Actelion delivers outstanding 2014 results
(Thomson Reuters ONE) -
Actelion Pharmaceuticals Ltd /
Actelion delivers outstanding 2014 results
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The issuer is solely responsible for the content of this announcement.
ALLSCHWIL/BASEL, SWITZERLAND - 16 February 2015 - Actelion Ltd (SIX: ATLN) today
announced its results for the full year 2014.
OPERATING HIGHLIGHTS
* Opsumit - Sales of CHF 180 million reflect highly successful first year on
the market
* Selexipag (Uptravi) - positive morbidity/mortality Phase III pivotal study
results
* Selexipag (Uptravi) - Registration dossier submitted to US and European
regulators
* Tracleer - Continued strong demand in markets where Opsumit is not yet
available
* Tracleer - PIP Compliance Statement for Tracleer issued in Europe
* Veletri - Growing 84% (at CER) versus 2013 - becoming a global asset
FINANCIAL HIGHLIGHTS
* Product sales of CHF 1,956 million, up 12% at CER (up 10% ex US rebate
reversals)
* Core earnings of CHF 743 million, up 25% at CER (up 20% ex US rebate
reversals)
* Core EPS of CHF 5.58, an increase of 33% at CER
* Proposed increased dividend of CHF 1.30 on the back of strong cash
generation
* New second-line share buyback program - up to 10 million shares within 3
years, subject to approval by the relevant authorities
* 2015 financial guidance - from 2014 base (excluding US rebate
reversals) Low-single digit core earnings growth expected at CER
----------------------------------------------------------------------
% variance
--------------------
in CHF millions 2014 2013 in CHF at CER((1))
(except for per share data)
----------------------------------------------------------------------
Product sales 1,956 1,784 10 12
----------------------------------------------------------------------
US GAAP Operating income 570 482 18 24
----------------------------------------------------------------------
Core earnings (Core operating income) 743 619 20 25
----------------------------------------------------------------------
US GAAP EPS (fully diluted) 5.11 3.92 30 37
----------------------------------------------------------------------
Core EPS (fully diluted) 5.58 4.41 27 33
----------------------------------------------------------------------
As of 31 December 2014, Actelion had cash and cash equivalents of CHF 1.2
billion. In addition, Actelion holds 3 million treasury shares.
(1) CER percentage changes are calculated by reconsolidating both the FY 2014
and FY 2013 results at constant currencies (the average monthly exchange rates
for FY 2013)
Jean-Paul Clozel, MD, Chief Executive Officer, commented: "2014 was an
outstanding year for Actelion, with successes on all fronts. We've delivered
strong sales growth and saw a substantial uptake of the recently launched
Opsumit. A particular highlight was the Phase III results for our novel PAH
treatment selexipag (Uptravi), which we filed for regulatory review in both the
US and EU at the end of 2014. We have also strengthened our innovation by
advancing the pipeline and will share more details throughout 2015. Reflecting
on the successes of 2014, as well as our promising pipeline, I am confident that
we are well positioned for future success."
Jean-Paul Clozel added: "We have delivered on our commitment to create continued
value to our shareholders with almost 1.1 billion Swiss francs being returned
through a second-line share buyback program and dividend payments over the past
three years. In addition, during 2014, the company purchased 5.7 million shares
on the first-line of the Swiss Stock Exchange to mitigate dilution arising from
employee stock compensation programs." Jean-Paul Clozel concluded: "Moving
forward, and as part of our continued commitment to shareholder value creation,
the Board will recommend that shareholders approve the payment of an increased
dividend amounting to CHF 1.30 per registered share. In addition, the Board has
authorized in principle, subject to approval by the relevant authorities, a new
second-line share repurchase program of up to 10 million shares, within three
years."
André C. Muller, Chief Financial Officer, commented: "The strong 2014
performance has set a high bar for 2015, a year where Tracleer, Ventavis and
Zavesca will all be facing increased generic and pricing pressures. Despite the
continued unfavorable foreign exchange environment, further compounded by the
Swiss National Bank's decision to discontinue the 1.20 Swiss franc minimum
exchange rate to the euro, we are confident that our long-term strategy coupled
with tight financial oversight will result in continued shareholder value
creation."
Barring unforeseen events and the benefit of US rebate reversal in 2014,
Actelion forecasts 2015 core earnings growth, at constant exchange rates, to be
in the low-single digit percentage range.
ANNUAL REPORT
Full details on the progress made in 2014 are available in Actelion's 2014
Annual Report, at www.actelion.com/annual-report.
NOTES TO SHAREHOLDERS:
The Annual General Meeting (AGM) of Shareholders to approve the Business Report
of the year ending 31 December 2014 will be held on 8 May 2015.
At the AGM, the Board of Directors will recommend that shareholders approve a
dividend of CHF 1.30 per share, an increase of 8%.
Shareholders holding more than CHF 1,000,000 nominal value of shares (i.e.
2,000,000 shares at nominal value of CHF 0.50), being entitled to add items to
the agenda of the general meeting of shareholders, are invited to send in
proposals, if any, to Actelion Ltd, attention Corporate Secretary,
Gewerbestrasse 16, CH-4123 Allschwil, to arrive no later than 27 March 2015. Any
proposal received after the deadline will be disregarded.
