OUTSTANDING 2015 RESULTS - Actelion€¦ · cash returned to shareholders . almost chf 1 billion . core eps . chf 6.16 . core earnings >chf 800 million . 2015 . product sales >chf

Copyright © 2016 Actelion Pharmaceuticals Ltd

OUTSTANDING 2015 RESULTS

Financial Reporting Investor Webcast 09 February 2016

© 2016 Actelion Pharmaceuticals Ltd

The following information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

Full Year 2015 Financial Results 09 February 2016 2


Jean-Paul Clozel, CEO

ACTELION’S TRANSFORMATION PROGRESSING WELL



KEY FINANCIAL HIGHLIGHTS

CASH RETURNED TO SHAREHOLDERS

ALMOST CHF 1

BILLION

Core EPS CHF 6.16

CORE EARNINGS

>CHF 800 MILLION

2015

PRODUCT SALES

>CHF 2 BILLION



WAVE 1: – PAH franchise evolving from single compound to

entire portfolio of unique and complementary products

WAVE 2: – Pipeline moving beyond PAH to consist of broad

portfolio of innovative compounds

ACTELION 2015 – 2020 TRANSFORMING THE COMPANY



TRANSFORMING OUR PAH PORTFOLIO PAH



MAXIMIZING THE VALUE OF OUR PAH PORTFOLIO

Macitentan OPUS Macitentan ORCHESTRA Macitentan SOPRANO Macitentan SYMPHONY Macitentan PORTICO Macitentan & Selexipag TRITON Selexipag GRIPHON Macitentan MAESTRO Macitentan MELODY Macitentan MERIT

Phase I Phase II Phase III Phase IV



DIVERSE PORTFOLIO: KEY PROJECTS BEYOND PAH

Ponesimod: Multiple sclerosis

Clazosentan: Reversal of vasospasm post-aSAH

Cadazolid: Clostridium difficile associated diarrhea

Other projects in early stage: Progressing well


Cenerimod:Systemic lupus erythematosus


Otto Schwarz, COO

EXCELLENT COMMERCIAL PERFORMANCE



1,956 2,042

FY 2014 FY 2015

+11% CER Growth (1)

(1) Excluding impact of prior-year US rebate reversals

STRONG PERFORMANCE FY

2015

CHF million

2013 2014 2015

US 43% 45% 50%

Europe 37% 37% 32%

Japan 11% 9% 9%

RoW 9% 9% 8%



MOVING FROM SYMPTOM-BASED TO OUTCOME-BASED THERAPY

WE ARE TRANSFORMING OUR PAH PORTFOLIO



TRANSFORMATION PROGRESSING WELL OPSUMIT+VELETRI: 31% OF PAH SALES

2013 total sales: CHF 1,784 million

2015 total sales: CHF 2,042 million

Others Tracleer Opsumit Veletri



GLOBAL LAUNCH EVOLUTION



EXTRAORDINARY LAUNCH MOMENTUM IN ALL MARKETS

2014

2015 AVAILABLE IN

>35 COUNTRIES

2013



5 13 29

44 46 68 80

105 109

2 9

14 22

27 33

42 53

-1,000

1,000

3,000

5,000

7,000

9,000

11,000

13,000

15,000

0

20

40

60

80

100

120

140

160

180

200

Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015

US sales ex-US sales Patients

GLOBAL NET SALES & PATIENT EVOLUTION

CHF million Patients

48%

35%

17%

US Europe RoW

Patient distribution Dec 2015



Gaining share in ERA market across all markets launched

No major impact of Ambition on Opsumit trajectory - key competitive challenge in 2016 post-Ambrisentan label changes US, Europe

Expansion of ERA market: SERAPHIN & AMBITION drive combination

Strong, sustained trajectory across markets

STATE OF THE BUSINESS – END 2015

New markets to launch: eg. Russia, Brazil, Poland, France (TBD)



TRANSITION TO OPSUMIT – RESILIENCE vs. GENERICS

1,418 1,212

FY 2014 FY 2015

- 6% in Units -11% at CER(1)


CHF million ~ 7,000 DU patients

(+9%)

~ 39,000 PAH patients

(-9%)



TRANSITION TO OPSUMIT – RESILIENCE vs. GENERICS

Sales dynamics driven by:

– Erosion due to impact of Opsumit – Growth in DU indication (JP: Launch Sept. ‘15) – US price increase absorbed by erosion ex-US

Expected price decrease in Japan (bi-annual review process) on 01 March ‘16

Generic competition increasing

– Gained broad experience in orphan Gx with a solid toolbox of strategies – Commercial operations still effective in CA, TR, BR, MX, PO, CZ & SK – New entries 2015: ES, GR – US: shared REMS negotiations with 7 Gx companies



CONTINUED SIGNIFICANT GROWTH

62

83

FY 2014 FY 2015

Available in 15 markets

> 1,900 patients on drug Dec 2015 (> 50% from US)

