AI assistant
SPT — Investor Presentation 2021
Nov 10, 2021
51922_rns_2021-11-10_b5b2666a-dcc0-4b1e-912d-b1aa13394e03.pdf
Investor Presentation
Open in viewerOpens in your device viewer
1789 TT
ScinoPharm
November 10, 2021
Disclaimer
This material has been prepared by ScinoPharm Taiwan, Ltd. (“ScinoPharm”).
Any opinions expressed in this material are subject to change without notice as a result of using different assumptions. ScinoPharm is under no obligation to update or keep current the information contained herein. The information contained in this presentation is ScinoPharm’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 ScinoPharm. 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 forward-looking 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 [82 x 26] intentionally omitted <==
Table of Content
Business Update
Financial Performance
3
==> picture [720 x 88] intentionally omitted <==
Business Update
4
==> picture [161 x 150] intentionally omitted <==
----- Start of picture text -----
Optimize
Generic API
Portfolio
----- End of picture text -----
Generic API Business Update
Leverage Tainan/Changshu production advantage and strengthen sales/production coordination The impact of Covid-19 pandemic and dual control of energy consumption in China are still manageable Generic API Portfolio
==> picture [497 x 231] intentionally omitted <==
----- Start of picture text -----
38
40 Data as of 2021/09/30
35 Pipeline
30 Approved
20
25
20
12
15
10 18 7 6 6
5 4 2 3 2 2 2 2 1
5 2 4 3 2 11 2 2 1
0
----- End of picture text -----
==> picture [34 x 34] intentionally omitted <==
==> picture [377 x 58] intentionally omitted <==
5
==> picture [161 x 150] intentionally omitted <==
----- Start of picture text -----
Optimize
Generic API
Portfolio
----- End of picture text -----
2021 Generic API Product A roval Plan pp
| Type | Product | Region | Indication | Brand Marketer |
|---|---|---|---|---|
| Generic API | Fondaparinux Sodium |
CN( ) | Anti-thrombotic | Mylan |
| Generic API | Irinotecan HCl | CN | Colorectal cancer | Pfizer |
| Generic API | Anastrozole | CN | Breast cancer | ANI Pharmaceuticals |
| Generic API | Sodium Phenylbutyrate |
CN( ) | Urea cycle disorders | Horizon Therapeutics |
| Generic API | Azilsartan | CN | Hypertension | Arbor Pharmaceuticals |
| Generic API | Letrozole | CN( ) | Breast cancer | Novartis |
| Generic API | Bimatoprost | CN | Glaucoma | Allergan |
| Generic API | Regadenoaon | US | MPI | Astellas |
| Generic API | *PemetrexedDisodium 7H2O CEP |
EU | Non-small cell lung cancer |
Eli Lilly |
| Generic API | Topiramate | EU | Weight management |
Vivus |
:Approved*:Collaborative project for drug product developmentData as of 2021/09/30 |
6
==> picture [161 x 151] intentionally omitted <==
----- Start of picture text -----
Expand
CDMO
Business
----- End of picture text -----
CDMO Business
==> picture [494 x 336] intentionally omitted <==
----- Start of picture text -----
10 9 9 9
1
8
4 4 6
6
1
SciAnda (Changshu)
ScinoPharm Taiwan
8
4
5 5 5
2
0
Phase 1 Phase 2 Phase 3 Commercial
----- End of picture text -----
Data as of 2021/09/30
7
| Expand CDMO Business |
2021 CDMO API Product Approval Plan | 2021 CDMO API Product Approval Plan | 2021 CDMO API Product Approval Plan | 2021 CDMO API Product Approval Plan | 2021 CDMO API Product Approval Plan |
