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Hope to see your spreadsheet again when you get time to update it. I enjoy looking at the projections.
Not sure if you are rounding or using the same share count, I came up with 3.28
$933,656.00 / 28,455,447
SMID:
I am quite happy with the results for the year. I agree with this market probably don't get much movement. I think SMID has been getting a bad rap for several reasons:
1-Seen as a construction play
2-Poor management/execution
3-Past inconsistent results
As a shareholder I obviously do not agree with these reasons (at least not completely).
1) It is worth noting that the the company did quite well for the year with Slenderwall (used in construction) down significantly from 2006. Soundwall (highway wall barriers) were up rather significantly this shows some of the benefits of their wide diversification.
2) If we judge them on just 2007 and consider they are a microcap I think they executed adequately. And much better then prior years. I think there is plenty of opportunity to improve (better bidding/estimating, margin improvement, a few other areas too). They did manage to avoid a big blotch as seemed to have happened once or twice each year for several years so hopefully that is a good sign.
3) This year they were very consistent. I am hopeful that we can take this as a good sign to come.
Going forward I think things look MUCH better:
1) The backlog of 15.7 is actually 17.1 if you count the 1.4 mil of letter of intent. Plus the regular 7 mil or so in repeat business means we are up to 25 mil (if all the backlog gets done in '08) and I'm sure there will be more orders though I'ld suspect some of the backlog may carry into '09
2) January '09 there will be an inauguration and we have had the barrier rental for this for 20-30 years and it has huge margins! (I keep trying to press on management to try to get more national barrier rental work).
3) The licensing and royalty revenue had a nice increase from '06 growth here goes almost completely to the bottom line if they can continue to grow this it offers a lot of EPS upside.
4) They took a hit for high fuel. I know everyone thinks prices are going to the moon but hopefully SMID can adjust there bidding accordingly and if they stabilize or go down I think it'd really help us.
Amicus had said they were doing some preclinical work looking at the possibility of administering their chaperone with ERT (I don't recall which of the three but think either in Fabry or Gaucher). While it would open up a very interesting opportunity this doesn't make a lot of sense to me as wouldn't this imply the replaced enzyme also has the mutation?
The Shire time line may not have changed my comment was from when TKT was a standalone company and they were looking at possible commericialization in 2008 here is a PR after their Phase I/II.
http://phx.corporate-ir.net/phoenix.zhtml?c=95926&p=irol-newsArticle&ID=698247&highlight
I think initially they had hoped to get approval based on just that one trial (Cerezyme may have needed just 1 trial to go from Ceredase)
FYI RE the zacks piece and LSD's in general (more so Gaucher)
#msg-28479668
Do you have an updated timeline for Protalix?
I don't think much of Zavesca its sales and label are not very strong, though I don't have your background to comment from a scientific standpoint. I had seen side effects I believe due to its non-selective nature where quite high.
I was looking at some of my old TKT stuff and I don't know if Shire had some setbacks but their time-line for GAGCB is a lot longer then what TKT had talked about.
For the poster who asked the Zacks blurb on Amicus I don't think much of Zacks reports. I saw an early one and will give them credit for having some detail and industry comp's, but basically they pulled a bunch of stuff from their filings and/or presentation. The actual analysis seemed lacking IMO. I am still quite long Amicus and am more curious at what some of the Oral Small molecules do rather then the ERT's. A fund has been really supporting the price the past few months (not there is much volume).
Abstract of ATS presentation of Shionogi Phase III Pirfenidone study.
[2:15 pm] A Phase III, Double-Blind, Placebo-Controlled Clinical Trial of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis in Japan, [Publication Page: A768]
T. Ogura, M.D., M. Ebina, M.D., H. Taniguchi, M.D., A. Azuma, M.D., M. Suga, M.D., Y. Taguchi, M.D., H. Takahashi, M.D., K. Nakata, M.D., A. Sato, M.D., T. Nukiwa, M.D., S. Kudoh, M.D., Yokohama, Japan
Background: To confirm encouraging results of the previous study of Pirfenidone (PFD), an anti-inflammatory and antifibrotic compound, in patients with idiopathic pulmonary fibrosis (IPF) in Japan (Am J Respir Crit Care Med, 171, 1040-47, 2005), that PFD might be effective in retarding progression of IPF and stabilizing pulmonary function, we conducted a double-blind, placebo-controlled, multicenter clinical trial of PFD in patients with IPF. Study design: A total of 275 patients were randomly assigned to high dose (1800 mg/day) of PFD group (H), low dose (1200 mg/day) of PFD group (L), and the placebo group (P) (H: L: P = 2: 1: 2). The primary endpoint was the change in vital capacity (VC), and a key secondary endpoint was the progression-free survival (PFS) defined as a period without an event of death or more than 10% decrease in VC. Results: Of 275 patients, 267 were included in the full analysis set (108 assigned to Group H, 55 to Group L, and 104 to Group P). PFD significantly affected the change in VC; at week 52, the difference in the adjusted mean change in VC from baseline between Group H and P was 0.07 liter (p=0.0416). PFD significantly affected the secondary endpoint of PFS: the difference between Group H and P was statistically significant (p=0.0280, Log-rank test). The most common adverse events reported in patients treated with PFD were photosensitivity in the skin and appetite loss. No significant difference in the serious adverse events was noted among three groups. Conclusion: The current study demonstrated that PFD therapy stabilized lung function and improved PFS in patients with IPF. With the safety and tolerability established, we conclude that PFD therapy is useful for treating patients with IPF. This abstract is funded by none.
