Kyowa Kirin Co., Ltd. TSE:4151
Kyowa Kirin : Results Presentation Fiscal 2026 First Quarter
Source: MarketScreener
Results Presentation Fiscal 2026 First Quarter
Agenda
01
Management Focus & Q1 2026 Highlights
02
03
04
05
Financial Review Commercial update Business update R&D update
Chairman
Masashi Miyamoto
President and
Chief Executive Officer (CEO)
Abdul Mullick
Chief Medical Officer (CMO)
Yoshifumi Torii
Chief Financial Officer (CFO)
Koji Igarashi
© Kyowa Kirin Co., Ltd. 1
This document contains forward-looking statements regarding the outlook, targets, plans, and other
future-related matters of the Company (including its consolidated subsidiaries in Japan and overseas). These statements are based on our reasonable judgments using current information and forecasts but involve uncertainties that could cause actual results to differ materially.
These uncertainties include, but are not limited to, risks inherent in the domestic and international pharmaceutical industry, intellectual property rights, side effects, legal regulations, product defects, fluctuations in raw material/fuel prices, market prices, and exchange/financial markets.
This document is for investor information purposes only and contains information on pharmaceuticals (including products under development), but it is not intended for promotional advertising or medical advice.
2
© Kyowa Kirin Co., Ltd.
Q1 2026 Highlights (Executive Summary)
Management Focus
Q1 Financial Results
Revenue of JPY 118.5 billion (+13% YoY) and Core Operating Profit of JPY 20.0 billion (+78% YoY).
Performance is tracking in line with the full-year plan
Revision of FY2026 Plans
Core Operating Profit revised upward due to clinical program discontinuation of Rocatinlimab
However, Profit remained unchanged due mainly to closing costs of the clinical program.
Financial KPIs announced in the "Vision 2030 and Beyond: Our Growth Story" will not change
Business Topics
3
Announced plans to reorganize the Research institute to strengthen drug discovery capabilities
© Kyowa Kirin Co., Ltd.
Vision 2030 Provide
pharmaceuticals for unmet medical needs
Kyowa Kirin will realize the successful
creation and delivery of life-changing value* that ultimately makes people smile, as a Japan-based Global Specialty Pharmaceutical company built on the diverse team of experts with shared passion for innovation.
We are focused on developing medicines
for diseases where there is a clear patient need for new options. We make full use of multiple therapeutic modalities, including biotechnology such as antibody technology, and beyond, building on our Kyowa Kirin established strengths.
* Make patients smile through dramatic improvements in quality of life by identifying the unmet medical needs of people battling with medical conditions and by creating and supplying new drugs or services that help them overcome those challenges.
Address patient-centric
healthcare needs
By applying scientific insights and cutting-edge technologies cultivated through our pharmaceutical business, we aim to create new value that focuses on the needs of people living with diseases.
We will continue to meet society's medical needs through patient-centered innovation.
Retain the trust of society
We pursue world-class product quality and operational excellence to grow our business in ways which build long-term trust with
our stakeholders
4
© Kyowa Kirin Co., Ltd. 4
Our Strategy for Creating Life-changing Value - Story for Vision 2030
Amid significant environmental changes, Kyowa Kirin is formulating the Story for Vision 2030 to ensure the steady realization of its vision
By enhancing clarity around the vision and linking strategies and challenges more organically, we will advance CSV management that enables the creation and delivery of Life-changing value
Disease Science
Focus disease areas: bone & mineral, intractable hematological diseases/hemato oncology, & rare diseases
Explore UMN, causes & mechanisms of disease in depth
Pursuit of molecular and cellular regulatory mechanisms for therapeutic realization
Drug Discovery Technology
Strengthening innovative modalities: advanced antibody technologies, hematopoietic stem cell gene therapy
Application of optimal modalities for therapeutic realization
Evolution of drug discovery methods through AI and
data science
External Collaboration
Open innovation
Partnering
Life-changing value creation
Assets in focus disease areas
Strategic partnering assets*
Value delivery on our own
Collaborative value delivery
Full-licensing
Global deployment of products developed by taking full advantage of the company's strengths
Aim to maximize value by combining the strengths of the company and its partners
Maximize the value of developed products and deliver them to patients faster by out-licensing to the most appropriate partners
* Assets outside of the disease areas of focus are designated as strategic partnering assets, and value maximization is achieved through collaboration with partners.
© Kyowa Kirin Co., Ltd. 5
Our Strategy to Deliver Life-changing value: Building on Strengths, Driving Growth
As a unique J-GSP with strong expertise across therapeutic areas and modalities, we are expanding our business globally through our proven commercialization
Strengths
Modalities
Antibody therapeutics Gene and cell therapy
Utilization of AI
& Data Science
ADC
Engineered HSC-GT
Next-generation antibody technologies
Proven
Commercialization
Know-how for discovering rare disease patients
Deep knowledge and experience with the disease
Maintain close engagement
with patients and patient advocacy groups
Maximize pipeline value
through out-licensing to the right partners
and Execution Structures
Supporting Business Growth Operational Excellence Optimization of Governance
© Kyowa Kirin Co., Ltd. 6
Focus on
Disease areas
Bone &
Mineral
Hematology/
Hemato-oncology
Rare
Diseases
Strategic
Partnerships Assets/Other
Key Priorities Under the New C-Suite Executive Team
Creating and delivering Life-changing
value
To realize Life-changing value and achieve the financial targets of "Vision 2030 and beyond : Our Growth Story" we clarify the growth pillars as follows:
Maximize the value of our key products
Continue robust growth of Crysvita and Poteligeo, with value maximization through lifecycle management initiatives
Actively pursue strategic investments with financial discipline
Accelerate growth through proactive strategic investments (in-licensing, M&A) in our focus areas
Mid- to Long-term
Financial Targets (in the early 2030s)
ROE in the low -10%
Core operating margin of 30%
7
Establish the next-generation growth platform focusing on priority disease areas
Successful development and commercialization of pipeline assets in priority disease areas
(expansion of KOMZIFTI's indication to AML*¹ first-line treatment, KK8123, KK2845, OTL-203 etc..)
