CORRECTION: Algeta ASA : Algeta Results for the Third Quarter 2013
(Thomson Reuters ONE) -
This is a correction of the announcement from 07:00 06.11.2013 CET. Reason for
the correction:
Earnings per share figures in the "Condensed consolidated income statement" has
been updated.
Basic and fully diluted earnings per share for the third quarter 2013 changed
from NOK (2.31)to NOK (2.24), Basic and fully diluted earnings per share for
third quarter 2012 changed from NOK (0.92) to NOK (0.93).
Basic earnings per share for the period January-September 2013 changed from NOK
2.64 to NOK 2.72 and diluted earnings per share for the period January-September
2013 changed from NOK 2.58 to NOK 2.64."
Not intended for US media
Oslo, Norway, 6 November 2013 - Algeta ASA (OSE: ALGETA), a company focused on
the development of novel targeted cancer therapeutics, announces its results for
the third quarter 2013.
A presentation of the results in Oslo will be webcast live from 10:00 CET and
can be accessed through www.algeta.com. An international conference call will
take place at 14:30 CET/ 08:30 Eastern Time. Details of both events are at the
end of this announcement.
"We are very pleased with the initial phase of the US commercialization of
Xofigo(®)", commented Andrew Kay, Algeta President & CEO. "Since approval in
late May, the launch strategy has been executed well by the teams from Algeta
and Bayer, and that is reflected in both the encouraging sales figures for this
quarter as well as the number of facilities that are now licensed and ready to
treat patients with Xofigo. The recent positive CHMP opinion for Xofigo in
Europe is a key step towards its anticipated approval and highlights the need
for new therapies for castration-resistant prostate cancer patients that confer
a survival benefit."
Oystein Soug, Algeta's Chief Financial Officer, added, "The first full quarter
of Xofigo sales place Algeta on a clear and defined trajectory towards
profitability. Algeta is an ambitious company, and our proven development
expertise, our growing commercial experience in oncology and our strengthened
financial profile give us the confidence to seek to build a broad portfolio of
novel cancer therapeutics beyond Xofigo."
Highlights of the third quarter 2013:
Xofigo (radium Ra 223 dichloride)
* In the third quarter 2013, net sales of Xofigo in the US market (as
recognized by Bayer) amounted to NOK 99m (USD 17m).
* Xofigo was approved in the US in May 2013, and Algeta and Bayer have been
working together to execute the launch strategy. A key focus has been to
support the licensing of clinical centers to enable them to start treating
patients. Progress has been good, and facility licensing has progressed
faster than expected with 626 sites across the US classified as "Patient-
Ready" on 18 October.
* On 20 September 2013, the European Medicines Agency's (EMA) Committee for
Medicinal Products for Human Use (CHMP) recommended the approval of Xofigo
for the proposed indication of the treatment of adults with castration-
resistant prostate cancer, symptomatic bone metastases and no known visceral
metastases. The decision of the European Commission (EC) on the approval is
expected in the fourth quarter of 2013.
* Data from the phase III ALSYMPCA trial were published in the 18 July 2013
issue of the New England Journal of Medicine[1].
* Further analyses of data subsets from the phase III ALSYMPCA study were
presented at the 2013 European Cancer Congress (ECCO/ESMO/ESTRO), on 30
September, in Amsterdam, The Netherlands.
Corporate
* On 4 September 2013, Algeta raised USD 120m from a Convertible Bond
offering. The Company intends to use the net proceeds of the offering for
general corporate purposes, for its working capital needs and the
development of its product candidates. The Company may also use a portion of
the net proceeds to invest in products or technologies complementary to its
portfolio.
* In August, Dr Andreas Menrad was appointed Chief Scientific Officer,
bringing more than 20 years of experience in oncology and therapeutic
antibody development. He was formerly Chief Scientific Officer at Ablynx NV,
and worked previously at Genzyme (Sanofi) as General Manager and Vice
President of Antibody Therapeutics.
Key financials
* Operating revenue for the third quarter 2013 amounted to NOK 55m compared
with NOK 60m in the same period in 2012.
* Algeta's recognized share of the net result of US co-promotion activities
for the third quarter 2013 was an expense of NOK 27m, compared with an
expense of NOK 17m in the same period in 2012. Algeta recognizes 50% of the
net result of Xofigo co-promotion activities in the US.
* Core operating expenses[2], which exclude currency effects, interest income
and costs directly related to the commercial launch of Xofigo in the US, for
the third quarter 2013 amounted to NOK 124m, compared with NOK 74m in the
same period in 2012.
* Cash on hand amounted to NOK 1,465m as at 30 September 2013 compared with
NOK 369m as of the 31 December 2012.
The Third Quarter Report 2013 and accompanying presentation will be available on
www.algeta.com from 07:00 CET today.
Details of presentation and webcast
A presentation by Algeta's executive management team to investors, analysts and
the press will take place in Oslo at 10:00 CET.
KS-Agenda Møtesenter
Haakon VIIs gate 9
0161 Oslo
Norway.
Details of international conference call
Algeta will also host an international conference call at 14:30 CET/08:30
Eastern Time.
