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SPT Interim / Quarterly Report 2017

Feb 23, 2018

51922_rns_2018-02-23_671d62dd-c3cb-4986-b743-c0dd1abc9f7c.pdf

Interim / Quarterly Report

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1789 TT

ScinoPharm Taiwan, Ltd. Fourth Quarter 2017 Investor Meeting

February 23, 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

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Company Overview and Key Priorities

Operating Results

Business Highlights and Company Outlook

3

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Company Overview and Key Priorities

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4

ScinoPharm at a Glance

  • ScinoPharm specializes in high potency (steroid/cytotoxic) APIs and injectable provider, serving customers worldwide

  • Facility & offices established in Taiwan and expanding in China with a new GMP plant in Changshu & marketing base in Shanghai

  • 73 generic APIs in current portfolio with 25 APIs launched; 56 US DMFs filed (767 DMFs WW), 33 US DMFs in oncology APIs. 100+ NCE CRAM projects, with 6 NDAs launched and 4 in phase III

  • 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

5

Driving Long Term Growth by Dual Profits

Self-Developed Products

Contract Services

  • Target difficult-to-make (peptide)API in our portfolio

Tap into drug product related to our API core competencies

  • Target 505(b)(2) and Paragraph IV drug product via strategic alliances

Provide CRO/CMO for APIs

Offer integrated service from API to formulation for niche injectables

  • Provide biologics fill & finish CMO services

6

World Class Facilities

Taiwan

China

API Plant

  • 5 of 16 production lines equipped with high potency capabilities for cytotoxic/steroid

  • Provides comprehensive contract research & manufacturing services for brand drug companies

Injectable Plant

  • Vial and cartridge production lines for oncological and peptide products

  • To meet US, EU, Japan GMP standards with adopting state-of-the-art isolator technology and single use technology for product contact path

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API Plant

  • 3 of 7 production lines equipped with high potency capabilities for cytotoxic

  • US FDA approved cGMP facility for intermediates & high potency API

  • Full scope capabilities in the development and production of APIs on small to large scales for generic & CRAM markets

  • Strategic partnerships with China clients with downstream formulations and mutually target for global and China markets

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7

We Value Our R&D

  • Strong focus on R&D with +125 experts (Ph.D:27)

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16%
84%
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 R&D investments remain stable

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Strong API Portfolio for Generic Product

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36
40 unlaunched
35 launched
30
25 23
20
13
15
10 7 7 6
13 4
5 6 2 2 2 3
6
3
4
2 2 3
1 1
0
Note: Other (Women's Health, Gastrointestinal, Immunology and Metabolic)
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Note: Other (Women's Health, Gastrointestinal, Immunology and Metabolic)

9

ScinoPharm - Oncology API Leader

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Stand-Alone API Companies

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ScinoPharm 32 21
Shilpa 12 11 3
Polymed 10 2 3
MacChem Products 6 5 2 # Oncology DMF Overlap with SPT
Laurus Labs 8 7 16 # Non-overlapping Oncology DMF
# Other DMFs
Sichuan Xieli 1 2 1
Chemwerth 3 5 34
Apicore 5 8 27
0 10 20 30 40 50 60
Large Generic Pharmaceutical Companies
ScinoPharm 32 21
Teva 18 28 264
Dr. Reddy's 14 13 176
Cipla 11 17 128
Sun 17 12 164
Hisun 11 19 44
# Oncology DMF Overlap with SPT
Qilu 8 3 8
# Non-overlapping Oncology DMF
Hengrui 3 3 11 # Other DMFs
0 50 100 150 200 250 300
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Source: US FDA DMF Q2 2017 database

10

Focus Drug Product Pipeline- on Complex Generics

Indication Format Enter Barrier & Advantage
Osteoporosis Pen Complex Drug-Device Combination
Diabetes Pen Complex Drug-Device Combination
Anti-thrombotic Syringe Complex API
Multiple Sclerosis Syringe Complex API
Antineoplastic Lyo Difficult to make API and Formulation
Anti nauseant Lyo Difficult to make API and Formulation
Antineoplastic Lyo,Vial Difficult to make API
Antineoplastic Lyo Difficult to make API, Complex Route of Delivery
and Formulation
Antineoplastic Lyo Difficult to make API
Antineoplastic Lyo,Vial Difficult to make API
Antineoplastic Lyo,Vial Difficult to make API and Formulation
Antineoplastic Vial ExistingAPI
Antineoplastic Vial ExistingAPI
Antineoplastic Vial ExistingAPI

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Potential Headwinds & Tailwinds

