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Thanks JR.
RRdog
JR
You are entitled to your opinions and to your technical perspective, most of which I disagree with, but you are not entitled to your own facts.
Of the four examples you cited, two "virtually" broke all technical resistance before rebounding if not "absolutely" and one "absolutely" was crushed. The latter, INHX, is a stock I actually use to compare valuations when I try to assess a reasonable "first stage" for PPHM.
INHX, just for the factual record, was at a high of $12.76/ sh in 2004 before falling to $.18 cents/sh in 2008. It was as low as $.23cents in 2009 , a low of $.88 cents in 2010. INHX has rebounded as high as $16.49 in 2011. So frankly, I just don't know what you are talking about.
As PPHM gets closer to meaningful data releases I notice all kinds of valuation projections on this board. They range from angry doom and gloomers predicting bankruptcy, to technicians worried about which moving average PPHM may approach, all the way to rosy predictions of price rises with multiple splits at numbers that even I can't conceive. Trying to get one's head around all these assumptions is a little like trying to herd a group of (manic depressive) cats.
IMO I have a general sense that PPHM will be successful in some of their endeavors and the big error that shareholders will make will be in selling too soon. It is difficult to predict what the long term value of the IP will be because there are too many moving parts in an expanding and ever morphing biotech universe. In addition, the macro world of stock market valuation is changing and the world of medical payments and insurance is also morphing rapidly. Lastly, it is still unknowable exactly what types of deals PPHM mgmt and BOD will make and whether they will try to sell the whole company or retail IP and keep parts of geographies and technologies for PPHM. For accuracy re price/ share it is also difficult to predict the time and dilution it will take mgmt and BOD to get from point A to point B.
Given all the moving parts, I find it helpful to think in intermediate stages since investment conditions, margin requirements, FDA approvals, etc., etc., will change at each level and the investment potential vis a vis competition will change at each level.
Right now IMO it is best to focus on the immediate future and look for "comparisons" to gauge what the "market" might pay for PPHM after "good data" results and without a deal or partner. A good comparison might be INHX which is an early stage biotech involved in a similar area to one of PPHM's technologies, and with a 78 mm share equity base which is also similar to PPHM.
INHX has more forward cutting edge tech in oral/non INF treatment for Hepc than PPHM, but the PPHM pipeline overall seems far superior. INHX has a superior BOD (not surprising) but PPHM much superior on the regulatory side. INHX actually uses an ATM but in a much better planned and superior fashion than PPHM. Recently, INHX placed 20mm in ATM funding using MLV (a firm PPHM has a relationship with). PPHM has a shot at INF replacement market where INHX has none. PPHM also has data coming in more than just viral area.
INHX has risen sharply in recent months, as their early stage data results have been good and the Hepc derby has heated up, from approx 200mm market cap to 1.2 billion market cap.
Should PPHM show good viral results, and some combo of results moving Cotara and bavi for NSCLC forward, it would not be unimaginable IMO, that PPHM trade for somewhere in the area of 50% of INHX valuation or 600mm market cap. This is only a "stage one" move IMO for PPHM and could certainly be high or low on this figure.
A 600mm market cap would imply about a $6-7/ share price for PPHM (assuming some dilution since last report), allow for additional less dilutive financing at higher prices to flush out the balance sheet and remove "going concern", allow PPHM to be marginable and "able to be accumulated" by a larger universe of institutions and then allow shareholders to assess the next stage of corporate development from a stronger position.
Other reasons that I use INHX as a comparison is that it has not partnered or sold IP, has little revenue and the analysts are using a target of $25/share "independent" which is above the market price. So what INHX is getting ($15.51/ share) is what the actual market place will pay in price per share for early stage development in a very difficult macro environment.
Of course, if PPHM partners, then I would look at things in a different manner and need to assess the terms and nature of the partnership. That would be a "stage two" comparison.
Best Regards,
RRdog
Don't lose your nerve now. Only 1 pt risk as of current moment. Stay in the present not the past IMO. Upside is huge. Stop thinking in terms of getting out at 3-5 IMO.
Think big picture and stop worrying about all the little nitpick things like how they announce a cc.
Big picture IMO (on only one small part of IP) is 11 billion market for Hepc market up for grabs in competition between old guard and new BP. And, 11 billion market in INF replacement up for grabs. Maybe PPHM will eventually trade for a function of this market size like INHX.
PPHM 80mm market cap. Incl shots on goal for virus, Avid improvement, shot on goal for Cotara, shots on goal NSCL.
Also, remember this dilution thing works two ways. Sell 20mm ATM at 5 and the balance sheet looks a whole lot different.
Tis the season---so go out and have some egg nog and stop fretting. Just accept the possible wipe out and then hope for the best and be of good cheer.
Best Regards for the holiday season.
RRdog.
Fire Fox,
IMO an excellent comment and very real world instead of just inexplicable speculation on every possible absurd scenario.
