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1、,North America Equity Research13 July 2010US Biotechnology2Q10 Earnings Preview;CELG,ACOR,and UTHRAre Best Ideas,2Q10 earnings season for biotech kicks off next week with Biogen,Gilead,andGenzyme all reporting.As we wrote in last weeks Priority Review,the tone in biotechremains quite negative,but ex
2、pectations are generally low.For 1Q earnings season thefocus was on US healthcare reform;we expect continued emphasis in 2Q on pricingpressure in the US/EU as well as the risks for 2011 such as the HC excise tax anddonut hole elimination.Hence,2Q earnings arent likely to provide a change intone with
3、 the best opportunities being launch stories(ACOR/ALTH/UTHR andAMGN)or those with new indications/data leading to volume gains(CELG).Were cautious on GENZ with a likely downward revision to guidance,and we thinkthat earnings for GILD and BIIB should provide limited volatility given TMC-278phase 3 da
4、ta after 2Q(GILD)and higher level comments from a new CEO(BIIB).Amgen:Our 2Q estimate is a penny ahead of consensus at$1.30,though we aremore cautious on Aranesp(WW sales$21M below at$620M)and Enbrel($20Mbelow at$859M).There are no expectations for Prolia(launched last month),andAmgen has already gi
5、ven a preliminary view of the 2011 reform impact.Hence,weexpect the focus to remain on the phase 3 dmab prostate prevention study(data4Q10e)and dmab SRE approval(1H11e).,US BiotechnologyACGeoffrey Meacham,Ph.D.(1-212)622-J.P.Morgan Securities Inc.G Krishna Gorti,MD(1-212)622-J.P.Morgan Securities In
6、c.Michael E Ulz(1-212)622-J.P.Morgan Securities Inc.Monika Sahni(91-22)6157-J.P.Morgan India Private Limited,Biogen:In 2Q we expect a modestly better picture for WW Tysabri end user sales($315M versus$307M),but were even with the Street on EPS at$1.12.Importantly,WW Tysabri new starts could accelera
7、te to 200/wk after seeing a down sequentialquarter in 1Q to 148/wk.This may be due to increased comfort with the JCV assay.The focus may also be on the Gilenia impact.Celgene:Were modestly raising our Revlimid forecasts to$560M from$556M(cons:$553M)given likely continuation of favorable OUS trends.W
8、e dont expectanother guidance raise,and we are in line with the Street on EPS at$0.66.The focusof the call is likely on the pending Abraxis deal as well as the regulatory strategysurrounding the maintenance myeloma opportunity.Genzyme:The key 2Q metric is the Myozyme/Lumizyme uptick following the 2Q
9、approval,which should show a nice q/q impact(JPMe:$102M;cons:$107M).Otherthan that,2010 guidance may be formally lowered with the full impact of theconsent decree felt(JPMe:$2.22;cons:$2.51).The focus will be on the consentdecree deadlines and transfer of fill/finish out of Allston given the risk of
10、 a royalty toFDA should Genzyme miss the Nov 28 deadline.Gilead:IMS data look good for 2Q,and were almost$20M ahead of the Street onWW HIV sales(to$1.6B),leading to two pennies ahead on EPS(to$0.89).Thefocus of the call,however,will be on the pipeline and TMC-278 phase 3 data,thelatter of which is p
