Idorsia Ltd. · SIX:IDIA
Idorsia — Idorsia Pharmaceuticals — FY2021 Earnings Presentation
42 slides from Idorsia's earnings presentation, Feb 8, 2022
Slide 1: Full Year 2021 Financial Reporting
Financial Reporting 20 FULL YEAR 21
Slide 2: Forward-looking statements
The following 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”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”,
Slide 3: Vision: create a sustainable mid-size pharma company based on innovation
“We have one simple vision: create a sustainable mid-size pharma company based on innovation” Jean-Paul Clozel Chief Executive Officer 3 Full Year 2021 Financial Reporting | 08 Feb 2022
Slide 4: Our Strategic Priorities
Our Strategic Priorities Our mid-term key priorities to 2 Build a world-class commercial organization achieve long-term 3 Bring Idorsia to success: sustainable profitability 1 Deliver at least three products to market 4 Fuel our pipeline with new discoveries 5 Utilize state-of-the-art technologies t
Slide 5: We promised and delivered in 2021
We promised and delivered in 2021 Entered and closed 2021 with a strong balance sheet Filed daridorexant in the US, EU, Canada and Switzerland J&J received approval for ponesimod Idorsia has a revenue-sharing agreement in respect to ponesimod 2021 Filed clazosentan in Japan Started Phase 3 (under SP
Slide 6: Deliver at least three products to market
1 Deliver at least three products to market Compound Mechanism of Action Target Indication Status Approved as QUVIVIQ™ in the US, Daridorexant Dual orexin receptor antagonist Insomnia MAA under review in other countries Aprocitentan* Dual endothelin receptor antagonist Resistant hypertension managem
Slide 7: Clinical pipeline advancing
Clinical pipeline advancing Lucerastat for Fabry disease Cenerimod for systemic Aprocitentan for difficult-to- lupus erythematosus control hypertension • Further characterize by continuing the open-label • Advance into Phase 3 • Delivering results by mid- extension of the Phase 3 • Cenerimod 4 mg sh
Slide 8: Daridorexant – On track to becoming a global product
Daridorexant – On track to becoming a global product Market authorization application under review in Health Canada Market authorization application under QUVIVIQ™ review in European Phase 3 (daridorexant) Medicines Agency, ongoing in approved by SwissMedic Japan the US FDA Daridorexant is only appr
Slide 9: The Lancet Neurology: daridorexant phase 3 trials
The Lancet Neurology Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials Emmanuel Mignot, David Mayleben, Ingo Fietze, Damien Leger, Gary Zammit, Claudio L A Bassetti, Scott Pain, Dalma Seb
Slide 10: Primary endpoint: Wake after sleep onset
Primary endpoint: Wake after sleep onset A measure of sleep maintenance 120 placebo 25 mg 50 mg Mean of observed values (min) 100 p<0.0001 80 p<0.0001 Daridorexant 25 mg and 50 mg 60 significantly improved wake p<0.0001 p<0.0001 after sleep onset compared to 40 placebo at months 1 and 3 20 0 Baselin
Slide 11: Primary endpoint: Latency to persistent sleep
Primary endpoint: Latency to persistent sleep A measure of sleep onset 80 placebo 25 mg 50 mg Mean of observed values (min) 60 Daridorexant 25 mg and 50 mg P=0.0005 40 p=0.0015 significantly improved latency to persistent sleep p<0.0001 p<0.0001 compared to placebo at 20 months 1 and 3 0 Baseline Mo
Slide 12: Secondary endpoint: Subjective Total Sleep Time
Secondary endpoint: Subjective Total Sleep Time A measure of how the patient think they slept 400 placebo 25 mg 50 mg p<0.0001 p<0.0001 p=0.033 Mean of observed values (min) p=0.0013 350 Daridorexant 25 mg and 50 mg significantly improved subjective total sleep time compared to placebo at 300 months
Slide 13: Secondary endpoint: IDSIQ sleepiness domain
Secondary endpoint: IDSIQ sleepiness domain A measure of daytime functioning 24 placebo 25 mg 50 mg How energetic did you feel today? How mentally tired did you feel today? Mean of observed value (score) 22 How physically tired did you feel today? How sleepy did you feel today? 20 18 p<0.0001 Darido
Slide 14: Exploratory endpoints: IDSIQ other scores
Exploratory endpoints: IDSIQ other scores A measure of daytime functioning placebo 25 mg 50 mg 35 80 22 Mood domain Alert/cognition domain Total Mean of observed value (score) 20 30 70 18 16 60 25 14 12 20 50 0 0 0 Baseline Month 1 Month 3 Baseline Month 1 Month 3 Baseline Month 1 Month 3 IDSIQ mood
