Pharmaessentia Corp. · TWSE:6446
Pharmaessentia — J.P. Morgan Healthcare Conference 2026
30 slides from Pharmaessentia's conference presentation, Jan 16, 2026
Slide 1: PharmaEssentia
PharmaEssentia TWSE 6446 PharmaEssentia
Slide 2: Forward-looking Statements
Forward-looking Statements This presentation contains forward-looking statements, including statements regarding the plans and expectations for commercializing BESREMi® in the United States and globally, and the potential benefits or competitive position of BESREMi® . For those statements, we claim
Slide 3: A Fully Integrated, Operating Biopharmaceutical Company
A Fully Integrated, Operating Biopharmaceutical Company Our Commercial Product and R&D Pipelines PharmaEssentia (6446.TW) ROPEG Growth Drivers FOUNDED EMPLOYEES (Ropeginterferon alfa-2b ) 2003 Will reach 1,000 by 2026 • Approved for adults with • Geographic expansion for PV market HEADQUARTER AND R&
Slide 4: Leadership team with extensive Biotech/Global pharma experience
Leadership team with extensive Biotech/ Global pharma experience, combining innovative R&D and strong commercial execution Ching-Leou Teng Ko-Chung Lin Jack Hwang Albert Qin Lih-Ling Lin PhD PhD PhD MD / PhD MD / PhD Chairperson Founder & CEO Taiwan General Chief Medical Chief Scientific Manager Off
Slide 5: Key milestones (2003–Present): from bench to innovative drug launch
Key milestones (2003–Present): from bench to innovative drug launch 2003 2012 2016 2019.2 2021.10 2023.3 PharmaEssentia began Groundbreaking listed on Taipei ROPEG ROPEG ROPEG operation at Taichung Exchange on EMA Approval in PV Korea MFDS1 Japan MHLW manufacturing site July 19th approval on Oct 13t
Slide 6: ROPEG, first FDA-approved novel long-acting interferon for PV in 4 decades
ROPEG, with excellent safety and efficacy, became the first FDA-approved novel long-acting interferon for PV in 4 decades Interferon approved in Two pegylated forms ROPEG is a single isomer the 1980s by the FDA approved by the FDA with novel structure The usage is limited due to short half- Although
Slide 7: ROPEG redefining the future of MPN care
A new hope in Myeloproliferative Neoplasms (MPN) Treatment: ROPEG redefining the future of MPN care Classes of Myeloproliferative 3 Mutation in Neoplasms (MPNs) stem cells1 Polycythemia Vera (PV) 1 Trilineage disease with the sine qua non being an excess production of red blood cells 2 Essential Thr
Slide 8: The global MPN treatment market exceeds USD 20 billion
The global MPN treatment market exceeds USD 20 billion, with ROPEG poised to lead the next wave of innovation Myeloproliferative Neoplasm (MPN) Global MPN Market size ( 2025 ) Global MPN Market size ( 2035 ) CAGR $15.33Bn (2025-2035) $21.25Bn Global PV Market 3.32% Global ET Market Unit : USD Billio
Slide 9: A significant opportunity just from US Patients with PV
A significant opportunity just from US Patients with PV Geographically Expanding ROPEG's Reach to Benefit More Patients with PV Worldwide 148K 163K Essential Thrombocythemia (ET) • SURPASS – data readout Jan 6, 2025 Polycythemia Vera ( PV ) • NCCN Guideline submission • 2025 China, Taiwan, Japan sub
Slide 10: ROPEG approved in nearly 50 Countries for PV
ROPEG approved in nearly 50 Countries for PV, with global patient access steadily expanding EU Approval Singapore Approval Colombia EMA Approval/2019.2.15 HSA Approval/2024.5.29 BLA submission date/2024.4.24 TFDA Approval Malaysia Approval Mexico TFDA Approval/2020.5.5 Approval date/2024.6.11 BLA su
Slide 11: ROPEG recommended by NCCN Guidelines as the only first-line therapy
ROPEG recommended by NCCN Guidelines as the only first-line therapy for both low-risk and high-risk PV Key updates on PV treatment in the NCCN Guidelines Treatment For Low-Risk PV NCCN 2025 Version 2 age 60 years or younger with no history of thrombosis Guideline Symptomatic with potential indicatio
Slide 12: Proven long-term safety, efficacy, and effective reduction of driver mutations
Proven long-term safety, efficacy, and effective reduction of driver mutations Approved in 2021 by PROUD / CONTINUATION PV Study Ropeginterferon alfa-2b (CONTI-PV3) USFDA Median JAK2 V617F Allele Burden (%) 60 76.2% 52 50 Overall CHR 50 45 44 45 45 48 Median JAK2V617 Allele Discontinued patients in
Slide 13: Phlebotomy alone is inadequate for controlling hematocrit in low-risk PV
Phlebotomy alone is inadequate for controlling hematocrit in low-risk PV ; Early intervention is key Key updates on PV treatment in the NCCN Guidelines NCCN Treatment For Low-Risk PV 2025 Version 2 Guideline age 60 years or younger with no history of thrombosis Preferred regimens: Preferred regimens
Slide 14: Earlier Intervention: ROPEG + Phlebotomy for Low-Risk PV
Earlier Intervention : ROPEG + Phlebotomy for Low-Risk PV showed superior reduction of phlebotomy and hematocrit control Ropeg Control Takeda and Protagonist January 5th, 2026 P < 0.001 P = 0.006 100 Announce Submission of New Drug 81.3 81.3 Application (NDA) for Rusfertide for 80 Treatment of Polyc
Slide 15: Group revenue exceeding USD 500M in FY2025
