Pharming reports on financial results first half year 2013
August 01 2013 - 1:00AM
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 €4.9
million (H1 2012: €1.8 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 €6.3 million (H1
2012: €12.3 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 €5.9
million (H1 2012: €3.2 million), mainly as a result of non-cash
financial costs relating to the new €16.35 million convertible
bond, while the 2012 costs mainly related to the €8.0 million 2012
convertible bond
- The net loss decreased to €7.2 million from €16.6
million for H1 2012
- Net cash outflows from operations decreased to
€7.5 million (H1 2012: €8.2 million) while net cash inflows from
financing activities amounted to €14.8 million (including €16.0
million in relation to 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 first half year of 2013
increased to €13.9 million (2012 FY: €6.3 million). The negative
equity position decreased to €0.6 million from €7.7 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$10 million from
Santarus. I am particularly pleased to note the FDA's acceptance
for review of the BLA for Ruconest®, a pivotal event for Pharming
and one that represents the most significant step to date in our
efforts to obtain marketing approval for Ruconest® in the U.S. I am
also delighted to note the post period announcement of our
strategic collaboration with SIPI in China for the development,
manufacture and commercialisation of new products based on the
Pharming technology platform. This collaboration represents our
first step towards leveraging the Pharming technology platform and,
combined with SIPI's capabilities, will represent an important
source of future products and provides access to the fastest
growing pharmaceutical market in the world; China."
FINANCIAL
RESULTS
In the first half year of 2013,
the Company generated revenue and other income of €4.9 million (H1
2012: €1.8 million). This increase results from the achievement of
a milestone of US$ 5 million from our US partner Santarus for FDA
acceptance for review of our BLA for Ruconest. Product sales in H1
2013 amounted to €0.2 million compared to €0.8 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 € nil in H1 2013 compared to €0.8 million in
H1 2012. In H1 2012, there was an inventory impairment of
€2.2 million, while there were no impairments in H1 2013.
Total operating costs in the the
first half year of 2013 decreased to €6.3 million from €12.3
million in the same period in 2012. Research and development costs
decreased by €4.2 million to €5.0 million in H1 2013 from €9.2
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 €0.5 million to €1.1 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 €1.2 million in H1 2012 operating
costs.
On 16 January 2013, the Company
entered into a 8.5% convertible bond transaction of €16.35 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 €6.5 million. Financial income in H1 2013
amounted to €1.0 million compared to €2.0 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 €7.2 million
from €16.5 million in the same period of 2012.
FINANCIAL
POSITION
Total cash and cash equivalents
(including restricted cash) increased to €13.9 million at 30 June
2013 from €6.3 million at year end 2012. The increase follows from
net cash outflows from operations of €7.5 million with net cash
inflows from financing activities amounting to €14.8 million and
net cash inflows from investing activities amounting to €0.2
million. Financing cash flows mainly result from the 2013 issue of
convertible bonds which raised gross €16.0 million in cash.
NEGATIVE
EQUITY
The Company has negative
equity since December 2011. The negative equity position at 30 June
2013 amounts to €0.6 million, a decrease of €7.1 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,
www.pharming.com.
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.
Contact
Sijmen de Vries, CEO: T: +31 71 524 7400
FTI Consulting
Julia Phillips/ John Dineen, T: +44 (0)207 269 7193
# # #
The full report including tables
can be downloaded from the following link:
Q2 Report 2013
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Source: Pharming Group N.V. via Thomson Reuters ONE
HUG#1720346