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  • 3 Small Biotechs Worth Watching Over The Next 6 Months [View article]

    I am more than happy to comment.

    In regards to TNXP, those results did not meet the PE, but there is a lot of promise there. One of the SOM's which they did meet, specifically, was nearly identical to what Savella got approved for the FM space. So, my thoughts there are that the drug will still get to market for the indication, however perhaps with a few more restrictions regarding addressable population.

    As to AHRO, it is a unique circumstance. That company's offering was unexpected, and many felt poorly timed. With results for the P1 trial pending, it seemed odd. As a result, I did reach out to the company and speak to them. The fact of the matter is that the reverse split was a disaster, because the capital requirements which they expected to be met post split never came to fruition. As a result, the up-listing never happened, and the price dwindled. The offering was needed for a series of expenses, all of which will be disclosed in the 10-Q, but net proceeds should be 3 million. That means the company, right now, is barely trading at cash on hand. Therefore the market is valuing AHRO-001 at nothing; zero. That's absurd. Just a few months ago, with less than 500K in cash on hand, the company had a MC of 10 million. So, then, AHRO-001 was valued at 9.5 million or so. Since then, NOTHING has changed regarding the candidate. In fact, they're only closer to getting trial results. Now, on top of that, the company is filing an IND next year for AHRO-002, and prospectively filing their IND for AHRO-001 as well (keep in mind the trial ongoing now is not with an IND filed for it with the FDA, its more for market share in Russia through CaridoNova and the Maxwell Group, currently). Bottom line, it's undervalued comically currently, and IF the results are good, and the IND's are filed in 2015, this should still be a company with a 40-50M MC in 2015 by EOY.

    As for CNAT, still steady. IF they have positive results in both ACLF and NASH they will have "bookended" liver disease (in other words it will stand to reason that all the indications in between the two extremes would benefit from the therapy). If that happens, IF that happens, it could jump much higher than the PT indicated.

    Good Luck.
    Nov 8, 2014. 09:45 PM | Likes Like |Link to Comment
  • AEterna Zentaris: The Bear Case In Front Of The November 5th PDUFA [View article]
    Sorry to the longs and/or catalyst traders that took a hit here. That's never easy. But, then again, this is "biotech". It's the nature of the beast I suppose.

    I honestly believe that the FDA's comments regarding failure to meet primary efficacy endpoints was making direct reference to what I had expressed concern about above; the GH cut-point adjustments in obese subjects. Without the FDA accepting those adjustments, this was doomed. That said though, I did believe there was an 80% of success (as stated above) and I'm surprised that those adjustments were, apparently, completely and utterly disregarded. That said, the price is floating around where Daniel and I had discussed it landing; in and around .70 cents. So the risk / reward was adqauetely conveyed and measured.

    What I will say here is this; I now believe, firmly, that the company is highly dependent on its Zoptarelin Doxorubicin candidate. Dodd wants to move from R&D into commercialization. That is why he was brought in. If the DSMB sees any issues with the trial in Q1, or if the prelim data is anything less than impressive, this could turn into an elongated Greek Tragedy of sorts. So, that will be the next point of measure (in my summation anyway).

    Again, sorry to those who took a loss here. I've been there myself, and it is certainly no fun. I wish everyone the best of luck moving forward, and I hope that those who shorted here are gracious in victory and judicious with their profits. I also hope that those who took a loss here are patient and thorough in the decisions regarding reallocation of funds, or holding of shares, and that whatever decisions they make prove to advantageous. Good luck to each of you.
    Nov 6, 2014. 11:11 AM | 2 Likes Like |Link to Comment
  • Paragon Shipping: Following Up With CEO Michael Bodouroglou [View article]
    Disagreements makes markets, and moreover, they are inevitable in capitalist infrastructure. Thus, I welcome such exchanges given the professional and courteous nature of them. Therefore, in return, I thank you for your studious and even handed points of contention pertaining to Paragon.

