Advanced Accelerator Applications announced today its Q4 and full year 2014 financial results. The company reported an increase in year-on-year sales of 29.8% for the full-year and 32% for Q4 2014 compared to Q4 2013. For the year ended 31 December 2014 total sales were €69.9 million (+29.8% vs. 2013).
Other key news includes the completion of enrollment in the Lutathera Phase III Trial with pivotal data expected in 2015.
Mr. Stefano Buono, AAA’s CEO, commented, “2014 was a very successful year for AAA. We continued our trend of significant revenue growth, while also completing enrollment of our Phase III clinical trial for therapeutic candidate Lutathera. We anticipate presenting topline data in the second half of 2015 and expect to file both a New Drug Application (NDA) with the U.S. FDA and a Marketing Authorization Application (MAA) with the EMA within 2016. Another achievement was gaining the orphan drug designation in the U.S. and Europe for Somakit, which will be used as a companion diagnostic for Lutathera. We plan to file an NDA and MAA for this product by the end of 2015.”
Mr. Buono concluded, “Looking ahead, with a significantly strengthened balance sheet following a successful capital raise in February 2014, and having both consolidated and diversified our revenue stream through strategic acquisitions, we are well positioned to further develop and expand our pipeline of radiopharmaceuticals.”