Allschwil, Switzerland - 24 October 2017 - Idorsia Ltd (SIX: IDIA) today announced its financial results as of 30 September 2017, which represent the business activity in the three and a half months since the demerger from Actelion on 15 June 2017.
Jean-Paul Clozel, CEO of Idorsia, commented: "Idorsia has been fully functional since the demerger from Actelion, and separation activities continue well on track thanks to the excellent collaborative efforts of all parties, making this innovative transaction with J&J a great success. With the rich collection of compounds we brought over from Actelion, we are working hard to advance our highly innovative pipeline and further enhance our value proposition from these assets. Discussions with health authorities are progressing well, so that we should see key compounds moving into Phase 3 in the near future."
Key figures
- US GAAP operating loss in Q3 2017: CHF 68 million / YTD* 2017: CHF 79 million
- Non-GAAP** operating loss in Q3 2017: CHF 61 million / YTD* 2017: CHF 71 million
- Guidance for Full Year 2017: non-GAAP operating expenses of CHF 160-170 million
At the end of the third quarter, Idorsia's liquidity (including cash, cash equivalents, short- and long-term deposits) amounted to CHF 952 million.
| Period ending Sept. 30, | Third quarter | |||||||||
| 2017 | 2017 | |||||||||
| (in CHF millions, except EPS) | US GAAP | Non-GAAP | US GAAP | Non-GAAP | ||||||
| Operating income (loss) | (79) | (71) | (68) | (61) | ||||||
| Net income (loss) | (82) | (73) | (71) | (62) | ||||||
| Basic and diluted EPS | (0.73) | (0.65) | (0.59) | (0.52) | ||||||
| Number of shares (weighted average) | 111.8 | 111.8 | 119.1 | 119.1 | ||||||
* Year-to-date results correspond to the three and a half months operations since the demerger from Actelion.
** Idorsia measures, reports and issues guidance on non-GAAP operating performance. Idorsia believes that these non-GAAP financial measurements more accurately reflect the underlying business performance and therefore provide useful supplementary information to investors. These non-GAAP measures are reported in addition to, not as a substitute for, US GAAP financial performance.
Financial results
For the period ending 30 September, the US GAAP operating loss amounted to CHF 79 million, including a non-GAAP operating loss of CHF 71 million, driven by R&D expenses of CHF 57 million and G&A expenses of CHF 14 million, depreciation and amortization of CHF 5 million and share-based compensation of CHF 3 million.
The US GAAP net loss amounted to CHF 82 million resulting in a net loss per share of CHF 0.73.
André C. Muller, CFO of Idorsia, commented: "Idorsia is making good progress by advancing its pipeline and in separating from Actelion. This gives us more clarity on our cost base, and so we now expect our non-GAAP operating expenses to be between 160 and 170 million Swiss francs for the financial year of 2017, which fundamentally represents six and a half months of operations.
Liquidity and indebtedness
| Sept. 30, | June 30, | |||
| (in CHF millions) | 2017 | 2017 | ||
| Liquidity | ||||
| Cash and cash equivalents | 552 | 607 | ||
| Short-term deposits | 150 | 150 | ||
| Long-term deposits | 250 | 250 | ||
| Total Liquidity | 952 | 1,007 | ||
| Indebtedness | ||||
| Convertible loan | 363 | 361 | ||
| Other financial debt | - | - | ||
| Total indebtedness | 363 | 361 | ||
Pipeline Update
- The Phase 2 dose-finding study with aprocitentan in essential hypertension showed positive results. The asset is progressing towards a pivotal registration program in resistant hypertension. Johnson & Johnson through its subsidiary Janssen Biotech, Inc. has the option to collaborate with Idorsia to jointly develop and solely commercialize aprocitentan worldwide.
- The comprehensive Phase 2 program with the dual orexin receptor antagonist ACT-541468 (DORA) in insomnia showed positive results. 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 showed the desired effect on sleep maintenance and onset and a significant dose-response relationship, supporting the decision to advance ACT-541468 into a pivotal registration program.
| Status | Compound | Mechanism of Action | Target Indication | |||
| Phase 2 | Aprocitentan* | Endothelin receptor antagonist | Resistant hypertension | |||
| ACT-541468 | Dual orexin receptor antagonist | Insomnia | ||||
| Clazosentan** | Endothelin receptor antagonist | Vasospasm associated with aneurysmal subarachnoid hemorrhage (aSAH) | ||||
| Cenerimod | S1P 1 receptor modulator | Systemic lupus erythematosus | ||||
| 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 and allergy disorders | ||||
| ACT-539313 | Selective orexin 1 receptor antagonist | Anxiety | ||||
| ACT-709478 | T-type calcium channel blocker | Epilepsy |
* Johnson & Johnson has option to jointly develop and solely commercialize aprocitentan worldwide.
** In Japan, a Phase 2 study was completed earlier in 2017. Market registration trials have started.
*** Idorsia has exclusive option to worldwide rights to ReveraGen's Vamorolone.
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 .
Upcoming Financial Updates
- Full-Year 2017 Financial Results reporting on 6 February 2018
- 3 Months 2018 on 19 April 2018
- Half-Year 2018 on 24 July 2018
- 9 Months 2018 on 23 October 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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