corporate october 2015
DESCRIPTION
ÂTRANSCRIPT
Corporate / October 2015
History
HISTORY• 50 years ago, a small team of scientists, lead by a visionary pharmacist, with limited financial resources, set the foundation for a modern and dynamic pharmaceutical company
• ELPEN’s philosophy “We care for People” inspires and drives all of us at ELPEN and aspires further expansion in our activities
STRATEGYTo maintain its leading position and top quality ELPEN: • Dedicates significant financial resources to R&D• Aims to enter new therapeutic areas• Invests in and secures new strategic partnerships with selected multinational companies• Enhances and enriches its product portfolio
ELPENHALER®
The Elpenhaler® is ELPEN’s proprietary, patent protected, breath-activated, multi single-dose dry powder inhaler Advantages:• Robust construction, accurate dosing, medication protection, ease of use, taste and visual verification of drug uptake Additional use:• administration of other medications that could be delivered via the lungs in the treatment of local or systemic diseases
ROLENIUM®
Rolenium® is ELPEN’s fluticasone/ salmeterol combination product for the treatment
of asthma and COPD, launched in Greece in November 2009
• Strengths: 100/50 mcg
250/50 mcg500/50 mcg
• 3rd brand of the Greek ICS + LABA the market, with 16% m.s.
ELPEN Pharma GmbH• ELPEN’s subsidiary• Founded: February 2012 in Berlin, Germany• Offers high quality medicinal products in various therapeutic categories
ELPENHALER® PRODUCTS, UPDATEFour Elpenhaler® medications have been developed to date. Their registration status and market presence is as follows: • Formopen® (formoterol): Registered and launched in 5 countries• Fluticapen® (fluticasone): Registered and launched in 5 countries• Rolenium® (fluticasone + salmeterol): Registered in 28 EU countries and launched in 9 countries• Pulmoton® (budesonide + formoterol): Registered in 9 EU countries and launched in 2 countries
Further worldwide registrations are on-going and new launches are planned in the near future for all products above
1965 1970 1990 2002 2009 2012 2015
VISION• To offer pharmaceuticals of high quality standards at affordable prices• To increase our social contribution towards our fellow humans and the Greek economy
RESEARCH & DEVELOPMENTEstablishment of the first private fully fledged R&D facility in Greece. ELPEN’s R&D unit facilitates the internal development of selected generics, and the establishment of strong collaborations with major academic and private research institutes in Greece and abroad, and operates a state of the art Experimental and Research Center
EX
PERI
MENTAL - RESEARCH CEN
TER
ΕΡΕΥΝ
ΗΤΙΚΟ - ΠΕΙΡΑΜΑΤΙΚΟ ΚΕΝ
ΤΡΟ
INDUSTRIAL FACILITIESElpen establishes its own production facilities, which turn the company into a leading player in the Greek market.The company owns over 10,000m2 in facilities, which operate according to international GMP and ISO standards.We possess full production lines of: Oral Solids, Oral Liquids, Dry Powder Inhalation, Injectable & Lyophilized products. In independent & dedicated facilities, we operate the production of Oral Solid Penicillin
EXPORTSEstablishment of the Exports Department of Elpen. The company wins its first major National Tender and organizes local private market product portfolios with the aid of carefully selected local partners
HISTORY• 50 years ago, a small team of scientists, lead by a visionary pharmacist, with limited financial resources, set the foundation for a modern and dynamic pharmaceutical company
• ELPEN’s philosophy “We care for People” inspires and drives all of us at ELPEN and aspires further expansion in our activities
STRATEGYTo maintain its leading position and top quality ELPEN: • Dedicates significant financial resources to R&D• Aims to enter new therapeutic areas• Invests in and secures new strategic partnerships with selected multinational companies• Enhances and enriches its product portfolio
ELPENHALER®
The Elpenhaler® is ELPEN’s proprietary, patent protected, breath-activated, multi single-dose dry powder inhaler Advantages:• Robust construction, accurate dosing, medication protection, ease of use, taste and visual verification of drug uptake Additional use:• administration of other medications that could be delivered via the lungs in the treatment of local or systemic diseases
ROLENIUM®
Rolenium® is ELPEN’s fluticasone/ salmeterol combination product for the treatment
of asthma and COPD, launched in Greece in November 2009
• Strengths: 100/50 mcg
250/50 mcg500/50 mcg
• 3rd brand of the Greek ICS + LABA the market, with 16% m.s.