11、resented on 7/22 with the abstract on 7/17.SMids:Our favorite SMids going into 2Q earnings season are ACOR(Ampyra JPMe:$6M ahead of cons.to$18.5M);ALTH(Folotyn JPMe:$1M below cons.to$11M)and UTHR(Tyvaso JPMe:$2M below cons.to$30M).Like the large caps,the SMid focus will likely be on the US/EU pricin
12、g environment and reimbursmentread-through from DNDN given the CMS ongoing national coverage analysis.See page 57 for analyst certification and important disclosures,including non-US analyst disclosures.J.P.Morgan does and seeks to do business with companies covered in its research reports.As a resu
13、lt,investors should be aware that the firm mayhave a conflict of interest that could affect the objectivity of this report.Investors should consider this report as only a single factor in making theirinvestment decision.,N,Geoffrey Meacham,Ph.D.(1-212)622-Equity Ratings and Price Targets,North Ameri
14、ca Equity Research13 July 2010,Mkt Cap,Rating,Price Target,CompanyAcorda Therapeutics Inc.Allos Therapeutics,Inc.AMAG PharmaceuticalsAmgen IncAmicus TherapeuticsAVEO Pharmaceuticals,Inc.Biogen IdecCelgene CorporationGenzyme CorporationGilead Sciences,Inc.InterMune,Inc.Ironwood Pharmaceuticals,Inc.Me
15、divation,Inc.PDL BioPharmaPharmasset,Inc.United TherapeuticsVertex Pharmaceuticals,SymbolACORALTHAMAGAMGNFOLDAVEOBIIBCELGGENZGILDITMNIRWDMDVNPDLIVRUSUTHRVRTX,($mn)965.94573.28628.1959,362.0846.1641.4617,739.4822,047.6815,077.5133,470.67416.231,076.27306.58728.412,640.854,500.74,Price($)33.875.6236.7
16、052.442.076.5451.6651.1153.7434.489.0611.059.165.9125.7549.0533.47,CurOWOWOWOWNOWNOWNOWNOWNNOWOWN,Prevn/cn/cn/cn/cn/cn/cn/cn/cn/cn/cn/cn/cn/cn/cn/cn/cn/c,Cur48.0010.0042.0065.0014.0055.0070.0050.0055.0013.0018.0012.007.0035.0065.0043.00,Prevn/cn/cn/cn/cn/cn/cn/cn/cn/cn/cn/cn/cn/cn/cn/cn/cn/c,Source:
17、Company data,Bloomberg,J.P.Morgan estimates.n/c=no change.All prices as of 12 Jul 10.Large Cap Biotech 2Q10 PreviewTable 1:2Q10 Large Cap Biotech Earnings Calendar,Company,Ticker,JPM,Release,CC,Dial-In,Passcode,Replay,Replay,Rating,Date,Time(ET),Dial-In,(Passcode),Amgens Q2,AmgenBiogenCelgeneGenzyme
18、Gilead,AMGNBIIBCELGGENZGILD,OWNOWOW,7/297/207/297/217/20,5:00 PM ET8:30 AM ET9:00 AM ET11:00 AM ETTBD,877-233-5736877-650-1145TBD773-799-3828TBD,Earnings ConfBiogenTBDGenzymeTBD,800-642-1687TBDTBD402-998-1512TBD,84162323TBDTBDTBDTBD,Source:J.P.Morgan estimates,Bloomberg.J.P.Morgan Ratings:OW=Overwei
19、ght,N=Neutral,UW=Underweight.Table 2:Large Cap Coverage Universe Valuation Table,Company,Ticker,Rating,Price,Market,JPM 10,JPM 11,JPM 09-12,JPM 10,JPM 11,JPM 09-12,JPM 10,JPM 11,JPM 12,7/9/10,Cap(M),EPS,EPS,EPS CAGR,Rev(M),Rev(M),Rev CAGR,P/E,P/E,PEG,AmgenBiogen IdecCelgeneGenzymeGilead,AMGNBIIBCELG
20、GENZGILD,OWNOWNOW,52.5651.7151.1853.9334.74,53,66414,96923,91914,78132,451,5.194.532.602.223.66,5.724.753.353.764.23,11%6%24%26%18%,15,1714,5173,3575,0258,027,16,7274,5864,1145,7378,799,8%2%20%10%12%,10.111.419.724.39.5,9.210.915.314.38.2,0.91.80.80.90.5,Mean,17%,11%,15.0,11.6,1.0,Source:J.P.Morgan
