Almirall Sa · BME:ALM

Almirall Sa — H1 2020 Earnings Presentation

52 slides from Almirall Sa's earnings presentation, Jul 27, 2020

  1. Slide 1: H1 2020 Financial Results & Business Update

    H1 2020 Financial Results & Business Update 27th July 2020

  2. Slide 2: Disclaimer

    Disclaimer This document has been prepared by Almirall, S.A. (the “Company”) exclusively for use during the presentation. This document includes only summary information and does not intend to be comprehensive. This document may not be disclosed or published or used by any person or entity for any r

  3. Slide 3: Agenda

    Agenda 1. H1 2020 Highlights & Growth Drivers Peter Guenter, CEO Financial Results & Business Update 2. SeysaraTM Label Update Volker Koscielny, CMO 3. R&D Update Bhushan Hardas, CSO 4. Financial Review Mike McClellan, CFO 5. Closing Remarks Peter Guenter, CEO

  4. Slide 4: H1 2020 Highlights

    H1 2020 Highlights Z 9 © almirall

  5. Slide 5: H1 2020 Highlights

    H1 2020 Highlights Performance adversely impacted by Covid-19 Q2 business performance impacted by Covid-19: • H1 Net Sales €426 MM -1% (+6% ex-AczoneTM), Total Revenues €433 MM -8%, EBITDA €137 MM -17%. 1 • Medical Dermatology over proportionally impacted by Covid-19. • Progressive normalization of

  6. Slide 6: H1 2020 European market impact of Covid-19

    H1 2020 European market impact of Covid-19 Recent customer interactions have shown growth vs. previous weeks  Stocking effect in March reversed in April and May.  Face to face customer interactions have started to increase in June.  Across both Retail Prescription (Rx1) and Consumer Health (CH) m

  7. Slide 7: H1 2020 US market impact of Covid-19

    H1 2020 US market impact of Covid-19 Daily new Covid cases show an upward trend in July  As numerous states report rapid increases in positive cases, prescription trends show signs of retreat.  Prescription trends at 73MM remaining below average pre-Covid of 80MM.  Q2 vs Q1 branded OAB down >40%.

  8. Slide 8: Q2 2020 Dermatology most impacted by Covid

    Q2 2020 Dermatology most impacted by Covid Patient consultations and prescribing habits in Dermatology significantly altered during Q2  US Dermatologists interviewed experienced a drop of 71% in patient appointments while this figure was 65% in EU, leading to a significant drop in new patients init

  9. Slide 9: Growth Drivers

    Growth Drivers 9

  10. Slide 10: Ilumetri: IL-23 the winning class within biologics

    Ilumetri® IL-23 the winning class within biologics Ilumetri® increases competitiveness inside the anti-IL23 class Market share new patients* by class in the German biologics market Anti-IL-23 Anti-IL-17 Anti-IL-TNF Anti-IL-12/23 IL-23 market share new patients* 2020 50% Ilumetri IL-23’s becoming the

  11. Slide 11: Ilumetri: Growth trend returning to pre-Covid levels

    Ilumetri® Growth trend returning to pre-Covid levels Back on track despite Covid impact Germany, Spain, Austria and Switzerland monthly Net Sales European monthly Net Sales €18MM in H1 2020 Jan Feb Mar Apr May Jun Jan Feb Mar Apr May Jun Jan Feb Mar Apr May Jun Jan Feb Mar Apr May Jun Jan Feb Mar Ap

  12. Slide 12: Ilumetri: Continued momentum during Q2

    Ilumetri® Continued momentum during Q2 Reimbursement in France an important boost for Ilumetri® Ilumetri® continued good momentum despite Covid-19 impact  Strong H1 performance with sales more than doubling to €18 MM year-on-year.  Positive momentum continues in Germany, June was the highest month

  13. Slide 13: Skilarence: Performance affected by Covid-19

    Skilarence® Performance affected by Covid-19 as anticipated Legal proceedings underway in The Netherlands related to compounding Skilarence® challenging performance during H1  Net Sales performance flat year-on-year excluding compounding impact in The Netherlands.  Favourable decisions by the Dutc

  14. Slide 14: Seysara: TRx stabilized and market share maintained

    SeysaraTM TRx stabilized and market share maintained Covid-19 delaying the rebuilding of TRx, but NRx starts to increase with opening of states US acne market severely impacted by Covid-19  Overall US OAB market has declined during Covid-19, but SeysaraTM maintained market share.  Absence of new p

