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MicroPort Scientific Corporation Investment and Strategic Partnership Agreement with Lombard Medical, Inc. December 21, 2016

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Page 1: MicroPort Scientific Corporation Investment and Strategic ... · MicroPort Scientific Corporation Investment and Strategic Partnership Agreement ... MicroPort Transaction Strategic

MicroPort Scientific Corporation

Investment and Strategic Partnership Agreement with

Lombard Medical, Inc.

December 21, 2016

Page 2: MicroPort Scientific Corporation Investment and Strategic ... · MicroPort Scientific Corporation Investment and Strategic Partnership Agreement ... MicroPort Transaction Strategic

Contents

Transaction Overview

Endovascular Market Overview

Overview of Lombard Medical

Key Products Overview: Altura & Aorfix

MicroPort Transaction Strategic Rationale

Q&A

Appendix

Conference Call Agenda

Page 3: MicroPort Scientific Corporation Investment and Strategic ... · MicroPort Scientific Corporation Investment and Strategic Partnership Agreement ... MicroPort Transaction Strategic

Executive Summary

2

MicroPort Management team is pleased to announce an investment and strategic

partnership transaction to expand MicroPort’s Endovascular business.

Lombard Medical is a UK headquartered, Nasdaq publicly traded company (ticker: EVAR)

that manufactures two innovative endovascular devices, Altura and Aorfix, to treat patients

with Abdominal Aortic Aneurysms (AAA).

The proposed transaction will have the following elements:

$5 million equity investment in Lombard common stock (represents 28.85%

ownership)

$10 million convertible bonds issued by Lombard

MicroPort Fully Diluted Ownership in Lombard of approximately 49.1%, assuming

conversion of convertible bonds

2 Board Seats for MicroPort on Lombard’s Board

China manufacturing and distribution rights for Altura and Aorfix

Brazil distribution rights

The Board of Directors for MicroPort and Lombard have approved this transaction

Announcement regarding the transaction was released on 19 December.

MicroPort Management believes this transaction has significant strategic benefits for

its endovascular business and MPSC shareholders

Page 4: MicroPort Scientific Corporation Investment and Strategic ... · MicroPort Scientific Corporation Investment and Strategic Partnership Agreement ... MicroPort Transaction Strategic

Contents Transaction Overview

Page 5: MicroPort Scientific Corporation Investment and Strategic ... · MicroPort Scientific Corporation Investment and Strategic Partnership Agreement ... MicroPort Transaction Strategic

Key Transaction Terms Summary

4

Indicative Terms

Equity Investment • $5 million in Lombard common stock • Issued at Lombard common stock price of $0.62 per share,

representing a discount of 22.59% to Lombard closing stock price (12/16/16)

• MicroPort ownership percentage of approximately 28.85%

Convertible Bond

• Principal Amount: $10 million • Issuer: Lombard • Interest Rate: LIBOR + 4.0%, with a 6-month LIBOR • Term: 5 years, unless earlier repaid by Lombard • Conversion Price: $0.90 per share, representing a premium of

12.37% to Lombard closing stock price (12/16/16) • Shares underlying: approximately 11.1 million Lombard shares • Ranking: Unsecured and subordinated to Lombard’s existing

secured debt

MicroPort Investment Holding Structure

• $4 million of $15 million total investment to be funded by Certain Investors which include: Lead Power, Maxwell, and New Alliance

• MicroPort to have voting control of Equity Investment and Convertible Bond issuance to be held by two MicroPort controlled legal entities : MicroPort NeuroTech (BVI) and MicroPort NeuroTech CHINA (HK)

Page 6: MicroPort Scientific Corporation Investment and Strategic ... · MicroPort Scientific Corporation Investment and Strategic Partnership Agreement ... MicroPort Transaction Strategic

Key Transaction Terms Summary (Cont’d)

5

Indicative Terms

Board of Directors

Post transaction, Lombard’s Board shall consist of 5 members and shall include 2 Board representatives as designated by MicroPort

Strategic Partnership

China Distribution and Manufacturing Rights to Altura and Aorfix • MicroPort shall be granted exclusive commercial and manufacturing

rights for Altura and Aorfix for the Territory which shall include Mainland China, Hong Kong and Macau.

Component Manufacturing Agreement • MicroPort to manufacture certain components of Lombard’s Aorfix

and Altura devices at its endovascular manufacturing facility in Shanghai.

