Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

SPT Investor Presentation 2014

Aug 25, 2014

51922_rns_2014-08-25_f22b6b6e-0fe7-48c4-826d-8cd56b829aa6.pdf

Investor Presentation

Open in viewer

Opens in your device viewer

==> picture [721 x 136] intentionally omitted <==

==> picture [721 x 136] intentionally omitted <==

ScinoPharm Management Presentation

TWSE 1789

August 7, 2014

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 cause actual results to differ from those such may materially implied by forward-looking statements.

2

Table of Content

==> 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 <==

  • Overview of ScinoPharm

  • Financial & Operating Results

  • First US ANDA filing allied with SAGENT

  • Product Launch Table

  • Q&A

3

==> picture [721 x 136] intentionally omitted <==

Overview of ScinoPharm - An API + ANDA Company

Active Pharmaceutical Ingredients Abbreviated N ew Drug Application

4

Background

  • Established in 1997 in Taiwan by founders from Syntex, listed in 2011, current market cap around US$1.6Bn

  • Major shareholders include Uni-President Group, National Development Fund, Taiwan Sugar, etc.

  • Facility & organization designed & built in Taiwan by experienced Syntex team, received multiple regulatory inspections from US FDA, Australia, EU, Japan, etc.

  • Specializes in high potency (steroid, cytotoxic), peptide, & injectable APIs

Expanding in China with a new plant in Changshu & sales & marketing base in Shanghai

5

Business Overview

  • ScinoPharm has established its leading position in Oncology APIs and is integrating into formulation; running two GMP compliant facilities in Taiwan & China, and building an injectable plant in Taiwan

  • Developed 70+ generic APIs with 26 launched. Filed 47 DMFs in US (674 DMFs WW), a leader in oncology injectable APIs with 22 US DMFs

  • 80+ NCE CRAMs projects, with 6 in phase III for NDA filing in 2-3 years & 5 already launched. The only company in Asia supplying APIs for multiple commercial NCEs

6

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 unmet oncological medical needs of high prevalence in Asia

7

Keys to Generic Formulation Biz

  • Expanding formulation portfolio:

  • Injectable (oncology & non-oncology): 11 drugs planned

  • Oral (oncology & non-oncology): 10 drugs plannedOphthalmic: 3 drugs planned

  • To be launched in 2016 through 2024

  • Building on-site oncological injectable facility and establishing a complete supply chain

  • Sustaining B2B model, promoting our formulations via strategic alliance, especially in China and US

  • Acquiring critical resources via M&A

8

==> picture [721 x 136] intentionally omitted <==

Financial & Operating Results

9

Quarterly P&L - Consolidated

In NT$ million, except for EPS
2Q,’14
(Reviewed)
1Q,’14
(Reviewed)
2Q,’13
(Reviewed)
QoQ
YoY
In NT$ million, except for EPS
2Q,’14
(Reviewed)
1Q,’14
(Reviewed)
2Q,’13
(Reviewed)
QoQ
YoY
In NT$ million, except for EPS
2Q,’14
(Reviewed)
1Q,’14
(Reviewed)
2Q,’13
(Reviewed)
QoQ
YoY
In NT$ million, except for EPS
2Q,’14
(Reviewed)
1Q,’14
(Reviewed)
2Q,’13
(Reviewed)
QoQ
YoY
In NT$ million, except for EPS
2Q,’14
(Reviewed)
1Q,’14
(Reviewed)
2Q,’13
(Reviewed)
QoQ
YoY
In NT$ million, except for EPS
2Q,’14
(Reviewed)
1Q,’14
(Reviewed)
2Q,’13
(Reviewed)
QoQ
YoY
In NT$ million, except for EPS
2Q,’14
(Reviewed)
1Q,’14
(Reviewed)
2Q,’13
(Reviewed)
QoQ
YoY
In NT$ million, except for EPS
2Q,’14
(Reviewed)
1Q,’14
(Reviewed)
2Q,’13
(Reviewed)
QoQ
YoY
In NT$ million, except for EPS 2Q,’14
(Reviewed)
1Q,’14
(Reviewed)
2Q,’13
(Reviewed)
QoQ YoY
Net Sales 1,148 1,097 1,339 5% -14%
Gross Profit 500 433 724 15% -31%
Gross margin 44% 40% 54%
Operating Expenses (287) (250) (267) 15% 7%
Operating Income 213 183 457 16% -53%
Operating margin 19% 17% 34%
Other Rev.(Exp.) (1) 2 11 -107% -102%
Net Income before Tax 212 185 468 15% -55%
Net Income after Tax
193
165
406
16%
-53%
Net margin after tax
17%
15%
30%
EPS (after tax)
0.28
0.24
0.60
17%
-53%
Net Income after Tax 193 165 406 16% -53%
Net margin after tax 17% 15% 30%
EPS (after tax) 0.28 0.24 0.60 17% -53%

