In the context of immediate and continuous flow of information to the investment community, Lavipharm S.A. informs that the launch date of its fentanyl transdermal system in the USA, which was scheduled to take place by the end of September 2007, is transferred due to a delay in the product's validation process.
The Company has been informed by the manufacturer that in one of the three validation batches, the results of certain analysis have exhibited deviation from the specifications. It is noted that the results of the other two batches are entirely satisfying and within specifications. Investigation according to USA regulations on the causes of the deviations has already commenced, for which additional time is required. It is noted that in Greece, the corresponding validation process of three consecutive batches under a similar manufacturing method and equally strict regulations, was successful and the product has already entered the market.
The expected delay for the completion of the required procedures and the exact timing of the product launch in the USA cannot be accurately determined at this point. Nonetheless, the Company, based on available data, estimates that the delay will not exceed 60 days.
This fact obliges the Company to review the initial forecasts on the expected consolidated key figures of 2007, which are modified as follows:
- Consolidated Sales (2007) are modified from euro million to euro million
- Consolidated EBITDA (2007) are modified from euro 40 million to euro 24 million
The rest expected key figures regarding years 2008-2010 remain unaltered.
It is noted that the confirmed orders, upon which initial projections for 2007 were based, are still valid.
Above information is a summary of the Addendum to the Prospectus for the Share Capital Increase of the Company, which was submitted today, September 14th, 2007, for approval to the Board of Directors of the Hellenic Market Commission.
Lavipharm is an integrated Group of Companies that develops, manufactures, markets and distributes pharmaceutical, cosmetic and consumer health products in Greece, with a strong international activity.