Brazil Registration and Distribution Rights • MicroPort to register Altura and Aorfix with Brazil regulatory body

and exclusive distribute products upon receiving regulatory approval

Parties to finalize agreements for the above within 90 days of Closing

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Contents Endovascular Market Overview

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Endovascular Aortic Repair (EVAR) Market Overview – Large Growing Market with Room for Expansion

7

Medtronic, 34%

Gore, 33%

Endologix, 16%

Cook, 15%

Other, 2%

U.S. Market Share(1)

Medtronic, 42%

Gore, 21%

Endologix, 9%

Cook, 25%

Other, 3%

E.U. Market Share(1)

• Aging and “westernization” of global population

• Conversion from Open Surgical Repair to EVAR – facilitated by technology

• Expanding indications with newer technologies

• Strong reimbursement and screening – SAAAVE Act serving as catalyst for EVAR

• AAA still considerably under-diagnosed: ~10% of all AAAs are diagnosed(1)

____________________

(1) Wall Street Research and “EVAR Update: Companies Target Complex Anatomies With Innovative

Solutions”, MedTech Insight, April 2016.

(2) Lombard Medical 2015 20-F, “Expanding the EVAR Toolbox: A Glimpse into the Future”, MedTech

Insight, March 2012.

$1.4 $1.5 $1.6 $1.7 $1.8 $1.9

2013 2014 2015 2016 2017 2018

USD: billion

55% 30% 25%

45% 70% 75%

0%

100%

2007 2011 2015

Open Surgery EVAR

Market Drivers and Industry Dynamics

Worldwide EVAR Market Size & Growth (1)

EVAR Vs Surgical Repair (2)

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EVAR Evolution of Therapeutic Options

8

Open Surgical Repair EVAR Percutaneous EVAR

(PEVAR)

Percutaneous EVAR (PEVAR) is the least invasive of therapeutic options, only

enabled for by select devices including Lombard’s Altura stent graft

Open Surgical Repair EVAR PEVAR(1)

30-Day Mortality 4.3% 1.8% 0.6%

30-Day Major Adverse Event (MAE) Rate

56% 11% 2.5%

Length of Hospital Stay (Days)

10.4 3.6 2.3

Applicable Devices Aorfix Aorfix Altura

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Global EVAR Landscape

9

United States, ~$714M(1)

•13th leading cause of death in US and the 10th leading cause of death in US men aged 65 years and older

•Each year, 200,000 patients are diagnosed with AAA

•High EVAR volumes and higher selling price

Europe~$477M(2)

• Market was estimated to be $477M in 2014; growing at an average growth rate of 6%

• Germany and the United Kingdom are two of the three largest and the most receptive EVAR markets

Japan, ~$158M(2)

• 2nd largest standalone EVAR market in the world growing at an average rate of 18%

• Highly developed and lucrative market with high barriers to entry

• ~400 physicians at 200 clinics performing EVAR and it is estimated that approximately 55% of Japanese AAA patients are treated using this method

The U.S., Europe and Japan comprise ~90% of the global EVAR marketplace China EVAR market is rapidly growing at 13%

____________________

(1) iData Research Inc.: US Market for Peripheral Vascular Devices and Accessories (2013).

(2) Medtech Ventures: Aortic Intervention Market (2014).

(3) MicroPort internal estimates

.

China, ~$145M(3)

•Rapidly growing market at CAGR of greater than 13%

•Approximately 12,000 annual procedures

•End user pricing consistent with Western markets

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Contents Overview of Lombard Medical

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Lombard Medical An Innovative Vascular Device Company

11

• A global, commercial stage medical technology company with 116 employees

• Corporate headquarters in Oxfordshire, UK

• Focused on the $1.7B(1) abdominal aortic aneurysm (“AAA”) repair market

• Objective – To offer a patient focused, innovative portfolio approach to AAA treatment to treat the broadest range of patients

• Altura™: New CE marked ultra low profile stent graft offering a simple, predictable and accurate solution for standard AAA anatomy

• Aorfix™: The only globally approved AAA stent-graft for aortic neck angles up to 90 degrees

Aorfix Altura

____________________

(1) Medtech Ventures: Aortic Intervention Market (2014).

