GlobeNewswire

Idorsia announces financial results for the first quarter 2021 – substantial progress made across the pipeline – launch preparations well underway

Share

Allschwil, Switzerland – April 22, 2021

Idorsia Ltd (SIX: IDIA) today announced its financial results for the first quarter of 2021.

Business highlights

  • Daridorexant new drug application (NDA) submitted to the US FDA in January 2021 and has been accepted for review
  • Daridorexant marketing authorisation application (MAA) submitted to the European Medicines Agency (EMA) in March 2021
  • Daridorexant MAA submitted to Switzerland’s health authority, Swissmedic, in April 2021
  • Daridorexant Phase 3 program has concluded – supporting the chronic use of daridorexant in insomnia
  • Ponesimod to treat relapsing forms of multiple sclerosis was approved by the US FDA and a positive CHMP opinion was received in March 2021, Idorsia has a revenue-sharing agreement in respect to ponesimod
  • Clazosentan NDA submitted to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in March 2021
  • MODIFY Phase 3 study with lucerastat for Fabry disease fully recruited, results expected in Q4 2021
  • PRECISION Phase 3 study with aprocitentan for resistant hypertension fully recruited, results expected mid-2022
  • Recruitment of patients into the CARE Phase 2b study with cenerimod for systemic lupus erythematosus completed, results expected in Q4 2021
  • Recruitment commenced into Phase 2 study with ACT-539313 for binge eating disorder in March 2021

Financial highlights

  • US GAAP operating expenses in Q1 2021 at CHF 129 million
  • Non-GAAP operating expenses in Q1 2021 at CHF 121 million
  • Guidance for 2021: US GAAP operating expenses below CHF 685 million and non-GAAP operating expenses below CHF 640 million (both measures include inventory build of around CHF 35 million and exclude unforeseen events).

Jean-Paul Clozel, MD and Chief Executive Officer, commented:
“This first quarter of 2021 is loaded with important progress and milestones; we submitted the marketing registration dossiers for daridorexant to both the FDA, and the EMA and for clazosentan in Japan, and now in April the MAA submission for daridorexant to Switzerland’s Swissmedic has also occurred. J&J received the marketing approval for ponesimod in the US and a positive CHMP opinion in the EU which represents patients being able to benefit from a drug discovered by our scientists and the first revenues for Idorsia. We also completed the recruitment of patients into the pivotal trials for lucerastat and aprocitentan, as well as the large Phase 2b study with cenerimod. We are all getting ready for the launch of our first products and the transformation of Idorsia into a fully-fledged biopharmaceutical company based on science.”

Simon Jose, Chief Commercial Officer of Idorsia, commented:
“It’s an exciting time at Idorsia and our growing commercial team continues to work with a laser focus on preparing for the successful launches of daridorexant in the US and Europe and clazosentan in Japan. Following the NDA submission for daridorexant, we continue to build our US team and engage with the medical community and other key stakeholders to advance the science and raise awareness about the burden of insomnia on patients’ daily lives. The MAA filing for daridorexant in Europe is also an important milestone. We see a significant medical need for new safe and effective treatment options for insomnia in Europe and are ramping up our activities here following the appointment of Jean-Yves Chatelan, President, Region Europe and Canada.”

Financial results

US GAAP resultsFirst Quarter
in CHF millions, except EPS (CHF) and number of shares (millions)20212020
Revenues75
Operating expenses(129)(116)
Operating income (loss)(122)(111)
Net income (loss)(105)(120)
Basic EPS(0.63)(0.91)
Basic weighted average number of shares166.6131.3
Diluted EPS(0.63)(0.91)
Diluted weighted average number of shares166.6131.3

US GAAP revenue of CHF 7 million in the first quarter of 2021 consisted of contract revenue recognized in connection with the collaboration agreements with Neurocrine Biosciences, Inc. (CHF 1 million), Janssen Biotech, Inc. (CHF 3 million), Roche (CHF 2 million) and Mochida Pharmaceutical Co., Ltd (CHF 1 million) compared to a revenue of CHF 5 million in the first quarter of 2020.