Drive Operational Excellence to Support Growth
Transform the operating model through AI and DX
Simplify Processes, Focus Resources, and Stay Agile
© Kyowa Kirin Co., Ltd.
*For acute myeloid leukemia with menin dependency
Engagement with key stakeholders
In an increasingly challenging world, facing environmental and geopolitical instability and an ever-evolving healthcare landscape, connecting with stakeholders is a vital part of our success to create and deliver life-changing value.
Employees
Suppliers / Distributors
Patients
Listen to the voices of those living with diseases and commit to addressing unmet medical needs.
dialogue
dialogue
Investors / Shareholders
Improve the quality and frequency of dialogue with the capital market and drive shareholder value
Together with the CEO, our newly appointed CFO, Mr. Igarashi, will actively engage with investors & shareholders.
Regulators / Payers
/Governments
Patient Communities/
Healthcare provider
R&D and Sales partner
Community
Koji Igarashi Chief Financial Officer (CFO)
© Kyowa Kirin Co., Ltd.
8
Financial Review
9
© Kyowa Kirin Co., Ltd.
Summary of FY26 Q1 Results
FY2025
Jan-Mar
104.7
[73%]
80.1
[77%]
40.4
[39%]
28.6
[27%]
11.2
[11%]
6.2
Q1 results showed increases in both revenue and profit, tracking in line with the full-year plan
(Billion JPY / Rounded)
Revenue
[Overseas Ratio]
Gross Profit
[Gross Profit Margin]
SG&A*1
[SG&A Ratio]
R&D Exp.
[R&D Ratio]
Core Operating Profit*2
[Core OP Margin]
Profit
Change FY 2026 Rev. Plans
FY2026
Jan-Mar
118.5
[77%]
88.2
[75%]
41.1
[35%]
27.2
[23%]
20.0
[17%]
12.0
+13.7 (+13%) |
+8.1 (+10%) |
+0.7 (+2%) |
-1.4 (-5%) |
+8.8 (+78%) |
+5.9 (+95%) |
520.0→
520.0
[77%]
391.0→
388.0
169.0→
163.0
[31%]
[75%]
122.0→
95.0
[18%]
100.0→
130.0
[25%]
75.0→
75.0
Progress
23%
23%
25%
29%
15%
16%
Foreign Exchange Assumptions
FY2025Q1 Actual: ¥154 / USD
FY2026Q1 Actual: ¥155 / USD
FY2026 Rev. Plan: ¥150 / USD
*There has been no change in the foreign exchange assumptions in the revision to our earnings forecast announced on May 7, 2026.
*1 Excludes amortization of intangible assets (sales rights amortization)
*2 Core operating : GP - SG&A (excl. intangible asset amortization) - R&D - Non-recurring items as determined by the Company
© Kyowa Kirin Co., Ltd. 10
YoY Analysis ~Revenue~ by Region
In addition to the growth of global strategic products, mainly in North America and EMEA, sales increased due to increased tech-licensing revenue
(Billion JPY)
FY25 Q1
Japan
North America
EMEA
Others
FX Impact
FY26 Q1
Revenue excl.FX
+11.2
Revenue
+13.7
-0.9
104.7
+0.5
+1.1
+10.5
+2.6
118.5
Rocatinlimab upfront deferred revenue
Temporary factors
FY25 Q1 2.0 billion yen
FY26 Q1 9.7 billion yen(+7.6 billion)
Japan
-0.9
Although Phozevel (+25%), Crysvita (+24%), and Duvroq (+20%) grew, sales in the Japan region decreased by 3% due to the impact of drug price revisions.
North America
+0.5
(excl. FX Impact +0.2).
Crysvita (-3%) was impacted by channel inventory destocking, while Poteligeo (+28%) showed strong growth, leading to a 1% revenue increase in North America.
EMEA
+1.1
(excl. FX Impact +2.4)
Despite a decline in royalty income following the divestment of the established products joint venture, sales of Crysvita (+11%) increased, resulting in a 5% revenue growth in the EMEA region. Poteligeo (+0%) remained flat year on year due to sales phasing.
FX impact
+2.6
Others
+10.5
(excl. FX Impact +0.1)
Other revenue increased by 47%, mainly due to higher tech-licensing income from the one-time recognition of deferred upfront revenue for rocatinlimab following the termination of the Amgen development collaboration.
USD -0.0 billion、GBP +0.1 billion、EUR +2.2 billion
11
© Kyowa Kirin Co., Ltd.
YoY Analysis ~Revenue~ by Product
Revenue growth driven by Crysvita and Poteligeo, along with increased tech-licensing revenue
(Billion JPY)
FY25 Q1
104.7
Despite weak performance in North America (-3%) due to factors such as channel inventory destocking, sales increased in EMEA (+21%) and Japan (+24%), resulting in Crysvita total revenue growth of 8%.
Crysvita
Poteligeo
Libmeldy/ Lenmeldy
Tech-licensing
Other Products
Revenue
+13.7
-0.6
+3.2
+2.3
-3.1
+11.9
Crysvita
+3.2
Poteligeo
+2.3
Poteligeo total revenue grew 23%, led by North America
(+29%).
Libmeldy/Lenmeldy
-0.6
While the newborn screening environment has steadily improved, including the addition to the U.S. Recommended Uniform Screening Panel (December 2025), revenue decreased in the current quarter due to a decline in the number of prescribed patients.
