GlobeNewswire

Idorsia announces financial results for the first half 2021 – Building momentum towards becoming a fully-fledged biopharmaceutical company

Share

Ad hoc announcement pursuant to Art. 53 LR

Allschwil, Switzerland – July 27, 2021
Idorsia Ltd (SIX: IDIA) today announced its financial results for the first half of 2021.

Business highlights

  • Daridorexant for the treatment of insomnia under review with US FDA, EMA, and Swissmedic
  • Nine scientific presentations for daridorexant shared at SLEEP 2021
  • Ponesimod to treat relapsing forms of multiple sclerosis was approved by the US FDA and the European Commission, Idorsia receives first income from the revenue-sharing agreement in respect to ponesimod
  • Clazosentan NDA for the treatment of cerebral vasospasm post aneurysmal subarachnoid hemorrhage (aSAH) submitted to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in March 2021
  • “SOS-AMI” Phase 3 registration study with selatogrel in suspected acute myocardial infarction (AMI) initiated in June 2021
  • Phase 2 study with ACT-539313 for binge eating disorder initiated in March 2021
  • Results for MODIFY Phase 3 study with lucerastat for Fabry disease expected in Q4 2021
  • Results for PRECISION Phase 3 study with aprocitentan for resistant hypertension expected mid-2022
  • Results for CARE Phase 2b study with cenerimod for systemic lupus erythematosus expected in Q4 2021

Financial highlights

  • US GAAP operating expenses HY 2021 at CHF 265 million
  • Non-GAAP operating expenses HY 2021 at CHF 248 million
  • Guidance for 2021: US GAAP operating expenses around CHF 665 million and non-GAAP operating expenses around CHF 620 million (both measures include inventory build of around CHF 35 million and exclude unforeseen events)

Jean-Paul Clozel, MD and Chief Executive Officer, commented:
“The company is making great progress with delivering on the strategic priorities we defined on Day 1 of Idorsia. Now, just 4 years after establishing the company, we are on the verge of transformation into the fully-fledged biopharmaceutical company we intended to be. The regulatory review and the commercial preparation for daridorexant are progressing well and the team keeps its focus on this important asset. I’m also particularly proud of our newest advancement in the pipeline as selatogrel entered Phase 3 being evaluated as an emergency intervention for suspected AMI at the onset of symptoms. Yet another exciting innovation to watch for Idorsia.”

Simon Jose, Chief Commercial Officer of Idorsia, commented:
“We are progressing very well with our preparations for the anticipated approval and launch of daridorexant. In the US, our new medical team is starting to engage with key experts and the recruitment of our market access team is nearing completion. In Europe, we have made great progress in building our commercial footprint and have appointed General Managers in the major markets. In the second half we will increase our engagement with key stakeholders and begin to raise awareness of the science and burden of insomnia. Similarly, we are on track with our plans for the expected launch of clazosentan in Japan – where the incidence of aSAH is more than twice as high as in the rest of the world.”

Financial results

US GAAP resultsFirst HalfSecond Quarter
in CHF millions, except EPS (CHF) and number of shares (millions)2021202020212020
Revenues1458753
Operating expenses(265)(236)(137)(120)
Operating income (loss)(252)(178)(130)(67)
Net income (loss)(243)(189)(139)(69)
Basic EPS(1.46)(1.41)(0.83)(0.51)
Basic weighted average number of shares166.9133.8167.1136.4
Diluted EPS(1.46)(1.41)(0.83)(0.51)
Diluted weighted average number of shares166.9133.8167.1136.4

US GAAP revenue of CHF 14 million in the first half of 2021 consisted of contract revenue recognized in connection with the collaboration agreements with Neurocrine Biosciences, Inc. (CHF 2 million), Janssen Biotech, Inc. (CHF 5 million), Roche (CHF 4 million), Mochida Pharmaceutical Co., Ltd (CHF 3 million) and revenue share from J&J (CHF 0.4 million) compared to a revenue of CHF 58 million in the first half of 2020.

US GAAP operating expenses in the first half of 2021 amounted to CHF 265 million (CHF 236 million in the first half of 2020), of which CHF 192 million relates to R&D (CHF 197 million in the first half of 2020) and CHF 74 million to SG&A expenses (CHF 40 million in the first half of 2020).

US GAAP net loss in the first half of 2021 amounted to CHF 243 million compared to CHF 189 million in the first half of 2020. The increase of the net loss was mainly driven by lower contract revenues as well as higher operating expenses mainly in the commercial functions, which was partially offset by a positive contribution from financial income.