There is a real world market fight shaping up. Whose markets need to be protected?? What moves need to be taken???. Whose ox is being gored?? The analogy is something like the "paper" market. The "demise" of the use of paper was supported by the rise of e mail, fax, electronic print and publishing. All of those markets flourished and we still use more paper than before the electronic revolution.
In addition, whichever company buys or licenses Bavi viral from PPHM gets a leg up on the whole interferon replacement market which is a much larger question that Hepc. That's not only "old world" defense but that leads to "new world" offense in the marketing universe.
Thanks,
RRdog
Good pickup re Celgene. Anything is possible.
This BOD and specifically E.S. has been called every name from liars to penny stock charlatans. I am surprised noone has accused them of pedophilia given the news background.
I am just pointing out that they are much more sophisticated and connected than people generally give them credit for and, if a deal presents itself based on new double blind data, they are capable of doing it. In addition, other members of our regulatory team are very well connected and very able deal makers.
Any BOD that is so universally detested by its long term shareholders (incl myself at times) must be doing something right or there would be no long term shareholders.
Sometimes, staying indy, not making earlier stage deals, holding out longer into the IP and clinical process can pay dividends. Sometimes it can present opportunity. That's what we are talking about. Is the disconnect in PPHM market value vis a vis a stock like INHX (i.e.) a bankruptcy tell or an opportunity. One hint: bankruptcy is usually a function of debt of which PPHM has virtually none. IMO its an op.
Regards,
RRdog
RRdog
I hear you on that.
Let's hope that more and more of the real deal opportunity at PPHM is influenced by Garnick and his team.
RRdog
Geo,
Just for the record, along with the failures, Roswell had some success. As an example, they did an earlier stage financing for Celgene. Celgene now has a market cap of over 28 Billion dollars.
That should give PPHM shareholders a little better perspective.
I know it is popular to criticize Roswell Capital as inept but, they have been in business for over 17 years, have done over 150 financings for in excess of one billion dollars. One wonders if any of their critics have ever financed a company that grew to over 28 billion in market cap.
During the whole seventeen years of Roswell existance, E.S. has been one of two managing partners.
Therefore my confidence, IMO only, that PPHM mgmt can make a deal given mature phase II double blind data that is supportive.
Regards,
RRdog
The value discrepancy at PPHM relative to the biotech world at large appears tied to thin, isolated BOD and "business" mgmt that has spectacular weaknesses in background, in the areas of PR, and financing. Financing particularly has downweighted the valuation through overlong ATM program.
Depending on your view of the increasing or decreasing value of the IP portfolio you will view PPHM market value as either a screaming opportunity or a prelude to bankruptcy.
I take the former view of rapidly increasing IP valuation and throw in my lot with some of the most brilliant researchers, regulatory people, manufacturing people, institutional minds, and clinicians. This is of course supported by an amazingly consistant and growing body of data in ever more precise and substantial clinical trials and an increasingly mature relationshiip with the FDA..
What is different now as opposed to the last ten years is that the clinical data, FDA rulings, are about to overtake the poor PR and financing of the BOD.. Assuming data continues to come forward in the same positive vein (see MBC data et al.) then it is at a stage that positions the company to partner. Partnering changes the valuation equation at PPHM.
Can PPHM mgmt partner???? IMO even PPHM mgmt can and will partner. Even a blind (and stubborn) pig can root out a truffle now and then.
Therefore, IMO only, I view the current valuation as a huge opportunity.
Regards,
RRdog
Geo,
I think this post is closer to the truth as we know it at this moment. Strategically, I agree with you. Specifically to one company it is difficult to say.
My own answer would be BI could use some help in SVR but I dont know if Bavi can be adapted to their delivery system plans.
Since this field is rapidly moving, it will be interesting to see what niche pPHM can carve out.
Regards,
RRdog
Geo,
Our little discussion seems to have stimulated quite a lively debate with Dew and others. I'm not sure I really hear the answer to my question in all the tempest which was "Why BI specifically would pay big dollars to PPHM for bavi". Your answer, nevertheless is interesting and quite detailed. I guess there are lots of types of HCV and lots of potential combos. Still not real convincing but I am open minded and hope BI is as well and certainly open to a better answer.
Dew does seem to have a way of just picking snippets of an argument that agree with his position and not really getting at the whole picture.
IMO, as stated before, GILD way overpaid for VRUS. Time will tell.
Dew seems to think that anything injectable has little value. If anyone has anything to add re possible conversion of bavi to some oral form, or sub lingual form, or transdermal form of admin, I for one would be very interested in hearing it. Ditto for any form of bavi that could be comboed and then admin oral.
Likewise, I would be interested in understanding anything to do with Bavi advantages vs such mundane issues as time of treatment, cost, storage and shipping issues, marketing issues.
One also wonders why Dr. G et al are spending so much time in this area if it is worthless. As I understand things the current randomized phase II is a direct assault on IFN by measuring Bavi/RVN vs INF/RVN against Hepc. Therefore, if anyone can shed some light on the larger market that PPHM is going after --that would be IFN replacement period and not just the Hepc market--I would also be interested in those thoughts.