In order to attend and vote at the Annual General Meeting of Shareholders,
shareholders must be registered in the Company's shareholder register by 27
April 2015 at the latest.
UPCOMING EVENTS
* March 15, 2015: Selexipag - first scientific presentation of GRIPHON data at
American College of Cardiology (ACC.15), Actelion to host an investor
relations evening event by invitation only
* 3M 2015 Financial Results reporting on 21 April 2015
* Annual General Meeting 2015 on 08 May 2015
* HY 2015 Financial Results reporting on 21 July 2015
###
NOTES TO THE EDITOR
CHAIRMAN'S LETTER TO SHAREHOLDERS
Dear Shareholders,
2014 was an excellent year for Actelion and for the communities we serve. Once
again, the company made significant commercial and clinical progress. Not only
did we successfully launch Opsumit(®) (macitentan) in nearly 20 countries and
submit the selexipag (Uptravi(®)) registration dossier to European and US
regulators for marketing authorization, we also advanced our pipeline with
potential therapies which we expect to shape our future. Reporting strong
financial results and operating performance, we delivered substantial value to
our shareholders. These achievements are the fruits of more than a decade of
focused investments, validating the strategic decision to be a fully integrated
company that discovers, develops and commercializes our products around the
world. Building on this momentum, we are entering 2015 with great confidence in
our ability to execute our long-term strategy and accomplish our mission to
treat more patients with groundbreaking therapies.
BUSINESS PERFORMANCE
Our performance during 2014 reflects Actelion's leadership in the PAH market,
effective commercial execution and commitment to operational efficiency, as well
as the dedication of our people. Product sales increased by 12% to almost CHF 2
billion, while core earnings rose 25% to CHF 743 million, both at constant
exchange rates. As a result, core earnings per share amounted to CHF 5.58.
The company's excellent performance and news flow in 2014 was reflected in the
share price, as the top performer of the Swiss Market Index. At the end of
December, Actelion's stock traded at CHF 115.30 per share, an increase of 53%
for the calendar year. It is worth noting that, over the past three years,
Actelion shares have appreciated by almost 250%. This year's share price
performance, together with the increased dividend of CHF 1.20 per share, paid
out in May, resulted in a total shareholder return (TSR) of 55% for 2014
STRATEGY
Our success - not just during the past year, but throughout our history - has
been based on a clear strategy to ensure continued value creation. I am
confident that all the necessary elements are in place to deliver on the next
phase of value creation. We have the right infrastructure - a global commercial
presence in all key markets, a worldwide clinical development capability and our
R&D center of excellence in Switzerland. We have excellent new products -
Opsumit, Veletri(®) (epoprostenol for injection) and soon, hopefully, Uptravi -
and a solid pipeline to drive accelerated growth going forward. Most
importantly, we have the right leadership and highly dedicated people to execute
our strategy and maximize the value of our assets.
CORPORATE GOVERNANCE
Sound corporate governance and high standards of professional behavior are
essential to our continued growth and success as a company. With this in mind,
the Board of Directors and its subcommittees have met on several occasions
throughout the year to critically review the company's progress.
In a referendum held in 2013, Swiss voters approved the so-called Minder
Initiative, granting shareholders additional oversight on matters of executive
compensation, and the Ordinance against Excessive Compensation in Listed
Companies came into effect on January 1, 2014.
In response - a year ahead of the deadline - the Board proposed changes to our
Articles of Association, to enable the company to implement practices ensuring
full compliance with the new regulations. At the Annual General Meeting of
shareholders in 2014, these proposals were approved by an overwhelming majority,
and we would like to thank you for your ongoing support.
Shareholder engagement is crucial to our understanding of emerging issues,
trends and expectations, and it fosters increased trust and support. In addition
to our existing investor relations efforts, we have established a regular
dialogue on corporate governance matters with shareholders and representatives
of shareholder groups. Over the past few months, I have personally reached out
to many of our largest shareholders - discussing general corporate governance,
as well as compensation matters - and I look forward to continuing this dialogue
in the future.
DELIVERING VALUE TO SHAREHOLDERS
Actelion's approach to business development has always involved seizing
opportunities whenever they fit both our strategic and financial criteria. In
the current, intensely competitive environment, we have assessed several options
but have not yet found an appropriate opportunity that would create significant
value for the company and, ultimately, for our shareholders. These efforts will
be pursued, and - as a nimble company - we are well positioned to move rapidly
and proactively should the right opportunity arise.
In the meantime, while ensuring the requisite financial flexibility, we will
continue to return value to our shareholders.
In 2012, we made a commitment to return surplus capital to shareholders. We have
delivered on that promise, with almost CHF 1.1 billion being returned through a
second-line buyback program and dividend payments over the past three years.
In addition, during 2014, the company purchased 5.7 million shares on the first
line of the Swiss Exchange to mitigate dilution arising from employee stock
compensation programs.
