6-K 1 d6k.htm REPORT OF FOREIGN PRIVATE ISSUER Report of Foreign Private Issuer

 

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16 OF

THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of July/August 2004

 

Commission file number: 0-18892

 

MAYNE GROUP LIMITED

(Translation of Registrant’s Name Into English)

 

Mayne Group House

21/390 St Kilda Road

Melbourne, Victoria 3004

Australia

(Address of Principal Executive Offices)

 

(Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.)

 

Form 20-F x Form 40-F

 

(Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.)

 

Yes ¨ No x .

 

(If “Yes is marked indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-             .)

 


 


Media Releases /ASX Announcements

Exhibit 1 –

   Mayne settles Paclitaxel litigation with Mylan

Exhibit 2 –

   Pharma Symposium Presentation Slides – Mr Stuart James

Exhibit 3 –

   Pharma Symposium Presentation Slides – Benchmarking & Valuation Gap – Mr Paul Binfield

Exhibit 4 –

   Mayne launches fluconazole in the US

Exhibit 5 –

   Mayne Group announces Board appointment

Exhibit 6 –

   2004 Earnings update

 


EXHIBIT 1

 

Media Release

5 July 2004

 

Mayne settles paclitaxel litigation with Mylan

 

Mayne Group Limited (ASX:MAY) today announced that it has entered into a settlement and licence agreement with Mylan Laboratories Inc., ending the litigation relating to Mayne’s paclitaxel formulation patents.

 

Under the agreement, Mayne will receive a net benefit of approximately $US3 million and has provided Mylan with a licence to its intellectual property, reflecting the strength of Mayne’s global patent position in paclitaxel.

 

ooo0000ooo

 

Media and investor enquiries

Larry Hamson

Ph: 03 9868 0380

Mb: 0407 335 907

 


     LOGO

 

Mayne Group Limited

 

Pharma Symposium

Sydney, Australia

 

Mr Stuart James

Group Managing Director and Chief Executive Officer

6 July 2004

 


Mayne has reshaped itself    LOGO

 

 

LOGO    LOGO    LOGO

 

Based on FY03 divisional EBITA

 

Logistics EBITA to June Dec 2002 annualised

 


Rationale for symposium    LOGO

 

Introduce Mayne Pharma’s senior management team to the market

 

Reinforce Mayne Pharma’s strategy

 

Update progress against the pharmaceuticals growth strategy

 

Explain why Mayne Pharma will succeed

 


We are specialty pharma experts    LOGO

 

LOGO

 


Mayne Pharma snapshot    LOGO

 

An international leader in injectable specialty pharma

 

•      Sales FY04 (E)*

   $ 500 million

•      CAGR (5 year)*

   22.3%

•      EBITA margin**

   17 - 20%

•      Employees

   1,900

•      Geographic Presence

   direct - 20 countries - 5 continents
indirect distribution - 30 countries

 

    Americas

   EMEA

   Asia Pacific

    

•      Approved products

  40+    60+    115+     

 

* Based on FY04 revenue guidance provided on 28 May 2004

 

** Long term EBITA range

 


Global growth strategy    LOGO

 

Specialty Pharmaceuticals Focus:

Proprietary, Branded Generics, Commodity Generics

 

LOGO

 

GLOBAL MANUFACTURING CAPABILITIES TO ENSURE COMPETITIVE PRODUCT

COSTS AND SURETY OF SUPPLY

 


Building our business    LOGO

 

LOGO

 


Building our business    LOGO

 

LOGO

 


Acquisition update: MVI and Wasserburger    LOGO

 

MVI acquisition integration on track

 

  Sales team integrated

 

  Monthly sales in line with forecast

 

  Early indications that product transfer to Aguadilla may occur sooner than plan

 

  On track to meet or exceed FY05 forecast EBITA of $US 11m

 

Wasserburger integration running to plan

 

  Basic integration measures complete

 

  Facility expansion on schedule (revenue generation Sep 2004)

 

  Introduction of key products possibly before Dec 2006

 

  On track to meet or exceed FY05 forecast EBITA of € 2m

 


Acquisition update: paclitaxel    LOGO

 

Paclitaxel triumvirate* performance tracking to deliver or exceed expectations

 

  Strategic and tactical rationale for executing deal continue to hold true

 

  Paxene® now launched into all major EU countries

 

  US pricing continues to be tough

 

  On track to meet or exceed guidance for FY05

 

  Revenue of $US67 million

 

  EBITA of $US33 million

 

* (Paxene®, US sales and marketing, and API vertical integration)

 


Specialty pharma complexity    LOGO

 

LOGO

 


From pure generics to specialty pharmaceuticals    LOGO

 

LOGO   

•      Most generic companies now have specialty pharmaceutical product portfolios

