Sarecycline Hydrochloride

China’s National Medical Products Administration (NMPA) has approved Seysara ® (sarecycline hydrochloride) for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 9 years of age and older. Sarecycline hydrochloride is an innovative tetracycline-derived oral antibiotic treatment – the first that was specifically developed for use in dermatology. Almirall has entered into a licence agreement with Sinomune, who will commercialise and distribute the product in China. This approval in China is aligned with Almirall’s ambition to expand access to innovative treatments that make a real difference to more patients and the medical community. BARCELONA, Spain--(BUSINESS WIRE)-- Almirall, S.A. (ALM) a global pharmaceutical company dedicated to medical dermatology announced today that China’s National Medical Products Administration (NMPA) has approved Seysara ® (sarecycline hydrochloride). Sarecycline hydrochloride is the first oral antibiotic that was specifically developed for use in acne and is approved for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 9 years of age and older 1 . Acne vulgaris, a common chronic inflammatory disease most prevalent among adolescents 2 , is characterized by the appearance of inflammatory and non-inflammatory lesions in skin and often involves an overgrowth of bacteria such as Cutibacterium acnes (formerly known as Propionibacterium acnes ). Acne vulgaris frequently has significant negative psychosocial impact on patients which is especially important given its high prevalence in the formative years of adolescence. 3 Oral antibiotics such as sarecycline are the recommended treatment for moderate to severe acne in clinical guidelines. 4 They can decrease the population of C. acnes bacteria on the skin and therefore reduce the effects of the infection and prevent blockage of hair follicles and sebaceous glands. Sarecycline was first approved in the US in 2018 and is a narrow-spectrum antibiotic of the tetracycline-class, with the unique capability of dual binding to the 70S ribosome 5 which is thought to be the reason for the low propensity of C. acnes to develop antimicrobial resistance. “At Almirall, we are dedicated to medical dermatology and to addressing medical unmet needs of people living with skin conditions such as moderate to severe acne. We are delighted that with the approval of Seysara ® in China we can give more patients access to this innovative treatment which was the first oral antibiotic developed specifically for the use in dermatology. We are looking forward to collaborating with Sinomune in China to reach patients and the medical community in China as soon as possible,” said Almirall Executive Vice President, R&D, and Chief Scientific Officer Dr. Karl Ziegelbauer. Various clinical trials have shown the product’s efficacy and favourable safety profile 6,7 In line with Almirall’s commitment to addressing the needs of people living with skin diseases in different populations around the world, the product’s relevance for different patient populations was confirmed through the generation of real-world evidence (PROSES Study 8,9 ) and through conducting clinical studies in a variety of patient populations in the United States and China. Almirall has entered into a license agreement granting Sinomune the exclusive rights for the commercialisation and distribution of this innovative oral treatment for acne in China. It is expected that the product will be available to physicians and patients in China in 2026. About Seysara ® Sarecycline hydrochloride is a once-daily, oral tetracycline-derived antibiotic with anti-inflammatory properties for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 9 years of age and older. The product was approved by the FDA in October 2018 and has been commercialised by Almirall in the US since its launch in January 2019. The product has a favourable safety pro demonstrated consistent and significant efficacy in studies conducted in USA and China, showing reductions from baseline in inflammatory lesion counts and improvements in the percentage of patients with cleared or almost cleared facial lesions based on an Investigator’s Global Assessment (IGA); these effects were observed, as early as week 3 and maintained through week 12. About Almirall Almirall is a global pharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients' world by helping them realize their hopes and dreams for a healthy life . We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients´ needs. Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM). Almirall (total revenue in 2023: €898.8 MM, 1900 employees globally) has direct presence in 21 countries and marketed products in over 100. About Sinomune Sinomune Pharmaceutical Co., Ltd. is a leading dermatology-focused pharmaceutical company in China, with over thirty years of dedication to the skin health sector. Sinomune’s product portfolio is dedicated to addressing a range of conditions including fungal infections, acne, inflammatory skin diseases, and scalp disorders. Sinomune operates a national postdoctoral research station, a CNAS-certified laboratory, and several provincial R&D platforms. Moving forward, Sinomune will continue to advance its "Technology + Marketing" dual-drive strategy, expand its product coverage, enrich its product lines, accelerate global expansion, and strive to be a leader in the dermatology field. For more information, please visit almirall.com Legal warning This document includes only summary information and is not intended to be exhaustive. The facts, figures and opinions contained in this document, in addition to the historical ones, are "forward-looking statements". These statements are based on the information currently available and the best estimates and assumptions that the company considers reasonable. These statements involve risks and uncertainties beyond the control of the company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The company expressly waives any obligation to revise or update any forward-looking statements, goals or estimates contained in this document to reflect any changes in the assumptions, events or circumstances on which such forward-looking statements are based, unless required by the applicable law. References 1. Deeks ED. Sarecycline: first global approval. Drugs. 2019;79:325-329. doi:10.1007/s40265-019-1053-54 Sarecycline: First Global Approval - PubMed 2. Zhu Z, Zhong X, Luo Z, Liu M, Zhang H, Zheng H, Li J. Global, regional and national burdens of acne vulgaris in adolescents and young adults aged 10-24 years from 1990 to 2021: a trend analysis. Br J Dermatol. 2025 Jan 24;192(2):228-237. doi: 10.1093/bjd/ljae352. PMID: 39271178. 3. Morshed ASM, Noor T, Uddin Ahmed MA, Mili FS, Ikram S, Rahman M, Ahmed S, Uddin MB. Understanding the impact of acne vulgaris and associated psychological distress on self-esteem and quality of life via regression modeling with CADI, DLQI, and WHOQoL. Sci Rep. 2023 Nov 30;13(1):21084. doi: 10.1038/s41598-023-48182-6. PMID: 38030667; PMCID: PMC10687248. 4. Reynolds RV, Yeung H, Cheng CE, Cook-Bolden F, Desai SR, Druby KM, Freeman EE, Keri JE, Stein Gold LF, Tan JKL, Tollefson MM, Weiss JS, Wu PA, Zaenglein AL, Han JM, Barbieri JS. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024 May;90(5):1006.e1-1006.e30. doi: 10.1016/j.jaad.2023.12.017. Epub 2024 Jan 30. PMID: 38300170. 5. Batool Z, Lomakin IB, Polikanov YS, Bunick CG. Sarecycline interferes with tRNA accommodation and tethers mRNA to the 70S ribosome. Proc Natl Acad Sci U S A. 2020 Aug 25;117(34):20530-20537. doi: 10.1073/pnas.2008671117. Epub 2020 Aug 12. PMID: 32817463; PMCID: PMC7456112. 6. Zhang J, He L, Chen X, Tu Y, Kostov B, Cabedo J, Baykal T, García Gil E. Efficacy and Safety of Sarecycline in Chinese Patients with Moderate-to-Severe Acne Vulgaris: Randomized Phase 3 Clinical Trial with Open-Label Follow-Up. Dermatol Ther (Heidelb). 2025 Nov;15(11):3285-3300. doi: 10.1007/s13555-025-01526-8. Epub 2025 Aug 28. PMID: 40877730; PMCID: PMC12549459. 7. Moore A, Green LJ, Bruce S, Sadick N, Tschen E, Werschler P, Cook-Bolden FE, Dhawan SS, Forsha D, Gold MH, Guenthner S, Kempers SE, Kircik LH, Parish JL, Rendon MI, Rich P, Stein-Gold L, Tyring SK, Weiss RA, Nasir A, Schmitz C, Boodhoo TI, Kaoukhov A, Berk DR. Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials. J Drugs Dermatol. 2018 Sep 1;17(9):987-996. PMID: 30235387. 8. Baldwin HE, Graber E, Harper JC, Alexis AF, Stein Gold L, Kircik L, Del Rosso J, Hebert AA, Rieder EA, Fried RG, Narayanan S, Koscielny V, Kasujee I. INDIVIDUAL ARTICLE: Sarecycline Improves Acne Severity, Symptoms, and Psychosocial Burden in Non-nodular Acne Vulgaris: PROSES Study. J Drugs Dermatol. 2024 Feb 1;23(2):SF405634s12-SF405634s18. doi: 10.36849/JDD.SF405634. PMID: 38306152. 9. Graber E, Baldwin HE, Fried RG, Rieder EA, Hebert AA, Del Rosso J, Kircik L, Stein Gold L, Harper JC, Alexis AF, Narayanan S, Koscielny V, Kasujee I. INDIVIDUAL ARTICLE: Impact of Acne Vulgaris and Sarecycline on Social/Emotional Functioning and Daily Activities: PROSES Study. J Drugs Dermatol. 2024 Feb 1;23(2):SF405634s5-SF405634s11. doi: 10.36849/JDD.SF405634. PMID: 38306151. Contacts Corporate Communications: Corporate.communication@almirall.com Phone: (+34) 659 614 173 Investor Relations investors@almirall.com Phone: (+34) 93 291 30 87

