GNW-Adhoc: Idorsia announces financial results for the first quarter 2024 - advancing the company with renewed vigor

^Ad hoc announcement pursuant to Art. 53 LR

Allschwil, Switzerland - May 21, 2024

Idorsia Ltd (SIX: IDIA) today announced its financial results for the first

quarter of 2024.

Business highlights

* Viatris collaboration: Global research and development collaboration,

focused on the development and commercialization of two innovative

compounds, selatogrel and cenerimod.

Commercial highlights

* QUVIVIQ(TM) (daridorexant): Total net sales of CHF 10 million in Q1 2024.

* QUVIVIQ in the US: Citizens petition to deschedule the DORA class

progressing.

* QUVIVIQ in Europe: Further launches, including France, provide a solid base

to increase European sales in 2024.

Pipeline highlights

* TRYVIO(TM) (aprocitentan): Approved by the US FDA in March 2024.

* JERAYGO(TM) (aprocitentan): Recommended for approval in Europe.

* Daridorexant: Phase 3 study conducted by Simcere in Chinese patients fully

recruited.

Financial highlights

* Net revenue Q1 2024 at CHF 10 million.

* US GAAP operating expenses Q1 2024 benefiting from extraordinary income from

Viatris deal with non-GAAP operating expenses Q1 2024 at CHF 96 million.

* US GAAP operating income Q1 2024 of CHF 31 million and non-GAAP operating

loss of CHF 85 million.

* The Viatris deal: The upfront consideration of USD 350 million (CHF 308

million) was fully paid by Viatris to Idorsia in Q1 2024.

* Convertible bond 2024: Bondholders approve an extension of maturity by six

months.

Guidance for 2024

* QUVIVIQ net sales of around CHF 55 million.

* US GAAP operating loss to reach CHF 340 million (which includes a one-off

benefit of CHF 125 million from the Viatris deal), non-GAAP operating loss

of around CHF 420 million (excluding contract revenues and the one-off

benefit from the Viatris deal) - unforeseen events excluded.

Jean-Paul Clozel, MD and Chief Executive Officer, commented:

"We have already reached significant milestones in 2024. The deal with Viatris

to accelerate the development of selatogrel and cenerimod brought cash and

security for these assets, while retaining shareholder value. We came to an

arrangement with holders of the convertible bond 2024 due for repayment in July,

giving us the time we need to secure additional funding and avoid liquidity

constraints. Also, the quality of our research and development engine was once

again confirmed by the FDA's approval of TRYVIO (aprocitentan) and the CHMP

positive opinion received for JERAYGO (the trade name of aprocitentan in

Europe). This will now unlock value for Idorsia as we evaluate possible launch

strategies - including potential partnership - for the first antihypertensive

working on a new pathway seen in almost 40 years."

Jean-Paul continued: "Since the first launch of QUVIVIQ, more than 14 million

tablets have been dispensed worldwide, with well over 150,000 patients

benefiting from QUVIVIQ. We continue to believe in the huge potential offered by

this product and - thanks to a long patent life - there is plenty of time for

this potential to be realized. Continued innovation is essential to securing the

company's future. Despite the reduction of the workforce, we continue to

discover and develop new drugs with great potential in many areas of medicine. I

am very confident that our vision to create an innovative, profitable, and

sustainable science-based company will become a reality in the coming years."

Financial results

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US GAAP results First

Quarter

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

(millions) 2024 2023

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Net revenues 10 21

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Operating expenses 20 (219)

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Operating income (loss) 31 (198)

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Net income (loss) 30 (212)

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Basic EPS 0.17 (1.19)

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Basic weighted average number of shares 179.1 178.0

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Diluted EPS 0.13 (1.19)

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Diluted weighted average number of shares 233.3 178.0

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Net revenue of CHF 10 million in the first quarter of 2024 is the result of

QUVIVIQ product sales. This compares to CHF 21 million in the first quarter of

2023, which included CHF 13.5 million sales of PIVLAZ in Japan (now assigned to

Nxera Pharma as part of a transaction, more details can be found in the

dedicated press release (https://www.idorsia.com/investors/news-and-

events/media-releases/media-release-details?id=3041539)) and CHF 1 million

revenue share from Johnson & Johnson related to ponesimod sales (revenue-sharing

agreement now eliminated as part of the reacquisition of aprocitentan, more

details can be found in the dedicated press release

(https://www.idorsia.com/investors/news-and-events/media-releases/media-release-

details?id=3073952)).