Slide 15: Adverse events
Adverse events In the safety analysis population (n=1847) Study 1 Study 2 Dari 50 mg Dari 25 mg Placebo Dari 25 mg Dari 10 mg Placebo (n = 308) (n = 310) (n = 309) (n = 308) (n = 306) (n = 306) Participants with ≥1 adverse event* 116 (38%) 117 (38%) 105 (34%) 121 (39%) 117 (38%) 100 (33%) Adverse ev
Slide 16: Build a world-class commercial organization
Build a world-class commercial organization Simon Jose Chief Commercial Officer 16 Full Year 2021 Financial Reporting | 08 Feb 2022
Slide 17: Build a world-class commercial organization
Build a world-class commercial organization 2 Establish the commercial Prepare for the first footprint launches People Processes Infrastructure 17 Full Year 2021 Financial Reporting | 08 Feb 2022
Slide 18: The US insomnia market is large, highly dissatisfied, and ripe for disruption
The US insomnia market is large, highly dissatisfied, and ripe for disruption Who’s affected? Dissatisfaction What are the costs? ~25M In a recent poll of 1001 Americans who struggle $100B+ Total insomnia with sleep Insomnia related costs patients (~10% of US adults) 70% per year alone in the US say
Slide 19: High unmet need in US insomnia market
High unmet need in US insomnia market 100% 800 90% 700 Market volume Lunesta / Ambien CR launch (Millions of standard units) 80% FDA dose change & safety 600 warnings for z-drugs Share of standard units 70% 500 Trazodone* 60% 50% 400 40% 300 Z-drugs 30% 200 20% Benzodiazepines 100 10% DORAs 0% 0 Mel
Slide 20: QUVIVIQ (daridorexant) approved in the US
QUVIVIQ™ (daridorexant) approved in the US Daridorexant is only approved in the US under the tradename QUVIVIQ™ and will only be available following scheduling by the US Drug Enforcement Administration. Market authorization is under review in other countries. 20 Full Year 2021 Financial Reporting |
Slide 21: Why are we going to succeed?
Why are we going to succeed? Differentiated product Hand-picked & focused team Right commercial approach Daridorexant is only approved in the US under the tradename QUVIVIQ™ and will only be available following scheduling by the US Drug Enforcement Administration. Market authorization is under revie
Slide 22: Differentiated product
Differentiated product A comprehensive clinical program sets a new standard for insomnia treatment Comprehensive Assessment of next Demonstrated Precision sleep efficacy day consequences safety MOA • Fall asleep faster • 50 mg – evaluated in one • No evidence of tolerance • Targets only the part • S
Slide 23: Hand-picked & focused team
Hand-picked & focused team US leadership team Bill Gileza Joanna Stevens Michael Moye Scotty Bowman Ajay Ahuja VP, Finance / IT VP, Sales VP, Marketing VP, Market Access VP, Medical Affairs (Lupin, KV Pharma, Schein) (Takeda, Janssen) (Shire, Janssen, Merck) (Shire, Abbott) (GSK, Pfizer, Allergan) F
Slide 24: Right commercial approach: educational campaigns
Right commercial approach Educational campaigns to prime the US market The Alliance for Sleep Seize the Night & Day Wake up America The Quest for Sleep Sleep Survey Top sleep experts drive Partnering with Jennifer Consumer and HCP Documentary Film using education, awareness and Aniston to drive surv
Slide 25: Right commercial approach: pull-through to clinicians and payers
Right commercial approach Pull-through to clinicians and payers Dedicated US sales Advanced analytics Payer engagement Coast-to-coast representatives to drive dynamic securing coverage and MSL team calling on PCPs and customer targeting patient access engaging with specialists across and engagement,
Slide 26: PIVLAZ (clazosentan) in Japan
PIVLAZ (clazosentan) 150 mg in Japan Clazosentan is only approved in Japan under the tradename PIVLAZ™ and is investigational, in development and not approved or marketed in any other country. 26 Full Year 2021 Financial Reporting | 08 Feb 2022
Slide 27: The Japanese aSAH market
The Japanese aSAH market Who’s affected? Medical need Patient burden Long-term consequences of Global incidence of aSAH: No innovation vasospasm: 7.9 per for the events associated Death of an area of the brain may lead to a variety of serious 100,000 with cerebral vasospasm in more than long-term ef
Slide 28: Preparing for a successful launch in Japan
