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Trent MacDonald  

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  • Tekmira Pharmaceuticals' Ebola Run-Up Isn't In Touch With Reality [View article]
    1) You may want to do a little more research before making such a broad statement. First of all, over the past three decades alone there have been many NDA's submitted and ultimately approved by the FDA without having Phase III trials complete, or even full Phase II studies illustrating effectiveness. In many such circumstances the drug was given fast track status late in pre-clinical trials, or very early in clinical trials, very much like TKM-Ebola had received back in March when they were in Stage I clinical trials on humans. Narrow use and extensive warnings commonly accompany the approved labelling in these cases. if you look at the FDA website under "Accelerated Approval" they state the following:

    "Traditional approval requires that clinical benefit be shown before approval can be granted. Accelerated approval is given to some new drugs for serious and life-threatening illnesses that lack satisfactory treatments. This allows an NDA to be approved before measures of effectiveness that would usually be required for approval are available."

    They then say:

    "Most drugs to treat HIV have been approved under accelerated approval provisions, with the company required to continue its studies after the drug is on the market to confirm that its effects on virus levels are maintained and that it ultimately benefits the patient. Under accelerated approval rules, if studies don't confirm the initial results, the FDA can withdraw the approval."

    Not coincidently, the Security Council of the United Nations met just last week on the issue of Ebola, only the second time in history the council has met on a health issue, the other being .... you guessed it .... HIV. The FDA attended the WHO's conference on September 4-5, in which they spoke at length, (all public record), of their commitment to work with and fast track potential Ebola treatments and vaccines, as they had HIV.

    So, care to correct your statement?

    2) Only you know your motives for writing the article. I simply point out that you shorted the stock, then immediately published an article denouncing the underlying price using conjecture rather than relevant facts.

    3) Whatever figure you believe may be the most appropriate estimate of cases, clearly you used less than 6,000, then suggested that would be the ONLY one time payment a company such as TKMR could hope to receive because "presumably once the disease is cured and contained, it will stop spreading to other people, thereby eliminating the future "customer base." By saying this, you clearly, and I mean clearly, ignore any possible growth in cases from the current base. You know vaccines and treatments are not available for broad use yet, right? You know that the cases have doubled every 3 to 3 1/2 weeks six straight times, right? Without treatments or vaccines, you do realize that Ebola is going to continue to spread and that it's not going to magically halt at your 6,000 figure, (which in reality has already been long-since surpassed already)? So, while I cannot, nor can anyone, say with complete certainty how far this outbreak will spread, it is a blatantly ignorant statement to suggest 6,000 patients is the most that would occur.

    4) The value in most stocks is the future potential, so you have to at least try to determine where the outbreak is heading and what the demand will be for a treatment once available for use. It is abundantly clear that "if" any treatment does become available for use, the demand will be monumentally larger than the paltry estimates you have put forth. The "if" seems to be working itself out nicely in relation to TKM-Ebola based on all recent meeting of the WHO and CDC where this specific treatment tops their lists as the most promising treatment option, and through the press releases from the company itself over the past few days. You are evidently betting it won't get approved and that the FDA will never allow any treatment to come to market to help curtail Ebola until "years" from now, thus leaving the WHO and all international partners to fight the outbreak using traditional methods, something the WHO, CDC and U.N. have already said will NOT work. Normally I would use words like "perhaps" or "maybe", but in this case I'll be blunt ..... your prediction is "definitely" misguided. As far as commenting on the other treatments and vaccines in development that have been tested on NHP, there are only a few under consideration, as discussed at the WHO conference held September 4-5, (the WHO website has a complete summary of the discussions and treatments under review). At this time, there are only 3 therapeutic treatments that any investor should bother with, all of which I had already pointed out. There are also 2 vaccines, one by NLNK, the other by GSK that are under consideration, according to the WHO. Saying that the results of pre-clinical testing on NHP is "meaningless" further illustrates the irrational and supremely uneducated nature of your arguments. Clearly such pre-clinical trials are not meaningless. They are an extremely important part of the FDA approval process. Had these trials not shown TKM-Ebola to be effective, TKMR would never have been approved for Phase 1 trials, nor would the FDA have given TKM-Ebola a regulatory framework for emergency use.