Thanks to Libra for his thoughts on bavi as a primo immuno stimulator. That may be one of the reasons time is being spent in these tests vs IFN.
Best Regards,
RRdog
Let me respond briefly to three or four posts in one shot if I may.
Let's start with the easiest which is KT's post 71269 which seems to posit it will be difficult to source shares at lower prices. KT is always optimistic re PPHM and I appreciate that attitude. I hope that PPHM never goes to levels to make it interesting for MD1225 but, for my part--I continue to accumulate more shares as per plan and so far I have no difficulty at ever lower prices.
On the other hand, the MD1225 post seems particularly insipid. Here's a guy who's not even a shareholder posting on this board his technical opinion, his overall market and world political opinion, and his evaluation of relative value in the Biotech world. (BTW for every small biotech that is undervalued there are probably more that are over valued if someone is really looking for comparisons.) We have much better technicians that are shareholders (see JR posts) so why KT is even bothering to answer this guy is beyond me.
Re Geo post 71267 in response to my post 71266:
THIS IS AN ARGUMENT THAT I WOULD LIKE TO LOSE. However, it is late in the game for generalities. No interferon free drug by any drug company works for 100% of the people suffering Hepc. That doesn't mean BI is going to acquire product from PPHM for sizable dollars. BI doesn't need a replacement for IFN as their lead "stated" candidates are IFN free. There seems little interest shown so far by any drug company in replacing RVN.
Since BI efficacy already at 76%:
1. What results specifically would Bavi have to achieve in the PPHM Hepc trial to convince BI to go after bavi to enhance efficacy??
2. What specifically do you see in the BI results that would lead you to believe they need help in SVR or Recurrence?? I can't find it.
3. If you can find a specific area that would be worth BI interest, what dollar amount do you think they would be willing to pay PPHM to fill in that weakness (assuming strong bavi results)??
Re Sunstar post 71269:
It certainly is wild out there in the west.
I hope you are right and PPHM bavi/RVN posts knockout synergistic
efficacy. I like your deep dive into early stage data obtained in our gov't collaboration. Looking forward to Dec release of this data very, very much.
Would like to learn much more about "flexible " modes of delivery for this product.
Hint to PPHM mgmt and BOD:
Many shareholders would like to know specifically what the company plans to do going forward with the spectacular results in MBC.
Many shareholders would like to know if there is any progress in marketing to a partner PPHM "imaging IP".
Best Regard to all,
RRdog
Geo,
I'm sorry but I still dont see anything in all that data that would lead me to believe they need bavi.
The following is from your abstsract:
"All five treatment arms of the interferon-free oral combination therapy of BI 201335/BI 207127/RBV showed high virologic response rates through week 12, defined by measuring the level of HCV RNA in patient blood:
•70–76% of patients who received BI 201335 once daily (QD) + BI 207127 three times daily (TID) or twice daily (BID) with RBV achieved undetectable HCV RNA at week 12, with 13–21% of patients developing a viral load breakthrough during treatment
•57% of patients who received BI 201335 QD + BI 207127 TID without RBV achieved viral response at week 12
•SVR12, which is considered highly predictive of SVR and cure of the infection, was achieved after 16 weeks of treatment in 59% of patients.
The safety and tolerability profile was comparable to other direct acting antiviral regimens."
I suppose if Bavi could move the numbers north of 70-76% toward 96% that would be viable and if somebody could make a serious claim that bavi had some real viable effect on the percentage of future recurrence of the disease in patients that initially showed no virologic response that might be interesting. I just don't see it yet and believe me I'm looking for it.
The best fit I can see is Roche for the ANDS drug they acquired with high efficacy that was not oral and was combo with INF and RBV. I still say that drug is a "lock" looking for a "bavi key" re additional immuno stimulus for more efficacy and for SVR and a non- recurrence "up rating" while lowering all the inf side effects.
Also, IMO, since Roche was already a partner at VRUS, when they bought ANDS it was a market "tell" in hindsight that VRUS was going to get a knockout bid from some BP (it turned out to be GILD) that Roche would not match. IMO I would watch Roche very closely in this viral area because they want to compete and they know all the weaknesses in the VRUS approach which is clearly the leader by market value.
Best Regards,
RRdog
Sunstar,
Your post on Boehringer Ingelheim is very interesting. I will have to look at this company more closely. It is also interesting that they have done some manufacturing business with PPHM already.
I do note their interest in an interferon free regimen. If you have any information that they are specifically interested in an "interferon substitute" for improved SVR or any other reason please post back. I am not sure interest in an interferon free regimen which is universal in HCV candidates translates into a desire for Bavi as an additional component in their treatment. If it does for some specific reason, I would surely like to know about it and understand why. Ditto for any other companies that "specifically" say they are looking for an "interferon substitute" for specific reasons rather than to just be interferon free.
