medtech half-year review 2013 - evaluate...

Medtechhalf-Year review 2013

welcome to EP Vantage’s review of the medical device and diagnostic sector’s performance in the first half of 2013, an extensively researched report, based on EvaluateMedTech market intelligence, which identifies some of the key trends that defined the industry in the six months from January to June 2013.

The beginning of 2013 was expected to be a watershed period in the history of the medtech sector as the US medical device sales tax, an aspect of the Obamacare health reforms, became law on January 1. The 2.3% sales tax has been applied to the sale of almost every device in the US since then.

The direst predictions of the effect of the tax – job losses, plant closures and large-scale restructurings – have not come true. However, 2013 has so far been disappointing on two main fronts: the number of mergers and acquisitions that were completed was lower than at any point in the last decade, and a dramatic fall was seen in medical technologies approved by the FDA.

The value of the mergers completed in the first half of 2013 is so low that, if the rate does not improve, 2013 is on track to be the most disappointing year since 2003. Many of the larger companies, including Covidien, Abbott and J&J, are instead going the other way: spinning out non-core businesses in an attempt to become more specialised and efficient.

Elsewhere, only nine first-time premarket approvals (PMAs) were granted by the US FDA in the first half of 2013, compared with 19 for the first half of 2012. If the result for the full year continues this trend and is similarly disappointing, fingers will be pointed at factors including the tax and other industry headwinds. Increasing caution on the part of the FDA, spurred in part by the risk of lawsuits from patients harmed by faulty devices, will also have affected this.

It is to be hoped that the second half of 2013 will bring improvements, and indeed there are already signs of this. Research and development has not stood still during 2013, and once developers come to accept the new realities, the flow of new innovations will resume.

elizabeth cairns Medtech Reporter, EP Vantage [email protected]

2 fOrewOrd Copyright © 2013 Evaluate Ltd. and EP Vantage. All rights reserved.

fOrewOrd

2013 has so far proven to be a difficult time for medtech. While the impact of the medtech tax has not been as drastic as feared, a combination of regulatory changes, pricing pressures and increasing stress on requiring device makers to prove that their technology is more cost-effective than drugs or surgery means that companies are finding it hard going.

Healthcare systems, insurance companies and other payers are ever more reluctant to part with cash. Comparative effectiveness is a crucial hurdle companies must leap in order for their products to become widely used, and unless a developer can prove that its device offers better outcomes, such as reducing hospitalisation and its attendant costs, payers will keep their hands in their pockets.

Those companies that can boast evidence that their products are better than competitors’ and other therapies will not only enjoy increased sales but will attract greater investment and, should they desire it, takeover interest.

Consolidation of hospitals in the US and the concentration of purchasing power among centralised purchasing staff have also forced device prices down. With the US medtech tax on top, manufacturers are not seeing the cash roll in like they used to.

3 Medtech iN the firSt half Of 2013 Copyright © 2013 Evaluate Ltd. and EP Vantage. All rights reserved.

Medtech iN the firSt half Of 2013

THOSE COMPANIES THAT CAN

BOAST EVIDENCE THAT THEIR

PRODUCTS ARE BETTER THAN

COMPETITORS’ AND OTHER

THERAPIES WILL NOT ONLY ENJOY

INCREASED SALES BUT WILL

ATTRACT GREATER INVESTMENT

AND, SHOULD THEY DESIRE IT,

TAKEOVER INTEREST.

Market UpS aNd dOwNSLarger medical technology developers are often seen as safe bets for investors amid turbulent markets, and the growth seen in the medtech indices bears this out. The first half of 2013 saw share price growth for companies pursuing some of the most innovative and fastest-growing areas in medtech: next-generation sequencing, renal denervation and companion diagnostics.

The technology may be ground-breaking but the business strategies of the fastest-growing device makers are steadfast, eschewing large and aggressive mergers and playing to their traditional technological focuses. The large-cap risers, with the exception of Thermo Fisher Scientific, which this year announced the largest merger in the sector, are conservative multinationals – but it is worth bearing in mind that Thermo Fisher was the only large-cap company to pull away from the others in terms of share price growth.

percentage change in Medtech Stock indices over the first half of 2013

Thermo Fisher leads the field in the first half, and by a decent margin. It owes the growth to its acquisition of the gene sequencing specialist Life Technologies in April, the biggest purchase the sector has seen this year at $13.6bn. The acquisition will not close until early next year, which explains Life’s presence in the mid-cap risers, with a 51% jump.

