nine months 2014 financial results - …€¦ · fungoides–type cutaneous t-cell lymphoma (a rare...

Copyright © 2014 Actelion Pharmaceuticals Ltd

NINE MONTHS 2014FINANCIAL RESULTS Tuesday, 21 October 201414.00 Basel / 13.00 UK / 08.00 US

© 2014 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.

9M 2014 Financial Results21 October 20142


ACTELION MAINTAINS STRONG PERFORMANCEJean-Paul Clozel, CEO



Strong financial performance

– Sales of CHF 1,488 million, up 17% at CER(1) – 12% excluding US rebate reversals

– Core earnings CHF 630 million, increase of 34% at CER – 21% excluding US rebate reversals

Opsumit® launch momentum remains strong

– Strong Opsumit launch momentum continues– Approvals and well-differentiated label around the world

Selexipag data - as planned

– Regulatory filing process on track

WE MAINTAINED STRONG MOMENTUM

KEY FINANCIAL AND OPERATIONAL HIGHLIGHTS

4

1 Constant Exchange Rates


OUR STRATEGIC PRIORITIES

SUSTAIN AND GROW THE PAH

FRANCHISE

BUILD ADDITIONAL SPECIALTY FRANCHISE

OPTIMIZE PROFITABILITY




FRANCHISE





SUSTAIN AND GROW PAH FRANCHISESUSTAIN AND GROW PAH FRANCHISE

► Global PAH leadership with 3 products

► Substantial progress with global launches of Opsumit

► Opsumit strong launch momentum

► Selexipag poised to further strengthen PAH franchise

► Regulatory filing preparation for Selexipag on track



FRANCHISE





BUILD ADDITIONAL SPECIALTY FRANCHISESBUILD ADDITIONAL SPECIALTY FRANCHISES

► Valchlor launched in US, evaluated in other countries

► Good progress with pipeline

► Cadazolid, our first antibiotic for treatment of clostridium difficile-associated diarrhea, progressing as planned



FRANCHISE





OPTIMIZE PROFITABILITYOPTIMIZE PROFITABILITY

► Successful cost control

► Markedly increased core earnings per share

► Financial flexibility

► Increased guidance

Copyright © 2014 Actelion Pharmaceuticals Ltd

FIRST NINE MONTHS 2014COMMERCIAL PERSPECTIVEOtto Schwarz, Chief Operating Officer

9M 2014 Financial Results


45%

37%

9%9%

USEuropeJapanRoW

BOOSTED BY REVERSAL OF US REBATE ACCRUALS

9M 2014: STRONG COMMERCIAL PERFORMANCE

1,3221,488

9M 2013 9M 2014

17% CER GrowthCHF million



515

38

59

Q4 2013 Q1 2014 Q2 2014 Q3 2014

OPSUMIT® LAUNCH MOMENTUM CONTINUES

Strong launch momentum maintained– YTD 112 Mio SFR sales

Global roll-out update:

– Launched in: US, Germany, Austria, Switzerland, Canada, UK, Ireland, Denmark, Norway, Sweden and NL

– QIII launches: Italy, Belgium, Luxembourg and Australia

– QIV launches: Mexico*(private market) and Finland

Registration process proceeding well in Japan; filed in other markets

* Trade name Zependo


CHF million


Positive impact of US rebate reversals and 2013/2014 US price increases

Global units sales flat – despite erosion in Opsumit markets and increasing Gxcompetition (Poland, Czech, Mexico)

Stayveer launched by Marklas in Poland and Czech Republic

Solid growth ex-US – driven by Digital Ulcer and PAH emerging markets (China, Russia, Asian and Latin America business)

SOLID VOLUME GROWTH IN NON-OPSUMIT MARKETS

TRACLEER®

1,138 1,153

9M 2013 9M 2014

+5% CER Growth


CHF million


BECOMING A TRULY GLOBAL ASSET

VELETRI®

Accelerated growth trajectory

Ongoing global launches - most recently available in Australia and NZ

Continued strong uptake in Japan* - adversely affected going forward by price reduction March 01 2014

25

46

9M 2013 9M 2014

+93% CER Growth


CHF million

* Trade name Epoprostenol “ACT”


Increasing competitive pressure

16% decline in units shipped

Top line maintained through price increase and positive effects of US rebate accrual reversals

Ready to defend our position in the market

SUSTAINING OUR BUSINESS

VENTAVIS®

83 86

9M 2013 9M 2014

8% CER Variance


CHF million


NIEMANN-PICK TYPE C INDICATION DRIVING GROWTH EX-US

ZAVESCA®

Underlying volume growth +18%

Driven by continued growth in the Niemann-Pick Type C (NP-C) indication outside US and new markets (i.e. Japan*)

US growth driven by positive price effect

Gx Miglustat approved in Spain and Denmark for the GD1 indication only – more EU markets expected to follow

* Trade name Brazaves

7381

9M 2013 9M 2014

+15% CER Growth


CHF million


9M 2014 sales: CHF 6.6 million

For topical treatment of mycosis fungoides–type cutaneous t-cell lymphoma (a rare form of non-Hodgkin’s lymphoma) in patients who have received prior skin-directed therapy