Best Regards,
RRdog
Sunstar,
I agree with you completely on the Bavi for MBC. Simply put regardless of whether it is single arm or octo-arm and regardless of whether CR is documented by imaging or biopsy, one can't get away from a 24% complete remission. I still can not find a better stat in any study on MBC.
Your comments on PPHM 100% ORR in Her2-pos BC are of highest interest as well. I hadn't realized that segment of BC was so large (5 bill).
What was disturbing to me was the sort of orphan status of this single arm study on MBC within the PPHM clinical universe. However, the more I look into single arm studies the more I uncover the "myth" of their lack of utility. More and more the FDA is using single arm studies to move to accelerated drug development programs particularly in diseases that are deadly unmet needs.
No less a regulatory authority than PPHM's own Dr. Rob Garnick (who better) has been commenting repeatedly on the effective use of single arm studies at the FDA. His most recent comments on this subject were in reference to Pfizer's new drug accel approv by the FDA (Aug of this year) for Crizotinib in NSCLC that is AlK positive. This was after two single arm studies and by the way with only an ORR of just 50% and 61% respectively. I am now much less concerned about a path forward at PPHM for MBC and it will be interesting to see which direction the good Dr. opts for. (IMO I would still like to see it broken out (off platform) for partnership but am sure that Dr. G knows much better than I how best to utilize the ammunition.)
In closing I would like to hazard one more guess. Since very smart people chose to move forward into double blind randomized studies in NSCLC before MBC and other indications based on the preliminary studies, and we can see how good the data in MBC has been coming forth, IMO-- data from NSCLC has a high probablility of coming in "hot".
Holiday Greetings to all,
Best Regards,
RRdog
Thank you Stoneroad.
RRdog
Mojo,
Thanks again for an excellent pickup.
I have been thinking about this meta breast cancer data and though it is insufficient, it is probably the finest result in history overall in Breast cancer. (If you can find a better result please let me know.)
However, because of the trial design we need more data.(Mgmt error)
The best use of this data may not be in breast cancer. It may be in the overall negotiation with BP and in the overall discussion at the FDA re other products such as NSCLC when a discussion of the whole body of data on Bavi may be important.
Further alternatives:
1. As you suggest-- some form of FDA acceleration (Garnick) using the CR as foundation.
2. Immediate initiation of randomized larger test (time consuming)
3. Some form of partnering that isolates BC from the Bavi platform. Contrary to popular opinion, I believe that is possible with a strictly crafted agreement as to additional labeling and usage or perhaps better, to a geographic isolation.
Thanks again,
RRdog
Cheynew,
Great pickup. Real good third party article on lipids and PS.
Seeking Alpha has a broad following and is often quoted to me for other reasons by many market participants.
Thanks
RRdog
JR good morning,
Nice pickup on the 24% complete response. That is some increase.
You would think PPHM could do a better web site job and PR job..???!!! Jay must be on vacation. As for PR quality, it is defined not by just reporting the news but by explaining what is signifigant within that news and why. The PR quality at PPHM remains about the same level as Lytle financial forward planning.
Repetitive education is a big part of PR.
It is clear PPHM must do something further in breast cancer. It is a huge market and their results are outstanding. It would be interesting if mgmt could figure some way to break breast cancer out from the whole platform and partner it separately as opposed to just using this data to build the platform case. (Regardless of flack, IMO this is possible to do. It just has to be a very tight and well crafted agreement or an agreement limited to a certain geographic area. You get more for retail than for wholesale.)
Even though I agree with you that the technicals still look poorly both on a stock basis and market basis the following:
I know you are a man who can see the question from all sides. Wouldn't get too caught up in the negative technicals, thin trading , overall bearish market, world events, etc., etc.. One of the reasons to be in a "speculation" like PPHM is that when a good stepfunction really occurs none of the prior mentioned items really matter. Learn something from ANDS and more recently VRUS that had traded 20% off its high before offer. They are recent examples in a long line of quantum events in biotech.
Use your big picture brain. Though this data is not a clincher, "strategically" it is very strong. If you are Roche for example, that is looking at this company for viral and other reasons and just lost FDA for Avastin breast this picture is step by step becoming compelling. Ditto for other companies that compete with Roche.
Above having been said, would always be very interested "if and when you think technically PPHM gets strong enough to add shares" and I understand in advance that the market overall could easily test the 10/04 lows. Also, understand the MM's appear to have a "strangle" on the market place in PPHM in anticipation of further ATM action.
Best Regards,
RRdog
Thanks Cheynew,
Just want to know you are alive and thinking and not so put off by price and technicals that you miss the big picture.
Regards,
RRdog
Cheynew good morning,
We all know this is a thin stock with an ATM program so the price of the day could end up anywhere. However, why not suspend the cynicism for just five minutes and really look at the results.
The overall MOS seems to be improved by about 45% against similar tests. Granted this is not a double blind randomized test but this is very interesting data. This is a big step forward percentage wise.
