and possibly the closest event will be that Levadex has been approved. Word has been that the FDA would give their opinion in Q2....which ends this week. options with their quadruple witching are now behind us....could be a very interesting week.
"What money AZN collects will be funneled back into the post approval studies."
I strongly disagree. The costs of an observational study for AZN is much, much less than a fully controlled, randomized CVOT. Not even close. This will make money from the start for AZN/NKTR.
Despite all the angst and FUD put out there by one or two posters, a great phrase from Freud comes to mind: "Sometimes a cigar is just a cigar". Also....it was either Cow or hijacked who said it....they had trouble seeing how the committee could look at the extensive trials that AZN conducted, with no imbalances or signals being present, and advise or rule in strong negative terms against the drug. Of course, anything was possible but sometimes "a cigar is just a cigar" and there was nothing hidden in the data that would justify a CVOT, pre-approval. Any one who listened to the ADCOM testimony and discussion came away convinced after day one that the ruling would be one that AZN/NKTR wanted(you could even argue that they came out far ahead of the other sponsors). Even the moderator indicated he saw either an extremely weak signal or no signal at all. These were very reasonable professional who gave very reasonable advice. IMO, it is up from here.
"There were definitely a few zealots on the panel with an attitude of there's always a way to do the study, and I don't care what it costs that's on the invesigators tab".
Having listened to both days, it was clear to me that there was an even bigger subset who couldn't quite understand why they were even there discussing this....they simply did not see a meaningful signal. And the misunderstanding (with votes needing to be changed) on the major issue of a randomized CV trial was laughable. I agree, azn/nktr came out way ahead and, imo, only an observational study will be asked for. The match has been lit...
My understanding is that this discussion was about new drugs of this class which were currently under potential development. I listened to both days and came away with this being strongly positive for Nktr and AZN. One of the committee members even noted the "heroic" efforts that Azn made in their safety studies to evaluate all the moving parts.
then good news from the Adcom tomorrow will be followed very shortly by an approval of Levadex(supposedly any day now). Talk about a regauging of valuation!
Another way to look at the expanding royalty issue and doesn't include milestones:
"Robust Research and Development Activities with Many Drugs in Clinical Trials
The biggest strength that Nektar has is their robust research and development activities.
With a dozen drugs in their research and development pipeline, five of which are in the last
clinical trial stage, they have a bright future ahead. Nektar has found three partnerships for
four of the five late-stage programs with brand name pharmaceutical companies: Bayer,
Baxter, and AstraZeneca; they project that these five drugs could generate over $750 million
per year in royalty income.21 This puts Nektar Therapeutics into a good position to achieve
positive cash flow in the upcoming years.
21 31st Annual J.P. Morgan Healthcare Conference Presentation"
"An analyst estimated 8.5% royalty for BAX-855 a few years ago. Not sure where his info came from"
Not even close, according to the author who attended the JP Morgan conference awhile back:
"Contrast this with the lofty double digit royalties that Nektar has negotiated in each of its agreements with AstraZeneca, Bayer, and Baxter (in the latter case as high as 30% on sales of BAX-855 which is up for an NDA filing this year), and you will clearly see that they're not only science rich but business savvy."
You missed the point.....Most here have never put solid numbers to their projections for Naloxegol sales. But as this approval is for a drug that will provide enormous milestones as well as the new model for much higher(and I mean significantly higher) royalty payments; this amounts to a huge blockbuster deal for Nktr; especially in the current time frame. As to actual sales, we will see. But in all presentations, Azn makes clear that they believe the drug addresses a very large and unmet need, and they are currently looking to begin studies that will enlarge the footprint even further.
OK....let me see now. As we get near to ADCOM, the discussion being offered is that even if a favorable review is put forth next week by the committee, the drug will not be a blockbuster as far as sales. X-men superhero strikes again. As far as Nektar is concerned, Naloxegol is a blockbuster drug, as it will go a long way(with huge milestone payments) to smoothing the financial path forward for the company. Next week may finally light the match for real and the stock might never look back as then the value of the pipeline and near term events may finally receive validation.
" has given no one a good return unless you are a trader."
Well....no. I bought @ $5 or so 21/2 years ago. I, and others, now await the REAL return on this investment. If things work out even reasonably, this will be my best investment in a medium term horizon that I have had in a long time. We will see.
I especially agree with this idea. In these days of big pharma being pipeline challenged, imagine what they could do to expand the pipeline with their resources. Not only new molecules but an innumerable amount of current drugs can be optimized using NKTR's IP. Critical mass is rapidly being approached for a takeoff in valuation.
