MedRx : H1 FY2023 Business Highlight & Financial Results

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MEDRx (TSE:4586)

H1 FY2023 Business Highlight &

Financial Results

August 28, 2023

These materials are distributed directly by MEDRx Co., Ltd. and are available only through direct distribution. MEDRx retains all copyrights to these materials. These materials may not be copied or reused in any other way, electronically or mechanically, for any purpose without prior consent. Moreover, these materials were prepared based on the plans of MEDRx at the time of disclosure. Actual results may differ from the statements in these materials.

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Three Core Transdermal Drug Delivery Platforms

Ionic Liquid	Nano-sizedColloid	Microneedle
Transdermal System	Transdermal System	(MN)

These materials are distributed directly by MEDRx Co., Ltd. and are available only through direct distribution. MEDRx retains all copyrights to these materials. These materials may not be copied or reused in any other way, electronically or mechanically, for any purpose without prior consent. Moreover, these materials were prepared based on the plans of MEDRx at the time of disclosure. Actual results may differ from the statements in these materials.

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Pipeline : "Primary Target is US market"

Product name

Development Code

Drug Formulation

Development

Pre

Clinical

Ph-Ⅰ

Ph-Ⅱ

Ph-Ⅲ

NDA

Launch

MRX-4TZT	Phase 1b has got successful result.
Spasticity
Phase 2 to be prepared
(Tizanidine, transdermal, ILTS®)

MRX-5LBT "Lydolyte"	Refiling in March, 2023
Neuropathic Pain
PDUFA date: Sep 28, 2023
(Lidocaine, topical, ILTS®)
MRX-9FLT	Fast Track designation
Moderate-Severe Pain
Clinical Study on-going
(Fentanyl, transdermal, ILTS®)
MRX-7MLL
Alzheimer's Disease	IND acceptance
(Memantine, transdermal, NCTS®)
MRX-6LDT
Chronic Pain
(Diclofenac-lidocaine, ILTS®)

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Why USA market First?

• USA accounts for approximately half of the global pharmaceutical market and has been maintaining a high growth rate in recent years.

【Sales Share in 2022】Total Drug Sales: $1,334,900M（Data by IQVIA）

USA	EU 5	China	Japan	Emerging	Others
47.3%	Countries	8.4%	5.0%	Countries	12.5%
	14.9%			11.8%

【Compound Annual Growth Rate from 2020 to 2022】

USA 8.8%, EU 5 Countries 4.2%, China 4.7% and Japan ▲7.9% (Data by IQVIA)

In particular, regarding new dosage forms that MEDRx mainly develops (e.g. oral form to topical/transdermal delivery system), MEDRx believes that

The higher values added by new dosage forms, such as the increase efficacy, the decrease side effects and the improvements of QOL and convenience, easily reflect to Drug Prices.

• On the other hand, it is likely difficult to reflect the additional values of new dosage forms in prices compared to the US market as there are financial constraints in Japan and Europe, where public insurance and public funds cover the majority of medical costs and public drug prices are set. The drug price of new dosage forms trends to be set as the similar price with the previous dosage forms.

This document is distributed only by the way provided directly by MEDRx Co., Ltd. Please use only those who are provided. All rights to any part of this material belong to MEDRx, so please do not

reproduce it for any purpose without permission, whether electronically or mechanically. In addition, this document was prepared based on the current internal plan and is subject to change in the future.

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H1 FY2023 Business Highlight (1)

＜MRX-4TZT＞

• Execution of mutual termination and settlement agreement with Cipla Tech
• • All rights regarding MRX-4TZT return to MedRx
• Phase 2 study in preparation

＜MRX-5LBT "Lydolyte"＞

• Agreement with USFDA regarding the detail of the additional study and Successful Completion of the additional study
• USFDA Acceptance of NDA
• • Target action date under PDUFA is Sep 28, 2023

＜MRX-9FLT＞

• Clinical study on-going

These materials are distributed directly by MEDRx Co., Ltd. and are available only through direct distribution. MEDRx retains all copyrights to these materials. These materials may not be copied or reused in any other way, electronically or mechanically, for any purpose without prior consent. Moreover, these materials were prepared based on the plans of MEDRx at the time of disclosure. Actual results may differ from the statements in these materials.