Growth momentum due to:

– Launch in FR (June 2015) – continuing in ‘16 – US/EU achieved in most markets > 80% new

i.v. Epo patient share – JP* continues to grow – biannual price cut

expected 01 March ‘16

New markets in 2016: DE, TR, HU

+37% CER Growth(1)

CHF million

*Trade name Epoprostenol “ACT” (1) Excluding impact of prior-year US rebate reversals



106 105

FY 2014 FY 2015

20% decline in units shipped due to competitive pressure

Volume decline expected to accelerate due to competitive situation

-7% CER Variance(1)


WELL MANAGED PERFORMANCE

CHF million



OPENING THE PROSTACYCLIN PATHWAY TO MANY MORE PATIENTS



OPENING THE PROSTACYCLIN PATHWAY TO MANY MORE PATIENTS

US: FDA APPROVAL 21 DEC 2015 US: LAUNCH 04 JAN 2016 EU: CHMP POSITIVE OPINION 29 JAN 2016

Uptravi® (selexipag) is an orally available, selective IP prostacyclin receptor agonist, targeting and activating the prostacyclin pathway.



FC III FC II FC IV

+/- PDE-5 inhibitor

THERAPEUTIC GAP

CONTINUUM OF CARE IN PAH: THERE IS A THERAPEUTIC GAP! PAH



THERAPIES THAT TARGET THE PGI2 PATHWAY ARE UNDER-UTILIZED EVEN IN SEVERE PAH

Less than 1 out of 2 PAH patients receive prostacyclin in US before PAH-related death

Less than 1 out of 5 PAH patients receive prostacyclin in EU-5* before PAH-related death

*EU-5 = France, Germany, Italy, Spain, UK,



Only 25% of PAH prescribers

utilize prostacyclin therapy

Source: Actelion Market Sizing Exercise 2014; PH Market Model, Forecast 2014; CIA World Fact book, accessed June 2014

Only 14% of PAH prescribers utilize

prostacyclin therapy

RESULTING IN A LIMITED NUMBER OF PAH CENTER-BASED SPECIALIZED PAH PRESCRIBERS



FC III FC II FC IV

CONTINUUM OF CARE IN PAH: FILLING THE GAP!

+/- PDE-5 inhibitor



Prostacyclin Market

Development LAUNCH

2

Expand prescriber

base

Establish as prostacyclin therapy of 1st

choice

1st

Expand prostacyclin

therapy patients base

2

1

3

LAUNCH PRIORITIES

2

Establish as prostacyclin of

1st choice

Expand prostacyclin

therapy patient base

1st

Expand prostacyclin prescriber

base

2

1

3



Uptravi: Opening the prostacyclin pathway to many more PAH patients

Macitentan, Selexipag and Epoprostenol: All designated and distinguished with «outcome» benefits in the recent ERS/ESC PAH guidelines*

*2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension

UNIQUELY POSITIONED TO BUILD & SERVE PAH

Opsumit + Uptravi + PDE-5i: “all oral” triple combination therapy now possible – utilizing the benefits of all 3 established MoA in PAH



CONTINUED GROWTH IN NP-C

102 92

FY 2014 FY 2015

Increasing generic competition for type 1 Gaucher disease in selected EU markets (i.e. ES, SE, DE)

Underlying volume remained flat due to strong growth in NP-C patients outside of US (+16%)

Positive price in US but generic driven erosion in some EU markets (i.e. ES)

Potential miglustat generic entry in US during H2 2016

-3% CER Variance(1)


CHF million


© 2016 Actelion Pharmaceuticals Ltd 30

CONSISTENT PROGRESS: FY 2015 SALES CHF 27 MILLION

Shape 1st-line space between topical corticosteroids and light therapy

Increase yield per patients by i.e.

• Increase price: 6% in 2016 • Compliance / therapy adherence

• Re-treatment rate (to 28-30%)

