...
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
MNTA:
Was looking at the annual and proxy and a couple of small things caught my attention. I realize (rightfully so) the main valuation comes from M-Enoxaparin and M118 but here are a couple of things related to the generic Copaxone program
1. While I realize the compensation goals are generally on the easy to achieve side (IMO) for a lot of the biotechs I follow anyway. It found the following goal and percent achieved significant.
Advancement of our M356 ((Generic Copaxone) Program Value=15% Actual Level of Achievement=130%
2. On page three of the annual report (not the 10-k portion) there is the follow text at the end of the M356 update We made significant progress in this program in 2007 and look forward to substantial advancement in 2008 [Bold text is my addition not in the report].
UTHR:
There are also slides available on the company website.
There were no trends. The company sounded convincing in the robustness of the primary endpoint with various data imputation methods. The other point is the FDA may be more inclined given that the molecule is already approved and the potential to remove a safety risk for some patients who may transition from IV. I am still concerned about secondary end points considering the remarks when the elected to forgo the interim analysis.
The Oral data seems quite exciting. While the side effect profile was certainly a concern from what I've seen/heard it seems the small dose titrations should help and especially important is that 1.5 mg is equivalent to the dose tested in TRIUMPH (though obviously one is oral one is inhaled). Given that the target dose I believe is 7 or 8 mg I think the overwhelming majority will get a very therapeutic dose and since prostacyclins have been shown to have a dose response hopefully it helps.
The other thing is the company whether deliberate or not has managed enrollment well in both trials. It appeared to slow down before the .5 mg tablets were introduced. And then they enrolled > 351 in the study (target was 300) so it could help make up for the early patients who had titration problems. The other creative thing is adding 6 sites in India for the monotherapy study and coincidently enrollment the past few months has been very slow in the monotherapy. This is a mixed blessing on the one hand the IV denovo study had some issues (such as patients getting infections and was stopped early) but I believe their is a high need for treatment their demonstrated by the robust results on the small group that got treated. The company indicated they would go slowly allowing the centers to enroll a single patient to ensure done properly before enrolling others. They also indicated a substantial number of patients awaiting enrollment there. My guess is we get close to 180-200 patients (target is 150)
I replied on Silicon Investor (I have a paying membership their)
So anyone want to bet the one director sold again today? I've noticed it seems as soon as awards are granted they sell irrespective of price.
I want to add more but unfortunately I didn't have a bid in today.
Thanks I think you pointed that board out to me a year or two ago. I also follow the Yahoo boards on IPF, some other boards and a couple bloggers. I know patients hate InterMune but I am fairly confident of a strong up-take in Pirfenidone if the data is good (I don't think it even needs to be spectacular). At first I was concerned pricing would be a problem but I am pretty confident we get a US price in the 30K+/yr.
On PKU. I still own a fair amount of BMRN but even if PEG-PAL makes it to market I think an effective Oral therapy could trump it. What I don't get is why BMRN did/doesn't try to buy Altus out. They've been looking to add to their pipeline and they recently licensed to early CF products so unless they've looked and don't like what they've seen I don't get it. I think probably the company (Altus) was so messed up that it was turning off people and they weren't even sure what they wanted to do. I never cared for Mr. Berkle's comments about we are not sure what we want to do going forward. I think a more proactive CEO could have done a lot to offset some of the delays and to have developed other collaborations. The two Berkle did ended up both being terminated about a year after signing!
on altu:
I am glad to see that I am not the only one who thinks highly of 237 (I like the rare indications for quicker approval). I had missed the competitor (swiss company in Phase 3) but still think 237 could do well if its efficacious in man. Yeah tell me about delay we went from starting Phase 2 in late 2007 to lets see how the data is and we will see in what form we are around to decide what to do next. I also like their PKU product. I was hoping 237 would get to market and keep the burn down for these two products to get developed and perhaps their technology get wider development with some early stage deals.
On Inhaled Interferon Gamma:
I know InterMune did a CF study a long time ago (I am not sure how the results were but since it didn't progress I am assuming not compelling). I am not an expert but one would think a lung disease may be better treated administer the treatment that route. Ventavis didn't do that great though, UTHR is going to try it at some point with Viveta.
Not sure what you mean by disagreeing with me on treating the disease.
Didn't mean much just you seem more hash then I on the trial/Pirfenidone in general for treating the disease (not about market opp if successful).
IPF/exacerbations:
I believe the primary endpoint in the phase 2 was FVC or DLCO the trial was stopped because of the imbalanced number of acute exacerbation. I don't know the exact medical definition but generally speaking it is a sudden (days-weeks) drop in patient status, symptoms not attributable to another cause (such as infection, pulmonary emboli, etc.). Its a subtle difference from a patient decline because of disease progression in that it is an abrupt event. I've seen some studies (citations mostly don't have access to all) about significant mortality after one in the neighborhood of 50% 3-4 months after one. I think the incidence with someone with IPF is probably around 20% annually but have seen mention that it could be much higher. I don't believe their is any way to predict or a correlation with how severe the patient is either.
