may 2007 lisapharma – confidential 1. 2 company profile
TRANSCRIPT
May 2007 Lisapharma – Confidential 1
May 2007 Lisapharma – Confidential 2
Company profile
May 2007 Lisapharma – Confidential 3
LISAPHARMA at a glance
Fully owned by Italian capital
Family-ruled business from its foundation to today
Manufacturing plant of dosage forms in full GMP compliance, including β-lactam ceph derivatives dedicated line
Driven to technological developments throughout strong liaisons with different university bodies
Operative on the Italian and international markets through a portfolio of proprietary medicines
May 2007 Lisapharma – Confidential 4
Milestones
1925: Lisapharma is established in Bologna
1949: HHQQ and plant moved to actual site of Erba (Co)
1968: first export business to Taiwan
1970: establishment of international production units in Nicaragua & Costarica
1993: first manufacturing activity as toll manufacturer with Novartis
2000: start of phase-out of production of oral solid non-sterile products
2002: establishment of the j.-v. with Omicron for the manufacture of oral solid non-sterile products
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Key facts & figures
Fully owned Italian manufacturing plant for sterile injection products, non-sterile liquids, semisolids
J.-V. participation in Omicron plant (Italy) for oral solid non-sterile production
148 total headcounts, out of which 80 reps
International customers portfolio of 81 accounts
International sales in 32 different countries worldwide
Intellectual property of 18 patents covering original technologies
Development & RA expenditure up to 5.60% of company revenues
May 2007 Lisapharma – Confidential 6
Organization chart
MANAGING DIRECTOR
FINANCE & CONTROL
HUMAN RESOURCES
QUALITY ASSURANCE
OPERATIONMARKETING & SALES ITALY
INTERNATIONAL SALES &
LICENSINGPURCHASING
PHARMACOVIGILANCESCIENTIFIC 6 RA
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Goals
To consolidate the presence in the Italian market
To improve the penetration in existing countries outside Italy and to expand to further new markets its business partneriships
To enlarge the toll manufacturing activities for renowned international companies
BY………………………..
May 2007 Lisapharma – Confidential 8
Strategy
In-house development of generic registration dossiers focusing on niche products (injectable class,…)
Partnering and/or tightening strategic alliances allowing the best exploitation of the in-house developed patented technologies (Sucralfate Gel, Dome Matrix™, Patch-non-Patch™, Chimerical Agglomerates™)
Diversification of the product portfolio to include additional non-RX compounds “dedicated” to specialists (food supplements, medical devices,…)
Strengthening the existing collaborations through the proven high standard of quality and service provided, by doing so attracting new potential customers too
May 2007 Lisapharma – Confidential 9
Sales trend – comparable*
2002 2003 2004 2005 2006 2007-bgt
+1.0+15.9-0.8 +6.7 +7.9
*using Y03 €/$ rate for all years
t.over
Source: historical company data
May 2007 Lisapharma – Confidential 10
Sales breakdown by business type
ITALY
INTERNATIONAL
TOLLING
ROYALTY + OTHERS
35.9%
34.4%23.8%
5.8%
Source: company data 2006
May 2007 Lisapharma – Confidential 11
Sales breakdown by geographical area
AFRICA
AMERICAS
ASIA
EUROPE - ITALY
M. EAST
48.7%
14.0%
26.0%
6.7%4.6%
Source: company data 2006
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KPI
Robust sales growth in the last triennium, expected to similarily continue in the coming years
Revenues generated by three well balanced business sectors
International sales spread in many countries and areas, excellent contribution represented by fast growing markets (Asia), good room for increase the European-stable markets (development of the proprietary technologies)
Good existing network of partners either local or MNs’ companies
May 2007 Lisapharma – Confidential 13
Product list
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Product list
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Product list
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Product list
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Product list
May 2007 Lisapharma – Confidential 18
Products under development
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Products under development
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Operation – key data
Manufacturing plant and warehouse cover a surface of 6,000 sqm
Workforce of 35 people
Handling in excess of 2,500 references corresponding to 650+ presentations
Production capacity expanded up to 43 mio units
Production lines for:Injection products - liquids in ampoules and vials, powder in vials
Non-sterile liquids
Semisolids for topical use
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Operation – plant map
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Operation – main equipments
W.F.I. loop distribution system
Purified water loop distribution system
Compressed air distribution system
Nitrogen distribution system
HVAC systems
Continuous particle monitoring system
May 2007 Lisapharma – Confidential 23
Operation – plant overview
Steriles
Liquids in ampoules and vials
o Solutions
o Suspensions
o Aseptic filled and terminally sterilized
Powders in vials
o Aseptically filled sterile powders
May 2007 Lisapharma – Confidential 24
Operation – plant overview
Non-steriles
Liquids
Semisolids
May 2007 Lisapharma – Confidential 25
Operation- production lines
Sterile liquids dept.o Sterile 1 - high activity sterile liquid dept – ampoules & vials
o Sterile 2 – sterile liquids dept. - ampoules & vials
o Sterile 5 - high activity sterile liquid dept. – ampoules & vials
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Operation - production lines
Sterile powder dept.o Sterile 3 - sterile powder dept.
