AI assistant
SPT — Investor Presentation 2015
Oct 8, 2015
51922_rns_2015-10-08_5afc7c28-ec2a-4ce4-a3a8-d6fc7737561a.pdf
Investor Presentation
Open in viewerOpens in your device viewer
TWSE 1789
ScinoPharm Management Presentation
1
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
2
Confidential
Table of Content
- Overview of ScinoPharm
==> 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 <==
- ScinoPharm’s Strategies and Opportunities
� Operating Results & Outlook
3
3
Overview of ScinoPharm - an API + ANDA Company
Active Pharmaceutical Ingredients Abbreviated New D A rug pplication
Background
-
Established in 1997 in Taiwan and listed on TWSE in 2011, current market cap around US$830 million
-
Major shareholders include Uni-President Group, National Development Fund, Taiwan Sugar, etc.
-
Facility & organization built in Taiwan by experienced Syntex team, received multiple regulatory inspections from US FDA, EU, Australia, Japan, etc.
-
Specializes in high potency (steroid/cytotoxic) APIs and expands to injectable formulations
-
Expanding in China with a new GMP plant in Changshu & marketing base in Shanghai
5
5
World Class API Facilities
Taiwan
-
6.6 hectares of land, 330K sqft facilities with >200M[3] reactor volume
-
8 of 18 production lines equipped with high potency capabilities for cytotoxics/steroids
-
US FDA approved & 250+ CGMP audits by customers
-
Provides comprehensive contract research & manufacturing services for brand drug companies
-
Global Market
China
-
6.6 hectares of land with ~250M[3 ] reactor volume
-
2 of 8 production lines equipped with high potency capabilities for cytotoxics
-
cGMP designed facility for intermediates & high potency API
-
Full scope capabilities in developing and manufacturing APIs from small to large scale for generic & CRAM
-
Global market including China
==> picture [311 x 132] intentionally omitted <==
==> picture [187 x 112] intentionally omitted <==
6
Confidential
Business Overview
� Risk & return balanced model to offer APIs and fill/finish capability for both generic and new drugs
- 70 generic APIs developed with 27 APIs launched; 50 US DMFs filed (711 DMFs WW), 24 US DMFs in oncological APIs
� 80+ NCE CRAM projects, with 5 launched and 7 in phase III for NDA filing in 2-3 years; Qualified Asian supplier to provide APIs to global market for multiple commercial NCEs
7 7
7
Confidential
Strong Generics Product Portfolio
==> picture [527 x 307] intentionally omitted <==
==> picture [7 x 13] intentionally omitted <==
----- Start of picture text -----
8
8
----- End of picture text -----
==> picture [13 x 10] intentionally omitted <==
----- Start of picture text -----
11
----- End of picture text -----
Sales Breakdowns
==> picture [230 x 37] intentionally omitted <==
----- Start of picture text -----
Confidential
By Indication
----- End of picture text -----
By Business
==> picture [721 x 271] intentionally omitted <==
----- Start of picture text -----
By Region
Generic
77%
1H 2015
9
9
----- End of picture text -----
Confidential
Oncology as Worldwide Top 1 Therapy
Source: Evaluate Pharma
==> picture [721 x 136] intentionally omitted <==
==> picture [11 x 8] intentionally omitted <==
----- Start of picture text -----
10
----- End of picture text -----
==> picture [12 x 8] intentionally omitted <==
----- Start of picture text -----
19
----- End of picture text -----
Confidential
ScinoPharm – Global Oncological API Leader
==> picture [652 x 167] intentionally omitted <==
