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2014-04-17

Actelion Pharmaceuticals Ltd: Actelion announces first quarter 2014 financial results

Actelion Pharmaceuticals Ltd / Actelion announces first quarter 2014 financial
results. Processed and transmitted by NASDAQ OMX Corporate Solutions. The
issuer is solely responsible for the content of this announcement.
ALLSCHWIL/BASEL, SWITZERLAND - 17 April 2014
-
Actelion Ltd (SIX: ATLN) today announced financial results for the first three
months of 2014.

OPERATING HIGHLIGHTS

* Opsumit - Strong launch momentum in US, Germany, and Switzerland
* Tracleer - Solid volume growth in non-Opsumit markets
* Selexipag in PAH - Morbidity/Mortality Phase III topline results expected
Q2 2014
* Cadazolid - FDA grants Qualified Infectious Disease Product (QIDP)
designation

FINANCIAL HIGHLIGHTS

* Product sales of CHF 469 million, up 13% at Constant Exchange Rates (CER),
9% excluding US rebate reversals
* Core earnings of CHF 189 million, up 19% at CER, 9% excluding US rebate
reversals
* Core EPS of CHF 1.46, an increase of 29% at CER

----------------------------------------------------------------------
| Variance |
|CHF million 3M 2014 3M 2013 CHF % CER(1)% |
| |
|(except for per share data) |
|Product sales 469 433 8 13 |
|US-GAAP Operating income 153 124 23 33 |
|Core earnings (Core operating income) 189 169 12 19 |
|US-GAAP EPS (fully diluted) 1.09 0.85 28 38 |
|Core EPS (fully diluted) 1.46 1.23 19 29 |
----------------------------------------------------------------------
As of 31 March 2014, Actelion had cash and cash deposits of CHF 966 million.
In addition, Actelion holds 9.1 million treasury shares.

(1) CER percentage changes are calculated by reconsolidating both the Q1 2014
and Q1 2013 results at constant currencies (the average monthly exchange
rates for Q1 2013).

Jean-Paul Clozel, MD, Chief Executive Officer, commented: "I am very pleased
with Actelion's good start into 2014. The launch momentum for Opsumit, our
new lead product in Pulmonary Arterial Hypertension (PAH), is very strong in
all markets. Further launches throughout Europe are forthcoming, as well as a
regulatory filing for Opsumit in Japan."

Opsumit(macitentan) is currently available in the United States, in Germany,
Austria, Switzerland, Denmark, Norway and Canada. Sales for the first quarter
of 2014 amounted to CHF 15 million. This number does not reflect underlying
demand as the company continues to offer a Patient Access program in the US,
so patients can access this improved therapy as quickly as possible.

Otto Schwarz, Chief Operating Officer, commented: "Opsumit is quickly becoming
the drug of choice for new Endothelin Receptor Agonist patients, in all
markets where we have launched. By the end of March 2014, there were already
more than 2,300 patients on therapy, mostly in the United States. In
non-Opsumit markets, Tracleer is also performing well, with overall volumes
up by three percent."

Jean-Paul Clozel continued: "Our pipeline is advancing as well. Data
collection for the Phase III morbidity/mortality study with selexipag in PAH
is ongoing as planned and we expect top-line results in the next few weeks."

André C. Muller, Chief Financial Officer, commented: "We have started the year
well, with core earnings growth of nine percent - excluding the impact of US
rebate reversals -, with good product sales. Costs - as planned - only
increased modestly in a time when Actelion is launching new products and is
continuing to invest into innovation."

Jean-Paul Clozel concluded: "Based on this good start to the year, Actelion
will be well positioned to review its guidance for core earnings growth by
mid-year."

In February, Actelion issued 2014 core earnings guidance, expecting then core
earnings growth in the low-single digit range. For 2015, the company expects
core earnings to grow in the single-digit percentage range.

PRODUCT SALES REVIEW

Product sales for the first quarter of 2014 amounted to CHF 469 million, an
increase of 13% at CER compared to the first quarter of 2013. Excluding the
impact of US rebate reversals (Medicaid/Managed Medicaid) of CHF 18 million,
product sales increased by 9% at CER.

--------------------------------------------------
| Variance |
|CHF million 3M 2014 3M 2013 CHF % CER % |
|Opsumit 15 - - - |
|Tracleer 383 375 2 7 |
|Ventavis 28 27 1 5 |
|Veletri 15 7 118 134 |
|Zavesca 26 23 11 16 |
|Valchlor 1 0 - - |
|Others 1 1 - - |
|Total Product sales 469 433 8 13 |
--------------------------------------------------
PAH franchise

Opsumit (macitentan) sales for the first quarter of 2014 amounted to CHF 15
million. This number does not reflect underlying demand as the company
continues to offer a Patient Access program in the US, so patients can access
this improved therapy as quickly as possible. In the US, Actelion has made
significant progress with Opsumit in increasing reimbursement coverage.
Formulary inclusion has been obtained with many leading health care insurers,
with some of these positive coverage decisions already published or expected
shortly. Outside of the United States, Opsumit was successfully introduced
into markets in Germany, Austria and Switzerland.