US GAAP operating expenses in the first quarter of 2021 amounted to CHF 129 million (CHF 116 million in the first quarter of 2020), of which CHF 97 million relates to R&D (CHF 97 million in the first quarter of 2020) and CHF 31 million to SG&A expenses (CHF 19 million in the first quarter of 2020).

US GAAP net loss in the first quarter of 2021 amounted to CHF 105 million compared to CHF 120 million in the first quarter of 2020. The decrease of the net loss was mainly driven by a positive contribution from financial income, which was partially offset by higher operating expenses.

The US GAAP net loss resulted in a net loss per share of CHF 0.63 (basic and diluted) in the first quarter of 2021 compared to a net loss per share of CHF 0.91 (basic and diluted) in the first quarter of 2020.

Non-GAAP* measuresFirst Quarter
in CHF millions, except EPS (CHF) and number of shares (millions)20212020
Revenues75
Operating expenses(121)(106)
Operating income (loss)(114)(101)
Net income (loss)(95)(102)
Basic EPS(0.57)(0.78)
Basic weighted average number of shares166.6131.3
Diluted EPS(0.57)(0.78)
Diluted weighted average number of shares166.6131.3

* 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.

Non-GAAP net loss in the first quarter of 2021 amounted to CHF 95 million: the CHF 10 million difference versus US GAAP net loss was mainly due to depreciation and amortization (CHF 4 million), share-based compensation (CHF 4 million) and a negative non-cash financial result (CHF 2 million).

The non-GAAP net loss resulted in a net loss per share of CHF 0.57 (basic and diluted) in the first quarter of 2021 compared to a net loss per share of CHF 0.78 (basic and diluted) in the first quarter of 2020.

André C. Muller, Chief Financial Officer, commented:
“The whole company is working with a very cost-conscious attitude. We’ve hit several important milestones in the first quarter and I’m happy to report that all this has been achieved on a slightly lower spend than initially expected. As a result, we now expect US GAAP operating expenses below CHF 685 million and non-GAAP operating expenses below CHF 640 million for the full year 2021, both measures include an inventory build of around CHF 35 million and exclude unforeseen events.”

Liquidity and indebtedness
At the end of the first quarter of 2021, Idorsia’s liquidity (including cash, cash equivalents, short- and long-term deposits) amounted to CHF 1,065 million.

(in CHF millions)Mar 31, 2021Dec 31, 2020Mar 31, 2020
Liquidity
Cash and cash equivalents12814195
Short-term deposits741867357
Long-term deposits196192180
Total liquidity*1,0651,200632
Indebtedness
Convertible loan390388382
Convertible bond199199199
Other financial debt---
Total indebtedness589587581

*rounding differences may occur

Clinical Development
Idorsia has a diversified and balanced clinical development pipeline covering multiple therapeutic areas, including CNS, cardiovascular and immunological disorders, as well as orphan diseases.

In April and July of 2020, Idorsia reported positive results in each of the two pivotal Phase 3 studies of daridorexant in patients with insomnia. The Phase 3 registration program demonstrated efficacy of daridorexant on objective and subjective sleep parameters, and an improvement in daytime functioning, while maintaining a favorable safety profile. More details and commentary can be found in the dedicated press releases (first study release), (second study release) and the investor webcasts (first study webcast), (second study webcast) which are available for replay on Idorsia’s corporate website. This week, the final results of the 40-week extension study with daridorexant became available. The study collected information on the safety of long-term treatment as well as allowing an exploratory analysis of the maintenance of efficacy. There were no new emerging safety findings. Moreover, the efficacy on sleep and daytime functioning appeared to be maintained over the longer treatment duration. The Phase 3 program is therefore concluded.

A New Drug Application (NDA) was submitted to the US FDA on January 8, 2021 and a Marketing Authorization Application (MAA) to the European Union EMA on March 2, 2021 and to Switzerland health authority, Swissmedic, on April 20, 2021. Should approval be received, the company anticipates launch in the US in the first half of 2022, followed by other regions thereafter.

Guy Braunstein, MD and Head of Global Clinical Development of Idorsia, commented:
“I’m pleased to report that the Phase 3 development program with daridorexant has been successfully concluded. The final analyses of the 40-week extension study with daridorexant are aligned to the interim results submitted to the health authorities. The totality of the data supports the chronic use of daridorexant in insomnia."