Moving forward, and as part of our continued commitment to shareholder value
creation, the Board will recommend that shareholders approve the payment of an
increased dividend amounting to CHF 1.30 per registered share. In addition, the
Board has authorized in principle, subject to approval by the relevant
authorities, a new second-line share repurchase program of up to 10 million
shares, within three years. The Board will then propose the cancelation of these
repurchased shares at subsequent General Meetings of Shareholders.
OUTLOOK
In January 2015, the decision by the Swiss National Bank to discontinue the
minimum exchange rate of CHF 1.20 per euro resulted in a sharp fall in
Actelion's share price as part of a broad decline in the Swiss stock market.
While only time will tell where exchange rates will settle, we must be mindful
that - as most Swiss exporters - a strong Swiss franc will have a negative
impact on Actelion's Swiss franc earnings.
Despite these increased currency headwinds, I am confident that, with our sound
strategy and a culture rooted in science and innovation, we will continue to
deliver for all our stakeholders - patients and physicians, employees and
shareholders alike.
Yours sincerely,
Jean-Pierre Garnier,
Chairman of the Board of Directors
CEO'S LETTER TO SHAREHOLDERS
Dear Shareholders,
The highly successful launch of Opsumit(®) (macitentan) was one of the many
highlights of 2014 - an impressive year of progress for Actelion. This unique
drug for the treatment of pulmonary arterial hypertension (PAH) is now available
in nearly 20 countries around the world, demonstrating both our commitment to
the PAH community and our determination to maximize the value of our innovation.
Having announced the positive results of the Phase III PAH outcome trial with
selexipag (Uptravi(®)) in June, we submitted applications for marketing
authorization to the European Medicines Agency (EMA) and to the US Food and Drug
Administration (FDA) before the end of the year. Veletri(®) (epoprostenol for
injection) continued to advance in the US, Japan, Canada, Australia and various
EU markets, approaching an 80% share of new i.v. epoprostenol patients.
Meanwhile, Tracleer(®) (bosentan) continued to perform strongly in markets where
Opsumit is not yet available, and where it has been effectively defended against
generic competition. These achievements are reflected in a strong commercial
performance which, combined with rigorous financial discipline, allowed us once
again to excel.
Sales reached CHF 1,956 million, up 12% at constant exchange rates (10%
excluding US rebate reversals), and core earnings rose to CHF 743 million, up
25% at CER (20% excluding US rebate reversals), making 2014 a truly remarkable
year for Actelion.
As a scientist, I know that our company's success is founded on innovation. I'm
particularly proud of our achievements in the area of PAH, where our innovative
products have provided benefits for patients around the world.
Our strategy for long-term value creation, set out in 2012, is being delivered
around three key objectives - sustaining and growing our PAH franchise, building
additional specialty franchises, and optimizing profitability. I am pleased to
report that once again we have made significant progress on all three fronts.
SUSTAINING AND GROWING THE PAH FRANCHISE
Our success in the PAH arena began with Tracleer - the first and most successful
ERA on the market to date. Despite the competitive landscape, which now includes
generic bosentan in some countries, Tracleer is still holding its own in markets
where Opsumit has not yet been launched. In addition, I am very proud that last
year, Tracleer became the first PAH therapy to obtain a Pediatric Investigation
Plan (PIP) compliance statement from the European Committee for Medicinal
Products for Human Use (CHMP), with the European Commission Decision received in
January of this year. With our pediatric formulation of Tracleer already
available in Europe, the additional studies undertaken as part of the PIP have
increased the information available for physicians treating children with PAH,
underscoring our commitment to these patients. In addition, we can now apply for
a 6-month patent extension in most European markets.
Our leading position in PAH has been reinforced by the launch of Opsumit in
2014 - a very strong market introduction in multiple geographies and healthcare
systems. Opsumit is rapidly gaining new patient share in the ERA market, and
early uptake momentum has been supported by patients switching therapy from
Tracleer to Opsumit. The product's clinical utility has been enhanced - and
physician acceptance strengthened - by a large and diverse set of data published
over the past 18 months. As a result, more than 6,300 patients (about two-thirds
in the US) were treated with Opsumit by the end of 2014. Our task now is to
maintain the successful launch momentum in 2015, with further market
introductions anticipated.
The excellent news announced in June 2014 was that selexipag, a selective oral
prostacyclin receptor agonist (originally discovered by Nippon Shinyaku),
demonstrated long-term outcome benefits in a trial involving over 1,100
patients: selexipag reduced the risk of a morbidity/mortality event by 39%
versus placebo. At baseline, 80% of the patients in the study also received
background therapy - an ERA, a phosphodiesterase-5 inhibitor, or a combination
of the two - which makes the findings even more impressive. A vast amount of
data on selexipag was generated in this study, and we have been gratified by the
consistent efficacy observed across key subgroups. We are now eager to share the
results with regulators and the PAH community. Submissions have already been
filed with the major health authorities, and I look forward to the first
presentations at the 2015 American College of Cardiology congress in March. I am
convinced that selexipag has the potential to open the prostacyclin pathway to
more patients, and once again Actelion is leading the way in PAH.
If approved, selexipag - together with Opsumit and Veletri - will provide us
with a portfolio of products based on long-term outcome data. Our PAH franchise
will have been transformed from a single product approaching patent expiry to a
diversified, global franchise covering the continuum of care with outcome-based
medicines.