Yes ITMN had a PR. It was in with the fast track designation.
http://biz.yahoo.com/prnews/080519/aqm508.html?.v=9
I won't argue with your assessment of Protein replacement being much easier. And I won't even put Welch at the same level of Astrue yet anyway. I just appreciated the strategy he used which was similar.
FYI, while Intermune may have officially dropped Actimmune. A nebulizer company (by memory can't recall which) has since initiated an investigator study of Inhaled Interferon Gamma in IPF.
Agree completely with your assessment about IPF being heterogeneous and many are probably wrongly classified. You seem a bit harsher then me though in your estimation of by how much :).
I don't agree with you on treating the disease. I think Pirfenidone can treat one major symptom of the disease (fibrosis) while perhaps not treating the underlying cause it is a big step (I tend to compare it more to cancer therapy rather the PAH therpies in that respect). Plus I think their is a lot unknown about the disease and somehow if Pirfenidone is reducing the risk of an acute exacerbation I think doctors would have to be even more inclined to perscribe.
Do you have any thoughts on what will happen with Altus? I've seen you post on it a few times. Its been a big disappointment. I think Trizytek has a high probability of success but the company has found ways to have setbacks so it wouldn't shock me that the study had poor conduct or some other problems. I thought Pendergast would stay on but it didn't sound like it on the calls. (Obviously) i am hoping they some how get Astrue.
One could read the call two ways. The data is lacking in some way and InterMune wants to emphasize the difference (for example there is a high drop out rate or the treatment effect separation was more prominent later in the treatment period, etc.). The other is the results are pretty strong and InterMune wants to some positive PR.
With as big an orphan indication and the potential for significant revenue I think people don't give much recognition to InterMune for this side of their pipeline. No doubt the bad taste of Actimmune has something to do with it.
Gilead paid 2.5 billion for Myogen with 2 drugs and I estimate 2 billion of that was for Letaris (US rights and just a Royalty x-US) and it wasn't even approved at the time of acquisition. Actelion paid 400 million for CoTherix and Ventavis had only US rights, a royalty burden and short market potential with United's Inhaled Remodulin approaching the market.
Pirfenidone lacks a good patent estate and may not have as good of efficicacy for the disease as the PAH therapies but I think the lack of royalty obligation, worldwide rights and no current competition whats-over and not to mention a large patient population should more then make up for that. I've been looking at some things with Tracleer for IPF. If it works it would likely not prohibit combination use with Pirfenidone and its far from clear it works. The Phase 2 results were old good on retrospective subset analysis, I recall Bruce Given with Encysive stating his experts thought drugs in the class would not be likely to have much efficacy.
I was impressed when Dan Welch took a step back after the Actimmune failure and really increased the odds of success for CAPACITY. While the increase in duration costs us time and the increase in size money, the importance of success to the company necessitated that. It reminded me of when Michael Astrue took over at TKT one of the first things he did was do a longer trial for their Hunter drug wanting to increase odds of success. Hopefully the outcome will be similar!
I agree with you Mike!
From reading the posts hear and other boards it seems we had a lot of short term investors thinking the growth would steadily go through the roof and the stock would go up four-five fold every year for a couple more years. Perhaps for them it is a disappointing story. I tend to hold stocks longer term for the most part unless a stock gets way ahead of itself that makes me uncomfortable then I may sell sooner then I had originally intended and while I have owned Zynex it certainly has never done that!
I've been fortunate to have a few microcaps take off some not based on earnings/sales ramp just getting a bigger following from news, a (favorable) deal, coverage or what have you. I think at some point that will happen here. Then we will get a more respectable PE.
For now what do we have?
1-A company with sales and revenue growth that is triple digits on a year over year basis and still solid on a sequential quarterly basis.
2-The need for funding has basically disappeared and if one looks at how Mr. Sandgaard got us going he did not dilute us too heavily to start this dramatic growth (I was concerned about that when I first saw the 8-k about the company seeking an investment to hire more reps).
3-The CEO still owns about 2/3 of the stock and we have a float of less then 10 million shares.
4-I firmly believe the company will list on a bigger exchange this year (they announced Amex) and this should help in boosting the image of the company and perhaps attract bigger investors/funds. Along these lines I think we'll get more publicity and wouldn't be surprised to see Mr. Sandgaard doing more interviews/other IR type of publicity.
5-While it may not offer the dramatic revenue growth CE Mark approval should offer some potential for future European growth.
6-I recall their being some clinical trials for the Neuromove. If we get favorable data from this it would go a long way toward wider physician perscribition.
Well so much for the market thinking a buy out is in the works. As long as 135 (Trizytek) doesn't have any (further) setbacks and we got a signal (measuring oxalate in urine) for 237 then I would prefer no buyout just good permanent management!
I replied on the Biotech values board #msg-29372606
ALTU:
Interesting. Thanks for posting it. The MS presentation is by far the best to listen to for those interested in ALTU.
Their drug did not fail at least not that we publicly know. Their lead drug Trizytek (ALTU-135) for pancreatic insufficiency is in Phase 3 with efficacy results due in Q3 of this year. Nothing is easy especially with this company's history. Unless they have study conduct troubles this has an extremely highly likelyhood of success.
