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Page I 1 LOTUS PHARMACEUTICAL BUILDING A REGIONAL LEADER November 2018

LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

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Page 1: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 1

LOTUS PHARMACEUTICALBUILDING A REGIONAL LEADER

November 2018

Page 2: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 2

Safe Harbor Statement

Except for historical information contained herein, the matters set forth in this presentation are forward

looking statements that are subject to risks and uncertainties that could cause actual results to differ

materially. These forward looking statements are not based on historical facts but rather on

management’s expectations regarding future growth, results of operations, performance, future capital

and other expenditures, competitive advantages, business prospects and opportunities. Statements in

this presentation about our future plans and intentions, results, level of activities, performance, goals or

achievements or other future events constitute forward looking statements. Wherever possible, words

such as “anticipate”, “believe”, “expect”, “may”, “could”, “will”, “potential”, “intend”, “estimate”, “should”,

“plan”, “predict”, or the negative or other variations of statements reflect management’s current beliefs

and assumptions and are based on the information currently available to our management. Investors

are cautioned not to place undue reliance on these forward looking statements, which are made

as of the date of this presentation and we assume no obligation to update or revise any forward

looking statements.

Page I 2

Page 3: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 3

Table of Contents

Page I 3

Company Overview

3Q 2018 Financial Results and Operational Progress Highlights

Profitable Growth Strategy

Page 4: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 4Page I 4

COMPANY OVERVIEW

Page 5: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 5

LOTUS PHARMACEUTICAL IS AN APAC GENERICS LEADER

1

Page I 5

Founded in 1966Lotus Pharmaceutical is among Taiwan’s largest specialty-generic drug

developers and one of the early movers to export to the US market since 2011

Its portfolio includes CNS, CVS, oncology, women health, anti-obesity, respiratory

and pain relief in forms of tablet, capsule and soft gel capsule

The rising generic leader in APACLotus is positioned as a regional platform for Alvogen Group (63.4% holding in

Lotus) since Aug 2014 through private placement, sharing global commercial,

R&D and regulatory infrastructure

The current operation scope of Lotus spans across Lotus Taiwan’s domestic

business, Alvogen Korea’s domestic business, Alvogen Pharma India’s CRO

business, and export businesses

Capital market milestone

Lotus Pharmaceutical (1795. TWO) has been listed on Taipei Stock Exchange

since 2010 and became a Taiwan Market Biotechnology and Medical Care Index

stock in July 2017 and a TPEx 50 Index stock in April 2018

Extraordinary quality management Lotus’ R&D and manufacturing facilities in Nantou is the only one in Asia that’s

