I haven't read that analyst so I don't know what they base that on. I would think that is about right for worldwide pancreatic cancer sales. but it could be just US...
There are about 50,000 new cases of pancan in the U.S alone annually. If 20,000 received PEG at $50,000 per case, that would generate $1 billion by itself. Breast, lung, prostate, bladder, gastric... all dwarf pancan. So, peak sales on all indications, if approved, would be many multiples of $1.5 billion.
First, the language is "at least five years" and the particulars to be determined later. The negotiators were all tired and they wanted to get a deal they could sign off on. The biotech exclusionary time turned out to be too big a stumbling block, so they essentially tabled it.
If the deal is ratified by Congress, and all the other nations, it will likely be with more than 5 yrs exclusionary. And it will only be for these countries. After the exclusionary period, they will need to get regulatory approval for any biosimilars and it won't be any easier to get by the FDA than it is now.
Just another thing for the uninformed to get worried about and for the Wall Street manipulators to use to try to pressure biotech. It will all blow over when the manipulators want to take the market up. In the end, NVAX will produce a multi-billion dollar vaccine, and we will all be fine. Just hang on...
I reduced my position significant'y after the weak Knight deal. Could the knowledge that this was in the wings have been why Advaxis was so eager to make that deal? That twenty-five million dollars now looks pretty good.
This in the midst of the biotech bloodbath has been the perfect storm for ADXS. It will sell off tomorrow and stay low until the FDA allows the trial to resume. It sounds to me like this has all to do with the surprise of persistent cultures. It seems reasonable that the FDA will change the trial to exclude those with prostheses, or at least to recommend certain surgeries be delayed after dosing. Alternatively, pre-treatment with antibiotic before surgery may be required... At any rate, I'm sure the trial will resume and the share-price will pop. I will start re-establishing my position this week.
"Wild takeover talk" - in 2020? You are correct that recent price swings are wild and not for the investor who doesn't know his portfolio inside and out.
Let me see. You propose that HALO makes its first PEG sale in 4.5 years (presumably with approval the year before) and stays independent. I also propose a 2019 approval but HALO gets taken out in 4.5 years before it has to worry about manufacture and marketing. Not too different, IMO. Either way, be glad you are still holding your shares.
Well, I think that's where we misunderstand each other. What do you mean pegph20 is a combination drug? My understanding is that it is a stand alone drug.
You want my WAG HALO analysis? Here goes:
I don't think we ever get to produce any bulk sales before we are bought out. I think we sell HALO lock, stock and barrel as soon as we get PEG approval.
I think we get some very encouraging OS numbers on stage1 of 202 in January. I would estimate Ph2 202 completed EOY 2016 with good OS numbers. We might get a look at PFS earlier in the year - possibly Q1'16.
I'll guess the Ph3 starts 1H'16 and has good PFS numbers 2H'18 - good enough for FDA approval by EOY.
By 1H'19 we also have a completed Ph2 SWOG study, some Ph2 data on a couple of lung cancer trials, probably some good gastric data, and any number of new trials started with new compounds by companies excited by PEG's prospects. HALO is also well in the black by then because Hyqvia and Enhanze have grown to 200 million in annual revenues and trial costs of PEG are helped enormously (ie: reduced) by companies who want to trial their own drugs with it.
Big pharma then competes to buy this newly approved PEG that will clearly ramp sales over the next decade in one indication after another. HALO plays hard to get since it doesn't need cash and could keep the golden goose for itself. Ultimately, though, it caves to the pressures of impatient shareholders who want to monetize now and to the temptation of cushy positions with enormous salaries at the new company. The deal, north of 10 billion (a number with some history for our CEO), gets done in 1H'20.
Discount 20% per year and the company should be worth about $4 billion now - or $30 per share. The buyout price in 2020 would then be 80. If they diluted with large option and share grants just before sale, let's say $75.
Fezz will say we get approval sooner based upon outstanding early results and breakthrough status granted, perhaps, a year earlier. Maybe. But this is how I think about HALO. And that discount rate is fair because the MOA and early preclinical and clinical studies are so consistent.
