Welcome to Actelion’s Annual General Meeting 2012Chairman of the Board Business Review 2011...

Copyright © 2012 Actelion Pharmaceuticals Ltd

WELCOME TO ACTELION’SANNUAL GENERAL MEETING 2012

© 2012 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 201204 May 20122


MEETING STRUCTURE

ACTELION’S ANNUAL GENERAL MEETING 2012

Opening Remarks Jean-Pierre Garnier,Chairman of the Board

Business Review 2011 Jean-Paul Clozel, Chief Executive Officer

Andrew J. Oakley, Chief Financial Officer

Outlook by the CEO Jean-Paul Clozel, Chief Executive Officer

Agenda & Proposals

Jean-Pierre Garnier,Chairman of the Board

Dr. Marian Borovsky,Secretary of the Board of Directors



OPENING REMARKS BY THECHAIRMAN OF THE BOARD

Jean-Pierre Garnier



BACK TO THE FUTURE


2011 BUSINESS REVIEWBY THE CEOJean-Paul Clozel


Solid commercial performance in a very difficult environment

Balanced development pipeline with near- and mid-term opportunities

Highly productive Drug Discovery organization

Enhancing financial discipline – tight cost control throughout the company

Strong Board of Directors – smooth transition of Chairmanship

Highest quality in all we do

ACHIEVEMENTS IN BRIEF

ACTELION’S PERFORMANCE IN 2011



ACTELION 2011 – KEY PERFORMANCE NUMBERS

FY 2010 FY 2011 % of Change CHF

% of ChangeLC

Product sales 1,826.3 1,713.0 (6) 7

Non-GAAP EBIT 619.3 520.6 (16) 8

Non-GAAP EPS 4.54 3.31 (27) (4)



NEAR- AND MID-TERM OPPORTUNITIES

THE RIGHT GROWTH OPPORTUNITIES

MacitentanPAHMacitentanDigital UlcersSelexipagPAHACT-434964Lipid storage disordersPonesimodMultiple SclerosisPonesimodPsoriasisCadazolidClostridium difficile InfectionS1P1 follow-upImmunological DisordersMacitentanGlioblastomaImmunologyImmunological DisordersAnti-malarialMalariaCRTH2 follow-upAsthma / Allergic DisordersORA follow-upInsomniaCardiovascularCardiovascular Disorders

Phase I Phase II Phase III Reg.

Orp

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Dis

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Investor Presentation9


THREE MAIN TASKS

OUR LONG-TERM VISION

SUSTAIN & GROW PAH FRANCHISE

BUILD 2ND

FRANCHISE

OPTIMIZE PROFITABILITY



2011 BUSINESS REVIEW BY THE CFO

Andrew J. Oakley


FY 2010 FY 2011 % of Change CHF

% of ChangeLC

NetRevenues 1,929.0 1,796.1 (7) 5

OperatingIncome 457.3 12.2 (97) (95)

Non-GAAP EBIT 619.3 520.6 (16) 8

US GAAP EPS 3.22 (1.23) - -

FINANCIAL HIGHLIGHTS

in CHF million

CHF

in CHF million

in CHF million



1,826.3 1,713.0

FY 2010 FY 2011

Growth mostly driven by volume

All regions contributing to overall growth (LC):

– US + 2%– Europe + 6%– Japan + 20%– RoW + 24%

CONTINUED SOLID GROWTH

ACTELION PRODUCT SALES

in CHF million

+7% LC Growth



CONTINUED INCREASE IN PATIENT DEMAND

TRACLEER®

in CHF million

Unit growth 8%

Continued strong growth in Japan and “emerging” markets

DU growth in Europe

Negative impact from US ambrisentan label change

Small negative price variance (increase in US, pricing pressure in Europe)

+5% LC Growth

1,636.1 1,522.1

FY 2010 FY 2011



Growth due to price movement

8% decline in units shipped

Continuing competitive market

Leveraging superior efficacy label vs. other inhaled prostacyclins

MANAGING A COMPETITIVE ENVIRONMENT

VENTAVIS®

in CHF million

+7% LC Growth

118.7106.4

FY 2010 FY 2011



2.8

14.7

FY 2010 FY 2011

US Registry (PROSPECT) fully enrolled

Japan and EU: expected to become available in 2013

GOOD ADOPTION AMONGST US PRESCRIBER BASE

VELETRI®

in CHF million

+526% LC Growth



68.7 68.4

FY 2010 FY 2011

Unit growth 14%

Strong patient growth in NP-C

“Suspicion Index” in publication

GD1 patients – partial switch back to ERT

EUROPEAN NP-C BUSINESS DRIVING DOUBLE-DIGIT GROWTH

ZAVESCA®

+12% LC Growth

in CHF million



2010:

– Roche CHF 77.2 m– GSK CHF 18.9 m

2011:

– GSK CHF 76.5 m

FINAL RECOGNITION FROM ROCHE & GSK COLLABORATIONS

CONTRACT REVENUES

in CHF million

102.683.1

FY 2010 FY 2011



Increase spend on setipiprant (CRTH2), macitentan and selexipag

Decrease from discontinued clinical programs

Benefit from ponesimod transition from Phase II to III

Preclinical – 7 new compounds entered into man in 2011

Carefully managed fixed cost base

BALANCING SPEND WITH FUTURE GROWTH

NON-GAAP R&D OPEX

in CHF million

-5% LC Decrease

428.7 399.8

FY 2010 FY 2011



Masked commercial leverage

Doubtful debt provision - CHF 43 m

Streamlined sales and marketing activities

Corporate spend distorts underlying cost base

Careful headcount management

UNDERLYING COMMERCIAL LEVERAGE

NON-GAAP SG&A OPEX

in CHF million

+ 7% LC Increase

680.6 679.3

FY 2010 FY 2011



619.3520.6

FY 2010 FY 2011

Continued adverse currency impact – approx CHF 150 m

Adverse provision impact:CHF 43 m

NGE ex-provision +14% in LC

Margin improvement

Negative impact from contract revenue decrease

Impact from non-recurring expenses

SIGNIFICANT IMPACT OF STRONG SWISS FRANC

NON-GAAP EBIT

+ 8% LC Increase

in CHF million



Litigation provision CHF 340.6 m

Stock compensation CHF 84.9 m

Depreciation CHF 43.7 m

Amortization CHF 39.2 m

SIGNIFICANT IMPACT OF LITIGATION PROVISION

OTHER GAAP OPEX

in CHF million

162.1 167.8

340.6

FY 2010 FY 2011



(16.4)

(81.5)

Impairment on financial assets of CHF 24.7m

Interest expense on litigation provision: CHF 19.7m

Other financial expense CHF 22.9m related to hedging and valuation losses

Tax rate excluding provision 17.3%

FINANCIAL RESULT

in CHF million

FY 2010 FY 2011



3.22

(1.23)

Negative litigation provision impact

Negative doubtful debt provision impact

Negative currency headwinds

Non-GAAP EPS:

(27%) in Swiss Francs( 4%) in local currencies

LITIGATION PROVISION RESULTS IN NET OPERATING LOSS

EPS

in CHF

FY 2010 FY 2011

Non-GAAP EPS

CHF 3.31

Non-GAAP EPS

CHF 4.54



Q1 2011 Q1 2012 % of Change CHF

% of ChangeLC

Product sales 450.1 415.8 (8) (4)

OperatingIncome 164.7 67.1 (59) (54)

Core earnings 127.9 107.6 (16) (9)

US GAAP EPS 1.20 0.38 (68) (63)

FINANCIAL HIGHLIGHTS FROM Q1 2012

in CHF million

CHF

in CHF million

in CHF million



Product Sales Low single digit decrease in LC

Core earnings (Product sales minus Non-GAAP OPEX)

Flat in local currencies

2012 – GUIDANCE



OUTLOOKBY THE CEOJean-Paul Clozel


STUDY WITH ENDOTHELIN RECEPTORANTAGONIST INPULMONARY ARTERIAL HYPERTENSION TO IMPROVE CLINICAL OUTCOME


Discovered by Actelion

Tissue-targeting dual ERA

Highly potent

Once-daily dosing

Optimized pharmacokinetics / metabolism

Promising safety and tolerability profile

Patent life until mid 2020s

MACITENTAN: A UNIQUE PROFILE



First long-term outcome trial in PAH

Highly clinically relevant morbidity / mortality primary endpoint

Unprecedented trial size

Unprecedented length of treatment and patient follow-up

INNOVATIVE LANDMARK TRIAL

SERAPHIN PHASE III STUDY



10 mg dose group – the observed risk reduction was by 45 % (p<0.0001).

3 mg dose group – the observed risk reduction was 30 % (p=0.0108).

Macitentan appears to be well tolerated at both dose levels

– The number of adverse events reported and patients discontinuing treatment due to adverse events was similar across all groups.

Submission of the registration dossier to Health Authorities worldwide is expected by the fourth quarter of 2012

CONCLUSIVE STUDY – PRIMARY ENDPOINT MET

INITIAL CONCLUSION OF SERAPHIN



A first-in-class, potent, orally available, selective IP receptor agonist

– In-licensed in March 2008 from Nippon Shinyaku– Patent life until mid 2020s

Phase II proof-of-concept:

– Highly significant reduction in pulmonary vascular resistance on top of existing therapy

– Demonstrated promising tolerability

Updated Phase III GRIPHON protocol to optimize chance for success

OPENING PROSTACYCLIN THERAPY TO A BROADER POPULATION

SELEXIPAG



THREE MAIN TASKS

OUR LONG-TERM VISION

SUSTAIN & GROW PAH FRANCHISE

BUILD 2ND

FRANCHISE

OPTIMIZE PROFITABILITY



THANK YOU FOR YOUR CONFIDENCE


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Welcome to Actelion’s Annual General Meeting 2012Chairman of the Board Business Review 2011...

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