Idorsia Ltd. · SIX:IDIA
Idorsia — FY2020 Earnings Presentation
24 slides from Idorsia's earnings presentation, Feb 4, 2021
Slide 1: Full Year 2020 Financial Reporting
Financial Reporting 20 FULL YEAR 20
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: CEO quote: Jean-Paul Clozel
“I am very proud of all that has been accomplished at Idorsia in 2020.” Jean-Paul Clozel Chief Executive Officer 3 Full Year 2020 Financial Reporting | 04 Feb 2021
Slide 4: Highlights
Highlights Positive pivotal results with daridorexant for insomnia US commercial 20 Daridorexant NDA operations 20 submitted to US FDA established Positive results in the Liquidity strengthened Japanese registration by equity raise of program for clazosentan CHF 865 million
Slide 5: A rich development pipeline
A rich development pipeline Compound Mechanism of Action Target Indication Daridorexant Dual orexin receptor antagonist Insomnia NDA submitted, MAA in preparation Aprocitentan* Dual endothelin receptor antagonist Resistant hypertension management Phase 3 Vasospasm associated with aneurysmal Clazosen
Slide 6: Daridorexant for insomnia
Daridorexant for insomnia Dual orexin receptor antagonist First non-sedative sleeping pill to demonstrate an improvement in sleep and daytime functioning as measured with a validated instrument, without compromising safety • New drug application (NDA) submitted to US FDA January 2021 • Market author
Slide 7: Clazosentan for cerebral vasospasm
Clazosentan for cerebral vasospasm Selective endothelin receptor (ETA) antagonist Novel pharmacological intervention to protect against cerebral ischemia post- subarachnoid hemorrhage • Positive results in the Japanese registration program • NDA to be filed with the PMDA in H1 2021 • REACT: Recruitm
Slide 8: Lucerastat for Fabry disease
Lucerastat for Fabry disease Glucosylceramide synthase inhibitor Novel oral small molecule that can access tissues inaccessible to enzyme replacement therapy to reduce the damaging build-up of lipids irrespective of Fabry mutation • MODIFY: recruitment complete • Results expected in H2 2021 Lucerast
Slide 9: Aprocitentan for difficult-to-control hypertension
Aprocitentan for difficult-to-control hypertension Dual endothelin receptor antagonist Targeting the endothelin pathway for the first time in systemic hypertension has great potential for the treatment of difficult-to-control or “resistant” hypertension • PRECISION: recruitment complete • Results ex
Slide 10: Selatogrel for suspected AMI
Selatogrel for suspected AMI Highly-selective P2Y12 receptor antagonist Novel emergency, self-administered agent to protect heart muscle due to heart attack in the crucial time between symptom onset and first medical attention, so as to prevent severe clinical outcomes • Special Protocol Assessment
Slide 11: Cenerimod for systemic lupus erythematosus
Cenerimod for systemic lupus erythematosus Selective sphingosine-1-phosphate 1 (S1P1) receptor modulator First oral immune-modulator active on both B and T cells could represent a novel approach to the treatment of SLE • “Fast-track” designation received from FDA • CARE: recruitment complete by end-
Slide 12: Idorsia is at an inflection point with major catalysts
Idorsia is at an inflection point with major catalysts expected in the near-term 2021 2022 1H 1H 1H 2H Clazosentan 1H 1H 1H 2H 2H Clazosentan DATA: Phase 3 Aprocitentan APPROVAL & “REACT” commercial Daridorexant DATA: Phase 3 Cenerimod “PRECISION” LAUNCH in JAPAN Lucerastat APPROVAL & Selatogrel DAT
Slide 13: Building a commercial organization
Building a commercial organization Chief Commercial Officer Simon Jose President, President, Head of Global Head of Global Head of Global Idorsia US Idorsia Japan Marketing Market Access Supply Chain Patty Torr Satoshi Tanaka Rebecca Weil Christophe Segalini Olivier Nalinne President, Europe Head of
Slide 14: CFO quote: strengthened balance sheet
“Our strengthened balance sheet with CHF 1.2 billion liquidity will take us through to the next inflection points.” André C. Muller Chief Financial Officer 14 Full Year 2020 Financial Reporting | 04 Feb 2021
Slide 15: US GAAP net results
US GAAP net results 20 FULL YEAR in CHF millions, rounding differences may occur 20 Non-GAAP US GAAP Financial results as of December 31, 2020 15 Full Year 2020 Financial Reporting | 04 Feb 2021
Slide 16: Non-GAAP operating expenses
Non-GAAP operating expenses 20 FULL YEAR in CHF millions, rounding differences may occur 20 0 -9 0 -115 -107 -26 -212 -58 -90 -297 -470 -444 12M 2019 12M 2020 Research Development Milestones Inventory build SG&A Non-GAAP operating expenses Financial results as of December 31, 2020 16 Full Year 2020
Slide 17: Quarterly Non-GAAP operating expenses
Quarterly Non-GAAP operating expenses 20 FULL YEAR in CHF millions, rounding differences may occur 20 142 34 109 106 16 22 86 Milestones 9 17 SG&A 108 90 87 R&D 60 Q1 Q2 Q3 Q4 Financial results as of December 31, 2020 17 Full Year 2020 Financial Reporting | 04 Feb 2021
Slide 18: Cash flow
Cash flow 20 FULL YEAR in CHF millions, rounding differences may occur 20 Financial results as of December 31, 2020 18 Full Year 2020 Financial Reporting | 04 Feb 2021
Slide 19: Liquidity
Liquidity 20 FULL YEAR in CHF millions, rounding differences may occur 20 1,200 1,200 5 192 268 739 Cash deposits Other FX > 12 months 867 476 Cash deposits USD 927 < 12 months Cash and CHF Cash equivalents 263 141 Liquidity @ Liquidity @ Liquidity @ Dec 31, 2019 Dec 31, 2020 Dec 31, 2020 Financial
Slide 20: Financial Guidance for 2021
Financial Guidance for 2021 • Functional R&D expenses • Non-GAAP OPEX ~ CHF 370 million • Depreciation & Amortization • Functional SG&A ~ CHF 20 million ~ CHF 230 million • Stock-Based Compensation • Inventory build ~ CHF 25 million ~ CHF 35 million • Milestone payment CHF 5 million Non-GAAP operati
Slide 21: Idorsia's potential first revenue stream
Idorsia’s potential first revenue stream Ponesimod for relapsing multiple sclerosis Phase 3 data presented by Janssen Ponesimod showed superiority versus Aubagio (teriflunomide) 14 mg in adults with relapsing multiple sclerosis Janssen submitted an NDA and MAA for ponesimod in March 2020 Revenue sha
Slide 22: Idorsia revenues in the future
Idorsia revenues in the future Rich pipeline allows substantial leverage of the commercial organization Net sales • GP Product: daridorexant Milestones & • Orphan: lucerastat, Royalty streams clazosentan • ponesimod • Specialty: cenerimod, selatogrel • aprocitentan • T-type calcium channel blocker 2
Slide 23: 2021 is a key year for Idorsia
2021 is a key year for Idorsia Enter 2021 with a strong balance sheet Filing of daridorexant in the US and EU PDUFA of ponesimod for J&J Idorsia has a revenue-sharing agreement in respect to ponesimod 2021 Filing of clazosentan in Japan Start Phase 3 (under SPA) for selatogrel Phase 3 results for lu
Slide 24: CEO quote: 2021 is key for our vision
“2021 is key for our vision to build a sustainable mid-sized pharmaceutical company.” Jean-Paul Clozel Chief Executive Officer 24 Full Year 2020 Financial Reporting | 04 Feb 2021