Algeta ASA : CORRECTION: Algeta ASA : Algeta Results for the Third Quarter 2013

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."

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.  

• 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, 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.

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Xofigo® is a registered trademark of Bayer

For further information, please contact:

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.

 Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer, Parker, C. et al. New England Journal of Medicine 2013; 369 (3) 213-223.  
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.