 

•      Aim to increase specialisation and differentiation to higher margin products

 

•      Commodity generics still dominate revenue base

Forecast Overall Product Portfolio Breakdown, 11

leading specialty pharmaceutical companies (2008)

    

 

Source: Datamonitor, Global Generics Guide 2nd Edition

 

Companies assessed: TEVA, Stada, Alpharma, Mylan, Watson, Barr, IVAX, Ranbaxy, Andrx, Sicor, Biovail

 


Specialty Pharma examples    LOGO

 

LOGO   LOGO   LOGO
LOGO  

LOGO

 

 

LOGO

  LOGO

 


     LOGO

 

Why we will be successful

 


Generics growth outperforming proprietary    LOGO

 

LOGO

 

Source: IMS

 


Market share strength in established markets    LOGO

 

Strong positions in major molecules

 

Emerging US presence provides further growth opportunity

 

Use oncology strength to expand into new therapeutic classes

 

LOGO

 

* Mayne did not have marketing approvals in EMEA and Canada for IMS data in Dec 03.

 

Source: Dec 03 IMS data

 


Mayne is well positioned    LOGO

 

EMEA

Emerging Leader*


 

Asia Pacific

Regional Leader


 

Americas

Growing Presence


•      Market leader in generic injectables in continental Europe and UK

 

•      #1 generic injectable oncology in UK & France

 

•      #2 generic injectable oncology in Germany & Italy

 

•      Only pan European generic injectable sales force

 

•      505 employees

 

•      World class manufacturing in Wasserburg, Germany

 

•      Clear market leader in generic injectable pharma in Australia

 

•      Established positions in Thailand, Malaysia, Korea, Singapore, Taiwan, Hong Kong and China

 

•      1,089 employees

 

•      100 R&D and support staff

 

•      Large manufacturing facility (Mulgrave) with strong cytotoxic capabilities

 

•      Emerging US business

 

•      #2 generic hospital player in Canada

 

•      Pamidronate, paclitaxel and MVI beachhead

 

•      Strong pipeline

 

•      341 employees

 

•      Manufacturing facilities in Puerto Rico and Colorado (active ingredient processing)

 

Mayne has a global footprint with leading

market positions around the world

 

Source: IMS data adjusted for discounts & Mayne data.  *Ranking excludes Spain, Portugal, Ireland, Greece.

 


Global generic coverage    LOGO

 

5 of our top 10 generic molecules registered across all three regions

 

Global platforms driving significant synergies and competitive market positions

 

LOGO

 


Significant pipeline growth    LOGO

 

Robust pipeline that has been significantly strengthened over the last 2 years

 

Total pipeline to 2011 has a local market value of $US9.4 billion

 

Country launches and current Local Market Value (LMV) at launch

 

LOGO

 

Note: LMV in USD million

 

Source: IMS, Mayne Pharma

 


Earnings margin opportunities    LOGO

 

Selective vertical integration and collaborative API sourcing

 

Lower cost alternatives

 

  Alliance/collaboration opportunities in developing countries (India, CEE, China)

 

Accessing niche products and niche markets

 

  Acquisition and in-licensing

 

  Geographic expansion opportunities

 


Acquisition strategy/criteria    LOGO

 

Future acquisitions will fit with the pharma growth strategy:

 

  Focus on acute care, oncology and hospital products

 

  Increasing the specialty pharma focus

 

  Leverage synergies from existing businesses to broaden the pharma business

 

Acquisitions to meet Mayne financial criteria:

 

  1. ROIC > WACC in short term
  2. NPV positive
  3. Earnings accretive year 1

 

Acquisitions driven by regional Presidents with

corporate development support

 


Key take-aways    LOGO

 

We are experts in this field

 

Leading international market positions

 

Strong track record with a substantial platform for growth:

 

  Deep and broad pipeline

 

  Strong industry growth globally

 

  Geographic diversity across the business

 

  People, facilities and expertise to deliver

 

  Increasing specialty pharma focus to access specialised, higher margin niche products

 

We are undervalued by the market

 


     LOGO

 

Appendix

 


Presenters    LOGO

 

  1

   Group Overview and Strategy Review    Mr. Stuart James, Group Managing Director & CEO

  2

   Financials & Company Valuation    Mr. Paul Binfield, Chief Financial Officer

  3

   EMEA    Mr. Scott Richards, President - EMEA
          Mr. Jonathan Ody, Director UK Commercial Operations

  4

   Americas    Mr. Stuart Hinchen, President - Americas
          Mr. Michel Charbonneau, President - Canada

  5

   Asia Pacific    Mr. Michael Kotsanis, President - Asia Pacific
          Mr. Tan Cheow Choon, General Manager - Asia

