Idorsia announces financial results for the first quarter 2023 –
QUVIVIQ now the leading branded insomnia medicine in the commercial
market in the US
Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland – April
25, 2023
Idorsia Ltd (SIX: IDIA) today announced its financial results
for the first quarter of 2023.
Commercial highlights
- QUVIVIQ™ (daridorexant) total net sales of CHF
4.3 million in Q1 2023
- QUVIVIQ in the
US: Now the leading branded insomnia
medicine in new-to-brand prescriptions (NBRx) and total
prescriptions (TRx) in the commercial market. Net sales do not
reflect the volume as broad commercial coverage is under
negotiation.
- QUVIVIQ in
Europe: Demand continues to grow in
Germany and Italy
- PIVLAZ®
(clazosentan): Treated more than
5,000 patients in the first year of availability, with net sales of
CHF 13.5 million in Q1 2023, and approximately 27% of aSAH patients
treated with PIVLAZ in the month of March.
Pipeline highlights
- Aprocitentan – NDA accepted for review by the
US FDA – PDUFA December 19, 2023
- Aprocitentan – MAA submitted to the EMA at the
end of January 2023
Financial highlights
- Net revenue Q1 2023 at CHF 21
million
- US GAAP operating expenses Q1 2023 at CHF 219
million and non-GAAP operating
expenses Q1 2023 at CHF 202 million
- US GAAP operating loss Q1 2023 of CHF 198
million and non-GAAP operating
loss of CHF 181 million
- Guidance for
2023: The company is
committed to manage operating expenses in order to deliver US GAAP
operating loss of around CHF 735 million and non-GAAP operating
loss of around CHF 650 million – unforeseen events excluded
- Fundraising: With a liquidity of CHF 212
million at the end of Q1 2023 and the current guidance for 2023 –
the company is pursuing options including non-equity dilutive
funding avenues and/or equity raise should it be needed, to extend
the cash runway
- Profitability target: The company is
committed to become profitable in 2025 with global revenue above
CHF 1 billion
Jean-Paul Clozel, MD and Chief Executive Officer,
commented:“The company continues to deliver on the
strategic priorities and make progress on many fronts. PIVLAZ has
been available in Japan for a year now and more than 5,000 patients
have been treated, a great result. QUVIVIQ is approaching one year
on the market in the US, and it is already the number one branded
insomnia treatment in the commercial market. While there has been a
delay in securing reimbursement, progress has been made and the
situation is steadily improving. Demand is good and growing,
feedback from patients and prescribers is excellent, and refills
are accelerating. Uptake in the first markets of Europe is also
strong, with more markets set to launch in the coming year. We will
adapt our cost-base to accommodate the delay in reimbursement and
we are very active on several non-dilutive opportunities to extend
the cash runway. For a company based on science, that started from
zero less than 6 years ago, and launched two products in the past
year, there are many reasons to believe in Idorsia’s bright
future.”
Financial results
US GAAP results |
|
First Quarter |
in CHF millions, except EPS (CHF) and number of shares
(millions) |
|
|
2023 |
2022 |
Net revenues |
|
|
21 |
5 |
Operating expenses |
|
|
(219) |
(198) |
Operating income (loss) |
|
|
(198) |
(193) |
Net income (loss) |
|
|
(212) |
(198) |
Basic EPS |
|
|
(1.19) |
(1.12) |
Basic weighted average number of shares |
|
|
178.0 |
177.1 |
Diluted EPS |
|
|
(1.19) |
(1.12) |
Diluted weighted average number of shares |
|
|
178.0 |
177.1 |
US GAAP net revenue of CHF 21 million in the first quarter of
2023 (CHF 5 million in the first quarter of 2022) consisted of
product sales of QUVIVIQ (CHF 4.3 million) and PIVLAZ (CHF 13.5
million), contract revenue recognized in connection with Mochida
Pharmaceutical Co., Ltd (CHF 1 million) and Neurocrine Biosciences,
Inc. (CHF 1 million), and revenue share from Johnson &
Johnson (CHF 1 million).
US GAAP operating expenses in the first quarter of 2023 amounted
to CHF 219 million (CHF 198 million in the first quarter of 2022),
of which CHF 1 million related to cost of sales (no cost of sales
in the first quarter of 2022), CHF 93 million to R&D expenses
(CHF 95 million in the first quarter of 2022) and CHF 125 million
to SG&A expenses (CHF 103 million in the first quarter of
2022).
