J.P. 摩根-美股-生物科技行业-美国中小型生物科技：2019年摩根大通医疗保健会议后的评级调整-2019.1.23-29页.pdf

North America Equity Research23 January 2019Equity Ratings and Price TargetsMkt CapRatingPrice TargetCompanyTicker($mn)Price($)CurPrevCurEnd DatePrevEnd DateApellisAPLS US755.3513.44NOW34.00Dec-19n/cn/cDova PharmaceuticalsDOVA US219.437.78UWOW20.00Dec-1934.00n/cEidos TherapeuticsEIDX US469.4112.71NOW29.00Dec-19n/cn/cG1 TherapeuticsGTHX US662.3819.58NOW41.00Dec-1959.00n/cLa Jolla PharmaLJPC US166.336.04NUW9.00Dec-1918.00n/cNeurocrine BiosciencesNBIX US8,835.7291.28NOW100.00Dec-1997.00n/cReplimuneREPL US334.4710.60NOW26.00Dec-19n/cn/cOtonomyOTIC US60.951.99UWn/cn/cMerrimack PharmaceuticalsMACK US68.325.12UWn/cn/cSource:Company data,Bloomberg,J.P.Morgan estimates.n/c=no change.NC=Not Covered.All prices as of 22 Jan 19.US SMid BiotechnologyRatings Revisions for Our Coverage Universe Post 2019 J.P.Morgan Healthcare ConferenceSMid BiotechnologyAnupam Rama AC(1-212)622-Bloomberg JPMA RAMA Tessa T Romero(1-212)622-Matthew Bannon(1-212)622-J.P.Morgan Securities LLCSee page 25 for analyst certification and important disclosures.J.P.Morgan 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.Post the 2019 J.P.Morgan Healthcare Conference,we are rebalancing the ratings in our coverage universe for 1H19,a task that has become increasingly difficult given volatility in the broader markets.The J.P.Morgan ratings system is relative to the other stocks in our universe.As such,this requires identifying higher conviction names for 1H19 while stepping to the sidelines on some stories,despite in most cases still seeing ample opportunity for longer term upside in these names(greater than the 6-to 12-month horizon of our ratings system).Please see a summary of key ratings changes below,with a more comprehensive update on our theses in the back pages of this note.Top picks(unchanged from 2019 Outlook note;see note and further details here):Atara(ATRA)and InflaRx(IFRX).Upgrading to Neutral:La Jolla(LJPC).Downgrading to Neutral:Apellis(APLS);Eidos(EIDX);G1 Therapeutics(GTHX);Neurocrine(NBIX);Replimune(REPL).Downgrading to Underweight:Dova Pharmaceuticals(DOVA).Coverage terminations:Otonomy(OTIC);Merrimack(MACK).Due to a reallocation of resources,we are terminating coverage of Otonomy and Merrimack.The last research on this company should no longer be relied upon.Our last rating was Underweight on both companies.2North America Equity Research23 January 2019Anupam Rama(1-212)622-Table of ContentsApellis(APLS,Rama N).3Dova Pharmaceuticals(DOVA,Rama UW).4Eidos(EIDX,Rama N).5G1 Therapeutics(GTHX,Rama N).6La Jolla Pharmaceutical(LJPC,Rama N).7Neurocrine(NBIX,Rama N).8Replimune(REPL,Rama N).93North America Equity Research23 January 2019Anupam Rama(1-212)622-Apellis(APLS,Rama N)We are downgrading APLS shares to Neutral from Overweight and maintaining our December 2019 price target of$34.We continue to like APLS shares long term and view APL-2 as an underappreciated asset in the complement space,with opportunities in both geographic atrophy(GA)and paroxysmal nocturnal hemoglobinuria(PNH).Overall,we do believe both opportunities are underappreciated.Looking forward,Apellis clinical programs are largely in the trial initiation/execution stage in 1H19 for APL-2 including 1)the phase 3 DERBY&OAKS trial re-initiations in GA are expected in 2Q19(post voluntary pause due to observed cases of non-infectious inflammation in patients;enrollment completion expected 1Q20);and 2)phase 3 PEGASUS patient recruitment in PNH(first patient enrolled in June 2018).In terms of catalysts for the year,Apellis will report PNH phase 3 APL-2 head-to-head with Soliris designed to show superiority at the 4-month endpoint of change from baseline in hemoglobin levels(data expected in 4Q19).In addition,the phase 2 monotherapy trial of APL-2 in four types of complement-dependent nephropathies will also readout(1-year endpoint of change from baseline in proteinuria;data expected in 2H19).Most importantly for 2019,in PNH,we continue to see APL-2 as the most attractive,yet still underappreciated,non-Alexion developmental agent in the clinic(driven by hemoglobin differentiation);however,with data not until 4Q19,we expect APLS shares perform in line with the market in 1H19(i.e.,relative Neutral for 1H19).Downgrading to Neutral from Overweight.Maintaining December 2019 price target of$34.4North America Equity Research23 January 2019Anupam Rama(1-212)622-Dova Pharmaceuticals(DOVA,Rama UW)We are downgrading DOVA shares to Underweight from Overweight and adjusting our December 2019 price target to$20 from$34.While we continue to view Doptelet(avatrombopag)as a largely de-risked asset from a clinical standpoint,focus in the near term will be on the launch in CLD,which has underwhelmed thus far.With a new management team appointed at the end of 2018,Dova remains committed to getting the launch back on track,but we believe it may take several quarters for