A better question is why, when you look at the pipeline data on the PPHM site you cant even find a phase II breast cancer entry?? The only entry I find is phase I IST. Makes you wonder what else is missing from the web site and why???
Follow up question is where PPHM goes from here with breast cancer and what this means to the overall bidding corporately. In light of the Avastin failure does this study carry real weight for partnering??
Regards,
RRdog
PD,
This is a good "dig up" on Dr. V. He doesn't just have good credentials he has world class credentials and world class connections. One of the great "tells" in early stage investing is to watch the "feet" that move toward the subject company.
IMO Dr. V. would not make an investment in PPHM if he were not assured of a)survival and b)a reasonable exit strategy. Though again, the investment is not large to start with by institutional standards, the more important issue to a guy like Dr. V. will be his reputation.
Dr. V's network is as impressive as the Dr. himself. It is quite possible that there might be follow on to his 13 F filing. In addition, Dr. V. would be IMO in an ideal position to introduce PPHM to other medical entities he is close to should PPHM wish to divest itself of a technology like "imaging".
IMO it is unlikely that Dr. V. would buy into "me too" type technology in highly competitive fields populated by better connected and financed companies. Judging by his credentials he is too smart for that. IMO only it is more likely that he is interested in the "unique MOA" of PPHM tech. and the bigger picture.
Best Regards,
RRdog
You never know the full background, but these two buys are definitely intriguing.
Ayer Capital is private and my "swag" is that, unless they specialize in biotech, it is unlikely that they found PPHM on their own. It is highly likely that they were introduced by or certainly in close contact with one of the analysts that follows PPHM. Were that to be the case it means the analyst continues to like the developments he sees and that the story is salable to a professional buyer in spite of the sizable risk and weak balance sheet.
The Goldman Sachs buy speaks for itself. Goldman and or their clients have access to the best quality biotech research. Though this is a small buy by Goldman dollar standards they would not invest even one dollar if the story didn't really interest them because of "time" not "dollar" restraints. Obviously, should clinical research emanating from PPHM be compelling, this group could increase this position in size.
Best Regards,
RRdog
KT,
I think you are being difficult and disingenuous in your argument. This discussion has been going on for a long time.
Compare the optics of having big IB on your board that can promote your price to say three and then do an offering albeit with wts vs the low cost ATM dilutive financing between .50 and 1.00. There is a reason big banks make the big bucks. Sometimes it's good to have strong financial allies. (Not to mention how it strengthens your negotiating hand with BP. Once BP sees BF on the board the optics change there as well.)
Regards,
RRdog
Compare that to the price you are paying in dilution and see what looks better.
Regards,
RRdog
KT,
Thanks for the thoughtful reply.
I am aware that PPHM is seeking partners, trying to encourage bidding competition and is moving toward data inflection points.
They can posture going it alone but, "It is not in shareholder interests" for PPHM to go it alone. I repeat it means terminal dilution with an uncertain outcome.
PPHM could extend this "posture" if they could cure their glaring deficiency in "promotion" and their glaring deficiency in "financial or corporate alliances". How much better would the optics of PPHM be if someone from Lazard or Goldman went on the PPHM board?
From an informational point of view I found todays cc very interesting. One little noticed point was SK remark about liver cancer data being of interest to a potential non US partner. From a promotional point of view the presentation was as flat as ever. Unfortunately Lazard cut us out from the Q and A which could have been very interesting. Alas, we are not clients of Lazard.
One thing PPHM might consider is "the middle way" --sort of the zen of negotiating. They could consider a loss leader deal on 10-20% of assets at less than top dollar so as not to continually dilute 100% of the assets at rock bottom prices. They could consider regional sales of IP. Just a thought to throw out there.
Nothing is black or white or all or nothing.
Best Regards,
RRdog
Much of what you say I agree with KT but, "understanding who we are as a company" is critical and going it alone is not really a viable option for shareholders.
We are down to the short days now. It is very important that the management of PPHM really understand who and what they are and not try to be something they are ill suited for. IMO PPHM is an excellent research boutique that sorely needs partners. If it tries to become a major manufacturing unit or to go it alone as a drug development company and marketing company, while "underfinanced", there is nothing but terminal dilution with no guarantee of success.
Therefore, as most would agree, we need to get on with partnering.
Without any advance PR announcement, I expect the Lazard conference to be more of the same. It will be interesting to see if mgmt takes the hint and makes a more business like presentation. It will be particularly interesting to see if anyone at Lazard asks more intelligent questions about the business side and projected timing to partnering and ATM termination.
I think all the "sellers" in this stock are aware of FDA meeting for Cotara and high probability of FDA granting a phase III. The "sellers" are not fearful of this event. The much more important question then becomes whether PPHM gets an SPA allowing them or a partner to sell the product during the projected two year phase III. Without an SPA, the question is how quickly PPHM can partner Cotara and how many "front dollars".