Session Info: [**] Mini-Symposium, [C95] INTERSTITIAL LUNG DISEASE: EVALUATIONAL TREATMENT
Day/Date: Tuesday, May 20, 2008
Session Time: 1:30 PM - 4:15 PM
Presentation Time: 2:15 PM
Room: Room 717A-B (South Building, Level 700), Metro Toronto Convention Centre
Thanks for the link and private reply of Adam's update.
I guess that is his way of saying I was hasty in my judgment :)
There have been a number of misleading remarks and/or taunts by him on 191 (not dosed in humans, where is the data, safety issues, 3x day non starter, etc.) and in my opinion his overly bullish stance on Vertex may be part of the reason. Perhaps his history with Harkonen may be a factor as well.
Do you by chance have a link to this story? I can't find it under Adam's Articles. TIA
My only point was if one is to believe Vertex Boceprevir is a very inferior Protease Inhibitor. In my opinion as a potential drug I would have Boceprevir ahead of 191 but if things play out how Vertex was implying Boceprevir may be a commercial flop.
If you follow Adam's posts I think an objective person can see he is clearly bullish vertex and anti-Intermune. He backed off a bit on Vertex but I guess he still has something against 191. If you have search capability (I don't) you may want to see one of his past articles criticizing InterMune's 191 program and my reply's to some of his misleading comments.
And one more thing as to Adam's misleading remarks in this article he clearly doesn't read a PR. InterMune additionally reported that, based on a preliminary review of the available and still blinded clinical data from the four completed cohorts of the Phase 1b study, ITMN-191 was safe and well-tolerated. Since Intermune has stated they don't intend to treat HCV patients with 191 only(Pegasys and Copegasys will be part of the treatment regimine) Adam harping about monotherapy is not too real world and is nothing more then a red herring at this point. And his rant about a better then 4.4 well keep in mind the dosing to get that is 5-6x higher then 191 tested doses.
You can get rid of the link. Doesn't seem like there is much interest in InterMune here and have several time constraints of late.
On a Vertex call (my memory is not that good but I believe it was at the SIG conference) they pointed out some reasons why they believed Boceprevir results were cherry picked (my words) because of the way they prescreened.
Sorry I may not have caught the whole thread of what was being said and the exact intent of the question. I have only been skimming the board of late. TO me the important aspect was it was placebo controlled and thus the data is more robust. From the remarks today and the Q4 call, I would suspect they did not have access to all the data in real-time.
Today's call (about 7:45 in) they talk about the preliminary review of the still blinded data.
On Q4 call (I know you don't like seeking alpha transcripts the audio should still be available)
http://seekingalpha.com/article/63963-intermune-inc-q4-2007-earnings-call-transcript?source=side_bar_transcripts
"...what I mean by that is, of course, as any trail is ongoing, should there be concerning signals -- I mean we are watching it very closely in a blinded fashioned, we continue not to see anything there. But we remain blinded to the treatment assignment of all cohorts, and we don't have any data from cohort three other than just knowing that there is not a signal that's crossed up in the day-to-day monitoring of those patients."
As far as QD dosing there was one company with a Protease being tested at that dosing so I was happy to see 191 had that potential should it become an important factor. I am more excited about a combo pill of a protease and a polymerase I recall Intermune being asked about that some time ago (vague response). I'll be listening more closely to Pharmasset calls to see if they talk about any new formulations being explored.
FYI the ITMN-191 1B trial was placebo-controlled
http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle&ID=1055713&highlight=
Initial reaction the news release offers may potential avenues going forward. DIdn't get to hear all of the call yet but did hear about combining small molecules and possible coformulations. I See Pharmaset is up a fair amount today, if R7128&191 are combined safely Roche's position in HCV would be hard to match.
