ABCDEFGHIJKLMNOPQRSTUVWXYZAAABACADAEAFAGAH
1Main
2Brand NameProcritGeneric NameEpoetin alfa
3MechanismRecombinant protein which stimulates erythropoeisis (red blood cell production). Naturally produced in the kidney. 165AA. 30.4kD.
4IPEuropean patents have expired (2004). US August 2013? Generic biologics are non-substitutable globally (must be marketed by generic company).
5Approved6/1/1989 making it JNJ's oldest drug that is still marketed.
6Market20m patients with chronic kidney disease, 67% are anemic (US).
7SafetyDeath and tumor progression with higher doses.
8AdministrationSub-cutaneous injection, usually given qw versus Aranesp's q2w/q3w.
9CompetitionAranesp (AMGN). Suing AMGN for anti-competitive bundling. Discounting/Contracting cycle? Roche's CERA. Biogenerics from Teva, Stada. Affymax's Hematide. Shire's Dynepo. Merck EPO.
10Will Roche enter the market in the US? When will the first biogeneric be approved? How will changes to guidelines affect the competition between Procrit and Aranesp?
11ReimbursementMedicare rolling ASP+6%.
12GuidelinesCKD patients should have a hemoglobin less than 10g/dL for initiation.
13UsageProcrit is 50% oncology and 50% is CKD. 25% of oncology is used in "curative" patients (Stage 1-3).
14Model
15
16Procrit/EprexQ100Q200Q300Q400Q101Q201Q301Q401Q102Q202Q302Q402Q103Q203Q303Q403Q104Q204Q304Q404Q105Q205Q305Q405Q106Q206Q306Q406Q107Q207Q307Q407
17Domestic387411458554514554742525691764776803723707703671688582613578565566575540527524522491530449380331
18International215230233221254276286278300322320293274308302296289293274272271280269258259284276297287309302297
19Worldwide602641691775768830102880399110861096109699710151005967977875887850836846844798786808798788817758682628
20y/y0.275747508305647760.294851794071762760.487698986975398040.036129032258064520.290364583333333260.3084337349397590.066147859922178980.364881693648816840.006054490413723412-0.06537753222836096-0.083029197080292-0.11770072992700731-0.02006018054162484-0.13793103448275867-0.11741293532338304-0.1209927611168563-0.14431934493346976-0.03314285714285714-0.04847801578354005-0.06117647058823528-0.05980861244019142-0.044917257683215084-0.0545023696682464-0.012531328320802060.0394402035623409-0.061881188118811936-0.14536340852130325-0.20304568527918787
21Aranesp (AMGN)3956114207255348438503543617608705
22y/y5.5384615384615385.2142857142857142.84210526315789471.42995169082125621.12941176470588230.77298850574712640.388127853881278460.40159045725646125
23Epogen (AMGN)503518517609512570558620547611626651590633681697
24y/y0.0178926441351887620.100386100386100410.0793036750483560.018062397372742290.0683593750.071929824561403510.121863799283154160.0500000000000000440.078610603290676370.0360065466448444840.087859424920127880.07066052227342556
25Total Market1271134815451412154217121768192317991974206921212110212521762252
26y/y0.213217938630999140.270029673590504560.144336569579287980.361898016997167060.166666666666666740.153037383177569990.17024886877828060.102964118564742520.172873818788215730.07649442755825730.051715804736587770.06176331918906186
27
28Procrit/Eprex199719981999200020012002200320042005200620072008E2009E2010E2011E2012E2013E
29Domestic500752124018102335.330342804246122462064169012501000900810729656.1
30International6357438548991093.91234.5118011281078111611951100990891801.9721.71649.5390000000001
31Worldwide11351495209427093429.20000000000034268.5398435893324318028852350199017911611.91450.711305.6390000000001
32y/y0.317180616740088130.40066889632107030.29369627507163320.265854558877814730.24475096232357396-0.06665104837765023-0.09914658634538154-0.07383672332125946-0.04332129963898912-0.09276729559748431-0.1854419410745234-0.15319148936170213-0.09999999999999998-0.09999999999999998-0.09999999999999998-0.09999999999999998
33Aranesp (AMGN)42415.61543.82472.932733838.324992754479.325266539253583.46021323140032866.76817058512052723.42976205586462587.25827395307122457.89536025541752335.0005922426467
348.8952380952380962.71462945139557240.60182666148464840.32354725221399970.17272379857928510.167-0.2-0.19999999999999996-0.04999999999999993-0.050000000000000044-0.050000000000000044-0.04999999999999993
35Epogen (AMGN)1962.42108.122602434.62600.624552460.742485.34739999999972361.08002999999962313.85842939999972313.85842939999972336.99701369399962360.36698383093972383.9706536692493
