FRMSL — Investor Presentation 2021

Mar 5, 2021

==> picture [173 x 44] intentionally omitted <==

Formosa Laboratories, Inc. Company Presentation

TWSE 4746

==> picture [154 x 43] intentionally omitted <==

Disclaimer

This material has been prepared by Formosa Laboratories Inc. (“Formosalab”).

Any opinions expressed in this material are subject to change without notice as a result of using different assumptions. Formosalab is under no obligation to update or keep current the information contained herein. The information contained in this presentation is Formosalab’s confidential information.

Any disclosure, copying, distribution or any action taken or omitted to be taken in reliance on it is prohibited and may be unlawful.

No representation or warranty, express or implied, is or will be made in or in relation to, and no responsibility or liability is or will be accepted by the Company as to, the accuracy or completeness of this material and any liability therefore is hereby expressly disclaimed.

Statements made in this material include forward-looking statements, which include, without limitation, statements about the issues, plans and expectations of Formosalab. Without limiting the foregoing, statements including the words “believes”, “anticipates”, “plans”, “expects” and similar expressions are also forward-looking statements. Forward-looking statements reflect, among other

things, management’s plans and objectives for future operations, current views with respect to future events and future economic performances and projections of various financial items.

These forwardlooking statements involve known and unknown risks, uncertainties and other factors which may cause actual results to differ materially from those implied by such forward-looking statements.

2

==> picture [173 x 44] intentionally omitted <==

Operation Results

==> picture [154 x 43] intentionally omitted <==

Strong Top Line Results

M NTD

4

revenue

==> picture [154 x 43] intentionally omitted <==

2020 Sales Performance

2020 Sales Performance
NTD M	2020	YoY
Polymer	1,200		12%
Vitamin D Derivatives	590		16%
Other API’s	1,114		12%
Sub	2,904		12%
UV Filter	171		-3%
Total	3,075		11%

5

==> picture [154 x 43] intentionally omitted <==

API Product Mixture

6

==> picture [154 x 43] intentionally omitted <==

Profitability

2020 年 EPS NTD 3.78 BV per sh NTD 48.06

7

==> picture [173 x 44] intentionally omitted <==

Business Strategy

==> picture [154 x 43] intentionally omitted <==

Integrated CDMO partner

==> picture [193 x 338] intentionally omitted <==

• High Quality GMP

• •

• API Stable Supply • Effective Output

• Support development and

• Injectable commercialization stages

• International Standard

• One Stop Shop Solution

• • Strong Demand

ADC

• Full scale of API and DP

• CDMO development assistance

• Access to innovative technology

• Investment and new clients

9

==> picture [154 x 43] intentionally omitted <==

==> picture [139 x 49] intentionally omitted <==

==> picture [54 x 35] intentionally omitted <==

==> picture [78 x 57] intentionally omitted <==

Global Quality System

==> picture [76 x 39] intentionally omitted <==

==> picture [68 x 29] intentionally omitted <==

Agency and country	Total	First time	Last time
	inspection	(year)	(year)
	records
US FDA	7	2004	2018
Germany BGV	2	2007	2013
Japan PMDA	21	2009	2020
Mexico COFEPRIS	2	2010	2013
Europe EDQM	1	2013	＊
Taiwan TFDA	28	2002	2021

 GMP certificates on 41 products have been granted

• Filed 49 US DMFs, 14 European DMFs in 28 countries, 8 COS, 14 JMF

• Taiwan becomes a PIC/S member since 2013 and PIC/S members in principle will not need to inspect additionally

10

==> picture [154 x 43] intentionally omitted <==

High Potent Facility

==> picture [194 x 129] intentionally omitted <==

==> picture [192 x 154] intentionally omitted <==

==> picture [197 x 234] intentionally omitted <==

• Vit D derivatives

• Steroid hormones

• Anti-cancers

• ADCs

11

==> picture [173 x 44] intentionally omitted <==

API Business

==> picture [154 x 43] intentionally omitted <==

Product Overview

 Polymers

• Sevelamer Carbonate & Sevelamer HCl

• Constant Growth in EU

• Clients have 52% of the US generics market with 92% market share owned by generics

• Strong demand from the emerging markets

• Colevelamer HCl

• Exclusively supply to all approved generics companies except for AG

• Expect to launch in Europe in 2022

Colestipol

• Exclusively supply to all approved generics companies except for AG, generics market share in the US ~ 99%

• Line expansion

Strong Market Presence

13

==> picture [154 x 43] intentionally omitted <==

Product Overview

 Market in China

• Multiple products granted approval expected in 2021, including Sevelamer Carbonate, Temozolomide and Calcipotriol

• Montelukast 、 Paricalcitol 、 Calcipotriol cleared CN DMF

• Benzonatate commercialization in the US and China

14

==> picture [154 x 43] intentionally omitted <==

CDMO, new driver

==> picture [665 x 320] intentionally omitted <==

----- Start of picture text -----

Revenue contribution from
CDMO and Successful Commercialization
USD: Million
ADC
NDA
10% 14.0
18%
12.0
Generic
10.0
11%
Phase III
7% 8.0
6.0
Phase II
4.0
10%
PreIND 2.0
27%
-
Phase I
2017 2018 2019 2020
17%
----- End of picture text -----

