Astellas Pharma : Presentation Material for Astellas Rx+ Day(Media Seminar)

Astellas Rx+® DAY ~ Beyond the Rx business ~

CAUTIONARY STATEMENT

REGARDING FORWARD-LOOKING INFORMATION

In this material, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas Pharma. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.Information about pharmaceutical products (including products currently in development) that is included in this material is not intended to constitute an advertisement or medical advice.

3

AGENDA

Introduction

Naoki Okamura

Executive Vice President, Chief Strategy Officer and Chief Financial Officer

Outcomes and Future Perspectives of Developing the Rx+® Programs

Yuta Watanabe

Senior Vice President, Rx+ Business Accelerator

Topics of each program

Sphere：Patient outcome maximization (via precise surgery/diagnosis)

・Surgery cannot be performed with drugs, but surgery can be supported with drugs

Sphere：Chronic disease progression prevention

・A society where people can become healthy while having fun ・Digitalization can change behavior, change healthcare

・Start with early detection of arrhythmias/Contribute to extending healthy life expectancy

Sphere： Across all spheres

` Ultra-small medical devices beyond the pill

Wrap up

Naoki OkamuraAkira SuwaMotohiro Kanayama Naoyuki Kanda Makoto OginoKunitake Abe

Executive Vice President, Chief Strategy Officer and Chief Financial Officer

OUR VISION

Vision

On the Forefront of Healthcare Change to Turn

Innovative Science into

VALUE for Patients

We will achieve sustainable growth by pursuing innovative science to produce medical

solutions that provide VALUE

to patients

DEFINITION OF VALUE

DEFINITION OF VALUE

Outcomes

Cost

Double the outcomes

Double the VALUETriple

One third the VALUE the cost

TECHNOLOGICAL INNOVATION AND

RAPID CHANGES IN INDUSTRIAL STRUCTURE

2005

2013

WHY ASTELLAS DEVELOP RX+® PROGRAMS

Rx+® : HEALTHCARE SOLUTIONS BEYOND THE Rx BUSINESS

Combine our expertise and experiences with technology and knowledge from different fields to create new revenue streams separate from our core Rx products

Bioelectronics Ultra-small implant medical device

Digital Health & Digital Therapeutics

Disease management digital platformSmartphone exercise app with gamification and 3Dmotion technologies

APPROACH TO CREATING THE RX+ STORY®

Given the broad business scope and market uncertainty in Rx+®, a unique approach is taken

Start from our ASPIRATIONS 1(a world realized by Rx+®: "Rx+ World")

FUTURE-DRIVEN and OUT-OF-THE-BOX2thinking, breaking away from the traditional pharmaceutical business

AGILE and ITERATIVE3on the basis of hypothesis thinking

RX+ STORY®: STRATEGIC DIRECTION OF RX+®

Rx+® World

A world where people can live mentally and physically healthy lives and be true to themselves through healthcare solutions based on scientific evidence

SUMMARY OF CURRENT SPHERES

Enable prevention of disease progression in accordance with individual constitution and lifestyle

Free patients and caregivers from problems in daily life related to physical functionsFree patients and caregivers from problems in daily life caused by central nerve system-related diseases

Solve health problems in perinatal and menopausal women and children with non-invasive solutions

Improve accuracy of surgery and diagnosis to optimize treatment measures and maximize therapeutic outcome

Free patients and caregivers from problems in daily life related to sensory functions

https://www.astellas.com/jp/en/partnering/rx-plus

APPROACHES TO TECHNOLOGY AND EXPERTISE IN DIFFERENT FIELDS

Co-Creation: Accessing and working with state-of-the-art issues, findings, technologies, and capabilities

Astellas Rx+® Healthcare Innovation Challenge Recruiting new business ideas from start-up companies and students worldwide for commercialization

Tech ARINA: Idea Contest and Collaborative Research with the Theme of Healthcare Research Using Science and Engineering Technologies with Tokyo University of Industries

• • Recruitment of human resources in different fields

• • Internal idea challenge

• • Cross-border experience

• • Society task workshop

• • Leadership Training

Etc .......