    I'll hold my long until I reach my target of a $1B market cap, or $40 to $45 per share, and I may hold it even longer depending on market dynamics and what has transpired with the outbreak. If you want to short it at that point in hopes it comes all the way back down, be my guest. I'm already up 21% from my entry position while you're down 3% from your shorting mistake, so you have some catching up to do.
    Sep 24, 2014. 09:56 AM | 5 Likes Like |Link to Comment
  • Tekmira Pharmaceuticals' Ebola Run-Up Isn't In Touch With Reality [View article]
    You say "many years to find out". This appears to be false statement or assumption on your part. The WHO has held two separate symposiums over the past several weeks to discuss potential therapies and vaccines currently in development, one of which is TKM-Ebola, for the purpose of developing a safe, ethical and appropriate process for fast-tracking clinical trials and approvals, with the cooperation of the FDA. The FDA has long-since granted fast track status to TKM-Ebola, but on September 22nd, it was announced that the FDA had agreed upon a regulatory framework for the emergency use of TKM-Ebola for infected individuals, which was communicated by Tekmira on the morning of September 22nd, (prior to your article being published).

    Every indication leads to the fact that, even if Tekmira's Ebola drug does not eventually get approved, it's efficacy will be known well prior to "many years down the road". In support of this, look no further than Tekmira's press release the very next morning, September 23rd, in which the company states the following:

    "Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, today reported that it is collaborating with an international consortium to provide an RNAi based investigational therapeutic for expedited clinical studies in West Africa.

    Led by Dr. Peter Horby of the Centre for Tropical Medicine and Global Health at the University of Oxford and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), the consortium includes representatives from the World Health Organization (WHO), US Centers for Disease Control, Médecins Sans Frontières - Doctors without Borders (MSF), ISARIC, and Fondation Mérieux, among others.

    The Welcome Trust has announced it has awarded £3.2 million to the consortium to fund this initiative. The award will include funds for the manufacture of investigational therapeutics as well as the establishment of an operational clinical trials platform in two or more Ebola Virus Disease (EVD) treatment centers in West Africa."

    Clearly Tekmira is going down a path to determine efficacy in human patients, the results of which will be known well before "years down the road", again pointing out the falsity of such a claim on your part.

    You also say "would have meant a total one-time revenue addition of less than $30 million to Tekmira", then follow that up by justifying it with more banter, trying to emphasize the "one-time" nature of such a payment by suggesting the outbreak would be controlled after treatment.

    There is so much wrong with this type of uneducated argument, it's hard to know where to start. That said, when you divide $30M by the $5K estimate for the treatment you put forth, it equals 6,000 patients. Have you read any press releases relating to the statistical models for this outbreak? The WHO has clearly stated that the reported cases are a dramatic underestimate of actual cases in existence. The CDC released a study just today saying the outbreak could reach over 1.4M people by the end of January while the WHO has now said that their best estimate is more than 20,000 cases by the end of October. While I cannot say for sure why you are doing so, you are clearly undervaluing the current and potential market for therapeutic treatments for Ebola, not to mention the impact this outbreak will have on the demand for such treatments on behalf of developed and developing countries who will most assuredly want to stockpile such drugs for the future.

    I noticed your article was published on September 22nd at 6:20pm, after the market was closed. While you'd know the exact time the you submitted the article to the editor for publication, it is not unreasonable to assume it was no later than late in the trading session of September 22nd.

    In your own comment to the article above, you say "I just covered this @ $24.88 (shorted yesterday @ $24.17)." Meaning the you shorted the stock immediately before publishing this article, an article that, in my own humble opinion, I would argue represents little more than "mindless bashing". I'm not sure what your motivations were for writing this extremely educational article, but I'm sure readers and investors will draw their own conclusions. In the meantime, it would at least appear the share price did not react the way you may have expected at the time you took out your short position, thus the likely reason you exited the position the very next morning, by your own admittance.
    Sep 24, 2014. 12:53 AM | 4 Likes Like |Link to Comment
  • Tekmira Pharmaceuticals' Ebola Run-Up Isn't In Touch With Reality [View article]
    Your "one-time" revenue prognostication is not only a vast underestimate, but irrelevant for the long-term valuation of this stock. First of all, TKM-Ebola will not be competing against NLNK or GSK, who have the most promising vaccines, because TKM-Ebola, as you know, is a treatment, not a vaccine. As such, they will compete mainly against ZMAPP and BCRX's candidate, neither of which has had any human trials, (and in the case of BCRX, they are just now starting clinical trials on NHP). Regardless, based on all data available, the WHO itself, as well as several experts in the field, have already labelled TKM-Ebola as the most promising of all current treatments in development.

