EirGenix Corporate 法說會PresentationDecember 05, 2017

EirGenix台康生技 : A New Asia Development & Manufacturing Hub for Biologics一個嶄新的亞洲生技藥物開發與製造中心

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Forward Looking Statement Disclaimer

All information and other statements contained in thispresentation, other than statements of historical fact,constitute forward looking statements within the meaning offederal securities laws. These forward-looking statementsinvolve a number of risks, uncertainties, assumptions and otherfactors that could affect our future results and cause actualresults and events to differ materially from our historical andexpected results and those expressed or implied in theseforward looking statements.

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Development Center for BiotechnologycGMP BioPharmaceutical Pilot Facility

Formosa Laboratories A strategic Investor

Investment BankVC and NDF

SPIN OFF ACQUISITION

Confidential3

12/5/2012

Inception on 12/21/2012

March 15, 2013 The acquisition deal was signed

13Formosa Laboratories

%

Doctoral Degree

Master Degree

Bachelor Degree

Total Employees : 154

27 %

59 %

14 %

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Major Investors

Formosa Laboratories, Inc. (Including 2 Affiliates) 13.9%

China Investment and Development CO.,Ltd. (including 8 Affiliates) 11.4%

National Development Fund, Executive Yuan 8.2%

CTBC Venture Capital Co., Ltd. 6.1%

Mega International Commercial Bank Custodial Trust Account 5.2%

Development Center of Biotechnology 5.2%

Northern Region Branch, National Property Administration, MOF 3.5%

Cathay Life Insurance Co., Ltd. 3.4%

DCI Partners Co., Ltd. 3.4%

Hang Tong Venture Capital Co., Ltd. 2.9%

Employees Holding Stocks & Options 6.8%

EirGenix Mission

“To provide the high quality and cost effective

Contract Development & Manufacturing services

for our clients, and to develop high quality and

cost effective biologic products together with

partner(s) to the benefit of our communities

and society as a whole”

Lee-Cheng Liu

President & CEO

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EirGenix Business Strategy – Sustainable Profit Growth

• CD&M SERVICES

• BIOSIMILARS

• Bio-betters/ Novel

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Lee-Cheng (L-C) Liu, Dr.Eng.Sci. | President & CEO

Ex-President & COO of AnGes with 30 years of leadership experience in Pharma, Biotech and specialty chemical industries. He holds a doctoral degree from Columbia University.

Thomas Schulze, Ph.D. | VP, Product & Business Development

Ex-CEO of Formycon and Avontec with more than 25 years of leadership experience in Pharma (Bayer AG) and Biotech. He holds a Ph.D. from Free University Berlin (Max-Planck Institute).

Chih-Jung (CJ) Chang, Ph.D. | VP, CDMO Business & PM

Ex-Director of PM for Oncology at TTY with 20 years experience in pharmaceutical industry. He holds a PhD from National Taiwan University.

Hsiu-Chuan (Cathy) Yang | VP & CFO, Finance Opertions

Ex-General Manager of ERS, a JV company between Fresenius and Excelsior, overseeing the operations of 100+ kidney dialysis centers in Taiwan. She holds a Master of Science in Accounting from Connecticut (U.S) and has 20 years of experiences in FMCG (Fast Moving Customer Goods) and medical industries.

You-Nan Shih, Ph.D. | Sr. VP, Quality Assurance & EHS

Ex-Chief Quality Officer of ScinoPharm Taiwan with more than 25 years of quality system management experience and has lead the team for inspections by FDA, EMA and PMDA. He holds a Ph.D. from

Frank Ho, Ph.D. | VP, Manufacturing & Technical Operations

Ex-Head of Technical Operations at A-Bio Pharma (Singapore) with more than 20 years experience in the US biotech industry. He holds a Ph.D. from UC Davis.

Shang-Chung (SC) Ju, Ph.D. | Executive Director, Process Engineering & Facility Operations

Ex-Head of Production at DCB BPPF with 25 years experience of research and production of biologics. He holds a Ph.D. from National Taiwan University.

Ae-Ning (Irene) Lin, Ph.D. | Executive Director, Analytical Sciences & Quality Control

Ex-head of Purification and Protein Characterizations at DCB BPPF with 25 years of experience of biologic product research and development. She holds a Ph.D. from University of Maryland College Park.

An Experienced Senior Management Team:

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Core

Competence

CDMO Business UnitProduct Development Unit

BiosimilarsSpecialty biologics

Novel Biologics/bio-betters

Process Development & Manufacturing Platform

Mammalian Cell line PlatformE. Coli. Cell line Platform

Core Competence and EirGenix Business Units

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Product Development Unit

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Market : Biosimilars – the Growing Business Opportunity

The global biologics market is projected to exceed US$390 billion by 2020, by which time biologics will account for up to 28% by value of the global market for pharmaceuticals.

