the FDA in Q1 2018.
Momentum in revenue growth sustained in third quarter 2017
The strong sales momentum, which BioPorto exhibited in the first half of 2017, continued into the third quarter of the financial year where total revenue was DKK 6.0 million – an increase of 30 % compared to same quarter last year. This brought total revenue for the first nine months of 2017 to DKK 18.3 million corresponding to a year-over-year growth rate of 27%.
As previously indicated this year, the primary drivers of growth in the third quarter were a strong performance in sales of The NGAL Test™, which doubled to DKK 0.9 million, and a solid sales performance in antibodies leading to an increase in revenue from DKK 2.1 million last year to DKK 3.3 million this year.
Year-to-date, sales of The NGAL Test™ has increased from DKK 2.3 million to DKK 4.2 million, a very solid growth of 84%, largely attributable to the introduction of Research Use Only sales in the US causing revenue to increase by 388% year-over-year in the period. Revenue from The NGAL Test™ in the EU and the rest of the world has also been performing well with a growth rate of 33% in the first nine months of 2017 compared to the same period in 2016.
BioPorto’s operating loss before interest and tax (EBIT) for the first nine months of 2017 was DKK 28.3 million compared to a loss of DKK 20.3 million last year in the same period. The increase in the loss is primarily related to higher spending on the US clinical study and increased spending on the US subsidiary.
Successful private placement with proceeds of DKK 41.7 million to prepare for US roll-out
To support the ongoing uptrend in sales, prepare for a commercial US roll-out after FDA approval and strengthen the company’s overall liquidity, BioPorto initiated a private placement cash issue on October 27, 2017. In an oversubscribed offering, 13,015,625 new shares corresponding to 9.13 % of the registered shares prior to the implementation of the issue were offered at a price of DKK 3.20 per share to a limited number of selected investors. The private placement yielded gross proceeds of DKK 41.7 million which has been added to BioPorto’s cash position.
Sales and EBIT guidance for 2017 maintained
Revenue in 2017 is expected to be in the range DKK 26-28 million, equivalent to a growth rate of 25-35%.
EBIT forecast for the financial year 2017 is maintained at a loss between DKK 28 - 35 million.
Peter M. Eriksen, CEO comments: “With yet another quarter of high growth, BioPorto continues along the strong execution path we set out on earlier this year. US sales of The NGAL Test™ in the first nine months of 2017 has almost quadrupled compared to last year and ROW sales are up 33 %. And our antibody-business also continues to exhibit strong momentum with a hike of 31% from last year to this year. Meanwhile, we have enrolled more than 60% of the patients for our clinical study in the US, which means that we are on-track for handing in our FDA-application for The NGAL Test™ next year. With an oversubscribed private placement of shares in October this year and net proceeds of DKK 41.0 million, BioPorto is in excellent shape to prepare and execute an optimal commercial US roll-out of The NGAL Test™ once FDA approval has been obtained.”
Investor meeting
In connection with the release of the interim report for the first nine months of 2017, BioPorto will host an investor meeting on November 7, 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.
For further information, please contact:
Gry Husby Larsen, General Counsel
Peter Mørch Eriksen, CEO
Telephone +45 4529 0000, e-mail investor@bioporto.com
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.