Tech-licensing
+11.9
92% revenue growth driven by increased tech-licensing revenue, including one-time recognition of deferred upfront revenue for rocatinlimab following the termination of the development collaboration with Amgen.
FY26 Q1
118.5
Revenue decreased, reflecting the impact of drug price revisions in Japan and lower royalty income following the divestment of the established products joint venture in EMEA.
Other products
-3.1
© Kyowa Kirin Co., Ltd.
※Changes in revenue include the impact of foreign exchange(+2.6 billion JPY) 12
YoY Analysis ~Core Operating Profit*1~
Core operating profit up on global products, Tech-licensing income, and reduced rocatinlimab development costs
(Billion JPY)
FY25 Q1
Gross Profit
SG&A
R&D Expenses
FX Impact
Core OP excl. FX impact
+7.8
Core OP
+8.8
11.2
+5.8
+0.2
+1.8
+0.9
Gross profit increased due to higher revenue.
Gross Profit
+5.8
(excl. FX Impact +2.3)
The gross profit margin declined by 2 points, from 77% to 75%.
R&D Expenses
+1.8
(excl. FX Impact -0.4).
Decrease due to the peak-out of rocatinlimab development activities; impact from trial discontinuation to be reflected from 2Q onward.
R&D expense ratio fell by 4 points from 27% to 23%.
FY26 Q1
20.0
*1 Core operating profit: Gross profit - selling, general and administrative expenses (excluding amortization of intangible assets) - R&D expenses - non-recurring profit and loss as determined by the Company
© Kyowa Kirin Co., Ltd. 13
YoY Analysis ~Profit~
Although impairment losses related to rocatinlimab were recorded, profit increased due to an increase in core operating profit
(Billion JPY)
FY25 Q1
Core operating profit*1
Amortization of intangible assets
Equity Method Finance &
Others
Tax Expenses
FY26 Q1
Equity Method
+1.9
Profit
+5.9
6.2
Amortization of intangible assets
-1.1
-1.1
-3.5
-0.2
12.0
+8.8
Finance & Others
-3.5
+1.9
Increased amortization of sales rights due to the launch of KOMZIFTI in the U.S. (November 2025)
FKB contributed +¥1.6 billion (including a +¥1.1 billion reclassification to financial expenses), and the established products joint venture contributed +¥0.5 billion.
Despite income of ¥4.2 billion from the divestment of the established products joint venture (including derivative valuation gains), expenses increased due to ¥5.0 billion in impairment losses related to the discontinuation of the rocatinlimab clinical program.
Tax Expenses
-0.2
Increased in line with the growth in pre-tax income.
As the gain/loss related to the share transfer of the established medicines Joint Venture Collaboration is a non-taxable transaction, the effective tax rate temporarily declined.
Effective tax rate: FY25 Q1 21.5% → FY26 Q1 13.6%
© Kyowa Kirin Co., Ltd.
*1 Core operating profit: Gross profit - selling, general and administrative expenses (excluding amortization of intangible assets) - R&D expenses - non-
recurring profit and loss as determined by the Company 14
Summary of Revised FY26 Plans
FY2025
Results
496.8
[74%]
368.9
[74%]
157.9
[32%]
101.2
[20%]
109.8
[22%]
67.0
7.7%
(8.3%)
3.8%
FY2026 Rev. Plans | |
520.0→ | 520.0 [77%] |
391.0→ | 388.0 [75%] |
169.0→ | 163.0 [31%] |
122.0→ | 95.0 [18%] |
100.0→ | 130.0 [25%] |
75.0→ | 75.0 |
8.2% (7.7%) | |
4.1% | |
The full-year forecast has been revised upward for core operating profit, while net profit remains unchanged and is still expected to increase year on year
( Billion Yen / Rounded )
Revenue
[Overseas sales ratio]
Gross Profit
[Gross Profit Margin]
SG&A *1
[SG&A ratio]
R&D Exp.
[R&D Ratio]
Core Operating Profit*2
[Core OP margin]
Profit ROE
(3-year average)
DOE
Change
+23.2
(+5%)
+19.1
(+5%)
+5.1
(+3%)
-6.2
(-6%)
+20.2
(+18%)
+8.0
(+12%)
Foreign Exchange Assumptions
FY2025 Actual: ¥150 / USD
FY2026 Rev. Plan: ¥150 / USD
*There has been no change in the foreign exchange assumptions in the revision to our earnings forecast announced on May 7, 2026.
© Kyowa Kirin Co., Ltd.
*1 Excludes amortization of intangible assets (sales rights amortization)
*2 Core operating : GP - SG&A (excl. intangible asset amortization) - R&D - Non-recurring items as determined by the Company 15
Earnings Forecast Update
Core operating profit will increase due to cost reductions from the discontinuation of the rocatinlimab clinical program, while net profit is expected to remain unchanged due to closing costs and other expenses.
(Billion JPY)
Profit (initial forecast)
Gross Profit
SG&A
R&D Expenses
Others, Finance, etc.
Profit(after revision)
Core operating profit +30.0
Profit
±0
-3.0
-30.0
75.0
+6.0
75.0
+27.0
Cost variance due to production plan changes
SG&A
+6.0
Gross Profit
-3.0
Reduced costs due to no longer incurring
preparation costs for rocatinlimab
R&D Expenses
+27.0
Rocatinlimab clinical program discontinuation
reduces R&D expenses
Equity method, finance, and others
-30.0
Other expenses Increased due mainly to the estimated closing costs associated with the discontinuation of the clinical program for rocatinlimab, as well as the impact of impairment losses (¥5.0 billion) , which arose incidentally in connection with the discontinuation of the rocatinlimab clinical program.
