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Joseph Krueger

 
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  • Mannkind's Afrezza: No Real Benefits for Diabetics or Investors [View article]
    I understand the importance of rapid insulin, I just dont like Afrezza. Look into VIAject from Biodel....it has the same PK profile as Afrezza and since it is injected and not inhaled, it has none of the problems. The PDUFA date for VIAject is in October through a 501b2 mechanism, it will likely get approved before Afrezza.
    May 2, 2010. 04:03 PM | 3 Likes Like |Link to Comment
  • Mannkind's Afrezza: No Real Benefits for Diabetics or Investors [View article]
    The article was the result of discussing finer points of the clinical data- people who posted comments seemed to be regurgitating managements statements without looking closely at the clinical data. A closer look at the data reveals some classically misleading concepts about the "improvements" Afrezza demonstrates. Indeed, the FDA will look at it this way.

    The purpose of the article was to discuss these specific issues. My general statements are that Afrezza does not have a smooth path to approval or partnerships. Afrezza does offer the same benefits of fast acting injectable insulin, with some potential ease of use but also some potential restrictive regulation and risk.

    Given the market cap of MNKD is almost $1 billion, I think it is overvalued. I also think DNDN is overvalued- I agree with Michael Shulman's points about DNDN's current situation.
    seekingalpha.com/artic....
    Given the lack of anything else near term or substantial in their pipeline, the risk/reward ratio here for MNKD is off.

    Although oncology is indeed my specialty, I do have some indirect experience in diabetes drug development, certainly more than the average investor. Because of my background, I also am able to decipher the real meaningful data from clinical and non-clinical studies without management's biased reporting. That is the take home message of this article.

    If expertise is the issue, should MNKD drop their oncology programs and stick to diabetes, then?
    May 2, 2010. 10:39 AM | 3 Likes Like |Link to Comment
  • Mannkind's Afrezza: No Real Benefits for Diabetics or Investors [View article]
    Despite the (misleading) numbers, Afrezza did not improve these issues- read again:
    "There was a lower incidence of hypoglycemic events in the AFREZZA group (61.8% versus 66.05% for the usual care group). As well, there were 2.36 severe events per 100 subject-months in the AFREZZA group compared to 3.76 for the usual diabetes care group."

    The numbers look good, but is 61.8% vs 66.05% clinically relevant? Is 2.36 vs 3.76 clinically relevant? Note that despite this numerical difference the phrase "significant statistical difference" was not used. This means that the differences were within the range of error and thus there was no statistical difference.
    May 2, 2010. 10:22 AM | 3 Likes Like |Link to Comment
  • Mannkind's Afrezza Seems Short of Breath [View article]
    pacard, I honestly appreciate your comments, you are a wealth of knowledge about MNKD, but you are extremely biased and all of your information comes from vague statements made by MNKD management and are as full of conjecture as any statements I have made.
    The fact is that management (of any company) is always optimistic and always seems to have just the right amount of vague facts to support their statements- but I try to only judge hard data, because in the end that is all that matters. Your quotes from conference calls are not really helpful- they are biased opinion from the management....investors should never drink the cool-aid.

    Let me make some clear statements for you:
    I do believe that MNKD will get Afrezza approved- maybe not the first try though. The approval problem Afrezza faces is that it shows non-inferiority over injectables and adds potential risks. So you have an equivalent product with new potential risks...hmmmm.

    I do believe that market acceptance of Afrezza will be low for all the reasons discussed.

    I know you are going to hate the article I just wrote, taking a good hard look at the data. seekingalpha.com/artic...

