Actelion delivers strong nine months results
(Thomson Reuters ONE) -
Actelion Pharmaceuticals Ltd /
Actelion delivers strong nine months results
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The issuer is solely responsible for the content of this announcement.
ALLSCHWIL/BASEL, SWITZERLAND - 21 October 2014 - Actelion Ltd (SIX: ATLN) today
announced its results for the first nine months of 2014.
PRODUCT HIGHLIGHTS
* Opsumit - strong uptake in all markets launched
* Selexipag - regulatory US/EU filing in coming months
* Tracleer - solid sales in non-Opsumit markets
* Veletri - rapidly becoming i.v. epoprostenol of choice
FINANCIAL HIGHLIGHTS
* Product sales of CHF 1,488 million, up 17% at Constant Exchange Rates (CER)
* Core earnings of CHF 630 million, up 34% at CER (up 21% ex US rebate
reversals)
* Core EPS of CHF 4.77, an increase of 42% at CER
* Upgraded 2014 financial guidance - Core earnings growth now expected to be
in the low twenties percentage range at CER
--------------------------------------------------------------------------
% variance
--------------------
in CHF million 9M 2014 9M 2013 in CHF at CER((1))
(except for per share data)
--------------------------------------------------------------------------
Total product sales 1,488 1,322 13 17
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US-GAAP Operating income 519 397 31 39
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Core earnings (Core operating income) 630 496 27 34
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US-GAAP EPS (fully diluted) 4.87 2.65 84 95
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Core EPS (fully diluted) 4.77 3.54 35 42
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As of 30 September 2014, Actelion had cash and cash equivalents of CHF 1.1
billion. In addition, Actelion holds 3 million treasury shares.
(1) CER percentage changes are calculated by reconsolidating both the 9M 2014
and 9M 2013 results at constant currencies (the average monthly exchange rates
for 9M 2013).
Jean-Paul Clozel, MD, Chief Executive Officer, commented: "Actelion continues to
make significant progress. We are launching Opsumit successfully around the
globe and we are very close to filing selexipag with healthcare authorities in
the EU and the US. With these two new assets we can strengthen our leadership in
PAH and continue to create value for all stakeholders."
Otto Schwarz, Chief Operating Officer, commented: "With sales of CHF 59 million
during the third quarter 2014, Opsumit's strong launch momentum continues as we
gain ERA market share and continue to roll out the product in all major markets.
Opsumit's highly differentiated label drives its rapid adoption in daily medical
practice. By the end of the third quarter, Opsumit was available to patients in
16 markets including the most recent additions: Australia, Belgium, Iceland,
Italy, and Luxembourg."
André C. Muller, Chief Financial Officer, commented: "Strong product sales
across the portfolio and around the globe, as well as ongoing cost control have
resulted in core earnings growth of 21 percent - excluding the impact of
reversals for US rebates accrued in prior years. These strong results have again
increased our expectations for core earnings growth for the full year."
Barring unforeseen events, Actelion now expects 2014 core earnings growth to be
in the low twenties percentage range at constant exchange rates. Excluding the
impact of US rebate reversals, Actelion now expects 2014 core earnings growth to
be in the mid-teen percentage range, also at constant exchange rates. Actelion
will review its 2015 guidance early next year.
FINANCIAL REVIEW
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 million 9M 2014 9M 2013 in CHF at CER((1))
-------------------------------------------------------------------------
Total product sales 1,488 1,322 13 17
-------------------------------------------------------------------------
Core R&D expenditure 254 251 1 3
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Core earnings((2)) 630 496 27 34
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Core net income 554 407 36 43
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Diluted core EPS (CHF)((3)) 4.77 3.54 35 42
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Key highlights - quarterly
-------------------------------------------------------------------------
% variance
-----------------------
in CHF million Q3 2014 Q3 2013 in CHF at CER((1))
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Total product sales 496 438 13 16
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Core R&D expenditure 88 83 6 7
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Core earnings((2)) 209 165 27 31
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Core net income 176 137 28 32
-------------------------------------------------------------------------
Diluted core EPS (CHF)((3)) 1.52 1.20 27 31
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1. CER percentage changes are calculated by reconsolidating both the CY 2014
and PY 2013 results at constant exchange rates (the average monthly exchange
rates PY 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.