FY20

FY19

FY18

1

10

8

6

4

12 11 9 8

10

4

• ⚫ "Project ABC PAC-MAN Squat Challenge" by Astellas and BANDAI NAMCO Entertainment

• ⚫ Research Collaboration with Actinium for Molecular Targeted Radiotherapy

• ⚫ Completed acquisition of iota Biosciences

• ⚫ U.S. FDA Fast Track Designation for ASP5354

• ⚫ Service start of Fit-eNce®

• ⚫ Astellas, City of Yokohama, and Yokohama City University Developed Science-Based Exercise Programs

• ⚫ Astellas and BANDAI NAMCO Entertainment Enter into Agreement to Co-Develop and Co-Commercialize Smartphone Exercise Support Application

• ⚫ Announcement of Rx+ Story® Story

• ⚫ Astellas and Welldoc enter into Strategic Alliance for Digital Therapeutics

• ⚫ Astellas and iota Biosciences enter into Collaborative Research and Development Agreement

• ⚫ Yokohama City University, Tokyo University of the Arts and Astellas Launched Health Mock Lab. to Create New Digital Healthcare Solutions Using Gamification

• ⚫ Astellas and BANDAI NAMCO Entertainment to Jointly Develop Smartphone Exercise Support App

• ⚫ Newly established Rx+ Business Accelerator

Business Producer,	Business Producer,	Principal, Project Lead,	Business Producer,	Business Producer,
Rx+ Business Accelerator	Rx+ Business Accelerator	Rx+ Business Accelerator	Rx+ Business Accelerator	Rx+ Business Accelerator
Akira Suwa	Motohiro Kanayama	Naoyuki Kanda	Makoto Ogino	Kunitake Abe

Sphere：

Patient outcome maximization

(via precise surgery/diagnosis)

PART 3

Surgery cannot be performed with drugs, but surgery can be supported with drugs

Akira Suwa

Business Producer, Rx+ Business Accelerator

Image-guided Precision Surgery / Image-guided Precision Surgery

Establish

More Precise, Safer and Efficient procedures

Key point

➢Maximize patient outcome using Image-guided technology ➢Realize precise procedures with drugs and devices

Image-guided surgery can be achieved by capitalizing on device (Mechanical-based) and pharma (Biology-based) technology

Smart Surgery

merged with advanced technologies

➢

AI Artificial Intelligence

➢

VR/AR

Virtual Reality/Augmented Reality

➢

3D Hologram

➢

PM Projection Mapping

➢

HMD Head Mounted Displays

Risk factors

Background of disease and patient

Decreased surgical outcome

Surgery-related complications

⚫ Improve Surgical and Patient

Outcomes using advanced surgical technology

Decreased patient outcome

Challenges with current surgical treatments - focus points

Iatrogenic Ureteral Injury (IUI)

●

Caused by accidental injury to the ureter during abdominal and pelvic surgeries

●

IUIs are associated with higher mortality, morbidity, longer length of hospital stays, and increased healthcare cost1

●

The best method for preventing IUI is intraoperative identification of both ureters2

There is no approved method for non-invasively visualizing ureters in clinical practice

1. Halabi WJ et al., Dis Colon Rectum. 2014;57:179-86. 2. The International Urological Guidelines

Iatrogenic Ureteral Injury

- Challenges with current method

Current method to identify ureters

The ureter position is approximated or possibly identified by the surgeon's experience

There is a method of inserting a ureteral stent before surgery. The stenting allows the ureter to be located haptically (and partly visually if lighted).

Challenges with the stenting method

• ⚫ Low efficacy：May not effectively identify the ureter

• ⚫ Needs the support from experts：The stenting procedure is difficult and requires the consultation of a urologist

• ⚫ Extended surgery time：Additional time for stenting required

• ⚫ Risk of adverse events：Hematuria, ureteral damage, renal dysfunction, etc.

• ⚫ High medical costs：Around $1,500 including the stenting method fee (U.S.)1

1. Chahin F et al,. JSLS. 2001;6(1):49-52.

Image-Guided Precision Surgery

Use Image: Image-Guided Precision Surgery

Graphical illustration of ureter imaging with ASP5354 in the clinical setting

Detection device NIR-F camera

Imaging agent ASP5354

(I.V. injection)

Image-guided precision surgery enables easy, safe and precise visualization of organs or tissues that are particularly difficult-to-identify, with improved global post-operative outcomes

NIR-F : Near InfraRed fluorescence

The safety and efficacy of this investigational agent has not been established. ASP5354 is not approved for use in any jurisdiction.