  6

   API Strategy    Mr. Brian McCudden, VP Boulder Ops. & Global API

  7

   Paxene Agreement & EU Launch    Mr. Scott Richards, President - EMEA
          Mr. Michael Lonsert, VP Commercial Operations Europe

  8

   MVI Update    Mr. Stuart Hinchen, President - Americas

  9

   Product Development    Mr. Mark Bisset, VP Global Business Development

10

   Research and Development    Mr. Hugh Burrill, VP Global Product Development

11

   Manufacturing    Mr. Alex Bell, VP Global Manufacturing & Supply

 


     LOGO

 

Mayne Group Limited

 

Pharma Symposium

Benchmarking and Valuation Gap

 

Mr Paul Binfield

Chief Financial Officer

6 July 2004

 


Pharma revenue growth    LOGO

 

Revenue

AUD millions

  

22.3 % CAGR Revenue

Growth for 2000 - 2004 (E)

LOGO   

 

Notes (financial year ending 30 June)

 

(1) Based on F H Faulding & Co Limited (Faulding) financial statements

 

(2) Based on Faulding management accounts for three months to September 2001, plus Mayne financial statements for nine months to 30 June 2002

 

* Based on guidance provided on 28 May 2004. Incorporates results of paclitaxel, MVI and Wasserburger acquisitions.

 


Pharma EBITA growth    LOGO

 

EBITA

AUD millions and Margin %

  

Guidance range:

(17 - 20% EBITA margin)

LOGO   

 

Notes (financial year ending 30 June)

 

(1) Based on F H Faulding & Co Limited (Faulding) financial statements

 

(2) Based on Faulding management accounts for three months to September 2001, plus Mayne financial statements for nine months to 30 June 2002

 

(3) Based on (Faulding) management accounts

 

* Based on guidance provided on 28 May 2004. Incorporates results of paclitaxel, MVI and Wasserburger acquisitions.

 


EBITA PIIP impact    LOGO

 

  PIIP over the last 3 years has averaged $8 million per year

 

  Benefit of the P3 program going forward is significantly less

 

  In FY05, we are committing an extra $10 million towards R&D

 

  Despite these factors, we are still expecting EBITA growth of 30% in FY05

 

PIIP - The Pharmaceutical Industry Investment Program

 

P3 - Pharmaceuticals Partnerships Program

 


2003 revenue (USD)    LOGO

 

Primary injectable peers

 

LOGO

 

Mayne Pharma revenues calendar year end 2003 (converted at 0.70 AUD/USD)

 

Hospira: Specialty Injectible Pharmaceuticals Division only (proforma 2004)

 

Medac & EBEWE revenues converted @ Euro/USD 1.21

 

Sicor 2003 revenues nine months annualized (due to Teva acquisition)

 

Bedford, Medac & Ebewe based in Mayne internal estimates

 


2003 R&D % of sales    LOGO

 

LOGO

 

Source: Company filings & annual reports

 

Mayne result taken from 2H03 & 1H04 (i.e. calendar year 2003)

 

Hospira result taken from Q1 04 results

 


Revenue CAGR 2000 - 2003    LOGO

 

LOGO

 

Source: Company filings & annual reports

 

Mayne 4 year CAGR based on revenues for FY00 to FY03

 

Data not available for Hospira

 


2003 EBITDA margin    LOGO

 

LOGO

 

Mayne Pharma result annualised for the 2003 calendar year

 

Source: Company filings & annual reports

 

Data not available for Alpharma

 

Hospira EBITDA margin from UBS analysis of Q104 results

 

Sicor result UBS estimate for the full year 2003

 


2003 EBITDA + R&D    LOGO

 

LOGO

 

Source: Company filings & annual reports

 

Data not available for Alpharma

 

Hospira EBITDA margin from UBS analysis of Q104 results

 

Sicor result UBS estimate for the full year 2003

 


EV/EBITDA Multiples    LOGO

 

LOGO

 

Source: UBS (based on company reports, broker reports, Bloomberg)

 

Share prices as at 17/5/04, forecast Jun-05 EBITA

 

Sicor based on UBS Teva acquisition multiple EV/2004E EBITDA

 


Valuation analysis*    LOGO

 

     Enterprise Value

 
     low

    high

 

Specialty Pharma

     1,650       1,800  

Diagnostic Services

     1,050       1,150  

Other

     375       425  
    


 


Total

     3,075       3,375  
    


 


Net (debt)/cash

     (450 )     (400 )

Equity value

     2,625       2,975  

Shares on issue (m)

     640       640  
    


 


Value per share

   $ 4.10     $ 4.65  
    


 


 

Valuation gap of approx $0.70 to $ 1.15 (or 21% to 37%)

versus recent share price**

 

* Using EV/EBITDA market multiples, represents managements views only

 

** Closing share price on 2 July 2004 - $3.39

 


EXHIBIT 4

 

Media Release

30 July 2004

 

Mayne launches fluconazole in the US

 

Mayne Group Limited (ASX: MAY) today announced that the US Food and Drug Administration (FDA) had granted final approval for the company’s Abbreviated New Drug Application for the anti-infective drug, fluconazole mini bags, in 100ml and 200ml presentations. With this approval, Mayne has started selling fluconazole in the US market. Fluconazole is used for the treatment of systemic fungal infections.

