ABN 96 083 866 862 2/320 Lorimer Street, Port M elbourne VIC...

ABN 96 083 866 862
2/320 Lorimer Street, Port M
elbourne VIC 3207
Tel: +61 3 8681 4050 Fax: +61 3 8681 4099
Results for the Year Ended 30 June 2014
Calzada Ltd today released its financial results for the year ended 30 June 2014. For the period the Group
reported a net operating loss after tax of $2.941m an increase of 96% from the prior year loss of $1.497m.
The increase loss is predominantly attributable to the recognition in FY2013 of the Australian Government’s
research and development incentive for both FY2012 and FY2013, whereas 2014 result only has a single year,s
incentive as income.The change from guidance is a result of the
full expensing of Mr. David Williams options which were approved by shareholders on 1 July 2014. While Mr Williams did not
have his options granted until they were approved by shareholders on 1 July 2014 a ccounting standards require the
full expensing of these options in FY14.
The expense reported in FY14 is consistent with the valuation disclosed in the Notice of Meeting
and is a non -cash transaction.
PolyNovo
The Board announced the commitment to appoint a Managing Director and to increase the number of staff in
PolyNovo in the commercial, clinical, regulatory, quality and manufacturing roles.
These changes and additions
will enhance the prospects of the PolyNovo business by improving speed to market.
Positive developments for the year and key include:
∑
PolyNovo
has received
510(k) clearance for NovoPore
TM
in the US and CE Mark in EU
enabling
PolyNovo to market
NovoPore
TM
in these two large markets
;
∑
The
h
uman trial in burns
and the use
of NovoSorb
TM
under the authorised prescriber scheme c
ontinue to
provide further encouraging evidence of the benefits of the NovoSorb
TM
material in the treatment of 3
rd
degree burns
and surgical wounds
;
∑
The 510(k) submission for surgical wounds will be l
odged in the coming weeks. Once approval is received
from the FDA PolyNovo will have the ability to market NovoSorb
TM
in the USA for surgical wounds which
is a significant step for the business
;
∑
Negotiations continue with a specialist USA device company
to enter into a Licence and Supply
Agreement which will involve milestone payments and a share of royalties for the use of NovoSorb
TM
polymers in products for use in hernia repair
;
∑
The Victorian Government is funding a feasibility study that may lead to a
clinical trial at the highly
regarded Burns Unit at The Alfred
. Should PolyNovo
progress to the
second stage this
trial
will be used to
assist in satisfying
EU and Australian regulatory requirements
for the use of NovoSorb in 3
rd
degree