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Haupt Pharma Group. Company Presentation. In xx, on xx.xx.xxxx, Name of speaker. Full-Service Offering. Clinical Trial Supply Management. Pharma- ceutical Development. Scale-up & Technical Transfer. Contract Packaging. Contract Manufacturing. History.
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Haupt Pharma Group Company Presentation In xx, on xx.xx.xxxx, Name of speaker
Full-Service Offering Clinical Trial SupplyManagement Pharma- ceutical Development Scale-up & Technical Transfer Contract Packaging Contract Manufacturing
History 1937 Founded in Berlin by Heinz Haupt as one of the first German companies for pharmaceutical contract manufacturing 1990 Growth to more than 200 employees 1995 – 2000 Expansion phase I Acquisition of plants in Germany (3) and France (1) Establishment of Haupt Pharma AG as management holding in 2000 2007 – 2009 Expansion phase II Acquisition of plants in Japan, Germany (2) and Italy Establishment of a sales company in the USA 2010 – 2012 FDA audit & increased development activities Further expansion of the company’s production expertise forthe U.S. market (6 FDA-audited sites) Extensionof development capacities at five sites
Corporate Structure Haupt Pharma AG – Management Board LegalAffairs CorporateIT Corporate Purchasing TechnicalOperation Corporate QA Finance & Group Controlling Corporate HR Haupt Pharma Livron S.A.S.- France- Haupt Pharma Latina S.r.l.- Italy - Haupt Pharma Toride Co., Ltd.- Japan- Haupt Pharma Amareg GmbH Haupt Pharma Berlin GmbH Haupt Pharma Münster GmbH 33% Haupt Pharma Wolfratshausen GmbH Loxxess PharmaGmbH Haupt PharmaDevelopment GmbH Haupt PharmaSales GmbH Haupt Pharma Inc.- USA- Haupt Pharma Wülfing GmbH 33%
Key Facts One of the leading contract developers and manufacturers in Europe with a full-service offering 9 production sites in Europe and Japan, of which 5 have development departments, and a sales office in the USA More than 2,000 employees > 500 processed APIs> 1,500 products > 5,000 presentations / stock-keeping units Production for almost all pharmaceutical markets worldwide, with emphasis on Europe, USA and Japan More than 200 clients including the majority of the top 20 pharmaceutical companies worldwide
Sales Trend of the Group Revenue million € 400 295 300 284 273 258 240 250 200 149 150 113 105 100 50 0 2006 2007 2008 2009 2010 2011 2012 (FC) 2013 (Plan)
Haupt Pharma… … strives to be a preferred partner for the development and manufacturing of high-quality products for the pharmaceutical industry. … wants to attract talented and engaged people and maintain a long-term relationship. ... wants to be a sustainable and profitable actor in the market. Vision
Expertise in Contract Manufacturing Pharmaceuticals for Human Use – Solids • Cytotoxic APIs • Penicillins • Sex hormones • Thyroid hormones • Corticosteroids Pharmaceuticals for Human Use – Parenterals • Cytotoxic APIs • Penicillins, cephalosporins • Corticosteroids Veterinary • Penicillins, cephalosporins • Intramammary syringes Special Competences
Expertise in Contract Manufacturing Other dosage forms Parenterals • Ampoules and vials (aseptically filled / terminally sterilized) • Lyophilizates (vials) • Powder Solids • Tablets • Film-coated & sugar-coated tablets • Hard capsules • Dry syrups • Granulates • Powder Liquids / Semi-solids • Solutions (oral, nasal, other) • Emulsions • Suspensions • Gels, creams, ointments • Suppositories All production sites use various technologies for the packaging of the manufactured products.
Expertise in Contract Development (1/2) 5 development centers located in Germany (4) and Italy (1) Extensive experience in pharmaceutical development for Europe, USA and Japan Track record: > 40 generics > 30 formulations for new chemical entities (NCEs) Longstanding experience with all common dosage forms including liquid and lyophilized parenterals
Expertise in Contract Development (2/2) Special expertise in handling of high-potency formulations including cytotoxics and hormones Full scale development from non-GMP laboratory to industrial production level in GMP environment Formulation development based on “Quality by Design” Development and manufacturing of clinical trial supplies
Strategic Alignment • Expansion of strategic business segments • Cytotoxics • Hormones • Beta-lactam antibiotics: penicillin, cephalosporin • Veterinary pharmaceuticals • Organic growth in existing core technologies
Production Strategy • Expansion of capacities in the strategic business segments • Technology focus at the plants • Modernizing and upgrading of existing core technologies • Continuous optimization of production processes and the entire supply chain • Project related joint investments in strategic partnerships with clients
Development Strategy Expansion of personnel capacities, laboratories and equipment at the local development units Increase in the number of development projects including cooperations Increase the production share of in-house developed preparations in total manufacturing
Environment, Health, Safety and Quality (EHS & Q) • Haupt Pharma takes responsibility for: • its employees’ health and safety at the work place • high and constant quality of its products and services • sustainable interaction with natural resources and environment protection • Our EHS & Q – Management allows: • Transparency • Legally compliant actions • Standardization and alignment of structures • Continued improvement of EHS&Q-Services • Clear information policy towards employees, clients and the public