Medtech now faces a " new normal" wit h a confluence of new risks. The way to sust ain innovat ion is for medtech f irms to innovate in new ways. T he report also represent s some " innovation beyond The product " on our part.
Medtech now faces a " new normal" wit h a confluence of new risks. The way to sust ain innovat ion is for medtech f irms to innovate in new ways. T he report also represent s some " innovation beyond The product " on our part.
Medtech now faces a " new normal" wit h a confluence of new risks. The way to sust ain innovat ion is for medtech f irms to innovate in new ways. T he report also represent s some " innovation beyond The product " on our part.
To our client s and friends: Welcome to t he 2011 issue of Ernst & Youngs annual report on t he st ate of t he medical technology indust ry. It is increasingly clear t hat medtech now faces a new normal wit h a confluence of new risks f rom an uncert ain public policy environment to increased regulatory and pricing pressures, a challenging f inancing climate and a rapidly changing customer base. Our opening art icle, Innovat ion and risk, looks at t hese risks and how companies are responding to t hem. The way to sust ain innovat ion is for medtech f irms to innovate in new ways not just develop and improve product s, but expand into ent irely new kinds of offerings, including services, holist ic solut ions and more. If risk has moved beyond product development , so too must innovat ion. Accompanying our analysis are guest cont ribut ions f rom t wo leading execut ives, as well as a roundt able of indust ry veterans, providing a variety of perspect ives on t hese challenges. As always, Pulse of t he Indust ry provides an overview of key performance met rics, including US and European f inancial performance, f inancing and mergers and acquisit ions. But t his years report also represent s some innovat ion beyond t he product on our part . We have revamped t he way we communicate our insight s for an era in which t ime is increasingly scarce and blogs, iPads and Twit ter feeds are increasingly common. The indust ry performance art icles are more succinct , highlight ing only t he most salient insight s f rom each chart . We hope you f ind t he analysis and t he new format usef ul, and we look forward to cont inuing t he conversat ion wit h you. Ernst & Young, Global Life Science Center Content s Innovat ion and risk 2 Int roduct ion Innovat ion and risk 6 The new normal: innovat ion at risk? 13 Learning from t he past t o guide us forward Alex Gorsky, Johnson & Johnson 14 A proven pat h for growt h Michael A. Mussallem, Edwards Lifesciences Corp. Indust ry performance 16 Financial performance A solid performance 26 Financing Debt goes t hrough t he ceiling 38 Roundt able on mergers and acquisit ions A fundament ally new deal environment Kevin Davies, RBC Capit al Market s Ali Sat vat , Apax Part ners Aileen Stockburger, Johnson & Johnson Bryant Zanko, St ryker Corporat ion 44 Mergers and acquisit ions Let s make a deal 50 Scope of t his report Defining medical t echnology 51 Acknowledgement s 52 Dat a exhibit index 54 Global medical t echnology cont act s Innovat ion and risk 2 Int roduct ion Innovation and risk Overview: innovat ion and risk Medtech is an indust ry based equally on innovat ion and risk. Success in t his business has always hinged on t he ability to innovate f rom breakt hrough technologies t hat shif t ent ire paradigms to t he steady pace of iterat ive enhancement s t hat , over t ime, add up to huge improvement s in healt h outcomes. To innovate, companies and investors have to t ake on signif icant amount s of risk. Wit h every new technology and every generat ion of product enhancement , companies have inevit ably borne product development risk t he possibility t hat a new offering would not obt ain regulatory clearance or would fail to gain market t ract ion. And f inancing t hat innovat ion has required risk capit al. From vent ure capit alist s to t he public market s, investors have put t heir f unds at risk as t hey sought t he handsome ret urns t hat medtech companies have historically delivered. Today, t he indust ry faces new risks f rom an increasingly diverse range of sources not just f rom t he challenge of product development , but also f rom an uncert ain public policy environment , shif t ing regulatory requirement s and growing pricing pressures driven by an increasingly unsust ainable healt h care system all of which are st raining medtech innovat ion. To respond, companies will need to innovate in new ways. If risk has moved beyond product development , so too must innovat ion. The pat h forward will require companies to apply t heir invent iveness and creat ivity not just to developing and improving t he product s t hey have long focused on, but to expanding into ent irely new kinds of product s, complement ary services and more. The new normal: innovat ion at risk Since t he onset of t he global f inancial crisis in 2008 and t he economic downt urn t hat followed, t he term new normal seems to have become increasingly popular not just among pundit s and prognost icators, but also in t he common parlance. The term has been used to describe everyt hing f rom t he deleveraging of capit al market s to t he changing relat ionship bet ween emerging and mat ure market s and even shif t ing gender roles. And we have used it ourselves in Beyond borders, our sister publicat ion on t he biotechnology indust ry, to refer to t he new realit ies facing t hat indust ry. It is now becoming increasingly clear t hat medtech faces it s own new normal. This is an environment where companies face a confluence of risks and challenges: heightened regulatory scrut iny and payer pressure, a f undament ally different f unding climate and a rapidly changing customer base. Regulat ory and pricing pressures. In recent years, t he FDAs 510(k) process for clearing cert ain classes of medtech product s has come under considerable scrut iny. Crit ics have charged t hat t he 510(k) process which, unlike t he premarket approval (PMA) process used for life-sust aining product s, does not require clinical t rials needs to be changed. The FDA responded by init iat ing a review of t he 510(k) process and also asking t he Inst it ute of Medicine (IOM) to conduct a separate review. (For a f uller discussion of t hese development s, refer to t he Int roduct ion art icle in Pulse of t he indust ry 2010.) In July 2011, t he IOM released it s report , Medical Devices and t he Publics Healt h: The FDA 501(k) Clearance Process at 35 Years. The IOM report s recommendat ions were cert ainly bold rat her t han proposing reforms to t he exist ing system, t he inst it ute recommended scrapping t he 510(k) process altoget her and replacing it wit h an integrated premarket and post market regulatory f ramework t hat provides a reasonable assurance of safety and effect iveness t hroughout t he device life cycle. The FDA soon announced t hat it does not intend to implement t his proposal, while some policymakers cont inue to decry t he agency for not considering it . Pulse of t he indust ry Medical t echnology report 2011 Int roduct ion Innovat ion and risk Regardless of how t his part icular issue plays out , t he reality for medtech companies operat ing in t he US and investors in t hose f irms is t hat t he regulatory environment has become clouded wit h uncert ainty. Medtech execut ives st ill adjust ing to t he coming medical device excise t ax and t he move toward comparat ive effect iveness research imposed as par t of US healt h care reform now face quest ions about t he product approval process and t he fallout on Medicare spending f rom policymakers at tempt s to t ame t he count rys expanding public debt . Wit h an increasingly polarized and uncompromising environment on Capitol Hill, clarity on t hese mat ters will likely remain elusive for t he foreseeable f ut ure. The indust ry also faces an increasingly challenging reimbursement environment in developed market s. Payers bot h public and private have seen t heir budget s squeezed and are, in t urn, pressuring medtech companies to demonst rate how t heir product s improve healt h outcomes for pat ient s and eff icient ly use healt h care resources. Even if clinical t rials are not required to get a product approved, payers will increasingly focus on post-market ing dat a on t he comparat ive effect iveness of different intervent ions. It is not surprising t hat a number of execut ives in bot h t his years report , as well as t he 2010 issue of Pulse of t he indust ry allude to t he uncert ain regulatory and reimbursement environment as one of t heir biggest challenges. Despite t he fact t hat t he US remains t he worlds largest market for medtech product s, an out side US (OUS) st rategy in which emerging companies f irst obt ain market ing approval of new product s in non-US market s has become increasingly common in recent years. While t his approach may allow a company to obt ain regulatory clearance quicker, t he challenge of obt aining reimbursement is no easier in non-US market s European count ries, for inst ance, are wrest ling wit h sovereign debt crises t hat will only exacerbate t he pressures. Cust omer realignment . The convergence of several t rends is creat ing a f undament al realignment of t he customer base to which medtech companies have t radit ionally sold t heir product s increasing t he import ance of some customer channels, while reducing t he signif icance of ot hers. As government s across major market s move to rein in healt h care cost s, hospit als are f inding t heir margins reduced, exacerbat ing t he pressure t hey have already been under in t he af termat h of t he economic downt urn. In numerous market s, payers are st art ing to experiment wit h capit at ion approaches t hat allow t hem to place a cap on t he amount t hey will pay out per pat ient , effect ively t ransferring more of t he f inancial risk to providers. These pressures have, in part , driven a spate of mergers among US hospit als in t he last couple of years. As t hey face increasing pressures, hospit als have also adopted a slew of measures to cut cost s. They are increasingly relying on mechanisms such as technology assessment commit tees and group purchasing organizat ions to consolidate and st andardize purchasing decisions. Surgeons and ot her physicians who t radit ionally had free reign to pick t he device t hey preferred are increasingly f inding t hat f reedom curt ailed, as hospit als limit t he number of opt ions in each product category. In many cases, hospit als are imposing price caps and/or reducing t he number of vendors f rom which t hey will purchase. And, as a growing number of doctors abandon small private pract ices and become employees of large hospit al systems, more and more of t hem are affected by t hese t rends. 3 4 Pulse of t he indust ry Medical t echnology report 2011 Source: Ernst & Young, Capit al IQ, Dow Jones Vent ureSource and Windhover Char t shows capit al raised by US and European companies. Commercial leaders are def ined as companies wit h revenues in excess of US$1 billion. 2007 2008 2009 2010 Commercial leaders Other companies 69% 64% 49% 27% 31% 36% 51% 73% The rich get richer? Large companies share of t ot al capit al raised has grown dramat ically For medtech companies, which have t radit ionally relied on close relat ionships wit h individual physicians bot h to sell t heir wares and to obt ain feedback for f ut ure product enhancement s t hese t rends represent a f undament al realignment of t heir customer base. In medtechs new normal, companies will need to ret hink what t hey sell, how t hey sell and even how t hey develop t hose offerings in t he f irst place. A new funding environment . Compounding t he pressure on innovat ion, t he long-st anding model for f unding medtech is coming under increasing pressure. While t he overall f unding numbers in t he US and Europe have held up well in 2010 and 2011, most of t he money has gone t o a few mat ure companies, while t he majorit y of emerging f irms face a very different capit al environment . Medical t echnology companies in t he US and Europe raised more t han US$23.6 billion an ast ounding 66%increase over 2009s t ot al and t he highest annual t ot al in t he six years t hat we have been t racking medtech f unding numbers. However, t he remarkable increase in capit al raised was not driven by a f undament al improvement in investor sent iment toward medtech and it has not made t he f inancing environment any easier for t he vast majority of emerging medtechs. Instead, t he increase in f unding was most ly concent rated in a handf ul of mat ure companies t hat took advant age of historically low interest rates to raise debt f unds t hat were typically used to rest ruct ure balance sheet s, f inance acquisit ions or f und general operat ions. 5 Int roduct ion Innovat ion and risk US medt ech financings, 2005-H1 2011 Dist ribut ion of US and European vent ure invest ment by round, 2005-H1 2011 Source: Ernst & Young, Dow Jones Vent ureSource 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% H1 2011 2010 2009 2008 2007 2006 2005 Late rounds Middle rounds Early rounds 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 2005 2006 2007 2008 2009 2010 H1 2011 Furt hermore, while t he explosion in debt f inancing is a 2010 and 2011 phenomenon, it is just t he latest manifest at ion of a longer-term t rend. Since t he advent of t he f inancial crisis, t here is a growing disparity in f unds raised by est ablished and emerging companies. The share of f unds raised by companies wit h more t han US$1 billion in revenues has increased steadily over t his period, to reach a high of 73%in 2010. Meanwhile, emerging, pre-commercial companies faced a very different f unding environment . Vent ure f inancing dropped for t he t hird consecut ive year in 2010 falling by 13%relat ive to 2009 t hough t he amount raised is st ill consistent wit h levels seen in 2005 and 2006, before t he crest ing of t he easy money era. The challenging market condit ions faced by medtech companies including growing regulatory and pricing pressures and t he preference of st rategic buyers for later-st age asset s cont inue to delay exit s and squeeze ret urns for VCs. Compounding t he challenge is an IPO environment t hat remains weak. Af ter more t han t wo years of sluggishness, IPO act ivity picked up in 2010, but remains at levels below t hose seen prior to t he global recession. 