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^Ad hoc announcement pursuant to Art. 53 LR
* CEO, Jean-Paul Clozel, to update on how Idorsia is being adapted for
sustainable value creation
* The company is focused on extending the cash runway beyond the current
estimate of early April 2024, through various avenues, including potential
out-licensing deals
* Postponement of the publication of Full-Year 2023 Financial Results and the
subsequent Annual General Meeting of Shareholders
Allschwil, Switzerland - January 10, 2024
Idorsia Ltd (SIX: IDIA) today announced that Jean-Paul Clozel, Chief Executive
Officer of Idorsia, will present at the J.P. Morgan Healthcare Conference on
January 10, 2024, at 10:30 PST / 19:30 CET. The conference will take place at
the Westin St. Francis hotel in San Francisco, USA.
Jean-Paul will describe how Idorsia is being adapted for sustainable value
creation. The presentation will cover the progress of QUVIVIQ(TM) (daridorexant) in
the US and Europe, and the clinical data included in the new drug application
for aprocitentan with the US Food and Drug Administration (FDA) which is
currently under review. He will also present other unencumbered assets that
provide the company with strategic flexibility and several avenues to explore
potential fundraising. Follow this link
(https://jpmorgan.metameetings.net/events/healthcare24/sessions/49264-idorsia-
pharmaceuticals-ltd/webcast?gpu_only=true&kiosk=true) to access the audio stream
and find the presentation available here
(https://www.idorsia.com/dam/jcr:3b9c11d2-a3af-4914-935a-239588d0b046/2024-
idorsia-at-jpm-investor-webcast.pdf).
Jean-Paul Clozel MD and Chief Executive Officer of Idorsia commented:
"Creating a sustainable pharma company requires scientific innovation and
substantial investment. We have demonstrated our ability to innovate and bring
new drugs to the market and have a portfolio of innovative products, however, we
have limited financing, so we need to prioritize activities that offer the
maximum return in the near term. We estimate the current cash reserves to last
to early April 2024, we therefore plan to extend the cash runway through various
avenues, including potential out-license deals."
Expected highlights in 2024
* Secure additional funding to extend the cash runway
* Expand access and availability of QUVIVIQ (daridorexant) in the US, Canada
and across Europe
* Achieve FDA decision for the NDA for aprocitentan in resistant hypertension
* Achieve EMA decision for the MAA for aprocitentan in resistant hypertension
Jean-Paul commented on the portfolio:
"More than 11 million QUVIVIQ tablets have been dispensed to help patients
achieve better nights and days. We have made great progress with access and
availability in our key markets, and I expect to see that translating into
income in 2024. I also expect aprocitentan - the first antihypertensive working
on a new pathway for 30 years - to become available for treated patients whose
hypertension remains uncontrolled. Discussions with health authorities are going
well and I'm confident that the label will reflect the outstanding results we've
seen for these high-risk patients. We also intend to progress the two global
Phase 3 programs with selatogrel and cenerimod which have the potential to
transform treatment in their target indications."
Idorsia's portfolio
-------------------------------------------------------------------------------
Product / compound Mechanism of action Therapeutic area Status
-------------------------------------------------------------------------------
Commercially
available in the
US Germany,
Italy,
Switzerland,
Spain, the UK,
and Canada;
QUVIVIQ(TM) Dual orexin receptor Approved in the
(daridorexant) antagonist Insomnia EU; Phase 2 in
pediatric
insomnia -
recruiting
Partners: Mochida
& Sosei in Japan,
Simcere in China
and Hong Kong
-------------------------------------------------------------------------------
NDA under review
in the US,
MAA under review
Dual endothelin Resistant in the EU, other
Aprocitentan receptor antagonist hypertension filings in
preparation
Partner:
Unencumbered
-------------------------------------------------------------------------------
Phase 3 primary
endpoint not met;
Glucosylceramide open-label
Lucerastat synthase Fabry disease extension study
inhibitor ongoing
Partner:
Unencumbered
-------------------------------------------------------------------------------
Phase 3
Suspected acute recruiting
Selatogrel P2Y(12) inhibitor myocardial
infarction Partner:
Unencumbered
-------------------------------------------------------------------------------
Phase 3
S1P(1) receptor Systemic lupus recruiting
Cenerimod modulator erythematosus
Partner:
Unencumbered
-------------------------------------------------------------------------------
Multiple sclerosis Phase 2 in
ACKR3 / CXCR7 and other preparation
ACT-1004-1239 antagonist demyelinating
diseases Partner:
Unencumbered
-------------------------------------------------------------------------------
Rare lysosomal Phase 1 complete
Sinbaglustat GBA2/GCS inhibitor storage
disorders Partner:
Unencumbered
-------------------------------------------------------------------------------
Phase 1
ACT-1014-6470 C5aR1 antagonist Immune-mediated
disorders Partner:
Unencumbered
-------------------------------------------------------------------------------
Phase 1
ACT-777991 CXCR3 antagonist Recent-onset Type
1 diabetes Partner:
Unencumbered
-------------------------------------------------------------------------------
Phase 1
IDOR-1117-2520 Undisclosed Immune-mediated
disorders Partner:
Unencumbered
-------------------------------------------------------------------------------
Phase 1 in
Synthetic glycan Clostridium preparation
IDO-090 vaccine difficile
infection Partner:
Unencumbered
-------------------------------------------------------------------------------
Neurocrine Biosciences has a global license to develop and commercialize ACT-
709478 (NBI-827104), Idorsia's novel T-type calcium channel blocker.
On July 20, 2023, Idorsia sold its operating businesses in the Asia Pacific (ex-
China) region to Sosei Heptares, including the assignment of the license for
PIVLAZ (clazosentan) for the Asia Pacific (ex-China) region. Idorsia retains the
rights to clazosentan in the rest of the world.
Further details including the current status of each project in our portfolio
can be found in our innovation fact sheet
(https://www.idorsia.com/dam/jcr:ed5ae81e-28cc-4040-b984-f7b1be039bd1/fs-
innovation-portfolio.pdf).
Upcoming Financial Updates
The company has decided to postpone the publication of Full-Year 2023 Financial
Results and the subsequent Annual General Meeting of Shareholders.
* Full-Year 2023 and First Quarter 2024 Financial Results reporting on April
25, 2024
* Annual General Meeting of Shareholders on June 13, 2024
* Half-Year 2024 Financial Results reporting on July 25, 2024
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 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 and North America - 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 800 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 (mailto:investor.relations@idorsia.com)
media.relations@idorsia.com (mailto:media.relations@idorsia.com)
www.idorsia.com (http://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.
°
Quelle: dpa-AFX
