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>>ISRG I would like to know what the legacy procedure growth is.
Lets say what is the procedure growth and sales of supplies and instrumentation of Davincis in hospitals that have had one installed and operational for at least 6 months this would strip out the new installs and would be a good metric of growth of procedures. <<
I don't have that data, but would suggest that a good metric of growth of procedures is ... growth of procedures.
60% yoy, >11% sequential.
micro
VRNM, Phyzme
>>You are wrong on 90% of your post. One is EU did not approve Phyzyme until last week.<<
Nope.
>>Monday, April 16, 2007
EU Commission Approves the Use of Liquid and Granulate Phyzyme XP in Pig and Poultry<<
http://www.thepigsite.com/swinenews/13978/eu-commission-approves-the-use-of-liquid-and-granulate-phyzyme-xp-in-pig-and-poultry
http://www.efeedlink.com/ShowDetail/fd169828-80e7-412b-a966-8ef29afffed9.html
As I suggested, the new approval simply involves a reformulation of the previously approved version of Phyzyme:
>>Following a request from the European Commission, the European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the safety and efficacy of Phyzyme XP 10000 TPT/ L (6-phytase; EC 3.1.3.26) as feed additive for chickens for fattening, laying hens, ducks for fattening, turkeys for fattening, piglets (weaned), pigs for fattening and sows.
The product is a reformulation of an existing product (Phyzyme XP 5000) approved for all of the above species and containing double the concentration of phytase. It is intended to provide the same feed concentrations of phytase as the previous product by a lower rate of incorporation.<<
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902224372.htm
What else do you think I said that was wrong?
Keep in mind that you asked for help, and I tried to help you ...
micro
ISRG 'bet'
>>OK—I’ll do that provided that you post from time to time about what’s going on at ISRG.<<
Plus procedure growth has to be at least 50% for 2009?
Well, given that there is usually hardly any news from ISRG between earnings releases, the first part doesn't sound too difficult ...
micro
>>So you want to rescind the bet? That’s no problem<<
Jeez. Given that you were originally guessing that procedure growth would be negative and my estimate is 50% for the year, it hardly seems fair that I lose anything if the number comes in at 49%.
I thought you were just going to give me the 3-month subscription if I was right - no bet.
YES! (I rescind!)
micro
Using NOLs after a change of ownership.
Impressive. One last clarification, please. If company A buys company B, then company A can use company B's NOLs at the allowed rate as long as it (company A after the acquisition) is profitable, right? I.e. it is not necessary that company B, to the extent it can be defined after the transaction, be profitable.
micro
Recession, etc.
>>I'm not sure the "recession and our wall street problems go hand in hand.
Secondly, Obama's huge deficit spending goes well out into the future, a future that he's predicting 3% to 4% gdp growth.<<
Whatever. I simply find it annoying that many who were quiet or even supportive when the last administration was behaving immorally, incompetently, illogically and unscientifically for 8 years are suddenly so loud and critical because they don't like the way the new administration is trying to dig us out of the mess it inherited. Can we at least give these guys one year before we decide they are a bunch of socialistic morons spending the country into ruin?? They did win the election and they are doing pretty much what they said they would do, right? I think so ...
micro
ISRG - cluless
>>I think saying I am clueless because my opinion is different then yours is combative for no reason.<<
I did not call you and others "clueless" because of a disagreement in opinion. In your case it was because you used the I&A number - w/o the deferred revenue correction - to conclude (incorrectly) that there was no sequential procedure growth. As indicated, the company announced in the cc that there was sequential procedure growth, and it can be calculated to be approximately 11%.
Sorry I used the word "clueless". What I meant is that you were drawing hasty and incorrect conclusions w/o knowing much about the company. But to your credit, you did quality your statement by saying "maybe I am missing something".
micro
NOLs
Thanks, mouton!
>>If there an "ownership change," a loss corporation can only use its net operating loss carryforwards each year to the extent of the value of its equity multiplied by a rate published each month by the IRS that is based on tax-exempt interest rates. That rate is currently about 4.5%.<<
So if a company is acquired with a market cap of $100M and $1000M in NOLs (I am thinking of two companies which aren't that far away from those numbers), it would take minimum of $1000M/$4.5M = 222 years for those NOLs to be fully utilized. Is that right?
