Formosa Pharmaceuticals, Inc. · TWSE:6838
Formosa Pharmaceuticals — Investor's Meeting (June 2025)
43 slides from Formosa Pharmaceuticals's conference presentation, Jun 30, 2025
Slide 1: Investor's Meeting
Formosa Pharmaceuticals, Inc. Investor’s Meeting June 30, 2025 See the Power in the Small!
Slide 2: Disclaimer
Disclaimer ⚫ The forward-looking information, including the operating outlook and financial statements, mentioned in this presentation and related information released at the same time, is based on the current internal and external economic development of the Company. ⚫ The Company's actual future r
Slide 3: Meeting Outline
Meeting Outline 1 Formosa Pharma Company Profile 2 APNT® Nanoparticle Formulation Projects 2-1 BYQLOVI (APP13007) Clobetasol Ophthalmic Suspension 2-2 Other APNT® Nanoparticle Formulation Projects Topics 3 ADC Projects 3-1 TSY-110 - Kadcyla Biosimilar 3-2 Enhertu Biosimilar for HER2 related cancers
Slide 4: Company Profile
8 il & Es iJ 7 Formosa Pharma Company Profile 5D FORMOSA PHARMACEUTICALS. ING.
Slide 5: Corporate Milestones
Corporate Milestones • Acquisition of two APNT • APP13007 Phase 3 trials initiated • US FDA BPD Type 2 consultation meeting • Completed following APP13007 Licensing: projects, APP13007 and • APP13007 licensed to Grand for TSY-0110 Cipla (India & 11 countries), Saval (Chile & APP13002 Pharma (China,
Slide 6: Formosa Pharma Board of Directors and Shareholder Structure
Formosa Pharma Board of Directors and Shareholder Structure Shareholder Structure Paid-in capital NT$1.51bn Formosa Lab 40.66% Others 44.93% CDIB Capital Other top 10 3.98% shareholders Employees 9.17% 1.26% 6
Slide 7: R&D Strategy & Management Team
R&D Strategy & Management Team 1. Coordinate internal and external R&D resources. Nanotechnology 2. Direct technical advantages and R&D strategy. R&D 3. Provide guidance for intellectual property rights. 4. Outsourced manufacturing and supervision. 1. Project management, support and coordination of
Slide 8: See the power in the small
See the power in the small 2 See the power in the small
Slide 9: APNT Nanoparticle Formulation Technology
APNT® Nanoparticle Formulation Technology Key Features Amenable to aseptic filtration ~ 300x Tunable particle size reduction No polymorphic change in API Mild operational temperature No solvents and harsh additives Low risk of contamination Use of GRAS excipients 9
Slide 10: APNT / APP13007 Global Patent Landscape
APNT® / APP13007 Global Patent Landscape PCT Patent Family # of Patents Granted Countries Application 5 Patent Families 140 12 Countries + EU* Territories Method for producing pulverized organic 2008 22 CA, CN, EU (14), IL, JP, KR, TW, US compound particle Method for producing a composite organic 20
Slide 11: BYQLOVI (APP13007) Clobetasol Propionate Ophthalmic Suspension
BYQLOVI (APP13007) Clobetasol Propionate Ophthalmic Suspension
Slide 12: Clobetasol Propionate Ophthalmic Suspension (APP13007)
Clobetasol Propionate Ophthalmic Suspension (APP13007) Technology APNT Nanoparticle Formulation Technology API Clobetasol propionate Clobetasol propionate 丙酸氯倍他索 Topical Ophthalmic Nanosuspension for Target Use Inflammation and Pain after Ocular Surgery Dosing Twice daily dosing for 14 days Rapid an
Slide 13: Ophthalmic surgery and postoperative anti-inflammatory therapy
Ophthalmic surgery and postoperative anti-inflammatory therapy Challenges of existing ophthalmic Cataract Surgery postoperative anti-inflammatory （20 minutes） therapies: Anesthesia 1. Difficult dosing regimen • 3-4 times a day, resuting in poor Corneal incision compliance • Tapering, complicated reg
Slide 14: Evolution of Ophthalmic Steroids and APP13007 positioning
