Full Press Release Details
LEIDEN, Netherlands, Nov. 7, 2013 (GLOBE NEWSWIRE) --
Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today published its
financial report for the first nine months of 2013.
FINANCIAL HIGHLIGHTS
* Revenues and other income increased to 6.0 million (9M 2012: 2.4 million),
mainly as a result of a US$ 5 million ( 3.8 million) milestone payment by
our US partner Santarus on the receipt of FDA acceptance for review of the
* Operating costs from continuing operations decreased to 9.3 million (9M
2012: 17.9 million), driven by reductions following the 2012 restructuring
and lowering of project costs regarding Ruconest ;
* Financial income and expenses increased to 7.4 million (9M 2012: 5.5
million), primarily as a result of non-cash financial costs relating to the
January 2013 16.35 million convertible bond (2012 costs mainly related to
the 8.0 million 2012 convertible bond);
* The net loss decreased to 11.1 million (9M 2012 24.2 million), including
the 7.4 million (9M 2012: 5.5 million) of net financing loss;
* Net cash outflows from operations decreased to 7.1 million (9M 2012: 11.6
million) while net cash inflows from financing activities amounted to 14.2
million (including 16.0 million from the issue of convertible bonds) and
net cash inflows from investing activities amounted to 0.2 million received
upon transfer of an intangible fixed asset;
* Cash at the end of the third quarter of 2013 amounted to 13.5 million (2012
FY: 6.3 million). The negative equity position decreased to 1.6 million
from 7.7 million at year end 2012;
* Post events: On 1 October, the Company re-deeemed the final tranche ( 2.35
million) of the January 2013 Convertible Bond in cash. On 9 October the
Company announced a 12.0 million private placement with institutional
investors. As a result of this private placement, Pharming's equity position
has become positive again for the first time since December 2011;
* A reverse share split 10:1 was approved at the EGM of 28 February 2013. The
total number of shares as of today, 7 November 2013 is 332,434,319.
OPERATIONAL HIGHLIGHTS
* Biologics License Application (BLA) for RUCONEST was filed and subsequently
accepted by the US Food and Drug Administration (FDA)
* Pharming and Santarus are seeking U.S. marketing approval of RUCONEST
for the treatment of acute angioedema attacks in patients with
hereditary angioedema (HAE);
* Pharming and Santarus were recently informed by the FDA that an Advisory
Committee is not likely to be required as part of the RUCONEST review;
* Pharming and Santarus expect the FDA will complete its review or
otherwise respond to the RUCONEST BLA by 16 April 2014.
* European Medicines Agency (EMA) provided approval for Sanofi Chimie,
Pharming's Contract Manufacturing Organization partner, to manufacture drug
substance for Pharming's product RUCONEST at their Aramon (France) site,
completing an important up-scaling of the production capacity that will
allow for future significant economies of scale.
* New data from a pivotal Phase III clinical study (Study 1310) of RUCONEST
for the treatment of acute angioedema attacks in patients with hereditary
angioedema (HAE) featured in a poster presentation at the European Academy
of Allergy and Clinical Immunology (EAACI) & World Allergy Organization
(WAO) World Allergy & Asthma Congress in Milan, Italy.
* Results of a study demonstrating that RUCONEST has been shown to have a
beneficial effect as a donor pre-treatment therapy in an animal model of
kidney transplantation was presented at the American Transplant Congress in
Seattle, Washington.
* The Company entered into a strategic collaboration in China with Shanghai
Institute of Pharmaceutical Industry (SIPI), a Sinopharm Company, for the
development, manufacture and commercialisation of new products at SIPI,
funded by SIPI upto IND stage, based on the Pharming technology platform. In
addition, Pharming has also granted SIPI an exclusive license to
commercialise RUCONEST (conestat alfa) in China.
* For HAE prophylaxis, we submitted, under our investigational new drug
application, a protocol to the FDA with a request for a special protocol
assessment, or SPA. The FDA has indicated that modifications to the
protocol are needed before proceeding with the study and further discussions
will be required in order for the protocol to be approved pursuant to the
SPA process. We and Santarus are evaluating next steps to move the program
Sijmen De Vries, Chief Executive of Pharming commented: "During the third
quarter we have continued to build on the positive momentum experienced in the
first six months of 2013; momentum which allowed us to further strengthen our
balance sheet through a successful 12.0 million private placement with
institutional investors, completed directly after closing of the third quarter.
This was an important event for Pharming: as well as strengthening of our
balance sheet, the placement demonstrated the continued support of our existing
institutional shareholders as well providing new institutional shareholders with
the opportunity to take a position in Pharming. Significantly, the private
placing occurred after we fully redeemed the January 2013 Convertible Bond.
Together with our US partner Santarus, our team continues to work on the ongoing
FDA review of RUCONEST and in this context we are pleased to note today that
the FDA has recently informed us that an Advisory Committee is not likely to be
required as part of the RUCONEST review.
In the nine months to 30 September 2013 the Company generated revenue and other
income of 6.0 million (9M 2012: 2.4 million). This increase results from a
license fee following achievement of the US$ 5 million milestone from our US
partner Santarus for FDA acceptance for review of our BLA for Ruconest. Product
sales in the nine months of 2013 amounted to 0.6 million, of which 0.4 million
came in during the third quarter ( 0.8 million 9M 2012). Costs of revenues
amounted to 0.4 million in the first nine months of 2013 compared to 0.8
million in the same period of 2012. In the first nine months of 2012, there was
an inventory impairment of 2.3 million, while there were no impairments in
Total operating costs in the first nine months of 2013 decreased to 9.3 million
from 17.9 million in the same period in 2012. Research and development costs
decreased by 6.7 million to 7.4 million in the first nine months of 2013 from
14.1 million in the same period of 2012, which reflects reduced human capital
costs following the restructuring in 2012, as well as lower costs related to
clinical study 1310 and other cost savings. General and administrative costs
decreased by 0.7 million to 1.6 million in the first nine months of 2013
compared to the first nine months of 2012, mainly as a result of the
restructuring in 2012. In the first nine months of 2013, there were no