Pharming announces nine month financial report 2010
(Thomson Reuters ONE) -
Leiden, The Netherlands, October 21, 2010. Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today published its
financial report for the nine month period ended September 30, 2010.
Financial Highlights first nine months
* Income from grants and license fees for the nine month period of ?0.7
million (9M 2009: ?0.5 million)
* Received US$15.0 million (?11.7 million) upfront payment from Santarus for
the commercialization of Rhucin® in North America
* Received ? 3.0 million upfront payment from SOBI for commercialization of
Ruconest in the EU
* Significant decrease in operating cash outflows (?3.4 million in first nine
months of this year compared to ?18.4 million in the same period 2009)
* Operating loss of ?18.3 million (9M 2009: ?21.0 million)
* Cash at September 30, 2010 of ?17.0 million
* Bondholders converted all of the ?7.5 million bonds issued in January 2010
Operational Highlights in third quarter
* Agreement entered with Santarus for the commercialization of Rhucin in North
America
* Signed manufacturing agreement with Sanofi Chimie for the drug substance of
Ruconest(TM)
* Dr Karl Keegan joined the Company as Chief Financial Officer (CFO)
* Intention to submit BLA to the FDA to obtain US marketing approval for
Rhucin announced
* Spin off of DNage successfully completed
Subsequent to September 30, 2010
* Shareholders approved appointment Dr Keegan as CFO and member of Pharming's
Management Board
* Shareholders also approved increase of the authorized share capital at
Company's EGM
* Published peer reviewed randomized clinical trial results with recombinant
human C1 esterase inhibitor in Journal of Allergy and Clinical Immunology
* Anticipated exercise of the put option by the 2007 public bondholders to
repay the remaining outstanding 2007 convertible bonds per 31 October 2010
was confirmed
Sijmen de Vries, CEO, commented: "The first nine months of 2010 have been an
important period for Pharming, during which we have consistently delivered on
our stated targets of progressing our lead asset through the requisite
developmental and regulatory pathways and maintaining tight control of our cost
base. We believe that the progress we have made during the period is an
endorsement of management's strategic focus. We look forward to working with our
marketing partners towards the first commercial launch of our lead program, an
historic point in Pharming's history and an important step towards bringing the
Company to financial stability."
Financial Highlights first nine months
Pharming's income from grants and license fees were ?0.7 million for the nine
month period ended September 30, 2010. In the same period of 2009, Pharming
recognized ?0.5 million.
Operating loss decreased to ?18.3 million from the ?21.0 million recorded for
the corresponding period in 2009. The decrease is mainly a result of timing of
(pre)clinical and regulatory activities, our continued strong focus on cost
savings and control, as well as the implementation of a strategic focus of our
business resulting in the spin out of DNage. In the nine month period, operating
losses attributable to DNage were approximately ?2.0 million compared to ?2.8
million in the first three quarters of 2009. General and administrative costs
remained broadly constant but R&D expenses declined by ?4.5 million in the nine
month period 2010 compared to the corresponding period in 2009.
In the nine month period to September 30, 2010, Pharming recorded a net loss of
?34.6 million compared to a net loss of ?23.1 million for the same period in
2009. The vast majority of this loss was attributable to financing measures and
their consequences that were triggered by financing activities during 2010. The
net loss per share was ?0.15 for the first nine months of 2010 compared to ?0.22
in the first nine months of 2009. At the end of the period, the number of shares
outstanding was 358,800,199 compared to 120,850,520 at the end of the
corresponding period in 2009.
The increase in the current number shares by 3,018,702 from 355,781,497 on
September 2, 2010 results from 2,171,117 shares in relation to exercise of
cashless warrants and 847,585 shares issued to the Board of Management and
various employees in settlement of bonuses due.
Pharming ended the nine month period with a cash position of ?17.0 million,
compared to a ?10.6 million cash balance on September 30, 2009 and ?2.3 million
on December 31, 2009.
Pharming has recorded a significant decrease in operating cash outflows (?3.4
million in first nine months of this year compared to ?18.4 million in the same
period 2009). This achievement is primarily related to the receipt of upfront
cash payments from SOBI and Santarus. The US$15.0 million (?11.7 million) non
refundable and non off-settable upfront payment from Santarus is detailed in the
consolidated statement of cash flows for the third quarter. The ?3.0 million
upfront from SOBI was recognized similarly in Q2 2010. In accordance with
International Financial Reporting Standards, Pharming will recognize these
upfront payments in the consolidated statement of income from Q4 2010 onwards as
the amount received spread evenly over a period of approximately 10 years.
Operational Highlights in third quarter
Pharming entered into an agreement with specialty biopharmaceutical company
Santarus, Inc for the commercialization of Rhucin in North America (the United
States, Canada and Mexico) for the treatment of acute attacks in HAE patients
and other future indications.
