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THINKING AHEAD! LIMEDex Index, ConCep+, September 2015 1 + ConCep Think Tank & Strategy Consultant Partner Beatus Hofrichter, Dr. Patrick Dümmler THINKING AHEAD! 3 rd LIMEDex Index Report A Quarterly Economic Outlook for MedTech Leaders Published on September 16 th , 2015 Conceplus GmbH, Switzerland

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Page 1: A Quarterly Economic Outlook for MedTech Leaders …MedTech’s fast response to the Swiss National Bank’s currency decision in January 2015 has yielded a positive effect on EBIT

THINKING AHEAD! LIMEDex Index, ConCep+, September 2015 1

+ConCep Think Tank & Strategy Consultant

Partner

Beatus Hofrichter, Dr. Patrick Dümmler

THINKING AHEAD! 3rd LIMEDex Index Report A Quarterly Economic Outlook for MedTech Leaders

Published on September 16th, 2015

Conceplus GmbH, Switzerland

Page 2: A Quarterly Economic Outlook for MedTech Leaders …MedTech’s fast response to the Swiss National Bank’s currency decision in January 2015 has yielded a positive effect on EBIT

3rd THINKING AHEAD! LIMEDex Index Report

3rd THINKING AHEAD! LIMEDex Index, ConCep+, September 2015 2

Table of Contents 1.   LIMEDex – Outlook for the next 12 months ....................................................................... 3  2.   Market Access Outlook ...................................................................................................... 6  3.   Policy updates and their impacts ....................................................................................... 9  4.   Operations Outlook .......................................................................................................... 10  5.   Financial Outlook .............................................................................................................. 12  6.   Food for Thought .............................................................................................................. 14  7.   Conclusion ........................................................................................................................ 16  8.   Appendix .......................................................................................................................... 17  

Publisher:

ConCeplus GmbH, Weggis, Switzerland

Authors: Beatus Hofrichter, Dr. Patrick Dümmler

Contributors: Dr. Sarah Moyle, Dr. Urs Mattes

Editor: Valerie Thompson

We thank our partner for the engagement and granted strong support in LIMEDex Index

We hope that this edition of THINKING AHEAD! LIMEDex Index Report provides you with the right level of actionable strategic insights and thought-leadership. If you would like to start a dialogue on any of the outlined subject with us, we sincerely welcome you to contact us at your convenience. Save the Date: The 4th LIMEDex Index survey is commencing on November 09th 2015 If you are interested to participate in LIMEDex, please contact us on [email protected] or call +41 79 254 0968 For your personal copy of the LIMEDex Index Report, please visit and register under www.conceplus.com/en/ If you desire to use LIMEDex as an aspirational toolset within your organization, your cluster or region, ConCep+ welcomes you to participate actively in LIMEDex as industry partner or sponsor. Please contact Mr. Beatus Hofrichter, Founder & Managing Director of ConCep+, [email protected] personally.

© 2015. All rights reserved. This publication is an exclusive property of ConCeplus GmbH, Switzerland

+ConCep Think Tank & Strategy Consultant

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3rd THINKING AHEAD! LIMEDex Index Report

3rd THINKING AHEAD! LIMEDex Index, ConCep+, September 2015 3

1. LIMEDex – Outlook for the next 12 months Black Monday, currency volatility and the M&A frenzy has dampened expectations in the MedTech sector. Sentiment is less optimistic this quarter. The LIMEDex growth score fell by 0.5pts to 3.3pts from 3.8pts in the second quarter. The outlook on operations and the financial outlook, contrast sharply with market access expectations and marginal growth.

We believe that the MedTech sector will continue to consolidate even more quickly to acquire market share and consolidate product portfolios. The largest players will get larger and those with smaller market shares will feel the squeeze. A shake-out is underway affecting many functional aspects in R&D, Commercial & Operation departments, as consolidation and cost cutting may be required. There is an increasingly urgent need to undertake strategic reviews, particularly for the sales force structure. It is critical that managers address market access issues, not to mention strengthening their teams’ abilities to cope with regulatory changes and compliance. An assessment of R&D efficacy on outcome improvements and digitalization strategy is required to make sure that device companies can target the next profitable niche product.

LIMEDex Index! Slightly less optimistic

Figure 1.1: LIMEDex Index Score of Q3/ 2015

“In an economic slow-down, we cannot avoid negative quarters in key markets and segments.” – C-Level

"There’s a need for a portion of paranoia and vision to stay ahead of the market" – Board-level

“Asia continues to grow despite the Chinese “Black Monday” – and so will we by serving our customers with best premium quality” – Board-level

LIMEDex Index! Current MedTech leadership sentiment

Figure 1.2: LIMEDex Index – Info graphic Q3/ 2015 (Percentages stated above in “blue” indicate an optimistic development while “red” highlight a pessimistic tendency)

© 2015. ConCep+

3.3

LIMEDex Index

Q3/ 2015

Score

Past period (Q2-2015) Actual period

LIMEDex Index is based on 27 KPIs, obtaining the LIMEDex Index. We derive three Sub-Indexes, namely the Market Access Outlook and Operational comprising 60.0% of the KPIs each, and Financial Outlooks comprising of 44% of the KPIs,

Financial Outlook

Operational Outlook

Market Access Outlook

10 -10 5 -5 0

0.3

-6.0

5.7

6.0

-7.6

-0.0

© 2015. ConCep+

LIMEDex GROWTH PREDICTION Q3/ 2015

GROWTH DECLINE

NEUTRAL SLOW

MEDIUM

FA

ST

SLOW

MED

IUM

FAST

Current lever - LIMEDex Q3/ 2015 Expectation

Previous lever - LIMEDex Q2/ 2015 Expectation

LIMEDex

$

$ 82.8%

believe current challenges will significantly affect business

78.4%

Believe pricing levels of top10 products will significant affect portfolio mix until 2017

!!!!

0%

100%

Portfolio Pricing

51.2%

predict a low EBIT margin in the coming 12 months

63.2%

anticipate good investment times for strategic project in the next year $

81.4%

expect positive revenue growth in the coming 12 months

54.3%

anticipate recent policy changes impacting EBIT growth in the next 2 years §

0101101011011001001000100101000101001000100111101101010100101000101000010010010010111010011110101010100101001010100010010101111010010100001000101010100100100010010110101101100100100010010100010100100010011110110101010010100001011010110110010010001001010110010100100010011110110101010010100010100001001001001011101001111010101010010100101010001001010101001010001111

14.4%

made progress in a digitalization strategy in disease management and healthcare

59.1%

foresee declining access potential growth markets in next 12 months

Market Access D

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3rd THINKING AHEAD! LIMEDex Index Report

3rd THINKING AHEAD! LIMEDex Index, ConCep+, September 2015 4

LIMEDex is at +3.3pts this quarter. It is a gain of +1.3 since Q4/ 2014, but a decrease over last quarter (by 0.5pts) due to rising uncertainty, e.g. on weaker growth expectations in the BRIC region Leaders predict a flat growth rate in the low single digits The view on certain KPIs is negative, namely: § Ability to transform business models § Market share development § Price point realization in Europe § Sales forces effectiveness Figure 1.3: LIMEDex Index – Outlook development since Q4/ 2014