ELPEN Pharma GmbH• ELPEN’s subsidiary• Founded: February 2012 in Berlin, Germany• Offers high quality medicinal products in various therapeutic categories
ELPENHALER® PRODUCTS, UPDATEFour Elpenhaler® medications have been developed to date. Their registration status and market presence is as follows: • Formopen® (formoterol): Registered and launched in 5 countries• Fluticapen® (fluticasone): Registered and launched in 5 countries• Rolenium® (fluticasone + salmeterol): Registered in 28 EU countries and launched in 9 countries• Pulmoton® (budesonide + formoterol): Registered in 9 EU countries and launched in 2 countries
Further worldwide registrations are on-going and new launches are planned in the near future for all products above
1965 1970 1990 2002 2009 2012 2015
VISION• To offer pharmaceuticals of high quality standards at affordable prices• To increase our social contribution towards our fellow humans and the Greek economy
RESEARCH & DEVELOPMENTEstablishment of the first private fully fledged R&D facility in Greece. ELPEN’s R&D unit facilitates the internal development of selected generics, and the establishment of strong collaborations with major academic and private research institutes in Greece and abroad, and operates a state of the art Experimental and Research Center
EX
PERI
MENTAL - RESEARCH CEN
TER
ΕΡΕΥΝ
ΗΤΙΚΟ - ΠΕΙΡΑΜΑΤΙΚΟ ΚΕΝ
ΤΡΟ
INDUSTRIAL FACILITIESElpen establishes its own production facilities, which turn the company into a leading player in the Greek market.The company owns over 10,000m2 in facilities, which operate according to international GMP and ISO standards.We possess full production lines of: Oral Solids, Oral Liquids, Dry Powder Inhalation, Injectable & Lyophilized products. In independent & dedicated facilities, we operate the production of Oral Solid Penicillin
EXPORTSEstablishment of the Exports Department of Elpen. The company wins its first major National Tender and organizes local private market product portfolios with the aid of carefully selected local partners
ELPEN is the Leading Pharmaceutical Company in Greece, ranking 6th among more than 300 multinational and local companies
Rank Corporation Values, € mill % m.s. Volume mill % m.s. (total market 2.7 € bill) (total 380 mill)1 NOVARTIS 227,997,447 8.5 24,291,752 6.42 PFIZER 182,136,640 6.8 27,221,401 7.23 SANOFI 164,481,511 6.1 25,266,598 6.74 ASTRA ZENECA 147,197,841 5.5 14,767,288 3.95 GSK PHARMA 142,272,873 5.3 26,227,327 6.96 ELPEN 122,257,893 4.6 13,860,566 3.67 MERCK SHARP DOHME 114,528,029 4.3 7,377,400 1.98 VIANEX 104,647,147 3.9 12,645,535 3.39 PHARMASERVE 103,587,383 3.9 4,592,892 1.210 BOEHRINGER INGELHEIM 93,263,502 3.5 13,682,372 3.611 BAYER HEALTH CARE 75,999,775 2.8 8,975,529 2.412 MENARINI 72,042,629 2.7 6,231,043 1.613 ABBOTT 46,004,238 1.7 6,865,049 1.814 LUNDBECK 45,858,604 1.7 2,588,620 0.715 JANSSEN CILAG 41,013,628 1.5 3,509,228 0.916 NOVO NORDISK 37,793,331 1.4 960,351 0.317 SERVIER 36,968,728 1.4 4,929,982 1.318 WINMEDICA 36,596,012 1.4 2,734,830 0.7
Successful product selection and dedication to quality by applying the highest production standards and strict quality controls have been amongst the determining factors to ELPEN’s exponential growth
GREECE, IMS, MAT 07/2015
Goal:• Maintaining leading position
in local markets
• Expending internationalpresence
• Increasing exports
• Development of added value generics (innovative formulations)
ELPEN Group of CompaniesPrivate Company: Family owned, not listedEstablished: 1965 Group: ELPEN Pharmaceutical Co. Inc. Aenorasis SA WinMedica SA ELPEN Pharma GmbH Turnover 2014: €140 million (Group: € 200 million)Employees: 656 (Group: 900) Production Facilities: 10.000 m2 (Pikermi, Attica) Offices: 3.000 m2 (Athens, Thessaloniki, Berlin) Research Facilities: 1.000 m2 (Pikermi) Activities: - Production - Marketing and Sales - Regulatory Affairs - Clinical Development - Exports - Distribution - R&D
ELPEN Yearly Turnover Progress
ELPEN has enjoyed truly exceptional growth rates in the last years, a trend set to continue
ELPEN Employees Increase Over The YearsThe successful transformation of ELPEN into a leading local player is due first and foremost to our people, their commitment to ELPEN’ s business goals and their dedication to customer needs
74
88105
130
140
126 126 128
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
63
130
140
410
450
522
550560
570 570 570
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
375
621627
