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I think there are several factors here:
1) Shorts covering because there are *many* more fertile fields to plow
2) Shorts covering because the underlying funds are getting margin calls
3) Longs buying because of the near-term prospect of recession-proof revenue
4) The fact that whichever fund that was holding this that was liquidating appears to be done.
Volume was down dramatically the last 2 days (not including today which is exceptional because of all the panic) which is a good sign. A stock like this should be trading 200,000 shares/day, no more.
That said, I'm having *real* difficulties figuring out when I can devote more funds to JAV. I have a ton of dry powder.
Over the past 2 weeks, I've been dollar-cost averaging into high-yielding stocks, with regular buys every Thursday. At the rate I'm buying, it's going to take me 20 weeks to run out of dry powder, so as long as the nadir falls in there somewhere I should be okay.
JAV
I have given up trying to figure out what's going on with this thing. I have a large amount of cash waiting on the sidelines to buy JAV...I just can't figure out why it's up 3% today. Maybe someone knows that they passed inspection?
Forget it...now I know.
OT: Okay, don't leave me in mystery. Could you point to a source.
As I am accounting-impaired, rather than try to explain read the following:
http://www.businessweek.com/magazine/content/05_37/b3950084_mz020.htm
>This however may not be such a problem for smart small bio stocks that have a financial cushion and/or seek partnerships from the big pharma stocks that are getting decimated and looking for additional business. That also could drive a takeover spree by big pharma that could give some of these a boost.<
I'd agree with that. Many small biotechs who might otherwise stubbornly hold tight to their products are likely to partner or be bought out in such a situation. Although premiums are likely to be lower in this situation, there will still be money to be made. Combine with dry pipelines and changes in accounting rules and it's bye bye baby biotech.
JAV Conference Call Notes
Still waiting to buy the bulk of my position in JAV…seems like volume dried up today…finally. These are my messy notes.
1) Reviewed milestones for last quarter—completion of secondary stock offering, coverage by 6 analysts, signed commercial agreement with Baxter to act as secondary manufacturer of Dyloject.
2) Gained additional 10 y of patent protection for Dyloject in Europe. Additional patents are pending in US
3) Top-line results released for Rylomine, which met its primary end point of significantly reducing post-surgical orthopedic pain. Will be published in peer-reviewed journals.
4) Accrual completed in first of 2 US trials for Dyloject in US
5) Simultaneously started second US trial for Dyloject
6) Ketamine program: PK studies will be completed to fill out label on how to alter dose under certain conditions. These studies are on schedule.
7) Plant inspection for Dyloject by MHRA is complete. Approval will likely occur “before the end of summer.”
8) Have $53M in cash, burn $11M for SIX-month period.
9) Adam Greene (JP Morgan): asked about comparison with injectable ibuprofen product. Carr indicated that there is *no* literature on the use of IV ibuprofen for pain, in contrast to diclofenac, which has been used for years by the pain community and has “vast” literature supporting its efficacy
10) Adam Greene asked about reporting of the ketamine trials. Carr indicated that the trials will be reported before submission to the FDA. Duh.
11) Leerink-Swan asked whether they are in labeling discussions for Dyloject. The VP for Risk Management indicated that they have received and replied to labeling comments.
12) Leerink-Swan asked about preparation for the UK launch. Javelin said sales force is being hired and offer letters will be sent in “near term.” There will be 10-15 in sales force. Javelin has had extensive conversations with key opinion leaders and “are very comfortable that their marketing strategy will allow for immediate acceptance in the formulary process.” Carr reiterated that their advisory panels have included multiple specialties, including pharmacists that play a key role in formulary decisions.
13) Same guy asked “is it fair you wouldn’t have started a second phase III [for Dyloject] if you didn’t have a sense of how the first phase III went.” Carr emphasized that “Javelin does not embark on phase III trials on an exploratory basis.”
14) Top-line data from first phase III of Dyloject will be released in second half of 2007. Will be released by press release, abstract/poster at meeting, and publication.
15) R&R analyst asked about timeline of PK studies for ketamine product. Javelin said “they’re going very well.” Will complete by first half 2008 and file NDA around middle of 2008.
16) Juan Sanchez (not the coffee guy): asked a dumb question about label extension.
JAV Conference Call Notes
Still waiting to buy the bulk of my position in JAV…seems like volume dried up today…finally. These are my messy notes.
1) Reviewed milestones for last quarter—completion of secondary stock offering, coverage by 6 analysts, signed commercial agreement with Baxter to act as secondary manufacturer of Dyloject.