Seems strange. For example if the acquired company was testing a drug which later became a blockbuster ... I think the NOLs should be able to be used up as quickly as if the acquired company had remained an independent entity.
But I guess the 4.5% number is a lot easier to compute ...
micro
ISRG wager
>>I’ll bet you a 3-month iHub membership that they don’t grow full-year 2009 procedures by as much the 50% you expect. Ok?<<
Whoa! I don't owe you the cost of a 3 month iHub membership if they come in at 49%, do I??? Making such a bet certainly wasn't my intention!
micro
>>What do you guys think of Verenium (VRNM) they just won approval from the EU on enzymes.<<
Phyzyme was approved in the EU two years ago. This must simply be a new version of that product.
Verenium's main thrust is not industrial and food-related enzymes, but cellulosic ethanol, which also relies on enzymes.
IMO the company's business strategy is completely flawed and has been for years. Verenium wishes to build out a fleet of ethanol manufacturing facilities around the country with BP, and therefore is competing in an area which is extremely capital intensive despite having almost no cash, a ton of debt and negative earnings. It is clear that BP isn't going to pay for everything, and with the debt overhang it is too late for Verenium to settle for royalties. Royalties are also probably no longer a possibility because 50% of the rights to the technology have already been signed over to BP, and if Verenium is unable to move forward with BP, it seems that BP can move forward alone.
Verenium is likely to get some financial assistance from the government, but it probably won't be enough and it will probably involve loans, not just grants. Eventually I believe Verenium will go BK or be acquired for pennies on the dollar or will barely stay afloat by diluting shareholders equity until it fits on the head of a pin. And I've been saying this, or something very close to this, since the share price was >$10. (It is now $0.54.)
Phyzyme has sold rather well, but not well enough to get Verenium out the hole it has dug for itself with its stupid business plan. My recommendation is to stay away from this company.
micro
NOL limits
>>As a general matter, the NOL limits are worth keeping in mind for those who think that a biotech with large NOLs and not much else has a valuable asset that can easily be monetized.<<
Would you be so kind as to review those limits - just the Cliff notes to the Cliff notes version?
micro
..Well, Georges deficits ran around 2% of our gdp, what word do we use for Obama's deficits that are running closer to 13% of gdp?<<
Surely you must be aware of the reason for the spending hike - which began at the tail-end of the previous administration and was a desperate attempt to bring what may be the worst recession in ~80 years under control ... a recession generated by deregulating everything to hell and letting thieves and swindlers free reign. You are aware of that, right?
>>We all called Bush stupid for his (what seemed) huge deficits. <<
That's not why, actually. It was because he wasn't very smart ...
micro
ISRG
>>You did? I could’ve sworn you used an array of assumptions to arrive at an estimate of 11.2% QoQ procedure growth. That’s not exactly what I would call proof.<<
I only used publicly available numbers and calculated the sequential procedure growth. What assumptions do you think I made??
>>why wouldn’t ISRG management simply disclose the actual figure?<<
For the nth time, management often reports on procedure growth, but generally they focus on annual and yoy numbers. That's the way they've done things for the past 9 years. Maybe they have started disclosing more information beginning in 1Q09. It is common for companies to disclose additional metrics beginning with a new year. We can see if they disclose the Q2 procedure number in July. But in any case, the Q4 procedure number was disclosed implicitly, and if you look back at my post where I calculated it, you will be able to verify that this is the case. I made no assumptions; I simply pointed out there were roundoff errors.
micro
>>ISRG could prove be an exception, of course, but I would be more than a trifle concerned if I were long.<<
I'm more than a trifle disappointed in you, Dew. I proved that the sequential procedure number growth was 11.2% ... which is 53.1% annualized. Recall that first you said you were willing to bet that that number was negative. Then you said it must be anemic.
I showed it was neither.