|---|---|---|---|---|---|
| Type | Product | Region | Indication | Brand Marketer | |
| CDMO API | Donafenib | CN( ) | Cancer | Suzhou Zelgen | |
| CDMO API | Camcevi | US( ) EU |
Cancer | Foresee | |
| CDMO API | Eflornithine | US/EU | FAP | CPP | |
| Data as of 2021/09/30 |
Donafenib:
-
Approved and launched in China in June, 2021 (Indication: Advanced liver cancer)
-
Summited to NMPA in Oct. 2021 (Indication: RAIR-DTC)
-
Camcevi:
-
Approved by FDA in June, 2021; MAA review in progress
-
Replied Canada Healthcare in Sep. 2021
-
Eflornithine:
-
Submitted to FDA and EMA by customer
8
==> picture [161 x 151] intentionally omitted <==
----- Start of picture text -----
Advancing
to
Injectables
----- End of picture text -----
==> picture [132 x 114] intentionally omitted <==
==> picture [134 x 114] intentionally omitted <==
==> picture [127 x 100] intentionally omitted <==
==> picture [387 x 18] intentionally omitted <==
----- Start of picture text -----
Peptides Sterile Injectables Pen Injectors
----- End of picture text -----
-
Registration batches of Vial line (prefilled-syringed /pen device) and Cartridge line (liquid solution/ lyophilized powder) products were completed
-
ANDA of 1[st] in-house prefilled-syringe product was submitted to FDA in May, 2020 - Responded to FDA CRL in Sep. 2021
-
ANDA of 1[st] in-house liquid solution product was submitted to FDA in June, 2021 – FDA’s review in progress
-
Registration batches of 2[nd] prefilled-syringed product in progress
-
Target to summit the ANDA of 1[st] in-house lyophilized powder product to FDA in year-end of 2021
-
Completed the 1[st] TFDA on-site inspection in April, 2021 - Replied TFDA in Q3, 2021, and TFDA’s review in progress
9
==> picture [222 x 144] intentionally omitted <==
----- Start of picture text -----
Actively Develop
Japan, China and
Emerging Markets
----- End of picture text -----
Japan Market
Completed the establishment of Japan branch in Q3, 2021 to cultivate Japan market
-
The largest generic API supplier for Galantamine HBr and Capecitabine in Japan
-
Indication:Alzheimer’s disease / Various cancers
-
Japan market size:c. USD 200 million / over USD 100
- million
Leverage Japan’s late patent expiration and our new injectables capacity to explore opportunities for generic APIs + CDMO projects
10
==> picture [222 x 136] intentionally omitted <==
----- Start of picture text -----
Actively Develop
Japan, China and
Emerging Markets
----- End of picture text -----
China Market
-
Customer’s Fondaparinux Sodium PFS launched in Feb. 2021 Indication:Anti-thrombotic
-
Market Size:c. RMB 200 million
-
CFDI on site inspection in Changshu site
| Inspection | Product | Approval | Indication | Market |
|---|---|---|---|---|
| 2020.09 | Sodium Phenylbutyrate |
2021.05 | Urea cycle disorders |
Urea cycle disorders |
| 2021.02 | Donafenib | 2021.06 | Advanced liver cancer first-line treatment |
1st year sales projected by research report: c. RMB 220 million |
| 2021.06 | Bimatoprost | Expected by 2021 year-end |
Glaucoma | c. RMB 1 billion |
-
Clinic trial of customer’s Sodium Phenylbutyrate for new indication in progress
-
Customer’s Donafenib summited to NMPA in Oct. 2021 for new indication - RAIR-DTC
11
==> picture [720 x 88] intentionally omitted <==
