Almirall Sa · BME:ALM
Almirall Sa — Q1 2022 Earnings Presentation
45 slides from Almirall Sa's earnings presentation, May 9, 2022
Slide 1: Q1 2022 Financial Results & Business Update
Q1 2022 Financial Results & Business Update 9th May 2022 1
Slide 2: Disclaimer
Disclaimer This document has been prepared by Almirall, S.A. (the Such forward-looking statements are based on current “Company”) exclusively for use during the presentation. expectations and projections about future events and are This document includes only summary information and subject to vario
Slide 3: Agenda
Agenda 1. New Chairman & President of the Board of Directors Carlos Gallardo Piqué, Chairman & President 2. Q1 2022 Highlights & Growth Drivers Gianfranco Nazzi, CEO 3. Pipeline Updates Karl Ziegelbauer, CSO 4. Financial Review Mike McClellan, CFO 5. Closing Remarks Gianfranco Nazzi, CEO Financial R
Slide 4: New Chairman & President of the Board of Directors
New Chairman & President of the Board of Directors Carlos Gallardo Piqué 4
Slide 5: Mr. Carlos Gallardo Piqué
Mr. Carlos Gallardo Piqué Appointed as Chairman & President of the Board of Directors Carlos Gallardo new Chairman & President of the Board of Directors ▪ Carlos started his pharmaceutical career in Pfizer prior to joining Almirall where he held positions of increasing seniority over nearly 10 years
Slide 6: Q1 2022 Highlights & Growth Drivers
Q1 2022 Highlights & Growth Drivers 6
Slide 7: Q1 2022 highlights
Q1 2022 highlights Good business performance, on track to meet FY 2022 Guidance Good start to the year: 1 • Core Net Sales* €218.8 MM +1.6% and EBITDA €59.6 MM -19.7% year-on-year, in line with expected performance, with EBITDA decline mainly due to one-offs in Q1 2021. • Solid Core performance with
Slide 8: Ilumetri highlights
Ilumetri® highlights Higher contribution from new country launches in Europe Market share of new patients by class in the German biologics market* EU Net Sales €27 MM in Q1 2022 50% 45% Anti-IL23 c.+60% 40% yoy growth 35% 30% Anti-IL17 25% Anti-TNF 20% 15% 10% 5% Anti-IL12/23 Q2 2020 Q3 2020 Q4 2020
Slide 9: Recent launches in Europe: Klisyri & Wynzora
Recent launches in Europe: Klisyri® & Wynzora® Positive initial uptake following launch Wynzora® for the treatment of mild to moderate psoriasis Klisyri® for the treatment of actinic keratosis vulgaris, including scalp psoriasis, in adults* Very positive initial uptake in countries launched Successf
Slide 10: US market: Klisyri & Seysara
US market: Klisyri® & Seysara® Building a sustainable growth platform Klisyri® for the treatment of actinic keratosis Seysara® for the treatment of acne Focused on driving demand and gaining market access Focused on differentiation and improving quality of coverage Klisyri® gaining market share in t
Slide 11: Pipeline Update
\\\ \) follaalicell| Pipeline Update i
Slide 12: Promising late-stage Pipeline
Promising late-stage Pipeline Strong position across significant dermatology indications Molecule / Under Commercial name Indication Expected launch Phase 1 Phase 2 Phase 3 registration Geography Lebrikizumab* Atopic dermatitis Late 2023 Klisyri (extended label) Actinic keratosis US 2024 / EU 2025 S
Slide 13: ADvocate 1&2 Week 16 primary endpoints: EASI-75 & IGA
ADvocate 1&2 Week 16 primary endpoints: EASI-75 & IGA >50% of the patients achieved at least 75% improvement in overall disease severity ADvocate 1 (ITT, MCMC-MI) ADvocate 1 (ITT, MCMC-MI) ADvocate 2 (mITT, MCMC-MI) ADvocate 2 (mITT, MCMC-MI) * p<0.05; ** p<0.01; *** p<0.001 vs. PBO based on the Coc
Slide 14: ADhere phase 3 randomized trial completed
ADhere phase 3, randomized, placebo-controlled trial completed Designed to evaluate Lebrikizumab in adult & adolescent patients with moderate-to- severe atopic dermatitis in combination with topical corticosteroids (TCS) Treatment Perioda Randomization Co-Primary endpoints: LDb LEB 250 mg Q2W + TCS
Slide 15: ADhere primary endpoints at Week 16: EASI-75 & IGA
ADhere primary endpoints at Week 16: EASI-75 & IGA * p<0.05; ** p≤0.01; *** p≤0.001 vs. PBO based on the Cochran-Mantel-Haenszel test stratified by geographic region (US vs. Europe vs. rest of world), age (adolescents 12 to <18 years old vs. adults ≥18 years old), and disease severity (baseline IGA
Slide 16: ADhere secondary efficacy endpoints
ADhere secondary efficacy endpoints * p<0.05; ** p≤0.01; *** p≤0.001 vs. PBO based on the Cochran-Mantel-Haenszel test stratified by geographic region (US vs. Europe vs. rest of world), age (adolescents 12 to <18 years old vs. adults ≥18 years old), and disease severity (baseline IGA score of 3 vs.