It has been suggested that the medical device industry is maturing, having passed though a period of rapid growth to a time in which sales are starting to plateau thanks to increased pricing pressure. The ageing western population and the lacklustre worldwide economy has increased the need for governments and payers to ensure that healthcare is affordable long-term, and pricing is under pressure as never before.

If slower, steadier growth is the new normal, only Thermo Fisher seems to have broken away from this maturing market. Share prices of the other large-cap companies grew steadily and at very acceptable rates over the first six months of the year, but Thermo Fisher’s audacity defied market pressures and enabled it to leave its fellows far behind.

4 Market UpS aNd dOwNS Copyright © 2013 Evaluate Ltd. and EP Vantage. All rights reserved.

Stock Index % change in H1 2013

Thomson Reuters Europe Healthcare 11%

Dow Jones U.S. Medical Equipment Index 18%

S&P Composite 1500 HealthCare Equipment & Supplies (US) 13%

http://www.epvantage.com/Universal/View.aspx?type=Story&id=442782&isEPVantage=yes

Share Price

(Local Currency) Market Capitalisation

($bn)

Rank Top 5 Risers 31-Dec-

12 30-Jun-

13 Change 31-Dec-

12 30-Jun-

13

1 Thermo Fisher Scientific ($) 63.78 84.63 33% 22.80 30.48

2 Medtronic ($) 40.79 51.47 26% 41.44 51.85

3 Roche (SFr) 184 235.00 24% 170.72 216.38

4 Johnson & Johnson ($) 70.10 85.86 22% 194.77 241.17

5 3M ($) 92.85 109.35 18% 63.80 75.47

Rank Top Fallers

1 Allergan ($) 91.64 84.24 (8%) 27.52 25.91

2 Siemens (€) 82.20 77.70 (5%) 93.29 89.16

large cap ($30bn+) top risers and fallers in h1 2013

Both of the large-cap fallers are conglomerates. Allergan, down 8% this half, is con-sidering taking a step away from medtech; its Lap-Band weight loss device has been performing poorly for some time, and the company has been attempting to shed it to pursue its more profitable pharma business. Indeed, the fact that there were only two large-cap fallers in the first half further indicates the strength of the market.

Canadian diagnostics firm Med BioGene saw an almost sixfold increase in its share price in the first half. This is likely due to its GeneFx Lung test, which identifies patients with early-stage non-small cell lung cancer, gearing up for market launch. Med BioGene will sell the test in the US through its CLIA certified laboratories.

But it would be well advised to make hay while the sun shines: plans in the US to tighten the regulation of these kinds of lab-developed tests are liable to make life very difficult for small companies such as Med BioGene.

Boston Scientific’s share price rise is an encouraging sign; the company is working hard to turn itself around after a difficult few years through investments in leading-edge technologies such as renal denervation and heart valves. However, proving that it is not the hand you are dealt that matters so much as how you play it, another cardiovascular specialist is in the fallers. Edwards Lifesciences, which leads the heart valve sector, had a tough time of it in the first six months of 2013, posting disappointing first-quarter sales and lowering full-year guidance, causing its shares to crash 10% in late April.

Another cardiovascular specialist, Volcano, also fell. Competing with established be-hemoths like Medtronic and St Jude Medical is a tall order, and the latter company particularly hurt Volcano late last year when it won a patent dispute. Partly as a result, February saw Volcano downgrade its sales guidance for fiscal 2013, to $406-$412m from a previously expected $422-$428m.


Source: EvaluateMedTech © 2013


Other Significant risers & fallers in h1 2013 (ranked on Market cap.)

Dry eye is a large, fast-expanding yet underpenetrated market. TearLab’s diagnostic for the disorder works by measuring the osmolarity of tears – saltier tears mean drier eyes – in a growing population of usually elderly patients. TearLab plans to place at least one of its instruments in every eye practice in the US.