What we are waiting on prior to Triztek is Phase 1 results for ALTU-237 even though it is primarily a safety study in healthy volunteers a signal on if the drug is working is a key objective is to see if it reduces the amount of oxalate in the urine (study subjects get a high oxalate diet). I really like the potential in the rare hyperoxaluria if they show it works. Then they claim it is the same mechanism as 236 (PKU) and 242 (Gout).
Then we have what has killed the company ALTU-238. WHen Genentech walked away in addition to losing half our market cap we had the burden of doubling our cash burn. This to me has created the biggest sense of urgency. If we had this burn off our shoulders we could push through.
If the wire story you posted is accurate I wonder if they hit another setback somewhere or perhaps now with 237 data the picture is a lot clearer. To me it is almost a no brainer for biomarin since they just invested in a couple of early stage CF drugs and Kuvan is going to be a key revenue source so locking out any potential PKU competition. I would personally like to see the company stay independent and get someone like former TKT CEO Michael Astrue.
SMID:
I am sure people have seen the NT-10QSB and about 2.5 cents eps for the quarter.
I was surprised by the relatively high volume today. And it seemed to go in the 1.70 range. I am not a short term trader so perhaps people were betting on good earnings for the quarter. IMHO Q1 is the worst time to do that (with the exception of next year because of barrier rental revenue from inauguration). Last year we had a good Q1 (both revenue and EPS) but that is by far the exception.
Hopefully we got the decent sized seller out but if I were guessing I'ld say we get a selloff tomorrow. I have a big position but if it gets too cheap again I'll probably look to add.
SMID:
They don't PR everything these days you need to keep an eye on their IR page. ( http://www.smithmidland.com/news.shtml ). Saw this order today.
http://www.smithmidland.com/releases/gaylord.shtml
Gaylord National Resort & Convention Center features Smith-Midland® Soundwall
SoundwallMIDLAND, Va. – Smith-Midland® Corporation has announced its involvement in the construction of the high profile Gaylord National Resort & Convention Center on the Potomac. Upon its completion, the Gaylord Complex will be the largest private development in the Washington DC metropolitan area.
Smith-Midland® will construct a precast concrete Soundwall and retaining wall to surround and support the center’s loading dock area. The wall will provide a visual screen for surrounding residential neighborhoods allowing them to retain their quiet beauty. The wall will also act as a noise barrier providing insulation from associated loading dock noises. The contract is valued at more than $1 million.
What makes the project unique is that the wall is a combination retaining wall and Soundwall. The bottom portion of the wall is designed as a retaining wall used to support a section of the loading dock area. In this area, the wall has to support the weight of the tractor trailers using the loading dock as well as be designed to withstand the impact load if a tractor trailer should drive into the wall. The retaining wall will have a tormline finish that looks like a hand-laid
stone wall. The upper part of the wall, the Soundwall, will have a high-end architectural preconcrete mix to match the Gaylord building itself. The wall will average 20 feet high with its highest points peaking at 30 feet.
The strength, permanence and weather-resistant qualities of concrete make it the best material for retaining walls. The Soundwall provides unmatched strength and durability of precast concrete with a variety of finishes to provide an effective Soundwall, security, is attractive and versatile and economically priced.
Panel production of the project began in late January 2008 with completion projected for early March. The wall was installed in less than 4 weeks, making the precast concrete system fast, efficient and cost effective.
The Gaylord National Resort & Convention Center is the cornerstone of the exciting new National Harbor project in Prince George’s County, Maryland. The National Harbor is a 300-acre development that includes nature settings, retail and office space, a marina, residential units, and the Gaylord Center. Sitting on the banks of the magnificent Potomac River, the entire project will have cost more than $2 billion when complete.
DSCO:
Does anyone else smell something fishy here? Didn't we already know that there problem was CMC and they are touting no new trials. I don't follow the company that closely though so just a hunch. I liked what the Janney Montgomery Scott analyst Brian D. Rye said (portion highlighted below).
http://biz.yahoo.com/ap/080505/discovery_labs_mover.html?.v=3
Discovery Labs shares soar on word of no new Surfaxin trials
Monday May 5, 6:24 pm ET
Discovery Labs shares soar as no new Surfaxin trials needed, sees filing FDA response in weeks
WARRINGTON, Pa. (AP) -- Shares of Discovery Laboratories Inc. soared Monday after the biotechnology company said it will not need to conduct additional clinical trials of its lead drug candidate and a Jefferies & Co. analyst reinstated his "Buy" rating on the stock.
On Friday, the Food and Drug Administration asked the company for additional information on Surfaxin, which is designed to prevent repiratory distress syndrome in premature infants, thereby delaying approval. Discovery shares closed down 50 percent at market close on Friday.
However, shares recovered some of the earlier losses Monday, gaining 45 cents, or 31 percent, to $1.90.
Discovery said Monday it believes it can file a response to the FDA in about six to eight weeks and once the resubmission is received, believes a decision will follow within 60 days.
Jefferies & Co. analyst Adam A. Walsh wrote Monday that while issues related to the Surfaxin appalication "appear resolvable in the near-term," he noted that Discovery's timing projection represents a best-case scenario. He has a $5 price target on shares.
Janney Montgomery Scott analyst Brian D. Rye was less sanguine about Discovery, citing uncertainty regarding Surfaxin's regulatory approval and the company's need for additional cash over the next year.
