things! 
 
   Sincerely, 
 
   Mathieu Simon, 
 
   Chairman of the Board 
 
   Letter to Shareholders from the CEO (as published in Idorsia's 2020 
Business Report on February 4, 2021) 
 
   Dear Shareholders, 
 
   I want to begin by recognizing that, while Idorsia has had a very 
successful year, 2020 was extremely difficult for many people. No doubt 
some of you will have been seriously affected by the COVID-19 pandemic, 
and to you I extend my sincere sympathy. 
 
   This year, the public has gained a new appreciation of the efforts of 
all frontline healthcare workers, and also of the mission that drives 
everyone in the pharma world -- finding medicines to prevent or treat 
illness. Let us hope that the vaccines developed in record time can help 
the world return to some semblance of normality. I myself am very proud 
to be a member of this industry, and to see how our efforts in research 
are helping patients. 
 
   In spite of the pandemic, the company has made great strides this year. 
Our employees achieved every one of the ambitious key goals set for 2020 
-- and much else besides. Their performance was simply phenomenal. In 
the development of new medicines, hard work does not always guarantee 
good results, which makes it all the more rewarding when our efforts are 
crowned with success. 
 
   Revolutionizing the field of insomnia 
 
   Our review of the progress made in 2020 must start with the outstanding 
results achieved with daridorexant. The Phase 3 registration program 
demonstrated statistically significant and clinically meaningful 
improvements in sleep maintenance, sleep onset, total sleep time and 
daytime functioning, which were sustained over time. Daridorexant was 
well tolerated, with a favorable safety profile in adult and elderly 
patients. 
 
   Particularly important, as well as efficacy during the night, are the 
effects seen during the day. While a negative impact on daytime 
functioning is part of the definition of insomnia, not one of the 
treatments currently available have rigorously assessed their effect on 
this key aspect of the condition. Here, in fact, most therapies have a 
negative impact -- especially first thing in the morning, when patients 
may feel hangover effects of their medication. For the millions of 
people suffering from insomnia, daridorexant is an absolute gamechanger, 
whose excellent benefit and safety profile will encourage patients to 
seek treatment. 
 
   It is important to recognize that these gratifying results were no 
accident. They are a direct result of our efforts to design a dual 
orexin receptor antagonist (DORA) with the properties required to 
deliver all the benefits of a good night's sleep. For more details, I 
invite you to read the interview with Martine Clozel on page 30 of the 
Business Report. 
 
   The team responsible worked tirelessly to evaluate the huge amount of 
data generated and to present the results appropriately for regulatory 
agencies. A new drug application was submitted to the FDA in January 
2021, and the submission to the European authorities will follow 
shortly. In anticipation of regulatory approval, the commercial team is 
now working flat out to prepare for the launch. 
 
   Perseverance finally paying off 
 
   Our efforts to design the perfect DORA began in our labs as long ago as 
1998, but our work with clazosentan goes back even further. This year, 
the Japanese studies of clazosentan for patients suffering cerebral 
vasospasm following aneurysmal subarachnoid hemorrhage also demonstrated 
excellent efficacy results, without any unexpected safety findings (for 
more information on clazosentan, see pages 52 to 57 of the Business 
Report). I am truly delighted to finally have the evidence that 
clazosentan can improve outcomes for these patients -- often young 
adults with so much life left to live. These results give the commercial 
team even more to get their teeth into. The impressive data has renewed 
the enthusiasm of the whole REACT team to complete the global study of 
clazosentan as soon as possible, so that patients around the world can 
benefit. 
 
   More to come from the pipeline 
 
   Thanks to the development group's speedy response to the COVID-19 
pandemic, our ongoing late-stage studies were able to continue, and risk 
mitigation procedures were agreed with global health authorities. 
 
   Recruitment for both the CARE study (cenerimod) and the MODIFY study 
(lucerastat) was affected, but following some adjustments, in 
consultation with health authorities, patient enrollment was adapted. 
Accordingly, we should see the results of CARE and be able to plan for 
Phase 3 development of cenerimod by the end of 2021, and the results of 
MODIFY -- the Phase 3 registration study for lucerastat -- should also 
be available in the second half of 2021. 
 
