AI assistant
SPT — Interim / Quarterly Report 2017
Aug 3, 2017
51922_rns_2017-08-03_9dad2a51-574a-426e-b352-481e46a49e73.pdf
Interim / Quarterly Report
Open in viewerOpens in your device viewer
Ticker: TWSE 1789
Second Quarter 2017 On-Line Investor Meeting
==> picture [721 x 136] intentionally omitted <==
August 03, 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.
2
Table of Contents
==> picture [5 x 5] intentionally omitted <==
==> picture [4 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [4 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [4 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [4 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [4 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [4 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [4 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
==> picture [5 x 5] intentionally omitted <==
� Overall Updates of ScinoPharm
� Financial & Operating Results in 2Q, 2017
- Business Updates
3
==> picture [721 x 136] intentionally omitted <==
Overall Updates of ScinoPharm
==> picture [721 x 136] intentionally omitted <==
4 4
Confidential
Business Overview
-
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
-
72 generic APIs in current portfolio with 25 APIs launched; 53 US DMFs filed (762 DMFs WW), 32 US DMFs in oncology APIs. 100+ NCE CRAM projects, with 6 APIs launched and 4 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
5
Recap of Performances and Major Events
-
Reported the consolidated revenues for 1H17 were NT$1.773 billion, net profits after-tax were NT$ 255 million, gross margin was 45%, EPS was NT$0.33
-
The performances were mainly suffered by the unfavorable sales volumes and product mix of generic products in 2Q plus strongerthan-expected appreciation of the NT dollar against the US dollar in 1Q
-
CRAM business and Double A strategy started to gain momentum
-
Providing CMO service for Melinta ’s newly-approved serious skin infections drug, Baxdela™
-
Issued 2016 corporate responsibility report verified by an independent third party
6
==> picture [721 x 136] intentionally omitted <==
Financial & Operating Results 2Q, 2017
7 7
Quarterly P&L - Consolidated
| In NT$ million, except for EPS |
2Q,’17 (Reviewed) |
1Q,’17 (Reviewed) |
2Q,’16 (Reviewed) |
QoQ | YoY | ||
|---|---|---|---|---|---|---|---|
| Operating Revenue | 853 | 919 | 1,015 | -7% | -16% | ||
| Gross Profit | 326 | 470 | 465 | -31% | -30% | ||
| Gross margin | 38% | 51% | 46% | ||||
| Operating Expenses | (240) | (249) | (236) | -4% | 2% | ||
| Operating Income | 86 | 221 | 229 | -61% | -62% | ||
| Operating margin | 10% | 24% | 23% | ||||
| Other Rev.(Exp.) | (7) | (29) | (29) | -76% | -76% | ||
| Net Income before Tax | 79 | 192 | 200 | -59% | -61% | ||
| Net Income after Tax | 84 | 170 | 174 | -51% | -52% | ||
| 8 Net margin after tax 10% 18% 17% EPS (after tax) 0.11 0.22 0.23 -50% -52% |
Net margin after tax | 10% | 18% | 17% | |||
| EPS (after tax) | 0.11 | 0.22 | 0.23 | -50% | -52% |
Half Year P&L - Consolidated
| In NT$ million, except for EPS 1H,’17 (Reviewed) 1H,’16 (Reviewed) YoY |
In NT$ million, except for EPS 1H,’17 (Reviewed) 1H,’16 (Reviewed) YoY |
In NT$ million, except for EPS 1H,’17 (Reviewed) 1H,’16 (Reviewed) YoY |
In NT$ million, except for EPS 1H,’17 (Reviewed) 1H,’16 (Reviewed) YoY |
In NT$ million, except for EPS 1H,’17 (Reviewed) 1H,’16 (Reviewed) YoY |
In NT$ million, except for EPS 1H,’17 (Reviewed) 1H,’16 (Reviewed) YoY |
|---|---|---|---|---|---|
| In NT$ million, except for EPS | 1H,’17 (Reviewed) |
1H,’16 (Reviewed) |
YoY | ||
| Operating Revenue | 1,773 | 2,037 | -13% | ||
| Gross Profit | 796 | 896 | -11% | ||
| Gross margin | 45% | 44% | |||
| Operating Expenses | (488) | (471) | 4% | ||
| Operating Income | 308 | 425 | -28% | ||
| Operating margin | 17% | 21% | |||
| Other Rev.(Exp.) | (36) | (34) | 6% | ||
| Net Income before Tax | 272 | 391 | -30% | ||
| Net Income after Tax | 255 | 346 | -26% | ||
| 9 Net margin after tax 14% 17% EPS (after tax) 0.33 0.46 -28% |
Net margin after tax | 14% | 17% | ||
| EPS (after tax) | 0.33 | 0.46 | -28% |
Balance Sheet - Consolidated
| In NT$ million | 2017/6/30 (Reviewed) |
2017/6/30 (Reviewed) |
2016/6/30 (Reviewed) |
2016/6/30 (Reviewed) |
||
|---|---|---|---|---|---|---|
| Cash and Cash Equivalents | 3,721 | 29% | 2,964 | 24% | ||
| Accounts Receivable | 726 | 6% | 678 | 5% | ||
| Inventories | 1,802 | 14% | 2,062 | 16% | ||
| Long-Term Investments | 391 | 3% | 364 | 3% | ||
| Property, plant & equipment | 5,136 | 40% | 5,355 | 43% | ||
| Other assets | 1,105 | 8% | 1,122 | 9% | ||
| Total Assets | 12,881 | 100% | 12,545 | 100% | ||
| Current Liabilities | 1,365 | 11% | 2,248 | 18% | ||
| L-T Liabilities and Others 1284 10% 339 3% Stockholders’ Equities 10,232 79% 9,958 79% |
L-T Liabilities and Others | 1284 | 10% | 339 | 3% | |
| Stockholders’ Equities | 10,232 | 79% | 9,958 | 79% |
10
Cash Flows - Consolidated
==> picture [721 x 463] intentionally omitted <==
----- Start of picture text -----
1H 2017 1H 2016
In NT$ million
(Reviewed) (Reviewed)
Cash and cash equivalents at
