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SPT — Interim / Quarterly Report 2018
Aug 2, 2018
51922_rns_2018-08-02_7979dca9-d431-4b78-8650-c4ccd736f67d.pdf
Interim / Quarterly Report
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1789 TT
ScinoPharm Taiwan, Ltd. H1 2018 On-Line Investor Meeting
August 2, 2018
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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Table of Content
� Overall Updates of ScinoPharm
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Business Updates
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Financial & Operating Results in H1, 2018
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Overall Updates of ScinoPharm
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ScinoPharm at a Glance
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ScinoPharm specializes in high potency (steroid/cytotoxic) APIs and injectable provider, serving customers worldwide
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Facility & offices established in Taiwan and expanding in China with a new GMP plant in Changshu & marketing base in Shanghai
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71 generic APIs in current portfolio with 26 APIs launched; 57 US DMFs filed (776 DMFs WW), 34 US DMFs in oncology APIs. 100+ NCE CRAM projects, with 6 NDAs launched and 5 in phase III
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Fully compliant with world-class cGMPs and international regulatory requirements; Certified by US FDA, EMA, EDQM, Australia TGA, Japan PMDA, Korea KFDA, Mexico COFEPRIS and Germany regulatory Authority
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Driving Long Term Growth by Dual Profits
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Target difficult-to-make (peptide)API in our portfolio
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Tap into drug product related to our API core competencies
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Target 505(b)(2) and Paragraph IV drug product via strategic alliances
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Provide CRO/CMO for APIs
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� Offer integrated service from API to formulation for niche injectables
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� Provide biologics fill & finish CMO services
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Strong API Portfolio for Generic Product
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40 35 unlaunched
launched
35
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25 22
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13
15
10 7 7 6
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5 6 2 2 2 3 3
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4 1 2
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Note: Others (Women's Health, Respiratory and Immunology )
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Recap of Performances and Major Events
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Reported the consolidated revenues for H1 2018 were NT$1.847 billion, net profits after-tax were NT$ 267 million, gross margin was 41%, EPS was NT$0.34
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Financial performances were mainly benefited from the favorable sales volumes for colorectal cancer product of generics plus the increase of intermediates shipment for Phase III diabetes project
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The 1st ANDA approved by US FDA, an oncological product and codeveloped with Sagent
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Passed Japanese PMDA site inspections both in Taiwan and Changshu
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Rated top 5% in the Corporate Governance Evaluation by TWSE
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Issued 2017 corporate responsibility report verified by an independent third party
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Business Updates
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Strategic Alliance Highlights
* 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 | 2018* | 1st US ANDA filing, triggering US FDA inspection in Changshu, China site. Approved by US FDA in March 2018 |