3. Core EPS for 9M 2013 was recalculated to apply the prevailing tax rate for
each adjustment (formerly CHF 3.60, using an average blended rate).
PRODUCT SALES
Product sales for the first nine months of 2014 were CHF 1,488 million, up 17%
at CER compared to the first nine months of 2013. Excluding the net impact (CHF
69 million) at CER of US rebate reversals (9M 2014: CHF 74 million; 9M 2013: CHF
8 million), product sales increased by 12% at CER.
Sales by product - year-to-date
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% variance
------------------
in CHF million 9M 2014 9M 2013 in CHF at CER
------------------------------------------------------------
Opsumit 112 0 - -
------------------------------------------------------------
Tracleer 1,153 1,138 1 5
------------------------------------------------------------
Veletri 46 25 82 93
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Ventavis 86 83 4 8
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Valchlor 7 0 - -
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Zavesca 81 73 12 15
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Others 4 3 - -
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Total product sales 1,488 1,322 13 17
------------------------------------------------------------
Sales by product - quarterly
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% variance
------------------
in CHF million Q3 2014 Q3 2013 in CHF at CER
------------------------------------------------------------
Opsumit 59 0 - -
------------------------------------------------------------
Tracleer 361 371 (3) (1)
------------------------------------------------------------
Veletri 16 11 43 48
------------------------------------------------------------
Ventavis 28 30 (6) (4)
------------------------------------------------------------
Valchlor 4 0 - -
------------------------------------------------------------
Zavesca 27 25 9 11
------------------------------------------------------------
Others 1 1 - -
------------------------------------------------------------
Total product sales 496 438 13 16
------------------------------------------------------------
Sales by region - year-to-date
------------------------------------------------------------
% variance
------------------
in CHF million 9M 2014 9M 2013 in CHF at CER
------------------------------------------------------------
United States 673 560 20 25
------------------------------------------------------------
Europe 542 496 9 11
------------------------------------------------------------
Japan 136 137 (1) 11
------------------------------------------------------------
Rest of the world 138 130 6 12
------------------------------------------------------------
Total product sales 1,488 1,322 13 17
------------------------------------------------------------
Sales by region - quarterly
------------------------------------------------------------
% variance
------------------
in CHF million Q3 2014 Q3 2013 in CHF at CER
------------------------------------------------------------
United States 231 193 20 22
------------------------------------------------------------
Europe 174 159 10 12
------------------------------------------------------------
Japan 44 46 (5) 2
------------------------------------------------------------
Rest of the world 47 41 16 17
------------------------------------------------------------
Total product sales 496 438 13 16
------------------------------------------------------------
PAH franchise
Opsumit(®
)Opsumit (macitentan) sales for the first nine months of 2014 amounted to CHF
112 million, reflecting a strong momentum in all markets where the product has
been launched with reimbursement. Global launch activities are progressing
rapidly with launches in Australia, Belgium, Iceland, Italy and Luxembourg
during the third quarter. To date, Opsumit has been successfully introduced in
the US, Germany, Austria (reimbursement achieved 1 Sep 2014), Switzerland,
Canada, the UK, Ireland, Denmark, Norway, Sweden, the Netherlands, Luxembourg,
Iceland, Italy, Belgium and Australia. Launches are planned in France, Spain,
and Japan, among other countries, in 2015.
Tracleer(®
)Tracleer (bosentan) sales amounted to CHF 1,153 million for the first nine
months of 2014, an increase of 5% at CER compared to the same period in 2013.
