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SPT — Investor Presentation 2017
Oct 30, 2017
51922_rns_2017-10-30_fdd315c6-a943-47c3-b47f-591cb1236d3c.pdf
Investor Presentation
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1789 TT
ScinoPharm Management Presentation Daiwa Investment Conference New York & San Francisco 2017
May 30, 2017
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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.
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Confidential
Table of Content
� Overview of ScinoPharm
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� ScinoPharm’s Strategies and Opportunities
� Operating Results & Business Updates
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Overview of ScinoPharm
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ScinoPharm at a Glance
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Company specializes in high potency (steroid/cytotoxic) APIs and is expanding into sterile/aseptic injectable formulations
-
Facility & organization established in Taiwan and expanding in China with a new GMP plant in Changshu & marketing base in Shanghai
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72 generic APIs in current portfolio with 25 APIs launched; 53 US DMFs filed (759 DMFs WW), 32 US DMFs in oncology APIs. 100+ NCE CRAM projects, with 5 APIs launched and 5 in phase III for NDA filing in 1-3 years
-
Fully compliant with world-class cGMPs and international regulatory requirements; Certified by US FDA, EMA, EDQM, Australian TGA, Japanese PMDA
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Specialty Pharmaceutical Company with Two Businesses
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Partner’s Third
Injectable Party’s
API Plant Plant
API +
ANDA
NCE
Generic
CRO+CMO
In-house
Injectable
Plant
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World Class Facilities
Taiwan
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6.6 hectares of land, 330K sq.ft. facilities with >200M[3] reactor volume
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5 of 16 production lines equipped with high potency capabilities for cytotoxic/steroids
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Passed US FDA, EMA, EDQM, Australian TGA, Japanese PMDA inspections, & 300+ cGMP customer audits
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Provides comprehensive contract research & manufacturing services for brand drug companies
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In-house injectable plant with vial and cartridge production lines for oncologicals and peptides
China
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6.7 hectares of land with > 250M[3 ] reactor volume
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3 of 7 production lines equipped with high potency capabilities for cytotoxics
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US FDA approved cGMP facility for intermediates & high potency API
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Full scope capabilities in the development and production of APIs on small to large scales for generic & CRAM markets
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Partnerships with downstream formulation and target for global market including China
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Confidential
Strong Generics Product Portfolio
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36
40 unlaunched
launched
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30
25 23
20
13
15
7 7
10 6
13 4
5 6 2 2 2 2
6 4 3
1 2 2 2 1
0
Note: Other (Women's Health, Gastrointestinal, Immunology and Metabolic)
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Confidential
ScinoPharm - Oncology API Leader
Stand-Alone API Companies
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ScinoPharm 31 21
Shilpa 12 11 3
Polymed 10 2 3
MacChem Products 6 5 2 # Oncology DMF Overlap with SPT
# Non-overlapping Oncology DMF
Laurus Labs 7 7 14
# Other DMFs
Sichuan Xieli 6 8 13
Chemwerth 3 5 33
Apicore 5 6 24
0 10 20 30 40 50 60
Large Generic Pharmaceutical Companies
ScinoPharm 31 21
Teva 17 26 249
Dr. Reddy's 14 14 187
Cipla 11 17 125
Sun 17 11 174
Hisun 11 19 48 # Oncology DMF Overlap with SPT
Qilu 8 3 8 # Non-overlapping Oncology DMF
# Other DMFs
Hengrui 33 10
0 50 100 150 200 250 300
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9 Source: USFDA DMF Q3 2016 database
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Confidential
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2017 Q1 Sales Distribution
By Indication
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By Business
By Region
Oncology
63%
Generic
77%
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ScinoPharm’s
Strategies and Opportunities
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Business Growth Drivers
1.Deploying the network of development, production and distribution of injectables
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Build partnerships to speed up the momentum of vertical integration
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− Achieve critical mass workforce for in-house injectable plant facility
2.CRAM has promising development potential in the next three years
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Focus on small-molecule targeted therapies and CNS agents based on new mode of action
