PRESS RELEASE. Pierrel S.p.A.

Transcription

1 PRESS RELEASE Pierrel S.p.A. The Board of Directors approved: - the draft Financial Statement of Pierrel S.p.A. and the Consolidated Financial Statement of the Group as at 31 December 2009 Consolidated results as at 31 December 2009: Consolidated revenues: euro 44.4 million (compared with euro 46.3 million as at 31 December 2008); EBITDA: negative for euro 3.9 million (compared with a negative euro 3.2 million as at 31 December 2008); net of non recurring charges 1 for euro 2.1 million, EBIDTA is negative for euro 1.8 million improving if compared to December 31, 2008; Net result: negative for euro 12.8 million (compared with a negative euro 10 million as of December 31, 2008). Net of the total of non recurring items 2 for euro 4.2 million, the Net result is negative for euro 8.6 million improving therefore in respect to December 31, 2008; Net financial position: negative for euro 27,1 million (compared with a negative euro 22,8 million at 31 December 2008): Net financial debts with banks: euro 18,2 (compared with euro 19.1 million at 31 December 2008): - approved the project aimed to the incorporation of Pierrel Research International AG, with offices in Zurich which will receive as contribution in kind all the companies being part of the Division CRO of the Group; - approved the project aimed to the incorporation of Pierrel Pharma International S.r.l. which will became the owner of all Articaine Pierrel registrations as well as of the others molecules owned by Pierrel and handling also the development of new therapeutic formulations for drugs related to pain treatment; - the calling of the ordinary shareholders meeting; - the Business Plan ( the Plan ) for the Period : Revenues for euro 100 million in 2012; positive Ebitda for euro 1,9 million in 2010 reaching euro 16,5 million in 2012 and with a Net Financial Position negative for euro 9,5 million at the end of the Plan. Milan, March The Board of Directors of Pierrel S.p.A., provider of research, development (Contract Research) and manufacturing (Contract Manufacturing) of drugs for third parties, has today approved 1. Non recurring charges due mainly to the completion of the Group s operations for obtaining the two FDA authorizations granted respectively on October 7, 2009 (plant of Capua) and on March 2, 2010 (Articaine Pierrel) 2. Non recurring items related mainly to the operations cited above.

2 the Draft Financial Statement of Pierrel S.p.A. as well as the Consolidated Financial Statement of Pierrel Group both as at December 31, In the fiscal year 2009 Pierrel S.p.A. posted consolidated Net revenues for euro 44,4 million, (a reduction of 4% in respect of euro 46,3 million in 2008). Such a reduction is due mainly to lesser revenues of the CMO Division and lesser Pass Trough costs" 3 of the CRO Division. In particular, at December , the Division Contract Research (CRO) posted net revenues for euro 36,4 million which are in line with euro 36,9 million posted at the end of However the CRO Division posted Net Revenues of euro 27 million, net of Pass Through Costs, with an increase of about 9% as compared to the fiscal year At December 31, 2009, the Contract Manufacturing (CMO) Division, posted Net Revenues for euro 8,0 million with a reduction of euro 0,8 million compared to the previous fiscal year. Such a reduction is due to the partial stoppage of the Capua plant needed to allow the completing of activities aimed to obtain the FDA s approval Food and Drug Administration - ultimately obtained on October At December 31, 2009, the Pierrel Group posted a negative EBITDA for euro 3,9 million with a reduction of 21% as compared to 3,2 million posted at December 31, Such a result, net of nonrecurring charges for euro 2,1 million, is negative for euro 1,8 million, showing therefore a significant improvement in respect to the previous year. At December 31st, 2009, the Division CRO Contract Research posted a positive EBITDA for euro 2,5 million showing a growth as compared to euro 2,1 million posted in the previous year. Such a result, net of non-recurring items related to the costs for the integration and rationalization project of the Division CRO, has been equal to euro 2,6 million (with an increase of 24% with respect to the previous year ). At December 31st, 2009, the Division Contract Manufacturing (CMO) posted a negative EBITDA for 3,2 million as compared to the fiscal year 2008, when it was negative for euro 1,9 million. Such a reduction is due to both the higher costs for the completion of the FDA project and the consequent long production stoppage at the Capua plant. At December 31st, 2009, Pierrel Group posted a negative EBIT for euro 10,9 million as compared to a negative euro 8,3 million in the previous year. This result was due mainly to higher depreciations and devaluations in respect to the fiscal year At December 31st, 2009, Pierrel Group posted a Net loss of euro 12,8 million (euro 10,1 million in 2008). Net of non-recurring items totalling euro 4,2 million, the Net loss would have been negative for euro 8,6 improving therefore in respect to December 31, The non-recurring items affecting the devaluations, are mainly due to the definitive closing down of the Elk Grove facilities (Chicago, USA) Illinois) which is not any longer functional to the Manufacturing project following the FDA approval of the Capua plant on October 7 last year. 3. The Pass Through Costs are related to recharges of costs to customers such s the payment of the fees to the Ethical Committees as well as the compensations to the hospitals participating to the clinical studies.