3,707 2,336
beginning of period
Cash flows from operating activities 353 826
Financial assets measured at cost (27) (25)
CAPEX (324) (371)
Short-term borrowings (513) (241)
Long-term borrowings 516 255
Others 9 184
Cash and cash equivalents at
3,721 2,964
end of period
11
----- End of picture text -----
Sales by Business
2017 1H
==> picture [721 x 363] intentionally omitted <==
----- Start of picture text -----
BD
CMO 8%
2016 1H 8%
CRO
CRO CMO BD 8%
4% 1% <1%
Generics
76%
Generics
94%
----- End of picture text -----
12
Sales by Indications
2017 1H
==> picture [674 x 347] intentionally omitted <==
----- Start of picture text -----
Others
2016 1H 20%
CNS
12%
Others
Oncology
CNS
12%
68%
14%
Oncology
74%
----- End of picture text -----
==> picture [13 x 9] intentionally omitted <==
----- Start of picture text -----
13
----- End of picture text -----
Sales by Region
2017 1H
==> picture [675 x 377] intentionally omitted <==
----- Start of picture text -----
CN ROW
JP
2% 11%
7%
2016 1H
India
JP 6%
AU+NZ ROW
US+CAN
6%
3% 7%
39%
India
EU
9%
35%
US+CAN
EU
52%
23%
----- End of picture text -----
==> picture [13 x 9] intentionally omitted <==
----- Start of picture text -----
14
----- End of picture text -----
==> picture [721 x 136] intentionally omitted <==
Business Updates
==> picture [721 x 136] intentionally omitted <==
15 15
Confidential
ScinoPharm Will Be the API Supplier for Melinta’s Baxdela™
-
Taiwan facility will provide commercial manufacturing of API for Melinta’s Baxdela™, a new drug for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) approved by the US FDA
-
Antibiotic resistance is a growing concern, and physicians need more tools in the fight against this threat to modern medicine
-
Approximately 3 million patients hospitalized each year in the U.S. with ABSSSI often present treatment challenges owing to their underlying medical conditions, making optimal antibiotic selection difficult
16
Confidential
The New and Effective Antibiotics
-
Baxdela™ was given priority review by the US FDA due to its designation as a Qualified Infectious Disease Product (QIDP) , which is qualified for certain incentives including a five-year extension of any non-patent exclusivity period awarded to the drug
-
Melinta is also assessing Baxdela™ in a clinical trial in patients with hospital-treated community-acquired bacterial pneumonia (CABP) and planning to initiate a clinical trial in complicated urinary tract infections (cUTI) in the near future
17
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 Oncolo Meloid 1st US ANDA filin trierin US FDA insection* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Oncolo Meloid 1st US ANDA filin trierin US FDA insection* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Oncolo Meloid 1st US ANDA filin trierin US FDA insection* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Oncolo Meloid 1st US ANDA filin trierin US FDA insection* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Oncolo Meloid 1st US ANDA filin trierin US FDA insection* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Oncolo Meloid 1st US ANDA filin trierin US FDA insection* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Oncolo Meloid 1st US ANDA filin trierin US FDA insection* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Oncolo Meloid 1st US ANDA filin trierin US FDA insection* |
|---|---|---|---|---|---|---|---|
| Partner | Product |
Indications |
Region |
Launch Year(E) |
Remarks |
||
| Genovate | Entecavir | Hepatitis B Virus | Taiwan | 2013* | 1st co-developed formulation product launch | ||
| Oncolo | Meloid | 1st US ANDA filin trierin US FDA insection | |||||
| Sagent | gy Injectable |
y Leukemia |
US | 2017 | g, ggg p 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 |
||
| 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 | ||
| 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 18 |
|||||||
| 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 |
2017 Product Launch Plan
| Type Product Region Indication Brand Marketer Regional Sales WW Sales |
Type Product Region Indication Brand Marketer Regional Sales WW Sales |
Type Product Region Indication Brand Marketer Regional Sales WW Sales |
Type Product Region Indication Brand Marketer Regional Sales WW Sales |
Type Product Region Indication Brand Marketer Regional Sales WW Sales |
Type Product Region Indication Brand Marketer Regional Sales WW Sales |
Type Product Region Indication Brand Marketer Regional Sales WW Sales |
Type Product Region Indication Brand Marketer Regional Sales WW Sales |
Type Product Region Indication Brand Marketer Regional Sales WW Sales |
|---|---|---|---|---|---|---|---|---|
| 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 API |
Baxdela™ | 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 |
Source: IMS Data (2015Q3-2016Q2)
Launched
19
==> picture [721 x 136] intentionally omitted <==
uestions Q
& Answers
20
==> picture [721 x 136] intentionally omitted <==
Brand Quality with Asian Advantages www.scinopharm.com
==> picture [721 x 136] intentionally omitted <==
21