Idorsia Ltd. · SIX:IDIA
Idorsia — 9M 2022 Earnings Presentation
27 slides from Idorsia's earnings presentation, Oct 25, 2022
Slide 1: Nine-Month 2022 Financial Reporting
Financial Reporting 20 NINE-MONTH 22 1 Nine-Month 2022 Financial Reporting | 25 Oct 2022
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: transformation into a commercial company
“Idorsia is making great progress with the transformation into a commercial company.” Jean-Paul Clozel Chief Executive Officer 3 Nine-Month 2022 Financial Reporting | 25 Oct 2022
Slide 4: Highlights
Highlights 20 NINE-MONTH 22 Commercial Financial Research & Development • QUVIVIQ™ (daridorexant) • Sale & leaseback • Phase 3 with aprocitentan becoming a global brand agreement to be presented at AHA • PIVLAZ™ (clazosentan) • Other non-dilutive • Phase 2b with cenerimod changing the treatment meas
Slide 5: CCO quote: QUVIVIQ demand growth in the US
“The growth in demand of QUVIVIQ in the US means that we are close to becoming the leading branded insomnia medication in new-to- brand prescriptions.” Simon Jose Chief Commercial Officer 5 Nine-Month 2022 Financial Reporting | 25 Oct 2022
Slide 6: QUVIVIQ (daridorexant) launched in the US in May 2022
QUVIVIQ (daridorexant) launched in the US in May 2022 Daridorexant is only available in the US under the tradename QUVIVIQ. Market authorization has been granted by the European Commission and subsequently by the Medicines and Healthcare products Regulatory Agency in Great Britain. Daridorexant is u
Slide 7: Supporting patient access and generating demand
Supporting patient access and generating demand CHF 2.3 million net sales since launch in May 2022 7 Nine-Month 2022 Financial Reporting | 25 Oct 2022
Slide 8: Strong growth in demand continues…
Strong growth in demand continues… QUVIVIQ Monthly TRxs by Strength QUVIVIQ Monthly TRxs by Source 12’000 25mg 50mg Total QUVIVIQ VitaCare IQVIA 10’000 8’000 71% 6’000 72% 4’000 73% 2’000 73% 29% 78% 28% 27% 27% 0 22% May Jun Jul Aug Sep May Jun Jul Aug Sep Source: IQVIA + VitaCare Pharmacy Services
Slide 9: …along with sustained growth in our writer base
…along with sustained growth in our writer base Cumulative QUVIVIQ Writers 9’000 % Writers by Specialty 8’000 7’000 15% 6’000 5’000 4’000 22% 63% 3’000 2’000 1’000 0 PCP PSYCH Other May Jun Jul Aug Sep Source: IQVIA + VitaCare Pharmacy Services 9 Nine-Month 2022 Financial Reporting | 25 Oct 2022
Slide 10: QUVIVIQ quickly tracking to be the leading branded insomnia medicine in NBRx
QUVIVIQ quickly tracking to be the leading branded insomnia medicine in NBRx September 9’000 NBRx Share: 8’000 Belsomra 45% 7’000 QUVIVIQ 39% 6’000 5’000 4’000 3’000 Dayvigo 15% 2’000 1’000 0 Oct-21 Nov-21 Dec-21 Jan-22 Feb-22 Mar-22 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Source: IQVIA Market Dyn
Slide 11: QUVIVIQ is driving growth in the DORA class
QUVIVIQ is driving growth in the DORA class DORA NBRx 18’000 100% 16’000 82% 80% 14’000 63% Year over Year Growth 12’000 60% DORA NBRx 10’000 40% 8’000 27% 21% 6’000 20% 8% 4’000 -5% 0% -7% -10% 2’000 -10% 0 -20% January February March April May June July August September October November December 2
Slide 12: A small percentage of patients on QUVIVIQ are coming from other DORAs
A small percentage of patients on QUVIVIQ are coming from other DORAs Patient Type % of Switches to QUVIVIQ 6% Z Drugs 7% New Benzos 42% 33% Trazodone 13% Anti-depressants DORA Switch 13% A-Typ Anti Psych 58% Other 27% Source: IQVIA, cumulative, launch through 9/30 – does not include VitaCare data 1
Slide 13: Celebrity TV advertisements launched
Celebrity TV advertisements launched Early impact demonstrates promotional sensitivity of this market Lindsey Vonn TV Taye Diggs TV Launched August 15th launched September 26th +79% +173% +38% Increase in branded Increase in unique Est. increase in site traffic1 copay card NBRx New Patient registrat
Slide 14: On track to become a global brand
