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SnowWorld N.V. Earnings Release 2009

Jan 26, 2010

3886_iss_2010-01-26_9e3ab243-3b97-4dcf-825d-a98f22ad80f0.pdf

Earnings Release

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PRESS RELEASE

Lelystad, 26 January 2010

FORNIX PUBLISHES PROVISIONAL RESULTS FOR 2009

FORNIX REALISES HIGHER NET PROFIT WITH SMALL DECLINE IN TURNOVER

PROPOSAL: TO DISTRIBUTE THE ENTIRE NET PROFIT AS (OPTIONAL) DIVIDEND

In EUR x million
(other than figures stated per share)
2009 2008 Increase/(de
crease)
Turnover 37.8 39.8 (5.0%)
Gross
turnover
result
30.3 32.9 (7.9%)
Other operating income 0.3 0.2 50.0%
Total costs 1
)
16.8 20.5 (18.0%)
1
) of which related to allergy research
3.4 5.8 (41.4%)
Result from operating activities
(EBIT)
13.8 12.6 9.5%
Net financing income/expenses 0.9 1.3 (30.8%)
Profit before taxation 14.7 13.9 5.8%
Profit after taxation 10.9 10.3 5.8%
Earnings per share EUR
1.42
EUR 1.39 2.2%

Financial highlights in 2009

  • Fornix net profit up 5.8% to € 10.9 million on 5% lower turnover;
  • Fornix EBIT up 9.5% to € 13.8 million due mainly to decline in research costs of € 2.4 million;
  • Allergy Division maintains leading market position (market share of around 70%) despite extremely turbulent market conditions;
  • Turnover by the Allergy Division in the Netherlands down 10.6% to € 26.1 million (2008: € 29.2 million);
  • Reimbursement for allergen products Oralgen® Pollen and Oralgen® Mites assured until mid-2012, or until the registration decision if earlier;
  • Continuing market uncertainty regarding permissibility of non-registered allergen products;
  • First treatment year of 3-year Oralgen® Grass Pollen study has been completed; the interim results after first year will be published in a later stage;
  • Turnover in Germany more than doubled from € 1.4 million to € 2.9 million, completely due to the sale of medical aids;
  • EBIT in Germany is € 0.3 million positive compared to € 0.6 million negative in 2008;
  • Decline in turnover at the Medical Aids Division of 4.5% from € 9.7 million in 2008 to € 9.3 million in 2009;
  • EBIT of the Medical Aids Division falls to € 2.6 million (2008: € 2.9 million); loss of two distribution agreements from 2010;
  • Once again, proposal to distribute the entire profit of € 10.9 million as (optional) dividend;

  • Financial position remains strong;

  • Earnings per share up 2.2% to € 1.42 (2008: € 1.39);
  • No forecast for 2010 due to continuing uncertainty regarding the registration of allergen products;
  • Strategic reorientation is still ongoing.

Fornix BioSciences N.V. (Euronext Amsterdam: AFORBI) announces its provisional results for 2009 today. Compared to 2008, net profit was up 5.8% at € 10.9 million, against expectations in November 2009 of € 10.2 million. The reason for this discrepancy is born by lower than expected cost developments. EBIT was up 9.5% at € 13.8 million (2008: € 12.6 million). The increase in profit compared to 2008 is chiefly due to reduced costs, particularly clinical research costs at the Allergy Division. Our German subsidiary produced a good performance and doubled its turnover, thereby making a positive contribution to the company's profit for the first time. Given Fornix's still excellent cash position, we will once again propose that the entire net profit over the financial year be distributed to shareholders as (optional) dividend.

Turnover by Fornix BioSciences was 5% lower at € 37.8 million (2008: € 39.8 million). The decline occurred mainly at the Allergy Division (Artu Nederland), which had to deal with continuing uncertainty regarding the permissibility of and reimbursement for non-registered allergen products, especially in the fourth quarter. The objections of several manufacturers against the regulation for these products originally introduced as of 1 October 2009 has been granted legitimately as of the end of 2009. In fact with this the unregulated situation prior to October 1 2009 has been re-established. The Ministry of VWS has announced to initiate new legislation in relation to these products. The reimbursement for the company's major allergen products Oralgen® Pollen and Oralgen® Mites has been provisionally assured after a ruling by the Court of Appeal in The Hague.