BUILDING ADDITIONAL SPECIALTY FRANCHISES
Our specialty products outside of PAH also performed well in 2014. Zavesca(®)
(miglustat) passed the CHF 100 million revenue threshold for the first time.
This was mainly attributable to the Niemann-Pick type C disease indication,
which - as a result of expanding diagnostic tools and heightened awareness - saw
double-digit growth in the number of patients treated outside the US.
After just over a year on the market in the US, Valchlor(®) (mechlorethamine)
gel is making progress in establishing itself in the cutaneous T-cell lymphoma
(CTCL) market. 2014 has been a year of extensive learning for us in this new
market, which has taken more time than initially anticipated. Our newly created
sales force is now working with dermatologists in the CTCL centers of excellence
and beyond, to shape the space for Valchlor within the treatment algorithm of
the disease.
While we have built up an unrivaled PAH franchise over the past decade, we are
also focusing our R&D efforts on other diseases with high unmet medical need.
We aim to expand the clinical utility of macitentan by conducting additional
studies - both in specific PAH populations, such as pediatric patients and those
with Eisenmenger's syndrome (PAH associated with a congenital heart defect), and
in the broader pulmonary hypertension (PH) setting, including chronic
thromboembolic pulmonary hypertension (CTEPH) and combined pre- and post-
capillary pulmonary hypertension (CpcPH) due to left ventricular dysfunction.
Finally, we are investigating the use of macitentan in other disorders where
elevated endothelin levels appear to play a role, such as glioblastoma.
Progress is also being made with other highly promising compounds arising from
our drug discovery efforts in other specialty areas. Cadazolid, a novel
antibiotic for Clostridium difficile infections, is in Phase III development.
Innovative approaches are being considered - and discussed with health
authorities - for the further development of our S1P(1) receptor modulator
ponesimod in several indications. The ongoing extension study in multiple
sclerosis is providing a substantial amount of long-term efficacy and safety
data for this novel compound. However, I would reiterate that any pathway
forward will carefully balance clinical risk and investment, medical need and
commercial opportunity.
OPTIMIZING PROFITABILITY
When we announced our strategy in 2012, we committed to deliver profitable
growth, and year after year we have exceeded expectations. While we aim to
advance our pipeline over the coming years, you may rest assured that this
investment in our future will not be at the expense of our profitability, which
we will endeavor to maintain and even enhance in the medium term.
That said, our performance in 2014, even excluding the US rebate reversals, was
truly outstanding, indeed making it more challenging to deliver continued growth
in 2015. We are anticipating generic pressures for Ventavis(®) (iloprost) in the
US and for Zavesca in the Type 1 Gaucher disease market, while continuing to
roll out Opsumit and to prepare for the launch of Uptravi. Our commercial
organization will therefore once again have to focus on excellence in execution,
while the rest of the company keeps a tight control on costs and prioritizes the
most important projects.
With all this in mind, barring unforeseen events and the benefit of US rebate
reversal in 2014, we are forecasting 2015 core earnings growth, at constant
exchange rates, to be in the low-single digit percentage range.
OUTLOOK
With the continued strong performance of Tracleer, the successful launch of
Opsumit and the outstanding results obtained with selexipag, we have made
considerable progress with our objective to transform our PAH business. Actelion
is uniquely positioned to serve the PAH market, covering the continuum of care
with outcome-based medicines. By offering the ERA and, potentially, the
prostacyclin receptor agonist of choice, we could expand our market share in
each segment.
Looking ahead, given the strength of our people and culture, of our marketed
products and exciting pipeline, I am convinced that we can continue to create
significant value for all our stakeholders. I would like to thank you, our
shareholders, for your continued confidence in Actelion. Stay tuned as we move
on to the next chapter of growth!
Yours sincerely,
Jean-Paul Clozel,
Chief Executive Officer
FINANCIAL UPDATE
CORE PERFORMANCE
Actelion continues to measure, report and issue guidance on its core operating
results, which more accurately reflect the underlying business performance.
Core results exclude contract revenues, as well as costs related to employee
stock-based compensation programs, depreciation, amortization, impairments,
certain income tax effects and other items that management deems exceptional.
A full reconciliation between US GAAP and core results can be found on
www.actelion.com.
Key highlights - year-to-date
----------------------------------------------------------------
% variance
-----------------------
in CHF millions 2014 2013 in CHF at CER((1))
----------------------------------------------------------------
Product sales 1,956 1,784 10 12
----------------------------------------------------------------
Core R&D expenditure 369 356 4 4
----------------------------------------------------------------
Core earnings((2)) 743 619 20 25
----------------------------------------------------------------
Core net income 648 509 27 34
----------------------------------------------------------------
Diluted core EPS (CHF) 5.58 4.41 27 33
----------------------------------------------------------------
Key highlights - quarterly
--------------------------------------------------------------------
% variance
-----------------------
in CHF millions Q4 2014 Q4 2013 in CHF at CER((1))
--------------------------------------------------------------------
Product sales 468 462 1 0
--------------------------------------------------------------------
Core R&D expenditure 115 105 9 9
--------------------------------------------------------------------
Core earnings((2)) 113 124 (9) (11)
--------------------------------------------------------------------
Core net income 94 102 (7) (9)
--------------------------------------------------------------------
Diluted core EPS (CHF) 0.81 0.87 (7) (9)
--------------------------------------------------------------------
1. CER percentage changes are calculated by reconsolidating both the FY 2014
and FY 2013 results at constant exchange rates (the average monthly exchange
rates FY 2013).
