Pharming reports financial results first quarter 2012
(Thomson Reuters ONE) -
Leiden, The Netherlands, 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 ?1.0 million (Q1 2011: ?0.7 million)
* Operating costs from continuing operations increased to ?5.2 million (Q1
2011: ?4.9 million). Total net loss from continuing operations increased to
?6.5 million (Q1 2011: ?4.2 million), mainly as a result of the costs
associated with the December 2011 ?8.4 million convertible bond
* Cash outflows from operations decreased to ?3.5 million (Q1 2011: ?4.5
million)
* Cash increased to ?8.8 million (2011 year end: ?5.1 million) The negative
equity position of ?1.2 million at year end 2011 increased by ?2.4 million
to ?3.6 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 ?1.0 million (Q1 2011: ?0.7 million). This
increase comes, in part, from Ruconest® sales of ?0.4 million (up from ?0.15
million in Q1 2011) and increased income from grants of ?0.1 million. Costs
associated with the revenues and other income amounted to ?0.4 million (Q1
2011: ?0.1 million).
Total operating costs from continuing operations increased by ?0.3 million from
?4.9 million in the first quarter of 2011 to ?5.2 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 ?8.4 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 ?1.9 million as compared to a ?0.1
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
?2.3 million to ?6.5 million in Q1 2012 (Q1 2011: ?4.2 million). Due to a one-
time ?0.6 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 ?3.6 million to ?6.5 million. The net
loss per share for the first quarter of both 2011 and 2012 amounted to ?0.01.
FINANCIAL POSITION
Total cash and cash equivalents (including restricted cash) increased by ?3.7
million from ?5.1 million at year end 2011 to ?8.8 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 ?1.2 million at year end 2011, as expected,
increased by ?2.4 million to ?3.6 million and reflects the ?6.5 million net loss
for the first quarter, net of ?4.1 million posted for shares issued as a
repayment of convertible bonds (?3.8 million) and other share-based payments
(?0.3 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 ?19.7
million upfront payments and milestones received from Sobi and Santarus as
equity (at March 31, 2012 the deferred license fees income amounted to ?16.9
million; if release to the statement of income would have been permitted under
IFRS, the Company would have reported a positive equity position of ?13.3
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.
Contact
Sijmen de Vries, CEO: T: +31 (0)71 524 7400
Karl Keegan, CFO: T: +31 (0)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:
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]
Unternehmensinformation / Kurzprofil:
Datum: 26.04.2012 - 07:00 Uhr
Sprache: Deutsch
News-ID 139385
Anzahl Zeichen: 12850
contact information:
Town:
Leiden
Kategorie:
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