Biosimilar medicines have the potential to enter markets by 2020 for a number of key biologics that have the current sales of more than US$50 billion.

The forecasting of biosimilar sales:

$0

$5

$10

$15

$20

$25

$30

2015 2016 2017 2018 2019 2020

USD

Bill

ion

High Basis

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351(a) Package

351(k) Package

Biosimilar development pathwayNovel biologics development pathway

Development pathways for novel biologics VS biosimilar

Development of novel biologics requires much higher resources for conducting non-clinical studies and a series of clinical trials

Development of biosimilar requires much higher resources to make a compound to be highly similar based on the physiochemical and biological product profiles

$$$$$

$$$

$$

$$

$$

R&D (target verification) 3 – 5 years$$

Non-clinical(Pahrm., Tox., PK)

Phase 1 Clinical Trial

Phase 2 clinical trial

Phase 3 clinical TRial

Efficacy and Safety

2 – 3 years

$$$

$

$

$

3 – 5 years

$

Phase 3 Clinical

Trial

PK/PDPhase 1 Clinical Trial

Pre-clinical

CMC, Biological Characterizations

CMC, Physiochemical Characterizations

Equivalency and Safety

3 – 4 years

5 – 7 years

Process Development

Analytics

Process Development

Analytics

CMC, Mol. Character.

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EirGenix’s Pipeline

Development IND / Phase I/II Phase IIIMAA/BLA

SubmissionBD/Alliance

Negotiations with potential business alliances in EU, Japan, Taiwan/Asia, Turkey/MENA and Brazil are ongoing

Co-develop with Formosa Laboratories

Co-develop with a Taiwanese pharma. Reagent business distribution agreement with a Japanese company.

EG1104X ADC Me too/Me better l Cancer

EG12014 (Trastuzumab)

Biosimilar l Cancer

EG74032 Carrier protein l Vaccines for infectious diseases and cancer *No need of clinical development just file DMF

EG12021 Biosimilar l Cancer

EG6205X Biosimilar l AMD & Cancer

EG1206X (Pertuzumab)

Biosimilar l Cancer

EG1307X (Trastuzumab – SC Formulation)

Biobetter l Cancer

He

r2 Fam

ily Pro

du

cts

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EirGenix Her2 Target Family Product Potential

• TRZ ADC (2024)

• Total market:>1bn

• Pertuzumab(2024)

• Total market:>5bn

• TRZ SC (2024)

• Total market: >1bn

• Trastuzumab IV (2020)

• Total market: >7bn$

ca. 200m$ >100m$

>100m$>500m$

Estimated peak sales(position of entry)

Trastuzumab i.v.EirGenix Top 5 (6)

Trastuzumab s.c.EirGenix Top 3

PertuzumabEirGenix Top 3

Tratuzumab ADCEirGenix Top 3

*Roche, IMS data, public sources and own projections

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EG12014 Product Development Status

EirGenix starts global Phase 3 trial for its Herceptin biosimilar EG12014 in Q2, 2018

EG12014 matches the US and EU reference product (critical quality attributes)

EG12014 is highly similar to Herceptin at all tested scales and across all structural

and functional tests under a comprehensive similarity assessment program

EG12014 (DS) successfully scaled up to 1,000L (Phase 3/commercial scale)

EG12014 demonstrated PK bioequivalence in a Phase 1 trial to both US and EU-sourced Herceptin

FDA (BPD2 meeting) and EMA consultation meeting completed in Q2, 2017

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Partnering Strategy I

Current deliverables and the need to differentiate determine the strategy

1. NOW: Strategic partnering

2. LATER: Product-specific partnering

Ad 1. Strategic partnering is favored due to

- Her2 Family of Proteins: Lifecycle Concept

- Market (competitive) launch position

- Commercial impact (fast and robust)

Ad 2. Products are based on Pipeline

- Future products can be partnered at higher value (once EirGenix commercial footprint globally established)

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Partnering Strategy II

Partnering By Territories (according to priority criteria):

priorities: strategy/scope of deal > market reach/muscle > price/market share

1. Global

2. Semi-Global

3. Regional

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Partnering Strategy III

Deal Structure (agreement scope)

Exclusive License, Development, Commercialization, Supply, (Option)

Product Co-development (50/50): share risk/reward

Milestone Payments

Product Supply (supply agreement)

Royalty Stream

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Income stream from EG12014 partnering

Single payment: upfront with signature

Co-development cost sharing

Milestone-driven Payments

Commercial drug supply (Zhubei facility)

Royalties from product sales

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CDMO Business

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$8,577

$53,803

$102,784

252,947 $253,812

$20,755

$148,122

$326,303$339,658

$363,868*

$0

$50,000

$100,000

$150,000

$200,000

$250,000

$300,000

$350,000

$400,000

2013 (Apr-Dec) 2014 2015 2016 2017 (Jan-Oct.)

