For Idorsia, sophisticated partnerships are a way of gaining strategic access to technologies or products and fully exploiting our discovery engine and clinical pipeline. In general, we seek suitable external project partners to maximize the value of internal innovation.

Johnson & Johnson

In 2017, Idorsia and Actelion Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, entered into a revenue-sharing agreement in respect of ponesimod.

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In 2021, ponesimod was approved and subsequently launched in the US, Europe, and Canada to treat patients with relapsing forms of multiple sclerosis. Under the terms of the revenue-sharing agreement, Idorsia is entitled to receive quarterly payments of 8% of the net sales of ponesimod products from Actelion Pharmaceuticals Ltd.

www.investor.jnj.com

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Janssen Biotech, Inc.

In 2017, Idorsia entered into a collaboration agreement with Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to jointly develop aprocitentan and any of its derivative compounds or products. Janssen Biotech has sole commercialization rights worldwide. The Phase 3 study of aprocitentan in patients with resistant hypertension reported positive results in May 2022.

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Idorsia received a one-time milestone payment of USD 230 million. Both parties have joint development rights over aprocitentan. Idorsia has conducted the Phase 3 development and will be responsible for the regulatory submission for the treatment of patients whose hypertension is not adequately controlled. The costs are shared equally between both partners. Janssen Biotech, Inc. has sole commercialization rights worldwide, whereas Idorsia is entitled to receive tiered royalties on annual net sales in each calendar year (20% up to USD 500 million, 30% from USD 500 million up to USD 2.0 billion, and 35% above USD 2.0 billion) for the licensed products in the collaboration indications. Janssen Biotech, Inc. will oversee the Phase 3 development and submission for any additional indications.

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Antares Pharma

In 2019, Idorsia entered into a global agreement with Antares Pharma to develop a novel drug-device product combining selatogrel – Idorsia’s potent, fast-acting, reversible and highly selective P2Y12 receptor antagonist – with the Antares subcutaneous QuickShot® auto-injector. In 2021, Idorsia initiated the Phase 3 study SOS-AMI with the selatogrel drug-device for the treatment of suspected acute myocardial infarction.

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With almost 20 years of experience, Antares has a proven track record in developing and commercializing complex drug device products that are tailored to the patient and the therapeutic need.

Idorsia will pay for the development of the drug device product and will be responsible for applying for and obtaining global regulatory approvals for the product.

The parties intend to enter into a separate commercial license and supply agreement pursuant to which Antares will provide fully assembled and labelled product to Idorsia at cost plus margin. Idorsia will then be responsible for global commercialization of the product, pending regulatory approval.

Antares will be entitled to receive royalties on net sales of the commercial product.

www.antarespharma.com

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Mochida

In 2019, Idorsia and Mochida Pharmaceutical entered into an exclusive license agreement for the supply, co-development and co-marketing of daridorexant, Idorsia’s dual orexin receptor antagonist (DORA), for insomnia and related disorders in Japan.

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Idorsia will receive an initial payment of 1 billion Japanese yen (approximately 9 million Swiss francs) and will be entitled to three additional development and regulatory milestones. Idorsia will also be entitled to sales milestones and tiered royalty payments based on net sales achieved by Mochida. Costs associated with the co-development of daridorexant will be shared.

With regards to the future development program, Idorsia will be responsible for the design and conduct of additional preclinical and clinical studies, and for health authority registration, with oversight from a Joint Development Committee. Should Idorsia wish to out-license daridorexant for use in any field other than insomnia and related disorders to a third party in Japan, Mochida will be offered the right of first refusal.

www.mochida.co.jp

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Neurocrine

In 2020, Idorsia entered into a global license agreement with Neurocrine Biosciences for the development and commercialization of ACT-709478, Idorsia’s potent, selective, orally active and brain-penetrating T-type calcium channel blocker, for the treatment of a rare form of pediatric epilepsy; in addition, a research collaboration was established to discover, identify and develop additional novel T-type calcium channel blockers. In 2021, Neurocrine also initiated a Phase 2 study in essential tremor.

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In 2019, Neurocrine Biosciences paid a $5 million upfront fee to Idorsia for the option rights to ACT-709478 and a preclinical research collaboration. In May 2020, upon Investigational New Drug (IND) application acceptance by the US Food and Drug Administration (FDA), Neurocrine Biosciences exercised the option to license ACT-709478. The exercise of the option triggered an upfront payment of $45 million in cash from Neurocrine Biosciences to Idorsia. In addition, Neurocrine Biosciences provided an incremental $7 million in funding to Idorsia as part of the research collaboration to discover, identify and develop additional novel T-type calcium channel blockers. In January 2022, the research collaboration was extended for a further year.

The agreement is subject to the following terms:

  • ACT-709478 milestones: In addition to the up-front payment, Idorsia may also receive up to $365 million in additional development and regulatory milestone payments. Furthermore, Idorsia may also be entitled to one-time commercial payments based on sales thresholds.
  • ACT-709478 royalties: Idorsia will have the right to receive a tiered royalty ranging from the low double-digits to upper teen percentage in the US and a tiered royalty at slightly lower rates outside the US based upon aggregate global net sales.
  • Preclinical research collaboration: The parties will work together to identify novel T-type channel blockers and explore their use in potential new disease states. Idorsia may be entitled to additional development, regulatory and commercial milestones as well as tiered royalties on annual sales for each product included in the research collaboration.

www.neurocrine.com

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Santhera

In 2020, Idorsia’s license, collaborative development and commercialization agreement with ReveraGen BioPharma in respect of vamorolone was transferred in its entirety to Santhera Pharmaceuticals, with the latter replacing Idorsia as a party to the agreement.

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As part of this transition, Santhera exercised the option to obtain the worldwide rights to vamorolone in Duchenne Muscular Dystrophy and all other indications from ReveraGen.

In exchange for the assignment and transfer of the agreement, Idorsia received 0.4 million shares of Santhera and an exchangeable note in the amount of CHF 10 million, which was redeemed against a payment in cash of CHF 3.5 million and 3.6 million shares in Santhera.

Idorsia will be entitled to development and sales milestones, as well as low single-digit percentage payments on net sales of vamorolone.

www.santhera.com

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Syneos Health

In 2020, Idorsia and Syneos Health entered into an innovative commercial partnership to build the salesforce for the US launch of QUVIVIQ™ (daridorexant). In January 2022, Idorsia expanded this commercialization partnership to support the potential launch of daridorexant and effectively reach the primary care market in Europe and Canada.

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The strategic collaboration brings Idorsia’s lead investigational compound, daridorexant, and expertise in the science of the orexin system, together with Syneos Health’s robust customer-facing sales expertise and proven track record in launching new products.

Idorsia is building the core capabilities needed to successfully launch daridorexant, while collaborating with Syneos Health in order to effectively reach the primary care market, which accounts for a large volume of insomnia prescriptions. Together the companies will collaborate to lead the transformation and modernization of the insomnia market.

www.syneoshealth.com

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