Idorsia six months after demerger from Actelion posts €12M net loss, announces investing in pipeline and OPEX of €336M in 2018

Idorsia six months after demerger from Actelion posts €12M net loss, announces investing in pipeline and OPEX of €336M in 2018

February 6, 2018 Off By Dino Mustafić

Idorsia Ltd has made meaningful collaboration with industry leaders in the six and a half months since the demerger from Actelion on June 15, 2017, the company’s CEO has said Tuesday in a press release announcing the results for the first half year.

Jean-Paul Clozel, CEO of Idorsia, said: “We have made great progress in establishing Idorsia, while simultaneously advancing our pipeline without any loss of momentum. We have also entered into meaningful collaborations with industry leaders Janssen Biotech and Roche. Looking ahead, I am very excited by the prospect of advancing four compounds into Phase 3 development this year. With our substantial pipeline and these strong partnerships, we have every reason to be optimistic about our future.”

The company has reported US GAAP CHF 158 million (€136M) in the period, with CHF 166 million (€143.29) of operating expense.

The US GAAP net loss amounted to CHF 14 million (€12.1M) resulting in a net loss per share of CHF 0.13.

André C. Muller, the company’s CFO expects to have non-GAAP operating expense for this year to be around 390 million CHF (€336.6M).

Muller said: “We have a diverse pipeline with unique assets that offer significant potential to patients and investors alike. We must invest in this pipeline now in order to make Idorsia a profitable company, in a sustainable manner, as quickly as possible. With this in mind, unforeseen events and potential milestone expenses excluded, we expect non-GAAP operating expenses for 2018 to be around 390 million Swiss francs, mainly depending on when each of the different Phase 3 programs commences.”

Collaboration with JJ’s Janssen

Idorsia has a diversified and balanced clinical development pipeline covering multiple therapeutic areas, including CNS, cardiovascular and immunological disorders, as well as orphan diseases. In December 2017, Janssen Biotech exercised its option to enter into a collaboration agreement with Idorsia to jointly handle aprocitentan and any of its derivative compounds or products.

Idorsia received a one-time milestone payment of $230 million (€185). Idorsia will oversee Phase 3 development and regulatory submission for the first indication. The costs will be shared equally between the two partners. Janssen will oversee Phase 3 development and submission for any additional indications.

Orphan drug

Lucerastat for Fabry disease has received Orphan Drug designation in the US and in the EU and at the beginning of 2018, the European Medicines Agency (EMA) agreed with Idorsia’s paediatric investigation plan for lucerastat for the treatment of pediatric patients with Fabry disease.