  15. Slide 15: Seysara: China phase to start later this year

    SeysaraTM China Phase 3 to start later this year Potential 13 million moderate to severe treated acne patients Patient breakdown acne vulgaris market (2028) China is a large opportunity for SeysaraTM  Acne is a high unmet need in China with a large number of patients with moderate to severe acne. H

  16. Slide 16: Seysara Label Update

    Seysara!™ Label Update Z 9 © almirall

  17. Slide 17: Seysara: FDA label approval, microbiology section

    SeysaraTM A key milestone for SeysaraTM – FDA label approval: Microbiology section (12.4) Resistance “Propionibacterium acnes strains displayed a low propensity for the development of resistance to sarecycline, with spontaneous mutation frequencies being 10−10 at 4 – 8 × MIC”1 Why is antimicrobial r

  18. Slide 18: Seysara developed for moderate to severe acne vulgaris

    SeysaraTM SeysaraTM developed specifically for the treatment of moderate to severe acne vulgaris  Significant inflammatory lesion count reduction in as early as 3 weeks + ~50% mean percent reduction of inflammatory lesions at Week 121.  Seysara has been prescribed for close to 100,000 patients sin

  19. Slide 19: R&D Update

    R&D Update The information presented herein is information already published. The data shows the results of a Phase 2b clinical trial conducted with Lebrikizumab and a Phase 3 clinical trial conducted with Tralokinumab. The data cannot be compared as it results from different clinical development ph

  20. Slide 20: Lebrikizumab anti-IL-13 monoclonal antibody

    Lebrikizumab anti-IL-13 monoclonal antibody Lebrikizumab has best-in-class potential Several areas of differentiation Differences in antibody design leads to difference in mechanism of action Lebrikizumab Tralokinumab Selectively blocks IL-13 signaling by preventing Binds IL-13 and prevents IL-13 bi

  21. Slide 21: Lebrikizumab: Phase 2b efficacy

    Lebrikizumab Opportunity to improve efficacy, tolerability and convenience via best-in-class anti-IL-131-2 Strong efficacy profile observed in phase 2b Proportion of patients with IGA response (0/1 + ≥2 EASI75 at week 16 (mITT) points improvement) at week 16 (mITT) Lebrikizumab Phase 2b data (No TCS

  22. Slide 22: Tralokinumab: Phase 3 data for reference

    Tralokinumab Phase 3 data for reference Proportion of patients with IGA response (0/1 + ≥2 EASI75 at week 16 (mITT) points improvement) at week 16 (mITT) Tralokinumab Phase 3 data (No TCS allowed) Tralokinumab Phase 3 data (No TCS allowed) Active Active 70 70 Placebo Placebo 60 60 50 50 % of patient

  23. Slide 23: Lebrikizumab: Commercially attractive attributes

    Lebrikizumab Commercially attractive attributes An important improvement in itch, the most relevant complaint in AD Proportion of patients pruritus NRS change of ≥ 4 points at week 16 (mITT) Lebrikizumab Phase 2b data (No TCS allowed) Active 80 Placebo 70 60 70.0 % of patients 50 40 47.4 30 20 27.3

  24. Slide 24: Tralokinumab: Phase 3 itch data for reference

    Tralokinumab Phase 3 data for reference Proportion of patients pruritus NRS change of ≥ 4 points at week 16 (mITT) Tralokinumab Phase 3 data (No TCS allowed) Active 80 Placebo 70 60 % of patients 50 40 30 20 25,0 10 20,0 9,7 10,3 15,5 9,5 0 TRALOKINUMAB 300MG TRALOKINUMAB 300MG Q2W PH3 ECZTRA 1 Q2W

  25. Slide 25: Lebrikizumab: Compelling business opportunity

    Lebrikizumab Compelling business opportunity c. 30M Prevalent Atopic Dermatitis Sizable market Patients in EU5 by 2028 • Atopic dermatitis is an underserved and growing market. Mod-Severe • Need for new, differentiated therapy. diagnosed 5.3M Differentiated Mod-Severe • Lebrikizumab has a very high

  26. Slide 26: Strategic deal with Bioniz

    Strategic deal with Bioniz Positive new efficacy and safety data from interim analysis of Phase 1/2 study in CTCL Option decision in Q4 2020 ahead of potential launch in CTCL as early as 2023 Superior safety profile and efficacy in most refactory patients shown in interim data  Over 80% of subjects