US GAAP operating expenses in the first quarter of 2024 benefitted from

extraordinary income of CHF 125 million from the Viatris deal resulting in a

negative expense of CHF 20 million (CHF 219 million in the first quarter of

2023), of which CHF 4 million related to cost of sales (CHF 1 million in the

first quarter of 2023), CHF 33 million to R&D expenses (CHF 93 million in the

first quarter of 2023), and CHF 68 million to SG&A expenses (CHF 125 million in

the first quarter of 2023).

US GAAP net income in the first quarter of 2024 amounted to CHF 30 million (CHF

212 million net loss in the first quarter of 2023). The decrease of the net loss

is mainly attributable to the one-off income related to the Viatris Deal but was

also driven by lower operating expenses throughout all functions.

The US GAAP net income resulted in a basic net income per share of CHF 0.17

(diluted net income per share of CHF 0.13) in the first quarter of 2024,

compared to a net loss per share of CHF 1.19 (basic and diluted) in the first

quarter of 2023.

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Non-GAAP* measures First Quarter

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

(millions) 2024 2023

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Net revenues 10 21

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Operating expenses (96) (202)

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Operating income (loss) (85) (181)

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Net income (loss) (86) (189)

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Basic EPS (0.48) (1.06)

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Basic weighted average number of shares 179.1 178.0

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Diluted EPS (0.48) (1.06)

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Diluted weighted average number of shares 179.1 178.0

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* 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 2024 amounted to CHF 86 million: the

CHF 116 million difference versus US GAAP net income was mainly due to the one-

off effect of the Viatris Deal (CHF 125 million income), depreciation and

amortization (CHF 4 million), and share-based compensation (CHF 4 million).

The non-GAAP net loss resulted in a net loss per share of CHF 0.48 (basic and

diluted) in the first quarter of 2024, compared to a net loss per share of CHF

1.06 (basic and diluted) in the first quarter of 2023.

Viatris collaboration

In March 2024, Idorsia closed agreements with Viatris Inc. (NASDAQ: VTRS), a

global healthcare company, for collaboration on the global development and

commercialization of two Phase 3 assets - selatogrel and cenerimod - with

Idorsia receiving an upfront payment of USD 350 million, and the right to

potential development and regulatory milestone payments of up to USD 300

million, potential sales milestone payments of up to USD 2.1 billion, and

potential contingent tiered royalties from mid-single- to low-double-digit

percentage on annual net sales.

A joint development committee is overseeing the development of the ongoing Phase

3 programs for selatogrel and cenerimod up to regulatory approval. Idorsia will

contribute up to USD 200 million in the next 3 years and transferred the

dedicated personnel for both programs to Viatris.

Viatris has worldwide commercialization rights for both selatogrel and cenerimod

(excluding, for cenerimod only, Japan, South Korea, and certain countries in the

Asia-Pacific region). Idorsia has also granted Viatris a right of first refusal

and first negotiation for certain other pipeline assets.

Convertible bonds 2024

In July 2018, the Group issued CHF 200 million of senior unsecured convertible

bonds (ISIN: CH0426820350), which were due to mature on July 17, 2024. On May

6, 2024, a bondholder meeting was held, where 83.5% of the total outstanding

bondholders voted in favor of amendments to the terms of the bonds. The approved

bond terms include an amended conversion price of CHF 6.00, extended maturity

date of January 17, 2025, and the option to call the bonds at par, in full or in

part, at any time upon giving ten trading days' notice. The company has applied

to the higher cantonal composition authority and upon approval the amendments to

the bond terms will become binding and effective. A consent fee of 8,000,000

Idorsia shares will be delivered through SIX SIS once the amendment of the bond

terms is effective.

Financial outlook 2024

For 2024 - excluding unforeseen events - the company expects QUVIVIQ net sales

of around CHF 55 million; SG&A expenses of around CHF 300 million; R&D expense

of around CHF 165 million for Idorsia-led pipeline assets; non-GAAP operating

expenses of up to CHF 470 million. This performance would result in a non-GAAP

operating loss of around CHF 420 million (excluding contract revenues and the

one-off benefit from the Viatris deal).