approved by US FDA, EU EMA, Japan PMDA and TFDA PIC/S

1

2

3

4

Page 6: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 6

70+ Generic products in pipeline

2 Biosimilar products in pipeline (mab’s)

8 MAs in the US; 27 MAs in Europe;

10 MAs in Japan; 1 MA in China

A FAST GROWING GENERICS & SPECIALTY PHARMACEUTICAL POWERHOUSE

Lotus facts

Page I 6

1000+ Employees

3 Manufacturing and R&D Centers

300+ Marketed products

150+ Submissions since 2012

10%

18%

23%

49%

Lotus Taiwan EmployeesTotal: 402

G&A

R&D

S&M

Plant

10%

8%

48%

34%

Alvogen Korea Employees Total: 531

G&A

R&D

S&M

Plant

Page 7: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 7

2015-2016

POST MERGERINTEGRATIONPHASE

2017-2018

INITIALGROWTHPHASE

2019~

EXPLOSIVEGROWTHPHASE

LOTUS SEES TANGIBLE PROGRESS TOWARD TRANSFORMATION

Page I 7

• Upgrade Nantou plant

• Change management team

• Reshape Portfolio and

pipeline

• Adjust sales and marketing

strategy

• Resolve legacy issues

• Build key franchises in each

APAC market

• Focus on specialty driven

markets

• Continue to increase

operational efficiency

• US and EU export revenues to

significantly grow

• High value products and

economies of scale to drive up

gross margin

• Strengthen balance sheet

• Invest in key franchises and

become category leader

• More aggressive CAPEX plan

Page 8: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 8

WE STABILIZED IN 2017 AND HAS LAID A SOLID GROWTH GROUND

8

-1000

0

1000

2000

3000

4000

5000

6000

7000

2014 2015 2016 2017 9M2018

4 Year Trend (NT$mn)

Rev. Gross Profit Operating Profit

50%

59% 56% 48%

-19%

8% 4% 8%

48%

7%

Page 9: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 9Page I 9

3Q 2018 FINANCIAL RESULTS

AND OPERATIONAL PROGRESS

HIGHLIGHTS

Page 10: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 10

CONTINUOUS MARGIN IMPROVEMENT AND HISTORICAL-HIGH NET INCOME

BEFORE TAX REPORTED DURING THE QUARTER

Page I 10

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MORE CASH GENERATED FROM OPERATIONS ATTRIBUTABLE TO PROFITABLE

OPERATING RESULTS AND IMPROVED WORKING CAPITAL

Page I 11

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APAC MARKET FRANCHISE SOLIDIFICATION CONTINUES

Page I 12

INN Indication YTD (NT$mn) YoY (%) Remarks

1 Goserelin (Zoladex) Breast cancer 乳癌 420.8 +4%Exclusive marketing alliance with

AstraZeneca KR; launched Oct’16

2 Rosuvastatin/EzetimibeCardiovascular

降血脂與膽固醇396.0 +76% Dosage improved to 1/day

3 Sarpogrelate Anticoagulant 抗凝血 356.3 +18% FDC; launched in 1Q16

4Calcium Polystyrene

SulfonateNephrology 腎臟病 253.0 6%

5 Seroquel (Quetiapine) Schizophrenia 精神分裂症 220.4 -5%Exclusive marketing alliance with

AstraZeneca KR; launched Oct’15

6 Desogestrel/EE (Mercilon)Oral contraceptive

口服避孕藥213.4 +4%

Acquired from Bayer;

launched in May’16

7 Phentermine Anti-obesity 減肥 157.7 -17%

8 Bicalutamide Prostate cancer 攝護腺癌 157.2 -6%Exclusive marketing alliance with

AstraZeneca KR; launched Oct’16

9 Anastrozole (Arimidex) Oncology 癌症 148.6 +7%Exclusive marketing alliance with

AstraZeneca KR; launched 4Q’16

10 Zoledronic Acid (Aclasta) Osteoporosis 骨質疏鬆症 127.2 +11%Acquired from Novartis; launched

Apr’17; TW product

11 Phendimentrazine Anti-obesity 抑制食慾 121.2 -15%

12 Orlistat Anti-obesity 減肥 111.2 -3%

13 Methylprednisolone Anti-infection 抗感染 70.5 +41% Tender driven

14 Trazodone Anti-depression 憂鬱症 48.4 +49% CN product

15 Mifepristone Hormonal 賀爾蒙藥 44.0 +41% TW product

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13

SOLID EXECUTION ON CORE BUSINESS YEAR-TO-DATE

• Top 15 products generated >60% of

total sales and grew 7.5% YoY

• Net cash generated from operations

were NT$661.8mn, displaying a

38% increase

• Resolved IP level legal issues of

Buprenorphine/Naloxone for the US

Page 14: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

14

DRIVING GROWTH WITH INHOUSE PIPELINE

• Pending approval: Budesonide ER

(US FDA), Methotrexate (US FDA),

Lenalidomide(US FDA, still in 30

month stay), Vinorelbine (ROW),

LP149 (ROW), Acarbose (CFDA)

• Approved in 9M2018 and preparing

for launch: Lenalidomide (ROW),

Gefitinib (ROW)

• Approved in 9M2018 and launched:

Norethisterone/Ethinylestradiol

ULD (JP), Varenicline SR (KR),

Bazedoxifene HCL (KR)

• Late R&D phase: LP149 (US),

LP173 (ROW)

Page 15: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 15Page I 15

PROFITABLE GROWTH STRATEGY

Page 16: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

IN A RAPIDLY CHANGING ENVIRONMENT, WHAT MAKES US DIFFERENT 16

ENVIRONMENT

• Shifting demographics

• Political and regulatory

volatility

• High impact therapies for

high demand patients

RESOURCES WE EMPLOY

• Strong collaborations and

partnerships

• Plant and equipment

• Talented employees and

Alvogen culture

HOW WE STAND OUT

• Commitment to internal and

external innovation

• Strong franchises that

enable leadership

• Relentless focus on unmet

medical needs

Page 17: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 17

OUR GOAL FROM NOW TILL 2020– GROWTH, MARKET SHARE, REINVESTMENT

Back to Basics

Value Differentiation

Geared Up For The Future

Page I 17

Profitable

Growth

Page 18: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 18Page I 18

BACK TO BASICS

• Strong Portfolio

• Best Service

• Best Quality

Page 19: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 19

ONLY VERY FEW SELECTED CATEGORIES WILL GROW, AND WE ARE THERE

Page I 19

As a fast follower, what does innovators’ trend tell us?

