Laboratorios Farmaceuticos Rovi, S.a. · BME:ROVI
Laboratorios Farmaceuticos Rovi — Investor Day (March 2025)
59 slides from Laboratorios Farmaceuticos Rovi's investor day presentation, Mar 25, 2025
Slide 1: Capital Markets Day 2025
CREATING VALUE FOR INVESTORS THROUGH OUR NEXT PHASE OF GROWTH CAPITAL MAKETS DAY 2025 25th March 2025
Slide 2: Disclaimer
Disclaimer • This Presentation has been prepared by Laboratorios Farmacéuticos ROVI, S.A. (the “Company”) and comprises the slides for a presentation concerning the Company and its subsidiaries (the “Group”). For the purposes of this disclaimer, “Presentation” means this document, its contents or an
Slide 3: Agenda for today
Agenda for today Section I – Update on ROVI’s strategy • Juan López-Belmonte, Chairman and CEO Section II – CDMO 10:00 am • Miguel Ángel Ortega, Corporate Industrial Director Section III – Specialty Pharma • Miguel Ángel Castillo, International and Business Development Director Section IV – Update o
Slide 4: Section I - Update on ROVI's Strategy
Section I - Update on ROVI’s Strategy Juan López-Belmonte Chairman and CEO
Slide 5: Brief overview of ROVI
Brief overview of ROVI CDMO Specialty pharma ISM® technology platform Contract development and Research, development and sale of heparin and In-situ micro implants technology manufacturing organization other specialty pharma products Patent-protected, long-acting sustained-release injectable One of
Slide 6: Our proven track-record: operating revenue evolution 2018-2024
1400 Our proven track-record 1200 Operating revenue evolution 2018-2024 (€m) 1000 818 830 800 764 649 600 414 420 Consistent and 428 sustainable 420 384 growth since 381 2018 400 303 328 200 316 404 409 249 336 265 55 66 92 0 2018 2019 2020 2021 2022 2023 2024 CDMO Specialty pharma 6
Slide 7: ROVI today
ROVI today • Significant current available capacity in fill and finish (F&F) addresses structural market shortages in high growth markets CDMO • Vertical integration with 4 fully-invested manufacturing plants that allow ROVI to offer high-value-added injectable and oral forms CDMO services • Approve
Slide 8: ROVI in the future
ROVI in the future • New filling lines providing additional pre-fill syringes (PFS) and cartridges capacity • Expansion assembling capacities to include autoinjectors and pens CDMO • Higher-priced contracts due to complex production of high added-value products • Global leader in complex injectable
Slide 9: ESG valuations
ESG valuations ESG strategy Sustainalytics: 16.1 (low risk) 5º ranking in the global pharmaceutical industry ROVI has an ESG director plan for the period 2023-2025, which promotes sustainability through 5 pillars: Benchmark of governance committed to sustainability Sustainable management of global c
Slide 10: Section II - CDMO
Section II - CDMO Miguel Ángel Ortega Corporate Industrial Director
Slide 11: Outsourcing services are still increasing their penetration
Outsourcing services are still increasing their penetration Pharma production 2014 vs 2023 Global pharmaceutical CDMO market growth 2024 – 2034E ($bn) % of expenditure 2023 369 346 321 2014 299 51% 49% 278 259 34% 242 226 211 197 185 66% Outsourcing In-house • The demand for outsourced manufacturing
Slide 12: ROVI's CDMO business focuses on high value-added sterile F&F
ROVI’s CDMO business focuses on high value-added sterile F&F, with a high growth market in PFS… • Injectables are the fastest-growing route of administration for the pharma market, accounting for >70% of all drugs under development • Growth predominately driven by the biologics market, including bio