For Pete's sake, Fezz! After all this time you still insist on modeling PeG's sales after the Enhanze deals. A bull like you should realize such a model severely limits revenues for Halozyme. Reality is MUCH better. So, let me give my q6 month reminder...
PEGPH20 will be sold separately and will earn HALO revenues independent of the other chemo drugs it is used with. There will be no "mid single digit royalty " since, unless there is some sort of marketing deal, or the like, there will be no royalties at all. Every dime will fall into the. Halozyme coffers. All Halozyme has to do is get this drug approved for any indication and pharma companies will be running their own trials with their drug plus PEG. All subsequent indications will simply increase its use and sales and HALO keeps it all.
Enhanze is a different animal all together. It must be approved each and every time as a combo and thus, after the BP runs the trial, the BP owns the combo drug and pays HALO single digit royalties. Every time you suggest. HALO will "own completely" the rights to some PEG + generic chemo (eg:FOLFIRINOX ) it shows a fundamental misunderstanding.
Love your DD and never miss a tweet. Thanks, Fezz. :-)
I appreciate original thoughts but I don't believe the BMGF grant would be considered as anything but positive by an acquiring party. That market is almost a write-off, anyway. And the consideration of entanglements is minimal compared to many of the other deals that any acquired company would have.
Very nice summary of why RSV maternal vaccination should be a success. Thanks, One small thing, though. The half life of antibodies in the elderly isn't really the same issue as with the infants post placental transfer since the elderly, and the mother, unlike the infant, made their own antibodies. The sensitized immune system can then ramp up a response to a later challenge in the elderly and the mom. The infant can't - at least until its scheduled RSV vax at, perhaps, 4-6 mos.
I can't believe what a fantastic deal NVAX is right now.
That's just an add-on trial. It will go into the file to show increased efficacy with repeat dosing. No big deal. Ph3 RSV elderly will be wrapping up in a year and could be approved in 2017. Revenues likely to start to ramp in 2018. Maternal and pediatric RSV may take until 2020 - not much later. Quad flu and the RSV/flu combo will sell some time in there. NVAX has good funding until then and there will be plenty of options to partner in the meantime if they need.
NVAX is likely to have revenues of 4-8 billion per year in 6-8 years. That could easily be worth $100 billion in market cap - 50 times where we are today. Any buyout would have to take that ramp into consideration.
I am putting my money on this selling being a combination of indiscriminant ETF selling and some misunderstanding regarding the Ph2 results. It is also a good point that many short sellers are attracted to biotechs that are at least a year out from significant results. Bought a lot more NVAX today and getting out my umbrella for the near term.
The Ph2 maternal showed antibodies sufficient to protect infants through 3 mos old.
One would expect better efficacy from the cocoon effect of mother's protection.
Ph3 maternal will vaccinate mothers earlier in the third trimester so to increase the number of infants born 30 days after vaccination. This increase infant protection further.
Piper's comments came before this discussion.
results are definitely good enough for Gates and they are good enough for me.
Bought more shares this AM.
traderross is right. Any fundamentally positive news by HALO, or any other biotech company, would be swallowed up in this tsunami. The selling is EFT related and indiscriminate. If you have cash, now would be a great time to start to move into companies you know well. Hopefully, the biotech sector has at least exhausted its sell-off, if not heading back in an upward direction, when the companies I own release good news. I'm sure HALO understands this as well as anybody.
This is all about the ETFS. They are now the elephant in the room.
People who own the IBB want to sell and the enormous ETF sells it's holdings without regard to underlying fundamentals. We go up either when the IBB goes up or when the fundamentals generate enough buyers to overcome the ETF selling. Long term, the fundamentals win.
You seem sincere in your investment advice to this board and I don't believe you are trying to manipulate anyone. So let me try to help you.
What you don't understand is that most of the brains on this board are long term investors who make decisions based upon fundamental data. Some of us have been at this decades and have built wealth by ignoring short term economic news. Traders, who look to play algorithms and charts and try to handicap broad economic trends, eg: what the fed will do next, are simply gambling and they do not last. They show up on message boards when a stock is shooting up, or falling down, and then leave when the trend breaks. In my experience, they do not accumulate wealth. Most of us ignore them. I'd like to invite you to reconsider your investment approach.