The strategic gap between market access and operations is widening steadily. As market access becomes more difficult, companies are trying to compensate for lower growth rates by streamlining operations. Overall this trend puts top-line growth at risk over the next 12 months The outlook on market access is at its lowest point since January (-7.6pts) and is down by -1.2pts since last survey Managers see market-facing activities becoming less effective. Additionally, sales performance has been hit by aging portfolio and increased competition in most segments The outlook on both financial and operations improved only marginally (+0.3 pts) for the coming 12 months Thus many companies believe that a further top-line growth can only be achieved by cutting back margins

Figure 1.4: LIMEDex Index – Mood shift on all three sub-indices since Q4/ 2014 Definition: Each sub-index provides a short-term prediction of participating MedTech leaders choosing between optimistic, unchanged or pessimistic in their outlook. Market access outlook focuses on commercial excellence (Order entries, channel strength, price point realization, etc.) Operations outlook focuses on operational excellence (business model, employee retention, project excellence, etc.) Financial outlook focuses on the performance excellence (e.g. Revenue, EBIT, COGS, investment sentiment, etc.)

More than 80% of companies share the view about industry challenges, specifically: § Pressure on prices § Competition for prime market access § Increased regulatory pressure in

China, India, France and USA §

Two-thirds of companies surveyed have tempered growth expectations compared to last quarter

Only 5% do not feel exposed to any of the aforementioned challenges

Figure 1.5: Core challenges affecting growth of MTI industry in the next 12 months

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+

Decline

Growth

! LIMEDex Index

+ NASDAQ Health Care Index

2.0 3.6 4.1

2.6 3.8 3.3

-25

25

11/14 12/14 01/15 02/15 05/15 08/15

+ConCep Think Tank & Strategy Consultant

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+ Financial outlook for the next 12 months

Market access outlook for the next 12 months Trend Market access

Operations outlook for the next 12 months Trend Operations

-0.1

2.2 2.6

-0.9

0.0 0.3

2.4

5.5

7.4

6.0 5.7 6.0

-0.2

-1.4

-3.7

-6.9 -6.4

-7.6

-10

0

10

11/14 12/14 01/15 02/15 05/15 08/15

+ConCep Think Tank & Strategy Consultant

85%

82%

81%

81%

73%

67%

66%

65%

54%

46%

43%

0%

Price pressure

Regulations

International competition

Cost pressure

Market access

Consolidation

Skilled resources

Innovation cycles

Financing

Globalization

Tenders

Patent issues

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+

Perception of challenges

Top Challenges

Secondary Challenges

Low impact

Overall perception

No impact

Significant to high impact

5.2%

27.9%

66.9%

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3rd THINKING AHEAD! LIMEDex Index, ConCep+, September 2015 5

The key financial KPIs reflect a reaction to current events. The three main KPIs dipped between -0.5% to -1.5% vs. Q2/ 2015, reflecting expectations of single digit growth Since the initial LIMEDex study (Q4/ 2014), confidence in revenue growth and achieving growth in new markets is still positive but has declined Delta/ Average since Q4 2014: § Revenue -1.2% / 4.85% § New markets -4.2% / 3.67% MedTech’s fast response to the Swiss National Bank’s currency decision in January 2015 has yielded a positive effect on EBIT Delta/ Average since Q4 2014: § EBIT +0.8% / -0.40%

Two critical observation: § The current prediction of the

Revenue/Ebit ratio was +10 : 1 in January 2015 and narrowed to +2.9 : 1 today, indicating that rebates exceeding the internal achievements of cost savings

§ These indications may have a direct impact on business plans. Current budgets may be unaligned. Managers need to review strategy and margin pressures.

Figure 1.6: Development of growth expectation of key financial KPIs since Q4 2014

We foresee the following …

§ Research spending moves towards digital solutions and partnerships. Cross-discipline expertise and ability to engage in multi-partnering projects will be required

§ R&D spending will be analyzed for its “cost efficient outcome” and impact. More attention will be paid to radical innovation rather than incremental product improvements. Because market is only paying premiums for substantial outcome improvements

§ High-level of operational & commercial excellence will become more important for time-to-market/ -peak sales in order to achieve both top-and bottom-line growth

§ Manufacturers will increasingly outsource non-core capabilities, providing growth opportunities for suppliers and service providers based on strategic alliances

§ There will be data protection risks related to “loose ends” of patient data outside the control of provider as digitalization enables greater data access and inflates data generation at the level of individual devices

§ The ability to provide virtual first-care touch-points is an emerging trend. Cleveland Clinics is an early adopter broadening its video visit applications into the home-care market, providing 24x7 access to patients in urgent care

§ M&A activity will continue into 2016 driven by the need to acquire complementary product portfolios and/or promising technologies

5.9%

5.0%

4.6%

2.7%

6.2%

4.7%

0.5% 0.4%

-0.7%

-4.5%

2.6%

1.3%

6.3% 5.9%

3.2%

1.9%

2.6% 2.1%

-5%

0%

5%

10%

11/14 12/14 01/15 02/15 05/15 08/15

+ConCep Think Tank & Strategy Consultant

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+ Avg. expected EBIT growth in next 12 months

Avg. expected Revenue growth in next 12 months

Avg. expected Growth in new markets in next 12 months

-1.2%

-4.2%

CAGR since

Q4/ 2014

+0.8%

+ConCep Think Tank & Strategy Consultant

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3rd THINKING AHEAD! LIMEDex Index, ConCep+, September 2015 6

2. Market Access Outlook

”We must take disruptive avenues to reach new market segments.” – C-Level

“It is unavoidable that we rethink strategic pricing, in light of the new emerging disruptive competition and constant OPEX benchmarks in order to retain long-term reimbursement listing in key markets” – VP level

“We find ourselves amidst a huge transition – from physical products to digital service platforms” – Board-Level

Top-line growth expectations declined by -1.2% since Q4/ 2014 to +4.7%. The majority of MedTech firms appear to be heading towards the “Zero Growth Zone”. The ability to cope with changes underway amongst clients (hospital, reimbursement and insurer segments) is what will determine the viability of many MedTech businesses from now on. Clearly, some players are positioning themselves. Fresenius continues to buy hospitals in local and foreign markets in its pursuit of forward integration. Big MedTech firms are partnering with healthcare networks that have cross border coverage to improve market access. Some players are making strategic moves to tap the new geographies. GE Healthcare, for example, announced it is spending USD1 billion on educating two million health professionals worldwide over the next five years. Some of the innovation leaders and high premium niche competitors are experiencing growth in their main geographies and have successfully launched new products, enabling them to stabilize average selling prices.

