Actelion announces Half Year 2011 financial results
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Actelion Pharmaceuticals Ltd /
Actelion announces Half Year 2011 financial results
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The issuer is solely responsible for the content of this announcement.
Total Product sales up 10% in local currencies - Non-GAAP EBIT of CHF 346.5
million, up 8% in local currencies - Negative impact of Asahi provision - Sound
commercial performance impacted by currency headwinds - Significant value
drivers ahead
ALLSCHWIL/BASEL, SWITZERLAND - 21 July 2011 - Actelion Ltd (SIX: ATLN) today
announced its financial results for the first half of 2011.
In CHF Million | Results | Results | % Variance | % Variance
(except for per share data) | H1 2011 | H1 2010 | In CHF | In LC
-----------------------------+---------+---------+------------+------------
Total net revenues | 969.9 | 1,024.9 | (5) | 8
-----------------------------+---------+---------+------------+------------
Product sales | 890.1 | 933.2 | (5) | 10
-----------------------------+---------+---------+------------+------------
US GAAP EBIT | (223.1) | 326.6 | - | -
-----------------------------+---------+---------+------------+------------
Non-GAAP EBIT | 346.5 | 405.1 | (14) | 8
-----------------------------+---------+---------+------------+------------
US GAAP EPS (fully diluted) | (2.20) | 2.10 | - | -
| | | |
As of 30 June 2011, Actelion had cash and cash equivalents of CHF 1.4 billion.
In addition, Actelion holds 11.2 million treasury shares.
Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "In a
highly challenging environment for our industry globally and for Swiss companies
more specifically due to strong negative currency headwinds, Actelion has
delivered a solid commercial performance with sales growth of 10% in local
currencies for the first six months of 2011. In Swiss Franc terms this sales
performance translates into a decrease of 5%."
Jean-Paul Clozel continued: "Actelion made progress in building a long-term
business by taking measures to maximize the value generated by our current
product portfolio and to build and develop our business beyond our core disease
areas. One such example is the positive Phase II study with our CRTH2 antagonist
providing the proof that this mechanism can bring clinically relevant benefit to
patients suffering from allergic rhinitis."
Jean-Paul Clozel added: "In the coming weeks we expect results of the Phase II
study with ponesimod in multiple sclerosis. This will be followed shortly
thereafter by macitentan reporting Phase II results for the exploratory study in
idiopathic pulmonary fibrosis (IPF). These results are eagerly anticipated
since, in addition to determining the future development path of macitentan in
IPF, the study will generate additional safety and tolerability data at the 10
mg dose, ahead of the conclusion of the Phase III study with macitentan in PAH
expected in the first few months of next year."
Jean-Paul Clozel concluded: "By the end of the year we also expect the results
of the study with olesoxime - conducted by Trophos - as a treatment for
amyotrophic lateral sclerosis. This data will then determine whether Actelion
will exercise its option to acquire Trophos."
Andrew J. Oakley, Chief Financial Officer of Actelion commented: "With 99% of
product sales generated outside of Switzerland and close to 50% of our operating
expenditure in Swiss Francs, the underlying performance of our business is not
fully transparent at first glance. Our performance and profitability has been
further negatively impacted by the provision related to the litigation with
Asahi Kasei in the California courts."
Andrew J. Oakley added: "A provision reflecting the jury verdict of USD 577
million has been made in the second quarter financial statements. When a final
judgment is entered by the court, we will adjust the provision in the third
quarter as required. Given current exchange rates and should the judgment award
remain at USD 577 million, the company will likely record a US GAAP operating
loss for the full year."
The company and its external advisors believe that the verdict is neither
supported by the facts nor is it correct as a matter of law. The company is
therefore confident that there are significant grounds for a successful appeal,
which will be filed in due course.
Andrew J. Oakley continued: "The impact of the strengthening Swiss Franc is even
more evident when looking at the second quarter results. As reported, in Swiss
Francs, product sales decreased by 9%. On a local currency basis product sales,
increased by 8% despite a very strong second quarter in 2010."