656
Over the next years, sales are projected to grow as ELPEN enters new markets and exploits new opportunities and collaborations
*From 2010 onwards turnovers were greatly affected by numer-ous price decreases in Greece
Marketing and Sales Force Teams comprise together approximately half of ELPEN employ-ees (350 people). They are one of the largest and most effective pharmaceu-tical sales teams in Greece, covering more than 24,000 medical doctors (12,000 in the hospital sector and 12,000 in the private sector) in all major medical specialties. They also visit 3,500 pharmacies all over Greece
ProductsELPEN specializes in branded generics and branded pharmaceuticals through collaborations with multinational companies:
SPECIALTY % by values (YTD, MAT 07/2015)
CARDIOLOGY 68
RESPIRATORY 18
CENTRAL NERVOUS SYSTEM 11
GASTROINTESTINALS 10
ANTIMICROBIALS 9
HAEMATOLOGY 4
UROLOGY / GYNECOLOGY 2
REST 1
Furthermore, nine (9) of ELPEN’s major products are included in the top 100 best performing product list:
Product (API) Rank
Xarelto® (rivaroxaban) 15th
Lepur® (simvastatin) 17th
Copalia® (valsartan + amlodipine) 33rd
Copalia® HCT 38th (valsartan + amlodipine + HCTZ)
Rolenium® (fluticasone + salmeterol) 53rd
Penrazol® (omeprazole) 60th
Clovelen® (clopidogrel) 78th
Entact® (escitalopram) 83rd
Carvepen® (carvedilol) 84th
Greece, IMS, MAT07 2015
The quality of our products has won the trust of the local medical and pharmaceutical community and along with our ethics, has given ELPEN the confidence of conducting business like a multinational pharmaceutical company
BRANDED PHARMACEUTICALS
42%BRANDED GENERICS
58%
Quality Policy:• ELPEN implements a quality policy to cater for the needs of its prod-
ucts, while fully complying with the standards required by law
• The company’s management is committed to the implementation of
an integrated Quality System that is fully aligned with ISO
9001:2000, the Good Manufacturing & Laboratory Practices and the Good
Storage & Distribution Practices
Branded Pharmaceuticals, Biosimilars & Generics
Licensing-in, Marketing & Distribution Collaborations
We continuously seek and evaluate products that have completed or are under late stage clinical develop-ment (ph.III / registration trials) and products registered or under registration in Europe We are interested in discussing various types of collaborations:
• Co-Marketing &/or Co-Promotion
• Marketing & Distribution
• Co-Development
• Contract Manufacturing, and
• Third Party Services (Product Development, Preparation and submission of registration e-CTD dossiers, Monitoring of the registration process, Contract Manufacturing)
and we welcome all proposals for collaborations regarding products in the following therapeutic groups:
Anti-infectiveCardiology
Gynecology
Hematology
Biosimilars
MedicalDevices
Metabolicdisorders
Nichemarkets
Gastrointestinal Disease Oncology
Musculoskeletal disorders
Neurology
OTC
Respiratory
Renal Diseases
Genitourinary
CollaborationsOur experience is extensive in all types of partnerships including contract manufacturing, third party services, licensing-in, co-marketing, co-promotion and distribution. Thus ELPEN and affiliate companies enjoy a reputation for being the partner of choice for the Greek market as shown below:
International Partnerships & Collaborations
COLLABORATION TYPE COMPANY SINCE PRODUCT (API)
Third Party Services Aceto, DE 2000
Actavis, US 2012
Pharmacare, IT 2004
Distribution/ Bayer, DE 2000 Octegra® (moxifloxacin)
Marketing & Sales Ferring, CH 2012 Tractocile® (atosiban)
2012 Zomacton® (somatropin human recombinant)
2012 Glypressin® (terlipressin)
Hospira, US 2006 Retacrit® (epoetin-z)
2009 Nipent® (pentostatin)
2011 Nivestim® (filgrastim)
2015 Inflectra® (infliximab)
Venture Life, UK 2013 NeuroAge® (OTC for memory enhancing: iron, pantothenic acid, uridine, cytidine, l-glutamine)
Licensing – in Italfarmaco, IT 1990 Legofer® (iron proteinsuccinylate)
Co-marketing Lundbeck, DK 2005 Entact® (escitalopram)
Novartis, CH 2007 Copalia® (amlodipine + valsartan)
2007 Copalia® HCT (amlodipine + valsartan + HCTZ)
Takeda Pharma S/A, CH 2015 Vipidia® (alogliptin)
2015 Vipdomet® (alogliptin + metformin)
2015 Incresync® (alogliptin + pioglitazone)
Co-promotion Bayer, DE 2012 Xarelto® (rivaroxaban)
ELPEN offers great experience in all necessary aspects for the dynamic introduction and promotion of pharmaceuticals in Greece
Research & Development