"DC i can't believe how you changed the context of HR's words"
Oh....I can believe it."
"That is an entirely inappropriate way to make a point."
Unless, of course, sowing the seeds of doubt was the real reason for the post. Spend some time, look over the many, many posts of his and come to your own conclusions. As board member once said in a great reply to a post of his...."I guess you just made that up"
There is room for every and all kinds of opinions about Nktr on this board. It truly is one of the best out there. Agendas are always present....of that I have absolutely no doubt and I take nothing anyone posts at face value. But taken as a whole, the evidence of hundreds of posts generally speaks for itself. Good luck to all and the answers many have been waiting years for are about to be revealed.
Another point, the biotech industry is like no other out there. There is no product to sell until....you suddenly have the product to sell because of approval. It is simply a binary choice until approval is given.....but if you wait for this to first occur you miss out on the extraordinary value that was there before approval. And therein lies the conundrum for the investor....it really is the wild west in this arena. Many times, the company has absolutely nothing more to say until the results of the many phases can be presented. You either understand this or not , in which case you are bound to be disappointed with most cc's. At this time and imo, the complaints about HR are ludicrous. There are so many events on the near horizon, with and without strong partnerships involved, and the time frame for finally knowing where many pieces of the puzzle fit is now so short that I hope that the many who have waited with the patience of Job over these many years for this very time frame will be patient a bit longer. The good news, imo, is about to unfold and there will be no looking back if that happens. We will see.
Nicholson's remark about PEG was given significant added color by HR with a very different take on the issue. You somehow did not mention this.
As far as HR and the adcom: He added additional comments on this and folks will have to listen and decide for themselves. In any event, i refuse to get tangled in any more discussion about whether the meeting will take place . There is no indication whatever that it will not. By the way, this is a tactic in any shorts manifesto: Any bit of doubt about anything is worthy of discussion and a conversation about this is even better.
As far as a discussion about the current price compared to any meaningful yardstick.....essentially worthless....for now. We are on the cusp of the event explosion that will take place over the next 1-12 months....resulting in more news on orders of magnitude higher than Nktr has ever presented in the past in a similar time frame. At that point, we can judge the price. We will know much, much more; very shortly.
Here he goes again. I challenge anyone to review his many postings and determine what you think his agenda is. Once every 6 months or so , I make my thoughts known about him and I guess you can figure out what they are.
"NKTR customers are starting to make their own peg juice. That's why manufacturing revenue is down."
Not exactly what he said. Revenue will vary from quarter to quarter depending on Nktr needs as well as others. In addition, company has stated that they do not consider themselves to be a supplier of PEG and rather will concentrate on growing their vision of the company.
"Adcom date still hasn't been confirmed for June. AZN/NKTR haven't received briefing material. The date could move out again."
While this is true, you forgot to add that HR was very confident that the date was real and he was not concerned.
"Oncology (except for NKTR-214) and other applications falling by wayside".
Ummm, no. -102 is very much in the forefront of what Nktr is evolving into, and with the many indications emerging for which -102 might be a strong solution, they stated numerous times on the call how important this fast track drug was becoming for future applications.
Look....maybe you are that one investor who comes down on almost every occasion with a negative spin(and sometimes it is very subtle) and has absolutely no agenda. If so, you are the first one I have come across in my nearly 35 years of investing experience. If I am wrong well.....ya learn something new every day, I guess. In any event....good luck.
"First and foremost.. more detail on why taken so long. 102 has fast track, 181 has fast track, yet we heard last September on Phase 2 results."
Huh? You expected to hear that? You got some extraordinary news on -102 and the many indications it is now involved with and -181 had a firm explanation(for the first time) of why they now believe the placebo arm was misleading and their plans for phase 3 going forward. Listen to the call again, powerful stuff, imo. In any event, we will soon see.
I don't know exactly what you all expected to hear on today's call. Many of the events that you have waited for for 5 years and more are now about to happen within the next 3 months to a year. If they are successful, there will be no looking back. If some do not meet expectations, at least you will now know. Listening to the pipeline discussion and other tidbits that HR let drop, I am fine with where the company is heading. We need to see approvals but at least now we will know in reasonably short order. The potential is certainly there, the science has been proven in numerous instances, the areas of concentration for the company are among the most important out there and I believe new partnerships will be there, if need be(although I certainly want them to try to go as much of it alone as is reasonably doable). I repeat....what else did you expect to hear?