6 Pulse of t he indust ry Medical t echnology report 2011 The new normal: innovation at risk? Average 510(k) approval t imes (mont hs) January February March April January February March April May 2003-07 2010 3.1 4.5 Average PMA approval t imes (mont hs) January July February August March Sept ember April Oct ober May November June December January February March April January July February August March Sept ember April Oct ober May November June December January February March April January July February August March Sept ember April Oct ober May November June December 2003-07 2010 15.5 27.1 Number of US hospit al M&As announced 2006 2010 57 77 Number of PMA approvals 2006 2010 20 39 Capit al raised in medt ech IPOs (US$b) 2005-07 2008-10 4.3 0.9 6 Pulse of t he indust ry Medical t echnology report 2011 Number of 510(k) approvals 3,200 2,778 2006 2010 Devices receiving FDA invest igat ional device exempticns after hrst review 76% 56% 32% 2006 2009 2010 Number of Class I product recalls 2006 2010 65 426 Number of warning let t ers issued by t he CDRH 2006 2010 154 204 US healt h expendit ures as percent of GDP 2007 2009 2050 16 18 37 Capit al raised by US vent ure funds (all sect ors, US$b) 2007 2010 31.2 12.3 7 Int roduct ion Innovat ion and risk Percent age of US privat e pract ice physicians 30 24 33 2005 2009 2013 Number of aest het ic procedures in t he US (millions) 11.7 9.3 2007 2010 8 Pulse of t he indust ry Medical t echnology report 2011 US and European early vent ure rounds by product class and disease st at e Source: Ernst & Young, Capit al IQ and Dow Jones Vent ureSource Therapeut ic devices Hemat ology/ renal 9% Therapeut ic devices Cardiovascular/ vascular 11% Therapeut ic devices Neurology 8% Therapeut ic devices Ort hopedic 7% Therapeut ic devices Respirat ory 6% Research and ot her equipment 2% Therapeut ic devices Ot her 21% Imaging 6% Non-imaging diagnost ics 25% Ot her 5% There is evidence t hat t hese challenges are affect ing investor sent iment and behavior. As investors seek more de-risked asset s and as VCs carry t heir portfolio companies longer because of challenging exit s, t here has been a marked decline in t he share of vent ure f unding going to early rounds. Meanwhile, t he lit t le money t hat is going to early rounds is being invested in categories t hat carry less regulatory and payer risk. In 2010 and t he f irst half of 2011, 25%of early vent ure rounds were invested in non-imaging diagnost ics well exceeding t his segment s current share of medtech revenues likely because of percept ions of an easier FDA clearance and reimbursement process, as well as growt h opport unit ies f rom t rends such as personalized medicine. The mult iplicity of challenges in t he new normal also appears to have affected investors out look on t he prospect s for f ut ure revenue and earnings growt h by public medtech companies. Our analysis reveals t hat while t he median earnings per 9 Int roduct ion Innovat ion and risk A t ale of t wo t rends While medt ech earnings have grown st eadily, P/ E rat ios have fallen 100% 0% 100% 200% 300% 400% Median earnings per share Median price/earnings ratio 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Source: Ernst & Young and Capit al IQ Char t based on non-conglomerat es wit h 2010 revenues in excess of US$1 billion which exist ed for t he ent ire t ime f rame shown. P/ E rat ios based on net losses are excluded f rom t he calculat ion. share of t he largest US non-conglomerates has grown steadily over t he last decade including during t he global recession t he median price to earnings rat io of t hese companies has declined over t hat t ime, and part icularly over t he last t hree years. Taken toget her, t hese t hree issues are placing increased pressure on medtech innovat ion. Heightened regulatory and payer scrut iny are making it harder to bring new product s to market , while t heir lingering uncert ainty is dissuading investors. Sweeping changes in t he hospit al sector, medtechs t radit ional customer base, are squeezing margins and increasing product scrut iny all of which raises risk for investors and lowers potent ial ret urns. As a result of t hese and ot her factors, t he f unding environment has become increasingly distorted as emerging companies historically a key source for new product s and technologies are f inding it more difficult t han ever to f und innovat ion. 10 Pulse of t he indust ry Medical t echnology report 2011 The next new normal: demonst rat ing healt h out comes Even while medtech companies st ruggle wit h t he challenges of t he new normal, some of t he same t rends are propelling t he indust ry and indeed, all of healt h care toward t he next new normal. The increasingly urgent need to rein in escalat ing healt h care cost s already manifested in t he growing pressure on prices, t he movement toward comparat ive effect iveness research, and more is also inexorably pushing us to a f ut ure where companies success or failure will hinge on t heir ability to demonst rate how t hey are improving healt h outcomes for pat ient s and for t he broader healt h system. Indeed, t he incent ives for all of t he part icipant s in t he healt h ecosystem f rom companies to providers to pat ient s will be realigned around t he ability to improve outcomes, as payers increasingly demand proof of an intervent ions eff iciency before agreeing to pay for it . (For a f uller discussion of t hese t rends, refer to our sister publicat ion on t he pharmaceut ical indust ry, Progressions 2011: Building Pharma 3.0.) This is a f ut ure t hat will also be enabled by new informat ion technologies. Informat ion technology has already reinvented scores of indust ries in our lifet imes. Ret ail t rade has become vast ly more eff icient and t ransparent t hanks to e-commerce, along t he way empowering consumers and squeezing cost s out of t he system. The business model of t he music indust ry has been t urned on it s head by MP3 players and Apples vast ly successf ul iTunes store. Print news media is being shaken up by an onslaught of websites, blogs and e-readers. In each of t hese inst ances and many ot hers, consumers have been empowered, while long-ent renched companies have given up cont rol and seen t heir business models upt urned. Today, t he healt h sector is on t he cusp of a similar revolut ion. Making healt h care sust ainable will require vast improvement s in eff iciency across t he system, and will require pat ient s to t ake more responsibility for managing t heir healt h. Technology can provide a big part of t he answer. New technologies and platforms are creat ing an explosion in t he quant ity and types of dat a everyt hing f rom elect ronic healt h records to social media discussion t hreads to real-t ime dat a generated by increasingly mobile devices and diagnost ics. All of t his creates opport unit ies to mine dat a for insight s on t he relat ive effect iveness and eff iciency of different intervent ions. Informat ion technology is also st art ing to enable anot her f undament al shif t : t he empowerment of t he pat ient . Just as new technologies have empowered consumers in t he indust ries we listed before, similar development s in healt h care promise to dramat ically empower individuals, t ransforming t hem f rom t he passive pat ient s of yesterday to t he educated, engaged superconsumers of tomorrow. And as incent ives change in t he new ecosystem, pat ient s will have a greater interest in act ively managing t heir healt h. While sweeping changes inevit ably produce winners and losers, medtech companies are well posit ioned to benef it f rom t hese changes. Their devices and diagnost ics generate reams of real-t ime dat a t hough most companies have not exploited t he f ull potent ial of t his t reasure t rove in t he past . The f ut ure we are moving toward is one in which more and more healt h care will be delivered out side t he hospit al or doctors off ice. Just as generat ions of increasingly mobile comput ing devices laptops, net books, t ablet s, smart phones and more have made access to informat ion and comput ing power ubiquitous, new waves of mobile healt h devices promise to do t he same for t he delivery of healt h care. Here, too, medtech companies are well posit ioned to be t he innovators of new technologies t hat will allow superconsumers to manage t heir own healt h care. A number of medtech companies are recognizing t hese opport unit ies and moving to seize t hem. In t he last year alone, we have seen a proliferat ion of new offerings to make healt h care delivery more eff icient by giving providers real-t ime informat ion and enabling bet ter decision making at t he point of care. Medt ronic, for inst ance, launched it s CareLink Pro 3.0 t herapy management software in December 11 Int roduct ion Innovat ion and risk 2010 to offer advanced decision support to healt h care professionals managing diabetes. The program analyzes dat a f rom a pat ient s insulin pump, cont inuous glucose monitoring device and blood glucose meter; ident if ies t he most import ant pat ient informat ion in a single dashboard; and suggest s relevant intervent ions. In February 2010, St ryker part nered wit h Capsule, a leading provider of medical device connect ivity, to connect pat ient dat a f rom St ryker smart beds direct ly into hospit al elect ronic medical records. And in March 2010, GE Healt hcare launched it s Qualibria sof t ware in collaborat ion wit h Ut ah-based Intermount ain Healt hcare. The program cent ralizes pat ient dat a to allow providers access to real-t ime informat ion, allowing t hem to make bet ter decisions and monitor performance against quality met rics. Even more compelling, however, is t he explosion of new offerings t argeted at pat ient s, allowing t hem to bet ter manage t heir own care. Boston Scient if ic, for inst ance, has launched t he LATITUDE Pat ient Monitoring system, a wireless remote pat ient management system. Pat ient s can have remote follow-ups, and t heir heart and cardiac device st at us can be monitored while t hey are at home. Spanish st art-up Nuubo has part nered wit h Telefonica to develop a smart T-shirt t hat uses elect ro-conduct ive text iles to record a medical quality elect rocardiogram and detect a pat ient s respirat ion rate. A number of companies have launched websites to educate pat ient s about t heir condit ions and/or build social net works connect ing pat ient s wit h each ot her, while ot her f irms are developing new technologies to boost adherence to drug regimens. The pat h forward: business model innovat ion In todays new normal, companies face a slew of risks f rom policy uncert ainty to regulatory const raint s and payer pressures which are collect ively put t ing unprecedented st rain on medtech innovat ion. As discussed earlier, t his is affect ing invest ment in t he sector, wit h f unding gravit at ing toward later-st age and mat ure companies. As t hey face a f ut ure clouded by uncert ainty and risk, medtech companies have seen t heir price to earnings rat ios fall. Yet despite t hese challenges and t heir impact on overall market sent iment , medtech st ill has signif icant growt h opport unit ies ahead. To realize t hese opport unit ies, companies will need to do several t hings. First and foremost , emerging companies will need to ensure t hat t hey can survive and sust ain innovat ion t hrough t he lean f unding climate. For many emerging companies, t his will involve searching more broadly for f unding opt ions beyond vent ure capit al, to include est ablished medtech companies, government grant s and disease foundat ions. Companies of all sizes will need to cont inue exploring ways to leverage OUS market s to offset challenges in t he US f rom emerging market s t hat offer higher growt h potent ial to European count ries t hat could provide quicker and easier routes to product launch and cash f lows. And as t he pressures f rom payers and providers cont inue to grow, it will be crit ical for companies to ret ain t heir focus on operat ional eff iciency. But t he biggest opport unit ies will be seized by t hose who can realign t hemselves for t he next new normal t he consumer and payer-cent ric f ut ure where proving outcomes will be paramount . This will involve innovat ion t hat extends beyond t he product . Among ot her t hings, it will require companies to reinvent various part s of t heir business models, including what t hey sell (t he offer), how t hey sell it (sales and market ing) and even how t hey develop t hose new offerings (R&D). While product innovat ion may be at risk in t he current environment , t he answer to long-term sust ainability will likely come f rom business model innovat ion. The offer. Medtech companies have historically focused on developing innovat ive product s. In t he new outcomes-focused ecosystem, however, companies will also need to demonst rate how a part icular intervent ion improves pat ient outcomes and enhances t he ellciency ol Lhe healLh care sysLem. Firms may consider expanding t heir offer f rom product s alone to include dat a and services as parL ol a lullledqed soluLion. They should be asking t hemselves if t here are ot her opport unit ies to monet ize t he value of what t hey know for instance, pat ient monitoring dat a rat her t han just what t hey manufact ure. For some categories of product s, business models may even evolve to discount ing or giving away t he product in order to sell an informat ion-based service of real-t ime pat ient diagnost ic dat a. 12 Pulseof t he indust ry Medical t echnology report 2011 Sales and market ing. As described above, t he sales st rategy is shif t ing f rom one based on t arget ing individual physicians to approaches t hat simult aneously focus on customer segment s t hat are becoming relat ively more import ant payers, hospit als and pat ient s. Medtech companies will need to revamp t heir sales, market ing and market access f unct ions to address t he different needs of each of t hese customer segment s. In dealing wit h payers, companies will need t he ability to argue for t heir product s based on compelling dat a part icularly in a world where ot hers may be conduct ing comparat ive effect iveness research on t heir product s. Sales forces and market ing st rategies will be sLrucLured Lo relecL how Lhe customer is organized, as opposed to t he ways in which medtech sales forces have historically been st ruct ured. As hospit als look to reduce t he number of vendors, medtech companies