10

Half Year P&L - Consolidated

In NT$ million, except for EPS
1H,’14
(Reviewed)
1H,’13
(Reviewed)
YoY
In NT$ million, except for EPS
1H,’14
(Reviewed)
1H,’13
(Reviewed)
YoY
In NT$ million, except for EPS
1H,’14
(Reviewed)
1H,’13
(Reviewed)
YoY
In NT$ million, except for EPS
1H,’14
(Reviewed)
1H,’13
(Reviewed)
YoY
In NT$ million, except for EPS
1H,’14
(Reviewed)
1H,’13
(Reviewed)
YoY
In NT$ million, except for EPS
1H,’14
(Reviewed)
1H,’13
(Reviewed)
YoY
In NT$ million, except for EPS 1H,’14
(Reviewed)
1H,’13
(Reviewed)
YoY
Net Sales 2,245 2,524 -11%
Gross Profit 933 1,379 -32%
Gross margin 42% 55%
Operating Expenses (538) (534) 1%
Operating Income 395 845 -53%
Operating margin 18% 33%
Other Rev.(Exp.) 2 30 -92%
Net Income before Tax 397 875 -55%
Net Income after Tax 358 756 -53%
Net margin after tax 16% 30%
EPS (after tax) 0.53 1.12 -53%

11

Balance Sheet - Consolidated

==> picture [721 x 383] intentionally omitted <==

----- Start of picture text -----

2014/6/30 2013/6/30
In NT$ million
(Reviewed) (Reviewed)
Cash and Cash Equivalents 2,184 18% 3,379 29%
Accounts Receivable 793 7% 870 7%
Inventories 2,676 23% 2,288 20%
Long-Term Investments 255 2% 273 2%
Fixed Assets 4,658 40% 3,897 33%
Total Assets 11,795 100% 11,702 100%
Current Liabilities 2,569 22% 2,527 22%
L-T Liabilities and Others 66 -% 66 -%
Stockholders’ Equities 9,160 78% 9,109 78%
----- End of picture text -----

12

Cash Flows - Consolidated

==> picture [721 x 428] intentionally omitted <==

----- Start of picture text -----

1H 2014 1H 2013
In NT$ million
(Reviewed) (Reviewed)
Cash and cash equivalents at
2,289 3,035
beginning of period
Cash flows from operating activities 248 457
CAPEX (694) (506)
-
Long-term investment (107)
Short-term borrowings 317 491
Others 24 9
Cash and cash equivalents at
2,184 3,379
end of period
----- End of picture text -----

13

Sales by Business

1H 2013

1H 2014

==> picture [330 x 236] intentionally omitted <==

----- Start of picture text -----

CRO
>1%
CMO
30%
Generic
70%
----- End of picture text -----

==> picture [333 x 256] intentionally omitted <==

----- Start of picture text -----

CRO
3%
CMO
20%
Generic
77%
----- End of picture text -----

14

Sales by Indications

==> picture [674 x 308] intentionally omitted <==

----- Start of picture text -----

1H 2014
1H 2013
Others Others
5% 16%
CNS
CNS
36% Oncology 19% Oncology
59% 65%
----- End of picture text -----

