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Trouble? I don't believe so. We discussed what rules are involved with insiders doing trades last time around on the RB board. The last time, Eric Swartz made scheduled purchases in share quantities reflecting an outlay of the same sum, each increment. The view at that time was that, if purchases are being done in that scheduled manner, timing concerns with news being released is neutral. I don't recall who posted on that, but there was reference made to trading rules. Does any one else recall that exchange?
I think it is great that ES has decided to purchase more shares as we are approaching the publicly anounced release of Tarvacin safety data. That sounds bullish to me.
Best wishes and IMO.
KT
Jazz & Katie, I had read it the same way as Jazz.
My first thought was that the PPHM pr writer had read my recent posts and crafted a note to confirm that PPHM doctors will have safety data at hand to release to us all at the end of February PLUS will be holding insightful HUMAN EFFICACY data, as well. This data will be used to design studies that will fit the design criteria of the scientific community. PPHM's announcement for shareholders will be implied by the nature of the studies announced, which will be designed to affirm demonstration of efficacy. I was also being told I don't have to look for 2007 to see the shades of preliminary efficacy results. PPHM has a story to tell in 2006 that will be, perhaps, in journals in 2007. Of course, we don't get to know the story until it is peer review quality ready.
I found it very significant that, with the exchange of five million shares today, the pps was not held below a buck. Someone lost an arm wrestling match because they had not counted on PPHM doing the unprecedented: releasing news twice in one day. A close above a buck restarts the clock for those that were attempting to put PPHM into a squeeze with delisting hype. Kudos to the PPHM management team for that achievement. I don't think there are thirty trading days before now and the presentation in which the hold can be effectively reworked. Did Ricardo fail to meet his objective, or what, LOL? Recall Ricardo disappeared after the Russell Index listing preservation had failed.
Best wishes and all IMO.
KT
Katie, I haven't reviewed details of the latest UU placement, but the previous placement involved a hold period where no new registrations of shares was allowed followed by a right of first refusal period. I thought that was the case in this latest deal, as well, but I will take your word for it. Curiously, the most recent UU deal was enacted after the ROFR period had expired, by my figuring. There should still be 4 million registered shares that have not been placed left over from last year, figuring the warrant hold arrangement that had been announced before the annual SHM. It is not clear if those shares are going to be placed, because that results in PPHM taking a short term pps hit for just 2 1/2 months of operational funding burn rate coverage. The PPHM burn rate has been about 1 1/3 million $ per month.
I have a sense of confidence about what PPHM has in formation, translating to share holder value later this year and getting reflected in the pps. When that will happen is something I keep seeing put back in time, for what look to be good reasons. I am guessing we will see another private placement that buys PPHM another five months of development time before there is a pharma deal. Why? Five months is showing enough resiliancy in pps to absorb eight million new shares and it gets PPHM through the summer in which current trial results start posting and new trials get announced. I am also guessing that a pharma deal could be done now if PPHM management accepted conditions that would not meet their, and likely our, expectations. PPHM needs to have both safety and efficacy of Tarvacin demonstrated in humans before they can negotiate $$$ instead of just $, LOL. $$$$$ would be nice, but that is likely a 2007 thing (funny, perhaps, but maybe not too far from the truth).
Best wishes and IMO.
KT
Katie I have been too busy to keep on posts except a review maybe once or twice a week. Raging Bull is swarming with bashers now, so I don't bother reading, I just screen for trusted posters.
Regarding cash on hand, PPHM brought in $6.7 from the Double U placement. PPHM posted end of july $16.5 million and end of October $11.9 million. Assuming the same burn rate for three months, end of January would be $14 million (7.3+6.7). Will Avid bring in revenue from their two commercial contracts? If so, PPHM has more cash on hand than $14 million. The U2 deal was November 23, so I anticipate PPHM will be seeking more cash after the hold period and right of first refusal period is over. Is that March?
It is hard to predict what PPHM is doing about cash, but they appear to be doing the private placements to match their burn rate. Will PPHM deliver a deal that brings cash before more dilution is needed? I would guess not. The Godofsky trial efficacy against Hep C may not be released at all with the current trial, although safety info is due to be released end of February. We are speculating safety info will move pps, but why should it? Showing Tarvacin doesn't do harm is not a revenue booster, it just means Tarvacin is a viable prospect. Will PPHM release news about effective treatment against Hep C in humans before more operating funds are needed or Avid revenue kicks in? We don't know.
Hope this helps. All IMO, of course.