Slide 17: Lebrikizumab for atopic dermatitis
Lebrikizumab for atopic dermatitis Almirall to leverage strong commercial footprint in Europe Fast onset of action with Lebrikizumab rapidly improved skin and itch symptoms within 4 weeks. Phase 3 study confirms Lebrikizumab On track for a 2022 submission may potentially offer a compelling in the EU
Slide 18: Financial Review
\\\ \) follaalicell| 18
Slide 19: Q1 2022 Core Results
Q1 2022 Core Results* Good start to the year Highlights Core Net Sales* €218.8 MM +1.6% Total EBITDA €59.6 MM and Core EBITDA* €50.3 MM Core Gross Margin* of 66.7% in helped by positive impact from -26.0% year-on-year, tracking in line with expectations. Product other income related to line, with po
Slide 20: Q1 2022 Core Net Sales breakdown by products
Q1 2022 Core Net Sales* breakdown by products Q1 2022 Core Net Sales breakdown YTD March YTD March of the core business Dermatology; € Million % Chg YoY 48% 2022 2021 Europe 186.4 176.4 5.7% Dermatology 85.8 65.5 31.1% General Medicine & OTC 100.5 110.9 (9.3%) Q1 2022 Core Net Sales Ebastel franchis
Slide 21: Q1 2022 Dermatology Sales breakdown
Q1 2022 Dermatology Sales* breakdown YTD March YTD March € Million % Chg YoY 2022 2021 Europe 85.8 65.5 31.1% Ilumetri 27.0 16.9 59.8% RoW; 4% Ciclopoli franchise 15.3 13.6 12.7% US Decoderm franchise 7.5 7.3 2.6% 15% Skilarence 7.4 6.4 14.7% Solaraze 4.5 4.0 11.8% Others EU 24.2 17.3 39.3% US 15.4
Slide 22: Q1 2022 Core Results
Q1 2022 Core Results* Reconciliation from Core EBITDA* to Total EBITDA % Chg % var. € Million Q1 2022 Q1 2021 YoY CER Core Net Sales* excludes AstraZeneca Core Total Revenues 219.7 216.3 1.6% 0.8% Deferred Income Core Net Sales 218.8 215.4 1.6% 0.8% Core Other Income 0.9 0.9 0.0% (11.1%) Cost of Goo
Slide 23: Q1 2022 EBITDA to Normalized Net Income
Q1 2022 EBITDA to Normalized Net Income Good quarterly performance on target for FY 2022 Guidance % var. € Million Q1 2022 Q1 2021 % Chg YoY CER EBITDA 59.6 74.2 (19.7%) (19.9%) % of sales 27.2% 33.6% Q1 2021 boosted by product Depreciation & Amortization 29.1 29.2 (0.3%) (3.1%) divestments with a c
Slide 24: Q1 2022 Balance Sheet
Q1 2022 Balance Sheet Solid Net Debt and flexible capital structure € Million March 2022 Dec 2021 Variation Goodwill & Intangible assets 1,239.7 1,252.0 (12.3) Property, plant and equipment 117.1 117.4 (0.3) Decrease relating to depreciation, partly offset Financial assets 51.3 80.5 (29.2) by milest
Slide 25: Q1 2022 Cash Flow
Q1 2022 Cash Flow Operating Cash Flow affected by Working Capital & Taxes Working Capital decrease due to a timing € Million Q1 2022 Q1 2021 impact on accounts payable and higher accounts receivable Profit Before Tax 28.1 38.4 Depreciation and amortization 29.1 29.2 Q1 2021 mainly boosted by CIT Cas
Slide 26: Closing Remarks
\\\ \) follaalicell| 26
