CCSB — Interim / Quarterly Report 2021

Mar 18, 2021

Chunghwa Chemical Synthesis & Biotech Co., Ltd.

Fourth Quarter 2020 Investor Conference March 19, 2021 Presenter：Eason Wang, Manager.

Chunghwa Chemical Synthesis & Biotech Co., Ltd.

Safe Harbor Notice

 CCSB’s presentation contains forward‐looking statements subject to significant risks and uncertainties. Actual results may differ materially from those contained in the forward‐looking statements.

 The forward‐looking statements in this release reflect the current belief of CCSB’s as of the date of this release, we undertake no obligation to update these forward‐looking statements for new information, future events or otherwise.

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2020Y Consolidated Income Statement

Amount: NT$ Thousand

Item	2020Y	2020Y	YOY (%)	2019Y	2019Y
	Amount	%		Amount	%
Net Sales	1,543,589	100%	33%	1,156,642	100%
Gross Profit	686,753	44%	47%	468,629	40%
Operating Profit	268,920	17%	122%	121,108	10%
Profit before Tax	650,297	42%	352%	143,743	12%
Net Profit	532,063	34%	354%	117,124	10%
Net Profit Attributable to Owners of Company	531,873	34%	355%	117,003	10%
Basic EPS(NT$)	6.86			1.51

Note ：Gain on disposal of land for 2020Y is NT$ 346,722 thousand dollars.

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Consolidated Profitability Of The Latest 5 Years

Note ：Revenue growth rate,gross margin and operating margin of 2020Y are highest of the Latest 5 Years.

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2020.12.31 Consolidated Balance Sheet

	Amount: NT$ Thousand	Amount: NT$ Thousand	Amount: NT$ Thousand	Amount: NT$ Thousand
Item	2020.12.31		2019.12.31
	Amount	%	Amount	%
Cashand Cash Equivalents	148,625	5%	101,220	3%
Accounts Receviable /Notes Receivable	357,906	12%	149,906	5%
Inventory	481,244	15%	412,184	12%
Property,Plant &Equipment	1,539,251	49%	2,180,308	63%
Total Assets	3,147,140	100%	3,438,847	100%
Short Term Loan/Short-Term Notes and Bills Payable	-	-	289,740	8%
AccountsPayable/NotesPayable	97,710	3%	78,418	2%
LongTerm Loan	-	-	600,000	17%
Total Liabilities	648,477	21%	1,423,715	41%
Total Shareholder's Equity	2,498,663	79%	2,015,132	59%
Debt to Total Asset Ratio Current Ratio	21% 41% 250% 119%

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Brief History of CCSB

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1, Tung-Hsing St., Shu-Lin Dist., New Taipei City 23850, Taiwan.
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Profile

 Founded in 1964

• First registered and one of the largest bulk pharmaceutical chemical manufacturers in Taiwan

• First FDA approved plant (1984) in Taiwan

 Turning Points

• Formed the New Management Team in 1997, 4 cGMP Plants for Synthetic Products and 2 cGMP Plants for Biotechnology Products

• Established US Sales Office- Pharmaports in 2000

• Initial public offering on December 20, 2010

 Products

Active Pharmaceutical Ingredients (API) for brand drug and generic drug

• Antifungal

• Immunosuppressant

• Oncology

• Cardiovascular

• Peptide Drug

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Business scope

Supply Chain

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Non-GMP
Raw GMP
Formulation
Material intermediate API
Intermediate
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CCSB focuses on APIs, provide the high level of quality and regulatory compliance

Production life cycle

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Preclinical Phase I Phase II Phase III Registration Commercial Generic
CDMO/CMO
NCE-1 / Paragraph IV &III APIs
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Global Distributor Partner

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US office
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Equipment

Reactors

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50 L Glass Lined Reactor
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3,000 L Glass Lined Reactors

75 L Stainless Steel Reactor Stainless Steel Reactors

Freeze Dryers

6 inch MPLC system

50 L Cone Dryer & 25” Centrifuge

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Dryer
Mills
Centrifuges
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Fermentation