15

Sales by Region

==> picture [96 x 19] intentionally omitted <==

----- Start of picture text -----

1H 2013
----- End of picture text -----

1H 2014

==> picture [721 x 272] intentionally omitted <==

----- Start of picture text -----

Rest of AU & NZ ROW Rest of AU & NZ ROW
Asia 4% <1% Asia 4% <1%
14% 9%
India
India
13%
12%
US & CAN
US & CAN
50%
EU EU 49%
20% 25%
----- End of picture text -----

16

==> picture [721 x 136] intentionally omitted <==

First US ANDA Filing Allied with Sagent

17

Background on Sagent

Sagent Pharmaceuticals (Nasdaq: SGNT), ScinoPharm’s long term customer, is a leading specialty pharma emphasizing on the injectable. Sagent has well-developed marketing channels into hospitals throughout the US

Sagent’s China facility -- Sagent (Chengdu) is one of the few US FDA-qualified injectable plants in China. The company has also produced the first batch of oncological injectable products approved for direct export from China to the US

18

Collaboration in Oncological Product

  • ScinoPharm and Sagent have jointly developed and produced an oncological injectable product used for the treatment of myeloid leukemia

  • Its market value exceeded US$280 million in 2013 WW, while US$250 million from the US

  • ANDA has been submitted to the US FDA, which will help trigger FDA to audit ScinoPharm’s Changshu site (SPC) and enable SPC’s volume API shipments into the US regulated market

  • Commercial launch upon US FDA approval, expected as early as late 2016

19

Collaboration Scheme

  • ScinoPharm Taiwan developed the API and lyophilized formulation processes

  • ScinoPharm Changshu produces the API

  • Sagent’s China affiliate in Chengdu prepares the injectable formulation

  • Sagent leads filing the ANDA with the US FDA and eventually marketing this drug after launch

20

Collaboration Flow Chart

==> picture [702 x 361] intentionally omitted <==

----- Start of picture text -----

Successfully
developed API and
formulation
Outsourcing
ScinoPharm formulation
Taiwan
US
Sagent
Sagent
Outsourcing US Market
China
Injectables
API API
Sales/
Formulation
Marketing
OEM
ScinoPharm in the US
Changshu
File ANDA
API OEM
US FDA
on-site audit
----- End of picture text -----

21

21

==> picture [721 x 136] intentionally omitted <==

2014 Product Launch Plan

==> picture [721 x 136] intentionally omitted <==

22

2014 Product Launch Plan

API Region Indications Brand Marketer Regional Sales WW Sales
Azacitidine US MDS,
Anti-cancer
Celgene US$358MM* US$818MM*
Dantrolene
(injectable)
US Malignant
hyperthermia
JHP
Pharmaceuticals
US$20MM* US$46MM*
Decitabine US MDS, AML
Anti-cancer
Eisai US$250MM* US$289MM*
Docetaxel
trihydrate
JP Anti-cancer Sanofi Aventis US$180MM
(Taxotere)**
US$1,422MM*
Entecavir TW Hepatitis B virus BMS US$67MM*** US$1,413MM*
Exemestane US Breast cancer Pfizer US$99.5MM* US$300.1MM*
Riluzole
(liquid)
EU Amyotrophic
lateral sclerosis
Sanofi Aventis US$66MM* US$187MM*
Zoledronic acid JP Osteoporosis Novartis US$120MM*** US$1,361MM*

Source: * IMS Data (Year 2013)

Launched

* Datamonitor In-house research**

23

Confidential

==> picture [598 x 119] intentionally omitted <==

Brand Quality with Asian Advantages

www.scinopharm.com

24