US GAAP net loss in the first quarter of 2023 amounted to CHF
212 million (CHF 198 million in the first quarter of 2022). The
increase of the net loss was mainly driven by higher operating
expenses, largely in the commercial functions, a negative financial
result and partially offset by higher net revenues.
The US GAAP net loss resulted in a net loss per share of CHF
1.19 (basic and diluted) in the first quarter of 2023, compared to
a net loss per share of CHF 1.12 (basic and diluted) in the first
quarter of 2022.
Non-GAAP* measures |
|
First Quarter |
in CHF millions, except EPS (CHF) and number of shares
(millions) |
|
|
2023 |
2022 |
Net revenues |
|
|
21 |
5 |
Operating expenses |
|
|
(202) |
(188) |
Operating income (loss) |
|
|
(181) |
(183) |
Net income (loss) |
|
|
(189) |
(189) |
Basic EPS |
|
|
(1.06) |
(1.07) |
Basic weighted average number of shares |
|
|
178.0 |
177.1 |
Diluted EPS |
|
|
(1.06) |
(1.07) |
Diluted weighted average number of shares |
|
|
178.0 |
177.1 |
* 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 2023 amounted
to CHF 189 million: the CHF 23 million difference versus US GAAP
net loss was mainly due to depreciation and amortization (CHF 4
million), and share-based compensation (CHF 12 million) and a loss
on marketable securities (CHF 7 million).
The non-GAAP net loss resulted in a net loss per share of CHF
1.06 (basic and diluted) in the first quarter of 2023, compared to
a net loss per share of CHF 1.07 (basic and diluted) in the first
quarter of 2022.
Creation of Treasury SharesIn January 2023, the
Company created 10.0 million treasury shares with a nominal value
of CHF 0.05 each, thereby increasing its registered share
capital from CHF 8,848,349.75 to CHF 9,348,349.75. The new
shares, created on January 6, 2023, out of the Company’s authorized
share capital, were subscribed at nominal value by Idorsia
Pharmaceuticals Ltd, a wholly owned subsidiary, and were listed on
the SIX Swiss Exchange on January 9, 2023. With this increase, the
Company holds treasury shares that can be used in a cash
preservative manner for potential share-based compensation,
effective fund raising, or business development purposes.
Financial outlookPIVLAZ (clazosentan) is
available in Japan and QUVIVIQ (daridorexant) in the US, Germany,
and Italy, and additional launches are anticipated in Switzerland
and the UK during 2023. Regulatory applications for aprocitentan
have been filed with the FDA and the EMA. Phase 3 studies with
selatogrel and cenerimod are expected to be actively recruiting
throughout 2023. The company is prioritizing those projects in drug
discovery and early clinical pipeline that are expected to result
in the greatest return in the near term, as well as seeking
partnership opportunities to share risk and rewards. The company
therefore expects US GAAP operating loss of around CHF 735 million
and non-GAAP operating loss of around CHF 650 million – unforeseen
events excluded.
André C. Muller, Chief Financial Officer,
commented:“Due to the slower than expected speed of payer
coverage and resulting uncertainties in the US revenue development,
the company is taking steps to manage its operating expenses in
order to deliver on our 2023 guidance – unforeseen events excluded.
Furthermore, we must address our near-term liquidity needs. Hence,
we are pursuing non-equity dilutive funding avenues, while
preparing an equity raise should it be needed, to extend the cash
runway.”
Liquidity and indebtednessAt the end of the
first quarter of 2023, Idorsia’s liquidity amounted to CHF 212
million.
(in CHF millions) |
|
Mar 31, 2023 |
Dec 31, 2022 |
Liquidity |
|
|
|
Cash and cash equivalents |
|
212 |
146 |
Short-term deposits |
|
- |
320 |
Long-term deposits |
|
- |
- |
Total liquidity* |
|
212 |
466 |
|
|
|
|
Indebtedness |
|
|
|
Convertible loan |
|
335 |
335 |
Convertible bond |
|
795 |
795 |
Other financial debt |
|
162 |
162 |
Total indebtedness |
|
1,292 |
1,292 |
*rounding differences may occur
Commercial operationsIn 2022, Idorsia launched
two products in different markets, QUVIVIQ™ (daridorexant) in the
US and the first countries in Europe, and PIVLAZ® (clazosentan) in
Japan, generating total product sales of CHF 18 million in Q1
2023.
