I have to be brief. The family is on the road and the house is asleep. Checking my iPad and I appreciate your contributions, muddyc. Didn't the abstract come from you? Thanks.
While they could run their deadline into early June, I think it very likely they will PR something about flu soon. But, again, I'm not losing sleep over it. And, yes, every indication is that they are moving away from their old flu progress. If not for RSV, I'd be very disappointed.
Let me speculate that NVAX feels they have a blockbuster on their hands with RSV and they are not inclined to waste time and money on a flu vax that shows incremental advances over the current market when others are already swinging for the fences with the stem HA target. NVAX may feel they have the time and tech savvy to bring a "universal" flu vaccine to market. They will have the money if RSV is a success.
If the ten year plan includes combo flu, and the flu target is moving, don't waste time on old antigens. If the combo flu vaccine is much easier to produce without using VPL technology, and they can save a royalty payment to boot, then go for it. It isn't like the flu vaccine is the lead product where a setback might cost you a few more financings. NVAX should stay on the cutting edge.
Warning: ALL LATE NIGHT SPECULATION. let's see what they PR.
I am also surprised there has been no PR. Stan still has a few days left to keep his promise of an update. I'd be more surprised if he blew this off. Didn't his words emphasize by the end of the month? Perhaps Friday after market close?
That said, it seems to me they have laid out the flu-vax plan already and are changing course. We are a few years away from a new NP vaccine. While I am curious about the science and business plan, as an investor I don't think the flu update will have much effect on SP. It's all about RSV now.
you are right skeedaddle,
Let him sell a little. The rest of the story:
Not only does he own 4,000 shares indirectly each for Casey and Dustin Evans (presumably family), he now still owns 340,977 shares directly and on 12/31/15, had options for another 305,000 shares per the Annual Report. Since last year Mr, Evans was awarded 40,000 of those options at the ASM (exercise price $8.94), I would expect another similar award for him in June.
While I love the premise of pegph20, this and few other inconsistencies in the stage 1 data has me cautious ahead of stage 2. Like everyone else, I'm looking forward to robust and consistent data in the unhalted cohort sometime this fall.
Muddyc - Here it is, but this is a pretty early document and it's relevance is fading fast.
Too add a minor point: some might not realize that because of the calls, every share converted when the share price is over $6.81 puts cash into the bank for NVAX. For instance, converting with SP = 8.81 makes $2.00 per share.
birdy - sort of. I'm a deadhead. I have lived most of my life in and around the SF Bay Area and am of that generation. I have used some variation of fotd on multiple mbs for a long time and the connection to the song seems to align with my tendency to play the devil's advocate in discussions. And, yes, in my younger days I spent many long nights in the ED.
I agree with filvax on the short term pop. but by the time of FDA approval, it will make no difference.
You may be right, birdy but, as you know, that sort of precautionary language is standard in ARs. In the first place, Novavax has to negotiate with the attitude that marketing is not a substantial issue. In the second place, in fact, a vaccine covered by Medicare and recommended by the ACIP will almost sell itself. I would not give away too much for access to someone else's sales-force.
Three wholesalers account for 85% of the distribution and sales of all prescriptions in the U.S.: McKesson, Cardinal Health, and AmerisourceBergen. I'm sure they've had numerous discussions with at least Cardinal Health about the roll-out of RSV in the elderly. They don't need to give away the company to sell the product. I am one who is hoping they stay independent long enough at least to see $1 billion in sales. The undiluted path to there looks fairly open to me.
Controlled Release - Liposomal and Inhalation Delivery Technologies Global Market Analysis, Size, Growth, Share, Trends and Forecast 2012 - 2018
5/12/2016 - NVAX busy in many areas.
A few paragraphs with Novavax mentioned:
The controlled release liposomal delivery technology market is segmented into Novasome lipid vesicles and micellar nanoparticles by Novavax Inc, proliposomes by ADD Drug Delivery Technologies, stealth liposomes by Sequus Pharmaceuticals and others. The inhalation drug delivery technologies are broadly classified into dry powder inhalation, nebulizers, and metered dose inhalation technologies.
North America being the most economically developed economy, dominated the market in terms of market share in 2011. Emerging economies such as China and India make Asia the fastest growing region.
Some of the major market participants include Sequux Pharmaceuticals, Novavax Inc, ADD Technologies, QLT, Bend Research, and BIND Biosciences.
muddyc, any idea if NVAX does anything special to a NP to help it self assemble?
related, from a FT of London article a few days ago:
Another approach is to attack a vital protein called haemagglutinin, or HA, that enables the flu virus to bind to the cell it is infecting. HA has a very variable “head region”, which sticks out of the viral surface, and a less accessible but stable “stem region”. Two teams, one at the US National Institutes of Health and the other a collaboration between the Scripps Research Institute in California and Johnson & Johnson, have reported promising results with animal tests of an experimental vaccine based on different approaches to the HA stem.