Slide 13: A critical part of the value chain with low available capacity and strong demand
…a critical part of the value chain with low available capacity and strong demand • One of the primary drivers is the increasing incidence of chronic diseases globally, which has led to a heightened demand for injectable therapies. Conditions such as obesity, diabetes, cancer, cardiovascular disease
Slide 14: ROVI's CDMO business across the Company's history
ROVI’s CDMO business across the Company’s history <2019 2020-2023 2024 2026 Transition Transformation Execution Leadership • ROVI founded in 1946 • Agreement with Moderna to • Agreement with leading • Further capacity expansion become the first CDMO in global pharma to manufacture and wider service
Slide 15: ROVI's CDMO business in a nutshell (1/2)
ROVI’s CDMO business in a nutshell (1/2) • Premium European end-to-end CDMO platform capitalizing on robust fundamental forces to capture attractive market growth • Focus on high growth, highly competitive markets including GLP-1s, vaccines, monoclonal antibodies, ADC’s1, insulins, heparins, biotech
Slide 16: ROVI's CDMO business in a nutshell (2/2)
ROVI’s CDMO business in a nutshell (2/2) • Established and growing base of more than 30 blue-chip customers, including long-term contracts with large biopharma customers • Signing a new contract is a time-consuming process. It takes around 12-18 months from signature with a new customer to the produ
Slide 17: ROIS has an integrated CDMO end-to-end network
ROIS has an integrated CDMO end-to-end network • ROVI aims to develop a one-stop shop for its CDMO business, providing customers with comprehensive, end-to-end solutions for drug development and manufacturing Drug Substance Drug Product Injectable Packaging Complex API development services ROIS Juli
Slide 18: 4 fully-invested manufacturing plants
4 fully-invested manufacturing plants that allow ROIS to offer high- value-added injectable and oral forms CDMO services RTU1 Auto Packag. FDA Approval API PFS Vials Pens Solids Cartridges injectors ROIS Granada ✓ - - - - - - - ✓ ✓ ROIS Julián Camarillo (Madrid) - - - - - - ROIS San Sebastián de los
Slide 19: Investment process across CDMO network (1/2)
Investment process across CDMO network to drive long-term growth and capture new opportunities (1/2) Evolution of key metrics 2022 – 2026E Capacity evolution 2022 – 2026E (m#) PFS Vials Cartridges RTU 2022 2024 2026E 4 85-110 3 CDMO sites (#) 4 4 4 140-180 3 140 - 180 Aseptic filling lines (#) 81 11
Slide 20: Investment process across CDMO network (2/2)
Investment process across CDMO network to drive long-term growth and capture new opportunities (2/2) CDMO market imbalance Competitiveness • There is an infra capacity vs demand, • Cost efficiency: ability to leverage structural exacerbated in the short and medium term by advantages in the Spanish l
Slide 21: CDMO revenues evolution and 2030 guidance
CDMO revenues evolution and 2030 guidance CDMO revenue evolution 2020-2030E (€m) Targeted CDMO +3.7x 336 revenue 2030 x ~€700m (+2.0x vs 2024) Targeted 70-75%1 Utilization Rate % 92 2020 2024 Our focus is to become one of the top 1 CDMO worldwide in high value added injectables in PFS, cartridges an
Slide 22: Section III - Specialty Pharma
Section III - Specialty Pharma Miguel Ángel Castillo International and Business Development Director
Slide 23: Well-balanced European specialty pharma company with diversified growth drivers
Well-balanced European specialty pharma company with diversified growth drivers Vertically integrated LMWH franchise Risperidone ISM® (Okedi®) Leading Specialty Pharma Franchise • Developed and successfully launched proprietary • Immediate and sustained therapeutic levels • Strong market leadership
