Algeta ASA: Algeta results for the fourth quarter and full year 2013
Not intended for US media
Oslo, Norway, 5 February 2014 - Algeta ASA (OSE: ALGETA), a company focused on
the development of novel targeted cancer therapeutics, announces its financial
results for the fourth quarter and full year 2013.
"There is no doubt that Algeta has achieved significant successes in the past
12 months, most notably the marketing authorizations for and subsequent launches
of Xofigo in the US and Europe" said Andrew Kay, Algeta's President & CEO.
"These achievements mark important milestones on a journey that began in the
1990s and has seen Algeta take Xofigo through all phases of clinical development
and into its launch, with Bayer, in the US. This journey has also created
significant value for Algeta's shareholders, and I would like to take this
opportunity to thank all of the Company's employees as well as our collaborators
and other stakeholders for their contributions to this success."
Highlights of the fourth quarter 2013
* On 19 December 2013, Algeta's Board of Directors unanimously recommended a
voluntary cash offer (the "Offer") from Bayer to acquire the entire issued
share capital of Algeta. The Offer of NOKÂ 362 per Algeta share values Algeta
at approximately NOKÂ 17.6 billion (USDÂ 2.9 billion) on a fully diluted
basis. Complete details of the Offer were distributed to Algeta shareholders
on 20 January 2014. Bayer expects to close the transaction during the first
quarter of 2014.
* In November 2013, Bayer received European marketing authorization for Xofigo
solution for injection for the treatment of adults with castration-resistant
prostate cancer, symptomatic bone metastases and no known visceral
metastases. The marketing authorization provides approval for the
commercialization of Xofigo in all 28 countries of the EU. Further national
approvals have been reached in additional countries outside the US and
European Union, including Norway.
Highlights of the full year 2013
* Xofigo received marketing authorization from the US Food & Drug
Administration (FDA) in May 2013.
* Data from Algeta's pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic
Prostate Cancer) trial of radium-223 in CRPC patients with symptomatic bone
metastases were published in the 18 July 2013 issue of the New England
Journal of Medicine.
* Algeta continued to make progress with its early stage Targeted Thorium
Conjugates (TTC) platform and preclinical pipeline during 2013, and remains
on track to generate a first clinical candidate from the TTC platform
towards the end of 2014.
* In September 2013, Algeta raised USDÂ 120m from a Convertible Bond offering.
* In the fourth quarter 2013, net sales of Xofigo in the US market (as
recognized by Bayer) amounted to NOKÂ 230m (USDÂ 38m). For the full year
2013, net sales of Xofigo in the US market (as recognized by Bayer) amounted
to NOKÂ 332m (USDÂ 55m). In the US, Xofigo was approved and launched during
* Algeta's reported operating revenue for the fourth quarter and full year
2013 amounted to NOKÂ 65m and NOKÂ 635m, respectively, compared with NOKÂ 440m
and NOKÂ 627m in the same periods in 2012.
* Core operating expenses for the fourth quarter and full year 2013
amounted to NOKÂ 187m and NOKÂ 549m, respectively, compared with NOKÂ 99m and
NOKÂ 316m in the same periods in 2012.
* Algeta's recognized share of the net result of US co-promotion activity for
the fourth quarter 2013 amounted to a profit of NOKÂ 36m. To ease cross-
period comparisons in 2013, this amount has been recorded as a negative
expense for the fourth quarter 2013. In the fourth quarter 2012, there were
no sales of Xofigo and Algeta's recognized share of the net result of US co-
promotion activity was an expense of NOKÂ 28m.
* Algeta's recognized share of the net result of US co-promotion activity for
the full year 2013 amounted to a loss of NOKÂ 94m, and as such was recorded
as an expense. For the full year 2012, there were no sales of Xofigo and
Algeta's recognized share of the net result of US co-promotion activity was
an expense of NOKÂ 72m.
* Cash on hand amounted to NOKÂ 1,367m as of the 31 December 2013, compared
with NOKÂ 1,465m as of 30 September 2013, and NOKÂ 369m at the end of December
The Fourth Quarter and Full Year 2013 Report is available via www.algeta.com.
About Xofigo(Â®) (radium Ra 223 dichloride)
Xofigo(Â®) is an alpha particle-emitting pharmaceutical. Xofigo's 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 Xofigo is less than 100 micrometers (less than 10
cell diameters), which minimizes damage to the surrounding normal tissue.
Xofigo solution for injection is approved in Europe for the treatment of adults
with castration-resistant prostate cancer, symptomatic bone metastases and no
known visceral metastases.
Xofigo is approved in the US for the treatment of patients with castration-
resistant prostate cancer, symptomatic bone metastases and no known visceral
In September 2009, Algeta signed an agreement with Bayer for the development and
commercialization of Xofigo. Under the terms of this 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.
For further information, please contact:
Oystein Soug +47 90 65 65 25
Chief Financial Officer
Mike Booth +1 646 410 1884
Communications & Corporate Affairs firstname.lastname@example.org
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
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 expectations 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 the development of our product
candidates, the Offer, conditions relating to the Offer and expected timing of
the Offer, including the expected timing of closing. 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, the risk that research & business
development will not yield new products that achieve commercial success, risks
in obtaining regulatory approvals for our other products and difficulties of
obtaining relevant governmental approvals for new products, satisfactions of
conditions to the Offer, investor participation in the Offer and the other risks
and uncertainties described in our annual report.
Â Defined as the sum of External R&D expenses, Payroll and related costs,
Depreciation and General and Administrative expenses, excluding net loss from
co-promotion while including some US overhead costs
This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
Fourth Quarter Report 2013:
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: Algeta ASA via GlobeNewswire