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.
Making the money last
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.
Phase 3 open-label extension study ongoing – kidney biopsy sub-study results expected in Q2 2025 – regulatory pathway to be further discussed with FDA.
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.
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.
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.
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.
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.
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
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.
