BRUSSELS, BELGIUM--(Marketwire - October 22, 2009) -
* Financial performance in line with expectations
* Strong early roll-out of major new products Cimzia®, Vimpat® and
Neupro®
* Diversification of debt begun with successful offering of EUR 500
million convertible bonds
* Financial outlook 2009 confirmed
Brussels (Belgium), October 22, 2009 - 07:00 (CEST) - regulated
information - UCB announced today its interim report for the first
nine months of 2009.
"While it is still early in the launch roll-out of our major new
products, Cimzia®, Vimpat® and Neupro®, we are pleased with trends in
prescription uptake." said Roch Doliveux, CEO of UCB.
As expected, revenue declined in the first nine months of 2009
compared to the same period in 2008 as a consequence of generic
competition to Keppra® (levetiracetam) in the U.S. This was partially
compensated by the strong performance of Keppra® in Europe which
continued to show double-digit percentage net sales growth and by the
similarly strong growth of Xyzal (levocetirizine) in the U.S. and of
Zyrtec® (cetirizine) in Japan. Net sales of Tussionex® (hydrocodone
polistirex and chlorpheniramine polistirex) declined due to the mild
cough and cold season in the U.S. earlier in the year, while net
sales of Metadate™ CD (methylphenidate) increased.
Prescription data for Cimzia (certolizumab pegol) in the treatment of
Crohn's disease (CD) and rheumatoid arthritis (RA) in the U.S. are
promising with a 20.2%[1] and a 2.9%[2] share respectively of new
prescriptions (NRx) in the subcutaneous anti-TNF market. Progress
with reimbursement in the U.S. is also being made with around 95% of
insured people able to have Cimzia reimbursed for CD, and around 60%
for RA. Cimzia was recently approved in Europe for the treatment of
RA. Patients were treated with Cimzia the following day in Germany
while other European countries are expected to launch in the coming
months.
The new anti-epileptic drug, Vimpat® (lacosamide), available in
Europe since late 2008 and launched in the U.S. in June 2009 as an
add-on therapy for the treatment of partial-onset seizures, continues
to gain market share. At the end of July, more than 15 000 patients
were being treated with Vimpat® in Europe and, at the end of
September, more than 10 000 patients were being treated with Vimpat®
in the U.S. The prescription take-off by Vimpat® in the U.S. exceeds
that of Keppra® and of Keppra XR making it the most successful launch
in the U.S. epilepsy market. In Europe, Vimpat® has just been
launched in France and Spain in addition to Germany, the U.K. and
nine smaller markets. Launches in other European markets will follow
in the coming months, following local pricing reimbursement
approvals.
Since the approval by the European Commission in June 2009 for UCB to
again promote Neupro® for Parkinson's disease, and to launch the drug
for restless legs syndrome, more than 33 000 patients are currently
being treated with the drug in Europe. European neurologists have
welcomed the drug's return and the cold-chain storage and
distribution system is well-accepted. Neupro® is now available in
Germany, Italy, Spain and the U.K. and in nine smaller European
markets for Parkinson's disease. It is launched in Germany and the
U.K. and two smaller European markets for restless legs syndrome.
Launches in other European markets will follow in the coming months.
In the U.S., an extensive update on Neupro® and cold-chain storage
and distribution was submitted to the Food and Drug Administration
(FDA) in June 2009. Dialogue with the FDA continues. UCB expects to
be able to make Neupro® available for U.S. patients again during
2010.
UCB will communicate its view on the sales potential of Cimzia,
Vimpat and Neupro with the publication of its 2009 results on 2 March
2010.
SHAPE
By mid-2009, UCB had completed the implementation of its SHAPE
programme, designed to focus the organisation and its resources on
future product and market opportunities. All targets were either met
or exceeded. The company continues to focus on its core assets, to
look for additional efficiencies, and to optimise its non-core
assets.
Development pipeline
In August 2009, UCB and Immunomedics announced positive top-line
results from UCB's Phase IIb clinical study comparing epratuzumab to
placebo in patients with systemic lupus erythematosus. A Phase III
clinical trial programme is expected to be put in place after
completion of the detailed analysis of the full Phase IIb study data
and after consultation with regulatory authorities in the US and EU.
UCB expects to communicate details of its next steps in the
development of epratuzumab with the publication of its 2009 results
on 2 March, 2010.
Also with the publication of its 2009 results, UCB expects to
communicate its next steps in the development of brivaracetam in
epilepsy and of Vimpat® in diabetic neuropathic pain following
consultation with regulatory authorities in the U.S. and Europe
expected at the end of this year or early next year.
Finance
On 30 September 2009, UCB announced that it had successfully
completed the offering of EUR 500 million senior unsecured
convertible bonds, due 2015. The Bonds will be issued and redeemed at
100% of their principal amount and will have a coupon of 4.5% per
annum, and unless previously converted, repurchased or redeemed will
mature on the sixth anniversary of their issue, in 2015. The initial
conversion price is EUR 38,746 per share and is set at a premium
of 35% to the volume-weighted average price of the Company's shares
on Euronext Brussels from launch to pricing. If all of the Bonds
were to be converted into new shares at the initial conversion
price, 12 904 558 new shares would be issued, representing a dilution
of 6.6% of the Company's share capital. The net proceeds from the
issue of the Bonds will be used by UCB for general corporate purposes
and form part of UCB's diversification of funding.
Outlook 2009
As communicated in July 2009, revenue for the full year 2009 is
expected to reach between EUR 3.1 - 3.3 billion, underlying
profitability (recurring EBITDA) is expected to end the year greater
than EUR 680 million, and net profit as reported is expected to
increase from the previous year to EUR 550 million.
For further information
Richard Simpson, Investor Relations, UCB
T +32.2.559.9494, richard.simpson@ucb.com
Michael Tuck-Sherman, Investor Relations, UCB
T +32.2.559.9712, michael.tuck-sherman@ucb.com
Nancy Nackaerts, External Communications, UCB
M: +32 473 86 44 14, nancy.nackaerts@ucb.com
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company
dedicated to the research, development and commercialization of
innovative medicines with a focus on the fields of central nervous
system and immunology disorders. Employing approximately 10 000
people in over 40 countries, UCB generated revenue of EUR 3.6 billion
in 2008. UCB is listed on Euronext Brussels (symbol: UCB).
Forward-looking statements
This press release contains forward-looking statements based on
current plans, estimates and beliefs of management. Such statements
are subject to risks and uncertainties that may cause actual results
to be materially different from those that may be implied by such
forward-looking statements contained in this press release. Important
factors that could result in such differences include: changes in
general economic, business and competitive conditions, effects of
future judicial decisions, changes in regulation, exchange rate
fluctuations and hiring and retention of its employees.
[1] IMS Xponent weekly prescriptions for CD in U.S., week ending 25
September 2009
[2] IMS National Prescription Audit (NPA) Weekly for RA in U.S., week
ending 9 October 2009
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