will need to bet ter art iculate t heir value proposit ion, including across broad product categories. Last ly, selling to increasingly empowered and informed pat ient s will require companies to underst and t heir needs. To succeed wit h a less scienLilcally aware cusLomer base Lhan highly t rained physicians, companies may need to increase t he levels and form of informat ion and educat ion t hey provide. And interact ing wit h stakeholders in new channels such as social media will require meaningful engagement from companies not just pitching t heir wares, but being fort hcoming and t ransparent , and providing relevant informat ion at t he right t ime. R&D. Medtech innovat ion has of ten been out side-in. Iterat ive innovat ion has of ten originated at t he bedside, as physicians provide feedback t hat sows t he seeds for t he next generat ion of product . Today, sunshine laws, which effect ively limit companies access to physicians, could potent ially put some of t his process at risk. But t he new healt h ecosystem, wit h it s rapidly emerging technologies and more widely dist ributed informat ion, could also provide opport unit ies to cast a wider net . Medt ronic, for inst ance, has begun crowdsourcing some of it s innovat ion wit h t he November 2010 launch of Medt ronic Eureka, a European web-based port al t hat allows physicians and medical technology innovators to submit product ideas. Conclusion: seeking sust ainabilit y Even as t he medtech indust ry grapples wit h t he challenge of sust aining innovat ion, it is wort h keeping in mind t hat sust ainability is now a global issue spanning many indust ries and ent ire economies. Government s, for inst ance, are st ruggling wit h put t ing t heir f iscal affairs on a sust ainable course, and payers across major market s are looking for ways to sust ain healt h care spending. These pressures may, over t ime, provide some of t he answers t hat medtech companies are seeking. As pressure builds on healt h care cost s, policymakers, payers and regulators will increasingly be pushed to realign incent ives around improving healt h outcomes. The companies best posit ioned for success will be t hose t hat develop t he new offerings and solut ions most relevant to t his changing ecosystem. Medtech companies have always t aken on risk to innovate new product s and technologies. Going forward, one of t he biggest risks may be t he failure to innovate beyond t he product and develop new offerings in new ways. 13 Int roduct ion Innovat ion and risk Learning from the past to guide us forward Alex Gorsky Johnson & Johnson Vice Chairman, Execut ive Commit t ee Having spent t he bulk of my healt h care career in t he pharmaceut ical indust ry, it s been a wonderf ully enriching experience for me to have now spent t he past several years focused on t he medtech space. There are many similarit ies bet ween t he t wo indust ries t he t remendous impact t hat bot h have on peoples lives, for example. But t here are differences, too, such as t he much faster pace of innovat ion in medtech compared wit h t he 15 years of R&D (not to ment ion t he more t han $1 billion) t hat it now t akes, on average, to bring a new drug to market . As medtech companies wrest le wit h an increasingly complex and difficult business environment , t here are some lessons we can learn f rom t he pharma indust ry, which began dealing wit h many of t he same issues about 10 years ago not always successf ully. While pharma seems to be on t he mend t hese days, medtech companies should t ry to avoid a similarly painf ul and lengt hy learning curve. Medt ech can learn t hree lessons from pharmas experience: 1. Change is here t o st ay embrace it . As I write t his, concerns are growing over a double-dip recession in t he US, t he lnancial crisis in Lurope is LhreaLeninq Lo enqull several more counLries and world sLock markeLs are down siqnilcanLly lrom t heir 52-week highs. Will t he global economy always be so volat ile? Hopef ully not , but it s likely t hat many of t he changes wrought during t he current crisis t ighter regulat ion, lower prices, st ricter ut ilizat ion st andards are here to st ay. While I remain very opt imist ic about our f ut ure, given demographic Lrends, scienLilc and Lechnoloqical advances and qeoqraphic expansion opport unit ies, it s import ant for us to underst and t he challenges we are facing and to lean forward into t hem rat her t han to hunker down and wait for t hem to pass. 2. Reinvent our business model soon. As t he pharma indust ry began to st ruggle, t here was lot s of t alk about t he need to move to a new business model. But more of ten t han not , companies simply moved to smaller versions of t he old model smaller sales forces, smaller R&D budget s and so on. There is no need for t he medtech indust ry to discard our current business model overnight . It has worked well for a long t ime, and many element s will cont inue to be essent ial as we move forward. But we must accelerate t he pace of experiment at ion wit h t ruly novel approaches to t he way we do business new R&D, commercial and customer service models, for example and we must quickly and broadly adopt t hose t hat prove most effect ive instead of hanging on to t he st at us quo for too long. 3. Pay at t ent ion t o how we are perceived. We recent ly met wit h a group of fait h-based inst it ut ional investors, whose concerns in Lhe pasL have cenLered on pharmaspecilc issues, such as access to HIV medicines in t he developing world. This t ime around, t hey asked us several quest ions about t he safety, ellcacy and allordabiliLy ol our medical devices. How we address t hese quest ions which are increasingly being asked by ot her stakeholders will go a long way toward determining how we are perceived. Will we be seen as a faceless, uncaring indusLry LhaL places prolLs ahead ol people? Or will we be seen as an indust ry t hat get s it t hat is helping to improve t he lives of tens of millions of people every day and understands t he need to do our fair share in order to bring our product s and services to even more people in t he years ahead? Im not suggest ing t hat we abandon our principles or accede to every demand t hats made of us. But if we are seen as part of t he problem rat her as part of t he solut ion society will deal wit h us as a problem, wit h unpleasant long-term consequences. Despite t he challenges we face, I cont inue to be excited by our potent ial to t ransform peoples lives and to grow our businesses. By learning f rom ot hers, we can realize our f ull potent ial even sooner. 14 Pulse of t he indust ry Medical t echnology report 2011 Michael A. Mussallem Edwards Lifesciences Corp. Chairman and Chief Execut ive Of f icer Healt h care reform and ot her light ning rod issues, increased regulatory scrut iny, pressures on reimbursement and a weak economy now shrouded in fog have all cont ributed to slower growt h in t he medical technology indust ry, especially in t he US. Many companies are seeking t he sunshine of emerging market s, such as China, India and Brazil, where wealt h is increasing and healt h care is a rapidly rising priority. This t rend cont inues to gain moment um wit h mult inat ional companies as regional expansion grows in importance. Yet I propose our indust ry not overlook t he excit ing opport unit ies we have to innovate technologies to address t he signif icant unmet needs in core market s. Innovat ion remains a compelling value proposit ion and, in my opinion, is t he pat h to successf ul outcomes for pat ient s, healt h care providers and medtech companies. Slower growt h in market s such as t he US, Europe and Japan does not mean opport unit ies dont exist . It just means t hat we have to be savvy and work harder to f ind t hem. Despite signif icant advancement s in medical t reat ment s and technologies, t here are st ill many unmet clinical needs in t hese regions. Millions of pat ient s are relying on our indust ry to innovate t he technologies t hat will enable t hem not just to live longer, but also to lead healt hier and higher-quality lives. In t he current environment , where f iscal discipline is of ten necessary, I believe it is becoming more import ant for our indust ry to focus resources on innovat ing technologies t hat build on our exist ing core competencies. St akeholders across t he board are demanding clinically superior product s t hat add proven economic value and markedly improve quality of life for pat ient s. Because of t his, our indust rys burden of proof is rising dramat ically. Companies are f inding t hat t hey need to invest in more dat a driven clinical t rials and pat ient regist ries t hat prove A proven path for growth t he value of new technologies t hat will impact t he pract ice of medicine. When adding t his factor into t he value equat ion, t he cost of pursuing me too technologies of ten becomes insurmount able. Therefore, now may be t he t ime for us to examine our portfolios and consider shif t ing invest ment toward t he disrupt ive core technologies, leaving t he non-st rategic technologies to companies more focused in t hose areas. Simply put , I believe a focused approach will result in greater pat ient benef it s and increase t he likelihood of value creat ion. Cert ainly, t here is no one-size-f it s-all solut ion to t he current challenges facing our indust ry. I can say, however, t hat focusing on innovat ion in core areas has produced a consistent t rack record of successes for our company for more t han 50 years, sust aining us t hrough many economic storms. It has also helped us to develop t he life-saving technologies we offer today. For example, in our recent history, we have intensif ied our focus on heart valves and crit ical care technologies, areas in which we are global leaders. This focus has led to t he evolut ion of heart valves and t he commercializat ion of t he game-changing t ranscat heter heart valve. This technology enables t he replacement of a failed nat ive valve via a cat heter, while t he heart cont inues to beat , rat her t han by open-heart surgery, t hereby offering cert ain pat ient s a t reat ment opt ion where previously none existed. It also holds great potent ial to reduce morbidity, mort ality and lengt h of hospit al st ay all of which are considerable wins for everyone. While t he current healt h care environment is dynamic and punct uated by uncert ainty, t here are t wo unwavering const ant s: t he needs of pat ient s and t he passion of t hose in our indust ry to help t hem. I am confident t hat if we use t hese guidepost s to lead us along t he pat h of innovat ion, we will succeed and improve t he quality of pat ient s lives around t he world a goal we all seek to achieve. 15 Sect ion Page name Financial performance The big pict ure Publicly t raded medtech companies in t he US and Europe t urned in a solid performance in 2010, wit h growt h in each of t he major f inancial indicators out pacing 2009 growt h rates a sign t hat t he impact of t he recession may have lessened. Revenue growt h was led in large part by conglomerates t hat rebounded af ter declining in 2009. The net income of non- conglomerates grew by 43%t he second consecut ive year of double-digit growt h. (After adjust ing for t he impact of large, one- t ime charges in 2009, net income growt h was 9%st ill a very solid growt h rate). Companies increased t heir spending on R&D by 7%an improvement over t he anemic 1% increase in 2009. Cash holdings grew at a double-digit rate for t he second year in a row. However, more worrisome was t he fact t hat nearly one out of every two non-cash-flow posit ive companies had less t han one year of money remaining in bot h t he US and Europe. Looking ahead, t he indust ry cont inues to grapple wit h mount ing pressures and faces considerable uncert ainty. GDP and unemployment numbers remain weak in much of t he developed world. Western government s are faced wit h unprecedented levels of debt and some are t aking ext reme measures to slash budget s. In t he US, ent it lement programs such as Medicare are expected to see payment reduct ions t hat will t rickle down to providers, physicians and, ult imately, medtech companies. Meanwhile, considerable uncert ainty remains around US healt h care reforms most not ably wit h respect to comparat ive effect iveness and t he medical device excise t ax and t he f ut ure of t he 510(k) clearance process. Last ly, a changing customer environment marked by hospit al consolidat ion, physicians becoming hospit al employees and hospit als and healt h systems implement ing value-based pricing and gain-sharing arrangement s, as well as technology assessment commit tees are all put t ing pressure on t he growt h of medtech companies. (For a f ull discussion of t hese t rends, refer to t he Int roduct ion art icle.) Furt her expansion into emerging and underserved market s, aging Western populat ions, longer life expect ancies and a gradual improvement in t he global economy are expected to posit ively impact medtechs long-term growt h. However, to sust ain growt h in t he immediate f ut ure, companies will need to address t he pressures listed above. 16 Pulse of t he indust ry Medical t echnology report 2011 Financial performance A solid performance Public company dat a 2010 2009 %change Revenues $315.9 $303.6 4% Conglomerates $122.3 $116.5 5% Non-conglomerates $193.7 $187.1 4% R&D expense $12.4 $11.6 7% Net income $17.4 $12.2 43% Cash and cash equivalent s and short-term invest ment s $42.0 $35.8 17% Number of employees 764,355 739,531 3% Number of public companies 436 443 -2% Medical t echnology at a glance, 2010 (US$b, dat a for non-conglomerat es except where indicat ed) Source: Ernst & Young and Capit al IQ Dat a shown for US and European public companies. 