70.0%

30.0%

Mainstream On-label Challenging Anatomy

• Low Neck Angulation

• Moderate Neck

Diameters

• Longer Necks

• High Neck Angulation

• Large Neck Diameters

• Short Necks

Lombard’s portfolio now allows patient driven

treatment choice with “on-label” coverage of 85% of

cases

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Lombard Medical Timeline

12

2009 2013 2014 2015 2016

2009: Aorfix

approved

for neck

angulations

up to 90°

April 2012:

Aorfix:

AorFlex™

Delivery

System

Feb. 2013:

Aorfix:

FDA

Approval

2014:

Aorfix:

Japanese

Approval

July 2015:

Altura™

Medical

Acquisition

April 2014:

Lombard

Medical

Nasdaq

Listing

June

2016:

Aorfix:

IntelliFlex

™ Low

Profile

Delivery

System

June

2016:

Aorfix:

Australian

Approval

US IDE – PYTHAGORAS Study 0°-

90°

Feb 2016:

Altura: First

Commercial

Case

Pre-2007:

2003: Aorfix

approved

for neck

angulations

0°- 60°

2012

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Altura: Revolutionizing AAA Treatment

13

• Design Concept – Bilateral D-shaped (kissing stents) aortic grafts with overlapping

iliac legs

• Features/Benefits – Simple

• Ultra-low profile (14F) – percutaneous use

• Ability to deliver ‘out-patient’ and proctor free EVAR for many patients

• No cannulation

• No polymer injection

• Market leading inventory requirement

– Altura – 6 product codes cover all patients

– Market leaders – 20-80

– Predictable

• Consistently shorter procedure time

• Less exposure to radiation for physician and patient

– Accurate

• Proximal end can be recaptured and redeployed

• Reverse Iliac deployment for exact placement

• Offsetting bilateral stents allows use of total Aortic neck length

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Altura: Key Design Features

14

• Fully supported, flexible nitinol braided frames

• Exceptional Flexibility while maintaining radial strength

• Ultra low porosity, woven polyester graft material

• Graft material outside of frame improves seal

• Two sets of suprarenal anchors on each aortic endograft

• Radiopaque markers for precise positioning and easy septum alignment

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Altura: Comparative Analysis

15

Technology Comparisons

System Altura - Lombard Competitor I Competitor II Competitor III

French Size 14Fr (OD) 18-20Fr (OD) 14Fr (OD) 14Fr (OD)

Complexity - Cannulation No cannulation required

for contralateral deployment

Cannulation required for contralateral deployment

Cannulation required for perpendicular deployment

Cannulation required for contralateral deployment

Iliac Deployment Accurate reverse

deployment Standard deployment Standard deployment Standard deployment

Recapture Ability

Yes

Reposition during

placement of proximal

endograft

No No No

Inventory 6 product codes 75 product codes 23 product codes 40+ product codes

Polymer No No No Yes

Waiting time 20 mins before retraction.

Renal off-set positioning Yes No No No

Page 17: MicroPort Scientific Corporation Investment and Strategic ... · MicroPort Scientific Corporation Investment and Strategic Partnership Agreement ... MicroPort Transaction Strategic

Aorfix Product Summary

16

• Unique design

• Only device with FDA & Global Approvals to treat severe infra-renal neck angulation

• Pythagoras US Pivotal Trial has shown excellent results at 5 years: Presented at SVS 2016, publication under review at JVS

• ARCHYTAS Registry – 500 patient global registry collecting “real world” clinical data on Aorfix

• Competitors' “Z” type metallic ring designs are more rigid, may kink in tortuous anatomy increasing re-interventions and poor clinical outcomes

Competitors Aorfix

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Aorfix: Delivery System vs. IntelliFlex LP Delivery System

17

• 22F OD Profile

• Support tubes limit proximal control of implant

• SS nose cone with long tip severely limits vascular maneuverability

• Twist / bayonet design requires multiple non-intuitive movements

• No integrated sheath, requires additional sheath device to use additional devices

• Dated Industrial design

AorFix Delivery System

• 18F ID / 20F OD Profile

• Actively expanding “Y” mechanism provides high grade proximal control of implant

• 50% smaller nose cone with shorter and stiffer tip provides much better vessel maneuverability

• Single variable, rotational design uses single intuitive movement

• Integrated exchange sheath eliminates need for additional sheath for other steps

• Modern, elegant quality design

• CE Mark Approval Q2 2016

• FDA approval expected Q4 2017

IntelliFlex LP Delivery System

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Contents MicroPort Transaction Strategic Rationale

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MicroPort Transaction Rationale

19

Expand the technology portfolio of MicroPort’s Endovascular business by securing the

distribution and manufacturing rights in China to the Target Company’s two innovative

products for Abdominal Aortic Aneurysm (“AAA”) repair market, Aorfix and Altura. The

combined product portfolio of the Group’s endovascular business with Target Company’s

Altura and Aorfix products would create the broadest product portfolio for the endovascular

AAA market in China to address multiple market segments.