To participate in the conference call, please dial the appropriate number below
five minutes prior to the call:
US: +1 877 423 0830
UK: +44 20 7153 9154
Norway: +47 21 06 61 13
Sweden: +46 8-506 443 86
Denmark: +45 32 71 42 62
Switzerland: +41 44 580 65 22
Participant pin code: 873878#
To access the replay, please dial:
US: +1 877 679 2989
UK: +44 203 364 5200
Norway: +47 23 50 02 03
Sweden: +46 8-505 564 73
Conference reference: 348995#
A replay of the conference call will also be available at www.algeta.com.
About Radium Ra 223 Dichloride
Radium Ra 223 dichloride (radium-223) is currently not approved by the European
Medicines Agency (EMA) or other authorities outside the US. Bayer submitted a
Marketing Authorisation Application to the EMA for radium-223 in December 2012
and subsequently in other territories.
Radium-223 (as Xofigo(®) injection) is approved in the United States and is
indicated for the treatment of patients with castration-resistant prostate
cancer (CRPC), symptomatic bone metastases and no known visceral metastatic
disease.
Radium Ra 223 dichloride (radium-223) is an alpha particle-emitting
pharmaceutical. Its active moiety mimics calcium and selectively targets bone,
specifically areas of bone metastases, by forming complexes with the bone
mineral hydroxyapatite. The high linear energy transfer of alpha emitters (80
keV/micrometer) leads to a high frequency of double-strand DNA breaks in
adjacent tumour cells, resulting in a potent cytotoxic effect. Additional
effects on the tumour microenvironment including osteoblasts and osteoclasts
also contribute to the in vivo efficacy. The alpha particle range from radium-
223 is less than 100 micrometers (less than 10 cell diameters) which minimises
damage to the surrounding normal tissue.
In September 2009, Algeta signed an agreement with Bayer for the development and
commercialization of radium-223. Under the terms of the agreement, Bayer will
develop, apply for health authority approvals worldwide and commercialize Xofigo
globally. Algeta is eligible for royalties and milestones based on Bayer's sales
of Xofigo outside the US, and Algeta US, LLC is co-promoting Xofigo with Bayer
in the US.
###
Xofigo(®) is a registered trademark of Bayer
For further information, please contact:
Mike Booth +1 646 410 1884
Communications & Corporate Affairs ir(at)algeta.com
Media enquiries:
Mark Swallow +44 207 638 9571
Citigate Dewe Rogerson mark.swallow(at)citigatedr.co.uk
Knut Ekern +47 22 04 82 00
Gambit Hill & Knowlton knut.ekern(at)hkstrategies.com
Investor enquiries:
Tricia Truehart +1 646 378 2953
The Trout Group ttruehart(at)troutgroup.com
About Algeta
Algeta is a company focused on developing, manufacturing and marketing novel
targeted therapies for patients with cancer. The Company is headquartered in
Oslo, Norway, and has a US subsidiary, Algeta US, LLC, based in Cambridge, MA
performing commercial marketing operations in the US. Algeta is listed on the
Oslo Stock Exchange (Ticker: ALGETA). For more information please visit
www.algeta.com.
Forward-looking Statements
This news release contains certain forward-looking statements that are based on
uncertainty, as they relate to events and depend on circumstances that will
occur in the future and which, by their nature, may have an impact on results of
operations and the financial condition of Algeta. Such forward-looking
statements reflect our current views and are based on the information currently
available to Algeta. Algeta cannot give any assurance as to whether such forward
looking statements will prove to be correct. These forward looking statements
include statements regarding our co-promotion of Xofigo in the US and the
development of our other product candidates. There are a number of factors that
could cause actual results and developments to differ materially from those
expressed or implied by these forward-looking statements. These factors include,
among other things, general economic and business conditions, the impact of
competition, the ability to successfully commercialize Xofigo, the risk that
costs associated with the co-promotion of Xofigo may be greater than
anticipated, the risk that research & business development will not yield new
products that achieve commercial success, manufacturing capacity, the risk of
non-approval of patents not yet granted, risks in obtaining regulatory approvals
for radium-223 and our other products and difficulties of obtaining relevant
governmental approvals for new products, and the other risks and uncertainties
described in our annual report.
[1] Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer, Parker,
C. et al. New England Journal of Medicine 2013; 369 (3) 213-223.
[2] Defined as the sum of External R&D expenses, Payroll and related costs,
Depreciation and General and Administrative expenses. Core operating expenses do
not include costs from co-promotion activities.
This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
Third Quarter Presentation 2013:
http://hugin.info/134655/R/1741054/584800.pdf
Third Quarter Report 2013:
http://hugin.info/134655/R/1741054/584826.pdf
Press release:
http://hugin.info/134655/R/1741054/584798.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Algeta ASA via Thomson Reuters ONE
[HUG#1741054]
Unternehmensinformation / Kurzprofil:
Datum: 06.11.2013 - 15:55 Uhr
Sprache: Deutsch
News-ID 313538
Anzahl Zeichen: 13466
contact information:
Town:
Oslo
Kategorie:
Business News
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