Speech David Ebsworth: Business update 2009 and ... - Galenica.com

SPEECH 

Date 16 March 2010 

Speaker David Ebsworth, CEO of Vifor Pharma 

Subject Business update 2009 and outlook 2010 of Vifor Pharma 

The spoken word shall count 

Ladies and gentlemen, 

It’s a great pleasure to have the opportunity to talk to you today as the new CEO of Vifor Pharma. 

Since it is my first presentation, I thought it might be appropriate for me to introduce myself. 

30 YEARS EXPERIENCE IN HEALTHCARE – WELL 

PREPARED FOR MY ROLE IN GALENICA AND VIFOR 

PHARMA 

1980-82 Sales Representative/Product Manager, Pfizer 

1983-86 Marketing Manager, Bayropharm (Bayer) 

1987-89 General Manager Pharma, Miles Canada 

1990-91 Global Cardiovascular and CNS Marketing 

1992-95 Global Marketing and Sales, Bayer AG 

2000-02 President Global Pharmaceutical Division 

1995-99 President Pharma Division North America, 

Bayer Corp., West Haven 

2002-03 Chief Executive Officer, Oxford GlycoSciences PLC, 

Abingdon, UK 

2006-08 Executive Chairman of the Board of Directors 

of A&D Pharma-Holdings, Romania 

2 © Galenica Group 12.03.2010 

My 30 years of experience in the pharmaceutical industry have prepared me well for my role, both 

in Galenica and in Vifor Pharma. 

I started in the pharmaceutical industry as a sales representative for Pfizer and after moving to 

marketing I joined the Bayer organisation with its subsidiary Bayropharm in Germany. During my 

time at Bayer I worked both in Canada and in numerous functions in Germany, in marketing as well 

as in sales and general management. I had a stint of 5 years as the General Manager of the 

pharmaceutical business based in West Haven Connecticut, completing my time with Bayer as the 

President of the Global Pharmaceutical Division. Following these 19 years with Bayer, I became 

the Chief Executive Officer of a publicly traded biotechnology company in the UK called Oxford 

GlycoSciences. In my time as a Non Executive Director one of the companies that I worked with 

was A&D Pharma Holdings, which is the leader in wholesale with the biggest pharmacy chain in 

Romania, thus teaching me something about the Santé business here in Galenica. With this broad 

background I am very happy to have taken my new role here at Vifor Pharma and I am looking 

forward very much to working closely with the management team both in Galenica and Vifor 

Pharma to ensure that we achieve our goals. 

Galenica Ltd. 

Untermattweg 8 · P.O. Box · CH-3001 Bern 

Phone +41 58 852 85 17 · Fax +41 58 852 85 58 

media@galenica.com · www.galenica.com 

The Galenica Group – excellence in the healthcare market


Page 2/8 

Subject 

Business update 2009 and outlook 2010 of Vifor Pharma 

KEY SUCCESSES 2009: 

STRENGTHENED NETWORK OF AFFILIATES 

Affiliates in Europe 

Status Markets Since 

Established 

Affiliates / JV 

• Switzerland 

• Romania 

• Germany 

• Nordics 

• France 

• Netherlands 

• Austria 

• Spain 

• UK 

Home market 

Q3 - 2005 

Q1 - 2007 

Q2 - 2008 

Q1 - 2009 




Q1 - 2010 

• 4 new affiliates in 2009 

• 1 strengthened in January 2010 

• Today present with 20 sites 

in 15 countries 


I’d like to talk today about some of the key successes that the organisation has enjoyed in 2009. 

We have recently created four new affiliates and strengthened one. We established affiliates in 

France, the Netherlands, in Austria, Spain and at the beginning of 2010 we were able to strengthen 

our UK affiliate with the purchase of our prior distributor and the full integration of the sales force. 

So today we are present with 20 sites in 15 countries, giving us direct access to the market. 

KEY SUCCESSES 2009: 

7 NEW FERINJECT ® LAUNCHES 

- Austria 

- Finland 

- Greece 

- The Netherlands 

- Portugal 

- Spain 

- Slovakia 

Ferinject ® is launched in 

13 and gained marketing 

authorisation in 19 

countries. 


The establishment of these affiliates has clearly supported new Ferinject ® launches across Europe. 

In 2009 we had 7 new launches of Ferinject ® : in Austria, Finland, Greece, in the Netherlands, in 

Portugal, in Spain and Slovakia. So today Ferinject has been launched in 13 of the countries where 

we have gained marketing authorisation. 