Evolution of Ophthalmic Steroids and APP13007 positioning Inveltys Significant potency gap High 2x daily APP13007 2018 2024 Dosing Convenience LotemaxSM 3x daily 2019 Pred Forte Lotemax Flarex Durezol 4x daily 1968 1998 1980 2008 6x daily Maxidex 1962 Low Prednisolone Loteprednol Dexamethasone Fluor
Slide 15: APP13007 Comparison to Standards of Care
APP13007 Comparison to Standards of Care (Posology and Comfort / Compliance） Eye Pain or # Drops Homogeneity and Appearance Foreign Body per treatment course Sensation Super- potent Homogeneous API anti-inflammatory strength APP13007 28 drops (Clobetasol Propionate No precipitate; N Ophthalmic Suspe
Slide 16: APP13007 Comparison to Available Therapies
APP13007 Comparison to Available Therapies Product Durezol Inveltys LotemaxSM APP13007 (BYQLOVI) US Approval Year 2007 2018 2019 2024 Key Active Ingredient (API) difluprednate loteprednol loteprednol clobetasol propionate Strength of API Potent Medium to weak Medium to weak Most Potent ophthalmic op
Slide 17: Ophthalmic Steroids Market Overview
Ophthalmic Steroids Market Overview (2024) (60s’) (90s’) (80s’) (60s’) 16major pharmaceutical (United States, China, EU5 (UK, Germany, France, Italy, and Spain), and other countries (Canada, Japan, Korea, India, Russia, Brazil, Mexico, Australia, etc.) 1. GlobalData. | 2. Market Scope | 3. EUSTAT |
Slide 18: APP13007 Global Licensing Footprint
APP13007 Global Licensing Footprint Since the first licensing agreement for China in June 2021, APP13007 has continued to secure multiple out-licensing deals over the past 4 years. To date, Formosa Pharmaceuticals has partnered with 10 internationally recognized pharmaceutical companies—including Ha
Slide 19: APP13007's License Partners Overview
APP13007’s License Partners Overview # of Partner Region Signing Date APP13007 Status Description Notes Markets One of the leading branded ophthalmic companies in the U.S., Harrow 1 USA 2025 Q2 Launched (USA) with strong presence in post-surgical eyecare. Replacing Eyenovia 2024 Q3 / Canada’s larges
Slide 20: Harrow – US Licensing Partner
Harrow – US Licensing Partner Mark Baum Harrow CEO and Co-Founder Harrow focuses on the commercialization of ophthalmic products. its product portfolio includes both prescription and non-prescription drugs for a wide range of eye conditions, such as dry eye, allergies, infections, and other inflamma
Slide 21: Harrow – US Licensing Partner
Harrow – US Licensing Partner ⚫ Go-to-market plans for BYQLOVI ⚫ Market to existing customers and users of Harrow branded steroid products including: FLAREX, MAXIDEX, TOBRADEX ST, MAXITROL ⚫ Build program to leverage Imprimis customer base and ordering platform to message the unique clinical attribu
Slide 22: Apotex – Canada/Mexico Licensing Partner
Apotex – Canada/Mexico Licensing Partner In 2024, a variety of ophthalmic brand drugs and About Apotex new drugs are in-licensed from Jarrow Ophthalmic preoperative anesthesia, allergic conjunctivitis, Inflammation and Pain Apotex is the largest pharmaceutical company in Symptomatic relief of dry ey
Slide 23: Adalvo – Europe Licensing Partner
Adalvo – Europe Licensing Partner Cataract Surgeries in Euro Area (Million Cases) 5.26 5.34 5.04 5.01 4.13 • Top 3 B2B Company in Europe with to market capabilities in 130+ countries • A sister company and European partner of Lotus Pharmaceuticals (Taiwan). 2018 2019 2020 2021 2022 • Backed by a str
Slide 24: BYQLOVI (APP13007) Global Market Size Estimate
BYQLOVI (APP13007) Global Market Size Estimate (not including dry eye and other indications) Ophthalmic Steroid APP13007Global Sales Forecast by Partners Market Size (2026-2030) (US$ k) 1.38 billion USD $90,468 $67,802 CAGR 2% $46,085 $26,055 $6,585 2026 2027 2028 2029 2030 2026 2027 2028 2029 2030
Slide 25: Other APNT Nanoparticle Formulation Projects
2-2 Other APNT® Nanoparticle Formulation Projects SEPESRMOSA PHARMACEUTICALS. ING.