© Kyowa Kirin Co., Ltd. 16
Commercial Update
Coordinated Actions to Maximize Patient Access to Global Strategic Products
17
© Kyowa Kirin Co., Ltd.
Crysvita 2026 Key Actions & Q1 Topics
2026 KEY ACTIONS
NA:
Continue investments in people and operations to support patient identification, customer education, and the evolution of patient support services, contributing to sustained Crysvita performance in the U.S. market.
EMEA:
Drive growth through improved patient identification, including AI-enabled initiatives, reinforcement of guideline-based use in pediatrics, expansion into adult patients.
JAPAN:
Adult patient penetration supported by enhanced promotion and disease awareness led by enhanced dedicated reps.
2026 Q1 TOPICS
NA: YTD Sales rev. YoY, in Yen -3%, in local currency -3%
Negative impacts from seasonal factors (destocking of inventory) made Q1 sales appear soft, but YoY demand growth remained strong, supported by robust patient support programs.
EMEA: YTD Sales rev. YoY, in Yen +21%, in local currency +11%
Commercial growth driven by robust underlying demand and increased adult patient uptake - supported by EU XLH treatment guidelines - contributed to an expanding treated patient base.
JP:YTD Sales rev. YoY, in Yen +24%
Strengthened promotion by dedicated reps and disease awareness efforts have been effective, resulting in steady new patient additions and penetration of the pre-filled syringe.
196.6
11.7
24.2
2.0 15.8
6.3
37.8
220.7
130.0
141.8
152.4
10.5
127.1
216.4
13.6
Others
NA
23.5
3.4
2.5
17.9
8.0
18.8
31.0
2.3
87.0
8.8
22.8
29.4
51.5
57.5
14.7
35.1
105.2
45.7
42.4
2.8
24.1
14.8
11.9
Sales Revenue (Billion yen) North America Sales Revenue ($M) North America Demand Trend
JapanEMEA
235.4
139 143 155 157 151
Sales Revenue($M) Demand (mg) 12 month MA22Q1 23Q1 24Q1 25Q1 26Q1
235
233
285
273
325
155
187
157
191
151
EMEA Sales Revenue (£M)
77 85
50 64
41
23Q4 24Q1 24Q2 24Q3 24Q4 25Q1 25Q2 25Q3 25Q4 26Q1
Crysvita XLH Prescription Mix
peds adult NA22Q1 FY22 23Q1 FY23 24Q1 FY24 25Q1 FY25
© Kyowa Kirin Co., Ltd.
26Q1
2026
Plan
22Q1 23Q1 24Q1 25Q1 26Q1
EMEA
JP 18
Poteligeo 2026 Key Actions & Q1 Topics
2026 KEY ACTIONS
Global: Support the Poteligeo franchise in MF/SS through aligned global execution and continued use of clinical and real-world evidence to reinforce long-term value.
NA: Focus on identifying appropriate MF/SS patients and supporting broader and earlier use through evidence-based communication. Continue to leverage ML & AI based technology.
EMEA: Focus on identifying appropriate MF/SS patients and supporting broader and earlier use through evidence-based communication. Support market expansion opportunities and reimbursement efforts. Utilize peer exchange programs and AI data to help identify patients earlier.
2026 Q1 TOPICS
Global: YTD Sales rev. YoY +23%, annual plan progress rate 22%
NA: YTD Sales rev. YoY, in Yen +29%, in local currency +28%
Growth driven by a strengthened sales organization, ML/AI-enhanced promotions, advanced analytics, and proactive patient-finding.
EMEA: YTD Sales rev. YoY, in Yen +9%, in local currency +0%
While performance was temporarily impacted by shipment phasing, underlying demand remained resilient, supported by accelerating evidence-based communication and sustained patient engagement initiatives.
Revenue (Billion yen) North America Revenue ($M) EMEA Revenue (£M)
22Q1
23Q1
24Q1
25Q1
26Q1
19
6
9
10
13
13
Japan EMEA
57
45
43
33
29
2.8
4.3
NA
Others
54.6
45.7
39.9
30.3
24.2
12.1
4.7
6.3
8.6
9.8
0.9
1.5
3.3
1.9
2.6
5.1
6.9
8.2
6.3
10.0
6.9
12.0
8.9
17.2
21.5
29.7
33.9
40.9
22Q1 FY22 23Q1 FY23 24Q1 FY24 25Q1 FY25
26Q1 26 Plan
22Q1 23Q1 24Q1 25Q1 26Q1
© Kyowa Kirin Co., Ltd.
KOMZIFTI (ziftomenib) 2026 Key Actions & Q1 Topics
KEY ACTIONS IN 2026
KOMZIFTI's efficacy, safety profile, and ease of use support its positioning as a competitive option in R/R NPM1-mutated AML, with the potential for increased market penetration over time.
2026 Q1 TOPICS
Confirming a good start to sales as an early stage of sales
Against the backdrop of a differentiated product profile, there were signals of strong interest from prescribers, patients and pharmacists in relapsed and refractory NPM1-mutated AML
More than 80% of private insurance companies have included KOMZIFTI in their policies
※ KOMZIFTI revenue is expected to be disclosed following Kura Oncology's earnings call (May 12).