Andrew Oakley concluded: "In this increasingly difficult environment and
unforeseen events excluded, I remain confident that we will meet the guidance
given earlier this year with product sales on a local currency basis increasing
in the mid-single digit, Cash OPEX flat and Non-GAAP EBIT also on a local
currency basis increasing in the low-double digit range."
Revenue performance
Product sales for the first half of 2011 were CHF 890.1 million (H1 2010
CHF 933.2 million), an increase of 10% in local currencies, with 43% of sales
coming from the United States, 39% from Europe, 9% from Japan and 9% from the
rest of the world. Product sales growth was driven by patient demand, supported
by price increases for Ventavis® and Zavesca® in the US.
For the first six months of 2011 sales of Tracleer® (bosentan) amounted to CHF
789.2 million compared to CHF 835.3 million for the same period in 2010. This
represents an increase of 8% in local currencies and 10% in unit growth.
Tracleer® sales growth was driven by Japan, Europe and emerging markets.
During the first half of 2011, Ventavis (iloprost) had sales in the United
States of CHF 59.7 million compared to CHF 61.9 million in the first half of
2010. In local currencies, this represents an increase of 17%, solely driven by
an increase in the effective net price.
Sales of Veletri®( )(epoprostenol for injection), launched in the United States
in April 2010, amounted to CHF 6.1 million during the first six months of 2011,
with CHF 3.5 million sales generated in the second quarter, demonstrating the
continued successful launch uptake. In Europe, the company withdrew the
application to the French health authorities in order to move forward in a
decentralized procedure with a second generation formulation demonstrating an
even better stability profile. We expect the new application to occur before the
end of the year. Registration in Japan, with the second generation formulation
is ongoing.
Otto Schwarz, Chief Operating Officer of Actelion commented: "I am satisfied
with the sound commercial performance in the first six months of 2011,
especially considering the difficult currency and competitive environment. In
the US we expect to benefit, for the full year 2011, from an increase in the
gross to net sales ratio (an effective price increase) as a result of lower
rebates and discounts."
Otto Schwarz concluded: "The strong performance in Japan, Europe and emerging
markets, together with the effective price increase in the US will, for the
remainder of this year, be somewhat offset by the impact of a change in the PAH
competitive landscape in the US, where a competitor product has received a
revision of its label. It is difficult to estimate the full impact of the label
change at this time; although we have seen expansion in the endothelin receptor
antagonist market, the label change for the competitor will affect sales growth
moving forward."
Sales of Zavesca (miglustat), for the first half of 2011 amounted to CHF 34.7
million compared to CHF 35.8 million during the same period last year. This
represents an increase of 10% in local currencies. The continued increase of
Niemann-Pick Type C patients on therapy is somewhat masked by a number of Type
1 Gaucher disease patients returning to enzyme replacement therapy (ERT)
following a shortage of ERT in 2010.
Contract revenues for the first half of 2011 amounted to CHF 79.8 million, with
the majority of this amount (CHF 76.5 million) from the recognition of the
remaining deferred revenue from the ongoing orexin collaboration with
GlaxoSmithKline.
Operating expenses
Total operating expenses for the first six months of 2011 were CHF 1,193.0
million compared to CHF 698.2 million for the first half of 2010, an increase
dominated by the Asahi litigation provision of CHF 485.2 million booked in the
second quarter. Cash operating expenses for the first half of 2011 were up 1% in
Swiss Francs and 7% in local currencies.
Research and Development (R&D) expenses in the first half of 2011 were down 2%
to CHF 228.7 million (H1 2010: CHF 233.2 million). Non-GAAP R&D expenses for the
same period, which excludes stock-based compensation expense, amortization and
depreciation, were CHF 199.7 million compared to CHF 206.7 million in the first
half of 2010, a 3% decrease.
