Idorsia Ltd. · SIX:IDIA
Idorsia — FY2022 Earnings Presentation
39 slides from Idorsia's earnings presentation, Feb 7, 2023
Slide 1: Full Year 2022 Financial Reporting
Financial Reporting 20 FULL YEAR 22
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: REACT study did not meet the primary endpoint
REACT study did not meet the primary endpoint Clazosentan is only marketed in Japan under the tradename PIVLAZ™. In other countries, clazosentan is investigational, in development and not approved or marketed. 3 Full Year 2022 Financial Reporting | 7 Feb 2023
Slide 4: Our achievements in 2022 provide great momentum going into 2023
“Our achievements in 2022 provide great momentum going into 2023.” Jean-Paul Clozel Chief Executive Officer 4 Full Year 2022 Financial Reporting | 7 Feb 2023
Slide 5: 2022 was a transformative year for Idorsia
2022 was a transformative year for Idorsia 2022 Idorsia became a commercial company… …plus a key year for future growth 1Q 1Q 2Q 2Q 2Q 2Q 4Q 4Q 4Q 4Q Aprocitentan Cenerimod FILING QUVIVIQ NDA filed with Aprocitentan Daridorexant First commercial INITIATION RESULTS Phase 3 US FDA QUVIVIQ QUVIVIQ RESU
Slide 6: 2022 was a transformative year (Simon Jose)
“2022 was a transformative year where we put our commercial plans into action by launching our first two products.” Simon Jose Chief Commercial Officer 6 Full Year 2022 Financial Reporting | 7 Feb 2023
Slide 7: QUVIVIQ (daridorexant) net sales in 2022
QUVIVIQ™ (daridorexant) CHF 6.5 million net sales in 2022* *since launch in the US in May 2022, and in Germany and Italy in November 2022; net sales do not fully reflect the volumes of the products dispensed in the US due to coupon and co-pay programs Daridorexant is available in the US and the firs
Slide 8: Demand continues to grow
Demand continues to grow QUVIVIQ Monthly TRxs by Strength QUVIVIQ Monthly TRxs by Source 16'000 25mg 50mg Total QUVIVIQ VitaCare IQVIA 14'000 12'000 10'000 71% 72% 8'000 70% 70% 6'000 72% 4'000 73% 2'000 72% 28% 29% 30% 30% 78% 28% 28% 27% 0 22% May Jun Jul Aug Sep Oct Nov Dec May Jun Jul Aug Sep Oc
Slide 9: Sustained growth in our writer base
…along with sustained growth in our writer base Cumulative QUVIVIQ Writers % Writers by Specialty 18'000 16'000 14% 14'000 12'000 10'000 21% 8'000 65% 6'000 4'000 2'000 Primary Care Physicians 0 Psychiatrist May Jun Jul Aug Sep Oct Nov Dec Other Source: IQVIA + VitaCare Pharmacy Services Daridorexan
Slide 10: Small percentage of patients 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 6% New Benzos 43% 33% Trazodone 14% Anti-depressants DORA Switch 14% A-Typ Anti Psych 57% Other 25% Source: IQVIA, cumulative, launch through December 30, 2022; does not include Vit
Slide 11: QUVIVIQ is growing the DORA class and taking share
QUVIVIQ is growing the DORA class and taking share DORA TRx DORA NBRx 250'000 +32% 60'000 +67% 50'000 200'000 19% Class share: 3% 12% 40'000 41% 34% QUVIVIQ 150'000 24% 21% 30% 28% 30'000 12% 25% 17% 14% Dayvigo 100'000 37% 20'000 69% 64% 60% 70% Belsomra 50'000 50% 45% 10'000 63% 63% 0 0 1Q2022 2Q2
Slide 12: Leading branded insomnia medicine in NBRx
Quickly becoming the leading branded insomnia medicine in NBRx – with accelerating CBRx New to brand prescriptions (NBRx) Continued brand prescriptions (CBRx) 2'500 2'500 Belsomra 2'000 2'000 1'500 1'500 QUVIVIQ 1'000 1'000 500 500 Dayvigo 0 - 6-May 6-Jun 6-Jul 6-Aug 6-Sep 6-Oct 6-Nov 6-Dec 6-Jan 6-
Slide 13: Tracking to become leading branded insomnia medicine in TRxs
Tracking to become the leading branded insomnia medicine in TRxs – where we can compete Commercial DORA TRxs* Dec-22 Share 14'000 12'000 43% Belsomra Commercial Rxs 10'000 QUVIVIQ Commercial Rxs* 29.0% 8'000 28.4% Dayvigo Commercial Rxs 6'000 4'000 2'000 0 May Jun Jul Aug Sep Oct Nov Dec * Includes
Slide 14: ESI coverage provides a significant increase in access