Create new value in collaboration with an external partner

Ureter imaging using ASP5354

ASP5354 features

• ● A derivative of indocyanine green that fluoresces upon excitation with a near-infrared light, a hydrophilic and iodine-free compound

●

●

●

ASP5354 was discovered by Mie University and Nagoya University. Astellas acquired exclusive development and marketing rights worldwide

Combined with the detection device (partnering with a medical device company), intraoperative identification of the ureters is expected to minimize the risk of IUI

Nonclinical and clinical data to date indicate ASP5354 has been well tolerated with no related adverse events

The nonclinical (porcine model) and preliminary human findings are consistent showing that ASP5354 illuminated the full extent of ureters under near-infrared light in both laparoscopic and open surgeries

Ureter visualization data using ASP5354

Non-clinical (Porcine)

Clinical Setting

Current situation and future plan

Ureter visualization using ASP5354 is an easy-to-use and effective method for minimizing the risk of IUI without the need for additional procedures or time.

• ⚫ Completed First-subject-first-treatment in P2 (U.S.): Oct 2020

• ⚫ Received U.S. FDA Fast Track Designation: Oct 2020

• ⚫ Target approval: FY2023

• ⚫ Investigating global development in addition to U.S. (Japan, China, EU)

Future perspective

Multiple needs exist for which image-guided precision surgery can improve patient outcomes

• ⚫ Prostate cancer

• ⚫ Colorectal surgery etc.

Target cases ~2 million / year

• ⚫ Colorectal surgery

• ⚫ Gynecological surgery etc.

• ⚫ Breast cancer

• ⚫ Melanoma surgery

• ⚫ Colorectal surgery etc.

1:indocyanine green, 2: 5-aminolevulinic acid

The safety and efficacy of this investigational agent has not been established. ASP5354 is not approved for use in any jurisdiction.

Sphere： Chronic disease progression prevention

PART 4

A society where people can become healthy while having fun

Motohiro Kanayama

Business Producer, Rx+ Business Accelerator

Key point Value creation and provision through ➢"Astellas x Entertainment x Medical" ➢"Astellas x Fitness x Medical"

*HCPs: Health Care Professionals

Developing new solutions/Market penetration

• ➢ Understanding disease, physicians/ patients needs

• ➢ Ability to build scientific evidence

• ➢ Wide networks with HCPs*

Society implementing health actions

World where people can live mentally and physically healthy lives and be true to themselves

CHALLENGES Macro perspective

The prevention of (the exacerbation of) "metabolic syndrome," "locomotive syndrome," and "dementia" are important issues for extending healthy life expectancy.

Major causes of conditions requiring long-term-care*

Challenges concerning extending healthy life expectancy

•	Cerebrovascular disease + cardiac disease: 19.8%	•	Metabolic syndrome
•	Joint disease + fracture/fall: 22.7%	•
Locomotive syndrome
•	Dementia: 18.7%
•	Dementia

Total

Male

Prevention of (exacerbation of) the above conditions is important for extending healthy life expectancy.

Female

Cerebrovascular disease	Cardiac disease	Joint	Dementi
(stroke)	(heart disease)	diseases	a
Fracture/fall	Debility due to	Others/unknown
advanced age

Materials: Ministry of Health, Labour and Welfare "Comprehensive Survey of Living Conditions" (2016) (Note) Excluding Kumamoto Prefecture.

* Major causes of conditions requiring long-term-care for persons aged 65 or older and receiving care.

Persons requiring long-term-care refer to persons at home among those who are certified as requiring support or care.

CHALLENGES Continuing exercise

A system to support health promotion through exercise is expected to be enhanced even further.

< Preventive viewpoint > ⚫ It is clear that a decrease in physical activity due to household and work automation, as well as the development of transportation along with changes in eating habits, has contributed to the recent increase in lifestyle diseases.

⚫ Although the effects of physical activity and exercise on health have become well known to the public, the percentage of people who actually exercise is small.

Source: Ministry of Health, Labour and Welfare website

< Viewpoint of clinical practice for diabetes mellitus >

Frequency of guidance during medical visit	Dietary guidance (%)	Exercise guidance (%)
Almost every time	11.4	11.1
Often (about 1 in 2-5 times)	16.8	14.5
Sometimes (about 1 in 6-10 times)	25.1	19.0
Rarely (about once a year)	36.7	25.4
Never	9.9	30.0

Prepared with reference to Current Situation of Diet and Exercise Therapy in Terms of Medical Consultations in Patients with Diabetes Mellitus in Japan: A Nationwide Survey - [Diabetes mellitus 58 (4): 265-278, 2015]

CHALLENGES

Each player's perspective

In order to become a society where "health promotion through science-based exercise" is practiced, several unmet needs must be met.