==> picture [652 x 167] intentionally omitted <==
11
Confidential
Targeted Therapy Dominates Oncology
==> picture [721 x 331] intentionally omitted <==
----- Start of picture text -----
Supportive care
1%
Protein
Kinase
Immunotherapy Inhibitor
23% Targeted
60%
therapy
Hormonal
60%
therapy
14% mAb
20%
ADC 11%
Chemotherapy
Others 9%
2% Source: 2020 Sales Forecast, Global Data
12
24
----- End of picture text -----
==> picture [75 x 9] intentionally omitted <==
----- Start of picture text -----
Confidential
----- End of picture text -----
ScinoPharm Pipeline Echoes Therapy Trend
==> picture [721 x 332] intentionally omitted <==
----- Start of picture text -----
Supportive
care 5%
Genito Urinary System & Ophthalmology Hematological
Sex Hormones 2% 2% disorder 2%
Respiratory 4%
Gastrointestinal 5%
Hormonal
therapy
Infectious disease
21%
8%
Oncology
36%
Targeted
Cadiovascular 8%
therapy
74%
Immunology
10%
Metabolic
CNS disorder 13%
10%
13
25
----- End of picture text -----
Diversified CRAM Portfolio
Confidential
| Confidential Diversified CRAM Portfolio |
Confidential Diversified CRAM Portfolio |
Confidential Diversified CRAM Portfolio |
Confidential Diversified CRAM Portfolio |
Confidential Diversified CRAM Portfolio |
Confidential Diversified CRAM Portfolio |
|---|---|---|---|---|---|
| Stage First Launch Year Indication Location Commercial 2005 Eluting Stent US Commercial 2009/2013 Skin Infection/HAP US/EU |
|||||
| Stage | First Launch Year | Indication | Location | ||
| Commercial | 2005 | Eluting Stent | US | ||
| Commercial | 2009/2013 | Skin Infection/HAP | US/EU | ||
| Commercial | 2011 | Depression | US | ||
| Commercial | 2012 | Obesity | US | ||
| Commercial | 2013 | Seizure | US | ||
| Stage | Est. NDA Filing Year | Indication | Location | ||
| Phase III | 2014 | Infections | US | ||
| Phase III | 2016 | Prostate & Ovarian Cancer | EU | ||
| ~~11~~ 14 Phase III 2017 Prostate Cancer US Phase III 2016-2017 Ovarian Cancer CN Phase III 2017 Seizure US Phase III 2017 Parkinson’s Disease US Phase III 2017 Opioid-Induced Constipation US 14 |
Phase III | 2017 | Prostate Cancer | US | |
| Phase III | 2016-2017 | Ovarian Cancer | CN | ||
| Phase III | 2017 | Seizure | US | ||
| Phase III | 2017 | Parkinson’s Disease | US | ||
| Phase III | 2017 | Opioid-Induced Constipation | US |
Strategic Alliances for Formulation
*** Already launched**
| Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch* |
|---|---|---|---|---|---|---|---|
| Partner | Product | Indications | Region | Launch Year(E) |
Remarks | ||
| Genovate | Entecavir | Hepatitis B Viral | Taiwan | 2013* | 1st co-developed formulation product launch |
||
| Sagent | Oncological Injectable |
Myeloid Leukemia | US | 2016 | 1st US ANDA filing to trigger US FDA inspection in Changshu site |
||
| Foresee | Leuprolide | Prostate cancer | US | 2018 | 505(b)2 NDA CRAM + Equity | ||
| Coland | Bortezomib | Multiple Myeloma | China | 2019 | 1st co-developed drug in China to trigger CFDA inspection in Changshu |
||
| Azacitidine | MDS | China | 2019 | Co-developed formulation | |||
| Lee’s Pharma Fondaparinux Anti-thrombotic China 2019 1st self-developed drug in China Travoprost Bimatoprost Glaucoma China 2020 Co-developed formulations Nanjing King Friend Regadenoson Stress agent for heart scan China 2020 1st type 3.1 co-developed new drug in China |
Lee’s Pharma | Fondaparinux | Anti-thrombotic | China | 2019 | 1st self-developed drug in China | |
| Travoprost Bimatoprost |
Glaucoma | China | 2020 | Co-developed formulations | |||