In November of 2020, Idorsia reported positive results in each of the two Japanese registration studies of clazosentan assessing the efficacy and safety of clazosentan in reducing vasospasm-related morbidity and all-cause mortality in patients following aneurysmal subarachnoid hemorrhage. More details can be found in the dedicated press release. A New Drug Application (NDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for clazosentan was submitted on March 1, 2021. Recruitment into the global REACT study of clazosentan has been impacted by the coronavirus pandemic but is steadily progressing.

The MODIFY Phase 3 study of lucerastat in Fabry disease was fully recruited in February 2021, with 118 patients in the Phase 3 study. Results are expected in the fourth quarter of this year, should all patients continue into the open label extension study.

Full recruitment has also just been achieved for PRECISION, a Phase 3 study to demonstrate the antihypertensive effect of aprocitentan when added to standard of care in patients with resistant hypertension, with 730 patients randomized. This 12-month study should deliver results in mid-2022.

The CARE study, a large Phase 2b multiple-dose, efficacy and safety study with cenerimod, for the treatment of systemic lupus erythematosus completed randomization at the end of February 2021, with 427 patients enrolled. The results are targeted for the fourth quarter of 2021.

A Phase 2 proof-of-concept study with ACT-539313, a selective orexin 1 receptor antagonist, in binge eating disorder has begun recruitment. Binge eating disorder is the most common eating disorder characterized by repeated episodes of eating unusually large portions of food in a short period of time (within any 2-hour period). It is associated with a sense of lack of control over what is being eaten and there is often an absence of pleasure in what has been eaten. Preclinical studies have shown that orexins play an important role in driving compulsive binge-like consumption and that orexin receptor antagonists have reduced binge-like eating behavior in animal models. This is the first study of orexin 1 receptor antagonism as a new mechanism of action for patients with binge eating disorder.

Idorsia’s clinical development pipeline


Compound
Mechanism of ActionTarget IndicationStatus
DaridorexantDual orexin receptor antagonistInsomniaUnder review with FDA/EMA
Aprocitentan* Dual endothelin receptor antagonistResistant hypertension managementPhase 3 recruitment complete
ClazosentanEndothelin receptor antagonistCerebral vasospasm assoc.
with aneurysmal subarachnoid hemorrhage
Japan: NDA submitted

Global: Phase 3
LucerastatGlucosylceramide synthase inhibitorFabry diseasePhase 3 recruitment complete
SelatogrelP2Y12 receptor antagonistSuspected acute myocardial infarctionPhase 3 in preparation
CenerimodS1P1 receptor modulatorSystemic lupus erythematosusPhase 2b recruitment complete
ACT-539313Selective orexin 1 receptor antagonistBinge eating disorderPhase 2
SinbaglustatGBA2/GCS inhibitorRare lysosomal storage disordersPhase 1 complete
ACT-1004-1239CXCR7 antagonistImmunologyPhase 1
ACT-1014-6470-ImmunologyPhase 1
ACT-541478-CNSPhase 1
ACT-777991-ImmunologyPhase 1

* In collaboration with Janssen Biotech to jointly develop aprocitentan, Janssen Biotech has sole commercialization rights worldwide

Neurocrine Biosciences has a global license to develop and commercialize ACT-709478, a novel T-type calcium channel blocker. In November 2020, Neurocrine announced it had initiated a Phase 2 study investigating ACT-709478 for the treatment of a rare form of pediatric epilepsy.

Further details including the current status of each project in the pipeline can be found in our clinical development fact sheet.

Collaboration update
In 2017, Idorsia entered into a research collaboration with Roche in the field of cancer immunotherapy. In the first quarter of 2021, the agreement was terminated. Idorsia continues drug discovery efforts on this promising molecular target.

About the Revenue Sharing Agreement for ponesimod
Idorsia and Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, have entered into a revenue-sharing agreement in respect to ponesimod. Under the terms of the revenue-sharing agreement, Idorsia is entitled to receive quarterly payments of 8% of the net sales of ponesimod products from Actelion.
Annual General Meeting –Note to Shareholders
The Annual General Meeting (AGM) of Shareholders to approve the Annual Report of the year ending December 31, 2020 will be held on Wednesday May 12, 2021.

