RE-CAP JAN 15 VIVUS EPS CONF.CALL.& RECENT NEWS
( this Review spans the last 15 days starting with the most recent events .Post has been reformated, upgraded.)
( This also is a continuous re-cap; just click on previous psot numbers to get older posts.)
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This week:
The Jan 30th VIVUS OPEN HOUSE meeting
Message 3305417
Dr BOND will report tonite
Message 3307504
Pebble Beach National Pro-Am Golf Site: :-) pgatour.com
and Message 3300071
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From last week
REVIEW OF PAPERS REPORTING NBC VIVUS AD SNAFU ( gave big jolt up to Vivus ).
Message 3229615
Tax breaks aid Vivus' incursion into Ireland -- The Business Journal of San Jose
amcity.com
Vivus announces direct to consumer campaign:
Message 3209717
****VIVUS JAN 15 EARNINGS CONFERENCE CALL RECAP*********
First the negatives:
-Approval by the FDA will be asked by mid Feb and then we have to wait. It may be Q2 before it is
inspected and approved.
-Out of 1.8 mill units shipped quarterly, more than the previous Q4 150000 units are going to be shipped to Astra, at lower margins, per previous agreement. (This is something they HAVE to do; when they signed with ASTRA 1 year ago I think that they never imagined it would take this long for FDA to approve).
-The above will lower margins.
-Greater advertising expenses.
-The decrease of Quarterly unit production from 2 mills to 1.8, due to the fact that some manpower and equipment had to be moved to new facility.
-The slight decreases in demand (which I interpret as backlog decrease rather than net decrease) because of lack of advertising and lack of product availability initially. This is relative however because refills are going up. So that in absolute numbers they are still running full steam; see in next section on positives).
The positives:
First Mr. Wilson CEO SOUNDED MUCH MORE POSITIVE AND AGRESSIVE!!!! AND FORWARD LOOKING!!.There was NO DEFENSIVE or UNCERTAIN undertones to his voice at all that I could note.
-He said at 130 mill $ sales in 97 this is one of the most successful Urology product launch ever. And this is with minimal advertising.
-They will concentrate in their GIANT Ad campaign to make this the No1
and 1st prescribed drug in ED!
-Giant Ad campaign to start Jan 31st with the AT&T Pebble Beach National Pro- Am Golf tournament
Then ads in Newsweek Time, magazines, ABC, CBS, Wall Street Journal and other major magazines and TVs. etc.
-Submit all paperwork for new factory to FDA by Feb 15 and ask them to inspect it and approve it.
-They have 75 sales reps, largest in Urology.
-The manufacturing problems in their new plant have been COMPLETELY
corrected.
-They settled their (hopefully) last lawsuit with a previous consultant, and did so to avoid prolonged litigation costs and to avoid going in front of a jury (same old reason.). The lawsuit was due apparently to
a small procedural error that Vivus committed early on in their filing of the patent but which ended up costing them a lot. NOTE: without the settlement they would have made 33-cents/ share.
-They have ~ 93 mill in cash:
Message 3196484
-They have been accepted by all the Urologic and medical community
well and Managed care so that 70% of prescriptions are now covered compared to 60% in Q2-3.
-They have mailed 300,000 packages to primary care MDs across the nation, containing a sample of the MUSE system and one packet dose with aan instructional video tape about how to administer it.
-They greatly stengthened management by adding to Marketing Director
the previous VP of Sales of Eli Lilly.
Probably one of the MOST EXCITING items is that
-THEY ARE PRODUCING RIGHT N O W in the NEW PLANT, s i g n i f i c a n t amounts of product which they are STOCKPILING and which will be shipped IMMEDIATELY as soon as United Kingdom MCA approval comes.
-" As for MCA plant approval, Leland did say that all data requested by the MCA to allow a FINAL APPROVAL would be submitted by mid Feb. But this date estimate IMO was a worst case scenario. VVUS could have all required data to the MCA by month end with an approval late FEB.
-Also that " product at risk " will be available to be ROCKETED OUT THE DOOR, first to UK and then US as soon as approval is obtained. This could SIGNIFICANTLY IMPACT Q1 revenues if it is shipped in March to UK if MCA approves in March. Look for Q3 EPS in the 60-70-cents/share aerea, a Q 4 of .80 with a 1998 EPS of at least $ 2.