Pipeline advances in 2026 span a range of dermatology disease areas, including atopic dermatitis, hidradenitis suppurativa, and alopecia areata, with 3 ongoing PoC/Phase II clinical studies* and 3 additional studies to be initiated in 2026. Almirall’s sustained trajectory of growth and profitability enables the company to reach more patients and supports a growth outlook of double-digit net sales through 2030, combined biologics peak sales of approximately €800 MM (Ebglyss ® and Ilumetri ® ), and a 25% EBITDA margin by 2028. Almirall's leadership in medical dermatology, biologics growth, and continued strong performance of its broad product portfolio fuel advancement of a diversified and innovative R&D pipeline addressing skin diseases with high unmet need. SAN FRANCISCO--(BUSINESS WIRE)-- Almirall, S.A. (ALM) , a global pharmaceutical company dedicated to medical dermatology, is participating in the 44 th J.P. Morgan Healthcare Conference 2026, taking place from 12 th to 14 th January 2026 in San Francisco, to provide an update on its business strategy, pipeline advancement, and business outlook. The company’s CEO and president, Carlos Gallardo, presents an update on the progress of the R&D pipeline in medical dermatology which is focused on developing impactful novel treatments for high unmet medical need skin diseases utilising a variety of different technology approaches. Advancing a broad Medical Dermatology pipeline Almirall’s continued investment in advancing its R&D capabilities and its medical dermatology pipeline are closely aligned with the company’s long-term perspective and commitment to positively impact patients and society, and further expansion of its leadership in medical dermatology. The company’s R&D pipeline strategy is based on Almirall’s strong capabilities, advancing the scientific understanding of skin diseases through collaborations with global leading experts and organisations. Almirall utilises a variety of modalities and novel technologies to address some of the most important unmet needs that often have a debilitating effect on patients. Almirall’s clinical development program currently features 3 ongoing proof-of-concept (PoC)/Phase II studies including an anti-IL-1RAP monoclonal antibody (mAb) targeting hidradenitis suppurativa, an IL-2muFc mutant fusion protein targeting alopecia areata and targeting atopic dermatitis - the latter led by Almirall's partner Simcere. In 2026, Almirall plans to initiate 3 additional PoC clinical studies with an anti-IL-21 mAb targeting hidradenitis suppurativa and one additional inflammatory skin disease for the anti-IL-1RAP and the IL-2muFc mutant fusion protein, respectively. Furthermore, Almirall plans to advance a bispecific antibody targeting both IL-13 and OX-40L for the treatment of atopic dermatitis into Phase I in the first half of 2026. In addition to the early-stage clinical pipeline, and as part of the ongoing lifecycle management activities, Almirall is also conducting – together with its partners – a variety of additional studies to enable further patient populations’ access to their biologics portfolio, specifically lebrikizumab and tildrakizumab. As part of this work Almirall is initiating a Phase III study with lebrikizumab in patients with nummular eczema. Nummular eczema is a debilitating condition that is distinct from atopic dermatitis but is thought to involve similar disease mechanisms and therefore makes targeting IL-13 by lebrikizumab a potentially promising therapy option. Several other ongoing clinical studies supporting Ebglyss ® and Ilumetri ® will further increase the body of evidence for these important biologics. Sustained growth and business performance fuel long-term investment in pipeline Almirall’s strong business performance and growth trajectory allow for sustained investment in its leading R&D capabilities following the previous investments into the commercial execution for the launch of breakthrough assets, as well as capabilities, expertise, and infrastructure. The company entered a new era for its business at the beginning of 2025 – and is advancing against its forecasted sustained double-digit growth of net sales (CAGR to 2030) and a substantial margin expansion. This new business era is driven by Almirall’s focus on medical dermatology, growth of its broad product portfolio, and commercial excellence across key markets. Throughout 2025, Almirall has demonstrated that it is on track to deliver against the business goals and has confirmed its guidance for the year based on the successful strategy of combining the advancement of its growth drivers, particularly the biologics portfolio, with the continued growth of its broad portfolio of medical dermatology solutions, including Klisyri ® , Wynzora ® , and Seysara ® . Almirall has shown the success of its recent biologics launches across key markets in Europe and is on track to deliver above €800 MM combined peak sales with expected peak sales for