21、estimates,Bloomberg.J.P.Morgan Ratings:OW=Overweight,N=Neutral,UW=Underweight.2,Geoffrey Meacham,Ph.D.(1-212)622-6531,North America Equity Research13 July 2010,Amgen Inc(Overweight)Summary:Amgen will host its earnings call after the close on Jul 29.We haveupdated our model with adjustments to 2Q sal
22、es on specific products,and we areraising our 2Q EPS estimate by$0.01 from$1.29 to$1.30(cons:$1.29).OurFY2010 EPS estimate is now$5.19 from$5.18 previously(cons$5.11).Thefocus on the call will likely be 1)an update on the US and EU timelines for Proliaoncology filings,2)upcoming clinical catalysts,3
23、)trends in the core business,and 4)thoughts on potential NCD by CMS for Aranesp and the impendingdecision by the CMS to bundle Epogen for a composite rate in ESRD.We believeStreet expectations for 2Q are not high but see upside potential from inventoryrestocking or incentive contracts(historically p
24、rovides a bump to 2Q and 4Qsales).Figure 1:Amgen Quarterly Price Performance(Average 5 Days Prior vs.One Day After),1Q104Q093Q092Q091Q094Q083Q082Q08,-3%0%-6%Top/bottom line beat;raised guidanceMiss top/bottom line(widely exp)-3%Top/bottom line beat;raised guidanceTop/bottom line beat;raised guidance
25、;dmab,Top-line Miss;concern over HC reformMiss top/bottom line;upside 10 guidance3Q beat,guid up but TREAT;CR dmab(TIBL)5%8%Top/Bottom line miss,light 09 guidance8%13%,-15%,-12%,-9%,-6%,-3%,0%,3%,6%,9%,12%,15%,Day After PerformanceSource:J.P.Morgan estimates,Bloomberg.Product Detail:We are lowering
26、our 2Q10 WW Aranesp sales estimate to$620M from$639M before(cons:$641M),implying-1%sequential decrease.We are retaining our 2Q Epogen sales estimate of$653M(cons:$654M).Wehave decreased our 2Q Neupogen estimates to reflect IMS trends.Our WWNeupogen estimate is now$310M from$317M previously(cons:$317
27、M),whileour WW Neulasta estimate is unchanged at$891M(cons:$871M).We areretaining our below consensus 2Q Enbrel sales estimate of$859M on the basis ofIMS data(cons:$879M).Our total product sales estimate for the quarter is now$3.63B,down from$3.66B previously(cons:$3.66B).3,Key Variables,Inventory,G
28、eoffrey Meacham,Ph.D.(1-212)622-6531,North America Equity Research13 July 2010,Table 3:Amgen:Key Variables for the QuarterProduct demand trends;any clinical data updates;thoughts on potential NCD and/or FDA panel focused on Aranesp in CKD and bundling,SeasonalityPrice Increases,2Q tends to be season
29、ally strong quarter on salesEnbrel(4.9%on Mar 5,10),Aranesp(2.9%on Jan 21 10),Neupogen and Neulasta(2.9%on Jan 21,10),Inventory drawdown of$21M in 1Q10;Neulasta below normal range and Neupogen at lower end of normal range exiting 1Q10Source:J.P.Morgan estimates,MediSpan.Table 4:Amgen:2Q10 and 2010 E
30、stimates($in millions except for per share data),2Q Estimates,Growth(JPMe),2010 Estimates,Growth(JPMe),RevenuesEpogenAranesp-WWWW Anemia Franchise TotalNeupogen-WWNeulasta-WWNeupogen-Neulasta TotalsEnbrelProliaTotal product sales,JPM 2Qe6536201,2733108911,20185903,631,Cons 2Qe6546411,2953178711,1888
