Pharming reports on financial results first half year 2012
(Thomson Reuters ONE) -
Leiden, The Netherlands, August 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 ?1.9 million (H1 2011: ?1.4 million)
* Operating costs from continuing operations increased to ?12.3 million (H1
2011: ?9.1 million). Total net loss from continuing operations increased to
?16.6 million (H1 2011: ?8.6 million) mainly as a result of non-cash
charges, including ?4.9 million in costs associated with the December 2011
?8.4 million convertible bond, inventory impairments of ?2.8 million and
impairment charges of ?1.2 million in relation to the closure of the US-
based cattle operations
* Cash outflows from operations decreased to ?8.2 million (H1 2011: ?8.9
million)
* Cash at the end of the first half year of 2012 decreased to ?3.4 million
(2011 year end: ?5.1 million) The negative equity position of ?1.2 million
at year end 2011 increased to a negative equity position of ?8.2 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 ?10.0 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 ?10 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 ?1.9 million (H1 2011: ?1.4 million). This
increase stems from Ruconest® sales of ?0.8 million (up from ?0.3 million in H1
2011). Costs of revenues amounted to ?0.8 million (H1 2011: ?1.1 million) with
impairments on inventories previously reserved for sales amounting to ?2.2
million (H1 2011: nil).
Total operating costs from continuing operations increased by ?3.2 million from
?9.1 million in the first half year of 2011 to ?12.3 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 (?1.2
million), impairments on inventories reserved for research and development
activities (?0.6 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 ?8.4 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 ?3.2 million as compared to a ?0.2 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
?8.0 million to ?16.6 million in H1 2012 (H1 2011: ?8.6 million). Due to a one-
time ?0.6 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 ?8.0 million to ?16.6 million. The net loss
per share for the first half year of 2012 amounted to ?0.03 (H1 2011: ?0.02).
FINANCIAL POSITION
Total cash and cash equivalents (including restricted cash) decreased by ?1.7
million from ?5.1 million at year end 2011 to ?3.4 million at the end of the
first half year 2012.
As explained in the financial results section, the Company has recently closed
on an ?10 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 ?1.2 million at year end 2011 increased by ?7.0
million to ?8.2 million and mainly reflects the ?16.6 million net loss for the
first half year 2012, net of ?9.4 million posted for shares issued as a
repayment of convertible bonds (?9.1 million) and other payments in shares (?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 June 30, 2012 the deferred license fees income amounted to ?16.4
million; if release to the statement of income would have been permitted under
IFRS, the Company would have reported a positive equity position of ?8.2
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.
Contact
Sijmen de Vries, CEO: T: +31 (0)71 524 7400
FTI Consulting
Julia Phillips/ John Dineen, T: +44 (0)207 269 7193
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
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#1635731]
Unternehmensinformation / Kurzprofil:
Datum: 23.08.2012 - 07:00 Uhr
Sprache: Deutsch
News-ID 176980
Anzahl Zeichen: 14349
contact information:
Town:
Leiden
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 191 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Pharming reports on financial results first half year 2012"
steht unter der journalistisch-redaktionellen Verantwortung von
Pharming Group N.V. (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