Slide 27: Conclusions
Conclusions Focused on execution of important product launches 1 We reiterate our 2022 Guidance after a good start to the year. 2 Positive momentum set to improve as we gain traction from our recent innovative product launches. Preparing the business for important launches like Lebrikizumab followin
Slide 28: Appendices
Appendices 28 Financial Results & Business Update
Slide 29: Q1 2022 Total Income Statement CER
Q1 2022 Total Income Statement CER % var. % Chg EURO CER 2022 Mar 2022 € Million CER Q1 2022 Q1 2022 var. Q1 2021 CER YoY Total Revenues 227.3 229.0 1.7 222.5 2.2% 2.9% USD 1.21 1.13 Net Sales 217.2 218.8 1.6 220.6 (1.5%) (0.8%) GBP 0.87 0.84 Other Income 10.1 10.2 0.1 1.9 n.m. n.m. PLN 4.55 4.62 Co
Slide 30: Q1 2022 Total Profit & Loss Breakdown
Q1 2022 Total Profit & Loss Breakdown € Million Q1 2022 Q1 2021 % Chg YoY Total Revenues 229.0 222.5 2.9% Net Sales 218.8 220.6 (0.8%) Other Income 10.2 1.9 n.m. Cost of Goods (72.8) (62.8) 15.9% Gross Profit 146.0 157.8 (7.5%) % of sales 66.7% 71.5% R&D (21.1) (13.4) 57.7% % of sales (9.6%) (6.1%)
Slide 31: European growth drivers
European growth drivers Net Sales Ilumetri® Net Sales € MM Skilarence® Net Sales € MM 27 25 9 8 8 8 8 8 20 20 7 7 7 7 7 7 7 17 14 12 9 9 5 5 6 4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 2019 2019 2019 2019 2020 2020 2020 2020 2021 2021 2021 2021 2022 2019 2019 20
Slide 32: Q1 2022 Core Net Sales by Geography
Q1 2022 Core Net Sales* by Geography € Million YTD March 2022 YTD March 2021 % Chg YoY Europe 186.4 176.4 5.7% US 15.7 23.4 (32.9%) Rest of World 16.7 15.6 7.1% Core Net Sales* 218.8 215.4 1.6% * Core business excludes AstraZeneca contribution: Deferred Income and Other Income. Includes product cons
Slide 33: Q1 2022 Leading Product Core Net Sales
Q1 2022 Leading Product Core Net Sales* € Million YTD March 2022 YTD March 2021 % Chg YoY Ilumetri 27.0 16.9 60% Ebastel franchise 21.8 22.0 (1%) Ciclopoli franchise 17.6 14.6 21% Efficib/Tesavel 12.2 11.8 3% Crestor 9.6 8.9 8% Sativex franchise 9.5 8.9 6% Almax 9.0 7.6 18% Skilarence 7.6 6.4 18% De
Slide 34: Reconciliations with audited financial statements
Reconciliations with audited financial statements Gross Margin & EBITDA € Million YTD March 2022 YTD March 2021 Net Sales(1) 218.8 220.6 - Procurements(1) (50.2) (45.1) - Other manufacturing costs(2) Staff costs (8.0) (7.8) Amortization & Depreciation (2.6) (2.6) Other operating costs (11.9) (7.3) G
Slide 35: Reconciliations with audited financial statements
Reconciliations with audited financial statements EBIT & Net Financial income/ (expenses) YTD March YTD March € Million 2022 2021 EBITDA 59.6 74.2 - Amortization & Depreciation (29.1) (29.2) EBIT 30.5 45.0 YTD March YTD March € Million 2022 2021 Financial cost (3.1) (4.7) Financial derivative 0.6 4.
