Actelion announces second quarter 2010 financial results
Actelion Pharmaceuticals Ltd / Actelion announces second quarter 2010 financial results processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Product sales of CHF 483.4 million, up 13 percent in local currencies - Total
net revenues of CHF 523.2 million - Non-GAAP EBIT of CHF 207.4 million -
Upgraded earnings guidance - Continued progress in PAH franchise - Option
acquired on late-stage compound in Amyotrophic Lateral Sclerosis (ALS) -
Clazosentan Phase III results in October 2010 - Macitentan PAH Phase III results
by end-2011 - Multiple other Phase II compounds advancing
ALLSCHWIL/BASEL, SWITZERLAND - 20 July 2010 - Actelion Ltd (SIX: ATLN) today
announced financial results for the second quarter 2010.
In CHF Million | Results | Results | % Variance | % Variance
(except for per share data) | Q2 2010 | Q2 2009 | In CHF | In LC
-----------------------------+---------+---------+------------+------------
Net Revenues | 523.2 | 449.6 | 16 | 18
-----------------------------+---------+---------+------------+------------
Non-GAAP OPEX | 315.8 | 291.3 | 8 | 8
-----------------------------+---------+---------+------------+------------
Non-GAAP EBIT | 207.4 | 158.3 | 31 | 35
-----------------------------+---------+---------+------------+------------
Diluted EPS - Non-GAAP | 1.36 | 1.26 | 8 | 12
-----------------------------+---------+---------+------------+------------
Diluted EPS - US GAAP | 1.00 | 0.95 | 5 | 9
As of 30 June 2010, Actelion had cash, cash equivalents and marketable
securities of CHF 1.3 billion. In addition, Actelion holds 10.3 million treasury
shares.
Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "In
2010 Actelion continues to successfully implement its long-term strategy. We are
advancing our existing product sales, we are moving forward with our preclinical
and clinical development compounds and we are complementing our in-house efforts
with external opportunities."
In a separate media release, Actelion announced today that it has obtained, for
EUR 10 million, an option to acquire privately-held Trophos SA, a clinical stage
pharmaceutical company. Located in Marseille/France, Trophos' lead compound
olesoxime is currently in a Phase III program in Amyotrophic Lateral Sclerosis
(ALS), also known as Lou Gehrig's disease.
This study is expected to report data by the end of 2011, at which time Actelion
may exercise the option for an acquisition price between EUR 125 and 195 million
in cash, contingent on different regulatory approvals and other clinical
progress of Trophos' pipeline. In a drug discovery collaboration, Actelion and
Trophos will also further explore the novel therapeutic approach pioneered by
olesoxime.
Andrew J. Oakley, Chief Financial Officer of Actelion commented: "Our strong
operational performance - further detailed in our 2010 Half Year Report - allows
me to re-affirm previous company full year 2010 guidance of total net revenue
growth in local currencies of above 10 percent. Unforeseen events excluded, I
now expect Non-GAAP EBIT growth - on a local currency basis - to be between 21
and 24 percent for 2010, up from close to 20 percent as previously guided. In
addition to near-term performance, our organization has been further geared so
as to continue operational leverage gains."
Revenue performance
Product sales for the second quarter of 2010 were CHF 483.4 million (Q2 2009 CHF
433.8 million), an increase of 13 percent in local currencies with 47 percent
coming from the United States, 36 percent from Europe and 17 percent from the
rest of the world. Product sales growth was mostly driven by patient demand.
Sales in the second quarter of 2010 of Tracleer(®) (bosentan) increased by 12
percent in local currencies and reached CHF 430.1 million compared to CHF 387.1
million for the same period in 2009.
During the second quarter of 2010, Ventavis(®) (iloprost) had sales in the
United States of CHF 34.2 million compared to CHF 34.6 million in the second
quarter of 2009, essentially flat in local currencies.
Actelion's fourth product, epoprostenol for injection, a parenteral prostacyclin
formulation providing the efficacy of epoprostenol with an increased stability
at room temperature without the use of ice packs, was launched in April 2010.
Sales of this product in the second quarter amounted to CHF 0.2 million.
