well, this is what i gleaned form tape; btw, did the CC end in the middle of a sentence? tape malfunction?
1.) Production upto 3Q levels by Jan, <didn't say when in Jan> They are also working on increasing yields.
2.) upon MCA approval, which is expected in 1Q98, they will use new facility to produce product. 150,000 units have already been shipped to ASTRA.
the 25% decline reported takes into account this 150,000 units. The earnings from these 150,000 units will be booked in 4Q97.
3.) They anticipate FDA approval of new plant in 2Q98.
4.) they expect to have additional international launches in 1Q98.
they expect to ship an additional 200,000 units in 1Q98 overseas.
5.) It is a GMP requirement to due the maintenance, hence the shutdown, They had expected to have new plant approved prior to having to due maintenance; but because of unforeseen delays, AND unforeseen decrease in yields just discovered, they are closing down to do maintenance. They had hoped to due maintenance after new plant approval so shutdown would be transparent to marketplace.
6.) 25% production shortfall occurred in Nov, and 1st week of Dec.,
7.) Q: Any problems with new facility. Ans.: NONE
final stages, just normal delays. expect 2Q approval instead of 1Q by FDA.
8.) Demand: Absolutely NO decrease in demand.
9.)10,000 units per week in new scripts
10.) inventory in channel is 45 days, up from 30 days; this is not due to decrease in demand, but rather from a higher than usual production from Aug to Oct.
They are shipping everything they produce; VVUS carries NO inventory.
11.) this 45 inventory in the channel is NOT adequate with ad campaign coming.
12.) Wholesalers are still ordering into backorders.
13.) 3 shifts a day; 6 days a week in production.
14.) New Plant, upon completion, 1 production line to start; hoping to have 4 running by end of 2Q; THE NEW FACILITY IS CAPABLE OF RUNNING UPTO 8 PRODUCTION LINES; the will evaluate demand in first half of 98, and condider expanding lines.
15.) in the 3Q of 1997, 800,000 units per month produced, currently producing 600,000 units <conservatively> because of transition.
16.) With MCA approval in 1Q98 they will be able to use new plant to satisfy international demand.
17.) buyback: 400,000 out of 2 million goal purchased; "we will diclose any additional purchases made when we nornally would, at end of Q)
18.) if yields low, how did inventory channel go from 30 days to 45 days, indicates decrease in demand; answer: production was higher then 800k units between Aug and Oct.
19.) PFE and VIAGRA
PFE has not released much data concerning Viagra; finds it "amazing for this late stage in development"
PFE------> "enhancement" product
paraphrased: very difficult to get a local response in a flaccid penis from a systemic drug; because there is low blood flow in flaccid penis, realtive to an "un-flaccid" one. difficult to get drug to the local site, particularly in flaccid penis.
per PFE: "No peer review article to date"
" no regulatory review completed yet"
that about covers my recollection/notes.
Mike |