| Nanjing King Friend |
Regadenoson | Stress agent for heart scan |
China | 2020 | 1st type 3.1 co-developed new drug in China |
15
==> picture [721 x 136] intentionally omitted <==
ScinoPharm’s
Strategies and Opportunities
==> picture [721 x 136] intentionally omitted <==
Confidential
Long Term Strategies
- Transforming to a full scope pharma company per our core competency of R&D and cGMP manufacturing in high-technical barrier APIs
-
:
-
Vertical Integration to Generic Formulations Developing dossiers per our difficult-to-make APIs to increase value proposition in the supply chain
-
:
-
Innovative Delivery Formulations Targeted delivery & extended release of proven APIs via 505(b)2 fast track
-
:
-
Brand New Chemical Entities (New Drugs) Collaborating with academic research institutes, focusing on un-met oncological medical needs of high prevalence in Asia
17
Keys to Generic Formulation Business
-
Expanding formulation portfolio: Two US ANDA filed
-
Building on-site oncological injectable facility and establishing a complete supply chain
-
Acquiring critical resources via M&A
-
Sustaining B2B model, promoting our formulations via strategic alliance, especially in China and US
18
Confidential
Golden Opportunities in China
-
Government’s strong support carrying into 13[th] five-year plan to encourage pharma industry’s CAGR of 20%
-
Tighten GMP requirements to align with US/EU
-
Motivate drug makers to improve quality by applying for US ANDAs, which need SPT’s world class APIs
-
MNCs and emerging virtual-model players create huge needs in API contract manufacturing in China for compliance
-
ScinoPharm timely captures oncological API needs via importing from Taiwan and local made in Changshu sites
19
19
Policy Reforms to Expedite Drug Approvals
-
Redefine new drugs and generics in China
-
Elevate the overall quality and efficacy requirements of submissions
-
Encourage innovative drugs via fast track approval
-
Allow new drug developers to own drug licenses without manufacturing sites
-
Clear the application backlog by discouraging redundant filings and fee raises
-
Impose severe penalties on fraudulent data/activities on research & trials
This reform will significantly lift the cost structure & entry barrier to Chinese market, with a heavy focus on quality and innovation
20
8
==> picture [721 x 136] intentionally omitted <==
Operating Results & Outlook
==> picture [721 x 136] intentionally omitted <==
Half Year P&L - Consolidated
| In NT$ million, except for EPS 1H,’15 (Reviewed) 1H,’14 (Reviewed) YoY Net Sales 1,942 2,245 -13% |
In NT$ million, except for EPS 1H,’15 (Reviewed) 1H,’14 (Reviewed) YoY Net Sales 1,942 2,245 -13% |
In NT$ million, except for EPS 1H,’15 (Reviewed) 1H,’14 (Reviewed) YoY Net Sales 1,942 2,245 -13% |
In NT$ million, except for EPS 1H,’15 (Reviewed) 1H,’14 (Reviewed) YoY Net Sales 1,942 2,245 -13% |
In NT$ million, except for EPS 1H,’15 (Reviewed) 1H,’14 (Reviewed) YoY Net Sales 1,942 2,245 -13% |
In NT$ million, except for EPS 1H,’15 (Reviewed) 1H,’14 (Reviewed) YoY Net Sales 1,942 2,245 -13% |
|---|---|---|---|---|---|
| In NT$ million, except for EPS | 1H,’15 (Reviewed) |
1H,’14 (Reviewed) |
YoY | ||
| Net Sales | 1,942 | 2,245 | -13% | ||
| Gross Profit | 709 | 933 | -24% | ||
| Gross margin | 37% | 42% | |||
| Operating Expenses | (442) | (538) | -18% | ||
| Operating Income | 267 | 395 | -32% | ||
| Operating margin | 14% | 18% | |||
| Other Rev.(Exp.) | 99 | 2 |
4850% |
||
