Post on 05-May-2018
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
© 2014 Actelion Pharmaceuticals Ltd
ACTELION MAINTAINS STRONG PERFORMANCEJean-Paul Clozel, CEO
9M 2014 Financial Results21 October 20143
© 2014 Actelion Pharmaceuticals Ltd
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
© 2014 Actelion Pharmaceuticals Ltd
OUR STRATEGIC PRIORITIES
SUSTAIN AND GROW THE PAH
FRANCHISE
BUILD ADDITIONAL SPECIALTY FRANCHISE
OPTIMIZE PROFITABILITY
9M 2014 Financial Results21 October 20145
© 2014 Actelion Pharmaceuticals Ltd
SUSTAIN AND GROW THE PAH
FRANCHISE
BUILD ADDITIONAL SPECIALTY FRANCHISE
OUR STRATEGIC PRIORITIES
OPTIMIZE PROFITABILITY
9M 2014 Financial Results21 October 20146
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
© 2014 Actelion Pharmaceuticals Ltd
SUSTAIN AND GROW THE PAH
FRANCHISE
BUILD ADDITIONAL SPECIALTY FRANCHISE
OUR STRATEGIC PRIORITIES
OPTIMIZE PROFITABILITY
9M 2014 Financial Results21 October 20147
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
© 2014 Actelion Pharmaceuticals Ltd
SUSTAIN AND GROW THE PAH
FRANCHISE
BUILD ADDITIONAL SPECIALTY FRANCHISE
OUR STRATEGIC PRIORITIES
OPTIMIZE PROFITABILITY
9M 2014 Financial Results21 October 20148
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
© 2014 Actelion Pharmaceuticals Ltd
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
9M 2014 Financial Results21 October 201410
© 2014 Actelion Pharmaceuticals Ltd
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
9M 2014 Financial Results21 October 201411
CHF million
© 2014 Actelion Pharmaceuticals Ltd
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
9M 2014 Financial Results21 October 201412
CHF million
© 2014 Actelion Pharmaceuticals Ltd
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
9M 2014 Financial Results21 October 201413
CHF million
* Trade name Epoprostenol “ACT”
© 2014 Actelion Pharmaceuticals Ltd
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
9M 2014 Financial Results21 October 201414
CHF million
© 2014 Actelion Pharmaceuticals Ltd
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
9M 2014 Financial Results21 October 201415
CHF million
© 2014 Actelion Pharmaceuticals Ltd
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
9M 2014 Financial Results21 October 201416
USD million
© 2014 Actelion Pharmaceuticals Ltd
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
© 2014 Actelion Pharmaceuticals Ltd
NINE MONTHS 2014 STRONG FINANCIAL PERFORMANCEAndré C. Muller, Chief Financial Officer
9M 2014 Financial Results21 October 201418
© 2014 Actelion Pharmaceuticals Ltd
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
9M 2014 Financial Results21 October 201419
© 2014 Actelion Pharmaceuticals Ltd
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
9M 2014 Financial Results21 October 201420
© 2014 Actelion Pharmaceuticals Ltd
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
9M 2014 Financial Results21 October 201421
© 2014 Actelion Pharmaceuticals Ltd
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
© 2014 Actelion Pharmaceuticals Ltd
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
NINE MONTHS 2014 – CORE EARNINGS
9M 2014 Financial Results21 23
CHF million
© 2014 Actelion Pharmaceuticals Ltd
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
NINE MONTHS 2014 – CORE EARNINGS
9M 2014 Financial Results21 24
CHF million
© 2014 Actelion Pharmaceuticals Ltd
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
9M 2014 Financial Results21 25
CHF million
© 2014 Actelion Pharmaceuticals Ltd
519 566
304
19 66
9M '14 OperatingIncome
Financial result Taxes 9M '14 Net Income 9M '13 Net Income
NINE MONTHS 2014 – NET INCOME
9M 2014 Financial Results21 26
CHF million
© 2014 Actelion Pharmaceuticals Ltd
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
9M 2014 Financial Results21 27
© 2014 Actelion Pharmaceuticals Ltd
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
9M 2014 Financial Results21 28
CHF million
© 2014 Actelion Pharmaceuticals Ltd
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
9M 2014 Financial Results21 October 201429
© 2014 Actelion Pharmaceuticals Ltd
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
9M 2014 Financial Results21 October 201430
© 2014 Actelion Pharmaceuticals Ltd
APPENDIX
9M 2014 Financial Results21 October 201431
© 2014 Actelion Pharmaceuticals Ltd
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%
9M 2014 Financial Results21 October 201432