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SnowWorld N.V. Earnings Release 2009

Nov 5, 2009

3886_iss_2009-11-05_ae78e310-29dd-4b6a-9b4c-0f104db7bd5f.pdf

Earnings Release

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P R E S S R E L E A S E

Lelystad, 5 November, 2009

FORNIX PUBLISHES NINE MONTHS' TRADING UPDATE 2009

  • Significant increase in net profit resulting from lower (research) costs
  • Turnover first nine months lags slightly behind 2008
  • Crucial Fornix allergen products not affected by recent Healthcare Inspectorate decision concerning the availability of non-registered allergen products
  • Prospects for whole year 2009: slight fall in turnover and profit after taxes expected to be in line with 2008

Fornix BioSciences N.V. (Euronext Amsterdam: AFORBI) today publishes its trading update for the first nine months of 2009. Turnover in the first three quarters up to the end of September fell slightly compared to the same period in 2008. Net profit, however, increased substantially compared to last year due to the lower level of costs realised throughout the company, particularly in the area of clinical research. Due to a disappointing month in October and continued uncertainty about turnover developments at its Allergy Division, Fornix forecasts net profit for the whole year 2009 to be more or less in line with that of 2008 (€ 10.2 million), with marginally lower turnover.

According to Fornix, the continued uncertainty among physicians and patients regarding the reimbursement and availability of non-registered allergen products has led to a decrease in sales, particularly in October 2009. Predicting the results for the months of November and December is consequently almost impossible. The German activities over the first nine months performed better than expected, particularly in activities other than allergy. The Medical Aids Division realised a fractionally lower turnover while being faced with increasing pressure on both turnover and margins. Moreover, the future position of the current range of products will be affected by the expiry of two distribution contracts, particularly as of 2010. Despite measures to replace those products that will be taken out of circulation, these developments will affect turnover and margins from the financial year 2010 onwards.

Main Allergy Division developments

The decision of 1 October 2009 by the Healthcare Inspectorate (IGZ) on the reimbursement and availability of non-registered allergen products will most likely lead to a significant limitation of the number of sublingual (under the tongue) allergen products now still permitted for new patients. The immunotherapeutic Fornix products Oralgen® Pollen (grass and tree pollen) and Oralgen® Mites are strictly speaking now the only permissible and reimbursable products for patients who choose for sublingual (SLIT) allergen products, with the exception of one registered alternative for grass pollen.

As of 1 October 2009, all other comparable, non-registered SLIT products on the Dutch market may practically no longer be distributed to new patients (barring a very limited number of strictly regulated exceptions). For existing patients it is permitted to supply and reimburse all currently available preparations for the duration of their cures.

The decision by the IGZ specifically states that the previously mentioned products Oralgen® Pollen and Oralgen® Mites may continue to be supplied until an irrevocable decision has been reached concerning the registration applications for these products. Moreover, the Court of Justice in The Hague recently ruled that the reimbursement of these products must be continued until 1 July 2012, or until such date when the issue of the registration

application has been definitively settled. Regarding the appeal proceedings in the matter of the registration application for Oralgen® Grass Pollen, a court hearing will take place in November 2009.

The Dutch market for immunotherapeutic products is currently dominated for approximately 80% by SLIT products. The market share of Fornix here is more than 70%. The decision by the IGZ therefore might have a favourable effect on the Dutch market share of these Fornix products.

Incidentally, there appear to be many obscurities among manufacturers as well as physicians and patients concerning the impact of the IGZ decision. It is therefore still unclear to which extent the manufacturers will appeal against these regulations.

Backgrounds decision IGZ

The supply of allergen products for immunotherapy has for many years included both registered and non-registered preparations. According to legislation known as the 'named patient regulation', supplying non-registered products is allowed for use by specific patients if there is no properly registered alternative for those products. The Healthcare Inspectorate (IGZ) has recently assessed all non-registered allergen preparations currently available against these regulations.

Over the past year the Healthcare Inspectorate (IGZ) has assessed 155 applications for permission to market non-registered allergen preparations. The results have been incorporated in the decision of 1 October 2009.

Strategy

The ruling by the Court of Justice in The Hague regarding the continuation of reimbursements and the decision made by the IGZ are important for the short-term as well as medium-term continuity of Fornix. It had already been established that, even without the outcome of the IGZ decision, the company will still be able to generate a positive cash flow. The developments that have taken place in the third quarter have only strengthened this prospect.

The continued negative reactions to the registration application for Oralgen® Grass Pollen by the Dutch Medicines Evaluation Board (MEB) were in part reason for Fornix BioSciences to seriously consider its future position. Given the fact that the legislation for the admittance of allergen products has been formulated by the IGZ as recently as 1 October 2009, this process is currently still in full swing. The main issues here are:

  • optimisation of stakeholder's interests;
  • the impact of registration on the future position of Fornix;
  • the impact of the reimbursement status on the future position of Fornix;
  • protective measures for the distribution network in the Netherlands;
  • entering into strategic alliances;
  • the two current division strategies.

In view of the turnover ratios, Fornix BioSciences is currently focusing its attention on the marketing, production and sales of diagnostic and therapeutic allergen products. One of the consequences of this is that the expansion of the Medical Aids Division must preferably be realised through autonomous growth. Concerning the possible divestment of this division, no such action is expected in the short term, mainly in view of the unfavourable present market conditions.

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E N D O F P R E S S R E L E A S E

For more information, please contact:

Fornix BioSciences N.V. C.L. Bergman, CEO Fornix BioSciences N.V. Tel. (0320) 26 77 99

Website: www.fornix.nl

Profile of Fornix BioSciences N.V.

Fornix BioSciences N.V. is a listed company (Euronext Amsterdam, code AFORBI) which engages in the development and sale of diagnostic and therapeutic allergen products and the distribution of medical aids and medical and nursing consumables.

Fornix BioSciences N.V. has sites in Lelystad, Beuningen and Hamburg. The company currently has a workforce of around 130 and is active mainly in the Netherlands and Germany. Its activities are carried out by two divisions, which in turn are made up of operating companies.

The Allergy Division, which consists of Artu Biologicals Europe and, since 1 June 2007, Artu Biologicals Deutschland, is the most profitable division. Its activities include the development, production and sale of a wide range of patient-friendly immunotherapeutic products, under the Oralgen®, Igevac® and other trade names. These products are used in the causal treatment of allergies triggered by various allergens, such as grass and tree pollen and house-dust mites. The development programme is supported by high-quality R&D activities and pan-European clinical studies of the effectiveness of the various products. The Medical Aids Division, which consists of Laprolan in Beuningen, engages in the sale, marketing and distribution of a wide range of medical aids and medical and nursing consumables.