The US GAAP net loss resulted in a net loss per share of CHF 1.46 (basic and diluted) in the first half of 2021 compared to a net loss per share of CHF 1.41 (basic and diluted) in the first half of 2020.

Non-GAAP* measuresFirst HalfSecond Quarter
in CHF millions, except EPS (CHF) and number of shares (millions)2021202020212020
Revenues1458753
Operating expenses(248)(193)(128)(86)
Operating income (loss)(234)(134)(121)(33)
Net income (loss)(223)(138)(128)(36)
Basic EPS(1.34)(1.03)(0.77)(0.26)
Basic weighted average number of shares166.9133.8167.1136.4
Diluted EPS(1.34)(1.03)(0.77)(0.26)
Diluted weighted average number of shares166.9133.8167.1136.4

* 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 half of 2021 amounted to CHF 223 million: the CHF 20 million difference versus US GAAP net loss was mainly due to depreciation and amortization (CHF 8 million), share-based compensation (CHF 8 million) and a negative non-cash financial result (CHF 4 million).

The non-GAAP net loss resulted in a net loss per share of CHF 1.34 (basic and diluted) in the first half of 2021 compared to a net loss per share of CHF 1.03 (basic and diluted) in the first half of 2020.

André C. Muller, Chief Financial Officer, commented:

“I’m pleased to now see a regular income stream, albeit modest, with the revenue-sharing agreement relating to ponesimod, which was launched by J&J in the second quarter following its approval for relapsing forms of multiple sclerosis in the US and EU. With regulatory discussions for daridorexant in the US and Europe, and clazosentan in Japan, progressing well, the investment into our global commercial infrastructure and launch preparations will gradually increase over the next quarters leading to US GAAP operating expenses for the full year 2021 around CHF 665 million and non-GAAP operating expenses around CHF 620 million, both measures include an inventory build of around CHF 35 million and exclude unforeseen events.”

Liquidity and indebtedness

At the end of the first half of 2021, Idorsia’s liquidity (including cash, cash equivalents, short- and long-term deposits) amounted to CHF 927 million.

(in CHF millions)Jun 30, 2021Mar 31, 2021Dec 31, 2020
Liquidity
Cash and cash equivalents164128141
Short-term deposits763741867
Long-term deposits-196192
Total liquidity*9271,0651,200
Indebtedness
Convertible loan392390388
Convertible bond199199199
Other financial debt---
Total indebtedness592589587

*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. 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. A New Drug Application (NDA) for daridorexant 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 second quarter of 2022, followed by other regions thereafter.

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 aSAH. More details can be found in the dedicated press release. A New Drug Application (NDA) to the Japanese PMDA for clazosentan was submitted on March 1, 2021. Due to the intensive care setting for the study, recruitment into the global Phase 3 study of clazosentan (REACT) has been impacted by the coronavirus pandemic but is steadily progressing. The study is enrolling approximately 400 patients with a high risk of developing cerebral vasospasm and delayed cerebral ischemia (high-risk prevention group). The recruitment of patients with confirmed cerebral vasospasm (early treatment group) has been very low, so following a recommendation received by the study Independent Data Monitoring Committee (IDMC), the company has decided to discontinue this relatively small treatment group. Results continue to be expected in the second half of 2022.

The MODIFY Phase 3 study of Idorsia’s oral substrate reduction therapy lucerastat in patients with Fabry disease irrespective of mutation type was fully recruited in February 2021, with 118 patients. Results continue to be expected in the fourth quarter of this year.

Full recruitment has also 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.

In June 2021, Idorsia announced the initiation of a Phase 3 registration study “SOS-AMI” to evaluate the efficacy and safety of self-administered subcutaneous selatogrel, Idorsia’s P2Y12 receptor antagonist, in suspected acute myocardial infarction (AMI). More details and commentary can be found in the dedicated press release and the investor webcast.

The CARE study, a large Phase 2b multiple-dose, efficacy and safety study evaluating 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 is recruiting. This is the first study evaluating orexin 1 receptor antagonism as a new mechanism of action for patients with binge eating disorder.

Based on initial clinical pharmacology investigation with ACT-541478, the company has decided not to pursue the development of this CNS compound further.

The company has closed a natural history study called “RETRIEVE” which collected disease information from pediatric patients with early onset of rare lysosomal storage disorders (LSDs). The company is now considering development options for sinbaglustat.

Neurocrine Biosciences recently initiated a second Phase 2 study with ACT-709478 (NBI-827104), Idorsia's novel T-type calcium channel blocker, in patients with essential tremor, in addition to the ongoing Phase 2 study in a rare form of pediatric epilepsy.