MedTech firms are improving their product warranties and adding cost-sharing guarantees in the hope of increasing sales. Making the case for product value to hospitals are companies like Medtronic, St. Jude Medical and Johnson & Johnson. They offer warranties that would have them bear or share in follow-up treatment costs linked to their heart devices. Developers of orthopedic implants are also considering improved warranties for knee and hip implants.

New market opportunities are emerging. In the MEA market, Iran may soon emerge as a fast growing target market if sanctions are lifted as expected. It would be the fifth largest MEA market with an estimated sales volume of about USD 840m.

There are also tech-driven opportunities. Market research suggests that digital technologies will grow the global home healthcare telemedicine market by +7% (CAGR). The advanced monitoring market segment is estimated to hit USD 45bn by 2020. Forecasts for the Asian home healthcare market are even more optimistic (CAGR +9.5%)1. Johnson & Johnson is quite bullish on this topic. It recently formed a new digital partnership with Apple and IBM, integrating electronic medical records (EMR) so that the right data is matched with the right patient record. The system enables hospitals and doctors to monitor outcomes better. Early trials show that outcomes can be tracked and improved. Patient’s expressed greater satisfaction and fewer readmissions occurred.

Business models and applications are emerging to bring “technology/services to patient”, supporting Homecare and Mobility, to increase convenience for patients. For example, FirstLineapp.com enables doctor consultation calls, texting, video appointment requests and in-person visits to home or office. Theranos, a US based lab-on-a-chip technology provider launched “MD Connect” in July, enabling patients to locate Test center/ GPs (currently online in Arizona, USA), for test result consultations, and allowing patients access to their own data.

Processes related to market access, patient engagement/ monitoring and remote consultation are converging. The idea is that MedTech provides better support to providers and payers with the right process interface and data tools. This requires a different modus operandi for client-facing and account teams.

1 ”Home-Healthcare Market Report” – Press release, Grand View Research, San Francisco, USA, June 2015

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3rd THINKING AHEAD! LIMEDex Index, ConCep+, September 2015 7

The majority of MedTech firms are expecting to slide towards the “Zero Growth Zone” Outlook on ability to improve market access in growth markets dropped almost to zero, as international competition and price pressure remain top challenges Two KPI’s have a negative trend, namely Market Access in growth markets and Export growth The outlook on exports took a hit (-47.2% since Q4/ 2014) based on § Fears about growth prospects in

BRIC and new emerging markets § FOREX volatility (US dollar strength) § Rising regulatory burden (see “Policy

updates and their impacts” at end of this chapter)

Figure 2.1: Market Access strength impact in the next 12 months

Definition: Market access strength can be defined by the degree of customer retention, account penetration rate, degree of access to key decision makers beyond procurement and the order win rate. Companies’ growth markets are defined from an individual, company perspective, i.e. Chinese companies entering into EU market and/or SME’s entering new territories outside their home market

MedTech’s commercial team structure is still perceived to be sub-optimal despite improvement of +17.3% since Q4/ 2014

Since January 2015, certain regions have shifted in the rankings for growth Asia is still perceived as the top growth region, but the expectation for BRIC markets has fallen behind North America. European SME’s are skeptical about growth for Europe and Latin America Suppliers’ regional outlook differs from manufacturers. The USA, Asia and Europe lead growth expectations, while Asia is becoming more important for European suppliers. This might reflect the trend to co-locate alongside big international MedTech or Pharma firms that are building up local manufacturing capabilities in Asia

Figure 2.2: Global economic outlook per main region for the MedTech industry in the coming 12 months

Figure 2.3: Perceived portfolio performance …

Current top 10 products portfolio strategy is still exposed to severe price pressure. It influences negotiating power distorting entry price points across the portfolio causing rebates and greater margin erosion. The top-line net effect of improved time to peak sales for new products is not strong enough to fully compensate for decreasing portfolio price levels Observation: Product-led innovation is not enough to overcome the market challenges if portfolio mix is neglected

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+ Net perception of MA strength across all categories impacting S&D structure

Net perception of export growth

Net perception of market access (MA) improvement in growth markets

40.0%

-44.0%

27.3%

71.1%

1.6%

63.3%

0.0%

46.7%

24.2%

28.9%

16.1%

-29.5% -30.0%

-38.2%

-30.7%

-6.3%

-12.2%

-60%

-40%

-20%

0%

20%

40%

60%

80%

11/14 12/14 01/15 02/15 05/15 08/15

Trend Export growth

Trend Market access

Trend Category strength

Zero Growth Zone

+ConCep Think Tank & Strategy Consultant

LIMEDex

Global Large Medium Small Micro Supplier

Asia 1 1 1 1 1 1 2

North America 2 2 2 2 3 2 1

BRIC 3 3 4 4 5 3 5

LATAM 4 6 3 3 7 4 6

Europe 5 4 7 7 3 5 3

MEA 6 6 6 6 5 6 5

New Emerging Markets

7 7 5 5 6 7 7

1 = Top growth region vs. 7 = Least growth region

Company Size Company Type

Manu-facturer

-21.7%

0.0%

12.0%

-6.3%

7.2% 3.0%

-44.0%

-57.7%

-48.0%

-60.6% -62.2%

-56.7%

-80%

-60%

-40%

-20%

0%

20%

11/14 12/14 01/15 02/15 05/15 08/15

+ConCep Think Tank & Strategy Consultant

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+

Perceived time-to-peak-sales ratio in the next 2 years

Pricing levels of Top 10 products impacting portfolio strategy in next 2 years

Pricing pressure

exposure gap

+ConCep Think Tank & Strategy Consultant

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3rd THINKING AHEAD! LIMEDex Index, ConCep+, September 2015 8

MedTech leaders are less optimistic about top-line growth (now at 4.7%, a -1.5% decline) and ability to expand in growth markets (now at 2.1 %, decreasing by -0.5% since last quarter)

Global revenue growth expectation: § Large firms: 3.2% -0.7% § Medium: 6.3 % 6.4% § Small: 0.0% 5.0% § Micro: 5.3%

… and in growth markets:

§ Large firms: 1.3% § Medium: 2.1% § Small: 2.1% § Micro: 3.2%

Small firms (between 25 to 50 employees) and large companies (between 250 to 1’000s FTEs) predict rather low overall revenue growth to sustain long-term profitability (see also figure 4.1). Such firms could disappear if the underlying uncertainties continue longer than anticipated

Figure 2.4: Revenue projections to expectation in growth markets in %

The confidence on entry price point realization is more positive in North America, BRIC and MEA since last quarter, but increasingly negative in the firms’ home market, LATAM, and Asia

It is noteworthy that MedTech firms are confronted with value-based purchasing and reimbursement models2. It means: § Higher accountability of

manufacturers (similar to Pharma) § Greater attention to cost control by

buyers/ insurers § Cash incentives for providers § The requirement to meet or improve

certain healthcare quality measures Figure 2.5: Average entry price point realization per region

Additionally, we observe the emergence of market access “Lock-outs” where segment leaders are erecting digitalized proprietary platforms supporting their “Own the disease” business models

Warning signs from China - Troubling time for business ahead?

