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Biotech / Medical : Millennium Pharmaceuticals, Inc. (MLNM) -- Ignore unavailable to you. Want to Upgrade?

To: SemiBull who wrote (1896)	10/17/2003 4:05:18 AM
From: software salesperson	Read Replies (3) \| Respond to of 3044

10/16/03 Analyst Day notes Mark Levin more than 250 salespeople for V and I V indications- - mm, nhl, solid tumors, ra, stroke I will be $ 500 m + product; will begin new trial for early use acs 3 key pathways where mlnm has expertise: proteasome inhibition; cell trafficking; cell signaling - - want to leverage these skills crucial to p 1 / p 2 portfolio mgmt. is using pathways, imaging and biomarkers to rule in/ out early stage candidates p 2/ p 3- - need operational excellence there will be more proteasome products see being at level of top 2 biotech companies by 2011 10 molecules in clinic- - 2 approved products; 8 candidates Bob Tepper commercial products focus: V - - cancer, ra, stroke; I - - early acs pipeline now divided into high priority: 2704 - - prostate 944 - - solid tumors 518 - - aml, glioblastoma; studying ITD biomarker found in 30% of aml patients 1202 - - ra, ms, restenosis and lower priority: 02 - - ibd 591 - - prostate 519 - - various proteasome inhibitors 576 - - solid tumors differentiating approach: wants to use molecular pathway expertise on unprecedented targets with precedented pathways areas of expertise to be leveraged, i.e. common mechanisms across multiple therapeutic areas: chemokine receptors - - 1202 + preclinical rtks - - 518 + preclinical proteasome - - V, 519 + preclinical stks - - preclinical integrins - - I, 02 has over 20 ongoing discovery programs that will generate 2 development candidates each year into clinic + will expand indications for both approved drugs and existing clinical candidates making go/no go decisions earlier based on proof of concept 90% of r&d projects use genomic strategies bio-marker driven clinical development 1st q & a 1. are you aware of a proteasome inhibitor being tested in hiv and do you see potential for V in hiv? - - has existing effort with V in infectious diseases 2. how is morale after layoff? - - agile, resilient, upfront with employees; will be using a revitalization team for a year 3. 90% of pipeline came from acquisitions. Will there be more internally generated molecules in next 10 years? - - over next several years, there will be more genomics –based targets; took many years to set up infrastructure; will be generating small molecules in chemokine receptor areas in next few years 4. why did 2704 leapfrog 591? - - based on pk and tolerability 5. you will need manufacturing capability for some of your high priority candidates. will you build or partner? - - happy with contractors; will not build; will look for partners with commercial and manufacturing capabilities in ex US market deal while retaining US rights 6. when does I patent expire? - - 2014 7. what is your role in personalized medicine? - - biomarkers and pathways; also, fda is very interested in personalized medicine; mlnm has been brought in to teach fda about them; fda wants to know how they should be regulated; fda wants personalized medicine tests for all drugs 8. what’s been successful in genomics? - - known pathways and streamlines entire process 9. is ccr2 in ra an example of an unprecedented target with a precedented pathway? - - yes; but not sure if ra is right disease; others to be studied include ms and restenosis 10. how has 2704 safety been demonstrated? - - few adverse events 11. how do you know that the 2704 conjugate isn’t dislodged prior to getting to target tissue? - - 4 pk measures 12. a question was raised about 2704 and seattle genetics, but the end of the question and the answer was cut off 13. a question was raised about the economics of using genomics for more efficient trials vs. smaller markets, but the answer was cut off 14. dna status of 02? - - had an efficacy signal; still discussing 15. why did psma and ccr2 move so quickly in clinic? - - good results 16. why did you terminate drugs that you had recently put in clinic? - - proud of that David Schenkein - - V EU regulatory process on schedule; technology transfer with OBI product supply established in EU; global filing plan established for ROW Accrued p 3 apex trial - - 600 patients; 340 in crossover trial Mlnm –sponsored p 2 studies: Mantel cell lymphoma- - 6% of all lymphomas: - - V alone Nsclc - - V alone or V + docetaxel Colorectal - - V alone or V + irinotecan Has seen activity in follicular and sll/cll lymphomas P 1 ovarian cancer - - V + carboplatin - - 67% response rate Data to be presented: Ash 2003 - - mm combo, mm frontline,mm duration, nhl, safety updates Asco 2004 - -all of the above + solid tumors p1 and p 2 Ash 2004 - - same as ash 2003 V marketing: consistent across geographic regions;reimbursement process on track; has medicare pass-through status for outpatient use Bob Terifay - - I How to expand I use in cath lab? - - questions Angiomax’s replace 2 study results, e.g. excluded all high-risk patients, encouraged inappropriate uses of heparin and overly high doses of I to elderly Says A has had little impact on gp iib-iiia inhibitor market gp inhibitors grew since intro of A A has 9% share, which includes combo with gp inhibitors Starting 2 competitive studies: Protect - - a high risk angioplasty study; I with heparin vs A; already initiated Remove - - I vs. I with heparin in elective PCI; to