15

==> picture [154 x 43] intentionally omitted <==

Strong CDMO Demand

• Strong income generation capability

• Clients including Big Pharma entered into efficacy confirmation and scale up stages, boosting demands

• Well known ADC development and commercialization platform with multiple services contracts for domestic and international clients

• Generated RD and manufacturing services up to formulation development and injection for any need against COVID-19 pandemic

16

==> picture [154 x 43] intentionally omitted <==

Antibody Drug Conjugate

==> picture [216 x 57] intentionally omitted <==

==> picture [153 x 87] intentionally omitted <==

 Process Development  Scale Up to Commercialization  Analysis  Injection

17

==> picture [173 x 44] intentionally omitted <==

Injectable DP

==> picture [154 x 43] intentionally omitted <==

Global Standard

• NNE design

• USA(FDA), EMA and PMDA standard

• Competence for small molecules and protein drugs

• Capacity for regular line over 100M

• doses per anna.

• Capacity for cytotoxic line over several dozen M doses per anna.

• Eligible to support million doses for pre-clinical demand

• Scheduled inspection by government agents from 2021Q1 to 2022Q2

==> picture [245 x 285] intentionally omitted <==

19

==> picture [154 x 43] intentionally omitted <==

Partner from DS to DP

==> picture [607 x 407] intentionally omitted <==

----- Start of picture text -----

Partner from DS to DP
Cytotoxic
Liquid/ Lyo. Vial
Drug Pre-filled Syringe
High Potent Protein
Drug Drug BLA
Biosimilar
Biobetter
Vaccine
Specialty
ADC
Pre-filled syringe Injectable
Cartridge
Large volume
Lyophilized
----- End of picture text -----

20

==> picture [173 x 44] intentionally omitted <==

New Drug Development

==> picture [216 x 63] intentionally omitted <==

==> picture [154 x 43] intentionally omitted <==

Formosa Pharmaceutical

• Proprietary nanoparticle formulation platform (APNT)

• Technology • Antibody-Drug Conjugate process development

• • Small-molecule and Fermentation production

Therapeutic Areas

• Ophthalmology

• • Oncology

• • Anti-infectives

• Cost effective and time manageable Development development route including 505(b)(2), Strategy Biosimilar and NCE

22

==> picture [154 x 43] intentionally omitted <==

API Nanolization

==> picture [66 x 54] intentionally omitted <==

----- Start of picture text -----

Columnar
Shape
~40,000 nm
----- End of picture text -----

SEM: 20,000x APNT

magnification nanolization

Spherical Shape

• ~140 nm

==> picture [296 x 174] intentionally omitted <==

----- Start of picture text -----

APP13007 API API only in water
drug product Formulation (API
without APNT precipitation)
----- End of picture text -----

 APNT Formulation Platform enhances the dissolution and distribution of poorly soluble compounds, thereby improving bioavailability.

• Reliable and tunable particle reduction

• Chemical integrity and purity are conserved

• Strong patent protection in multiple countries/regions

23

==> picture [154 x 43] intentionally omitted <==

APP13007

• Phase 3 start in US in Feb., 2021

Phase 2 Summary

• Expected Launch in 2023

Response rate of APP13007 strongly suggests superiority over competitors in reducing inflammation and pain for critical Phase 3 endpoints

ACC= 0Pain Grade = 0

==> picture [269 x 205] intentionally omitted <==

==> picture [308 x 27] intentionally omitted <==

• Graphs are a comparison of published clinical data; These data are not from a head-to-head clinical study.

24

==> picture [154 x 43] intentionally omitted <==

TSY0110

==> picture [92 x 41] intentionally omitted <==

• Approved in 2013 as second-line treatment for metastatic breast cancer

• Early Breast Cancer indication added in 2019

• Additional HER2-related indications being explored in clinical trials > 30 combination trials ongoing

==> picture [101 x 56] intentionally omitted <==

==> picture [141 x 37] intentionally omitted <==

==> picture [184 x 113] intentionally omitted <==

----- Start of picture text -----

Purity and Composition
#1 #2 Kadcyla #3 #4
Purity
DAR
----- End of picture text -----

==> picture [147 x 117] intentionally omitted <==

----- Start of picture text -----

Drug-Antibody Ratio (DAR)
distribution
Kadcyla
RLD
TSY-
0110
----- End of picture text -----

Similarity

==> picture [355 x 126] intentionally omitted <==

----- Start of picture text -----

BT-474
cell line
Incubation Time (h) at 37 ° C
Log Remaining (%)
----- End of picture text -----

25

==> picture [173 x 45] intentionally omitted <==

==> picture [182 x 32] intentionally omitted <==

Q&A