Medtech Issue 87 Pharma Intelligence Informa March 26, 2018 medtech.pharmaintelligence.informa.comInsight ness and help customers relying on Ani- J&J Offloads LifeScan To Private mas Vibe or the OneTouch Ping insulin pump find a suitable Medtronic pump. Equity Firm For $2.1bn (Also see "Medtronic Stands To Be Biggest Beneficiary Of J&J's Exit From Insulin Pump REED MILLER [email protected] Market" - Medtech Insight, 8 Oct, 2017.) During J&J's Jan. 23 fourth-quarter latinum Equity, a Southern Cali- across a variety of industries. Platinum 2017 earnings call, Gorsky reiterated that fornia private equity firm, will buy Equity does not have any other medical the company was actively looking for P Johnson & Johnson's LifeScan Inc. device companies in its current portfo- strategic options for its diabetes busi- blood glucose monitoring device busi- lio, according to its website, but since its nesses, which have been a significant ness for $2.1bn. The move, announced founding in 1995, the firm has helped a drag on the company's overall device March 16, comes as no surprise. J&J an- many other large publicly traded corpo- revenues in recent years. In 2017, rev- nounced in the beginning of 2017 that rations – including Bayer, IBM and AT&T enue from J&J's diabetes care device it was exploring strategic options for its – divest underperforming units maintain- business declined 10.5% year-over-year shrinking diabetes businesses. (Also see ing business continuity and operational – including a 17.2% slide in the US – to "Earnings Winners & Losers: Billion-Dollar- stability during the transition. $1.61bn. J&J's overall device business Revenue Players JNJ, ABT, GE, PHG, BAX" - "We have worked closely with Johnson grew 5.7% to $26.6bn during the same Medtech Insight, 8 Feb, 2018.) & Johnson to craft a divestiture solution period. But excluding the impact of ac- "This initiative is part of our ongoing, for LifeScan that would create a global quisitions and divestitures, J&J's world- disciplined approach to portfolio man- standalone business and set the stage for wide device sales increased 1.5% and US agement to focus on our most promising continued investment in growth and in- sales were flat. opportunities to help patients and drive novation," Platinum Equity Partner Jacob J&J says the 2018 sales and earnings growth," Ashley McEvoy, J&J's company Kotzubei said in a release. projections it provided in January ac- group chairman for consumer medical The deal still must be accepted by the counted for the likely sale of LifeScan, devices, said in a release. relevant works councils representing Lif- although the company did not precisely LifeScan is headquartered just outside eScan employees, but Platinum Equity ex- quantify the impact of the deal. The com- Philadelphia and also has a facility in Zug, pects the deal to close by the end of 2018. pany predicts 2018 full-year sales will be Switzerland. It serves 20 million patients in In January 2017, J&J CEO Alex Gorsky said between $80.6bn and $81.4bn, reflecting more than 90 countries with the OneTouch that, despite the optimism surrounding the operational growth of 3.5% to 4.5%, with brand of blood glucose meters, testing launch of the Animas Vibe insulin pump in earnings per share of $8 to $8.20. strips, lancets, point-of-care testing sys- 2014, it was losing faith in its diabetes de- In a March 16 note, Wells Fargo analyst tems, and integrated digital systems. LifeS- vice businesses, as pricing pressure and Larry Biegelsen wrote that the LifeScan can president Valerie Asbury will continue competition – especially with market leader divestiture will boost J&J's medtech sales to lead the business during the change in Medtronic – has made it difficult for J&J to growth and pretax margin by at least 50 ownership, according to Platinum Equity. grow diabetes device revenues. basis points. Platinum Equity has $13bn in assets and In October, the company announced a portfolio of more than 30 companies plans to terminate its Animas Corp. busi- Published online 03/18/19 FROM THE EDITORS OF: THE GRAY SHEET, CLINICA, START-UP AND MEDTECH INSIGHT NEWSLETTER POLICY & REGULATION COMMERCIAL R&D Saudi FDA seeks feedback, p. 9 Exec chat with Zimmer Biomet's Prognos' AI disease-prediction EMEA head, p. 10 platform, p. 14 2018 Plan to attend MDMA’s 2018 Annual Meeting in our Nation’s Capital, May 2nd – May 4th, 2018. MDMA’s Annual Meeting will cover key issues impacting the United States’ leadership position in med-tech innovation, and how we can all help shape the regulatory and legislative agendas. This year’s Opening Address will be given by FDA Commissioner Scott Gottlieb, M.D. who will discuss his vision for the agency, and the latest reforms he and his team are working on. Commissioner Gottlieb is one of many leading policy makers and industry experts who will share their insights and priorities with medical technology innovators at this premier MDMA event. Value of Attending • Engage industry executives, government