    But regarding this conversation, here are a few facts that support my statements:

    fact- MNKD reported quantitative changes in two tests of lung functions, which reversed after users stopped taking Afrezza. The fact that they were there and went away after stopping use clearly shows they were caused by Afrezza. They exist- MNKD found them- the FDA may or may not care about them.

    fact-MNKD has no partner yet, despite the expectation from most investors that they would by now.
    fact-MNKD recently filed a $200 million shelf. If they had a partner, they wouldnt need money for marketing. If they had sales, they wouldnt need the money. Clearly the shelf is "plan B".
    fact- MNKD has no oncology drugs past phase I
    fact- MNKD's vaccines are very undeveloped and are still in pre-clinical studies

    Finally, in regards to management, an investor might be a little wary of a company that has no focused expertise- what do inhaled insulin, small molecule oncology, and cancer vaccines have in common? Essentially nothing. This does not shine favorably on management. Only very large companies can spread themselves into different areas....small companies should stay focused.
    May 2, 2010. 10:02 AM | Likes Like |Link to Comment
  • Mannkind's Afrezza Seems Short of Breath [View article]
    These are all good points, great research, thanks for sharing that. I stand corrected where wrong. Like you, I am more interested in seeing all sides of a situation and making the best decision than I am swearing loyalty to a long or short side.
    I believe that the number one thing for any biotech company is management; you are really investing in management. Poor management will prevent a good drug from reaching market,and good management will bring even bad drugs to market. Mann is much more the former than the latter. But Mann may be good at developing drugs, not marketing them- these are two different beasts. I see the issue with Afrezza being potential FDA restrictions that make patient acceptance and thus marketing difficult. Perhaps Mannkind has had the benefit of watching the mistakes made before it, and will avoid these previous pitfalls. Time will tell.

    MNKDs $200 million shelf suggest that there will be no partner- they are going to market it alone.
    May 1, 2010. 10:10 AM | 1 Like Like |Link to Comment
  • Mannkind's Afrezza Seems Short of Breath [View article]
    There are two sides to every story, and each side formulates an opinion and uses the facts available to support their opinion. In several cases, we are seeing the same thing in two different ways. You have alot of well thought out opinions in that post , supported by facts, and I respect your points of difference.
    Since you clearly feel that making sweeping assumptions about one's state of mind based on a short article or blog post is basis for understanding them, my reply to you is that your quaisi-religious fervor about MNKD tells me that you are only seeing one side of the story. I am seeing the other side. The "truth", or reality of the situation, likely rests in the middle.
    No, I have not listend to every conference call.....I actually dont care what Mannkind says, they are inherently biased...I have never met a CEO that didnt spin things positively....I choose to gather as many unbiased facts as possible and interpret them objectively...to use your own words: that is what researchers do. The gathering of those facts have lead me to the (brief, or no one would read it) opinion I wrote.

    Yes, Abrezza is an improvement over Exubera. But companies only market drugs when they think they will make money...the unwillingness of three major pharmaceutical companies to even try to market them, one with almost $3 billion in development costs at stake, should speak alot to the likelyhood of marketing success for this class of products. Answer this: Why arent the partners lining up for Abrezza?

    I agree that the Exhubera lung cancer connection is overblown, it was one point of many to demonstrate that market acceptance (reagardless of FDA approval) may be limited...again, where is the parnter?

    True, the FDA did not raise "any new saftey issues", but MNKD pointed out "small, non-progressive differences" in pulmonary function decline over time and the risk of respiratory difficulty immediately post-inhalation. MannKind said the changes disappeared three months after patients resumed usual therapy....so is it possible that patients have to take FDA mandated "Afrezza holidays" to avoid these issues? Sounds bad to me...and likely to the potential partners that we hear are shying away.

    As far the pharmacokinetics, , I was very careful to compare Abrezza to FAST ACTING INSULIN, which it has only shown NON-INFERIORITY to, not comparing it to basal insulin. Mannkind compares superiority to regular insulin....not FAST ACTING insulin. So check your argument again.....

    As far as their oncology drugs....show my anything past phase I! Any phase I results are meaningless for effiacy...so where are their "better than DNDN" results?

