LEIDEN, NETHERLANDS--(Marketwire - April 26, 2012) - Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today published its
financial report for the first quarter ended March 31, 2012.
FINANCIAL HIGHLIGHTS
* Revenues and other income increased to EUR1.0 million (Q1 2011: EUR0.7
million)
* Operating costs from continuing operations increased to EUR5.2 million
(Q1
2011: EUR4.9 million). Total net loss from continuing operations increased
to
EUR6.5 million (Q1 2011: EUR4.2 million), mainly as a result of the costs
associated with the December 2011 EUR8.4 million convertible bond
* Cash outflows from operations decreased to EUR3.5 million (Q1 2011:
EUR4.5
million)
* Cash increased to EUR8.8 million (2011 year end: EUR5.1 million) The
negative
equity position of EUR1.2 million at year end 2011 increased by EUR2.4
million
to EUR3.6 million
OPERATIONAL HIGHLIGHTS
* The ongoing pivotal clinical trial Study 1310 remains on track and is
expected to readout by the third quarter of 2012
* New agreements signed for the commercialization of Ruconest® with
Transmedic
Pte Ltd. (for the territories of Brunei, Indonesia, Malaysia, Philippines,
Singapore, and Thailand) and 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
Sijmen de Vries, CEO, commented: "The first three months of 2012 has seen
us
delivering on extending the geographical coverage for Pharming's C1
inhibitor
franchise, and this remains a key goal. We are also pleased to report that
recruitment into our ongoing pivotal clinical trial Study 1310 remains on
track
and we look forward to updating on further progress."
FINANCIAL RESULTS
In the three months to March 31, 2012 the Company generated revenue and
other
income from continuing operations of EUR1.0 million (Q1 2011: EUR0.7
million). This
increase comes, in part, from Ruconest® sales of EUR0.4 million (up
from EUR0.15
million in Q1 2011) and increased income from grants of EUR0.1 million.
Costs
associated with the revenues and other income amounted to EUR0.4 million
(Q1
2011: EUR0.1 million).
Total operating costs from continuing operations increased by EUR0.3
million from
EUR4.9 million in the first quarter of 2011 to EUR5.2 million in the same
quarter of
2012. The increase reflects the Company's activities in relation to Study
1310
required for US regulatory approval for Rhucin®. Successful completion
of this
study, which is anticipated to readout by the third quarter of 2012, 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 have to be repaid in six monthly instalments and can be settled
in
cash and/or in shares. To date four of the six payments have been made. If
the
Company elects to pay in shares the instalment amount plus interest is
converted
to a number of shares based on the share price (average of volume weighted
average price over the period and to which a discount is applied). With
regards
to these
pay-backs in shares, the Company issued a total of 67,437,000 shares
until the end of the first quarter of 2012. These items largely accounted
for a
net loss in financial income and expense of EUR1.9 million as compared to a
EUR0.1
million net profit on financial income and expenses in the comparative
quarter
of 2011.
As a result of the above items, net loss from continuing operations
increased by
EUR2.3 million to EUR6.5 million in Q1 2012 (Q1 2011: EUR4.2 million). Due
to a
one-time EUR0.6 million profit on discontinued operations in the first
quarter of
2011, which followed liquidation and deconsolidation of the DNage business
early
in 2011, total net loss increased from EUR3.6 million to EUR6.5 million.
The net
loss per share for the first quarter of both 2011 and 2012 amounted to
EUR0.01.
FINANCIAL POSITION
Total cash and cash equivalents (including restricted cash) increased by
EUR3.7
million from EUR5.1 million at year end 2011 to EUR8.8 million at the end
of the
first quarter 2012.
As explained in the financial results section, the Company anticipates
receiving
US$10.0 million from Santarus upon the successful completion of
Ruconest®'s
Study 1310 in Q3 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 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, as expected,
increased by EUR2.4 million to EUR3.6 million and reflects the EUR6.5
million net loss
for the first quarter, net of EUR4.1 million posted for shares issued as a
repayment of convertible bonds (EUR3.8 million) and other share-based
payments
(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 March 31, 2012 the deferred license fees income amounted to
EUR16.9
million; if release to the statement of income would have been permitted
under
IFRS, the Company would have reported a positive equity position of EUR13.3
million). Anticipated receipt of the two development milestones associated
with
the successful readout 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.
As a result of the negative equity position announced in December 2011, the
Company committed to comply with Euronext Amsterdam Notice 2011-001
paragraph 3
requirements, which include the publication of quarterly financial
statements
within two months after the end of the quarter in compliance with
International
Accounting Standard 34 (Interim Financial Reporting). Therefore, the
condensed
consolidated interim financial statements for the quarter ended March 31,
2012
can be found on Pharming's website as of today.
RHUCIN Phase III Study
Pharming is conducting a Phase III clinical study with RHUCIN 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). RHUCIN 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 RHUCIN 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 third quarter
of
2012.
About RUCONEST® (RHUCIN®) in non-European territories) 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 milk of transgenic rabbits and in Europe is approved under
the
name RUCONESTfor treatment of acute angioedema attacks in patients with
HAE.
RHUCIN® 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® (RHUCIN® in non-European territories) 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). RHUCIN®
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.
The full report including tables can be downloaded from the following link:
Q1 Report 2012:
http://hugin.info/132866/R/1606112/508952.pdf
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#1606112]