    As usual, best of luck to you, and all others as well.
    Nov 5, 2014. 11:35 AM | Likes Like |Link to Comment
  • AEterna Zentaris: The Bear Case In Front Of The November 5th PDUFA [View article]

    I concur with Daniel to that specific end.

    IF you are indeed considering a true long position here, then post approval, (hopefully), and post the dilution which will inevitably follow, there will be a far more attractive entry point even if it is just from a standpoint of lower risk and more cash on hand. Personally, for a true long position (3-plus years) I would prefer to pay a slightly higher price per share if that higher price came with certain revenues (post approval), more cash on hand (post offering), and a much lower risk (due to more cash and a commercial product of the company's own IP library). But, that's me.

    I admit, with the likelihood of approval in favor (again I say 80/20), that if the price dropped to 1.03 or less (perhaps with a disappointing earnings report) that I may even initiate a spec position after hours. But, that would be strictly for the possible catalyst of approval tomorrow. If one could get in at 1.00 and out at 1.60 within 24-48 hours, well, I think just about anyone would consider that a big win.

    Nonetheless, just sharing my perspective here. I wish good fortune to all investors here, regardless of position or risked capital.
    Nov 4, 2014. 12:37 PM | 1 Like Like |Link to Comment
  • Paragon Shipping: Following Up With CEO Michael Bodouroglou [View article]
    My continued apologies for late responses to commenters. In addition to my schedule, I have also been getting notices from this article well after the fact (for reasons unbeknownst to me).

    Regardless, in an effort to address all open comments, I will offer a blanket response. You're all correct. The company has lost 90% since 2010, the company has not kept pace with the Dow, the NASDAQ, or the S&P, and the massive BV discount is, to some extent, justifiable. Those are well measured and accurate assertions. However, LongDividend's did make a valid positive point (even if it was meant to passively mock part of my contention), and that was that from here, where can it really go but up?

    "I guess you're going with the 'there is no place to go but up' theory on this one, eh?"

    Consider these facts; the dry bulk recovery remains slow, retractable, and subject to market fears and hesitations. Paragon is, regardless of the attributable cause, trading at a significant discount to NAV. The company now operates 16 DBV's across four classes and is expected to expand it's fleet by an additional 30% by EOY 2015 across five classes. Thus, assuming the recovery continues methodically, and functioning under the premise that company margins can only improve from severely depressed levels, wouldn't there be continued cause for optimism?

    I fully concede that there are better options in the dry bulk sector right now; especially based on fundamentals for medium horizon investors. But between now and April, does anyone really expect to not see 50% upside from current levels? Moreover, looking 2-5 years ahead, does anyone really see significant downside?

    I'm not saying long holders, who initiated positions during the sector peak, should be proponents of the company or it's management. Those investors are absolutely within their right to be in possession of animosity and pessimism. I am simply saying that Paragon appears reasonably well positioned to grow from current levels. I did re-initiate a small position here at 2.94, and I intend to hold it for the foreseeable future.

    Again, best of luck to all, and thank you for continuing to share respectful, reasonable, and well supported insights and opinions.
    Nov 4, 2014. 12:28 PM | Likes Like |Link to Comment
  • Venaxis: Latest Clinical Data Reveals Huge Market Potential [View article]
    That I agree with entirely. Well said.
    Nov 2, 2014. 10:57 AM | Likes Like |Link to Comment
  • AEterna Zentaris: The Bear Case In Front Of The November 5th PDUFA [View article]

    Hard to really argue with any of that, and truth be told, I don't wish to. I agree with the entirety of the premise, even if we differ a bit on the details.

    In terms of the "track record" though, while the company has had a long history of dilution, failures, and erratic decisions regarding share count and consolidation, it must be said that Dodd wasn't "the man in charge" during the vast majority of those events. Dodd didn't come on until April of 2013, and his hire was largely a decision to move from R&D into, specifically, commercialization. To that end, approval of Macrilen would be the first step in the company truly becoming "his."