2) Gained additional 10 y of patent protection for Dyloject in Europe. Additional patents are pending in US
3) Top-line results released for Rylomine, which met its primary end point of significantly reducing post-surgical orthopedic pain. Will be published in peer-reviewed journals.
4) Accrual completed in first of 2 US trials for Dyloject in US
5) Simultaneously started second US trial for Dyloject
6) Ketamine program: PK studies will be completed to fill out label on how to alter dose under certain conditions. These studies are on schedule.
7) Plant inspection for Dyloject by MHRA is complete. Approval will likely occur “before the end of summer.”
8) Have $53M in cash, burn $11M for SIX-month period.
9) Adam Greene (JP Morgan): asked about comparison with injectable ibuprofen product. Carr indicated that there is *no* literature on the use of IV ibuprofen for pain, in contrast to diclofenac, which has been used for years by the pain community and has “vast” literature supporting its efficacy
10) Adam Greene asked about reporting of the ketamine trials. Carr indicated that the trials will be reported before submission to the FDA. Duh.
11) Leerink-Swan asked whether they are in labeling discussions for Dyloject. The VP for Risk Management indicated that they have received and replied to labeling comments.
12) Leerink-Swan asked about preparation for the UK launch. Javelin said sales force is being hired and offer letters will be sent in “near term.” There will be 10-15 in sales force. Javelin has had extensive conversations with key opinion leaders and “are very comfortable that their marketing strategy will allow for immediate acceptance in the formulary process.” Carr reiterated that their advisory panels have included multiple specialties, including pharmacists that play a key role in formulary decisions.
13) Same guy asked “is it fair you wouldn’t have started a second phase III [for Dyloject] if you didn’t have a sense of how the first phase III went.” Carr emphasized that “Javelin does not embark on phase III trials on an exploratory basis.”
14) Top-line data from first phase III of Dyloject will be released in second half of 2007. Will be released by press release, abstract/poster at meeting, and publication.
15) R&R analyst asked about timeline of PK studies for ketamine product. Javelin said “they’re going very well.” Will complete by first half 2008 and file NDA around middle of 2008.
16) Juan Sanchez (not the coffee guy): asked a dumb question about label extension.
Thanks Docbanker for your reply. Even if you haven't been following JAV closely, your perception matters...we all know that biotech is more often driven by perception than reality.
That's how I make my money
OT: Hey Docbanker,
Just a question, not related to RPRX. Thought you might be able to answer as you're more involved on the financial end of things than I am.
Can you advance a hypothesis as to why JAV is so incredibly volatile? In my reasonably broad experience a stock like JAV should be somewhat less volatile, and trading in the 100k/d range rather than 500k+.
Many of us who own RPRX also own JAV...sorry for cluttering the board, though, and feel free to disregard the question.
I would tend to agree with dewophile, although right now I have far more RPRX than JAV.
JAV should be a relatively low-risk play, at least in comparison with RPRX. I say that with some hesitation because someone--or a group of someones--is f*cking with JAV hard. There's no other reason why a stock like this would go up and down like it has.
JAV's products are much lower risk than RPRX's. With the latter, you have not one but two novel molecular entities with novel mechanisms of action (at least from an approval standpoint). With androxal, we have a drug that could be considered by some a lifestyle drug, which will face very large hurdles for approval. That said, if either Androxal or Proellex succeed, the sky's the limit.
Compare with JAV: Three relatively low-risk products--one (ketamine) that has essentially been approved already, and one (Dyloject) that is about as unexciting a drug as you can imagine. Remember that The Medicines Company's former 1-billion dollar market cap was supported by Angiomax alone, a $200 to $250 million dollar product. JAV has more potential than that when the pipeline is taken together, and I'd argue it's products are lower risk.
I think we're also discounting the possibility that JAV could be purchased. I know for a fact that The Medicines Company is actively looking at other companies with hospital-based products to acquire.
I have only a trivial investment in JAV, just waiting for it to get done oscillating. Then I'll scale in to a position that is at least equivalent to my RPRX position, if not more.
When looking at comparators, JAV should have a value of $400-500M even before approval of Dyloject, and more after. Again, all of this is in the context of a market in which stocks are valued according to their potential. JAV right now is being used hard as a trading vehicle.
JAV
After listening to yesterday's conference call, I started to repurchase my shares this morning.
I recommend listening to the call...later today I'll post a summary.
Semi-OT: I was thinking today that raising taxes is going to be politically impossible--not to mention economically unwise--given that so many of the middle class are living so close to bankruptcy thanks to Toll Brothers et al. Taking an extra few percent off of their paychecks is inevitably going to tip a bunch of them into insolvency.
