AI assistant
SPT — Investor Presentation 2013
Jan 30, 2013
51922_rns_2013-01-30_6b7ad8ec-7b25-4e17-9f8c-1a9ab348e25e.pdf
Investor Presentation
Open in viewerOpens in your device viewer
==> picture [349 x 193] intentionally omitted <==
==> picture [344 x 208] intentionally omitted <==
ScinoPharm Management Presentation
==> picture [39 x 55] intentionally omitted <==
TWSE 1789
January, 2013
1
Confidential
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 forwardlooking 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 Content
Overview of ScinoPharm
Financial & Operation Results ScinoPharm’s opportunities and competition in China API Market Business Outlook
Q&A
3
Overview of ScinoPharm - An Active Pharmaceutical Ingredient Company
4
Confidential
Background
-
Established in 1997 in Taiwan by founders from Syntex, current market cap ~ US$1.3 billion
-
Major shareholders include Uni-President Group, Government’s Development Fund, Taiwan Sugar, etc.
-
Facility & organization built by experienced team from Syntex
-
Brand new facility designed & built in Taiwan, received multiple inspections of US FDA and authorities from Australia, EU, Japan, etc.
-
Specialized in high potency (steroid & cytotoxic) & injectable APIs
5
Confidential
Company Overview
-
Maintain dominant position in Specialty APIs for generic market. Established strong presence in US/EU generic market, some channeled through Indian generic companies. Aggressively developing Japanese and Chinese markets
-
Developed ~60 generic APIs with 21 launched. Filed 43 DMFs in US (631 DMFs WW), leader in supplying oncology injectable APIs with 20 US DMFs
-
70+ NCE CRAMs projects, with 5 in phase III with NDA filing in 2-3 years & 4 already launched. The only company in Asia supplying API for multiple NCEs for commercial
6
World Class Facilities
Taiwan
China
-
6.6 hectares of land, 330K sqft facilities with >200M[3] reactor volume after 2 large product lines expansion
-
Eight of our production lines are equipped with the special capability to produce APIs used in high-potency sterile injections
-
US FDA approved & >200 GMP audits by customers
-
Provides comprehensive contract research services for brand drug companies
Global market
==> picture [311 x 171] intentionally omitted <==
-
With nearly 250M[3] reactor volume
-
The first phase completed in Q1, 2012. The second phase completed in Q1/Q2 2013
-
cGMP designed facility for intermediates & high potent API
-
Complete capabilities in API development, and manufacturing from small to large scale for global and China generic as well as CRAMs (Contract Research And Mfg Services) markets
-
Global market including China
==> picture [305 x 172] intentionally omitted <==
7 7
Recent developments in SPT & SPC
- SPT’s Bay 5 has started production in December 2012, Bay 4 will start production in early 2013
SPC’s phase I production facilities have obtained pharmaceutical production permits from local authorities
SPC’s phase I small, mid, and large production lines (total of 4 production lines and 2 clean areas) have completed IQ/OQ and started full production in September
8
Confidential
ScinoPharm - Oncological API Leader
==> picture [698 x 220] intentionally omitted <==
==> picture [636 x 247] intentionally omitted <==
9
Comparison among Taiwan API peers ScinoPharm is a leader in DMFs and Patents
| ScinoPharm | Other Taiwanese API Co.’s |
Other Taiwanese API Co.’s |
Other Taiwanese API Co.’s |
|
|---|---|---|---|---|
A |
B | C | ||
| # of DMFs | 43 | 14 | 11 | 9 |
| # of patents since 1997 |
38 | 9 | 6 | 5 |
10
CPhI
Convention on Pharmaceutical Ingredients CPhI holds more than 5 major exhibits/year
-
CPhI Madrid, Oct. 9-11, 2012
-
CPhI India, Nov. 21-23, 2012
-
CPhI California w/ informEx, Feb. 20-22, 2013
-
CPhI Japan, Apr. 24-26, 2013
-
CPhI China, Jun. 25-27, 2013
-
CPhI Germany, Oct. 22-24, 2013
11
ScinoPharm at CPhI Madrid
==> picture [576 x 386] intentionally omitted <==
Convention center
12
ScinoPharm at CPhI Madrid
==> picture [571 x 383] intentionally omitted <==
Convention entrance
13
ScinoPharm at CPhI Madrid
==> picture [571 x 396] intentionally omitted <==
==> picture [200 x 16] intentionally omitted <==
----- Start of picture text -----
ScinoPharm Booth
----- End of picture text -----
14