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− Provide integrated service from API to formulation for niche injectables
3. Active development of Chinese and Japanese market
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Target projects to utilize capacity and accelerate growth for Changshu site
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− Develop partnership with major Japanese pharmaceutical companies and international pharmaceutical groups with Japan-based operation site
4.Continue optimizing existing generic APIs
- Maintain the market share and profit of the top 5 marketed products
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We are Transforming our Company
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Confidential
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Transforming into a
Positioning as a
Gateway into China full-scope pharma Tightening cost control, and
process optimization with
providing Supply-Chain company by executing
enhanced management
to Multinationals
“Double A” strategy
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Keys to Generic Formulation Business
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Opportunity Strategy Tactics
� Already the leader in � Developing dossiers per our � Expanding formulation
providing oncology APIs to difficult-to-make APIs to increase portfolio
regulated markets worldwide value proposition in the supply � Establishing on-site
� Injectable CMOs are in short chain oncology injectable facility
supply � Targeted delivery & extended and providing an integrated
� Can be customer’s injectables release of proven APIs via supply chain
provider by developing 505(b)(2) fast track � Promoting our formulations
formulations using our own � Collaborating with start-ups & via strategic alliances,
oncology APIs or others’ APIs, research institutes, focusing on especially in China and
up to and including ANDA un-met oncology medical needs US/EU
filing with FDA of high prevalence in Asia
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� 2 US ANDAs
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- 16 co-development and cost/profit sharing products with various partners
Strategic Alliance Highlights
*** Already launched**
| Strategic Alliance Highlights * Already launched |
Strategic Alliance Highlights * Already launched |
Strategic Alliance Highlights * Already launched |
Strategic Alliance Highlights * Already launched |
Strategic Alliance Highlights * Already launched |
Strategic Alliance Highlights * Already launched |
Strategic Alliance Highlights * Already launched |
Strategic Alliance Highlights * Already launched |
|---|---|---|---|---|---|---|---|
| Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Sagent Oncology Injectable Myeloid Leukemia US 2017 1st US ANDA filing, triggering US FDA inspection in Changshu, China site* |
|||||||
| Partner | Product |
Indications |
Region |
Launch Year(E) |
Remarks | ||
| Genovate | Entecavir | Hepatitis B Virus | Taiwan | 2013* | 1st co-developed formulation product launch | ||
| Sagent | Oncology Injectable |
Myeloid Leukemia | US | 2017 | 1st US ANDA filing, triggering US FDA inspection in Changshu, China site |
||
| Foresee | Leuprolide | Prostate cancer | US | 2019 | 505(b)(2) NDA CRAM + Equity | ||
| Coland | Bortezomib | Multiple Myeloma | China | 2020 | 1st co-developed drug in China to trigger CFDA inspection in Changshu site |
||
| Azacitidine | MDS | China | 2021 | Co-developed formulation in China | |||
| Lee’s Pharma | Fondaparinux | Anti-thrombotic | China | 2021 | Co-development collaboration | ||
| Travoprost & Bimatoprost |
Glaucoma | China | 2021 | ||||
| Nanjing King Friend |
Regadenoson | Stress agent for heart scan |
China | 2020 | Co-developed formulation in China | ||
| 15 US partner Project A Non-small cell lung cancer US 2017 US NDA 505(b)(2). The estimated launch year is subject to US FDA review US & China partners Project B Imaging agent US 2021 ANDA with Paragraph IV filing. The estimated launch year is subject to litigation results Baxter 5 niche injectables Anti-cancer & antinauseant US/EU 2020& continuing thereafter Baxter has the right to add up to 15 additional injectable products for collaboration Indian Int’l partner Niche injectable Anti-thrombotic US/EU 2018 1st self-developed US ANDA launched. Executive right for marketing & sales |
|||||||
| US partner | Project A | Non-small cell lung cancer |
US | 2017 | US NDA 505(b)(2). The estimated launch year is subject to US FDA review |
||
| US & China partners |
Project B | Imaging agent | US | 2021 | ANDA with Paragraph IV filing. The estimated launch year is subject to litigation results |
||
| Baxter | 5 niche injectables |
Anti-cancer & antinauseant |
US/EU | 2020& continuing thereafter |
Baxter has the right to add up to 15 additional injectable products for collaboration |
||
| Indian Int’l partner | Niche injectable | Anti-thrombotic | US/EU | 2018 | 1st self-developed US ANDA launched. Executive right for marketing & sales |
In-House Injectable Plant Progress
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Taiwan-based facility will accommodate R&D, Quality Control, washing, sterilization, manufacturing, filling, lyophilization, packaging, and storage.
