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21.10.2013 17:45:00

Stallergenes : Q3 Revenue Growth of 3.6%, Driven by Positive Performance of Sublingual Immunotherapy Treatments

Regulatory News:

Stallergenes (Paris:GENP):

€ million   2012     2013     13/12
    € m   %Sales   € m   %Sales   Var.%
Southern Europe (1) 30.5 68 31.2 68 2.3
Other Europe 10.0 23 11.5 25 15.4
Other markets 3.8 9 3.2 7 (15.5)
 
Total Q3 sales 44.3 100 45.9 100 3.6
 
Sublingual immunotherapy 35.9 81 38.4 84 6.9
Subcutaneous immunotherapy 6.7 15 5.6 12 (16.7)
Other products 1.7 4 1.9 4 12.9
 
Total Q3 sales   44.3   100   45.9   100   3.6
Southern Europe (1) 122.5 71 123.6 70 0.9
Other Europe 39.2 23 41.1 24 4.9
Other markets 9.8 6 9.9 6 1.6
 
Cumulative revenues 171.4 100 174.6 100 1.9
 
Sublingual immunotherapy 146.2 85 149.9 86 2.6
Subcutaneous immunotherapy 19.2 11 18.0 10 (6.5)
Other products 6.0 4 6.7 4 10.8
 
Cumulative revenues   171.4   100   174.6   100   1.9
(1) Portugal, Spain, France, Italy

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

ABOUT STALLERGENES

Stallergenes is an international biopharmaceutical company dedicated to the treatment of allergy-related respiratory diseases, such as severe rhinoconjunctivitis and rhinitis, as well as allergic asthma, using allergen immunotherapy. The leader in sublingual immunotherapy treatments, Stallergenes devotes around 20% of its annual gross revenues to Research & Development and is actively involved in the development of a new therapeutic class: sublingual immunotherapy tablets.

In 2012, the Company generated revenues of € 240 million, and more than 500,000 patients were treated with Stallergenes products.

Euronext Paris (Compartment B)
CAC small
ISIN: FR0000065674
Reuters: GEN.PA
Bloomberg: GEN.FP

Additional financial information is available at http://finance.stallergenes.com

Forward-looking statements related to Stallergenes

This press release may contain forward-looking statements, including forecasts of future revenue and operating profit as well as expected business-related events. Such statements are based upon the current beliefs and expectations of Stallergenes’ management and are subject to risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, changes in competitive factors and reliance on suppliers. The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events and except as required by law.

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