Israel’s Mazor Robotics leads the micro-cap risers. Surgical robotics is a troubled field, with sales of the most expensive systems falling precipitously, but Mazor seems to be bucking the trend, tripling its share price in the first half.

Retinal imaging company Optos has nobody to blame but itself for its shares shedding a third of their value since January. An unorthodox method of reporting its income meant that its profits dropped suddenly and sharply in May; it also lowered its full-year guidance.


Share Price (Local Currency)

Market Capitalisation

($m) EP Vantage Comment & Analysis

Risers 31-Dec-12

30-Jun-13 Change 31-

Dec-12 30-

Jun-13

Boston Scientific ($) 5.73 9.27 81% 5,291 9,426 EP Vantage interview – Boston remakes itself to face the future

Life Technologies ($) 49.03 74.00 51% 8,448 1,275 Thermo Fisher spends $14bn to finally get a Life

TearLab ($) 4.10 10.62 159% 118.8 307.7 Smallest device companies take biggest leaps in H1

Mazor Robotics (ILS) 8.39 25.28 201% 79.7 240.2 Intuitive’s poor sales cast a pall over the robotic surgery sector

Med BioGene (C$) 0.02 0.10 567% 1.2 7.6

Fallers

Edwards Lifesciences ($) 90.17 67.20 (25%) 10,306 7,591 Boston and Medtronic take aim at

Edwards’ valves

Volcano ($) 23.61 18.13 (23%) 1,274 988.8 St. Jude banks on innovation to see it through tough times for medtech

Given Imaging ($) 17.47 14.01 (20%) 543.0 439.5 US approval for colon camera pill looks a Given second time round

Optos (£) 1.70 1.15 (33%) 199.2 126.5 Optos blindsides investors with big profit drop

EnteroMedics ($) 2.80 1.14 (59%) 155.7 63.4 Trial miss gives EnteroMedics a jolt, but approval push continues











veNtUre fiNaNciNG cONStraiNtS cONtiNUe The large amounts of venture financing available to medtech companies in 2010 and 2011 coincided with a lull in funding for pharmaceutical and biotech companies, as investors realised that devices and diagnostics could be brought to market more quickly and cheaply than drugs.

Tightening regulation with higher bars for both safety and efficacy over 2012 and the first half of 2013 may now be driving those same financiers back into the arms of pharma.

The amount of venture capital raised in 2012 dipped on the previous two years, and 2013 does not look likely to show a marked improvement.

Regulatory changes are taking shape on both sides of the Atlantic, and look likely to make it harder to get certain devices to market. In the US, it appears that early-stage diagnostics companies seeking to exploit the CLIA pathway as a source of revenue before obtaining full approval may soon find this route barred.

annual vc investments

7 veNtUre fiNaNciNG cONStraiNtS cONtiNUe Copyright © 2013 Evaluate Ltd. and EP Vantage. All rights reserved.


In Europe, meanwhile, laws designed to harmonise the somewhat fragmented CE mark pathway are taking shape, with a vote on the current proposals scheduled for September. In both cases the putative changes will make gaining approval for devices longer, more difficult and more costly, potentially making these companies a less attractive investment opportunity for venture capital firms.

After all, a company developing a product soon to be caught in a regulatory net will be less likely to attract a buyer. With the majority of exits in medtech coming in the shape of acquisitions, this will in turn increase the demand for venture financing, just as the lack of clarity over regulation decreases the supply.

Quarterly vc investments

8 veNtUre fiNaNciNG cONStraiNtS cONtiNUe Copyright © 2013 Evaluate Ltd. and EP Vantage. All rights reserved.


The second quarter of 2013 saw fewer medtech VC rounds than the first, though at 62 the number is still respectable. Importantly, though, at $891m the total amount of cash raised was higher, suggesting that while fewer companies were able to persuade investors to part with their money, those that did reaped significant rewards.

The second quarter is traditionally the best period for VC investment, with the total raised in this period over the past six years averaging $966m. But this has not been borne out when it comes to individual deals: the largest VC funding round in the first half actually came in the first quarter.

Biggest rounds of h1 2013

Morrisville, North Carolina-based TearScience’s $70m funding, earmarked for com-mercialisation of its dry eye therapy, leads the pack so far this year.

