巴克莱-美股-生物制药业-美国生物制药：下周有何期待？-2019.1.4-26页.pdf

Equity Research 4 January 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 20.U.S.Biopharmaceuticals What To Expect Next Week in SF Focus on catalyst-rich year and overall sentiment heading into 2019.The 2019 healthcare conference season kicks off next week in San Francisco,and we anticipate much of the commentary to focus on overall expectations looking ahead to FY2019 given what wed characterize as a tough end to 2018(NBI-9%;DRG+4%;S&P-6%).Broadly speaking,we think the general tone will be largely conservative in large cap Biopharma after an uninspiring 3Q18 and low growth expectations,though could be more bullish in SMid cap Biotech given the pace of innovation poised to accelerate this year.In our view,the modest expectations and negative sentiment heading into the year set the group up well for a modest re-rating in 2019,and we maintain our positive outlook on the sector;see The 2019 Outlook Global Pharma Outlook and Company Profiles A Focus on 2019,both published on 1/3/2019.While we do not anticipate any major data disclosures at the conference,we could be provided with incremental updates on the numerous catalysts expected near-term across biotech(i.e.Gileads NASH program,Biogens Alzheimers assets,Celgenes luspatercept/bb2121,Alexions Ultomiris,and Vertexs CF franchise).Potential 4Q18 pre-announcements:Unlike in past years,Celgene is not expected to release 2018 financial results given what was characterized on the 3Q earnings call as“tight timelines between year-end and the conference”but with the pending Bristol deal,it is less relevant.Additionally,we suspect Regeneron could announce 4Q18 US Eylea saleswe forecast$1.028B vs.consensus at$1.035Bas well as some guidance metrics(e.g.,unreimbursed R&D,SG&A,Sanofi reimbursement of commercialization expenses and tax rate).Lastly,we suspect that Vertex could provide 4Q CF sales details but the main focus is on the clinical development side.Potential 2019 and longer-term guidance updates:Several of the major pharmas have already provided initial 2019 guidance in conjunction with 3Q18 earnings.While AbbVie has given preliminary growth expectations for 2019 EPS,we think management may provide us with a more concrete range for the year.Additionally,we look for Celgene to provide 2019 guidance(total revs,EPS,and product sales).We also anticipate Vertex will provide 2019 CF revenue guidance(unlikely broken out on a product-by-product basis)and non-GAAP R&D/SG&A expense guidance.Regulatory and commercial updates:While we expect minimal late-stage pipeline updates,despite a catalyst-heavy 1H19/mid-2019,we may be provided incremental regulatory and commercial updates.Namely,we expect interest in the BMY/CELG deal that was announced yesterday to be a topic that is widely brought up at the conference(see BMY/CELG-Top 20 Questions for BMY/CELG deal;BMY/CELG-Additional Thoughts on Bristol/Celgene Deal;and BMY/CELG-Initial Thoughts on Bristol/Celgene,1/03/19).INDUSTRY UPDATE U.S.Biopharmaceuticals POSITIVE Unchanged U.S.Biopharmaceuticals Geoff Meacham,Ph.D.+1 212 526 2795 BCI,US Olivia Brayer+1 212-526-5914 BCI,US Scott Puckhaber,MD+1 212 526 5157 BCI,US Jason Zemansky,PhD+1 212 526 6608 BCI,US Greg Harrison,CFA+1 212 526 1544 BCI,US Barclays|U.S.Biopharmaceuticals 4 January 2019 2 CONTENTS Johnson&Johnson.3 Pfizer.4 Merck&Co.5 Amgen.6 Gilead.7 AbbVie.8 Bristol-Myers Squibb.9 Celgene.10 Eli Lilly.11 Biogen.12 Regeneron.13 Alexion.14 Vertex.15 Incyte.16 Seattle Genetics.17 United Therapeutics.18 Neurocrine Biosciences.19 Barclays|U.S.Biopharmaceuticals 4 January 2019 3 Johnson&Johnson What We Expect to Hear High level comments on market growth rates in 2019 and general expectations given the overall uncertain macroeconomic outlook Comments addressing the potential 2019 impact of drug pricing reform rhetoric from the current administration Litigation positioning/strategy given the ongoing talcum powder concerns following last months Reuters report What We Dont Expect to Hear Detailed commentary on Remicade IP litigation/generic Zytiga launches(in 4Q18)Our Take As in prior years,we expect JNJ to set the tone for the healthcare sector in 2019 at JPM with commentary on macroeconomic themes affecting the overall space.While we view the recent weakness in shares(-8%vs.DRG+4%in 2018)from talc litigation concerns as overdone,we expect it to remain a major overhang at least for 1H19.Fundamentally,we think 2019 could be more of a challenging year for JNJ particularly in Pharma given multiple generic launches,the biggest of which will be Zytiga(4Q18 generic launches);indeed consensus Pharma growth in 2019 could trough at 3.1%,(vs.11.7%in 2018e and 5.6%in 2020).In our view,the Medical Device(-1%)and Consumer(+2.5%)segments are not enough of an offset and neither are in an acceleration phase to positively impact growth,hence,we suspect that JNJ shares are unlikely to see multiple expansion in 2019.While valuation isnt high at current levels,it isnt attractive enough to change our EW thesis and in our view,the growth profile in Pharma in 2020 looks more compelling relative to 2019.FIGURE 1 JNJ Presentation Expectations and 4Q18 and 2019 Consensus vs.Barclays Estimates Source:Barclays Research,company reports,Refinitiv,First Order Analytics.