Leverage the MicroPort’s Endo expertise in manufacturing endovascular devices to

significantly reduce the manufacturing costs of Aorfix and Altura which can improve the

gross margin and thereby increase the financial profitability of Lombard

Expanding MPSC’s endovascular business in international markets by securing the

commercial rights of Aorfix and Altura for Brazil.

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MicroPort Endovascular Business Summary

20

8.2 8.9

10.3

12.2 13.2

15.4

7.4

10.5

2010 2011 2012 2013 2014 2015 20151H 20161H

Revenue

Highlights

Soli

Sales growth by products

HT HBL HBB AB surgical

20151H 20161H

Achieved Y/Y sales growth of 40% in RMB and 32% in USD,

exceeding market average level

Hercules Thoracic Stent-Graft System maintains strong

growth momentum with 74% and 60% growth rate in volume

and revenue, respectively .

Significant growth of AAA related products

Castor TM Thoracic Branch Stent-Graft System granted

Green Path with 70 follow-up clinical trial completed

Reewarm TM PTX Drug balloon dilatation granted Green

Path

USD:million Excl. FX USD:million Excl. FX

Extensive product pipeline ~ 17 products by 2019 across all sectors

Product Name

Castor

Next Generation TAA

多分支

Ultra-LP

ReeWarm PTX(0.018)

ReeWarm PTX(0.014)

ReeWarm(0.018) Drug PTX

Next Generation Surgical Stent

2016 Q4 2018 Q1

*

*

2018 Q4

*

*

*

2019 Q2

*

*

*

TAA

A

AA

Pe

riph

eral Su

rgical

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Broad and Deep Endovascular Product Portfolio for China Endovascular Market

21

The combined MP Endo and Lombard product portfolio will be the best in class TAA and AAA devices to address all patient segments for endovascular repair market

Hercules™分叉型

覆膜支架及输送系统

Aegis™ 分叉型

大动脉覆膜支架及输送系统

Hercules-LP直管型

覆膜支架及输送系统 CRONUS™术中支架系统

CROWNUS™外周血管支架系统

Hercules™球囊

扩张导管

Endovascular

Aorfix™AAA

stent graft to

treat neck

angles >60

degrees

Altura™- 14F

low profile

AAA stent

system for

PEVAR

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Leverage MicroPort Endovascular Shanghai Operations

22

• MicroPort Endovascular has expertise in manufacturing endovascular devices in its facility in Shanghai China.

• In the near term, MicroPort will leverage this endovascular manufacturing expertise to provide low cost components to Lombard’s Altura and Aorfix – which will significantly reduce the manufacturing cost for Lombard’s devices

• In the long term, MicroPort Endo will have the China manufacturing rights to support the commercialization of Altura and Aorfix for China market

• Both of these activities will significantly leverage the existing MicroPort Endovascular operations

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Expanding MicroPort Endovascular Portfolio into the International Market

23

United States

UK

Germany

Japan

Australia

China

Philippines Thailand

Brazil

Colombia

Chile

Argentina

Spain

Netherlands

While MP Endo can commercialize Lombard’s products in our home China market, Lombar will focus on commercializing on Europe, Japan and US markets…

…and MPSC can offer local access for the important Brazil market.

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Contents Q&A

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Contents Appendix

Page 27: MicroPort Scientific Corporation Investment and Strategic ... · MicroPort Scientific Corporation Investment and Strategic Partnership Agreement ... MicroPort Transaction Strategic

Lombard Medical Management Team

26

Simon Hubbert Chief Executive Officer

• Joined Lombard Medical in 2010; Appointed CEO in 2011 • Previous roles include sales & marketing positions at Johnson

& Johnson and Medtronic

William J. Kullback Chief Financial Officer

• Over 30 years of corporate finance and accounting experience

• Over 20 years in CFO roles at companies such as ActivStyle, Inc., IntriCon Corporation, MedSource Technologies, Inc., and Pemstar, Inc.

