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Idorsia announces financial results for the first quarter 2022 – first product launched, second in the starting blocks

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Idorsia Pharmaceuticals Ltd
Idorsia Pharmaceuticals Ltd

Ad hoc announcement pursuant to Art. 53 LR

Allschwil, Switzerland – April 26, 2022

Idorsia Ltd (SIX: IDIA) today announced its financial results for the first quarter of 2022.

Business highlights

  • PIVLAZ™ (clazosentan) for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage launched in Japan on April 20, 2022

  • US launch of QUVIVIQ™ (daridorexant) for the treatment of adult patients with insomnia on May 2, 2022

  • EC decision for QUVIVIQ expected in early May 2022 – CHMP adopted a positive opinion in February 2022

  • PRECISION, a Phase 3 study to demonstrate the antihypertensive effect of aprocitentan when added to standard of care in patients with resistant hypertension, on track to deliver results before mid-2022

Financial highlights

  • US GAAP operating expenses in Q1 2022 at CHF 198 million

  • Non-GAAP operating expenses in Q1 2022 at CHF 188 million

  • Guidance for 2022 (unchanged): Net revenue around CHF 145 million – US GAAP operating expenses around CHF 975 million and non-GAAP operating expenses around CHF 920 million – leading to US GAAP operating loss of around CHF 840 million and non-GAAP operating loss of around CHF 785 million – unforeseen events excluded

Jean-Paul Clozel, MD and Chief Executive Officer, commented:
“The months of April and May 2022 will be recorded in the Idorsia history books. These are the months in which we launch our first two products in two of the world's largest pharmaceutical markets. This transforms Idorsia into a fully-fledged biopharmaceutical company, delivering our innovations from bench to bedside, just 5 years after launching the company. PIVLAZ is already available in Japan for patients with aSAH, and now that the scheduling is complete, QUVIVIQ will become available in the US for patients with insomnia from May 2nd. I am incredibly proud of the entire Idorsia team who have put in an immense effort to make this possible.”

Financial results

US GAAP results

First Quarter

in CHF millions, except EPS (CHF) and number of shares (millions)

2022

2021

Revenues

5

7

Operating expenses

(198)

(129)

Operating income (loss)

(193)

(122)

Net income (loss)

(198)

(105)

Basic EPS

(1.12)

(0.63)

Basic weighted average number of shares

177.1

166.6

Diluted EPS

(1.12)

(0.63)

Diluted weighted average number of shares

177.1

166.6

US GAAP revenue of CHF 5 million in the first quarter of 2022 consisted of contract revenue recognized in connection with the collaboration agreements with Janssen Biotech, Inc. (CHF 3 million), Mochida Pharmaceutical Co., Ltd (CHF 1 million) and Neurocrine Biosciences, Inc. (CHF 1 million) and revenue share from J&J (CHF 0.2 million), compared to a revenue of CHF 7 million in the first quarter of 2021.

US GAAP operating expenses in the first quarter of 2022 amounted to CHF 198 million (CHF 129 million in the first quarter of 2021), of which CHF 95 million relates to R&D (CHF 97 million in the first quarter of 2021) and CHF 103 million to SG&A expenses (CHF 31 million in the first quarter of 2021).

US GAAP net loss in the first quarter of 2022 amounted to CHF 198 million compared to CHF 105 million in the first quarter of 2021. The increase of the net loss was mainly driven by higher operating expenses, mainly in the commercial functions and a negative financial result.

The US GAAP net loss resulted in a net loss per share of CHF 1.12 (basic and diluted) in the first quarter of 2022 compared to a net loss per share of CHF 0.63 (basic and diluted) in the first quarter of 2021.

Non-GAAP* measures

First Quarter

in CHF millions, except EPS (CHF) and number of shares (millions)

2022

2021

Revenues

5

7

Operating expenses

(188)

(121)

Operating income (loss)

(183)

(114)

Net income (loss)

(189)

(95)

Basic EPS

(1.07)

(0.57)

Basic weighted average number of shares

177.1

166.6

Diluted EPS

(1.07)

(0.57)

Diluted weighted average number of shares

177.1

166.6

* 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 2022 amounted to CHF 189 million: the CHF 9 million difference versus US GAAP net loss was mainly due to depreciation and amortization (CHF 5 million), share-based compensation (CHF 5 million) and a positive non-cash financial result (CHF 1 million).