17 Financial performance A solid performance US public medt ech cash index European public medt ech cash index Source: Ernst & Young and Capit al IQ Char t excludes companies t hat are cash f low posit ive. Less than 1 year 2-3 years 1-2 years More than 5 years 3-5 years 2009 2010 0% 20% 40% 60% 80% 100% 18% 9% 9% 22% 42% 17% 6% 9% 19% 49% Source: Ernst & Young and Capit al IQ Char t excludes companies t hat are cash f low posit ive. Less than 1 year 2-3 years 1-2 years More than 5 years 3-5 years 2009 2010 0% 20% 40% 60% 80% 100% 31% 9% 3% 12% 45% 31% 8% 3% 11% 47% 18 Pulse of t he indust ry Medical t echnology report 2011 Unit ed St at es The revenues of all US publicly t raded medtech companies increased by 4%in 2010, af ter having declined by 0.1%in 2009. Wit h st rong top-line growt h at companies such as Danaher and Agilent Technologies, conglomerate revenues grew by 7%, an improvement over t he 0.9%drop in 2009. As in prior years, more det ailed analysis of f inancial performance is only possible for non-conglomerates, since conglomerates do not report separate f inancial result s for t heir medtech divisions. At t hese companies, revenues increased by US$3.8 billion (3%). R&D expense increased by US$0.7 billion (8%) and SG&A by US$0.8 billion (2%). Net income increased by signif icant ly more t han t he Public company dat a 2010 2009 %change Revenues $204.9 $196.7 4% Conglomerates $73.3 $68.8 7% Non-conglomerates $131.6 $127.8 3% R&D expense $9.8 $9.1 8% SG&A expense $41.4 $40.6 2% Net income $12.4 $7.9 57% Cash and cash equivalent s and short-term invest ment s $33.0 $27.9 18% Number of employees 462,730 456,150 1% Number of public companies 279 285 -2% Source: Ernst & Young and Capit al IQ US medt ech at a glance, 2010 (US$b, dat a for non-conglomerat es except where indicat ed) top line, growing by US$4.5 billion (57%). However, t his is largely because 2009 net income had been lowered by large merger, impairment and lit igat ion related charges incurred by Hologic, Medt ronic and Hill- Rom. If t hese charges were not included, net income would have increased by approximately 8%. Region Number of public companies Market capit alizat ion 30 June 2011 Revenue R&D Net income Cash and cash equivalent s Tot al asset s Massachuset t s 38 -3% $84,180 6% $39,891 2% $2,574 2% $1,223 -201% $6,304 -6% $89,070 3% Minnesot a 19 -10% $59,482 -10% $22,188 8% $2,252 10% $4,155 33% $4,731 85% $41,541 25% Sout hern California 37 3% $53,066 33% $17,069 12% $1,612 12% $1,244 -7% $5,177 23% $32,381 9% Nort hern California 33 6% $31,772 12% $8,471 13% $979 10% $840 78% $4,619 31% $12,492 19% New Jersey 16 0% $29,632 6% $11,182 4% $681 6% $1,892 9% $2,558 -7% $15,158 13% Michigan 2 -33% $21,463 6% $7,380 9% $397 16% $1,271 15% $4,404 48% $11,266 24% Indiana 3 0% $13,414 -7% $6,051 3% $283 38% $736 120% $1,134 17% $9,859 5% Pennsylvania 11 0% $9,611 3% $4,922 4% $154 53% $426 3% $871 13% $7,984 6% Texas 11 -8% $5,912 18% $2,833 5% $176 2% $395 39% $672 27% $4,363 8% New York 23 0% $4,985 16% $2,701 4% $195 22% $101 1,164% $554 22% $4,618 5% US medt ech non-conglomerat es, public company financial highlight s by region, 2010 (US$m, percent age change over 2009, except market cap over 30 June 2010) Source: Ernst & Young and Capit al IQ 19 Financial performance A solid performance US medt ech financings, 2005-H1 2011 The revenues of companies in t he Therapeut ic devices segment increased by 3.3%(US$2.5 billion) in 2010, compared to an increase of 1.9%in 2009. Twelve of t he 16 disease categories saw t heir top lines increase, versus only 8 t he year before. Of t he six largest disease segment s by revenue, mult iple and ort hopedic saw t he largest top line expansion, growing by 4.9%(US$1.6 billion; t hree-quarters of which came f rom Medt ronic) and 6.4%(US$896 million; t wo-t hirds f rom St ryker), respect ively. The Cardiovascular/ vascular and Womens healt h segment s saw revenues decline in 2010 due to t he acquisit ion of companies in t hese segment s. Adjust ing for t hese acquisit ions, bot h segment s would have seen top-line increases in 2010. Each of t he six segment s improved t heir bot tom lines in 2010. Medt ronic was responsible for more t han half of t he US$1.8 billion increase in t he mult iple categorys net income, while t he US$2.2 billion increase in t he net income of womens healt h was almost exclusively t he result of a US$2.3 billion goodwill impairment charge t hat had lowered Hologics net income in 2009. Change in US t herapeut ic device companies revenue and net income by disease cat egory, 200910 Source: Ernst & Young, Capit al IQ, BMO Capit al Market s, Dow Jones Vent ureSource and Windhover Orthopedic Multiple Oncology Dental Cardiovascular/ vascular Womens health $-0.5 $0.0 $0.5 $1.0 $1.5 $2.0 $2.5
C h a n g e
( U S $ b ) Revenue Net income 20 Pulse of t he indust ry Medical t echnology report 2011 While acquisit ions are a signif icant driver of growt h in t he medtech indust ry, it is notewort hy t hat t he t hree fastest growing (and six of t he ten fastest-growing) non-conglomerates expanded t heir top lines organically, wit hout t he assist ance of a signif icant acquisit ion. On t he conglomerate side, however, all of t he fastest growing medtech divisions were signif icant ly aided by mid-to-large scale acquisit ions of ot her companies. While medtech is const ant ly being altered by mergers and acquisit ions, it is encouraging to see t hat t he indust ry is dynamic enough to consistent ly replenish t he loss of seasoned companies wit h new generat ions of leaders. So while large companies such as Advanced Medical Opt ics, Applied Biosystems and Respironics have been acquired, ot hers such as Alere, CareFusion and Hologic have been added to t he billion dollar club. Select ed fast -growing medt echs by revenue growt h, 200510 (US$m) Non-conglomerat es 2005 2010 %growt h Illumina $74 $903 1,128% NuVasive $62 $478 671% Int uit ive Surgical $227 $1,413 522% Hologic $288 $1,680 484% Alere $422 $2,155 411% Thermo Fisher Scient if ic $2,633 $10,789 310% Masimo $108 $405 276% Life Technologies $1,198 $3,588 199% Integra LifeSciences $278 $732 163% ResMed $426 $1,092 157% Conglomerat es 2005 2010 %growt h Danaher: Medical Technologies $1,182 $4,123 249% Abbot t Diagnost ics and Vascular $2,942 $6,988 138% Agilent Technologies: Bio-analyt ical $1,421 $2,660 87% Corning Life Sciences $282 $508 80% Telef lex Medical $831 $1,433 72% Source: Ernst & Young and Capit al IQ Non-conglomerat es in it alics have made signif icant acquisit ions bet ween 2005 and 2010. The billion dollar club, 200610 Source: Ernst & Young Char t shows non-conglomerat es segment ed by t ot al revenues in each year. 2007 26 companies 2006 25 companies 2008 31 companies 2009 30 companies 2010 30 companies 15 companies 5 companies 4 companies 1 company 1 company 3 companies 3 companies 3 companies 5 companies 3 companies 3 companies 4 companies 4 companies 4 companies 6 companies 5 companies 16 companies 21 companies 18 companies 18 companies US$1-2.5b US$2.5-5b US$5-10b US>$10b 21 Financial performance A solid performance US market capit alizat ion, 2009H1 2011 US market capit alizat ion by size, 2009H1 2011 2009 2010 2011 -50% -25% 0% +25% +50% +75% +100% Jan Feb Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Mar EY US medtech industry Dow Jones Industrial Average NASDAQ Russell 3000 Source: Ernst & Young and Capit al IQ 2009 2010 2011 -50% -25% 0% +25% +50% +75% +100% Jan Feb Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Mar Micro cap (<US$250m) EY US medtech industry Large cap (market cap >US$5b) Mid cap (US$1-5b) Small cap (US$250m-1b) US medt echs have kept pace wit h broader indices wit h mid caps leading t he charge, and micro caps lagging well behind. 22 Pulse of t he indust ry Medical t echnology report 2011 Europe The European indust ry grew slight ly slower t han it s US counterpart in 2010. Wit h t he except ion of headcount and non- conglomerate revenue, t he US out paced Europe in every ot her indicator. In 2010, t he top-line growt h of publicly t raded European companies was very similar to t hat in 2009. All European public companies grew by 4%, essent ially replicat ing t he growt h experienced in 2009. For conglomerates, led by Roche Diagnost ics and Philips Healt hcare, t he growt h rate was 3%, compared to 2%a year earlier, while non-conglomerates saw revenues improve by 5%(compared to a 2.4%increase in 2009). The net income of non-conglomerates grew by 17%in 2010, down f rom t he 22%increase seen in 2009. This second consecut ive year of Source: Ernst & Young and Capit al IQ European medt ech at a glance (US$b, dat a for non-conglomerat es except where indicat ed) Public company dat a 2010 2009 %change Revenues $111.1 $106.9 4% Conglomerates $49.0 $47.6 3% Non-conglomerates $62.1 $59.3 5% R&D expense $2.6 $2.5 3% Net income $5.1 $4.3 17% Cash and cash equivalent s and short-term invest ment s $9.0 $7.9 13% Number of employees 299,174 283,073 6% Number of public companies 157 158 -1% European medt ech non-conglomerat es, public company financial highlight s by region, 2010 (US$m, percent age change over 2009, except market cap over 30 June 2010) Region Number of public companies Market capit alizat ion 30 June 2011 Revenue R&D Net income Cash and cash equivalent s Tot al asset s Germany 22 -4% $41,897 16% $20,832 8% $449 10% $1,537 24% $527 1% $29,390 7% France 14 17% $23,436 27% $8,008 10% $477 2% $820 3% $695 3% $10,022 15% Swit zerland 9 0% $13,215 -18% $3,508 8% $181 1% $557 -10% $1,033 23% $5,119 29% United Kingdom 24 -11% $11,978 -10% $4,812 -3% $218 -8% $646 38% $310 0% $5,886 5% Sweden 28 0% $11,495 49% $4,681 7% $205 5% $385 -4% $502 4% $6,897 1% Israel 23 5% $1,930 35% $650 41% $75 32% $(34) -20% $173 33% $1,063 26% Source: Ernst & Young and Capit al IQ double-digit expansion was spearheaded by st rong organic growt h at Smit h & Nephew and Sonova. Af ter a 2%drop in 2009, R&D spending bounced back in 2010 as year-over-year tot als were up by 3%. Medtech payrolls cont inued to edge up for t he second consecut ive year. While not separately disclosed by companies, headcount growt h has been gravit at ing towards high-growt h geographies, part icularly in emerging market s. 23 Indust ry performance A solid performance Source: Ernst & Young and Capit al IQ In 2010, t he revenues of Therapeut ic devices companies increased by 6%to US$53 billion down slight ly f rom t he 8% growt h rate in 2009. Of t he f ive largest t herapeut ic devices disease segment s, all but one (Mult iple) experienced year over year growt h in 2010. Fresenius Medical Care was solely responsible for t he Hematology/ renal 7%jump (US$829 million) while Essilor helped spur t he expansion in Opht halmic. Each of t he f ive largest segment s improved t heir bot tom lines in 2010. Change in European t herapeut ic device companies revenue and net income by disease cat egory, 200910 0 0.2 0.4 0.6 0.8 1.0 C h a n g e
( U S $ b ) Revenue Net income Non-disease- specic Hematology/renal Orthopedic Multiple Opthalmic 24 Pulse of t he indust ry Medical t echnology report 2011 Similar to t he US, six of t he ten fastest- growing non-conglomerate medtechs in Europe have seen t heir top lines swell predominant ly t hrough organic means and wit hout t he assist ance of large acquisit ions. Among conglomerates, Philips, Roche and Siemens have used signif icant acquisit ions to bolster t heir top lines, while Carl Zeiss and Draeger Medical have grown largely t hrough organic means. Select ed fast -growing medt echs by revenue growt h, 200510 (US$m) Source: Ernst & Young and Capit al IQ Non-conglomerat es in it alics have made signif icant acquisit ions bet ween 2005 and 2010. Non-conglomerat es Locat ion 2005 2010 %growt h Shamir Opt ical Indust ry Israel $52 $158 204% Ion Beam Applicat ions Belgium $170 $513 202% Qiagen Net herlands $398 $1,087 173% Sonova Holding Swit zerland $539 $1,440 167% ELEKTA Sweden $438 $1,027 135% Ossur Iceland $161 $359 123% Syneron Medical Israel $87 $190 118% Get inge Sweden $1,590 $3,081 94% Given Imaging Israel $87 $158 81% Q-Med Sweden $131 $202 54% Conglomerat es Locat ion 2005 2010 %growt h Carl Zeiss Meditec Germany $412 $953 131% Siemens Healt hcare Germany $9,698 $16,380 69% Roche Diagnost ics Swit zerland $6,628 $9,998 51% Philips Healt hcare Net herlands $7,897 $11,394 44% Draeger Medical Germany $1,378 $1,950 42% 25 Financial performance A solid performance European market capit alizat ion, 2009H1 2011 Source: Ernst & Young and Capit al IQ 2009 2010 2011 -50% -25% 0% +25% +50% +75% +100% Jan Feb Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Mar EY European medtech industry DAX FTSE 100 CAC 40 2009 2010 2011 -50% -25% 0% +25% +50% +100% +75% +125% +150% Jan Feb Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Mar Micro cap (<US$250m) EY European medtech industry Large cap (market cap >US$5b) Mid cap (US$1-5b) Small cap (US$250m-1b) European medt echs have out performed t he broader European market s as small caps expanded by more t han 125%, while micro caps st ruggled. European market capit alizat ion by size, 2009H1 2011 26 Financing Debt goes through the ceiling The big pict ure Medical technology companies in t he US and Europe raised nearly US$23.6 billion in 2010 an astounding 66%increase over 2009s tot al and t he highest annual tot al in t he six years t hat we have been t racking medtech f unding numbers. The t rend cont inued in t he f irst six mont hs of 2011, wit h f inancing tot als generally keeping pace wit h t hose seen in 2010. However, t he remarkable increase in capit al raised was not driven by a f undament al shif t in investor sent iment toward medtech and it has not made t he f inancing environment any easier for t he vast majority of emerging companies. Instead, t he increase in f unding was most ly concent rated in a handf ul of mat ure companies t hat took advant age of historically low interest rates to raise debt f unds t hat were typically used to rest ruct ure balance sheet s, f inance acquisit ions or f und general operat ions. Meanwhile, emerging, pre-commercial companies faced a very different f unding environment . Vent ure f inancing dropped for t he t hird consecut ive year in 2010 falling by 13%relat ive to 2009 t hough t he amount raised is st ill consistent wit h levels seen before t he crest ing of t he easy money era. The challenging market condit ions faced by medtech companies including growing regulatory and pricing pressures and t he preference of st rategic buyers for later-st age asset s cont inue to delay exit s and squeeze ret urns for vent ure capit al f irms. Compounding t he challenge is an IPO environment t hat remains weak. Af ter more t han t wo years of sluggishness, IPO act ivity improved in 2010, but not at t he pace seen prior to t he global recession. Over t ime, t he indust ry faces t he prospect t hat t he challenging f unding environment for R&D-st age companies will place medtech innovat ion at risk somet hing t hat is discussed in greater det ail in t his years Int roduct ion art icle, as well as in last years report . Type 2005 2006 2007 2008 2009 2010 H1 2011 Vent ure $3,214 $4,423 $5,108 $5,043 $4,809 $4,204 $2,211 IPO $988 $1,445 $1,816 $125 $103 $568 $329 Follow-on public offering $733 $1,060 $1,828 $1,435 $1,537 $961 $1,301 Debt $1,306 $10,341 $6,061 $4,506 $7,073 $17,030 $6,020 PIPE $702 $2,309 $1,095 $389 $655 $824 $201 Tot al $6,943 $19,578 $15,908 $11,498 $14,177 $23,587 $10,062 Capit al raised in t he US and Europe, 2005H1 2011 (US$m) Source: Ernst & Young, Capit al IQ, BMO Capit al Market s, Dow Jones Vent ureSource and Windhover Pulseof t he indust ry Medical t echnology report 2011 27 Indust ry performance Financing Unit ed St at es US medt ech financings, 2005-H1 2011 US medtech companies at t racted more t han US$16.7 billion in f inancing in 2010, a 37%increase over 2009 and t he highest annual tot al since at least 1999. Debt f inancing cont ributed US$11.4 billion (68%) of t he 2010 tot al, surpassing t he prior record of US$6.8 billion raised in 2009. This t rend cont inued t hrough t he f irst half of 2011, when debt const it uted 59%(US$4.9 billion) of t he US$8.3 billion in medtech f inancing. Wit h interest rates hovering near historic lows, several large companies issued corporate debt . Alt hough many of t hese companies had healt hy cash posit ions, t hey took advant age of t he low interest rate environment to ref inance exist ing debt , undert ake stock buybacks and pursue acquisit ions. Non-conglomerates t hat issued signif icant amount s of debt over t he past 18 mont hs include Medt ronic (US$4 billion), Thermo Fisher Scient if ic (US$2.9 billion), Life Technologies (US$2.3 billion), Becton Dickinson (US$1 billion) and St ryker (US$1 billion). U S $ b $0 $2 $4 $6 $8 $10 $12 $14 $16 $18 2006 2005 2007 2008 2009 2010 H1 2011 Venture nancing Debt PIPE Follow-on public offering IPO US medt ech financings, 2005H1 2011 Source: Ernst & Young, Capit al IQ, BMO Capit al Market s, Dow Jones Vent ureSource and Windhover Ind I 28 Pulse of t he indust ry Medical t echnology report 2011 The pict ure was dramat ically different for non-debt financings. Af ter excluding debt f rom t he numbers, t he amount of capit al raised by US medtech companies act ually declined by 3%. While t his represent s t he fourt h consecut ive year of decline in t he amount of non-debt f unding, we should note t hat t he decline in 2010 was relat ively modest and t hat t he f unding levels are st ill consistent wit h t hose seen in years prior to t he easy money era. US medt ech financings wit hout debt offerings, 2005H1 2011 Source: Ernst & Young, Capit al IQ, BMO Capit al Market s, Dow Jones Vent ureSource and Windhover U S $ b $0 $1 $2 $3 $4 $5 $6 $7 $8 2006 2005 2007 2008 2009 2010 H1 2011 Venture nancing PIPE Follow-on public offering IPO 29 Indust ry performance Financing As in prior years, companies in California, Massachuset t s and Minnesot a at t racted t he lions share of invest ment over t he past 18 mont hs US$17.5 billion or 70% of t he US tot al. However, t he nat ure of f unding was quite different across t hese clusters. In Minnesot a, a remarkable 95%of t he f unding was comprised of debt offerings by just t wo mat ure companies Medt ronic and St . Jude Medical. Consequent ly, Minnesot a led t he nat ion in tot al capit al raised, wit h a tot al of US$5.2 billion, coming out ahead of Sout hern California (US$4.6 billion) and Massachuset t s (US$4.5 billion). However, t he number of rounds in Minnesot a was much lower t han in t he ot her leading clusters and was more in line wit h t he number of rounds in second-t ier clusters. Conversely, in t he t hree ot her leading f unding clusters Nort hern California, Sout hern California and Massachusett s f unding was more broadly dist ributed in a larger number of relat ively small rounds. Nort hern California dominated t he vent ure capit al scene in bot h t he amount raised (US$2.0 billion) and t he number of f inancings (125). Capit al raised in 2010 and H1 2011 by leading US regions T o t a l
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( U S $ m ) $0 $1 $2 $3 $4 $5 2006 2005 2007 2008 2009 2010 H1 2011 Total amount raised $0 $3 $6 $9 $12 $15 Average deal size 31 Indust ry performance Financing Five US medtech companies completed init ial public offerings in 2010 and grossed a tot al of US$501 million. These f igures surpassed t he combined tot als for 2008 and 2009 (4 IPOs for US$206 million), but st ill fell well behind t he levels seen in 2007 (when 13 IPOs raised US$1.2 billion). In t he f irst half of 2011, anot her t hree US companies went public, raising US$142 million. It is wort h not ing t hat t he majority of t he companies t hat have gone public since January 2010 have been in t he Research and ot her equipment or Non-imaging diagnost ics segment s. The relat ive scarcity of t herapeut ic device companies may be one more sign t hat private and public investors are increasingly interested in companies t hat are bet ter posit ioned to avoid t he pitfalls of FDA approval and reimbursement . US IPOs, 2010H1 2011 Company Ticker Locat ion Product t ype (disease) Gross raised (US$m) Quart er DynaVox DVOX Pit t sburgh, Penn. Ot her 141 Q2 2010 GenMark Diagnost ics GNMK Pasadena, Calif. Non-imaging diagnost ics 28 Q2 2010 Pacif ic Biosciences PACB Menlo Park, Calif. Research and ot her equipment 200 Q4 2010 REVA Medical REVA San Diego, Calif. Therapeut ic devices (cardiovascular/ vascular) 78 Q4 2010 Complete Genomics GNOM Mount ain View, Calif. Research and ot her equipment 54 Q4 2010 Fluidigm FLDM Sout h San Francisco, Calif. Research and ot her equipment 86 Q1 2011 BG Medicine BGMD Walt ham, Mass. Non-imaging diagnost ics 40 Q1 2011 Kips Bay Medical KIPS Minneapolis, Minn. Therapeut ic devices (cardiovascular/ vascular) 16 Q1 2011 Source: Ernst & Young, BMO Capit al Market s, Capit al IQ and Windhover 32 Pulse of t he indust ry Medical t echnology report 2011 The majorit y of US IPOs priced below t heir desired ranges... ...and most were down in subsequent t rading. $0 $5 $10 $15 $20 $25 P r i c e
( U S $ m ) Range Offer price DVOX GNMK PACB GNOM FLDM BGMD KIPS Source: Ernst & Young and Renaissance Capit al Only four members of t he current IPO class DynaVox, Fluidigm, Kips Bay Medical and Pacific Biosciences were able to go public at a price wit hin t heir desired range. In addit ion, more t han half of all t he companies saw t heir share prices fall below t heir launch prices as of 30 June 2011. Wit h four medtech IPOs pulled since t he fourt h quarter of 2010, and only four more companies in t he queue as of 30 June 2011, we expect t he environment for medtech IPOs will cont inue to be challenging over t he coming mont hs. Given t he recent market volat ility, investors are likely to become more risk adverse and t hose companies t hat do find a posit ive recept ion by investors will likely have to be mat ure businesses wit h a clear pat h to profitability. Should t he performance of t his recent batch of IPOs improve, and overall public medtech valuat ions begin to recover, investors may be more willing to consider platform/ technology companies t hat have modest revenues as potent ial IPO candidates. Unt il t hen, we may see more US companies looking to go public on overseas exchanges, like REVA Medical and GI Dynamics, which went public on t he Aust ralian Securit ies Exchange in recent mont hs. Source: Ernst & Young and Capit al IQ -60% -40% -20% 0% 20% 40% 60% 3 0
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p r i c e DVOX GNMK PACB RVA GNOM FLDM BGMD KIPS 33 Indust ry performance Financing Europe US medt ech financings, 2005-H1 2011 European f inancing t rends were very similar to t hose seen in t he US. As in t he US, f unding rose to t he highest level since at least 1999 in t his case, surging by a remarkable 251%year over year to US$7.0 billion. Once again, t his was largely driven by corporate debt , which accounted for US$5.6 billion an astounding 80%of all f unds raised. This t rend cont inued in t he f irst half of 2011, when debt accounted for US$1.1 billion out of t he US$1.7 billion in tot al f inancing. As was t he case in t he US, debt f unding was driven by a handf ul of companies. Germanys Fresenius Medical Care f loated t he largest cumulat ive amount of debt (US$3.7 billion) during t he 18-mont h period ending in June 2011. Fresenius used t he proceeds for general corporate purposes, working capit al needs, to repay indebtedness and for acquisit ions. European medt ech financings, 2005H1 2011 Source: Ernst & Young, Capit al IQ, BMO Capit al Market s, Dow Jones Vent ureSource and Windhover U S $ b $0 $2 $4 $6 $8 2006 2005 2007 2008 2009 2010 H1 2011 Venture nancing Debt PIPE Follow-on public offering IPO 34 Pulse of t he indust ry Medical t echnology report 2011 Af ter removing debt f inancing f rom t he tot al, t he pict ure is very different . While tot al f unding increased by 251%, non-debt f inancing declined by 19%. Europes f inancing performance was even weaker because, unlike t he US, public offerings (IPOs and follow-ons combined) yielded a meager US$112 million in 2010. However, 2010 did see a slight upt ick in vent ure invest ment , as well as st rong growt h in PIPEs. Looking at 2011, t he market s for bot h follow- ons and PIPEs were ext remely weak t hrough t he f irst six mont hs of t he year, while vent ure f inancing showed some encouraging year-over-year growt h. However, given t he ongoing European debt crisis, t he f unding environment may become more difficult for some public companies and IPO candidates. European financings wit hout debt offerings, 2005H1 2011 Source: Ernst & Young, Capit al IQ, BMO Capit al Market s, Dow Jones Vent ureSource and Windhover U S $ b $0 $1 $2 $3 2006 2005 2007 2008 2009 2010 H1 2011 Venture nancing PIPE Follow-on public offering IPO 35 Indust ry performance Financing Primarily driven by a series of large debt offerings by Fresenius Medical Care, Germany (US$4.2 billion) raised 48% of tot al capit al in Europe, while t he UK (US$1.5 billion) and t he Net herlands (US$468 million) rounded out t he top t hree. The UKs tot al was primarily t he result of a debt offering by Smit h & Nephew, whereas t he Net herlands tot al was driven in part by Europes largest medtech IPO, Tornier. Israel (US$265 million) once again led Europe in vent ure capit al raised. For t he second consecut ive period, Israeli, French, Brit ish and German medtechs all raised more t han US$100 million of vent ure capit al. Capit al raised in 2010 and H1 2011 by leading European count ries Source: Ernst & Young, Capit al IQ, BMO Capit al Market s, Dow Jones Vent ureSource and Windhover Size of bubbles shows relat ive number of f inancings per region. T o t a l
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( U S $ b ) $0 $50 $100 $150 $200 $250 $300 $0 $1 $2 $3 $4 $5 Venture capital raised (US$m) Germany United Kingdom Israel France Sweden Switzerland Netherlands Source: Ernst & Young, BMO Capit al Market s, Capit al IQ and Windhover Company Ticker Locat ion Product t ype (disease) Gross raised (US$m) Quart er Aposense APOS Israel Imaging 16 Q2 2010 Carmat ALCAR France Therapeut ic devices (cardiovascular/ vascular) 21 Q3 2010 CellCura CELL Norway Research and ot her equipment 3 Q4 2010 Stentys STNT France Therapeut ic devices (cardiovascular/ vascular) 30 Q4 2010 Tornier TRNX Net herlands Therapeut ic devices (ort hopedic) 166 Q1 2011 Tekka ALTKA France Therapeut ic devices (dent al) 16 Q1 2011 Biosynex ALBIO France Non-imaging diagnost ics 4 Q1 2011 European IPOs, 2010-H1 2011 After two years of virt ually no act ivity, t he European IPO market began to show some signs of life as four companies went public in 2010, followed by anot her t hree in t he first half of 2011. However, out side of t he Dutch ort hopedic company Torniers US$166 million IPO, t he average IPO size for t he ot her six companies was only US$15 million, well below t he average seen in t he US. 36 Pulse of t he indust ry Medical t echnology report 2011 European vent ure invest ment was up 4.7%to US$707 million in 2010, compared to a 15%drop in t he US, and t he amount raised in t he f irst half of 2011 was on pace to equal 2010 tot als. Once again, despite t he drop relat ive to t he height s achieved in 2007, vent ure f unding compares favorably to levels seen in 2005 and before (prior to t he easy money years). The average vent ure round in Europe was roughly two-t hirds it s US counterpart in 2010 (US$5.8 million vs. US$9.0 million). Unlike t he US, where seven of t he ten largest vent ure capital rounds were invested in eit her research and ot her equipment or non-imaging diagnost ic companies, only two of t he ten largest rounds in Europe went toward t hese types of companies. The five largest rounds were raised by t herapeut ic device and imaging companies. European vent ure capit al, 2005H1 2011 Source: Ernst & Young, Capit al IQ, Dow Jones Vent ureSource and Windhover T o t a l
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( U S $ m ) $0 $200 $400 $600 $800 $1,000 2006 2005 2007 2008 2009 2010 H1 2011 Total amount raised $0 $2 $4 $6 $8 $10 Average deal size 37 Indust ry performance Financing US medt ech financings, 2005-H1 2011 Unlike t heir US counterpart s, t he majority of European IPO companies were successf ul in pricing wit hin t heir desired f iling ranges. By 30 June 2011, four of t he seven were t rading up relat ive to t heir IPO prices (wit h one company French heart prost hesis company Carmat SA seeing it s price increase by an astonishing 845%). As in t he US, a number of European companies have pulled planned offerings and t he mid-2011 IPO pipeline is very t hin. European IPO performance class of 2010 and H1 2011 -100% 3 0
