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Page 1: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

AUGUST 2017TICKER: 4167

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Page 2: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

DISCLAIMER

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This presentation has been provided by Savior Lifetec Corporation (SLC) for informational purposes only. It is not an offer to buy or sell or a solicitation of an offer to buy or sell any security issued by SLC or other parties.

This presentation may contain forward-looking statements which reflect SLC management’s views, estimates, and currently available information. These statements are SLC management’s opinion and SLC does not provide warranty for the accuracy, reliability, and completeness of the information. Investors should not place undue reliance on the statements, as there are significant risks that could cause actual results or future developments to differ materially from those expressed or implied by forward looking statements. Potential risks include economic conditions, foreign exchange fluctuations, competitive product and pricing pressures, and regulatory developments.

SLC has no obligation to update any forward-looking statement or figures, whether as a result of new information, future events, or otherwise.

Page 3: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

關於展旺

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Current Products and Products in Development➢ Penem Injectables➢ Non-Penem Injectables

Company Scale➢ ~500 Employees➢ 2016 Annual Revenues NT$1.5bn

Industry Leadership➢ Top 3 Global Penem Supplier➢ One of Leading Suppliers of Meropenem ➢ Taiwan’s Largest Injectable Supplier by US Sales➢ Amongst the Few Drug Manufacturers Compliant With

US/EU/JP GMP(Fewer Than 10 Out Of 113 Taiwan Manufacturers)

Page 4: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

SLC Challenges

How can we change our business model to increase our

profit potential?

Current Products

What is our product development strategy? How can we leverage our current platform and experience? Which products should we target

for development?

New Products

💉

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Page 5: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

Stage 4New

Antibiotics

Stage 3 Non-Penems

Stage 2 Penem Vials US Market

Stage 1 Penem APIAbout to take off

Enablers

Reverse Engineering

Quality Infrastructure

Vertical Integration Complex

ChemistryR&D Expertise

Low Cost Structure

Vertical Integration

Regulatory Expertise

時間Current

Savior StrategyStages 1 and 2 have been completed. SLC is making progress in Stages 3 and 4

2016Gretai

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Page 6: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

Agenda

Entering the US Market

New Antibiotics

Breaking Even

Ertapenem

Non-Penems

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Entering the US Market

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Source: Internal

The proportion of injection increased significantly

1% 5% 11% 4% 5% 8%

23%

46% 50%

0100200300400500600700800900

1000

1H13 2H13 1H14 2H14 1H15 2H15 1H16 2H16 1H17

FDF Other

(NT$mn)

Double-A StrategySLC is now Taiwan’s largest injectable suppler by US sales

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Page 9: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

Breaking Even

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2Q17 2Q16 YoY 1H17 1H16 YoY

Net Sales 444 348 28% 910 641 42%

COGS 282 307 629 620

Gross Profit 162 41 296% 281 21 1238%

Gross Margin 37% 12% 31% 3%

Operating Expense 88 93 (5%) 167 183 (9%)

Operating Income 74 (52) 114 (162)

Operating Margin 17% (15%) 13% (25%)

Non-Op Income (Expense) (28) (9) (55) (16)

Net Income 46 (61) 59 (178)

Net Margin 10% (18%) 6% (28%)

EPS 0.19 (0.25) 0.24 (0.72)

Cash & Cash Equivalents 879 388 127%

1H17 Financials3 consecutive quarters of profit

Page 11: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

Turned to profit for three consecutive quarters

3Q16 4Q16 1Q17 2Q17

Net Income(NT$K) (48,883) 19,630 13,130 45,699

EPS (0.20) 0.10 0.05 0.19

Savior’s Last 4 quarters of net income and earnings/share

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FinancialsProfitability began in September 2016

Page 12: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

Ertapenem

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The positioning of Ertapenem

Background➢ Broad spectrum antibiotic ➢ Does not include pseudomonal coverage(Nonpseudomonal) ➢ Different from other Penem products➢ Used primarily for Community Acquired G- infections

(coverage of over 98%)➢ 1x a day, which reduces hospital labor costs and patient complications

Increasing antibiotic resistance➢ Cephalosporin and Quinolone resistance becoming severe in regards to

G- infections (coverage of less than 80%)➢ More than 20% treatment failure in urethra, kidney, abdominal and

other➢ Urgent unmet medical needs

Page 14: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

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Ertapenem Clinical UsageGram Positive Cocci Gram Negative Bacilli

AnaerobesMRSA MSSA Streptococci

E.Coli,KlebsiellaPseudomonas ESCAPPM*

Proteus

Amoxicillin(Penicillin)

Amoxicillin-Clavulanate(Penicillin + BLI)

Amoxicillin-Clavulanate(Penicillin + BLI)

Piperacillin-Tazobactam(Penicillin + BLI)

Piperacillin-Tazobactam(Penicillin + BLI)

Moxifloxacin(Fluoroquinolone)

Moxifloxacin(Fluoroquinolone)

Ceftriaxone(Cephalosporin)

Cefepime(Cephalosporin)

Meropenem(Carbapenem)

Imipenem-Cilastatin(Carbapenem)

Ertapenem(Carbapenem)

Ertapenem(Carbapenem)

Daptomycin(Lipopeptide)

Ertapenem is generally prescribed to treat nonpseudom-onalG- infections. Ertapenem is administered once a day, which lowers hospital labor costs and patient complications

Note: ESCAPPM organisms are Enterobacter spp.,Serratia spp.,Citrobacter freundii.,Aeromonasspp.,Proteus spp.,Providencia spp.,Morganella morganii

Source: Wellington ICU Drug Manual

Page 15: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

Determinants of Ertapenem Launch Timing

Ertapenem PIV ANDA DA

► July 2014 ANDA filing

► October 2016 US FDA EIR

► Expected to complete the contracting in the second half

Litigation

► US District Court has ruled the‘323 Orange Book patent as valid, and the ‘150 patent as invalid

► Merck is appealing.