Slide 24: Low Molecular Weight Heparins (LMWH)
Low Molecular Weight Heparins (LMWH)
Slide 25: Bemiparin and Enoxaparin biosimilar international presence
Bemiparin and Enoxaparin biosimilar international presence Enoxaparin Bemiparin Enoxa&Bemi No. countries where Product commercialized in 20241 Enoxaparin 41 Bemiparin 35 Enoxa. & Bemi. 13 TOTAL >60 25 1. As of January, 2025
Slide 26: Fully vertically integrated in the heparin value chain
Fully vertically integrated in the heparin value chain Glicopepton Pig mucosa Crude heparin Sodium heparin Low molecular weight heparin 1 plant in Huesca (expected 1 plant in Escúzar (approved by 1 plant in Granada to be operative in 2026) European authorities in June 2024) 1 plant in Escúzar (opera
Slide 27: Bemiparin is ROVI's first internally-developed flagship heparin product
Bemiparin is ROVI’s first internally-developed flagship heparin product Unparalleled know-how of the heparin market • ROVI has been engaged in the development of heparin-based drugs for over 70 years Bemiparin is the LMWH with the highest anti • Bemiparin is a Low Molecular Weight Heparin (LMWH) Xa/
Slide 28: ROVI's Enoxaparin was one of the first enoxaparin biosimilars launched in Europe
ROVI’s Enoxaparin was one of the first enoxaparin biosimilars launched in Europe International approach to maximize value of the product Commercial strategy through partners • Continue expansion in other markets with strong growth potential through out- ROVI markets enoxaparin licensing agreements:
Slide 29: Okedi
Okedi ®
Slide 30: Risperidone ISM (Okedi): fast onset long-acting injectable of risperidone
Risperidone ISM® (Okedi®): fast onset long-acting injectable of risperidone with balanced efficacy and tolerability Schizophrenia Market Superior value proposition when compared to alternatives • Chronic and progressive disease • The World Health Organization estimates it affects • Ongoing monitorin
Slide 31: Okedi offers superior characteristics vs competitors in Europe
Okedi® offers superior characteristics vs competitors in Europe INVEGA INVEGA INVEGA ABILIFY RISPERDAL ABILIFY SUSTENNA®/ TRINZA® / HAFYERA®/ MAINTENA® OKEDI® CONSTA® MAINTENA® XEPLION® TREVICTA® BYANNLI® 720/960 mg (Risperidone) (Risperidone) (Aripiprazole) (Paliperidone) (Paliperidone) (Paliperido
Slide 32: Main attributes of Okedi that contribute to cover an unmet medical need
Main attributes of Okedi® that contribute to cover an unmet medical need • Okedi® is the only product that can be used for a wide range of adult patients with schizophrenia without the need of using loading doses or concomitant oral antipsychotic medication Sustained therapeutic levels from DAY 1 Hi
Slide 33: Okedi launch plan in Europe and the rest of the world
Okedi® launch plan in Europe and the rest of the world Launch 2022 2023 2024 Okedi® Countries total market size: €925m LAI market size per 213* 65 257* 36* 123* 31* 25 5 65 77 28 country (€m) Okedi® estimated roll out 2025 2026 2027 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Netherlands Hong Kong Romania New
Slide 34: Schizophrenia LAI market & Okedi market share evolution
Schizophrenia LAI market & Okedi® market share evolution Okedi® % market share evolution in schizophrenia LAI market (in value) 10% 9% 8% 7% 6% 5% 4% 3% 2% 1% 0% Spain Germany Italy Portugal Austria 34
Slide 35: ROVI's market leadership in Spain positions it as partner of choice
ROVI’s market leadership in Spain positions the Company as the partner of choice for global pharma players Servier Presence in the market 2007 since 1946 Organon 2008 Well-known proprietary portfolio driving strong leadership position Ebewe Pharma Servier 2010 Organon Franchise focused business: 16