 

This approval follows Mayne’s announcement on 9 December 2003 regarding the FDA’s tentative approval of the product.

 

The fluconazole mini bags are generic equivalents to Pfizer’s Diflucan® mini-bag which generated sales in 2003 of approximately $US220 million according to IMS data.

 

Fluconazole is an important addition to Mayne’s business in the US because it extends the Company’s presence in anti-infectives in the region and broadens the range of oncology and hospital-specific specialty products sold in the region.

 

Mayne Group Limited is listed on the Australian Stock Exchange and has businesses in pharmaceuticals (the manufacture of injectable and oral pharmaceuticals for distribution to more than 50 countries), diagnostic services (pathology, diagnostic imaging, and medical centres), pharmacy, and health-related consumer products.

 

oooo0000oooo

 

Media and investor enquiries:

Larry Hamson

Ph: 03 9868 0380

Mb: 0407 335 907

 


EXHIBIT 5

 

Media Release

3 August 2004

 

IAN BLACKBURNE JOINING MAYNE BOARD

 

Mayne Group Limited (ASX:MAY) today announced that Dr Ian Blackburne will join the Board of the Company as a non-executive director on 1 September 2004.

 

Dr Blackburne holds a PhD in Chemistry and an MBA. He is currently the Chairman of CSR Limited and the Australian Nuclear Science and Technology Organisation, and sits on the boards of Suncorp Metway and Teekay Shipping Corporation. He was previously the Managing Director of Caltex Australia. He also holds the honorary post of Adjunct Professor at the University of Queensland in the Schools of Molecular Sciences and Management.

 

Mayne’s Chairman Mr Peter Willcox said that he was very pleased with Dr Blackburne’s decision and welcomed him to the Board.

 

“Mayne is at an exciting time in its history with leading positions established in each of its businesses and Dr Blackburne’s strong academic and business qualifications will be valuable to us as we continue to develop the company,” Mr Willcox said.

 

Ian Blackburne said that he was looking forward to joining the board of Mayne Group at a time when it was focused on driving improved performance from its Australian healthcare businesses and was having considerable success expanding internationally.

 

“It is exciting to be involved in an Australian company that is investing strongly and successfully in its technological future,” he said.

 

Mayne Group Limited is listed on the Australian Stock Exchange and has businesses in international specialty pharmaceuticals (the manufacture of injectable and oral pharmaceuticals for distribution to more than 50 countries), diagnostic services (pathology, diagnostic imaging and medical centres), pharmacy, and health-related consumer products.

 

oooo0000oooo

 

Media and investor enquiries

Larry Hamson

Ph: 03 9868 0380

Mb: 0407 335 907

 


EXHIBIT 6

 

ASX & Media Release

4 August 2004

 

2004 EARNINGS UPDATE

 

Mayne Group Limited (ASX:MAY) today announced that based on its unaudited, preliminary full year results, the Company expects net profit after tax for the year ended 30 June 2004 to be approximately 15-20% higher than the average analyst forecast of A$79.8 million. This is driven by a combination of factors including better operating performances in most business units, a lower interest expense and a lower effective tax rate.

 

Mayne’s Group Managing Director and Chief Executive Officer, Mr Stuart James said that the stronger than expected operating earnings are the result of the close attention that has been paid to managing the performance across the whole portfolio of Mayne’s businesses.

 

“Our operating businesses have leading positions in their respective markets and we are committed to driving continuing performance improvements in all of them,” he said.

 

Further information will be provided in Mayne’s full year results announcement on 26 August 2004.

 

Mayne Group Limited is listed on the Australian Stock Exchange and has businesses in international specialty pharmaceuticals (the manufacture of injectable and oral pharmaceuticals for distribution to more than 50 countries), diagnostic services (pathology, diagnostic imaging and medical centres), pharmacy, and health-related consumer products.

 

oooo0000oooo

 

Media and investor enquiries

Larry Hamson

Ph: 03 9868 0380

Mb: 0407 335 907

 


SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

MAYNE GROUP LIMITED
By:   /s/ Karen Kee
   

Name:

Title:

 

Karen Kee

Company Secretary

 

Date: 6 August 2004