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SPT — Interim / Quarterly Report 2017
Oct 30, 2017
51922_rns_2017-10-30_81ac7459-1c72-4a8b-8c49-a8e3e2f92941.pdf
Interim / Quarterly Report
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Ticker: TWSE 1789
First Quarter 2017 On-Line Investor Meeting
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May 08, 2017
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 presentation 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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Table of Contents
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� Overall Updates of ScinoPharm
� Financial & Operating Results in Q1, 2017
- Business Updates
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Overall Updates of ScinoPharm
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4 4
Confidential
Business Overview
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Company specializes in high potency (steroid/cytotoxic) APIs and is expanding into sterile/aseptic injectable formulations
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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
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Fully compliant with world-class cGMPs and international regulatory requirements; Certified by US FDA, EMA, EDQM, Australian TGA, Japanese PMDA
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Recap of Performances and Major Events
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Reported the consolidated revenues for 1Q17 were NT$919 million, net profits after-tax were NT$ 170 million, gross margin was 51%, EPS was NT$0.22
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The revenues was suffered by the stronger-than-expected appreciation of the NT dollar against the US dollar. However, the impact was offset by tighter cost control and process optimization
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Building exclusive strategic partnership with Baxter for generic oncology injectables
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Taiwan site completed the 6[th] times US FDA inspection with no resulting 483 concerns
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On schedule to carry out equipment assembly and installation for both cartridge and vial production lines, followed by verification and cGMP system deployment
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Financial & Operating Results Q1, 2017
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Quarterly P&L - Consolidated
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Q1, 2017 Q1, 2016
In NT$ million, except for EPS YoY
(Reviewed) (Reviewed)
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)
Net Income before Tax 192 191 1%
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
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Balance Sheet- Consolidated
| In NT$ million | 2017/03/31 (Reviewed) |
2017/03/31 (Reviewed) |
2016/03/31 (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% | 10027 | 80% |
| , |
Cash Flows- Consolidated
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Q1, 2017 Q1, 2016
In NT$ million
(Reviewed) (Reviewed)
Cash and cash equivalents
3,707 2,336
at beginning of period
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
3,715 2,560
at end of period
Free Cash flow 101 399
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Sales by Business
2017 Q1
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BD&
CMO other
2016 Q1
8% 6%
CRO
5%
CMO BD
CRO
1% 1%
6%
Generics
81%
Generics
92%
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Sales by Indications
2017 Q1
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Others
12%
2016 Q1 CNS
11%
Others
Oncology
CNS 14%
77%
11%
Oncology
75%
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Sales by Region
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2016 Q1
CN ROW
JP
<1% 10%
8%
India
3%
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2017 Q1
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JP
CN ROW
8%
2% 5%
India
5%
US+CAN
EU
44%
36%
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Business Updates
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Confidential
Injectable Products Allied with Baxter
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ScinoPharm and Baxter Healthcare establish worldwide partnerships to co-develop 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 injectables products for collaboration with ScinoPharm
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Confidential
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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Marketing Territory
- All countries throughout the world, excluding China and Taiwan
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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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FDF: Finished Dosage Form
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Confidential
Benefits of the Collaboration
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Aggressively expanding our “Double A” strategy for inhouse 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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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 Myeloid US 2017 1st US ANDA filing, triggering US FDA inspection* |
|||||||
| Partner | Product |
Indications |
Region |
Launch Year(E) |
Remarks |
||
| Genovate | Entecavir | Hepatitis B Virus | Taiwan | 2013* | 1st co-developed formulation product launch | ||
| Sagent | Oncology |
Myeloid |
US | 2017 | 1st US ANDA filing, triggering US FDA inspection |
||
| Injectable | Leukemia | 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 | Glaucoma | China | 2021 | ||||
| &Bimatoprost | |||||||
| Nanjing King Friend |
Regadenoson | Stress agent for heart scan |
China | 2020 | Co-developed formulation in China | ||
| 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 |
Project B | Imaging agent | US | 2021 | ANDA with Paragraph IV filing / The estimated launch year is subject to |
||
| partners 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 20 |
partners | 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 |
Confidential
CRO Phase III Product Portfolio
*** Already Filed**
| Code Est. NDA Indication Sales Region Production Site |
Code Est. NDA Indication Sales Region Production Site |
Code Est. NDA Indication Sales Region Production Site |
Code Est. NDA Indication Sales Region Production Site |
Code Est. NDA Indication Sales Region Production Site |
Code Est. NDA Indication Sales Region Production Site |
Code Est. NDA Indication Sales Region Production Site |
|---|---|---|---|---|---|---|
| Code | Est. NDA |
Indication | Sales Region | Production Site | ||
| Filing Year | ||||||
| A | 2016* | Infectious Disease | US / EU / Asia |
Taiwan | ||
| B | 2018 | Type I,II Diabetes |
US/ EU | Changshu (Intermediate) |
||
| C | 2018 | Advanced Hepatocellular Carcinoma/ Myelofibrosis/ Autoimmune disease, etc. |
CN | Changshu | ||
| D | 2018 | Prostate Cancer | US / EU | Taiwan | ||
| E 2018 Parkinson’s Disease US Taiwan |
E | 2018 | Parkinson’s Disease | US | Taiwan |
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2017 Product Launch Plan
| Type Product Region Indication Brand Regional WW |
Type Product Region Indication Brand Regional WW |
Type Product Region Indication Brand Regional WW |
Type Product Region Indication Brand Regional WW |
Type Product Region Indication Brand Regional WW |
Type Product Region Indication Brand Regional WW |
Type Product Region Indication Brand Regional WW |
Type Product Region Indication Brand Regional WW |
Type Product Region Indication Brand Regional WW |
|---|---|---|---|---|---|---|---|---|
| Type | Product | Region | Indication | Brand |
Regional |
WW |
||
| Marketer | Sales | Sales | ||||||
| Generic API |
Desmopressin Acetate |
USA | Polyuria | Ferring | US$166M | US$405M | ||
| Generic |
Tamsulosin HCl | USA | Benign Prostatic |
Boehringer |
US$333M | US$1706M | ||
| API | Hyperplasia (BPH) |
Ingelheim | ||||||
| CMO API |
Oral Product | USA EU |
Antibiotics | N/A | N/A | N/A | ||
| Generic Drug Oncology Injectable US Myeloid Leukemia MDS US$183M US$278M |
Generic Drug |
Oncology Injectable |
US | Myeloid Leukemia |
MDS | US$183M | US$278M |
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Source: IMS Data (2015Q3-2016Q2)
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uestions Q
& Answers
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Brand Quality with Asian Advantages www.scinopharm.com
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