AI Terminal

MODULE: AI_ANALYST
Interactive Q&A, Risk Assessment, Summarization
MODULE: DATA_EXTRACT
Excel Export, XBRL Parsing, Table Digitization
MODULE: PEER_COMP
Sector Benchmarking, Sentiment Analysis
SYSTEM ACCESS LOCKED
Authenticate / Register Log In

Almirall S.A.

Investor Presentation Jan 10, 2023

1785_rns_2023-01-10_a184bede-fc00-45c3-8757-7af57a452586.pdf

Investor Presentation

Open in Viewer

Opens in native device viewer

Almirall – European dermatology leader

41st Annual J.P. Morgan Health Care Conference January 2023

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 reason without the prior, express written consent of the Company. Information in this document about the price at which securities issued by the Company have been purchased or sold in the past, or information about the yield on securities issued by the Company, cannot be relied upon as a guide to the future performance of the Company's securities.

Forward looking information, opinions and statements contained herein are based on the Company's estimates (using assumptions that the Company believes to be reasonable) and on sources believed to be reliable by the Company, but have not been verified by independent experts. The Company does not warrant the completeness, timeliness or accuracy of any such information, opinions and statements, and, accordingly, no reliance should be placed on them in this connection.

Certain statements contained herein that are not historical facts are forward-looking statements.

Such forward-looking statements are based on current expectations and projections about future events and are subject to various risks and uncertainties, many of which are difficult to predict and are beyond the control of the Company. Therefore, actual results may differ materially from those discussed in, or implied by, such forwardlooking statements. Except to the extent required by the applicable law, the Company expressly disclaims any obligation to revise or update any forward-looking statements, the expectations of the Company, the conditions or circumstances on which the forwardlooking statements are based, or any other information or data included herein.

This document does not constitute an offer or invitation to acquire or subscribe for securities, in accordance with the provisions of the restated text of the Securities Market Act approved by the Royal Legislative Decree 4/2015, of 23 October 2015 and its amendments. Furthermore, this document does not constitute a purchase, sale or swap offer, nor a request for a purchase, sale or swap offer for securities, or a request for any vote or approval in any other jurisdiction.

A research-focused medical dermatology leader

  • Leading medical dermatology specialist founded in 1943 and headquartered in Barcelona (Spain).
  • Established portfolio of products with growing dermatology business and promising pipeline.
  • Internationally experienced leadership team driving long-term stakeholder value.
  • Listed in 2007, with reference shareholders owning c.59% of shares.

  1. Last quarter reported. 2. As of 31 December 2021.

Strong European dermatology business poised for future growth

  • FY 2021 Core Net Sales €809.8mm Dermatology at 48% and positioned to grow as a share of business
  • European focus leveraging strong footprint in Spain and Germany, with solid presence in the UK, France and Italy
  • Strong product portfolio & promising pipeline, with unprecedented growth potential and low exposure to patent risk
  • A niche business developing in the US market

4

Dermatology, an attractive commercial space over \$40 B(1) worldwide net sales Sharp strategic focus on areas of high unmet medical needs

  • Maximizing recent launches and commercializing dermatological therapies in key markets, with a particular focus on the \$32 B biologics segment which is expected to grow +40% through 2026.(1)
  • Opportunity for accelerated growth through expected launch from late-stage pipeline driven by Lebrikizumab in AD.
  • Building product ranges across dermatology disease severities and patient journey - efficient marketing and meeting patient need.
  • Early-stage pipeline development through bolt-on acquisitions and internal innovation, including earlier stage R&D candidates with high potential to be first/best in class.

1 2022 Net sales are based on Evaluate Pharma's indication-specific sales which are indicative of market expectations and have a degree of uncertainty. Evaluate Pharma classifies Actinic Keratosis as a Miscellaneous Cancer and Onychomycosis as a Fungal Infection. Other Dermatological category includes total sales related to skin indications per Evaluate Pharma's classification, less sales related to Psoriasis, Atopic Dermatitis and Acne.

