Idorsia presents at J.P. Morgan Healthcare Conference 2025 –
fighting to create value for all stakeholders
Ad hoc announcement pursuant to Art. 53 LR
- Presentation to take place on January 15, 2025, at 15:00 PST /
00:00 CET and will be available for replay on demand
Allschwil, Switzerland – January 15, 2025
Idorsia Ltd (SIX: IDIA) today announced that André C. Muller, Chief
Executive Officer of Idorsia, will present at the J.P. Morgan
Healthcare Conference on January 15, 2025, at 15:00 PST / 00:00
CET. The conference will take place at the Westin St. Francis hotel
in San Francisco, USA. Follow this link to access
the live audio stream and find the presentation available
here. A replay will be available on the company
website after the event.
André will describe the status of the prerequisite initiatives
which will allow the company to continue to operate. These include
an agreement for the global rights to aprocitentan, currently in
exclusive negotiations with an undisclosed party; the completion of
the recently announced operational restructuring; a balance sheet
restructuring, including the 2025 and 2028 convertible bonds; and
raising additional funding, as well as other strategic options.
André C. Muller, CEO of Idorsia, commented:
“The team at Idorsia has been very successful at generating
innovative drugs that can redefine the way diseases are treated.
Last year, we received approval for our third drug, an innovative
and highly differentiated treatment for uncontrolled hypertension –
a revolution for millions of potential patients. I am pleased to
take some time at J.P. Morgan to give an overview on some of our
other potentially first- or best-in-class discoveries. I believe
that it is in the best interest of all stakeholders for us to fight
as hard as possible to continue the Idorsia journey.”
André continued: “The company began 2025 with a
cash balance of just over 100 million Swiss francs which will
sustain activities until around the end of the first quarter 2025.
However, we cannot wait until then to find definitive solutions. We
have a comprehensive plan to keep Idorsia operating, but it is
dependent on reaching an agreement for the rights to aprocitentan.
I believe that an agreement can be reached, but more time is
needed, so we are exploring all options to extend the company’s
operational cash runway to bridge to a potential binding
agreement.”
André will also show that if the company is successful in
navigating the short-term priorities, a dual revenue stream model
with revenues from the company’s own commercial efforts with
QUVIVIQ, coupled with milestone payments and royalties from
partnered assets builds a strong case for significant value
creation.
The company has defined the following strategic priorities that
would drive decision-making at Idorsia:
- Unlocking the value of QUVIVIQ
We must overcome the barriers to prescription wherever we find
them, to awaken the value of QUVIVIQ for all our stakeholders.
- Nurturing strong alliances
Idorsia often retains a vested interest in the success of our
partnered products. Supporting our partners will maximize the value
of our innovation.
- Leveraging our innovative pipeline
To attract potential partners, the R&D team will generate
preclinical and clinical evidence enabling others to recognize the
value of our innovation in a portfolio for out-licensing.
- Targeting our drug discovery
Our specialized drug discovery engine will focus on
small-molecule therapies designed to redefine the way diseases are
treated.
We will exercise financial discipline, spending within our
means, and thus paving the way to sustainable profitability.
Research & Development portfolio
The company has focused its drug discovery efforts, reducing the
number of active projects in research and development and preparing
some for out-licensing. Each project or portfolio compound has been
assessed – in the context of the competitive landscape – for the
feasibility of Idorsia being able to develop alone or how we can
generate preclinical and clinical proof-of-concept data enabling
others to recognize the value of the asset. The prioritization has
resulted in an Idorsia-led portfolio with a combination of assets
where Idorsia intends to develop to the next inflection point and
when feasible and appropriate, even further, and a partner-led
portfolio of assets already partnered, as described below.
Idorsia-led portfolio
The company will develop each asset to the next inflection point or
seek a partner.