United
States
Product |
Mechanism of
action |
Indication |
Commercially available since |
|
Dual orexin receptor antagonist |
Treatment of adult patients with insomnia, characterized by
difficulties with sleep onset and/or sleep maintenance |
May 2022 |
QUVIVIQ (daridorexant) continues to gain
traction in the US insomnia market. After just 11 months, QUVIVIQ
has surpassed all other branded insomnia medications in
new-to-brand prescriptions. Along with this, refills continue to
increase – leading to strong growth in total prescriptions in the
first quarter, with over 22,000 prescriptions of QUVIVIQ dispensed
in March alone.
Net sales in the first quarter of 2023 reached CHF 3 million. To
enable early patient access to QUVIVIQ, Idorsia continues to offer
a strong copay program, including a free first 30-day prescription.
However, due to this approach, the net sales numbers do not reflect
actual dispensed prescriptions or product demand. Today, QUVIVIQ is
covered by Express Scripts National Preferred Formulary (NPF) and
Tricare Uniform Formulary, which together represent over 32 million
lives in the US. The company continues to actively engage with
other commercial and Part D payers.
Additionally, earlier this month the company filed a Citizen
Petition with the United States Drug Enforcement Administration
(DEA) requesting that the DORA class of insomnia medications be
de-scheduled and removed from the controlled substance list (they
are currently schedule IV medications in the US). The Citizen
Petition outlines 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. Idorsia is
confident that there is a solid and compelling case and hopes the
DEA acts expeditiously on the petition. De-scheduling the class
would remove many access barriers for patients and prescribing
complications for physicians.
For more information about QUVIVIQ in the US, see the Full
Prescribing Information (PI and Medication Guide).
Simon Jose, Chief Commercial Officer of Idorsia,
commented:“It’s great to see QUVIVIQ is now the leading
insomnia brand in the US commercial market in terms of
prescriptions. Although payer access has been slower than
anticipated, we have secured access with ESI and TriCare and are in
active discussions with other major payers. As further
reimbursement is secured, we expect paid prescriptions to continue
to increase, boosting net sales. Equally important to establishing
QUVIVIQ as the leading branded treatment for insomnia is
transforming and modernizing the entrenched, generic market we have
entered.”
Europe and Canada region
Product |
Mechanism of
action |
Indication |
Commercially available |
|
Dual orexin receptor antagonist |
Treatment of adult patients with insomnia characterized by symptoms
present for at least three months and considerable impact on
daytime functioning |
Germany: Nov 2022Italy: Nov 2022 |
In April 2022, marketing authorization for QUVIVIQ was granted
by the European Commission and subsequently by the Medicines and
Healthcare products Regulatory Agency (MHRA) in Great Britain. In
November 2022, QUVIVIQ was launched in Italy and Germany. Launch
preparations are underway in the UK, with a target launch in the
second half of 2023, later followed by Spain and France. For more
information about QUVIVIQ in the EU, see the Summary of Product
Characteristics. Marketing authorization for QUVIVIQ was granted by
Swissmedic in December 2022, and the company aims to make QUVIVIQ
available to patients in Switzerland in June 2023. For more
information about QUVIVIQ in Switzerland, see the Patient
Information and Information for Healthcare Professionals. The
review of daridorexant by Health Canada is expected to reach its
conclusion in the coming weeks.
The launches in Germany and Italy are progressing well with
positive feedback from physicians and patients to the
differentiated profile of QUVIVIQ, the first and only dual orexin
receptor antagonist available in Europe. In addition to educating
healthcare professionals on the clinical data for QUVIVIQ, the
local teams are raising awareness on the burden of chronic
insomnia, as highlighted in the recent publication of the RAND
report, “The Societal and Economic Burden of Insomnia in Adults: An
International Study.” Pricing and reimbursement processes are
underway in key European markets to secure access to QUVIVIQ for
chronic insomnia patients. Net sales in the first quarter of 2023
in Germany and Italy were CHF 1 million.
Japan
Product |
Mechanism of
action |
Indication |
Commercially available since |
|
Endothelin receptor antagonist |
Prevention of cerebral vasospasm, vasospasm-related cerebral
infarction and cerebral ischemic symptoms after aneurysmal
subarachnoid hemorrhage (aSAH) |
April 2022 |
PIVLAZ (clazosentan) was launched in Japan in
April 2022 for the prevention of cerebral vasospasm,
vasospasm-related cerebral infarction and cerebral ischemic
symptoms in patients suffering from aneurysmal subarachnoid
hemorrhage (aSAH). Neurosurgeons in Japan are incorporating PIVLAZ
into aSAH treatment protocols and approximately 27% of Japanese
aSAH patients were treated with PIVLAZ in March based on the
estimated incidence of aSAH. Awareness of PIVLAZ has reached over
95% among target neurosurgeons in Japan as the local customer
facing teams continue to share the clinical data demonstrating the
efficacy and safety of PIVLAZ in Japanese patients. Net sales in
the first quarter of 2023 were CHF 13 million.