    That all said, as you say, you are not about the science, you're suggestion is that the market is too small to support a $450M market cap. There have been several VERY legitimate studies recently published estimating the spread of the current outbreak, with several of these studies now using "millions" as the potential for cases. While I do not have a crystal ball, it seems logical to now assume the cases will at least reach into the hundreds of thousands before any type of control over the spread is accomplished. What does this mean for potential treatments and vaccines. Well, if you think such vaccines and treatments will ONLY be used strictly in relation to the current outbreak in West Africa, then you have no business being an investor, which requires at least some amount of foresight when it comes to the valuation of any company. You see, once cases reach into the hundreds of thousands, it becomes increasingly more difficult to control and the chance of spread beyond the borders of the countries already impacted becomes greater and greater, thus the reason the WHO, CDC and the U.N have all called this a threat to International Security. All of these parties have data illustrating the truly exponential growth of the outbreak already exhibited, and have seen and/or commissioned the studies estimating the potential spread. As such, the U.S., the U.N and every member of the U.N., are now urgently piling money and resources into the stop of EBOLA to the tune of more than $1.5B .... so far. If/when this particular Ebola outbreak is finally brought under control, every developed and developing country in the world will stockpile treatments and vaccines, and if you don't believe that, then you have your head buried in the sand. The FDA will, in absolute terms, approve treatments and vaccines on an extremely expedited basis, after which TKMR will be free to sell such treatments to all comers.

    One last thing, the poor countries you refer to, who you say would have to purchase such treatments but would not be able to afford it, would not have to purchase the treatments. There is beyond plenty of incentive for the U.N., United States, World Bank and many other impacted parties, (who have all given resources to the current fight), to purchase such treatments on West Africa's behalf ..... and they will.
    Sep 23, 2014. 09:19 AM | 2 Likes Like |Link to Comment
  • Ebola: Desperate Days Ahead [View article]
    It's a complicated question. Over the coming month or two, no, I do not see a very high risk of this spreading internationally. If the spread continues in West Africa at its current pace, I predict more than 150,000 cases by year's end. Many similar models released over this past week have resulted in the same predictions. If a vaccine is not made widely available until at least March, there could be more than 500,000 cases by then. Once the numbers escalate to those levels, the answer becomes yes. The greater the number of cases, the more chaos will ensue and the more difficult it becomes to contain the spread. It becomes inevitable that it gets to neighboring countries, then goes from there. Right now, it is a very scary situation. The US has long-since come to grips with this very thing, which is why they are putting so many resources towards the containment RIGHT NOW. They have to try to stop it before cases spiral out of control.
    Sep 18, 2014. 11:38 AM | Likes Like |Link to Comment
  • Ebola: Desperate Days Ahead [View article]
    It appears other experts are now starting to publically state what many already suspect, that the window for containment has closed: http://bit.ly/1nPvOBg
    Sep 11, 2014. 11:29 PM | Likes Like |Link to Comment
  • Ebola: Desperate Days Ahead [View article]
    The symptoms of Ebola can best be found on the CDC website using the following link. http://1.usa.gov/1nPvaUq
    Sep 11, 2014. 11:21 PM | Likes Like |Link to Comment
  • Taking Profits On First Solar As 'Promises, Promises' Begins To Be The New Theme [View article]
    Good reply and fair enough. We can agree to disagree on whether or not FSLR dissappointed for 1st quarter, (eps guidance was $0.70-$0.90 before restructuring and they came in at $0.69, while revenue guidance was $650-$750M and they came in at $755M, maintained full-year guidance). We can also agree to disagree on whether SPWR stock is depressed, given my firm belief that by any legitimate measure possible that it is overvalued. I can take a company missing guidance, even when reporting in relative to proximity to the released guidance. What I can't take is a company who refuses to talk in measures that are "generally accepted", instead always trying to snowball the investing public into thinking they are performing better than they are by constantly changing the way they report thier results. It's misleading to say the least.
    May 8, 2013. 07:01 PM | Likes Like |Link to Comment
  • Taking Profits On First Solar As 'Promises, Promises' Begins To Be The New Theme [View article]
    DoctorRx - Over the past two years there have been dozens of news stories and analyst's grouping FSLR with silicon based manufacturers drawing erroneous parrallels between companies and their performance. While many continue to point out the losses sustained by FSLR in 2011 and 2012 so as to draw such conclusions, it appears that there are only a few that look at the underlying cause of the losses, that being one-time restructing and goodwill impairment charges. FSLR has always been operationally porfitable, and not to any small degree at that. Given the current market cap versus book value, the lack of clarity surrounding the companies past and future performance, the state of their technology and the state of the industry, many felt a day to provide clarity was more than warranted.