    Yes, dilution and offerings have still occurred on his watch (on more than one occasion), however those events, much like cutting of certain expenses and consolidation of staff, has been about improving the balance sheet. These things were required. You can't move from R&D into commercialization without two things; approved products & liquidity. So, it depends largely how one views the dilution on Dodd's watch; has it been out of preparation or desperation? Depending on how one answers that question should dictate how they see the opportunity here.

    All that said, a true "long" position here is likely best assumed post PDUFA and dilution. We agree 110% on that point. But, as it stands to the most enticing upcoming event, the PDUFA date, it's all about risk/reward and MC projections. A 50-100% return in a week is hard to come by, so there is legitimate cause for consideration here today. Either way, whether in the game, or on the sidelines, this will be interesting to watch.
    Oct 30, 2014. 03:11 PM | 1 Like Like |Link to Comment
  • AEterna Zentaris: The Bear Case In Front Of The November 5th PDUFA [View article]

    Well said, and well reasoned.

    In assumption of a 7-year out projection (2014-2021) the applicable discount of 20% seemed reasonable, but I'll credit your assertion that 5X sales is appropriate for that scenario. So, we'll call it 120M MC projected with the assumption of approval and calculable market response (which I admit is an assumption in and of itself - reasonable market response). So we'll call it about 80% upside (give or take fluctuations in entry price day to day). If a "3-1 ratio" for "reward v.s. risk" is considered reasonable for binary event and/or catalyst trading that means one could tolerate about 26% downside from the point of entry based on 80% upside. I admit, capping the downside at .96 cents is optimistic. I see downside being as low as .70 cents with my model (.0697).

    Therefore, I think 1.03 (or less) is the target entry point for catalyst traders. To that end, I concede, there has been some "run up" already priced in. But, if, for whatever reason, this dropped to 1.03 or less, pre-PDUFA, then it may well be worth it.

    As to the other matters, we certainly agree on most counts. I do, however, believe that Dodd could well be the right guy to lead the development of the pipeline into the future. Can he do it alone? Certainly not. However, with judicious financial allocations, and assuming approval on November 5th, as well as strong support from the DSMB in Q1 of 2015 regarding the P3 trial of Zoptarelin Doxorubicin, the company could earn itself well deserved momentum moving forward.

    Again, thanks for the article, and for your comprehensive and well mannered responses to all comments. Civility is underrated in these discussions, and this comment thread is enjoyable and valuable.
    Oct 30, 2014. 12:26 PM | 1 Like Like |Link to Comment
  • AEterna Zentaris: The Bear Case In Front Of The November 5th PDUFA [View article]

    I appreciate this article for a multitude of reasons, not the least of which is that the bear argument for the stock, as you present it herein, is even handed and well presented. I applaud that sort of analytical presentation.

    As I have already commented in a lengthy and detailed fashion on Trevor's article, which you referenced in your above piece, I will spare readers the redundancy of those data points. However, I would like to know what you feel the upside is for a potential catalyst trade. Given the data (assuming acceptance of the GH cut-point adjustments in obese subjects) approval should be seen as probable (say about 80/20 in favor of). The current market cap, if the price is baked in already, would be giving almost no value at all to the rest of the companies pipeline (assuming Macrilen is projected out at 30M per year in peak sales by 2021, tempered back 20% to 24M, projected conservatively at 3X sales, would be about 72M in MC). That, on it's own, is conservative for the sector, and gives no value at all (as stated) to any other developments. For the sector, even in this cap-space, 6X peak sales at the same consideration would be about a 144M cap. Thus, I see potential for a short term double from current levels with approval. I would be interested in your case for upside if you would like to share it.

    All that said, I agree wholeheartedly with your assertions regarding dilution (as I mentioned on Trevor's article). I feel dilution is inevitable regardless of PDUFA outcome. Therefore, it may be a buy right now as a catalyst trade, however will likely present with better long term options after the fact between Nov 6th and the end of Q1 in 2015.