Compound
Mechanism of action
Target indication |
Status |
QUVIVIQ™ (daridorexant)
Dual orexin receptor antagonist
Insomnia |
Commercialized by Idorsia in the US, Germany, Italy, Switzerland,
Spain, the UK, Canada, Austria, France, and Sweden; approved
throughout the EU. |
Lucerastat
Glucosylceramide synthase inhibitor
Fabry disease |
Phase 3 open-label extension study ongoing – kidney biopsy
sub-study results expected in Q2 2025 – regulatory pathway to be
further discussed with FDA. |
Daridorexant
Dual orexin receptor antagonist
Pediatric insomnia |
Phase 2 in pediatric insomnia expected to read out results in Q3
2025. |
ACT-777991
CXCR3 receptor antagonist
Vitiligo |
Idorsia will conduct a proof-of-concept study for patients with
vitiligo. Unique precision medicine with a dual targeting of CD8+
CXCR3+ T cells offers potential for a first-in-class targeted
systemic therapy for effective and safer treatment of
immuno-dermatology and autoimmune disorders. |
ACT-1004-1239
ACKR3 receptor antagonist
Progressive multiple sclerosis |
Idorsia will conduct a proof-of-concept study for patients with
progressive MS. Unique combination of re-myelination and
anti-inflammatory effect with decreased inflammatory cell
infiltration. |
IDOR-1117-2520
CCR6 receptor antagonist
Immune-mediated disorders |
Phase 1 program ongoing. Unique potential as a first-in-class,
oral, targeted systemic therapy for effective treatment of
Th17-driven immuno-dermatology and autoimmune disorders. |
ACT-1016-0707
LPA 1 receptor antagonist
Immune-mediated and fibrosis related
disorders |
Entry-into-human package complete. Potential best-in-class due to
insurmountable binding mode – proven inhibitory activity in
preclinical models of inflammation and fibrosis. |
IDOR-1141-8472
Orexin 2 receptor agonist
Orexin-related CNS disorders |
Entry-into-human package ready to begin. Potential best-in-class –
sustained chronic efficacy in a preclinical model of
narcolepsy. |
IDOR-1126-6421
Undisclosed mechanism
Organ injury |
Entry-into-human package in progress. Broad potential of
undisclosed mechanism for inhibiting organ injury and fibrosis –
proven effectiveness in several preclinical models of organ
injury. |
|
|
Synthetic Glycan Vaccine Platform |
Idorsia will seek a partner for the platform or individual
vaccines. |
IDOR-1134-2831
Synthetic glycan vaccine
Clostridium difficile
infection |
Idorsia is conducting a Phase 1 clinical pharmacology study which
has the potential to show whether the vaccine induces an immune
response. Results expected in Q2 2025. |
IDOR-1142-0810
Synthetic glycan vaccine
Klebsiella pneumonia
infection |
Entry-into-human package in progress. |
Partner-led portfolio
Compound
Mechanism of action
Target indication |
Partner/status |
TRYVIO™ (aprocitentan)
Dual endothelin receptor antagonist
Systemic hypertension in combination with other
antihypertensives |
To be defined: worldwide development and
commercialization rights
Commercially available in the US |
JERAYGO™ (aprocitentan)
Dual endothelin receptor antagonist
Resistant hypertension in combination with other
antihypertensives |
To be defined: worldwide development and
commercialization rights
Approved in the EU and UK; Marketing authorization applications
submitted in Canada, and Switzerland |
QUVIVIQ™ (daridorexant)
Dual orexin receptor antagonist
Insomnia |
Nxera Pharma: license to develop and commercialize
for Asia-Pacific region (excluding China)
Launched for the treatment of insomnia in Japan; Phase 3 ongoing in
South Korea |
Daridorexant
Dual orexin receptor antagonist
Insomnia |
Simcere: license to develop and commercialize for
Greater China region
NDA submitted in Greater China; approved for the treatment of
insomnia in Hong-Kong |
Selatogrel
P2Y12 inhibitor
Acute myocardial infarction |
Viatris: worldwide development and
commercialization rights
Phase 3 “SOS-AMI” program ongoing |
Cenerimod
S1P1 receptor modulator
Systemic lupus erythematosus |
Viatris: worldwide development and
commercialization rights (excluding Japan, South Korea, and certain
countries in the Asia-Pacific region)
Phase 3 “OPUS” program ongoing |
Daridorexant
Dual orexin receptor antagonist
Posttraumatic stress disorder (PTSD) |
US Department of Defense (DOD): Idorsia is
supporting a clinical study sponsored by the US DOD to develop new
therapies to treat PTSD |
ACT-1002-4391
EP2/EP4 receptor antagonist
Immuno-oncology |
Owkin: global license to develop and
commercialize
Phase 1 ongoing |
IDOR-1134-9712
CFTR Type-IV corrector
Cystic Fibrosis |
Undisclosed: Option to license following the
completion of ongoing entry-into-human package |
Non-GAAP financial guidance for the Idorsia-led business
in 2025
For 2025 – excluding unforeseen events – the company expects a
continued acceleration of QUVIVIQ with net sales of around CHF 110
million, SG&A expenses of around CHF 210 million, R&D
expense of around CHF 100 million for Idorsia-led pipeline assets,
leading to non-GAAP operating expenses of around CHF 325 million.
This performance would result in an Idorsia-led business non-GAAP
operating loss of around CHF 215 million.
Notes to the editor
About Idorsia
Idorsia Ltd is reaching out for more – we have more passion for
science, we see more opportunities, and we want to help more
patients.
The purpose of Idorsia is to challenge accepted medical
paradigms, answering the questions that matter most. To achieve
this, we will discover, develop, and commercialize transformative
medicines – either with in-house capabilities or together with
partners – and evolve Idorsia into a leading biopharmaceutical
company, with a strong scientific core.
Headquartered near Basel, Switzerland – a European biotech hub –
Idorsia has a highly experienced team of dedicated professionals,
covering all disciplines from bench to bedside; QUVIVIQ™
(daridorexant), a different kind of insomnia treatment with the
potential to revolutionize this mounting public health concern;
strong partners to maximize the value of our portfolio; a promising
in-house development pipeline; and a specialized drug discovery
engine focused on small-molecule drugs that can change the
treatment paradigm for many patients.
Idorsia is listed on the SIX Swiss Exchange (ticker symbol:
IDIA).
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.
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