Message 3197245
= MrWilson's EXACT quote (I wrote that down; everything else I am writing is out the top of my head):
" You will see SIGNIFICANTLY INCREASED product NOT TOO FAR
Down the road ".
-They aim to be the LEADER in ED, (not 2nd to PFE, my quote, gg).
He answered questions on effectiveness and demand:
-Demand and acceptance have increased steadily, according to REFILL
Prescription rate, which has steadily gone up, and as of Jan 3, a slow period, they are up 43% from before.
-The Asensio quoted Italian study, was not published and peer reviewed, was only a letter in the Lancet, was done on the worst ED patients, they were ALL on the needle; quality of these studies was low compared to the NEJM study and their end point was not done according to established Urologic literature methods, their patients were not educated in the use of MUSE as in the NEJM study. Same would apply to the J of Urology study (less educational quality standards, but even so, in their needle patients the response was 37%, better than the 5% Italian: how do you explain that?)
-The Lahey Clinic, world's most renowned diabetes center has a 50% success rate in 300 patients, same as the NEJM classic study with a 45% success rate. Lahey clinic has a much more sophisticated patient education program because they deal with diabetes.
On the issue of shares sold by insiders, Wilson said that they HAVE
To sell during fixed windows. That even though they sold 150000 shares in 1997, they also bought 130000.
A lot was options that they exercised.
As far as " share rebuying ", " and why not buy now that it's cheap ", he said that their policy is to answer that question the following quarter from the rebuy, i.e. Q2 forQ1 buys. As far as Q4 is concerned they bought ~ 300000 shares (~ $ 7.5 mill), so that they can buy 1.7 mill more that were authorized. IMHO, look for a big buy in Q1.
Somebody asked about rumors of Viagra being asked for more study data by the FDA: Wilson simply stated that he would not comment to rumors.
Also he did not at this cc mention of adding Viagra to MUSE like he did last time. He did not give aid and comfort to the competition guess he probably feels that Viagra must first prove itself in the medical literature and FDA before piggybacking it unto MUSE.He was also generous when the usual Zonagen question was asked: no comment (i.e. he was generous in not kicking Zonagen in the gutter where it is laying now.)
In my humble opinion this was a very good cc. It answered a lot of questions. Company management came out forcefully to dispel any rumors about....gg ? Vivus demise?
In Wilson's words,
" While we face short term challenges...we are ready to shoot out the door with 12 cylinders, very soon ".
All in my opinion only.
TA
MISCELLANEOUS MEDICAL/INVESTMENT INFO FOR NEW VIVUS INVESTORS;
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.\\ ~ ~ //
.( @ @ )
._oOOo_\_^__oOOo__
It's ok, VVUS, we all gotta be 40 someday.
Yes, and even more.
Frostman Oct 3 1997 : #531
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Vivus intraday chart
investor.msn.com./charts/charting.asp?C2=4&Symbol=vvus
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Medical Articles on Vivus/Muse:
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1 )Alprostadil/Muse/Vivus
Treatment of men with erectile dysfunction with transurethral
alprostadil Padma Nathan H, Hellstrom WJG, Kuiser FE, Labasky, Tom
Lue,Nolten,Norwood,Peterson, Shabsigh,Tam, V.Place,Gesudheit,and 90
other collaborators, for the MUSE study group.
( New England Journal of Medicine, Jan. 1997; 336: 1-7 )
Alprostadil was delivered transurethrally in a double -blind
placebo-controlled study of 1511 men, 27 to 88 years of ag, who had
CHRONIC erectile dysfunction.The men were first tested in the clinic
with up to four doses of the drug (125,250,500,and 1000 mcg); those who
had sufficient responseswere randomly assigned to treatment with either
the effective dose of Alprostadil or placebo for three months at home.