Clinical developmentIdorsia's
diversified and balanced clinical development pipeline – covering
multiple therapeutic areas, including CNS, cardiovascular and
immunological disorders, as well as orphan diseases – is on track
and progressing as described in the full year 2022 financial
results press release.
Idorsia’s portfolio
Product / compound |
Mechanism of action |
Therapeutic area |
Status |
PIVLAZ®(clazosentan) |
Endothelin receptor antagonist |
Cerebral vasospasm assoc. with aneurysmal subarachnoid
hemorrhage |
Commercially available in Japan |
QUVIVIQ™
(daridorexant) |
Dual orexin receptor antagonist |
Insomnia |
Commercially available in the US Germany and
Italy;approved in the EU, UK and Switzerland;under review in
Canada;Filing in Japan expected in H2 2023;Phase 2 in pediatric
insomnia – recruiting |
Aprocitentan* |
Dual endothelin receptor antagonist |
Difficult-to-control (resistant) hypertension |
NDA under review in the US, MAA under review in the EU, other
filings in preparation |
Lucerastat |
Glucosylceramide synthase inhibitor |
Fabry disease |
Phase 3 primary endpoint not met, OLE ongoing** |
Selatogrel |
P2Y12 inhibitor |
Suspected acute myocardial infarction |
Phase 3 recruiting |
Cenerimod |
S1P1 receptor modulator |
Systemic lupus erythematosus |
Phase 3 recruiting |
ACT-1004-1239 |
ACKR3 / CXCR7 antagonist |
Multiple sclerosis and other demyelinating diseases |
Phase 2 in preparation |
Sinbaglustat |
GBA2/GCS inhibitor |
Rare lysosomal storage disorders |
Phase 1 complete |
ACT-1014-6470 |
C5aR1 antagonist |
Immune-mediated disorders |
Phase 1 |
ACT-777991 |
CXCR3 antagonist |
Recent-onset Type 1 diabetes |
Phase 1 |
IDOR-1117-2520 |
Undisclosed |
Immune-mediated disorders |
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 was investigated in a Phase 2
study for the treatment of a rare form of pediatric epilepsy. The
study did not meet the primary endpoint. ACT-709478 was generally
well tolerated. Neurocrine continues to analyze the data generated
in the study.
Further details including the current status of each project in
our portfolio can be found in our innovation fact sheet.
Note to ShareholdersThe Annual General Meeting
(AGM) of Shareholders to approve the Annual Report of the year
ending December 31, 2022, will be held on Thursday, May 4, 2023, at
09.00 CEST at the Congress Center, Messe Basel, Switzerland.
The invitation was published in the Swiss Official Gazette of
Commerce (Schweizerisches Handelsamtsblatt) and distributed to
Shareholders by post. It is also available, together with the
Company’s Annual Report and Compensation Report,
on www.idorsia.com/agm.
In order to attend and vote at the AGM, shareholders must be
registered in the company's shareholder register by April 25, 2023,
17:00 CEST, at the latest.
Results Day CenterInvestor community: To make
your job easier, we provide all relevant documentation via the
Results Day Center on our corporate website:
www.idorsia.com/results-day-center.
Upcoming Financial Updates
- Annual General Meeting of Shareholders on May 4, 2023
- Half-Year 2023 Financial Results reporting on July 25,
2023
- Nine-Months 2023 Financial Results reporting on October 24,
2023
- Full-Year 2023 Financial Results reporting on February 6,
2024
Notes to the editor
About IdorsiaIdorsia 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 20-year heritage of drug
discovery, a broad portfolio of innovative drugs in the pipeline,
an experienced team of professionals covering all disciplines from
bench to bedside, and commercial operations in Europe, Japan, and
the US – the ideal constellation for bringing innovative medicines
to patients.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol:
IDIA) in June 2017 and has over 1,300 highly qualified specialists
dedicated to realizing our ambitious targets.
For further information, please contactAndrew
C. WeissSenior Vice President, Head of Investor Relations &
Corporate CommunicationsIdorsia Pharmaceuticals Ltd,
Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10
10investor.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.
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