I haven't seen any analyses to addressing this issue, though. So perhaps the 15% tax on LT investments and dividends is safe.
I hereby revoke your license to post.
The gold-plated bathroom fixture/leased BMW crowd is running out of money and nobody will lend them more. So sad.
JAV
I see that it is holding up incredibly well in today's market disaster. Anyone listen to the conference call? Care to give a summary?
I've said it before but I'll say it again: JAV will be a $500M+ company within 6 mo to 1 year. I will buy in again when volatility decreases. I also want to hear what they say tomorrow on the CC--these guys are notorious for sticking their collective feet in their mouths.
You all suck
But it looks like it's getting smacked down again anyway.
Yes, it did leave me at the dock. Throughout the decline, I kept a very small position (about 1/15 of my original position). Nothing to write home about, unfortunately.
Woman has pencil removed from head
I didn't know anyone else suffered from this condition!
By KRISTEN ALLEN, Associated Press WriterTue Aug 7, 12:30 PM ET
After being plagued for 55 years with the torment of a pencil lodged in her head, a German woman has finally had it removed.
Margaret Wegner, now 59, was 4 years old when she fell while carrying the 3.15 inch-long pencil, which went through her cheek and into her brain.
"It bored right through the skin and disappeared into my head," Wegner told Germany's best-selling newspaper, Bild. "It hurt like crazy."
At the time the technology did not exist to safely remove the pencil, so Wegner had to live with it — and the chronic headaches and nosebleeds that it brought — for the next five-and-a-half decades.
But on Friday, Dr. Hans Behrbohm, an ear, nose and throat specialist at Berlin's Park-Klinik Weissensee, was able to use modern techniques to identify the exact location of the pencil so that he could accurately determine that the risks of removing it, and then take most of it out.
The operation was particularly difficult because of the way the pencil had shifted as Wegner grew, Behrbohm told The Associated Press on Tuesday.
"This was something unique because the trauma was so old," said Behrbohm, who has also operated to remove bullets from the brains of shooting victims, and glass from the brains of people involved in car accidents.
Though a 0.79-inch piece of the pencil could not be removed, Behrbohm said it does not present a danger.
And now Wegner, the wife of German boxing coach Ulli Wegner, will no longer have the headaches and nosebleeds, and her sense of smell should also return soon, Behrbohm said.
"She shouldn't suffer any longer," he said.
Hi Microcapfun,
Read the Celsentri briefing doc for a good backgrounder on this.
Transition from a macrophage tropism (CCR5) to T-cell (CXCR4) tropism is a natural phenomenon in the natural history of HIV, for the simple reason that the macrophages are usually among the very first cells infected after exposure to HIV because of their location. A gradual evolution to CXCR4 chemokine receptor use causes a shift in the proportion of productively infected cells toward the CD4+ T-cells.
I would assume the presence of a very small percentage of CXCR4-tropic virions in every infected individual. Otherwise T cells wouldn't be infected reasonably early after exposure, and of course they are.
Also, in reading through the aforementioned briefing doc, I noted that mutations can also arise that allow the virus to use CCR5 even in the presence of maraiviroc.
Oh no, you too?
there is clearly a market for a next-generation NNRTI
You mean like TMC125? The resistance profile is so good for that one, I think it pretty much puts a capstone on the class.
It'll be an ugly day when that thing goes ex-dividend.
Sorry to discuss this here...just slowly shifting still more of my assets into income-producing investments.
Quoting myself: >there's no reason to suspect that a mutation in CCR5<
Should have said "mutation to CXCR4 tropism."
Here's a reference.
http://gateway.nlm.nih.gov/MeetingAbstracts/102249495.html
No, I was addressing two different points. Sorry if I wasn't clear. In any case it doesn't matter if resistance arises as a result of selection of pre-existing virus or mutation. In the first case (selection) development of resistance should be relatively rapid. In the second case (mutation) there's no reason to suspect that a mutation in CCR5 would be less likely to occur than a mutation in RT.
Not at all. In almost every infected individual there is already a population of virus that is dependent on CXCR4 for entry. No mutations necessary. In fact, if I remember correctly, HIV infections shift from a largely CCR5-dependent (macrophage-tropic) population early in infection to a CXCR4-dependent (T-cell tropic) population later in infection. Or the other way around, I can't remember.
Mutations occur on a genomic level. If every base has an equal probability of mutation (an oversimplification, of course) the potential for mutations is simply a function of target size.