20,000 L & 30,000 L Fermenters

ABEC 75L, 250L & 1250 L Bioreactors

Purification Equipment

Ultra Filtration

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Autoclave
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Biosafety Cabinet
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Active US DMF List

13080

METHOCARBAMOL

17573

TRANDOLAPRIL

23213

TACROLIMUS SD20

26819

EVEROLIMUS PRE‐MIX

31189 RAPAMYCIN (SIROLIMUS)

23144

GUAIFENESIN

18494 MYCOPHENOLATE MOFETIL

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23434
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METAXALONE

27216

EVEROLIMUS

31276

CARFILZOMIB

14235

PRAVASTATIN SODIUM

18985

TACROLIMUS

24372 MYCOPHENOLATE MOFETIL HCL 27585

CASPOFUNGIN ACETATE

33333 MYCOPHENOLATE MOFETIL (PROCESS B)

17399

RAPAMYCIN

22430

OLOPATADINE HCL

26271

ETHYL ICOSAPENTATE

30103

OMEGA‐3‐ CARBOXYLIC ACIDS

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Latest News

Invest CFP equipment to increase production capacity of Icosapent ethyl.

Keep improving fermentation equipment and process optimization. To expand the capacity for Tacrolimus and Everolimus.

US FDA approved customer’s ANDA of Icosapent Ethyl, antihypertriglyceridemic drugs license for Capsules, 1 gm and 500mg.

US FDA approved customer’s ANDA of Everolimus, breast cancer drugs license (First Generic Drug Approvals), including 2.5mg, 5mg, 7.5mg drugs license.

Obtained US patent of Method for synthesizing Etelcalcetide or salts, Secondary hyperparathyroidism API.

Manufacture accomplished customer’s remote audit and inspection from Taiwan, USA, Ireland, Poland, Turkey.

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2020Y Sales Distribution By Region

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Domestic
12%
Asia
18% US
48%
Europe
22%
US Europe Asia Domestic
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• US:

• EPAE, EVE, MMF, RAPA

• • Domestic:

FK506 SD20, MCB, GGE • Asia: FK506, EVE, RAPA

• Europe: CAS, EVE

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Share of Revenue by Key Products

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Future Outlook (1/3)

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• Process optimization, strain improvement and capacity increase of key products, Icoaspanet, Everolimus, Tacrolimus and Icosapent will be completed continuous flow production (CFP) process, which will further boost market penetration and share.

• Launch of P4 products, Everolimus and Icosapent, for organ transplantation, breast cancer and hyperlipidemia, which will boost income and profit over the next 3 years.

• Short term increase of revenue from CDMO/CMO. Develop the drugs substances in advance and involve the Internarial new drugs R&D.

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Future Outlook (2/3)

P4 Product (5-10 year launch)

 Multiple Sclerosis Ozanimod HCl

• Oncology Midostaurin

 Development Milestones

• Breast cancer Ribociclib succinate

• Rheumatoid Arthritis Baricitinib

P3 Product (3-5year launch)

• Anti-coagulant Edoxaban tosylate monohydrate

• Breast cancer Palbociclib

• Rheumatoid Arthritis Tofacitinib Citrate

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Commercial
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DMF
Process Validation
GMP
Sample
Technical package
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Non GMP Sample/ COA

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Future Outlook (3/3)

Synthetic Peptide

 Osteoporosis Abaloparatide  Acromegaly & Neuroendocrine Tumors Lanreotide acetate  Secondary Hyperparathyrodismy Etelcalcetide HCl

• Setmelanotide acetate Obesity

Negative pressure glovebox

Nano filtration

Filter reactor

MPLC

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Always a Team Player

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Thanks for your attention

Chunghwa Chemical Synthesis & Biotech Co., Ltd.

• 1, Tung-Hsing St., Shu-Lin Dist., New Taipei City 23850, Taiwan. Tel. +886-2-86843318 Fax.+886-2-86843202

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