WARNER CHILCOTT PLC
8-K, EX-99.1, 2000-10-24
PHARMACEUTICAL PREPARATIONS
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Galen Holdings PLC

“Building an International Specialty Pharmaceutical
Products and Services Business”


 


Galen Holdings PLC


  Founded 1968; Northern Ireland - based integrated pharmaceutical co.
 
  1997 - Listed on London Stock Exchange (LSE:GAL)
 
  Engaged in the supply of pharmaceutical products and services
 
  Consistent sales and profit growth

    Sales - five year CAGR of 30%
 
    Operating profit(1) - five year CAGR of 49%

  Strong growth in pharmaceutical products business

    Significant historical base in the UK and Ireland

  Acquired Warner Chilcott adding US sales & marketing capability
 
  Listed on Nasdaq in September 2000 — Ticker symbol: GALN

(1) Operating profit before goodwill and exceptionals

 


Galen Holdings PLC
Five Year Earnings Progress


 
         
  Operating Profit Before Goodwill
Sales and Exceptional Items


         
*Galen ’99 sales = $100 m (£67m) UP 187% from ’95
Pro Forma = $219 million ((£147m)
*Galen ’99 op prof = $29 m (£19.4m), UP 401% from ’95
Pro Forma = $70 million (£47m)

 


Warner Chilcott PLC
Acquired 9/29/00


  US-based specialty pharmaceutical business
 
  Women’s healthcare focus – branded product portfolio
 
  Competitively scaled women’s healthcare salesforce in the US
 
  Warner Chilcott name associated with branded pharmaceuticals for over 90 yrs
 
  Strong management team with proven pharmaceutical industry track record
 
  Portfolio of women’s healthcare products
 
  Profitable and strong cash flow generator

     

(1) Except in 1999(PF), excludes benefit from the acquisition of Estrace Cream
and Ovcon in February 2000

 


Building an International Specialty Pharmaceutical
Products and Services Business


      The acquisition of Warner Chilcott internationalized Galen’s business and provided

    US branded products business with significant women’s healthcare focus
 
    Competitively scaled US women’s healthcare salesforce
 
    Ability to commercialize Galen’s IVR in largest market – U.S.

  Opportunity to accelerate R&D/product pipeline

  Greater scale provides opportunities for further growth

    in-licensing/acquisitions

 


Two Growth Companies Combined
Proforma Revenues – Business and Geographic


         

 


Strong Management Team


International Management team with extensive
pharmaceutical industry expertise

     
John King
Roger Boissonneault
Geoffrey Elliott
Paul Herendeen
Executive Chairman
Chief Executive Officer
Chief Financial Officer
Executive Vice President

 


Shareholder Value


  International investor profile
    and liquidity
 
  2000 – Listed on Nasdaq
    National Market
    (Nasdaq:GALN)

  London Stock Exchange
    (LSE:GAL)
 
  Irish Stock Exchange (GAL)
 
  Market capitalization now
    nearly $2 billion

 


Galen Holdings PLC
An Integrated Pharmaceutical Company


     
Branded Prescription
Medicines
R&D Services for
International Pharma

 


