Summary of Q3 2010
The upscaling phase for the production of the NGAL Test has concluded, and the
product design is finalized. The test was prelaunched for research use in
November 2010 and is currently being validated with a view to registration for
diagnostic use at the beginning of 2011. Product sales have also made good
progress in Q3 2010.
• Revenues increased in Q3 2010 by 33% to DKK 3.52 million (DKK 2.65 million)
for an overall growth rate of 26% in the first three quarters of 2010, compared
to 2009.
• The financial result for Q3 was a loss of DKK -3.31 million (DKK -3.53
million).
• In November, BioPorto was able to prelaunch the NGAL Test, a renal injury
assay which can be used on most fully-automated diagnostic analyzers. Prior to
the final launch for diagnostic use, it will be registered with national drug
agencies, initially in Europe.
• BioPorto has just entered into a non-exclusive global distribution agreement
with Dako A/S, which will be offering the test from January 2011. The agreement
will secure a fast, direct access for the NGAL Test to most of the world
market.
• BioPorto has also continued its collaboration discussions with global
diagnostics companies interested in marketing the renal injury marker for their
own analyzers. Several of the companies have received the NGAL Test for
performing internal validation and adaptation to their respective analyzers.
• In Q3, BioPorto's NGAL cut-off patent was approved for issuance in Australia.
Patent applications are currently pending in a number of countries, including
the US. To follow up on the initial processing of the patent application,
BioPorto has prepared and submitted a reply to the US patent authorities.
• BioPorto carried out a private placement by issuing convertible bonds. The
placement generated gross proceeds of DKK 13.95 million for BioPorto, from
which costs must be deducted.
Forecast for 2010
• BioPorto maintains its forecasts of a growth rate in product sales of 20-30%,
and revenues are expected to be DKK 13-14.5 million.
• BioPorto maintains its forecast of a net loss of DKK -14-15 million for 2010.
• The launch of the homogeneous renal injury assay is carried through and the
company's capital resources are in place. BioPorto's earnings are expected to
be generated primarily by sales of The NGAL Test and not from licensing. In
addition, the field of prospective licensees and the prior expectations to
licensing has narrowed, as BioPorto does not wish to relinquish its rights to
the homogeneous format. For these reasons, the company does not expect large
licensing incomes within the near future and will primarily report on the
registration and distribution of The NGAL Test.
The full report is attached as a file
