巴克莱-美股-医疗保健行业-2019年上半年美国生命科学与诊断调查结果-2019.4.29-74页.pdf

Equity Research 29 April 2019 CORE 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 have 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 68.Restricted-Internal U.S.Life Science Tools&Diagnostics 1H19 OB/GYN Survey Says:Volumes Positive,Focus on Dx&GYN Surgical In April 2019,we performed our 5th biannual survey of 50 OB/GYNs to gauge market trends for GYN Surgical and Dx(HCT,NIPT,and carrier screening).A)Volume trends:Underlying volume trends look consistent and positive,with OB/GYNs expecting volumes to increase over the next year across all areas included in our survey.Volume expectations skewed positively for all of the testing categories included in our survey.Sentiment on growth appears modestly better than our 2H18 survey,but weaker than our three prior surveys.Amongst the categories,NIPT posted the strongest results with 58%of physicians expecting volume growth,of which 16%expect significant growth(42%unchanged,0%decline).Carrier screening was also positive,with 32%of physicians anticipating growth,including 10%for significant growth(68%unchanged).Together,the positive market environment is an encouraging read-through for market dynamics for LabCorp,Quest,and at Myriads recently acquired Counsyl business.Market growth for Hologics GYN Surgical categories also screened as positive-with 47%of physicians expecting volume growth in endometrial ablation(47%unchanged,7%decline)and 41%expecting growth in polypectomy/myomectomy procedures(57%unchanged,2%decline).B)GYN Surgical:For Hologic,trends in the GYN Surgical categories appear consistent heading into FY2Q19 earnings.NovaSure market share looks stable versus our prior survey,and the surgical tool continues to outperform the competition in terms of physician views on clinical effectiveness.That said,we believe its prudent to monitor competitive threats on the horizon given recent sales weakness.For MyoSure,physician adoption continues to steadily increase,from 46%in our 1H17 survey to 54%in 2H17,62%in both 1H18 and 2H18,to 72%in 1H19.We believe there is still near-term runway for MyoSure to drive penetration,though the gap relative to the adoption of the more mature NovaSure is closing.With competitive threats on the horizon,as well as rising Myosure adoption,we believe strong commercial execution is going to be needed to sustain mid-single digit organic growth Hologics GYN Surgical segment(13%of revs)going forward.C)Diagnostics:Overall,trends in womens health diagnostics appear consistent with our prior surveys,which should support continued growth for participants,notably LabCorp,Myriad,and Quest in our coverage.For NIPT and expanded carrier screening,potential upside could be driven by more favorable reimbursement policies.Physicians have a desire to consolidate testing suppliers,which should be a strategic positive for LabCorp,Myriad,and Quest with broad womens health offerings.Expanded network access for LabCorp and Quest in 2019 will further reduce barriers to single vendor adoption.For more company thoughts,please see from 4/16/2019,“1Q19 Preview:Focus on Biopharma as Tools&Dx Remain Relative Safe Haven”.INDUSTRY UPDATE U.S.Life Science Tools&Diagnostics NEUTRAL Unchanged U.S.Life Science Tools&Diagnostics Jack Meehan,CFA+1 212 526 3909 BCI,US Mitchell Petersen,CFA+1 212 526 3367 BCI,US Andrew Wald+1 212 526 9436 BCI,US Barclays|U.S.Life Science Tools&Diagnostics 29 April 2019 2 CONTENTS INTRODUCTION AND SURVEY METHODOLOGY.3 Introduction.3 Survey Methodology.4 VOLUME TRENDS LOOK CONSISTENT AND POSITIVE.5 GYN SURGICAL:STABLE TRENDS WITH FOCUS ON COMPETITION AND MYOSURE ADOPTION LEVELS.7 Overall GYN Surgical Takeaways.7 Endometrial Ablation Takeaways.13 Polypectomy/Myomectomy Procedure Takeaways.19 WOMENS HEALTH DIAGNOSTIC TESTING:TRENDS REMAIN POSITIVE,POTENTIAL TAILWINDS FROM COVERAGE EXPANSION.26 Overall Diagnostic Testing Takeaways.26 Hereditary Cancer Testing Takeaways.34 Non-Invasive Prenatal Testing Takeaways.38 Carrier Screening Takeaways.44 GYN SURGICAL APPENDIX.50 Endometrial Ablation:Placement Analysis by Doctor.50 Endometrial Ablation:Head-to-Head Analysis.51 Endometrial Ablation:Clinical Effectiveness.54 Endometrial Ablation:Economic Benefit.56 Endometrial Ablation:Patient Experience.58 Myomectomy/Polypectomy:Placement Analysis by Doctor.60 Myomectomy/Polypectomy:Head-to-Head Analysis.61 Myomectomy/Polypectomy:Clinical Effectiveness.62 Myomectomy/Polypectomy:Economic Benefit.64 Myomectomy/Polypectomy:Patient Experience.66 Barclays|U.S.Life Science Tools&Diagnostics 29 April 2019 3 INTRODUCTION AND SURVEY METHODOLOGY Introduction In April 2019,we performed a survey of 50 OB/GYNs to gauge trends in the market for Hologics GYN Surgical segment and diagnostics(hereditary cancer testing,NIPT,and carrier screening).This is our fifth biannual OB/GYN survey,and we continue to build interesting