officials For more information and and expert panelists on critical issues to register, please visit • Hear first-hand updates on the latest news and medicaldevices.org/events. must have information for med-tech CEOs • Build relationships while networking with over 200 med-tech CEOs and senior executives 2018_AM_One Pager_RTP.indd 1 2/22/18 2:13 PM 6 7 17 inside: explore more: Cover / J&J Offloads LifeScan To Private Equity Firm For exclusive online content $2.1bn – Following a strategic review of the business, Johnson & Johnson, as expected, sold its LifeScan blood EU competent authorities glucose monitoring device business. http://bit.ly/2pz9RAH EDITORS' PICKS It's a vital entity now, but we explore what the longer- 5 Siemens Healthineers Floats On Frankfurt Stock term future might be for the EU's Competent Authorities Exchange – The health unit is now an independent for Medical Devices group as industry transitions to the publicly listed company. The initial public offering is one of new Medical Device and IVD Regulations. Germany's biggest listings in the last few years. Registry of registries 5 Theranos Execs Slammed By SEC For "Massive Fraud" – The http://bit.ly/2DIChwh US Securities and Exchange Commission came down hard US FDA is working with manufacturers, researchers on Theranos CEO Elizabeth Holmes and former company and other stakeholders to assemble a comprehensive President Ramesh Balwani for allegedly defrauding investors. network of registries of cardiac device data. But 6 New Report Spotlights Intensifying Rivalry Between cardiologists and device firms say the project faces Tech And Health-Care Companies – Life-science and multiple challenges. medtech companies with a single focus on developing products risk being outpaced and outsmarted by the rising Orthofix doubles down crop of tech companies. http://bit.ly/2HMyGje 7 mHealth Developer Works Around Traditional Orthofix is investing in the high-growth cervical spine Reimbursement Barriers – Diabetes-management-app firm implant market with the acquisition of Spinal Kinetics. Glooko is looking to bypass the traditional reimbursement How is this bet going to play out? path by partnering with self-insured employers and working with payers in different ways to get their app directly to Finger on the pulse patients. It's one model for the digital-health sector. http://bit.ly/2G08bpG Find out what is driving demand for pulse oximetry POLICY & REGULATION devices in and out of hospitals, and how big players, 9 Saudi FDA Consults On Regulating Device Software, including Medtronic, Philips and Masimo, are capitalizing Distribution Requirements – The Saudi Arabia authority is on the growth. inviting stakeholder feedback on two draft guidelines – one on the regulation of software as a medical device, and the other specifying requirements for the storage, handling and Device Week transportation of medical devices. http://bit.ly/2y4lpgk Check our latest podcast discussion focusing on 9 China Overhauls Regulatory Bodies – China's State confusions surrounding the impact of Brexit on device Council has proposed a reorganization plan that will regulations in Europe. reduce the number of state agencies overseeing drug and device regulation. medtech.pharmaintelligence.informa.com 17 Brexit To Force Large-Scale Review Of Medtech Contractual Arrangements Throughout EU – If there is a medtech.pharmaintelligence.informa.com March 26, 2018 | Medtech Insight | 3 Medtech insight hard Brexit and no mutual recognition agreement between DAVID FILMORE @MEDTECHDAVID the UK and the EU, the dynamic between UK manufacturers [email protected] and their product distributors in the EU27 will change to a TINA TAN @MEDTECHTINATAN more formal exporter-importer relationship. [email protected] SHAWN M. SCHMITT @MEDTECHSHAWN 20 Medicare Finalizes NGS Test Coverage – CMS expanded [email protected] its final coverage determination from an earlier proposal REED MILLER @MEDTECHREED to cover next-generation sequencing diagnostics for more [email protected] stages of cancer, and it did away with coverage-with- AMANDA MAXWELL @MEDTECHAMANDA evidence-development data-collection responsibilities. [email protected] MARION WEBB @MEDTECHMARION 21 Abbott, Merck Like FDA's Plan To Amass More Summary [email protected] Adverse Event Reports, But P&G Says There's A Better SUE DARCEY @MEDTECH_INSIGHT Way – While a handful of large device firms and combination [email protected] product-makers are supporting the US agency's proposed FERDOUS AL-FARUQUE @MEDTECH_DANNY Voluntary Malfunction Summary Reporting Program, Procter [email protected] & Gamble is urging FDA to think twice. ELIZABETH ORR @ELIZABETHJORR [email protected] 23 Health Canada Changes The Rules For Device CATHERINE LONGWORTH @MEDTECHCATE Disinfectants And Sterilants – Health Canada has [email protected] reclassified high-level disinfectant and sterilant solutions ASHLEY YEO @ASHLEYPYEO that are intended for use on medtech products as medical [email protected] devices.