巴克莱-美股-医疗用品与设备行业-医疗科技研讨会关键要点-2018 1 19-29页

1、Equity Research19 January 2018U.S. Medical Supplies & DevicesMedTech Symposium: Top TakesMATTS MINDSET: On 1/3/2018, we hosted our seventh annual MedTech Symposium with six physician panels to garner insights on key markets in MedTech. Below we provide our top takeaways for each panel, webcast links

2、 so investors can view the panels online, and audience response data to show attendee views on important questions in each market.INDUSTRY UPDATE U.S. Medical Supplies & DevicesNEUTRALUnchangedU.S. Medical Supplies & Devices Matthew Taylor, CFA+1 212 526 6965 BCI, US1) EP

3、 Doctors believe BSX is best positioned to gain share in CRM given longer battery life, the HeartLogic algorithm, and its MRI label. BSXs Watchman is expected to continue its strong growth trajectory off of a small base. The doctors noted some use of MDTs leadless pacer and prefer MDTs LINQ to ABTs

4、Confirm.Young Li+1 212 526 1961 BCI, US2) TAVR/TMVR The doctors expectation for US TAVR market growth was bullish and higher than the audience, despite them being at established centers as referrals continue and doctors are more comfortable with the procedure. While the doctors

5、 expect non-inferiority in low risk patients, they are skeptical about treating asymptomatic ones. Despite BSXs Lotus delays, they think the valve will come to market but be only a niche player. TMVR is 5-10 years away in the US.Ian Mahmud+1 212 526 2404 BCI, US3) Large Joints

6、Both doctors were positive on robotics, including SYKs MAKO and SNNs Navio, and believe it could become standard of care in 10-20 years. They highlighted SNN could gain the most share due to its willingness to give price and the attractiveness of the BlueBelt/Navio robotic offering, which Dr. Iorio

7、prefers to MAKO.4) Surgical Robotics The doctors agree thereis room for ISRGs da Vinci to grow in their practice to 30% from 20% of procedures. In terms of competition, the doctors are unclear what large competitors like MDT may offer, but view Transenterix as a step in the wrong direction. New syst

8、ems could potentially improve on da Vinci with haptic feedback, easier setup, better visualization, and improved instrumentation. Price would also be a factor.5) Diabetes In pumps, Dr. Baker thinks that TNDM has the most exciting next change in pump software, but also thinks that PODD growth will co

9、ntinue to increase and MDTs 670G could give MDT a small uptick. In sensors, Both Dr. Goland and Dr. Baker see the Freestyle Libre as the one that will see the biggest uptick in sales forglucose monitoring in 2018, given itis the newestandagood tool for T2Dpatients. There would also be an uptickin th

10、e use of DXCMsensors with the launch of G6.6) Spine Dr. Mammis thinks BSX could make some strides in neuro in 2018 based on pipeline products (WaveWriter) with different waveforms from the same array that could be superior. His views on ABTs Burst and DRG and Nevros HF10 systems were also positive.

11、In core spine, the doctors viewed most products as differentiated commodities, noting ZBHs Mobi C is promising.Barclays Capital Inc. and/or one of its affiliates does and seeks to do business with companies covered in its research reports. As a result, investors should be aware that the firm may hav

12、e a conflict of interest that could affect the objectivity of this report. Investors should consider this report as only a single factor in making their investment decision.PLEASE SEE ANALYST CERTIFICATION(S) AND IMPORTANT DISCLOSURES BEGINNING ON PAGE 23.Barclays | U.S. Medical Supplies & DevicesCO

13、NTENTSElectrophysiology: CRM BSX Best Positioned; WATCHMAN Growing; Leadless Pacers Help MDT3Interventional Cardiology Docsare Bullish on TAVRGrowth & Low Risk, but TMVR will Take Time6Ortho: Positive on Robots, Costs Remain in Focus10Robotics Growth Opportunity Remains; Competition An Unknown13Diab

14、etes ABTs Libreto Gain, Mostly in T2D; Interest in MDTs 670G and DXCMs G6; PODD Seeingan Uptick16Spine and Neuromod Positive for BSX In Neuro; Interest in ZBHs Mobi-C, Robotics ValueUncertain1919January 20182Barclays | U.S. Medical Supplies & DevicesElectrophysiology: CRM BSX Best Positioned; WATCHM