KEY SUCCESSES IN 2009: 

FURTHER MARKET EXPANSION IN 

SWITZERLAND 

thousands CHF 

3500 

3000 

2500 

2000 

1500 

1000 

500 

0 

Sales in Switzerland 

Jan07 - Dec09 

Q1 07 

Q2 07 

Q3 07 

Q4 07 

Q1 08 

Q2 08 

Q3 08 

Q4 08 

Q1 09 

Q2 09 

Q3 09 

Q4 09 


Vifor Pharma ProductsProdukte 

Venofer ® 

Ferinject ® 

- Long market development: 

- Start with launch of Venofer ® in 2001 

- Basis for successful launch of Ferinject ® 

in February 2008 

- Efficient marketing and sales 

organisation established 

- Focus on iron deficiency 

- High awareness among healthcare 

professionals and patients 

- Support of healthcare 

professionals through medical education 

programs 

- Creation of a broad market based on GPs 

We continue to be extremely successful in Switzerland. During 2009 we saw further market 

expansion. The reasons for this strong position in Switzerland are clearly the long development that 

we have enjoyed building up Ferinject ® , the focus on iron deficiency without anaemia and the


Page 3/8 

Subject 


support that healthcare professionals have given us through medical education programs and 

through work of our sales force. This has created a broad-based market with a strong position 

amongst General Practitioners. 


FERINJECT ® SALES EXCEED VENOFER ® 

SALES IN GERMANY 

thousands CHF 

Sales in Germany 

Jan07 - Dec09 

1600 

1400 

1200 

1000 

800 

600 

400 

200 

0 

Q1 07 

Q2 07 

Q3 07 

Q4 07 

Q1 08 

Q2 08 

Q3 08 

Q4 08 

Q1 09 

Q2 09 

Vifor Products Pharma Products 

Venofer ® 

Q3 09 

Q4 09 

- Appropriate investment into 

sales force size (2007: 10, 

2008: 20, 2009: 30) and good 

targeting 

- Well coordinated marketing 

activities including a strong 

trade PR 

- Good KOL network and local 

clinical program 

Ferinject ® 


In Germany we continue to see expanded success. In 2009 Ferinject ® sales exceeded Venofer ® 

sales. We have been increasing the sales force one step at a time using good targeting and 

penetrating the market. We have well coordinated marketing activities including impactful trade 

public relations work. We have a strong KOL network, a local clinical program and a well-qualified 

team. 


INCREASED VIFOR PHARMA IV IRON SALES 

2009 vs. 2008 (unit based) 

Spain: +28% 

UK: +24% 

Greece: +2% 

- Arrested decline caused by ISS 

-Ferinject ® launched in August 


Further examples of our ability to drive the total sales of Vifor Pharma IV iron products with the 

launch of Ferinject ® are provided by Spain and UK. In Spain our total IV unit based growth 

increased by 28% in 2009. 

In the UK we saw our IV iron sales grow last year by 24%. With the integration of the Synermed 

sales team we are now well positioned for further growth. 

Greece is an excellent example of Ferinject ® sales growth achieved by our partner Genesis 

Pharma. This is based on a solid foundation of Venofer ® sales. Venofer ® was losing ground to 

generics. Since the launch of Ferinject ® , we have regained growth and achieved hospital listings for 

the new product in two thirds of the hospitals stocking Venofer ® .


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Subject 


KEY SUCCESS IN 2009: 

FERINJECT ® - NEW THERAPEUTIC OPTION FOR 

ANAEMIA TREATMENT IN HEART FAILURE PATIENTS 

FAIR-HF: 

- Primary and secondary endpoints fully met 

- Presented at the American Heart Association’s Late-Breaking 

Clinical Trials Sessions in Orlando, USA 

- Publication in November 2009 in: 


As Mister Jornod has already mentioned, one of our key successes in 2009 was the publication of 

the FAIR-HF study in the New England Journal of Medicine. This provides a new therapeutic option 

for anaemia treatment in heart failure patients. As you know, the primary and secondary endpoints 

were fully met. This study was therefore presented at the American Heart Association’s Late 

Breaking Clinical Trials Sessions in Orlando. 

The Vifor Pharma organisation is very proud of the successes that they have achieved in 2009. It’s 

my privilege to present those to you although I personally have very little to do with these efforts. 