Galen Holdings PLC
Group Divisions


         
Products Services


Based in Craigavon (Northern Ireland), the Galen division develops, manufactures and markets prescription medicines to healthcare professionals in key therapeutic areas: analgesics, antibiotics, cardiovascular, gastrointestinal, respiratory and women’s health. These products are marketed through a sales force of over 100 representatives throughout the UK and Ireland. Research within Galen is focused on the development of applications of novel drug delivery technology. Clinical Trial Services (CTS) designs, manufactures and distributes patient packs used in clinical trials to investigator sites worldwide. From state-of-the-art facilities in Craigavon (Northern Ireland), Audubon (Pennsylvania, USA) and Durham (North Carolina, USA), CTS provides a global service to many of the world’s largest multinational pharmaceutical companies. Interactive Clinical Technologies Inc (ICTI) provides interactive voice response systems (IVRS) for clinical trials’ management from its US bases in Lambertville (New Jersey, USA) and San Francisco (California, USA), along with a European base in Maidenhead (England). ICTI’s leading edge systems and technology enable clients to efficiently manage supplies of clinical trial packs and collect real-time patient enrolment data.
The Warner Chilcott division is a marketer of prescription pharmaceutical products in the United States, primarily focused on the women’s health therapeutic category. Through its national sales force of over 220 representatives, Warner Chilcott markets branded pharmaceutical products directly to physician specialists across the country, particularly obstetrician/gynecologists and urologists. Chemical Synthesis Services (CSS) operates an integrated chemical development service for the pharmaceutical industry from custom research through process development to kilo scale synthesis of intermediates and actives at cGMP. Research in pharmaceutical chemistry is conducted within a facility at Queen’s University in Belfast, which provides access to an extensive technology base; pilot plant manufacture is carried out within a world-class facility at Craigavon (Northern Ireland). Pharmaceutical Development and Manufacturing Services (PDMS) provides a broad range of specialist services for the pharmaceutical, healthcare and biotechnology industries. Utilizing Galen’s state-of-the-art facilities in Northern Ireland, PDMS’s services include drug product formulation, process development, analytical method development and validation, pack design, commercial-scale manufacture, inventory management and worldwide distribution.

 


Pharmaceutical Products
Five Year Sales Progress   


    $177 million pro forma revenue in 1999; 81% of total
 
    Strong prescription base (UK, Ireland & USA)
 
    Women’s health, analgesia, gastroenterology, and respiratory
 
    134 products; 44 brands
 
    Facilities: Craigavon, Northern Ireland and Rockaway, NJ USA

 


Product Salesforce


  Increased global salesforce

    Galen/Warner Chilcott US   220 sales reps
 
    Galen/Warner Chilcott UK/Ireland   65 sales reps

    Total   285 sales reps

  Target Marketing
 
  Brand Management

 


Galen Product Group
UK/Ireland Products


         

 


Galen Product Group
Women’s Healthcare Products (US/UK)


             
Marketed Products Indication Status



Estrace Cream
Ovcon 35
Ovcon 50
NataChew
NataFort
Pyridium/Plus
HRT
Oral Contraceptive
Oral Contraceptive
Prenatal Vitamin
Prenatal Vitamin
Urinary Analgesic
Marketed
Marketed
Marketed
Marketed
Marketed
Marketed
             
Product Pipeline Indication Status



IVR
IVR
IVR
IVR
IVR
IVR
HRT (EU)
HRT (US)
Continuous Combined
Testosterone
Contraceptive
Infection Control
In Registration
Late Phase III
Phase III
Phase II
Phase II
Development

 


Research and Development
Proprietary Products for International Expansion


             



      

      Intravaginal drug delivery (IVR) system

  Technology platform for internationalization
 
  Products in development

    HRT
 
    Infection control
 
    Other

  Other drug delivery applications

    Eutectic technology

  Core therapeutic areas

    women’s health
 
    analgesia
 
    gastrointestinal

 


Future Product Growth Opportunities


  Expand women’s healthcare focus

    Commercialization of IVR technology platform

  Development and manufacture of US products
 
  In-licensing/product acquisition opportunities
 
  Platform to expand into Europe
 
  Opportunity to accelerate R&D

 


      
      
             
Pharmaceutical Services
Five Year Sales Progress
    


  $43 million revenue in 1999; 19% of total
 
  Clinical trial services and custom chemical design and synthesis
 
  41% sales now in US subsidiaries
 
  Facilities:

    Craigavon, Northern Ireland
 
    Maidenhead, UK
 
    4 in USA (PA/NC/CA/NJ)

 


Future Service Growth Opportunities


  Custom chemical design and synthesis business – large pharma/industry trends support growth
 
  New Drug Development – Clinical trials business
 
  Acquisition opportunities
 
  High profile customer list/reputation

 


Key Strengths


  Sales and Marketing

      • branded prescription pharmaceuticals in the US and UK

  Operational Excellence in Custom Chemical Synthesis and Clinical Trial Services
 
  R&D – Drug Development
 
  U.S. Regulatory Expertise/FDA
 
  cGMP Manufacturing

 