    Lastly, I will say, that David Dodd has made this company considerably more capable and well managed than it was previously. A long term spec position, assumed post PDUFA following inevitable dilution, wouldn't be a bad idea.

    Again, nice article here. It's well done and fairly presented.
    Oct 30, 2014. 10:49 AM | 2 Likes Like |Link to Comment
  • AEterna Zentaris Has A Great Value Proposition - CEO David Dodd Explains Why [View article]

    Greetings once again. This article is valuable, and I think it offers perspective which allows readers to deduce their own insight. That said, I think that crimsonbey makes a valuable point.

    There is a lot to consider here (well beyond the pipeline, partners, obligations, and previous failures). The upcoming PDUFA date is clouded in possibilities. First, it was a "carry over" trial. That is to say, AEZS took over a trial, and a candidate, abandoned by Ardana Biosciences. That means the majority of the data presented is years old and subject to applicability measures. Historically, the FDA has been hard on companies who pursue an SPA pathway from a carried over study by a previous developer, where 51% or more of the data is carried. AEZS only added 30 control subjects and 10 others. This is especially so where there is a multi-year gap between P3 and NDA submission. Yes, the FDA agreed to that in the SPA, and no it shouldn't be a concern from that standpoint logistically, but it's statistically relevant nonetheless. It's "harder that it would have been otherwise." The FDA will have their magnifying glasses out.

    Moreover, while the primary outcome measure was met in the P3 trial, there is still the matter of BMI adjustments. The primary outcome measure of the trial was "diagnostic efficacy measured under the ROC curve at a baseline standard of greater than .85." AFTER BMI adjustments, the readings were .923 and .925 in PP groups, and .912 and .918 in MITT groups. It stands to reason that those requisite reports meet or exceed the standard. However, BEFORE BMI adjustments, sensitivity measurements in obese subjects failed to meet the outcome. Thus, while the trial itself was a "success", the FDA may have concerns about that "subgroup", and could either request further studies and a resubmission (hence a CRL), or could approve with a restricted label requiring post-marketing studies in obese subjects. The FDA will have to be okay with peak GH cut-points being adjusted in obese subjects for the drug to stand for approval.

    That (after a long winded statement) leads me to crimsonbey's point. Dilution is probably a certainty post PDUFA regardless of outcome. Let's assume that the PDUFA decision goes well, and Macrilen gets approved. In that case, let's say the price moves to above 2.00 and even settles there. Companies tend to dilute at peak share prices in order to minimize the impact on the OS count. Seeing as there is no certainty as to the prelim data quality which would come in Q1 2015, diluting before hand hedges the companies bets. It's a smart thing to do from a standpoint of judicious fiscal planning. So, dilution there is probable. In the event the PDUFA date goes poorly, and the company receives a CRL, it could be detrimental short to medium term. A CRL with any additional trials or hefty AI requests would drive the price well below a dollar (say .60 - .80). Of course, those requirements would then prove costly. In addition, the same data uncertainty which accompanies next years trial data would be at play. With NASDAQ listings often requiring a minimum share price for a consecutive period, and certain liquidity requirements providing favor, the company would be faced with the prospect of a reverse split followed by dilution. That certainly wouldn't be received well by shareholders or the market.

    Thus, crimsonbey's statement regarding dilution for commercial viability is one worth noting. Moreover, dilution in the event of failure is worth thinking about as well. It's a double edged sword.

    All that said.........I still think AEZS is a decent consideration for investors. But they have to know what their betting on. Is it the catalyst trade for the PDUFA Date hoping for a possible double (approval and a nice label could see 125M MC), or is it the long term play for pipeline development? In the latter, people may be wise to wait for the PDUFA decision. It will either de-risk the stock further, or offer a floor level entry point at rock bottom following failure to procure approval.

    Nonetheless, nice job again. I enjoy your articles Trevor. Best of luck to you.