The notice was published in the Swiss Official Gazette of Commerce (Schweizerisches Handelsamtsblatt) on April 6, 2021, distributed to Shareholders by post on April 16, 2021, and is available, together with the Company’s Annual Report and Compensation Report, on www.idorsia.com/agm.

In order to vote at the Annual General Meeting, shareholders must be registered in the company's shareholder register by May 3, 2021 at the latest.

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

  • Annual General Meeting of Shareholders on May 12, 2021
  • Half-Year 2021 Financial Results reporting on July 27, 2021
  • Nine-months 2021 Financial Results reporting on October 26, 2021
  • Full-Year 2021 Financial Results reporting on February 8, 2022

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 will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.

Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, state-of-the-art facilities, and a strong balance sheet – the ideal constellation to translate R&D efforts into business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 900 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
investor.relations@idorsia.commedia.relations@idorsia.comwww.idorsia.com

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.

Attachment


About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

Underskott för staten i april 20217.5.2021 09:30:00 CEST | Pressemelding

Underskott för staten i april 2021 Statensbetalningar resulterade i ett underskott på 16,9miljarder kronor i april. Riksgäldens prognosvar ett underskottpå 24,9 miljarder kronor.Statens skatteinkomster var något högre än förväntat samtidigt som Riksgäldens nettoutlåning var lägre. Det primära saldot var 5,4 miljarder kronor högre än prognos. Det beror främst på att skatteinkomsterna var cirka 4 miljarder kronor högre än beräknat. Riksgäldens nettoutlåning till myndigheter m.fl. var 3,5 miljarder kronor lägre än prognos. Det beror på högre inlåning från ett antal myndigheter. Räntebetalningarna på statsskulden var 0,8 miljarder kronor högre än prognos. För tolvmånadersperioden till och med april 2021 visade statens betalningar ett underskott på 148,1 miljarder kronor. Statsskulden uppgick till 1 226 miljarder kronor i slutet av april. Utfallet för maj 2021 publiceras den 7 juni kl. 09.30. Nya prognoser för 2021 och 2022 publiceras den 27 maj, kl. 09.30. Kontakt Pressfunktionen, 08 613 4

Deficit for Swedish central government in April 20217.5.2021 09:30:00 CEST | Press release

Deficitfor Swedish central government in April2021 Swedish central government payments resulted in a deficitof SEK 16.9 billion inApril. The Debt Office's forecast was a deficitof SEK 24.9 billion.Central government tax income were slightly higher than expected, while the Debt Office's net lending was lower. The primary balance was SEK 5.4 billion higher than the forecast. This was mainly due to tax income being approximately SEK 4 billion higher than calculated. The Debt Office’s net lending to government agencies etc. was SEK 3.5 billion lower than forecasted. This is explained by higher deposits by a number of government agencies. Interest payments on central government debt were SEK 0.8 billion higher than the forecast. For the twelve-month period up to the end of April 2021, central government payments resulted in a deficit of SEK 148.1 billion. Central government debt amounted to SEK 1 226 billion at the end of April. The outcome for May 2021 will be published on June 7 at 9.30 a

Nexstim Receives a New NBS System Order from a Leading California Based Academic Hospital7.5.2021 09:00:00 CEST | Press release

Press release,Helsinki, 7.5.2021 at 10:00 AM(EEST) Nexstim Receives a New NBS System Order from a Leading California Based AcademicHospital Nexstim Plc (NXTMH:HEX, NXTMS:STO) ("Nexstim" or "Company") announces that it has received an NBS system order from a distinguished academic hospital based in Northern California, US. Nexstim NBS systems use the unique SmartFocus® TMS technology that enables accurate stimulation of the targeted area in the brain. The Nexstim NBS system is the only FDA cleared system based on navigated Transcranial Magnetic Stimulation (nTMS) for non-invasive mapping of the speech and motor cortices of the brain. Mikko Karvinen, CEO of Nexstim, says: “We are happy to announce the sale of this new NBS system to a renownedacademic hospital. The NBS business has been a stable source of revenue for us during the COVID-19 pandemic, and we are glad to see an increasing number of patients benefiting from our SmartFocus® TMS technology as the system will be used for motor a