The past comments about low dose have an added clarity now that they are taking about QD potential
Did they talk at either of the panel sessions on HCV? I tried hearing the archive and it said it didn't start but thought it was scheduled for the 5th. InterMune's presentation Dr. Porter mentioned being at that talk.
http://www.wsw.com/webcast/sig7/session9/ is the one on HCV if you know of another link that works I'ld appreciate it.
Thanks in advance.
SMID:
nelson1234, Where did you hear about them not getting the Republic convention? Any word on the Democratic one? TIA. I think with them being further away it would have been through a licensee and not as lucrative anyway.
bigpike, Where did you hear about the 3rd shift? I had asked specifically a while back and got the impression a third shift was extremely unlikely at the Midland plant. TIA
Mike, good to see you're on another company I own. I don't know that I would put smid in the same category as some of the others. Your time frame may not be the same as mine (I've had it for some time and likely will hold for quite a while) but Q1 '09 should good a big boost from the inaguration. I wish they would try to do a lot more in the rental and licensing!
Going by memory (don't have good access to dig things up) but the one CFO was an interim I believe it was the controller filling in until a new CFO could be found. Don't want people to think he resigned or was let go. At the annual meeting the CFO leaving was talked about and it was pretty clear the controller was an interim and a search was on for a new CFO (at least in my mind). Can't blame one for getting more concerned when one CFO goes (I certainly became so) but the post about the last one using SMID as a temp to a better job and mgm not being able to read him right as very plausible.
Just a guess based on the Array compound, I'ld say AstraZeneca it not some other company developing a Mek inhibitor I believe Arqule is another. OK I guess I only get one guess :)
This is from the most recent filing. You can find similar (if not exact) wording going back to various 10-K's so nothing has changed significantly.
"Often more than 100 days is required to collect initial payment from insurance carriers and considerably longer from many attorney, personal injury and worker's compensation cases. Such delayed payment impacts the Company's cash flow and can slow its growth."
thanks for posting the link didn't see it.
One problem I have with it is he is misleading about the diluted share count. First, when a company is not profitable the basic=diluted. Second, I am not an accountant so perhaps someone with a better understanding can verify this, I believe as the stock goes up the the options that were out of the money now become dilutive they were always there just not calculated in diluted since they were above the current price. Third and most important, he neglects to mention the offering that got things started in growing orders (rather small in comparison to the tremendous growth we have gotten).
Its interesting the writer notes he doesn't own (though he indicates he would if he had the money).
At Friday's closing price, SUPG was priced at twice cash value at $2.8/share. It’s acting as if the ongoing EORTC 06011 has already failed.
I haven't looked at SUPG in quite a while but it seems to me that selling at 2x cash is not out-of-the-ordinary lately. I could probably come up with a dozen off the top of my head (unfortunately I own a few that have dropped to better then that). A number with Phase 3's too. I believe rkrw recently posted a bunch selling at/near cash [though buyer be ware on some].
At first I couldn't tell if they said billion or [multi-?]billion. Thanks for posting the transcript! I like to listen to calls and refer to the transcripts when possible.
The main significance of a decision upholding the lower court will be that the 180-day H-W exclusivity clock finally starts ticking.
I have heard Momenta say this on a couple of occasions. If they don't receive FDA approval though, challenge when the 180 day exclusivity begins or is that pretty cut-and-dry? I remember hearing Craig Wheeler saying another avenue would be to try and have the 180-day waiting period waived if a competitors FDA approval is futile. Another possibility was negotiating with whomever would get the 180-day.
Thanks for the through reply!
IJ,
Would you care to handicap the possible outcomes? Do you know if the court decision is upheld would this be the last avenue of appeal for Sanofi? If there is another trial are we talk a year or so of a set back? Thanks in advance!
I remember a conference call a couple years ago where a caller indicated a friend or family member took the drug and was doing great (sorry don't recall the company but I believe it was a phase 1 trial). I give the company credit they didn't cut him off but immediately indicated they were not a party to the call and the information should not be taken as something the company agrees with.
I believe non-institutional investors should get the same opportunities as larger holders and analysts but unfortunately some are making it justifiable for companies to screen.
I think the question was not asked properly and that generated the laughing of course you look for as much as you can get. I believe if it was asked are you looking for more up-front or backended or someone to pickup all development costs, etc. I think Craig Wheeler answered it well (after the laughing) in terms of looking for a big partner.