Your response is to say that longs should be "more than a trifle concerned"??
Okayyyyyyyyyy.
micro
HGS, Novozymes, albumin fusion
>>It’s unclear to me why HGSI still has rights to the albumin-fusion technology that is the subject of this revised license with Novozymes. I thought Teva had acquired the rights to such technology when it bought HGSI’s CoGenesys subsidiary in early 2008<<
It seems HGS only gave CoGenesys a non-exclusive license to the albumin-fusion tech.
>>Human Genome Sciences will grant CoGenesys exclusive rights to develop and commercialize biological products based on certain human genes discovered by HGS, and will grant CoGenesys a license to use its proprietary albumin-fusion technology to develop and commercialize certain albumin-fusion proteins for therapeutic use.<<
http://www.hgsi.com/latest/human-genome-sciences-announces-decision-to-spin-off-cogenesys-division-as-an-independent-co-2.html
micro
>>You could’ve sprung that quoted passage on me and won some serious money (like a 3-month iHub membership)<<
I'm impressed, Dew. I didn't realize you had such a highly developed sense of humor.
>>you have yet to furnish one good reason why ISRG reported the procedure count for 1Q09 and the procedure count for full-year 2008, but not the procedure count for 4Q08. What possible reason for such selective reporting can there be other than management's being embarrassed by anemic quarter-over-quarter growth? <<
They decided to provide an additional number (Q1 procedure number) that they don't usually give in order to give investors more information about the state of their business during these difficult economic times. And you get suspicious because they didn't give yet another number that you would like (Q4 procedure number). Big deal.
>>What possible reason for such selective reporting can there be other than management's being embarrassed by anemic quarter-over-quarter growth?<<
>>my suspicion is that ISRG’s business is showing signs of flatlining and management is going to great lengths to mask this from the investment community<<
Well you are wrong - and I can prove it.
From the Q1 cc:
>>The amount of instrument and accessory revenue we realized per procedure including initial stocking orders and adding back the deferred revenue of $2.1 million was approximately $1800 per procedure, down approximately $200 per procedure compared to the fourth quarter<<
There are two other numbers that we need to calculate the sequential procedure growth rate.
Q4 I&A revenue was $81.575M, and Q1 I&A revenue after adding back the $2.1M (obviously they are rounding off) in deferred revenue was $81.663M. The I&A numbers are in the SEC filings.
If we call the Q1 procedure number n1 and the Q4 procedure number n4, we have ...
n1*1800 = 81663000
n4*2000 = 81575000
Dividing, n1/n4 = 1.11231, i.e. sequential procedure number growth was 11.2% ... which is 53.1% annualized.
Of course there are some roundoff errors (e.g. 1800 might be 1820), so the true number could be a bit higher or lower.
>>I’ll bet you a 3-month iHub membership that they don’t grow full-year 2009 procedures by as much the 50% you expect. Ok?<<
I'd prefer something more useful ... like a t-shirt, but O.K. Dew. (I could probably get a 3-month trial membership for free, right?)
Cheers,
micro
>>ISRG - da Vinci systems
Suspension of guidance for systems revenue and instruments and accessories revenue, makes me cautious about the increased overall 2009 procedure growth guidance. Is it the just the stocking orders or other reasons? If there were also fewer procedures/system, it might get worse.<<
I guess there are just too many moving parts right now, and management would rather not give guidance than give guidance with a huge uncertainty. But they did give some guidance, in fact the most important guidance ...
>>Moving on to procedures, our procedure growth has been stronger than we previously expected. Procedures grew approximately 60% in the first quarter consistent with our procedure growth for all of 2008. As a result, we expect procedures to grow more than 40% this year compared with our previous forecast of 35% to 40%.<< (Q1 cc)
Their modus operandi is to give guidance for the year each quarter - and then raise that guidance the quarter after. So if my estimate of 50% procedure growth for 2009 is correct (which was obtained partly by looking at the individual high-volume procedures and how adoption for each has been growing), look for them to say something like "40% to 45%" during the Q2 call, "at least 45%" in the Q3 call and then report 50% in the Q4 call.
