UCB: Delivering for patients through innovation
(Thomson Reuters ONE) -
Statement of the CEO of UCB at the AGM
· For 2009: Dividend +4% of EUR 0.96 gross (EUR 0.72 net) per share
· Outlook 2010:
o Top priority is the continued launch and growth of Cimzia(®), Vimpat(®) and
Neupro(®) around the world
o Financials: revenue of approx. EUR 3.0 billion, recurring EBITDA of approx.
EUR 700 million, Core earnings per share of approx. EUR 1.76
· All resolutions passed the Annual General Meeting
Brussels (Belgium), April 29, 2010 - Today, UCB held its Annual General Meeting
(AGM). During the course of this meeting Roch Doliveux, Chief Executive Officer
UCB, gave the shareholders of UCB an overview of the financial year 2009 and the
interim report for the first three months of 2010.
"2009 was a pivotal year, marking a new stage in the implementation of our
strategy and opening up the way for a new phase of growth. The transformation of
UCB into a leading patient-centric bio-pharmaceutical company is coming closer
to reality with every day that passes. Our strategic priority to focus on
serious diseases of the central nervous system and immunology disorders not only
enables us to use our resources effectively but, above all, to build a global
reputation for expertise in these fields of science. With the successful launch
of three new drugs in the crucial US and/or European markets, we are improving
quality of life for a considerable number of people and, at the dawn of a new
decade, paving the way for a promising level of growth.
Before outlining UCB's plans for 2010, I would like to look back at the
achievements of the past year and our financial and operating results.
2009: A key year
The last 18 months will be remembered as an exceptional time for UCB in terms of
product approvals and launches. In the United States and/or Europe (two regions
that represent 80% of the global market), we obtained approval for Cimzia®,
Vimpat® and Neupro®, the three drugs at the core of our strategy for future
growth. Once these approvals were obtained, our teams worked tirelessly to
market these drugs within the tightest deadlines, sometimes in barely two hours,
as was the case for Cimzia® in Germany. Results of this kind would not be
possible without the effort and commitment of all my colleagues at UCB, and I
would like to offer my heartfelt thanks to them all for what they have achieved.
Their performance is even more remarkable because it was achieved in a context
of continuous change, involving a refocus of our activities, organisational
changes and strict cost management. In spite of the difficulties often
experienced, our teams maintained their levels of efficiency and determination.
They proved their capacity to react promptly and overcome any obstacles, and the
Executive Committee is extremely grateful to them for that.
Financial results
UCB's financial performance for 2009 was in line with expectations. UCB achieved
revenues of 3.1 billion Euros, down by 13% on the 3.6 billion figure achieved in
2008. The loss of exclusivity for Keppra® and Zyrtec(®) in the United States,
competition from generic products in this market and our divestments in smaller
emerging markets are the main reasons behind this reduction in turnover. This
was partially compensated by growth for Keppra(® )in Europe and in major
emerging markets.
In 2009, UCB showed underlying profitability, recurring EBITDA, of 698 million
Euros, 5% down on the previous year, but a solid financial performance
nevertheless, in line with our expectations and above market expectations. We
have largely absorbed the loss of ?473 million of income due to competition from
generic versions of Keppra® in the United States by reducing operational costs
through the refocusing of activity on our core areas.
As anticipated, we felt the full impact of the expiry of the patents of Zyrtec®
and Keppra® in the United States end 2007 and end 2008 respectively. This
resulted in a loss of nearly 800 million Euros in terms of operating income
before non-recurring items. Nearly all of this impact has been absorbed. Our
operating income before non-recurring items went from 480 million Euros in 2007
to 453 million Euros in 2009.
Finally, our net result went from 42 million Euros in 2008 to 513 million Euros
in 2009. This is due to the positive impact of non-recurring gains from the
disposals of non-strategic assets, more than compensating the negative impact of
non-recurring charges for restructuring and refinancing the debt.
Given that UCB's dividend policy continues to be based on the company's
potential for long-term growth, and not on short-term fluctuations in results,
the Board of Directors is proposing a gross dividend of 0.96 Euros per share,
which is 4% up on 2008.
These financial results are a healthy basis from which to go forward, equipping
us for sustainable growth. At the dawn of a new decade, we believe that UCB is
in a good position to face competition on the bio-pharmaceuticals market. While
our competitors will have to cope with the expiry of major patents over the next
few years, UCB has already overcome most of these challenges, even if we still
have to deal with some losses of exclusivity for Xyzal(®) and Keppra(® )in
Europe, which will keep growth in check throughout 2010 and 2011. Once we have
overcome this particular hurdle, we are forecasting strong company growth
through the new products of Cimzia®, Vimpat® and Neupro®, with no further major
loss of exclusivity or patents in the near future.
Products and pipeline
The key feature of 2009 was the approval and market launch of our three new
flagship products: Cimzia®, Vimpat® and Neupro®.
