Algeta ASA : Algeta results for the fourth quarter and full year 2013

OSLO, Norway, Feb. 5, 2014 (GLOBE NEWSWIRE) -- 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 (radium Ra 223 dichloride) 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 approved in the United States and is indicated 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.

Xofigo is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. The active ingredient in Xofigo is the alpha particle-emitting isotope radium-223, which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of radium-223 may cause double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium-223 is less than 100 micrometers which may limit the damage to the surrounding normal tissue[i].
Important Safety Information for Xofigo (radium Ra 223 dichloride)

Xofigo is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman.

In the randomized trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (less than 1%) was similar for patients treated with Xofigo and placebo. Myelosuppression - notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia - has been reported in patients treated with Xofigo.

Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure.

Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be greater than to equal to 1.5 × 109/L, the platelet count greater than or equal to 100 × 109/L, and hemoglobin greater than or equal to 10 g/dL. Prior to subsequent administrations, the ANC should be greater than or equal to 1 × 109/L and the platelet count greater than or equal to 50 × 109/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care.

Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued.

Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations.

The most common adverse reactions (greater than or equal to 10%) in the Xofigo arm vs. the placebo arm, respectively, were nausea (36% vs 35%) diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (greater than or equal to 10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs.53%), leukopenia (35% vs. 10%), thrombocytopenia (31% vs. 22%), and neutropenia (18% vs. 5%).

For full US prescribing information visit:
http://labeling.bayerhealthcare.com/html/products/pi/Xofigo_PI.pdf

###

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
[i] XOFIGO Prescribing information. May 2013

Press release http://hugin.info/134655/R/1759211/594922.pdf

HUG#1759211

Source:Algeta ASA