RESULTS ; During in- clinic testing, 996 men ( 65.9% ) had erections
sufficient for intercourse.Of these men, 961 reported the results of at
least one home treatment;. Of these996 men ( 65.9 % )had a erectile
response satisfactory for intercourse
and were subsequently entered into a placebo controlled double-blind
trial: 461 received Alprostadil and 500 received placebo.Of the 461
receiving Alprostadil 299 had intercourse at least once( 64.9 % ), as
compared to 93 of the 500 who received placebo ( 18.6 %, p<0.001 ) ). On
average 7 of 10 men who received Alprostadil were followed by
intercourse in men responsive to treatment.
The efficacy of Alprostadil was similar regardless of age or the cause
of erectile dysfunction, including vascular disease, diabetes, surgery
and trauma ( p<0.001 for all comparisons with placebo ) .
10.8% of patients suffered from penile pain but this rarely resulted in
discontinuing treatment. Hypotension occurred in the clinic in 3.3 % of
men receiving Alprostadil.Hypotension- related symptoms were uncommon at
home.No men had priapism or penile fibrosis.
( from the Departments of Urology of:
Univ of Southern California;The Mayo Clinic ; Tulane Univ Med Center;St
Louis Univ;Univ of Utah;Univ of Calif; Peachwood Medical
Group,Clovis,Calif.,Univ of Wiconsin;Univ of Columbia,
Columbia-Presbyterian Hospital;)
( over 100 Urologists participated in the study and are listed in the
Apendix of the article).
This is an important paper with large numbers of patients in a well
organised study.
The response rates appear surprisingly good in patients with
vasculogenic impotence according to this study.
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2 )Alprostadil/Muse/Vivus after radical prostatectomy
pslgroup.com
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3 )Alprostadil/Muse/ Vivus in Diabetics, one of the largest causes of
impotence:
vivus.com
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4 )Another study on the excellent safety of intravenous ( in the
peripheral
vein by drip, and then by local intracavernous injections ) of
Alprostadil in the last, Oct 97 issue of ther Journal of
Urology,Vol158,1403-1497;
PHARMACOKINETICS OF PROSTAGLANDIN E1 AND IT'S MAINMETABOLITES AFTER
INTRACAVERNOUS INJECTION AND SHORT - TERM INFUSION OF PROSTAGLANDIN E1
IN PATIENTS WITH ERECTILE DYSFUNCTION:
BY Willi Cawelo,Horst Schweer, Bruno Dietrich, Hannsjofg WIlhelm,
Seyberth,Albrecht et al:
From the Univ of Marbufg, Ulm, Germany:
www3.techstocks.com
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| INVESTMENT UPDATE ON VIVUS |
===========================
Vivus chart ( Brian Malloy,post #514 ).
investor.msn.com./charts/charting.asp?C2=4&Symbol=vvus
- Options page for VVUS:
-From: Navigator One Reply #391
webservices.pcquote.com
- Check out Vvius 2nd opinion site;( Dr. Bond, post #207 ):
etrade.stkwtch.com
-Vivus patent by Gene Voss, MD.-
www4.techstocks.com
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VIVUS COMPETITION
=================
A )VIAGRA ( " THE PILL " ) by Pfizer
-published articles ( in peer reviewed journals ):
a) British Journal of Urology(1996)78, 257-261 this is the first clinical article .12 patients
Message 2703575
b) International Journal of Impotence Research (1996) 8, 47-52
Message 3209803
-Zebra compares MUSE to VIAGRA
Message 2817790
-phosphodiesterase ( PDE ) sideeffects ( in relation to upcoming? Approval of Viagra Sildenafil,also a
- -PDE ):
www3.techstocks.com
- www3.techstocks.com
-
B ) INVICORP ( by Senetek ), ( another needle; uses phentolamine and a so called " vasoactive peptide ". regardless, it is STILL the needle-----> pain, fibrosis, penile angulation and plaques, carrying this big shotgun in the bedroom will be a challenge in itself gg).
Message 2690453
C ) Harvard Scientific Liposomal sytem. ( Liposomal Delivery).
Message 3307182
Message 3305926
Message 3307956
D ) VASOMAX ( BY Zonagen )
This is generic phentolamine. No patent. Company facing multiple lawsuits for fraud.
Not a contender. For details please their extensive SI post.
Message 2757783
www3.techstocks.com
( PS If after you've read all of the above you are still confused, write to the Editorial Board and we'll see what we can do for you, gg, - no promises. ).
TA |