KT
It looks like I need to learn the IHub edit feature better. Nice to be able to correct typos within 15 minutes after posting.
KT
Thanks CJ. So the reference to nonenveloped viruses was in the patent application. I remembered reading it but could not recall where. I also recall that some of the first references by Steve King or ? around that timing had included the reference to nonenveloped viruses, but that the references were soon dropped and only the enveloped virus references carried forward. My guess at the time was that PPHM didn't want to carry the baggage for that "stretchier" assertion while they attempted to explain to the medical world the significance of Tarvacin and its antiPS functionality. If the nonenveloped virus application is patent protected and it soon becomes shown that Tarvacin is effective against enveloped viruses, there should be plenty of opportunity for the noneveloped virus applications to be addressed using the resources drawn to PPHM with the enveloped virus treatment, demonstrated success. I would not be surprised if nonenveloped virus applications bring as much value to PPHM as the enveloped virus treatment, especially if trials demonstrate that Tarvacin needs to be a cotreatment for enveloped virus treatment effectiveness.
Regarding recent stock price, I fully expect that, if PPHM has what we think they have in terms of developing value with Tarvy, Cotara and Avid commercial production, that there will be a major shakeout exercised by market makers before pps starts to trend up. Is what we are experiencing such a shakeout? I think back to the dynamics when pps dipped to the 40 cent to 60 cent range (that is when I was able to cost average my holdings that started at $7 down to averaging around a buck!). There are parallels in play now, but it appears that PPHM is currently finding support in the 90 cent range compared to the 40 cent range of a few years back.
Will this hold? While great news can be released by PPHM in February (we still don't really know!), can we expect that results from the Godofsky clinic Hep C trials will be sufficient to move the stock? It is perhaps likely that such announcements will be technical only, that PPHM will not announce financial deals that take the edge off of their cash flow needs and that PPHM may even need to implement another private placement with Double U around that timing to groom along their trials progress while PPHM negotiates the deals with big Pharma that longs have been anticipating.
Katie had suggested PPHM might do well to see $3 and hold that. My view is that we could still find PPHM hovering around a buck if PPHM management decides to do a placement for raising more operational funding to feed into the demand for shares one might expect with announcement of successful Hep C trial news.
Most can agree that what will move the pps up is the announcement of events that translate to significant $$$ for PPHM. Unless Avid delivers crowd pleasing revenues, I can see PPHM being compelled to wait until Fall 2006 or 2007 before major partnering or funding can be achieved. For now, all longs are likely feeling strain to hold onto shares while PPHM plods along to deliver the potential their technologies hold through trials and studies. Will announcement of more government funded trials suffice to move pps? I would guess not enough to move beyond the pps downward pressure of another U2 placement.
At what point in study/trials will PPHM have crossed the treshhold at which big Pharma will feel the sense of urgency to act to get proprietary rights established with Tarvacin or Cotara to established their lead over their competition? I see this milestone is critical for PPHM's future. Leading up to that point, I would anticipate that the board bashers and market makers will attempt to suppress PPHM perceived value, perhaps even causing the 90 cent support level to collapse for a while. For my own circumstances, I have an influx of new funds to invest in my 401(k) in February that I intend to put to good use if market makers continue to play the pps suppression game with PPHM. However, I already hold enough PPHM shares to live a comfortable retirement if PPHM delivers on value, so my appetite for picking up cheap shares is beginning to be balanced by my interest in balancing retirement fund investments with lower risk. Why attempt to pick up another 100,000 shares if one already has six figure holdings? To me, that brings home the point that it is new investors drawn to PPHM and the value of its technology that are needed to really move the pps. My guess is that many of the longs that have posted here and on RB for years have similar circumstances as I... plenty of twinkies in the food shelf to serve my appetite but a weakness to stock some a few more if they are offered on the cheap.
An off topic.. Has anyone looked at the MCET recent news about their new in-licenses with Amarin Corporation for the treatment of fatigue in multiple sclerosis? The MCET folks were cheeky enough to suggest in their press release that the cumulative world sales could run $3 billion and Amarin could receive up to $275 million in royalty payments. Of course, this company, currently trading at sixty cents, needs to go through a Phase IIb/III study expected to begin during 2006, before that value can begin to be realized. Maybe that is why the MCET pps has hardly budged in response to the news. I had picked up several thousand shares when Alan and a few others drew my attention that way a couple years ago, but pps is significantly down from my entry point. The cost averaging opportunity there after MCET's 5:1 reverse split parallels what PPHM did when pps had dropped to 40 cents. The MS treatment is something completely different than the immortalized hepatocyte product that had been developed for pharma to use when checking out their new drug impacts on liver functions, so MCET is emerging into what is, for me, unfamiliar territory.