3 The Net Financial Position was negative for euro 27 million (euro 22,7 million at December 31, 2009). Such a worsening is due to both the use of the cash flow of the Group for covering the operating losses and the investments made in the period. Pierrel S.p.A. Results The holding Pierrel S.p.A., closed the fiscal year 2009 with Net Revenues of euro 9,2 million dropping therefore from euro 9,7 million of At December 31, 2009, the EBITDA was negative for euro 4,6 million in respect of the 3,6 million posted in the previous fiscal year. At December 31, 2009, Pierrel S.p.A net loss was euro 12,5 million increasing therefore in respect to euro 8,8 million posted at December 31, The same reasoning made for the consolidated financial statement with respect to non-recurring costs and devaluations applies also to Pierrel SpA. The holding s net financial position at December 31, 2009 was negative for euro 22,8 million compared to euro 19,9 million at December 31, IMPORTANT EVENTS OCCURRED FOLLOWING THE CLOSING OF THE FISCAL YEAR 2009 On March 2, 2010, Pierrel S.p.A. obtained the registration of its drug Articaine Pierrel dental anaestetic by FDA (the US Regulatory Agency). Such an authorization represents an outstanding achievement for Pierrel which, as of today, is the fifth Italian company having developed a drug and obtained the NDA New Drug Application- in the USA. This will allow the Group to increase significantly the production volumes of the manufacturing Division and to obtain royalties from the licensingout of Articaine Pierrel to distributors for the US market. On March , Pierrel S.p.A. signed with ARWAN Pharmaceutical Industries S.A.L, a Lebaneese company specialized in the distribution of injectable drugs, a five years agreement for the manufacturing of Articaine Pierrel, Mepivicaina e Lidocaina in the MENA Area Countries (Middle-East and North African countries. The market size of the dental anaestetic in the MENA Area Countries is being estimated in about 40 million cartridges per year. The minimum value guaranteed provided for in the agreement is about euro 3 million. On March 10, 2010, the Board of Directors of Pierrel S.p.A. approved the new internal structure of the Contract Manufacturing (CMO) Division, headed by the new General Manager of the Manufacturing Division, Mr. Francesco Caputo effective April 6, In addition the Board also appointed Maria Grazia Falchi as new Administrative Officer of Pierrel S.p.A. as well as officer in charge of the drafting of the accounting documents as required by the law. She was also granted the due operational powers.

4 The Board of Pierrel S.p.A. also approved the project aimed to the incorporation of Pierrel Research International AG, with registered and operative offices in Thalwil(Zurich-Svitzerland) which will receive as contribution in kind all the companies being part of the CRO Division, i.e. Pierrel Research Europe GmbH (Germany); Pierrel Research Switzerland AG (Switzerland), Pierrel Research Hungary kft (Hungary); Pierrel Research Italy S.p.A (Italy) and Pierrel Research USA (USA). Pierrel Research International AG will also manage the marketing and development activities, contracts and administration and financial activities for the entire CRO Division. The Pierrel Group s decision to form Pierrel Research International AG is mainly due to the importance of having an stronger presence of the Group in Switzerland, a country with the highest concentration worldwide of pharmaceutical and biotech companies and where investments in R&D keep growing despite the economical and financial crisis. The Board also approved the project aimed to the incorporation of Pierrel Pharma International S.r.l., which will became the owner of all Articaine Pierrel as well as of the others molecules owned by Pierrel registrations both European and North American. Pierrel Pharma International S.r.l., then, thanks to internal services of CRO and CMO of Pierrel Group will be also active in the development of new molecules, new pharmaceutical formulations or Drug Delivery Systems in the area of pain therapy for which the Group enjoys an important know-how since 50 years. Both companies will become operational from next June Business Plan The Board also approved the Business Plan ( the Plan ) with the aim to further consolidate its position as global provider in the bio-pharmaceutical segment. The new Plan s target is to achieve a growth both in terms of revenues and profitability of both Divisions, Research and Manufacturing, during the next three years by acquiring new contracts at international level bearing high gross margins in addition to a considerable increase of cartridges volumes manufactured at the Capua plant. Targets for 2010 For the fiscal year 2010 Pierrel Group foresees a growth of the turnover of 35% as compared to the fiscal year In particular the expected growth of the newly formed Pierrel Research International AG, in 2010 reaches 27% as compared to Taking into consideration the pro-forma revenues as of December 31, 2009 of research internatio still to be incorporated ( which include for the entire fiscal year the revenues of the Pierrel Research USA and Pierrel Research IMP Srl), the expected growth OF Pierrel Research International AG reaches 15% in line with the average growth rate of the referred market which is in the range of 10-13%. For the Manufacturing Division, the expected growth is about 77%, compared to 2009, thanks to higher production volumes of the Capua plant.

