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


To: scaram(o)uche who wrote (2307)1/27/2005 8:31:09 PM
From: software salesperson  Read Replies (1) | Respond to of 3044
 
1/27/05 conference call notes

1.financial review

restated 2005 guidance; at least 1 significant revenue-generating alliance in 05; reduce sga expenses slightly in 05;

700 m cash 12/31/04; convertible debt 106 m

2. product update - - bob tepper

V - -

1st priority - - expand mm indications

2nd priority - - nhl subtypes; mantel cell; follicular; marginal zone; large diffuse b-cell lymphoma

3rd priority - - lung (nsclc, sclc) , prostate, ovarian

nsclc in 2nd line- - planned 05 trials- - (i) V single agent, (ii) V + alimta, (iii) V + egfr inhibitors, (iv) V + taxotere at different dose and schedule than 048 trial

nsclc in front line - - will make decision to go forward based on current SWOG trial(V+ gemcitabine + carboplatin) and also based on single agent investigator-initiated trial that is currently enrolling

also, will initiate BAC trial and adenocarcinoma with BAC-like features trial; these two groups represent 20% of nsclc patients

sclc- - studies led by investigators in both single agent and combo

prostate - - p 1 / 2 V + taxotere ongoing

ovarian - - single agent is enrolling with Gynecologic Oncology Group

I - - protect trial supports early upstream use prior to cath lab; clear platelets trial demonstrates that the addition of I achieves platelet inhibition and a lower incidence of heart muscle death; early acs trial ongoing; crusade quality initiative ongoing

518 - - ash data; single agent activity in aml

8054 - - advanced into development candidate status

2704 - - p 1 /2 MAD ongoing; has seen psa declines and clinical partial remissions

1202 - - expanded p 2a to include additional dose group

3897 - - p1 MAD ongoing; favorable safety profile and pk data

3. goals and objectives - - mark levin

drew comparison(without naming by name) to amgn, dna , and , I think, bgen, over past 25 years; they used 3 different routes to success; mlnm will find its own route

claimed that mlnm will have strongest r&d engine at year 12( expected year of mlnm profitability) than any of the above 3 companies

V 05 objective - - to be included in compendia listing in mantel cell, and potentially follicular, marginal zone and front line mm

2704 - - prostate and other solid tumors; planned to advance pivotal p2/ p3 in next 12-24 months

518 - - preclinical activity in glioblastoma

8054 - - p1 05 solid tumors

1202 - - p 2 ra trial ongoing; p2 in ms in 1st ½ 05; p2 in scleroderma and secondary atherosclerosis over next 12-24 months

3897 - - finalizing p1 trial; could move forward in ra, ms or psoriasis over next 12-24 months

3701 - - p 1 in 05

at least one revenue-generating strategic alliance that accesses ex US markets and reduces expenses/risks; will pursue in-licenses and acquisitions

will benchmark performance against industry leadership

4. q & a

(i) when V + rituxan data released? - - interim analysis at asco

(ii) what is the opportunity in mantel cell and follicular vis-à-vis current standard of care? - - re: mantel cell, beyond front line, physicians not satisfied with options; physicians have reacted positively to response rates; V will be major player in relapsed refractory mantel cell as soon as medicare reimbursement is achieved; local carriers are reviewing, as well as compendia- - re: follicular, physicians excited about response rates; if see favorable activity in combo p 2 with rituxan, V could achieve major share in relapsed follicular; investigating opportunity in investigator initiated trials using V upfront with RCHOP and RCVP; follicular offers major upside opportunity

(iii) update on I inventory? - - moving distribution from sgp to mlnm; it’s lower than in former years; feels comfortable with inventory levels

(iv) off-label use of V in front line mm, follicular, mantel cell, nsclc? - - 20-30% share 2nd line mm; 2-4% front line mm; nominal usage mantle cell and follicular; anecdotal usage nsclc

(v) why was there an increase in sga expenses in 4 q? - - continue to build commercial infrastructure

(vi) if 2704 may not advance to pivotal trial for 24 months, are you planning another trial before pivotal one? - - not necessarily; could move to pivotal directly; also, it’s complex to manufacture product

(vii) V launch in EU? - -contact jnj for sales data; jnj is aggressively pursuing registration in EU and ROW

(viii) V data at asco? - - mm- - subset apex; update front line studies; nhl - - interim analysis in mantel cell and in rituxan combo; investigator initiated- - nhl; nsclc - - 048 with and without taxotere; will also present at other conferences later in year , e.g. Europe, front line nsclc combo data with gemcitabine and carboplatin

5. impressions

the analyst community seemed to be largely uninterested or asleep; no questions on ken bate replacement or ucb deal; of course, the highlight of the call was levin’s comparison of mlnm’s progress to that of amgn,dna and bgen; he's certainly had a consistent goal; either he’s in space or the market is; I guess time will tell

sales