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Headwind

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Tailwind

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  • Generic business continues facing negative pricing environment

  • Increased consolidation among the

  • US distribution supply chains  More and faster ANDA approvals leading to quicker price erosion  Fewer small molecule blockbuster drugs invented

  • Impact of patent linkage and patent term extension in Taiwan

 Pipeline of complex generics benefits from a faster approval cycle and higher margins

  • CRAMs grow faster than the pharma

  • Pharmerging markets are expected to grow due to increasing geriatric population and healthcare expenditure

12

Focused Execution into 2018

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Expanding into formulation business by synergizing with our APIs - Complete the production of 4 registration batch drug products

  • Establish partnership for self-developed drug products

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Strengthening Manufacturing and Quality

  • Create leaner and flexible cost structures by improving operating efficiency, RD productivity and portfolio optimization

  • Comply with the modern strict environmental laws in China

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Near term CRO projects pose to propel the company to next level - Focus on targeted therapies and orphan drugs /first in class or best in class - Provide integrated service from API to formulation for niche injectable

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Continuous process optimization on our existing APIs

  • Maintain market share and profits of our major products

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Operating Results

14

Quarterly P&L - Consolidated

In NT$ million, except for EPS Q4 2017
(Unaudited)
Q3 2017
(Reviewed)
QoQ Q4 2016
(Audited)
YoY
Revenue 895 100% 849 100% 5%
-24%
1,002 100% -11%
2%
Cost of Goods Sold (548) -61% (441) -52% (559) -56%
Gross Profit 347 39% 407 48% -15%
3%
444 44% -22%
-6%
OperatingExpense (247) -28% (256) -30% (234) -23%
Operating Income 100 11% 152 18% -34%
10%
210 21% -53%
-928%
Non-operatingIncome,Net (23) -3% (25) -3% 3 0%
Income before Tax 77 9% 127 15% -39% 213 21% -64%
Net Income 61 7% 107 13% -43% 147 15% -59%
0.08 0.14 0.19
EPS (NT$)
*Weighted average outstandingshares were 790.739m units in 4Q17.

15

Profit & Loss - Consolidated

(note)
In NT$ million, except for EPS FY 2017
(Unaudited)
FY 2016
(Audited)
YoY
Revenue 3,516 100% 4,031 100% -13%
12%
Cost of Goods Sold (1,966) -56% (2,225) -55%
Gross Profit 1,550 44% 1,806 45% -14%
-6%
OperatingExpense (991) -28% (938) -23%
Operating Income 559 16% 868 22% -36%
-45%
Non-operatingIncome,Net (84) -2% (58) -1%
Income before Tax 475 14% 811 20% -41%
Net Income 422 12% 659 16% -36%
0.53 0.83
EPS (NT$)
EBITDA 986 28% 1,294 32% -24%
* Total outstandingshares were 790.739m units at 12/31/2017.

Note: 2016 vs 2017: 5.96% NTD appreciation against USD YoY

16

Profit & Loss (ScinoPharm stand-alone)

(note)
In NT$ million, except for EPS FY 2017
(Unaudited)
FY 2016
(Audited)
YoY
Revenue 3,449 100% 3,889 100% -11%
13%
Cost of Goods Sold (1,778) -52% (2,041) -52%
Gross Profit 1,671 48% 1,848 48% -10%
-11%
OperatingExpense (870) -25% (782) -20%
Operating Income 801 23% 1,066 27% -25%
-28%
Non-operatingIncome,Net (313) -9% (244) -6%
Income before Tax 489 14% 822 21% -41%
Net Income 422 12% 659 17% -36%
0.53 0.83
EPS (NT$)
EBITDA 823 24% 1,178 30% -30%
* Total outstandingshares were 790.739m units at 12/31/2017.

Note: 2016 vs 2017: 5.96% NTD appreciation against USD YoY

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Sales by Business

FY2017

FY2016

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Sales by Indications

FY2017

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FY2016

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Sales by Region

FY2017

FY2016

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Balance Sheet- Consolidated

(In NT$ million) 2017/12/31
(Unaudited)
2016/12/31
(Audited)
Cash and Cash Equivalents 3,911
567
1,675
391
5,089
1,068
31%
4%
13%
3%
40%
9%
3,707
638
1,830
364
5,209
1,035
29%
5%
14%
3%
41%
8%

