IDORSIA LTD On July 28, 2021, Idorsia placed CHF 600 million senior unsecured convertible bonds (the "Bonds"), due 2028. The Bonds have a maturity of 7 years and are convertible into 19.0 million newly issued registered shares of Idorsia, sourced from the existing listed conditional share capital, on or after September 14, 2021.
The Bonds have a coupon of 2.125%, and a conversion price of CHF 31.54, corresponding to a conversion premium of 40% above the reference share price of CHF 22.5250, being the volume weighted average price of a share on SIX between launch and close of trading on July 28, 2021.
Liquidity and indebtedness
At the end of the first nine months of 2021, Idorsia's liquidity (including cash, cash equivalents, short- and long-term deposits) amounted to CHF 1,399 million.
(in CHF millions) Sep 30, 2021 Jun 30, 2021 Dec 31, 2020 -------------------------- ------------ ------------ ------------ Liquidity -------------------------- ------------ ------------ ------------ Cash and cash equivalents 122 164 141 --------------------------- ------------ ------------ ------------ Short-term deposits 1,117 763 867 --------------------------- ------------ ------------ ------------ Long-term deposits 160 - 192 --------------------------- ------------ ------------ ------------ Total liquidity* 1,399 927 1,200 --------------------------- ------------ ------------ ------------ Indebtedness -------------------------- ------------ ------------ ------------ Convertible loan 394 392 388 --------------------------- ------------ ------------ ------------ Convertible bond 794 199 199 --------------------------- ------------ ------------ ------------ Other financial debt - - - -------------------------- ------------ ------------ ------------ Total indebtedness 1,188 592 587 --------------------------- ------------ ------------ ------------
*rounding differences may occur
Clinical Development
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 April and July of 2020, Idorsia reported positive results in each of the two pivotal Phase 3 studies of daridorexant in patients with insomnia. More details and commentary can be found in the dedicated press releases (first study release https://www.idorsia.com/media/news-details?newsId=2284972 ), (second study release https://www.idorsia.com/media/news-details?newsId=2329316 ) and the investor webcasts (first study webcast https://www.idorsia.com/investors/news-and-events/webcast-daridorexant ), (second study webcast https://www.idorsia.com/investors/news-and-events/webcast-daridorexant-302-results ) which are available for replay on Idorsia's corporate website. A New Drug Application (NDA) for daridorexant was submitted to the US FDA on January 8, 2021, and a Marketing Authorization Application (MAA) to the European Union EMA on March 2, 2021, to Switzerland's health authority, Swissmedic, on April 20, 2021, and to Health Canada on August 25, 2021, where it has been formally accepted for review. Should approval be received, the company anticipates launch in the US in the second quarter of 2022, followed by other regions thereafter.
In November of 2020, Idorsia reported positive results in each of the two Japanese registration studies of clazosentan assessing the efficacy and safety of clazosentan in reducing vasospasm-related morbidity and all-cause mortality in patients following aSAH. More details can be found in the dedicated press release https://www.idorsia.com/media/news-details?newsId=2410833 . A New Drug Application (NDA) to the Japanese PMDA for clazosentan was submitted on March 1, 2021. Due to the intensive care setting for the study, recruitment into the global Phase 3 study of clazosentan (REACT) has been impacted by the coronavirus pandemic but is steadily progressing. The study is enrolling approximately 400 patients with a high risk of developing cerebral vasospasm and delayed cerebral ischemia. The study is expected to conclude around the end of 2022.
In October 2021, Idorsia reported that MODIFY, the Phase 3 study of lucerastat for adult patients with Fabry disease did not meet the primary endpoint. Lucerastat was well tolerated and a substantial and consistent reduction of plasma Gb3 was observed, confirming the pharmacological activity of lucerastat. Despite this biological effect, the decrease in neuropathic pain observed in both treatment groups did not differ statistically after six months of treatment, using the patient reported outcome tool. Most patients continued into the open-label extension study and a decision on the future of the program will be determined once the interim data is available, expected before the end of the year.