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p r i c e APOS ALCAR CELL STNT TRNX ALTKA ALBIO 0% 100% 200% 900% Source: Ernst & Young, Renaissance Capit al and Google f inance 38 Pulse of t he indust ry Medical t echnology report 2011 Kevin Davies RBC Capit al Market s Managing Direct or, Head of Healt hcare Group Ali Sat vat Apax Part ners Principal Aileen St ockburger Johnson & Johnson, Inc. Vice President , Worldwide Business Development Bryant Zanko St ryker Corporat ion Vice President , Corporat e Business Development Medical t echnology has always been a deal-driven indust ry. Aft er reaching loft y height s in 2006 and 2007, M&A act ivit y plummet ed in t he wake of t he financial crisis and bot t omed out in 2009. While we have seen a significant rebound in t ransact ion act ivit y since t he beginning of 2010, a host of ot her challenges cont inue t o cloud t he long-t erm prospect s of M&As, product innovat ion, t radit ional business models and t he indust ry as a whole. To bet t er underst and t he current M&A environment , we sat down in July 2011 (prior t o t he market volat ilit y t hat occurred in August ) wit h four vet erans of t he medt ech deal environment . These include business development execut ives from t wo of t he indust rys most act ive acquirers Johnson & Johnson and St ryker. Our panel also includes insight s from an invest ment banker from RBC Capit al Market s and a principal from t he privat e equit y firm Apax Part ners who made a big splash in July when it announced it s planned acquisit ion of Kinet ic Concept s. Ernst & Young: Medt ech M&A act ivit y seems t o have rebounded in 2010 and t he first half of 2011. What s driving t his upt ick? Zanko: I believe we have a perfect confluence of factors. Wit h st rong balance sheet s and lot s of cash, companies are looking to M&A to boost growt h. Were also in a period of historically cheap and, unt il most recent ly ,available credit and t here is pent-up demand f rom mot ivated sellers who are looking to exit f rom t he invest ment s t hey made before t he recession in 2008. Davies: I agree wit h all of Bryant s comment s. Sust aining growt h has been a challenge, as have a host of uncert aint ies surrounding t he FDA approval process, healt h care reform in t he US and a changing sales environment where payers and providers have more inf luence over physician choices. Now t hat medtechs are beginning to come to terms wit h t hese uncert aint ies and general economic condit ions have improved companies are more confident about conduct ing M&As. Roundt able on mergers and acquisit ions A fundamentally new deal environment 39 This is not just about an upt ick in t he number and size of t ransact ions it s about a fundament ally different deal environment . Kevin Davies Indust ry performance Mergers and acquist ions This is not just about an upt ick in t he number and size of t ransact ions it s about a f undament ally different deal environment . Not too long ago, t he sector t raded at a premium relat ive to t he S&P 500 because it s growt h typically exceeded such benchmarks. That is no longer t he case, because t he growt h rates of t he largest medtechs have slowed. To really boost revenue growt h and price to earning mult iples, companies will need to go beyond run-of-t he-mill t uck-in acquisit ions. Indeed, t he large medtechs are looking for big breakt hrough technologies or seeking to st rengt hen t heir posit ions in growing, mult ibillion-dollar market s. In order to do t hat , acquirers need to do somet hing t hat s eit her big, like Johnson & Johnsons acquisit ion of Synt hes, or t hey need to t ake a calculated risk on new technologies. Even if a new technology cost s hundreds of millions of dollars, it may be wort h making a bet to enter a new mult ibillion-dollar market . St ockburger: Even in t he downt urn, J&J never really stopped looking for acquisit ions. However, smaller medtechs were unwilling to sell because t heir valuat ions had nosedived and many were unwilling to accept t he new market values due to market uncert ainty. Today, people feel t he market is pret ty st able and t hey are much more comfort able accept ing a reasonable acquisit ion price for t heir company. Ernst & Young: The indust ry faces increasing const raint s on increment al product innovat ion and growing requirement s t o demonst rat e healt h out comes for product approval and reimbursement . How are t hese challenges affect ing medt ech M&A st rat egies? St ockburger: While t he development cycle in t he US is becoming longer and more expensive, t hese pressures arent necessarily affect ing our M&A st rategy. However, t he uncert ainty around t he US product approval process and t he higher bar to demonst rate outcomes to gain reimbursement is cert ainly impact ing emerging companies. We are seeing fewer emerging companies focused on early-st age R&D because t he pool of vent ure capit al isnt get t ing any bigger. So while t he current impact on acquirers like J&J may be minimal, t he ability of emerging companies to weat her t he current environment may ult imately impact t he way we evaluate t he market in t he long term. Zanko: Five years ago, st rategic acquirers were pursuing riskier, early-st age t ransact ions wit h signif icant cont ingent payout s, milestone payment s and ot her risk-sharing mechanisms. In todays heightened regulatory/ payer risk environment , t hey are instead more likely to focus on de-risked deals. This may include larger, later-st age t arget s, f irms t hat are profit able or cash f low-posit ive or, at t he very least , generate signif icant sales. To pay top dollar for a company in todays environment, it s product s must have out standing healt h care economics, deliver superior pat ient outcomes and make a meaningful difference for surgeons. The target also needs to meet financial t hresholds not only long- term payback, but also short-term earnings per share. Davies: These pressures are cert ainly changing t he way acquirers look at t arget s. In recent years, emerging companies wit h PMA devices typically seek to f irst gain European approval and some European reimbursement before t hinking about clinical t rials in t he US. In t he current regulatory environment , large st rategic buyers considering acquiring such emerging companies are increasingly asking t rusted clinicians and sales reps to gauge t he need for and clinical ut ility of t he t arget s device, as well as t he likelihood of securing approval and reimbursement . If t he device passes t his review, t he st rategic acquirer has more confidence t hat it can demonst rate a st rong value proposit ion to payers. 40 Pulse of t he indust ry Medical t echnology report 2011 Sat vat : I have a somewhat different perspect ive. As Bryant pointed out , buyers are now moving to later-st age, de-risked asset s. However, wit h t he t radit ional early-st age f unding model under f ire, t here is more need t han ever for st rategic investors to acquire f irms sooner in t he development cycle to avoid any potent ial gaps in product innovat ion. While some buyers are acquiring early-st age companies, t hey are proceeding wit h signif icant caut ion. They are more willing t han ever to kill deals quickly if t he regulatory or commercial hurdles become too cumbersome. I hope t hat st rategic buyers remain cognizant of t he t remendous potent ial upside f rom early-st age deals and balance t he potent ial upside along wit h t he increased risks and any necessary hassles and headaches. Ernst & Young: Today t here is a much great er emphasis on selling t o payers and providers, in addit ion t o physicians. How will t his change t he way medt echs look at pot ent ial t arget s bot h companies and t echnologies? Sat vat : Companies must ensure t hat t hey are sensit ive to t he different requirement s of t heir many const it uent s physicians, payers and providers who are all involved in t he purchasing process. Each const it uent will have different needs and ment alit ies and will be asking different quest ions. While we expect t hat many product s will ret ain t heir exist ing physician preference st at us, it is now more import ant t han before to spend t ime during bot h t he diligence and t he post-t ransact ion periods to underst and t he approach of payers whet her public or private given t he reality of cost consciousness. Asset s t hat provide t ruly different iated clinical outcomes in a cost-effect ive manner for t he healt hcare system will become increasingly relevant t arget s. St ockburger: This greater focus on payers and providers is affect ing how we evaluate potent ial sales force and go to market synergies. Tradit ionally, we have looked for synergies bet ween t he t arget and ourselves wit h respect to t he sales force, t he product s and t he interact ions wit h t he doctor. If a sales rep is calling on a cardiologist , what else can we put in her bag? But now, if my sales rep is no longer visit ing only a cardiologist , but also needs to see t he purchasing agent , t hat is a much different sales st rategy. As always, t he most at t ract ive product s are t hose t hat are wanted by doctors, are cost effect ive and signif icant ly improve pat ient outcomes. To succeed, companies will need to sat isfy all of t hese requirement s. Unfort unately, we st ill see many small companies only focused on one set of requirement s t hose of t he doctors. They come up wit h great new technologies, but t heir bubbles are burst when we st art asking about t heir reimbursement st rategy and t hey havent formulated one yet . Well, t hat s a pret ty big omission no mat ter how revolut ionary t he product is. Zanko: I would argue t hat we have always sought to acquire asset s t hat not only improve clinical outcomes but also deliver value to t he system. We also t hink about regulatory pat hways, healt h economics and how long it might take to secure reimbursement . Theres always an element of risk and a t ime value of money, so we have to weigh all of t hose in terms of how much were willing to pay for an opport unity, how we might st ruct ure t he t ransact ion, t he risk profile, etc. That being said, I do agree wit h Aileen. It is no longer enough for companies to merely place a great product in t he hands of a surgeon. All of t he st akeholders physicians, payers, providers and even pat ient s play an import ant part in t he system and need to be aligned. But we have to be caref ul in overst at ing t he decline in t he physicians role in purchasing. I believe physicians whet her t hey are employees or running t heir own pract ices will cont inue to play a signif icant role in ident ifying t he best product s, procedures and clinical approaches. In t odays height ened regulat ory/ payer risk environment , [st rat egic acquirers] are inst ead more likely t o focus on de- risked" Iarer, Iater-stae tarets, hrms that are prchtabIe cr cash Bcw-pcsitive cr, at the very Ieast, enerate sinihcant sales. Bryant Zanko 41 Indust ry performance Mergers and acquist ions Ernst & Young: Recent ly, a number of medt ech companies have been diversifying t heir operat ions by eit her acquiring services capabilit ies or forming joint vent ures wit h non-t radit ional players. Do you see t his t rend cont inuing? St ockburger: We are always looking for opport unit ies t hat will make our offerings more comprehensive. While t he idea of a holist ic solut ion sounds great in t heory, in pract ice such arrangement s are ext remely complicated. You need to come up wit h an offering t hat is unique and you need to determine if your organizat ion will be bet ter at delivering t hat offering t han ot hers. I remember an example of an operat ing room consult ing company we bought about 15 years ago. We ended up selling it t wo years later because we could not make it a viable offering. Our customers t hought t he services were great but t hey werent willing to pay for t hem. It s one t hing to go out and buy a services company, but it s anot her to determine how youre act ually going to use it to enhance your offering or value proposit ion. You need to make sure you can ident ify, underst and and communicate t he economics of such a part nership. Zanko: It s a misconcept ion t hat medtech manufact urers are not already service-driven organizat ions. Medtech service cost s tend to be baked into t he device price, but f rom supply chain management to physician t raining and clinical support , service is a cornerstone of t he medtech businesses. That said, we are cert ainly commit ted to exploring new opport unit ies to make our service offerings more comprehensive. Wit h t he acquisit ion of Ascent , now St ryker Sust ainability Solut ions, we not only focused on improving our relat ionships wit h surgeons, but just as import ant ly, we demonst rated to hospit al CFOs and procurement off icers t hat we were commit ted to delivering out st anding product s at a lower cost . In short , I t hink anyt hing we can do as an organizat ion to broaden our appeal wit h our varied const it uent s, including service-related act ivit ies, should be essent ial moving forward. Sat vat : Like Aileen and Bryant, I t hink t hat combining a service element wit h a product offering is ext remely important, as it furt her enhances t he value t hat a medtech company can deliver. I also believe t hat medtech companies will cont inue to look for ways to incorporate technology into standard product s to make t hem smarter. For example, component s such as sensors, which can t rack and communicate informat ion in real t ime, add value for t he pat ient, t he physician and t he payer. However, managing such complex, real-t ime data is typically beyond t he exist ing core competencies of most medtech companies. So, t hey will need to eit her acquire t hese capabilit ies or to part ner wit h out side part ies to gain access to t hem. Of course, as Aileen stated, t he real challenge for medtech companies in developing t hese new service capabilit ies is finding ways for payers to act ually pay for t hem. Theres a huge wasteland of ideas t hat sounded great at t he out set but for which companies were unable to obtain reimbursement. Ernst & Young: How are vent ure funding challenges affect ing medt ech innovat ion? Davies: In t he current environment , VCs are already challenged to invest in PMA-type clinical t rials. While t he t ime frames and t he amount of capital needed have increased almost to t he levels of clinical t rials for drugs ret urns and mult iples have not . VCs and t heir portfolio companies can st ill earn huge ret urns wit h a breakt hrough product and in t he right market , but t he risks associated wit h a long, uncertain FDA approval pat h are too large for many investors. Companies must ensure t hat t hey are sensit ive t o t he different requirement s of t heir many const it uent s physicians, payers and providers who are now involved in t he purchasing process. Ali Sat vat 42 Pulse of t he indust ry Medical t echnology report 2011 Zanko: Kevin is right . There is no doubt t hat t he current US medtech regulatory environment has clearly shifted t he VC invest ment paradigm. VCs play a crit ical role in fostering indust ry innovat ion, but t he addit ional risks associated wit h longer product approval t imes are requiring t hem to invest more capital per company. By plowing more of t heir money into t heir exist ing portfolio companies, VCs are earning severely diluted rates of ret urn on t he back end and it is also leaving t