5 Furthermore the Group expects to achieve a positive EBITDA of 1,9 million at the end of 2010 with a net debt of euro 28,5 million. Targets for Pierrel Group for the three years period of the Plan, foresees growing revenues exceeding euro 100 million in In connection to the three business lines, Research, Manufacturing and Pharma, the Plan describes the following developments and scenarios: - the Group indicates that the new Pierrel Research International AG during the Plan s period achieves an average yearly growth of the revenues equal to 27%, thanks to the conclusion of new agreements for clinical studies at international level, a stronger presence in the area of oncoimmunology studies, where the 40% of new drugs under development is being concentrated, in addition to the use of its own web-based (Hypersuite ) technology, ideal for the running of the clinical studies on an international scale; - For the Manufacturing Division the Groups foresees almost to triple the production volumes of cartridges -up to a saturation of approximately 80% of the manufacturing capacity of the Capua plant thanks to the finalization of supply agreements in Countries like USA, Canada, Russia, Germany, UK, East Europe countries, Australia, North Africa and Middle East.. This will create margins such to compensate the investments made by the Group on the period and equal to approximately euro 20 million; - the Group then foresee that the newly formed Pierrel Pharma International S.r.l., as from 2011 may contribute to the revenues and margins of the Group through royalties deriving from the licensing out of the commercialization rights of Articaine Pierrel to the distributors for the North American and Russian markets. The estimated value of the royalties for the fiscal years 2011 and 2012 shall be respectively equal to euro 1,3 million and euro 2,6 million. The attainment of the operational targets as defined in the Plan will allow the Group to reach an EBITDA of euro 16,5 million and a negative net financial position of euro 9,5 million in Summarizing, in the period the Group expects to obtain the following results: Revenues EBITDA Net Debt (NFP) million 1.9 million 28.5 million million 9.7 million 22.3 million million 16.5 million 9.5 million

6 The Board of Directors of Pierrel S.p.A. finally resolved to call the ordinary shareholders meeting on April 26, 2010 first call and on April 27, 2010 second call to approve the Financial statement 2009 and for the presentation of the Consolidated Financial Statement 2009 as well as to approve the authorization to the purchase and disposal of own shares. The Draft of Financial Statement as at December 31, 2009, the management report, the Report of the Board of Statutory Auditors as well as the Audit Report will be available, pursuant to the Law, upon request at the company s registered office and at Borsa Italiana S.p.A.; and it will be also available in the company website in the Investor Relations section. * * * The officer of the company in charge for the preparation of the corporate accounting documents of Pierrel S.p.A., Mrs. Maria Grazia Falchi, declares pursuant to paragraph 2 of article 154-bis of legislative decree no.58 of 1998 that the accounting information of the half-year Report as of June 30, 2008, contained in this press release, is consistent with the accounting entries and the books of account of the company. Pierrel S.p.A. Pierrel S.p.A., a global provider to the pharmaceutical and life science industries, specialized in Research and development (Contract Research) and production (Contract Manufacturing) of drug products, is listed in the Italian Stock Exchange market. The Pierrel Group enjoys more than 50 years experience in the pharmaceutical sector and is one of the main European manufacturers of dental anaesthetic drug products. The CRO division, Pierrel Research, with about 20 subsidiaries operates both in Europe and USA, providing consultancies and full services for research and development of new molecules and drug products. The manufacturing plant in Capua, near Naples (Italy), has been authorized by FDA for the production of sterile small volumes parenteral drugs. Pierrel S.p.A Corporate Office is located in Milan, Italy. For further information Pierrel S.p.A. Investor Relator Dott. Aurelio Matrone investor.relations@pierrelgroup.com tel fax Image Building Simona Raffaelli, Valentina Burlando Tel. 02/ pierrel@imagebuilding.it