HOYLU MOTTAGER ORDER FRÅN STOR BYGGFIRMA I USA7.5.2021 08:45:00 CEST | Pressemelding

Stockholm den 7 maj 2021 – Hoylu, ledande inom visuella samarbetslösningar för distribuerade team, meddelade idag att man fått en order från Barton Malow, (www.bartonmalow.com), ett fullservice entreprenad företag med huvudkontor i Michigan, USA. Ordervärdet uppgår till 340 000 sek och representerar expansionen av Hoylus verksamhet inom byggbranschen med high-end arkitektonisk design och projektledning. För ytterligare information, vänligen kontakta: Stein Revelsby, VD på Hoylu + 1 213 440 2499 e-post: sr@hoylu.com Karl Wiersholm, CFO på Hoylu + 1 425 829 2316 e-post: kw@hoylu.com Om Hoylu Hoylus uppdrag är att göra distansarbete och informationsutbyte enkelt. Genom vår anpassningsbara Connected Workspaces™ levererar vi programvarulösningar till företag, organisationer och individer i praktiskt taget alla branscher som gör det möjligt för alla team, stora som små att arbeta effektivt och säkert i ett intuitivt och enkelt arbetsflöde. För mer information: www.hoylu.com Testa Hoylu grati

HOYLU RECEIVES ORDER FROM LARGE CONSTRUCTION FIRM IN THE US7.5.2021 08:45:00 CEST | Press release

Stockholm, Sweden, May 7, 2021 – Hoylu, a leader in visual collaboration solutions for distributed teams, announced today that it has received an order from Barton Malow, (www.bartonmalow.com), a full-service construction firm headquartered in Michigan, US. The order value is 340,000 SEK and represents an expansion of Hoylu’s business within the construction industry with high-end architectural design and project management. For more information, please contact: Stein Revelsby, CEO at Hoylu +1 213 440 2499 Email: sr@hoylu.com Karl Wiersholm, CFO at Hoylu +1 425 829 2316 Email: kw@hoylu.com About Hoylu Hoylu’s mission is to empower distributed teams to collaborate easily and seamlessly while always staying in sync. Hoylu’s Connected Workspaces™ helps enterprises as well as small and medium companies run projects, programs, and initiatives across time zones and continents with the same level of engagement and clarity as if everyone were working in the same room. For more information: www

Dlab partner in European digital transformation project for a more sustainable energy system7.5.2021 08:30:00 CEST | Press release

Cleantech company Dlaboratory Sweden AB (publ) joins a European consortium in applying for funds from EU’s joint programming platform ERA-NET Smart Energy Systems (SES) for a project on power grid resilience. The overall aim of the project is to advance the green energy transition in all sectors of the energy system while also ensuring security of supply in the power grid. Swedish KTH Royal Institute of Technology, Austrian Institute of Technology (AIT), Siemens, Wiener Netze, Fraunhofer ISE, OFFIS, and Solandeo GmbH join forces with dLab for the ERA-Net SES call for transnational projects on digital transformation for green energy transition. The proposed project called Resili8 – Resilience for Cyber-Physical Energy Systems – is aiming to increase grid resilience through a digitalized smart system. Part of the project proposal plan is an installation of dLabs solution in Austrian utilities company Wiener Netze’s power grid to study improved resilience possibilities. - The future energ

Yara International ASA ex-dividend NOK 20 today7.5.2021 08:01:00 CEST | Press release

Oslo, 7 May 2021: Shares in Yara International ASA will be traded ex-dividend NOK 20 as of today, 7 May 2021. Contact Thor Giæver, Investor Relations Cellular: (+47) 480 75 356 E-mail: thor.giaver@yara.com About Yara Yara grows knowledge to responsibly feed the world and protect the planet. Supporting our vision of a world without hunger and a planet respected, we pursue a strategy of sustainable value growth, promoting climate-friendly crop nutrition and zero-emission energy solutions. Yara’s ambition is focused on growing a climate positive food future that creates value for our customers, shareholders and society at large and delivers a more sustainable food value chain. To achieve our ambition, we have taken the lead in developing digital farming tools for precision farming, and work closely with partners throughout the food value chain to improve the efficiency and sustainability of food production. Through our focus on clean ammonia production, we aim to enable the hydrogen econo