Very strong performance in the first half of 2016 - enhanced by successful Uptravi US launch
(Thomson Reuters ONE) -
Actelion Pharmaceuticals Ltd /
Very strong performance in the first half of 2016 - enhanced by successful
Uptravi US launch
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The issuer is solely responsible for the content of this announcement.
ALLSCHWIL/BASEL, SWITZERLAND - 21 July 2016 - Actelion Ltd (SIX: ATLN) today
announced its results for the first six months of 2016.
OPERATING HIGHLIGHTS
* Excellent Opsumit(®) (macitentan) trajectory and new patient referrals
sustained
* Continued outstanding US launch momentum for Uptravi(®) (selexipag), Q2
launches in Germany, Canada (private market) and France (cohort ATU)
* Initiation of Phase III study to evaluate the efficacy and safety of long-
term use of macitentan (Opsumit) for the treatment of children with PAH
* Initiation of Phase II program with new dual orexin receptor antagonist for
the treatment of insomnia
FINANCIAL HIGHLIGHTS
* Sales of CHF 1,179 million (+13% at CER) - portfolio transformation well
underway
* Opsumit sales grow to CHF 378 million
* Uptravi sales of CHF 90 million
* US GAAP operating income of CHF 412 million (+12% at CER)
* Core operating income of CHF 499 million (+11% at CER)
* 2016 financial guidance upgrade: core operating income growth in the low-
teen percentage range, at constant exchange rates and barring unforeseen
events
------------------------------------------------------------------------
% variance
----------------------
in CHF million H1 2016 H1 2015 in CHF at CER(1)
(except for per share data)
------------------------------------------------------------------------
US GAAP results
------------------------------------------------------------------------
Net revenue 1,180 1,011 17 13
------------------------------------------------------------------------
Operating income 412 344 20 12
------------------------------------------------------------------------
Net income 361 287 25 17
------------------------------------------------------------------------
Diluted EPS 3.32 2.50 33 23
------------------------------------------------------------------------
Core performance((2))
------------------------------------------------------------------------
Product sales 1,179 1,008 17 13
------------------------------------------------------------------------
Core operating income 499 423 18 11
------------------------------------------------------------------------
Core net income 440 357 23 16
------------------------------------------------------------------------
Core diluted EPS 4.05 3.11 30 23
------------------------------------------------------------------------
------------------------------------------------------
Cash flow H1 2016 H1 2015
------------------------------------------------------
Operating cash flow 420 278
------------------------------------------------------
Capital expenditure -31 -11
------------------------------------------------------
Free cash flow 14 -540
------------------------------------------------------
Net cash position as of 30 June 418 430
------------------------------------------------------
1. CER percentage changes are calculated by reconsolidating both the H1 2015
and H1 2016 results at constant currencies (the average monthly exchange
rates for H1 2015).
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.
Jean-Paul Clozel, MD, Chief Executive Officer, commented: "We have had an
excellent first half year, mainly driven by the strong performance of both
Opsumit and Uptravi. We have also made significant progress with our development
pipeline by initiating a Phase III long-term study with macitentan for the
treatment of children with PAH and a Phase II program with our new dual orexin
receptor antagonist. All in all, the transformation of the company is well
underway and I am very pleased with our achievements. What's more, I am
confident that we can sustain this momentum moving forward."
Otto Schwarz, Chief Operating Officer, commented: "The strong uptake of Uptravi
is the result of the robust clinical data generated with this innovative drug,
combined with our strong commercial capabilities to launch specialty therapies.
Sales reached 90 million Swiss francs for the first six months of the year with
about 1,150 patients benefiting from Uptravi at the end of June. Along with the
continued strong Opsumit launch momentum and the Veletri growth, the
transformation of our PAH portfolio is progressing well, with almost half of the
second quarter 2016 sales stemming from our new outcome-based therapies."
