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CCSB Interim / Quarterly Report 2021

Aug 26, 2021

51917_rns_2021-08-26_c7dcd3da-1516-4972-9cfc-5df27cc26ba5.pdf

Interim / Quarterly Report

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Stock Code:1762

Chunghwa Chemical Synthesis & Biotech Co., Ltd.

Second Quarter 2021 Investor Conference

August 27, 2021

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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Consolidated Comprehensive Income Statement

Amount: NT$ Thousand

Year
Item
2021/1/1-6/30 2021/1/1-6/30 2020/1/1-6/30 2020/1/1-6/30 YoY
(%)
Amount % Amount %
Net Sales $921,442
100%
$699,352 100% 32%
Gross Profit 464,699 50% 298,606 42% 56%
Operating Profit 258,919 28% 114,938 16% 125%
Profit before Tax 273,096 30% 482,953 (Note)
69%
-43%
Net Profit $224,742
25%
$398,976 (Note)
57%
-44%
Net Profit Attributable to
Owners of Company
$224,576
25%
$398,903 (Note)
57%
-44%

Basic EPS(NT$)
$ 2.90 $ 5.14

Note :Gain on disposal of land from January to June 2020 amounting NT$ 346,722 thousand dollars.

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Sales Distribution By Region

2021/1/1-6/30

  • US: EPAE, EVE, MMF, RAPA

  • Europe: CAS, EVE

  • Asia: FK506, EVE, RAPA

  • Domestic: FK506 SD, MCB, GGE

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Share of Revenue by Key Products

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Consolidated Profitability Of The Latest 5 Years and Jan~Jun 2021

Note 1:Gross margin and operating margin for the period of January to June 2021 has growth compared to the latest 5 years.

Note2:Net sales from January to July 2021 amounting NTD$1,117,756 thousand dollars, a 36% increase over the same period compared to last year. 6

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Consolidated Balance Sheet

Amount: NT$ Thousand Amount: NT$ Thousand Amount: NT$ Thousand Amount: NT$ Thousand
Year
Item
2021/06/30
2020/06/30
Amount % Amount %
Cash and Cash Equivalents 199,661 5% 331,777 11%
Accounts Receviable/Notes Receivable 333,190 9% 202,288 6%
Inventory 598,890 16% 392,332 13%
Property,Plant & Equipment 1,685,047 45% 1,500,256 49%
Total Assets 3,783,150 100% 3,073,956 100%
Short Term Loan/Short-term notes and
bills payable
150,000 4% - -

Accounts Payable/Notes Payable
100,485 3% 97,214 3%
LongTerm Loan 200,000
5%
- -
Total Liabilities 982,461 26% 697,495 23%
Total Shareholder's Equity 2,800,689 74% 2,376,461 77%
Debt to Total Asset Ratio
Current Ratio
26%
23%
222%
216%

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Latest News

Investment 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 Everolimus, breast cancer drugs license (First Generic Drug Approvals), including 2.5mg, 5mg, 7.5mg drugs license.

CCSB accomplished the US DMF application for Mycophenolate Sodium (DMF no.35848) and Favipiravir (DMF no.35849)

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

Manufacture accomplished customer’s remote audit and inspection from Greece, India, Taiwan and USA. And manufacture accomplished cGMP system inspection by TFDA.

CCSB has been selected by TWSE Corporate Governance 100 Index constituents for two years.

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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

  • Breast cancer Ribociclib succinate

  • Rheumatoid Arthritis Baricitinib

P3 Product (3-5year launch)

  • Anti-coagulant Edoxaban tosylate monohydrate

  • Breast cancer Palbociclib

  • Rheumatoid Arthritis Tofacitinib Citrate

Development Milestones

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

  • Epilepsy, Seizures Eslicarbazepine acetate

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Future Outlook (3/3)

Synthetic Peptide

Osteoporosis AbaloparatideAcromegaly & Neuroendocrine Tumors Lanreotide acetateSecondary Hyperparathyroidism Etelcalcetide HClObesity Setmelanotide acetate

Negative pressure glovebox

Nano filtration

Filter reactor

MPLC

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Appendix-Brief History of CCSB

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

  • Immunosuppressant

  • Oncology

  • Lower triglyceride

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

  • Peptide Drug

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Appendix-Active US DMF List

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14234
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13080

METHOCARBAMOL

GUAIFENESIN 18494 MYCOPHENOLATE MOFETIL 23434

17573 23213

TRANDOLAPRIL

TACROLIMUS SD20 METAXALONE 26819 27216 EVEROLIMUS PRE‐MIX EVEROLIMUS

31189 RAPAMYCIN (SIROLIMUS)

31276

CARFILZOMIB

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35849
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35848 MYCOPHENOLATE SODIUM

FAVIPIRAVIR

14235

PRAVASTATIN SODIUM

18985 TACROLIMUS 24372 MYCOPHENOLATE MOFETIL HCL 27585

CASPOFUNGIN ACETATE

33333 MYCOPHENOLATE MOFETIL (PROCESS B)

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17399
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RAPAMYCIN

22430

OLOPATADINE HCL

26271

ETHYL ICOSAPENTATE

30103

OMEGA‐3‐ CARBOXYLIC ACIDS

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Always a Team Player

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http://www.ccsb.com.tw

Stock Code:1762

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