Selling, General and Administrative expenses (SG&A) for the first half of 2011
were CHF 357.4 million (H1 2010: CHF 342.6 million). The increase can be
attributed to higher legal costs. Non-GAAP SG&A expenses for the first half of
2011, which excludes stock-based compensation expense, amortization and
depreciation, were CHF 322.2 million compared to CHF 312.2 million in the first
half of 2010.
As announced on 29 June 2011, the company recorded a provision of USD 577
million (CHF 485.2 million) in the second quarter financial statement related to
Asahi Kasei Pharma Corp. v. Actelion Ltd. et al. This provision follows the jury
verdict in which Asahi was awarded up to USD 577 million in compensatory and
punitive damages. The provision reflecting the judgment award as entered may be
subject to adjustment in the third quarter financial statements. Given current
exchange rates, should the judgment award remain at USD 577 million, the company
will likely record a US GAAP operating loss for 2011.
Operating loss
Operating loss for the first six months of 2011 was CHF 223.1 million compared
to an operating profit of CHF 326.6 million for the same period in 2010.
In order to better compare the company's underlying performance, Actelion
continues to report Non-GAAP EBIT, which excludes employee stock options,
amortization and depreciation as well as other one-off elements, such as the
above-mentioned provision, that distort comparison. Non-GAAP EBIT for the first
half 2011 was CHF 346.5 million (H1 2010: CHF 405.1 million), an increase of 8%
in local currencies compared to the same period last year.
Net loss
Net loss for the first half of 2011 amounted to CHF 262.3 million (H1 2010: net
income of CHF 254.2 million).
Net loss for the period includes interest income of CHF 4.6 million, interest
expense of CHF 6.9 million, amortization of debt discount of CHF 9.6 million,
other financial income of CHF 1.8 million as well as an income tax expense of
CHF 29.0 million.
The net loss translates into a loss per share of CHF 2.20 compared to fully
diluted earnings per share of CHF 2.10 in the first half of 2010.
Dividend payment
At this year's Annual General Meeting on 5 May 2011, Actelion's shareholders
voted to approve the Board's recommendation that Actelion become the first
biotech to offer a regular dividend payment. As a result of their support,
Actelion's first dividend was paid at CHF 0.80 per registered share five days
later.
Clinical Development
Actelion is currently pursuing three ongoing Phase III programs:
Macitentan in pulmonary arterial hypertension
Macitentan is investigated in a Phase III study, SERAPHIN, designed to evaluate
the efficacy and safety of this highly potent, tissue-targeting, endothelin
receptor antagonist. The primary endpoint is morbidity and all-cause mortality
in patients with symptomatic PAH.
Global enrollment was completed in December 2009, with more than 700 patients
included in the trial. The study is event-driven and, based on the progress
observed, results are expected to become available in the first half of 2012.
During its plenary meeting on 06-08 July 2011, the Committee for Orphan
Medicinal Products (COMP) at the European Medicines Agency (EMA) adopted a
positive opinion recommending macitentan for the treatment of pulmonary arterial
hypertension for designation as orphan medicinal product to the European
Commission.
This recommendation is based on well-justified assumptions that macitentan will
be of significant benefit compared to the existing authorized medicinal products
or methods at the time of designation.
In the United States, the orphan drug designation was granted in September 2009.
Selexipag in pulmonary arterial hypertension
Selexipag is investigated in a Phase III study, GRIPHON, designed to evaluate
the efficacy and safety of this first-in-class, orally available, selective IP
receptor agonist in patients with pulmonary arterial hypertension. The primary
endpoint is morbidity and all-cause mortality in patients with symptomatic PAH.
Global enrollment is ongoing and early estimates of the availability of results
indicate 2013 but, as an event-driven study, timelines are subject to change.