Accounts Receivable
Inventories
Long-Term Investments
Property,Plant & Equipment
Other Current/Non-Current Assets
Total Assets 12,701 100% 12,783 100%
Current Liabilities 1,115
1,169
9%
9%
1,692
863
13%
7%
Long-Term & Other Liabilities
Total Liabilities 2,284 18% 2,555 20%
Total Shareholders' Equities
Key Indices
A/R Turnover (Days)
Inventory Turnover (Days)
Current Ratio (x)
ROE (%)
10,417 82% 10,228 80%
65.6
434.5
5.8
4.1
71.6
405.6
3.9
6.6
A/R Turnover (Days)
Inventory Turnover (Days)
Current Ratio (x)
ROE (%)

21

Cash Flows- Consolidated

(In NT$ million) FY 2017
(Unaudited)
FY 2016
(Audited)
From Operating Actavities 972 1,665
Profit before tax 475
434
209
811
447
449
Depreciation & Amortization
Net change in workingcapital
From Investing Actavities (437) (202)
Capital expenditure (402) (447)
From Financing Actavities (314) (138)
Short-term loans (584)
518
(228)
204
(720)
803
(219)
1,371
Long-term loans
Cash dividends
Net Change in Cash
Beginning Balance 3,707 2,336
Ending Balance 3,911 3,707
Free Cash Flow 570 1,218

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Business Highlights and Company Outlook

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Focusing on Weathering Near-Term Headwinds While Positioning for Long-Term Growth

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2017 2018 2019 and beyond
• Industry headwinds •
• Market conditions
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market conditions,
leading to price erosion
and volume decline
Gained some, lost some
in CRAM business
China site still faced a
financial loss
Focused on cost
reductions and portfolio



expected to continue
Sales from CRAM projects
are expected to boost
Speed up momentum of
downstream integration
strategy by establishing
alliance with partner
Aggressively expand
formulation products
Further cost reductions




expected to improve
Continue investment in
growth opportunities
Maintain high level of
quality and compliance
Strong pipeline to drive
growth from:
- CRAM business
- Drug products business
optimization and portfolio optimization
Accelerate progress to
create positive cash flow
for Changshu site

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  • Developing dossiers per our high-entry-barrier APIs to increase value proposition in the supply chain

  • Building a pipeline of complex and difficult to make generic injectable products

  • Significant investment in injectable R&D in the next few years

  • Quality driven, diversified manufacturing operations

  • Promoting our formulations via strategic alliance, especially in China and US

  • Acquiring critical resources via M&A

Expected > 15 drug product launched in the next 5 years

Introducing 3 to 4 drug products per year in our pipeline

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2018 In-House Injectable Plant Progress

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First Half
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Second Half

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 Kick-off registration batch
production for other
products and offering CMO
services for both brand and
proprietary drugs
 Expected submission of 1st
in-house produced ANDA
 Taiwan FDA on-site
inspection
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  • Already launched

Strate ic Alliance Hi hli hts g g g

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
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 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
US partner Project A Non-small cell
lung cancer
US 2018 US NDA 505(b)(2) / The estimated launch year
is subject to litigation results
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
Fondaparinux Anti-thrombotic US/EU 2018 1st self-developed US ANDA submitted .
Executive right for marketing & sales

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CRAM Business Gaining Momentum

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  • CRAM business is on track to regain growth momentum

  • Sales from CMO will be boosted by Melinta's newly launched Baxdela™ , indicated for acute skin infections (ABSSSI), and other shipment by the CRO projects

  • Baxdela™ , expected to become top 5 products in 2018, is designated as a qualified infectious disease product (QIDP)and enjoys a five-year extension of any non-patent exclusivity period

  • More indications on the way for Baxdela™ include Serious Community-Acquired Bacterial Pneumonia (CABP) in Phase III and Complicated Urinary Tract Infections (CUTI) in Phase I

  • Four CRO projects in Phase III trials are expected to file NDAs in 2018/2019 and if successful could result in the drugs being launched in 2019/2020 with incremental sales

28

CRO Phase III Products Portfolio

NDA Filing
Year(E)

Indication
Region Remarks
2018 Type I,II
Diabetes
US/ EU Intermediate project made both in
Changshu & Taiwan sites. Expected revenue
of several million USD per year after launch
2018 Advanced
Hepatocellular
Carcinoma,
Myelofibrosis,
Autoimmune disease
CN API project made in Changshu site. CFDA
granted accelerated review under its
category 1.1 innovative drug. Anticipated
launch in 2019 with demand in tons
2018 Prostate Cancer US / EU Started process validation. Anticipated
launch in 2019 and revenue of several
million USD per year
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

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China Market Dynamics

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  • China has paved the way for integration with global standard and move up to key positions in value chain, requiring dedication to quality and innovation