Player	Common challenges	Individual challenges
Exercise service provider	Medical rationale It is not easy to build a medical rationale.	-
Physician	Opportunities There are few opportunities to obtain information on exercise services.	Time It is difficult to secure time for exercise guidance.
Patient or person who wants to be healthy	-	Emotion/implementation There are psychological and practical issues.

Source: Prepared by Astellas based on the results of interviews with exercise service providers, physicians, and web surveys.

32
CHALLENGES
End user's perspective
People who want	People who
to be healthy	continue proper

through exercise

Psychological barrierImplementation barriers

exercises

Source: Created by Astellas based on the results of web-based surveys

Direction to solutions

People who want to be healthy through exercise

Envisioned services

Science-basedExercise support app that uses gamification and IoT technology which allows one to enjoy and continue proper exercises

Provide science- based services

People who continue proper exercises

Provided as a new healthcare tool

Collaboration with a fitness club Service overview

• ⚫ We provide exercises tailored to the physical strength of individuals through exercise design with logic used in medical research.

• ⚫ You can share your exercise log with your primary care physician.

• ⚫ The app allows you to start the service and record your exercising, helping you to start and continue exercising.

Change in HbA1c at Week 13

A system that supports exercise menus and exercise implementations based on scientific evidence provided by Astellas

User

Physician

Changesfrombaseline

(Results of medical research)

(%)

Database

Personal Trainerv

−0.2

−0.4

0.2

Least squares mean 0.13

-0.31

0.0

-0.44 (p<0.001＊)

Exercise group (n = 97)

Non-exercise group (n = 108)

*:Cases analyzed: Full Analysis Set

Mixed-effect model for repeated measures (explanatory variables include study group, assessment time point, value at Week 0, interaction between assessment time point and study group, interaction between assessment time point and value at Week 0)

Fit-eNce

Future perspective

We will be exploring the optimal form of the service through small repeated trials.

We will work on service development with science-based exercise as a common value.

Business concept

For health insurance societies / companies

For

individuals

Extensibility in terms of business scheme
Fit-eNce (Original)	Extensibility in terms of improved convenience

Limited exercise facilities

More exercise facilities / home

Location of exercise

Example 1: Cooperation with BANDAI NAMCO Entertainment Exercise support application using game know-how

We are aiming to provide the value of "preventing metabolic syndrome or improving obesity by continuing proper exercise while having fun."

①

• • Science-based exercise guide

• • Providing games that merge with exercise

④ Feedback on game and exercise implementation

② Game and exercise implementation

⑤

Continuing exercise while having fun

Example 2: Cooperation With Bandai Namco Entertainment Project ABC Pac-Man Squat Challenge

Project ABC was launched with the aim of providing opportunities for health promotion through exercise and creating a feeling of unity and cheerfulness to overcome the current situation.

⚫ We provided this WEB application between 26 January to 23

February 2021.

⚫ We did squats 149,429 times together!

https://abc.asobistore.jp/

Project ABC Pac-Man Squat Challenge Available today from noon to 10 p.m.

You can try the Pac-Man Squat Challenge today only!

• ● The special website for the Project ABC Pac-Man Squat Challengehttps://abc.asobistore.jp/

• ● Recommended environment

  [Recommended OS] iOS: iOS 10 or later, Android: Android 6.0 or later [Recommended browser] iOS: the latest version of Safari, Android: the latest version of Chrome

Previous topics

https://abc.asobistore.jp/

©BANDAI NAMCO Entertainment Inc.

Desired image

Developing new solutions/Market penetration

• ➢ Understanding disease, physicians/ patients needs

  Astellas

• ➢ Ability to build scientific evidence

• ➢ Wide networks with HCPs*

Society implementing health actions

World where people can live mentally and physically healthy lives and be true to themselves

Sphere：

Chronic disease progression prevention

PART 5

Digitalization can change behavior, change healthcare

Naoyuki Kanda

Principal, Project Lead, Digital Health,

Rx+ Business Accelerator

Key Points

Clinically Relevant Holistic Mobile Healthcare Solutions

• ▪ Provides a personalized treatment and continuous interaction with the healthcare providers (HCPs)

• ▪ Optimal timing of medical intervention leading to improved outcomes and cost saving