Group revenue exceeding USD 500M in FY2025 FY 2025. $503.7M 180 157.21 160 140 130.56 Units : USD million 120 117.06 98.90 100 80 60 40 20 0 Q1'25 Q2'25 Q3'25 Q4'25 • The quarterly TWD/USD revenue exchange rate is based on the average of the Customs late-month (21st–31st) exchange rates [https://reu
Slide 16: Expected to obtain U.S. and Global ROPEG ET drug approvals in 2026
Expected to obtain U.S. and Global ROPEG ET drug approvals in 2026, benefiting nearly 100,000 patients ET patient population in the US effectively doubles the market potential 148K 163K Essential Thrombocythemia (ET) • SURPASS – data readout Jan 6, 2025 Polycythemia Vera ( PV ) • NCCN Guideline subm
Slide 17: A key breakthrough for treatment of ET in 30 Years
ET regulatory submission completed; approval expected in 2026 A key breakthrough for treatment of ET in 30 Years China NMPA U.S. FDA Submission Date: 2025.07.16 Submission Date: 2025.10.30 (EST) Expected Approval Date: 2026.7 PDUFA Date: 2026.08.30 Japan PMDA Health Canada Submission Date: 2025.09.1
Slide 18: Clinical Trials Supporting sBLA for Label Expansions
Clinical Trials Supporting sBLA for Label Expansions The results of SURPASS-ET serve as the pivotal evidence for safety and A Phase 3, 52-week, Open-Label, efficacy while EXCEED-ET serve as A Phase 2b, 56-week, A Single-arm, Randomized, Active-controlled confirmatory evidence Multicenter Study to As
Slide 19: SURPASS-ET results garnering international attention
ROPEG’s compelling clinical performance highlighted by SURPASS-ET results garnering international attention Primary Efficacy Endpoint – JAK2 Allelic Burden, Baseline and Month 12 Durable Modified ELN Response at Month 9 and 12 3 60% 2 50% 42.9% 1 40% P = 0.0001 0 Response Rate (%) 30% -1 20% -2 10%
Slide 20: EXCEED-ET data comparable to SURPASS-ET
EXCEED-ET data comparable to SURPASS-ET, with superior results in treatment-naïve patients EXCEED Study: HU naïve versus HU treated Durable Modified ELN Response Rate 90 36/47 46/67 80 76.6% 68% at Month 10 and 14 70 36/67 60 53.7% 50 8/24 6/19 40 6/24 31.6% 33.4% 30 25% 20 10 0 Worst Case Scenario
Slide 21: Substantial PMF Patient Population Represents a Critical Market Opportunity
Substantial PMF Patient Population Represents a Critical Market Opportunity to Prevent Progression to Myelofibrosis A High-Value Market Opportunity Driven by the Significant PMF Patient Population 148K 163K Essential Thrombocythemia (ET) • SURPASS – data readout Jan 6, 2025 Polycythemia Polycythemia
Slide 22: ROPEG PMF IIT two-year results gain international recognition
ROPEG PMF IIT two-year results gain consecutive international recognition at ASH, EHA, and ASCO • In Early Myelofibrosis, PMF, and Secondary MF, ROPEG has shown significant efficacy, maintaining hemoglobin (Hb) levels and reducing blood cell counts, alongside other key clinical, hematological, and m
Slide 23: HOPE-PMF drives mid- to long-term growth
ROPEG powers near-term revenue; HOPE-PMF drives mid- to long-term growth, with additional new indication anticipated by 2028 Ropeginterferon alfa-2b (P1101) in Pre-fibrotic/ Early PMF Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 3 Clinical Study to Assess Efficacy and Safety of Rop
Slide 24: Zhubei facility will be ready to supply for 100,000 patients
Zhubei facility will be ready to supply Zhubei facility will be ready to supply for 100,000 patients for >100,000 worldwide patients worldwide
Slide 25: ROPEG phase III and IIT trials accelerating, with new indications
ROPEG phase III and IIT trials accelerating, with new indications, driving future growth Oncology and Immunology IND CANDIDATE INDICATION DISCOVERY PHASE 1* PHASE 2* PHASE 3 DEVELOPMENT UPDATE ENABLING Polycythemia Vera (PV) Commercialization ROPEG Essential Thrombocythemia (ET) Under Approval Revie
Slide 26: Five products entering phase 1 in 2026
Five products entering phase 1 in 2026, strong early-stage oncology and immunology pipeline propelling future growth Oncology and Immunology CANDIDATE INDICATION DISCOVERY IND ENABLING PHASE 1* DEVELOPMENT UPDATE PEG-IL-2 (P11838) Immunology IND submission H1 2026 PEG cytokine PEG-Cytokines Solid Tu
Slide 27: Ample capital powers high-potential investments
Ample capital powers high-potential investments, driving accelerated R&D, pipeline expansion, and revenue growth Two major strategic investments: TBMC, Accelerating biopharmaceutical A innovation! • TBMC Platform: Accelerating biologics development and time to market • Manufacturing & Supply: Enhanc
Slide 28: Two major strategic investments: Immuxell and PIRC
▼ PharmaEssentia Innovation Research Center (PIRC) — Boston, USA Two major strategic investments: Immuxell’s assets integrated, strengthening B PEC’s presence in cell therapy • Technology Innovation: PharmaEssentia Innovation & R&D ▼ National Biotechnology Research Park (NBRP) Center (PIRC) integrat
Slide 29: Four Strategic Forces Accelerating Rapid, Risk-controlled Growth
Billion-Dollar Revenue, Tens of Billions in Ambition: Four Strategic Forces Accelerating Rapid, Risk-controlled Growth Top-tier Innovation Develop novel best-in-class (BiC) and first-in-class (FiC) immune checkpoint inhibitors - Advance TCR-T cell therapy targeting both surface and intracellular ant
Slide 30: Thank You
nce, Better Lives. PharmaEssentia
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