Larger companies and MNEs are facing rising regulatory risks in China, while and SME are increasingly exposed its current economical reality. These are in brief: § High volume growth projections turned into much lower growth projections – and underlying KPIs are believed to stand

on rather shaky ground

§ Premium product prices fell due to fiercer competition from local providers able to offer volume discounts. Forecasts and business plans should be revised to reflect a truer picture

§ Local senior management are not meeting business plan milestones, causing churn and headcount freezes in foreign affiliates

§ Investors turning towards other Asian markets with higher growth, e.g. Japan, South Korea, Thailand, or Vietnam

§ Importing Western manufacturing capacities game is “over” as China turns towards the “global services“ game

§ Severe delay in reregistration of products is experienced by foreign firms, enforcing sales stop, raising barriers to entry and a fear of hidden “Protectionism”, as governmental officials are recommending hospitals/ buyers to “buy local”

2 Jamie Hartford, “Value-Based Purchasing: Why Medical Device Developers Should Care”, MD&DI Online.com, May 20th, 2015

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+

Expe

ctat

ion

in G

row

th M

arke

ts in

%

Revenue growth projection in %

By company size

+ConCep Think Tank & Strategy Consultant

-20%

0%

20%

-20% 0% 20%

Average Micro Small Medium Large MNE's Trend

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+

Q2/ 2015

Q1/ 2015

27.3

%

18.8

%

21.2

%

-12.

1%

9.4%

9.4%

-39.

4%

18.6%&

0.0%

&

2.7%

&

*20.0%

&

*5.9%&

*14.1%

&

*29.2%

&

24.6%&

2.5%

&

*8.6%&

*10.3%

&

*10.4%

&

*20.6%

&

*29.6%

&

*50%&

*25%&

0%&

25%&

50%&

North America BRIC Home Market MEA LATAM Asia Europe

+ConCep Think Tank & Strategy Consultant

Q3/ 2015

Page 9: A Quarterly Economic Outlook for MedTech Leaders …MedTech’s fast response to the Swiss National Bank’s currency decision in January 2015 has yielded a positive effect on EBIT

3rd THINKING AHEAD! LIMEDex Index Report

3rd THINKING AHEAD! LIMEDex Index, ConCep+, September 2015 9

3. Policy updates and their impacts There were a number of policy changes around the globe of late. In Russia, China, France and USA, MedTech firms face additional unbudgeted regulatory and compliance costs already in 2015. Reimbursement flows will suffer as a result of consolidation amongst health insurers. Policy and legislation backpedaling makes the market difficult to predict, although Singapore and USA were able to withstand policy challenges over the summer. A noteworthy trend is the emergence of tele-visits/ consultation via video and the emergence of Tele-health parity act in the USA, which requires insurers to compensate equal to an in-practice visit. This decision is likely to spark a faster than anticipated shift towards telemedicine and the digitalization of early patient journeys. Policy changes since April/ 2015 – an overview

Figure 3.1: Overview on policy changes impacting MedTech sector

The majority of MedTech leaders are pessimistic about bottom-line growth as result of recent regional policy changes Pessimism is most evident in the outlook for Asia, the USA and Europe For the following reasons: § Costs for medical device approvals

in the US will climb § India is ramping-up regulatory and

policy to better control quality and safety for patients

§ Device approval costs in Taiwan and Hong Kong will climb as a result of regulatory changes

§ European regulators are factoring in reduced prices in their reimbursement calculations for a wide range of devices

Figure 3.2: Policy impacting Top & Bottom-line growth

M&A (Health insurer Aetna buying Humana) Leads to increase bargaining power vs. MedTech manufacturers.!

Medicare/ Medicaid plan initiative to hold hospitals accountable for hip/ knee replacements on outcomes for entire care cycle incl. 90 days post discharge!

July 2015 Telehealth parity law is in 29 US States enacted. Health insurers must pay equal fees for telehealth vs. in-person visits removing geographic barriers.

August 2015 As of Oct. 1st FDA’s Medtech products review costs increase by 4.2%

May 2015 - USA!US Supreme Court rejects lawsuit against Affordable Care Act; now add. 6.5 million people receive coverage on HC treatments/ interventions!

June 2015 - Brazil ANVISA extends the deadline for Medtech firms to respond to technical queries on registration filings

April 2015 - China Additional soaring registration fees on imports of Medtech class II & III devices introduced

June 2015 . India National Medical Devices Authority (NMDA) founded, focusing on regulate Medtech product pricing

August 2015 - Singapore Telemedicine Master Plan 2025 signed-off combining its strengths in ICT and Life Sciences.

August 2015 - Russia!A weak ruble, sanctions, low oil prices cause Medtech imports to shrink by -30%!

July 2015 - Iran Implementation of Iran nuclear agreement may open healthcare market est. USD +30bn, incl. USD +1bn Medtech.

June 2015 - France EUR 70m saving on single-use medical devices and reimbursement tariff cuts for highly innovative medical devices planned!

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+

+ConCep Think Tank & Strategy Consultant

Ease of regulations/ policies

Tighter regulations/ policies

August 2015 Registration and Brazil GMP fees raised (by 2.9-fold)

!33.3%%

!14.5%%!11.5%%

!7.1%%!3.3%%

!1.8%%

11.9%%

!40%%

!30%%

!20%%

!10%%

0%%

10%%

20%%

Asia North America Europe MEA BRIC LATAM New Emerging Markets

+ConCep Think Tank & Strategy Consultant

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+

Net sentiment on recent policy changes affecting bottom line growth in the next 2 years

Bottom-line

erosion

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3rd THINKING AHEAD! LIMEDex Index, ConCep+, September 2015 10

4. Operations Outlook The outlook for the next 12 months on Operations is positive at 5.7 pts, with a slight decline of -0.3 points since the last quarter. MedTech leaders may be positive on their ability to achieve operational excellence but outlook is dampened by external developments, fear of declining market share and price pressures. We observe that sound operational excellence improvement is keeping the level of confidence but the trend-line is stagnant. The bottom line savings cannot compensate for the top line losses. Despite the improved outlook on Revenue/ EBIT ratio since the initial monitoring, it is so tight that any order bit loss, any rebate granted or any delay in new product introduction will cause unavoidable cost cuttings tightening the belt even further, while the competitiveness is necessarily improved.