longitudinal data on volume and product trends.Key takeaways:A)Volume trends:Underlying volume trends look positive,with OB/GYNs expecting volumes to increase over the next year across all areas included in our survey.We note that physicians were given five options to select from A)decline significantly,B)decline,C)unchanged,D)grow and E)grow significantly.Amongst the categories,NIPT posted the strongest results with 58%of physicians expecting volume growth,of which 16%expect significant growth(42%unchanged,0%decline).Carrier screening was also positive,with 32%of physicians anticipating growth,including 10%for significant growth(68%unchanged).Together,this is a positive read-through for market dynamics in the Myriads recently acquired Counsyl business.That said,we remain cautious on the near-term outlook at Counsyl as Myriad continues its integration(see our 10/18/18 report:“Counsyl Financial Statements 8-K Thoughts for MYGN”).Hologics GYN Surgical categories also skewed positive with 47%of physicians expecting volume growth in endometrial ablation(47%unchanged,7%decline)and 41%expecting growth in polypectomy/myomectomy procedures(57%unchanged,2%decline).B)GYN Surgical:For Hologic(HOLX,EW/Neu,trends in the GYN Surgical categories appear consistent though we believe its prudent to monitor competitive threats on the horizon.As positives,1)underlying volumes are positive.2)Hologics products are the clear market leaders,with NovaSure used by 93%of doctors that perform endometrial ablation(n=43),and MyoSure used by 78%that perform fibroid/polyp removal(n=46).3)NovaSure outperformed competitor products in a head-to-head analysis of clinical effectiveness.Comparing NovaSure to Minerva(n=7),3 physicians preferred NovaSure,3 rated them equally,and 1 favored Minerva.4)Following some initial competitive pressure from Minerva,it appears that NovaSures competitive position has stabilized.As negatives:1)The launch of new therapeutics could pose new risks for MyoSure,though there are also opportunities,so we believe its too early to call.2)Similarly,a new cryo-ablation device launch in the US could have competitive implications for NovaSure.That said,awareness of the device remains low,and approval of the device is a late 2019,early 2020 event.3)MyoSure adoption(72%of n=50 docs)remains below NovaSure(80%),though survey data suggests the gap is closing.All in,with competitive threats on the horizon,as well as rising Myosure adoption,we believe strong commercial execution is going to be needed to sustain mid-single digit organic growth Hologics GYN Surgical segment(13%of revs)going forward.C)Diagnostics:Overall,trends in womens health diagnostics appear consistent with our prior surveys,which should support continued growth for participants,notably LabCorp(LH,OW/Neu),Myriad(MYGN,UW/Neu),and Quest(DGX,OW/Neu)in our coverage.As takeaways,1)Underlying volumes are positive(see the volume section above).2)Testing utilization trends amongst OB/GYNs remain stable,with several OB/GYNs referring these tests to a geneticist.A broader shift to the geneticist channel in HCT would favor Invitae(NVTA,Not Covered)and Ambry(private)over Myriad given relative share positions in this channel.3)Physicians have a desire to consolidate testing suppliers,which should be a strategic positive for LabCorp,Myriad,and Quest with broad womens health offerings.Expanded network access for LabCorp and Quest in Barclays|U.S.Life Science Tools&Diagnostics 29 April 2019 4 2019 will further reduce barriers to single vendor adoption.4)Myriads reputation amongst OB/GYN should help drive incremental adoption of Counsyls menu,with 6(or 12%)of respondents noting that they expect to order more testing from the combined organization.5)Expanded reimbursement for average risk NIPT and expanded carrier screening(ECS)would represent a tailwind to volumes,as reimbursement is often a barrier for testing.6)Views on the value of ECS remain mixed,but showed an improvement from our August 2018 survey.All in,these trends should support continued growth for the HCT,NIPT,and carrier screening markets,with upside coming from more favorable reimbursement policies.With more competitors working to develop end-to-end offerings,it will be important to share dynamics moving forward.Survey Methodology In total,we surveyed 50 OB/GYNs on various aspects of our coverage,including surgical products,hereditary cancer testing(HCT),non-invasive prenatal(NIPT)testing,and carrier screening.The goal of our survey was to determine sentiment around volume growth,better understand competitive dynamics and utilization trends,and gain insight into ongoing changes in treatment paradigms.By comparing results to our previous surveys(see links below),we can track changes in physician sentiment and utilization.Our survey consisted of 38 gynecologists and 12 obstetricians.Of the 50 OB/GYNs,26 were affiliated with hospitals and 24 were not.On average,annual patient volumes for OB/GYN practices surveyed were roughly 2,662.FIGURE 1 What is your medical specialty?