Pharming announces preliminary financial results 2011
(Thomson Reuters ONE) -
Leiden, The Netherlands, March 1, 2012. Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today published its
preliminary (unaudited) financial results for the year ended December 31, 2011.
FINANCIAL HIGHLIGHTS
* Revenues increased to ?3.0 million (2010: ?0.6 million) and include the full
year effect of license fee revenues and product supplies to Sobi
* Operating costs decreased to ?18.2 million (2010: ?25.1 million; ?22.2
million excluding DNage, which was put into voluntary liquidation early
2011)
* Research and development costs decreased to ?13.8 million (2010: ?21.2
million; ?18.3 million excluding DNage) reflecting 2010 inventory
impairments on R&D inventories, the prioritization of R&D expenditure and an
increased focus on cost containment throughout the business
* Net loss decreased significantly to ?17.2 million. 2010 loss (?56.4 million)
impacted by losses incurred with respect to financing activities and the
discontinued DNage business
* Cash outflows from operating activities were ?16.9 million (2010: ?22.9
million; excluding license payments received from Santarus and Sobi of ?19.7
million in total)
* At year-end 2011 cash and cash equivalents (including restricted cash) were
?5.1 million* (2010: ?10.5 million)
*This excludes approximately ?1.1 million to be received from Sobi for Q4 2011 -
Q2 2012 supplies and the ?8.0 million proceeds following the late December 2011
issuance of convertible bonds.
OPERATIONAL HIGHLIGHTS
* Expansion of the geographical coverage off Ruconest(®) through a new
agreement with Megapharm for Israel and an extension of the agreement with
Sobi to include territories in the Balkans, North Africa and the Middle
East
* Study 1310 progresses under a Special Protocol Assessment (SPA) from the
FDA
* Enhancements of the intellectual property portfolio: extension of the
protection of Pharmings Core Technology Platform in the US to 2027; and US
patent granted on Ischemia Reperfusion, covering a method of preventing,
reducing or treating an ischemia and/or reperfusion injury by administering
recombinant C1 inhibitor (Ruconest(®)/ Rhucin(®)). The broad claims in the
patent provide protection until 2028.
* Signing of a service agreement with Renova Life which focuses on the
development of transgenic rabbits to produce recombinant human Factor VIII.
This represents the first step towards potentially unlocking the value
inherent in Pharming's transgenic platform.
(A conference call for analysts and press will be held at 10:00 CET, details
provided below)
Chief Executive Officer of Pharming, Sijmen de Vries, commented: "During the
year we have focused on improving our operational cash burn and have continued
to seek new business development opportunities in new geographies and new
projects. The ability to access capital is a key risk to our business and in
2011, despite difficult market conditions, we were able to identify new sources
of funding, enabling us to bridge the financing gap between the Refusal To File
letter that we received early in 2011 from the US FDA for Rhucin(®) and the
anticipated read-out of our ongoing clinical trial, Study 1310, which continued
with changes requested by the FDA through a SPA agreement. All in all, 2011
proved to be a challenging year, but despite that we were able to strengthen the
foundations for future growth and we look forward to building on this in 2012."
OUTLOOK
The most important activity in the near term continues to be the ongoing pivotal
clinical trial (Study 1310) which is required for US regulatory approval for
Rhucin(®). This study remains on track and we anticipate readout by Q3 2012. If
successful we anticipate submitting a BLA approximately three months thereafter.
These events are associated with large milestones payments which will have a
significant impact on the company's future growth. On successful achievement of
the primary endpoint of the Phase III clinical study, the Company is eligible to
receive a US$10.0 million milestone payment from Santarus and a further US$5.0
million at the acceptance of the BLA by the FDA.
We remain focused on supporting our commercialisation partners in facilitating
the rollout of Ruconest(®) across the licensed territories and look forward to
continued progress over the coming quarters. Discussions are on-going with
several parties regarding the potential commercialisation of Ruconest(®) in
other territories of the world, such as South America, other South-East Asian
countries and Japan. Such deals are important in increasing the geographical
coverage of our Hereditary angioedema (HAE) franchise. In early 2012 we signed
our first distribution partner in South-East Asia (Transmedic Pte) and we hope
to be able to update you on additional deals over the coming quarters.
Following the validation of our transgenic platform with the EU approval of
Ruconest(®), we have received multiple requests regarding the potential
licensing of the platform, and/ or co-development collaborations to produce
complex proteins. These discussions are at an early stage and focus on
significant indications which already have protein therapeutics on the market.
The attractiveness of our platform appears to be its scalability, low upfront
capital investments in manufacturing and its flexibility associated with
manufacturing costs. We do envisage moving forward with new platform projects
with partners and are currently exploring such possibilities. In 2011 we took
the important initial step of signing an agreement with Renova Life to produce
rabbits for the production of recombinant Factor VIII.
In 2011 we prioritized our pipeline and decided to out-license our non-core
programmes. Discussions are ongoing with potential partners for lactoferrin and
fibrinogen.
