CCSB — Interim / Quarterly Report 2022

Apr 12, 2022

Stock Code：1762

Chunghwa Chemical Synthesis & Biotech Co., Ltd.

Fourth Quarter 2021 Investor Conference

April 13, 2022

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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Company Highlight

• Stock Code:1762

• Market Cap:5 billion

• Employee:338

• 2021 Revenue 1.9 billion

• Brief History

• 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

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Key Strength

• An API factory with bio-fermentation and chemical synthesis technology and equipment at the same time

• Comply with and pass the US FDA and European PIC/S regulations and related factory inspections

• Certified API master file DMF for a variety of products, Export products are competitive

• Entered the API market for small batch R&D

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Active US DMF List

13080 14234 14235 17399 17573 PRAVASTATIN METHOCARBAMOL GUAIFENESIN RAPAMYCIN TRANDOLAPRIL SODIUM 18494 18985 22430 23213 23434 MYCOPHENOLATE TACROLIMUS OLOPATADINE HCL TACROLIMUS SD20 METAXALONE MOFETIL 24372 26271 26819 27216 27585 MYCOPHENOLATE ETHYL EVEROLIMUS CASPOFUNGIN EVEROLIMUS MOFETIL HCL ICOSAPENTATE PRE‐MIX ACETATE 30103 31189 31276 33333 35848 OMEGA‐3‐ RAPAMYCIN MYCOPHENOLATE MYCOPHENOLATE CARFILZOMIB CARBOXYLIC ACIDS (SIROLIMUS) MOFETIL (B) SODIUM 35849 36030 36174 36640 FAVIPIRAVIR BARICITINIB Ribociclib succinate Midostaurin 5

CCSB accounts for over half of US DMF filing from Taiwan in 2021

DMF#	STATUS	TYPE	SUBMIT DATE	HOLDER	SUBJECT
35848	A	II	6/24/2021	CHUNGHWA CHEMICAL SYNTHESIS & BIOTECH CO LTD	MYCOPHENOLATE SODIUM USP
35849	A	II	6/17/2021		FAVIPIRAVIR
36030	A	II	8/4/2021		BARICITINIB
36174	A	II	11/30/2021		RIBOCICLIB SUCCINATE
36640	A	II	12/29/2021		MIDOSTAURIN
36660	A	II	12/30/2021	FORMOSA LABORATORIES INC	GADOBUTROL MONOHYDRATE
35543	A	II	5/31/2021	GNT BIOTECH AND MEDICALS CORP	FA003 DRUG SUBSTANCE
35708	A	II	3/31/2021	SCINOPHARM TAIWAN LTD	ELAGOLIX SODIUM
36546	A	II	12/24/2021	SCINOPHARM TAIWAN LTD	OSIMERTINIB MESYLATE

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Key Products

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

• Tacrolimus：As an immunosuppressant API, it is used to prevent organ transplant rejection

• Everolimus：It is an anticancer drug or a cardiovascular stent coating drug and an immunosuppressive raw material drug.

• Ethyl Icosapentate：Triglyceride lowering medication.

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Consolidated Comprehensive Income Statement

Amount: NT$ Thousand

	Amount: NT$ Thousand	Amount: NT$ Thousand	Amount: NT$ Thousand	Amount: NT$ Thousand	Amount: NT$ Thousand
Year Item	2021Y		2020Y		YoY (%)
	Amount	%	Amount	%
Net Sales	$1,934,702	100%	$1,543,589	100%	25%
Gross Profit	949,388	49%	686,753	44%	38%
Operating Profit	438,475	22%	268,920	17%	63%
Profit before Tax	497,613	25%	650,297(Note)	42%	-23%
Net Profit	$401,050	20%	$532,063(Note)	34%	-25%
Net Profit Attributable to Owners of Company	$400,778	20%	$531,873(Note)	34%	-25%
Basic EPS(NT$)	$5.17		$6.86

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

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2021Y Sales Distribution By Region

Region/ Product	%	EPAE	EVE	MMF	RAPA	CAS	FK506	FK506 SD	MCB
US	65%	●	●	●	●
Asia	15%		●		●		●
Europe	11%		●		●	●
Taiwan	9%							●	●

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Share of Revenue by Key Products

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Consolidated Profitability Of The Latest 5 Years

Note：Gross margin and operating margin have increased year by year of the Latest 5 Years.

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Consolidated Balance Sheet

Amount: NT$ Thousand	Amount: NT$ Thousand	Amount: NT$ Thousand	Amount: NT$ Thousand	Amount: NT$ Thousand
Year Item	2021/12/31		2020/12/31
	Amount	%	Amount	%
Cash and Cash Equivalents	195,250	5%	148,625	5%
Accounts Receviable	379,880	9%	357,906	12%
Inventory	753,850	17%	481,244	15%
Investments accounted for using equitymethod	1,032,860	24%	511,434	16%
Property, Plant & Equipment	1,866,152	43%	1,539,251	49%
Total Assets	4,380,761	100%	3,147,140	100%
Short and Long Term Loan	750,000	16%	-	-
Accounts Payable/Other payables	376,306	9%	285,396	9%
Deferred tax liabilities	250,299	6%	247,499	8%
Total Liabilities	1,486,487	34%	648,477	21%
Total Shareholder's Equity	2,894,274	66%	2,498,663	79%
Debt to Total Asset Ratio Current Ratio	34% 21% 214% 250%

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Latest News

Capacity	Regulatory	New Patent/Technology
1.Completed new production line for Tacrolimus.	1.US FDA approved customer’s ANDA of Everolimus for breast cancer drugs of 10 mg.	Obtained US and Taiwan patent of Icosapent ethyl, a patent of "Method for Purifying Polyunsaturated Fatty Acid by Using Continuous Reactor”.
2.Installed the new equipment to increase production capacity of Icosapent ethyl.	2.accomplished the US DMF application for Baricitinib (DMF no. 36030) ,Ribociclib Succinate (DMF no. 36174) and Midostaurin (DMF no.36640)
3.Accomplished customer’s remote audit and inspection from US, Japan, Ireland, Turkey, France and India. Also accomplished cGMP system inspection by TFDA.		~~13~~

Future Outlook (1/2)

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 Process optimization, strain improvement and capacity increase of key products Everolimus, Tacrolimus and new capacity of Icosapent will be installed, 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 (2/2)

P4 Product (5-10 year launch)

• Rheumatoid Arthritis Baricitinib

• Multiple Sclerosis Ozanimod HCl

• Breast Cancer Ribociclib Succinate

P3 Product (3-5year launch)

• Anti-coagulant Edoxaban Tosylate Monohydrate

• Epilepsy, Seizures Eslicarbazepine Acetate

• Oncology Midostaurin

 Development Milestones

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Commercial
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DMF
Process Validation
GMP Sample
Technical package
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• Breast cancer Palbociclib

Non GMP Sample/ COA

• Rheumatoid Arthritis

Tofacitinib Citrate

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Always a Team Player

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http://www.ccsb.com.tw

Stock Code：1762

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