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Planned kick-off registration batch production by 2017. Expected submission of 1st in-house ANDA in 2018 and subsequent US FDA inspection approval in 2019
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Target products with high entry barrier or unit-pricing as in peptides and oncology agents.
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Offering CMO services for both brand and proprietary drugs
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Aseptic Fill & Finish Service
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Confidential
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Vial
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CRO Phase III Product Portfolio
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Confidential
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| Code Est. NDA Filing Year Indication Region Regional Sales Remarks Completed process validation. Anticipated launch in** |
Code Est. NDA Filing Year Indication Region Regional Sales Remarks Completed process validation. Anticipated launch in** |
Code Est. NDA Filing Year Indication Region Regional Sales Remarks Completed process validation. Anticipated launch in** |
Code Est. NDA Filing Year Indication Region Regional Sales Remarks Completed process validation. Anticipated launch in** |
Code Est. NDA Filing Year Indication Region Regional Sales Remarks Completed process validation. Anticipated launch in** |
Code Est. NDA Filing Year Indication Region Regional Sales Remarks Completed process validation. Anticipated launch in** |
Code Est. NDA Filing Year Indication Region Regional Sales Remarks Completed process validation. Anticipated launch in** |
Code Est. NDA Filing Year Indication Region Regional Sales Remarks Completed process validation. Anticipated launch in** |
|---|---|---|---|---|---|---|---|
| Code | Est. NDA Filing Year |
Indication | Region | Regional Sales** |
Remarks | ||
| Completed process validation. Anticipated launch in | |||||||
| A | 2016* | Infectious Disease | US / EU / Asia |
$1.4 bn | 2017 with demand in tons. Expected revenue of several million USDperyear |
||
| B | 2018 | Type I,II Diabetes |
US/ EU | $2.4 bn | Intermediate project made in Changshu site. Expected revenue of several million USD per year after launch |
||
| C | 2018 | Advanced Hepatocellular Carcinoma, Myelofibrosis, Autoimmune disease, etc. |
CN | N/A | API project made in Changshu site. CFDA granted accelerated review under its category 1.1 innovative drug. Anticipated launch in 2019 with demand in tons |
||
| Started process validation. Anticipated launch in 2019 | |||||||
| D 2018 Prostate Cancer US / EU $2.4 bn and revenue of several million USDperyear E 2018 Parkinson’s Disease US $1.0 bn Novel mechanism with promising demand. Anticipated launch in 2019 with demand in tons. Expected revenue of several million USD per year |
D | 2018 | Prostate Cancer | US / EU | $2.4 bn | and revenue of several million USDperyear |
|
| E | 2018 | Parkinson’s Disease | US | $1.0 bn | Novel mechanism with promising demand. Anticipated launch in 2019 with demand in tons. Expected revenue of several million USD per year |
*** Already Filed ** Source: BioMedTracker, GlobalData and DataMonitor**
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China and Japan Market Development
China
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Confidential
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Accelerate progress to create positive cash flow
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Focus on mid- to late-phase CRO projects. Current portfolio includes agents for oncology, antihypertension, and diabetes
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Seek generic APIs/intermediates with large demand to increase production utilization
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Develop partnerships with downstream formulation for collaborative development and registration, realizing shared profit creation
Japan
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Among 20 customers, 6 are top 10 drug firms. Less established players have exited the more concentrated market