ESI coverage provides a significant increase in access Total Insomnia Market1 Key Commercial Payers2 Cash 4% Medicaid 15% 32.4% of the Commercial market 30.6% of the Commercial market Commercial NPF (~13%) Downstreams (~19%) (incl. downstreams) 47% Medicare Part D 35% 5.4% of the Commercial market 1
Slide 15: Direct-to-consumer campaigns reaching patients
Our direct-to-consumer campaigns are reaching patients and driving them to ask about QUVIVIQ Over 1.7M consumer website visits since launch1 +318% Copay Card +508% Organic Downloads Search for Since launch of DTC TV QUVIVIQ campaign2 Since launch of DTC TV campaign2 1. Consumer website traffic from
Slide 16: On track to become a global brand
On track to become a global brand New Drug Submission under review with Health Canada Exclusive licensing Approved by the European agreement with Medicines Agency and MHRA Simcere in China Launched in the US Launched in Germany and Phase 3 study Italy with further EU successful in Japan; countries t
Slide 17: Preparing for more launches in Europe
Preparing for more launches in Europe • NICE Advisory Committee in March • Launch planned for H2 2023 • Launched in November 2022 • G-BA issued a draft resolution which would exempt QUVIVIQ from the 4-week prescription limitation for hypnotic and sedating agents (Anlage III) • Reimbursement dossier
Slide 18: QUVIVIQ off to a great start in Germany
QUVIVIQ off to a great start in Germany Volume of packs purchased by pharmacies 1000 >6,000 packs 25mg 50mg 900 purchased in the first 11 weeks 800 700 600 61% 68% 62% 500 60% 61% 400 72% 68% 62% 300 57% 200 63% 39% 38% 32% 60% 40% 39% 100 38% 32% 43% 28% 40% 37% 0 W 46 W 47 W 48 W 49 W 50 W 51 W 52
Slide 19: Building support among specialists in Italy
Building support among specialists in Italy Volume of packs purchased by pharmacies 160 >900 packs 25mg 50mg purchased in the 140 first 12 weeks 120 100 84% 84% 80 84% 61% 60 96% 85% 40 66% 86% 48% 20 45% 39% 92% 34% 52% 16% 16% 16% 55% 14% 15% 0 4% 8% W45 W46 W47 W48 W49 W50 W51 W52 W1 2023 W2 W3 W
Slide 20: PIVLAZ (clazosentan)
PIVLAZ™ (clazosentan) Clazosentan is only marketed in Japan under the tradename PIVLAZ™. In other countries, clazosentan is investigational, in development and not approved or marketed. 20 Full Year 2022 Financial Reporting | 7 Feb 2023
Slide 21: Successful launch in Japan
Successful launch in Japan Approved in January 2022, launched in April 2022 CHF 44 million >95% ~25% net sales since of target accounts of aSAH patients launch in April 2022 are ordering treated with PIVLAZ PIVLAZ in December 2022 Clazosentan is only marketed in Japan under the tradename PIVLAZ™. In
Slide 22: We continue to carefully weigh our funding options
“We continue to carefully weigh our funding options, including non-equity dilutive opportunities.” André C. Muller Chief Financial Officer 22 Full Year 2022 Financial Reporting | 7 Feb 2023
Slide 23: US GAAP net results
US GAAP net results 20 FULL YEAR in CHF millions, rounding differences may occur 22 Non-GAAP US GAAP Financial results as of Dec 31, 2022 23 Full Year 2022 Financial Reporting | 7 Feb 2023
Slide 24: Non-GAAP operating expenses
Non-GAAP operating expenses 20 FULL YEAR in CHF millions, rounding differences may occur 22 0 -6 -112 -117 -5 0 -24 0 -250 -240 -221 -612 -854 12M 2021 -492 12M 2022 Cost of sales Research Development Milestones Inventory build SG&A Non-GAAP operating expenses Financial results as of Dec 31, 2022 24
Slide 25: Cash flow
Cash flow 20 FULL YEAR in CHF millions, rounding differences may occur 22 Financial results as of Dec 31, 2022 25 Full Year 2022 Financial Reporting | 7 Feb 2023
Slide 26: Liquidity
Liquidity 20 FULL YEAR in CHF millions, rounding differences may occur 22 1,188 1,188 8 101 157 Cash and Other FX Cash equivalents Cash deposits USD 927 < 12 months 466 466 1,023 21 Cash deposits CHF 146 > 12 months 116 320 336 160 Liquidity @ Liquidity @ Liquidity @ Liquidity @ Dec 31, 2021 Dec 31,
Slide 27: Financial Guidance for 2023
