Algeta results for the fourth quarter and full year 2012

Algeta results for the fourth quarter and full year 2012 
OSLO, NORWAY -- (Marketwire) -- 02/28/13 --  
Intended for US Media only 
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
Ra  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." 
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
health authorities. 
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. 
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     castration-resistant prostate  cancer (CRPC) 
patients with  bone metastases. 
The first complete submission
triggered a EUR 50m milestone payment from Bayer     to Algeta. 
* In November, Algeta ent
ered 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((R)) 
generated  by Ablynx. 
* 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 Development. 
Post-period events 
* In  February 2013, the  FDA granted  priority review  of the NDA
for radium-    223. The  FDA  grants  priority  review  to  medicines
 that  may 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. 
* In  January  2013, the  US  Nuclear  Regulatory  Commission 
(NRC) issued a     licensing decision on the medical use of
radium-223. 
* 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  prioritisation 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. 
Key financials 
* Operating  revenue for  the fourth  quarter and  full year  2012
amounted to     NOK 440m  and NOK 627m, respectively, compared  with
NOK 73m and NOK 250m in     the same periods in 2011. 
* Core operating expenses[1], 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 NOK 99m and NOK 316m, 
respectively, compared
with NOK 84m 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 NOK 28m 
and NOK 72m.  In 2011, the     activity had not yet commenced. 
* Liquid  funds amounted to NOK 369m as of the 31 December 2012,
compared with 
NOK 426m as of 30 September 2012, and NOK 317m at
the end of December 2011. 
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. 
Shippingklubben
 Haakon VIIs gate 1
 0161 Oslo
 Norway. 
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: +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: 434633# 
---- 
To access the replay, please dial: 
US: +1 877 679 2989
 UK: +44 20 3364 5196
 Norway: +47 23 50 02 03 
Sweden: +46 8-505 564 73 
Conference reference: 345360# 
A   replay   version   of   the  conference  call  will  also  be
available  at www.algeta.com. 
### 
About Radium Ra 223 Dichloride 
Radium  Ra  223 dichloride  (radium-223), formerly  referred  to  as
radium-223
chloride,  is  an  investigational  alpha 
particle-emitting pharmaceutical  in development for CRPC patients
with bone metastases. 
Radium-223 is  an  investigational  agent  and  is  not approved by
the FDA, the European Medicines Agency (EMA) or other health
authorities. 
About Algeta 
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. 
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 
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. 
[1] 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 
Algeta results for the fourth quarter and full year 2012:
http://hugin.info/134655/R/1681797/549901.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#1681797] 
For further information, please contact: 
Mike Booth / Renate Birkeli
Communications & Corporate Affairs
+47 23 00 67 32
ir@algeta.com 
Media enquiries:
Mark Swallow
Citigate Dewe Rogerson
+44 207 638 9571
mark.swallow@citigatedr.co.uk 
Kari Watson
MacDougall Biomedical Communications
+1 781 235 3060
kwatson@macbiocom.com 
US investor enquiries:
Tricia Swanson
The Trout Group
+1 646 378 2953
tswanson@troutgroup.com
 
 
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