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ContentsCOMMERCIAL/R&D STORIESAbbott Rolls Out COVID-19 Antibody Test3‘Hunker Down, Expect The Worst And Hope For The Best’: Investment AnalystAdvises Medtech Businesses To Cut Costs4Wall Street Tries To Guess The Impact Of Pandemic On Medtech Revenues6TytoCare Raises 50M Amid Rising Demand To Remotely Monitor COVID-19 Patients13COVID-19: Medtronic Shares Ventilator Specs Amid Multi-Industry EffortsTo Increase Ventilator Production14POLICY/REGULATION ABOUT COVID-19Belgium Bans COVID-19 Antibody Self-Tests But UK Goes Ahead16UK Publishes COVID-19 Self-Test Specifications17Telemedicine Is Riding High, Hopes For More Provisions In ‘Phase Three’ COVID-19 Stimulus Package19COMPLIANCE CORNERCompliance Corner: How To Survive An FDA ‘Desk Audit’ During The COVID-19 Crisis21‘Have Some Level Of Fear’: How Scrapped FDA Inspections, Hastily Made VentilatorsCould Portend Product Problems24CMS Doubles Up On Test Reimbursements, Will Pay Labs 100 Per Test For COVID-19Clinical Diagnostic Assays28FDA NEWSWeathering The ‘Cytokine Storm’: US FDA Gives EUA To Blood Purification Machine30FDA Relaxes Regs For COVID-19 Mental Health Apps32COVID-19: String Of FDA Guidance Docs Lay Bare Enforcement Policies For Infusion Pumps,ECMO Devices, Thermometers, And More352 / May 2020 Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)
COMMERCIAL/R&D STORIESAbbott Rolls Out COVID-19 Antibody TestExecutive SummaryAbbott has launched its first COVID-19 antibodytest to help determine if a person has beenpreviously infected with the virus. The diagnosticsgiant said it intends to ship a total of 4 milliontests in April.Abbott Laboratories Inc. has launched a newantibody test to identify people who have beeninfected with COVID-19.Abbott’s SARS-CoV-2 IgG test is the third COVID-19diagnostic developed by the company. Lastmonth, it launched a real-time polymerase chainreaction test, Abbott m2000 RealTime SARS-CoV-2test, and a rapid, point-of-care test for its ID NOWplatform (Also see “Abbott Launches Five-MinutePOC Rapid COVID-19 Test” - Medtech Insight, 28Mar, 2020.)The new test identifies the IgG antibody, a proteinproduced by the body’s immune system in thelate stages of coronavirus infection. The test willinitially be available on Abbott’s Architect i1000SRand i2000SR laboratory instruments which canrun up to 200 tests per hour.authorization pathway established in newguidelines announced on 16 March. Abbott said itplans to file for an EUA with the FDA and for a CEMark in the European Union. Multiple companies,including Becton Dickinson & Co., Cellex Inc.and Ortho-Clinical Diagnostics Inc. are launchingserology tests to detect SARS-CoV-2 antigens orantibodies under the new guidelines. (Also see“COVID-19: Nanomix Wins BARDA Funding ForMobile Point-Of-Care Assay” - Medtech Insight, 8Apr, 2020.)Antibody testing will be a critical step in tacklingthe coronavirus pandemic as tracking thepopulation that has already been infected mayallow some people to return to work and help reopen the economy.The UK’s Medicines and Healthcare productsRegulatory Agency published specifications forat-home and point-of-care serology COVID-19tests after none of the self-tests acquired by theUK government met its standards. (Also see “UKPublishes COVID-19 Self-Test Specifications” Medtech Insight, 9 Apr, 2020.)Abbott said it expects to ship a total of 4 milliontests in April and expand laboratory antibodytesting to the detection of the IgM antibody.The Belgian government has banned self-tests,including antibody tests, as it considers these testinsufficiently accurate to be used in the pandemic.(Also see “Belgium Bans COVID-19 Antibody SelfTests But UK Goes Ahead” - Medtech Insight, 31Mar, 2020.)Abbott will initially make the test available byfollowing the U.S. Food and Drug Administration’snotification without an emergency useMedtech Insight is tracking the global diagnosticpipeline of COVID-19 tests. See our COVID-19 testtracker for a full listing.3 / May 2020 Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)
COMMERCIAL/R&D STORIES‘Hunker Down, Expect The Worst And Hope For The Best’:Investment Analyst Advises Medtech Businesses To Cut CostsExecutive SummaryMaxim Jacobs, managing partner at EdisonInvestment Research, urges medtech companiesto be financially prudent as the COVID-19pandemic worsens. Cancellations of routinesurgeries are creating a huge strain on devicebusinesses which could continue for months.As hospitals prioritize COVID-19 patients, massesof elective and routine procedures have beencancelled, creating a black hole of revenue fordevice business.Maxim Jacobs, managing partner at EdisonInvestment Research told Medtech Insightcompanies must strategize how to cutunnecessary costs and preserve capital tocompensate for lost sales during this period oflow procedure volumes and uncertainty. “Not onlyare sales going down to almost zero for many ofthese companies, clinical trial timelines are beingpushed out which means of course more fundingstress as companies don’t have enough money tosee the year through,” said Jacobs.