Slide 26: Other APNT Nanoparticle Formulation Projects
Other APNT® Nanoparticle Formulation Projects Ophthalmic： Inhalational： Topical Injectable： ⚫ APP13002 Ophthalmic Antibiotic ⚫ 505(b)(2) Inhaled Antibiotic Solution ⚫ Potential Applications in Dermatology and Orthopedics ⚫ Two APNT-based formulations ⚫ Published in OnDrugDelivery under co-developmen
Slide 27: See the power in the small
3 See the power in the small
Slide 28: ADC Market Size / Trastuzumab-based ADC Market Size
ADC Market Size / Trastuzumab-based ADC Market Size Global ADC Sales Forecast (2022-2030) Target Distribution of ADCs under (USD Billion) 25.5 Development 23.5 21.2 HER3 18.8 11.0 7% c-Met 16.5 10.3 7% 14.5 8.5 9.5 mucin HER2 12.5 10.7 6.2 7.3 7% 29% 5.3 CLDN18.2 7.6 4.5 7% 2.7 Nectin4 7% TROP2 B7-H
Slide 29: Formosa Pharma and EirGenix collaborate on TSY-0110/EG12043
⚫ Formosa Pharma and EirGenix collaborate on TSY-0110/EG12043 to build the research and development of HER2-positive breast cancer drugs based on the ADC production capacity of Formosa Laboratories. ⚫ EirGenix’s Herceptin biosimilar EG12014 used has obtained approval in EU and Taiwan, and its qualit
Slide 30: Trastuzumab-based ADC Biosimilars
Trastuzumab-based ADC Biosimilars Development Targets: Trastuzumab-based ADCs Comparison of ADC Biosimilars and Traditional Biosimilars First-in-class Best-in-class Item Traditional Biosimilars ADC Biosimilars Market HER2+ drugs High Low Competition Structural Moderate High Complexity Kadcyla Enhert
Slide 31: Biosimilarity Assessment of ADC Biosimilars: Example TSY-110
Biosimilarity Assessment of ADC Biosimilars: Example: TSY-110 Distribution of Drug-Antibody Ratio (DAR) of TSY-110 compared to Kadcyla demonstrates high similarity. Plasma stability is regarded as a critical preclinical assessment for biosimilarity. →The trends of TSY-110 and Kadcyla® in plasma are
Slide 32: TSY-110 - Kadcyla Biosimilar
-* gi Pa ~~ OR Ww oP : we. it ~ % ae Na Mo - we: ep on ‘ 74g val / v- le 4 ¥O% ae <td rs s Sid -— ox ¢ a 4 r \ TSY-110 - Kadcyla Biosimilar 5D FORMOSA PHARMACEUTICALS, INC. e the pol
Slide 33: TSY-110 / Kadcyla Biosimilar
TSY-110 / Kadcyla Biosimilar (US$ mm) Kadcyla Global Sales 2,169 2,179 2,189 2269 Japan 1,860 ROW Europe 1,403 ⚫ Kadcyla is another blockbuster drug for HER2- US positive breast cancer after Herceptin, based on 844 928 1,001 799 Herceptin antibody, for the treatment of HER2+ 585 early breast cancer
Slide 34: TSY-110 / Kadcyla Biosimilar
TSY-110 / Kadcyla Biosimilar Development Achievements Progress in Co-Development Discussions ⚫ Achieve batch-to-batch consistency ⚫ Held preliminary business discussions with ⚫ Potency and stability were confirmed to be similar to more than 15 multinational or regional those of the comparator Kadcyl
Slide 35: Enhertu Biosimilar for HER2 related cancers
Enhertu Biosimilar for HER2 related cancers {PEORMOSA See
Slide 36: Enhertu Biosimilar Opportunity
Enhertu Biosimilar Oppotunity Approved Indications: Gastroesophageal junction gland cancer, bladder cancer, uterine neck cancer, large intestine cancer, uterine endometrial cancer, epithelial ovarian cancer, gastric cancer 、 HER2+breast ⚫ Enhertu is the second HER2-target ADC to be marketed cancer 、
Slide 37: Enhertu Biosimilar Opportunity
Enhertu Biosimilar Oppotunity Enhertu total sales risk adjusted by different indication Danske Bank (UK): Enhertu has the potential to achieve peak sales of USD13.3bn (USD mm) CRC, Gastric, Pan-tumor HER2 mutation, 1L HER2+ post-neoadjuvant HER2+ neoadjuvant HR+/- HER2-low (1L) HR+/- HER2-low (2L) H
Slide 38: 3-3
3-3 See the power in the small
Slide 39: TSY-310 (ALM-401) Overview
TSY-310 (ALM-401) Overview Anti-ROR1 Anti-EGFR ALM-401 is a bispecific ADC developed by Almac Discovery and in-licensed by Formosa Pharma in 2025 intended for the treatment of solid tumors, including NSCLC. It’s core is a novel bispecific antibody engineered to be smaller in size by utilizing a sing
Slide 40: ALM-401 Developer - ALMAC Discovery
ALM-401 Developer - ALMAC Discovery Almac Group provides services to the pharmaceutical and biotechnology industries, including, Drug Development, Clinical Trial Supply, Commercial Manufacturing and Analytical Services. Group turnover surpasses £1 billion. Almac Discovery is a drug discovery company
Slide 41: Financial Information
Financial Information GPEORMOSA
Slide 42: Trends in Revenue, EPS, and Asset Changes
Trends in Revenue, EPS, and Asset Changes Trends in Revenue and EPS Trends in Liquidity (NTD 1,000) Revenue (NTD 1,000) 營業收入(千元) Current Assets 流動資產 160,000 143,356 5 流動負債 Current Liability EPS (NTD) 每股盈餘(元) 120,000 4 1,727,790 1,681,578 3 80,000 2 1,288,330 40,000 28,529 31,172 1 594 1,315 0 - -0.2
Slide 43: Thank you for your interest
Thank you for your interest See the Power in the Small!
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