ScinoPharm at CPhI Madrid
==> picture [578 x 387] intentionally omitted <==
ScinoPharm meeting with clients
15
ScinoPharm at CPhI Madrid
==> picture [594 x 398] intentionally omitted <==
Business meetings
16
ScinoPharm at CPhI Madrid
==> picture [588 x 394] intentionally omitted <==
==> picture [196 x 23] intentionally omitted <==
----- Start of picture text -----
Business meetings
----- End of picture text -----
17
ScinoPharm at CPhI Madrid
==> picture [554 x 395] intentionally omitted <==
==> picture [196 x 23] intentionally omitted <==
----- Start of picture text -----
Business meetings
----- End of picture text -----
18
ScinoPharm at CPhI Madrid
==> picture [587 x 393] intentionally omitted <==
ScinoPharm delegates
19
ScinoPharm at CPhI Madrid
During 10/9~11 at CPhI Madrid, ScinoPharm had
Meetings with more than 100 clients
-
Categories of clients
: -
Generic pharma
:65% -
New drug co.’s
:20% -
Others
:15% (incl. agents and starting material suppliers)
20
Observations from CPhI on API industry
Central/Eastern Europe generic market is ScinoPharm has connected to the market fast-growing – Brazil in South America and Indonesia in South East Asia are two potential markets India’s strategy to bring global recognition to its quality
EU’s new regulations on API imports
21
Financial & Operation Results
22
P&L - Consolidated
| NT$MM, except EPS | 1~3Q, 2012 (reviewed) |
1~3Q, 2011 (reviewed) |
YoY |
|---|---|---|---|
| Net Sales | 3,168 | 2,824 | 12% |
| Gross Profit | 1,601 | 1,387 | 15% |
| Gross margin | 50% | 49% | |
| OperatingExpense | (735) | (600) | 23% |
| OperatingIncome | 866 | 787 | 10% |
| Operating margin | 27% | 28% | |
| Other Rev.(Exp.) | 16 | (24) | 167% |
| Net Income after Tax | 748 | 639 | 17% |
| Net margin before tax Net margin after tax |
28% 24% |
27% 23% |
|
| EPS(after tax) | 1.15 | 1.02 | 13% |
EPS are calculated based on weighted average number of outstanding shares
23
Balance Sheet- Consolidated
| **Balance Sheet- Consolidated ** | **Balance Sheet- Consolidated ** | **Balance Sheet- Consolidated ** | **Balance Sheet- Consolidated ** | **Balance Sheet- Consolidated ** |
|---|---|---|---|---|
| NT$MM | 2012/09/30 (reviewed) |
2011/09/30 (reviewed) |
||
| Cash and Cash Equivalents | 2,303 | 24% | 3,195 | 36% |
| Accounts Receivable | 959 | 10% | 669 | 7% |
| Inventories | 1,962 | 20% | 1,403 | 16% |
| Long-Term Investments | 150 | 2% | 195 | 2% |
| Fixed Assets | 3,609 | 38% | 3,099 | 35% |
| Other Assets | 562 | 6% | 404 | 4% |
| Total Assets | 9,545 | 100% | 8,965 | 100% |
| Current Liabilities | 853 | 9% | 651 | 7% |
| L-T Liabilities and Others | 30 | 0% | 27 | 0% |
| Stockholders’ Equities | 8,662 | 91% | 8,287 | 93% |
24
Cash Flows- Consolidated
| NT$MM | 1~3Q, 2012 (reviewed) |
1~3Q, 2011 (reviewed) |
|---|---|---|
| Cash and cash equivalents at beginningofperiod |
3,294 | 1,908 |
| Cash flows from operating activities | 314 | 922 |
| CAPEX | (619) | (497) |
| Cash flows from financing activities | (631) | 898 |
| Other Investing activities | (55) | (36) |
| Cash and cash equivalents at end ofperiod |
2,303 | 3,195 |
25
Sales by Business
==> picture [70 x 13] intentionally omitted <==
----- Start of picture text -----
2011 1-9
----- End of picture text -----
2012 1-9
==> picture [720 x 227] intentionally omitted <==
----- Start of picture text -----
CRO, 2% [CMO, 9% ]
CMO, 15%
CRO, 3%
Generic, 82%
Generic, 89%
----- End of picture text -----
26
Sales by Indications
==> picture [411 x 284] intentionally omitted <==
----- Start of picture text -----
2011, 1-9
Others,
15%
CNS, 16%
Oncology,
69%
----- End of picture text -----
==> picture [385 x 282] intentionally omitted <==
----- Start of picture text -----
2012, 1-9
Others,
11%
Oncology,
57%
CNS, 32%
----- End of picture text -----
27
Confidential Confidential
Sales by Region
2011, 1-9
2012, 1-9
ROW <1%
ROW <1%
==> picture [364 x 217] intentionally omitted <==
----- Start of picture text -----
Asia
US & CAN
20%
AU & NZ 38% US & CAN
4% EU 47%
30%
EU
29% Asia
26%
----- End of picture text -----
==> picture [351 x 209] intentionally omitted <==
----- Start of picture text -----
Asia
US & CAN
26% US & CAN
33%
36%
AU & NZ
EU
5%
32% EU
33% Asia
28%
----- End of picture text -----
Out of the 20% Asia sales in 2012, India was 11%, rest of Asia was 9%