Best wishes and all IMO.
KT
CJ, Your reference about Tarvacin impacting viral entry and egress to an infected cell and killing infected cells is the one I had inquired about a month or so back but could not find. Thanks. It is by this mechanism that I recall that Tarvacin was suggested as having prospective effectiveness in treating against the nonenveloped viruses. When the virus leaves an infected cell, it would expose the PS from the host cell and make it vulnerable to treatment with Tarvacin. This point may be inconsequential, but I think is worth watching. After some initial info about Tarvacin maybe working against nonenveloped viruses, such references ceased, likely due to the obviously more direct benefit against enveloped viruses that expose PS.
Hope all had a great new year.
KT
Seamoss. What kind of treatment is Tarvacin?
Is it a wonder drug like aspirin? Lives were saved when aspirin was first introduced but now it is so common that folks take a baby aspirin every day to be a preventative treatment for cardio vascular disease. You can buy a bottle of 50 doses of this wonder drug for a buck.
Is it a wonder drug like penicillin? Perhaps, this is getting closer, since application is more like how Tarvacin will be used if found effective for avian flu. A clinic might charge under $50 for a penicillin shot.
Is it a drug like interferon? Sort of, but not really, since interferon doesn't deliver into the world of treating tumors like Tarvacin does. The pegylated interferon and ribavirin treatment for Hep C costs tens of thousands.
Where does Tarvacin fit? As you said, Tarvacin's prospective universal nature is both a marketing blessing and a bane.
Either way, if Tarvacin proves it works, PPHM can expect more demand for product than can be associated with a company with under $200 million in capitalization, $5 million in annual sales and a burn rate of maybe 20 million per year. PPHM should quickly become a different kind of company and I expect to be glad that I have accumulated and held my shares over the last five years.
Best wishes and IMO.
KT
Seamoss, if the cost per dose is cut by two thirds by means such as you suggested where the dose size is reduced from 1 mg/kg to 0.3, the marketing viability looks more realistic.
Of course, Tarvacin needs to prove it works first, before any of these Avid production issues get their chance to be timely!
Thanks for sharing your production cost estimates.
KT
Jazz, I think the product being purchased is one treatment dose stockpiled for Influenza, whether it be a vaccine, an anti viral drug or a MAB. Perhaps, PPHM Tarvacin could command more because it is a MAB but affordability expectations may not accept the distinction. The news reports about stock piling look like the targeted payment per dose is in the $15 to $60 range, depending on the reference. The announced $1.2 billion for flu pandemic vaccination reserves worked out to be maybe $60 per dose.
Using Seamoss's batch treatment vs. continuous reactor math, the cost for PPHM to produce a dose dropped from about $150 to $53. $53 is bringing Tarvacin into the zone, but that is the production cost and the price per dose for use of Tarvacin for bird flu is going to need to be maybe $100 to $150 per dose minimum to give a reasonable markup for covering distribution etc and return a typical profit margin. Can PPHM make an adequate profit selling a dose of a mab like Tarvacin at $60 if the order volume is high enough?
And if PPHM does sell Tarvacin to the government for under a hundred dollars a dose, will PPHM still be able to charge thousands per treatment when Tarvacin is used to treat tumors or people that are infected with viruses?
We know that Tarvacin is the same product applied to either viruses or tumors. Do we know if Tarvacin involves the same relative dosing regimine, be it for tumors or viruses (e.g. 1 mg/kg)? What would prevent Tarvacin delivered on the cheap for a pandemic stock pile from being delivered for patient treatment of Hep C etc. where PPHM may have expected a better profit margin?
TIA
KT
Seamoss58. How do you figure PPHM can charge $500 per dose when current mass production runs being issued for government stock piling are only offering 1/10th that?
TIA
KT
seamoss88 Thanks for sharing your math.
It does bring to question how much per dose is reasonably alloted for the very large orders that the government might issue for Tarvacin. One article suggested $1.2 billion to create 30 million doses, which works out to be $40 per dose. If the PPHM production cost per run is $4.9 million and a run produces 32,407 doses, the production cost to PPHM per dose is about $150 per dose ($151.20).
