STALLERGENES : Significant Growth : Q3 2010 + 10% and +12% Over the First 9 Months / Shionogi Partnership: First EUR24 Million Instalment

Oct 14, 2010, 12:54 ET from Stallergenes

    ANTONY, France, October 14, 2010 /PRNewswire-FirstCall/ --

    EUR million              2009         09-Aug     2010         10-Sep
                             EURm  %Sales  Var.%     EURm  %Sales  Var.%

    Southern Europe(1)         26      68      9     29.2      70     12
    Other EU countries(2)    10.3      27     20     10.6      25      3
    Other markets             1.9       5      8      2.2       5     15

    SLIT                     30.5      79     16     34.7      83     14
    SCIT                      6.3      17     -2      5.9      14     -6
    Other products            1.4       4      0      1.3       3     -8

    Total Q3 sales           38.2     100     12       42     100     10
    Southern Europe(1)       96.3      71      9    108.4      71     13
    Other EU countries(2)    34.4      25     27       38      25     10
    Other markets             5.2       4     -5      6.2       4     21

    SLIT                    111.6      82     14      129      85     16
    SCIT                     19.1      14      2     18.4      12     -4
    Other products            5.2       4      7      5.2       3     -1

    Cumulated sales         135.9     100     12    152.6     100     12

    (1) Portugal, Spain, France, Italy, Greece; (2) Switzerland included

Sales growth

Consolidated sales for the 3rd quarter of 2010 grew by 10% compared to the same period last year to EUR 42.0 million, resulting in sales growth of 12% during the first 9 months of the year. Foreign exchange effects were negligible.

The slight slowdown in the pace of growth compared to the first half of the year (up 13%) was primarily due to the relatively weak grasses and tree pollen season, as well as the recognition of a 10% regulatory rebate in Germany, applicable over the last two months of the quarter.

Change in financial position

The financial position improved: at 30 September 2010, the net cash position remained substantial, in spite of a very slight decline which was consistent with business seasonality.

Significant transactions and events of the quarter

On 6 September, Stallergenes announced having entered into an exclusive partnership agreement in Japan with Shionogi & Co., Ltd. for the development and distribution in Japan of Actair(R) (house dust mite allergen tablets) and a Japanese cedar pollen allergen tablet.

In respect of this partnership, on 6 October 2010 Stallergenes collected a first instalment of EUR 24 million: corresponding revenues will be recognised over a period of 2 to 3 years as development work progresses, including about EUR 3 million over 2010. Stallergenes may subsequently receive up to EUR 46 million as the various clinical and regulatory milestones are achieved, compounded by marketing milestone payments and royalties on net sales of products sold by the partner.

The rollout of Oralair(R) is ongoing at a very satisfactory pace in Germany and early feedback from markets recently launched - the Netherlands, Austria, Slovakia and the Czech Republic - is very encouraging.

In France, the Commission de Transparence of the Haute Autorite de Sante (French HTA) issued a favourable ruling for the inclusion of Oralair(R) on the formulary of the public health insurance (Securite Sociale), while considering that the file was not sufficient enough to support Oralair(R)'s claims to public health interest in relation to morbidity and quality of life. As a consequence, the SMR (medical service rendered) should be classified as weak in this first assessment, thereby entitling to a 15% health insurance refund. A further assessment is to take place early in 2011 based on new data to be provided by the Company.

As a result, the Company will not be in a position to market Oralair(R) for the 2011 pollen season in France or other European countries where refund granting procedures are progressing well but are still ongoing.

Outlook for the current year

Strong growth in the quarter allows us to confirm our guidance in excess of 10% for the full year and a significant increase in earnings, due to a stabilised R&D effort this year as well as revenue from the partnership in Japan.

ABOUT STALLERGENES

Stallergenes is a European biopharmaceutical laboratory specialising in treatments by immunotherapy for the prevention and treatment of allergy-related respiratory conditions, such as rhino conjunctivitis, rhinitis and allergic asthma. A pioneer and a leader in immunotherapy treatments by sublingual administration, Stallergenes dedicated more than 20% (gross) of its sales in 2009 to its Research and Development activities, which are primarily directed at developing a new therapeutic range enabling the provision of immunotherapy treatments by sublingual tablets.

Stallergenes achieved 2009 sales of EUR 193 million, with over 500,000 patients treated with Stallergenes products.

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For further information, please visit our website: http://www.stallergenes.com

SOURCE Stallergenes