welcome to actelion’s annual general meeting 2010 · 2017-02-20 · crth2 antagonist, cns assets,...

Copyright © 2011 Actelion Pharmaceuticals Ltd

WELCOME TO ACTELION’SANNUAL GENERAL MEETING 2011

© 2011 Actelion Pharmaceuticals Ltd

The following information contains certain “forward-looking statements”, relating to thecompany’s business, which can be identified by the use of forward-looking terminology suchas “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”,“would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions ofstrategy, plans or intentions. Such statements include descriptions of the company’sinvestment and research and development programs and anticipated expenditures inconnection therewith, descriptions of new products expected to be introduced by the companyand anticipated customer demand for such products and products in the company’s existingportfolio. Such statements reflect the current views of the company with respect to futureevents and are subject to certain risks, uncertainties and assumptions. Many factors couldcause the actual results, performance or achievements of the company to be materiallydifferent from any future results, performances or achievements that may be expressed orimplied by such forward-looking statements. Should one or more of these risks or uncertaintiesmaterialize, or should underlying assumptions prove incorrect, actual results may varymaterially from those described herein as anticipated, believed, estimated or expected.

Actelion AGM 201105 May 20112


MEETING STRUCTURE

ACTELION’S ANNUAL GENERAL MEETING 2011

Business Review 2011 Robert E. Cawthorn,Chairman of the Board

Jean-Paul Clozel, Chief Executive Officer

Andrew J. Oakley, Chief Financial Officer

Agenda and proposals Robert E. Cawthorn,Chairman of the Board

Joe Scodari,Vice-Chairman



BUSINESS REVIEW BY THECHAIRMAN OF THE BOARD

Robert E. Cawthorn

05 May 2011 Actelion AGM 20114


10 YEARS OF CONTINUED STRONG REVENUE GROWTH

ACTELION


19 132307

472664

946

1,3171,474

1,7731,929

FY'01 FY'02 FY'03 FY'04 FY'05 FY'06 FY'07 FY'08 FY'09 FY'10

Annual Revenue Growth

CHF million

+13% LC growth


10 YEARS OF CONTINUED EBIT GROWTH

ACTELION


-65 -36 6 105 179320

471 477568 619

FY'01 FY'02 FY'03 FY'04 FY'05 FY'06 FY'07 FY'08 FY'09 FY'10

Non-GAAP EBIT

CHF million +19% LC growth


0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

80.0

Apr/00 Jan/01 Nov/01 Sep/02 Jul/03 May/04 Mar/05 Jan/06 Oct/06 Aug/07 Jun/08 Apr/09 Feb/10 Dec/10

Inde

xed

to A

ctel

ion

shar

e pr

ice

Actelion Nasdaq Biotech Index

ACTELION

TRACK RECORD OF SUPERIOR VALUE CREATION

Source: Bloomberg as at 31 Dec 2010.Note: Actelion was first listed at the Swiss Stock Exchange (SIX) New Market on 6 April 2000 at a price of CHF 260 per share (equivalent to a price of CHF 13 after two stock splits which occurred in

2001 and 2007).

(10%)

294%



BUSINESS REVIEW BY THECHAIRMAN OF THE BOARD

Robert E. Cawthorn



2010 REPORTBY THE CEO

Jean-Paul Clozel



4 PRODUCTS ON THE MARKET 13 YEARS AFTER FORMATION

ACTELION


ZAVESCA ®

TRACLEER ®

VELETRI ®VENTAVIS ®


Maximize Tracleer in all approved etiologies

Shape and innovate the PAH market beyond Tracleer:Ventavis, Veletri, Macitentan, Selexipag

Create a specialty portfolio beyond PAH:Zavesca, Tracleer in DU, Ponesimod (i.e. MS), Antibiotic (CDI), Olesoxime (ALS)

Build a business - employing tailored partnerships - beyond specialty:CRTH2 antagonist, CNS assets, CV assets

OUR FOUR-PILLAR BUSINESS STRATEGY

ACTELION


Build a long-term sustainable business with a diverse product & disease portfolio