Five key areas of focus

  • Atopic dermatitis
  • Onychomycosis
  • Psoriasis
  • Actinic keratosis
  • Acne

Expansion plans in dermatology

  • Alopecia areata
  • Vitiligo
  • Non-melanoma skin cancer
  • Rare diseases

Strong and growing strategic medical dermatology portfolio

Other autoimmune diseases, nonmelanoma skin cancer, rare diseases Psoriasis Acne AK Onycho ▪ Serving patients and dermatologists with added value innovation in very common disease areas ▪ Efinaconazole filed in the initial EU countries Atopic Dermatitis Others ▪ Sharpened R&D focus on areas of high unmet need Lebrikizumab ▪ Highly promising Phase 3 profile ▪ Filed and on track for approval in late 2023 ▪ Only company covering the entire Psoriasis severity spectrum ▪ Ilumetri performing well vs Big pharma

Progressing promising late-stage pipeline, while building early stage Strong position across significant dermatology indications

INTERNAL USE

J.P. Morgan Healthcare Conference 2023 7

Lebrikizumab

Almirall to leverage strong commercial footprint with EU rights

Lebrikizumab in licensed from Dermira / Eli Lilly.

INTERNAL USE

J.P. Morgan Healthcare Conference 2023

Lebrikizumab - very competitive product in growing market

1 2 Lebrikizumab shows a consistent profile across a clinical development program with more than 2000 patients.

The safety profile of the Phase 3 is consistent with prior Lebrikizumab studies in Atopic Dermatitis.

3 4 Atopic dermatitis is an IL-13 dominant disease and we believe lebrikizumab is the best antibody targeting IL-13.

For the maintenance of patients that responded at Week 16, Q4W dosing shows similar results as compared to Q2W dosing.

INTERNAL USE

Lebrikizumab in licensed from Dermira / Eli Lilly.

Building early-stage pipeline with promising in-licensing

ALM223* – Innovative IL-2 mutein for a broad spectrum of autoimmune diseases

  • ALM223 is an IL-2-mutant fusion protein (IL-2muFc) that activates regulatory T-cells.
  • Preclinically, ALM223 exhibits improved PK profile and potential to restore immune balance.
  • Start of phase I in the US/EU is expected in the second half of 2023.
  • Ambition to develop and commercialize globally (ex-Greater China).

ALM27134**: First-in-class asset currently in phase 1

  • ALM27134* is an anti-IL-1-RAP (Interleukin-1 receptor accessory protein) monoclonal antibody that blocks signaling of six member of the IL-1 cytokine family (IL-1,a,b, IL-33, IL-36,a,b,g)
  • Opportunity to address unmet need in several autoimmune dermatology indications.
  • Phase I ongoing
  • Ambition to develop and commercialize globally.

Recent news-flow and potential events in 2023

11

1 Lebrikizumab EU filing accepted Q4 2022
2 Anti-IL-1RAP Phase 1 study initiated 2022
3 Klisyri Large field post-marketing
study data for label expansion
Filing 2023
Expected approval in 2024 US and
2026 Europe
4 2023 Guidance Feb 2023
5 Seysara China P3 data 2023
6 IL-2-mu-Fc US/EU Phase 1 initiation H2 2023
7 Lebrikizumab Potential EU approval Q4 2023
8 Efinaconazole EU approval & launch 2023

Capital allocation focused on creating long term shareholder value

  1. Invest in current and future product launches (Lebrikizumab, Ilumetri, Wynzora, Klisyri) to drive significant mid-term revenue acceleration.

  1. Focus on innovation by strengthening the pipeline both by proprietary research and inlicensing assets.

  1. Secure stable dividend to shareholders.

4.

Opportunistic inorganic growth while maintaining a prudent financial policy & solid liquidity position.

Thank You

Appendices

Well established and performing portfolio of general medicine and OTC products

Other key products

Imunorix: immuno-correcting therapy of bacterial, fungal and viral infection of upper and lower airways and urinary tracts, as part of complex therapy.

Osteomuscular key products

Airtal: non steroid, anti-rheumatic, analgesic, and anti-inflammatory product for the treatment of odontalgia, posttraumatic tumefaction, lumbosciatica, myalgia, post-episiotomiae pain, postlabour pain, primary dysmenorrhea, and extra-articular rheumatism.