      Financial Information

 


Financial Policies & Objectives


      “Our guiding principle is to increase shareholder value through fundamentally sound operating and financial decision-making"

  Maintain financial flexibility to pursue growth strategy and build upon presence in European and US markets

           Adhere to highly selective acquisition criteria

           Pursue acquisitions at measured pace – integration a priority

  Future financial reporting – $US/US GAAP

 


Proforma Profit & Loss


Unaudited Proforma Consolidated Profit and Loss Account

                 
FYE YE
(in millions)

9/30/99 PF 3/31/00 PF


Revenue $ 219.1 $ 243.8
Gross profit $ 139.2 $ 154.3
Operating expenses $ 69.1 $ 73.9


EBITDA and non operating $ 70.1 $ 80.4
items




 


Proforma Capitalization


Unaudited Proforma Capitalization

           
(in millions)
3/31/00 PF

Cash $ 71.5
Funded debt $ 228.0

Net debt 156.5

Book equity $ 440.1

 

 


Outlook


“Building an International
Specialty Pharmaceutical
Products and Services Business”

 

 


Strategic Objectives


Strategic

  Build upon company strengths in products and services
 
  Leverage U.S./UK market position to expand global presence
 
  Growth through internal development and selective acquisitions/in-licensing

Operating

  Focus on specialty therapeutic categories; women’s health
 
  Leverage cGMP and technological strengths
 
  Achieve organizational excellence

Financial

  Attain 10% average annual revenue growth
 
  Achieve 25% average annual growth in cash earnings

 


Why Invest in Galen Holdings?


  Two growth companies combined = pro forma revenues of $244 million and $80 million EBITDA
 
  International investor profile and liquidity
 
  Multiple avenues of growth

    Internal growth – existing products and services
 
    R&D Pipeline/Technology
 
    Acquisitions/in-licensing

  Strong management team with significant equity stake

 


Galen Holdings PLC

 

“Building an International Specialty Pharmaceutical
Products and Services Business”


Legal Information


  This presentation contains forward-looking statements which are based on assumptions and external factors, including assumptions relating to, but not limited to, the compatibility of the combined businesses, regulatory action, product pricing, competitive market conditions, unaudited financial data, new product development and other risks or uncertainties. These forward-looking statements represent the companies’ judgement as of the date of this presentation and any changes in the assumptions or external factors could produce significantly different results
 
  This presentation does not constitute an offer to sell or issue, or a solicitation of any offer to purchase or subscribe for, any ordinary shares in the Company, nor shall it form the basis of, or be relied upon in connection with, any contract for such purchase or subscription. No representation or warranty, express or implied, is made or given by the Company as to the accuracy or completeness of the information or the opinions contained in this presentation, and no liability is accepted for any such information or opinions
 
  Nothing in this presentation should be construed as a profit forecast or be interpreted to mean that the earnings per share of Galen as enlarged by this Transaction for the current year or future years will necessarily match or exceed the historical published earnings per share of Galen and Warner Chilcott.

 


Legal Information (continued)


  Investors and security holders may obtain free copies of documents filed by Galen and Warner Chilcott with the Securities and Exchange Commission at the Commission’s web site at www.sec.gov. Further information may also be obtained for free by directing such requests to: Galen Holdings/Warner Chilcott PLC, 80 Corporate Centre, 100 Enterprise Drive, Suite 280, Rockaway, New Jersey 07866, USA, Attention: Investor Relations, telephone: +1 973 442 3200, e-mail:[email protected] or from Galen by directing such requests to: Galen Holdings PLC, Seagoe Industrial Estate, Craigavon, Northern Ireland, BT63 5UA, Attention: Investor Relations, telephone: +44 28 3833 4974,
e-mail:[email protected]
 
  Certain financial data (including the pro forma information) contained in this documents is calculated on or derived from data which is based on UK or US generally accepted accounting principles. Investors and security holders should be aware that this financial data may be reconciled to US or UK generally accepted accounting principles in the Shareholder Documentation and accordingly such financial data may be different in such Shareholder Documentation

 



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