André C. Muller, Chief Financial Officer, commented: "The balance of sales
growth with disciplined R&D investment in the company's future has resulted in
double-digit US GAAP and core operating income growth. Based on this excellent
first half year, along with more clarity on a number of factors, including the
strong Opsumit and Uptravi launch dynamics, stable pricing in Japan for Opsumit
and Tracleer, and the unlikely entry of generic competition for Tracleer in the
US in 2016, the company has increased the outlook for the full year. Barring
unforeseen events, we now expect 2016 core operating income growth in the low-
teen percentage range at constant exchange rates."
SALES UPDATE
Actelion delivered an outstanding first half 2016, driven by a very strong
Uptravi launch in the US and the continued successful uptake of Opsumit. The
excellent performance of the company's outcome-based PAH portfolio is the result
of consistently strong referrals of new PAH patients across markets, as well as
an increase in the number of patients benefitting from double and triple
combination PAH therapy.
In the US, sales increased by 25% at CER, driven by the strong Uptravi launch,
continued Opsumit momentum and ERA market share gains. European sales were 1%
lower at CER, despite increased Opsumit uptake and Tracleer use in the digital
ulcer indication, due to continued pricing pressure and market erosion from
generics, particularly in Spain. Sales in Japan increased by 20% at CER, mostly
driven by very strong sales of Opsumit (launched in June 2015), Veletri and
Zavesca (Japanese trade name Brazaves).
Comparing average exchange rates for the first six months of 2016 to the first
six months of 2015, the Swiss franc weakened, mostly against the US dollar, euro
and Japanese yen, resulting in a positive currency variance of 39 million Swiss
francs.
Sales by product - H1 2016
--------------------------------------------------------------
% variance
------------------
in CHF millions H1 2016 H1 2015 in CHF at CER
--------------------------------------------------------------
Opsumit(®) 378 208 82 76
--------------------------------------------------------------
Tracleer(®) 546 645 -15 -18
--------------------------------------------------------------
Uptravi(®) 90 - nm nm
--------------------------------------------------------------
Veletri(®) 48 38 24 19
--------------------------------------------------------------
Ventavis(®) 43 57 -24 -27
--------------------------------------------------------------
Valchlor(®) 18 12 49 43
--------------------------------------------------------------
Zavesca(®) 52 44 17 15
--------------------------------------------------------------
Others 4 3 17 22
--------------------------------------------------------------
Total product sales 1 ,179 1,008 17 13
--------------------------------------------------------------
Sales by product - Q2 2016
--------------------------------------------------------------
% variance
------------------
in CHF millions Q2 2016 Q2 2015 in CHF at CER
--------------------------------------------------------------
Opsumit(®) 200 113 77 71
--------------------------------------------------------------
Tracleer(®) 256 301 -15 -19
--------------------------------------------------------------
Uptravi(®) 56 - nm nm
--------------------------------------------------------------
Veletri(®) 24 19 24 18
--------------------------------------------------------------
Ventavis(®) 17 26 -35 -37
--------------------------------------------------------------
Valchlor(®) 9 7 24 20
--------------------------------------------------------------
Zavesca(®) 27 25 8 6
--------------------------------------------------------------
Others 2 2 13 15
--------------------------------------------------------------
Total product sales 590 493 20 15
--------------------------------------------------------------
Sales by region - H1 2016
-------------------------------------------------------------
% variance
------------------
in CHF millions H1 2016 H1 2015 in CHF at CER
-------------------------------------------------------------
United States 639 495 29 25
-------------------------------------------------------------
Europe* 322 318 1 -1
-------------------------------------------------------------
Japan 116 86 34 20
-------------------------------------------------------------
Rest of the world 102 109 -6 -3
-------------------------------------------------------------
Total product sales 1,179 1,008 17 13
-------------------------------------------------------------
*Europe = EU28 and Switzerland
Sales by region - Q2 2016
--------------------------------------------------------------
% variance
------------------
in CHF millions Q2 2016 Q2 2015 in CHF at CER
--------------------------------------------------------------
United States 313 243 29 25
--------------------------------------------------------------
Europe* 158 155 1 -3
--------------------------------------------------------------
Japan 66 45 48 29
--------------------------------------------------------------
Rest of the world 54 50 8 10
--------------------------------------------------------------
Total product sales 590 493 20 15
--------------------------------------------------------------
*Europe = EU28 and Switzerland
PAH FRANCHISE
Opsumit(®)
Sales of Opsumit (macitentan) amounted to 378 million Swiss francs for the first
six months of 2016, an increase of 76% at CER compared to the first six months
of 2015. This increase continues to be driven by the uptake trajectory with
commercial availability in over 30 countries. The strong increase in patients
benefitting from Opsumit is driven by referral of treatment-naïve patients
together with increased early combination with PDE-5 inhibitors, and some
switching from Tracleer, notably in Japan.