We obtained market authorisations for Cimzia®, indicated for rheumatoid
arthritis (RA) in adults, in May 2009 in the United States and October 2009 in
Europe. Progress made with this drug is promising, and by the end of 2009 over
9,200 patients had already been treated with Cimzia® for RA. The double benefits
of Cimzia(®) with its fast mode of action and prolonged efficacy is being
increasingly recognised by patients, prescribers and payers. Since begin January
2010, the average growth of Cimzia(® )is significantly bigger than any of our
competitors. We made administration easier with an innovative practical
injection device, perfected by and with patients in partnership with OXO®.
Global sales of Cimzia® reached 75 million Euros in 2009, and are showing strong
continued growth. Based on our forecasts, peak sales of Cimzia® should reach in
excess of 1.5 billion Euros in the second half of the decade.
The second core element of our strategy, Vimpat®, was launched in the United
States for the treatment of epilepsy in June 2009. We launched the product a few
days later. In Europe, where Vimpat® was approved in September 2008, the drug
was available in 11 countries by the end of 2009.
We are delighted to report that Vimpat® is showing excellent results, in line
with the best-performing anti-epileptic drug ever launched in the USA in terms
of number of prescriptions at the same point in time of launch. By the end
of 2009, 46,000 patients were already benefiting from Vimpat®, and sales reached
46 million Euros in 2009. Based on our forecasts, Vimpat® should achieve peak
sales in excess of 1.2 billion Euros in the second half of the decade.
Finally, since June 2009, Neupro® is now available again in Europe for the
treatment of Parkinson's disease and restless legs syndrome. By the end of 2009,
53,000 patients had been treated with Neupro®, compared with 30,000 in June when
we were authorised to re-launch the product. Sales of Neupro® reached
61 million Euros in 2009 and are continuing to rise.
Neupro® should achieve peak sales in excess of 400 million Euros in the second
half of the decade. The recommendation on Neupro(®) made by the FDA that the
product needs to be reformulated before being relaunched on the U.S. market,
although disappointing, does not change our faith in the product nor does it
change the sales estimates that we have made. We remain convinced that Neupro(®
)can contribute significantly to the lives of people living with Parkinson's
disease and restless legs syndrome and we are doing all that we can to make this
medication available again to these people in the U.S.
Besides launching them, UCB intends to maximise the benefits of these products
by studying their potential for application in other therapeutic indications
and increasing sales by obtaining authorisations in other major markets. We are
also continuing to build on the potential of older products that have already
proved their worth. Keppra(®) for example, a key product in the treatment of
epilepsy, is still generating double digit sales growth across Europe. In
September 2009, Keppra(®) was approved in Europe as an adjunctive treatment for
partial seizures in infants and young children under the age of four. In Europe,
Keppra(®) is increasingly used as a single treatment, or monotherapy.
However, promising beginnings for our new drugs should not make us lose sight of
the importance of continuing to develop and invest in our pipeline. Around 22%
of revenue is invested in research and development.
Our aim is to continue accelerating research in our key areas, namely the
central nervous system and immunology disorders. We shall focus research on
patients and their unmet needs. Our goal is to enable the greatest possible
number of patients to live as normal an everyday life as possible.
With this in mind, Dr Ismail Kola has joined the UCB management team as Head of
UCB NewMedicines(TM), our unit responsible for drug discovery to proof of
concept. Ismail has an impressive experience in pharmaceutical research. He has
been at UCB for some months now, and has already given new impetus to our
research teams. Two new molecules have moved into Phase 1 clinical research in
recent months (UCB2892, CDP7657).
It is with Dr. Kola and his team that we are continuing to develop our open
innovation model. This model looks to actively encourage the use our internal
expertise as basis for the development of external partnerships primarily with
universities - we already have more than 150 collaboration projects underway
with these institutions - among them the University of Liége and the University
of Leuven - and with biotech companies. Current industry partnerships include
Wilex, Germany and Biogen Idec, US.
In terms of clinical development, we made major progress in 2009, particularly
with a new antibody (epratuzumab) for the treatment of systemic lupus
erythematosus. The Phase IIb dosage study has been successfully completed. In
addition to this, the successful completion of Phase I together with our
strategic partner Amgen has enabled us to move a new antibody (anti-sclerostin)
for the treatment of bone loss disorders into Phase II. Trials are focused on
the treatment of post-menopausal osteoporosis and fracture healing.
UCB has completed two phase III clinical trials on the effectiveness of a new
treatment for epilepsy (brivaracetam). One of these trials brought proof of a
significant reduction in the frequency of seizures. After analysing the results
and consulting with opinion leaders and regulatory bodies, we plan to start an
additional phase III study to confirm the drug's effectiveness.
Finally, based on research that we have conducted with Cimzia(® )into Crohn's
disease, we have decided to continue our development work in the field of
inflammatory bowel disease, particularly chronic ulcerative colitis, an area of
major medical need not currently addressed.
Cimzia(®) is also being developed in two other important new indications:
ankylosing spondylitis and psoriatic arthritis.
As well as these developments with our new medicines UCB also succeeded in the
full refinancing and the diversification of its debts in 2009. This
diversification has allowed us to spread our new repayments more evenly and in
line with our expected cash-flow over the coming years.