| Foresee | Leuprolide | Prostate cancer | US | 2019 | 505(b)(2) NDA CRAM + Equity |
| Lee’s Pharma |
Fondaparinux | Anti-thrombotic | China | 2022 | Co-development collaboration |
| Travoprost &Bimatoprost |
Glaucoma | China | 2022 | ||
| Nanjing King Friend |
Regadenoson | Stress agent for heart scan |
China | 2021 | Co-developed formulation in China. Submitted ANDA in October 2017 |
| US partner | Project A | Non-small cell lung cancer |
US | 2018 | US NDA 505(b)(2) /Estimated launch year is subject to litigation results |
| US & China partners |
Project B | Imaging agent | US | 2021 | ANDA with Paragraph IV filing / 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 |
Fondaparinux | Anti-thrombotic | US/EU | 2018 | 1st self-developed US ANDA submitted . Executive right for marketing & sales |
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CRO Phase III Products Portfolio
| NDA Filing Year (E) |
Indication | Region | Remarks |
|---|---|---|---|
| 2018 | Type I Diabetes |
US/ EU | Intermediate project made both in Changshu & Taiwan. Type I anticipated launch in 2019.Type II expected submission in 2019. Expected revenue of several million USD per year after approval |
| 2019 | Type II Diabetes |
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| 2018 | Advanced Hepatocellular Ci Mlfibi |
CN | API project made in Changshu site. CFDA granted accelerated review under its category |
| arcnoma, yeoross, Autoimmune disease |
1.1 innovative drug. Anticipated launch in 2019 with demand in tons |
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| 2018 | Prostate Cancer | US / EU | Started process validation. Anticipated launch in 2019 and revenue of several million USD per year after approval |
| 2019 | Familial Adenomatous Polysis |
US / EU | API project made both in Taiwan & Changshu sites. Anticipated launch in 2020 with demand in tons to tens tons after approval |
| 2019 or 2020 | Recurrent Anaplastic Astrocytoma |
US / EU | Demand in tons after approval |
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2018 CPhI China Observations
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Fewer Western exhibitors in CPhI Trade Show this year
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New drug flourishing as new guidelines make China a more drug-friendly market
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As government is cracking down on noncompliance with environmental rules, API producers were buffeted by raw material and intermediate factory closures, suffered from supply chain disruption and volatility in chemicals pricing
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New inspection regimen, tightened environment laws and high standard drug license approval process pushing out lowquality API suppliers
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| Ranking | API Product | Indication |
|---|---|---|
| 1 | Paclitaxel | Breast, Ovarian and Lung Cancer |
| 2 | Irinotecan HCI | Colorectal Cancer |
| 3 | Intermediates for CRAM project | Diabetes |
| 4 | Gemcitabine Hydrochloride | Pancreatic, Non-Small-Cell Lung Cancer |
| 5 | Docetaxel Anhydrous | Breast, Non-Small-Cell Lung Cancer |
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2018 Product Launch Plan
| Type | Product | Region | Indication | Brand Marketer |
Regional Sales |
WW Sales |
|---|---|---|---|---|---|---|
| Generic API | Tamsulosin HCl |
CN | Benign Prostatic Hyperplasia (BPH) |
Boehringer Ingelheim |
US$97MM | US$1,731m |
| Generic API | Flumazenil | JP | Reversal of Conscious Sedation and General Anesthesia |
Roche | US$13.5MM | US$78.4m |
| Generic API | Capecitabine | JP | Antineoplastic | Roche | US$122MM | US$797.4m |
| Generic Drug |
Oncology Injectable |
US | Myeloid Leukemia |
MDS | US$172.2m | US$305m |
| Generic Drug |
Fondaparinux | US | Anti-thrombotic | Mylan | US$69.6m | US$191.2m |
Launched
Source: IMS Data 2017
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Financial & Operating Results H1, 2018
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Quarterly P&L - Consolidated
| In NT$ million, except for EPS | Q2 2018 (Reviewed) |
Q1 2018 (Reviewed) |
QoQ | Q2 2017 (Reviewed) |
YoY | |||
| Revenue | 986 | 100% | 861 | 100% | 14% -7% |