Peter Phillips Chief Technology Officer

• Ph.D. from Guy’s Hospital London • Co-developer of the Aorfix stent-graft and led the

development and commercialization of Aorfix in 1995 • Previously a Director of Surgicraft Ltd.

Paul Hardwick Vice President of International Sales & Marketing

• Joined Lombard Medical in 2006 as Business Manager • Previously Regional Business Manager, of Endoscopy at

Boston Scientific

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Lombard Ownership Summary

27

Current Pro Forma Pro Forma

Shares % Equity % Equity + Convert %

MicroPort Scientific - 0.0% 8,064,516 28.9% 19,175,627 49.1%

Invesco Asset Management 6,317,851 31.8% 6,317,851 22.6% 6,317,851 16.2%

Abingworth Management Ltd 3,473,452 17.5% 3,473,452 12.4% 3,473,452 8.9%

SV Life Sciences Advisers, Inc. 1,270,305 6.4% 1,270,305 4.5% 1,270,305 3.3%

New Leaf Ventures II LP 1,072,634 5.4% 1,072,634 3.8% 1,072,634 2.7%

All Other 7,751,723 39.0% 7,751,723 27.7% 7,751,723 19.8%

Total 19,885,965 100.0% 27,950,481 100.0% 39,061,592 100.0%

Page 29: MicroPort Scientific Corporation Investment and Strategic ... · MicroPort Scientific Corporation Investment and Strategic Partnership Agreement ... MicroPort Transaction Strategic

Lombard Public Financials Income Statement

28

Year Ended Nine months ended Three months ended

($ in thousands) December 31, September 30, September 30,

2014 2015 2015 2016 2015 2016

Revenue 13,277 15,115   12,171   9,769 4,227 3,044

Cost of sales 7,541 8,296 6,183 8,020 2,164 2,694

Gross profit 5,736 6,818 5,988 1,749 2,063 350

Selling, marketing and distribution expenses 21,363 23,125 17,331 11,197 5,384 3,600

Research and development expenses 9,213 11,279 7,961 6,336 2,915 1,739

Administrative expenses 11,303 11,707 8,069 5,594 3,144 1,776

Total operating expenses 41,879 46,111 33,361 23,127 11,443 7,115

Operating loss (36,143) (39,293) (27,373) (21,378) (9,380) (6,765)

Finance income 247 134 114 89 32 18

Finance costs (83) (860) (591) (1,633) (335) (547)

Change in fair value of contingent liabilities - - - (997) - (289)

Loss before taxation (35,979) (40,019) (27,850) (23,919) (9,683) (7,583)

Taxation 1,227 2,215 1,651 576 1,223 161

Loss for the period (34,752) (37,804) (26,199) (23,343) (8,460) (7,422)

Other comprehensive income/(loss):

Items that may subsequently be reclassified to profit or loss

Currency translation differences (1,947) (975) (688) (3,052) (938) (700)

Total comprehensive loss for the period (36,699) (38,779) (26,887) (26,395) (9,398) (8,122)

Source: Lombard Medical 20-F filing and Q3 2016 financial earnings press release.

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Lombard Public Financials Balance Sheet

29

September 30, December 31,

($ in thousands) 2016 2015

Assets

Goodwill 15,671 16,052

Intangible assets 20,951 21,889

Property, plant and equipment 2,001 3,043

Trade and other receivables 171 176

Non-current assets 38,794 41,160

Inventories 8,942 6,462

Trade and other receivables 4,576 4,168

Taxation recoverable 1,974 1,618

Cash and cash equivalents 9,857 32,332

Current assets 25,349 44,580

Total assets 64,143 85,740

Liabilities

Trade and other payables 8,143 8,236

Current portion of borrowings 2,642 -

Curreny liabilities 10,785 8,236

Borrowings 23,423 23,115

Deferred tax liabilities 674 674

Contigent consideration 11,597 10,600

Non-current liabilities 35,694 34,389

Total Liabilities 46,479 42,625

Net assets 17,664 43,115

Equity

Called up share capital 199 199

Share premium account 63,853 63,853

Capital reorganization reserve 205,686 205,686

Translation reserve (1,782) 1,270

Accumulated loss (250,292) (227,893)

Total equity 17,664 43,115

Source: Lombard Medical 20-F filing and Q3 2016 financial earnings press release.