LEIDEN, NETHERLANDS--(Marketwire - Aug 23, 2012) - Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today published its
financial report for the first half year ended June 30, 2012.
FINANCIAL HIGHLIGHTS
-- Revenues and other income increased to EUR1.9 million
(H1 2011: EUR1.4 million)
-- Operating costs from continuing operations increased to EUR12.3 million
(H1 2011: EUR9.1 million). Total net loss from continuing operations
increased to EUR16.6 million (H1 2011: EUR8.6 million) mainly as a
result of non-cash charges, including EUR4.9 million in costs
associated with the December 2011 EUR8.4 million convertible bond,
inventory impairments of EUR2.8 million and impairment charges of
EUR1.2 million in relation to the closure of the US-based cattle
operations
-- Cash outflows from operations decreased to EUR8.2 million (H1 2011:
EUR8.9 million)
-- Cash at the end of the first half year of 2012 decreased to
EUR3.4 million (2011 year end: EUR5.1 million) The negative equity
position of EUR1.2 million at year end 2011 increased to a negative
equity position of EUR8.2 million
-- Post the reporting period (August 1, 2012) the Company announced
it had secured an equity working capital facility with institutional
investors of up to EUR10.0 million for a two year term.
OPERATIONAL HIGHLIGHTS
-- Ongoing pivotal clinical trial for Ruconest® Study 1310, remains
on track and is expected to be completed by the end of the third
quarter of 2012, with the read-out of the top-line results soon
thereafter
-- New agreements signed with Transmedic Pte Ltd. for the
commercialization of Ruconest® inBrunei, Indonesia, Malaysia,
Philippines, Singapore, and Thailand and with Hyupjin Corporation
for the Republic of Korea
-- Commenced an open-label Phase II clinical study evaluating Ruconest®
for the treatment of acute attacks of angioedema in pediatric patients
with HAE
-- Positive study results published in peer-reviewed journal Biodrugs
demonstrated that recombinant human C1 inhibitor was not observed to
have a prothombotic effect when used to treat acute HAE attacks
-- Post the reporting period (August 2, 2012) the Company announced a
strategic restructuring plan of its Dutch operations
Sijmen de Vries, CEO, commented: "The first half of 2012 has been a
challenging
period for Pharming, marked by the unexpected delay in the read out of
Study
1310, as reported in June. However, the proposed restructuring, whilst
regrettable, will allow Pharming to adopt a lean, efficient business model.
We
believe that the new structure, in the context of the current financing
climate
for small cap biotechs, is essential to Pharming's future success .We have
also
recently secured a EUR10 million equity working capital facility which
should
enable us to complete Study 1310 by the end of September and to analyse the
results in the weeks following. In addition we are evaluating additional
financing options going forward. The successful outcome of this study will
trigger a US$10.0 million milestone payment by our partner Santarus,
followed by
a further US$5.0 million on the acceptance of the BLA for review by the US
FDA.
We look forward to updating the market on these events and on our ongoing
discussions with potential partners for our protein pIatform."
FINANCIAL RESULTS
In the six months to June 30, 2012 the Company generated revenue and other
income from continuing operations of EUR1.9 million (H1 2011: EUR1.4
million). This
increase stems from Ruconest® sales of EUR0.8 million (up from EUR0.3
million in H1
2011). Costs of revenues amounted to EUR0.8 million (H1 2011: EUR1.1
million) with
impairments on inventories previously reserved for sales amounting to
EUR2.2
million (H1 2011: nil).
Total operating costs from continuing operations increased by EUR3.2
million from
EUR9.1 million in the first half year of 2011 to EUR12.3 million in the
same period
of 2012. The increase reflects non-cash items such as second quarter 2012
impairment charges related to the US-based cattle platform operations
(EUR1.2
million), impairments on inventories reserved for research and development
activities (EUR0.6 million) and cash related items such as the Company's
activities in relation to Study 1310 required for US regulatory approval
for
Rhucin®. Successful completion of this study will trigger a US$10.0
million
milestone payment by Santarus. In addition, the Company anticipates
submitting a
BLA filing approximately three months thereafter with another US$5.0
million due
from Santarus as and when the U.S. Food and Drug Administration accepts the
BLA
filing for review.
Early in 2012 the Company finalized a transaction announced in December
2011
under which it issued EUR8.4 million convertible bonds plus 38,717,484
warrants.
The bonds had to be repaid in six monthly instalments and could be settled
in
cash and/or in shares. To date the bonds have been fully repaid; all
instalments
plus interest were in shares with the number of shares based on volume
weighted
average price, a reference period minus a discount. With regards to these
pay-
backs in shares, the Company issued a total of 174,925,970 shares until the
end
of the first half of 2012. In addition to results on derivative financial
liabilities, these items largely accounted for a substantially non-cash net
loss
in financial income and expense of EUR3.2 million as compared to a EUR0.2
million
net profit on financial income and expenses in the comparative period of
2011.