    SPWR has a similar day coming up, yet you are long SPWR. Now talk about pumping a stock. You are long a company who reports almost every single financial result in non-GAAP terms, and changes these non-GAAP measures every single quarter (just look at the reconciling items on their GAAP to non-GAAP eps - they change every time they report). SPWR has not had GAAP based eps in 3 years (even when removing restructuring and goodwill impairment charges) and just confirmed that they will not have GAAP eps for 2013. Unlike FSLR, they actually operate at a loss before "legitimate and comparable" one-time expenses. Their GAAP based gross margin has been single digit for 10 straight quarters because they have to give away their product to get a sale, yet everyone talks about FSLR's shrinking margins because they have come out and said they will level out in the 17-20% GAAP-based margin range. The difference is that FSLR can make $4.00 per share at those margins, SPWR losses money hand over fist at their current margins. The problem for SPWR is that once they try getting margins up, they become even less competitive . .... it's a real quandry, especially as FSLR's panel efficiency improves while maintaining much lower up-front capital costs than SPWR (and that's at today's unreasonably low silicon pricing). I could debate you all day long on this, but you'd lose. It's the benefit I have of being long in a company where almost every single possible KPI for both operational performance and financial position is better (dramatically better), than SPWR's.
    May 8, 2013. 09:18 AM | Likes Like |Link to Comment
  • Taking Profits On First Solar As 'Promises, Promises' Begins To Be The New Theme [View article]
    Moon - Are you serious?? "Demand for better efficiency solar panels will make the solar industry tough for some time" . . . Really?? Efficiency goes hand and hand with the economics of a solar farm. The ROI versus traditional forms of energy is based on the capital and ongoing operational costs per watt produced. FSLR is the best in the world in this regard and is close to parity with many of the other more traditional growth forms of energy production, such as natural gas (which will be increasing in cost over time).

    "Fortunately they are large or they'd be dead already". That's like saying fortunately people like listening to music on Apple products or Apple would be out of business, or it's great people enjoy a Big Mac, otherwise McDonald's would be in trouble. First Solar is "large" for a reason, they have $8.0B in forward contracts for a reason, have doubled their sales over the past 3 years for a reason, are going to make between $4.00 and $4.50 per share this year for a reason, that being because the solar industry is growing and will continue to grow for years to come and FSLR, as they have proven and continue to prove, are the best in the world at capitalizing on the opportunities, and, unlike everyone else, can do so profitably. The efficiency of their solar panels is improving dramatically and will continue to do so over the next several years, which is why the economics of their solar farms make it worthwhile for those investing in such farms.

    "Buy new technology . . . . their R&D is pretty sad". GE is sinking R&D into CdTe, just like FSLR has been doing for the past several years. It is by far the most promising of all solar panel technologies and has the most upside for efficiency improvements, (and that's starting from now when it already provides the best economic value for solar farm projects). FSLR spends more on R&D than the next two largest solar companies do . . . combined.

    Your comments seem more like something a person would say just for the sake of commenting versus adding any educated value.
    May 7, 2013. 04:08 PM | Likes Like |Link to Comment
  • Taking Profits On First Solar As 'Promises, Promises' Begins To Be The New Theme [View article]
    I agree with Rodolfo. I wouldn't be quick to sell out of a long-term position, but if short-term gain was someone's goal, then playing the recent run-up would have been a good thing. I'm not sure how much it will pull back given the full-year guidance remained intact, which will inevitably lead to a very good second and subsequent quarters. That said, any significant pull back should be looked upon as an opportunity to take a new or additional position. In the end, FSLR just added to their net book value and once again strengthened their financial position. In my opinion, the company remains undervalued relative to there past, current and expected future performance, and certainly in comparision to peers like SPWR.
    May 7, 2013. 02:54 PM | Likes Like |Link to Comment
  • China's H7N9 Bird Flu And Novavax [View article]
    Thinking a company should have a higher pps based on the progress made to date can be frustrating. I have a few thoughts that I hope will help:

    1) NVAX has a current market cap over $325M, which is in line with many development stage biotechs in early stage clinical trials (i.e. - no phase III), other than those deemed to be developing a "blockbuster" drug.

    2) There are many vaccine development companies at this time, and while I believe NVAX has as good or better science than the others in terms of the breadth of immunogenic vaccines that could be developed using VLP, one still has to consider market share and ultimate ability to sell approved vaccines when the times comes.

