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2017-08-03 07:00 CEST
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Idorsia announces half year results for 2017 - successful start of new biopharmaceutical company

Allschwil, Switzerland - 03 August 2017 - Idorsia Ltd (SIX: IDIA) today announced the first half year results in its young history. The half-year reporting 2017 for Idorsia was majorly driven by the performance since the demerger from Actelion, i.e. in the period from 15 to 30 June 2017, representing two weeks of operational business.

Financial highlights

  • Idorsia demerged on 15 June 2017 with CHF 1 billion in cash
  • US GAAP operating loss in Half Year 2017: CHF 11 million
  • Non-GAAP operating loss in Half Year 2017: CHF 10 million
  • Guidance for Full Year 2017: non-GAAP operating expenses of CHF 180-190 million

Operating highlights

  • Idorsia fully operational on 15 June, with over 600 employees
  • Successful listing on SIX Swiss Exchange; two major shareholders with Jean-Paul & Martine Clozel (> 25%) and Johnson & Johnson (9.9%)
  • Successful start of business, with no interruptions through the demerger from Actelion
  • Positive dose-finding results with aprocitentan (ACT-132577) - asset moving into Phase 3 development in resistant hypertension
  • Positive results for Phase 2 program with ACT-541468 (DORA) in insomnia announced on 28 July 2017

Jean-Paul Clozel, CEO of Idorsia, commented: "I am very pleased and proud that we are fully functional after the successful demerger from Actelion. Innovation is and will always be the key to our success, and we are starting out with a highly innovative pipeline, with four compounds moving into Phase 3 in the near future. In addition, within the space of the last few months, we have received positive results for two Phase 2 programs - both for DORA and aprocitentan."

FINANCIAL RESULTS

US GAAP operating loss amounted to CHF 11 million, driven by R&D expenses of CHF 8 million and G&A expenses of CHF 2 million. US GAAP net loss amounted to CHF 11 million. US GAAP net loss per share amounted to CHF 0.11, based on 106 million of shares outstanding (time-weighted average).

Non-GAAP operating loss amounted to CHF 10 million, driven by R&D expenses of CHF 8 million and G&A expenses of CHF 2 million. Non-GAAP net loss amounted to CHF 10 million. Non-GAAP net loss per share amounted to CHF 0.10, based on 106 million of shares outstanding (time-weighted average).

André C. Muller, CFO of Idorsia, commented: "We launched Idorsia on 15 June 2017 with a fully operational research and development engine and CHF 1 billion in cash. For the shortened financial year of 2017, we expect our non-GAAP operating expenses to be between CHF 180-190 million."

Key figures

At the end of the first half year, Idorsia's liquidity (including cash, cash equivalents, short- and long-term deposits) amounted to CHF 1,007 million.

         
    Period ended June 30, 2017
(in CHF millions, except EPS)   US GAAP   Non-GAAP
         
Operating loss   (11)   (10)
Net loss   (11)   (10)
Basic and diluted EPS   (0.11)   (0.10)
Number of shares (weighted average)   106.023   106.023

Liquidity and indebtedness 

     
    June 30,
(in CHF millions)   2017
     
Liquidity    
Cash and cash equivalents   607
Short-term deposits   150
Long-term deposits   250
Total Liquidity   1,007
     
Indebtedness    
Convertible loan   361
Other financial debt   -
Total indebtedness   361

PIPELINE UPDATE

Idorsia has a clinical pipeline of drug candidates in different areas of medicine where patients' needs are not met with existing therapies.

Status   Compound   Mechanism of Action   Target Indication
Phase 2   Aprocitentan
(ACT-132577)
  Endothelin receptor antagonist   Resistant hypertension
  ACT-541468   Dual orexin receptor antagonist   Insomnia
  Clazosentan*   Endothelin receptor antagonist   Vasospasm associated with aneurysmal subarachnoid hemorrhage (aSAH)
  Cenerimod   S1P1 receptor modulator   Systemic lupus erythematosus
Phase 1b   Lucerastat   Glucosylceramide synthase inhibitor   Fabry disease
Phase 1   ACT-246475   P2Y12 receptor antagonist   Acute coronary syndrome
  ACT-774312   CRTH2 receptor antagonist   Asthma and allergy disorders
  ACT-539313   Selective orexin 1 receptor antagonist   Anxiety
  ACT-709478   T-type calcium channel blocker   Epilepsy


* In Japan, a Phase 2 study that evaluated the efficacy, pharmacokinetics, and safety of clazosentan against cerebral vasospasm after clipping surgery in Japanese and Korean patients with aSAH was completed in 2017. Market registration trials have started.

On July 28, Idorsia announced positive results for the comprehensive Phase 2 program with the dual orexin receptor antagonist ACT-541468 (DORA) in insomnia. The program comprised two dose-response studies evaluating the safety and efficacy of ACT-541468 in both adult and elderly patients with insomnia. The results of both studies show the desired effect on sleep maintenance and onset and a significant dose-response relationship, supporting the decision to advance ACT-541468 (DORA) into a confirmatory Phase 3 program.

On May 22, positive results were announced for the Phase 2 dose-finding study with aprocitentan (ACT-132577) in essential hypertension. The asset will progress to Phase 3 development in resistant hypertension.

On the same day, positive results for a Phase 2 safety study with cenerimod in Systemic lupus erythematosus (SLE) were announced, which created the basis to progress into larger Phase 2 development in this indication.

Jean-Paul Clozel concluded: "I believe that we can create long-term value with Idorsia, and I therefore increased my equity stake in the company. This is the best personal investment I can think of."

RESULTS DAY CENTER

Investor community: To make your job easier, we provide all relevant documentation via the Results Day Center on our corporate website: www.idorsia.com/results-day-center.

HALF YEAR REPORT

Full details on the financial results are available in Idorsia's 2017 Half Year Report, available from www.idorsia.com/half-year-report.

UPCOMING FINANCIAL UPDATES

  • 9M 2017 Financial Results reporting on 24 October 2017
  • FY 2017 Financial Results reporting on 6 February 2018

***

Notes to the editor

About Idorsia

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this we intend to develop Idorsia into Europe's leading biopharmaceutical company, with a strong scientific core.

Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet - the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets.

For further information, please contact:
Andrew C. Weiss
Senior Vice President, Head of Investor Relations & Corporate Communications
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil
+41 58 844 10 10
www.idorsia.com

This document does not constitute an invitation or an offer to purchase, sell, trade or subscribe for any shares or other securities of the companies involved. Furthermore, this document is neither a prospectus according to Art. 652a of the Swiss Code of Obligations nor a listing prospectus according to the listing rules of SIX Swiss Exchange Ltd.

The above 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.

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