31、7933,662,Q/Q5%-1%2%-2%3%2%7%NA3%,Y/Y2%-11%-4%-5%7%4%-5%NA0%,JPM 2010e2,6462,5155,1601,2533,5744,8263,42622114,882,Cons 2010e2,6182,5285,1461,2633,5214,7843,44715614,778,Y/Y3%-5%-1%-3%7%4%-2%NA4%,Other revenues,75,77,289,303,Total RevenuesCOGS(non-GAAP),3,706519,3,739532,3%3%,0%-1%,15,1712,128,15,081
32、2,155,4%2%,Gross Margin,85.7%,85.5%,85.7%,85.4%,R&D(non-GAAP),665,675,8%,1%,2,722,2,760,-1%,R&D%Sales,18.3%,18.4%,18.3%,18.7%,SG&A(non-GAAP),933,937,7%,5%,3,970,3,871,6%,SG&A%Sales,25.7%,25.6%,26.7%,26.2%,Operating Expenses(non-GAAP)Operating Income(non-GAAP)Total Other IncomePretax Income(non-GAAP)
33、Taxes,2,1171,58951,594319,2,1441,595(2)1,593320,6%-1%25%0%0%,2%-3%-113%0%10%,8,8196,352196,3711,274,8,7866,295(58)6,2361,224,3%4%-137%6%25%,Tax Rate,20%,20%,20%,20%,Fully diluted non-GAAP EPS,1.30,1.29,0%,0%,5.19,5.11,6%,Source:J.P.Morgan estimates,Bloomberg.4,1%,3%,2%,11%,Geoffrey Meacham,Ph.D.(1-2
34、12)622-6531,North America Equity Research13 July 2010,Biogen Idec(Neutral)Summary:Biogen Idec will report 2Q10 earnings on Jul 20,before the marketopen,and will host a conference call at 8:30am ET.We have lowered our 2QEPS estimate to$1.12 from$1.14 previously(cons:$1.12).We expect the focuson the q
35、uarter to be on 1)commentary from new CEO Dr.George Scangos(appointment became effective on July 15)and 2)Tysabri utilization trends(netadds and revenue per patient)as well as 3)discussion surrounding emergingcompetition from oral MS drugs.Figure 2:Biogen Quarterly Price Performance(Average 5 Days P
36、rior vs.One Day After),1Q10,-1%,Miss top/bottom line;10 guid unchanged,4Q09 EPS beat;2010 guid above expectations,3Q09,-3%,3Q beat;Tysabri concern;pipeline setback,2Q09 EPS miss on Acorda;better Tysabri trends,1Q09,-4%,Top-line miss;EPS beat;Tysabri concern,4Q08 Top-line miss;EPS beat;inline 2009 gu
37、id,3Q08,-2%,Beat on revs,EPS;Tysabri concern,2Q08 Top and bottom line beat;raised guidance,-18%,-15%,-12%,-9%,-6%,-3%,0%,3%,6%,9%,12%,15%,18%,Day After PerformanceSource:J.P.Morgan estimates,Company data.Product Detail:US Net patient adds declined to 146/wk in 1Q10 from 177/wk in4Q09,but the company
38、 did indicate that net adds for the quarter improved inMarch to 190/wk.We are retaining our WW Tysabri end-user sales estimate of$315M(cons:$307M).On Avonex,we lowered our WW estimate to$580Mfrom$601M previously,but we remain slightly above consensus give strong IMStrends(cons:$573M).Meanwhile,our a
39、bove-consensus Rituxan revenueestimate is unchanged at$270M(cons:$258M).In all,our total revenue estimatedeclines to$1,131M from$1,152M previously(cons:$1,127M)(see Table 6).5,Inventory,Geoffrey Meacham,Ph.D.(1-212)622-6531,North America Equity Research13 July 2010,Table 5:Biogen Idec:Key Variables
40、for the Quarter,Key VariablesSeasonalityPrice Increases,Strategic update from new CEO;Tysabri sales and utilization trends;Avonex growth potential;R Tysabri 18.7%on Jun 30,10(wont affect 2Q),Avonex inventory levels were 2.25 wk at the end of 1Q10;no commentary was provided for Tysabri or RituxanSour