Additionally, the fact that these tend to be later rounds adds weight to the idea that venture-backed companies are finding it harder to get an exit in the shape of a buyout. In this situation one would expect to see a scarcity of mergers – and in fact this is precisely what the data show.

9

Company Financing Round Investment ($m)

TearScience Series Undisclosed 70.0

Proteus Digital Health Series F 62.5

Mevion Medical Systems Series Undisclosed 55.0

Natera Series E 54.6

Nevro Series C 48.0

veNtUre fiNaNciNG cONStraiNtS cONtiNUe Copyright © 2013 Evaluate Ltd. and EP Vantage. All rights reserved.


valUe Of MerGerS craSheSIf venture funding is getting scarcer, the picture for merger activity in the first half of 2013 was even more dire. The medical technology sector was so barren of acquisitions that, should the trend persist, this year will be the most disappointing in a decade.

Only one deal closed in the first half was worth more than $1bn, disappointing con-sidering that 2012 saw six ten-figure deals. With the largest acquisition announced so far this year – that of sequencing company Life Technologies by Thermo Fisher Scientific – not expected to close until early 2014, the total spent this year could struggle to top $10bn.

With sales under pressure mergers would ordinarily be expected to increase as firms take advantage of one of the few remaining routes to boosting their top line. In fact, the data show that the opposite has occurred.

Medtech M&a activity

10 valUe Of MerGerS craSheS Copyright © 2013 Evaluate Ltd. and EP Vantage. All rights reserved.

$70bn

$50bn

$36bn

$13bn

$76bn

$45bn

$6bn

197

231

201

154

239 231

210

88

0

50

100

150

200

250

0

10

20

30

40

50

60

70

80

90

100

2006 2007 2008 2009 2010 2011 2012 H1 2013

Dea

l Cou

nt

Dea

l Val

ue ($

bn)

Deal Value Deal Count

$21.3bn

$42.5bn

Boston [GDT]

($27bn)

Novartis [ACL]

($28.1bn)

Sanofi [GENZ]

($20.1bn)

$$56bn

Novartis[ACL]

s

$49bn



Rank Acquiring Company Target Company or Business Unit M&A Deal Type

Deal Value ($m)

1 Bayer Conceptus Company acquisition 1,100

2 Stryker Trauson Company acquisition 764

3 Bausch + Lomb Technolas Perfect Vision Company acquisition 645

4 Illumina Verinata Health Company acquisition 450

5 Wright Medical Group BioMimetic Therapeutics Company acquisition 380

Without the Thermo Fisher deal and Valeant Pharmaceuticals’ acquisition of Bausch + Lomb, which closed in the second half, the largest take-out so far has been Bayer’s purchase of contraceptive device specialist Essure. Compared with 2012, though, the $1.1bn transaction is a small deal.

In second place falls Stryker’s buy of Hong Kong trauma specialist Trauson for $764m, betraying an understandable interest in one of the fastest-growing medtech markets. Such a relatively tiny deal so high in the table is a worry in itself: last year the Trauson deal would not have troubled the top 10.

top 5 M&a deals in h1 2013

Acquisitions of smaller device companies, which sometimes have just one product, are much more common in medtech than pharma. Despite this, 2013 has so far seen just 88 take-outs in total. It is likely that wider economic trends are partly responsible, but there is another explanation: many of the larger companies are selling rather than buying.

With Covidien, Abbott and J&J all moving to shed some of their businesses in an attempt to become more specialised and efficient, other firms may have opted out of burdening themselves with new buys and all the integration costs they entail. This trend also makes buyouts of medtech firms by pharma companies less likely as they move away from diversification rather than towards it.



top 5 M&a deals in 2012

The value of acquisitions in the medical technology space was already trending downwards. Even excluding the distorting effect of the mega-merger between Sanofi and Genzyme in 2011, the spend in 2012 was 20% lower than the year before. But if 2013 does not improve, the year-on-year drop in total spend will be 72%.


