DUBLIN – Idorsia Pharmaceuticals Ltd. is raising up to CHF521 million (US$525 million) in a mix of equity and debt to fund a slew of phase III development programs that have gotten underway in recent weeks. (See BioWorld, May 17, 2018, and June 12, 2018.)

The company announced after the market closed Tuesday plans to offer up to 11.9 million shares through an accelerated book-building process and to raise up to CHF200 million more in convertible bonds. It did not disclose pricing information, but the stock component of the offering would generate gross proceeds of CHF321.1 million if priced at Tuesday's closing price of CHF26.96 (ZURICH:IDIA). The outcome of the offering will be reported Wednesday, prior to market opening.

Idorsia's main shareholders, CEO Jean-Paul Clozel and Chief Scientific Officer Martine Clozel, who have a 28.4 percent stake in the company, are participating in both the share and bond offerings on a pro rata basis. It's the first cash call for Idorsia since it was spun out of Actelion Ltd. in June 2017.

The Allschwil, Switzerland-based company has set its stall out as Actelion 2.0 from the get-go, operating at a scale and speed that is unusual, if not unprecedented, for a European biopharma company. Unlike its former parent – which Johnson & Johnson, of New Brunswick, N.J., acquired last year for $30 billion – Idorsia began life as a listed company with some CHF1 billion on its balance sheet. By year-end, it added another $230 million, as J&J's Janssen Biotech arm exercised an option to co-develop aprocitentan (ACT-132577), a dual endothelin receptor antagonist now in phase III trials for treating resistant hypertension.

It's one of just four development programs that are either in phase III or soon will be – and is the only one that it is not fully funding itself. Also in phase III are lucerastat, a glucosylceramide synthase inhibitor in development for the X-linked lysosomal storage disorder Fabry disease, and nemorexant, a dual orexin receptor antagonist, in development for insomnia. Clazosentan, a selective endothelin A receptor antagonist, will shortly enter phase III trials for treating vasospasm – a sudden constriction of a blood vessel – associated with aneurysmal subarachnoid hemorrhage (aSAH), a form of brain hemorrhage. A registration trial is ongoing in Japan, with data due later this year.

It's the second time around for a drug that failed a pivotal phase III program in the same indication back in 2010. Since then, Idorsia has established that a higher dose – 15 mg per hour – explored in one prematurely terminated study (Conscious-3) resulted in a 44 percent relative risk reduction of all-cause morbidity and mortality. The study in Japan, where the problem has double the prevalence of other countries, has employed a 10-mg/hour dose. (See BioWorld Today, Sept. 28, 2010.)

Idorsia exited the first quarter this year with CHF1.016 billion on its balance sheet, as well as debt of CHF367 million. It racked up CHF73 million in operating expenses and has guided about CHF390 million in operating expenditure for the whole year.

The stock component of the transaction is likely to be the largest equity raise by a European firm so far this year. Privately held immuno-oncology firm Biontech AG, of Mainz, Germany, took in $270 million in a series A round in January, while Hellerup, Denmark-based specialty pharma firm Ascendis Pharma A/S took in $258.7 million in a follow-on offering on Nasdaq and Martinsried, Germany-based antibody developer Morphosys AG raised $239 million when listing on Nasdaq.