By the way, if you just use the annualized Q1 number of 4 x 45,500 procedures you come up with 34% growth for 2009 over 2008. So that's what you'd come up with if you pessimistically assumed no sequential growth from Q1 through the end of the year.
micro
>>But reporting the quarterly procedure count selectively, which is what ISRG evidently does, suggests to me that they do indeed have something to hide.<<
Again, Intuitive is not the sort of company which hides bad things; it is more likely to point out possible bad things which never occur (beyond what are typically seen in 10-Q risk factors).
But there is no reason you would or should believe me. The conservative nature of management is something that requires following the company seriously for at least a few years. (Which, by the way, is why I like to follow companies for a decade or more, even if they fail to meet my initial expectations. It gives me a significant advantage in interpreting information correctly.)
>>Based on the financial metrics that ISRG did report for 4Q08, I would be willing to bet money that the procedure count in 1Q09 was less than in 4Q08.<<
Alright, Dew. How much money would you like to bet?
>>First quarter revenues by product category are as follows: First quarter instrument and accessory revenue was $79.5 million, up 29% compared with $61.9 million for the first quarter of 2008, and down 3% compared with $81.6 million in the fourth quarter of 2008. The change compared with the first quarter of last year was driven by the 60% procedure growth partially offset by the revenue deferral of $2.1 million and lower instrument and accessory revenue per procedure. The change compared with the fourth quarter reflects increased procedure volume more than offset by the revenue deferral of $2.1 million and lower revenue per procedure.
The amount of instrument and accessory revenue we realized per procedure including initial stocking orders and adding back the deferred revenue of $2.1 million was approximately $1800 per procedure, down approximately $200 per procedure compared to the fourth quarter and down approximately $400 per procedure compared to last year.<< (Q1 cc)
I'm looking for about a 50% increase in procedure count (not I&A revenue) from 2008 to 2009. Do you want to guess the procedure count will be down from 2008? We can compare our predictions to reality in January 2010.
Regards,
micro
RR, PFS, RCC
>>Given that rcc median pfs times are on the order of 3 to 6 months I'd expect a fairly strong correlation between rr and pfs.<<
Nexavar had a ~2% RR in RCC but doubled PFS compared to placebo.
micro
>>Q4 is always the peak for system sales, but yes - of course hospital cap ex is down.<<
Before somebody jumps on me ... the exception to this rule was 2008. The hospital cap ex crunch was already hitting by Q4, so Q3 system sales exceeded Q4 system sales in 2008.
micro
>>If the procedure count is the metric of all metrics by which investors should be evaluating ISRG’s business, doesn’t it seem odd that this isn’t disclosed on a quarterly basis?<<
Intuitive has always discussed annual guidance and targets, rarely quarterly numbers beyond revenue, revenue breakdown and a few others. So this is not something new that they are hiding because their business is self-destructing and they want to hide that for another quarter or two. Quite the contrary. Intuitive has hardly ever given quarterly procedure numbers, but they did give the number for 1Q09. Nevertheless they do emphasize procedure count as a key metric and have for many years.
>>There should be no seasonal slowdown whatsoever in Q1, so it makes perfect sense to compare the 1Q09 procedure count to the 4Q08 procedure count.<<
I was talking about comparing I&A revenue, NOT the procedure count. Let me explain why it does not make perfect sense to compare the 1Q09 I&A revenue to the 4Q08 I&A revenue.
As I said in a previous post, da Vinci system sales tend to peak in Q4. (This is apparently due to the sales force wanting to make their quotas in order to get their huge bonuses - which depends on the number of systems sold by December 31 of each year. It also may depend on hospital administrators wanting to spend their cap ex budget before the end of the year and not have anything left which might reduce their following-year allocation.) With each system purchased by a hospital is an order for an inventory of instruments - typically several months worth, I think. That's why it doesn't make perfect sense to compare the 1Q09 I&A revenue to the 4Q08 I&A revenue - although you can certainly do it.