Slide 36: ROVI has internationalised with subsidiaries in 6 countries
In 7 years ROVI has successfully internationalised with subsidiaries in 6 countries and more than 120 employees Germany Portugal Headcount: 54 Headcount: 15 • Enoxaparin • Risperidone ISM® • Risperidone ISM® • Iomeron • Falithrom • Enoxaparin • Other Italy France Headcount: 44 Headcount: 4 • Enoxapa
Slide 37: Section IV - Update on the R&D Strategy
Section IV - Update on the R&D Strategy Ibon Gutierro Corporate R&D Director
Slide 38: Quarterly Letrozole with Superior Estrogen Suppression (Letrozole SIE)
Quarterly Letrozole with Superior Estrogen Suppression (Letrozole SIE)
Slide 39: Letrozole SIE: a quarterly formulation of Letrozole
Letrozole SIE: a quarterly formulation of Letrozole with Superior Inhibition of Estrogens A quarterly injectable aromatase inhibitor for the treatment of hormone receptor positive breast cancer that provides superior estrogen suppression compared to Femara® intends to achieve the same indications as
Slide 40: Most breast cancers are HR+ and aromatase inhibitors remain primary treatment
Most of breast cancers are HR+ and aromatase inhibitors remain as primary treatment Subtypes Stage at diagnosis (%) Use of endocrine therapy Hormone • Most of the postmenopausal women with Intrinsic Distribution receptor HER2 HR+ start their endocrine treatment with subtype (%) 66 status an aromatas
Slide 41: Phase I results confirm Letrozole SIE provides superior estrogen suppression
Phase I results confirm Letrozole SIE provides superior estrogen suppression • Quarterly 225 mg injections of Letrozole SIE provide superior inhibition of estrogens compared to daily 2.5 mg Femara® in healthy female postmenopausal volunteers • Current readout of tolerability results on a single 225
Slide 42: Phase III Clinical Trial program to start in Q4 2025
Phase III Clinical Trial program to start in Q4 2025 for Quarterly Letrozole SIE Regulatory strategy for a LAI of Letrozole SIE is identical to Okedi® and involves two clinical trials: A Phase III Efficacy Clinical Trial A PK/Bioavailability Study • Study population: HR+ HER2 - female patients • To
Slide 43: Letrozole SIE: approach to ROVI's potential market
Letrozole SIE: approach to ROVI’s potential market Potential market for Letrozole SIE1 Approach to prostate cancer LAIs market • There are 1.126 m daily units of the two molecules (letrozole and • Breast cancer can be compared to prostate cancer, as it has a similar anastrazole) that, converted to y
Slide 44: Quarterly Risperidone (Risperidone QUAR)
Quarterly Risperidone (Risperidone QUAR)
Slide 45: Quarterly Risperidone (Risperidone QUAR)
Quarterly Risperidone (Risperidone QUAR) A quarterly injectable Risperidone for the treatment of Schizophrenia that provides plasma levels in the therapeutic range from day 1 without the need of oral doses, previous injections of monthly Risperidone formulation or additional loading doses intends to
Slide 46: Positive readout from Phase I with Quarterly Risperidone
Positive readout from Phase I with Quarterly Risperidone (QUAR) allows progression to Phase III clinical trial Expected clinical trial package is similar to Okedi® and will require two additional clinical trials: A Phase III Efficacy Clinical Trial A PK/Bioavailability Study • Design pending to be d
Slide 47: Creation of Terafront Pharmatech for R&D of Advanced Therapies
Creation of Terafront Pharmatech for R&D of Advanced Therapies
Slide 48: Creation of Terafront Pharmatech for the R&D of advanced therapies