Together with this, our focus on the severe conditions has also been accompanied
by a refocusing of our efforts on to the important markets of today and
tomorrow, essentially North America, Europe and Asia (including China, Japan,
Korea and India). Along with this we have divested a number of mature UCB
products in non-strategic markets as well as other non-strategic products.
People
Everything that we achieved in 2009, be it drug launches, sales of mature
products,research and development, refinancing, new partnerships, the change of
our strategic focus could not have been done without the determination and
commitment of the staff at UCB.
Even in difficult times, and there were quite a few in 2009, they continue to
commit themselves with passion, flexibility and perseverance.
UCB's transformation is not happening magically. The SHAPE programme and other
necessary organisational changes that we have made over the past two years have
had a considerable impact on staff. At the end of 2009, UCB employed 9,324
people which is approximately a quarter less than at the start of the programme.
We set up a job centre 'relais emploi' to help the people affected to retrain
for other jobs, and we are delighted to report that, so far, more than 70% of
them have already found work or are starting new careers.
In spite of such changes and challenges, we are happy to report that the
determination of UCB's teams remains strong, as demonstrated by an annual survey
carried out among over 1,000 of our management staff. This helps us to continue
to consider ways in which we can improve how we manage and train our teams,
enabling them to develop and flourish in their work.
Finally, we can also proudly state that our business culture, focused as it is
on the patient, is a driving force behind our teams, who are increasingly
applying the advantages this focus brings in their work each day. And it is not
only the patients we are able to help, it is also those who continue to suffer,
that provide a great source of inspiration to all who work at UCB.
2010
So, what can we hope for in 2010?
This year follows on logically from what has already been achieved. We now have
to build on the foundations laid. Our top priority will, of course, be to
continue marketing Cimzia®, Vimpat® and Neupro® around the world and support
their growth. Early sales are very encouraging, confirming that we made the
right decision. Continuous development of new generation therapies and feeding
our product 'pipeline' will also remain a core focus in 2010. We are still
planning to make a considerable investment in developing staff potential, which
has always been a priority for UCB. In other domains, strict control of
efficiency and costs will continue.
From a financial point of view, we believe that total revenue is expected to
reach approximately 3 billion Euros in 2010. This reflects full annualised
generic erosion of Keppra(®) in the U.S and the loss of exclusivity for
Keppra(®) in the E.U. in the second half of 2010, impacts by the divestitures
made early 2009 and further erosion of mature products. These impacts should be
partially offset by the growth of the newly launched products Cimzia(®),
Vimpat(®) and Neupro(®).
In 2010, UCB's recurring EBITDA is expected to reach approximately EUR 700
million.
Core EPS 2010 are expected to reach approximately EUR 1.76 versus EUR 1.74 in
2009 (based on EUR 180 million non-diluted shares).
Finally, I would like to emphasise that all our achievements, be they
commercial, scientific or human, are part of a clear and ambitious long-term
strategy that has been consistent since 2004. They all strive towards the same
objective, namely to make a difference to patients facing a serious disease, and
to the people close to them.
2009 was a major milestone for UCB. The way is now open to us for future growth,
and we can go into this new decade with great confidence, energy and ambition.
In conclusion, I would like to thank the Board of Directors and shareholders for
their support, encouragement and commitment in the continued development of
UCB."
At the Ordinary Annual General Meeting (AGM) 109,028,033 shares (60.51% of
shares outstanding) were represented. For details please see UCB's website
www.ucb.com/investors/calendar.asp
The AGM approved for the fiscal year 2009 the payment of a gross dividend of EUR
0.96 per share (net dividend of EUR 0.72 per share) compared with EUR 0.92 per
share for 2007 (net EUR 0.69). The dividend will be payable on 6 May 2010
(coupon No. 12).
The AGM re-elected Roch Doliveux as Director and Peter Fellner as an Independent
Director. The AGM appointed Alexandre Van Damme as a new Director and Bert De
Graeve, as a new independent Director. For curriculum vitae of the Board
members, please see UCB's website www.ucb.com/investors/governance.asp
The Annual Report 2009 of UCB is published on the internet:
www.ucb.com/investors/financials/annual-reports.asp
An interim report on the first three months has been published today, the
financial results for the first half year 2010 will be announced on 2 August
2010 and an interim report for the first nine months of 2010 is due on 21
October 2010. Next year's AGM will be held on Thursday 28 April 2011 at 11:00 am
in Brussels (Belgium).
For further information
Antje Witte, Corporate Communications & Investor Relations, UCB
T +32.2.559.9414,antje.witte(at)ucb.com
Nancy Nackaerts, External Communications, UCB
T +32 473 86 44 14, nancy.nackaerts(at)ucb.com
About UCB
UCB, Brussels, Belgium (www.ucb.com
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 9 000 people in
over 40 countries, UCB generated revenue of EUR 3.1 billion in 2009. UCB is
listed on Euronext Brussels (symbol: UCB).
Forward looking statement
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.
For the pdf-version of this press release, please click on the link below:
[HUG#1410241]
Press Release (PDF): http://hugin.info/133973/R/1410241/362803.pdf
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Datum: 29.04.2010 - 18:40 Uhr
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