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
US GAAP results First
Quarter
in CHF millions, except EPS (CHF) and number of shares
(millions) 2024 2023
Net revenues 10 21
Operating expenses 20 (219)
Operating income (loss) 31 (198)
Net income (loss) 30 (212)
Basic EPS 0.17 (1.19)
Basic weighted average number of shares 179.1 178.0
Diluted EPS 0.13 (1.19)
Diluted weighted average number of shares 233.3 178.0
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/me dia-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.
Non-GAAP* measures First Quarter
in CHF millions, except EPS (CHF) and number of shares
(millions) 2024 2023
Net revenues 10 21
Operating expenses (96) (202)
Operating income (loss) (85) (181)
Net income (loss) (86) (189)
Basic EPS (0.48) (1.06)
Basic weighted average number of shares 179.1 178.0
Diluted EPS (0.48) (1.06)
Diluted weighted average number of shares 179.1 178.0
* 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.
(in CHF millions) March 31, 2024 Dec 31, 2023
Liquidity
Cash and cash equivalents 335 145
Short-term deposits - -
Total liquidity* 335 145
Indebtedness
Convertible loan 335 335
Convertible bond 797 796
Other financial debt 162 162
Total indebtedness 1,293 1,293
*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
Product Mechanism of action Indication Commercially available
since
Dual orexin receptor Treatment of adult May 2022
antagonist patients with insomnia,
characterized by
difficulties with sleep
onset and/or sleep
maintenance
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).
Product Mechanism of action Indication Commercially available
since
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
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/me dia-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
Product Mechanism of action Indication Commercially available
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
Management of adult Canada: Nov. 2023
patients with insomnia,
characterized by
difficulties with sleep
onset and/or sleep
maintenance
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
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
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
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
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
Daridorexant
Phase 2 in pediatric insomnia
Dual orexin receptor antagonist ongoing
Pediatric insomnia
ACT-1004-1239
ACKR3/CXCR7 antagonist Phase 2 in preparation
Demyelinating diseases including multiple
sclerosis
Sinbaglustat
GBA2/GCS inhibitor Phase 1 complete
Rare lysosomal storage disorders
ACT-777991
CXCR3 antagonist Phase 1 complete
Recent-onset Type 1 diabetes
IDOR-1117-2520
Undisclosed Phase 1 ongoing
Immune-mediated disorders
IDOR-1134-2831
Synthetic glycan vaccine Phase 1 initiating
Clostridium difficile infection
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 °
ISIN CH0363463438
AXC0041 2024-05-21/06:55
Relevante Links: Idorsia Ltd