Approx. 18,000 patients in US of which 30-40% considered candidates for Valchlor treatment

Sales force expansion complete

The registration process for othercountries is under evaluation

EXPANDING OUR SPECIALTY BUSINESS

VALCHLOR®

16

1.2

2.3

3.8

Q1 2014 Q2 2014 Q3 2014


USD million


Strong overall commercial performance continues in QIII / YTD across all regions

Opsumit strong launch trajectory continues across all markets –Fast global roll-out proceeding as planned

Veletri becomes a global asset supporting overall growth dynamics

Valchlor – making progress in establishing its value in the CTCL market and expanding our portfolio beyond PAH

STATE OF THE BUSINESS – 9M 2014

21 October 2014 9M 2014 Financial Results17


NINE MONTHS 2014 STRONG FINANCIAL PERFORMANCEAndré C. Muller, Chief Financial Officer



Variance

9M 2013 9M 2014 CHF CER

Product salesCHF million

1,322 1,488 13% 17%

Core earningsCHF million

496 630 27% 34%

Operating incomeCHF million

397 519 31% 39%

Core EPSCHF

3.54 4.77 35% 42%

FIRST NINE MONTHS 2014 – FINANCIAL OVERVIEW



IMPACT OF US REBATE REVERSALS

NINE MONTHS 2014 – PRODUCT SALES

1,3151,415

8

74

1,000

1,200

1,400

1,600

9M 2013 9M 2014

Product sales ex US rebate reversals US rebate reversals

+ 12% at CER



IMPACT OF US REBATE REVERSALS

NINE MONTHS 2014 – CORE EARNINGS

489563

767

9M 2013 9M 2014

Core earnings ex US rebate reversals US rebate reversals

+ 21% at CER



1,3221,545 1,488 1,488

69154 57

9M '13 Productsales

Net impact ofrebate reversals

9M '14 intrinsicsales growth

9M '14 Productsales at CER

FX 9M'14 Productsales as reported

PRODUCT SALES UP 12% AT CER - EX REBATE REVERSALS

NINE MONTHS 2014 – PRODUCT SALES

CHF million

9M 2014 Financial Results21 22


496664 630 630

63105

34

9M '13 CE Net impact ofrebate reversals

9M '14 intrinsic CEgrowth

9M '14 CE at CER FX 9M'14 CE asreported

CORE EARNINGS UP 21% AT CER - EX REBATE REVERSALS



CHF million


1'488

1'079

630

155

254

449

9M 14 Product sales Core COS Core R&D Core SG&A 9M '14 Core earnings

CORE EARNINGS UP 34% AT CER



CHF million


630517 519

75 38 2

9M '14 Core earnings D&A Stock Compensation DDP, Others 9M '14 OperatingIncome

RECONCILIATION BETWEEN CORE AND US GAAP PERFORMANCE

NINE MONTHS 2014 – OPERATING INCOME


CHF million


519 566

304

19 66

9M '14 OperatingIncome

Financial result Taxes 9M '14 Net Income 9M '13 Net Income

NINE MONTHS 2014 – NET INCOME


CHF million


Variance

9M 2013 9M 2014 CHF CER

Net incomeCHF million

304 566 86% 97%

Basic EPS Number of shares in calculation (m)

2.73111.6

5.09111.2

87% 98%

Fully diluted EPSNumber of shares in calculation (m)

2.65114.9

4.87116.2

84% 95%

NINE MONTHS 2014 – EARNINGS PER SHARE



8781'105

455 458 609

133

449206

3

Unrestrictedgross cash31 Dec 13

Operatingcash flow(ex Asahi)

Asahipayment

Freedrestricted

cash

Dividend 1st line sharepurchase

Proceedsfrom ESOP

Capex, otheritems

Unrestrictedgross cash30 Sep14

NINE MONTHS 2014 – SOLID FINANCIAL POSITION


CHF million


AT CONSTANT EXCHANGE RATES

GUIDANCE UPGRADE

2014 Core earnings Growth low twenties percentage range

2014 Core earningsex US rebate reversals Growth mid-teen percentage range

2015 Core earnings Due to higher 2014 base, 2015 guidance will be reviewed early next year



QUESTION & ANSWER SESSIONJean-Paul Clozel – Chief Executive Officer

Otto Schwarz – Chief Operating Officer

André C. Muller – Chief Financial Officer

Andrew Weiss – Head of Investor Relations & Corporate Communications



APPENDIX



As reported Q1 2014 CER% Q2 2014 CER% Q3 2014 CER%

Product sales 469 13% 524 21% 496 16%

Core earnings 189 19% 233 52% 209 31%

IMPACT OF US REBATE REVERSALS - QUARTERLY

Excluding US rebate reversals Q1 2014 CER% Q2 2014 CER% Q3 2014 CER%

Product sales 450 9% 484 14% 480 12%

Core earnings 172 9% 196 34% 195 23%


nine months 2014 financial results - …€¦ · fungoides–type cutaneous t-cell lymphoma (a rare...

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