“There are companies that are usually reasonablein terms of their expenditure so they won’thave much to cut, but then there are some bigspenders that assume the market will always beopen.” His advice for companies is to “hunkerdown, be prepared for the worst and hope forthe best. We are in uncharted waters. Try and beas offensive with your financial and commercialdecisions as you possibly can.”Companies that are dependent on the proceduresthat can be most easily deferred, such asorthopedic or ophthalmological procedures, will4 / May 2020likely see a bigger impact from COVID-19. (Alsosee “Wall Street Tries To Guess The Impact OfPandemic On Medtech Revenues” - MedtechInsight, 24 Mar, 2020.)Jacobs said many medical device managers maynot have experience with previous recessionssince the last one was over a decade ago. “Decidewhat do I really need for [the] business and theurgency of that need,” he advised. “Can it holdoff? You want to make sure that if it’s still bad inJune, you have money. Being as conservative aspossible is the best way to go.”No WinnersDespite some medtech companies rampingup production of in vitro diagnostic (IVD) testsand ventilators, Jacobs said he sees no financialwinners from the pandemic. With the economicimpact so difficult to measure, Jacobs said nocompany should rely on any revenue boom out ofCOVID-19.“Some of the small companies may benefit if theyhave an IVD test that catches on but for the largercompanies, I don’t think these sales will move theneedle that much,” he said. “We don’t know thefull implications of this but if it sparks a significantrecession/depression that has a global characterto it, then for example in the US people might losetheir insurance and then won’t necessarily be ableto pay the deductibles for future procedures.”He warned companies should be ready for a longwait to see their stock prices improve. “There’s stilla lot we don’t know about the virus itself. Is therea risk of re-infection, is it going to be seasonal?We know that in the 1918 pandemic, the firstround was not as bad as the second round whichoccurred later in the year.” Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)
COMMERCIAL/R&D STORIESWith social distancing measures and closures,business could potentially resume by June, butcompanies have no certainty of that, he said.5 / May 2020“You’ve fallen off a ship and you don’t know whenyou’re going to be rescued. You need to have araft.” Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)
COMMERCIAL/R&D STORIESWall Street Tries To Guess The Impact Of Pandemic OnMedtech RevenuesExecutive SummaryAs the pandemic unfolds with an uncertainoutcome, US securities analysts that cover publiclytraded medtech companies are developingmathematical models to estimate the impact ofthe COVID-19 pandemic on medtech companies.US securities analysts are trying to estimatethe impact of the COVID-19 pandemic on theperformance of medtech companies by buildingmathematical models that account for disruptionof supply chains and the widespread deferral ofelective procedures.Following the outbreak of COVID-19 in Chinaat the end of 2019, most medtech companiesaddressed the impact of COVID-19 during theirmost recent sales and earnings reports. Much ofthat discussion was about disruption to supplychains in Asia. For example, Boston ScientificCorp. announced it expected the outbreak wouldhave a 10m to 40m impact on its first-quartersales, due to deferred procedures and disruptionsto its supply chains in China. (Also see “TheCost Of Coronavirus: Medtech Market Wins AndLosses” - Medtech Insight, 28 Feb, 2020.)Since then, the number of patients with COVID-19has continued to rise around the world, especiallyin Europe and North America. Analysts are nowfocused on the increasing number of hospitalsaround the world that are deferring electiveprocedures to make room for an expectedwave of COVID-19 patients. Also, hospitals maychoose to defer capital purchases while they tryto manage the surge of COVID-19 patients. (Alsosee “US Hospitals Cancel Elective Surgeries, TeamUp With Medtechs To Find Remote-Monitoring6 / May 2020Solutions” - Medtech Insight, 17 Mar, 2020.)“Having evaluated and analyzed the risks andpotential range, scope and duration of theseissues on our universe, we believe the potentialimpact may vary significantly, based on regionalexposures and revenue mix of each company,”Credit Suisse analysts Matt Miksic and Vik Choprawrote in a 6 March report on the impact of thepandemic on the medtech companies they cover.Companies that are dependent on the proceduresthat can be most easily deferred, such asorthopedic or ophthalmological procedures, willlikely see a bigger impact from COVID-19. Forexample, Credit Suisse predicts the COVID-19outbreak could reduce Zimmer Biomet HoldingsInc.’s 2020 sales by more than 20% versusestimates before the outbreak, because manyorthopedic surgeries will being postponed.Analysts will likely have to adjust their forecastsat least weekly as they get new information fromphysicians. For example, on 6 March, Credit Suissereported that it expected the impact of COVID-19may have relatively little impact on EdwardsLifesciences Corp. because most of Edwards’revenues come from transcatheter aortic valvereplacement (TAVR), which is usually an urgentprocedure that cannot be delayed indefinitely.But in a 19 March report, Miksic and Choprareported that at least one surgeon thatperforms TAVR told them that “most” TAVRand transcatheter mitral repair cases can bedeferred. The exact impact on the volume of theseprocedures completed in 2020 is unknown, butMiksic and Chopra expect these cases will “catchup” when the pandemic subsides. Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)
COMMERCIAL/R&D STORIESWells Fargo analyst Larry Biegelsen expectsthat most of the deferred procedures will stillbe completed, which will mitigate impact of thedeferrals over the long term. “While our analysisdoes not assume any catch-up from procedurespostponed during the COVID-19 pandemic, webelieve a majority of postponed procedures willeventually be done once the pandemic subsides,”Biegelsen wrote in a 15 March report.Several analysts have conducted small surveysof physicians to get a clearer picture of whichprocedures are being deferred to make resourcesavailable to treat COVID-19 patients.On 10 March, Jefferies analysts conducteda survey of 62 interventional cardiologists,orthopedic surgeons and anesthesiologists toevaluate procedure volume trends in response tothe COVID-19 outbreak.At the time of that survey, the impact of COVID-19on procedure volumes had been minimal, but23% of the doctors surveyed said they expecteda reduction in procedure volumes because ofthe pandemic and 55% expected deferrals andcancellations to increase.About 29% of interventional cardiologists reporteda change in procedure volume related to thepandemic while only 13% of anesthesiologistsreported a change in their procedure volume.About 23% of orthopedic surgeons said theirprocedure volume had changed.“Most [doctors surveyed] also noted theirinstitutions are preparing for a reallocationof resources as a result of the virus. Mostprocedures are likely to be shifted out as opposedto cancelled outright. But over the near term,[companies] with less elective exposure are bestpositioned,” Jefferies analyst Raj Denhoy wrote ina 10 March report.7 / May 2020That survey was finished five days before theUS Surgeon General, the American College ofSurgeons and other medical societies formallycalled for all non-essential procedures to bedelayed, Denhoy pointed out in a 15 March report.“While most cases are likely to be shifted outas opposed to canceled outright, a concern fordevice companies is their ability to withstand aprotracted turn-down from a cash perspective,” heexplained.On 22 March, Wells Fargo analysts announcedthe results of a similar survey of 117 US-basedphysicians across nine specialties and 14procedures. On average, the physicians in thatsurvey expect to postpone 75% of the surveyedprocedures during the COVID-19 pandemic.The respondents expect to postpone about 68% ofcardiovascular procedures and 82% of orthopedicprocedures, with 84% of the procedures beingperformed within four months of the pandemicsubsiding.Although they expect more orthopedic surgeriesto be deferred than cardiovascular surgeries, thesurvey respondents expect most of the postponedorthopedic procedures to be performed fasterthan the postponed cardiovascular procedures.“[According to the respondents] the mostcommon reason for a patient not having his/herprocedure done once the pandemic subsideswas due to the patient finding an alternativetreatment, although with cardiovascularprocedures, the most common reason tended tobe due to the patient passing away,” Wells Fargo’sBiegelsen explained.Grey Sky Vs. Blue SkyBecause of the volatility in the industry and therapid pace of news related to the pandemic,Credit Suisse analysts published the “framework”they are using to understand the potential impact Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)
COMMERCIAL/R&D STORIESof the pandemic on companies’ sales and earningsin addition to the specific sales estimates for eachcompany.“Our scenario analysis provides a reasonableframework for where estimates can go,” Miksicand Chopra wrote.For each company, Credit Suisse’s modelproduced a “blue sky” best case scenario wherethe pandemic has a minimal impact on thecompany’s revenues, a “grey sky” estimate wherethe impact is more severe, and a “base case”representing a middle point between the blue skyand grey sky estimates. (See chart below)Credit Suisse believes the revenue impact ofCOVID-19 beyond 2020 will be modest, withprocedure volumes stabilizing by the first quarterof 2021.Impact Of COVID-19 On Medtech Company SalesCredit Suisse's base case, best case and worst case estimates of COVID-19's impact on the 2020 revenue ofselected medtech companies.Source: Company, Credit Suisse estimatesWells Fargo provided Medtech Insight with “basecase” and “best case” estimates for the 2020revenues of companies they cover. (See chartbelow)outbreak will be most disruptive in China inFebruary and March and afflict the rest of theworld from mid-March through May. Wells Fargo’sbest-case scenario assumes the world largelyrecovers by the end of April.The base case estimates assume that the8 / May 2020 Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)