2. Actelion continues to measure, report and issue guidance on its core
operating performance, which management believes more accurately reflects
the underlying business performance. The Group believes that these non-GAAP
financial measurements provide useful supplementary information to
investors. These non-GAAP measures are reported in addition to, not as a
substitute for, US GAAP financial performance.
PRODUCT SALES
Actelion's commercial performance during 2014 was strong across all regions with
excellent underlying demand for key assets. In the US, despite unmitigated
competitive pressures, sales increased by 16% driven by price increases and a
net impact of CHF 42 million (at CER) reversals of rebate accruals relating to
patient support programs (CHF 73 million in 2014 versus CHF 35 million in
2013). European sales increased by 10% at CER in a continually negative pricing
environment. European sales growth was driven by the performance in Germany -
the first EU market to launch Opsumit, and the digital ulcer indication, while
Japan continued its strong performance, increasing by 9%. Sales in the rest of
the world increased by 8% at CER, driven by strong growth in PAH-emerging
markets such as China, Taiwan, Russia and Mexico. Comparing average exchange
rates in 2014 with average exchange rates during 2013, the Swiss franc was
stronger against many major currencies, in particular the Japanese yen and the
US dollar. The overall impact resulted in a negative currency variance of CHF
51 million.
Sales by product - year-to-date
--------------------------------------------------------
% variance
------------------
in CHF millions 2014 2013 in CHF at CER
--------------------------------------------------------
Opsumit 180 5 nm* nm
--------------------------------------------------------
Tracleer 1,481 1,532 (3) (1)
--------------------------------------------------------
Veletri 64 37 76 84
--------------------------------------------------------
Ventavis 112 110 2 3
--------------------------------------------------------
Valchlor 11 - nm nm
--------------------------------------------------------
Zavesca 103 96 8 11
--------------------------------------------------------
Others 5 4 nm nm
--------------------------------------------------------
Total product sales 1,956 1,784 10 12
--------------------------------------------------------
*nm = not meaningful
Sales by product - quarterly
------------------------------------------------------------
% variance
------------------
in CHF millions Q4 2014 Q4 2013 in CHF at CER
------------------------------------------------------------
Opsumit 68 5 nm nm
------------------------------------------------------------
Tracleer 328 393 (17) (17)
------------------------------------------------------------
Veletri 18 11 63 62
------------------------------------------------------------
Ventavis 26 27 (5) (11)
------------------------------------------------------------
Valchlor 4 0 nm nm
------------------------------------------------------------
Zavesca 22 23 (5) (5)
------------------------------------------------------------
Others 2 1 nm nm
------------------------------------------------------------
Total product sales 468 462 1 0
------------------------------------------------------------
Sales by region - year-to-date
--------------------------------------------------------
% variance
------------------
in CHF millions 2014 2013 in CHF at CER
--------------------------------------------------------
United States 879 768 14 16
--------------------------------------------------------
Europe 717 660 9 10
--------------------------------------------------------
Japan 185 188 (1) 9
--------------------------------------------------------
Rest of the world 175 169 4 8
--------------------------------------------------------
Total product sales 1,956 1,784 10 12
--------------------------------------------------------
Sales by region - quarterly
------------------------------------------------------------
% variance
------------------
in CHF millions Q4 2014 Q4 2013 in CHF at CER
------------------------------------------------------------
United States 207 208 0 (7)
------------------------------------------------------------
Europe 174 164 6 8
------------------------------------------------------------
Japan 49 51 (3) 3
------------------------------------------------------------
Rest of the world 37 39 (5) (4)
------------------------------------------------------------
Total product sales 468 462 1 0
------------------------------------------------------------
PAH franchise
Opsumit(®)
Opsumit (macitentan) sales for 2014 amounted to CHF 180 million, reflecting a
highly successful launch in several geographic regions. The robust long-term
outcome data of Opsumit are perceived as clinically very relevant and
differentiated from other ERAs on the market. Opsumit is rapidly gaining new
patient ERA market share. At the end of 2014, over 6,300 patients were
benefiting from the product. Additional important clinical data, further
documenting the clinical utility of Opsumit, has been presented at various
medical congresses throughout the year.
At the end of 2014, Opsumit was successfully launched in the United States,
Germany, Austria, the UK, Ireland, Denmark, Sweden, the Netherlands, Australia,
Italy, Belgium, Luxembourg, Canada, Finland, Mexico (marketed as Zependo(®),
private market), Norway, Iceland and Switzerland. Further launches will take
place during 2015 and beyond, pending final price negotiations, which in some
countries are proving to be more challenging than previously anticipated.
In Japan where the registration dossier was filed in June 2014, the regulatory
process is proceeding well. The company also filed Opsumit in Russia, Turkey,
China, Brazil and other Asian and Latin America markets.