Profit
Kyowa Kirin P/L Image
Unit: Billions of yen
KOMZIFTI
Items | FY2025 | 2026 Q1 |
Net Profit/Net Loss before tax | (8.2) | (1.5) |
Product P/L Image
Unit: Billions of yen
Loss
Items | FY2025 | 2026 Q1 |
Revenue | ー | ー |
SG&A | (4.1) | (0.7) |
Core Operating Profit | (4.1) | (0.7) |
Amortization of intangible assets | (0.7) | (1.1) |
Profit before tax | (4.8) | (1.8) |
50%
Progress
50% of the Net Profit / Net Loss is recorded in Kyowa Kirin's P/L
Ziftomenib (Development)
KOMZIFTI (Non-Development)Added to the National Comprehensive Cancer Network® (NCCN) Guidelines for Acute Myeloid Leukemia
2025 ASH Annual Meeting - Presentation of Efficacy and Safety Results of the KOMET-007 P1b Combination Cohort
Initiation of a Phase 2 clinical trial in Japan for relapsed and refractory AML with NPM1 mutation
Press release Nov 26, 2025
Press release Dec 9, 2025
Press release Apr 24, 2026
Schedule
KOMET-007 P1b Study: 1st line treatment 7+3 combination therapy data
KOMET-007 P1 Study: Publication of ven/aza combination data in relapsed and refractory NPM1-mutated AML KOMET-008 P1 Study: Initial Data on the Combination of Gilteritinib in NPM1/FLT3 co-mutated AML
First Half of 2026
First Half of 2026 Second Half of 2026
© Kyowa Kirin Co., Ltd.
20
Business Update21
© Kyowa Kirin Co., Ltd.
Taking Another Step Forward Toward "Creating Innovative Life-changing value"From Vision 2030 and Beyond: Our Growth Story
Delivering Life-changing value to Patients
Pursuing Operational Excellence with Super Team
Creating Innovative Life-changing value
Leverage our strengths in advanced antibody technologies and hematopoietic stem cell gene therapy
Steadily advance late-stage development pipelines, including ziftomenib and KHK4951
Pursue new pipelines and earnings opportunities through strategic investments
Further Strengthening Our Proven Global Commercial Platform
Maintain close engagement with patients and patient organization
Continue to grow Crysvita and Poteligeo
Deliver a successful launch and market uptake of KOMZIFTI
Build a "Super Team" with strong strategy execution capabilities
Transform the operating model through AI and DX
Simplify Processes, Focus Resources, and Stay Agile
22
Consolidating Our Japan Research Sites and Relocating to a New Facility in Yokohama
© Kyowa Kirin Co., Ltd.
Further Strengthening Drug Discovery Capabilities - Consolidating Domestic Research Sites and Relocating to a New Research Facility in Yokohama
Clinical Trials
Phase 1
Phase 2
Phase 3
Research
Development
TRP1
Drug discovery Incubation Research
FRP2 TRP
FRP
Drug Discovery
Research
Development
Research
Translational Research (TR)
FRP
Manufacturing Technology Research
(CMC3 Research Center and Part of
Biomanufacturing Technology Institute)
FRP
Takasaki
Investigational Drug Manufacturing
Takasaki Plant HB7
Completion in 2025
New Plant in Sanford
Scheduled to be completed in 2027
Production
Manufacturing Technology Research (Bioproduction Technology Research Institute)
Takasaki
New Yokohama Site
Initiatives to Evolve Kyowa Kirin's Drug Discovery Process in Response to the Latest Technologies
Aiming to establish an R&D model that organically connects Drug Discovery, TR, CMC, and Development Research from an early stage
Together with Takasaki Plant HB7 (completed in 2025) and the Sanford plant (scheduled to be completed in 2027), Kyowa Kirin will further enhance its drug discovery capabilities
© Kyowa Kirin Co., Ltd.
1. Tokyo Research Park, 2. Fuji Research Park, 3. Chemistry, Manufacturing and Control 23
R&D Update
24
© Kyowa Kirin Co., Ltd.
Development Pipeline: News Flow
As of May 7, 2026
New information highlighted in orange
Product | Indication | Event | Status | |
Ziftomenib | Already marketed as KOMZIFTITM | AML (1L Combo) | P3 (KOMET-017) P1 (KOMET-007) | Ongoing Ongoing |
OTL-203 | MPS-I (Hurler Syndrome) | Registrational Study (P3 Equivalent) | Ongoing | |
KK8398 infigratinib | Achondroplasia | P3 | Ongoing | |
Hypochondroplasia | P3 | In Preparation | ||
KHK4951 tivozanib eyedrop | nAMD | P2 | Ongoing | |
DME | P2 | Ongoing | ||
OTL-201 | MPS-IIIA (Sanfilippo Syndrome Type A) | PoC Study (P1/2 Equivalent) Awarded Innovation Passport Designation(ILAP) | Ongoing April 2026 | |
KK4277 | SLE, CLE | P1 | Ongoing | |
KK2260 | Advanced or metastatic solid tumors | P1 | Ongoing | |
KK2269 | Advanced or metastatic solid tumors | P1 | Ongoing | |
KK2845 | AML | P1 | Ongoing | |
KK8123 | XLH | P1 | Ongoing | |
KK3910 | Essential Hypertension | P1 | Ongoing | |
OTL-200 | Already marketed as Libmeldy®/Lenmeldy® | MLD | P3 (Japan) NDA (Japan) | In Preparation March 2026 |
KK2223 | CTCL, PTCL | P1 | In Preparation |
25
© Kyowa Kirin Co., Ltd.
Appendix
26
© Kyowa Kirin Co., Ltd.
Revenue of Major Items(Units are billion JPY, rounded)
Product Name, etc.