Uptravi(®)
Sales of Uptravi (selexipag) amounted to 90 million Swiss francs for the first
six months of 2016. Of this total amount, approximately 30 million Swiss francs
can be attributed to the build-up of the US launch inventory as 10 different
presentations of the drug across the various doses were made available. Uptravi
has been fully launched in the US since 4 January 2016 and in Germany since 15
June 2016.
During the second quarter 2016, Uptravi also became available in France under a
cohort ATU and in Canada for the private market segment. At the end of June,
about 1,150 patients were using this outcome-based, oral selective IP receptor
agonist.
Tracleer(®)
Sales of Tracleer (bosentan) amounted to 546 million Swiss francs for the first
six months of 2016, a decrease of 18% at CER compared to the first six months of
2015. This decrease is mostly a consequence of lower use in countries where
Opsumit is available, due to lower referral of new patients as well as switches
to Opsumit. Underlying volumes decreased globally by 16%. Tracleer sales were
further impacted by increased generic bosentan competition, notably in Spain,
continued pricing pressure in Europe, and order phasing/inventory adjustment in
the US.
Positively, Tracleer sales were supported by the digital ulcer indication in
Europe and Japan and continued solid demand in markets where Opsumit is not yet
available.
Following the Pediatric Investigation Plan (PIP) compliance statement from the
European Committee for Medicinal Products for Human Use (CHMP), applications for
extension of the Supplementary Protection Certificate (SPC) were filed in 19 EU
countries and have been granted in 15 of those, with 4 still pending.
Veletri(®)
Sales of Veletri (epoprostenol for injection) amounted to 48 million Swiss
francs for the first six months of 2016, an increase of 19% at CER, compared to
the first six months of 2015. This increase was mostly driven by increased
market penetration, successful launches in additional markets, and continued
growth in Japan (where it is marketed as Epoprostenol "ACT"). In March 2016,
Actelion Japan was notified of an average 12% price cut for Veletri, effective
March 1, 2016. At the end of June 2016, Veletri was available in 15 countries
globally.
Ventavis(®)
Sales of Ventavis (iloprost) amounted to 43 million Swiss francs for the first
six months of 2016, a decrease of 27% at CER, compared to the first six months
of 2015. This is due to the competitive environment, including the availability
of Uptravi. Underlying units decreased by 34%.
SPECIALTY PRODUCTS
Valchlor(®)
Sales of Valchlor (mechlorethamine) amounted to 18 million Swiss francs for the
first six months of 2016, an increase of 43% at CER, compared to the first six
months of 2015. In the US, the company is continuing its efforts to establish
Valchlor as an option in the treatment algorithm for early-stage mycosis
fungoides, a type of Cutaneous T-Cell Lymphoma (MF-CTCL).
In France, patients benefited from the drug under a temporary nominative
authorization for use ("ATU") program initiated during the second half of 2014.
The regulatory dossier is currently under review with the European Medicines
Agency (under the trade name Ledaga(®)).
Zavesca(®)
Sales of Zavesca (miglustat) amounted to 52 million Swiss francs for the first
six months of 2016, an increase of 15% at CER compared to the first six months
of 2015. Sales in the US were strong due to a relatively low prior year base as
a consequence of last year's inventory adjustment. The global number of patients
receiving therapy grew by 5% compared to the first half of 2015, driven by a
14% increase in Niemann-Pick type C demand.