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Encourage local generic customers to engage more in direct business
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Support Japanese companies and foreign pharmaceutical companies to enable and extend business outreach
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With the resources in Taiwan and Changshu, API supply is more flexible and can be incorporated to injectable drug product via integrated services
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Confidential
Capturing Chinese Growth on Multiple Fronts
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MNCs and emerging virtual-model players create a sizable demand in high-quality and compliant API contract manufacturing in China
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Existing review and approval mechanisms significantly raise the entry barrier and cost structure in the Chinese drug market, requiring dedication to quality and innovation
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We have domestic presence plus world-class strength in:
*** Global, first-tier customer base**
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High-technical-barrier oncology APIs
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Quality and EHS/GMP compliance
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Confidential
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Selected List of CRAM Projects at Changshu
| Confidential Selected List of CRAM Projects at Changshu |
Confidential Selected List of CRAM Projects at Changshu |
Confidential Selected List of CRAM Projects at Changshu |
Confidential Selected List of CRAM Projects at Changshu |
Confidential Selected List of CRAM Projects at Changshu |
Confidential Selected List of CRAM Projects at Changshu |
Confidential Selected List of CRAM Projects at Changshu |
|---|---|---|---|---|---|---|
| Customer Project Type Product Indication/stage Product Type Remarks/ Market Top 10 global pharma CMO Approved antidepressant drug in US GMP Intermediate Passed Mexican authority (APIF) GMP inspection |
||||||
| Customer | Project Type |
Product Indication/stage | Product Type | Remarks/ Market | ||
| Top 10 global pharma | CMO | Approved antidepressant drug in US | GMP Intermediate | Passed Mexican authority (APIF) GMP inspection |
||
| Top 5 global pharma | CMO | Approved African sleeping disease drug | API | Site transfer from Taiwan | ||
| Lee’s Pharma | CRO / CMO | >15 projects, including brain tumor, antibiotic, hypertension, eye drops, etc. |
API | China | ||
| China pharm company | CRO | Phase II/ III clinical trial for cancer | API | China | ||
| China pharm company | CRO | Phase IIb for age-related macular degeneration | API | US/China | ||
| Taigen Biotech | CRO | Phase II clinical trial for myocardial infarction | API | China/Taiwan | ||
| US-based new drug company | CRO | Phase II clinical trial for prevention of HIV infection | API | US | ||
| Aslan Pharmaceuticals CRO Phase II clinical trial for cancer API China/Global Top 5 global pharma CRO Phase III clinical trial for diabetes Intermediate US Top 5 global pharma CRO Phase I clinical trial API NA US NASDAQ listed pharma CRO Phase III clinical trial for opioid-induced constipation Crude API US US-based new drug company CRO Phase I clinical trial for sickle cell disease API US 22 |
Aslan Pharmaceuticals | CRO | Phase II clinical trial for cancer | API | China/Global | |
| Top 5 global pharma | CRO | Phase III clinical trial for diabetes | Intermediate | US | ||
| Top 5 global pharma | CRO | Phase I clinical trial | API | NA | ||
| US NASDAQ listed pharma | CRO | Phase III clinical trial for opioid-induced constipation | Crude API | US | ||
| US-based new drug company | CRO | Phase I clinical trial for sickle cell disease | API | US |
Maintain Market Share of Existing APIs - 2016 Major Products account for 65% of total sales
| API Product Indication 2016 MKT h # of US DMF/EDMF & h fili* |
API Product Indication 2016 MKT h # of US DMF/EDMF & h fili* |
API Product Indication 2016 MKT h # of US DMF/EDMF & h fili* |
