Isis Pharmaceuticals, Inc. Message Board

Gary Evans sold 79,000 shares on April 24th. While investors tend to react negatively to insider selling, one always has to put it in perspective. I don't know what the use of the funds would be for the sale, what Gary's financial situation is, etc, but even after selling 79,000 shares leaves he still holds more than 700,000 shares. As such, the sale does not represent any type of liquidation in advance of news or financial results. Conversely, the only other insider transaction posted on the SEC site for a Form 4 since May 2012 was a purchase of 100,000 shares on March 11th, 2013 by James Young at an average price of $2.08. With the sale of Gary's 79,000 shares, Directors and Exzecutives still hold close to 6.5M shares, not including 12.5M held by Rajiv Modi. I think we can try to put this is perspective.

Sentiment: Strong Buy

The big thing is that when it comes to pandemic influenza and virus vaccines, they are now (and finally), basically ready to develop a vaccine that qualifies for fast-tracking to FDA and European approval. This puts them in the same position as everyone else who would have to develop and gain approval for the same vaccine(s), given there are no approved vaccines for H5N1, H7N9 or nCoV. As such, it just comes down to immunogenic response, low cost production, adequate supply (thus the reason for adjuvents to better ensure immunogenic response with a lesser dose), and time to market, all of which put NVAX up there with the best of the best. Again, this is all "in the event of" a potential pandemic.

Sentiment: Strong Buy

Thank you Lou. Everyone loves a buy-out because it's like winning the investment lottery given most are at a significant premium to whatever the current trading price would have been. Realistically, however, most buy-outs in the bio-tech sector, (not all), occur after FDA approval of a product as it minimizes risk on the part of the purchaser and provides them with a more timely ROI, even it adds to the potential cost of the purchase.

Sentiment: Strong Buy

I’ll say this to finish, everyone is entitled to an opinion. When it comes to offering mine to other potential investors, I try to do so responsibly. If there is anything you can note in my article that over-inflates the companies potential, or misleads potential investors, let me know. In the meantime, good luck to you on your investing.

Sentiment: Strong Buy

I’ll tell you this though, in all my years of investing I can say with absolute certainty that the MOST dangerous and misleading dialogue that can take place with regard to a potential investment is the “buy-out” conversation. You clearly talk about such a potential fate for NVAX to exhaustion. While you can likely name some development stage bio-techs that have been bought-out prior to FDA approval of any product, I can name 2,000 that haven’t for each one you name. It is a very small percentage of companies (even with an FDA approved and marketed drug), that actually get bought-out. Starting or adding to such rumours is only done for one reason . . . to pump the share price. Unfortunately, some investors buy into such hype and believe what are inevitably the inflated buy-out price scenarios . . . look no further than AMRN, which had tangible rumours brought on by reliable sources, including their own CEO during multiple conference calls . . . yet, no buy-out to date and investors who may have bought and held shares since the rumours have lost more than 60% of their investment.

I’ve read one of your recent posts saying that $50 would be a potential price, but the company would be right to block such a bid given the company is more valuable. I’m not sure if you were joking or believe this, but what I can say is that such prognosticating on the part of someone selling themselves to others as ultra-knowledgeable is not remotely responsible and clearly carries with it an ulterior motive. The company has a current market value of $335M. Thinking that any large bio would purchase NVAX for more than 20 times this price, (i.e. - $7.0B) is beyond ludicrous. My estimate of a market cap of over $1.0B in the coming 24 months is both reasonable, and let’s face it, provides a would be investor with a 200% return, which most people would gladly take over such a time frame.

(con't)

Sentiment: Strong Buy

Clearly writing an article is meant to bring investor’s attention to the company, but it has to be based on fact. Everyone who invests should do their own due diligence, I simply help in that process by giving a brief, and hopefully accurate, account of the company’s path to today and what their prospects may be in the future. While you clearly know a lot about the company, its science, the manufacturing hurdles that exist, etc, when writing an article you have to be cognizant of the audience. I indicate that manufacturing readiness under the BARDA contract should be achieved within the next several months, (as indicated by Stanley Erck on the recent conference call) . . . do I then need to spend several paragraphs of an article detailing exactly what this means?? I talk about the start of Phase II and III trials and the potential timing of FDA approval and the process to get there, but do I need to clarify in intricate detail how the necessary vaccines are going to be produced to ensure compliance with the FDA prior to starting the trial?? Do investors really need to know this in order to invest??

The article was meant to illustrate 2 things:

1) That NVAX is in a much better position to profit from a potential pandemic today than it was back in 2008/09 and why I believe this to be so. Was I wrong?? Do you not agree that are they are in a better position and that, depending on timing of a potential pandemic, that they could be called upon to produce a vaccine??

2) They have strengthened their strategic direction such that, beyond seasonal and pandemic influenza, they
have a clear path with estimateable timelines to bring a vaccine to market through the regulatory process, that being their RSV vaccine. Is this incorrect or somehow misleading??

I’m not sure who you are trying to save or what damage you think I’ve done, but to me your reaction sounds just a bit paranoid and overly dramatic.

(con't)

Sentiment: Strong Buy

Truth - You cannot be more correct, although in my experience, most Yahoo message board's carry the same mix. I like getting on StockTwits as well as you'll sometimes pick up some pretty good information. I don't know what it is about biotech stocks, but more often than not you get a few dedicated longs who spend far too much time focused on one stock (at least based on the sheer number of posts) and even more ridiculous bashers that post like it was their job (which oddly enough it is sometimes), and blow every small negative out of proportion. You'll find this same dynamic on the VVUS, AMRN and ARNA message boards, all of which I've posted to a few times and each of which I've been in and out of over the past 18 months as an investment.