Otto Schwarz, President of Business Operations of Actelion commented:
"Tracleer(®) continues as the treatment of choice for first-line therapy in PAH
due to a combination of proven efficacy and treatment experience. Ventavis(®)
performed very well despite new competition in the space of inhaled prostacylins
as our increased strength formulation is well received by patients. I am also
encouraged by the initial positive feedback from physicians on our improved
formulation of intravenous epoprostenol. This is very promising for future
uptake of our third PAH franchise product."
Sales of Zavesca(®) (miglustat) for the second quarter of 2010 increased by 62
percent in local currencies to reach CHF 18.9 million compared to CHF 12.1
million during the same period last year.
Otto Schwarz concluded: "Zavesca(®) is growing very well in GD1 disease in
Europe and the US as well in the NP-C indication in Europe. Additional approvals
for Zavesca(®) in
NP-C in Australia, New Zealand and most recently in Columbia and Turkey are
giving further access to patients suffering with this devastating disease. In
the United States we are currently reviewing how to move forward following a
complete response letter and subsequent discussions with the FDA."
Contract revenues for the second quarter of 2010 were CHF 39.8 million compared
to CHF 15.8 million in the second quarter of 2009. The increase was driven by
the accelerated recognition of milestones from the selective S1P(1) receptor
agonist collaboration with Roche. As of mid-June these milestones were fully
recognized.
Operating expenses
Total operating expenses for the second quarter of 2010 were CHF 359.8 million
compared to CHF 328.4 million for the same period in 2009, an increase of 10
percent. The increase was driven by ongoing investments into both R&D as well as
to further expand the use of our marketed products.
Research and Development (R&D) expenses in the second quarter of 2010 were CHF
117.1 million compared to CHF 113.7 million in the second quarter of 2009.
Non-GAAP R&D expenses for the second quarter of 2010, which excludes stock-based
compensation expense and amortization and depreciation, were CHF 102.3 million
compared to CHF 100.6 million in the second quarter of 2009.
Selling, General and Administrative expenses (SG&A) for the second quarter of
2010 were CHF 178.8 million compared to CHF 160.8 million in the second quarter
of 2009. Non-GAAP SG&A expenses for the second quarter of 2010, which excludes
stock-based compensation expense and amortization and depreciation, were CHF
160.5 million compared to CHF 144.7 million in the second quarter of 2009.
Operating income
Operating income for the second quarter of 2010 was CHF 163.4 million compared
to CHF 121.2 million for the same period in 2009, an increase of 40 percent in
local currencies.
In order to better reflect the company's profitability, Actelion continues to
report non-GAAP EBIT, which excludes employee stock options, amortization and
depreciation as well as other one-off charges that distort comparison.
Non-GAAP EBIT for the second quarter of 2010 was CHF 207.4 million, an increase
of 35 percent in local currencies compared to the same period last year.
Net income
Net income for the period includes interest income of CHF 0.8 million, interest
expense of CHF 2.0 million, amortization of debt discount of CHF 4.6 million,
other financial expense of CHF 20.7 million as well as an income tax expense of
CHF 15.4 million.
Net income for the second quarter of 2010 amounted to CHF 121.4 million compared
to CHF 116.2 million during the second quarter of 2009.
US-GAAP earnings per share on a fully diluted basis in the second quarter of
2010 increased by 5 percent to CHF 1.00 compared to the same period a year ago.
Non-GAAP earnings per share on a fully diluted basis increased by 8 percent to
CHF 1.36.
Andrew J. Oakley commented: "Our strong operational performance is not reflected
in our earnings per share, with currency fluctuations at the end of Q2 2010
adversely impacting our financial income line in the form of non-cash valuation
losses on outstanding intercompany receivables."
Update on Actelion's Research and Development efforts
At the end of June 2010 Actelion was developing 10 different compounds in its
clinical pipeline with around 25 active projects in drug discovery: four
compounds were in Phase III. First results from one of these advanced programs -
clazosentan in aneurysmal subarachnoid hemorrhage (aSAH) - are expected in
October 2010.