"Given the company's troubling regulatory track record thus far, we bluntly don't believe it is prudent for investors to accept management's description of the remaining steps at face value, particularly in light of the fact that the company still needs to meet with the agency to clarify these issues," he wrote Monday.
Rye has a "Neutral" rating on Discovery shares.
ARRY:
Thomas any thoughts on todays financing? I don't follow array too close these days. The large amount of warrants bothers me as I am a longer term shareholder plus paying a fee in addition to interest. I think if I am a shareholder I would have preferred the straight issuance of equity at a discount to share price.
Do you buy chance have a list of near term catalysts? TIA
Nice to see you wake up the quiet board :).
Do you have any thoughts on producing Enzymes in CHO cells (I won't get Dew into the debate :) ). I recall read somewhere about some of the docs treating patients saying the new batches of Myozyme were inferior (I take it from observing their patients). I also recall Novazyme (one of John Crowley's old company) having all sorts of trouble with their Pompe ERT before they sold out to Genzyme (but not what is now Myozyme) having consistency problems between batches.
Didn't see it in your comments before but I believe Genzyme is treating a significant number of patients in the US just it is not revenue producing till they get the new facility OK'd.
Appreciate your comments as always except when your picking on my companies :). Enjoy the rest of your weekend.
I just noticed the most recent report is dated just a couple days ago.
http://screen.yahoo.com/d?vw=0&db=reports&z=dat&tk=ZYNX.OB
I think a lot of these are bogus reports that are mostly computer generated but this last one is priced considerably higher and seems to be done by a company that has a focus on the industry. Wonder if it has some positive comments?
I don't give yahoo as much credit as you :) though I have used there screen (occasionally) I never trusted their numbers and would go to company filings when I wanted to know.
You may very well be right Mike I have never before followed how Yahoo updates correlated with Volume. Have you by chance?
Sandgaard did a nice interview I believe it was a couple years ago now (on their website) I went through before I bought. Now with the pending move no a bigger exchange I would image that he is/will start doing more PR work and could see more of these type of interviews.
Not that I think this necessarily happened or to accuse anyone but I wouldn't be surprised to see some sort of report or something in the coming weeks. Gee I wonder if ZynexWB was trying to bash the stock to create a buying opp before publication of one of these, its interesting how he/she disappeared.
Does anyone think the volume is unusual? Granted all it would take is one descent sized buyer but I wouldn't think that Yahoo updating their figures would attract this much would it? It was good to get some of the short-termers/weaker shareholders out with todays volume though!
I owned a stock that started taking off (volume and price) for what I thought was no apparent reason then it turned out it was on one of IBD's lists (I don't read it). I don't know if Zynex would qualify on one of their lists but that is really all we need to take it to the next level. I don't think we'll ever (again) garner a be 50-100PE but we certainly have EPS growth that has gotten stocks higher PE's.
Earnings should be out any day now. I've noticed them being late a few times the past couple quarters. I am speculating it may be due to having more companies. When I spoke with the CEO he seemed to not be concerned with burding management with paper work as long as they are doing their jobs well. I am sympathetic with that perspective but at the same time don't like financials to be late. I posted this on another board. If anyone wants to know more about the company I'ld be happy to discuss it or better yet you can contact management I think they are pretty receptive to talking to people.
#msg-28785359
I've posted this before and with the annual due any day (they are late) it may be worthwhile to post this information again. The stock is at $2 now and the spread is 1.9 - 2.05 about as low as it gets (I've seen close to $1 spread before). I am not one to forecast price as I have been a shareholder for a couple years and intend to for years more but one can do simple valuations and see it is quite cheap. I think SMID surprised a few people with actual earnings in Q4 and while it is not the strongest quarter for Moro unless we lose substantial money the PE is in the mid single digits. Like SMID I think they may be getting stereotyped as a pure construction play and they are not (rebar and HVAC so a lot of infrastructure). For long term investors I'ld really recommend reading the Interview with David Menard. For shorter term looking at the financial for the past couple years. Oh and they have added another company in Q4 which should be good for a couple cents EPS (on an annual basis). The business model and execution the past few years make it a gem of a company that is really been punished lately! Disclosure I am quite long and have been adding since early 2006.
MRCR Brief DD
1) Read the WallStreet Transcript Interview http://www.morocorp.com/news/Moro%20Corp%20-%20Wall%20Street%20Transcript.pdf
(or get from http://www.morocorp.com/news/index.htm )
2) Filings http://www.pinksheets.com/pink/quote/quote.jsp?symbol=MRCR&tabValue=4#getFilings
3)
Year Sales EPS Shares
2000 7.7M .06 5.65M
2001 10.9M .09 5.65M
2002 14.6M .07 5.77M
2003 23.1M .06 6.25M
2004 30.6M .18 6.25M
2005 34.9M .23 6.25M
2006 58.4M .25 6.28M
2007* 47.9M .25 6.28M (*9 months)
4) Managed in a similar fashion as Warren Buffet for microcaps. Acquires good solidly profitable (though low margin companies). Wants management to stay on. Invests in growing acquired companies and looking to acquire at low multiples. Mainly HVAC and construction at this time but open to other areas.