In 1,500 m2 facilities at Pikermi, equipped with state-of-the-art instrumentation we perform research n the following sectors:
1. Developing new Branded Generics The departments of Patent Affairs, Formulation, Analytical Methods, Regulatory Affairs, and Clinical
Affairs collaborate in the development of selected products in the therapeutic areas of interest. The Elpenhaler® , Elpen’s proprietary dry powder inhaler, and the related branded generics were developed for the treatment of asthma and COPD. Products comprise: Formopen® (formoterol), Fluticapen® (fluticasone), Rolenium® (fluticasone / salmeterol), and Pulmoton® (budenoside / formoterol)
2. Collaboration with Greek Universities and Research Institutions in projects of common interest The projects are co-financed by the Greek Secretariat of Research and Technology. ELPEN participates as the
Industrial Partner by financing up to 50% of the total budget Aims of the projects include the study of disease mechanisms, possible therapeutic interventions as well as
development of new formulations and technologies in the areas of Cardiology, Respiratory diseases, Endocrinology and Oncology
3. The Experimental – Research Center ELPEN Ranking by the International Scientific Bodies in the top 5 in Europe, for its contribution in
Research Activities and Training Workshops The Center, is the first and largest laboratory for Experimental Biomedical Research and Training in Greece
that originates from the private sector
The Experimental Research Centre activities for apply biomedical research and training include: 1. Scientific Partnerships on innovative research ideas with clinics and laboratories of Greek Universities,
the Greek National Health System and the private Hospital sector 2. International Research Collaborations 3. Experimental Projects of ELPEN with the General Secretariat for Research and Technology,
the European Union and other bodies 4. Preclinical (in vivo) Experimental Research on new molecules where ΕLPEN retains exclusive rights 5. National & International Conferences and Meetings
> 700 presentations in international meetings
> 230 publications in peered review Journals
> 130 awards, from many Greek and Foreign Scientific Societies
Special Award for Investment
in R&D, (July 2005, June 2014). The Athens
Chamber of Commerce and Industry Selection from the
entire industrial sector
Exports
Our goal is to form successful strategic alliances and to become the partner of choice in offering services and innovative and branded generic pharmaceuticals all around the world
We aim to establish long-term business co-operations with local Agents, Distributors and Manufacturers for our products, services, technologies and know-how, for private markets, national and institutional tenders
ELPEN has been active in export activities since the 1990’s and the quality of our regulatory files and our products have been acknowledged in numerous markets around the world
The Exports team is supported by ELPEN’s GMP certified departments of Product Development, Production, Quality Assurance and Regulatory Affairs to meet all local Quality, Regulatory and Pricing requirements
Elpen’s Worldwide Presence
ELPEN currently exports its products in four continents, including the following countries:
Europe Africa Asia Oceania
Albania Algeria Azerbaijan Australia
Cyprus Botswana Brunei
Denmark Kenya Hong-Kong
Germany Libya Jordan
Hungary Namibia Iran
Iceland Nigeria Iraq
Italy South Africa Lebanon
Kosovo Tanzania Macau
Malta Tunisia Malaysia
Netherlands Philippines
Norway Singapore
Poland Thailand
Portugal UAE
Sweden Vietnam
UK
MissionTo form successful strategic alliances and to be-come the partner of choice in offering services and innovative and branded generic pharma-ceuticals all around the world
StrategyΤo explore all possible collaborations related to:• ELPEN’s products portfolio • Services: - Product development - Product supply agreements• Technologies and know-how• Co-development of new products
Model of Actions Establish long-term business co-operations with:• Local Agents• Manufacturers • Distributors• National Health Authorities• Joint ventures
INTERNATIONAL BUSINESS DIVISION
ELPEN Pharmaceutical Co. Inc.
95 Marathonos Ave190 09 Pikermi, Attica, GreeceTel.: +30 211 18 65 000 +30 210 60 39 326 (-9) Fax: +30 210 60 39 300E-mails: [email protected] [email protected] [email protected] [email protected] [email protected]
www.elpen.gr
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