Tracleer®(bosentan) sales amounted to CHF 383 million for the first quarter of
2014, an increase of 7% at CER compared to the same period in 2013. This
increase was partially the result of a US rebate reversal and US price
increases. Nevertheless, in markets where Opsumit is not available yet,
Tracleer demand remained strong, driven by the Digital Ulcer indication in
Europe and by strong growth in Japan, augmented by unchanged pricing
following the regular bi-annual price review.

Ventavis®(iloprost) had sales in the US of CHF 28 million for the first
quarter of 2014, an increase of 5% at CER. This increase is driven entirely
by price and rebate reversals as competitive pressures continue to erode
volume sales.

Veletri®(epoprostenol for injection) sales amounted to CHF 15 million for the
first quarter of 2014, an increase of 134% at CER compared to the same period
in 2013. This increase was driven by Japan, where demand continues to grow
following the launch in June 2013. At the beginning of March, the price has
been reduced as part of the bi-annual price review.

Specialty Products

Zavesca®(miglustat) sales amounted to CHF 26 million for the first quarter of
2014, an increase of 16% at CER compared to the same period in 2013. This
performance was driven predominantly by strong ex-US patient demand in the
Niemann-Pick Type C indication and positive price movement in the US.

Valchlor(TM) sales for the first quarter of 2014 amounted to CHF 1 million.
The product was launched in November 2013 to CTLC Centers of Excellence only,
and will be more widely available to US prescribers later in spring 2014.

CLINICAL DEVELOPMENT UPDATE

Actelion provided a clinical pipeline update in the Annual Report, published
on
11 February 2014. All programs are on track with the following updates:

Selexipag is being evaluated in the Phase III GRIPHON, (Prostacyclin (PG
I2)R
eceptor agonistI
nP
ulmonary arterialH
ypertensiON
) trial. GRIPHON is a multicenter, double-blind, placebo-controlled trial
evaluating the efficacy and safety of oral selexipag in patients with
pulmonary arterial hypertension. In February 2014, the study reached the
total number of primary endpoint events required to close the study. As a
result Actelion is on-track to deliver final study results by mid-2014.

The novel antibiotic cadazolid in patients suffering fromClostridium difficile
-associated diarrhea is in Phase III clinical development. On 27 February, the
US Food and Drug Administration (FDA) designated cadazolid as both a
Qualified Infectious Disease Product (QIDP) and a Fast Track development
program for the treatment ofClostridium difficile-
associated diarrhea (CDAD).

The COMPASS-2 study evaluated efficacy and safety of the use of the dual
endothelin receptor antagonist bosentan in combination with a
phosphodiesterase type 5 inhibitor, sildenafil. On 17 March, Actelion
announced that the COMPASS-2 did not meet the primary endpoint of time to
first morbidity or mortality event.

CORE OPERATING EXPENSES

------------------------------------------------------
| Variance |
|CHF million 3M 2014 3M 2013 CHF % CER % |
|Core cost of sales 51 49 4 8 |
|Core R&D 82 80 2 4 |
|Core SG&A 147 135 9 14 |
|Core operating expenses 280 264 6 10 |
------------------------------------------------------
Cost of sales for the first quarter of 2014 amounted to CHF 51 million, an
increase of 8% at CER compared to the same period in 2013, in-line with
higher product sales.

Core R&D expenses, which exclude stock-based compensation expense,
amortization and depreciation, were CHF 82 million for the first quarter of
2014, an increase of 4% at CER compared to the same period of 2013 as
clinical development expenses increased slightly.

Core SG&A expenses, which exclude stock-based compensation expense,
amortization, depreciation and the impact of doubtful debt provisions, were
CHF 147 million compared to CHF 135 million in the first quarter of 2013, an
increase of 14% at CER as the company is launching Opsumit, Valchlor and
Veletri in various markets around the globe.

CORE EARNINGS

---------------------------------------------------------------
| Variance |
|CHF million 3M 2014 3M 2013 CHF % CER % |
|Product sales 469 433 8 13 |
|Core operating expenses 280 264 6 10 |
|Core earnings (operating income) 189 169 12 19 |
---------------------------------------------------------------
Core earnings amounted to CHF 189 million for the first quarter of 2014
compared to

CHF 169 million during the same period in 2013, an increase of 19% at CER
driven by solid underlying operational performance. Excluding the impact of
US rebate reversals, core earnings increased by 9%.

CORE NET INCOME AND CORE EARNINGS PER SHA...

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