Tracleer(®)
Tracleer (bosentan) sales amounted to CHF 1,481 million for 2014, a decrease of
1% at CER compared to the full year 2013 due to erosion in markets where Opsumit
is available as well as in market price pressures and increased generic bosentan
competition. Tracleer sales were supported by the digital ulcer indication in
Europe as well as continued strong demand for Tracleer in markets where Opsumit
is not yet available. US rebate reversals related to patient assistance programs
and US price increases mitigated the decline to a certain extent. Underlying
units sold globally decreased by 2%.
Amidst increased generic competition, Actelion is successfully defending
Tracleer in markets like Canada, Turkey and Mexico. In addition, Actelion has
introduced a generic bosentan in Brazil in 2012 and launched in Poland and Czech
Republic branded generic bosentan under the name of Stayveer(®) to compete with
generics. In the US, the compound patent for bosentan is expected to expire in
November 2015.
Veletri(®)
Veletri (epoprostenol for injection) sales reached CHF 64 million for the full
year 2014, an increase of 84% at CER compared to 2013 driven by successful
launches in additional markets (i.e. Australia, the Netherlands, Spain). Japan
continues to do very well, despite a price cut on 1 March 2014 of 5%. Veletri is
well adopted approaching an 80% share of new of global i.v. epoprostenol
patients. At the end of 2014, Veletri was available in the US, Japan (marketed
as Epoprostenol "ACT"), UK, Spain, the Netherlands, Australia, New Zealand,
Portugal, Poland, Belgium, the Czech Republic and Switzerland, Canada and Italy
(marketed as Caripul(®)).
Ventavis(®)
During 2014, Ventavis (iloprost) had sales in the US of CHF 112 million, an
increase of 3% at CER. This increase was driven entirely by price increases, and
rebate reversals, as sales volumes eroded by 17% due to competitive pressures.
These pressures are expected to intensify during 2015 as a consequence of
potential generic entry.
Specialty Products
Valchlor(®)
Valchlor (mechlorethamine) sales for the full year 2014 amounted to CHF 11
million. Valchlor was launched in the US in November 2013 for Stage IA and IB
mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) in patients who have
received prior skin-directed therapy. In March 2014, the expansion of the sales
team was completed, and the company is now working with dermatologists beyond
the CTCL Centers of Excellence. We are making progress in establishing Valchlor
as an option in the treatment algorithm of early stage MF-CTCL.
Zavesca(®)
Zavesca (miglustat) sales amounted to CHF 103 million for the full year 2014, an
increase of 11% at CER compared to the full year 2013. This performance was
mainly driven by continued strong patient demand outside the US in the Niemann-
Pick type C indication. In the type 1 Gaucher disease market, the performance of
Zavesca remained strong, with relatively stable demand and positive price
movement in the US. Underlying units sold increased by 14%. The company is
anticipating competitive pressures in early 2015 as generic miglustat has been
approved for the type 1 Gaucher indication in select European markets.
CORE OPERATING EXPENSES
------------------------------------------------------------
% variance
------------------
in CHF millions 2014 2013 in CHF at CER
------------------------------------------------------------
Core cost of sales 212 208 2 4
------------------------------------------------------------
Core R&D expenses 369 356 4 4
------------------------------------------------------------
Core SG&A expenses 631 601 5 7
------------------------------------------------------------
Core operating expenses 1,213 1,165 4 6
------------------------------------------------------------
Core cost of sales
Core cost of sales for 2014 amounted to CHF 212 million, an increase of 4% at
CER compared to the same period in 2013. Core cost of sales excludes an
accretion expense of CHF 3 million related to Valchlor.
Core R&D expenses
Core R&D expenditure for 2014 increased by 4% compared to the prior year as
investment in the earlier-stage pipeline and clinical trial expenses increased.
Core R&D expenditure represented 19% of product sales in 2014. This level may
increase going forward as several exciting opportunities are advancing through
the pipeline. However, Actelion will continue to focus on carefully balancing
investment in the right programs to ensure future growth with delivery of
appropriate shareholder return.
Core SG&A expenses
Core SG&A increased by 7% at CER to CHF 631 million in 2014. This increase was
driven entirely by costs related to the launches of Opsumit and Veletri in
various markets around the globe as well as the set-up of a dedicated sales
force for Valchlor. The G&A portion remains flat, as Actelion continues to
carefully manage operating expenses.
CORE EARNINGS
----------------------------------------------------------------
% variance
------------------
in CHF millions 2014 2013 in CHF at CER
----------------------------------------------------------------
Product sales 1,956 1,784 10 12
----------------------------------------------------------------
Core operating expenses (1,213) (1,165) 4 6
----------------------------------------------------------------
Core earnings 743 619 20 25
----------------------------------------------------------------
Core earnings amounted to CHF 743 million for the full year of 2014, compared to
CHF 619 million during the same period of 2013, an increase of 25% at CER.
Excluding the net core earnings impact (at CER) of CHF 38 million US rebate
reversals (2014: CHF 66 million; 2013: CHF 32 million), core earnings rose by
20%, driven by a solid underlying operational performance and a continued focus
on cost management.