Rank Acquiring Company Target Company or Business Unit M&A Deal Type

Deal Value ($m)

1 Johnson & Johnson Synthes Company acquisition 19,700

2 Hologic Gen-Probe Company acquisition 3,700

3 Valeant Pharmaceuticals International Medicis Pharmaceutical Company acquisition 2,600

4 Asahi Kasei ZOLL Medical Company acquisition 2,210

5 Agilent Technologies Dako Company acquisition 2,200


13 US apprOvalS Of iNNOvative deviceS halve Copyright © 2013 Evaluate Ltd. and EP Vantage. All rights reserved.

US apprOvalS Of iNNOvative deviceS halveWhether companies succeed in achieving exits or buying exciting new startups, and whether they raise money through venture rounds or enjoy a share price ramp, the entire industry is underpinned by getting new and better products to patients. And here, the first half of 2013 has not been a resounding success.

The FDA granted just nine first-time premarket approvals (PMAs) in the first half of 2013, plus one humanitarian device exemption (HDE) – a 47% drop from the 19 PMAs issued in the first half of 2012. Roughly half the devices approved in 2012 were approved in the first six months, suggesting that the rate of approvals is near-constant throughout the year. If that holds true for 2013, it will be a dismal year indeed.

The regulatory bar at the FDA appears to be getting higher.

Cardiology and in vitro diagnostics, perennially popular sectors for innovation, are the most-represented therapeutic categories for first-time PMAs in 2013.

first-time premarket approvals (pMas) by therapy area, 2012 and 2013

EvaluateMedTech Device Classification - L1

Number of First PMAs FY 2012

Number of First PMAs H1 2012

Number of First PMAs H1 2013

Anesthesia & Respiratory 0 0 1

Cardiology 14 6 2

Diabetic Care 1 0 0

Diagnostic Imaging 3 2 0

Drug Delivery 1 1 0

Gastroenterology 1 1 0

General & Plastic Surgery 2 1 2

In Vitro Diagnostics (IVD) 13 7 3

Ophthalmics 2 1 0

Orthopedics 3 0 0

Radiology 1 0 0

Wound Management 0 0 1

Total 41 19 9



14

2013 has also seen approvals in the respiratory and wound healing sectors, neither of which was present last year. J&J’s Sedasys device is the first computer-assisted personalised sedation system to be approved in the US for use by clinicians in endos-copy suites. The system administers propofol whilst monitoring sedation in patients undergoing upper and lower endoscopies.

fda approval activity

As could be expected of the largest medtech company, J&J is the only firm to obtain PMA for two products so far this year. Its other entry is a surgical sealant, ArterX, an elastic gel developed to seal suture holes formed during surgical repair of blood vessels.

Vascular repair is also the purpose of Vascade, a device developed by Cardiva to stop bleeding at femoral access sites for minimally-invasive interventional cardiology tech-niques. With catheter based procedures like renal denervation and the implantation of transcatheter heart valves growing in popularity, Vascade should have a strong future.

Also in the cardiovascular field is Lombard Medical Technologies’ Aorfix stent graft, the only such product approved for cases where the artery above the aneurysm bends particularly sharply. Lombard feels that this will give it an edge over other grafts even in patients who do not have particularly tortuous anatomy as, once doctors start using it for the more acute cases, they will also use it in patients with straighter vessels.

US apprOvalS Of iNNOvative deviceS halve Copyright © 2013 Evaluate Ltd. and EP Vantage. All rights reserved.


15

first-time pMas and hdes Granted by the fda in h1 2013

One thing that is unsurprising is that all three IVDs approved in the first half are molecular diagnostics.

The most recently approved, Abbott’s RealTime HCV Genotype II, is a laboratory test that can differentiate hepatitis C genotypes 1, 1a, 1b, 2, 3, 4, and 5 in a sample of plasma or serum from a chronically infected individual. Hep C is the most common chronic blood-borne infection in the US and the leading cause of liver transplants. With Gilead’s sofosbuvir heading to market with enormous expectations, not least related to its ability to treat the especially tricky genotype 1, Abbott’s test could do well.

The other two IVDs are companion diagnostics for cancer drugs: bioMérieux’s BRAF diagnostic can assess a patient’s suitability for GlaxoSmithKline’s melanoma drugs Mekinist and Tafinlar, whereas Roche’s EGFR mutation test can determine whether a non-small cell lung cancer patients will benefit from treatment with Tarceva.