Financial Performance
12
Consolidated Income Statement
| In NTD Million, except for EPS |
3Q 2021 (Reviewed) |
3Q 2021 (Reviewed) |
YoY | 3Q 2020 (Reviewed) |
3Q 2020 (Reviewed) |
|---|---|---|---|---|---|
| Revenue | 2,043 | 100% | -8% | **2,209 ** | 100% |
| Gross Profit | 945 | 46% | -11% | 1,058 | 48% |
| Operating Profit | 227 | 11% | -36% | 354 | 16% |
| Net Profit before Tax | 235 | 11% | -32% | 346 | 16% |
| Net Profit after Tax | 190 | 9% | -31% | 274 | 12% |
| EPS (NTD) | 0.24 | - | - | 0.35 | - |
13
3Q 2021 Sales Distribution
==> picture [676 x 227] intentionally omitted <==
----- Start of picture text -----
CDMO Drug China Others
Product India 7% 8%
14%
10% 7%
US+Canada
Japan
Generic 25%
29%
EU
API
24%
76%
by Business CNS Others
by Region
24% 7%
----- End of picture text -----
by Indication
14
Sales Distribution – YoY
By Business Unit: USD Generic API CDMO Drug Product 3Q 2021 Sales 55.2M 10.4M 7.3M YoY 3.4% -39.4% 105.3%
By Indication
Oncology CNS Others 3Q 2021 Sales 50.6M 17.6M 4.7M YoY 5.6% -16.0% -10.4%
By Region US & Canada EU Japan India China Others 3Q 2021 Sales 18.4M 17.6M 20.8M 5.3M 4.8M 6.0M YoY 27.1% -42.1% 71.7% -46.7% 125.7% 17.0%
15
Consolidated Balance Sheet
| In NTD Million | 2021/9/30 (Reviewed) |
2021/9/30 (Reviewed) |
2020/9/30 (Reviewed) |
2020/9/30 (Reviewed) |
|---|---|---|---|---|
| Cash and Cash Equivalents | 3,732 | 33% | 3,759 | 31% |
| Accounts Receivable | 284 | 2% | 468 | 4% |
| Inventories | 1,373 | 12% | 1,350 | 11% |
| Property, Plant & Equipment | 4,066 | 36% | 4,211 | 35% |
| Other Current/Non-Current Assets | 1,994 | 17% | 2,212 | 19% |
| Total Assets | 11,449 | 100% | 12,000 | 100% |
| Financial Debt | 0 | 0% | 244 | 2% |
| Other Current Liabilities | 503 | 4% | 638 | 6% |
| Other Non-Current Liabilities | 624 | 6% | 633 | 5% |
| Total Liabilities | 1,127 | 10% | 1,515 | 13% |
| Total Shareholders' Equities | 10,322 | 90% | 10,485 | 87% |
16
Consolidated Cash Flow Statement
| In NTD million | 3Q 2021 (Reviewed) |
3Q 2020 (Reviewed) |
|---|---|---|
| From Operating Activities | 331 | 616 |
| From Investing Activities | (238) | 51 |
| From Financing Activities | (411) | (210) |
| Effect of foreign exchange rate changes | (5) | (3) |
| Net Change in Cash | (323) | 454 |
| Beginning Balance | 4,055 | 3,305 |
| Ending Balance | 3,732 | 3,759 |
17
==> picture [720 x 88] intentionally omitted <==
Q & A
18
==> picture [720 x 88] intentionally omitted <==
Appendix Company Overview
19
ScinoPharm at a Glance
-
Est. in 1997 in Taiwan (Tainan) with cGMP plants/R&D in Tainan and Changshu and marketing forces in Tainan, Shanghai and Tokyo
-
Specializes in high potency (cytotoxic/steroid) API and injectable R&D and manufacturing with customers worldwide
-
74 generic APIs in portfolio with 32 referred and approved by ANDA/NDA*
-
875 active DMFs worldwide with 64 US DMFs*
-
150+ contract projects with 9 approved/launched (7 NCEs) and 6 in phase 3 for NDA/MAA filing in 1-3 years*
Certified by key international regulators - US FDA, EMA, EDQM, Australian TGA, Japanese PMDA, Korea KFDA, Mexico COFEPRIS and German Authority
- Data as of 2021/09/30
20
==> picture [81 x 27] intentionally omitted <==
==> picture [676 x 127] intentionally omitted <==
Brand Quality with Asian Advantages
www.scinopharm.com
1789 TT
21