Despite extremely turbulent market conditions, the Allergy Division managed to maintain its market share in the Netherlands last year at the very high level of 70%.

In Germany, turnover developed in line with expectations. Turnover more than doubled, to € 2.9 million (2008: € 1.4 million), due to strong growth mainly in the field of medical aids. EBIT was a positive contribution of € 0.3 million, against a negative contribution of € 0.6 million in 2008.

At the Medical Aids Division, turnover fell to € 9.3 million (2008: € 9.7 million) and EBIT declined to € 2.6 million (2008 € 2.9 million), due to continuing price and margin pressure and increased parallel imports. In the course of last year, it became clear that two relatively important distribution contracts would not be extended.

The year was turbulent in many respects, including the government regulation regarding reimbursement and permission for non-registered allergen products and the legal proceedings that Fornix had to initiate in relation to this registration and reimbursement.

Availability and reimbursement

During the past year, the government intervened in the until that time unregulated market for non-registered allergen products. According to new regulation as of 1 October 2009, nonregistered allergen products could only be made available to new patients in a very limited number of cases. This decision has since been reversed as a result of legal proceedings successfully conducted by two other allergen manufacturers. Under a ruling by the Court of Appeal in The Hague in September 2009, Fornix is assured of reimbursement for its most

important Oralgen® (Pollen and Mites) products until 1 July 2012, or at such time as a final decision regarding the registration applications for these products is made, if earlier. Besides one other registered alternative, these products are strictly speaking the only sublingual (application under the tongue) allergen products for which permission and reimbursement are currently assured. Fornix thus expects to be able to maintain its dominant market position in this area for the time being.

Clinical development and registration

As an extension to the problem of reimbursement, there is also still the issue of registration of Oralgen® Grass Pollen. After the Dutch Medicines Evaluation Board (MEB) decided in March 2009, on the results of a follow-up study to a pan-European study of the effectiveness and safety of Oralgen® Grass Pollen, that there were no grounds for reversing the previous rejection of the registration application for this medicine, the appeal lodged against a previous rejection by the District Court of Zwolle was continued. This led to a hearing in November 2009. The ruling on the substance of this case is expected in the near future.

In the meantime, as part of the clinical development plan, a new multi-year clinical phase III study AB0801 on the effectiveness and safety of Oralgen® Grass Pollen had been initiated in early 2009. The first interim analysis was completed at the end of December 2009. The results have, however, not been published for reasons relating to the scientific integrity of the remainder of the study and the assessment of the data by the registration authorities. We cannot predict when further information on the results of the study can be provided at this time.

In view of the disappointing rejection of the results of the Oralgen® Grass Pollen follow-up study by the MEB in March 2009, Fornix decided in mid-2009 to put the clinical phase III studies of the products Oralgen® Mites and Oralgen® Tree Pollen on hold for the time being. A decision will, however, have to be taken with regard to the continuation of these studies within the foreseeable future. One issue at stake is that by mid-2012, Fornix needs to have sufficient research data available in order for these products to have a serious chance of completing the registration applications concerned. As a result of this decision, the costs of clinical research declined by 41.4% to € 3.4 million in 2009. If the clinical research activities regarding the products Oralgen® Tree Pollen and/or Oralgen® House Dust Mites are resumed, the costs of clinical research will of course increase again.

Strategy

The study of all the company's strategic options is ongoing. Based on the information currently available, the company expects that once the ruling in the proceedings regarding the registration dispute at the court in Zwolle is obtained, progress can be achieved in this respect.

Outlook for 2010

In view of the still uncertain situation regarding the registration of Oralgen® Grass Pollen, Fornix BioSciences cannot issue any forecasts with regard to turnover and profit development in 2010.

Agenda

This press release is based on provisional figures and data for the 2009 financial year. The final audited results for 2009, including the income statement, balance sheet and other

financial information, will be announced before the stock exchange opens on 11 March 2010. The General Meeting of Shareholders will be held on 23 April 2010 in Lelystad.

_______________________________________________________________________

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 140 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.