Jean-Paul Clozel, MD and Chief Executive Officer, commented:
"We are taking an in depth look at the results of MODIFY to fully understand the data and some observations made in the six-month double-blind placebo-controlled treatment period. Together with the interim analysis of the open-label extension study, we will be able to determine the potential long-term benefits to patients and make decisions on how to proceed."
PRECISION, a Phase 3 study to demonstrate the antihypertensive effect of aprocitentan when added to standard of care in patients with resistant hypertension, completed recruitment with 730 patients randomized. This 12-month study should deliver results in mid-2022.
In June 2021, Idorsia announced the initiation of a Phase 3 registration study "SOS-AMI" to evaluate the efficacy and safety of self-administered subcutaneous selatogrel, Idorsia's P2Y(12) receptor antagonist, in suspected acute myocardial infarction (AMI). More details and commentary can be found in the dedicated press release https://www.idorsia.com/media/news-details?newsId=2545303 and the investor webcast https://www.idorsia.com/investors/news-and-events/webcast-selatogrel .
The CARE study, a large Phase 2b multiple-dose, efficacy and safety study evaluating cenerimod, for the treatment of systemic lupus erythematosus completed randomization at the end of February 2021, with 427 patients enrolled. The results are targeted for the fourth quarter of 2021.
A Phase 2 proof-of-concept study with ACT-539313, a selective orexin 1 receptor antagonist, in binge eating disorder is recruiting. This is the first study evaluating orexin 1 receptor antagonism as a new mechanism of action for patients with binge eating disorder. Results of the study are expected around the middle of 2022.
The company has closed a natural history study called "RETRIEVE" which collected disease information from pediatric patients with early onset of rare lysosomal storage disorders (LSDs). The company is considering development options for sinbaglustat.
Idorsia's clinical development pipeline
Mechanism of Target Indication Status
Compound Action
------------- ---------------- ---------------------------------------- -----------------------------------
Daridorexant Dual orexin Insomnia Under review with health
receptor authorities
antagonist
------------- ---------------- ---------------------------------------- -----------------------------------
Aprocitentan* Dual endothelin Resistant hypertension management Phase 3 recruitment complete
receptor
antagonist
------------- ---------------- ---------------------------------------- -----------------------------------
Clazosentan Endothelin Cerebral vasospasm assoc. Japan: NDA submitted
receptor with aneurysmal subarachnoid hemorrhage Global: Phase 3
antagonist
------------- ---------------- ---------------------------------------- -----------------------------------
Lucerastat Glucosylceramide Fabry disease Phase 3 primary endpoint not met
synthase Awaiting interim analysis of OLE**
inhibitor
------------- ---------------- ---------------------------------------- -----------------------------------
Selatogrel P2Y(12) receptor Suspected acute myocardial infarction Phase 3
antagonist
------------- ---------------- ---------------------------------------- -----------------------------------
Cenerimod S1P(1) receptor Systemic lupus erythematosus Phase 2b recruitment complete
modulator
------------- ---------------- ---------------------------------------- -----------------------------------
ACT-539313 Selective orexin Binge eating disorder Phase 2
1 receptor
antagonist
------------- ---------------- ---------------------------------------- -----------------------------------
Sinbaglustat GBA2/GCS Rare lysosomal storage disorders Phase 1 complete
inhibitor
------------- ---------------- ---------------------------------------- -----------------------------------
ACT-1004-1239 CXCR7 antagonist Immunology Phase 1
------------- ---------------- ---------------------------------------- -----------------------------------
ACT-1014-6470 - Immunology Phase 1
------------- ---------------- ---------------------------------------- ----------------------------------- (MORE TO FOLLOW) Dow Jones Newswires
October 26, 2021 01:00 ET (05:00 GMT)