VIFOR PHARMA GOALS 2010: 

3 STRATEGIC PILLARS FOR VALUE CREATION 

Main Objective: 

Creating Stakeholder Value for Galenica 

Growth Drivers 

Ferinject ® 

Geographic 

Expansion / 

Strengthened 

Invest in Future 

PA21 

Venofer ® 

Partnerships VIT91 

Oral Iron 

Evotec 

CellCept ® 

Collaboration 

CHC Products 

OM Pharma Products 

Build and protect Vifor Pharma’s reputation 


We have set ourselves clear goals for Vifor Pharma in 2010; goals that are based around three 

strategic pillars, each of which is designed to achieve the main objective of creating stakeholder 

value for Galenica. We have goals focusing on growth drivers, whether they be Ferinject ® , Venofer ® , 

Oral Iron, Cellcept ® , Consumer Healthcare or OM Pharma products. We also see geographic 

expansion and further partnerships as a driver of stakeholder value at Galenica. Of course in the 

longer term we need to secure our future through the pipeline. We have a number of interesting 

projects, such as PA21 as well as VIT91, and an early stage anaemia compound, where we 

recently announced our collaboration with Evotec. All of that is based on the foundation of building 

and protecting Vifor Pharma’s image by continuing to strengthen our organization and work 

processes. 

I’d like to talk about a number of these points in a little bit more detail.


Page 5/8 

Subject 



MAXIMIZE FERINJECT ® 

- Further Market penetration in countries where Ferinject ® is launched 

- Successful national market access discussions to set the stage for 

further Ferinject ® launches in 2011 in Wave II countries 

- Focus on Key Therapeutic Areas 

- Brand support through broad clinical development program to build 

scientific evidence 

- Data dissemination of FAIR-HF to penetrate Ferinject ® in Heart 

Failure 


Clearly within 2010 it is our goal to further maximise the sales of Ferinject ® . We’re particularly 

driving the market share of Ferinject ® in countries where it is launched today. In addition, in 2010, 

we will successfully prepare our future launches by appropriate national market access discussions 

for the wave II approval countries. In each country we will be focusing on specific key therapeutic 

areas. By providing brand support through broad clinical development to help us to build scientific 

evidence and also by further disseminating the FAIR-HF data in Heart Failure. 


EXPAND FERINJECT ® MARKET 

PENETRATION 

Ferinject ® launched 

• Austria 

• Denmark 

• Finland 

• Germany 

• Greece 

• Ireland 

• Netherlands 

• Portugal 

• Slovak Republic 

• Spain 

• Sweden 

• Switzerland 

• United Kingdom 

Europe 

• France 

• Italy 

• Belgium 

• Romania 

• Norway 

• Iceland 

• Slovenia 

• Hungary 

• Bulgaria 

• Malta 

• Cyprus 

• Luxembourg 

• Poland (ongoing) 

• Czech Rep. (ongoing) 

• Baltics (on hold) 

Future launches 

• Mutual Recognition 

Procedure (MRP) 

successfully 

completed in March 

2010 

• National approval 

phases have started 

RoW 

• Turkey 

• Russia 

• Brazil 

• Argentina 

• Korea 

• Lebanon 

• Saudi Arabia 


From a market expansion perspective the launch countries - you can see them on the left side 

highlighted in purple - are the key to our current success. We are also preparing launches in a 

whole series of European countries as well as countries in the rest of the world, where we are 

convinced that there is also significant market potential for Ferinject ® . In March we successfully 

completed the Mutual Recognition Procedure (MRP) in 11 European countries. This is an important 

success and the national approval phases have already started. 


BUILD CLINICAL EVIDENCE FOR 

FERINJECT ® EFFICACY 

Brand support through 

Clinical development program: 

9 trials ongoing / planned in 7 different therapeutic areas 

IBD 

FERGI COR 

FERGI MAIN 

Ob&Gyn 

PREGNANCY 

CHF 

FAIR-HF 

(finished) 

IDwA 

PREFER 

HD 

CKD 

FIND-CKD 

SURGERY 

FER-SURG-02 

HEM/ONC 

FER-AOC-MM 

FER-FID-CHEMO 

12 © Galenica Group 12.03.2010


Page 6/8 

Subject 


We are building clinical efficacy for Ferinject ® through 9 ongoing clinical trials in 7 different 

therapeutic areas. 