new management to put into motion a revised strategy.This revised strategy will also account for the Doptelet launch in ITP,which will be important to monitor in the back half of the year(PDUFA 6/30/19).While there are important catalysts on the horizon(particularly on the regulatory side with ITP),without a clear Doptelet strategy in place for CLD/ITP and/or without an inflection in CLD sales it has become difficult for us to recommend owning DOVA shares.Net-net,we believe Dova has the potential to create long-term value,but believe that DOVA shares will underperform in 1H19 as the new management puts into place the Doptelet sales/marketing strategy.Downgrading to Underweight from Overweight.Adjusting December 2019 price target to$20 from$34.5North America Equity Research23 January 2019Anupam Rama(1-212)622-Eidos(EIDX,Rama N)We are downgrading EIDX shares to Neutral from Overweight and maintaining our December 2019 price target of$29.To be very clear,we continue to believe AG10 will emerge as a best in class stabilizer with time.This said,2019 appears to be more of an execution year.On the clinical front,the primary clinical catalyst for the year is phase 2 open-label extension(OLE)data in ATTR-CM.We know from prior data that serum TTR concentration increase is best in class for AG10,and we believe OLE updates should continue to support the emerging profile of the compound.On the regulatory front,we believe that there will be two important events to monitor,including 1)phase 3 trial initiations in ATTR-CM and ATTR-PN for AG10(guidance to start mid-2019),and 2)approval of Pfizers tafamidis is expected by July 2019.On the latter point,the tafamidis approval should be no surprise,and in fact,we believe the launch of tafamidis with time will validate the broader ATTR market(and the potential for AG10).Net-net,while we acknowledge there is long-term fundamental upside value in EIDX shares,we believe shares will perform in line with broader markets in 1H19.While we believe EIDX shares will be a relative Neutral in 1H19,we do believe EIDX shares remain attractive for investors with a multi-year horizon.Downgrading to Neutral from Overweight.Maintaining December 2019 price target of$29.6North America Equity Research23 January 2019Anupam Rama(1-212)622-G1 Therapeutics(GTHX,Rama N)We are downgrading GTHX shares to Neutral from Overweight and decreasing our December 2019 price target to$41 from$59.The move to Neutral is largely dictated by key clinical data being weighted towards 2H19.We believe the myelopreservation benefit of trilaciclib is clear via 2H18 updatesacross treatment settings/chemotherapy backbones,and the program has value on this alone.That said,while regulatory clarity in 2Q19 for trilaciclib should provide some clarity/comfort on the regulatory path forward,we believe a much better understand of the totality of the trilaciclib data are needed via medical conference presentation(s).Based on comments at the J.P.Morgan Healthcare Conference in January,trilaciclib updates are more likely to occur in the 2Q+timeframe/2H19 timeframe.In particular,we believe the long-term/maturing benefits of myelopreservation and a better understanding of commercial dynamics are needed(some of latter point may come at the March 6thAnalyst Day).While we believe there is potential upside on trilaciclib alone from current levels,we note that lerociclib/G1T48 early stage updates are also expected in 2H19.We maintain the G1 story has long-term potential;however,we are moving to a relative Neutral rating for 1H19 with catalysts more in the likely summer/2H19 timeframe.Downgrading to Neutral from Overweight.Adjusting December 2019 price target to$41 from$59.7North America Equity Research23 January 2019Anupam Rama(1-212)622-La Jolla Pharmaceutical(LJPC,Rama N)We are upgrading LJPC shares to Neutral from Underweight and adjusting our December 2019 price target to$9 from$18.Our initial concerns with the Giapreza launch/high consensus estimates(also pricing too high for broad adoption)played out in 2018,and indeed 2019 guidance for Giapreza sales came in well below consensus estimates(guidance$24-28M;shares down 50%on the announcement).Looking forward,we expect the focus to shift away from Giapreza US launch to other clinical programs,in particular the LJPC-401 program.Recall,phase 2 data for LJPC-401 in hereditary hemochromatosis are expected in 2H19,and we note the phase 1 data are interesting(i.e.,the program has value).That said,we believe the program is a“show me”story,in the context of negative sentiment from the Giapreza launch.Despite the potential for upside based on LJPC-401,in our view,we believe LJPC shares will be more range bound in 1H19,and it will indeed take potential positive data for the phase 2 HH to reinvigorate interest in the company(data not until 2H19)and broader developing pipeline(including NDA for LJPC-0118 in severe malaria expected in 4Q19).This