API Product Indication 2016 MKT h # of US DMF/EDMF & h fili* |
API Product Indication 2016 MKT h # of US DMF/EDMF & h fili* |
API Product Indication 2016 MKT h # of US DMF/EDMF & h fili* |
|---|---|---|---|---|---|
| API Product | Indication | 2016 MKT h* |
# of US DMF/EDMF & h fili |
||
| sare | oter ngs | ||||
| Irinotecan HCI | Antineoplastic | 42% | 63 | ||
| Paclitaxel | Antineoplastic | 34% | 57 | ||
| Gemcitabine | Antineoplastic | 24% | 76 | ||
| Exemestane | Antineoplastic | 22% | 44 | ||
| Galantamine HBr | Antischotic | 17% | 38 | ||
py Docetaxel Anhydrous Antineoplastic 15% 69 |
py | ||||
| Docetaxel Anhydrous | Antineoplastic | 15% | 69 |
*Source: IMS data from Newport
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Operating Results & Business Updates
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Quarterly P&L - Consolidated
| In NT$ million, except for EPS Q1, 2017 (Reviewed) Q1, 2016 (Reviewed) YoY Operating Revenue 919 1,022 -10% |
In NT$ million, except for EPS Q1, 2017 (Reviewed) Q1, 2016 (Reviewed) YoY Operating Revenue 919 1,022 -10% |
In NT$ million, except for EPS Q1, 2017 (Reviewed) Q1, 2016 (Reviewed) YoY Operating Revenue 919 1,022 -10% |
In NT$ million, except for EPS Q1, 2017 (Reviewed) Q1, 2016 (Reviewed) YoY Operating Revenue 919 1,022 -10% |
In NT$ million, except for EPS Q1, 2017 (Reviewed) Q1, 2016 (Reviewed) YoY Operating Revenue 919 1,022 -10% |
In NT$ million, except for EPS Q1, 2017 (Reviewed) Q1, 2016 (Reviewed) YoY Operating Revenue 919 1,022 -10% |
|---|---|---|---|---|---|
| In NT$ million, except for EPS | Q1, 2017 (Reviewed) |
Q1, 2016 (Reviewed) |
YoY | ||
| Operating Revenue | 919 | 1,022 | -10% | ||
| Gross Profit | 470 | 431 | 9% | ||
| Gross margin | 51% | 42% | |||
| Operating Expenses | (249) | (236) | 6% | ||
| Operating Income | 221 | 195 | 13% | ||
| Operating margin | 24% | 19% | |||
| Other Rev. (Exp.) | (29) | (4) | |||
| N I bf T | 192 | 191 | 1% | ||
| et ncome eore ax Net Income after Tax 170 172 -1% Net margin after tax 19% 17% EPS (after tax) 0.22 0.23 |
et ncome eore ax | ||||
| Net Income after Tax | 170 | 172 | -1% | ||
| Net margin after tax | 19% | 17% | |||
| EPS (after tax) | 0.22 | 0.23 |
* Taiwan New Dollar per 1 US Dollar quarterly average: 2017Q1: 30.93, 2016Q1: 33.16 25
Balance Sheet- Consolidated
| In NT$ million 2017/03/31 (Reviewed) 2016/03/31 (Reviewed) Cash and Cash Equivalents 3,715 29% 2,560 21% Accounts Receivable 635 5% 645 5% |
In NT$ million 2017/03/31 (Reviewed) 2016/03/31 (Reviewed) Cash and Cash Equivalents 3,715 29% 2,560 21% Accounts Receivable 635 5% 645 5% |
In NT$ million 2017/03/31 (Reviewed) 2016/03/31 (Reviewed) Cash and Cash Equivalents 3,715 29% 2,560 21% Accounts Receivable 635 5% 645 5% |
In NT$ million 2017/03/31 (Reviewed) 2016/03/31 (Reviewed) Cash and Cash Equivalents 3,715 29% 2,560 21% Accounts Receivable 635 5% 645 5% |
In NT$ million 2017/03/31 (Reviewed) 2016/03/31 (Reviewed) Cash and Cash Equivalents 3,715 29% 2,560 21% Accounts Receivable 635 5% 645 5% |
In NT$ million 2017/03/31 (Reviewed) 2016/03/31 (Reviewed) Cash and Cash Equivalents 3,715 29% 2,560 21% Accounts Receivable 635 5% 645 5% |
In NT$ million 2017/03/31 (Reviewed) 2016/03/31 (Reviewed) Cash and Cash Equivalents 3,715 29% 2,560 21% Accounts Receivable 635 5% 645 5% |
|---|---|---|---|---|---|---|
| In NT$ million | 2017/03/31 (Reviewed) |
2016/03/31 (Reviewed) |
||||
| Cash and Cash Equivalents | 3,715 | 29% | 2,560 | 21% | ||
| Accounts Receivable | 635 | 5% | 645 | 5% | ||
| Inventories | 1,941 | 15% | 2,167 | 17% | ||
| Long-Term Investments | 364 | 3% | 364 | 3% | ||
| Property, Plant & Equipment | 5,155 | 40% | 5,361 | 43% | ||
| Other Current/Non-Current Assets | 1,043 | 8% | 1,394 | 11% | ||
| Total Assets | 12,853 | 100% | 12,491 | 100% | ||
| Current Liabilities 1,692 13% 2,374 19% Long-Term & Other Liabilities 803 6% 90 1% Stockholders’ Equities 10,358 81% 10,027 80% |
Current Liabilities | 1,692 | 13% | 2,374 | 19% | |
| Long-Term & Other Liabilities | 803 | 6% | 90 | 1% | ||
| Stockholders’ Equities | 10,358 | 81% | 10,027 | 80% |
26
Cash Flows- Consolidated
| In NT$ million Q1, 2017 (Reviewed) Q1, 2016 (Reviewed) Cash and cash equivalents at beginning of period 3,707 2,336 |