Olesoxime in amyotrophic lateral sclerosis
In July 2010, Actelion and Trophos entered into a binding agreement whereby
Actelion obtained an exclusive option to acquire privately-held Trophos SA, a
clinical-stage pharmaceutical company. The decision on whether Actelion will
exercise the option to acquire Trophos will be made upon completion of the
ongoing pivotal Phase III study with olesoxime, expected by the end of 2011.
Olesoxime is investigated in a Phase III study designed to evaluate the efficacy
and safety of this mitochondrial pore modulator in patients with amyotrophic
lateral sclerosis (ALS, often referred to as Lou Gehrig's disease) who are
currently receiving standard care.
Enrollment was completed in the first quarter of 2010 with a total of 512
patients. The primary endpoint of the study is the overall 18-month survival
rate;study results are therefore expected to become available at the end of
2011.
The mid-stage clinical development programs include:
Ponesimod in multiple sclerosis and psoriasis
Actelion's selective S1P(1) receptor agonist, ponesimod, is currently in
development as an immunomodulator, with the potential for once-a-day oral dosing
for multiple autoimmune disorders.
Ponesimod is investigated in a dose-response study in patients with relapsing-
remitting multiple sclerosis. The study is designed to evaluate the efficacy,
safety and tolerability of three doses administered for 24 weeks. Enrollment has
concluded with a total of 464 patients and results are expected in the coming
weeks.
Ponesimod is also investigated in a dose-finding study in patients with moderate
to severe chronic plaque psoriasis. The study is designed to evaluate the
efficacy, safety, and tolerability of two doses of this compound administered
for up to 28 weeks. Enrollment commenced in the fourth quarter of 2010 and the
study is estimated to enroll 320 patients.
Actelion's CRTH2 receptor antagonist in asthma and allergic rhinitis
Actelion's CRTH2 receptor antagonist blocks the effects of prostaglandin D2
(PGD2) in inflammation and, as a consequence, the amplification and maintenance
of allergic reactions.
A Phase II study with orally-active CRTH2 antagonist in seasonal allergic
rhinitis has met its primary endpoint with statistical significance (p<0.05).
The study assessed the efficacy and tolerability of various doses of this novel
CRTH2 antagonist in 579 adult patients with seasonal allergic rhinitis due to
mountain cedar pollen. Treatment in the study was well tolerated across all
treatment groups and no serious adverse events were reported.
A Phase II dose-finding study in asthma is currently enrolling and is expected
to report results mid-2012.
Cadazolid (Actelion's novel antibiotic) in Clostridium difficile infection
Actelion's first potent, novel antibiotic, cadazolid, is investigated in a Phase
II study in patients with Clostridium difficile infection (CDI). The study is
designed to investigate the efficacy, safety and tolerability profile of three
doses of drug in an estimated 92 patients. Global enrollment commenced in the
fourth quarter of 2010, recruitment is slower than anticipated and therefore
study results are expected in the first half of 2012.
Macitentan in idiopathic pulmonary fibrosis (IPF)
Actelion is conducting an exploratory Phase II study, MUSIC, with macitentan in
patients with IPF, which completed enrollment of 178 patients at the end of June
2010. Patients are followed for 1 year and study results are therefore expected
in the second half of 2011.
The company is also developing earlier-stage compounds and may enter several
compounds into the clinic before the end of the year.
Legal update
On 4 May 2011, a California jury awarded Asahi Kasei Pharma ("Asahi") up to USD
547 million in compensatory damages from Actelion. In addition, the jury awarded
punitive damages of USD 30 million against certain individual officers of
Actelion. In a post-trial motion, Actelion requested an election between damages
of USD 358.95 million for alleged lost profits or USD 187.4 million in alleged
development costs. In addition, from either amount, the motion requested the
deduction (off-set) of USD 78.4 million from a previous payment made by Actelion
related to arbitration proceedings in 2009. A judgment has not yet been entered
by the trial court.
The company and its external advisors believe that the verdict is neither
supported by the facts nor is it correct as a matter of law. The company is
therefore confident that there are significant grounds for a successful appeal,
which will be filed in due course.