5) Forget the bumps and look at growing revenue, EPS, consistent profitability, return on equity. Stable share count (deals financed in mix of existing cash, debt and equity/equity stake to explain the occasional jump)
6) Its thinly traded, CEO owns majority stake. Was exchange listed went to Pink Sheet (With sarbanes oxley) and now OTC-QX listed.
7) Be Happy to discuss on Value Microcaps board or MRCR board (http://investorshub.advfn.com/boards/board.asp?board_id=8604 )
VRTX:
I don't envy some of these writers I can't keep up with as many companies as they follow... the problem I have with them is when they report things in at least an unfair way to mislead in support of their case when they either aren't fully researching or if they are then are deliberately misleading.
I don't know why Vertex went down today. I heard the call and didn't catch anything. The one thing is they said about treating for 48 weeks for non-responders. Don't know if people were hoping that treatment duration would be the same as for treatment naive. For those like me who may not have as much understanding of the science in the Q&A their is a good discussion on why the Protease is so important to target for those that are non-responders. One thing I wondered is why boceprevir would not have efficacy in the same ball park and so perhaps another PI could have better efficacy then telaprevir.
Maybe investors have finally learned their lesson about Phillip Frost-related companies.
I am not too up on PLX what's his tie in to the company? TIA
P.S.
I haven't heard pip on another board too :).
EDIT:
OK I see he was on PLX's board
http://www.forbes.com/finance/mktguideapps/personinfo/FromMktGuideIdPersonTearsheet.jhtml?passedMktGuideId=42303
This board seems to be pretty quiet lately. This may be of some relevance.
Senate votes to ban insurers from discriminating based on DNA
A few comments at #msg-28775161
I don't like insider sales either but it is worth noting that they are 10-5b and not exactly huge amounts. The CEO also is not an extremely wealthy individual and I am sure he has additional expenses (beyond what the company pays) considering his two children afflicted with Pompe Disease. Also a fund (I believe they have a board position) has been buying quite regularly in support of the price.
This news article may help open the door for early screening of several of the LSD's. I have heard TKT people and Henri Treemer saying for years how important early treatment in these LSD's can prevent some damage that may not be reverseable with later treatment.
http://news.yahoo.com/s/ap/20080424/ap_on_go_co/genetic_discrimination_10
WASHINGTON - The Senate has passed legislation that prohibits health insurance companies and employers from discriminating against people based on the results of genetic testing.
ADVERTISEMENT
The 95-0 vote sends the bill back to the House for a final vote early next week. President Bush supports the legislation.
DNA testing can show some people to be at greater risk of cancer or other serious illnesses. The bill bars health insurance companies from using such information to set premiums or determine eligibility. Employers couldn't use that information for hiring and firing decisions.
Don't know if it's been posted or not. If anyone is interested i'ld gladly sell one for a lot less, and it would be brand new!
http://sports.yahoo.com/mlb/news?slug=ap-yankees-cursefoiled&prov=ap&type=lgns
Red Sox “curse” jersey fetches $175,100 in charity auction
By MELISSA TRUJILLO, Associated Press Writer
BOSTON (AP)—The Boston Red Sox jersey secretly buried under the new Yankee Stadium in a failed curse attempt sold Thursday for $175,100 in a charity auction.
The bid from Kevin Meehan, the owner of Imperialcars.com in Mendon, Mass., was the highest of 282 for the battered No. 34 David Ortiz jersey.
“I actually thought it was going to sell for more money,” said Meehan, who bid only in the final moments of the weeklong eBay auction that ended at 12:30 p.m. “I have three young boys that I take to the games and they would have killed me if I didn’t buy the shirt.”
The Yankees jackhammered the jersey out from under two feet of concrete earlier this month, then donated it to the Jimmy Fund, the Red Sox’s official charity that is affiliated with Boston’s Dana-Farber Cancer Institute.
Mike Andrews, The Jimmy Fund chairman and former Red Sox second baseman, said the charity was “absolutely thrilled.”
“We are grateful for the generous bid, and extend our deep gratitude to the New York Yankees and the Boston Red Sox for coming together again in the fight against cancer,” he said in a statement.
Meehan said he was eager to give to the Jimmy Fund because his father died of cancer and his stepfather has the disease.
“It’s personal,” he said. “It’s a lot deeper than just the shirt.”
Meehan plans to eventually display the jersey from his favorite Red Sox player in one of his car dealerships. He said he has no intention of selling it.
“It was just a win-win all the way around,” said Meehan, who also will receive a new Ortiz jersey, a Yankees T-shirt and two tickets to a Red Sox game where he will be presented with the unusual piece of sports memorabilia.
Construction worker Gino Castignoli, a Red Sox fan from the Bronx, dropped the jersey in wet concrete during construction of the new stadium, hoping to hex the Yankees. The team found the jersey after receiving information from anonymous tipsters.
OT: inNexus - I first heard of the company when I saw they had signed a deal with Royalty Pharma.