15、AN Growing; Leadless Pacers Help MDTPanelists: Manish Undavia, MD, Cardiac Electrophysiologist, South Shore Heart Associates and Jose Dizon, MD, Columbia University Medical School, New York Presbyterian.Battery Life and HeartLogic Help BSX; MRI will Drive Some Share Reversion1) Dr. Undavias mix of d

16、evices is currently 40% MDT, 40% BSX, and 20% STJ, with BSX gaining at the expense of ABT/STJ (MDT remains stable). Over the past 6 months, Biotronik reps have been more aggressive promoting product and he thinks Biotronik may beabletogainmoreshareinthefuture. Biotronik iscatchingupto the bigthree w

17、ith small devices that have a reasonable number of features and are typically at a discount. For CRT- Ds, he uses MDT more also because he believes it has better algorithms and prefers the devices shape. He also uses the Emblem S-ICD from BSX, but in less than 5% of his patients, and thinks S-ICDs a

18、re a niche product at this stage (which could change with connectivity to pacers in the future).Dr. Dizon believes BSXs corporate culture seems to be more liberal and creative as BSX was able to do deals like an incentive plan that can save the hospital money. His share used to be a 40-30-30 split w

19、ith MDT taking the lead, which will now change based on the BSX incentive deal, which includes WATCHMAN also. He will nowshiftsharetowards BSX as he likes their product differentiation and algorithms. He views Biotronik products as adequate for most patients, and commented they are marketing aggress

20、ively.We asked our audience which company they expect to gain share in the US CRM market in 2018 and 75% picked BSX, with 15% picking ABT. The doctors agreed with this ranking.FIGURE 1Which company do you expect to gain the most market share in the US cardiac rhythm management in 2018? (n=20)Source:

21、 Barclays Research2) Dr. Undavia doesnt believe there will be much growth in the CRM market, given a lack of groundbreaking trials that can expand indications and lack of new referral channels. Both doctors noted the market is relatively mature for pacemakers and ICDs and they do not expect much cha

22、nge from either the recent update to the NCD for high voltage devices or inflections in replacements. Our audience also expects a roughly flat CRM market with 90% picking between -2% to +2% market growth.19January 20183Barclays | U.S. Medical Supplies & DevicesFIGURE 2How much will the CRM market gr

23、ow in 2018? (n=21)Source: Barclays Research3) While both doctors use Pacers and ICDs from the 3 major companies as well as Biotronik (which has a small share), they agree that BSX is best positioned at this stage. Notably, BSX recently launched its Resonate family of devices, which extends its alrea

24、dy best in class battery life and adds HeartLogic, an algorithm for detecting issues with HF patients that could lead to hospitalization and complications. Both physicians were excited by data they had seen on HeartLogic and excited to use it in their practice and emphasized the importance of longer

25、 battery life, as it means less risk and fewer change- outs for patients. Dr. Undavia thinks battery longevity is the most important factor when choosing his devices. BSX leads the pack and had done an impressive job with battery longevity, and he is seeing that prospectively now as many devices imp

26、lanted in 2008-2009 still havent reached 60% battery life. Dr. Dizon also highlighted that battery life was a very important factor in choosing a device. While the doctors agreed that ABTs MRI label could help it to regain some share in the high voltage market, they noted that ABT continues to be in

27、 the penalty box given STJs recall in 2016, weaker offering, and to a lesser extent cyber security issues.FIGURE 3Now that BSX and ABT have launched MRI compatible ICDs in the US, which company do you view as having the best high power offering overall? (n=18)Source: Barclays Research19January 20184

28、Barclays | U.S. Medical Supplies & DevicesMicra is Great for the Right Patients A Growing Niche5) Dr. Undavia uses MDTs pacing products because he thinks MDT has better technology and a proven track record of innovation and support. He has also been using MDTs leadless pacer, Micra, over the past 6

29、month and likes the product. He believes these are best for younger patients (40-50 year olds) as they can have up to 3 of them implanted over their lifetime (each has 9-10 years in battery life). He believes 5-10% of patients qualify for Micra today given it is limited to pacing one chamber, and se