360.074245821443130740.072055405341302730.077256637168141570.06818368520496176-0.055987079904637360.0023380855397148180.01-0.05-0.0200.010.010.01
37Total Market4671.45579.36944.17962.48662.590529479.064992759849.6726665392498294.54024323147170.626599985126828.2881914558646536.15528764707056268.9723440863576024.610245911896
380.194352870659759480.244618500528740230.14664247346668380.087925751029840350.044963924963924870.0471790756462660.039097492640118636-0.1578867111585197-0.13550041476541486-0.04774177036773419-0.04278274372987578-0.040877692129755894-0.0389796101756571
39
40JNJ Sales
41Procrit/Eprex % of Total Sales
42Gross Margin0.90.90.90.90.90.90.90.90.90.90.90.90.90.90.90.90.90.90.90.9
43Gross Profit897.3000000000001913.5904.5870.3000000000001879.3000000000001787.5798.3000000000001765752.4761.4759.6718.2707.4727.2718.2709.2735.3000000000001682.2613.8000000000001565.2
44FTE700700700700700700700700700700700700700700700700700700700700
45Cost/FTE0.0750.0750.0750.0750.0750.0750.0750.0750.0750.0750.0750.0750.0750.0750.0750.0750.0750.0750.0750.075
46FTE Expenses52.552.552.552.552.552.552.552.552.552.552.552.552.552.552.552.552.552.552.552.5
47Operating Expenses52.552.552.552.552.552.552.552.552.552.552.552.552.552.552.552.552.552.552.552.5
48Operating Income844.8000000000001861852817.8000000000001826.8000000000001735745.8000000000001712.5699.9708.9707.1665.7654.9674.7665.7656.7682.8000000000001629.7561.3000000000001512.7
49Operating Margin0.84734202607823470.84827586206896550.84776119402985070.84570837642192350.84626407369498470.840.84081172491544540.83823529411764710.83720095693779910.83794326241134750.83779620853080570.83421052631578950.8332061068702290.83502475247524750.83421052631578950.83337563451776650.83574051407588750.83073878627968340.82302052785923760.8164012738853504
50JNJ Operating Profit
51Procrit/Eprex % of Total OP
52
53
542006200720082009201020112012201320142015201620172018
55Competitive Entries00000-0.05-0.1-0.1-0.1-0.1-0.1-0.1
56Pricing-0.02-0.02-0.02-0.02-0.02-0.02-0.02-0.02-0.02-0.02-0.02-0.02
57Unit Growth - Pre-Dialysis-0.02-0.02-0.02-0.02-0.02-0.02-0.02-0.02-0.02-0.02-0.02-0.02
58Unit Growth - Cancer-0.2-0.2-0.1-0.05-0.05-0.05-0.05-0.05-0.05-0.05-0.05-0.05
59Market Share-0.05-0.05-0.02-0.02-0.02-0.02-0.02-0.02-0.02-0.02-0.02-0.02
60Patent Expiry Penalty000000000000
61
62Pre Dialysis0.4802.4000000000001732.0937120000001667.9476609545601628.6669949091444591.6963462725274556.8998675409325497.942215124056421.7933064033365357.28963707633216302.65033328923244256.3668652402434217.16139836627562183.95151376603653
63Cancer0.61203.6896.4412799999998667.6694653439998577.1067790647397526.5406830830872480.40518843134697416.3964815299427341.9206396364602280.76539787236214230.54826033970718189.31285959186783155.45274015098553127.64877395306056
64
65Domestic Forecast20061628.53499199999991335.617126298561205.7737739738841118.23702935561461037.3050559722794914.3386966539988763.7139460397966638.0550349486944533.1985936289396445.6797248321112372.61413851726115311.6002877190971
66
67
68International20642218.82053.68000000000031902.23400000000021763.23651635.5774551518.251084251410.34578183751311.0350193656251219.56914235534371135.26797179977641057.5141311157677985.7470266753612
69Pre-dialysis0.25516567.6539.22512.259486.64605462.3137475439.198060125417.23815711874994396.37624926281245376.5574367996718357.72956495968816339.84308671170373322.8509323761185
70Dialysis0.25516567.6539.22512.259486.64605462.3137475439.198060125417.23815711874994396.37624926281245376.5574367996718357.72956495968816339.84308671170373322.8509323761185
71Cancer0.510321083.6000000000001975.2400000000001877.7160000000001789.9444000000001710.9499600000001639.8549640000001575.8694676000001518.2825208400001466.4542687560001419.8088418804001377.8279576923601340.0451619231241
72
73
74Total Procrit (WW)40703847.3349923389.297126298563108.00777397388452881.4735293556152672.88251097227932432.5897809039992174.05972787729661949.09005431431931752.76773598428331580.94769663188751430.12826963302881297.3473143944582
75-0.05470884717444713-0.11905328406646842-0.0829934177626589-0.07288728378199127-0.07239039896020938-0.08990022160789712-0.10627770249475743-0.10347906760714098-0.10072511421187325-0.09802784238033035-0.09539811299271339-0.09284548670074344