Cardiovascular key products

Crestor and Provisacor: effective treatment for high levels of cholesterol in the blood and elevations in LDL cholesterol and triglyceride (TG) levels.

GI & Metabolism key products

Efficib: indicated for type 2 diabetes patients when diet and physical exercise, and the administration of metformin in monotherapy, do not adequately control blood glucose levels.

Almax: one of the products with the most longevity in our portfolio, tried-and-true treatment for heartburn and gastric acidity in adults and children over 12.

Respiratory key products

Ebastel franchise: H1 receptor, oncedaily, non-sedating, selective, and longacting treatment for allergic rhinitis (seasonal and perennial), chronic idiopathic urticaria, and conjunctivitis resulting from allergies

CNS key products

Sativex: only approved CBD:THC medicine, indicated for the treatment of resistant muscle spasticity in multiple sclerosis (MS) patients.

Top 10 proprietary and in-licensed products

Based on Net Sales

Origin
Principal brand
(Product active ingredient)
Therapeutic area Pathological indication Propritetary In-Licensed Net sales for the
year ended Dec
31, 2021
(€ in millions)
Approximate
% of Net Sales
Ilumetri Dermatology Psoriasis 81.9 10.1%
Ebastel
franchise
(Ebastine)
Respiratory Allergy 63.6 7.9%
Ciclopoli
franchise
Dermatology Onychomycosis 55.9 6.9%
Tesavel/Efficib
(Sitagliptin/ sitagliptin + Metformin)
Gastrointestinal/ Metabolism Diabetes 47.9 5.9%
Sativex franchise Nervous
System
Multiple
sclerosis
36.5 4.5%
Crestor Cardiovascular System Hyperlipidemia 36.4 4.5%
Almax Gastrointestinal Heartburn 33.4 4.1%
Decoderm
franchise (Fluprednidene)
Dermatology Mycotic
dermatitis
29.3 3.6%
Skilarence Dermatology Psoriasis 27.5 3.4%
Seysara Dermatology Psoriasis 25.5 3.1%
Total 437.9 54.1%

Strong in-licensing execution track record

Lebrikizumab phase 3 data Week 52 results (EADV Congress) Design of 36 weeks maintenance period in ADvocate 1&2 studies

a LEB-treated patients received a 500-mg LD at Weeks 0 and 2; b Patients who used rescue therapy (including topical) during the Induction Period were considered to be non-responders; c Responders who received PBO and were re-randomized to LEB received an LD of LEB 500 mg at Week 16 or at Weeks 16 and 18, based on the active treatment group assigned in the Maintenance Period; d Patients who completed the study were offered treatment in ADjoin; otherwise, patients participated in a safety follow-up 12 weeks after their last dose.

INTERNAL USE

EASI75=75% improvement from baseline in Eczema Area and Severity Index score; IGA=Investigator's Global Assessment; LD=loading dose; LEB=lebrikizumab; PBO=placebo; Q2W=every 2 weeks; Q4W=every 4 weeks; R=randomization

Lebrikizumab phase 3 data Week 52 results (EADV Congress) 80% of responders at Week 16 maintained improvements at Week 52

Maintenance phase data confirms potential as first-line Biologic and may support less frequent dosing

Lebrikizumab in licensed from Dermira / Eli Lilly.

The percentages (%) in the table represent the patients maintaining response rates on the mentioned endpoints at the end of the maintenance period. EASI=Eczema Area and Severity Index; IGA=Investigator's Global Assessment; NRS=Numeric Rating Scale; Q2W=every 2 weeks; Q4W=every 4 weeks.

We are a global biopharmaceutical company focused on medical dermatology, passionate about science and committed to transform patients' life.

Our Noble Purpose

Transform the patients' world by helping them realize their hopes and dreams for a healthy life.

Our Commitment

  1. Bring medical dermatology solutions that impact patients' lives

2.

Be the Partner of choice for companies that require focus, agility and broad experience

3.

Enhance our focus on innovation by investing in transformative therapies that meet patients needs

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

Talk to a Data Expert

Have a question? We'll get back to you promptly.