Fosters patients and HCPs behavioral changes and coaching using novel technology

• ▪ BlueStar regulatory clearance (Class II)

• ▪ HIPAA compliant

• ▪ SOC 2 certified

• ▪ ISO 13485 for International Business

• ▪ Cybersecurity functionality

Ease Access Using Digital Technology

• ▪ Regulatory Clearance

  (or, as appropriate, approval)

• ▪ Clinical and health-economic value

• ▪ Enhance user engagement

• ▪ Evidence-based business models

Medical needs

Healthcare Challenges

Changed World

Escalating of Healthcare CostIncreasing health care disparities

DIGITALDATA DRIVEN

Difficult to continue or intensify treatment

EASY TO CONNECT

EVIDENCE BASED

Significant cost saving with digitalUniversal AccessPersonalized goals and outcomes

Our collaboration

PLATFORM

• ▪ Innovative Technology

• ▪ Artificial Intelligence

• ▪ Machine Learning Algorithms

• ▪ Continuous monitoring and tracking

PRODUCT QUALITYREGULATORYEVIDENCECOMMERCIAL

Welldoc platform value

Product pipeline

PRODUCTINDICATIONREGION	PLANNING	DEVELOPMENT	CLINICAL TRIAL	COMMERCIAL
BlueStar	Diabetes	Japan	FY21
ASIA*
New DTx	Chronic Disease	Global
New DTx	Chronic Disease	Global

*Countries outside of Japan

Further expansion of the platform

BlueStar

Diabetes: JAPAN

• ▪ 10 million people are strongly suspected of having diabetes

• ▪ 10 million people who cannot rule out the possibility of diabetes

  Cardiovascular: US

• ▪ Number of Americans projected to have CVD by 2035 will have increased to nearly half of the U.S. population

• ▪ By age 45, cardiovascular disease risk is 50%, at 65 it jumps to 80%

Sources: 1) Cardiovascular Disease: A Costly Burden for America Study, AHA; 2) Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association; 3) 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation; 4) 厚生労働省健康局「平成28年国民健康・栄養調査

Sphere： Chronic disease progression prevention

PART 6

Start with early detection of arrhythmias Contribute to extending healthy life expectancy

Makoto Ogino

Business Producer, Rx+ Business Accelerator

Innovation of Heart Disease Patient Management

Key point

➢ Ecosystems to support patients with heart disease ➢ A Simple, Cost-Effective Solution Incorporating Novel Technologies

Support ecosystems for patients with heart disease

At home

Medical institutions

Impact of heart disease on society

Medical costs for cardiovascular diseases was

highest at 6 trillion yen (19.7%)

2017, "National Health Expenses" (MHLW)

The major cause of the need for long-term care: Cerebrovascular disease accounted for 16.1% and heart disease for 4.5%, and 20.6%, the highest, when both were

combined 2019, National Basic Survey of Life (MHLW)

Heart disease is the second leading cause of death, and cerebrovascular disease is the fourth leading cause of death.

Together, it is the second leading cause of death after cancer, with more than 310,000 people dying annually.

2019, National Basic Survey of Life (MHLW)

●

About sixty percent of strokes are cerebral infarctions (blocked blood vessels)

●

Cerebral infarction (cardiogenic cerebral embolism) caused by a clot (thrombus) in the heart that blocks an artery in the brain or neck accounts for 2-30% of cerebral infarctions

●

Cardiogenic cerebral embolism is associated with a high mortality rate (20%) due to the large size of the infarct, and severe sequelae, such as bedridden, often remain (40%).

●

Three-fourths of the causes of cardiogenic cerebral embolism are AF, and prevention of the development of cardiogenic cerebral embolism from AF is crucial.

http://www.shinbousaidou-week.org/

The total number of patients with AF was estimated to be 33.5 million males and 12.6 million females worldwide (2010).

Circulation 2014; 129: 837-847

Regions focused on realizing Rx+ Story®

Early detection of AF

- Holter electrocardiography (ECG) -

The Holter ECG is a test that takes an electrocardiogram for about 24 hours and is useful for detecting arrhythmias.

[Problems with the Holter ECG examination]

• ● Since a 24-hour heart rate is about 100,000 beats, many people such as clinical laboratory technicians are required to analyze the test results.

• ● Further accuracy improvement is desired for the current automatic analysis.

If the efficiency and accuracy of the automatic analysis are improved, more Holter ECG tests will be possible more easily.