ATU FR proceeding well: > 230 patients

Regulatory process ongoing – EU approval anticipated by Q1 2017

«Go to Market» strategy ex-US: TBD 0

300

600

900

1,200

1,500 Total Patients on drug

Patients on drug



Execute Uptravi® launch roll out – 2016 focus: US & DE launches

Manage increasing generic competition across portfolio

Pursue growth opportunities beyond PAH, esp. Veletri® & Valchlor®

Maintain Opsumit® trajectory – expand ERA market

STRATEGIES WORK! DISCIPLINED EXECUTION IS KEY

PRIORITIES 2016



STRONG START TO 2015

André C. Muller, CFO

STRONG FULL YEAR 2015



Variance

FY 2014 FY 2015 CHF CER CER

Ex US rebate reversals

Product sales CHF million

1,956 2,042 4% 7% 11%

Core earnings CHF million

743 814 9% 14% 25%

Core diluted EPS CHF

5.58 6.16 10% 15% 26%

Operating income CHF million

570 656 15% 21% -

US GAAP diluted EPS CHF

5.11 4.91 -4% 1% -

STRONG PERFORMANCE FY

2015



PRODUCT SALES – INTRINSIC GROWTH + 11%

1,956 1,883 515 2,042

73 213 55

FY '14Sales as reported

US rebatereversals

FY'14 Salesex US rebate

reversals

FY '15 intrinsic sales growth

FX FY'15 Sales

FY 2015

CHF million



743 677 677 814

66 168 32

FY '14 Coreearnings as

reported

US rebate reversals FY'14 Coreearnings

excluding USrebate reversals

FY '15 intrinsicgrowth

FX FY'15 Coreearnings

CORE EARNINGS – INTRINSIC GROWTH + 25%

FY 2015

CHF million



0

200

400

600

800

1,000

1,200

USD EUR JPY CHF OtherSales Core opex

20% 32%

27%

52%

11% 9% 7%

29% 1% 13%

CURRENCY DISTRIBUTION FY

2015


CHF million


FX ENVIRONMENT IN 2015 FY

2015

Average rate 2015

Impact on sales

Impact on core earnings

US dollar 0.96 51 36

Euro 1.07 (71) (54)

Japanese yen 0.80 (16) (8)

All other currencies (19) (5)

TOTAL (55) (32)

CHF million



FX SENSITIVITIES FY

2015

PRO FORMA IMPACT ON 2015 RESULTS

Average rate January 2016

% impact on sales

% impact on core earnings

US dollar 1.01 50 36

Euro 1.10 15 12

Japanese yen 0.85 13 7

TOTAL 78 or 4% 54 or 7%

CHF million



2,042

814 814

176

404

648

FY '15 Product sales Cost of sales R&D SG&A FY '15 Core earnings

CORE EARNINGS FY

2015

CHF million



OPERATING INCOME FY

2015

CHF million

814 656 656 656

570

90 57 11 -

FY '15 Coreearnings

D&A Stock-basedcompensation

Milestone payment Other FY '15 OperatingIncome

FY'14 OperatingIncome



656 548 552 594

20

88 4

FY '15 OperatingIncome

Financial result Income taxes Non-controllinginterest

FY'15 Net Income FY '14 Net Income

NET INCOME FY

2015

CHF million



Variance

FY 2014 FY 2015 CHF CER

Core Net income CHF million

648 693 7 11

Core Diluted EPS Number of shares in calculation (m)

5.58 116.2

6.16 112.5

10 15

US GAAP Net income CHF million

594 552 -7 -3

US GAAP Diluted EPS Number of shares in calculation (m)

5.11 116.2

4.91 112.5

-4 1

EARNINGS PER SHARE FY

2015



1,205 936

609 609 453 406 405

658

142

785

327 79 235

47

Gross cash31 Dec 14

Operatingcash flow

Dividend 2nd line sharerepurchase

1st line sharepurchase

ESOPproceeds

Bond repayment Capex,other items

Net cash31 December 15

CASH POSITION & CASH FLOW FY

2015

CHF million



0

100

200

300

400

500

CHF 25%

15%

USD 33%

EUR 23%

JPY 8%

31 December 2015

– CHF 405m net cash position

No outstanding debt

Retaining full financial flexibility

CHF million

CASH BALANCE – FX EXPOSURE FY

2015


Other 10%


FINANCIAL GUIDANCE 2016

Low single-digit percentage core operating income growth, at constant exchange rates and barring unforeseen events



Jean-Paul Clozel, CEO

VISION FOR FUTURE GROWTH



OUTSTANDING YEAR FOR ACTELION


Strong Opsumit performance & Uptravi approval success

Sales of over CHF 2 billion

Significant pipeline progress beyond PAH

Guidance: Low single-digit percentage core operating income growth at CER

Strict financial discipline - Core earnings up 25%

2015


Second-line share repurchase continues Dividend: Board proposes increase to CHF 1.50 per share

SHARE PRICE PERFORMANCE CASH RETURNED TO SHAREHOLDERS

2016 – FURTHER RETURNS TO COME

358 588

133

927

2012 2013 2014 2015

OUTSTANDING YEAR FOR SHAREHOLDERS



ACTELION 2015 – 2020 UNIQUE OPPORTUNITY FOR FUTURE GROWTH


WAVE 1: – Transformation of PAH portfolio – Opsumit and Uptravi poised for success

WAVE 2: – Diversifying our pipeline beyond PAH: Well

balanced portfolio based on innovation


ACTELION 2015 – 2020 CLEAR VISION FOR FUTURE GROWTH

First European-born biopharma company to make it to the major league!


Documents

OUTSTANDING 2015 RESULTS - Actelion€¦ · cash returned to shareholders . almost chf 1 billion . core eps . chf 6.16 . core earnings >chf 800 million . 2015 . product sales >chf