K N

TD

CDMO Business Striking Sustainable Growth

Rrvenue (K NTD)

Signed Contact Amount (K NTD)

2016 1H CDMO Break-even

100% 100%

75%

66%63%

0% 0%

25%

34%37%

0%

20%

40%

60%

80%

100%

2013 (Apr-Dec) 2014 2015 2016 2017 (Jan-Oct.)

%Revenue Analysis – Ratio of Domestic and

Overseas ClientsDomestic (%) Overseas (%)

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78%

22%

64%

36%

0%

20%

40%

60%

80%

100%

Domestic Overseas

%

Signed Contact Analysis by 2016/2017 Compare to Domestic and Overseas Clients

2016 (%) 2017 (%)

64%42%

58%

0%

20%

40%

60%

80%

100%

Exist Customer New Customer

Exist Customers Return Ratio by Signed Contact on 2017

EU/US/JP/China/HK

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EirGenix Home Base : Taiwan, Japan, China and Asia

Expand to EU countries and North America

EirGenix’ CDMO Home Base and Extending Area

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~ $ 5bn

In 2020 CDMO in Asia will reach to $ 16.5 bn.

Biologics CDMO Global Market Trend

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EirGenix GMP Certificates -Planning and Milestone

Year Certificate and Inspection

2005Mammalian Cell culture production facility got the GMP certificatefrom TFDA

2013 Microbial production facility got the GMP certificate from TFDA

2014Mammalian cell culture and microbial production facilities were certificated by TFDA as a PIC/S facility

2017EirGenix got accreditation certificate of foreign manufacturer (AFM)

from minister of health, labor and welfare, Japan

Coming Event

2018 Expect to be inspected by Japan PMDA

2018 Expect to be inspected by EU EMA

2019-2020

Expect to be inspected by US FDA

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Stage I (2016 – 2018)Build Line 1: (1x50/200/1000L SUB) 1 set of 2x2000L (expandable to 3 sets of 2X2000L in Stage III)+ DSP, WH, QC Lab, PS, Office for (mfg/QC/QA/PS)

Stage II (2019 – 2021)Build Microbial facility 1x1000L, 2 DSP suites, HQ Offices

Stage III (2019 - 2024)Expand line1: adding 2 sets of 2x2000LBuild line 2: 3 sets of 6x2000L + DSP

Mammalian Cell Culture Production Lines

Microbial Fermentation Production Line - Planned

Plant Planning Production Line 1 2018 Fully Operational

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2017/12/04竹北生產廠工地實景

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Taiwan

Japan/CN

Asia

Global

2017 TOP in Taiwan

2020 TOP 5 in Asia

2022 As a Global player

Sustainable Revenue/

Profit Growth

Establish Capability

and Capacity

Extent Asia/Global

Business

The Vision of EirGenix CDMO Business

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Finance

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Total Fund Raising Activities since the Inception of EriGenix

Unit：000Until June, 2017

Source of Capital Dollar Amount

Initial Capital 8,000

Cash Injection 1,649,570

Employee Stock Option 26,518

Total 1,684,088

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NTD 1,684 million

Running cashNTD 49 million

Cash and time depositNTD 719 million

CapexNTD 506 million

Product developmentNTD 410 million

Total Usage of Fund RaisingUntil June, 2017

Conclusion

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EirGenix Five Years Productive Story

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Having been building up a strong senior management team Secured long term financing

Raised cash of NTD 1,68 billion (US$56 million) last five years Secured a NTD 850 million (US$28 million) low interest syndicated loan for construction our

Zubei facility Obtained high tech business application was approved by MOEA-IDB (經濟部工業局高科技事

業核准)on 9/22/2017; IPO (上市/櫃) submission is in 2018 Established the unique strategy for product pipeline in development

Total 7 products in our pipeline include 4 biosimilars, 1 SC formulation biosimilar, 1 ADC and 1 carrier protein

Her2 family product life cycle management Completed EG12014 Phase 1 clinical study. The results show EG12014 (trastuzumab biosimilar)

has reached bioequivalence in the primary endpoint assessment compared to Roche product Herceptin® from EU and the US, and its safety profiles are also comparable to the reference drug sourced from EU and the US. Initiated the Phase 3 preparations. Business alliance is in progress.

Continuing growth of CDMO business Double digital growth for signed contracts value (> US$10M per year) Reached P&L break even point for CDMO business in 2016

Establishing the late stage & commercial production facility Zhubei facility will be on stream for operation in 2018 Expecting PMDA (Japan) and EMA inspections in 2017/2018 for commercial production of two

client’s products

Client’s Success is Our Priority