Comparing 1Q09 procedure count to 4Q08 procedure count would make perfect sense. I just don't know the 4Q08 procedure count.
I realize most companies tend to hide the bad and flaunt the good, but if you followed Intuitive for a decade you'd know that they are an unusually conservative company. They often guide to 'hits' which do not come to pass - an expected dip in gross margin due to a change in manufacturing or the introduction of a new da Vinci model, for example. So not having followed the company you are absolutely right to have quivering antennas and look for dirt under every rock. But as one who has followed the company since the IPO in the year 2000, I am here to tell you that Intuitive is the rare company which will lift up the rocks for you and show you the dirt and even tell you about potential dirt which doesn't materialize.
micro
>>ISRG - da Vinci systems sales:
4Q08: 85 WW (55 U.S. and 30 O-U.S.)
1Q09: 66 WW (44 U.S. and 22 O-U.S.)<<
Q4 is always the peak for system sales, but yes - of course hospital cap ex is down.
>>Think an important data are instrument revenue per system installed and believe these were slightly declining.<<
Yes, and I discussed why. It is because instruments used per procedure is down - see my previous post for the details. Obviously the instruments being used per procedure will not continue going down until they reach 0. This is a temporary trend. A few years ago, I&A revenue per procedure was going up. You are focusing on issues which are more noise than signal. The signal is 60% growth in adoption of the technology - as measured by procedures carried out.
Next year you will probably see hospitals' cap ex back to normal with them catching up on the da Vinci demand. They will also be restocking their instrument inventory. This will generate a revenue bump in the opposite direction for Intuitive.
And while some investors and analysts will go crazy when that happens, it will not affect the adoption of the technology, which is what really matters long term.
micro
Nexavar failure in melanoma
>>It doesn't seem that any of the vegf drugs have helped the skin cancers. Any reason?<<
Nexavar was originally theorized to work in melanoma because of blocking mutant BRAF, not because of antiangiogenesis. But for technical reasons, apparently that blockage didn't work in melanoma and that was known before the recent Phase 3 failure.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=36050090
That failure was also anticipated because a nearly identical Phase 3 trial with the exact same chemo combination already failed. The only difference was the line of therapy. I was surprised ECOG even bothered to continue the 2nd Phase 3 trial after the first failed. The 2nd Phase 3 trial was still at a very early stage at that time. A lot of first-line patients were 'burned' on an extreme longshot.
Of course their other options were probably longshots as well.
micro
ISRG
>>What was the quarter-over-quarter growth in procedures? I couldn’t find the 4Q08 procedure count in the prior threads on this board. T.i.a.<<
I'm not sure that number was disclosed. But here are a few others. 4Q08 procedures grew 61% yoy and 15% sequentially. During the full year 2008, procedures grew by 60% over 2007 - to approximately 136,000. Procedure growth was ~71% in 2007 (over 2006).
There are some modest seasonal effects in procedure numbers, so I still think yoy provides more information than sequential.
Before the Q1 earnings release and cc I was only expecting about 40% year over year procedure growth during 2009. That's why it was so bizarre to read posts here talking about how badly Intuitive is doing after they reported 60% procedure growth in Q1. In the number that counts the most - adoption rate of the technology - they had an absolutely blowout 2008 and 1Q09, and there are no signs of that hitting a wall anytime soon.
What is happening right now is that da Vinci prostatectomies are beginning to saturate, whereas hysterectomies and other GYN procedures (a much larger market) are still in the bottom part of the S curve. This year I'm estimating ~84K da Vinci prostectomies, ~65K hysterectomies and ~55K other procedures - for a total of ~50% yoy growth (adjusted after Q1).
There are other procedures just beginning to take off, but even ignoring them there is no way the adoption rate is going to slow before hysterectomies begin to saturate - and that won't be this year or next.
There are ~650,000 hysterectomies carried out each year in the U.S. alone.
micro
Nexavar
>>"K vitamins ... appear to enhance the effects of sorafenib, thus requiring lower, less-toxic doses," Dr. Brian Carr of Thomas Jefferson University in Philadelphia said in a statement.