It peaked my curiosity and I looked a little at inNexus but thought it too speculative (very early and I couldn't see anything particular in their science that would give them a competitive edge). I didn't look too closely though do you have an opinion on inNexus? TIA
For what its worth I wouldn't take the Royalty Pharma deal as a validation to their technology. I owned drug royalty which had a deal with Cambridge Antibody I believe it was for 1 percent of all revenue (for life). I took it as a cheap call option a royalty company buys. In Drug Royalty's case it was extremely prudent the bad thing management wasn't too great and they eventually sold us (shareholders) out for peanuts! CAT was smart enough to see the potential value and tried to buy out Drug Royalty which lead to mgm selling out for a bit more to someone else.
Thanks rkrw. I haven't been too impressed with current (Predix) mgm (going by calls) having to revise their Alzheimer's data doesn't give them much creditability either. The convertible seems far out (2024) and at a high conversion price $44.66. Still if they get anywhere near the 100 million + cash you are looking at close to $4 a share less what they burn during the year.
The problem I am having in todays Biotech market is valuing companies as you've pointed out many times the list of biotech's near/below cash is quite high and several have some products I see of having a descent chance of generating some value. I guess the market today is saying otherwise. It'll be interesting to look back and see how good of a buying opportunity existed today.
EPIX: On the call they said the NPV for Vasovist is 100 million+. Granted it is managements take. FYI, the market cap of EPIX is well south of that figure especially x-Cash.
Since you don't sleep did you catch the call any comments? I see it is on the long side (over an hour). Early look is like the market is not impressed.
I thought 500-999 but I am going by memory and maybe I chickened out and voted a lower figure. I thought PML would happen very infrequently if it was dosed monotherapy and perhaps they would discover other risk factors. I thought the benefit of the drug would make enough people start therapy if not at first then when other treatments became less effective. I did not expect meaningful revenue in other indications (Chrohns) nor did I factor any major new therapies coming in that time frame.
FYI no position in BIIB though I was a shareholder a number of years ago (before the merger) and did OK. I do own a small amount of MNTA.
If I recall you were not too optimistic about its prospects. have conditions (lack of PML) led you to change your forecast (for 2009)?
Too bad I-hub doesn't let you see when the votes were cast. I don't recall how I voted (I think it was in the 500M-1B). The late voters seem to have an unfair advantage, Kinda like voting now for McCain to get the Republic nomination :)
http://investorshub.advfn.com/boards/board_survey_results.asp?board_id=1418&Survey_Num=89
Considering where the stock was in late '04 before they started getting bad news from the FDA and even adjusting for the merger with Predix I would think the stock would move a lot more on the news, its 1.7 - 1.88 in AH and not too much volume.
http://biz.yahoo.com/bw/080423/20080423006234.html?.v=1
EPIX Pharmaceuticals Announces Positive Results From Re-Read of Vasovist(R) Phase 3 Images
Wednesday April 23, 4:01 pm ET
Company to Resubmit New Drug Application Mid-2008
Management To Host Conference Call To Discuss Results April 24, 2008 at 10:00 A.M. EDT
LEXINGTON, Mass.--(BUSINESS WIRE)--EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX - News), a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform, announced today it has achieved positive results from the blinded, independent re-read of images of its novel blood pool magnetic resonance angiographic (MRA) agent, Vasovist (gadofosveset trisodium). In the re-read of images obtained from previous phase 3 studies, EPIX met all pre-specified endpoints prospectively agreed to with the U.S. Food and Drug Administration (FDA). EPIX plans to resubmit a New Drug Application (NDA) to the FDA for Vasovist in mid-2008. Vasovist is currently approved for marketing in 33 countries.
ADVERTISEMENT
There are currently no contrast agents approved in the United States for use with MRA, a non-invasive modality for imaging blood vessels. However, it is estimated that approximately 1.5 million MRAs will be conducted in the United States during 2008 using gadolinium-based products.
“We believe these positive results confirm the efficacy upon which the NDA was based and allow us to move forward with our strategy of achieving U.S. regulatory approval,” said Andrew Uprichard, M.D., president and head of research and development at EPIX. “We worked closely with the FDA to design the protocol and statistical analysis plan for the re-read of these images and look forward to continuing our work with the FDA to bring Vasovist to market in the United States.”
“We remain focused on monetizing our Vasovist asset in the near- to mid-term and these positive results are a significant milestone towards achieving this goal,” added Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. “We believe these positive results position us well for FDA approval and that our product, if approved, will serve a large and unmet need in the U.S. MRA market. We are hopeful that we will be able to work with the FDA to achieve approval for Vasovist by the end of 2008. Currently, there are no MRA imaging agents approved in the United States, however, market research suggests that unapproved gadolinium-based agents are used for MRA. We are confident that Vasovist has distinguishing characteristics that will be appealing to physicians and patients for this indication. Based upon these market dynamics, we believe we will be able to utilize this asset to support the multiple product opportunities in our clinical pipeline. We remain on track with our plans to initiate our Phase 2b clinical program for PRX-03140 in Alzheimer’s disease, partnered with GlaxoSmithKline (GSK) and the Phase 2b right-heart catheter study in pulmonary hypertension with chronic obstructive pulmonary disease. We also continue to engage in strong partnerships with GSK, Amgen and Cystic Fibrosis Foundation Therapeutics involving several of our early stage programs and look forward to continuing to achieve milestones in these programs.”