This increase was largely the result of US rebate reversals related to patient
assistance programs, as well as US price increases. Demand for Tracleer in
markets where Opsumit is not yet available remains solid. Overall, underlying
units were flat compared to the same period last year. Actelion's branded
bosentan generic, Stayveer(®), was successfully launched by Marklas in Poland
and the Czech Republic.
Veletri(®
)Veletri (epoprostenol for injection) sales amounted to CHF 46 million for the
first nine months of 2014, an increase of 93% at CER compared to the same period
in 2013. This increase was driven by continued strong uptake in Japan (as
Epoprostenol "ACT"), and supported by an increasing share of the intravenous
epoprostenol market in the US as well as launches in various European markets
during the first half of 2014 and, in Australia, where the product was launched
in the third quarter of 2014.
Ventavis(®
)Ventavis (iloprost) had sales in the US of CHF 86 million for the first nine
months of 2014, an increase of 8% at CER. This increase was driven entirely by
price and rebate reversals, as sales volumes continue to be eroded by
competitive pressures. These pressures are expected to intensify as a
consequence of potential generic entries, but Actelion is ready to defend its
position in the market.
Specialty Products
Valchlor(®
)Valchlor (mechlorethamine) sales for the first nine months of 2014 amounted to
CHF 7 million. Valchlor was first launched in the US in November 2013 for Stage
IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (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.
Zavesca(®
)Zavesca (miglustat) sales amounted to CHF 81 million for the first nine months
of 2014, an increase of 15% at CER compared to the same period in 2013. This
performance was driven predominantly by strong patient demand outside the US in
the Niemann-Pick type C indication. In the type 1 Gaucher disease market, the
performance of Zavesca remains strong, with relatively stable demand and
positive price movement in the US.
A generic miglustat - for the type 1 Gaucher disease (GD1) indication only - has
been approved in Spain and Denmark. Further national approvals are expected to
follow. Hence, in these markets generic competition has to be expected later in
Q4 and in 2015. In Europe, less than 25% of all patients receiving Zavesca are
treated for GD1 disease. The company is preparing to protect its Niemann-Pick
Type C (NP-C) business, which still has orphan drug protection for several
years.
CORE OPERATING EXPENSES
----------------------------------------------------------------
% variance
------------------
in CHF million 9M 2014 9M 2013 in CHF at CER
----------------------------------------------------------------
Core cost of sales 155 154 1 4
----------------------------------------------------------------
Core R&D expenses 254 251 1 3
----------------------------------------------------------------
Core SG&A expenses 449 421 6 10
----------------------------------------------------------------
Core operating expenses 858 827 4 7
----------------------------------------------------------------
Core cost of sales
Core cost of sales for the first nine months of 2014 amounted to CHF 155
million, an increase of 4% at CER compared to the same period in 2013, in-line
with higher product sales.
Core R&D expenses
Core R&D expenses - which exclude stock-based compensation expenses,
amortization and depreciation - were CHF 254 million for the first nine months
of 2014, an increase of 3% at CER compared to the same period of 2013, as
clinical development costs increased slightly.
Core SG&A expenses
Core selling, general and administration expenses - which exclude stock-based
compensation expenses, amortization, depreciation and the impact of doubtful
debt provisions - were CHF 449 million for the first nine months of 2014, an
increase of 10% at CER compared to the same period of 2013. This increase was
driven entirely by costs related to the launches of Opsumit, Valchlor and
Veletri in various markets around the globe. The G&A portion continues to remain
flat, as Actelion carefully manages operating expenses.