"Many patients need to discontinue treatment with sorafenib because of the debilitating side effects," Carr said. "If we could lower the dose, more patients would be able to complete their treatment."<<
Or they could raise the dose and make the drug more effective for those that can complete their treatment ...
micro
>>ISRG reported this morning.
The key number is the instrument and accessory revenue fell sequentially from 81.6 million to 79.6 million. This does not show procedure growth to me maybe I am missing something.<<
No offense, but you people are clueless with regard to Intuitive. The number of procedures during Q1 grew an astounding 60% year over year to 45,000 (180,000 annualized). That's obviously not off a low base.
There are several reasons why you don't see that growth in the sequential I&A number, most well known to anyone who is seriously following the company rather than skimming a PR or two.
1. Hospitals are drawing down their inventory reserves of instruments due to financial pressures. (How long can that go on?)
2. The procedure mix is moving from mainly prostectomies to mainly hysterectomies (and similar procedures). The latter involve fewer instruments. (I don't know why.)
3. As surgeons become more experienced, they are finding ways to carry out procedures just as well using less instruments, which they may fell some pressure to do given the cost-cutting environment in many hospitals these days.
4. Due to a system upgrade and accounting details you probably aren't interested in, $2.1M of perfectly good I&A revenue had to be deferred - as well as $18M of perfectly good systems revenue. Add in the former and I&A revenue did go up slightly from Q4, despite 1-3 above.
The key number is NOT I&A revenue, it is adoption growth, and that is 60% despite the fact that we are in a recession and many of da Vinci procedures are discretionary - or at least can be delayed (e.g. non-cancer hysterectomies).
To be redundant, the underlying business is growing at 60% ... from a large base ... during a recession.
ISRG is still drastically undervalued despite have recently increased in share price from 85 to 150+.
micro
>>CEGE has made a nice gain in the last 2 days
Any thoughts here on it<<
The gain before and after the message to which I am replying was obviously Dendreon related - but it's totally nuts. GVAX failed. GVAX prostate is 100% dead, and the other forms of GVAX are almost definitely dead. Plus GVAX involves a very different strategy than Provenge so the Provenge provides a further indication that Cell Genesys took the wrong road.
If you accept that GVAX is dead, and if you read CEGE's SEC filings indicating that essentially all their other 'assets' are gone (they even had to make a significant payment to get out of the lease on their manufacturing facility - which they spend over $100M on!), you can't value higher than cash minus what they have to pay to buy back the debt. (See the most recent PR about plans regarding the latter.)
At this point the maximum valuation becomes an exercise in elementary school arithmetic ... and you find the present stock price is too high by more than a factor of 2. Add in the fact that management is apparently not planning on liquidating (otherwise they wouldn't choose to hold onto debt not coming due until 2013), but instead apparently want to start over again and fritter away the remaining cash ... and it becomes clear that whoever is holding shares at the present price failed elementary school arithmetic and can't recognize a long lost cause when they see one.
micro
>>Speaking of HGSI… Bill Haseltine, of all people, penned a recent article in The Atlantic on how to “fix” the drug/biotech industry:
http://business.theatlantic.com/2009/03/why_big_pharma_mergers_magnify_failures.php
Inasmuch as Haseltine caused HGSI to achieve the dubious distinction of being the biggest-losing biotech company of all time (although it will be surpassed this year by VRTX), I find it curious that anyone would seek Haseltine’s viewpoint on to how fix anything relating to the drug/biotech business.
<<
Dew,
Don't know if you noticed that Haseltine and his wife ended up on the list of Madoff's clients. So Madoff presumably ended up blowing millions of dollars siphoned off from HGSI investors, and one con artist got screwed by an even better one.
What goes around comes around?
micro
>>MRNA issues common stock to pay the rent??<<
Geron has been doing that for many years. They also pay CRO's and CMO's with stock.
They would probably pay their electricity bill with stock if they could ...
micro
>>I’ll have to eat my hat because I was under the impression that the phase-3 Albuferon trials had SPA’s that specified non-inferiority to Pegasys as the primary goal and specified a (two-sided) non-inferiority delta of 12%, which was met in both trials.<<
I was surprised about that too, but here's the evidence:
7/30/08, 2Q08 cc ...
