Idorsia Reaching out for more Idorsia - Investor Webcast - 24 - - PowerPoint PPT Presentation

idorsia reaching out for more
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Idorsia Reaching out for more Idorsia - Investor Webcast - 24 - - PowerPoint PPT Presentation

Idorsia Reaching out for more Idorsia - Investor Webcast - 24 October 2017 The following information contains certain forward-looking statements, relating to the companys business, which can be identified by the use of


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Idorsia – Reaching out for more

Idorsia - Investor Webcast - 24 October 2017

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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.

Idorsia - Investor Webcast | October 2017 2

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We are off to an excellent start

Jean-Paul Clozel, CEO

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A new venture

1 2 3 4

Innovative deal with J & J is the basis for good start Excellent collaboration with Actelion / J & J Fully functional since day 1 Establishing strong foundation for successful future

Idorsia - Investor Webcast | October 2017 4

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An experienced team of highly qualified professionals A full research and development pipeline State-of-the-art facilities CHF 1 billion in cash

Idorsia’s strengths

The crucial elements for bringing R&D to successful medicines

Idorsia - Investor Webcast | October 2017 5

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Idorsia’s Clinical Development Pipeline

Status Compound Mechanism of Action Target indications Phase 2 Aprocitentan* Endothelin receptor antagonist Resistant hypertension ACT-541468 Dual orexin receptor antagonist Insomnia Cenerimod S1P1 receptor modulator Systemic lupus erythematosus Clazosentan** Endothelin receptor antagonist Vasospasm associated with aneurysmal subarachnoid hemorrhage Vamorolone*** Non-hormonal steroid modulator Duchenne muscular dystrophy Phase 1b Lucerastat Glucosylceramide synthase inhibitor Fabry disease Phase 1 ACT-246475 P2Y12 receptor antagonist Acute coronary syndrome ACT-774312 CRTH2 receptor antagonist Asthma & allergy disorders ACT-539313 Selective orexin 1 receptor antagonist Anxiety ACT-709478 T-type calcium channel blocker Epilepsy

*Johnson and Johnson has option to jointly develop and solely commercialize Aprocitentan worldwide **In Japan a Phase 2 study was completed in 2017 and market registration trials have started ***Idorsia has exclusive option to worldwide rights to ReveraGen’s Vamorolone

Idorsia - Investor Webcast | October 2017 6

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  • The effect of aprocitentan observed is clinically relevant
  • The effect of aprocitentan covers the 24 h period
  • Aprocitentan was well tolerated across all four doses

in this patient population

  • The overall frequency of adverse events was similar
  • n aprocitentan to placebo
  • It is anticipated that the results can be extrapolated to resistant hypertension
  • The study provides the necessary information for moving into pivotal registration

program Results from study of oral, potent, once-a-day drug for control of blood pressure

Aprocitentan

Aprocitentan is investigational, in development and not approved or marketed in any country.

Idorsia - Investor Webcast | October 2017 7

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Phase 2 program overview:

  • Two dose-response studies to evaluate the safety and efficacy of DORA in adult

and elderly patients with insomnia

  • Adult study with zolpidem as an active reference

− Study 1: 360 adult insomnia patients − Study 2: 58 elderly insomnia patients

Novel dual orexin receptor antagonist for treatment of insomnia

ACT-541468 (DORA)

ACT-541468 is investigational, in development and not approved or marketed in any country.

Idorsia - Investor Webcast | October 2017 8

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  • Idorsia has significant expertise in the discovery and development of DORAs
  • DORAs have the potential to promote sleep and maintain a natural sleep

architecture

  • PK/PD profile of ACT-541468 suggests an optimal combination of effect on

the CNS and low residual concentration next-day

  • Both Phase 2 studies, in adult and elderly patients, meet their primary

endpoints

  • Results show desired effect on sleep maintenance and onset – significant

dose-response relationship

  • Idorsia to advance ACT-541468 into pivotal registration program

ACT-541468 (DORA)

ACT-541468 is investigational, in development and not approved or marketed in any country.

Idorsia - Investor Webcast | October 2017 9

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Idorsia’s Clinical Development Pipeline

Status Compound Mechanism of Action Target indications Phase 2 Aprocitentan* Endothelin receptor antagonist Resistant hypertension ACT-541468 Dual orexin receptor antagonist Insomnia Cenerimod S1P1 receptor modulator Systemic lupus erythematosus Clazosentan** Endothelin receptor antagonist Vasospasm associated with aneurysmal subarachnoid hemorrhage Vamorolone*** Non-hormonal steroid modulator Duchenne muscular dystrophy Phase 1b Lucerastat Glucosylceramide synthase inhibitor Fabry disease Phase 1 ACT-246475 P2Y12 receptor antagonist Acute coronary syndrome ACT-774312 CRTH2 receptor antagonist Asthma & allergy disorders ACT-539313 Selective orexin 1 receptor antagonist Anxiety ACT-709478 T-type calcium channel blocker Epilepsy

*Johnson and Johnson has option to jointly develop and solely commercialize Aprocitentan worldwide **In Japan a Phase 2 study was completed in 2017 and market registration trials have started ***Idorsia has exclusive option to worldwide rights to ReveraGen’s Vamorolone

Idorsia - Investor Webcast | October 2017 10

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Financial Update

André Muller, CFO

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Financial results as of 30 September 2017

Operating results

  • 34
  • 23
  • 14
  • 5
  • 3
  • 71
  • 79

Revenues Research Development G&A Non-GAAP Operating results D&A SBC US-GAAP Operating results US-GAAP Non-GAAP

Idorsia - Investor Webcast | October 2017 12

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Financial results as of 30 September 2017

Net results

  • 71
  • 73
  • 2

+1

Operating results Financial results Income Tax results Non-Controlling Interests Net results

  • 79
  • 82
  • 4

US-GAAP Non-GAAP

Idorsia - Investor Webcast | October 2017 13

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Financial results as of 30 September 2017

Cash flow

1,000

  • 72

+22 +2 952

Cash at Demerger Funds from Operations Working Capital Requirements Capex / Other Liquidity as of 30 Sep 2017

Idorsia - Investor Webcast | October 2017 14

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Financial results as of 30 September 2017

Liquidity

1,000 552 150 250

Liquidity at demerger Liquidity as of 30 Sep 2017

Cash deposits > 3 months Cash deposits < 3 months Cash and Cash Equivalents 952

Idorsia - Investor Webcast | October 2017 15

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Financial results as of 30 September 2017

Convertible bond

445 363 135 82

Convertible Bond at demerger Convertible Bond as of 30 Sep 2017

Equity component Debt component 445 580

Idorsia - Investor Webcast | October 2017 16

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Financial results as of 30 September 2017

Potential issued shares

107.3 119.1 50.5 38.7 4.9

Potential shares at demerger Potential shares as of 30 Sep 2017

Equity instruments Equity derivatives Issued common shares 157.8 162.7 Issued common shares = 119.1 million Potential issued shares = 162.7 million

Idorsia - Investor Webcast | October 2017 17

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  • Non-GAAP Operating Expenses =

CHF -160 / -170 million

  • 2017 = 6 ½ months activity since

demerger from Actelion

As of 24 October 2017

Financial Guidance for 2017

  • 10
  • 61
  • 89
  • 160

Q2 2017 (Actual) Q3 2017 (Actual) Q4 2017 (Estimate) FY 2017 (Estimate)

  • 170
  • 99

Idorsia - Investor Webcast | October 2017 18

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Execution becomes the strategy

Idorsia - Investor Webcast | October 2017 19