| Net Income before Tax | 366 | 397 | -8% | ||
| Net Income after Tax | 245 | 358 | -32% | ||
| Net margin after tax | 13% | 16% | |||
| EPS (after tax) | 0.35 | 0.51 | -31% |
22
Balance Sheet - Consolidated
| In NT$ million 2015/6/30 (Reviewed) 2014/6/30 (Reviewed) Cash and Cash Equivalents 2,410 20% 2,184 18% |
In NT$ million 2015/6/30 (Reviewed) 2014/6/30 (Reviewed) Cash and Cash Equivalents 2,410 20% 2,184 18% |
In NT$ million 2015/6/30 (Reviewed) 2014/6/30 (Reviewed) Cash and Cash Equivalents 2,410 20% 2,184 18% |
In NT$ million 2015/6/30 (Reviewed) 2014/6/30 (Reviewed) Cash and Cash Equivalents 2,410 20% 2,184 18% |
In NT$ million 2015/6/30 (Reviewed) 2014/6/30 (Reviewed) Cash and Cash Equivalents 2,410 20% 2,184 18% |
In NT$ million 2015/6/30 (Reviewed) 2014/6/30 (Reviewed) Cash and Cash Equivalents 2,410 20% 2,184 18% |
In NT$ million 2015/6/30 (Reviewed) 2014/6/30 (Reviewed) Cash and Cash Equivalents 2,410 20% 2,184 18% |
|---|---|---|---|---|---|---|
| In NT$ million | 2015/6/30 (Reviewed) |
2014/6/30 (Reviewed) |
||||
| Cash and Cash Equivalents | 2,410 | 20% | 2,184 | 18% | ||
| Accounts Receivable | 568 | 5% | 793 | 7% | ||
| Inventories | 2,315 | 19% | 2,676 | 23% | ||
| Long-Term Investments | 339 | 3% | 255 | 2% | ||
| Property, plant & equipment | 5,142 | 43% | 4,658 | 40% | ||
| Other assets | 1,100 | 10% | 1,229 | 10% | ||
| Total Assets | 11,874 | 100% | 11,795 | 100% | ||
| Current Liabilities | 2,333 | 19% | 2,569 | 22% | ||
| L-T Liabilities and Others | 91 | 1% | 66 | 0% | ||
| Stockholders’ Equities | 9,450 | 80% | 9,160 | 78% |
23
Cash Flows - Consolidated
==> picture [721 x 279] intentionally omitted <==
----- Start of picture text -----
1H 2015 1H 2014
In NT$ million
(Reviewed) (Reviewed)
Cash and cash equivalents at
1,928 2,289
beginning of period
Cash flows from operating activities 589 248
CAPEX (345) (694)
Short-term borrowings 212 317
Others 26 24
Cash and cash equivalents at
2,410 2,184
end of period
----- End of picture text -----
24
2015 Product Launch Plan
| API | Region | Indications | Brand Marketer | Regional Sales | WW Sales | |
|---|---|---|---|---|---|---|
| Azacitidine | US | MDS Oncology | Celgene | US$323MM* | US$815MM* | |
| Benazepril | CN | Hypertension, CV | Novartis | US$65MM** | US$480MM* | |
| Desmopressin | US | Polyuria | Ferring | US$131MM* | US$395MM* | |
| Letrozole | JP | Breast Cancer | Novartis | US$51MM** | US$581MM* | |
| Tamsulosin | US | Benign prostatic hyperplasia (BPH) |
Boehringer Ingelheim |
US$335MM* | US$1,829MM* | |
| Launched | ||||||
| Source: * IMS Data | (2013Q3-2014Q2) | ** In-house research | ||||
| 25 | ||||||
| 24 |
Pipeline Outlook
==> picture [721 x 330] intentionally omitted <==
----- Start of picture text -----
� 4-5 new launches � 5-6 new launches � 5-6 new launches
� 1 [st] co-developed US � 1 [st ] home-made drug US � 3 drug products launched in China
ANDA launched � 1 [st ] home-made drug launched in US
ANDA filing
2015 2016 2017 2018 2019 2020
� 3-5 new launches � 4-5 new launches � 6-8 new launches
� SPC US FDA inspection � 1 [st] self-developed US � SPC China FDA inspection
� 1 [st] self-developed US ANDA launched � 3 drug products launched in China
ANDA filing � US FDA inspection at INJ
26
26
----- End of picture text -----
Confidential
==> picture [647 x 89] intentionally omitted <==
Brand Quality with Asian Advantages
www.scinopharm.com
==> picture [721 x 136] intentionally omitted <==
----- Start of picture text -----
27
----- End of picture text -----