• Oncology drugs are dominating US approvals

• Global pharma is growing at 10.8% YoY by sales value and nearly 60% of that growth comes

from oncology related and CVS according to IQVIA

• Small volume, high ASP is a must-play for pharma

24

8

2

6

8

10

11

9

19

59

16

9

14

18

13

13

10

16

Cancer

Diabetes

Respiratory

Infections viral

Other infections

Cardiovascular

Genetic

Immunology

CNS/Pain

2012-2017 2007-2011

‘17 TAM +21% YoY

US FDA new drug approval trend

Page 20: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 20

28%

22%

4%3%2%

41%

WE CAN NOT AFFORD TO GO AFTER GENERAL GENERICS ANYMORE

Page I 20

Balanced contribution from 5 main therapeutic areas

18%

19%

9%16%

8%

30%

2017A

What is our portfolio strategy?

• Complex products

• High-barrier oncology products

• OTC and lifestyle products

• Local/regional partnerships and big pharma tail-end brands

15%

23%

9%17%

9%

27% Anti-obesity

CVS

CNS

Oncology

Women health

Others

9M 20182016A

Continue to refine margin profile based on this breakdown

Page 21: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 21

BEST QUALITY MAKES US THE MOST PREFERRED PARTNER OF OUR CUSTOMERS

Lotus quality record

Page I 21

Korea – Gongju Plant Korea – Hyangnam Plant Taiwan – Nantou Plant

Products

• Tablets

• Coated tablets

• Hard capsules

• Powders, granules

• Tablets

• Coated tablets

• Hard capsules

• Powders, granules

• Tablets

• Coated tablets

• Softgel capsules

• Hard capsules

Capacity• Max capacity at 500mn

units of tablets

• Max capacity at 800mn

units of tablets

• Max capacity at 1.5bn

units of tablets

Accreditation • KGMP compliant • KGMP compliant

• US FDA, EU EMA, Japan

PMDA & TFDA PIC/S

approved

• Planning for China CFDA

inspection

Page 22: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 22

LOTUS PHARMACEUTICAL PROVIDES BEST SERVICE IN EVERY ASPECT

1

Page I 22

Growing key markets sales team

70 in-house sales in Taiwan and 299 in-house sales in Korea, covering drug

stores, clinics, general and community hospitals

The best R&D and manufacturing partner

We specialize in formulation development of high potency compounds, phase I,

and other technical services to fulfill the gap among critical CDMO projects.

Achieving vertical integration through CRO capabilities in India

Norwich Clinical Service provides biostudy, clinical and pharmacovigilance

services to Lotus & Alvogen Group and 3rd party customers, and holds an

oncology center in Bangalore, India

1

2

3

Page 23: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 23Page I 23

VALUE DIFFERENTIATION

• High Value Pipeline

• Short Time to Market

• Leader in Special Dosage

Page 24: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 24

Generic Name Indication

IQVIA

market size

(US$mn)

Formulation BE & CT Submission Approval

1Budesonide

ERGI 結腸潰瘍 US: 200

2Buprenorphine/

Naloxone

OUD

戒類鴉片毒癮US: 2,000

3 MethotrexateChemo

癌症US: 340

4 LenalidomideMultiple

Myeloma

血癌US: 7,000

5 Vinorelbine

Breast cancer

and NSCLC

乳癌與非小細胞肺癌

EU: 130

6 LP149 ROWWomen health

女性保健EU& APAC:

110

7 LP650GIST; inhibitor腸胃道間質腫瘤

EU & APAC:

609

THE EMERGING NON-INDIAN PHARMA WITH FIRST WAVE PURSUIT GLOBALLY

To be launched in 2018 - 2021

NO BE

Page I 24

PIV; non-infringement, CRL

PIV; non-infringement

CRL

Focusing high value innovation for patients and customers

NO BE

PIV; sued in US; US technical review done

Page 25: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 25

Generic

NameIndication

IQVIA

market size

(US$mn)