30、es that percentage increasing to 20-25% in the future as the atria are able to be paced as well. Dr. Dizon also thinks the main limitation for Micra is that it is a single chamber product, and therefore believes the market opportunity is less than 10%, with his current share at 5%. Both doctors were

31、 sceptical of STJs Nanostim given its “screwlike” attachment to the heart tissue, which has been shown to cause some perforation. In our view, MDTs Micra could be a modest positive for the company, helping it to belay some share give back to BSX and ABT as they have received MRI labels.ICMs Growing;

32、 MDTs LINQ in the Lead6) Both doctors noted that use of implantable cardiac monitors (ICMs) continues to grow at their centers with MDTs LINQ dominating the share there. Dr. Undavia has been aggressive with implanting LINQ in patients with moderate risk for strokes post afib, which is 5-10% of the p

33、atient population. Dr. Dizon is doing a few a day, which he think is a lot. In fact, he is surprised that payors havent applied the brakes on these procedures. Regarding ABTs new Confirm device, the doctors think it could gain some share but noted that ABT sacrificed some battery life (about 1 year)

34、 for a smaller profile and that could be a disadvantage. They both think MDTs LINQ algorithm is better or at least more proven. Our audience seems to think that ABT will gain a small share position with Confirm; 47% of our audience thinks ABT can attain 15-30% market share in the next 3 years with t

35、he remainder less than that.FIGURE 4Nowthat ABT has launchedits Confirm Rx ICMinthe US and Europe, how muchshare do you think ABT could attain in the ICM market versus incumbent MDT over the next 3 years? (n=19)Source: Barclays ResearchWatchman Growing Rapidly off a Small Base7) Dr. Undavia thinks W

36、atchman can grow 40-50% off a small base, with the critical limiting agent being a learning curve of 20-25 cases. As doctors have become more facile with the procedure and are more comfortable, he thinks they will begin to do more. However, he also noted that newer anti-coagulants are better, and co

37、uld be a519January 2018Barclays | U.S. Medical Supplies & Devicesheadwind for Watchman. Dr. Dizon thinks the initial enthusiasm had gone away a bit, and recent data releases have put some brakes on LAAC growth but agreed with the audience that WATCHMAN could grow 40-50% in the US in 2018. Our audien

38、ce continues to see robust growth for WATCHMAN in 2018 with 52% picking 41-60%, compared to our estimate of 45% growth and both doctors agreed this could be the right ballpark growth for themarket.FIGURE 5How much could BSXs Watchman grow in 2018 (we estimate Watchman growth of95% in 2017 and 45% in

39、 2018)? (n=23)Source: Barclays ResearchAblations Driven by Doctor Preference8) Dr. Undavia believes Biosense Webster is significantly better in mapping. While ABT/STJs Ensite is a more flexible platform that has compatibility with other companies catheters, the doctors do like Biosense catheters as

40、well. BSXs Rhythmia is joining the party later, and will take some convincing to get adoption and traction. Both doctors noted use of cryo and like the ease of use of MDTs balloon, which is sufficient for most paroxysmal patients.Interventional Cardiology Docs are Bullish on TAVR Growth & Low Risk,

41、but TMVR will Take TimePanelists: Dimitrios Avgerinos, MD, PhD, Assistant Professor of Cardiothoracic Surgery, Weill Cornell Medical College and Luigi Pirelli, MD, Cardiothoracic Surgeon, Lenox Hill Heart and VascularInstitute.Doctors Bullish on Volume Growth in 20181) Both Dr. Avgerinos and Dr. Pir

42、elli were bullish about potential growth in US TAVR volumes this year. Dr. Pirelli commented that he would estimate 21-25% growth or potentially even 26-30%. In his opinion, the potential candidates for TAVR (even those who are inoperable/high risk) continue to grow rapidly. Dr. Avgerinos agreed tha

43、t the growth number might be higher than 20%. In his view, the trend in Europe (especially Germany) will occur in the US. Cardiologists will become more aggressive, more devices will be approved, and the number of TAVR cases will surge. Valve-in-valve will alsobecomemore common. Dr. Avgerinos perfor

44、ms almost all of his valve re-ops with a valve-in-valve procedure rather than a SAVR. Dr. Pirelli noted that the mortality risk of SAVR is no less than2-3%, while the mortality risk associated with TAVR is 1% or less overall.19January 20186Barclays | U.S. Medical Supplies & Devices2) 90% of the audi

