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LEIDEN, THE NETHERLANDS--(Marketwired - August 01, 2013) - Leiden, The Netherlands, 1 August
2013. Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today
published its
financial report for the six months ended 30 June 2013.
FINANCIAL HIGHLIGHTS
* Revenues and other income increased to EUR4.9 million (H1 2012: EUR1.8
million),
mainly a result of achieving the milestone of FDA acceptance for review
of
the BLA for Ruconest® which triggered a US$ 5 million payment by
our US
partner Santarus
* Operating costs decreased to EUR6.3 million (H1 2012: EUR12.3 million),
mainly
as a result of the reduction of costs following the 2012 restructuring
and
lower direct project costs regarding Ruconest®
* Financial income and expenses increased to EUR5.9 million (H1 2012:
EUR3.2
million), mainly as a result of non-cash financial costs relating to
the new
EUR16.35 million convertible bond, while the 2012 costs mainly related
to the
EUR8.0 million 2012 convertible bond
* The net loss decreased to EUR7.2 million from EUR16.6 million for H1
2012
* Net cash outflows from operations decreased to EUR7.5 million (H1 2012:
EUR8.2
million) while net cash inflows from financing activities amounted to
EUR14.8
million (including EUR16.0 million in relation to the issue of
convertible
bonds) and net cash inflows from investing activities amounted to
EUR0.2
million received upon transfer of an intangible fixed asset
* Cash at the end of the first half year of 2013 increased to EUR13.9
million
(2012 FY: EUR6.3 million). The negative equity position decreased to
EUR0.6
million from EUR7.7 million at year end 2012
* A reverse share split 10:1 was approved at the EGM of 28 February 2013.
The
total number of shares as of today, 1 August 2013 is 229,042,869.
OPERATIONAL HIGHLIGHTS
* Biologics License Application (BLA) for Ruconest® accepted for
filing by the
US Food and Drug Administration (FDA)
* Santarus and Pharming are seeking U.S. marketing approval of
Ruconest®
for the treatment of acute angioedema attacks in patients with
hereditary angioedema (HAE)
* Santarus and Pharming 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
* On 1 July 2013, the Company announced that it had 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.
Sijmen De Vries, Chief Executive of Pharming commented: "During the
first six
months of 2013 we have continued to build on the positive momentum
experienced
in the closing months of 2012 - during which time we announced positive
top-line
phase III results for Ruconest® in acute HAE and received a related
milestone
payment of US$10 million from Santarus. I am particularly pleased to
note the
FDA's acceptance for review of the BLA for Ruconest®, a pivotal
event for
Pharming and one that represents the most significant step to date
in our
efforts to obtain marketing approval for Ruconest® in the U.S.
I am also
delighted to note the post period announcement of our strategic
collaboration
with SIPI in China for the development, manufacture and commercialisation
of new
products based on the Pharming technology platform. This
collaboration
represents our first step towards leveraging the Pharming technology
platform
and, combined with SIPI's capabilities, will represent an important
source of
future products and provides access to the fastest growing pharmaceutical
market
in the world; China."
FINANCIAL RESULTS
In the first half year of 2013, the Company generated revenue and other
income
of EUR4.9 million (H1 2012: EUR1.8 million). This increase results
from the
achievement of a milestone of US$ 5 million from our US partner Santarus
for FDA
acceptance for review of our BLA for Ruconest. Product sales in H1 2013
amounted
to EUR0.2 million compared to EUR0.8 million in H1 2012. The decline is
due to a
decrease in orders for Ruconest® from our EU partner Swedish Orphan
Biovitrium
(Sobi) which is a reflection of the underlying slow increase in EU sales.
Costs
of revenues amounted to EUR nil in H1 2013 compared to EUR0.8 million in H1
2012. In
H1 2012, there was an inventory impairment of EUR2.2 million, while there
were no
impairments in H1 2013.
Total operating costs in the the first half year of 2013 decreased to
EUR6.3
million from EUR12.3 million in the same period in 2012. Research and
development
costs decreased by EUR4.2 million to EUR5.0 million in H1 2013 from EUR9.2
million H1
2012, which reflects reduced human capital costs following the
restructuring in
2012, as well as lower costs related to Study 1310 as well as other
cost
savings. General and administrative costs decreased by EUR0.5 million
to EUR1.1
million in H1 2013 compared to H1 2012, mainly as a result of the
restructuring
in 2012. In H1 2013, there were no impairment charges while these
amounted to
EUR1.2 million in H1 2012 operating costs.