forms the basis of our Neutral rating.Upgrading to Neutral from Underweight.Adjusting December 2019 price target to$9 from$18.8North America Equity Research23 January 2019Anupam Rama(1-212)622-Neurocrine(NBIX,Rama N)We are downgrading NBIX shares to Neutral from Overweight and adjusting our December 2019 price target to$100 from$97.NBIX shares have been a best performer year-to-date(YTD)in our coverage universe(up 25%+YTD;versus NBI up 12%),despite disappointing Tourette Syndrome(TS)setback for Ingrezza in December 2018.The launch of Ingrezza in Tardive Dyskinesia(TD)has been stellar to date,highlighted by another nice consensus beat in 4Q18.More near-term,while 1Q19 will have traditional seasonal headwinds(we believe appreciated by the Street;1Q19 cons:$131M),we do believe the 2019 consensus estimate of$577M for Ingrezza is beatable.Longer-term,we continue to view Ingrezza as a best in class agent in TD within a market that is growing(we do not see fundamental issues in the launch frankly and sales force expansion should help continue to grow the market).That said,we believe that the upside observed in NBIX shares YTD largely accounts for Ingrezza beats in 2019 and continued growth longer-term.Related to Orilissa in endometriosis/uterine fibroids(UF),while we view these as large and compelling markets,we do believe it will take time to understand launch dynamics in endometriosis and for the product to become a more meaningful revenue contributor(on the horizon,UF NDA submission anticipated 2019;AbbVie).Onthe pipeline side,while the TS setback was disappointing,we believe it will take time to better appreciate the Parkinsons disease and congenital adrenal hyperplasia program opportunities(should occur over the course of the next several quarters but this will take time).Net-net,while we continue to see long-term potential in the company(albeit potential more range-bound near-term relative to other names in the coverage),at current valuation levels we would wait for a pull back before adding to NBIX positions(hence,the move to a Neutral rating).Downgrading to Neutral from Overweight.Adjusting December 2019 price targetto$100 from$97.9North America Equity Research23 January 2019Anupam Rama(1-212)622-Replimune(REPL,Rama N)We are downgrading REPL shares to Neutral from Overweight and maintaining our December 2019 price target of$26.We continue to believe that long-term Replimune will be a key player in the emerging oncolytic immunotherapy field.Indeed,there are multiple de-risking points to the platform story here,including 1)strong pre-clinical data and rationale for combination with checkpoint therapy for lead asset RP1,2)strong existing data for first-generation T-vec+I/O therapies that lends support to broader strategy(i.e.,RP1+nivo combination),and 3)a clear unmet need in for RP1 in CSCC(coupled with strong rationale).We also believe that earlier-stage RP2 and RP3 have the potential to create long-term value as they are further developed in indications that have historically been difficult to treat.That said,looking forward,in terms of clinical catalysts to monitor,Replimune is expected to initiate the phase 2 trial in CSCC in 1H19 and phase 1 data from RP1 alone and RP1+nivolumab in advanced solid tumors in 2H19(at a medical conference).Given the timing of the RP1+nivo combo readout in 2H19,we believe REPL shares are more likely to be range-bound in 1H19(i.e.,relative Neutral).Downgrading to Neutral from Overweight.Maintaining December 2019 price target of$26.10North America Equity Research23 January 2019Anupam Rama(1-212)622-ApellisNeutralCompany DataPrice($)13.44Date Of Price 22-Jan-1952-week Range($)32.00-11.45Market Cap($mn)755.35Fiscal Year End DecShares O/S(mn)56Price Target($)34.00Price Target End Date 31-Dec-19Apellis Pharmaceuticals,Inc(APLS;APLS US)FYE Dec2015A2016A2017A2018E2019E(Prev)2019E(Curr)2020E(Prev)2020E(Curr)EPS Reported($)Q1(Mar)-(0.43)A(0.70)(0.70)-Q2(Jun)-(0.61)A(0.68)(0.75)-Q3(Sep)-(0.64)A(0.71)(0.79)-Q4(Dec)-(0.65)(0.75)(0.75)-FY(8.03)(3.22)(3.68)(2.35)(2.85)(2.99)(2.99)(3.26)Source:Company data,Bloomberg,J.P.Morgan estimates.Investment Thesis,Valuation and RisksApellis(Neutral;Price Target:$34.00)Investment Thesis We believe Apelliss lead asset,APL-2,represents a differentiated,mid-to late-stage clinical asset in the complement space,with opportunities in both GA and PNH.Apellis clinical programs are largely in the trial initiation/execution stage in 1H19 for APL-2 including 1)the phase 3 DERBY&OAKS trial re-initiations in GA are expected in 2Q19;and 2)phase 3 PEGASUS patient recruitment in PNH(first patient enrolled in June 2018).Most importantly for 2019,in PNH,we continue to see APL-2 as the most attractive,yet still underappreciated,non-Alexion developmental agent in the clinic(driven by hemoglobin differentiation);however,with data not until 4Q19,we expect APLS shares perform in line with the market in 1H19(fo