The non-GAAP net loss resulted in a net loss per share of CHF 1.07 (basic and diluted) in the first quarter of 2022 compared to a net loss per share of CHF 0.57 (basic and diluted) in the first quarter of 2021.

Financial outlook
On April 20, 2022, the company launched PIVLAZ (clazosentan) in Japan. Furthermore, the company will soon launch QUVIVIQ (daridorexant) in the US and, pending marketing authorization from the European Medicines Agency, in the first European markets before the end of the year. The clinical pipeline will advance with highlights including the conclusion of the Phase 3 registration study for aprocitentan and the Phase 2 proof-of-concept study with the selective orexin 1 receptor antagonist, the ramp-up of recruitment into the pivotal SOS-AMI study with selatogrel, as more sites are initiated around the globe, and the planned initiation of Phase 3 development of cenerimod. Accounting for all these activities, the company continues to anticipate net revenue around CHF 145 million, US GAAP operating expenses around CHF 975 million and non-GAAP operating expenses around CHF 920 million, all leading to a US GAAP operating loss of around CHF 840 million and a non-GAAP operating loss of around CHF 785 million for 2022, unforeseen events excluded.

The company is committed to become profitable and with the current forecasts, continues to expect to reach this goal in 2025 with annual net sales above CHF 1 billion.

André C. Muller, Chief Financial Officer, commented:
“The launch of our first products is transforming the company into a commercial entity. I am happy that the first quarter of 2022 is the last quarter without sales figures, and I am really looking forward to seeing the initial uptake of our products and the corresponding results at the half-year reporting. No matter how well we guide the market, the proof of the pudding is in the eating. I am confident that we can deliver on our ambitious targets and that will put sustainable profitability within reach in the not-too-distant future.”

Liquidity and indebtedness
At the end of the first quarter of 2022, Idorsia’s liquidity (including cash, cash equivalents and short-term deposits) amounted to CHF 940 million.

(in CHF millions)

Mar 31, 2022

Dec 31, 2021

Liquidity

Cash and cash equivalents

146

101

Short-term deposits

794

927

Long-term deposits

-

160

Total liquidity*

940

1,188

Indebtedness

Convertible loan

335

298

Convertible bond

794

794

Other financial debt

-

-

Total indebtedness

1,129

1,093

*rounding differences may occur

Commercial operations
After establishing Idorsia’s commercial footprint – the people, infrastructure and processes required for commercial operations – the company is now launching two differentiated products in two of the largest pharmaceutical markets at the same time, PIVLAZ in Japan and QUVIVIQ in the US.

United States
On January 7, 2022, QUVIVIQ™ (daridorexant) 25 mg and 50 mg was approved by the FDA for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. More details can be found in the dedicated press release.

Under the leadership of Patty Torr, several innovative initiatives to educate the US market about the seriousness of insomnia as a very real, but often overlooked medical condition are fully up and running. These include a partnership with Jennifer Aniston to launch a unique educational campaign, Seize the Night & Day, aimed at revealing the dual impact of insomnia on both nights and days. Additionally, eye-opening results from Wake Up America, the largest US survey of people with trouble sleeping, as well as healthcare professionals, were published recently to bring to life the true burden of insomnia. The survey, which was supported by Idorsia, was created under the direction of The Alliance for Sleep, an organization comprised of some of the nation’s foremost experts in sleep medicine. The Idorsia US team has also produced a feature-length documentary, The Quest for Sleep, which premiered in March and explores people’s struggles with insomnia and the science of sleep.

On April 7, 2022, the US Drug Enforcement Administration (DEA) placed QUVIVIQ in schedule IV of the Controlled Substance Act (CSA), as expected based on the scheduling of other sleep medications. QUVIVIQ will be available to patients in the US from May 2, 2022. For more information about QUVIVIQ in the US, see the Full Prescribing Information (PI and Medication Guide).