PPHM would completely misidentify itself were it to go it alone on phase III with no assurance of ever being commercially viable. PPHM might get lucky and partner Europe and try to hold on to the USA. The only other tack that occurs to me would be to finance Cotara in a separate vehicle with PPHM acting as a sort of GP. IMO I dont think PPHM mgmt has shown this kind of financial creativity and I would put it at lower probability. Once we see the complete FDA decision, speculation as to partnering may pick up.
Pretty much the same scenario for Bavi viral and Bavi NSCLC. In the same way PPHM mgmt insists they "dont need money" or will have "no problem accessing money" , mgmt also insists that they are prepared to "go it alone" if they don't get what they feel is a fair market value for their products. Both sets of statements appear to be false negotiating positions IMO "on the merits". IMO there might be some pick up in speculative buying should the Bavi numbers on these clinicals be positive -- and again--- relative to partnering.
Hint to PPHM mgmt: If you can't even fool your retail shareholders, there is virtually no chance of fooling BP which is familiar with the time and dollars for clinicals and marketing. If you can't even fool your retail shareholders, IMO there is virtually no chance of fooling major financing which is much more sophisticated about business plans and cash flow than say the CFO of PPHM. So LET'S GET ON WITH PARTNERING.
Even "ANDS", one of the few company with as bad a ten year chart or worse than PPHM, was able to partner and able to partner on Phase II data. LET'S GET ON WITH PARTNERING.
Best Regards,
RRdog.
PPHM mgmt is to be applauded for getting invited to the Lazard Health Care Conference. This is a clear step up in class.
There may be many representatives of BP at the conference and I am sure they will be interested in the usual scientific presentation. However, the vast majority of the audience will be investors and bankers. It would be interesting if PPHM could also emphasize the "WHY" it does what it does as well as the "HOW".
1. PPHM should emphasize why it chooses certain hard to treat diseases, deadly diseases, unmet medical needs, as the quickest way to regulatory approval.
2. PPHM should emphasize the size of each particular market it is addressing. Investors love to know the numbers and the size of the "P" in the equation V=P x S (V=value, P= the size of the problem, and S = the elegance of the solution).
3. PPHM should be less opaque on their BUSINESS plan. They should talk about their timetable to partner, sell or lease their IP. Investors love to know what the timetable is.
I admonish PPHM mgmt to seriously consider the above points. Why waste another golden opportunity to speak in front of a major INVESTING audience. I am sure PPHM mgmt does not enjoy selling equity at rock bottom prices and would enjoy higher prices for their stock.
Any shareholder that agrees with the above should feel free to pass this open letter on to management as frequently as they deem necessary.
Best Regards,
RRdog
Geo's point is well taken. The Hepc market is approx 10 bill moving upwards of 15 billion in all studies going forward. It is large and complex with varying types of the disease. Even smaller sections of the market would be huge for a company the size of PPHM whose product moa covers parts of that market difficult to treat.
In response to JR I think CP makes some good points. There are difficulties with non interferon products and interferon was used for a reason so an interferon "substitute" may be better than simply removing the interferon moa. Also, there are a lot of difficulties with oral products that are not present in injected products. There is a long way to go in clinical trials to prove efficacy with oral administered drugs. IMO ,i.e., I think VRUS is way overvalued and the market is beginning to look at that valuation as other competitors like Abbott announce their own product plans.
Roche seems to be covering the whole roulette wheel in its approach (its always good to have lots of money). IMO the Roche acquisition of ANDS at six times its recent low market valuation was for the "efficacy" shown by Septobruvir and has little to do with oral admin. (Roche has its own "oral" approach which may or may not combine well with Septo). Septo's results were in combo with "interferon" and ribavirin. There is a lot of testing and recombining of this drug to go if you remove the interferon component.
IMO only if Roche were willing to pay 320mm for the Septo "lock" they might (and I only suggest "might") be willing to pay for Bavi as an interferon substitute and "key" to that lock.
I have not seen any info yet from PPHM on the difficulties and or possibilities of administering Bavi in an oral form. I would like to learn more about that set of problems and or possibilities. Obviously it would behoove PPHM mgmt to address this question were they awake.
It will be an interesting view of mgmt's wisdom ( and here I include Garnick specifically)-- assuming the Bavi viral results are reasonably positive--to see what commercial results they can get. They understand the competitive nature of the Hepc field and they have chosen to spend scarce PPHM dollar resources in this area. So if Bavi viral results are good I would want to see some commercial result. Again, this is an area where SK has specifically said in public that he would like to license.
Ditto on the above paragraph for all other product lines going forward. This is not testing for testing sake. Mgmt is making a judgement not only that the tests have a reasonable chance of success but that clinical success can be translated to commercial success. This is why we hire guys like Garnick with bravado statements like "I also know how to kill a drug."
Ditto on the above two paragraphs specifically for Cotara. PPHM has spent a great deal of time and money in this field (as we know) and IMO does not have the resources to drive large multi year phase three studies both nationally and internationally by themselves. The time grows short to see if our resources were wisely spent or squandered, and to see what kind of commercial arrangements PPHM can make for Cotara with or without an SPA.