Joseph Schwartz - Leerink Swann
Yes, I think that is helpful. And then if I could follow-up on Albuferon as well. In terms of the non-inferiority bands that you have chosen, how confident are you that the FDA is on board with the comparisons that you have proposed and the magnitude of effect that will be considered, statistically, non-inferiority just given their problems with non-inferiority trials recently?
Davis Stump
We have clear end-of-Phase II agreement. This was a point of very specific discussion in our end-of-Phase II discussion with FDA where we set the boundary to be excluded of 12%. That roughly would translate in to the statistical outcome being met if Albuferon was no more than 5% worse – observed worse than Pegasys.
Non-inferiority trial design – that’s a whole day's conversation. You do better in non-inferiority trials when you have got more external data to point to. We were fortunate that we had the data comparing native interferon to placebo then having comparison between Pegasys to native interferon. So there is fair amount of data that pointed as a 12% margin is being clinically meaningful.
I am going to say that I do not think that was a great point of contention during the discussion. So I am pretty comfortable, short of us actually going and getting an SPA which we chose not to do because of the time that that would have taken, that we have agreement on that boundary.<<
I don't know very much about the inner workings of the FDA, but my impression is that an "end of Phase II agreement", if there is such a thing, is little more than non-binding FDA guidance and advice. Would there even be a document signed by the FDA which states something about the 12% margin? I doubt it.
micro
Some thoughts about Albueron and HGS
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_H/threadview?m=te&bn=8514&tid=71127&mid=71452&tof=5&frt=2#71452
micro
>>ONNX - Nexavar in melanoma
The failed phase III melanoma trial was in refractory patients and the ongoing one is in patients who have not received prior cytotoxic chemotherapy or an inhibitor of Ras, Raf, or MEK. In a randomized, double blind, placebo controlled, multicenter, phase II study in chemotherapy-naive melanoma patients, Nexavar improved time to progression, increased PFS, and doubled the response rate (all stst-sig), when compared to the DTIC arm. However, overall survival only showed a positive trend (not stat-sig). It is a long shot but chances are better for the drug to work in chemotherapy-naive patients.<<
I think the Phase 2 trial is largely irrelevant, because the ongoing P3 trial is Carboplatin + Paclitaxel +/- Nexavar (same as the P3 that failed), not DTIC +/- Nexavar.
http://www.cancer.gov/clinicaltrials/ECOG-E2603
In other words I think the chemo you combine with is probably a lot more important than the line of therapy and so my guess is that the 2nd Carboplatin + Paclitaxel +/- Nexavar trial will probably fail just like the first one.
I am unaware of a P3 DTIC +/- Nexavar trial planned.
micro
>>I'll eat my shoe if nexavar works in melanoma.<<
I wasn't implying that Nexavar works in melanoma, although it is worth noting that there is a 2nd Nexavar Phase 3 melanoma trial ongoing (which unfortunately differs very little from the previous Phase 3 melanoma trial which failed). I was merely saying that just as finally there was a drug approved in liver cancer after more than 100 failed pivotal trials, success in melanoma and lupus may be on the way.
In particular, Rituxan might still end up being approved in lupus, despite the recent failure. A lot of people seem convinced that it works and that it is just a matter of crafting the appropriate trial to convince the FDA.
micro
Orange Book
>>The three Tarceva patents in the Orange Book expire between 2018 and 2020.<<
The Orange Book doesn't include drugs which have yet to be approved, right? Is there a simple way to find out the patent expiration dates for those?
micro
>>everything just fails in melanoma. is it like .. in the last 50 years, nothing has come to market. reminds me of lupus.<<
Liver cancer was the same way. Then along came Nexavar. Wouldn't surprise me if both the melanoma and lupus nuts were cracked soon.
micro
GVAX
>>Yes and no. This goes along with other immunotherapy data that indicates a later response (e.g. MDX-010, 9901/2a). But that said I would treat this data as weak support at best - since I am sure that they don't have too many patients out there. And it is CEGE, the author of my favorite example of completely asinine analysis.<<
I agree. Did they show us the KM curve and let us judge for ourselves? No. They put their spin on it.