$million except for EPS4Q18 Results2019 GuidanceCons.BarclaysCons.BarclaysRemicadeNoNo$1,214$1,241$4,438$4,648 StelaraNoNo1,2981,2925,6785,675TremfyaNoNo138194712836DarzalexNoNo5495312,8012,674ImbruvicaNoNo6776863,1742,988ZytigaNoNo7268882,5252,507PAHNoNo6446562,7412,788InvokanaNoNo200192766807XareltoNoNo7156562,9162,778PharmaceuticalsNoNo9,96610,05641,78141,377OrthopedicsNoNo2,2332,1488,8688,742SurgeryNoNo2,5372,3579,8249,656Medical DevicesNoNo6,7066,57526,75327,291ConsumerNoNo3,5503,42914,22214,043RevenueNoNo$20,147$20,058$82,757$82,712 EPSNoNo$1.95$1.95$8.62$8.60 Pre-Announcements4Q18E2019EJNJ Stock Rating EQUAL WEIGHT Industry View POSITIVE Price Target USD 137.00 Price(03-Jan-2019)USD 125.72 Potential Upside/Downside+9.0%Barclays|U.S.Biopharmaceuticals 4 January 2019 4 Pfizer What We Expect to Hear General commentary regarding capital allocation including the potential for a near-term acquisition and the outlook for shareholder return(share repurchases and dividends)Details on the JV Consumer Health decision and its financial implications Outlook for new/key Innovative Health products;updates of ongoing I/O combo studies What We Dont Expect to Hear Commentary regarding 2018 guidance,which the company has historically provided during the 4Q call(scheduled for Jan 29,2019)Detailed color on potential acquisition targets Our Take PFE shares were among the best performers in Pharma in 2018(+21%vs.the DRG index+4%),largely driven by increased consensus expectations and multiple expansion.Admittedly,we agree that fundamentals are on much more solid footing versus the previous five years,but wed argue that this is broadly reflected in the multiple at current levels and wed expect upside to be more incremental in 2019.With top-line growth to remain driven by Innovative Health(continued headwinds facing Essential Health given LOEs and pricing pressures),we expect management to reassure investors on the outlook for operational performance/commercial execution looking forward to 2019with updated outlooks for key drivers(Prevnar,Ibrance,Eliquis).We think the conversation will largely remain centered on revenue growth and pipeline expansion/execution,however,unlike in recent years,we anticipate focus will begin to move away from transformational deals/large restructuring.We dont believe incoming CEO Albert Bourla is in the market for a large-scale,transformational deal;instead,it seems to us that Bourlas overall strategy going forward will be one of fine-tuning,with smaller-scale deals that are more product-specific or R&D-centric and not necessarily yielding cost savings or having significant operational synergies.Next weeks presentation is also likely to include commentary on the recent Consumer Health decision to form a JV with GSKwhich we think is viewed favorably by investors and makes sense from a strategic point of view for both companiesas well as high-level plans for capital deployment.With regards to financial performance,we do not anticipate any insights into the outlook for 2019,with management likely to wait until the 4Q18 call(scheduled for Jan 29th).FIGURE 2 Pfizer Presentation Expectations and 4Q18 and 2019 Consensus vs.Barclays Estimates Source:Barclays Research,company reports,Refinitiv,First Order Analytics$million except for EPS4Q18 Results2019 GuidanceCons.BarclaysCons.BarclaysLyricaNoNo$1,140$1,172$2,890$3,049 PrevnarNoNo$1,482$1,540$5,812$5,840 IbranceNoNo$1,127$1,093$4,784$4,657 XtandiNoNo$201$219$896$903 RevenueNoNo$13,948$13,934$54,502$54,596 EPSNoNo$0.64$0.65$3.08$3.06 Pre-Announcements4Q18E2019EPFE Stock Rating EQUAL WEIGHT Industry View POSITIVE Price Target USD 40.00 Price(03-Jan-2019)USD 42.04 Potential Upside/Downside-4.9%Barclays|U.S.Biopharmaceuticals 4 January 2019 5 Merck&Co.What We Expect to Hear Keytruda growth should remain strong in 2019 with increasing PD-L1 testing,deeper penetration in 1L NSCLC,geographic expansion,and other indications to drive sales Non-Keytruda immuno-oncology pipeline assets continue to progress,with some potential earlier-stage readouts in 2019 Business development remains a priority but bolt-on acquisitions are still preferred over transformative deals What We Dont Expect to Hear Details on the timing for KEYNOTE-426(1L RCC)or KEYNOTE-522(TNBC)Insights into the KEYNOTE-042 approval(months ahead of delayed April 2019 PDUFA)Our Take MRK shares took longer than expected to undergo a significant re-rating in 2018(based