hem wit h less money to invest in ot her opport unit ies. If VCs are not willing or able to fund clinical t rials for disrupt ive technologies in t he fut ure, indust ry innovat ion will be hindered. And unfort unately, I dont see corporates or t he US government filling in t he funding gap. So t here is a real danger of diminished innovat ion. Sat vat : Wit h t he aforement ioned challenges hindering t he ability of VCs to invest in early-st age companies, I t hink t hat we may see VCs increasingly move into t he growt h equity landscape. VCs may t ake t heir product knowledge and sector expert ise to invest in later- st age, revenue-producing companies. So, I t hink t hat t here may be some morphing of t he exist ing VC model because t he overall market challenges wont be going away anyt ime soon. This change in focus could pose a subst ant ial problem for early-st age product innovat ion and also make t he later-st age landscape more compet it ive. Ernst & Young: A number of large companies have divest ed non- core asset s over t he past several years. Are t here any common t rends around t hese divest it ures? What st eps should companies t ake t o maximize value in divest it ures? Zanko: I dont believe t hese divest it ures are eit her a t rend or a t heme. Rat her, t hey ref lect t act ical portfolio management . When St ryker sold it s Physiot herapy business, t here wasnt necessarily a change in t he companys overall st rategy. Rat her, we believed t hat we werent t ruly maximizing t he value of t hat asset and t hat new owners could possibly do a bet ter job. St ockburger: A divest it ure is of ten viewed as a failure on t he part of t he seller but , as Bryant st ated, t hey are really about portfolio management moving asset s to opt imize a book of business. I would rat her invest in an asset t hat is st rategic to t he company t han one t hat is not core to our mission. I cert ainly see more and more companies performing or considering divest it ures. Corporate business development teams are openly t alking about divest it ures, and private equity investors are inquiring about asset s t hat might potent ially be spun off. I t hink t his level of interest in divest it ures by potent ial buyers and sellers is good for everyone. Sat vat : From my experience, management teams f rom spun-out companies are of ten very support ive of a divest it ure. Generally, t hese propert ies havent received much focus f rom t he parent company, and t hey arent able to properly reorganize or revit alize t heir operat ions unt il and unless t hey are spun out . In order to maximize value as an acquirer of divested asset s, we have to go t he ext ra mile in performing due diligence, part icularly around regulatory issues. Is t here anyt hing about t his asset t hat I dont underst and? Is t here anyt hing about a system t hat Im inherit ing t hat might be challenging? Also, am I buying just an asset or instead a platform t hat can be developed and grown f urt her? Can I integrate it wit h t hose t hat I already own? Finally, and most import ant ly, it s import ant to focus on asset s t hat are market leaders t hat st ill have an opport unity to grow whet her t hat s wit h an inf usion of addit ional capit al and resources or t he backing of an exist ing management team wit h renewed focus or a new management team t hat can bring f resh ideas. It s one t hing t o go out and buy a services company, but it s anot her t o det ermine how youre act ually going t o use it t o enhance your offering or value proposit ion. You need t o make sure you can ident ify, underst and and communicat e t he economics of such a part nership. Aileen St ockburger 43 Indust ry performance Mergers and acquist ions Ernst & Young: How is t he uncert aint y around US healt h care reform and t he FDA approval process affect ing deals? Has t his driven you t o focus more on acquisit ion t arget s out side t he US? Zanko: While weve historically seen US companies pursue t he route of developing out side US (OUS) dat a and commercial experience before earning product approval in t he US, we are now seeing somet hing new US-based medtechs building t heir ent ire business case overseas and bypassing t he US altoget her. As a large company, we would st ill prefer to see a pat hway to US approval before acquiring a company. The US is st ill t he most import ant healt h care market in t he world, and to just ify t he values t hat t heir vent ure investors want , companies have to show a st rategy for entering t he US. Of course, t he bigger issue is t hat we need to ensure t hat innovat ive product s can f irst be commercialized in t he US so t hat pat ient s here can benef it sooner. Unfort unately, unt il posit ive regulatory reform occurs in t he US, medtech innovat ion will cont inue to shif t overseas. St ockburger: I dont believe t he lack of visibility in t he US has changed our M&A st rategy at all. We cert ainly see many US-based medtechs avoiding t he FDA approval process and going to Europe. While it may offer a quicker and cheaper alternat ive to product approval and reimbursement , we st ill would like to see a US product as well. Like Bryant , we also like business plans t hat t ake t he US into considerat ion. The ability of a potent ial t arget to event ually receive US product approval and reimbursement is very import ant . Yes, t he US FDA approval process is long and expensive, but it is also necessary. Davies: While I agree wit h Bryant and Aileen t hat t he US is st ill an ext remely import ant market , emerging companies OUS st rategies may act ually open up greater opport unit ies elsewhere. If a device is being paid for in Europe, why couldnt a company also make money in underpenet rated market s such as China, India and Brazil? Also, wit h a lot of t heir cash sit t ing offshore, large medtechs are very interested in using t hat cash for more non-US t ransact ions. Sat vat : The lack of clarity in t he US product approval process has increased our spending on external advisors to ensure t hat we have as complete an underst anding as possible of issues around asset s t hat we purchase and a means of remedying challenging regulatory sit uat ions. Also, as a global private equity f irm, we have t he ability not only to leverage learnings f rom one geography to anot her, but also t he f lexibility to invest in asset s across various geographies. Ernst & Young: Aft er a brief hiat us, privat e equit y (PE) appears t o have reignit ed it s int erest in medt ech. What is your view on PEs ret urn t o t he market ? Zanko: As long as t he cost of capit al remains low and companies cont inue to produce good corporate earnings, I t hink PE is going to be a player in t he medtech market . That being said, we dont typically run into PEs on our deals, especially for t arget s t hat have signif icant synergies wit h our exist ing core business. However, if we were to look at an ent ire new platform, where we dont really have synergies, I can cert ainly see PE becoming a compet itor. St ockburger: Private equity definitely seems to be back in force. I seem to receive a phone call a day f rom PEs asking if J&J is selling anyt hing. In fact , we know t hat PE f irms were interested in Synt hes an acquisit ion on which we are spending about US$21 billion! Consider t hat if you t hink private equity doesnt have serious sums of money to spend. More import ant , t hey have banks lined up t hat are willing to f inance medtech-related t ransact ions. It looks like t he medtech deal environment is about to get even more interest ing in t he mont hs ahead. Mergers and acquisit ions Let s make a deal The big pict ure Type 2007 2008 2009 2010 H1 2011 Number of M&As 309 238 171 201 135 Tot al value of M&As $61,968 $30,709 $15,725 $30,624 $47,340 Average deal size $348 $274 $175 $243 $351 Number of M&As more t han US$1 billion 15 6 2 7 7 M&As in t he US and Europe, 2007H1 2011 (US$m) Source: Ernst & Young and Capit al IQ Average deal size calculat ed using deals wit h announced values. The appet ite for medical technology asset s rebounded in 2010. A year af ter t he market for medtech mergers and acquisit ions bot tomed out , M&As involving US and European medtech companies tot aled nearly US$31 billion, almost double t he amount seen in 2009. Taking advant age of st rong balance sheet s, healt hy cash f lows, pent-up demand, historically low interest rates and steady valuat ions, buyers used acquisit ions to boost revenues or diversify. There was also evidence t hat more acquirers were get t ing back into t he game af ter sit t ing on t he sidelines for t he bet ter part of t wo years, as t he number of M&As increased f rom 171 in 2009 to 201 in 2010. This upt ick cont inued t hrough t he f irst half of 2011, when more t han US$47.3 billion wort h of t ransact ions were announced. M&As ranged from riskier, long-term bet s on breakt hrough technologies to st rategic t uck- in acquisit ions. There was also a notable increase in t he number of large takeovers. The number of M&As valued at more t han US$1 billion ret urned to pre-recessionary levels and t he t hird-largest M&A (Johnson & Johnson/ Synt hes) of t he last decade occurred during t he first half of 2011. Private equity (PE) ret urned to t he scene in medtech M&A. In a number of recent cases, PE f irms were act ively involved in pursuing high-prof ile t arget s such as Synt hes, Beckman Coulter and Ast raZenecas dent al division Ast ra Tech even t hough ot her buyers ult imately prevailed. In July 2011, Apax Part ners (Apax) and t wo Canadian pension f irms revealed t heir intent ion to acquire Kinet ic Concept s (KCI) for US$6.3 billion. Meanwhile, TPG made waves by announcing a US$2 billion buyout of Immucor. Should t he Apax/ KCI deal go t hrough (in late August , private equity- owned ConvaTec reportedly made an offer to buy KCI), it would be t he largest leveraged buyout since t he collapse of Lehman Brot hers in 2008. As accessing subst ant ial amount s of capit al has become easier, PE f irms are expected to cont inue t heir push into medtech, at t racted by t he sectors sound f undament als, perceived low public valuat ions and internat ional expansion opport unit ies. As we go to press in September 2011, concerns around sovereign debt and a potent ial double-dip recession has resulted in some t ightening of t he credit market s. While t his will not affect large st rategic acquirers, it will make access to capital more challenging for small to midsize companies. In t he longer term, an unpredictable regulatory environment, part icularly in t he US, increased pricing pressures, changing sales models and impending healt h care reforms could drive more indust ry consolidat ion. Acquirers will likely cont inue to shy away from riskier, early-stage t ransact ions in favor of deals t hat t hey perceive to have less risk acquisit ions of later-stage firms t hat produce revenue and, in many cases, t urn a profit. Source: Ernst & Young, Capit al IQ, Windhover and BMO Capit al Market s S h a r e
o f
t o t a l
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v a l u e 2000-01 2002-03 2004-05 2006-07 2008-09 2010-Jun 2011 Other Pharma Private equity Medtech Conglomerate 0% 20% 40% 60% 80% 100% 44 Pulse of t he indust ry Medical t echnology report 2011 Source: Ernst & Young, Capit al IQ, Windhover and BMO Capit al Market s US and European M&As by t ype of buyer, 2000H1 2011 S h a r e
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v a l u e 2000-01 2002-03 2004-05 2006-07 2008-09 2010-Jun 2011 Other Pharma Private equity Medtech Conglomerate 0% 20% 40% 60% 80% 100% 45 Indust ry performance Mergers and acquist ions The value of M&As involving US medtech companies surged 84%to US$27.1 billion in 2010, driven by healt hy balance sheet s and cash reserves, recept ive and inexpensive capit al market s, st able company valuat ions and pent-up demand f rom buyers looking to accelerate revenue growt h. Headlined by t he announced US$21.3 billion purchase of Synt hes by Johnson & Johnson, t he deal environment remained heated t hrough t he f irst half of 2011. While average deal sizes have spiked in t he years cont aining mega deals, median deal sizes have remained largely consistent over t he past decade. The median deal size in 2010 was US$53 million. Source: Ernst & Young, Capit al IQ, Windhover and BMO Capit al Market s US mergers and acquisit ions, 2000H1 2011 Total deal value Average deal size Total deal value of mega deals (>US$10b) 2008 2009 2010 H1 2011 2006 2005 2002 2000 2001 2003 2004 2007 T o t a l
d e a l
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( U S $ b ) $0 $200 $400 $600 $800 $1,000 $0 $20 $40 $60 $80 $100 A v e r a g e
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( U S $ m ) 46 Pulse of t he indust ry Medical t echnology report 2011 European medtech M&As bounced back wit h renewed hope in 2010. The value of M&A t ransact ions surpassed 2009s abysmal result s by more t han US$10 billion (327%), wit h more t han half of t he years tot al being driven by Germanys Merck KGaAs acquisit ion of Millipore. Mercks t ransact ion enabled t he company to f urt her diversify it s material science and t herapeut ic portfolio by incorporat ing Millipores life science tool product s. M&A act ivity cont inued to grow in t he f irst half of 2011, wit h t he value of deals on pace to exceed t he 2007-2010 aggregate average. Source: Ernst & Young, Capit al IQ, Windhover and BMO Capit al Market s European mergers and acquisit ions, 2007H1 2011 T o t a l
d e a l
v a l u e
( U S $ b ) 0 10 20 30 2008 2007 2009 2010 H1 2011 A v e r a g e
d e a l