  • Tightened GMP, Environment/Health/Safety laws and drug

  • license approval process significantly raise the cost structure  Full Market Authorization Holder (MAH) rolled out creating a sizable demand in high-quality CDMO services  Reduction of application backlog and review timeline acceleration for NDA and China+US dual-track drug filing

30

ScinoPharm Changeshu - Capturing Chinese Growth on Multiple Fronts

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Position as a gateway into China providing supplychain to MNCs

Adopt dual-track drug filing process in China and the US

Seek generic APIs or intermediates with large demand to increase production utilization

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Focus on mid- to late-phase CRO projects. Current portfolio includes agents for oncology, anti-hypertension, and diabetes

Tighten cost control and process optimization with enhanced management

As the back up site for generic API after the Implementation of patent term extension

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Maintain Market Share of Existing APIs - 2017 Major Products account for 50 % of total sales

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API Product
Indication
MKT share
# of US DMF/EDMF
& other filings
Irinotecan HCI
Antineoplastic
37%
64
Exemestane
Antineoplastic
25%
46
Paclitaxel
Antineoplastic
21%
60
Gemcitabine
Antineoplastic
17%
76
Docetaxel
Anhydrous
Antineoplastic
15%
72*
API Product
Indication
MKT share
# of US DMF/EDMF
& other filings
Irinotecan HCI
Antineoplastic
37%
64
Exemestane
Antineoplastic
25%
46
Paclitaxel
Antineoplastic
21%
60
Gemcitabine
Antineoplastic
17%
76
Docetaxel
Anhydrous
Antineoplastic
15%
72*
API Product
Indication
MKT share
# of US DMF/EDMF
& other filings
Irinotecan HCI
Antineoplastic
37%
64
Exemestane
Antineoplastic
25%
46
Paclitaxel
Antineoplastic
21%
60
Gemcitabine
Antineoplastic
17%
76
Docetaxel
Anhydrous
Antineoplastic
15%
72*
API Product
Indication
MKT share
# of US DMF/EDMF
& other filings
Irinotecan HCI
Antineoplastic
37%
64
Exemestane
Antineoplastic
25%
46
Paclitaxel
Antineoplastic
21%
60
Gemcitabine
Antineoplastic
17%
76
Docetaxel
Anhydrous
Antineoplastic
15%
72*
API Product Indication MKT share* # of US DMF/EDMF
& other filings
Irinotecan HCI Antineoplastic 37% 64
Exemestane Antineoplastic 25% 46
Paclitaxel Antineoplastic 21% 60
Gemcitabine Antineoplastic 17% 76
Docetaxel
Anhydrous
Antineoplastic 15% 72

*Source: IMS data from Newport

32

2018 Product Launch Plan

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Type Product Region Indication Brand
Marketer
Regional
Sales
WW Sales
Generic
API
Tamsulosin
HCl
CN Benign Prostatic
Hyperplasia (BPH)
Boehringer
Ingelheim
US$97MM US$1,652.8MM
Generic
API
Flumazenil JP Reversal of Conscious
Sedation and General
Anesthesia
Roche US$13.5MM US$76.1MM
Generic
API
Capecitabine JP Antineoplastic Roche US$122MM US$834.7MM
Generic
Drug
Oncology
Injectable
US Myeloid
Leukemia
MDS US$175.9MM US$284.4MM
Generic
Drug
Fondaparinux US Anti-thrombotic Mylan US$75.1MM US$194.9MM

Source: IMS Data (2016Q3-2017Q2)

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Pipeline Outlook Timeline

  • 3 generic APIs launched

  • 5-7 generic APIs launched

  • 3 in-house drug ANDAs filed

    • 2 co-developed China ANDAs
  • 1[st] BD & 1[st ] self-developed US ANDA launched3 APIs by CRAM customers launched

  • 3 NDAs filed by CRAM customers 2018 2019 2020 2021

    • 3 APIs by CRAM customers launched
  • 5-7 generic APIs launched

  • 1 BD US ANDA launched

  • 3 APIs by CRAM customers launched

  • US FDA inspection at Injectable plant

  • CFDA inspection at Changshu site

  • 6-8 generic APIs launched

  • 3 BD & 1 self-developed ANDA launched

  • 5 APIs by CRAM customers launched

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Four Key Pillars to Achieve Strategic Roadmap

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BUILD
strong pipelines of complex drug
products / APIs and expand
geographic presence
CONTINUE
to drive transformation and
operational excellence through
leadership, people and culture
FOSTER
partnership and collaboration to
increase value and capture untapped
opportunity
FOCUS
long term value creation for our
shareholders
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Brand Quality with Asian Advantages

www.scinopharm.com

1789 TT

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