In NT$ million Q1, 2017 (Reviewed) Q1, 2016 (Reviewed) Cash and cash equivalents at beginning of period 3,707 2,336 |
In NT$ million Q1, 2017 (Reviewed) Q1, 2016 (Reviewed) Cash and cash equivalents at beginning of period 3,707 2,336 |
In NT$ million Q1, 2017 (Reviewed) Q1, 2016 (Reviewed) Cash and cash equivalents at beginning of period 3,707 2,336 |
In NT$ million Q1, 2017 (Reviewed) Q1, 2016 (Reviewed) Cash and cash equivalents at beginning of period 3,707 2,336 |
|---|---|---|---|---|
| In NT$ million | Q1, 2017 (Reviewed) |
Q1, 2016 (Reviewed) |
||
| Cash and cash equivalents at beginning of period |
3,707 | 2,336 | ||
| Cash flows from operating activities | 304 | 663 | ||
| CAPEX | (203) | (264) | ||
| Short-term borrowings | (51) | (16) | ||
| Long-term borrowings | (41) | - | ||
| Others | (1) | (159) | ||
| Cash and cash equivalents at end of period 3,715 2,560 Free Cash flow 101 399 |
||||
| Cash and cash equivalents at end of period |
3,715 | 2,560 |
27
Historical Performance
Unit: millions of NT$
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5,088
4,572
5,000
3,887 3,953 4,098 3,955 4,031
3,791
4,000
3,145
2,494
3,000
2,000
872
613 1,041
1,000 1,040 961 1,170 1,273
484
484 635 659
0
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
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Recent Financials
In NT$
| Year 2013 2014 2015 2016 Total assets 11,484 M 11,372 M 12,222 M 12,783 M |
Year 2013 2014 2015 2016 Total assets 11,484 M 11,372 M 12,222 M 12,783 M |
Year 2013 2014 2015 2016 Total assets 11,484 M 11,372 M 12,222 M 12,783 M |
Year 2013 2014 2015 2016 Total assets 11,484 M 11,372 M 12,222 M 12,783 M |
Year 2013 2014 2015 2016 Total assets 11,484 M 11,372 M 12,222 M 12,783 M |
Year 2013 2014 2015 2016 Total assets 11,484 M 11,372 M 12,222 M 12,783 M |
Year 2013 2014 2015 2016 Total assets 11,484 M 11,372 M 12,222 M 12,783 M |
|---|---|---|---|---|---|---|
| Year | 2013 | 2014 | 2015 | 2016 | ||
| Total assets | 11,484 M | 11,372 M | 12,222 M | 12,783 M | ||
| Shareholders’ equity | 9,643 M | 9,380 M | 9,857 M | 10,228 M | ||
| Sales | 5,088 M | 4,098 M | 3,955 M | 4,031 M | ||
| Net profit after tax | 1,273 M | 484 M | 635 M | 659 M | ||
| Earnings per share | 1.88 | 0.69 | 0.87 | 0.87 | ||
| Cash dividends | 1.2 | 0.2 | 0.3 | 0.3 | ||
| Stock dividends | 0.4 | 0.4 | 0.4 | 0.4 | ||
| Pay-out ratio 85% 87% 80% 80% |
||||||
| Pay-out ratio | 85% | 87% | 80% | 80% |
Note : All of the above figures represent consolidated information
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Injectable Products Allied with Baxter
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ScinoPharm and Baxter Healthcare establish worldwide partnerships to codevelop and commercialize five niche generic injectable products at the initial stage
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ScinoPharm develops all APIs and injectable formulations. Baxter leads regulatory submissions in the US/EU and eventually market & sell the injectable products via its extensive presence in the hospital channel
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Both parties work on a cost-and-profit-sharing collaboration model
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Baxter has the right to add up to 15 additional injectable products for collaboration with ScinoPharm
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Collaboration Framework
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Initial product portfolio including the generic injectables for breast cancer, lung cancer, multiple myeloma and antinauseant. Targeting US/EU markets first and expect to expand to other territories
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This exclusive partnership will utilize each other's strengths and expertise in order to achieve large scale of synergies in providing niche and affordable generic injectable products
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Commercial launch for the first 5 products upon FDA approval, with product launches beginning in 2020 and continuing thereafter