IMO GVAX is dead as a doornail. And not just GVAX prostate.
micro
Dire stats for biotech
http://www.the-scientist.com/blog/display/55480/
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Dire stats for biotech
Posted by Alla Katsnelson
[Entry posted at 26th February 2009 03:52 PM GMT]
Comment on this news story
The Biotech Industry Organization (BIO) this morning released a set of statistics that give a rather dire snapshot of the industry's health. Here are some of the highlights -- or, should I say, lowlights -- straight from their roundup:
- 120 companies (30%) are now trading with less than 6 months of cash on hand. This represents a jump of 90% over the number of companies with less than 6 months cash on hand in 2007. (source: BIO)
- 180 companies (45%) have less than 1 year of cash remaining. This represents a 65% jump vs. 2007. (source: BIO)
- Only 10% of the 370 public US biotech companies have positive income [cash flow].(source: BIO)
- By comparison with 2007, funds raised from initial public offerings in 2008 fell 97% and follow-on/secondary offerings [a second round of stock issuance after an IPO] fell 56%. Total capital raised by the industry in 2008 fell by 55% vs. 2007. (source: BioCentury).
- In 2006, 32 life sciences companies raised $1.7 billion through IPOs. In 2007, 41 raised $1.9 billion. In 2008, there was only one IPO in the US, which raised $5.8 million. (source: BioWorld)
- 87% of US biotech stocks lost value in 2008.
- More than 80 companies laid off more than 5,000 employees in 2008, and 34 biotech companies have laid-off 10% or more of their workforce since September, 2008. (source: BioWorld, BIO)
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micro
HCV
>>still, there is no combination data with albuferon and the new direct antivirals, so i don't see how they are going to compete with roche and schering<<
They have some time to run a P2 study before the direct antivirals hit the market. I believe they are waiting to see if the P3 data vs Pegasys is positive before doing that. P2 studies looking at the combination of Albuferon with direct antivirals could begin as early as March.
This appears to be the panel referred to in your article, pharmaclown:
http://www.ceo.bio.org/opencms/ceo/2009/program/ID.html
Doesn't seem to have been webcast.
micro
ISRG
>>The fluctuation per se is not hugely consequential, but the drop in ASP may be a harbinger that ISRG does not have the flexibility to raise prices to offset flat or declining unit sales in the coming quarters. Thus, I would not automatically accept the notion that this metric is meaningless noise.<<
I accept that one should always be skeptical. However it is worth noting that management said that in Q4 some hospitals asked for discounts on system prices in order to close deals, but Intuitive refused and in many cases walked away. Also they said the lower average revenue per system primarily reflects changes in product and geographical mix and the strengthening of the dollar.
Indeed, the company had a larger than usual percentage of system sales from outside the U.S. in Q4, and these involve sales through distributors at a lower average selling price. Also as you know, the dollar was indeed strong in Q4. So I think management's claim is at least consistent with all known facts.
micro
>>Revenue (-2%), operating income (-2%), net income (-12%), and EPS (-14%) were all down relative to 3Q08. If this is not flatlining, what would you call it?<<
I can't stress strongly enough that the long-term growth is measured directly by number of procedures - which was up 15% sequentially and 60% year over year. The adoption curve *is* procedures versus time. This simple mindset is not a spin in response to present conditions. It has helped me understand the underlying trends in the company for many years.
>>You seem to be unduly sensitive to non-bullish comments about ISRG, which I find surprising for a seasoned biotech investor like you.<<
You should read some of my posts on the VI board. I am just about the most bearish of the long-timers there, and warned the stock was overvalued in the 300's and that the credit crunch (etc.) would eventually hit the company when management was still saying everything was hunky dory.
That said, I have reacted a bit too strongly in the past day or two - and for that I apologize, mainly to brideofsighs.
micro