Idorsia presents at the J.P. Morgan Healthcare Conference – Adapting Idorsia
for sustainable value creation
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™ (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 to access the audio stream and
find the presentation available here .
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 QUVIVIQ™
(daridorexant) Dual orexin receptor
antagonist Insomnia Commercially available in the US Germany, Italy,
Switzerland, Spain, the UK, and Canada; Approved in the EU; Phase 2 in
pediatric insomnia – recruiting
Partners: Mochida & Sosei in Japan, Simcere in China and Hong Kong
Aprocitentan Dual endothelin receptor antagonist Resistant hypertension NDA
under review in the US,
MAA under review in the EU, other filings in preparation
Partner: Unencumbered Lucerastat Glucosylceramide synthase
inhibitor Fabry disease Phase 3 primary endpoint not met; open-label extension
study ongoing
Partner: Unencumbered Selatogrel P2Y 12 inhibitor Suspected acute myocardial
infarction Phase 3 recruiting
Partner: Unencumbered Cenerimod S1P 1 receptor modulator Systemic lupus
erythematosus Phase 3 recruiting
Partner: Unencumbered ACT-1004-1239 ACKR3 / CXCR7 antagonist Multiple
sclerosis and other demyelinating diseases Phase 2 in preparation
Partner: Unencumbered Sinbaglustat GBA2/GCS inhibitor Rare lysosomal storage
disorders Phase 1 complete
Partner: Unencumbered ACT-1014-6470 C5aR1 antagonist Immune-mediated disorders
Phase 1
Partner: Unencumbered ACT-777991 CXCR3 antagonist Recent-onset Type 1 diabetes
Phase 1
Partner: Unencumbered IDOR-1117-2520 Undisclosed Immune-mediated disorders
Phase 1
Partner: Unencumbered IDO-090 Synthetic glycan vaccine Clostridium difficile
infection Phase 1 in preparation
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 .
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
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.
Anhang Medienmitteilung PDF