“We must stronger consider operational effectiveness in all functions in order to remain competitive and to meet our client’s objectives” – VP-Level

“We can learn from Pharma how to digitalize the clinical study process.” – Board level

“Through international ICT collaborations, we are now in a position to dramatically advance into patient monitoring” – C-Level

Confidence in current business models and market share is negative since Q4/ 2014 Current challenges affect the market share more than the business model The underlying perception is of intense international competition with tighter market access, and constant price pressures on slowly aging portfolios Attention needs to be paid to § Developing sales force efficiency

programs § Developing strategic account and

partnerships § Key Account Management

Such changes are already apparent in aspirational MNE (for example, JnJ moved into strategic partnerships to pilot new, innovative go-to-market models)

Figure 4.1: Confidence in ones’ business models is growing, while that on Market share is lagging

Figure 4.2: Order entries vs. inventory improvements

An improvement in order entries is expected, which should yield a positive impact on inventory levels. But confidence levels are not where they were 8 months ago. On a positive note, SME in the D-A-CH are reporting growing order entries The weak Euro helped to boost German MTI firms in export growth (for example, Siemens Healthcare order entries grew by 15%, led by imaging and therapy systems) US manufacturers expect slower order intake due to a strong USD Imports by China are not affected yet according to the LIMEDex survey

A slight majority expects disruptive

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+

Outlook impacting the current business models

Outlook impacting market share

-69.0%

-55.6% -57.7%

-9.1%

-28.9%

-3.1%

-64.3%

-25.0%

-15.4%

-21.9%

-13.4%

-19.7%

-75%

-50%

-25%

0%

11/14 12/14 01/15 02/15 05/15 08/15

+ConCep Think Tank & Strategy Consultant

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+

Perception of inventory improvements in the coming 12 months

Perception of order entries improvement in the coming 12 months

-3.8%

3.8%

24.0% 24.2%

19.5% 22.1%

8.0%

25.0%

20.0%

-21.2%

-12.2%

2.6%

-30%

-15%

0%

15%

30%

11/14 12/14 01/15 02/15 05/15 08/15

+ConCep Think Tank & Strategy Consultant

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3rd THINKING AHEAD! LIMEDex Index, ConCep+, September 2015 11

products/ technology to affect the financial outlook over the next two years Yet many MedTech leaders do not see the need for additional collaborative projects Both KPIs are declining, which means: § Focus on core “business” § Efficient cost containment on external

spending § Tight resource capacities for any

extra projects § No immediate additional portfolio

strengthening § Tighter listings and pricing limits at

providers and payers

Figure 4.3: The impact on financial outlook of disruptive technologies and collaborative projects

Currently, companies have no trouble with employee retention A small majority of firms anticipate a bottleneck in talent, which may affect competitiveness in the coming months SMEs feel they lack the right talent in marketing & sales and back-office functions to compete successfully +40% of MedTech leaders believe the industry is attractive to new talent3

Figure 4.5: Competitiveness through Competence and Employee retention

3A study by EVP Vantage shows that Medtronic, Essilor, B Braun, and Stryker have expanded payrolls by between 7% and 20% in recent years. Those who are shrinking payrolls include Alere, DJO Global, Dentsply and Mindray Medical.

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+

Likelihood of disruptive technology to change financial outlook in the next 2 years

Need for additional collaborative projects to improve top-line results in the next 2 years

86.7%&

42.6%&33.7%&

3.0%&+8.4%&

3.0%&

10.0%&

+23.3%& +20.0%& +15.2%&+20.5%&

+46.6%&

-100%

-50%

0%

50%

100%

11/14 12/14 01/15 02/15 05/15 08/15

+ConCep Think Tank & Strategy Consultant

73.3%

86.7% 86.7%

-12.1%

0.0%

-3.0%

61.5%

23.1%

-16.0%

6.1%

-24.1%

0.0%

-50%

0%

50%

100%

11/14 12/14 01/15 02/15 05/15 08/15

+ConCep Think Tank & Strategy Consultant

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+

Perceived competitiveness through improved skills/ competences

Perceived employee retention

Employee market

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3rd THINKING AHEAD! LIMEDex Index, ConCep+, September 2015 12

5. Financial Outlook The Financial Outlook rose slightly by +0.3 points above the zero line, indicating a modicum of confidence despite the rumblings in financial markets. The outlook is influenced by several factors. Speculation about the US Federal Reserve raising interest rates which may inspire re-location plans, and it might intensify market activity in the US. Inflation risks in the US and EURO Zone could affect the prices for precious metals, increasing margin pressures on suppliers and manufacturers alike. Sanctions on Russia are depressing its ability to import. It is expected that it will result in 25% less demand from the Russian market in 2015.4 We note that within the group of the top 90 MedTech companies many are forecasting single digit revenue growth and/ or results this year (For example, Philips, Medtronic, Abbott and Boston Scientific, Smith & Nephew and Stryker). Only a few, such as Illumina reported double digit sales growth (its growth is attributed to a successful launch of new products). Additionally, we note that the cost of outcome data in the US is now publicly available. US pharmaceutical and medical device companies paid local physicians USD 6.49 billion last year, according to data gathered through the Sunshine Act. More than 600,000 physicians and 1100 teaching hospitals received data payments from drug and device makers. This is a new cost affecting the bottom line.5

“The company is looking hard at its business to determine which businesses it might cut loose to improve earnings“ – C-Level

“Facing fierce international competition in existing markets has prompted critical strategic reviews.” - VP-Level

“We experienced double digit sales growth with two successful product launches” – C-Level

MedTech leader are optimistic on bottom-line growth (now at 1.4%, moving up +0.9% from 0.5% in Q4/ 2014) Overall positive growth expectation: § Top-line growth 85.3% of firms § Bottom-line growth 60.3% of firms Both KPIs remained stable since last survey

The EBIT expectation by company size: § Large firms: 0.8% -0.7% § Medium: 1.5% 6.4% § Small: 1.5% 5.0% § Micro: 1.1% Revenue growth/ EBIT growth expectations ratios for the next 12 months are positive, but the expectation for the future is that EBIT will have narrower revenues

Figure 5.1: Correlation of Revenue to EBIT growth

4 Russia Medical Devices Report, Espicom, August 2015 http://www.espicom.com/russia-medical-device-market.html#sthash.ahMiY77E.dpuf 5 B. Buntz “Medtech and Pharma Firms Paid $6.5B to Docs in 2014“ QMED.com, July 2nd 2015

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+

EBIT

gro

wth

pro

jec

tion

in %

Revenue growth projection in %

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The sentiment on EBIT and COGS is positive but ebbed to ~5% Fewer firms believe they can substantially improve both KPIs in the coming 12 months Recent inventory, reductions and faster order turnaround by US, German and Swiss producers improved COGS efficiency Some larger companies actually adjusted the EBIT projections or reported negative quarterly EBIT YonY growth, e.g. Alcon, Dräger Medical, GE Healthcare, or Getinge. Strong EBITDA results were reported by St. Jude Medical, and Philips (North America)

Figure 4.2: Confident in EBIT and COGS is stable and positive

MedTech leaders’ market outlook is optimistic; nevertheless it is at the lowest level since LIMEDex began monitoring outlooks Large and mid-sized firms are open to making strategic investments and forming alliances in verticals Low interest rates have caused 26.5% of MedTech leaders to believe it is a good time for M&A Since our last report, high M&A activity continued, totaling USD +18.9bn (see below) Some top 20 companies have set aside a war-chest for fast M&A Observations: Effective post-M&A integration is becoming a concern as a result of overstretched internal resources Constant competition for market access will drive M&A in the drive for efficiency gains and portfolio optimization

Figure 5.3: Is it a good time for strategic investments?