In Europe, sales decreased by 2% mainly due to the launch of generic miglustat
(approved for the type 1 Gaucher disease indication only), which has become
commercially available in Spain, Sweden and the Czech Republic. Sales in Japan
were 19% higher, driven by increased patient demand in the Niemann-Pick type C
indication.
PIPELINE
Actelion's pipeline has made significant progress, with macitentan (Opsumit)
entering into Phase III for the treatment of children with PAH, and the
advancement of the new dual orexin receptor antagonist into Phase II development
for the treatment of insomnia. In addition, inclusion of participants in the
ongoing Phase III studies for cadazolid and ponesimod is progressing well and is
on target to be completed by the end of 2016. The MERIT study of macitentan for
the treatment of patients with chronic thromboembolic pulmonary hypertension
(CTEPH) has completed enrollment and is on schedule to deliver results by the
end of the year.
Compound Indication Study Status
-------------------------------------------------------------------------------
Cadazolid Clostridium difficile- IMPACT Ongoing
associated diarrhea
---------------------------------------------------------------------
Phase III Macitentan Eisenmenger syndrome MAESTRO Ongoing
---------------------------------------------------------------------
Macitentan Pediatric PAH TOMORROW Initiating
---------------------------------------------------------------------
Ponesimod Multiple sclerosis OPTIMUM Ongoing
-------------------------------------------------------------------------------
Cenerimod Systemic lupus - Ongoing
erythematosus
---------------------------------------------------------------------
Reversal of vasospasm
Clazosentan associated with REVERSE Ongoing
aneurysmal subarachnoid
hemorrhage
---------------------------------------------------------------------
Dual Orexin Receptor Insomnia - Initiating
Antagonist
Phase II ---------------------------------------------------------------------
Endothelin Receptor Specialty cardiovascular - Ongoing
Antagonist disorders
---------------------------------------------------------------------
Macitentan Chronic thromboembolic MERIT Ongoing
pulmonary hypertension
---------------------------------------------------------------------
Combined pre- and post-
Macitentan capillary pulmonary MELODY Complete
hypertension
---------------------------------------------------------------------
Ponesimod Graft-versus-host disease - Ongoing
-------------------------------------------------------------------------------
Phase Ib Lucerastat Fabry disease - Complete
-------------------------------------------------------------------------------
New Chemical Entity Cardiovascular disorders - Ongoing
---------------------------------------------------------------------
Selective Orexin 1 Neurological disorders - Ongoing
Receptor Antagonist
Phase I ---------------------------------------------------------------------
T-type Calcium Channel Neurological disorders - Ongoing
Blocker
-------------------------------------------------------------------------------
RESULTS DAY CENTER
Investor community: To make your job easier, we provide links to all relevant
documentation, such as a full financial review, reconciliation US-GAAP to Core
results and geographical breakdown by product, from the Results Day Center on
our corporate website: www.actelion.com/results-day-center.
HALF YEAR REPORT
Full details on the progress made during the first six months of 2016 are
available in Actelion's 2016 Half Year Report, available from
www.actelion.com/half-year-report.
UPCOMING CLINICAL UPDATES
* Lucerastat future development
* Cardiovascular pipeline update with MERIT results
* Cadazolid Phase III program update
* Ponesimod Phase III program update
UPCOMING FINANCIAL UPDATES
* 9M 2016 Financial Results reporting on 20 October 2016
* FY 2016 Financial Results reporting on 14 February 2017
###
NOTES TO THE EDITOR
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 2,500 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
Press Release PDF:
http://hugin.info/131801/R/2029683/754792.pdf
Financial Fact Sheet:
http://hugin.info/131801/R/2029683/754822.pdf
Webcast:
https://www.actelion.com/en/investors/events/quarterly-reporting-webcast.page
Financial Statements:
http://hugin.info/131801/R/2029683/754823.pdf
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Source: Actelion Pharmaceuticals Ltd via GlobeNewswire
[HUG#2029683]
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Datum: 21.07.2016 - 07:00 Uhr
Sprache: Deutsch
News-ID 484501
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contact information:
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