COMMERCIAL/R&D STORIESUnder these assumptions, the median impact tomedtech companies’ 2020 sales would be -9.1% inthe base case and -5.4% in the best case.Wells Fargo's Coronavirus Impact AnalysisEstimates of the potential impact of COVID-19 on the 2020 revenue of companies covered by Wells Fargoanalysts.9 / May 2020 Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)
COMMERCIAL/R&D STORIES*Current WF forecasts1) Baxter enterprise value calculated as per our estimate of debt, cash and minority interest as of 2019-end andcurrent share count estimate2) Becton Dickinson- FY ending September3) Cooper - FY ending October4) Calendar Year 2020 data for MDTSource: Company reports; Wells Fargo Securities, LLC estimates; FactSetBiegelsen pointed out that the stock prices ofthe companies Wells Fargo covers declined by amedian of 22.7% between 19 February and 15March, while the S&P 500 overall declined 19.9%during this period. “[This decline] suggests to usthat the market is already pricing in at least 2.5months of impact outside of China,” he wrote.Wells Fargo’s estimates are a “rough guess” basedon the impact of COVID-19 in China and Februaryand the analysts’ conversations with physicians,Biegelsen cautioned. “It’s important to note thatsome companies have not provided much coloryet on the potential impact, so we’ve had to makeassumptions for those companies.”10 / May 2020He also points out that Wells Fargo’s model doesnot account for potential offsets from COVID-19that may bring in more revenue for medtechcompanies that make products needed to treatpatients with the disease. (Also see “COVID-19:US Auto Giant General Motors Wants To MakeVentilators, Trump Says; Ford And Tesla AlsoExpress Interest” - Medtech Insight, 20 Mar, 2020.)For example, Medtronic announced on 18 Marchthat it has increased production of ventilatorsby more than 40% and is on track to morethan double its capacity to manufacture andsupply ventilators in response to the crisis. (Alsosee “Ventilator Firms Across Europe Ramp Up Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)
COMMERCIAL/R&D STORIESProduction To Meet ‘Unprecedented’ Demand” Medtech Insight, 18 Mar, 2020.)considered a non-essential or able to be delayedprocedure,” Denhoy explained.Medtronic manufactures the Puritan Bennett980 and Puritan Bennett 840 high-performanceventilators for high-acuity settings at its facilityGalway, Ireland. The facility currently employs 250people dedicated to manufacturing ventilators.The company plans to rapidly add at least 250more, adding additional shifts and operating thefactory 24/7.“The good news is US medtech is in great shapewith most companies having very strong balancesheets; hence we do not see any obvious goingconcern risks across our coverage,” Denhoyconcluded. “However, we do see select companiesthat have high elective procedure exposurecoupled with low/negative [free-cash flow] profilesor maturities due next year as facing potentialliquidity risks.”Companies Can Weather The Storm, For NowWhile much of the focus of securities analysishas been on COVID-19’s impact on medtechcompanies’ bottom lines and stock prices, Jefferiesanalysts ran a “stress test” on each of the medicaldevice companies it covers to evaluate the cashposition of each company to determine if any areat risk of insolvency.“All companies in our coverage are very wellcapitalized and none appear at risk,” Jefferies’Denhoy wrote on 15 March. (See chart below)To prepare for the expected sales downturn,some companies have “extended maturities”– negotiated later due dates for certain debtrepayments. For example, Zimmer Biomet has a 1.5bn in term loans due to mature in 2020, butthe company recently announced a strategy topush those maturities to 2026 and 2030. Othercompanies will likely have to reduce spending,Denhoy suggested.Denhoy pointed out the stress test model showsLivaNova is facing a potential deficit of about 140m due to its low cash balance. However, themodel’s estimate for LivaNova’s free cash flow is“artificially low” due to recent higher-than-usual“one-off costs,” so “spending discipline shouldget them through.” (Also see “LivaNova’s VagusNerve Stimulator Earns CE Mark For TreatingDepression” - Medtech Insight, 10 Mar, 2020.)During its 26 February fourth-quarter 2019earnin
FDA NEWS Weathering The ‘Cytokine Storm’: US FDA Gives EUA To Blood Purification Machine 30 FDA Relaxes Regs For COVID-19 Mental Health Apps 32 COVID-19: String Of FDA Guidance Docs Lay Bare Enforcement Policies Fo
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