   In addition, again despite the impact of the pandemic, recruitment for 
the PRECISION (aprocitentan) study accelerated, with randomization now 
expected to be completed by mid 2021. 
 
   As well as the conclusion of studies, 2021 will also see the initiation 
of a very exciting study. Under a Special Protocol Assessment (SPA) 
agreed with the FDA in 2020, a 14,000 patient Phase 3 study will be 
commenced with selatogrel -- a drug-device product for patients with 
suspected heart attack. The investigation of selatogrel has been 
designated as a "fast-track" development program, indicating the FDA's 
interest in this innovative approach. Patients themselves will play a 
crucial role in the preparations for this study, as they need to be 
trained to identify symptoms and self-administer treatment. The 
potential implications for future heart attack patients are enormous, 
and I look forward to sharing more details in due course. 
 
   Taking our innovation to the patient 
 
   Work on building our commercial capabilities began in 2019, and we 
continued to fill key strategic roles on the global team in 2020. We 
also established our US commercial organization, securing premises and 
-- most importantly -- a leadership team. This is a very exciting 
development for Idorsia, and I am proud to have such an experienced and 
talented group of professionals on board. 
 
   Following the positive results achieved with daridorexant, a tremendous 
amount of work has been done to prepare for the US launch of this 
product in 2022 -- not least, engaging Syneos Health as the ideal 
partner to reach the large US primary care market. In addition, after 
the excellent results with clazosentan, the Japanese team is also 
gearing up for our first product launch in Japan. 
 
   With two product launches in preparation, we have also been building our 
global supply chain function, to ensure consistent supplies of our 
innovative medicines to patients. More information on our preparations 
can be found in the interview with Chief Commercial Officer Simon Jose 
on page 22 of the Business Report. 
 
   Ongoing innovation 
 
   We have always had a long-term focus for Idorsia, setting ourselves the 
goal of becoming a fully-fledged biopharmaceutical company, innovating 
from bench to bedside. As our late stage pipeline starts to bear fruit, 
it is essential that we keep the pipeline supplied with fresh innovation 
for sustainable success. As our Chairman emphasized, work in our 
laboratories continued unabated in 2020, and there is much to show for 
it. Progress was made with our early-stage clinical pipeline, and we 
advanced a new CNS compound into clinical pharmacology studies. On the 
preclinical front, four compounds were selected as preclinical 
candidates. These advances in our discovery efforts made during lockdown 
are a testament to our researchers' commitment and dedication. 
 
   Financing our future 
 
   Through a series of financing activities in 2020, we have secured 
additional funding of more than CHF 865 million. Our strengthened 
balance sheet with CHF 1.2 billion liquidity will take us through to the 
next inflection points -- namely, key clinical data from late-stage 
assets and the launch of our first product, daridorexant. As you may be 
aware, Martine and I have participated in each of the capital increases, 
believing more than ever in Idorsia and in the value that can be created 
for patients, employees and shareholders alike. 
 
   I am very proud of all that has been accomplished at Idorsia in 2020. 
2021 will be an extremely exciting year for our growing company, and I 
look forward to keeping you updated on our progress throughout the year. 
I would also like to thank you for your confidence in Idorsia. 
 
   Warmest regards, 
 
   Jean-Paul Clozel, 
 
   Chief Executive Officer 
 
   About Idorsia 
 
   Idorsia Ltd is reaching out for more -- We have more ideas, we see more 
opportunities and we want to help more patients. In order to achieve 
this, we will develop Idorsia into a leading biopharmaceutical company, 
with a strong scientific core. 
 
   Headquartered near Basel, Switzerland -- a European biotech-hub -- 
Idorsia is specialized in the discovery, development and 
commercialization of small molecules to transform the horizon of 
therapeutic options. Idorsia has a broad portfolio of innovative drugs 
in the pipeline, an experienced team of professionals covering all 
disciplines from bench to bedside, state-of-the-art facilities, and a 
strong balance sheet -- the ideal constellation to translate R&D efforts 
into business success. 
 
   Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in 
June 2017 and has over 900 highly qualified specialists dedicated to 
realizing our ambitious targets. 
 
   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 
 
   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", 

(MORE TO FOLLOW) Dow Jones Newswires

February 04, 2021 01:00 ET (06:00 GMT)