Early detection of AF and appropriate medical intervention will contribute to extending healthy life expectancy

Providing value through collaboration with partners Development of program for holter analyzer using AI

We have developed a program that analyzes data using an AI (artificial intelligence) algorithm so that Holter ECG data can be analyzed more efficiently in collaboration with M.Heart Co., Ltd., .

Features in Development:

No just AI, but successful proprietary development of more efficient analysis algorithms (patent pending) with less computer load and less motion

Received pharmaceutical certification as a program medical device (class II)

Product name Certification numberMy Holter II 303AGBZX00015000

Acquired Pharmaceutical Product Law Certification in March 2021 as a program for Holter analyzers using AI.

Providing value through collaboration with partners Introduction to M.Heart Co., Ltd.

https://www.emheart.co.jp/

M-Heart Co., Ltd. (Morioka-shi, Iwate, Japan) MedTech ventures established in 2016

While developing business with the cloud-type Holter ECG analysis system, "MYHOLTER", the company is promoting DX (Digital Transformation) of medical services to create a society where electrocardiography can be performed more closely and more easily.

If this Holter ECG analysis system is described in the international standard rules, MFER, an analysis of the data obtained from any type of Holter ECG device is

possible on the cloud.

Medical waveform Format Encoding Rules ISO 22077-1:2015 Health informatics - Medical waveform format - Part 1: Encoding rules

The MYHOLTER II, certified as a program medical device, will be implemented into the Holter ECG analysis service of M. Heart and commercialized in fiscal 2021.

• ⚫ Using the cloud to build environments where medical professionals can perform analysis tasksremotely from home or outside

• ⚫ In an effort to further improve the accuracy and efficiency of MYHOLTER II, the development of the next version was initiated.

• ⚫ Discussion on collaboration with Holter ECG device manufacturers were started.

  We are considering providing a total solution using the device and data analysis as a set.

Future Perspectives: Possibilities of an AI-ECG

The AI-ECG holds the promise to transform clinical care *1

• ● Supporting the long recording time of the Holter ECG device

  Considered to be able to detect paroxysmal arrhythmia, ECG devices that can record even longer times will likely be in demand in the future. Since even larger amounts of data will need to be analyzed as well, the AI-ECG will play an active part.

• ● Real-time ECG analysis

  If wearable ECGs are improved, performance that can be analyzed to some extent in situ will be expected. At this time, it is believed that the implementation of an AI analysis software that can be operated even on a smartphone will be in demand.

• ● Applied to 12-read ECG

  The application of AI to the so-called ECG data analysis is being studied. It is anticipated that ECG will enable not only pulse disturbance, but also some of the heart's functional assessments. Research is underway.

We will contribute to the early detection of AF by maximizing the potential of AI-ECG

*1 Nat Rev Cardiol. 2021 Feb 1;1-14

Key point

iota platform technology

➢Iota's Platform technology for tiny wireless medical implantables ➢Building our core business of the future in three steps

Deliver innovative value to medicine with bioelectronics

What is the iota platform?

1-10mm3

Piezo technology in iota platform

➢No wire, no battery ➢Bi-directional communication ➢Can provide power to sensors ➢Electrical stimulation

Lead bioelectronics to our future core business

Why iota? - background-

Background 1

Our intent is to keep providing new VALUE to society even in the next era, when everything will be measured, and the value of data mounts.

⚫ In 2013, it was predicted that by year 2022, trillion sensors will be used per year. ⚫ Many IT companies and other different industries are coming into the healthcare market to capture and utilize healthcare data.

→The acquisition and utilization of biological information deep within the body is a competitive advantage for pharmaceutical companies.

Background 2

What is an ideal treatment solution that utilizes new technology?

⚫

Rx：Compounds, Antibodies, Nucleic acid, cell, virus

⚫	Rx+：Software modality	Apps, visual, games, contents
Physics modality	radiations, heats, RF, magnetics, electronics

iota's technology could be the platform technology that underpins the Rx+ business across all spheres of the Rx+ Story.

What is bioelectronics?

●

●

●

Interdisciplinary field of biology and electronics Aims to improve lives of people with disabilities or diseases through obtaining biological data through methods using electronics or transmitting signals into organisms

Examples include cardiac pacemakers, deep brain stimulation devices, vagus nerve stimulation devices, or neuroprosthetics

• ● The market growth rate of implantable nerve stimulation devices is 12.5%

What is the iota platform?