Management update
Given the company's rapid growth and the ever-increasing complexity of the
healthcare environment, the company adapted the structure of Actelion's
leadership team, bringing the changes into effect in June 2011.
The position of Chief Operating Officer (COO) was created; Otto Schwarz was
appointed to the new role with the target of increasing the drive for excellence
- a growing demand in these times of operational challenges. The new position
allows the CEO function to focus even more on strategic matters. At the same
time, the company streamlined the membership of its major decision-making
bodies, such as the Actelion Executive Committee, to ensure transparent,
efficient and productive decision-making as well as effective execution.
Half Year Report
Full details on the progress made in the first half of 2011 are available in
Actelion's Half Year Report 2011, available from www.actelion.com - "Our
company" - "Half Year Report 2011".
Upcoming events
* Ponesimod in relapsing remitting multiple sclerosis Phase IIb results
* Macitentan in idiopathic pulmonary fibrosis exploratory Phase II results
* 9M 2011 financial results - 20 October 2011
* Olesoxime - conducted by Trophos - in amyotrophic lateral sclerosis Phase
III results - go/no-go decision on exercising the option to acquire Trophos
###
Actelion, Tracleer, Zavesca, Ventavis and Veletri are trademarks registered in
the United States and other countries.
For Documentation Purposes
Full Financial Statement:
The full financial statement for the first half of 2011 can be found as a PDF
attached to the media release. It is also available on www.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 H1 2011
In CHF Million | H1 2011 | H1 2010
--------------------------------+---------+---------
Non-GAAP EBIT | 346.5 | 405.1
--------------------------------+---------+---------
Stock option expenses | 43.1 | 41.2
--------------------------------+---------+---------
Amortization and depreciation | 41.2 | 37.3
--------------------------------+---------+---------
Litigation provision | 485.2 | -
--------------------------------+---------+---------
US GAAP EBIT | (223.1) | 326.6
| |
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 2,400 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) as part of the Swiss blue-chip index SMI (Swiss Market
Index SMI®).
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
Conference Call Information
Actelion Ltd will announce the first half 2011 financial results on Thursday,
21 July 2011, at 07.00 hrs CEST / 06.00 hrs BST / 01.00 a.m. EDT. An investor
conference call & webcast will be held at 14.00 hrs, CEST to discuss the
results.
Date/Time:
21 July
14.00 hrs Basel (CEST)
13.00 hrs UK (BST)
08.00 a.m US (EST)
Conference Call Connect #:
Dial-in participants should start calling the number below 10-15 minutes before
the conference is due to start.
Dial: Europe: +41 (0)44 580 00 74
UK: +44 (0)203 367 94 53
US: +1 866 9075 923
Participant's mode:
Listen-Only with possibility to open individual lines during Q&A session.
Participants will be asked for their Name and Company.
Webcast Access:
Webcast participants should visit the Actelion website http://www.actelion.com
10-15 minutes before the conference is due to start.
Participant's mode:
Listen-Only
Webcast Replay:
The archived Investor Webcast will be available for replay through
http://www.actelion.com approximately 60 minutes after the call has ended.
--- End of Message ---
Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland
ISIN: CH0010532478;
Financial Statement:
http://hugin.info/131801/R/1532368/466662.pdf
Financial Fact Sheet:
http://hugin.info/131801/R/1532368/466661.pdf
Webcast:
http://media10.simplex.tv/content/2/225/14714/
Press Release PDF:
http://hugin.info/131801/R/1532368/466659.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: Actelion Pharmaceuticals Ltd via Thomson Reuters ONE
[HUG#1532368]
Unternehmensinformation / Kurzprofil:
Datum: 21.07.2011 - 07:00 Uhr
Sprache: Deutsch
News-ID 56584
Anzahl Zeichen: 27589
contact information:
Town:
Allschwil
Kategorie:
Business News
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