FY2025
Jan-Mar
FY2026
Jan-Mar
YoY Change Key Reason FY2026 Rev. Plans*
Progress
42.4 | 45.7 | +3.2 (+8%) | 235.4 | 19% | ||
Japan | 2.8 | 3.4 | +0.7 (+24%) | 14.7 | 23% |
Crysvita
North America
24.1 23.5 -0.6 (-3%)
Market Penetration
EMEA | 14.8 | 17.9 | +3.1 (+21%) | 220.7 | 19% |
Others | 0.8 | 0.9 | +0.1 (+14%) | ||
9.8 | 12.1 | +2.3 (+23%) | 54.6 | 22% | |
Japan | 0.3 | 0.4 | +0.1 (+24%) | 1.4 | 25% |
North America | 6.9 | 8.9 | +2.0 (+29%) | Market Penetration 40.9 | 22% |
EMEA | 2.6 | 2.8 | +0.2 (+9%) | 12.0 | 23% |
Others | 0.0 | 0.0 | -0.0 (-32%) | 0.2 | 9% |
2.1 | 1.5 | -0.6 (-30%) | 10.0 | ||
United States | 1.1 | 1.1 | +0.0 (+0%) | Market Penetration 4.5 | 15% |
Poteligeo
Libmeldy / Lenmeldy
(2024.3US FDA approval)
EMEA 1.0 0.4 -0.6 (-61%) 5.5
Phozevel
Japan 1.5 1.9 +0.4 (+25%) Market Penetration
(Launched in February 2024)
11.6 17%
Duvroq
Japan 3.0 3.6 +0.6 (+20%) Market Penetration 16.2 22%
G-Lasta
Japan 4.3 3.5 -0.8 (-18%) Drug price revisions and the impact of competitors
16.2 22%
Romiplate
Japan 3.4 3.7 +0.3 (+10%) Market Penetration 11.4 33%
Tech-licensing
13.0 24.8 +11.9 (+92%) Fasenra growth and one-time recognition of
74.9 33%
Benralizumab Royalty 1
7.4 8.6 +1.2 (+16%)
deferred revenue for rocatinlimab
© Kyowa Kirin Co., Ltd.
Sales royalties of Fasenla sold by AstraZeneca (including our own estimates)
Overseas items are shown after deducting discounts, etc., including foreign exchange effects. Items in the Japan region display the amount before deductions. 27
*There is no change to the sales revenue assumptions in the revised 2026 Plans announced on May 7, 2026.
Source: Kyowa Kirin, "Discontinuation of Clinical Trials for Rocatinlimab," disclosed on March 4, 2026.
Impact on Business PerformanceShort-term profit increase due to elimination of SG&A and R&D expenses related to rocatinlimab
Certain negative profit impact expected in the medium to long term
Estimated Impact on Core Operating Profit
2026 : Approx. +¥20~30 billion
2027 : Approx. +¥30 billion
2028 : Approx. +¥10 billion
2029 onwards : Certain negative impact expected
Estimated Impact on Net Income for the Current Fiscal Year
In addition to the impact on core operating profit, closing costs arising from the termination of the clinical trials will be recorded as "other expenses"
Revision of FY2026 Earnings Forecast
Currently under review; revision to the earnings forecast will be disclosed at the time of the Q1 FY2026 earnings announcement
© Kyowa Kirin Co., Ltd. 28
Source: Kyowa Kirin, "Discontinuation of Clinical Trials for Rocatinlimab," disclosed on March 4, 2026.
Impact on Mid- to Long-term Financial Targets and Future Management PolicyNo changes to the mid- to long-term financial targets announced in "Vision 2030 and beyond : Our Growth Story" published on February 9, 2026. These remain the targets we aim to achieve.
Leveraging the following growth drivers, we aim to achieve ROE in the low-teens and a core operating margin of 30% in the early 2030s:
Continue robust growth of Crysvita and Poteligeo, with value maximization through lifecycle management initiatives
Achieve significant sales and profit growth from expansion of KOMZIFTI's indication to AML*¹ first-line treatment
Advance the development and commercialization of pipeline assets in our focused disease areas, including KK8123,
KK2845 and OTL-203
Strengthen resource allocation to focused disease areas and accelerate portfolio prioritization centered on delivering Life-changing Value
Improve profit margins through cost-structure optimization, including transformation into a more resilient organization
through DX/AI initiatives
Actively pursue strategic investments to accelerate inorganic growth
© Kyowa Kirin Co., Ltd.
*¹ For acute myeloid leukemia with menin dependency
29
Source: Kyowa Kirin, "FY2025 Financial Results
Briefing," disclosed on Feb 9, 2026.
(Updated 2026 Plans)
Change in Core Performance Metrics from FY2026
Background
Reviewing performance management post 2021-2025 Mid-term Business Plan, we change core performance metrics anticipating the impact of IFRS 18 "Presentation and Disclosure in Financial Statements" effective FY2027.
Consolidated P/L display change (intro of 3 categories: operating, investing, financing)
Equity method investment P&L excluded from operating profit
Intro of "Management-defined Performance Metrics" footnote (audited) for investor comms
Revisions to metrics for better comparability with global pharma, reflecting group's sustainable profitability
Details
Calculated by deducting SG&A (excl. amortization of intangible assets) and R&D from gross profit, and further excluding non-recurring items as determined by the Company
Compared to previous core operating profit, amortization of intangible assets (amortization of selling rights) and equity in earnings of
affiliates are excluded
© Kyowa Kirin Co., Ltd.
30
(Billion JPY) 2023 Actual 2024 Actual 2025 Actual 2026 Rev. Plans
Core Operating Profit [Core Operating Profit Margin] | (Current Metric) | 96.8 [22%] | 95.4 [19%] | 103.1 [21%] | 119.0 [23%] |
Excluded | Amortization of intangible assets (sales rights) | 5.6 | 7.6 | 7.6 | 11.0 |
Equity method investment P&L | 0.9 | 3.5 | 0.8 | 0.0 | |
Non-recurring items | - | - | - | - | |
Core Operating Profit [Core Operating Profit Margin] | (Revised Metric) | 101.4 [23%] | 99.4 [20%] | 109.8 [22%] | 130.0 [25%] |
[Ref.] Impacts arising from the adoption of IFRS 18 "Presentation and Disclosure in Financial Statements
From the fiscal year ending December 2027, the presentation of our consolidated statement of profit or loss will be revised as outlined below. Ahead of this change, we have updated our performance indicators starting from the fiscal year ending Dec. 2026. Core Operating Profit: Gross profit less selling, general and administrative expenses, R&D expenses, and related non-recurring items. Core Profit for the Year: Core operating profit less related income tax expense.
