Q3 revenue growth of 3.6% driven by positive performance of sublingual immunotherapy treatments

Q3 2013 revenues driven by the good performance of Oralair®

3rd quarter sales were € 45.9 million, an increase of 3.6% compared to the 3rd quarter of 2012. In Southern Europe, France continued its growth, offsetting the impact of the negative performance of Italy and Spain due to the unfavourable overall economic climate. The “Other Europe” region achieved a 15.4% revenue increase, thanks to the 61% growth of Oralair® in Germany and including a prior period adjustment related to the rebate in Germany (€ 1.1 million). The performance in this region is also due to the significant growth recorded in several Eastern Europe countries, including the Czech Republic and Poland. Despite the underlying positive trend, “Other markets” decreased by € 0.6 million, as a result of Oralair®’s launch activities in Australia and Russia last year.

Sublingual immunotherapy sales continued to grow in the 3rd quarter thanks notably to the fast adoption of Oralair® in France since its launch in November 2012. Overall, Oralair® sales grew 43%year-to-date.

Cumulative sales to the end of September 2013 reached € 174.6 million, showing an increase of 1.9% over the same period of the previous year.

Update on Oralair®’s access to the US market

In the USA, the registration process of Oralair® continues progressing. As announced, due to the US government shutdown, the US Food and Drug Administration (FDA) has postponed the Allergenic Products Advisory Committee meeting scheduled for 5 November 2013 to discuss the Biologic License Application (BLA). The FDA has not yet confirmed a new date for the Advisory Committee meeting.

With the objective of achieving a strong and rapid impact for Oralair® in the US market, the terms and conditions of the agreement with Greer Laboratories Inc., a leader in allergen immunotherapy in the US, are currently being discussed under the supervision of an ad hoc committee of the Stallergenes Board composed of independent members.

Annual targets and outlook for the current year

The 2013 full-year targets remain unchanged.

Financial calendar

2013 Revenue and results: 6 March 2014