ESTABLISH FERINJECT ® IN INDICATIONS 

SUCH AS CKD, IBD, CHF, OB-GYN 

- Build on FAIR-HF and disseminate data 

- Ongoing congress and medical education activities 

- Systematic KOL Management / Advisory Boards broaden network 

- Implement mid-term planning to tap full potential of Ferinject ® 


We are working diligently to establish Ferinject ® in these indications such as CKD, IBD and CHF as 

well as Gynaecology. We will use and build on the FAIR-HF data, we will strengthen our activities 

at congresses and our medical education activities. We are working systematically with KOLs and 

Advisory Boards, broadening our network and implementing mid-term planning to ensure we tap 

the full potential of Ferinject. 


COMPLETE ONGOING CELLCEPT STUDIES 

- Strengthen Roche relationship 

- Complete ongoing trials and prepare data dissemination 

Aspreva Lupus Maintenance Study (ALMS): 

- Maintenance phase approaching the end with Last Patient Last Visit 

(LPLV) in Q2 2010 

- Results expected in second half 2010 

- 4 publications of ALMS Induction data in 2009 

Pemphigus Vulgaris: 

- Publication provisionally accepted by Journal of Investigative 

Dermatology 

- Publication expected Q2/3 2010 


Another key goal is to ensure completion of the ongoing Cellcept studies. We need to strengthen 

our relationship with Roche, and disseminate data, such as from the ALMS study or the PV studies, 

where we hope to see a series of publications through the course of the year, so building on prior 

publications from previous years.


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Subject 



INTEGRATE OM PHARMA AND ACHIEVE 

SYNERGIES 

- Synergies in Switzerland Shared Sales Force 

- Joint organisation Romania 

- Analysing synergies Rx / CHC / OM sales organisation 

- Evaluation of organisational synergies (Medical Affairs, Regulatory 

Affairs, Quality Management) 


With the recent purchase of OM Pharma, our goal is to integrate OM Pharma into our sales 

networks and to achieve synergies. Such synergies have already commenced in Switzerland, 

where we now share a sales force promoting OM Pharma as well as Vifor Pharma products. We 

are creating a joint organisation in Romania, we will be analysing synergies between the 

prescription, the Consumer Healthcare and the OM Pharma sales organisations to see where we 

can leverage our partnerships in selected countries in a more effective way. Or we will look into 

evaluating organisational synergies in areas such as Medical, Regulatory and Quality. 


STRENGTHENED PARTNERSHIPS 


In markets, where we are not present ourselves, we will strengthen and intensify our partnerships 

further. Examples of such key partnerships are the ones with Fresenius Medical Care, both in North 

America and in Europe. Or Luitpold Pharmaceuticals, who are doing an excellent job of promoting 

Venofer ® to the audiences in the United States. But also such partners as Abdi Ibrahim, which is 

the largest Turkish pharmaceutical company and represents both Vifor Pharma and coincidentally 

OM Pharma products, and where we are using joint sales forces effectively to sell products from 

both lines of business. Or with Nycomed, where we have collaborations in a large number of 

countries in Latin America as well as in Europe.


Page 8/8 

Subject 



DEVELOP EARLY STAGE PIPELINE 

PRODUCTS 

- Preparing PA21 Development / Commercialisation 

- Alliance with Evotec in anaemia 

- Other preclinical projects 


In order to strengthen and build the future, we will be developing our early stage pipeline products 

further. PA21 is a good example where we have ongoing partnering discussions. Another example 

is the alliance which we recently announced with Evotec - created for the discovery of new 

products in anaemia. We also have other preclinical projects on which we are working. 


STRATEGY DEFINED, OBJECTIVES SET 

2010 WILL BE THE YEAR OF EXECUTION 


Main Objective: 

Creating Stakeholder Value for Galenica 

Growth Drivers 

Ferinject ® 

Venofer ® 

Oral Iron 

CellCept ® 

CHC Products 

OM Pharma Products 

Geographic 

Expansion / 

Strengthened 

Partnerships 

Build and protect Vifor Pharma’s reputation 

Invest in Future 

PA21 

VIT91 

Evotec 

Collaboration 

Ladies and gentleman, 2010 will be a year of execution! The strategy is defined, the objectives are 

set and now it’s up to us to STRIKE WHILE THE IRON’S HOT! 

Thank you very much.

Speech David Ebsworth: Business update 2009 and ... - Galenica.com

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