Core Technology

An implantable deviceand an external interrogator communicates information using ultrasound. The implants can be tiny as energy is provided externally and does not require batteries.

The implant can be placed deep within the body as ultrasound does not largely attenuate due to muscle, fat, blood etc.

Sensing: Output

send energy and input send energy and input for electrical stimulation

receive feedback

Sense biological parameters around the device location by combining multiple sensors※ Application examples

O2 level, pH, pressure, temperature... Different sensors lead to wider possibilities

Stimulation: Input

Implement an electrical stimulation apparatus to locally stimulate the area where the device was implanted ※ Application examples local muscle stimulation, local nerve stimulation...

Different implant locations lead to wider possibilities

What change would iota's platform provide?

• ● Provide easier measurement for biological parameters that currently cannot be obtained outside of hospitals

●

Discovery of novel, useful parameters that measure deep within the body that cannot be measured otherwise and that may indicate a disease status (measurements that cannot be done even in hospitals or with wearable devices)

For example...

• ● Measure organ temperature to monitor a disease?

• ● Would pressure measurement provide useful insights?

• ● Would consistency/discrepancy of the O2 level within the blood and organs locally provide useful insights?

• ● Can pH be monitored as an indicator of inflammation?

• ● Potential to discover new parameters and data, leading to novel treatments and disease monitoring methods

• ● A major point of consideration is how to lower the invasiveness of device implanting

What change would iota's platform provide?

Regular hospital visit once every three months

：monitoring

：insertion

Frequent measurement and monitoring of parameters at home

：hospital visit

?

●

If more frequent measuring of certain parameters with equal or higher accuracy than hospital measurements are possible at home, patients could respond to sudden changes in their disease status.

●

Hospital visits may be reduced by feeding self-measured data into hospital databases.

●

Patients can self-confirm the effect of treatments. Healthcare providers have more data to assess the suitability of treatments.

In the future, a secondary-use data business can be considered. A major point of consideration would be data privacy.

What can electrical stimulation do?

nerve

muscle

electrical stimulation to where the device is implanted

Control nerve excitation/inhibition

Control organ activity

Control muscle contraction/relaxation

• ● Aim for disease treatment and control with different approaches to prescription medicines

• ● Astellas no longer limits our business domain to prescription medicines because there are variety of ways to create and deliver VALUE to patients

What can electrical stimulation do?

Conventional implantables

Acts locally; less systemic adverse effectsxx

requires wires, limiting MRI use

requires batteries, may need surgery for battery change

large implantables cause burden on surgeons and

patients

Conventional prescription medicineregular intake leads to efficacycan be taken at homesystemic delivery may cause adverse effects

iota's implantables have a potential to become a new treatment option with strengths of both conventional medical devices and prescription medicines

Neuro

•PD •AD

•ET OCD •ALS •PTSD •Depression •Pain •Anxiety •BMI

•Sleep apnea •Phantom pain •Obesity

Respiratory

•Trauma •Schizophrenia •ED

•Brain pressure sensing •MS

•Memory storage ("time machine") •Spleen neuro paralysis •Autonomic failure •Epilepsy

•Motor Dysfunction

•COPD

•Airway pressure sensor

Urology

•Neurogenic bladder / Urination disorder (stimulation) •Reflux esophagitis (monitoring)

Locomotive / Muscular

•RA

•Muscular dystrophy

•Presbyopia

•Tinnitus •Cochlear implant •Hearing loss, difficulty

Cardiovascular

•Heart diseases (pacemaker) •Chronic heart failure (monitoring) •Abdominal aneurysm (monitoring) •Intracardiac pressure (monitoring)

Digestive/ metabolicEar

•CD

•Alcoholism •Drug addiction

•Immuno-Oncology •Tumor (monitoring)

•FI/GERD •NASH

•Diabetes (Glucose monitoring)

There is various potential upsides to the value of the platform

Source: Expert interviews

Aiming to make this one of Astellas' core businesses

2020

2030

2040?

sensing stimulationclosed-loop

multiple-auto control

• ● Existing sensing/electrical stimulation projects planned for launch in later 2020s

• ● Once concepts are validated, aim for closed-loop systems

• ● Reach for more complex, multiple closed-loop, auto-controlled projects

Astellas will grow its expertise in the bioelectronics field as one of its core business capabilities and aim to deliver value to patients

DEFINITION OF VALUE