“If the body can make an immune response against the HA stem, it is difficult for the virus to escape,” says Ian Wilson, a Scripps biology professor. “We are moving in the right direction for a universal influenza vaccine. This was the proof of principle.”
But a truly universal flu vaccine is not going to spring suddenly on to the market, says Dr Antrobus. “It is more likely that we will see a series of vaccines being released … which will provide more protection against a broader range of influenza strains.”
Abe - thanks for the info. Interesting stuff.
Wily - I'm not suggesting any recent changes to Novavax's flu vaccine has anything to do with a nasal formulation. But down the line, it could be something they work on. Some of their personnel already have a ton of experience inducing mucosal immunity with "Flu-nasal," the IDB product in late development when they were purchased.
Stopping the flu at the mucosa has some advantages in that mild flu symptoms are less frequent than with IM flu vaccines. (A potential disadvantage is a relative lack of systemic immunity which may be more important for the elderly). Since FluMist is live, it causes a minor infection. It is attenuated so the infection is local, where the mucosal tissues are cooler. Recipients experience some rhinitis and a scratchy throat for a day or two. But worry that this attenuated virus could spread into the lungs limits its use to 2 to 49 year olds who don't have asthma, chronic pulmonary issues or immunocompromise. While most patients prefer the nasal vaccine, especially kids, I think it's label restrictions severely limit its sales. There is likely a good market with premium pricing for a VLP intranasal flu vaccine. I am wondering if mainly lobster still thinks it's plausible.
I should be clear. I will ask the question.
Mainly, does a VLP or NP vaccine or any non-live flu vaccine stand a chance up the nose? Knowing the label restrictions on FluMist, is this a business NVAX might go after some day? thanks
wily - an intranasal flu vaccine was the cornerstone of the ID biomedical technology platform. It never came to market and was lost to history after the buy-out. I'm sure Red Lobster could write a book on your question.
No, they do not have to convert, unless the company is bought out. If any are holding converts without having already shorted the stock, they will enjoy the run-up with the rest of us longs. Most, though, are likely hedged and won't care either way. NVAX might be selling for $20 in Dec and their initial convert bond cost and the return are the same because their short obligation rose along with their long position.
Yes, and you only lose when you sell at a loss. Don't sell, don't lose.
Of course I agree, but I would add that I believe the call sellers are indeed covered with shares bought at these levels. Yes, there are games, but they also, in the end, make money from any share price rise up to $6.81, as well as the income from sale of the calls. I don't recall that there is any time element to these calls so I believe that takes the usual angle out of the game playing.
You see it clearly, navaxetogrind. As does stockflippermike and many others. Unfortunately, the dedicated shorts sow confusion and and it is difficult to have the same discussion over and over to make up for that confusion.
What is often misleading in these discussions is the idea that there was a viable alternative to the convert deal such as another SPO. In retrospect it seems clear that the moment Stan made it clear NVAX was staying independent, at least through the next stage of development, the share price was under pressure. This coincided with the worst six month period for biotech ever. If there was ever an opportunity to raise another $200-300 million in that time frame, I can guarantee it was for less than what we are selling for today.
The convertibles are almost certainly hedged with short sales. There are a few postings that show the math to calculate returns of about 30%. Pretty nice! And those convertibles also provide cover for the kind of games that are playing out right now. The company even warned about this, in so many words, in the SEC filing announcing the terms of the deal! (how these games are played is the topic of much discussion on these mbs and, IMO, are so much more complex than most can imagine, it isn't worth speculating what goes on in the dark corners of the shadow banking world) The calls the company bought are part of the games and make for some fun and interesting possibilities. Again, it would be tedious to discuss what these games might be but surely you can see how these instruments can embolden professionals to short and cover and accumulate in cycles that wear out retail.
Assuming good news this year, and all the actions of Stan depend on this assumption, the cost of this money to the company, in the long run, will be much less with these deals. The share price will go up and the effective cost to the company will be as though they did an SPO selling shares at over $9 per. Not bad.
I agree with Kobiashi. Institutional long holdings are interesting but really tell you little about how any institution is situated. With the increase in percent short that coincided with the convert bond offering, it makes much more sense that any convert buyer who had no prior long position has hedged most or all of the bonds. When you figure out the return on the investment, after shorting, it is in the 30% range.
IMO, it is interesting that we now know who purchased some of the bonds but it doesn't tell us much else. It begs the question now of who else bought the convertibles. I would have loved to have been on that short list.