The company expects US GAAP operating loss for 2024 to reach CHF 340 million

which includes a one-off benefit of CHF 125 million from the Viatris deal.

André C. Muller, Chief Financial Officer, commented:

"In addition to the funds already raised from our business development

activities, I am confident in our ability to raise additional funding this year.

We will continue to evaluate and prepare possible launch strategies - including

potential partnership - for TRYVIO. The significant progress with access and

availability of QUVIVIQ has started to gain traction, particularly in Europe,

this will translate into higher sales in 2024. At the same time, the cost

reduction initiative that took place in the latter part of 2023 is fully

effective and reflected in our 2024 guidance, with significantly lower expenses.

We must continue to control our costs and explore all avenues to extend our cash

runway, but I see many reasons to be optimistic for the future of Idorsia."

Liquidity and indebtedness

At the end of the first quarter of 2024, Idorsia's liquidity amounted to CHF

335 million.

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(in CHF millions) March 31, 2024 Dec 31, 2023

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Liquidity

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Cash and cash equivalents 335 145

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Short-term deposits - -

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Total liquidity* 335 145

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Indebtedness

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Convertible loan 335 335

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Convertible bond 797 796

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Other financial debt 162 162

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Total indebtedness 1,293 1,293

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*rounding differences may occur

Commercial operations

In the first quarter of 2024, QUVIVIQ(TM) (daridorexant) in the US, Germany, Italy,

Switzerland, Spain, UK, Canada, Austria, and France generated total product

sales of CHF 10 million.

United States

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Product Mechanism of action Indication Commercially available

since

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Dual orexin receptor Treatment of adult May 2022

antagonist patients with insomnia,

characterized by

difficulties with sleep

onset and/or sleep

maintenance

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In the US, net sales of QUVIVIQ(®) (daridorexant) in the first quarter of 2024

reached CHF 6.5 million. This net sales number includes the QUVIVIQ copay

program aimed at driving demand and product uptake, and thus does not reflect

the actual number of prescriptions dispensed.

As of the end of the first quarter of 2024, more than 140,000 patients have been

treated with QUVIVIQ, almost 400,000 prescriptions have been dispensed, and the

product has been prescribed by more than 42,000 healthcare professionals. To

begin with, the company ran a direct-to-consumer (DTC) television and digital

campaign and offered a copay program. The strategy was to create a recognizable

brand, enabling market access discussions. During 2023, the company made

significant progress, reaching over 65% reimbursement in the commercial sector.

As access increased, the commercial approach was adjusted, with the aim being to

switch from a consignment model (providing substantially reduced or free

prescriptions) to a payer paid model. In the first quarter of 2024, paid

prescriptions accounted for 68% of the total - an increase of 36 percentage

points from the same period in 2023 and of 7 percentage points from the previous

quarter.

The first Medicare Part D coverage - reaching 27% of covered lives - began in

January 2024, opening an entirely new channel which has the potential to

substantially improve product access and paid prescriptions.

In February, there was a cyberattack on Change Healthcare (UnitedHealth Group),

the largest adjudicator/processor of copay cards in the US, causing major

disruption across the pharmaceutical industry, including the QUVIVIQ copay

cards, with a negative impact on prescription dispensing levels. In March, the

Idorsia US Market Access team put a solution in place to remedy the disruption,

though the impact was still appreciable through to the end of March.

In April 2023, Idorsia filed a citizen petition (CP), urging the Drug

Enforcement Administration (DEA) to deschedule the DORA class of chronic

insomnia medications, based on a review of evidence from available data,

including post-marketing surveillance data. Starting in 2015, the independent

FDA approvals of other DORAs included a recommendation that these drug products

be scheduled based on preclinical data. The CP to deschedule the DORA class

outlines current scientific and medical evidence demonstrating that the DORA

class has a negligible abuse profile and potential for abuse, lacks non-medical

use in the community, lacks physical and psychological dependence, and

therefore, should not be a scheduled class under the Controlled Substances Act.