CORE NET RESULTS
----------------------------------------------------------
% variance
------------------
in CHF millions 2014 2013 in CHF at CER
----------------------------------------------------------
Core earnings 743 619 20 25
----------------------------------------------------------
Core financial result (18) (13) - -
----------------------------------------------------------
Core income tax (77) (97) - -
----------------------------------------------------------
Core net income 648 509 27 34
----------------------------------------------------------
Diluted core EPS (CHF) 5.58 4.41 27 33
----------------------------------------------------------
A full reconciliation between US GAAP and core results is available from
www.actelion.com.
The core financial expense of CHF 18 million relates mostly to interest paid on
the CHF 235 million bond (maturing on 7 December 2015) and expenses related to
the company's hedging programs.
The core tax expense of CHF 77 million translates into a core tax rate of 11%.
This tax rate is a result of a mix of profit in the main countries in which the
company operates.
Diluted core earnings per share were CHF 5.58 for the full year 2014, an
increase of 33% at CER compared to the same period of 2013.
US GAAP RESULTS
---------------------------------------------------------------------
% variance
------------------
in CHF millions 2014 2013 in CHF at CER
---------------------------------------------------------------------
Net revenue 1,958 1,786 10 12
---------------------------------------------------------------------
Operating income 570 482 18 24
---------------------------------------------------------------------
Financial result (33) (53) - -
---------------------------------------------------------------------
Income tax 57 23 - -
---------------------------------------------------------------------
Net income 594 453 31 38
---------------------------------------------------------------------
Basic earnings per share (CHF) 5.34 4.06 32 39
---------------------------------------------------------------------
Diluted earnings per share (CHF) 5.11 3.92 30 37
---------------------------------------------------------------------
US GAAP operating income includes the following items excluded from core
earnings (core operating income):
* Milestone payment upon NDA filing of selexipag of USD 20 million (CHF 19
million)
* Amortization of intangible assets of CHF 63 million (CHF 45 million in
2013), with the increase driven mostly by the amortization of Valchlor
* Other depreciation and amortization of CHF 38 million (2013: CHF 39 million)
* Stock-based compensation expenses of CHF 53 million (2013: CHF 50 million)
US GAAP net income includes the following items excluded from core net income:
* Interest of CHF 10 million on a concluded litigation
* Tax benefit of CHF 115 million mainly related to the release of a valuation
allowance on US deferred tax assets
* Tax effect of CHF 19 million on non-core operating expenses
CASH FLOW RECONCILED WITH NET CASH POSITION*
*Unrestricted net cash position includes unrestricted cash and cash equivalents
plus short-term deposits minus long-term financial debt.
-------------------------------------------------------------------------------
in CHF millions Twelve months ended 31 Twelve months ended 31
December 2014 December 2013
-------------------------------------------------------------------------------
Operating cash flow
(excluding litigation 616 592
settlement)
-------------------------------------------------------------------------------
Acquisition of tangible, (31) (27)
intangible and other assets
-------------------------------------------------------------------------------
Acquisition of a business (1) (231)
-------------------------------------------------------------------------------
Operating free cash flow
(excluding litigation 584 334
settlement)
-------------------------------------------------------------------------------
Litigation settlement (458) -
-------------------------------------------------------------------------------
Cash released (restricted) 609 (250)
for litigation
-------------------------------------------------------------------------------
Dividend (133) (113)
-------------------------------------------------------------------------------
Second-line share repurchase - (417)
program
-------------------------------------------------------------------------------
First-line share purchase (546) (58)
-------------------------------------------------------------------------------
Proceeds from exercises of 249 269
stock options
-------------------------------------------------------------------------------
Other items 22 (10)
-------------------------------------------------------------------------------
Free cash flow 327 (245)
-------------------------------------------------------------------------------
Rounding differences may occur.
* Operating cash flow, driven by the strong underlying business performance,
was strong at CHF 616 million during the full year of 2014 (excluding the
litigation settlement).
* The company paid a litigation settlement of CHF 458 million in March 2014,
out of restricted cash of CHF 609 million. The remainder (CHF 151 million)
has been released.
* The company continues to be pleased with cash collection particularly in
southern Europe with days of sales outstanding (DSO) at a record low of 63
days.
* On 15 May 2014, Actelion paid a dividend of CHF 1.20 per share amounting to
a total of
CHF 133 million to its shareholders.
* During 2014, the company purchased 5.7 million shares (CHF 546 million) on
the first-line of the Swiss Exchange to mitigate dilution arising from
employee stock compensation programs. During the full year of 2014, Actelion
employees exercised 4.8 million stock options resulting in proceeds of CHF
249 million.
* Free cash flow for 2014 amounted to CHF 327 million (FY 2013: CHF (245)
million), resulting in a gross cash position at year-end of CHF 1.2 billion.