Strong M&A activities in verticals and strategic alliances

MedTech M&A activities will continue in 2016 at a reduced pace. It will be motivated by the desire to achieve scale, diversification of product lines and expand geographic reach. M&A deals totaled to approx. USD 18.9bn since last report (see Appendix “M&A Deals and Rationale”). We note that several larger MedTech companies used favorable market conditions and cash positions to initiate stock repurchasing programs (for example, Agilent Technologies, Bruker Medical).

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+

Perception of absolute EBIT development in the coming 12 months

Perception of absolute COGS development in the coming 12 months

3.3%$6.7%$

'6.7%$

'42.4%$

24.1%$

5.9%$

'8.0%$

23.1%$

4.0%$

'3.0%$ 7.3%$

4.4%$

-50%

-25%

0%

25%

50%

11/14 12/14 01/15 02/15 05/15 08/15

+ConCep Think Tank & Strategy Consultant

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+

Economic outlook of Medtech industry in the coming 12 months

Good time for significant strategic investments along the value chain

73.3% 66.7%

50.0% 45.5%

77.1%

36.4% 53.8%

40.7%

-7.7% -9.1%

58.0%

26.5%

-50%

0%

50%

100%

11/14 12/14 01/15 02/15 05/15 08/15

+ConCep Think Tank & Strategy Consultant

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6. Food for Thought

Two trends are apparent, the impact of “own the disease” and the emergence of “digitalization in healthcare”. The “own the disease” business model is spreading with companies like Fresenius (dialysis processes and management), GE (Imaging-based surgery with end-to-end management), Stryker (Holistic-Satellite-based inbound-expert surgical lead management), or Straumann/ BioDenta (patient-chair-centered CAD processes). Success is based on creating a holistic ICT platform that combines the patient journey with administrative data/ payer flows, and a specialist end-user community. End-to-end singular process tool and databases are part of it too.

These players have proven business cases. They understand –the need for a holistic approach that is not necessarily limited to their segment or current disease focus. They are active globally, conquering additional market share along vertical value chains. Furthermore, as early movers they are positioned for a global “the winner takes all” approach. MedTech firms, in general, but also biotech, healthcare providers, and payers are still adapting to the game change.

Digitalization in healthcare is already affecting consumer behavior. Healthcare and its suppliers, the life science industry, are slowly adapting, probably too slowly. Large pharmaceutical players and some MedTech firms (Novartis, GSK, Medtronic, Sonova, Roche Diagnostic) are publicly announcing new alliances. But tech companies, like Google, Apple, Samsung, Sony, FitBit, Polar (to name a few) are faster. They understand the need for strategic collaboration and are poised to create end-to-end value chain consortiums. The momentum, quality and depth of activity of by these companies is breathtaking.

Government driven smart healthcare platforms and e-health are part of the digital trend, actually pre-dating it. And yet few countries and MNE’s are moving. Today’s mobile and connectivity technologies provide a firm foundation for adoption. Denmark was an early adopter and results are notable. Its sundhed.dk healthcare platform has been supporting national healthcare for more than ten years. It now boasts 1.3m users per month who seek advice and consultation, while all national supply, demand, quality and payment data is processed in the background.

Digitalization in MedTech is growing in importance slowly

Early Movers - About 15% of participating firms have an advanced digitalization/ healthcare platform strategy in place Fast Adaptors – About 16% are implementing an ICT strategy

Main Stream – more than one-third are in the planning stage or playing catch-up Current Laggers – Another third have not moved on this trend yet

Figure 6.1: How advanced is your organization regarding a Digital Healthcare strategy realization? Definition of Digitalization strategy: It may embrace the quality health care journey in its entirety in closed correlation to the strategic objective of a company, e.g. Education, prevention, treatment, intervention, homecare, mobile health, disease/ healthcare platforms, tele-health incl. virtual patient visits, etc.

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+

10.5%

3.9%

15.8%

36.8%

32.9%

0% 10% 20% 30% 40%

A healthcare platform/ consortium strategy implemented/ signed-off

An advanced digitalisation strategy implemented

An initial digitalisation strategy implemented/ signed-off

Digitalisation strategy in planning

No digitalisation strategy planned yet

Early Movers

Fast Adaptors

Main Stream

Current Laggers

“Digital offerings from established competitors –and not from digital start-ups – are the most significant source of competitive pressure.” – VP-Level

“We must embrace global changes in healthcare value chains with integrated innovation” - VP-Level

”We need new approaches to enable us identifying patients more appropriately,” – Head of Clinical Innovation, Pharma company

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Digital Healthcare will expand the R&D continuum by 2025

As adjacent industry players develop healthcare solutions, they apply ICT-enabled process engineering as the ultimate means to the end. Their disruptive approach is not materials-based, rather it is orientated on the vision of “Digital Health”. As a result R&D stakeholders face an altered model, which requires embracing downstream players and sharing project participation and leadership more broadly than earlier R&D value chains. ResearchKit by Apple goes as far as rewarding clinical trial participants for sharing their clinical data on.

MedTech leaders are going to be confronted by digitalization projects. The trend will affect all healthcare players by 2018, changing offerings and “citizens/ patient journey”. Strategies need to take into consider competitive advantages and the R&D environment.

We observe two realities, the materials-based product R&D activities vs. the digital health-based R&D approach The former one is well established with key players being mainly academia & industry The latter has a broader range of players and is still seeking the best models Project ownership tends to reside with those with the deepest capability In order to market products successfully in the future, MedTechs firm must master both, the material and digital health based R&D competencies Both models will have an effect, but we believe that digital health will make a greater impact

Figure 6.2: The R&D continuum in the Digital Healthcare age by 2025 Illustrative – This graphic may be a non-exclusive representation of on-going high potential R&D topics

ICT enables leaping beyond traditional collaboration networks

Today’s R&D networks are increasing in complexity as this graphic suggests Multiple stakeholders along the R&D continuum are involved. Depending on the underlying innovation (top row) a range of collaborators are needed to Direct interactions and indirect inter-dependencies of apps beyond material-based innovation will require all participants to take measures to ensure compliance, stability and seamless security The ability to deploy such projects puts SMEs at disadvantage because of their smaller resource pool. They should be seeking appropriate alliances and talent early-on

Figure 6.3: Todays R&D networks and ICT application interdependencies Illustrative – This graphic may be a non-exclusive representation of on-going high potential R&D topics

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+

Basic & Applied

R&D

Potential Consortium Stakeholder Continuum Selected Topical R&D Fields

Suppliers MedTech & Life

Sciences

Services Providers ICT Gov./Payers

Citizens

Ma

teria

l ba

sed

D

igita

l He

alth

ba

sed

Bio-limbs prothesis

Bio-absorbable materials

Injectable nano-sensors

Miniaturization/ Needlescopic

Tissue engineering

Personalize “devise”