Idorsia’s clinical development pipeline


Compound
Mechanism of ActionTarget IndicationStatus
DaridorexantDual orexin receptor antagonistInsomniaUnder review with health authorities
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
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-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 (NBI-827104), Idorsia'snovel T-type calcium channel blocker. ACT-709478is currently investigated in two Phase 2 studies for the treatment of a rare form of pediatric epilepsy and essential tremor.

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

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.

Half-year financial report
A full financial update is available in Idorsia's 2021 Half Year Financial Report, at www.idorsia.com/investors/corporate-reports.

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

  • Nine-months 2021 Financial Results reporting on October 26, 2021
  • Full-Year 2021 Financial Results reporting on February 8, 2022
  • First Quarter 2022 Financial Results reporting on April 26, 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 1,000 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

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

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

Repurchase of shares in Millicom24.9.2021 23:00:00 CEST | Press release

Repurchase of shares in Millicom Luxembourg, September24, 2021 - During the period September 16, 2021 – September 22, 2021, Millicom repurchased a total of 122,612 of its Swedish Depository Receipts (SDRs), hereinafter referred to as shares within the framework of the repurchase program announced on July 29, 2021 (the Repurchase Program), details of which are shown in the table below. DateNumber of shares repurchasedWeighted average repurchaseprice (SEK) excluding commissionsTotal daily transaction value (SEK), excluding commissions 16/09/2021 17,000 315.2166 5,358,682.20 17/09/2021 13,000 316.9849 4,120,803.70 20/09/2021 47,000 310.3055 14,584,358.50 21/09/2021 22,000 312.2228 6,868,901.60 22/09/2021 23,612 311.9609 7,366,020.77 All purchases were carried out on Nasdaq Stockholm by Citigroup Global Markets Limited on behalf of Millicom. Following the purchases, as of September 22, 2021, Millicom holds 915,037 treasury shares and has repurchased 739,438 shares under the Repurchase Prog

Jotul Holdings SA's direct subsidiary Jøtul AS issues senior secured floating rate bonds of NOK 475,000,00024.9.2021 18:00:00 CEST | Press release

Jotul Holdings SA's direct subsidiary Jøtul AS has successfully issued senior secured floating rate bonds in an amount of NOK 475,000,000 under a framework of up to NOK 750,000,000 with ISIN NO0011104069. The bonds were issued at par, are due in October 2024 and carry a floating interest rate of NIBOR 3m + 6.95 per cent. The proceeds from the bond issue will be used to finance, redemption of existing debt including Jotul Holdings SA's existing bond loan with ISIN NO0010815749, as well as general corporate purposes. Pareto Securities AB acted as sole arranger and bookrunner in connection with the bond issue. For more information, please visit Jotul Holdings SA’s website at www.intl.jotul.com/investor-relations or contact: Pareto Securities in capacity of Sole Bookrunner and Financial Advisor: Markus Wirenhammar, Head of Investment Banking Tel: +46 708 72 51 86 Jotul Holdings SA: Nils Agnar Brunborg, Chief Executive Officer Tel: +47 90 60 55 7869 35 90 00 Mail: Nils.Brunborg@jotul.no Thi

Nordic American Tankers Ltd (NAT) – Board Members of NAT buy stock in NAT24.9.2021 16:28:10 CEST | Press release

Friday, September 24, 2021 Dear Shareholders and Investors, All Board Members of NAT have recently increased their shareholdings in the company. The Founder, Chairman & CEO, Herbjorn Hansson, Norway, bought 75,000 shares in NAT September 17. Board Member Alexander Hansson, Monaco, bought 100,000 shares in NAT August 31, and 50,000 shares September 20. Board Member Jim Kelly, New York, has also adjusted his holding upwards to 175,000 shares in NAT. Doug Penick of Dallas, Texas, joined the Board at the NAT AGM July 19, 2021. He has already accumulated 125,000 shares in NAT. It is a strong sign of confidence that board members buy stock in our company. The Hansson family is the third largest shareholder group in NAT. Sincerely, Herbjorn Hansson Founder, Chairman & CEO Nordic American Tankers Ltd. www.nat.bm CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS Matters discussed in this press release may constitute forward-looking statements. The Private Securities Litigation Reform Ac