The time grows shorter and shorter to ask the old "Wendy's" question "Where's the beef?"
Best of luck and best regards,
RRdog
Merrill Lynch analyst ---certainly behind the curve---raises her target on INHX to $10/ share just prior to this message. (Check out INHX intraday chart and volume).
Reiterate IMO it will be interesting to look at the PPHM Hepc test data vs INHX data as PPHM not using interferon in primary arm. INHX data is Phase II data.
Reiterate today is the first real alpha day on volume versus a down market in a long , long time. IMO if possible would continue to average PPHM at least at the rate of ATM dilution so as to maintain percentage position.
RRdog
This Merrill report on INHX indicates they are testing their drug in combo with "interferon" and ribavirin.
They "would like" to do future interferon free cohorts??? but this may have other problems. IMO They need an interferon sub.
As a reminder PPHM is testing Bavi + ribavirin vs Hepc and of course no interferon in sight. It will be interesting to see what PPHM results are compared to INHX.
This report also talks about a $6/sh target for INHX roughly in line with other peer company valuations (i.e. co's primarily involved in Hepc) of about $400mm market cap. (INHX now trading at $8/ sh far in excess of 400mm)
IMO PPHM will be unable to target the $400mm plateau until the ATM is capped with some form of alternate financing or non dilutive dollar deal infusion. Were the ATM to be shelved, a $400mm cap area would seem (at minimum) a logical basing station IMO relative to the rest of the universe.
Regards,
RRdog
This Merrill report supports my theory IMO that big pharma will purchase components for their strategic goals. Bavi viral is a logical component for purchase as an interferon sub .
Regards,
RRdog
c58da9b710df662c BofA Merrill Lynch does and seeks to do business with companies covered in its research reports. As a result, investors should be aware that the firm
may have a conflict of interest that could affect the objectivity of this report. Investors should consider this report as only a single factor in making their
investment decision.
Refer to important disclosures on page 3 to 5. Analyst Certification on Page 2. Price Objective Basis/Risk on page 2. Link to Definitions on page 2. 11089953
Inhibitex Inc
INHX starts new studies as
planned
?? GT2/3 study details
INHX announced the initiation of a 90-patient Phase 2 study for its HCV
nucleoside inhibitor INX-189 in patients with genotype 2/3 disease, consistent with
its previously announced plans. The study is designed similarly to a competitor
trial from VRUS, using a combination of INX-189 with standard of care
interferon/ribavirin with the primary goal of selecting a dose that maximizes viral
cures (SVR) with 12 weeks of total therapy. We expect SVR results around mid
2012. The study is evaluating three once-daily INX-189 doses (25 mg, 50 mg,
and 100 mg) and placebo, and also allows for response guided therapy, in which
patients not rapidly responding would receive 24 weeks of therapy.
Initial look at higher doses
INHX also announced a new 7-day monotherapy study, designed to evaluate
higher doses of INX-189. This design is also consistent with expectations based
on management’s previous comments, and will evaluate 200 mg, 100mg 2x/day
and 100 mg in combination with ribavirin. Higher doses (400 mg+) are possible
pending results on viral declines and tolerability. We expect data from this study
before year end, with a possible update around the AASLD meeting (early
November) from the once daily 200 mg cohort.
Next steps: study expansion, IFN free evaluation
Management is focused on creating value by adding INX-189 to complementary
drugs to create an interferon free regimen. Management remains committed to
initiating drug interaction studies with potential partners before year end. Efficacy
studies would potentially start in 2012. The ongoing GT2-3 study could be
amended to include IFN free cohorts.
Company Update BUY
Equity | United States | Biotechnology
19 September 2011
Rachel McMinn +1 415 676 3519
Research Analyst
MLPF&S
rachel.mcminn@baml.com
Masha Chapman +1 415 676 3575
Research Analyst
MLPF&S
masha.chapman@baml.com
?? Stock Data
Price US$3.29
Price Objective US$6.00
Date Established 9-Aug-2011
Investment Opinion C-1-9
Volatility Risk HIGH
BofAML Ticker / Exchange INHX / NAS
Bloomberg / Reuters INHX US / INHX.O
Inhibitex Inc
19 September 2011
2
Price objective basis & risk
Inhibitex Inc (INHX)
Our $6 price objective is based on an enterprise value (EV) comp analysis for
INHX relative to peer HCV companies with early stage clinical assets. Our PO is
based on the belief that INHX will trade towards its peers and reach EV of $400M.