This brings up a curious question. Can PPHM reasonably deliver to a multi million dose order for government stockpiling without compromising market value of Tarvacin for treatment of viruses like AIDS and HEP C or treatment of tumors? A $40 per dose flu vaccine delivery price looks like it doesn't even cover the cost of production of Tarvacin out of a 1000 liter reactor. If your production cost math is right (I have no experience for comparison), it brings home the point that PPHM may need to serve a more "botique" supply market until which time production costs can be reduced enough to serve large scale government orders.
Of course, IMO.
KT
Katie.. Looks like RB has become too dysfunctional for posting. I haven't checked this board for a while. Glad to see members are still active and sharing their DD.
I had asked a question about Tarvacin's prospective impact on non-enveloped viruses. Several months ago, when PPHM was just introducing Tarvacin as a prospective viral treatment, there were some references that suggested Tarvacin might have some effect on non-enveloped viruses by attaching to PS exposed on the host cell. The prospect of Tarvacin impeding the viral replication process. Almost all recent news is focusing on Tarvacin for enveloped viruses and there is no residual cross mention of other applications. Staying focused on where results can best be documented makes sense. Perhaps, the Tarvacin impact on non-enveloped viruses will be allowed to catch up after demonstration of success on the viruses of the day.. Hep C, AIDS and Influenza Type A.
As a curiousity, I cross checked the math on announced government funding for stockpiling doses to treat the flue. The values worked out to between $15 per dose to about $60 per dose, depending on the reference. I wonder how many Tarvacin doses PPHM's Avid can deliver through a 1000 liter bioreactor batch? And if PPHM uses their production agreements with Lonza or exercises their banking agreements, I wonder how many total doses could be delivered within a six month turnaround if a stock piling order for 30 million doses were received?
Best wishes and IMO.
KT
Aiming4 There would be no reason for PPHM to give UTSW a stock premium when the shares could have been turned on the open market for the trading price. I don't believe the University has to disclose, so they could have already sold the shares. The point is, the University chose not to draw down the cash reserves of the company. Since the shelf offerings were being done at a discount to market of at least 15%, it would seem that the University saved both shareholders and PPHM resources. If the University held the shares, that would be bullish.
IMO
KT
Doesn't Steve King have a background in the research where he codeveloped PPHM products? Maybe not indispensible but if big deals are in formation, a new CEO would likely set back timing for moving along the PPHM business plan.IMO
KT
Katie,
I had made a post summarizing the Avid information after one of the conference calls when Avid production was disclosed. It was a couple years ago now and my memory is soft on the details. RB won't let me go back that far, so I will post the snippets I recall.
First of all, I don't know if the context of the Avid expansions are still valid, since the mabufacturing technology has changed. A few points:
1. Avid production was said to be applying new techniques that were allowing a higher level of productivity using the same size reactor. We don't know how the mabufacturing techniques have enhanced existing Avid production capacity.
2. At the time, Avid was talking about mixing up the expansion in stages, with there being room for a small, a mid size and potentially two large (1000 liter) reactors. I was surprised when Avid finally announced they were just installing a 1000 liter reactor, but assumed improved mab production efficiency with the existing reactors made their plan work without the small and mid size expansion, reactor scale up.
3. Another poster had guestimated revenue based on some of the snippets of information in the conference call but I recall that full subscription of the expanded Avid capacity had the potential of bringing in over $30 million annually. That level of cash flow and production was estimated as enough to make both Avid and PPHM self sufficient for operational needs. I recall that the financial officer for PPHM (Paul Lyttle?) had made a statement this spring that PPHM was expecting enough revenue from Avid to meet PPHM cash flow needs by the end of 2005. If so, the Avid expansion production estimates from two years ago received recent reinforcement.
4. I recall installation of the second 1000 liter reactor was supposed to allow Avid to generate revenue surplus to meeting PPHM needs. Someone had projected that efficiencies would allow Avid revenue to more than double (maybe $80 million per year total?). I have not heard anything more about the second reactor expansion but I might expect PPHM to announce that when demand so warrants.
5. At the time, we were projecting that Avid should soon be generating $4 million in revenue annually but shareholders were disappointed when the 10K at the timing showed production was more in the range of $1.5 million. The pps softened accordingly. Now, about 18 months to two years later than expected, Avid is generating revenues in the 4 to 5 million range, so it looks like the expansion plans are delivering, but at a slower pace than longs had speculated.
I hope this helps.
KT
Hi Katie,
I finally found my way over to iHub. Appreciate the work of you, Terry and CG.
Take care.
KT