Maybe someone can correct me if I am unduly optimistic. I realize Teva does not disclose much information on their application/review, though we were not the first to file if we take Craig Wheeler at his word and their is a chance to get action on this by year end, if Teva had the same time line wouldn't they have been approved by now? Thus either Teva can't meet the FDA demands and likely others can't as well or perhaps the bar is too high for everyone Momenta included (obviously I am hopeful of the former).
For the record while I'ld like to see the company partner M118 sooner rather then later i didn't get the impression it was for certain as others may have. There was a question about how the company could end up with two years of cash and Mr. Shea mentioned a few possibilities one of which was M118 partnership. He did not say so but I got the impression that issuing debt/equity is not out of the question. If we do get lucky and M-Enoxaparin is approved, the patent case is won and no one else comes to market perhaps Momenta would delay the partnering. Another possibility is perhaps another Sandoz like collaboration.
Appreciate the added info.
Dew, do you think Momenta's claims to be able to characterize complex sugars could give them an advantage over other Biosimilars companies/technologies? Or would legislations likely make any characterization advantage moot?
I have not seen their technology described in detail (it would probably be above my level of comprehension) but I thought if it is as true as billed and the FDA believes it perhaps a cautious FDA would allow a quicker path to approval for their products while other Biosimilars would require some sort of clinical trial.
I remember one of Craig Wheeler's first calls he said he didn't really believe it before he joined and went there (I believe when interviewing) and saw for himself.
Momenta.
Craig Wheeler, Q4 2007 Earnings Call opening remarks I believe. That seemed too easy :)
Andy's too honorable to just walk away to avoid the media pressure.
He has about 16 million reasons not to walk away. I would say honorable would be to decline that or do something honorable with it.
Being a part of # 27 is strong motivation.
Nothing personal against Andy but I hope he doesn't pitch in any more playoff games... I am a fan of the all-time post season victories leader and Andy is a close second :)
Part of the Q&A was hard to hear or was it where I got the webcast from, http://www.fulldisclosure.com/?
OT:
OK thanks for the explanation. Next time you make a bet make it for drinking a cup of Potato juice then you can tell us which is better (or least worst). If you suddenly feel your stomach/reflux improve be curious to know that too :)
OT: Just curious about why your eating the raw potato (sorry i didn't notice the post your referring to). Heard of drinking the juice to help stomach/reflux problems.
Problem?
The stock is only $3.00 (low $2's before today). Yes .23/Q going forward may not be the norm and they did announce a big order but to speak of it as a problem. Even if they make half of that going forward the PE is 6-7. If I'm not mistaken this was to validate a specific engine and there could be the opportunity to get follow-on business (going by memory so please check yourself).
Then one day we could wake up and hear they have come to an agreement with the NJ Wildlife or whomever is in charge and a portion of their land is no longer protected if even half of that is allowed we are looking at 6 million and lets see there are 1.36 million shares outstanding so your looking at a one time pay day of 4.4 (I know you could say it is not worth that today or it'll never happen or ... but it could be that we could be able to monetize all of it too.)
http://www.sec.gov/Archives/edgar/data/28561/000002856105000014/k8july2505.txt
Oh and btw management previously turned down a $5/share buyout offer.
http://www.sec.gov/Archives/edgar/data/28561/000002856102000014/resp8k.txt
If you are looking to get shares on the cheap I'ld say the float makes it hard. If you are looking for spots OK every company has some and you can find if you look but I think Dewey is pretty cheap here only wish I had gotten more (I generally don't by stocks on runups).
I don't have as much to go by as other companies CEO's that I own, however from the quarterly calls and few presentations that I've heard Craig Wheeler I've been pleased and he appears to be investor friendly not just in his presentations but things such as a required stock ownership plan that I believe he put in place soon after becoming CEO.
In the press conference congress said they only had the meeting because Clemens requested it. Considering how he came off he is not getting good advice from his counsel!
DEWY:
Just had a great Earnings quarter. They also have a hidden asset worth 5+/share if they can get some relief from the NJ government. I only own a little (good luck trying to get more then a little!)
Haven't listened/watched everything but I wonder if they gave Clemens an out if he would bite. For example... "Is it possible one or more of those B-12/lidocaine shots was not in fact what you thought?"
SPPI:
. I assume they pay a hefty royalty to Merck Eprova
Why would you think that? I would think it would be small and after some time [ok that may not be near term] we also have the ability to seek a cheaper manufacturer
http://www.sec.gov/Archives/edgar/data/831547/000119312506121176/d8k.htm
The problem I see is Spectrum does not appear to be preparing to market or partner the product and time soon so they'll likely have it sit and file for colorectal. Hopefully if it is approved sarcoma Raj has a good plan and/or it becomes easier to partner.