INHX trades at a significant discount compared to its peers IDIX and ACHN at a
similar stage of development. The key derisking event for INHX will be 12-week
safety data for INX-189 in 2Q12 that we expect will drive shares either materially
higher or lower relative to our PO. Assuming positive safety data and promising
initial direct antiviral data that INHX would generate in 2012, INHX has the
potential to monetize INX-189, which should also drive shares higher. Risks to
our valuation are: 1) negative safety and efficacy data, 2) inability to enter into
clinical collaborations, 3) disappointment around choice of future partners, 4)
positive competitive news flow, 4) negative news flow from potential partners.
c58da9b710df662c BofA Merrill Lynch does and seeks to do business with companies covered in its research reports. As a result, investors should be aware that the firm
may have a conflict of interest that could affect the objectivity of this report. Investors should consider this report as only a single factor in making their
investment decision.
Refer to important disclosures on page 3 to 5. Link to Definitions on page 2. 11098096
Biotechnology
Implications of ANDS
acquisition
?? Good for small cap HCV
Roche and ANDS announced today that the companies have entered into a
definitive agreement for Roche to purchase ANDS for ~$230M net, giving Roche
ownership of ANDS' Phase 2 HCV drug candidate setrobuvir (ANA598) if
successfully consummated. This announced acquisition underscores the point
that pharma will purchase experimental HCV drugs that complement (at least in
theory) internal pipeline efforts aimed at developing an interferon free all oral
regimen. The remaining small cap HCV companies (ACHN, IDIX, INHX) would
benefit from similar transactions. Additionally, we note that the price points of
HCV acquisitions have been overall small ($175M-$400M). We note that INHX’s
enterprise value is the smallest of the three at $219M. Nonetheless, the
acquisition itself is surprising to us, because setrobuvir is from a drug class that
has struggled significantly (non-nucleosides), and the combination with Roche's
nucleoside R7128 and protease inhibitor danoprevir decidedly expresses the view
that relatively impotent products incapable of being developed with interferon if
mixed together can create a competitive regimen. We favor stronger drug
backbones as the preferred combo approach.
Merger Acquisition Divestiture
Equity | United States | Biotechnology
17 October 2011
Rachel McMinn +1 415 676 3519
Research Analyst
MLPF&S
rachel.mcminn@baml.com
Masha Chapman +1 415 676 3575
Research Analyst
MLPF&S
masha.chapman@baml.com
Biotechnology
17 October 2011
2
Link to Definitions
Healthcare
Click here for definitions of commonly used terms.
Biotechnology
17 October 2011
3
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Biotechnology
17 October 2011
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Biotechnology
17 October 2011
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Regardless of where PPHM ends the day this is the first real alfa move I have seen in a long, long time on volume while vs a down market.
I note that mdvn moved up over 700mm market cap recently
I note that inhx moved up over 300mm market cap recently
I note that inhx is looking for an interferon substitute.
I believe everyone will be looking for interferon substitute or a drug that doesnt use it at all.
I note that PPHM is only about 90mm market cap.
I would not infer real fundamental progress from every technical move up or down. That is a fools game in small biotech stocks.
I recall that HEPC is just one small part of PPHM program.
Regards,
RRdog
Shooting "yourself" in the foot is a different matter--especially if you do it more than once. I am no advocate of the ATM as you know.
On the other hand, I hope they all go deep in the money on their options as soon as possible. Under your scenario that is what their intention clearly must be.
Regards,
RRdog
You are listening to too much drivel from this board and elsewhere. The likelihood that BP would short PPHM to buy it cheaper later would be a form of manipulation. BP has deep pockets and lots of lawyers to advise them and would not want to be open to a class action suit larger than all of PPHM IP is worth.
Go worry about something real.
Regards,
RRdog
CP,
If a brick ever hits you in the head you"ll know what a "lump sum" really is.
Even better, if PPHM ever makes a partnering deal with serious dollars involved you'll get a "lump sum improvement" in your net worth.
LOL
RRdog
What we do know is that JMP is a much bettr IB than any of the other houses PPHM has dealt with or who have reports on PPHM. Just do the standard diligence on JMP. Also , their analyst has first rate credentials. Also JMP MO is not to do small rinky dink financing. They are capable of much more sophisticated financing in size when appropriate. That's what we know and that's all we know.
If PPHM really wants to get close to JMP for future reasons and talk about fundamentals that are not well understood by the street all they have to do is have a well crafted non-disclosure letter signed. It's done all the time.
Best Regards,
RRdog
The crux of the matter is not whether mgmt took a long time or held off partnering. The crux of the matter is whether bavi is a good substitute for interferon and additive to overall efficacy and SVR and whether BP will pay a lot of money for that result.
As to "who takes what seriously" there is a big difference between posters on a message board and BP. Roche just paid 230mm for a phase II drug that had better efficacy vs HCV in combo with Ribi and interferon than (Ribavirin +peg interferon alone). PPHM is running randomized test with Bavi + ribi vs the same (Ribi + peg interferon alone). If PPHM Bavi also demonstrates better efficacy AND MUCH FEWER AEs, IMO a lot of people with a lot of money will take it very seriously.
Best regards,
RRdog
KT
Thank you for this excellent post which compliments my post 69694 but is better stated.
Regards,
RRdog