    3) Based on 3, RSV was a great choice because it would give them a monopoly, at least until other developers catch up.

    4) Unlike other bio-techs developing drugs that treat a certain disease or condition that would then give them market exclusivity and patents to protect them upon FDA approval, developing vaccines is really about how fast you can get it to market in the face of a new virus and how immunogenic it is versus competition trying to do the same things. This will really have an impact within the seasonal influenza market place. It's just not as easy to define the sales that will come with an approved product.

    5) As with most development stage biotechs, they have issued dilutive shares on several occasions. Unfortunately, most share issues are timed around a run-up in the share price to take advantage of the opportunity, (see ARNA and VVUS for two great examples of this). It's important the company keeps saying they have enough cash for the next 2 years, (as they did this morning in the Q1 press release). This will ease investors minds that there isn't a dilutive offering coming that will undermine the share price performance in the short to mid-term.

    As I've said, I think $1.0B market cap is the target at some point between now and the end of 2014. That would provide a very nice return for investors. Any pandemic scare will of course accelerate this target to within 30-60 days of the "tangible" scare, which H7N9 and cNoV have not turned into as yet.
    May 7, 2013. 09:54 AM | 1 Like Like |Link to Comment
  • China's H7N9 Bird Flu And Novavax [View article]
    Thanks Michael. I wrote an article recently on Amarin and feel it is going to be a great investment as well. It certainly has pulled back over the past several months and it is just a matter of time before it will consolidate and begin going up as prescriptions numbers improve and we move closer to FDA approval of their Anchor indication.

    With regard to NVAX, now that's it's pulled back to a lower market value than pre-H7N9 levels, a good entry point seems to be developing. I've been in and out several times since 2005, profiting along the way in full realization that I was playing along with the market versus investing in the underlying value. I've just taken a pretty substantial position and don't mind waiting it out for a while. I really do agree with the consenus estimates of approximately $4.00 within 12 months (nearly a double from the $2.18 close yesterday) and $6.50 within 18-24 months. Other than that, FSLR has worked out for me and I continue to believe that is has a lot more room to keep going.
    May 4, 2013. 09:47 AM | 2 Likes Like |Link to Comment
  • China's H7N9 Bird Flu And Novavax [View article]
    Moon -- I agree that it is always best to wait for trials, but given there is no approved H7N9 vaccine, it would be in the public's best interest to fast track such a vaccine in the even of a pandemic. Obviously if H7N9 does not mutate such that it can pass from human to human in a sustained way, then NVAX would not profit, but remain on its current path towards an RSV vaccine. In the event it does mutate, my point is that NVAX is now, more than ever before, in a position to develop a suitable H7N9 vaccine and have it fast-tracked through approval for the betterment of the public at large. Such was not the case in 2005/06 or in 2008/09.
    May 4, 2013. 09:39 AM | 3 Likes Like |Link to Comment
  • China's H7N9 Bird Flu And Novavax [View article]
    There is a correction I would like to make, as pointed out to me on the Yahoo message board, which I should have caught myself . . .

    "... have fully enrolled their phase I trial for healthy individuals over the age of sixty, which will be starting in the coming weeks"

    should read

    ".... have fully enrolled their phase I trial for healthy individuals over the age of sixty, with top line results expected in the coming weeks".

    The trial is well under way. Stanley Erck reported on the recent corporate update that topline results would be out before the end of the second quarter.
    May 3, 2013. 07:38 PM | 1 Like Like |Link to Comment
  • Why First Solar Is The Best Solar Investment [View article]
    The point I'd make is that the current trading price is undervalued given the prospects of future earnings, even given your points. If this was trading at over $150 like it was just 2 years ago, I wouldn't be writing this article, in fact, I would be arguing that the share price is overvalued. Margins have decreased, and may decrease even further to level out at 18-19%, while book to bill could stay at just under 1:1 again this year. The argument I make is that FSLR is likely going to make over $300M in 2013, and is in a position to easily earn over $150M per year for the next couple of years thereafter, even if things aren't going ideally for them. If you look at their cash salvage value of $1.55B (meaning the book value of all cash, receivables, salvage value of inventory and long-lived assets, less 100% value of all liabilities), then compare it to their current market cap, the market is only giving them a $750M premium for any potential future earnings. This is a very, VERY low earnings premium based on the their earnings potential. It's only a matter of time before this share price begins to trade over $40 again.
    Mar 19, 2013. 10:30 AM | 1 Like Like |Link to Comment
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