The DEA and FDA acknowledged the CP, and the process to analyze and examine the

request is moving forward. Notably, a report accompanying the FDA appropriations

bill that was finalized in March 2024 informed the FDA that the process for

descheduling the DORA class is a priority for Congress.

Tausif 'Tosh' Butt, President, and General Manager of Idorsia US, commented:

"I believe one of the biggest barriers to prescribing QUVIVIQ is the fact it is

currently a scheduled drug. Apart from the obstacles to prescribing scheduled

drugs, some payers require patients to be treated with low-cost drugs not

indicated for insomnia, and others that carry black box warnings before covering

QUVIVIQ. The US Congress has long supported the efforts of the FDA to address

the opioid and addiction crisis, and this year it encouraged the FDA to also

consider the impact of treatments for insomnia as a part of that larger public

health mission. I am very hopeful for our citizen petition requesting a review

of the evidence can lead to the descheduling of the DORA class of chronic

insomnia medications."

For more information about QUVIVIQ in the US, see the Full Prescribing

Information (https://www.idorsia.us/documents/us/label/Quviviq_PI.pdf) (PI and

Medication Guide).

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Product Mechanism of action Indication Commercially available

since

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Dual endothelin Treatment of hypertension Approved Mar. 2024

receptor antagonist in combination with other

antihypertensive drugs, to Planned availability:

lower blood pressure in H2 2024

adult patients who are not

adequately controlled on

other drugs

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On March 19, 2024, the US Food and Drug Administration (FDA) approved TRYVIO(TM)

(aprocitentan) for the treatment of hypertension in combination with other

antihypertensive drugs, to lower blood pressure in adult patients who are not

adequately controlled on other drugs. Lowering blood pressure reduces the risk

of fatal and non-fatal cardiovascular events, primarily strokes and myocardial

infarctions. The recommended dosage of TRYVIO is 12.5 mg orally once daily, with

or without food.

Idorsia plans to make TRYVIO available in the second half of 2024 to the

millions of patients in the US whose high blood pressure is not adequately

controlled by other drugs.

Further details on the approval, together with commentary from company

management can be found in the dedicated press release

(https://www.idorsia.com/investors/news-and-events/media-releases/media-release-

details?id=3195250) and investor webcast

(https://www.idorsia.com/investors/news-and-events/investor-

webcasts/aprocitentan-approval-webcast) available from the company corporate

website.

For more information see the Full Prescribing Information including BOXED

Warning (PI (https://www.idorsia.us/dam/jcr:d834ee09-2e6c-443d-b3ac-

c111e38f0990/tryvio_pi.pdf) and Medication Guide

(https://www.idorsia.us/dam/jcr:dec71faf-a4ad-45d5-b2ce-

b3efee29a1b4/tryvio_mg.pdf)).

Europe and Canada

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Product Mechanism of action Indication Commercially available

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Dual orexin receptor Treatment of adult France: Mar. 2024

antagonist patients with insomnia

characterised by Austria: Feb. 2024

symptoms present for at

least three months and UK: Oct. 2023

considerable impact on

daytime functioning Spain: Sep. 2023

Switzerland: Jun. 2023

Germany: Nov. 2022

Italy: Nov. 2022

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Management of adult Canada: Nov. 2023

patients with insomnia,

characterized by

difficulties with sleep

onset and/or sleep

maintenance

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QUVIVIQ (daridorexant) net sales in the first quarter of 2024 reached CHF 3.5

million in the EUCAN region.

In November 2023, treatment with daridorexant was added to the insomnia

treatment guidelines for Europe. In "The European Insomnia Guideline: An update

on the diagnosis and treatment of insomnia 2023", published in the Journal of

Sleep Research, the authors note that "The introduction of DORAs has probably

been the most significant recent development in the pharmacological treatment of

insomnia."

In Germany, QUVIVIQ was launched in November 2022. By law, sleep medications

were then subject to a 4-week prescribing limitation (Anlage III BtMG).