Financial Guidance for 2023* CHF million NON-GAAP US-GAAP Net Revenue 230 230 Operating expenses 880 965 EBIT (650) (735) *Excluding unforeseen events Non-GAAP metrics do not include Depreciation and Amortization, and Shared-Based Compensation 27 Full Year 2022 Financial Reporting | 7 Feb 2023
Slide 28: Profitability target
Profitability target The company is committed to reach sustainable profitability in 2025 with global revenue above CHF 1 billion Based on: • Sales of QUVIVIQ • Sales of PIVLAZ in Japan • Tiered royalties on aprocitentan Excluding unforeseen events 28 Full Year 2022 Financial Reporting | 7 Feb 2023
Slide 29: Continuing to advance our pipeline
“Continuing to advance our pipeline.” Jean-Paul Clozel Chief Executive Officer 29 Full Year 2022 Financial Reporting | 7 Feb 2023
Slide 30: Our drug discovery engine continues to deliver
Our drug discovery engine continues to deliver Compound Mechanism of action Target indication Status PIVLAZ® Cerebral vasospasm associated with Endothelin receptor antagonist Commercially available as PIVLAZ in Japan. (clazosentan) aneurysmal subarachnoid hemorrhage Commercially available as QUVIVIQ
Slide 31: Aprocitentan has significant and sustained efficacy
Aprocitentan has significant and sustained efficacy Part 3 Part 1 Part 2 Double blind Double blind Single blind withdrawal Placebo Aprocitentan 12.5 mg Aprocitentan 25 mg *Primary endpoint P=0.0042 for aprocitentan 12.5 mg vs placebo P=0.0046 for aprocitentan 25 mg vs placebo †Key secondary endpoint
Slide 32: Efficacy confirmed by ambulatory BP monitoring
Efficacy confirmed by Ambulatory BP monitoring at Week 4 (DB Part 1) Daytime Night-time * ** † ** *P=0.003, †P=0.0002, **P<0.0001 vs placebo, not corrected for multiplicity Placebo Number of patients 179 175 182 178 174 182 Aprocitentan 12.5 mg Aprocitentan 25 mg Placebo Aprocitentan 12.5 mg Aprocit
Slide 33: Aprocitentan for difficult-to-control hypertension
Aprocitentan for difficult-to- control hypertension New mode of action in systemic hypertension Aprocitentan demonstrated a sustained blood pressure reduction over 48 weeks and was well-tolerated • New drug application (NDA) filed with the US FDA in Dec 2022 • Market authorisation application (MAA)
Slide 34: Selatogrel – Potential to change the way AMI is treated
Selatogrel – Potential to change the way AMI is treated ‘Fast’ onset ‘Short’ duration of action of action Potent and highly Suitable for selective P2Y12 subcutaneous inhibitor injection Selatogrel is investigational, in development and not approved or marketed in any country. 34 Full Year 2022 Finan
Slide 35: Treatment approach in Phase 3 SOS-AMI
Treatment approach in Phase 3 SOS-AMI Onset of AMI Self-administer Patient calls for First medical Emergency medical symptoms selatogrel using emergency service or contact care follow-up at autoinjector at travels to hospital hospital symptom onset Slowing or stopping Our Heart hope: attack Early in
Slide 36: CARE Phase 2b delivered according to promise
CARE Phase 2b delivered according to promise • Clinically meaningful improvement in disease 4 mg cenerimod activity selected for Phase 3 − Treatment effect increases over time Potential to be the − Treatment effect is increased in patients with greater disease severity and high IFN-1 gene first new
Slide 37: OPUS: Confirmatory program design
OPUS: Confirmatory program design Two Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group studies to evaluate the efficacy, safety, and tolerability of cenerimod in adult patients with moderate-to-severe SLE on top of background therapy Open-label extension Randomizatio
Slide 38: Momentum building catalysts in 2023
Momentum building catalysts in 2023 2023 1H 1H 1H 1H mid- 2H 2H end- Aprocitentan QUVIVIQ FDA decision QUVIVIQ NDA in US QUVIVIQ QUVIVIQ Lucerastat Launch submission Launch Regulatory Future path in UK in Japan Aprocitentan in Switzerland QUVIVIQ decision decision MAA Secure broader submission in Ca
Slide 39: Building momentum in 2023
Building momentum in 2023 39 Full Year 2022 Financial Reporting | 7 Feb 2023