  27. Slide 27: Strategic deal with Bioniz: Potential launch by 2023

    Strategic deal with Bioniz Potential launch by 2023 Global market of CTCL is estimated to be $1.6Bn* CTCL  High unmet need in CTCL: high level of switching between systemic therapies due to toxicity profiles and lack of response.  CTCL has a prevalence of c. 40,000 patients in the US and EU, 70% o

  28. Slide 28: Financial Review

    Financial Review 28

  29. Slide 29: H1 2020 Results

    H1 2020 Results Q2 performance adversely impacted by Covid-19 Highlights • Net Sales and Total Revenues performance impacted by Covid-19, declining by -1% despite AczoneTM genericization and -8% respectively. A reversal of the March wholesaler stocking was seen in April and May, particularly in Euro

  30. Slide 30: H1 2020 Breakdown by products

    H1 2020 Breakdown by products YTD June YTD June € Million % var vs LY 2020 2019 Europe 309 315 (1.9%) Dermatology 112 113 (1.1%) General Medicine & OTC 197 202 (2.3%) Ebastel 31 33 (4.9%) Efficib/Tesavel 24 25 (4.0%) Crestor 18 17 5.9% Sativex 17 15 12.7% Almax 13 13 n.m. US 43 79 (45.6%) Dermatolog

  31. Slide 31: H1 2020 Dermatology sales breakdown

    H1 2020 Dermatology sales breakdown YTD June YTD June € Million % var vs LY 2020 2019 Europe 112 113 (1.1%) Ciclopoli franchise 26 24 7.2% Ilumetri 18 8 122.3% Skilarence 14 16 (11.9%) Decoderm franchise 13 13 n.m. Solaraze 10 15 (36.7%) Others 32 37 (14.4%) US 43 79 (45.6%) Aczone 11 38 (71.1%) Taz

  32. Slide 32: H1 2020 Net Sales Evolution

    H1 2020 Net Sales Evolution EU New launches and US portfolio Million Euros Growth drivers positive momentum during a Aided by Deferred Income challenging quarter US products performance Release +€26.5 MM adversely impacted by Covid-19 EU performance showed resilience in face and AczoneTM genericizat

  33. Slide 33: H1 2020 Profit & Loss Breakdown

    H1 2020 Profit & Loss Breakdown YTD June YTD June % var % var Net Sales decrease due to AczoneTM € Million genericization and adverse impact of 2020 2019 LY CER LY Covid-19 Total Revenues 433.0 469.0 (7.7%) (8.3%) Net Sales 426.0 430.3 (1.0%) (1.6%) Other Income declining as milestone related income

  34. Slide 34: H1 2020 EBITDA to Normalized Net Income

    H1 2020 EBITDA to Normalized Net Income Achieved Normalized EPS of €0.34 in challenging H1 YTD June YTD June % var % var € Million 2020 2019 LY CER LY EBITDA 137.2 166.2 (17.4%) (17.9%) % of sales 32.2% 38,6% EBITDA mainly impacted by Covid-19 and AczoneTM genericization Depreciation & Amortization

  35. Slide 35: H1 2020 Balance Sheet

    H1 2020 Balance Sheet June December € Million Var of BS 2020 2019 Decreases mainly due to depreciation Goodwill 316.0 316.0 - and US Legacy impairment (€ -16.8M), partially offset by Dermira’s Phase III Intangible assets 1,105.8 1,157.2 (51.4) 3rd development milestone Property, plant and equipment

  36. Slide 36: H1 2020 Cash Flow

    H1 2020 Cash Flow Operating Cash Flow reached €68 MM in a challenging H1 2020 Dividend delayed due to postponement of AGM YTD June YTD June € Million 2020 2019 Profit Before Tax 50.4 73.6 Depreciation and amortization 61.9 65.2 Negative change in Working Capital Impairment (reversals) / losses 16.8

  37. Slide 37: 2020 Full Year Guidance vs 2019

    2020 Full Year Guidance vs 2019 Guidance revised quantifying business impact from Covid-19 Net Sales Low to mid-single-digit decline EBITDA €230 - €250 MM Previously: Net Sales low to mid-single-digit growth and EBITDA between €260 - €280 MM Financial Results & Business Update 37 Closing Remarks

  38. Slide 38: Almirall EBITDA Evolution

    Almirall EBITDA Evolution Confident in our ability to execute on Growth Drivers launches Targeting future growth in Core EBITDA while investing in new launches and late stage pipeline. 2020 affected by AczoneTM Gx completion in the US and Covid-19 impacts Reported EBITDA: Core EBITDA + Other Income