Japan

Product

Mechanism of Action

Indication

Commercially available since



PIVLAZ™(clazosentan)

Endothelin receptor antagonist

Prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH)

20 April 2022

On January 20, 2022, PIVLAZ™ (clazosentan) 150 mg was approved for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH) in Japan. More details can be found in the dedicated press release. The approval was based on a robust Phase 3 program in Japanese patients, as published in “Effects of clazosentan on cerebral vasospasm-related morbidity and all-cause mortality after aneurysmal subarachnoid hemorrhage: two randomized phase 3 trials in Japanese patients” in the Journal of Neurosurgery.

On April 20, 2022, PIVLAZ was launched and made available to patients in Japan. More details can be found in the dedicated press release. The Idorsia Japan team, under the leadership of Satoshi Tanaka, has built a focused customer-facing organization to bring this innovative medicine to physicians and patients facing this life-threatening condition. The team is introducing PIVLAZ clinical data to physicians and engaging with local medical experts to improve and standardize the treatment of aSAH across Japan.

Simon Jose, Chief Commercial Officer of Idorsia, commented:
“We have all the ingredients needed to make both launches a success: two well differentiated products, hand-picked and focused teams with state-of-the-art commercial infrastructure, and innovative and ambitious go-to-market plans. We've been able to conclude all steps needed to launch PIVLAZ in Japan and QUVIVIQ in the US and finalize the pricing for both products. I'm very pleased that the innovative nature and impactful results of both products have been recognized by payors in Japan and in the US respectively. I am very confident that this will translate into commercial success, but more importantly, I am delighted that patients can now benefit from these innovative medicines.”

Europe and Canada region
Idorsia is expecting the European Commission decision for QUVIVIQ™ (daridorexant) in early May 2022. This follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) which recommended QUVIVIQ for the treatment of adult patients with insomnia characterized by symptoms present for at least three months and considerable impact on daytime functioning. More information can be found in the dedicated press release.

The core Idorsia country teams are in place in the top five European markets and Syneos Health has been engaged as the company’s partner to build a salesforce to reach the large primary care market for insomnia. The Idorsia team is engaging with local medical experts, policy makers and payors to introduce the company and raise awareness of the significant unmet patient need in insomnia in Europe. The first European launches of QUVIVIQ are expected before the end of the year following regulatory approval.

Clinical Development
Idorsia's diversified and balanced clinical development pipeline, which covers multiple therapeutic areas, including CNS, cardiovascular and immunological disorders, as well as orphan diseases, is on track and progressing as described in February.

Idorsia’s clinical development pipeline


Compound

Mechanism of Action

Target Indication

Status

Daridorexant

Dual orexin receptor antagonist

Insomnia

Approved as QUVIVIQ™ in the US

Under review in other countries

Aprocitentan*

Dual endothelin receptor antagonist

Resistant hypertension management

Phase 3 recruitment complete

Clazosentan

Endothelin receptor antagonist

Cerebral vasospasm assoc.
with aneurysmal subarachnoid hemorrhage

Phase 3 outside of Japan

Lucerastat

Glucosylceramide synthase inhibitor

Fabry disease

Phase 3 primary endpoint not met,

OLE ongoing**

Selatogrel

P2Y12 receptor antagonist

Suspected acute myocardial infarction

Phase 3

Cenerimod

S1P1 receptor modulator

Systemic lupus erythematosus

Phase 3 in preparation

ACT-539313

Selective orexin 1 receptor antagonist

Binge eating disorder

Phase 2 recruitment complete

Sinbaglustat

GBA2/GCS inhibitor

Rare lysosomal storage disorders

Phase 1 complete

ACT-1004-1239

CXCR7 antagonist

Immunology

Phase 1 complete

ACT-1014-6470

-

Immunology

Phase 1

ACT-777991

-

Immunology

Phase 1

* In collaboration with Janssen Biotech to jointly develop aprocitentan, Janssen Biotech has sole commercialization rights worldwide
** Open-label extension study

Neurocrine Biosciences has a global license to develop and commercialize ACT-709478 (NBI-827104), Idorsia's novel T-type calcium channel blocker. ACT-709478 is 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.

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

  • Half-Year 2022 Financial Results reporting on July 26, 2022

  • Nine-months 2022 Financial Results reporting on October 25, 2022

  • Full-Year 2022 Financial Results reporting on February 7, 2023

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 1,200 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.com – media.relations@idorsia.com – www.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.

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