Pharming signed a manufacturing agreement with Sanofi Chimie, wholly owned
subsidiary of sanofi-aventis to increase the production capacity of the drug
substance of Ruconest. This will improve Ruconest cost of goods and
competitiveness and will put Pharming in the position to satisfy future global
demand.
Pharming announced that it intends to submit the Biologic License Application to
the FDA to obtain marketing approval for Rhucin for the treatment of acute
angioedema attacks in patients with HAE. Following pre-BLA discussions with the
FDA, Pharming is preparing the BLA dossier for submission towards the end of
this year but no later than January 2011.
The spin off of DNage was completed and all earn-out liabilities due by Pharming
to former DNage shareholders were fully settled.
Subsequent to September 30, 2010
Dr Karl Keegan was appointed to the role of CFO and member of Pharming's Board
of Management. Also, the increase of the authorized share capital from 400
million to 500 million shares was confirmed. These decisions were taken by the
Shareholders at an Extraordinary General Meeting held on 1 October 2010.
The publication of the integrated analysis of Pharming's randomized placebo-
controlled clinical trials with recombinant human C1 esterase inhibitor for
treatment of acute angioedema attacks in HAE patients in the October issue of
the peer-reviewed Journal of Allergy and Clinical Immunology.
The anticipated exercise of the put option by the 2007 public bondholders to
repay the remaining outstanding 2007 convertible bonds per October, 31, 2010 was
confirmed.
Outlook Q4 2010 and beyond
Ruconest in Europe
Following the positive opinion on the Marketing Authorization Application for
Ruconest earlier this year, Pharming is anticipating the Market Authorization by
the European Commission within the next few weeks. As stated previously, the
main focus in Q4 2010 will continue to be on the market launch of Ruconest,
which is on track. This pivotal event in Pharming's evolution will be marked by
an associated milestone payment from SOBI upon European Market Authorization.
DNage
We have performed an impairment review on the intangible assets and goodwill
capitalized with respect to DNage, which as previously announced is seeking
additional funding through a combination of investors and government support.
Given that these financing activities are ongoing and given the uncertainty on
the valuation ascribed to DNage by third party investors in any such financing,
we have impaired the carrying value of goodwill associated with DNage in the
balance sheet. This leads us to include a non cash impairment charge in the Q3
2010 financial statements.
Finances
As announced to the market, the Company has received confirmation of the put
option from the bond holders. Thus, repayment of the remaining outstanding 2007
convertible bonds in cash and accrued interest (?11.3 million on aggregate) will
occur by October 31, 2010. Pharming anticipates further cost savings from
finalizing regulatory EU and US submission activities, co-funding development of
rhC1INH for additional indications and further streamlining of the organization.
List of used abbreviations and terms
BLA Biological License Application
DNage DNage BV (Pharming has 51% stake)
EGM Extraordinary General Meeting of Shareholders held on 1 October
2010
FDA US Food and Drug Administration
HAE Hereditary Angioedema
rhC1INH Pharming's recombinant human C1 esterase inhibitor
Registered name in non-European countries for recombinant human C1
Rhucin® esterase inhibitor or rhC1INH for treatment of acute attacks of
HAE
Ruconest(TM) Trademark for European marketing of recombinant human C1 inhibitor
for treatment of acute attacks of HAE
Sanofi Chimie Wholly owned subsidiary of sanofi-aventis (NYSE Euronext: SAN,
NYSE: SNY)
Santarus Specialty biopharmaceutical company Santarus, Inc (NASDAQ: SNTS)
SOBI Specialty pharmaceutical company Swedish Orphan Biovitrum (STO:
BVT)
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of genetic
disorders, specialty products for surgical indications, and nutritional
products. On June 24, the European Medicines Agency adopted a positive opinion
for Ruconest(TM) (Rhucin® in non-EU territories) for the treatment of angioedema
attacks. Market Authorization in the European Economic Area is therefore
expected imminently with an anticipated market launch in the fourth quarter
2010. The product is also under development for follow-on indications, i.e.
antibody-mediated rejection (AMR) and delayed graft function (DGF) following
kidney transplantation. The advanced technologies of the Company include
innovative platforms for the production of protein therapeutics, technology and
processes for the purification and formulation of these products. 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:
Marjolein van Helmond, T: +31 (0)71 52 47 431 or +31 (0)6 109 299 54
The full report including tables can be downloaded from the following link:
[HUG#1453716]
Q3 Report 2010:
http://hugin.info/132866/R/1453716/394269.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
Unternehmensinformation / Kurzprofil:
Datum: 21.10.2010 - 07:00 Uhr
Sprache: Deutsch
News-ID 45968
Anzahl Zeichen: 0
contact information:
Town:
Leiden
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 223 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Pharming announces nine month financial report 2010"
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).