28
ScinoPharm’s opportunities and competition in China API Market
29
Confidential
China API market trends
- Government’s 12[th] five-year plan sets a goal for pharmaceutical industry to grow at a CAGR of 20%, and
Explicitly requires 100% compliant with the latest GMP for nationwide pharma manufacturing. Also encourages pharma co.’s to apply for int’l certifications. China now ranks #3 in terms of number of US DMFs, only next to India and USA
- To cope with the latest GMP requirements, China pharma co.’s face stiff challenges
30
Confidential
ScinoPharm aims on China Market
-
ScinoPharm exports APIs to China market and has 6 customers
-
ScinoPharm Changshu complies with latest GMP standards and will benefit from the reduced competition after 12[th] five-year plan drives out disqualified companies
-
ScinoPharm’s specialty in oncology APIs meets China market demands: China oncology drug market ranks #2. Among top 20 oncology drugs, ScinoPharm provides 9 APIs
-
ScinoPharm cooperates with its US/EU customers to import drugs that have high unmet needs in China
31
Confidential
SPC’s Strategic Goals
Short-term goal: 1 year Expand capacities – To be able to produce intermediates and provides expanded capacities for SPT
Mid-term goal: 3 years
Adopt Double A (API+ANDA) business model – To team up with pharma co.’s to apply for ANDA in US/EU and export final drug products globally. Currently already has APIs working with customers to apply for ANDA Long-term goal: 5 years Penetrate into China domestic market – To develop 1[st] API to be sold domestically in China and 1[st] imported drug in 5 years. Aggressively penetrate into high-margin oncological and specialty API markets
32
Confidential
ScinoPharm Vs. Chinese API Peers
ScinoPharm
Chinese API Peers
Focus on high entry-barrier oncological APIs. Less competition, higher margin
Mostly producing lower entrybarrier APIs. Fierce competition, lower margin
Marketing globally, competitive in technology and quality
Has built a stronghold in global API market and started vertical integration
Mostly focusing on domestic market, products and quality are not competitive globally To fulfill 12[th] 5-yr plan, develop internationally and vertically
3
“ ” ScinoPharm’s Double A plan
Strategic Alliance ScinoPharm is in discussion with one of the top 3 Chinese pharma co.’s to develop oncological drugs for China market
Drug Product Co-development ScinoPharm is partnering with a marketer and a formulation producer to co-develop oncology injectables for China market
Vertical Integration ScinoPharm will vertically integrate to develop dossiers for difficult-to-make APIs and to increase our value proposition in the supply chain
34
Business Outlook
35
2013 Product Launch Plan
| API | Region | Indications | Brand Marketer |
Regional Sales | WW Sales |
|---|---|---|---|---|---|
| Azacitidine | US | MDS, Anti-neoplastic |
Pharmion | US$331.3MM* | US$729.7MM* |
| Decitabine | US | MDS, Anti-neoplastic |
MGI Pharma | US$238.0MM* | US$249.1MM* |
| Docetaxel Anhydrous, Trihydrate |
JP | Anti-neoplastic | Sanofi Aventis | US$236.9NM** | US$2,051MM* |
| Modafinil | US | Antinarcolepsy | Cephalon | US$1,219MM* | US$1,319M* |
| Paclitaxel JP |
Anti-neoplastic | Bristol Myers | US$307.1MM** | US$1,654M* | |
| Riluzole US |
ALS | Sanofi Aventis | US$55.0MM* | US$237.1MM* | |
| Topiramate | US | Seizures | Customer | NDA ( FDA tentative approval) |
Source: * Newport/IMS Data In-house research**
36
Outlook
-
Sustain Leadership Position in Oncological Injectable APIs Continue developing small molecule oncological injectable APIs and expand into other areas with high technology barriers including Peptides
-
Expand Presences in China
Expansion of API business to timely capture the Chinese market facing increasingly stringent GMP requirement
- Japanese Market Penetration
Establishing strategic partnerships with major pharma companies in Japan and expect to market total 6 products in 2012
Vertical Integration – Double A Strategy Reinforce overall API development and investment return; select difficultto-make APIs to formulate dossiers and provide one-stop services to customers
37
Confidential
==> picture [597 x 119] intentionally omitted <==
Brand Quality with Asian Advantages
www.scinopharm.com
38