Preparing for a successful launch in Japan Launch targeted for Q2 2022 Specialized MSLs Expert engagement to Dedicated sales Pricing and deployed since improve treatment of team recruited and reimbursement mid-2021 aSAH patients trained decision expected in early Q2 2022 Referral network being 650 c
Slide 29: Bring Idorsia to sustainable profitability
Bring Idorsia to sustainable profitability André C. Muller Chief Financial Officer 29 Full Year 2021 Financial Reporting | 08 Feb 2022
Slide 30: Bring Idorsia to sustainable profitability: Our strategy
Bring Idorsia to sustainable profitability: Our strategy 3 Rich pipeline allows substantial leverage of the commercial organization Net sales • Primary Care: daridorexant Milestones & Royalty streams • Orphan: clazosentan, lucerastat • ponesimod • Specialty: cenerimod, • aprocitentan selatogrel • T-
Slide 31: US GAAP net results
US GAAP net results 20 FULL YEAR in CHF millions, rounding differences may occur 21 Non-GAAP US GAAP Financial results as of Dec 31, 2021 31 Full Year 2021 Financial Reporting | 08 Feb 2022
Slide 32: Non-GAAP operating expenses
Non-GAAP operating expenses 20 FULL YEAR in CHF millions, rounding differences may occur 21 -107 -112 -9 -5 -26 -24 -212 -250 -90 -444 -221 -612 12M 2020 12M 2021 Research Development Milestones Inventory build SG&A Non-GAAP operating expenses Financial results as of Dec 31, 2021 32 Full Year 2021 F
Slide 33: Cash flow
Cash flow 20 FULL YEAR in CHF millions, rounding differences may occur 21 Financial results as of Dec 31, 2021 33 Full Year 2021 Financial Reporting | 08 Feb 2022
Slide 34: Financial Guidance for 2022
Financial Guidance for 2022* CHF million NON-GAAP US-GAAP Net Sales ~ 120 ~ 120 Contract Revenue ~ 25 ~ 25 SG&A OPEX ~ (520) ~ (545) R&D OPEX ~ (400) ~ (420) EBIT ~ (785) ~ (840) *Excluding unforeseen events Non-GAAP metrics do not include Depreciation and Amortization, and Shared-Based Compensation
Slide 35: Profitability target
Profitability target The company is committed to become profitable and expects to reach this goal in 2025 with annual net sales above CHF 1 billion Based on: • Daridorexant (US + EU4 + UK + Canada + Switzerland) • Clazosentan Japan Excluding unforeseen events 35 Full Year 2021 Financial Reporting |
Slide 36: Fuel our pipeline with new discoveries
Fuel our pipeline with new discoveries fulfilling clear medical need 4 Organic chemistry – Focus on small molecules more than ever! • Suitable for acute and chronic diseases • Suitable for oral use • Clear patent protection Top-quality chemists New technologies • High throughput screening • Artifici
Slide 37: Utilize state-of-the-art technologies to drive innovation
Utilize state-of-the-art technologies to drive innovation 5 Drug Discovery Clinical Development Commercialization • Artificial intelligence • Patient reported outcome • Digital & Social Media • Computer modelling measures • Advanced analytics • Creative clinical endpoints … innovation from bench to
Slide 38: 2022 – The year Idorsia becomes a commercial company
2022 – The year Idorsia becomes a commercial company 2022 1Q 1Q 1Q 2Q 2Q 2H QUVIVIQ First commercial Clazosentan QUVIVIQ LAUNCH in EU Commercial Commercial Clazosentan QUVIVIQ LAUNCH in LAUNCH in QUVIVIQ APPROVAL in APPROVAL in US JAPAN JAPAN EU APPROVAL in US 38 Full Year 2021 Financial Reporting |
Slide 39: 2022 – plus a key year for future growth
2022 – plus a key year for future growth 2022 1Q 1Q 1Q 2Q 2Q mid- 2H 2H 2H end- Clazosentan Cenerimod CONCLUDE QUVIVIQ INITIATION Phase 3 Aprocitentan ACT-539313 First commercial Phase 3 RESULTS “REACT” Clazosentan QUVIVIQ RESULTS LAUNCH in EU Commercial Phase 3 Phase 2 BED Commercial Clazosentan QU
Slide 40: 2022 will be a transformative year for Idorsia
2022 will be a transformative year for Idorsia Launching two products …putting sustainable …in two of the largest profitability within pharmaceutical markets …becoming a reach… …at the same time… fully-fledged biopharmaceutical company… … all while continuing to expand our product portfolio 40 Full
Slide 41: Profitability target
Profitability target The company is committed to become profitable and expects to reach this goal in 2025 with annual net sales above CHF 1 billion Based on: • Daridorexant (US + EU4 + UK + Canada + Switzerland) • Clazosentan Japan Excluding unforeseen events 41 Full Year 2021 Financial Reporting |
Slide 42: Idorsia – Be prepared for more
Idorsia – Be prepared for more
Idorsia Pharmaceuticals — FY2021 Earnings Presentation on 6ix