Conference Call
EPIX will host a conference call and a live webcast to discuss the positive results from the independent re-read of images of its novel blood pool magnetic resonance angiographic (MRA) agent, Vasovist at 10:00 a.m. (EDT) tomorrow, Thursday, April 24, 2008. The call can be accessed by dialing 1-866-314-5050 (domestic) or 1-617-213-8051 (international) five minutes prior to the start time and providing the passcode 35410110. The live webcast can be accessed by visiting the investor relations section of the EPIX website at http://investor.epixpharma.com. A replay of the call will be available on the EPIX website approximately two hours after completion of the call and will be archived for 30 days. The replay may be accessed by dialing 1-888-286-8010 (domestic) or 1-617-801-6888 (international) and using the passcode 11785733.
About Vasovist®
Vasovist is an injectable intravascular contrast agent designed to provide improved imaging of the vascular system through magnetic resonance angiography imaging (MRA). Vasovist has been approved for marketing in 33 countries, including, among others, all 27 member states of the European Union, Switzerland, Turkey, Australia and Canada. The initially approved indication for Vasovist in the EU, Canada and Australia is the use in MRA imaging of the abdominal and limb vessels. The Turkish and Swiss authorities granted a whole body MRA indication. The marketing rights to Vasovist are held by Bayer Schering Pharma in Europe and by Bayer HealthCare Pharmaceuticals in the United States and Canada. Both companies are part of Bayer AG. Vasovist is currently marketed in Canada and 18 European countries, including, among others, Germany, the Netherlands, Italy, all Nordic countries, United Kingdom, and Switzerland.
About EPIX
EPIX Pharmaceuticals is a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform. The company has a pipeline of internally-discovered drug candidates currently in clinical development to treat diseases of the central nervous system and lung conditions. EPIX also has collaborations with leading organizations, including GlaxoSmithKline, Amgen, Cystic Fibrosis Foundation Therapeutics and Bayer Schering Pharma. For more information, please visit the company’s website at www.epixpharma.com.
This news release contains express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on current expectations of management. These statements relate to, among other things, our expectations and assumptions concerning regulatory approval of Vasovist and its ability to achieve commercial success, the progress and timing of our clinical development programs and strategic collaborations and management's plans, objectives and strategies. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things: risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured; risks relating to our ability to advance the development of product candidates currently in the pipeline or in clinical trials; failure to obtain the financial resources to complete development of product candidates; our inability to further identify, develop and achieve commercial success for new products and technologies; competing products may be more successful; our inability to interest potential partners in our technologies and products; our inability to achieve commercial success for our products and technologies; our failure to comply with regulations relating to our products and product candidates, including FDA requirements; the risk that the FDA may interpret the results of our studies differently than we have; the risk that we may be unable to successfully secure regulatory approval of and market our product candidates; and risks of new, changing and competitive technologies and regulations in the U.S. and internationally. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional information regarding these and other risks that we face, see the disclosure contained in our filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K.
Contact:
EPIX
Kim C. Drapkin, 781-761-7602
Chief Financial Officer
or
Pure Communications
Kelly Hennessy, 617-227-0552
Source: EPIX Pharmaceuticals, Inc.
Interesting questions about Biosimilars on Genzyme call, about 22 minutes into the call (and then a followup about 29:30 in). It was a spoon fed question but Henri Termeer and Alison Lawton seemed to indicate that the hurdle could be higher for approval of biosimilars with the FDA being much more conservative.
#msg-28670925
A further setback for Genzyme having trouble with their Pompe Mfg. Amicus is a long way off but I wonder if some will see small molecule as less problematic.
http://biz.yahoo.com/prnews/080421/nem106.html?.v=37
Genzyme Provides Update on Myozyme(R) Manufacturing
Monday April 21, 4:00 pm ET
Will Host Conference Call Today at 5:00 p.m.
CAMBRIDGE, Mass., April 21 /PRNewswire-FirstCall/ -- Genzyme Corporation (Nasdaq: GENZ - News) announced today that the FDA has informed the company of its opinion that Myozyme® (alglucosidase alfa) produced at the 160L bioreactor scale and Myozyme produced at the 2000L scale should be classified as two different products because of differences in the carbohydrate structures of the molecules. Currently, Genzyme has U.S. approval to sell Myozyme manufactured at the 160L scale, and the company has been seeking clearance from the FDA for Myozyme produced at the 2000L scale. Production at this larger scale has already been approved in more than 40 countries.
ADVERTISEMENT
Based on the global clinical experience of nearly 900 patients of all ages currently receiving Myozyme produced at the larger scale, including patients who participated in the Late-Onset Treatment Study (LOTS), Genzyme believes that Myozyme produced at both the 160L and 2000L scales is clinically effective and safe. Myozyme is the only treatment for Pompe disease -- a severe, progressively debilitating and life-threatening inherited disorder affecting a very small number of people throughout the world.