Potential future integrate HC R&D collaborations parties

Influencer Active contributor Leader

Passive contributor

Preventive health

Home care integration

Telehealth

Mobile health integration

Influence on

tomorrow‘s offering

IoT in healthcare

Highly influential

Somewhat influential

MOBILE APPS INTEGRATED HC

SERVICES ICT

SERVICES NEW

TECHNOLOGIES NEW

MATERIALS

MEDTECH

HEALTHCARE PLATFORMS

PROVIDERS ACADEMIA ICT PAYERS GOVERNMENT

CITIZENS

PHARMA

SOLUTIONS

BIO LIMBS

SMART WATCH

SOFT TISSUE X-RAY

IMAGING

GOOGLE BASELINE

STUDY

HACKING MEDICINE INITIATIVE

PRECSION MEDICINE INITITATIVE

NANO TECH

GOOGLE SEARCH ADVERSE

REPORTING

SENSORS

TELE CONSULTATION

MATERIAL FOCUS

DIGITAL HEALTH FOCUS

DIRECT APPLICATION INTERACTIONS INDIRECT APPLICATION INTERACTIONS COLLABORATION NETWORKS

ILLUSTRATION ONLY

+ConCep Think Tank & Strategy Consultant Source: CC+ Think Tank

© 2015. ConCep+

INJECTABLE ELECTRONICS

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7. Conclusion

Market uncertainty was temporarily exacerbated by the Chinese Black Monday but confidence recovered to a low single digit level. While expected revenue-to-EBIT growth ratio improved, good operational efforts cannot camouflage troubles in market access and offering strategies.

Certain longitudinal cuts on the outlook of Exports, Revenue growths, Pricing levels and Entry-price-point realization reveal clearly the concerning urgency to improve current business models, strategic marketing, and restructure commercial operations to compete successfully in the coming 24 months. Simultaneously, further efficiency gain must be realized in order to yield a positive EBIT, stretching internal resources and projects to unused limits. The need to attract new talents, also with untraditional competencies will become a high necessity as innovation shifts from product & services to “Glocal” business models to digitalization.

“Early Movers” and fewer “Fast Adaptors” are deploying what amounts to a “lock-out” market access strategy, operating “Own the disease” models adapted to local markets – all founded on the smart, proprietary, and integrated ICT backbone. They also understood the need to collaborate with complementary consortium partners along the entire value chain achieving closeness to patients or end-providers.

Reviewing, revising and re-evaluating the current strategic plan is perhaps a good starting point, or even a necessity. Applying at least a 5-8 year horizon, you may find it helpful to initiate such reflection asking six key questions within their management team:

WHERE TO PLAY

§ What is the mid-term strategic positioning to master tomorrow’s physical and virtual market needs? § Are we (becoming) an essential insider to relevant local/ international healthcare platforms? § Do we have the right sense of urgency and competencies to compete successfully within our strategic sphere of

interest?

HOW TO WIN

§ Which strategic set is required to increase competitiveness? § Which alignments in R&D are required to collaborative effectively in leading digital health consortia? § Which management priorities will yield the greatest impact in key markets and channels?

Some high level recommendations

It might be worth considering additional management agenda items to support future growth and competitiveness:

§ Conduct a critical strategic review on internal and value chain pain points for fiscal year 2016 now § Develop the right sense of urgency about digitalization and then conduct critical portfolio and capability review § Short-term maintain high momentum of operational excellence, while enforcing stiff entry price point negotiations § Immediate to long-term it is essential to improve market access. Neglecting efforts may result in either shrinking orders

or depleting revenues. Without additional operational excellence contributions, the bottom-line will be severely affected § Accelerate restructuring of current sales & distribution structure to meet account objectives, i.e. Key Account

Management with holistic offerings to ensure commercial excellence in markets § Optimize customer & stakeholder segmentation based on critical market access review § Immediate to long-term engage in M&A or in-licensing activities seeking valuable companies/ technologies that are

struggling or seeking stronger partners

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8. Appendix

Methodology & Acknowledgements

LIMEDex – a leading MedTech Industry Index is developed and published quarterly by ConCeplus GmbH, Switzerland since 2015. LIMEDex is designed to identify and understand emerging trends and key themes, enabling MedTech leaders prompt insights to understand impacts and potential consequences for their business. It is qualitative monitor on market access, operations, and the financial performance given the underlying outlook on challenges to MedTech firms for the coming 12 months. LIMEDex is based on online surveys to determine expectations and attitudes, as well as selected interviews sharing interim results with survey participants to obtain first-hand their thinking on emerging trends during report writing, which represent “nowism - wisdom of the crowd”.

The LIMEDex Index survey applies a standard set of 27 focused questions on key performance indicators during the current quarter. The results usually show the net perception value of industry leaders, i.e. the delta between “confirming” and “disputing” answers is calculated, while subduing the “neutral” replies. The longitudinal data allows for high-level trends analysis per KPI.

The LIMEDex Index survey was conducted from August 11th to August 26th, 2015. Enriching secondary desk research of data publically accessible to substantiate our findings and highlight industry and macro-economical trends impacting MedTech ended on September 1st, 2015.

More than 65 international MedTech leaders and industry experts participated at least once in these surveys. The respondents represent mainly manufacturers, suppliers and engineering service providers of leading companies of all sizes, including larger corporations, as well as acknowledged niche leaders.

The authors want to thank all the MedTech executives and experts for their engagement, contribution, and support with the LIMEDex Index surveys.

Last but not least, CC+ would like to thank all those who contributed to the writing of 3rd THINKING AHEAD! LIMEDex Index Report (Q3/ 2015), particularly Mrs. Valerie Thompson, Mrs. Sarah Moyle, Ph.D (insights on policies), as well as Mr. Urs Mattes. Ph.D. (insights on China market)

The LIMEDex Samples in Q3/ 2015

Authors

Mr. Beatus Hofrichter is Founder & Managing Partner of ConCep+, an innovative MedTech&Healthcare value chain think tank and strategy consultant. He is a frequently invited speaker on the MedTech Industry, New Business Models, Business transformation, and innovative/ holistic Value Chain integrations. He has published numerous articles, the Swiss Medical Technology Industry (SMTI) survey since 2006, the Global MedTech Report 2012, inventor of the LIMEDex Index Reports, and co-authored a Swiss Hospital Management Report. Mr. Hofrichter has more than 15 years of strategy consulting experience in the medical devices and pharmaceutical industries. He studied in London, UK, and holds a Master of International Management and Business Administration.

Dr. Patrick Dümmler is Partner at ConCep+. He has 10 years consulting and industry experience in the MedTech and life science industry. Formerly, he was the Managing Director of MedTech Switzerland and as part of this he led the WMTF Lucerne Conferences (2012 & 2013). He has published over 80 articles, books and numerous reports on the medical devices industry, and since 2006, has co-authored the Swiss Medical Technology Industry (SMTI) survey. Additionally, he wrote and published multiple country reports on the local MedTech industry and foreign direct investment opportunities in these markets. Dr. Patrick Dümmler studied Economics at the University of Zurich and completed his PhD at the ETH Zurich.