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( U S $ m ) 0 $130 $260 $390 $ Total deal value Average deal size There has been a signif icant upt ick in t he number of M&As valued at more t han US$1 billion. There were 14 such t ransact ions bet ween January 2010 and June 2011, compared to only 4 during t he prior 18-mont h period. A wide variety of acquirers were behind t hese sizeable purchases. There were indust ry st alwart s making t heir f irst large purchases in years, big pharmas and conglomerates looking to f urt her diversify t heir portfolios and even a PE f irm making t he f irst US$1 billion-plus PE-backed purchase since t he onset of t he global recession. Acquiring company Locat ion Acquired company Locat ion Value (US$m) Merck KGaA Germany Millipore US $7,200 Covidien US ev3 US $2,600 Thermo Fisher Scient if ic US Dionex US $2,100 St ryker US Boston Scient if ic (neurovascular division) US $1,500 St . Jude Medical US AGA Medical US $1,300 Galderma Swit zerland Q-Med Sweden $1,200 Cinven UK Sebia France $1,100 3M US Arizant US $810 Medt ronic US Ardian US $800 Novart is (Alcon) Swit zerland LenSx Lasers US $744 Select ed M&As, 2010 Acquiring company Locat ion Acquired company Locat ion Value (US$m) Johnson & Johnson US Synt hes Swit zerland $21,300 Danaher US Beckman Coulter US $6,800 Thermo Fisher Scient if ic US Phadia Sweden $3,500 Endo Pharmaceut icals US American Medical Systems US $2,900 Terumo Japan CaridianBCT US $2,625 Dent sply Internat ional US Ast ra Tech (division of Ast raZeneca) UK $1,800 Forest Laboratories US Clinical Dat a US $1,200 Shire UK Advanced Biohealing US $750 Select ed M&As, H1 2011 Source: Ernst & Young, Capit al IQ, Windhover and BMO Capit al Market s 47 Indust ry performance Mergers and acquist ions 48 Pulse of t he indust ry Medical t echnology report 2011 St rategic acquirers are increasingly relying on milestone payment s and st ruct ured earn-out s to help pass some of an acquisit ions risk to t he seller. Bet ween 2008 and 2010, t he percent age of US and European M&As wit h milestone provisions t ripled, f rom 5%to 15%. At t he same t ime, milestones account for more of t he tot al potent ial value of M&As, growing f rom 9%to nearly 40%in t he f irst half of 2011. Boston Scient if ic, in part icular, has act ively used milestone payment s in it s acquisit ions (e.g., Ast hmat x, At ritech and Sadra Medical), as well as when it sold it s neurovascular division to St ryker. Wit h buyers cont inuing to have more bargaining power part icularly wit h cash- st rapped early-st age medtechs we expect t hese t rends to cont inue in t he immediate f ut ure. An increasing share of medt ech M&As have milest ones ... and t hey represent a larger share of t ot al deal value in t hese M&As. Source: Ernst & Young and Capit al IQ Source: Ernst & Young and Capit al IQ N u m b e r
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M & A s 2008 2007 2009 2010 H1 2011 0 4 8 12 16 20 P e r c e n t a g e
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w i t h
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p a y m e n t s 0% 6% 3% 9% 12% 15% Number of M&As with milestones Number of M&As with milestones/total number of M&As P o t e n t i a l
v a l u e
( U S $ b ) 2008 2007 2009 2010 H1 2011 $0.0 $0.4 $0.8 $1.2 $1.6 $2.0 S h a r e
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v a l u e 0% 20% 10% 30% 40% 50% Total value of M&As with milestones Total value of milestones/ total value of all M&As with milestones 49 Indust ry performance Mergers and acquist ions Ort hopedic, Research and ot her equipment and Cardiovascular/ vascular companies received t he largest share of M&A dollars in 2010 and t he first half of 2011, while Non- imaging diagnost ics companies were most in demand. Since t he beginning of 2007, Research and ot her equipment and Non-imaging diagnost ic companies have accounted for a large port ion of t he total value of M&A deals. Given t heir general insulat ion from complex FDA regulat ions and st ringent reimbursement pressures, it is not surprising t hat acquirers are increasingly att racted to t hese two product categories. US and European M&As by segment 20072009 2010H1 2011 Segment Number of deals Value (US$m) %of t ot al deal value Number of deals Value (US$m) %of t ot al deal value Therapeut ics devices 179 $47,246 43.6% 86 $44,995 57.7% Mult iple 14 $9,099 8.4% 1 $14 0.0% Opht halmic 11 $8,820 8.1% 3 $746 1.0% Cardiovascular/ vascular 36 $8,153 7.5% 26 $8,803 11.3% Ort hopedic 30 $7,652 7.1% 11 $22,578 29.0% Respiratory 9 $5,215 4.8% 3 $734 0.9% Wound care 11 $2,391 2.2% 3 $831 1.1% Aest het ics 10 $1,688 1.6% 7 $1,582 2.0% Ear, nose and t hroat 6 $1,496 1.4% 2 $142 0.2% All ot hers 52 $2,732 2.5% 30 $8,566 11.0% Non-imaging diagnost ics 82 $34,734 32.1% 39 $5,772 7.4% Research and ot her equipment 45 $14,365 13.3% 31 $25,410 32.6% Ot her 55 $8,444 7.8% 20 $2,252 2.9% Imaging 19 $3,577 3.3% 11 $536 0.7% Source: Ernst & Young, Capit al IQ, Windhover and BMO Capit al Market s Char t only shows deals where deal values were publicly disclosed. 50 Pulse of t he indust ry Medical t echnology report 2011 Scope of t his report Defining medical technology In t his report , medical technology (medtech) companies are def ined as companies t hat primarily design and manufact ure medical technology equipment and supplies and are headquartered wit hin t he United St ates or Europe. For t he purposes of t his report , we have placed Israels dat a and analysis wit hin t he European market , and any grouping of t he US and Europe has been referred to as global. This wide-ranging def init ion includes medical device, diagnost ic, drug delivery and analyt ical/ life science tool companies but excludes dist ributors and service providers such as cont ract research organizat ions or cont ract manufact uring organizat ions. By any measure, medical technology is an ext raordinarily diverse indust ry. Medtech companies run t he gamut f rom vent ure backed, pre-revenue st art-ups to mat ure global conglomerates. The product s of t hese companies range f rom relat ively inexpensive component s to complex, mult imillion-dollar magnet ic resonance imaging (MRI) systems. Any meaningf ul analysis of t he indust ry must t herefore measure performance not only across t he ent ire indust ry but also wit hin individual segment s. While developing a consistent and meaningf ul classif icat ion system is import ant , it is anyt hing but st raightforward. Exist ing t axonomies somet imes segregate companies into scores of t hinly populated categories, making it difficult to ident ify and analyze indust ry t rends. Furt hermore, t hey tend to combine categories based on product s (such as imaging or tools) wit h t hose based on diseases t argeted by t hose product s (such as cardiovascular or oncology), which makes it harder to analyze t rends consistent ly across eit her dimension. To address some of t hese challenges, we have categorized medtech companies across bot h dimensions product s and diseases t argeted. All publicly t raded medtech companies were classif ied as belonging to one of f ive broad product groups: Imaging: companies developing product s used to diagnose or monitor condit ions via imaging technologies, including product s such as MRI machines, computed tomography (CT) and X-ray imaging and opt ical biopsy systems Non-imaging diagnost ics: companies developing product s used to diagnose or monitor condit ions via non-imaging technologies, which can include pat ient monitoring and in vit ro test ing equipment Research and ot her equipment : companies developing equipment used for research or ot her purposes, including analyt ical and life science tools, specialized laboratory equipment and f urnit ure Therapeut ic devices: companies developing product s used to t reat pat ient s, including t herapeut ic medical devices, tools or drug delivery/ inf usion technologies Ot her: companies developing product s LhaL do noL lL in any ol Lhese caLeqories were classiled in Lhis seqmenL In addit ion to product groups, t his report t racks conglomerate companies t hat derive a signif icant part of t heir revenues f rom medical technologies. While a conglomerate medtech divisions technology could technically fall into one of the product groups listed above (e.g., General Elect ric into imaging and Allergan into t herapeut ic devices ), all conglomerate dat a is kept separate f rom t hat of t he non- conglomerates. This is due to t he fact t hat , while conglomerates report revenues for t heir medtech divisions, t hey typically do not report ot her financial result s for t heir medtech divisions, such as research and development or net income. Conglomerat e companies: Unit ed St at es 3M Healt h Care Abbot t Diagnost ics & Vascular Agilent Technologies: Life Sciences Allergan: Medical Devices Baxter: Medical Product s Corning Life Sciences Danaher: Medical Technologies Endo Pharmaceut icals: Devices and Services GE Healt hcare Hospira: Medicat ion Management Systems and ot her devices Johnson & Johnson Medical Devices & Diagnost ics Kimberly-Clark Healt h Care Pall Life Sciences 1elelex Medical Europe Agfa-Gevaert Alcon Surgical Ast raZeneca: Ast ra Tech Beiersdorf: Hansaplast Carl Zeiss Meditec Drger Medical Philips Healt hcare Roche Diagnost ics Siemens Healt hcare 51 Achnowledgement s Project leadership Gaut am Jaggi and Glen Giovannet t i once again acted as co-editors-in-chief for Pulse of t he indust ry. Their st rategic and t hemat ic guidance were invaluable in t he product ion of t his report and t hey ensured t hat it s ent ire content f rom cover to cover was clear and concise, and properly touched upon each of t he major t hemes t hat have been impact ing t he indust ry. Gaut am was also responsible for writ ing t he Innovat ion and risk int roductory art icle, as well as co-aut horing t he t hree indust ry performance art icles. John Babit t provided st rategic vision for t his report and brought his years of experience to t he ident if icat ion and analysis of indust ry t rends. John was also inst rument al in lining up and conduct ing interviews for t he A f undament ally new deal environment panel. As t he project manager for Pulse of t he indust ry, Jason Hillenbach had responsibility for t he ent ire content and quality of t his publicat ion. He was also account able for t he collect ion and analysis for much of t he report s dat a, and co-aut hored t he t hree primary art icles wit hin t he Indust ry performance sect ion. In addit ion, Jason conducted t he interviews for, and was t he editor of, t he A f undament ally new deal environment panel. St rat egic direct ion Special t hanks to Heinrich Christ en, Les Clifford and Dave DeMarco, who each played a key role in t he development of t his report . They provided invaluable insight s and f irst-hand experience t hat was used as t he foundat ion for t he report s key t hemes and focus. Dat a analysis The research, collect ion and analysis of f inancing dat a and European f inancial performance dat a was conducted by UIrike Traut h, Nina Hahn and Eva-Marie Hilgart h. Ulrike also provided addit ional analysis for a number of t ables and chart s t hroughout t he report . Namrit a Negi was responsible for pulling much of t he dat a used in t he Under pressure t ables. Chris Dumelle and Jimmy Zhong also assisted wit h dat a collect ion for many of t he chart s and t ables t hroughout t he publicat ion. Connie Aust in, Samir Goncalves, Susan Jones, Kim Medland and Namrit a Negi helped wit h t he fact-checking and quality review of t he dat a t hroughout t he publicat ion. Writ ing and edit ing assist ance Russell Colt on brought his incomparable skills as a copyeditor and proof reader to t his publicat ion. His pat ience, hard work and at tent ion to det ail were unparalleled. Richard Roback applied his proof reading expert ise t hroughout t he report . Design and layout This publicat ion would not look t he way it does wit hout t he diligence and creat ivity of Oliver Voigt . As lead designer, Oliver was responsible for managing and implement ing t he publicat ions design and layout . Addit ional design assist ance was provided by Robert Fernandez (chart illust rat ions). Market ing and support Public relat ions effort s related to t he report and it s launch were led by Susan Jones. Greg Kelley f rom t he PR f irm Feinstein Kean Healt hcare served as an integral part ner as well. Acknowledgment s Dat a for t he chart s on pages 6 and 7 were obt ained f rom t he following sources: Ernst & Young, Centers for Disease Cont rol and Prevent ion, Accent ure, Healt h Affairs, Centers for Medicare and Medicaid Services, Dow Jones Vent ureSource, Windhover, Nat ional Vent ure Capit al Associat ion and US Food and Drug Administ rat ion. 52 Pulse of t he indust ry Medical t echnology report 2011 Data exhibit index The rich get richer? 4 Dist ribut ion of US and European vent ure invest ment by round, 2005-H1 2011 5 US and European early vent ure rounds by product class and disease st at e 8 A t ale of t wo t rends 9 Medical t echnology at a glance, 2010 16 US public medt ech cash index 17 European public medt ech cash index 17 US medt ech at a glance, 2010 18 US medt ech non-conglomerat es, public company f inancial highlight s by region, 2010 18 Change in US t herapeut ic device companies revenue and net income by disease cat egory, 200910 19 Select ed fast -growing medt echs by revenue growt h, 200510 20 The billion dollar club, 200610 20 US market capit alizat ion, 2009H1 2011 21 US market capit alizat ion by size, 2009H1 2011 21 European medt ech at a glance 22 European medt ech non-conglomerat es, public company f inancial highlight s by region, 2010 22 Change in European t herapeut ic device companies revenue and net income by disease cat egory, 200910 23 Select ed fast -growing medt echs by revenue growt h, 200510 24 European market capit alizat ion, 2009H1 2011 25 European market capit alizat ion by size, 2009H1 2011 25 Capit al raised in t he US and Europe, 2005H1 2011 26 US medt ech f inancings, 2005H1 2011 27 53 Dat a exhibit index US medt ech f inancings wit hout debt offerings, 2005H1 2011 28 Capit al raised in 2010 and H1 2011 by leading US regions 29 US vent ure capit al, 2005H1 2011 30 US IPOs, 2010H1 2011 31 The majorit y of US IPOs priced below t heir desired ranges... 32 ...and most were down in subsequent t rading. 32 European medt ech f inancings, 2005H1 2011 33 European f inancings wit hout debt offerings, 2005H1 2011 34 Capit al raised in 2010 and H1 2011 by leading European count ries 35 European IPOs, 2010-H1 2011 35 European vent ure capit al, 2005H1 2011 36 European IPO performance class of 2010 and H1 2011 37 M&As in t he US and Europe, 2007H1 2011 44 US and European M&As by t ype of buyer, 2000H1 2011 44 US mergers and acquisit ions, 2000H1 2011 45 European mergers and acquisit ions, 2007H1 2011 46 Select ed M&As, 2010 47 Select ed M&As, H1 2011 47 An increasing share of medt ech M&As have milest ones ... 48 and t hey represent a larger share of t ot al deal value in t hese M&As. 48 US and European M&As by segment 49 54 Pulse of t he indust ry Medical t echnology report 2011 Global Life Sciences Cent er Bost on Glen Giovannet t i glen.giovannet t i@ey.com +1 617 585 1998 Connie Aust in connie.aust in@ey.com +1 617 585 1912 Gaut am Jaggi gaut am.jaggi@ey.com +1 617 585 3509 Jason Hillenbach 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