CORE EARNINGS
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% variance
------------------
in CHF million 9M 2014 9M 2013 in CHF at CER
----------------------------------------------------------------
Product sales 1,488 1,322 13 17
----------------------------------------------------------------
Core operating expenses (858) (827) 4 7
----------------------------------------------------------------
Core earnings 630 496 27 34
----------------------------------------------------------------
Core earnings amounted to CHF 630 million for the first nine months of 2014,
compared to CHF 496 million during the same period of 2013, an increase of 34%
at CER. Excluding the net core earnings impact (at CER) of CHF 63 million US
rebate reversals (9M 2014: CHF 67 million; 9M 2013: CHF 7 million), core
earnings rose by 21%, driven by a solid underlying operational performance and a
continued focus on cost management.
CORE NET INCOME AND CORE EARNINGS PER SHARE
----------------------------------------------------------------
% variance
------------------
in CHF million 9M 2014 9M 2013 in CHF at CER
----------------------------------------------------------------
Core earnings 630 496 27 34
----------------------------------------------------------------
Core financial expenses (10) (10) - -
----------------------------------------------------------------
Core tax expenses (67) (78) - -
----------------------------------------------------------------
Core net income 554 407 36 43
----------------------------------------------------------------
Diluted core EPS (CHF) 4.77 3.54 35 42
----------------------------------------------------------------
A full reconciliation between US GAAP and core results is available from
www.actelion.com.
The core financial result is mainly composed of the interest expense of CHF 8
million on the CHF 235 million bond, as well as a net loss of CHF 2 million from
hedging and valuation positions.
The core tax expense of CHF 67 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 4.77 for the first nine months of
2014, an increase of 42% at CER compared to the same period of 2013. Core EPS
for the first nine months of 2013 of CHF 3.54 was recalculated to apply the
prevailing tax rate for each adjustment (formerly CHF 3.60, using an average
blended rate).
US GAAP RESULTS
-------------------------------------------------------------------------
% variance
------------------
in CHF million 9M 2014 9M 2013 in CHF at CER
-------------------------------------------------------------------------
Net revenue 1,490 1,324 13 17
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Operating income 519 397 31 39
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Net income 566 304 86 97
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Basic earnings per share (CHF) 5.09 2.73 87 98
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Diluted earnings per share (CHF) 4.87 2.65 84 95
-------------------------------------------------------------------------
US GAAP operating income includes the following items excluded from core
earnings (core operating income):
* Depreciation and amortization of CHF 75 million (9M 2013: CHF 58 million)
* Stock-based compensation expenses of CHF 38 million (9M 2013: CHF 37
million)
* Reversal of doubtful debt allowance of CHF 2 million (9M 2013: CHF 10
million)
* Accretion expenses of CHF 1 million related to the Valchlor contingent
consideration
* Operating income for 9M 2013 included an arbitration settlement of CHF 13
million
US GAAP net income includes the following items excluded from core net income:
* Interest of CHF 10 million on the concluded Asahi litigation
* Tax benefit of CHF 121 million due to release of the US valuation allowance
related to the Asahi litigation
* Tax effect of CHF 11 million on non-core operating expenses (9M 2013:
CHF 26 million)
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 million Nine months ended 30 Nine months ended 30
September 2014 September 2013
-------------------------------------------------------------------------------
Operating cash flow
(excluding litigation 455 445
settlement)
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Acquisition of tangible, (21) (20)
intangible and other assets
-------------------------------------------------------------------------------
Acquisition of a business - (226)
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Litigation settlement (458) -
-------------------------------------------------------------------------------
Operating free cash flow (24) 199
-------------------------------------------------------------------------------
Cash released (restricted) 609 (250)
for litigation
-------------------------------------------------------------------------------
Dividend (133) (113)
-------------------------------------------------------------------------------
Second-line share repurchase - (417)
program
-------------------------------------------------------------------------------
First-line share purchase (449) 97
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Proceeds from exercises of 206 148
stock options
-------------------------------------------------------------------------------
Other items 19 (5)
-------------------------------------------------------------------------------
Free cash flow 227 (341)
-------------------------------------------------------------------------------
Rounding differences may occur.
* Operating cash flow excluding the litigation settlement remained strong at
CHF 455 million during the first nine months of 2014.