As far as an investment goes, NVAX is one that deserves a pretty good look. While your $2.20 could be a brilliant entry point, it may actually decrease a bit more as well, (it's hard to say). What I do feel, however, is that anywhere in the low $2 range will result in at least a 30-50% return within 6-8 months, and perhaps much, much sooner. It is most likely a double within 12 months and perhaps more than a triple within 24-36 months. It would be hard to have said that in the past.

Sentiment: Strong Buy

Thanks again. Unfortunately, the story was an exclusive for SA, so they have copyright. It is unlikely any other news outlet would want to pay for the right to pick it up. That said, Yahoo Finance is a widely accessed resource, which links directly to the story. If you look at the bottom of the story, you'll also notice that it was emailed directly to more than 280,000 people, In my experience, the fact that there are now 2,100 readers in less than 24 hours, and on a weekend no less, says a lot about the interest, especially considering that it was only emailed to 1,232 actual NVAX followers.

Sentiment: Strong Buy

Rez and rgfxrs - Thank you.

With regard to your comments Rez on rabies, malaria, foot and mouth . . . I wanted the article to highlight two key things . . 1) Their position to profit today from a pandemic versus in years past, and 2) Their focused strategy on finally getting a vaccine all the way through to FDA approval, that being RSV, (beyond seasonal and pandemic influenza). I just think potential investors need to know the company is focused and has a definitive timeline for profitability.

NVAX's technology can be used to create endless vaccines, as they have illustrated over the years. It's really time to focus on just a few, then bring more into the fold as you build financial strength through the sale of approved products, at which time you can add resources. There's always partnerships and organizations willing to partially fund the development of differing vaccines to suit their own interests, but, in my opinion, for a development stage company like NVAX, it just serves to scatter resources and take them off strategy.

I did not mention the 2 year extension they could obtain from BARDA in the event they meet their objectives under the current 3 year contract. I suppose I could have done so.

Regardless, their in a good place.

Just to let you know, the article has only been published for approximately 18 hours and has already been read by close to 2,000 people. Not bad.

Sentiment: Strong Buy

The Phase I trial on elderly is fully enrolled and "topline results should be reported" in the coming weeks is how it shoudl have read. That was a clear error on my part that I thought I had corrected, but clearly forgot to do so. With regard to FDA approval for an RSV vaccine, from the time of the NDA submission, it would take at least 6 months. Working backwards, it will take 12-18 months to complete a phase III trial from planning, enrollment, data collection, reporting and NDA submission. I was looking at approximately 2 years for Phase III and NDA submission through to approval, which led to my comment not "anytime before 2015". To be clear however, what further Phase I and II data and studies the FDA will require prior to planning a Phase III study will dictate what gets added to the two years. There is a possibility for the final quarter of 2015, but I would think 2016 is a very distinct possibility and a very reasonable time frame. If it takes all the way to 2017, something has gone wrong.

Sentiment: Strong Buy

That would be the one.

Sentiment: Strong Buy

A lot of opinions relating to the sufficiency of NVAX's clinical pipeline, whether investors are interested in the technology, etc. In my opinion, once NVAX abandoned Estrasorb (yes, remember that??), as their primary path to profitability and began focusing on VLP technology for the development of vaccines, they clearly began travelling what would ultimately be a very long road to having an approved and marketable vaccine. While success for any small biotech travelling the regulatory path comes from having good science, (namely a safe and effective product that meets a medicinal need), leadership with regard to a strategic focus cannot be understated. Their first pre-clinical trial results were published in August of 2005 relating to a VLP based vaccine for H9N2. Now close to 8 years later, we haven't started a Phase III study of any kind. Strategic focus was NEVER this companies strong point. Over that time they have focused on each pandemic strain as it came up, rabies, aids (for a bit), multiple collaborations with LG, GE, Cadila, PATH, BARDA, etc. A small company cannot afford to divide its resources into so many directive pathways, because, as can be evidenced, none lead to an approved product along an acceptable timeline. As such, I agree 100% with their ultimate decision to focus on RSV for long-term stable profitability while working with BARDA on pandemic and seasonal influenza. Everything else at this point is just noise. Had they made the decision to focus on RSV in 2006, the way they have over the past 24 months, they would have an FDA approved vaccine right now. NVAX is now in a much different stage of development, and has a very clear regulatory path forward. Looking at the could haves and would haves is not useful. What matters is where they are today and do they have a clearly defined strategy for the road ahead. I believe they do, and so do other investors. Once they near Phase III for RSV, they'll get a lot of attention.

Sentiment: Strong Buy

I wrote the article in my capacity as an investor/analyst. I submitted the article to Seeking Alpha, which will in turn be posted to Yahoo on the summary page for NVAX, as well as on Seeking Alpha. It will also be emailed directly to more than 150,000 potential investors looking for long ideas or who follow bio-technology stocks. Given the current interest in H7N9, I would expect a few people will read it. So far, more than 35,000 people have read the 5 articles I've published. Hopefully it garners some interest and perhaps starts a bit of a dialogue. I believe NVAX is ready to really take off sometime in the not so distant future.

If you want to see my author profile on Seeking Alpha, search Trent MacDonald on their site. You may want to read my articles on First Solar. I predicted back in November, using detailed analysis, that the pps would get to where it is today, that to spite the huge short interest and general bearish sentiment at the time.

Sentiment: Strong Buy

I wrote the article and submitted it early yesterday evening. It usually takes up to 24 hours for editorial review. Depending on whether there's feedback, it could be posted sometime today.

Sentiment: Strong Buy

I believe it is most likely a website set-up error having to do with only showing so many press releases on one page, then not having the scroll set-up to access the next page of releases in a given year. I'm sure if someone made them aware of the issue they could likely have it fixed.