Jean-Paul Clozel commented: "Actelion is proceeding with confidence; the company
has built the franchise in PAH and will continue to lead the way with its
expertise in the field. The addition of an improved formulation of epoprostenol
to our portfolio and the rapidly progressing development of new PAH compounds,
macitentan and selexipag, are all important steps toward a strong PAH franchise
for years to come."
Jean-Paul Clozel concluded: "Actelion will become an even stronger company when
we benefit from the multiple additional opportunities offered by our innovative
pipeline."
At the end of June 2010, the status of the most advanced Actelion R&D projects
were:
Clazosentan in aSAH: Clazosentan is investigated in the pivotal Phase III study
CONSCIOUS-2 in more than 1,150 patients with aSAH and treated with aneurysmal
surgical clipping. The study will measure the clinical benefits of clazosentan
through the primary endpoint of vasospasm-related morbidity and all-cause
mortality.
Actelion expects to obtain study results in October this year. If positive,
Actelion is planning to approach health authorities for filing.
A second global Phase III study with clazosentan, CONSCIOUS-3, is enrolling
patients whose aSAH was treated by endovascular coiling.
Macitentan in PAH: Macitentan is investigated in the Phase III study SERAPHIN.
The study is designed to evaluate the efficacy and safety of this highly potent,
tissue-targeting, endothelin receptor antagonist through the primary endpoint of
morbidity and all-cause mortality in patients with symptomatic PAH.
Global enrollment was completed in December 2009 with a total of 742 patients.
The SERAPHIN study with macitentan in PAH is making progress, with study results
most likely becoming available before the end of 2011, one year ahead of
schedule.
Selexipag in PAH: The Phase III morbidity/mortality study GRIPHON is currently
evaluating this first-in-class, orally available, selective IP receptor agonist
in patients suffering from PAH.
In a 43-patient Phase IIa study concluded in mid-2009, the primary endpoint of
pulmonary vascular resistance (PVR) change from baseline was met with high
statistical significance. The results were recently presented at the American
Thoracic Society (ATS).
Almorexant in primary insomnia: At the end of 2009, Actelion obtained positive
efficacy data with its dual orexin receptor antagonist almorexant in primary
insomnia. However, due to certain safety observations, the non-pivotal part of
the program was expanded during the first half of 2010 to better understand the
safety and tolerability profile of this innovative compound. In Q1 2011, data
from this non-pivotal program should allow Actelion and its collaboration
partner GSK to decide on the initiation of the remaining Phase III studies. The
almorexant development program was recently discussed at a meeting with the US
Food and Drug Administration.
Guy Braunstein, M.D. and Head of Clinical Development at Actelion commented:
"Actelion has significant late-stage compounds in clinical evaluation. I am
confident that Actelion, based on its global clinical development efforts, will
continue to deliver clinical data-sets of high quality in a timely and
cost-effective manner."
The earlier-stage clinical development programs include:
CRTH2 receptor antagonist: Following a positive proof-of-mechanism study with
the orally active CRTH2 receptor antagonist in mild asthma and a successful
update of the preclinical package, Actelion can now initiate Phase II
dose-response clinical studies in both asthma and allergic rhinitis in the
second half of 2010.
Macitentan in IPF: An exploratory clinical development study with this highly
potent, tissue-targeting, endothelin receptor antagonist in idiopathic pulmonary
fibrosis completed enrollment at the end of June with 178 patients. Study
results are expected in the second half of 2011. These results, together with
the detailed analysis of the BUILD- 3 data, will allow Actelion to better
understand the role of dual endothelin receptor antagonism in IPF and make
appropriate development decisions.
Selective S1P(1) receptor agonist in multiple sclerosis and psoriasis:
Actelion's first-in-class selective S1P(1) receptor agonist is currently under
evaluation for multiple sclerosis in Phase II. By the end of June 2010, this
dose-response study had enrolled more than half of the 400 planned patients.
Study results are expected in H2 2011. In psoriasis, a large Phase II study will
be initiated later this year.
Antibiotic compound: This novel molecule has shown, in preclinical studies, to
be highly active against problematic and multi-resistant pathogens. Following
encouraging results in Phase I studies, a Phase II program will commence later
this year.