On 16 January 2013, the Company entered into a 8.5% convertible bond
transaction
of EUR16.35 million convertible bonds plus 16,349,999 warrants that was
approved
at the EGM of 28 February 2013. The bonds are repayable in cash and/or in
shares
in seven installments until 1 October 2013. In the first half year of 2013,
four
installments were repaid in shares. With regards to these pay-backs, the
Company
issued a total of 107,742,342 shares in H1 2013. Total non-cash costs
associated
with these bonds amounted to EUR6.5 million. Financial income in H1 2013
amounted
to EUR1.0 million compared to EUR2.0 million in H1 2012. Financial
income is
non-cash in both periods and is exclusively related to decreases in the
fair value
of derivative financial liabilities.
As a result of the above items, net loss for the first six months of
2013
decreased to EUR7.2 million from EUR16.5 million in the same period of
2012.
FINANCIAL POSITION
Total cash and cash equivalents (including restricted cash) increased to
EUR13.9
million at 30 June 2013 from EUR6.3 million at year end 2012. The increase
follows
from net cash outflows from operations of EUR7.5 million with net cash
inflows
from financing activities amounting to EUR14.8 million and net cash
inflows from
investing activities amounting to EUR0.2 million. Financing cash flows
mainly
result from the 2013 issue of convertible bonds which raised gross EUR16.0
million
in cash.
NEGATIVE EQUITY
The Company has negative equity since December 2011. The negative
equity
position at 30 June 2013 amounts to EUR0.6 million, a decrease of
EUR7.1 million
compared to 31 December 2012. The decrease is a result of new equity
issues
related to the 2013 convertible bonds in H1 2013, partially offset by
the net
loss for the period.
The negative equity position has in itself no immediate impact on the
execution
of Pharming's business plan, nor does it imply that the Company is
legally
required to issue new share capital. However, the Company is considering
various
options in order to reduce the negative equity and return to a positive
equity
position.
Conference call information
Today, Chief Executive Officer Sijmen de Vries will discuss the
financial
results for the first half of 2013 in a conference call at 10:00am
(CET). To
participate, please call one of the following numbers 10 minutes prior
to the
call:
From the Netherlands: 31 (0) 45 631 6902
From the UK: 44 (0) 207 153 2027
(Conference ID: 4634352)
About RUCONEST® and Hereditary Angioedema
RUCONEST (INN conestat alfa) is a recombinant version of the human
protein C1
esterase inhibitor, and is produced with Pharming's proprietary
transgenic
technology. RUCONEST is approved in Europe for the treatment of acute
angioedema
attacks in patients with HAE, a genetic disorder in which the
patient is
deficient in or lacks a functional plasma protein C1 esterase
inhibitor,
resulting in unpredictable and debilitating episodes of intense
swelling. The
swelling may occur in one or more anatomical areas, including the
extremities,
face, trunk, genitals, abdomen and upper airway. The frequency and
severity of
HAE attacks vary and are most serious when they involve laryngeal edema,
which
can close the upper airway and cause death by asphyxiation. According
to the
U.S. Hereditary Angioedema Association, epidemiological estimates for HAE
range
from one in 10,000 to one in 50,000 individuals. RUCONEST is an
investigational
drug in the U.S. and has been granted orphan drug designation by the FDA
both
for the treatment of acute attacks of HAE and for prophylactic treatment of
HAE.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of
unmet
medical needs. RUCONEST® (conestat alfa) is a recombinant human C1
esterase
inhibitor approved for the treatment of angioedema attacks in patients with
HAE
in all 27 EU countries plus Norway, Iceland and Liechtenstein, and is
distributed in the EU by Swedish Orphan Biovitrum. RUCONEST® is
partnered with
Santarus, Inc. (NASDAQ: SNTS) in North America and a Biologics License
Application (BLA) for RUCONEST® is under review by the U.S. Food and
Drug
Administration. The product is also being evaluated for various follow-on
indications. Pharming has a unique GMP compliant, validated platform for
the
production of recombinant human proteins that has proven capable of
producing
industrial volumes of high quality recombinant human protein in a more
economical way compared to current cell based technologies. In July 2013,
the
Platform was partnered with Shanghai Institute for Pharmaceutical Industry
(SIPI), a Sinopharm Company, for joint global development of new products.
Pre-clinical development and manufacturing will take place at SIPI and are
funded by
SIPI. Pharming and SIPI initially plan to utilise this platform for the
development of rhFVIII for the treatment of Haemophilia A. Additional
information is available on the Pharming website, .
This press release contains forward looking statements that involve known
and
unknown risks, uncertainties and other factors, which may cause the actual
results, performance or achievements of the Company to be materially
different
from the results, performance or achievements expressed or implied by these
forward looking statements.
The full report including tables can be downloaded from the following link:
Q2 Report 2013:
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Pharming Group N.V. via Thomson Reuters ONE
[HUG#1720346]
Contact
Sijmen de Vries
CEO
T: +31 71 524 7400
FTI Consulting
Julia Phillips/John Dineen
T: +44 (0)207 269 7193
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