Creation of Terafront Pharmatech for the R&D of advanced therapies 25.5%1 25.5%1 49.0%1 Terafront Pharmatech • On March 2024, an agreement was reached between ROVI, Insud Pharma and Innvierte (investment company of CDTI - Centro para el Desarrollo Tecnológico Industrial EPE) to create Terafront Phar
Slide 49: Section V – Financial Results
Section V – Financial Results Javier López-Belmonte Deputy Chairman and CFO
Slide 50: Sound financial policy supported by strong track record
Sound financial policy supported by strong track record CDMO revenue 2020-24 (€m) Specialty pharma revenue 2020-24 (€m) ROVI operating revenue 2020-24 (€m) CDMO Specialty pharma 818 830 764 649 404 409 428 414 420 384 336 420 328 265 92 2020 2021 2022 2023 2024 2020 2021 2022 2023 2024 2020 2021 202
Slide 51: Specialty pharma revenues overview
Specialty pharma revenues overview Specialty pharma revenues breakdown (%) Main prescription products 2024 performance (€m) LMWH franchise €241.6m 13% €54.1m -2%1 +2%1 +13%1 +101%1 145.2 96.4 51.4 28.8 Enoxaparin Bemiparin Neparvis® Okedi® 87% €373.4m • Q4 2024 • 2024 • Specialty • Risperidone stron
Slide 52: EBITDA and CAPEX evolution
EBITDA and CAPEX evolution EBITDA1 2020-24 (€m and %) CAPEX 2020-24 (€m) EBITDA Pre-R&D R&D expenses Cash Mg. 2 22.4% 31.3% 34.1% 29.5% 27.2% conv.3 57.9% 79.8% 81.6% 77.4% 70.0% 279 62 244 55 203 207 51 40 41 94 303 269 230 233 118 (24) (27) (24) (25) (26) 2020 2021 2022 2023 2024 2020 2021 2022 20
Slide 53: 2024 results overview
2024 results overview Gross profit (€m) & gross margin (%) EBITDA (€m) & EBITDA margin (%) 489.2 478.5 244.5 207.4 +3.7p.p 62.7% -2.3p.p 59.0% 29.5% 27.2% EBITDA Pre-R&D1 -13.4% €233.2m 2023 2024 2023 2024 SG&A (€m & % of revenues) R&D expenses (€m) Net profit (€m) 245.2 170.3 219.7 +3.3% 25.8 -19.6
Slide 54: CAPEX, cash flow and debt structure
CAPEX, cash flow and debt structure CAPEX 2024 breakdown Cash flow 2024 evolution (€m) Maintenance CAPEX 9.0 129.3 13% 25% ISM industrialisation (62.2) (19.1) €62.2m 5% (38.6) (56.5) New filling lines and 0.8 operations expansion (47.8) (85.1) 1 57% ND (-) / Net cash WC CAPEX Invest. in Dividends Tr
Slide 55: Our capital allocation mixes shareholder returns, business expansion and innovation
Our capital allocation mixes shareholder returns, business expansion and innovation Shareholder remuneration Balance sheet strength • Attractive and recurring dividend policy • Strong balance sheet position due to low debt (35% of the consolidated net profit of 2024) position • Completion of several
Slide 56: Outlook 2025
Outlook 2025 2025 operating revenue growth rate Decrease by a mid-single-digit percentage vs 2024 The key growth expected levers in 2025: CDMO Specialty Pharma • New business to be acquired • Launch and marketing of Risperidone ISM® in new countries • Agreement with Moderna • LMWH franchise • Capaci
Slide 57: Long-term targeted guidance for 2030
Long-term targeted guidance for 2030 Operating revenue 2024 Targeted operating revenue 2030 €763.7m 1.5x – 1.8x vs 2024 CDMO revenue 2024 Targeted CDMO revenue 2030 €336.2m ~€700m (+2x vs 2024) Specialty pharma revenue 2024 Targeted specialty pharma revenue 2030 €427.5m Low single digit growth vs 20
Slide 58: Q&A
Q&A
Slide 59: For further information, please contact
For further information, please contact: Juan López-Belmonte Chairman and CEO www.rovi.es Javier López-Belmonte Deputy Chairman and CFO www.rovi.es Marta Campos Head of Finance mcampos@rovi.es www.rovi.es Beatriz de Zavala Investor Relations Analyst bdezavala@rovi.es www.rovi.es Victoria López-Belmo
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