(n=50)FIGURE 2 Is your practice affiliated with a hospital system?(n=50)Source:Barclays Research Source:Barclays Research To see thoughts from our prior surveys,please see:5/30/18:“U.S.Life Science Tools&Diagnostics:OB/GYN Survey Says:Volumes Solid,HOLX Surgical Competition in Focus”11/30/17:“U.S.Life Science Tools&Diagnostics:OB/GYN Survey Says:Solid Volumes/Adoption of AUB,Aesthetics,&Dx”4/6/2017:“Life Science Tools&Diagnostics:Jacks Tool Kit-Vol.3,Issue 14”4/5/2017:“Hologic:OB/GYN Survey Says:Seeing Demand for Aesthetics,PT to$50”Gynecologist76%Obstetrician24%Yes52%No48%Barclays|U.S.Life Science Tools&Diagnostics 29 April 2019 5 VOLUME TRENDS LOOK CONSISTENT AND POSITIVE Underlying volume trends look consistent and positive,with OB/GYNs expecting volumes to increase over the next year across all areas included in our survey.We note that physicians were given five options to select from A)decline significantly,B)decline,C)unchanged,D)grow and E)grow significantly.Amongst the categories,NIPT posted the strongest results with 58%of physicians expecting volume growth,of which 16%expect significant growth(42%unchanged,0%decline).Carrier screening was also positive,with 32%of physicians anticipating growth,including 10%for significant growth(68%unchanged).Together,the positive market environment is an encouraging read-through for market dynamics for LabCorp,Quest,and at Myriads recently acquired Counsyl business.Market growth for Hologics GYN Surgical categories also screened as positive-with 47%of physicians expecting volume growth in endometrial ablation(47%unchanged,7%decline)and 41%expecting growth in polypectomy/myomectomy procedures(57%unchanged,2%decline).Endometrial Ablation(AUB,n=43 performing procedures):47%of OB/GYNs expect an increase,while 47%expect volumes to be unchanged.Three OB/GYNs(7%)expect to see a decline in procedure growth over the next year,including 1 who expects a significant decline(the only response across all categories for a significant decline).Polypectomy/Myomectomy(AUB,n=46):41%of OB/GYNs expect an increase in volumes,57%anticipate flat procedures,and 2%expect to see a decline.Hereditary Cancer Testing(HCT,n=34):56%of OB/GYNs surveyed expect an increase in volumes,while 41%expect volumes to be unchanged.One physician(3%)expects a decline in volumes.Non-Invasive Prenatal Testing(NIPT,n=38):58%of OB/GYNs surveyed expect an increase in volumes,42%expect volumes to be unchanged,and no physicians anticipate a decline in volumes.Carrier Screening(n=41):32%of OB/GYNs anticipate an increase in volumes(including 10%citing“significant increase”),while 68%expect volumes to remain unchanged.No physicians expect to see a decline in carrier screening volumes.Barclays|U.S.Life Science Tools&Diagnostics 29 April 2019 6 FIGURE 3 How do you expect your procedure growth to trend over the next year?Source:Barclays Research Volume expectations skewed positively for all of the testing categories included in our survey.Sentiment on growth appears modestly better than our 2H18 survey,but weaker than our three prior surveys.By assigning the numbers 1 through 5 to the responses of“decline significantly”to“increase significantly,”we attempted to quantify expectations for procedure growth.By this methodology,an index over 3 indicates that procedure growth on average is expected to increase over the next year.Also,keep in mind that for our 1H18 and 2H18 surveys we split abnormal uterine bleeding(AUB)into two categories,endometrial ablation and polypectomy/myomectomy procedures.For the purposes of comparison,we averaged these two categories in the chart below.As you can see in the chart below,volume growth expectations maintained a positive skew,with each product category achieving an index above 3.With the exception of carrier screening,it appears that sentiment improved for every category we surveyed.Given a sample size of 50 physicians,it is possible to have some variation between surveys.FIGURE 4 Volume Growth Index:How do you expect your procedure growth to trend over the next year?Source:Barclays Research Note:Index based on 1 Decline Significantly,2 Decline,3-Unchanged,4 Increase,5 Increase Significantly;Carrier screening wasnt included in prior surveys 2%5%2%3%47%57%41%42%68%42%37%50%42%22%5%4%6%16%10%0%10%20%30%40%50%60%70%80%90%100%Endometrial Ablation(n=43)Polypectomy/Myomectomy(n=46)Hereditary Cancer Testing(n=34)Non-Invasive PrenatalTesting(n=38)Carrier Screening(n=41)Decline SignificantlyDeclineUnchangedGrowGrow Significantly3.553.794.003.923.854.003.413.763.563.363.483.713.453.433.593.743.410.00.51.01.52.02.53.03.54.04.55.0Abnormal Uterine Bleeding(AUB)Hereditary Cancer Testing (HCT)Non-Invasive Prenatal Testing(NIPT)Carrier ScreeningIndex1H172H171H182H181H19B