  39. Slide 39: Closing Remarks

    Closing Remarks 39

  40. Slide 40: Conclusions

    Conclusions Covid-19 impact on dermatology, especially in US - strong resilience of 1 our EU business. Very strong underlying performance of Ilumetri. Reimbursement obtained 2 in France. Clinically relevant FDA label improvement obtained for SeysaraTM. 3 Positions us well for regain of MS when marke

  41. Slide 41: Appendices

    Appendices 41

  42. Slide 42: Late stage pipeline: significant mid-term value

    Late stage pipeline Significant mid-term value Focus on Innovation and Science to unlock mid-term potential Under Indication Commercial name Expected Launch Phase I Phase II Phase III Geography registration US Q1 2021 Actinic keratosis Tirbanibulin Europe Q2 2021 Atopic dermatitis Lebrikizumab 2023

  43. Slide 43: Skilarence Net Sales

    Skilarence® Net Sales Skilarence® Net Sales € MM 9 8 8 8 8 7 6 4 4 3 2 1 Q3 2017 Q4 2017 Q1 2018 Q2 2018 Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020 Q2 2020 Financial Results & Business Update 43 Appendices

  44. Slide 44: Ilumetri Net Sales

    Ilumetri® Net Sales Ilumetri® Net Sales € MM 9 9 7 5 5 3 Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020 Q2 2020 Financial Results & Business Update 44 Appendices

  45. Slide 45: Seysara Net Sales

    SeysaraTM Net Sales SeysaraTM Net Sales € MM 9 7 6 5 3 2 Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020 Q2 2020 Financial Results & Business Update 45 Appendices

  46. Slide 46: H1 2020 Income Statement CER

    H1 2020 Income Statement CER YTD June YTD June YTD June % var. % var CER June € Million var. EURO 2020 2020 CER 2020 2020 2019 CER LY Total Revenues 430.0 433.0 0.7% 469.0 (8.3%) (7.7%) USD 1.14 1.10 CHF 1.13 1.06 Net Sales 423.4 426.0 0.6% 430.3 (1.6%) (1.0%) GBP 0.87 0.87 Other Income 6.6 7.0 6.1%

  47. Slide 47: H1 2020 Net Sales by Geography

    H1 2020 Net Sales by Geography YTD June YTD June % var vs € Million 2020 2019 LY Europe 335.2 308.2 8.8% US 50.4 83.0 (39.3%) Rest of World 40.4 39.1 3.3% Total 426.0 430.3 (1.0%) Financial Results & Business Update 47 Appendices

  48. Slide 48: H1 2020 Leading Product Sales

    H1 2020 Leading Product Sales YTD June YTD June % var vs € Million 2020 2019 LY Ebastel franchise 39 40 (2.8%) Ciclopoli franchise 26 25 4.8% Efficib/Tesavel 24 25 (7.1%) Ilumetri 18 8 119.8% Crestor 18 17 6.0% Sativex franchise 17 15 12.8% Almax 15 15 2.7% Skilarence 14 16 (12.4%) Decoderm franchis

  49. Slide 49: Reconciliations with audited financial statements: Gross Margin & EBITDA

    Reconciliations with audited financial statements Gross Margin & EBITDA€ Million YTD June 2020 YTD June 2019 Revenues (1) 426.0 432.6 ThermiGen Net Sales (3) - (2.3) Net Sales 426.0 430.3 - Procurements (1) (95.7) (88.8) ThermiGen Procurements (3) - 1.6 - Other manufacturing costs (2) Staff costs (1

  50. Slide 50: Reconciliations: EBIT & Net Financial income/(expenses)

    Reconciliations with audited financial statements EBIT & Net Financial income/ (expenses) YTD June YTD June € Million 2020 2019 EBITDA 137.2 166.2 - Amortization & Depreciation (61.9) (65.2) EBIT 75.3 101.0 YTD June YTD June € Million 2020 2019 Financial income - 0.8 Financial cost (8.8) (4.8) Chang

  51. Slide 51: References

    References 1. SEYSARA [package insert]. Exton, PA: Almirall, LLC. 2020. 2. Dreno B, Thiboutot D, Gollnick H, et al. Antibiotic stewardship in dermatology: limiting antibiotic use in acne. Eur J Dermatol. 2014;24(3):330-334. 3. https://www.who.int/news-room/fact-sheets/detail/antibiotic-resistance. 4

  52. Slide 52: www.almirall.com

    For further information, please contact: Pablo Divasson del Fraile Investor Relations & Corporate Comms. Tel. +34 93 291 3087 [email protected] Or visit our website: www.almirall.com

Almirall — H1 2020 Earnings Presentation on 6ix