41、ce:J.P.Morgan estimates,MediSpan.Table 6:Biogen:2Q10 and 2010 Estimates($in millions except for per share data),2Q Estimates,Growth(JPMe),2010 Estimates,Growth(JPMe),RevenuesTotal AvonexWW Tysabri end-user salesTysabri Revenue to BIIBTotal Product salesRevenue from unconsol(Rituxan)JVRoyaltiesTotal
42、RevenuesCOGS,JPM 2Qe580315237830270301,131101,Cons 2Qe573307229844258251,127103,Q/Q-2%8%8%1%6%15%2%4%,Y/Y-2%24%26%5%-2%20%3%12%,JPM 2010e2,3881,2799523,3921,0111084,517408,Cons 2010e2,4001,2379213,3911,0201104,521410,Y/Y3%21%23%8%-8%-13%3%7%,Gross Margin,87.8%,0.0%,88.0%,87.9%,R&D,322,308,6%,-22%,1,
43、228,1,201,-3%,R&D%Revenue,28.5%,27.3%,27.2%,26.6%,SG&A,232,243,-1%,8%,960,977,8%,SG&A%Revenue,20.5%,21.6%,21.3%,21.6%,Collaboration profit sharing(to ELN)Total pro-forma ExpensesOperating Income(non GAAP)Other income/expense(net)Pretax Income(non GAAP)Taxes,647194125417117,657184088115,0%3%0%-149%4%
44、14%,30%-6%26%-60%23%-1%,2522,8641,65351,658453,2522,8401,681111,692470,17%4%2%-84%0%0%,Tax Rate,28%,28%,27%,28%,Fully diluted non-GAAP EPS,1.12,1.12,3%,49%,4.53,4.57,10%,Source:J.P.Morgan estimates,Bloomberg.6,3%,Geoffrey Meacham,Ph.D.(1-212)622-6531,North America Equity Research13 July 2010,Celgene
45、(Overweight)Summary:Celgene will report 2Q results on Thursday,July 29,before the openand will host a conference call at 9:00 am ET.We are retaining our 2Q EPSestimate of$0.66(cons:$0.66).We expect the quarter to be solid on the top linewith strong Revlimid sales,where our total revenue estimate of$
46、825M is abovethe Street at$818M.In our view,the focus on the quarter will be on 1)the recentAbraxis acquisition;2)Revlimid sales,reimbursement,and duration trends;and3)potential upside from Revlimid label expansion into first line multiplemyeloma.Figure 3:Celgene Quarterly Price Performance(Average
47、5 Days Prior vs.One Day After),1Q104Q093Q092Q091Q09,Rev/EPS beat,raised guidance-2%Rev/EPS/Revlimid beatMM-015;top line beat;EPS in lineEPS beat,reiterated 2009 guidance*,4%Rev/EPS in-line;2010 guidance unchanged0%19%5%,4Q08 Rev/EPS beat,good expense guidance*,3Q082Q08,Revlimid not as bad as fearedR
48、evlimid beat;guidance up,3%,5%,-19%,-14%,-9%,-4%,1%,6%,11%,16%,21%,Day After PerformanceSource:Bloomberg.*Preannounced range at J.P.Morgan Healthcare Conference in Jan;*Preannounced on Mar 30.Product Detail:We have increased our WW Revlimid sales estimate slightly to$560M from$556M previously,based
49、on strong OUS rollout(Canada/Australia/UK/S.Korea)(cons:$553M).Our 2Q10 sales forecast for Thalomid isunchanged and remains in line with the Street at$101M.On Vidaza,we havelowered our estimate to$130M from$138M previously(cons:$131M).Our totalrevenue estimate for the quarter is now$825M(cons:$818M)
50、.7,Geoffrey Meacham,Ph.D.(1-212)622-6531,North America Equity Research13 July 2010,Table 7:Celgene:Key Variables for the Quarter,Key VariablesSeasonalityPrice IncreasesInventory,Revlimid metrics(share,duration);timelines for FDA Revlimid 8.9%and Thalomid 9.9%on Jan 4,10No commentary on inventory pro