PILLAR 1

PILLAR 2

PILLAR 3

PILLAR 4


Tracleer Pediatric Investigational Plan agreed and initiated

Macitentan SERAPHIN study in PAH progressing according to plan

MUSIC study in IPF fully recruited

Selexipag GRIPHON study SPA completed, study progressing

Olesoxime Actelion obtained an exclusive option to acquire privately-held Trophos SA

Ponesimod Multiple sclerosis dose finding study fully recruited

CRTH2 antagonist Dose finding study in asthma enrolling

Dose finding study in allergic rhinitis enrolling

Antibiotic Dose finding study in clostridium difficile infection initiated

Cardiovascular Proof of concept trial prepared

Entry into man S1P1 agonist follow up compound

2010 KEY DEVELOPMENT MILESTONES

OUR PRIMARY MISSION TO MOVE THE PIPELINE



WELL BALANCED PIPELINE


Phase I Phase II Phase III Reg.Macitentan

Selexipag

PonesimodCRTH2 antagonist

Ponesimod

MacitentanAntibiotic

Cardiovascular

IndicationPAH

Asthma

PAH

Psoriasis

Partner

Multiple Sclerosis

Idiopathic Pulmonary Fibrosis

Clostridium difficile Infection

Essential Hypertension

Olesoxime* ALS

CRTH2 antagonist Allergic Rhinitis

*

* Option to buy

Miglustat Cystic Fibrosis

S1P1 follow up Immunological Disorders


2011 Q2 Q3 Q4 2012

SIGNIFICANT NEAR-TERM VALUE DRIVERS AHEAD


Phase II resultsPonesimod

MS

Phase II resultsAntibiotic

CDI Phase III resultsOlesoxime

ALS

Phase III resultsMacitentan

PAH

Phase II resultsCRTH2Asthma

Phase II resultsPonesimod;

Psoriasis

Phase II resultsMacitentan

IPF

Phase II resultsCRTH2

Allergic Rhinitis


THE RIGHT ASSETS FOR CONTINUED SUSTAINABLE GROWTH

ACTELION


Leadership and Culture

Highly Profitable

Promising Pipeline

Global Organization

Tailored Partnerships

SUSTAINABLE GROWTH


2010 REPORT BY THE CFO

Andrew J. Oakley



SIGNIFICANT MARGIN IMPROVEMENT

FINANCIAL HIGHLIGHTS

17

FY 2009 FY 2010 % of Change CHF

% of ChangeLC

NetRevenues 1,773 1,929 9 13

OperatingIncome 339 457 35 50

Non-GAAP EBIT 568 619 9 19

US GAAP EPS 2.53 3.22 27 42

USD/CHF 1.0433 average (high: 1.1721 low: 0.9350)EUR/CHF 1.3833 average (high: 1.4889 low: 1.2400)


in CHF million

CHF

in CHF million

in CHF million


1,698 1,826

FY'09 FY'10

Growth driven by volume (11%pts)

Strong growth across all regions & all major markets

Emerging markets: + 41% in LC

CEE/MEA: +49% in LC

Managed volatile pricing & reimbursement environment in Europe and Health Care reform impact in the US

STRONG DOUBLE DIGIT GROWTH

ACTELION PRODUCT SALES


+12% LC Growthin CHF million


1,5081,636

FY'09 FY'10

> 41,000 pts on drug today

iPAH/PAH-CTD: Goal oriented treat-to-target strategy launched –supported by the guidelines

PAH-CHD: Significant growth potential. New strategies initiated

Digital Ulcer indication strong growth driver in Europe: > +30% vs. PY

Strong competitive defense: Tracleer share of ERA market > 80% (prior to Thelin withdrawal in Dec. 2010)

STRONG GROWTH ENGINE – DOUBLE DIGIT UNIT GROWTH

TRACLEER®


in CHF million+13% LC Growth


137119

FY'09 FY'10

Minimized impact of launch of competitive inhaled product

Successful conversion to 20 mcg/mLpresentation (> 70% of units)