* The company paid a litigation settlement of CHF 458 million in March 2014,
out of restricted cash of CHF 609 million. The remainder has been released.
* 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.
* The company bought 4.8 million shares (CHF 449 million) during the first
nine months of 2014 in connection with the first line share purchase program
announced in December 2013 in order to manage the dilution arising from
stock-based compensation. During the first nine months of 2014, Actelion
employees exercised 4 million stock options resulting in proceeds of CHF
206 million.
* Free cash flow amounted for the first nine months of 2014 to CHF 227
million, resulting in an unrestricted gross cash position of CHF 1,105
million and unrestricted net cash position of CHF 870 million.
ABBREVIATED BALANCE SHEET
-------------------------------------------------------------------------------
Nine months ended Twelve months
in CHF million 30 September 2014 ended 31 December Variance in CHF
2013
-------------------------------------------------------------------------------
Gross cash position(*) 1,105 878 227
- Unrestricted
-------------------------------------------------------------------------------
Gross cash position - - 613 (613)
Restricted
-------------------------------------------------------------------------------
Trade and other 438 406 32
receivables, net
-------------------------------------------------------------------------------
Other current assets 94 123 (29)
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Tangible assets 365 381 (16)
-------------------------------------------------------------------------------
Intangible assets 447 465 (19)
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Goodwill 132 126 6
-------------------------------------------------------------------------------
Other non-current 148 38 110
assets
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Total assets 2,729 3,030 (301)
-------------------------------------------------------------------------------
Litigation provision - 456 (456)
-------------------------------------------------------------------------------
Other current 415 516 (101)
liabilities
-------------------------------------------------------------------------------
Financial debt 235 235 0
-------------------------------------------------------------------------------
Other non-current 123 114 10
liabilities
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Total liabilities 773 1,321 (548)
-------------------------------------------------------------------------------
Share capital and 2,225 2,252 (26)
accumulated reserves
-------------------------------------------------------------------------------
Treasury shares (270) (543) 273
-------------------------------------------------------------------------------
Total shareholders' 1,955 1,709 246
equity
-------------------------------------------------------------------------------
Total liabilities and 2,729 3,030 (301)
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 includes the novel antibiotic cadazolid
under investigation for Clostridium difficile-associated diarrhea (CDAD).
-------------------------------------------------------------------------------
Phase Compound Indication Study Status
-------------------------------------------------------------------------------
III Selexipag Pulmonary arterial GRIPHON Filing in
hypertension preparation
-------------------------------------------------------------------------------
Clostridium
III Cadazolid difficile-associated IMPACT Ongoing
diarrhea
-------------------------------------------------------------------------------
III Macitentan Eisenmenger syndrome MAESTRO Ongoing
-------------------------------------------------------------------------------
II Ponesimod Multiple sclerosis Extension study Ongoing
-------------------------------------------------------------------------------
II Macitentan CTEPH MERIT Ongoing
-------------------------------------------------------------------------------
I Lucerastat Lipid storage - Phase II in
disorders preparation
-------------------------------------------------------------------------------
I Macitentan Glioblastoma - Ongoing
-------------------------------------------------------------------------------
I S1P(1) modulator Immunological - Ongoing
disorders
-------------------------------------------------------------------------------
UPCOMING EVENTS
* FY 2014 Financial Results reporting on 16 February 2015
* 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 EDITORS
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
Financial Statement:
http://hugin.info/131801/R/1864270/654286.pdf
Press Release PDF:
http://hugin.info/131801/R/1864270/654283.pdf
Financial Fact Sheet:
http://hugin.info/131801/R/1864270/654285.pdf
Webcast:
http://view-w.tv/p/120-121-14920/en
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#1864270]
Unternehmensinformation / Kurzprofil:
Datum: 21.10.2014 - 07:00 Uhr
Sprache: Deutsch
News-ID 345453
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contact information:
Town:
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