853 | 100% | 16% -7% |
| Cost of Goods Sold | (565) | -57% | (527) | -61% | (527) | -62% | ||
| Gross Profit | 421 | 43% | 335 | 39% | 26% -22% |
326 | 38% | 29% -9% |
| Operating Expense | (261) | -26% | (213) | -25% | (239) | -28% | ||
| Operating Income | 160 | 16% | 121 | 14% | 32% 94% |
86 | 10% | 85% 74% |
| Non-operating Income, Net | (2) | 0% | (31) | -3% | (7) | -1% | ||
| Income before Tax | 158 | 16% | 90 | 11% | 75% | 79 | 9% | 100% |
| Net Income | 131 | 13% | 136 | 16% | -3% | 84 | 10% | 55% |
| EPS (NT$) | 0.17 | 0.17 | 0.11 | |||||
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Profit & Loss - Consolidated
| (note) 4% -12% -5% 3% -9% YoY |
|||||||
|---|---|---|---|---|---|---|---|
| In NT$ million, except for EPS | H1 2018 (Reviewed) |
H1 2017 (Reviewed) |
YoY | ||||
| Revenue | 1,847 | 100% | 1,773 | 100% | 4% -12% |
||
| Cost of Goods Sold | (1,092) | -59% | (977) | -55% | |||
| Gross Profit | 755 | 41% | 796 | 45% | -5% 3% |
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| Operating Expense | (474) | -26% | (488) | -28% | |||
| Operating Income | 281 | 15% | 308 | 17% | -9% | ||
| Non-operating Income, Net | (33) | -2% | (36) | -2% | 9% | ||
| Income before Tax | 248 | 13% | 272 | 15% | -9% | ||
| Net Income | 267 | 14% | 255 | 14% | 5% | ||
| EPS (NT$) | 0.34 | 0.32 | |||||
| EBITDA | 498 | 27% | 523 | 29% | -5% | ||
Note: 2018H1 vs 2017H1: 3.2% NTD appreciation against USD YoY
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Sales by Business
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2018 H1
BD&
CMO Other
2017 H1
15% 1%
BD& CRO
Other 5%
CMO
8%
Generics
8%
CRO 79%
8%
Generics
76%
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Sales by Indications
2018 H1
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Others
Infectious
CNS
17%
3%
2017 H1 10%
Others
20%
Oncology
CNS
70%
12%
Oncology
68%
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Sales by Region
2018 H1
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CN ROW
JP
2017 H1
1% 6%
8%
India
CN ROW 10%
JP
2% 11% US+CAN
7%
36%
India EU
6% 39%
US+CAN
39%
EU
35%
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Balance Sheet- Consolidated
| (In NT$ million) | 2018/06/30 (Reviewed) |
2017/06/30 (Reviewed) |
||||
| Cash and Cash Equivalents | 4,017 275 709 1,517 - 4,957 1,174 606 |
30% | 3,721 - 726 1,802 391 5,136 1,105 - |
29% | ||
Financial asset measured at amortised cost |
2% 5% 11% 0% 37% 10% 5% |
0% 6% 14% 3% 40% 8% 0% |
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| Accounts Receivable | ||||||
| Inventories | ||||||
| Financial asset measured at fair value through | ||||||
other comprehensive income |
||||||
Financial assets carried at cost |
||||||
| Property, Plant & Equipment | ||||||
Other Current/Non-Current Assets |
||||||
| Total Assets | 13,255 | 100% | 12,881 | 100% | ||
| Current Liabilities | 2,654 71 |
20% 1% |
1,365 1,284 |
11% 10% |
||
| Long-Term & Other Liabilities | ||||||
| Total Liabilities | 2,725 | 21% | 2,649 | 21% | ||
| Total Shareholders' Equities Key Indices A/R Turnover (Days) Inventory Turnover (Days) Current Ratio (x) ROE(%) |
10,530 | 79% | 10,232 | 79% | ||
| 63.1 372.4 2.6 2.6 |
70.2 456.3 4.8 2.5 |
|||||
| A/R Turnover (Days) Inventory Turnover (Days) Current Ratio (x) ROE(%) |
||||||
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Cash Flows- Consolidated
| (In NT$ million) | H1 2018 (Reviewed) |
H1 2017 (Reviewed) |
||||
| From Operating Actavities | 370 | 353 | ||||
| Profit before tax | 248 208 (86) |
272 221 (140) |
||||
| Depreciation & Amortisation | ||||||
| Net change in working capital | ||||||
| From Investing Actavities | (350) | (351) | ||||
| Financial asset measured at | (275) | - | ||||
| amortised cost | ||||||
| Capital expenditure | (67) | (321) | ||||
| From Financing Actavities | 76 | 43 | ||||
| Short-term loans | 65 11 106 |
(477) 540 14 |
||||
| Long-term loans | ||||||
| Net Change in Cash | ||||||
| Beginning Balance | 3,911 | 3,707 | ||||
| Ending Balance | 4,017 | 3,721 | ||||
| Free Cash Flow | 303 | 32 | ||||
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Brand Quality with Asian Advantages
www.scinopharm.com
1789 TT
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