    Oct 29, 2014. 06:55 PM | 2 Likes Like |Link to Comment
  • Venaxis: Latest Clinical Data Reveals Huge Market Potential [View article]
    This is a well done piece.

    I happen to like APPY quite a bit at current levels, and even agree wholeheartedly with your long term price target (I have a $4.88 target on the stock). In my discussions with management however I do have some concerns simply regarding the timeline.

    Part of the FDA's requests have included the need to enroll 100 "healthy subjects" who are "not known to have abdominal issues" in an effort to better determine baseline readings. That's a tough sell; seeing as the patient population targeted is comprised of adolescent's and children. Not a lot of parents have, thus far, been willing to let their healthy child get randomly tested for acute appendicitis. The company admits that enrollment here has been an issue. Moreover, the European launch, thus far, has been a disaster; aside from Rubio in Spain. He is the only one who has made progress. To managements credit though, Venaxis CEO Steve Lundy didn't want to go into Europe due to it's geographic and demographic make up (many fragmented and smaller countries with varied regulatory boards and commissions) but the board and other influences disagreed with his assertions. Thus, revenue projections in Europe need to be marginalized due to a disappointing launch.

    Anyway, it's the "healthy subject" sample for the baseline results which may cause the delay. The FDA has been beating timeline estimates for MDUFA dates regarding devices and diagnostics, but nonetheless 120 days out post reception of AI is still four months post completion of AI requests. That said, the current entry point is very attractive. I just think investors need to be willing to accept the potential delays associated with meeting the AI requests and the accommodating potential complications.

    The last thing I will say here (as I am not trying to hijack your comment feed) is that the biomarker improvements in the APPY2 device seem, thus far, to be quite impressive. This leads one to wonder what the company will elect to do if the APPY1 device does not earn FDA clearance. Will the company continue it's pursuit of regulatory approval for the APPY1 device, or will it simply put all of its resources, focus, and efforts into APPY2? That is another consideration which should be weighed by potential shareholders.

    Again though, this is well done. I agree with the premise of the article and, perhaps more importantly, it's presented price target (even if I have slight hesitation regarding the timeline). Nice job.
    Oct 29, 2014. 12:19 PM | 4 Likes Like |Link to Comment
  • Paragon Shipping: Following Up With CEO Michael Bodouroglou [View article]

    I am always appreciative of your contributions. Thank you for offering a civil and fair opinion.

    As stated herein, this particular article was a courtesy to previous readers and investors who felt that certain additional questions required answers. As I have access to Mr. Bodouroglou, I thought it my responsibility to follow up on their behalf. I admit, I do continue to "beat the drum" to an extent, but nonetheless, it is largely a result of responding to readers and investors in a courteous manor.

    Please forgive the delay in response, I have been away. Best of luck to you, and Best Regards.
    Sep 29, 2014. 07:16 PM | Likes Like |Link to Comment
  • MannKind: Seeing The Forest Through The Trees [View article]

    The following question you pose.......

    "Does anyone believe that after trying an inhalant that works faster and better than an injectable they will go back to a needle?" certainly the simplest possible way to consolidate Afrezza into a single inquiry. Thank you for continuing to offer insights about Afrezza and Al Mann, and thus by the transient property, into technosphere as well.

    Best of luck.
    Sep 29, 2014. 07:11 PM | Likes Like |Link to Comment
  • MannKind: Seeing The Forest Through The Trees [View article]

    Thank you, once again, for offering opinion, insight, and civility to the board. I also believe quite strongly in the marketing strength of Sanofi, and look forward to the launch of Afrezza and future technosphere applications.

    Best of luck to you.
    Sep 29, 2014. 07:09 PM | Likes Like |Link to Comment
  • MannKind: Seeing The Forest Through The Trees [View article]

    Certainly it is a strong time to initiate a long position. Entry points, at these prices, are most attractive; especially for true long investors with an investment horizon congruent with product and technology development procedures.

    I wish you the best of luck.
    Sep 29, 2014. 07:07 PM | Likes Like |Link to Comment