o Sterile 4 – high activity (cephs derivatives) sterile powder dept.
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Operation - production lines
Non-sterile liquids dept.o Preparation and packaging of non sterile liquids
Semisolids for topical useo Preparation and packaging of semisolids
o Preparation and packaging of high-activity semisolids
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Operation - production equipments
Ampoule & vial automatically inspection dept.
o Automatic inspection machine
Packaging dept.o Labelling of ampoules & vials
o Secondary packaging dept.
Weighing roomso Weighing rooms A (API and excipients)
o Weighing rooms B (High activity API)
May 2007 Lisapharma – Confidential 29
Quality area
QC & QA account for 13 people
38% university degree, 38% high school degree
Year 2006 quality performance: 800+ batches
2,500+ analysis
Handling of 14 product defects with average time of solution and definition of corrective actions, if any requested, of 21 days in accordance to what defined in the relevant SOP (solution required within 30 days from receipt of product defect notice)
May 2007 Lisapharma – Confidential 30
Quality Control
QC activities Acceptance of incoming goods
Release of finished products
Performance of analytical validation
Performance of the stabilities
Analytical support for process & environmental validation
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QC departments
Chemical department HPLC assays, UV/VIS spectrophotometric analyses, GLC and TLC
analyses, IR spectrophotometric analyses, potentiometric and redox titration, TOC assays, dissolution test, viscometric tests, conductivity and pH analysis, Karl Fischer’s test
Microbiological department sterility testing of obligatory sterile products, determination of the microbial
loading of products non-obligatory sterile, qualitative and quantitative LAL test (gel cloth and chromogenic test), microbiological assays, bacterial identification, challenge test, microbiological and particle controls of controlled contamination environments
Classified goods department weight and volume control, primary and secondary packaging material
control, finished product control
May 2007 Lisapharma – Confidential 32
Quality Assurance
QA activities Quality system management
SOP management
Validation protocols of production processes performance
Oversee the installation and operating qualification of new equipments and performance qualification of the existing equipments
Product defects management
APR performance
May 2007 Lisapharma – Confidential 33
Regulatory inspections
Lisapharma plant has a very outstanding record of successful inspections, the most recent carried out by Official Authorities with no observation received, comprises the following:May 18-20, 2005: Taiwan MoH
April 26-28, 2006: Italian MoH
Audits by customers including MNs’ companies are also regularly performed and successfully passed
May 2007 Lisapharma – Confidential 34
Manufacturing authorization
May 2007 Lisapharma – Confidential 35
Manufacturing authorization
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Manufacturing authorization
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Proprietary technologies
Long-lasting cooperation between Lisapharma and well reputable Universities in Italy
Focusing in the development of novel delivery systems, due to the increased market demand for drug delivery technology
Aiming to develop versatility in drug delivery, as much as adaptability to different drugs to inhance patient compliance
ALL THIS HAS LED TO
May 2007 Lisapharma – Confidential 38
Proprietary technologies
Sucralfate Gel, as unti-ulcer for GI tract and skin wounds
Dome Matrix™, oral platform
Patch-non-Patch™, transdermal platform
Chimerical Agglomerates™, inhalation nasal platform
FOUR PLATFORMS
The technologies are covered by patents and available for discussions
May 2007 Lisapharma – Confidential 39
…Good tips to partnering with Lisapharma
Small though efficient and dedicated team group allowing quick decision process
Flexibility combined to first class service
Quick adaptation to market changes
Fast reacting to customers’ demands and needs
Commitment to innovation
Very promising tech package portfolio
Excellent expertise and know how in manufacturing of injection products
Independent company not belonging to any group
May 2007 Lisapharma – Confidential 40
Thank you
Alessandro Cescut
International Sales and Licensing Director
p. +39.031.641257-412