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 NOK 362 per Algeta share values Algeta at approximately NOK 17.6 billion (USD 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 USD 120m from a Convertible Bond offering. Key financials * In the fourth quarter 2013, net sales of Xofigo in the US market (as recognized by Bayer) amounted to NOK 230m (USD 38m). For the full year 2013, net sales of Xofigo in the US market (as recognized by Bayer) amounted to NOK 332m (USD 55m). In the US, Xofigo was approved and launched during 2013. * Algeta's reported operating revenue for the fourth quarter and full year 2013 amounted to NOK 65m and NOK 635m, respectively, compared with NOK 440m and NOK 627m in the same periods in 2012. * Core operating expenses[1] for the fourth quarter and full year 2013 amounted to NOK 187m and NOK 549m, respectively, compared with NOK 99m and NOK 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 NOK 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 NOK 28m. * Algeta's recognized share of the net result of US co-promotion activity for the full year 2013 amounted to a loss of NOK 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 NOK 72m. * Cash on hand amounted to NOK 1,367m as of the 31 December 2013, compared with NOK 1,465m as of 30 September 2013, and NOK 369m at the end of December 2012. The Fourth Quarter and Full Year 2013 Report is available via www.algeta.com. About Xofigo(®) (radium Ra 223 dichloride) Xofigo(®) 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 metastatic disease. 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 ir@algeta.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 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. [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 This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. Press release: http://hugin.info/134655/R/1759203/594921.pdf Fourth Quarter Report 2013: http://hugin.info/134655/R/1759203/594920.pdf 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 [HUG#1759203]