Formulation BE & CT Submission Approval

9 LP173

Late stage

onco for soft

tissues

sarcoma +

renal cell

carcinoma

腎癌、上皮細胞癌、軟組織

肉瘤(皆非一線)

Global: 792

10 LP337

Late stage

hepatocellular

carcinoma,

renal cell

carcinoma,

thyroid

carcinoma

晚期肝細胞癌、晚期腎癌、分化型甲狀腺癌(皆非一線)

EU & APAC:

470

11 LP149 USWomen health;

女性保健FTF

To be launched in 2021 - 2024

Page I 25

200mg

400mg

Page 26: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 26

Generic Name Indication

IMS

Market Size

(US$mn)

Formulation BE & CT Submission Approval

1 Varenicline SRSmoking Cessation

戒菸37

2Bazedoxifene

HCL (FDC)

Osteoporosis

骨質疏鬆18

3Bazedoxifene

(FTF)

Osteoporosis

骨質疏鬆8

4AK-R309

(FTF)

OAB

膀胱過動症24

THE LEADING SPECIALTY IMD DEVELOPER IN KOREA CONTINUES TO AIM HIGH

To be launched in 2018 - 2020

Page I 26

IMD in Korea is similar to US 505b2 filing path with much condensed development and regulatory time

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Page I 27

TIME TO MARKET IS ESSENTIAL AS MARKET SENTIMENT CHANGES

FDA is pro-active on

• Guidance on complex generics

• A basket of products without generics

• Prioritize FTM generics

Page I 27

Increased competitions amid generics market, yet FTM is always favored

Source: FDA

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Page I 28

LOTUS PHARMACEUTICAL IS THE REGIONAL LEADER IN SPECIAL DOSAGE

Soft Gel Manufacturing

• Safety, efficacy, bioavailability and solubility issues dominated

as the most significant factors in developing drug formulations

• According to BCS classification, ~70% of new chemical

entities (NCE) are class 2 or 4

• Lotus is the regional expert in delivering low-dose cytotoxic

and potent APIs as it can ensure dose uniformity, which is a

challenge with traditional tablet manufacturing and powder

capsulation processes

• Investment in dedicated manufacturing area starting 2009 and

current capacity at 500mn capsules / year

Page I 28

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Page I 29Page I 29

GEARED UP FOR THE FUTURE

• Emerging Headway in The China Storm

• Ongoing Investment In Specialty R&D

Page 30: LOTUS PHARMACEUTICAL · 2018-11-14 · Osteoporosis 骨質疏鬆 18 3 Bazedoxifene (FTF) Osteoporosis 骨質疏鬆 8 4 AK-R309 (FTF) OAB 膀胱過動症 24 THE LEADING SPECIALTY IMD

Page I 30Page I 30

10+ molecules in discussion

WE ARE MAKING GOOD PROGRESS IN THIS MARKET WITH RISING QUALITY AWARENESS

01BE study data integrity, tax reform, two-invoice system, and recent vaccine and API

scandal have led to increasing portfolio acquisition activities in China

02We have set up BD and regulatory teams in China in 2017 and identified several

molecules for potential partnerships with Chinese CSO and pharmaceuticals

03Expect to launch ~2 significant products in China before 2020 in addition to at least 3

new submissions to take advantage of climate change

4+ partners in DD phase

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Page I 31Page I 31

CONTINUE BUILDING “SPECIALTY” GENERICS FROM OUR POSITION OF STRENGTH

31

Molecule Exclusivity Status Forum & Success Rate How Not To Infringe

Orphan Drug: 7Y Delaware Seek IPR invalidation

Average NCE: 3Y New Jersey Polymorphic form redesign

Pediatric: N+6M Texas Composition redesign

Not NCE: None Label carve-out

• We focus on BCS Class 2 & 3 projects which

entail complicated in-vivo bioavailability and

bioequivalence studies

• We deploy softgel as a platform for BCS Class

2 & 4 projects

Small volume, High value Complex Molecules

Potential high market share from Complex IP Landscape

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Page I 32

The foundation for vision 2020

FUEL FOR GROWTH

We will continue to set a new standard for our

industry outlined in a simple strategic model

BEST IN CLASS CUSTOMER SERVICE

HIGHEST QUALITY

HIGH OPERTIONAL EFFICIENCY

TARGETED PORTFOLIO

ONLY THE BEST PEOPLE