As a result of the above items, net loss from continuing operations
increased by
EUR8.0 million to EUR16.6 million in H1 2012 (H1 2011: EUR8.6 million). Due
to a one-
time EUR0.6 million profit on discontinued operations in the first half of
2011,
which followed liquidation and deconsolidation of the DNage business early
in
2011, total net loss increased from EUR8.0 million to EUR16.6 million. The
net loss
per share for the first half year of 2012 amounted to EUR0.03 (H1 2011:
EUR0.02).
FINANCIAL POSITION
Total cash and cash equivalents (including restricted cash) decreased by
EUR1.7
million from EUR5.1 million at year end 2011 to EUR3.4 million at the end
of the
first half year 2012.
As explained in the financial results section, the Company has recently
closed
on an EUR10 million Equity Working Capital Facility and is evaluating
additional
options for financing going forward. In addition, the Company anticipates
receiving US$10.0 million from Santarus upon the successful outcomeof
Ruconest®'s Study 1310 in Q4 2012 and another US$5.0 million as and
when the
U.S. Food and Drug Administration accepts the BLA filing for review.
Receipts of
these milestones and equity financing are expected to significantly improve
the
Company's cash and equity position.
NEGATIVE EQUITY
In December 2011 the Company announced that it had entered negative equity.
This
negative equity position of EUR1.2 million at year end 2011 increased by
EUR7.0
million to EUR8.2 million and mainly reflects the EUR16.6 million net loss
for the
first half year 2012, net of EUR9.4 million posted for shares issued as a
repayment of convertible bonds (EUR9.1 million) and other payments in
shares (EUR0.3
million).
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.
Pharming is continuously reviewing its financial and liquidity position and
has
various options to improve its equity standing under International
Financial
Reporting Standards (IFRS). Notably, the Company reports that the negative
equity position was mainly caused by the inability to recognize the EUR19.7
million upfront payments and milestones received from Sobi and Santarus as
equity (at June 30, 2012 the deferred license fees income amounted to
EUR16.4
million; if release to the statement of income would have been permitted
under
IFRS, the Company would have reported a positive equity position of EUR8.2
million). Anticipated receipt of the two development milestones associated
with
the successful read out of Study 1310 (US$10.0 million) and acceptance of
the
BLA filing by the FDA (US$5.0 million) will, under IFRS, be recognized
immediately and thus augment the equity position.
RUCONEST® Phase III Study
Pharming is conducting a Phase III clinical study with RUCONEST® under
a
Special Protocol Assessment (SPA) that is intended to support the
submission of
a Biologics License Application (BLA) to the U.S. Food and Drug
Administration
(FDA). Ruconest is being evaluated for the treatment of acute attacks of
angioedema in patients with HAE in an international, multicenter,
randomized,
placebo-controlled Phase III study at a dosage strength of 50 U/kg with a
primary endpoint of time to beginning of relief of symptoms. Santarus has
licensed certain exclusive rights from Pharming to commercialize Ruconest
in
North America for the treatment of acute attacks of HAE and other future
indications. Under the terms of the license agreement, a $10 million
milestone
is payable to Pharming upon successful achievement of the primary endpoint
of
the Phase III clinical study. The study is expected to be completed by the
end
of the third quarter of 2012.
About Ruconest® and Hereditary Angioedema
Ruconest® (INN conestat alfa) is a recombinant version of the human
protein C1
inhibitor (C1INH). Ruconest is produced through Pharming's proprietary
technology in the milk of transgenic rabbits and is approved in Europe for
treatment of acute angioedema attacks in patients with HAE. RUCONEST®
is an
investigational drug in the U.S. and has been granted orphan drug
designation
for the treatment of acute attacks of HAE, a genetic disorder in which the
patient is deficient in or lacks a functional plasma protein C1 inhibitor,
resulting in unpredictable and debilitating episodes of intense swelling of
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.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of
unmet
medical needs. Ruconest® is a recombinant human C1 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 (OMX: SOBI). Ruconest® is partnered with Santarus,
Inc
(NASDAQ: SNTS) in North America where the drug is undergoing Phase III
clinical
development. The product is also being evaluated for follow-on indications
in
the areas of transplantation and reperfusion injury. The advanced
technologies
of the Company include innovative and validated platforms for the
production of
protein therapeutics, technology and processes for the purification and
formulation of these products. A feasibility study, using the validated
transgenic rabbit platform, aimed at the development of recombinant Factor
VIII
for the treatment of Haemophilia A is underway with partner, Renova Life,
Inc.
Additional information is available on the Pharming website,
www.pharming.com.
To download the Pharming Group Investor Relations App, click here.
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.
Conference call information
Today, Chief Executive Officer Sijmen de Vries will discuss the first half
2012
results in a conference call for 09:30 am (CET). To participate, please
call one
of the following numbers 10 minutes prior to the call:
From the Netherlands: 31 (0) 45 6316902
From the UK: 44-207-153-2027
The full report including tables can be downloaded from the following link:
Q2 Report 2012:
http://hugin.info/132866/R/1635731/525498.pdf
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(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#1635731]