Ebglyss ® of above €450 MM, and Ilumetri ® of above €300 MM. This growth trajectory enables Almirall to continue to invest sustainably into its leading R&D capabilities and pipeline dedicated to medical dermatology, especially immune-modulated skin diseases. Based on the sustained significant investment in its R&D pipeline, Almirall will further drive science leadership enabling the company to develop disruptive and innovative products that build sustained future growth as leader in medical dermatology. Medical Dermatology: Significant unmet needs and growth potential Significant unmet needs continue to persist in medical dermatology based on the severe patient impact of a wide range of dermatological diseases with many patients, especially with chronic diseases still being uncontrolled. Despite significant scientific progress, and the continuously increasing numbers of patients diagnosed with skin diseases, and the transition of more patients to advanced treatments, many patients still suffer from debilitating skin conditions. Therefore, Almirall has significant potential to deliver more and better treatments to many dermatology patients, and – based on its unique dedication to medical dermatology, commercial capabilities, close collaboration with the medical community, and its proven end-to-end capabilities across the entire value chain – has the opportunity for further business growth. This enables Almirall to give patients and the medical community access to innovative and relevant solutions and contribute to improving their lives. " We are excited about the opportunities our broad R&D pipeline offers – to patients, the medical community, and for the future growth of Almirall. In addition to the three ongoing Proof-of-Concept studies we are planning to initiate another three this year which makes this a first in Almirall’s long history and is testament to our dedication to medical dermatology. Progressing a number of promising assets to address high impact skin diseases is made possible by the sustained previous investments we have made into commercial excellence for the launch of breakthrough assets, as well as our expertise, scientific capabilities, and infrastructure which are key factors for our leadership in medical dermatology,” stated Carlos Gallardo, CEO and President of Almirall. Karl Ziegelbauer, Chief Scientific Officer, commented, " Our continued investment in our R&D expertise, infrastructure, and our collaborations has translated into the significant advancement of our pipeline we are seeing today. Our plans to have initiated six Proof-of-Concept studies before the end of 2026 is a demonstration of our ability to create meaningful innovation in medical dermatology, based on our track record of success across the entire R&D value chain ." “ Our sustained investment in R&D combined with Almirall’s robust financial situation are the foundation for our long-term perspective and our confidence in achieving our business ambition. Our commercial execution, the strength of our position in Europe, and our successful business model and execution enable us to continue to grow our business and further drive the future trajectory of Almirall in medical dermatology,” added Jon Uguzne Garay, Almirall’s Chief Financial Officer. About Almirall Almirall is a global pharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients' world by helping them realize their hopes and dreams for a healthy life . We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients´ needs. Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2024: €990 MM, over 2000 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries. For more information, please visit Legal notice: This document includes only summary information and is not intended to be exhaustive. The facts, figures, and opinions contained in this document, in addition to the historical ones, are "forward-looking statements." These statements are based on the information currently available and the best estimates and assumptions that the Company considers reasonable. These statements involve risks and uncertainties beyond the control of the Company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The Company expressly waives any obligation to revise or update any forward-looking statements, goals, or estimates contained in this document to reflect any changes in the assumptions, events, or circumstances on which such forward-looking statements are based, unless required by the applicable law. *including the clinical development program for IL-2muFc in Atopic Dermatitis which is led by Almirall’s partner Simcere Contacts Corporate Communications: corporate.communication@almirall.com Phone: +34 93 291 35 08 Investor Relations investors@almirall.com Phone: +34 93 291 30 87