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US$/1g

Ertapenem price trend

The Price of originate product is still increasing in US

Ertapenem’s Primary Market is the US

According to Merck’s report2016 Erta US sales : US $ 329mn

Source: CMS

Page 16: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

Source: Internal,IMS HealthAssumptions: Intended to provide a basic sensitivity analysis and do not represent the company’s formal guidance

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20163

Generics2

Generics1

Generic

US Market

Brand NSP (US$/Unit) 83

Brand Volume (Vials,mn) 4.0 4.0 4.0 4.0

Generic Penetration Assumption 85% 75% 40%

Generic Volume (Vials,mn) 3.4 3.0 1.6

Marketer Economics

Generic Market Share Assumption 30% 45% 100%

Volume (Vials,mn) 1.0 1.4 1.6

NSP (US$/Unit) Assumption 42 54 62

Sales (US$mn) 42 76 99

Ertapenem US Market Sensitivity AnalysisOrder Of ANDA Filing:Sandoz (Withdrawal), Hospira, SLC

Page 17: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

New Antibiotics

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Source: US FDA

In The Past Few Decades, Antibiotic Approvals Have DeclinedThis is due to technological, financial, and regulatory hurdles

0

1

2

3

4

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1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014

Number of Approvals

From 2002-13, the US FDA had only approved 7 new antibiotics

After QIDP, from 2014-2017, there have been 8 approvals

Page 19: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

Source: US Government Accountability Office Report Jan-2017

QIDP drugs receive an additional 5 years exclusivity. For instance, if an NCE was entitled to 5 years of exclusivity under Hatch Waxman, if the drug received QIDP status, it would receive 10 years of exclusivity.

Exclusivity

Priority ReviewThe FDA would decrease the target review time from 10 months to 6 months.

The FDA would increase communications, allow partial reviews. Fast Track

QIDP Advantages

THE 8 APPROVED QIDP ANTIBIOTICS

QUALIFIED INFECTIOUS DISEASE STATUS>100 new antibiotic development case obtained QIDP qualification(Admission rate of 90%)

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ChemicalTrade Name

FormFDA

Approval Date

Sponsor OriginatorIMS Avg

Price (US$/unit)

Est. Peak Market(US$mn)

Dalbavancin Dalvance Vials 2014/5/23 Allergan Durata 1,133 215

Tedizolid SivextroTabletVials

2014/6/20 Merck Cubist 265 615

Oritavancin Orbactiv Vials 2014/8/6

The Medicines Company

Eli Lilly 815 126

Ceftolozane-tazobactam

Zerbaxa Vials 2014/12/19 Merck Cubist 88 1,387

Ceftazidime-avibactam

Avycaz Vials 2015/2/25 Allergan Forest Labs 278 375

Isavuconazole CresembaTabletVials

2015/3/6 Basilea Basilea 77 NA

Bezlotoxumab Zinplava Vials 2016/10/21 Merck Medarex NA NA

Delafoxacin BaxdelaTabletVials

2017/6/19 Melinta Wakunaga NA NA

Source: FDA, US Government Accountability Office Report Jan-2017, Springer, IMS, Bloomberg, Various

THE 8 APPROVED QIDP ANTIBIOTICSAlmost all QIDP drugs are acquired or authorized by large pharmaceutical companies

Page 21: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

The US Congress is heavily subsidized to encourage the development of new antibiotics

(BARDA>$550mn/5yrs Non-Dilutive Funding).

QIDP makes it easier for these companies to fundraise

80% of antibiotic developers are small developers

Small developers are more likely to need CDMO partners

SLC plays key role in the new penem developement

QIDP status is especially useful for small developers

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New Drug Development Partnership Will Drive Revenue GrowthSavior is well positioned to collaborate with antibiotic developers

Savior and Global pharmaceutical companies signed a new drug development agreement on 2017/07/03

►The new drug development agreement Milestones totaling US$6mn, payment due after specified milestone events

Page 23: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

Non-Penems

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Page 24: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

Source: Symphony Health

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Generic Name Type Indications2016

US WAC (US$mn)

SLC-019 Small MoleculeNiche Injectable

ANDA

Muscle Relaxant 160

SLC-025 Hypotension 366

SLC-024 Nausea 357

SLC-006 Sustained Depot Complex InjectableWith IP Protection

Prostate CancerEndometriosis

2,774

SLC-021 Schizoaffective 1,530

SLC-010 Type II diabetes 779

Non Penem Injectable ProjectsNon penems are the mid/long-term revenue drivers, revenue contributions expected in 2020

Page 25: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

►API Tech Platforms►Biological recombinant peptide

expression►Solid phase peptide synthesis (SPPS)►Bio-chemical conjugation technology

►Sustained Release Formulation Tech Platforms►Microcapsule continuous process

manufacturing technology►Nanocrystal Formulation Tech Platforms

►Nanocrystal manufacturing technology

Key Steps ► January 2018 API and filling lines construction

completion►Apply for TFDA inspections, comply with TFDA

GMP►Complete high-speed filling lines►Complete US FDA GMP

Tech Platform

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Chunan-2 Site

Chunan-2 Site Map

Non-Penem Site PlanningPenem facilities need to be dedicated, Non-penem facilities will be at a different site

Page 26: AUGUST 2017 TICKER: 4167 · 關於展旺 3 Current Products and Products in Development Penem Injectables Non-Penem Injectables Company Scale ~500 Employees 2016 Annual Revenues NT$1.5bn

Q&A


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