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Current branded sales of the initial five products included in this partnership total more than $4 billion annually
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Responsibilities by ScinoPharm and Baxter
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API Development
API Production ScinoPharm
Formulation
Development
ScinoPharm
FDF Baxter
Manufacturing
CMO
Sales &
Baxter
Marketing
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Benefits of the Collaboration
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Aggressively expanding our “Double A” strategy for in-house developed/produced APIs and formulations. Providing an outlet for our injectable plant capacity
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A win-win solution and collaboration. ScinoPharm provides comprehensive APIs and formulation portfolio, while Baxter operates strong injectable product marketing channels throughout the US and worldwide
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Accelerate the momentum of our downstream integration strategy by establishing alliance with an world-renowned partner
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28
2017 Product Launch Plan
| Type Product Region Indication Brand Marketer Regional Sales WW Sales Generic API Desmopressin Acetate USA Polyuria Ferring US$166M US$405M |
Type Product Region Indication Brand Marketer Regional Sales WW Sales Generic API Desmopressin Acetate USA Polyuria Ferring US$166M US$405M |
Type Product Region Indication Brand Marketer Regional Sales WW Sales Generic API Desmopressin Acetate USA Polyuria Ferring US$166M US$405M |
Type Product Region Indication Brand Marketer Regional Sales WW Sales Generic API Desmopressin Acetate USA Polyuria Ferring US$166M US$405M |
Type Product Region Indication Brand Marketer Regional Sales WW Sales Generic API Desmopressin Acetate USA Polyuria Ferring US$166M US$405M |
Type Product Region Indication Brand Marketer Regional Sales WW Sales Generic API Desmopressin Acetate USA Polyuria Ferring US$166M US$405M |
Type Product Region Indication Brand Marketer Regional Sales WW Sales Generic API Desmopressin Acetate USA Polyuria Ferring US$166M US$405M |
Type Product Region Indication Brand Marketer Regional Sales WW Sales Generic API Desmopressin Acetate USA Polyuria Ferring US$166M US$405M |
Type Product Region Indication Brand Marketer Regional Sales WW Sales Generic API Desmopressin Acetate USA Polyuria Ferring US$166M US$405M |
|---|---|---|---|---|---|---|---|---|
| Type | Product | Region | Indication | Brand Marketer |
Regional Sales |
WW Sales | ||
| Generic API |
Desmopressin Acetate |
USA | Polyuria | Ferring | US$166M | US$405M | ||
| Generic API |
Tamsulosin HCl | USA | Benign Prostatic Hyperplasia (BPH) |
Boehringer Ingelheim |
US$333M | US$1706M | ||
| New Drug API |
Oncology Product | US | Non-Small Cell Lung Cancer |
N/A | N/A | N/A | ||
| New Drug |
Oral Product | USA |
Antibiotics | N/A | N/A | N/A | ||
| API EU Generic Drug Oncology Injectable US Myeloid Leukemia MDS US$183M US$278M |
API | EU | ||||||
| Generic Drug |
Oncology Injectable |
US | Myeloid Leukemia |
MDS | US$183M | US$278M |
Source: IMS Data (2015Q3-2016Q2)
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Pipeline Outlook
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2 generic API launched
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2 generic API launched � 5-6 generic API launched
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� 1[st] co-developed US ANDA launched � US FDA inspection at Injectable plant � 1 co-developed US ANDA launched 2017 2018 2019 2020
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� 3-5 generic API launched � 4-5 generic API launched � 1[st ] in-house drug US ANDA filed � 2 co-developed China ANDAs � 1[st] self-developed US ANDA launched � 1 co-developed US ANDA launched � 4 NDAs filed by CRAM customers � Chinese (CFDA) inspection at Changshu site
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Confidential
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Brand Quality with Asian Advantages
www.scinopharm.com 1789 TT
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