Device Name Company EvaluateMedTech Device Classification Level 1

EvaluateMedTech Device Classification Level 3

Type of Approval and Number

Decision Date

Vascade vascular closure system

Cardiva Medical Cardiology Vascular Closure Devices PMA (P120016) January 31

Aorfix flexible stent graft system

Lombard Medical Technologies Cardiology Graft Prosthesis PMA

(P110032) February 14

Natrelle highly cohesive silicone-filled breast implants

Allergan General & Plastic Surgery Breast Prosthesis PMA (P040046) February 20

ArterX surgical sealant Tenaxis Medical Wound Management Surgical Sealants PMA

(P100030) March 1

Sedasys computer-assisted personalized sedation system

Johnson & Johnson Anesthesia & Respiratory

Other Anesthesia & Respiratory Therapeutic Devices

PMA (P080009) May 3

cobas EGFR mutation test Roche In Vitro Diagnostics (IVD) Oncology Molecular

Diagnostics PMA (P120019) May 14

THxIDTM-BRAF assay kit bioMérieux In Vitro Diagnostics (IVD) Oncology Molecular

Diagnostics PMA (P120014) May 29

Mentor CPG breast implants

Johnson & Johnson General & Plastic Surgery Breast Prosthesis PMA

(P060028) June 14

Abbott RealTime HCV Genotype II, Abbott RealTime HCV Genotype II control kit, uracil-n-glycosylase

Abbott Laboratories In Vitro Diagnostics (IVD) Infectious Disease

Molecular Diagnostics PMA (P120012) June 20

Argus II retinal prosthesis system

Second Sight Medical Products Ophthalmics Other Ophthalmic

Prosthetic Devices HDE (H110002) February 13


16

If a first-time PMA is an indication of a device’s innovative nature, a humanitarian device exemption is doubly so. An HDE is similar to a PMA, but is almost exempt from effectiveness requirements; the FDA must be convinced that the device offers some benefit, but the level of proof is considerably lower than for a PMA.

The FDA must be convinced that the probable benefit to health outweighs the risk of injury or illness the device poses, that no comparable devices that treat or diagnose the condition yet exist, and that the manufacturer could not otherwise bring the device to market.

The Argus II retinal prosthesis developed by Second Sight Medical Products apparently meets these criteria. It is the first implanted device to treat adults with severe retinitis pigmentosa, and consists of an electronic device implanted in and around the eye, a tiny video camera attached to a pair of glasses, and a video processing unit that is worn or carried by the patient.

The industry will surely be keen for the FDA to relax its standards. With just nine PMAs and one HDE granted so far this year, the bottleneck appears to be becoming a problem. Device makers must hope that the second half of the year brings better news.

As for the longer-term future of the medtech sector as a whole, it appears that a tricky period of adjustment will be followed by a new phase of slower expansion and flatter profit growth. Despite an ageing population who would be expected to increase demand, the medtech industry is not seeing the same levels of growth as it has enjoyed in previous years. The medtech market is maturing.


17 cONtact iNfOrMatiON Copyright © 2013 Evaluate Ltd. and EP Vantage. All rights reserved.

EDITORIAL TEAM

lisa Urquhart Editor [email protected] @LisaEPVantage

amy Brown Senior Reporter [email protected] @AmyEPVantage

Jonathan Gardner Reporter [email protected] @JonEPVantage

Jacob plieth Senior Editorial Analyst [email protected] @JacobEPVantage

elizabeth cairns Medtech Reporter [email protected] @LizEPVantage

Joanne fagg Editorial Assistant [email protected] @JoEPVantage

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About EP Vantage: Written by a team of award-winning journalists, EP Vantage provides daily financial analysis of key industry catalysts including: regulatory and patent decisions, marketing approvals, licensing deals, and M&A – giving fresh angles and insight to both current and future industry triggers. Launched in 2007 by EvaluatePharma, EP Vantage’s unique access to EvaluatePharma and EvaluateMedTech data allows unrivalled, forward-looking coverage of the pharmaceutical, biotech and medtech industries. Visit www.epvantage.com to sign up for a free trial. www.epvantage.com

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