My guess is that you are in your thirties and have had some initial success playing the markets. If you can learn from some of the old timers on these message boards, you may do well in the long run. You cannot invest enough with your game to grow any real wealth without outsize risk, so you will be at this like a nickle slot player for as long as you continue. Instead, buy companies that you know very well and follow them like you are on the Board of Directors. Read every SEC doc and listen to every presentation. Discuss with others who are doing the same. Don't fall in love with a stock and leave when the company no longer meets your criteria. Do this well and I promise you will prosper. Try to beat other market timers and you will go nowhere.
Been out of this stock over a year. I'm back in now and will accumulate in the near term if it stays under 10. My reasoning:
I'm an ED doc who helps to run an infusion clinic, basically, next door. Community docs will send their patients to us daily or twice daily for about a week for al kinds of IV infusions to save an inpatient visit. One common patient is the resistant UTI and we are running out of drugs to use. These folks are usually elderly, or they have chronic urinary tract hardware, and they have been treated for recurrent UTIs so much they no longer respond to the usual sulfa, nitrofurantoin, cephalosporin and quinolone drugs. They may be in for gent or tobra or ertipenum but even those drugs are now seeing resistance. There is basically NOTHIING left to use. There is a real need for ervacycline and, at a minimum, should be able to be approved for a more narrow indication than ALL complicated UTIs.
I imagine the way forward is with a second Ph3 in culture proven resistant UTIs. Yes, the market will initially be more limited, but TTPH can develop their pipeline and increase the indications for ervacycline much more easily if already on the market. They swung for the fences on IGNITE2. TTPH has money, an active and safe drug, a good technology, experience, clinical connections and an atmosphere where the FDA will do almost anything to help a novel antibiotic get to market. Whether they get bought out or stay independent, TTPH goes up from here. I'm playing this for a safe 50% rise within a year. Might use covered calls to help with that.
You know that Kelley still owns ten times the amount he sold, right?
Agree. We need drugs on the market to treat resistant gram negatives. Eravacycline, at a minimum, fills a niche.
I had been in and out of this stock between single digits and low 20s. I'm back in.
I think it is a buy at these prices. Sorry for discussing TTPH here, but that board is a crowed mess right now.
I owned a lot of Tetraphase in 2013. That, and Durata, were the recipients of my antibiotic $$$ after Trius and then Cubist, was bought out. I got out in the low 20s and marveled as it continued to climb. Unfortunately, it was priced for perfection.
It is fairly easy to price the worth of an antibiotic these days with the market having so recently priced tedizolide, dalbavancin, and Cubicin for us. Easy to say with 20/20 hindsight, but TTPH was valued far higher than any of those other companies were at a similar stage of development. The reason was the promise of a great pipeline, plenty if cash, and something that could treat many of the worst bugs: resistant gram negatives ( the other companies I mentioned were in the relatively crowded MRSA space).
The thing is, TTPH still has the pipeline, the cash, and a drug that can beat the worst bugs better than the drug it just failed against, Levaquin. I think it will take a while, but Tetraphase will get back on its feet. It failed at a chance to to be the best drug for all complicated UTIs but, as a doc, I'll tell you that I still want their drugs on my formulary for the rare resistant case. That alone should get approval, though with a narrow indication. And TTPH still has exciting tech. They will be a bigger player some day when they figure out how to best use it.
I am buying now and will accumulate over the next month or two if it stays under ten. This investment could pay off in a year or two but I typically invest in biotech with a five year horizon.
My largest holdings now are HALO and NVAX
I don't consider the expense to be great but I do agree that now would be a perfect time to look again at the stage 1 data. I imagine a look at stage 2 might happen six mos from now.
My take is that the presentation has to be different from ASCO, but it doesn't have to be by much. (look up the differences between the 2013 ASCO poster and the 2013 ESMO poster - not much)
Stage 2 of the Ph2 PEG study 202 has only be enrolling new subjects for about a year. I truly doubt they will present data from that cohort. However, I have hope the January data from stage 1 will be updated since they didn't update much for ASCO. time will tell.