start in early ‘04 Starting 2 new trials in new settings: Titan -- I for stemi; early treatment vs. at time of primary angioplasty; already initiated Event - - bare metal or drug-eluting stents with and without gp inhibitors; hopes to show that gp inhibitors are still necessary to prevent thrombotic events regardless as to type of device used; to start in early ‘04 Grow I in early use setting by educating in acc/aha guidelines Planning new p 3 early non ste acs - - 1.3 m patient potential; in emergency room for prevention of early MI in combo with plavix, lovonex and stents; to start in early ‘04 Stemi advance MI market is shrinking, that’s why trial was cancelled Ken Bate Assumptions: Next 3 years: based on current labels on I and V; existing products and existing collaborations; all that we need to do is execute Growth beyond 2006: pipeline + new indications of existing products No plans to go to capital markets Likeliest revenue contributors in 2006-2010: 1202, 2704, 518, 944 20% annual r&d expense reduction = ~ 100 m, fully effective by 2nd ½ 2004 10-20 % sg&a annual increase, which includes I salesforce increase more than 800 m cash entering 2004 capex reduced 50% after restructuring restructuring charges: 225-250 M through 2005; 1/3 noncash, 2/3 cash over 3 years get 60% I in US I inventories coming down I price increase at end of 3rd q 2nd q&a 1. any measurement of V off-label use? - - don’t collect data like that 2. duration of V treatment? - - too early to tell 3. I inventory levels? - - market is flat to slightly growing; expects to end year with greater than 300 m of I revenue with about 1.2-1.3 months inventory; 4th q started weak 4. what will be effect of drug-eluting stents? - - does not foresee negative impact on gp inhibitors; expects that if stents are used in cath lab and angioplasty, then gp inhibitors will grow; will have better data in 6-8 months 5. how is V trial for colorectal cancer accruing? - - on target at 20 US sites 6. why did apex accrue rapidly? - - as expected 7. will crusade data achieve ss? - - after risk-adjustment with more patients, they expect it will 8. how big will acs study be? - - it will be large; in final design phase; will be realistic and well-powered 9. when will you update on 4 V signals? - - end of year 10. any residual value in metabolic program? - - no, all stuff went to abbott 11. update on V front line study? - - some trials are ongoing; 2 q ’05 fda commitment 12. update on maintenance trial? - - some people on 23 cycles; apex trial has some maintenance; apex data analysis early ‘05 13. are there mantel cell databases you will use? - - yes 14. barry greene’s departure? - - he was project leader and had limited role once V was approved; david is strategic V person now 15. what are risk factors for 2006 profitability ? - - V sales 16. what was I price increase? - - 5.2%; both competitors had taken price increases recently 17. 518 only effective with mutation? - - enrolling patients with and without mutation 18. when will we see 518 data? - - asco ’04 or ash ‘04 19. anecdotal data on V launch vis-a-vis T ? - - no direct answer 20. what % of I patients are treated at best practices hospitals? - - no direct answer 21. when p 1 data for 944? - - 1 year 22. 944 for what solid tumors? - - too early to tell 23. are competitors' discounts for large buyers of I causing you to do likewise? - - reopro gives 0-10% discount 24. how will 70 I salespeople cover all clinical cardiologists? - - 80/20 rule 25. do you assume that V will work in solid tumors beyond 2006? - - not specifically 26. how much impact did new I salesforce make on 3 q revenue? - - a direct effect 27. jnj payments booked as revenue? - - yes 28. is there pent-up demand for V? - - no direct answer 29. why did you go into larger colorectal cancer trial? - - strong preclinical models and (i) to establish V single agent activity and (ii) followup of p 1 safety trial with irinatecan 30. won’t there be a large cost for 5 new I trials? - - the acs trial would be large and expensive; the other 4 would be much less expensive; both expenditures are reimbursed in part by partners 31. I spend vs V spend? - - no direct answer; V has 40 investigator-initiated trials now and will likely go to 80 32. EU approval update? - - norm is beyond a year; expecting 1st ½ ‘04 33. 518-like competitors produced equivocal data. Why are you so aggressive? - - 518 is different from competitors 34. I inventories vary based on price increases. Are you trying to do something about that? - - increase demand 35. with uncertainty at sgp, will you get I for yourself? - - sgp says that I is one of their largest opportunities 36. I progress in europe by sgp? - - no direct answer 37. if get success in acs trial, can a 2% improvement in mortality be cost-justified? - - trying to reach 900,000 patients who go to cath lab; hospital administrators like gp inhibitors because it reduces the length of stay, a key financial element for them Impressions Great quarter. Faster than expected r&d savings; greater V and I revenue than expected; I share increased from 68% to 71%. The I marketing guy has both a keen strategic sense and tactical flair and has reinvigorated I program; great presentation and explanation on portfolio management criteria , as well as on how they will leverage their skills; ken bate certainly has instilled a strong sense of financial discipline; short-term, intermediate and longer-term plans make more sense. Looking good ! sales