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
BLA for Ruconest;
* 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
forward.
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.
FINANCIAL RESULTS
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
2013.
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
impairment charges while these amounted to €1.2 million in the same period of
2012.
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 were repayable in cash and/or in
shares in seven installments until 1 October 2013. In the first nine months of
2013, five installments were repaid in shares and one installment in cash. The
seventh installment has been redeemed in cash subsequent to the reporting
period, on 1 October 2013. With regards to these pay-backs in shares, the
Company issued a total of 127,369,529 shares in the first nine months of 2013.
Financial income in the first nine months of 2013 amounts to €0.6 million
compared to €1.7 million in the same period of 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 nine months of 2013
decreased to €11.1 million from €24.2 million in the same period of 2012.
FINANCIAL POSITION
Total cash and cash equivalents (including restricted cash) increased to €13.5
million at 30 September 2013 from €6.3 million at year end 2012. The increase
follows from net cash outflows from operations of €7.1 million with net cash
inflows from financing activities amounting to €14.2 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 September 2013 amounts to €1.6 million, a decrease of €6.2
million compared to 31 December 2012. The decrease is a result of new equity
issues related to the 2013 convertible bonds in the first nine months of 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.
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
Click here to download the full press release
[HUG#1741323]