Following a review by the Federal Joint Committee (G-BA) - the highest decision-

making body of the joint self-government of physicians, dentists, hospitals, and

health insurance funds in Germany - this limitation was lifted for QUVIVIQ in

November 2023. This makes it the only sleep medication in Germany that can be

prescribed for long-term treatment of chronic insomnia. In December 2023, the

price negotiated for QUVIVIQ under the AMNOG process became effective. Following

the lifting of the prescribing limitation, the company submitted a second AMNOG

dossier for the long-term treatment of chronic insomnia disorder (beyond 4

weeks), reflecting the indication approved by the EMA in 2022. The progress made

in Germany is reflected by the performance of QUVIVIQ on the market, with a 63%

increase in demand seen in Q4 2023 (compared to Q3 2023), followed by a strong

start to 2024 (February +41% compared to December 2023).

In Italy, QUVIVIQ was launched in November 2022. Currently, QUVIVIQ can only be

prescribed by neurologists, psychiatrists, and specialists from sleep centers,

and no sleep therapy is reimbursed. The company submitted a reimbursement

dossier in June 2023 and requested the expansion of the prescriber base. The

submission - detailing the efficacy and safety profile of QUVIVIQ and its

estimated budget impact and cost-effectiveness in Italy - is under review, with

the final outcome expected in the second half of 2024.

In Switzerland, QUVIVIQ was launched to the self-pay market in June 2023.

Following the launch of QUVIVIQ, awareness has increased among all specialties,

and demand has increased solidly (+32% in Q4 2023 compared to Q3 2023) ahead of

reimbursement, which is expected in the summer of 2024.

In Spain, QUVIVIQ was launched to the self-pay market in September 2023. Spain

represents the largest insomnia market in Europe, as was apparent in the first

months of this product's availability, despite it only being launched to the

self-pay market. The company is assessing the opportunity to submit a

reimbursement dossier to the Spanish authorities, in order to allow equal access

for all patients with chronic insomnia.

In the UK, QUVIVIQ was launched in October 2023. At the same time, technology

appraisal guidance was published by the National Institute for Health and Care

Excellence (NICE), allowing the transition to local access discussions and

listing by healthcare boards for England, Wales, and Northern Ireland. In April

2024, the Scottish Medicines Consortium (SMC) also accepted QUVIVIQ for use

within NHS Scotland. This means that the company has achieved full reimbursement

throughout the UK, where QUVIVIQ is now recommended as first-line pharmaceutical

treatment for patients with chronic insomnia, after, or as an alternative to,

cognitive behavioral therapy for insomnia (CBT-I). The priority in the UK now,

is to secure regional access.

In France, QUVIVIQ was launched in March 2024 as the first and only

pharmacotherapy recommended for the treatment of chronic insomnia disorder. In

January 2024, the inclusion of QUVIVIQ in both the hospital and the retail

formulary list of reimbursed pharmaceutical specialties was announced in the

French Official Gazette, together with the French public price. This official

publication means that, with a prescription from their doctor, patients with

chronic insomnia in France have access to the treatment if they meet the

requirements of the EU prescribing label for QUVIVIQ. The publication follows

the positive recommendation by the Transparency Committee in May 2023,

recognizing QUVIVIQ as providing clinical added value.

In Canada, after being approved in April 2023, QUVIVIQ was launched in November

2023 to the private market, representing 55% of the Canadian insomnia market.

The reimbursement dossier was submitted to private market payers in the third

quarter of 2023, and just a few months after the submission the team had secured

reimbursement for more than 60% of private market patients. The focus is now on

public payers with the submission to INESSS (Institut national d'excellence en

santé et en services sociaux) finalized in March 2024 and the submission to

CADTH (Canada's Drug and Health Technology Agency) expected in the second

quarter of 2024.

Jean-Yves Chatelan, President of Europe and Canada region, commented:

"The launch of Europe's first and only dual orexin receptor antagonist is

progressing well across all markets where we have made QUVIVIQ available.

Including Canada, we have expanded availability into more markets and improved

the reimbursement environment beyond many expectations. With continued positive

feedback from physicians and patients on the differentiated profile of QUVIVIQ,

I am very optimistic that the progress we have made will now translate into many

more patients benefiting from QUVIVIQ and increasing volumes advancing the

region towards profitability."

For more information about QUVIVIQ in the EU, see the Summary of Product

Characteristics (https://www.idorsia.com/documents/com/label/quviviq-smpc.pdf).