ABBREVIATED BALANCE SHEET
-------------------------------------------------------------------------------
Twelve months Twelve months
in CHF millions ended 31 December ended 31 December Variance in CHF
2014 2013
-------------------------------------------------------------------------------
Gross cash position(*) - 1,205 878 327
Unrestricted
-------------------------------------------------------------------------------
Gross cash position - - 613 (613)
Restricted
-------------------------------------------------------------------------------
Trade and other 400 406 (6)
receivables, net
-------------------------------------------------------------------------------
Other current assets 121 123 (2)
-------------------------------------------------------------------------------
Tangible assets 368 381 (13)
-------------------------------------------------------------------------------
Intangible assets 441 465 (24)
-------------------------------------------------------------------------------
Goodwill 134 126 8
-------------------------------------------------------------------------------
Other non-current assets 78 38 41
-------------------------------------------------------------------------------
Total assets 2,748 3,030 (282)
-------------------------------------------------------------------------------
Litigation provision - 456 (456)
-------------------------------------------------------------------------------
Other current 429 516 (86)
liabilities
-------------------------------------------------------------------------------
Financial debt 235 235 0
-------------------------------------------------------------------------------
Other non-current 163 114 49
liabilities
-------------------------------------------------------------------------------
Total liabilities 827 1,321 (493)
-------------------------------------------------------------------------------
Share capital and 2,208 2,252 (43)
accumulated reserves
-------------------------------------------------------------------------------
Treasury shares (288) (543) 255
-------------------------------------------------------------------------------
Total shareholders' 1,920 1,709 211
equity
-------------------------------------------------------------------------------
Total liabilities and 2,748 3,030 (282)
shareholders' equity
-------------------------------------------------------------------------------
*Gross cash position includes cash, cash equivalents and short-term deposits.
Rounding differences may occur.
CLINICAL DEVELOPMENT UPDATE
Actelion's promising R&D pipeline comprises novel compounds addressing a broad
range of diseases, including cardiovascular and immunological disorders as well
as central nervous system disorders and infectious disease.
Actelion's late-stage product candidates include the novel antibiotic cadazolid
under investigation for Clostridium difficile-associated diarrhea (CDAD).
-------------------------------------------------------------------------------
Phase Compound Indication Study Status
-------------------------------------------------------------------------------
Clostridium
III Cadazolid difficile-associated IMPACT Ongoing
diarrhea
-------------------------------------------------------------------------------
III Macitentan Eisenmenger syndrome MAESTRO Ongoing
-------------------------------------------------------------------------------
III Selexipag PAH GRIPHON Submissions
ongoing
-------------------------------------------------------------------------------
II Ponesimod Multiple sclerosis Extension study Ongoing
-------------------------------------------------------------------------------
Chronic
II Macitentan thromboembolic MERIT Ongoing
pulmonary
hypertension
-------------------------------------------------------------------------------
Combined pre- and
II Macitentan post-capillary MELODY Ongoing
pulmonary
hypertension
-------------------------------------------------------------------------------
Raynaud's phenomenon
II Selexipag secondary to - Ongoing
systemic sclerosis
-------------------------------------------------------------------------------
I Ponesimod Immunological - Phase II in
Disorders preparation
-------------------------------------------------------------------------------
I Lucerastat Lipid storage - Phase II in
disorders preparation
-------------------------------------------------------------------------------
I S1P(1) modulator Immunological - Phase II in
disorders preparation
-------------------------------------------------------------------------------
I Macitentan Glioblastoma - Ongoing
-------------------------------------------------------------------------------
I New Chemical Cardiovascular - Ongoing
Entity Disorders
-------------------------------------------------------------------------------
HUMAN RESOURCES
At the end of 2014, Actelion employed 2,470 permanent employees worldwide, an
increase of 3% (or 74 permanent positions) compared to the end of 2013.
ABOUT ACTELION LTD.
Actelion Ltd. is a leading biopharmaceutical company focused on the discovery,
development and commercialization of innovative drugs for diseases with
significant unmet medical needs.
Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our
portfolio of PAH treatments covers the spectrum of disease, from WHO Functional
Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.
Although not available in all countries, Actelion has treatments approved by
health authorities for a number of specialist diseases including Type 1 Gaucher
disease, Niemann-Pick type C disease, Digital Ulcers in patients suffering from
systemic sclerosis, and mycosis fungoides type cutaneous T-cell lymphoma.
Founded in late 1997, with now over 2,400 dedicated professionals covering all
key markets around the world including Europe, the US, Japan, China, Russia and
Mexico, Actelion has its corporate headquarters in Allschwil / Basel,
Switzerland.
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®). All trademarks
are legally protected.
For further information please contact:
Andrew Weiss
Senior Vice President, Head of Investor Relations & Corporate Communications
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
www.actelion.com
Webcast:
http://view-w.tv/p/120-121-15379/en
Financial Fact Sheet:
http://hugin.info/131801/R/1894511/671640.pdf
Press Release PDF:
http://hugin.info/131801/R/1894511/671638.pdf
Financial Statement:
http://hugin.info/131801/R/1894511/671641.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire 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 GlobeNewswire
[HUG#1894511]
Unternehmensinformation / Kurzprofil:
Datum: 16.02.2015 - 07:00 Uhr
Sprache: Deutsch
News-ID 371744
Anzahl Zeichen: 63362
contact information:
Town:
Allschwil
Kategorie:
Business News
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"Actelion delivers outstanding 2014 results"
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