On track to become a global brand New Drug Submission under review with Health Canada Approved by the European Medicines Agency and MHRA Launched in the US First EU launches in Germany Phase 3 study and Italy in November successful in Japan; filing expected in Market authorization 1H 2023 applicatio
Slide 15: High unmet need in EU insomnia market
High unmet need in EU insomnia market Estimated insomnia market volume*, standard units, millions Estimated 788 771 volume per 11.8 10.7 capita** 671 3’029 2’668 478 320 DE IT FR ES UK EU5 US Anti-depressants Anti-histamines Benzos Melatonin SR Z-drugs DORAs Source: IQVIA MIDAS EU5 – MAT/July 2022;
Slide 16: Excitement about QUVIVIQ in Europe
Excitement about QUVIVIQ in Europe How likely would you be to prescribe How likely would you be to ask QUVIVIQ to your insomnia patients? your HCP about QUVIVIQ? 23% 37% HCPs Patients likely to 91% 41% likely to 85% prescribe ask about 29% 19% 27% Source: Idorsia market research in EU5 (n=1200); 202
Slide 17: Preparing for first launches in Europe
Preparing for first launches in Europe • Launch in November with 1-year free pricing • G-BA issued a draft resolution which would exempt QUVIVIQ from the 4-week prescription limitation for hypnotic and sedating agents (Anlage III) • Launch in private market in November • Prescribing limited to speci
Slide 18: PIVLAZ (clazosentan) launched in Japan in April 2022
PIVLAZ (clazosentan) launched in Japan in April 2022 Clazosentan is only approved in Japan under the tradename PIVLAZ and is investigational, in development and not approved or marketed in any other country. 18 Nine-Month 2022 Financial Reporting | 25 Oct 2022
Slide 19: Positive momentum since launch
Positive momentum since launch CHF 25.1 >80% ~20% million of target accounts have ordered of aSAH patients treated with net sales since PIVLAZ PIVLAZ in launch in April 2022 September 2022* * Based on estimated incidence of aSAH in Japan 19 Nine-Month 2022 Financial Reporting | 25 Oct 2022
Slide 20: CFO quote: ensuring financing until profitability
“I am maintaining my focus on ensuring financing to bridge the gap until reaching profitability.” André C. Muller Chief Financial Officer 20 Nine-Month 2022 Financial Reporting | 25 Oct 2022
Slide 21: US GAAP net results
US GAAP net results 20 NINE-MONTH in CHF millions, rounding differences may occur 22 Non-GAAP US GAAP Financial results as of Sep 30, 2022 21 Nine-Month 2022 Financial Reporting | 25 Oct 2022
Slide 22: Non-GAAP operating expenses
Non-GAAP operating expenses 20 NINE-MONTH in CHF millions, rounding differences may occur 22 0 -4 -81 -86 -5 0 -14 0 -170 -173 -118 -388 -621 9M 2021 -358 9M 2022 Cost of sales Research Development Milestones Inventory build SG&A Non-GAAP operating expenses Financial results as of Sep 30, 2022 22 Ni
Slide 23: Cash flow
Cash flow 20 NINE-MONTH in CHF millions, rounding differences may occur 22 Financial results as of Sep 30, 2022 23 Nine-Month 2022 Financial Reporting | 25 Oct 2022
Slide 24: Liquidity
Liquidity 20 NINE-MONTH in CHF millions, rounding differences may occur 22 1,188 1,188 8 160 157 Cash deposits Other FX > 12 months 695 695 21 Cash deposits USD < 12 months 77 927 380 1,023 Cash and CHF Cash equivalents 597 315 101 Liquidity @ Liquidity @ Liquidity @ Liquidity @ Dec 31, 2021 Sep 30,
Slide 25: Financial Guidance for 2022
Financial Guidance for 2022* US GAAP operating loss of around CHF 840 million and non-GAAP operating loss of around CHF 785 million *Excluding unforeseen events Non-GAAP metrics do not include Depreciation and Amortization, and Shared-Based Compensation 25 Nine-Month 2022 Financial Reporting | 25 Oc
Slide 26: 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 26 Nine-Month 2022 Financial Reporting |
Slide 27: Busy end-of-year 2022
Busy end-of-year 2022 • Continue to grow demand for QUVIVIQ in the US • Launch QUVIVIQ in Germany and Italy • Initiate Phase 3 program with cenerimod • File the NDA for aprocitentan with FDA • Prepare for Phase 3 REACT readout 27 Nine-Month 2022 Financial Reporting | 25 Oct 2022