For more information about QUVIVIQ in Switzerland, see the Patient Information

(https://www.idorsia.ch/documents/com/label/quviviq-ch-patient-info.pdf) and

Information for Healthcare Professionals

(https://www.idorsia.ch/documents/com/label/quviviq-ch-info-for-hcp.pdf). For

more information on the marketing authorization of QUVIVIQ in Canada, see

the Product Monograph (https://www.idorsia.com/documents/com/label/quviviq-

product-monograph.pdf).

Research & Development

Idorsia has a diversified and balanced portfolio, comprising assets developed

and/or marketed by Idorsia and assets that are partner-led to maximize the value

we have created. Our drug discovery engine has produced innovative drugs with

the potential to transform the treatment paradigm in multiple therapeutic areas,

including CNS, cardiovascular, and immunological disorders, as well as orphan

diseases.

The company also has a vaccine platform for the discovery and development of

glycoconjugate vaccines containing synthetic antigenic glycan molecules, with or

without a carrier protein, to prevent infection.

Alberto Gimona, MD and Head of Global Clinical Development of Idorsia,

commented:

"Despite a difficult period for our organization, the team has shown

extraordinary commitment and made great progress with our portfolio. This is

particularly evident in the successful registration of aprocitentan in the US

and the positive opinion from the European Union's CHMP, with labels that

reflect the value of the compound. I was also very pleased to have found a way

for both selatogrel and cenerimod programs to be fully supported through the

collaboration with Viatris, while maintaining our involvement in their

development. I look forward to advancing the portfolio and bringing benefits to

patients in many areas of medical need."

Idorsia-led portfolio

Compound

Status

Mechanism of action

Target indication

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QUVIVIQ(TM) (daridorexant) Commercially available as QUVIVIQ in

Dual orexin receptor antagonist the US, Germany, Italy, Switzerland,

Insomnia Spain, the UK, Canada, Austria, and

France; approved throughout the EU

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TRYVIO(TM) (aprocitentan)

Dual endothelin receptor antagonist Approved as TRYVIO in the US, launch

Systemic hypertension in combination with planned for H2 2024

other antihypertensives

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JERAYGO(TM) (aprocitentan) Positive opinion from the European

Dual endothelin receptor antagonist Committee for Medicinal Products for

Resistant hypertension in combination Human Use (CHMP) received in April

with other antihypertensives 2024 - European Commission decision

expected in approx. 2 months

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Lucerastat Phase 3 primary endpoint not met;

Glucosylceramide synthase inhibitor open-label extension study ongoing

Fabry disease Phase 3 focused on renal function in

preparation

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Daridorexant

Phase 2 in pediatric insomnia

Dual orexin receptor antagonist ongoing

Pediatric insomnia

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ACT-1004-1239

ACKR3/CXCR7 antagonist Phase 2 in preparation

Demyelinating diseases including multiple

sclerosis

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Sinbaglustat

GBA2/GCS inhibitor Phase 1 complete

Rare lysosomal storage disorders

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ACT-777991

CXCR3 antagonist Phase 1 complete

Recent-onset Type 1 diabetes

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IDOR-1117-2520

Undisclosed Phase 1 ongoing

Immune-mediated disorders

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IDOR-1134-2831

Synthetic glycan vaccine Phase 1 initiating

Clostridium difficile infection

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Daridorexant

Daridorexant is a dual orexin receptor antagonist (DORA) which blocks the

binding of the wake-promoting orexin neuropeptides. Rather than inducing sleep

through broad inhibition of brain activity, daridorexant only blocks the

activation of orexin receptors. Daridorexant is commercially available as

QUVIVIQ in the US, Germany, Italy, Switzerland, Spain, the UK, Canada, Austria,

and France, and is approved throughout the EU (see "Commercial operations"

above).

A post-approval study to investigate the efficacy of daridorexant in patients

with insomnia and comorbid nocturia has completed recruitment and is expected to

report results in mid-2024 (NCT05597020).

Idorsia has initiated a Phase 2 dose-finding study to assess the efficacy,

safety, and pharmacokinetics of multiple-dose oral administration of

daridorexant in pediatric patients aged 10 to °