The FDA will require Genzyme to submit a separate biologics license application (BLA) to gain approval for Myozyme produced at the 2000L scale. The agency proposed that Genzyme initiate a rolling BLA review process by submitting results from the LOTS study. Genzyme expects the FDA to give the BLA priority review and to act on the application by the end of this year. The LOTS study, which met its co-primary efficacy endpoints, was undertaken to evaluate the safety and efficacy of Myozyme in juvenile and adult patients with Pompe disease. Genzyme had already been preparing to submit results from this study to the FDA to fulfill a post-marketing commitment. Genzyme anticipates that this process will culminate in the availability of two commercial versions of Myozyme in the United States: one produced at the 160L scale and the other produced at the 2000L scale. The company expects to begin providing U.S. patients with commercial 2000L Myozyme during the first quarter of 2009.
To ensure that severely affected adults with Pompe disease in the United States have access to treatment, Genzyme, in collaboration with the FDA, created the Myozyme Temporary Access Program (MTAP) in May 2007. Through this program the company is currently providing Myozyme produced at the 2000L scale free of charge to approximately 140 patients. Infants and children with Pompe disease in the United States continue to receive commercially approved Myozyme produced at the 160L scale.
"We are extremely disappointed in the FDA's decision because it will further delay broad patient access to Myozyme, which is not possible under the MTAP program," said Henri A. Termeer, Genzyme's chairman and chief executive officer.
Financial Impact
Myozyme sales for 2008 are now expected to be approximately $275-$285 million compared to previous guidance of $320-$330 million, reflecting the delay in the approval of 2000L production. Genzyme anticipates that this delay will have an impact on 2008 non-GAAP earnings of approximately $0.10 per diluted share. This reflects both forgone commercial sales margin and the costs of continued administration of the MTAP program. Genzyme now expects 2008 non-GAAP earnings of approximately $3.90 per diluted share, compared with previous guidance of $4.00 per diluted share. GAAP earnings for 2008 are now expected to be approximately $2.65 per diluted share, compared with previous guidance of $2.75 per diluted share. GAAP figures include anticipated amortization and stock-compensation expenses and the effect of contingent convertible debt. Genzyme reaffirmed its commitment to 20 percent compound average growth in non-GAAP earnings per share through 2011.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 10,000 employees in locations spanning the globe and 2007 revenues of $3.8 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation.
With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.
This press release contains forward-looking statements regarding Genzyme's financial outlook and business plans and strategies, including without limitation: its 2008 earnings guidance; its 2008 Myozyme revenue guidance; its plans regarding the timing and content of the BLA submission for Myozyme manufactured at the 2000L scale; it expectations regarding FDA approval of that BLA and the timing thereof; its anticipated non-GAAP compound growth rate through 2011; and its belief there is no difference in the clinical effectiveness or safety of Myozyme produced at the 160L and the 2000L scales. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those forecasted. These risks and uncertainties include, among others: Genzyme's ability to obtain and maintain regulatory approvals for Myozyme produced at the 2000L scale and the timing thereof; Genzyme's ability to accurately anticipate regulatory actions on its Myozyme manufacturing applications; Genzyme's ability to manufacture its products, including Myozyme, in a timely and cost effective manner and in sufficient quantities to meet demand; Genzyme's ability to accurately forecast Myozyme revenues and the impact of reduced Myozyme revenues and other costs associated with the regulatory delay on earnings; and the risks and uncertainties described in Genzyme's SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption "Risk Factors" in Genzyme's 2007 Annual Report on Form 10K. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of today's date and Genzyme undertakes no obligation to update or revise the statements.
Genzyme® and Myozyme® are registered trademarks Genzyme Corp. All rights reserved.
Conference Call Information
Genzyme will host a conference call today at 5:00 p.m. Eastern to discuss Myozyme manufacturing. To participate in the call, please dial 1-773-799-3828 and use passcode "Genzyme." The replay number for the call is 203-369-3292, and the replay will be available until midnight on May 5th. Today's call will also be Webcast on the investor events section of www.genzyme.com.
Genzyme's press releases and other company information are available at www.genzyme.com and by calling Genzyme's investor information line at 1-800- 905-4369 within the United States or 1-678-999-4572 outside the United States.
Media Contact:
Bo Piela
(617) 768-6579
Investor Contact:
Patrick Flanigan
(617) 768-6563
Crestor -
By chance would you know what the economics are for Shionogi (Is it a straight royalty/capped/etc.)?
The article said they had 218.6 million in royalties for first three quarters of '07.
http://www.forbes.com/markets/commodities/2008/04/01/shionogi-pharmaceutical-crestor-markets-equity-cx_vk_0401markets01.html
PS My interest in Shionogi is for another drug not yet approved :)
So will some Yankee fan/group buy it and burn it?
ZYNX:
I guess if you weren't impressed with them in the .80's #msg-20360857 you must really be unimpressed now. I've noticed you seem to always find something not to like (Sandgaard lending them money, late Q/K, 144, PE, did I miss something?). You wouldn't by chance be related to ZynexWB would you :)?
You seem to use a trailing PE in the past so by your calc we would be at 18 or so. If you annualize the Q4 number we are about 11. If you take a forward look (and we already know Q1 orders are about 15% higher then Q4) and see even 10% q over q growth the PE is more like 8. Maybe you think that is high but a company growing anywhere near that deserves a much higher PE even if it is a microcap and Yes I know they have some problems.