Core EPS: Core profit for the year divided by the weighted average number of shares outstanding.
Current Presentation (through FY2025)
Revenue
Cost of Sales
Gross Profit
SG&A
R&D Expenses
(Amortization of Intangible Assets) ※
Equity-method profit/loss
Other Operating Income / Expenses
Current Core Metrics (through FY2025)
Core Operating Profit
New Core Metrics (from FY2026)
(excluding non-recurring items)
Core Operating Profit
IFRS 18 (from FY2027)
Revenue
Cost of Sales
Gross Profit
SG&A
R&D Expenses
Amortization of Intangible Assets Other Operating Income / Expenses
Operating Profit
Operating
Finance income / costs Finance income / costs
Equity-method profit/loss
Other Investment Income / Expenses
Investment
Profit Before Finance and Income Taxes
Profit Before Tax
Income Tax Expense
Profit for the Year
Income Tax Expenses
(Excl. other income/expenses)
Core Profit for the Year Core EPS
Income tax expense
(Core operating profit items)
Core Profit for the Year Core EPS
Finance income / costs
Profit Before Tax
Income Tax Expense
Profit for the Year
Finance
© Kyowa Kirin Co., Ltd.
*Amortization of intangible assets (amortization of selling rights) was included in SG&A until 2025. Beginning in 2026,
it has been separately disclosed as amortization of intangible assets due to increased materiality.
31
Source: Kyowa Kirin, "FY2025 Financial Results Briefing," disclosed on Feb 9, 2026.
Capital Allocation Policy (2026-2028)
Prioritize growth investments while ensuring stable shareholder returns, leveraging strong cash position and borrowing capacity
R&D Investment
Growth Investment
3-year Total
¥920 B
Cash on hand
¥220 B
(Expected end of FY2025)
Source Allocation
¥380 BCash to be generated in 2026-2028
Operating cash flow before R&D expenses:
¥660 B
(Operating CF 280 +
R&D expenses 380)
Strategic Investment
Capital
Expenditures
Dividends
Shareholder Return
Investing cash flow
¥40 B
(EMBU business restructuring)
Investment in a U.S. biopharmaceutical manufacturing facility and IT, digital transformation and AI investments
DOE 4%+ and progressive dividend approach
Borrowing Capacity1
Share buybacks
To be considered flexibly, taking into account the status of
strategic investments, business performance, and shareprice trends, with a focus on ROE
1. Maintain Net D/E ratio at or below 0.5x in principle
© Kyowa Kirin Co., Ltd. 32
P/L Impact on EMEA established medicines portfolio
Before Aug 2023
After Aug 2023
2024 2025
unrealized 49% of the transfer value
£ 66.4M(JPY13.1B)
2026
£38.5M (JPY7.7B)
*Incl. price adj. diff. for 3
Product sales
Tostran until Oct
3 brands
IP transfer
1 brand
IP transfer
brands transferred last year
Revenue
Established portfolio 13 brands
Sales Royalties & license fees
Royalties decrease due to early IP transfer
Tostran IP transfer
(ADVANZ PHARMA)
Disposal proceeds
Contingency
income
COGs SG&A
Cost of product sales
SG&A costs
£ 62.5M (JPY 11.4B)
£8.5M (JPY 1.6B)
Equity
method
49% of profit for Joint Venture Collaboration, Grünenthal Meds
JPY 4.2 B Disposal of shares
+ derivative valuation gains
Other income
Share transfer *
51% of Grünenthal Meds share has transferred (Aug 1) Gain on sales of 51% share+ gain on valuation of remaining
49% share at £80.9M (JPY 14.8B) in total
9 brands
3+1 brands
Transfer of residual assets
+
Realization of unrealized profits
* Kyowa Kirin International plc ("KKI") transferred the remaining assets related to its established pharmaceutical business, including the IP for 9 brands (down from 13), to Grünenthal in the Q1 of FY2026. In prior periods, options held under a collaboration agreement were measured
© Kyowa Kirin Co., Ltd. at fair value and recognized as liabilities. Following the termination of the option agreements, the derivative liabilities were reversed and a 33
gain on derivative remeasurement was recognized.