Superior efficacy label

Strong sales force / physician interaction

MANAGING A COMPETITIVE ENVIRONMENT

VENTAVIS®


in CHF million

-10% LC


0.2

0.8

1.8

Q2 2010 Q3 2010 Q4 2010

Strong product acceptance –excellent sales uptake

Estim. 50% of patients are PGI2-naïve; 50% of patients are switched from i.v. PGI2

EPITOME 1 trial (US) progressing well

US label enhancement: 7 Days stability

2nd generation formulation filed in 2011

France: filed 2010, EPITOME 2 initiated

Japan: filed 2011

SUCCESSFULLY LAUNCHED IN THE US

VELETRI®


in USD million


53

69

FY'09 FY'10

NP-C market building progressing well

Strong NP-C growth in Europe (+42% in units) esp. EU5

GD1 business increase maintained post Cerezyme shortage

Maintenance trial in GD1 successfully completed

Market coverage increasing

STRONG GROWTH IN BOTH GD1 AND NP-C

ZAVESCA®


+ 37% LC Growthin CHF million


75

103

FY'09 FY'10

GSK - CHF 18.9 m (2009: 34.4 m)

Roche - CHF 77.2 m (2009: 20.4 m)

Other - CHF 6.5 m (2009: 19.8m)

IMPACTED BY PONESIMOD MILESTONES

CONTRACT REVENUES


38% increasein CHF million


Increased spend on Phase II compounds

Increase in trial costs of selexipag offset by 2009 USD 20 million milestone

Increase in discovery and chemistry capabilities

Decrease in almorexant costs

BALANCED INCREASE

NON-GAAP R&D OPEX


3% LC Increasein CHF million


Investment in emerging markets providing substantial return on investment

Investment in Japan to drive 29% growth in sales

Investment in product launches to drive future sales growth

Change in accounting treatment for bad debt provisions

Increase in legal costs

Improvement in IT infrastructure

INVESTMENT IN GROWTH

NON-GAAP SG&A OPEX


18% LC Increasein CHF million


568 619

FY'09 FY'10

Total revenues up 13% (LC)

Total cash opex up 10% (LC)

Further enhancement of operating margins in local currencies

SIGNIFICANT MARGIN IMPROVEMENT

NON-GAAP EBIT


19% LC Growth

in CHF million


2.533.22

FY'09 FY'10

Strong operating performance

2009 affected by litigation settlement

STRONG OPERATING PERFORMANCE

GAAP EPS - FULLY DILUTED


42% LC Growth

Totals in CHF


PROVIDING STRATEGIC FLEXIBILITY

BALANCE SHEET

28

FY’09 FY’10

Cash position 1,344 1,446

Cash from operations 424 316

Treasury shares 9.8 10.5

Shareholder’s equity 1,408 1,795


CHF million

million

CHF million

CHF million


Initiation of regular dividend payments

Proposal to AGM of dividend from capital reserves of CHF 0.80 per share

Share repurchase of up to CHF 800 million over 3 years continues as planned

SHARE BUYBACK AND REGULAR DIVIDEND

UNLOCKING VALUE FOR SHAREHOLDERS TODAY



Q1 2010 Q1 2011 % of Change CHF

% of ChangeLC

NetRevenues 501.7 528.2 5 15

OperatingIncome 163.3 164.7 1 22

Non-GAAP EBIT 197.8 206.0 4 22

US GAAP EPS 1.09 1.20 10 33

FINANCIAL HIGHLIGHTS


in CHF million

CHF

in CHF million

in CHF million


GUIDANCE

Product Sales Mid-single digit growth in LC

Total Cash Opexabsolute cost terms Flat compared to 2010

Non- GAAP EBIT Low double-digit growth in LC



THE CHAIRMAN OF THE BOARD

Robert E. Cawthorn


welcome to actelion’s annual general meeting 2010 · 2017-02-20 · crth2 antagonist, cns assets,...

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