Actelion is currently also evaluating a cardiovascular compound in Phase I and
has five preclinical candidates that could enter the clinic in the coming 18
months.
Corporate updates
* Actelion publishes Half-Year Report 2010 - The document is available to
download from the publications page onwww.actelion.com
(http://www.actelion.com/en/our-company/publications/index.page?)
Upcoming events
* Actelion to report Q3 financial results on 21 October 2010
* Actelion to report, in October 2010, the results from CONSCIOUS-2, a Phase
III study evaluating the clinical benefits of clazosentan on
vasospasm-related morbidity and all-cause mortality post aneurysmal
subarachnoid hemorrhage.
* Actelion to report Full Year financial results on 17 February 2011
###
For Documentation Purposes
Full Financial Statement:
The full financial statement for the second quarter of 2010 can be found as a
PDF attached to the media release. It is also available onwww.actelion.com in
the Investor section
(http://www.actelion.com/en/investors/financial-information/
finance-archive/index.page?)
Non-GAAP to US GAAP reconciliation for Q2 2010
In CHF Million | Q2'10 | Q2'09
 | |
-------------------------------+-------+-------
Non-GAAP EBIT | 207.4 | 158.3
-------------------------------+-------+-------
Stock option expenses | 24.9 | 22.4
-------------------------------+-------+-------
Amortization and depreciation | 19.1 | 14.7
-------------------------------+-------+-------
Operating income | 163.4 | 121.2
Key Financial Figures for H1 2010
In CHF Million | Results | Results | % Variance | % Variance
(except for per share data) | H1 2010 | H1 2009 | In CHF | In LC
-----------------------------+---------+---------+------------+------------
Net Revenues | 1,024.9 | 855.2 | 20 | 23
-----------------------------+---------+---------+------------+------------
Non-GAAP OPEX | 619.7 | 550.4 | 13 | 14
-----------------------------+---------+---------+------------+------------
Non-GAAP EBIT | 405.1 | 304.8 | 33 | 39
-----------------------------+---------+---------+------------+------------
Diluted EPS - Non-GAAP | 2.74 | 2.31 | 19 | 25
-----------------------------+---------+---------+------------+------------
Diluted EPS - US GAAP | 2.10 | 1.79 | 17 | 23
Non-GAAP to US GAAP reconciliation for H1 2010
In CHF Million | H1 2010 | H1 2009
 | |
-------------------------------+---------+---------
Non-GAAP EBIT | 405.1 | 304.8
-------------------------------+---------+---------
Stock option expenses | 41.2 | 34.5
-------------------------------+---------+---------
Amortization and depreciation | 37.4 | 27.5
-------------------------------+---------+---------
Operating income | 326.6 | 242.9
Notes to the editor:
Actelion Ltd.
Actelion Ltd is a biopharmaceutical company with its corporate headquarters in
Allschwil/Basel, Switzerland. Actelion's first drug Tracleer®, an orally
available dual endothelin receptor antagonist, has been approved as a therapy
for pulmonary arterial hypertension. Actelion markets Tracleer® through its own
subsidiaries in key markets worldwide, including the United States (based in
South San Francisco), the European Union, Japan, Canada, Australia and
Switzerland. Actelion, founded in late 1997, is a leading player in innovative
science related to the endothelium - the single layer of cells separating every
blood vessel from the blood stream. Actelion's over 2,300 employees focus on
the discovery, development and marketing of innovative drugs for significant
unmet medical needs. Actelion shares are traded on the SIX Swiss Exchange
(ticker symbol: ATLN).
For further information please contact:
Roland Haefeli
Vice President, Head of Investor Relations & Public Affairs
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
+1 650 624 69 36
www.actelion.com
[HUG#1432585]
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Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland
ISIN: CH0010532478;
Press Release PDF: http://hugin.info/131801/R/1432585/378649.pdf
Webcast: http://gaia.world-television.com/actelion/20100720/trunc
Financial Fact Sheet: http://hugin.info/131801/R/1432585/378651.pdf
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