CONDITIONS FOR RIKSBANK BID PROCEDURE KOMMUNINVEST BONDS24.9.2021 16:20:00 CEST | Press release

Bid procedure, 2021-09-28BondsKOMMUNINVEST I SVERIGE: 2410. SE0010469205. 2024-10-02 KOMMUNINVEST I SVERIGE: 2602, SE0013745452, 2026-02-04 BidsBids on interest and volume are entered via Bloomberg Bond Auction SystemBid date2021-09-28Bid times10.00-11.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)2410: 1500 mln SEK +/-750 mln SEK 2602: 1000 mln SEK +/-500 mln SEK Highest permitted bid volume (corresponding nominal amount)2410: 1500 mln SEK per bid 2602: 1000 mln SEK per bid Lowest permitted bid volume (corresponding nominal amount)SEK 50 million per bidExpected allocation timeNot later than 11.15 (CET/CEST) on the Bid dateDelivery and payment date2021-09-30Delivery of bondsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383General Terms and ConditionsGeneral Terms and Conditions General Terms and Conditions för the Riksbank’s Purchases of Bonds via Bid Procedure 2020:3. dated 20 November 2020 (see the Riksbank´s web

CONDITIONS FOR THE RIKSBANK´S PURCHASES OF COMMERCIAL PAPER24.9.2021 16:20:00 CEST | Press release

Bid procedure, 2021-09-29CertificateCommercial paper issued in SEK by non-financial companies with their registered office in Sweden and with a remaining maturity of up to six months on the Bid date. i.e. with the latest maturity date as of 2022-03-29 Delivery may not be made in commercial paper purchased by the Counterparty from the issuer less than one week prior to the date for announcing the Special terms, i.e. the purchase may not have been made after 2021-09-17 BidsCounterparties may make one bid per Credit rating class and maturity class. Bids are made to tel 08-696 69 70 and confirmed by e-mail to EOL@riksbank.se.Bid date2021-09-29Bid times09.00-09.30 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)SEK 4 billionHighest permitted bid volume (corresponding nominal amount)The total bid volume from one Counterparty for the two Credit rating classes may not exceed SEK 4 billion. No bid may contain Commercial paper in excess of SEK 250 million issued by the s

CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK GOVERNMENT BONDS24.9.2021 16:20:00 CEST | Press release

Bid procedure, 2021-10-01BondsSWEDISH GOVERNMENT: 1062. SE0013935319. 2031-05-12 SWEDISH GOVERNMENT: 1063, SE0015193313, 2045-11-24 Bid date2021-10-01Bid times09.00-10.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)1062: 500 mln SEK +/-250 mln SEK 1063: 500 mln SEK +/-250 mln SEK Highest permitted bid volume (corresponding nominal amount)1062: 500 mln SEK per bid 1063: 500 mln SEK per bid Lowest permitted bid volume (corresponding nominal amount)SEK 50 million per bidExpected allocation timeNot later than 10.15 (CET/CEST) on the Bid dateDelivery and payment date2021-10-05Delivery of bondsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383 Stockholm, 2021-09-24 This is a translation of the special terms and conditions published on www.riksbank.se. In the case of any inconsistency between the English translation and the Swedish language version, the Swedish language version shall prevail. Complete terms and conditions c

CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK COVERED BONDS24.9.2021 16:20:00 CEST | Press release

Bid procedure, 2021-09-30BondsSWEDBANK HYPOTEK AB: 196. SE0015244991. 2026-03-18 STADSHYPOTEK AB: 1587, SE0010441303, 2023-06-01 SWEDISH COVERED BOND: 147, SE0009383664, 2026-06-17 SKANDINAVISKA ENSKILDA: 575, SE0010546572, 2022-12-21 LANSFORSAKRINGAR HYPOTEK: 516, SE0009190390, 2023-09-20 DANSKE HYPOTEK AB: 2512, SE0013877214, 2025-12-17 NORDEA HYPOTEK AB: 5534, SE0012230415, 2024-09-18 Bid date2021-09-30Bid times09.00-10.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)196: 400 mln SEK +/-200 mln SEK 1587: 1900 mln SEK +/-950 mln SEK 147: 700 mln SEK +/-350 mln SEK 575: 500 mln SEK +/-250 mln SEK 516: 600 mln SEK +/-300 mln SEK 2512: 500 mln SEK +/-250 mln SEK 5534: 400 mln SEK +/-200 mln SEK Highest permitted bid volume (corresponding nominal amount)196: 400 mln SEK per bid 1587: 1900 mln SEK per bid 147: 700 mln SEK per bid 575: 500 mln SEK per bid 516: 600 mln SEK per bid 2512: 500 mln SEK per bid 5534: 400 mln SEK per bid Lowest permitted bid volume (co