04/29/04 cc notes
1.1 q results- - bate
V in Europe; V moderate growth in 2 q, with more dramatic growth in 2nd ½ based on apex;
I co-promotion % has been high and will continue throughout rest of year based on early acs trial expenses; I inventories are below target level
Cost reduction; non-gaap profit in 2006; 35 M milestone from jnj for Europe approval; sga will be somewhat higher throughout year
Campath royalty in 1 q; will receive modest royalties if over threshold in the future
3/31/04 cash = 838m ; convertible debt = 105 m
confirming 2004 guidance
2.progress against goals- - Levin
MM- -
V’s current label hits 25% of mm market; will file snda 2nd ½ 04 which will hit another 25% in 2nd line; p 4 frontline trial 4q 04/ 1 q 05 will hit the remaining 50%
Last week’s conference, there was a small frontline trial in turino, italy with V, T dex which produced a 74% response rate in 19 previously untreated mm patients
Asco - - (a) mm apex trial data; (b) update on ash frontline data for V alone and V + dex; (c) frontline data for V, dex and adriamycin
NHL- -
There was a ~ 50% response rate for mantle cell and follicular at ash
Started p 2 mantle cell for relapsed and refractory in 6/03
Plan 1st ½ 04 p2 V + rituximab for relapsed and refractory indolent nhl
2 investigator-initiated studies at asco: (a) relapsed follicular and mantle cell and (b) p2 relapsed indolent or aggressive nhl
SOLID - -ASCO
p 2 b nsclc- - V alone and V + taxotere; interim data
p 1 prostate cancer V + taxotere- - tolerability and activity of V
p2 colorectal- - V alone and V+ irinotecan (failed trial)
V alone and in combo for breast cancer
INTEGRILIN - - confirming guidance
Remove trial- - I with and without heparin in low risk patients; is heparin needed?
Protect trial- -to prove superiority of I over angiomax; data this year
Early acs trial 1st ½ 04 - - to demonstrate early use of I in high risk patients in accord with medical guidelines
Crusade study progressing
PIPELINE
3 molecules go/no go decision by end 2004
data asco p1/2 2704 prostate cancer- - enrolled in pilot 2 program
data asco 944 in solid tumors
data later this year 1202
3.Q&A
(i) what are your variable costs in r&d guidance? - - breadth of program development, i.e. how many indications, timing of programs and prioritization
(ii) what are the mantle cell enrollment #s? - - don’t comment on enrollment #s
(iii) re: turino, what were the doses in the combo V and T study? V= 1.3-1.7; T = 100 rising to 400 mg; V has no added toxicity to T
(iv) when mantle cell data? - - ash 04
(v) how much usage of V in 2nd line? - -V usage has primarily been 3rd line, consistent with label; increasing physician interest in earlier use as data comes in
(vi) I inventory levels? - - inventories down at wholesaler levels; doesn’t want fluctuating inventories
(vii) # typical V cycles ? - - 5-6
(viii) last I price increase? - - end of March 04
(ix) asco nsclc data? - - data from 1st stage group of patients ~ 50; by end of year, all data
(x) V off label use? - - after asco and ash, physician use typically picks up for cancer drugs; physicians want to see more data
(xi) Where is most of V use? - - tertiary care centers (majority) , teaching hospitals (next), community physicians( last)
(xii) Why waiting to start 1st line trial? - - figuring out best trial design; may be more than 1 trial
(xiii) Will V’s growth next q be a moderate 3%? - -no direct answer; apex will accelerate physicians’ confidence dramatically in 2nd ½ 04
(xiv) Is 15% the response rate hurdle for lung cancer the same as for colorectal? - - hurdle rate was never given out
(xv) If T is approved in 3 q, how will it affect you?- - don’t see T as competitive since they would have different labels
(xvi) Combo use with V? - - it’s been mainly dex, some T
(xvii) Do physicians adjust V dose? - - mainly consistent dose
(xviii) why different responses for nhls? - - they have different molecular pathways; V inhibits multiple pathways in cancer; there is no particular mutation
(xix) research estimates for 1st, 2nd, 3rd line use? - - no penetration rates to be given
(xx) V rollout in Europe? Pricing? - - no direct answer on price; jnj ready to go; initiation varies by country
(xxi) Preferred I inventory rate? - - 1 month
(xxii) Do you expect to pay milestone to 3rd party in 2004? - - no
(xxiii) Is 1 q r&d rate an accurate rate for the year? - - no direct answer
(xxiv) V data in ovarian? - - through cooperative group at end of year
(xxv) When will asco apex data be published? - - it’s a high profile study with a high priority
(xxvi) V wholesaler inventory levels? - - no direct answer
(xxvii) Compendia listing? - - if they have 2 publications, they will file for mm and nhl
(xxviii) Asco combo data? - - V, dex, adriamycin
4. impressions
management came off as flat; expenses way down; revenues down; analysts not buying a V revenue pickup after apex data will be released; unclear why I is off and how I revenue objective can be met by year-end; from last q’s call:
"4 q I sales were very strong; inventory drawdown with wholesalers in 4 q after earlier 4 q price increase; 3rd party audits say I sales were strong; drawdown reduced inventory levels by ½-3/4 months"
with 80 new I reps, not much progress
sales |
