Algeta ASA : Algeta results for the fourth quarter and full year 2012
Not Intended for US Media
Oslo, Norway, 28 February 2013 - Algeta ASA (OSE: ALGETA), a company focused
on the development of novel targeted cancer therapeutics, announces its
results for the fourth quarter and full year 2012.
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 EST (US). Details of both events are at the end
of this announcement.
"Algeta made significant achievements across its business in 2012, including
commercial preparations and expanding its manufacturing capabilities for
radium-223 dichloride (radium-223) as well as initiating further R&D
collaborations for the development of our Targeted Thorium Conjugate (TTC)
pipeline. This progress means that Algeta entered 2013 well placed to deliver
on its vision to be a world-class oncology company bringing novel targeted
medicines to cancer patients through its leadership in alpha-pharmaceuticals,"
said Andrew Kay, Algeta's President & CEO. "In parallel, we continue to make
significant investments in building our commercial operations for radium-223
in the US and look forward, with Bayer and if approved, to co-promoting this
novel product for castration-resistant prostate cancer (CRPC) patients with
bone metastases in the world's largest pharmaceutical market."
Radium-223 is an investigational agent and is not approved by the European
Medicines Agency (EMA), the US Food and Drug Administration (FDA) or other
Highlights of the fourth quarter 2012:
*In December, Bayer submitted applications seeking marketing authorization
to the EMA and the FDA for radium-223 for the treatment of CRPC patients
with bone metastases. The first complete submission triggered a EUR50m
milestone payment from Bayer to Algeta
*In November, Algeta and Bayer advanced the BC1-10 trial (radium-223 in
combination with docetaxel chemotherapy) into the phase IIa (expanded
safety cohort) portion of the study, based on the results of the dose
escalation (phase I) phase. Enrolment of approximately 45 CRPC patients
with symptomatic bone metastases has begun in eight centers across the US
*In November, Algeta entered a research collaboration with Ablynx to
evaluate a novel TTC based on combining Algeta's proprietary thorium-227
alpha-pharmaceutical payload with tumor-targeting Nanobodies^® generated
*In November, Algeta further strengthened its R&D capabilities,
particularly in chelation and conjugation technologies, with the
appointment of Dr Alan Cuthbertson as Senior Vice President, Research and
*In February 2013, the FDA granted priority review of the NDA for
radium-223. The FDA grants priority review to medicines that offer major
advances in care or that provide a treatment where no adequate therapy
exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to
complete its review within eight months from the submission of the NDA,
rather than the standard 12-month review cycle.
*In February 2013, further results from the ALSYMPCA phase III study of
radium-223 were presented at the 2013 Genitourinary Cancers Symposium. Two
presentations were made, highlighting the beneficial impact of radium-223
on the pain and analgesic use of CRPC patients, as well as providing
further analyses on the positive impact on skeletal-related events (SREs)
associated with bone metastases from castration-resistant prostate cancer.
*In January 2013, the US Nuclear Regulatory Commission (NRC) issued a
licensing decision on the medical use of radium-223, ruling that sites can
procure and administer radium-223 under the same framework as
routinely-used nuclear medicines. In addition, the NRC will not require
additional licensing to administer radium-223 for physicians who are
already licensed to dispense similar medications.
*In January 2013, Algeta initiated a new TTC research program using the
anti-CD22 monoclonal antibody (epratuzumab) developed by Immunomedics.
*In February 2013, and as part of the prioritization of the TTC portfolio,
Algeta deemed PDGFR-beta to be an unsuitable target for
alpha-pharmaceutical development. Accordingly, the decision has been taken
to terminate this element of the Affibody agreement.
*Operating revenue for the fourth quarter and full year 2012 amounted to
NOK440m and NOK627m, respectively, compared with NOK73m and NOK250m in
the same periods in 2011.
*Core operating expenses^, which exclude currency effects, interest
income and costs directly related to preparation of commercial launch in
the US, for the fourth quarter and full year 2012 amounted to NOK99m and
NOK316m, respectively, compared with NOK84m and NOK 289m in the same
periods in 2011.
*Algeta's recognized share of US co-promotion activity expenses for the
fourth quarter and full year 2012 was NOK28m and NOK72m. In 2011, the
activity had not yet commenced.
*Liquid funds amounted to NOK369m as of the 31 December 2012, compared
with NOK426m as of 30 September 2012, and NOK317m at the end of December
The Fourth Quarter and Full Year 2012 Report and accompanying presentation
will be available through www.algeta.com from 07:00 CET.
Details of presentation and webcast
A presentation by Algeta's senior management team to investors, analysts and
the press will take place in Oslo at 10:00 CET.
Haakon VIIs gate 1
The presentation will also be webcast live and can be accessed through
www.algeta.com. Questions can be submitted live during the webcast.
Details of international conference call
To participate in the conference call, please dial the appropriate number
below five minutes prior to the call:
US: +1877423 0830
UK: +4420 7153 9154
Norway: +47 21 06 61 13
Sweden: +468-506443 86
Denmark: +45 32 71 42 62
Switzerland: +41 44580 65 22
Participant pin code: 434633#
To access the replay, please dial:
US: +1877679 2989
UK: +44 20 3364 5196
Norway: +47 23 50 02 03
Sweden: +46 8-505564 73
Conference reference: 345360#
A replay version of the conference call will also be available at
About Radium-223 Dichloride
Radium-223 dichloride (radium-223), formerly referred to as Alpharadin, is a
therapeutic alpha particle-emitting pharmaceutical with targeted anti-tumor
effect on bone metastases in development for CRPC patients with bone
In September 2009, Algeta signed an agreement with Bayer Pharma AG (Berlin,
Germany) for the development and commercialization of radium-223. Under the
terms of the agreement, Bayer will develop, apply for global health authority
approvals, and commercialize radium-223 globally. Algeta will co-promote
radium-223 with Bayer in the US, and is eligible for milestones as well as
royalties on Bayer's sales outside the US. The ALSYMPCA trial was initiated by
Algeta in June 2008.
For further information, please contact:
Mike Booth / Renate Birkeli +47 23 00 67 32
Communications & Corporate Affairs firstname.lastname@example.org
Mark Swallow +44 207 638 9571
Citigate Dewe Rogerson email@example.com
Knut Ekern +47 22 04 82 00
Gambit Hill & Knowlton firstname.lastname@example.org
US investor enquiries:
Tricia Swanson +1 646 378 2953
The Trout Group email@example.com
Algeta is a company focused on developing novel targeted therapies for
patients with cancer based on its alpha-pharmaceutical platform. 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.
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 interactions with regulatory
authorities, our anticipated co-promotion of radium-223 in the US, additional
clinical development of radium-223 and our TTC program. 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, risks or uncertainties associated with
the success of future clinical trials, collaborations with other companies in
the development of targeting molecules, the ability to identify and hire a
sufficient number of qualified employees for the US field force, growth
management, general economic and business conditions and the pricing
environment, the impact of competition, the ability to successfully
commercialize radium-223 and our other products, the risk that costs
associated with the co-promotion of radium-223 may be greater than
anticipated, the risk that research & 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.
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 Presentation 2012
Annual report 2012
Fourth Quarter Report 2012
This announcement is distributed by Thomson Reuters on behalf of Thomson
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
information contained therein.
Source: Algeta ASA via Thomson Reuters ONE
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