Slide 36: ADvocate 1&2 Week 16 Primary Endpoint IGA
ADvocate 1&2 Week 16 Primary Endpoint IGA IGA patient response rate as early as week 4 ADvocate1 100 ADvocate1 Difference (ITT, MCMC-MI) = 29.6% (ITT, MCMC-MI) 80 Week 16 Patients (%) 60 43.0 40 20 12.8 *** Lebri Placebo 0 Placebo 250 mg LEB Q2W (n=141) Q2W (n=283) 100 ADvocate2 Difference ADvocate2
Slide 37: ADvocate 1&2 key secondary endpoints: EASI-90
ADvocate 1&2 Week 16 key secondary efficacy endpoints EASI-90 response rate 100 Difference ADvocate1 ADvocate1 = 29.1% (ITT, MCMC-MI) 80 (ITT, MCMC-MI) Patients (%) Week 16 60 40 38.2 20 9.1 *** Lebri Placebo 0 Placebo 250 mg LEB Q2W (n=141) Q2W (n=283) ADvocate2 ADvocate2 100 (mITT, MCMC-MI) Differ
Slide 38: ADvocate 1&2 key secondary endpoints: Pruritus NRS
ADvocate 1&2 Week 16 key secondary efficacy endpoints Pruritus NRS ≥4-point improvementa from baseline 100 Difference ADvocate1 ADvocate1 = 33.6% (ITT, MCMC-MI) 80 (ITT, MCMC-MI) Patients (%) Week 16 60 46.3 40 *** 20 12.7 Placebo Lebri 0 Placebo 250 mg LEB Q2W (n=130) Q2W (n=263) ADvocate2 ADvocate
Slide 39: ADvocate 1&2 key secondary endpoints: Sleep loss NRS
ADvocate 1&2 Week 16 key secondary efficacy endpoints Sleep loss NRS ≥2-point improvementa from baseline 100 Difference ADvocate1 ADvocate1 = 33.6% (ITT, MCMC-MI) 80 (ITT, MCMC-MI) Week 16 60 38.7 40 Patients (%) 20 *** 5.1 Lebri 0 Placebo Placebo 250 mg LEB Q2W (n=91) Q2W (n=195) ADvocate2 ADvocate
Slide 40: ADvocate 1&2 key secondary endpoints: DLQI
ADvocate 1&2 Week 16 key secondary efficacy endpoints Quality of life: DLQI ≥4-point improvementa from baseline Difference 100 = 41.7% ADvocate1 ADvocate1 (ITT, MCMC-MI) (ITT, MCMC-MI) 80 75.5 Week 16 60 *** 40 33.8 Patients (%) 20 Placebo Lebri 0 Placebo 250 mg LEB Q2W (n=116) Q2W (n=226) Differenc
Slide 41: Lebrikizumab was well tolerated: ADvocate 1&2 Week 16
Lebrikizumab was well tolerated: ADvocate 1&2 Week 16 Overall incidence of adverse events comparable to placebo ADvocate1 (Safety Population) ADvocate2 (Modified Safety Populationc) LEB 250 mg LEB 250 mg Placebo Q2W Placebo Q2W Q2W Q2W (N=141) (N=145) (N=282) (N=281) Any TEAE 72 (51.5) 128 (45.4) 96
Slide 42: ADvocate 1&2 baseline demographics
ADvocate 1&2 ADvocate1 (ITT) ADvocate2 (mITT) Placebo Q2W LEB 250 mg Q2W Placebo Q2W LEB 250 mg Q2W (N=141) (N=283) (N=146) (N=281) Age, years 34.2 (16.4) 36.1 (17.8) 35.3 (17.2) 36.6 (16.8) Baseline Adolescent (12 to <18 years old), n (%) 18 (12.8) 37 (13.1) 17 (11.6) 30 (10.7) demographics & Adult
Slide 43: ADvocate 1&2 baseline disease characteristics
ADvocate 1&2 ADvocate1 (ITT) ADvocate2 (mITT) Placebo Q2W LEB 250 mg Q2W Placebo Q2W LEB 250 mg Q2W (N=141) (N=283) (N=146) (N=281) Disease duration since AD 23.7 (15.4) 22.0 (14.8) 20.1 (14.4) 20.8 (15.2) Baseline disease diagnosis, years characteristics IGA, n (%) 3 (moderate) 83 (58.9) 170 (60.1)
Slide 44: ADvocate 1&2 use of rescue medication
ADvocate 1&2 ADvocate1 (ITT) ADvocate2 (mITT) LEB 250 mg LEB 250 mg Placebo Q2W Placebo Q2W Use of rescue Q2W Q2W (N=141) (N=146) (N=283) (N=281) medication Any rescue medicationa 47 (33.3) 30 (10.6) 58 (39.7) 56 (19.9) through week 16 Topical rescue medication 44 (31.2) 27 (9.5) 54 (37.0) 52 (18.5)
Slide 45: www.almirall.com
For further information, please contact: Pablo Divasson del Fraile Investor Relations & Corporate Comms. Tel. +34 93 291 3087 pablo.divasson@almirall.com Or visit our website: www.almirall.com Financial Results & Business Update 45