mostly on phase 3 wins for Keytruda)but finished the year as a strong performer(+36%vs.DRG+4%).Looking to 2019,we think sentiment around the stock is positive,which should continue as Keytrudas dominance across I/O becomes more pronounced over 2019.Investors are looking to see how dominant Keytruda can really be in lung and across I/O in general(i.e.,RCC and melanoma)in 2019,and while we recognize that we wont see an initial bolus of patients from recent label expansions,there is increasing emphasis in the magnitude of Keytruda upside each quarter.Indeed,we saw weakness in MRK shares after 3Q18 earnings from not beating expectations by$100-150M.Keytruda has mostly exceeded Street expectations in 2017-2018,but it has yet to dramatically beat consensus despite robust 1L results/line extensions in the large NSCLC market.In our view,this should play out by mid-2019 given a greater contribution from OUS sales on top of consistent market share gains in NSCLC in the US and,as a result,we are maintaining our bullish outlook on Merck in 2019.We suspect Merck will position 2019 as a growth year at the conference,with the I/O franchise poised to deliver robust growth as the year progresses.While it is evident that MRK needs to broaden product mix diversity away from oncology,in our view share performance will be primarily driven by the Keytruda franchise over the course of 2019.Outside of Keytruda,we think investors will closely watch Gardasil/Gardasil 9s market position(consensus:+14%growth in 2019)given recent line-extension/transition to the 2-dose regimen,along with Lynparza for metastatic breast cancer following a recent positive string of results(consensus:+63%in 2019).FIGURE 3 Merck Presentation Expectations and 4Q18 and 2019 Consensus vs.Barclays Estimates Source:Barclays Research,company reports,Refinitiv,First Order Analytics.$million except for EPS4Q18 Results2019 GuidanceCons.BarclaysCons.BarclaysKeytrudaNoNo$2,073$2,105$9,600$8,850 Januvia/JanumetNoNo1,5081,5255,8035,666GardasilNoNo7919293,4913,579ZepatierNoNo88115256400RevenueNoNo$10,993$11,327$44,531$45,094 EPSNoNo$1.05$1.06$4.71$4.70 Pre-Announcements4Q18E2019EMRK Stock Rating OVERWEIGHT Industry View POSITIVE Price Target USD 78.00 Price(03-Jan-2019)USD 74.04 Potential Upside/Downside+5.3%Barclays|U.S.Biopharmaceuticals 4 January 2019 6 Amgen What We Expect to Hear Commentary on the Aimovig launch and potential formulary positioning vs.rivals Color into the upcoming FDA ADCOM for Evenity for osteoporosis Clinical updates for tezepelumab(asmtha)and omecamtiv mecarbil(heart failure)What We Dont Expect to Hear Outlook into the potential for a near-term transformative deal Our Take Similar to 2017,Amgen overcame challenges to its core franchises Enbrel/Neulasta in 2018,delivering three consecutive quarters of beat and raises in 2018.With earnings growth benefiting(estimating of+13%y/y)significantly from share repurchases and lower taxes vs.more modest top-line growth(modest+2%y/y),in our view,Amgen is likely to yet again face questions over the outlook for revenue growthespecially given headwinds for a number of new products and major potential contributors in the pipeline still very early.Among critical updates,we look for insights into the ongoing early commercialization efforts for Aimovig for migraine.Facing competition from other recently launched anti-CGRP Abs including Tevas Ajovy and Lillys Emgality,Amgen(and partner Novartis)has been providing Aimovig at substantial discounts.Previous channel checks indicated that aggressively engaging prescribers,along with first mover position,would offer an advantage(see AMGN-Thoughts on Aimovig FDA approval,06/06/18)and feedback from Amgen may provide insight into the impact of this approach.We similarly expect feedback from the recent Repatha price reduction to whether there have been noticeable upticks in volumes(see AMGN-Thoughts on the Repatha price cut,10/24/18).The company may also provide color on its upcoming FDA ADCOM for Evenity(osteoporosis),with Street expectations still generally low following the 2017 CRL,along with progress insights for ongoing pivotal studies of tezepelumab(asthma)and omecamtiv mecarbil(heart failure).Ultimately,we view the pipeline as somewhat limited,in our view to offset the declines in the legacy franchises,justifying our neutral outlook.Following the Bristols recent deal for Celgene,however,given Amgens prodigious balance sheet,we expect investors to press the company on the potential for a transformative deal.FIGURE 4 Amgen Presentation Expectations and 4Q18 and 2019 Consensus vs.Barclays Estimates Source:Barclays Research,company reports,Refinitiv,First Order Analytics$million except for EPS4Q18 Results2019 GuidanceCons.BarclaysCons.BarclaysEnbrelNoNo$1,305$1,245$4,629$4,647 NeulastaNoNo9839623,6133,505ProliaNoNo6075922,4532,474KyprolisNoNo2522401,1031,086