45、ence estimated that the US TAVR market would grow 11-20% (40% estimating 11-15%; 50% estimating 16-20%). 7% expect the market to grow 5-10% and 3% expect the market to grow 26-30%.FIGURE 6What is your expectation for US TAVR market growth in 2018? (n=30)Source: Barclays Research.Scepticism of TAVR f

46、or Asymptomatic Patients1) Both doctors wereskeptical about treating asymptomatic AS patients with TAVR. Dr. Pirellis commented that the annual risk of sudden death for a patient with asymptomatic AS is much lower than the 1% associated with a TAVR procedure. In his view, if a patient has severe aor

47、tic stenosis, then after 3-6 months after discovery another echocardiogram typically will show some symptoms. Given the typical appearance of symptoms, EWs trial will be tough to enrol. Dr. Avgerinos noted that the current guidelines are for follow-up after severe AS is identified and agreed that fu

48、lly asymptomatic patients are rare.2) In considering whether or not the asymptomatic trial would be enrolled and the indicationwould be approved by the FDA, 60% of the audience believed thatitwould ultimately be approved by the FDA but were split over the impact of the approval. Half of the 60% beli

49、eve it will be an important driver of future TAVR growth, while the other half expect approval will result in little commercial uptake due to lack of patient or physician interest. Only 11% of respondents expect that the trial will never fully enrol, while 30% of respondents believe that the FDA wil

50、l not approve the indication.19January 20187Barclays | U.S. Medical Supplies & DevicesFIGURE 7Do you thinkthat the FDAwill ultimately approve the use of TAVRin asymptomatic patients? (n=27)Source: Barclays Research.Generally Positive on TAVR for Low Risk Patients1) The doctors take on TAVR for low-r

51、isk patients was mixed. Dr. Pirelli noted that the real answer wont be known for 10 years (when TAVR has long term data similar to SAVR). In his view, TAVR patients may have a higher pacemaker rate or other vascular complications and mortality is likely sub-1% for both SAVR and TAVR. Still, because

52、SAVR causes a lot of trauma to the body - bone is fractured and rehab is needed - he thinks that TAVR could be superior to SAVR (assuming durability is the same). Dr. Avgerinos added that he expects that TAVR will last as long as SAVR valves. Both doctors also noted that much of the data we have on

53、durability is based on older versions of TAVR valves, meaning that newvalves are likely to last longer and have better outcomes.2)In our poll of the audience, most (80%) expect that TAVR will show non-inferiority to SAVR in the partner low-risk trial on the primary endpoint of mortality and stroke.

54、20% expect that TAVR will be superior to SAVR on the endpoint and no respondents believe that SAVR will be superior to TAVR.FIGURE 8What do you expect low risk patient trials for TAVR to show? (n=20)Source: Barclays Research.19January 20188Barclays | U.S. Medical Supplies & DevicesLotus Could Gain S

55、ome Share Docs Not Concerned by Pin-Pull issue1) On how much share BSXs Lotus could gain when it ultimately launches (we estimate 1Q19 for the US), both doctors raised factors that they believe will need to be met by the valve for it to gain share. Dr. Avgerinos commented it would need to prove non-

56、inferiority to other valves and also demonstrate cost effectiveness (possibly involving a cut in price). Dr. Pirelli emphasized the importance of a reduction in permanent pacemaker implants. He believes with improvements it could gain share, but not more than 10% in the market. He was unconcerned by

57、 the pin-pull issue, commenting that it is probably easy tofix.2) The audience responses on the long-run Lotus TAVR share were scattered: 7% believe it will gain 0-5% share, 22% believe it will gain 6-10% share, 48% believe it will gain 11-15% share, 11% believe it will gain 16-20% share, 7% believe

58、 it will gain 21-25%, and 4% believe it will gain more than 25% share.FIGURE 9Based on what you know about TAVR valves and the market, what share do you see BSXs Lotus attaining at steady state after it launches in the US (we now expect a 2019 US launch). (n=27)Source: Barclays Research.Mitral Valve Replacement 5-10 Years Off in Docs View1) On the emergence of a transcatheter mitral valve replacement, Dr. Pirelli commented that a MitraClip implant is challenging to do and does not have excellent results (in comparison