HQ Countries Representation Participation by Company Size Participation by Industry Sectors Participation by Hierarchical Level

Others: A, B, CIN, DK, E, NL, I, S, RUS, and UK © ConCep+ 2015 n= 68 © ConCep+ 2015 n= 68 © ConCep+ 2015 n= 68 © ConCep+ 2015 n= 68

MNE's 16%

Large 32%

Medium 27%

Small 10%

Micro 15%

+ConCep Think Tank & Strategy Consultant

Board-Level 7%

C-Level 29%

VP-Level 12%

Director 49%

Manager 3%

Switzerland 60%

Germany 18%

Others 15%

USA 7%

Company Size

Company HQ

Locations

Manufacturer 68%

Supplier 10%

Service provider 18%

Academia 4%

Industry Sector

Hierarchy Level

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LIMEDex Index Data

LIMEDex Index - Net changes in actual quarter in %

LIMEDex KPIs - Net changes in actual quarter in %

LIMEDex KPIs – Net results per KPI in actual quarter in %

LIMEDex

Global Large Medium Small Micro Supplier

Strategic Outlook -0.5 -1.6 0.3 0.0 4.9 0.7 1.0

Financial Outlook 0.7 -0.1 2.9 0.0 4.6 1.9 -0.8

Operational Outlook

0.2 -2.3 -0.2 0.2 4.4 1.1 0.2

Market Access Outlook

-1.2 -2.1 -0.5 0.0 4.7 -1.1 1.0

Company TypeCompany Size

Manu-facturer

LIMEDex

Global Large Medium Small Micro Supplier

Average revenue projection

4.7% 3.2% 6.3% 0.0% 5.3% 4.5% 5.1%

Market access in potential/ growth regions

2.1% 1.3% 2.1% 2.1% 3.2% 1.8% 3.4%

Disruptive technology contribution

1.9% 1.8% 2.2% 2.2% 1.7% 2.0% 2.3%

Average EBIT projection

1.4% 0.8% 1.5% 1.5% 1.1% 1.4% 2.4%

Company Size Company TypeManu-

facturer

Source: CC+ Think Tank - LIMEDex Survey © 2015. ConCep+

LIMEDex KPIs – Net changes in actual quarter in %

51%

40%

33%

26%

24%

22%

20%

7%

7%

7%

3%

1%

1%

0%

0%

-3%

-5%

-7%

-9%

-11%

-14%

-21%

-26%

-46%

-57%

-58%

Cross functional effectiveness

Economic outlook

New talents

Strategic investment timing

Invertory levels

Access to finance

Access in growth markets

Disruptive technology

COGS projection

EBIT projection

Order entries

Entry price point realization

Employee retention

Export share

Business model

Projects delivery excellence

Revenue projection

Skills & competences strength

Time to peak sales impact

Source prices

Customer access strength

Market share development

Net challenges

Need for coll projects

Challenges affect growth

Portfolio pricing impact

+ConCep Think Tank & Strategy Consultant

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M&A deals and their rationales (since May 2015) – A non-exclusive overview

Category Companies Deal rationale Value

Consolidation

St. Jude Medical acquires Thoratec Entering left ventricular assist device player as new markets worth more than USD 1bn USD 3.4bn

Wright Medical and Tornier Vertical integration on portfolio/ production capabilities USD 3.3bn

Hill-Rom’s acquires Welch-Allyn USD 2.0bn

Cardinal Health and Johnson&Johnson Consolidation/ divest JnJ Cordis stent business unit USD 1.9bn

Cinven acquired Synlab and Labco Consolidation in lab-automation to achieve economy of scale EURO 1.0bn

Portfolio Development/Expansion  

Panasonic Healthcare acquired Bayer Diabetes device

EURO 1.0bn

Boston Scientific acquired AMS Urology portfolio including men's health and prostate devices EURO 1.6bn

IBM acquired Merge Healthcare Adding medical image analysis features to its Watson Health system.

USD1.0bn

Greatbatch wiil acquire Lake Region Medical

Broaden market reach in the advanced-surgical cardiology segment USD 0.7bn

Medtronic acquisitions RF Surgical, Twelve Inc. and Samsung

Expansion in transcatheter mitral valve business, surgical equipment, and diabetes +USD 0.7bn

Roche to acquire GeneWEAVE BioSciences Diagnostic on quick tests identify multidrug-resistant bacteria USD 0.4bn

Edwards Lifesciences to acquire CardiAQ Advanced cardivascular valve technologies USD 0.4bn

Integra LifeScience to acquire TEI Medical & Bioscience

Broaden surgery and regenerative wound care products portfolio

USD 0.3bn

Allergan acquired Oculeve Broaden offering with nasal neuro-stimulation system to remedy dry eye disease patients

USD 0.1bn

Teva Pharmaceutical Industries to acquire Microchips Biotech

Invest in implantable microchip technology delivering precise dosages over a period of months or years

USD 0.03 bn

Smith & Nephew will acquire DeOst Expanding trauma and orthopedics portfolio n.a.

Investment in alliances and licensing

Samsung partnered with Ping An (Chinese Insurer)

Create a joint digital health platform n.a.

Toshiba America Medical Systems and Merge Healthcare ! Drive integration of Toshiba's vascular X-ray systems with Merge's hemodynamic

monitors and cardiology PACS! n.a.

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Disclaimer

It is not permitted to modify or create derivative works of this report and presentation or to use it for commercial or other public purposes without the prior written permission of ConCeplus GmbH.

Based on experience publishing reports with insights from the national and international MedTech industry management since 2006, we created LIMEDex – a leading indicator of the MedTech Industry, enabling executives to track and plot their strategic thinking against their peers on market access environment, operations environment, and financial outlook and the underlying challenges facing MedTech industry leaders and experts for the coming 12 months. The strategic and tactical usage of LIMEDex to optimize one’s business shall only be applied as secondary opinion guidance.

In this respect the publication reflects and contains international MedTech industry leaders’ opinions and insights and is not intended to be comprehensive, nor to provide financial, investment, legal, tax or other professional advice or services at the date of the publication, and are subject to change without notice. Although the information used was taken from reliable and trusted sources, ConCep+ does not accept any responsibility for the accuracy or comprehensiveness of the details given. Therefore, this publication is not a substitute for personalized professional advice or services, and it should not be acted on or relied upon or used as a basis for any strategic decision, investment or other action that may affect you or your business. Before taking any such decision you may consult a suitably trusted source and/ or qualified professional service provider. Whilst reasonable effort has been made to ensure the accuracy of the information contained in this publication, this cannot be guaranteed and neither ConCeplus GmbH nor any of its Advisory Board members shall have any liability to any person or entity which relies on the information contained in this publication, including incidental or consequential damages or losses arising from errors or omissions related to this publication. Any such reliance is solely at the user’s risk.

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