FINANCIAL RESULTS
Revenues and other income from continuing operations increased to ?3.2 million
(2010: ?1.1 million), largely reflecting a revenue increase from ?0.6 million in
2010 to ?3.0 million in 2011. The revenue increase includes the full year effect
of license fee revenues of ?1.9 million (2010: ?0.5 million) and product
supplies to Sobi of ?1.1 million (2010: ?0.1 million). In 2011 the Company
incurred ?1.7 million inventory impairments related to production issues related
to a one-off event. The Company is investigating various possibilities to fully
recover these costs.
Operating costs from continuing operations excluding cost of sales decreased to
?19.9 million (2010: ?22.2 million). The reduction is mainly a result of
decreasing R&D costs from ?18.3 million in 2010 to ?13.8 million in 2011. This
reflects 2010 impairment charges on R&D inventories, the continued
prioritization of R&D expenditure towards Study 1310, minimal expenditure on
other projects and an increased focus on cost containment in our US business.
Net profit from financial income and expenses in 2011 was ?0.7 million compared
to a net loss in 2010 of ?16.5 million. These items in 2010 were largely driven
by the interest charges and settlement charges of various debts incurred in
2010 and earlier years.
Net loss from continuing operations decreased to ?17.8 million (2010: ?37.7
million). The net profit from discontinued operations in 2011 of ?0.6 million
compared to a net loss from discontinued operations in 2010 of ?18.7 million.
The effects of discontinued operations relate to the liquidation of the DNage
business in early 2011, with 2010 losses largely driven by ?20.7 million (non-
cash) impairment charges on goodwill and intangible assets. The overall net loss
significantly decreased from ?56.4 million in 2010 to ?17.2 million in 2011.
Throughout 2011, the company raised ?3.2 million of new funds through a private
placement and signed a convertible bond financing (?8.0 million gross proceeds)
subject to shareholder approval in 2012 (which has been obtained through an
Extraordinary General Meeting of Shareholders (EGM) held on February 3, 2012).
Year-end cash and cash equivalents (including restricted cash) amounted to ?5.1
million. This amount excludes the cash proceeds from the convertible bond (?8.0
million gross) and ?1.1 million outstanding as part of the Sobi extension
agreement, the former amount having been received in early 2012 and the latter
partially received early 2012 and partially due by end Q2 2012.
Net cash flows used in operating activities increased from ?3.2 million in 2010
to ?16.9 million in 2011. However, cash inflows in 2010 were augmented by one
off upfront and milestone payments paid by Santarus and Sobi of ?19.7 million
and in 2010 payments with respect to the discontinued DNage business of ?2.9
million (2011: nil). Thus, on a comparable basis, operating cash outflows
decreased by ?3.1 million in 2011 compared to 2010.
NEGATIVE EQUITY
In late 2011 the Company announced that it had entered negative equity. The
negative equity position has in itself no immediate impact on the execution of
the Pharming's business plan, nor does it imply that the Company is legally
required to issue new share capital. An EGM was held on February 3, 2012 and the
authorised share capital increased to 805 million shares. Pharming is
continuously reviewing its financial and liquidity position and has various
options to improve its equity standing under International Financial Reporting
Standards (IFRS). Most notably, the Company highlights that the negative equity
position was mainly caused by its inability to recognize the ?19.7 million
upfront payments and milestones received from Sobi and Santarus as equity and
that it expects to receive 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). Under IFRS, Pharming expects to be able to
recognize these milestones immediately and thus augment the equity position.
Pharming will hold its Annual General Meeting of Shareholders on May 14, 2012.
Conference Call Information
Today, Chief Executive Officer, Sijmen de Vries and Chief Financial Officer,
Karl Keegan will present the preliminary full year 2011 results in a conference
call for analysts at 10:00 am CET. To participate, please call one of the
following numbers 10 minutes prior to the call:
Analyst call (Confirmation Code: 4520748)
Participant Telephone Numbers:
From the Netherlands: 08002658611 (toll-free) or 31 (0) 45 6316902
From the UK: 0800-358-0886 (toll-free) or 44-207-153-2027
To view the presentation live during the call, please follow the below link:
http://event.on24.com/r.htm?e=411566&s=1&k=34F366E0488A4DB5E3906183B47930C8
Following a brief presentation of the results, the lines will be opened for a
question and answer session. An audio cast of the conference calls will be
available on Pharming's website shortly thereafter.
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 additional 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. Recently a new
project, using the validated transgenic rabbit platform, aimed at the
development of recombinant Factor VIII for the treatment of Haemophilia A was
initiated was initiated by partner, Renova Life, Inc. 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
Sijmen de Vries, CEO: T: +31 524 7400
Karl Keegan, CFO: T: +31 524 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:
Q4 Report 2011:
http://hugin.info/132866/R/1590352/499595.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#1590352]
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Datum: 01.03.2012 - 07:00 Uhr
Sprache: Deutsch
News-ID 120401
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