Key Development Pipeline (1)
As of May 7, 2026
Disease in development*1
Planned approval year*2
Development
status Market size*3
Number of patients*4
ziftomenib | AML (NPM1-m or KMT2A-r, Newly Diagnosed) | TBD | P3 (Global) | ★★★★ | 20K |
KK8398 | Achondroplasia | TBD | P3 (Japan) | ★ | 1 in 20K live births |
infigratinib | Hypochondroplasia | TBD | P3 (Japan) In preparation | ★ | 1 in 33K live births |
OTL-200 | Metachromatic Leukodystrophy | TBD | P3 (Japan) In preparation | ★ | 1 in 100K live births*6 |
KHK4951 | nAMD | TBD | P2 (JP/US) | ★★★★★ | 2672K |
tivozanib eyedrop | DME | TBD | P2 (JP/US) | ★★★★ | 2219K |
OTL-203 | MPS-IH (Hurler Syndrome) | 2029/2030 | Registrational study*5 (US, EU) | ★ | 1 in 100K live births*6 |
OTL-201 | MPS-IIIA (Sanfilippo syndrome type A) | TBD | Proof-of-concept study*7 | ★ | ~1 in 100K live births |
*1 This refers to diseases under development at the time of this presentation and may differ from the final indications approved by regulatory authorities. *2 Represents the anticipated year of regulatory approval for the indication currently under development. *3 Market size is our own independent estimate based on the total of all products for the "disease under development." The colored section is global, the rest are values for Japan only. ★: Under 50 billion yen, ★★: 50 billion yen or more- Under 100 billion yen, ★★★: 100 billion yen or more- Under 500 billion yen, ★★★★: 500 billion yen or more- Under 1 trillion yen, ★★★★★: 1trillion yen or more *4 This is an independent estimate by our company. Colored sections are values for global, the rest for Japan only. *5 Equivalent to phase 3 trial. *6 "1 in 100,000" is for all MPS-I cases,Hurler syndrome accounts for 60% of this value. *7 P1/2 Equivalent to trial.
© Kyowa Kirin Co., Ltd. 34
Key Development Pipeline (2)
As of May 7, 2026
Disease in Development*1 Development Status Modality, Technology Used
KK4277 Systemic Lupus Erythematosus Cutaneous Lupus Erythematosus
P1 (Japan/Asia) Antibody, POTELLIGENT®
KK2260 | Advanced/Metastatic Solid Tumors | P1 (JP: Ongoing, US: Prep) | Antibody, REGULGENTTM |
KK2269 | Advanced/Metastatic Solid Tumors | P1 (JP/US) | Antibody, REGULGENTTM |
KK2845 | Acute Myeloid Leukemia (AML) | P1 (Japan) | Antibody-Drug Conjugate (ADC) |
KK8123 | XLH | P1 (US/EU) | Antibody |
KK3910 | Essential Hypertension | P1 (Japan) | Antibody |
KK2223 | CTCL, PTCL | P1 (US/EU) | Targeted Therapy |
35
*1 Diseases in development as of this presentation; final approved indications may differ from regulatory authorities.
© Kyowa Kirin Co., Ltd.
Key Development Pipeline: Future Plans
Orange: Ongoing
Gray: Pre-initiation or Completed
As of May 7, 2026
Product Name | Target Disease | Development Phase | 2026 | 2027 | 2028 | + |
ALL
P1a1 (KMT2A-r)
P1a1 (non NPM1-m /
KOMET-
0073
P1
KOMET-0084
non-KMT2A-r AML)
KOMET
-0012
ziftomenib
AML
P11
KOMET-
0175
P3
KOMET-
J0016
P2
OTL-203 MPS-I
(Hurler Syndrome)
Registrational7
OTL-200
MLD
P3
In preparation
1. Dose escalation ongoing, 2. 2L+ Mono, 3. 1L, 2L+, Combinations with cytarabine + daunorubicin (7+3), venetoclax + azacitidine, and 7+3 and quizartinib, 4. 2L+, Combination with gilteritinib, FLAG-
IDA, LDAC, 5. 1L, Combinations with cytarabine + daunorubicin (7+3), and venetoclax + azacitidine, 6. Japan P2 monotherapy study in R/R NPM1-m AML, 7. Equivalent to P3. Studies on this slide sponsored by Kura Oncology. Bar graphs correspond to clinicaltrials.gov timelines
© Kyowa Kirin Co., Ltd.
36
Key Development Pipeline: Future Plans
Orange: Ongoing
Gray: Pre-initiation or Completed
As of May 7, 2026
Product Name | Target Disease | Development Phase | 2026 | 2027 | 2028 | + |
Wet AMD P2
KHK4951
tivozanib eyedrop
DME P2
KK4277 SLE CLE
KK2260 Advanced/Metastatic Solid Tumors
P1 P1 study nearly complete. Reviewing results to determine next steps.
P1
KK2269 | Advanced/Metastatic Solid Tumors | P1 |
KK2845 | Relapsed/Refractory AML | P1 |
KK8123 | XLH | P1 |
KK3910 | Essential HTN | P1 |
KK2223 | CTCL, PTCL | P1 In preparation |
Bar graphs correspond to clinicaltrials.gov timelines
© Kyowa Kirin Co., Ltd.
37
FX Info
Period Avg. FX Rate (yen)
2025 Q1 | 2026 Q1 | YoY | 2026 Rev. Plans* | |||
USD | 154 | 155 | +1 | ¥150 | ||
GBP | 193 | 210 | +17 | ¥205 | ||
EUR | 161 | 183 | +22 | ¥180 | ||
FY2026 Q1FX Impact (vs FY25, billion yen) | Revenue | Core OP | ||||
USD | -0.0 | -0.0 | ||||
GBP | +0.1 | -0.1 | ||||
EUR | +2.2 | +1.2 | ||||
FY2026 FX Sensitivity (vs FY26 Rev. Plans, billion yen)
Sensitivity | Revenue | Core OP | |
USD | 1 yen Weaker | +1.8B | +0.6B |
GBP | 1 yen Weaker | +0.1B | -0.1B |
EUR | 1 yen Weaker | +0.4B | +0.2B |
38
© Kyowa Kirin Co., Ltd.
There is no change to the foreign exchange assumptions in the revised 2026 Plans announced on May 7, 2026.
Ziftomenib ~Kura Oncology Collaboration~
US Ex-US
Dev. |
| |
Commercial. |
|
|
Sales Royalties |
| |
Supply |
| |
39
Kyowa Kirin to pay $330M upfront, up to $1,161M milestones. Includes:
$420M near-term milestones, $228M solid tumor option, future global sales royalties.
© Kyowa Kirin Co., Ltd.