Distribution agreement with Siemens Healthcare and continued preparations for roll-out in the USA
In early January 2016, the subsidiary BioPorto Inc. was established in the USA and BioPorto hired the first key employees to the US organi-zation. In preparation to the awaited FDA approval of The NGAL Test™, the new organization has initiated a dialogue with a number of selected hospitals and clinics in the USA regarding the use of The NGAL Test™ for research use.
BioPorto has submitted a reply to the FDA's questions in response to the company's application for approval of The NGAL Test™ for clinical use in the USA. Approval is expected to be achieved in time for the planned launch of the test in the US in Q2 2016.
In the beginning of January 2016, BioPorto entered a distribution agreement with Siemens Healthcare under which BioPorto is to pro-vide an NGAL test adapted for Siemens Healthcare BN II and BN ProSpec Systems. The agreement is expected to have economic effect from the second half of 2016.
An article by BioPorto’s European Advisory Board chaired by Prof. Dr. Jean-Louis Vincent on the suggested use of NGAL in clinical practice, specifically in cardiac surgical procedures, has been accepted into the prestigious American journal The Journal of Thoracic and Cardiovas-cular Surgery. The publication is an important recognition of NGAL as a biomarker of acute kidney injury (AKI) and is estimated to have pro-found implications for the global acceptance and implementation of The NGAL Test™.
The cooperation with the local distributor on the implementation of The NGAL Test™ in South Korea continues. In the first quarter, new users have been added. However, this has no direct impact on BioPor-to's turnover in the first quarter, as the distributor's next order is expected to land in the second quarter of 2016.
Sales growth of 26% and increased costs related to US preparations
BioPorto generated first quarter revenue of DKK 5.2 million compared to DKK 4.1 million in the year-earlier period, corresponding to a growth of 26%. This growth is primarily related to a significant growth in the sales of antibodies, which is up by 51% in the first quarter of 2016 compared to last year. In the first quarter of 2016, the NGAL product portfolio generated revenue of DKK 1.6 million compared to DKK 1.5 million in 2015, of which DKK 0.9 million relates to The NGAL TestTM compared to DKK 0.8 million the previous year.
EBIT amounted to DKK -5.4 million in the first quarter of 2016 com-pared to DKK -4.4 million the previous year. Costs are higher as the result of the establishment of the US subsidiary, increased sales and marketing costs, and the strengthening of the organization. Further-more, in the first quarter of 2016 additional trials for the FDA applica-tion have been conducted.
Guidance for 2016 maintained
Revenue is expected to be DKK 27-30 million in 2016, representing an increase of approximately 30-50%.
EBIT for 2016 is forecast at a loss between DKK 11-13 million. This is an adjustment from an EBIT loss of DKK 7-9 million in connection with the grant of warrants on April 8, 2016, based on an expected account-ing impact of DKK -3.8 million.
Peter M. Eriksen, CEO comments: “In the first quarter, we have delivered solid sales growth across product areas, which I am very pleased with. We continue to execute on our strategic objectives, including our preparations for the launch of The NGAL Test™ in the USA, and we have recently submitted answers to the FDA's questions, meaning we are a step further in the process of approval. The level of activity and investment in the United States is reflected in higher costs, but we are within budget. As announced, we expect the most part of the growth to materialize in the second half of 2016, following an FDA approval and effect of the Siemens collaboration. "
Investor meeting
In connection with the release of the first quarter results, BioPorto hosts an investor meeting on May 4, 2016 at 3 pm. Please note that the meeting is held at Radisson Blu Scandinavia, Margrethepladsen 1 in Aarhus. Please sign up at investor@bioporto.com.
For further information, please contact:
Peter Mørch Eriksen, CEO
Christina Thomsen, Investor Relations Manager
Tel: +45 4529 0000
E-mail: investor@bioporto.com
See the full report in the attached pdf