>Selzentry (a.k.a. maraviroc) is one of the cleverest pharmaceutical brand names in a while, IMO. Since the drug works on a host mechanism, it ought to be shielded from mutations in the HIV virus.<
Um, no. In the presence of maraviroc, CXCR4-dependent virus already present in the infected individual will be selected or escape mutants will shift to a CXCR4-dependent mechanism of entry. Even if you were to hypothetically treat a patient with both a CCR5 and a CXCR4 antagonist, HIV can use still mutate to use other mechanisms for entry.
Totally off topic, although I'd appreciate it if someone can give an opinion.
Any thoughts on ADVDX? I feel like I'm missing something--it has a 13.28% yield, which seems almost too good to be true. It fell off a cliff last week like everything else, but long-term results look decent.
I'm not back in yet, but I will be shortly.
I'm a strong proponent of JAV, but I'm still hesitant to get back in because of the trading pattern. It would suck to buy, just to get a 10% smackdown.
I suspect there are *many* like me waiting for the price to stabilize before getting in, or back in.
VRUS
For the first time, there's a reasonable spread for VRUS. Only 6,000 shares traded, though
I have lots of thoughts on JAV, but no intelligent ones.
Seriously, though, JAV appears to be a great company, with 3 low-risk, near-term products (Dyloject, nasal ketamine, and Rylomine). They have a decent amount of cash in the bank--they should only need to raise cash once more, probably late next year.
Dyloject has considerable commercial potential, given the limitations of products sold in the US and in Europe. JAV's management has made predictions based on taking a certain percentage of the market away from opioids, which I think is unrealistic. In short, I think they've *overestimated* the market share they're going to take from opioids, but *underestimated* the market share Dyloject will take from other NSAIDs. Could be up to a $250M product, but I think $150-$200 is more reasonable.
The ketamine product is very low-risk--given that it only has to complete PK studies for approval--and has a very significant market in emergency medicine and the military, and a *much* more significant market in breakthrough pain. Could be up to a $500M product.
Not sure what to think about Rylomine yet. It obviously works, and works well. No ideas about market potential or applications.
On paper, management is incredible from a US perspective. Carr (the CEO) wrote current pain guidelines. Another member of the management team led the division responsible for approving pain medications.
I think investors are really gun shy about JAV because of how it's been trading. Nobody wants to get in to a stock that regularly gets smacked down 10% intraday. JAV's trading pattern is unusual, to say the least--I think right now it's mostly a vehicle for day traders.
In my opinion, JAV should be valued ~$500M+ within the next 6 months. We'll see what happens.
JAV up to $4.20 as I write.
I predict a smackdown by 2 pm.
I suppose on the good side JAV lost no more than the market did last week
I haven't done a detailed analysis of Amgen from an investment standpoint, but I can say that their pipeline is impressive, particularly in oncology and osteoporosis. I suspect denosumab will become a mega-blockbuster in osteoporosis, particularly with the concerns surrounding bisphosphonates regarding osteonecrosis of the jaw. Justifiable or not.
>The further it goes down the harder you have to consider the alternative that all isn't as it seems to be.<
Write the company and ask them what they've disclosed to major shareholders that they have not disclosed to us.
The real issue here for long-term shareholders isn't where the price is now, it's where it is when Javelin has to raise more cash, which should be late next year.
Agitate a little...after all, you do own part of this company, and the people below work for you.
Would suggest copying senior management on any messages to Ricky.
**************************************************************
Daniel B. Carr, MD
Chief Executive Officer & Chief Medical Officer
dcarr@javelinpharmaceuticals.com
Fred H. Mermelstein, Ph.D.
President
fmermelstein@javelinpharmaceuticals.com
Stephen J. Tulipano, CPA, MBA
Chief Financial Officer
stulipano@javelinpharmaceuticals.com
Michael T. Sheckler, MBA
VP, Business Development
msheckler@javelinpharmaceuticals.com
June C. Gregg
Corporate Communications
jgregg@javelinpharmaceuticals.com
Frederick "Rick" E. Pierce, II
VP, Investor Relations
rpierce@javelinpharmaceuticals.com
It's nice to know that I predicted something right this summer! I think ALTU will be a fine investment later this year.
I still can't believe what has happened to JAV. It's ridiculous for this company to be sitting at 4 and change with 3 near-term, low-risk products.
I also thought RPRX would take off after some of the safety issues were clarified. Not.
I also thought that DNDN--the world's suckiest company--would dive a lot lower than it has.
I got VRUS right, though!
Top line data from the first of two pivotal post-surgical Phase 3 clinical trials of Rylomine are anticipated "this summer."
Not sure when the second is due.
He's a spammer
Actually it wasn't a terrible day for biotech. About half the 20 or so stocks on my watch list were up.