    Sheesh.
    Apr 30, 2010. 06:41 PM | 2 Likes Like |Link to Comment
  • Mannkind's Afrezza Seems Short of Breath [View article]
    No, you are wrong. Those comparisons are to long acting insulin, not fast acting insulin. I clearly stated fast acting insulin. Inhaled insulin is designed to assist in controlling blood sugar at mealtime. Type diabetics will still have to inject basal insulin regularly.

    There is no comparison between DNDN and MNKD....DNDN Provenge is a revolutionary cancer vaccine, MNKD is making an inhaled insulin product that has no real market and no drug company wants to partner.
    Apr 30, 2010. 12:33 PM | Likes Like |Link to Comment
  • Mannkind's Afrezza Seems Short of Breath [View article]
    Buccal delivery of insulin has been a challenge...an important aspect of insulin is the time it takes to enter the bloodstream and act, and it must do that with the appropriate dose to avoid hyper-and hypo glycemia. Oralyn has not (yet) been able demonstrate the precise timing/dose for delivery, there has been too much variability. It is a problem that GNBT may or may not be able to solve.
    Apr 30, 2010. 08:37 AM | 2 Likes Like |Link to Comment
  • Rosetta Genomics: Giving Isis and Alnylam a Run for Their miRNAs? [View article]
    I dont have an explanation- the price fluctuation was within the normal range of trading. The volume was higher because of the PR today- there doesnt seem to be a volume/price relationship, just coincidence. www.businesswire.com/p...
    Apr 29, 2010. 11:16 PM | Likes Like |Link to Comment
  • Rosetta Genomics: Giving Isis and Alnylam a Run for Their miRNAs? [View article]
    I like OGXI....OGX-011 shows alot of promise but is a risky drug, given that 99% of antisense drugs have failed. I think that is why the Teva deal was so unfavorable. OGXI is very risky IMO.
    ISIS is a great hold.
    Apr 26, 2010. 10:39 AM | Likes Like |Link to Comment
  • Terrible Housing Numbers Made to Seem Good [View article]
    Why wait? Why jump in front of a moving train?
    The fundamentals suggest that virtually ever sector is overvalued at present. The time will come to short, but it is not now.
    Apr 23, 2010. 03:29 PM | 1 Like Like |Link to Comment
  • CytRx: All That Glitters Could Be Gold [View article]
    You obviously have some inside information about INNO-206 I dont have.
    10 years ago, alot of companies jumped in the Bcr-Abl race and Gleevec came out on top. With the relatively recent understanding of Gleevec resistance, it has opened the failure of Novartis's own Tasigna was marketed to answer to Gleevec resistance, but it has still left large holes. Dasatinib and Sutent are trying to fill in this gap, bu they dont seem to be a great option, so there is still lots of room in this space.
    Apr 23, 2010. 03:26 PM | Likes Like |Link to Comment
  • CytRx: All That Glitters Could Be Gold [View article]
    There is no meaningful revenue. The company's cash position and burn rate should give them 18-24 months without capital raising. They have clearly stated that partnership is the path foward for all of their pipeline and phase II clinical trials, and that is obviously the best route for them. My feeling is that the above stated time is sufficient for them to proceed far enough in several of their programs to gain multiple partnerships.
    Apr 21, 2010. 11:22 AM | Likes Like |Link to Comment
  • Antigenics Should Emerge From Dendreon's Shadow Soon [View article]
    This is a great strategy, that is how I invest in them as well. You can have a $1,000 investment turn into $10,000 within 12-18 months if you are lucky. Usually the downside on that $1000 investment is a 50% shave, so the upside is greater than the downside.
    I do add/subtract around a core position depending on the wild price swings typical of these stocks, a dollar cost averaging approach. You never know where they can go- good news will cause a 300% multi-day run, bad news will cause a single day 75% drop. So it is a good idea to start with a small starting position and average down some by selling fractions on the upswings and buying fractions on the downswings. Given the frequency of the swings, you will find that after some time you may be able to sell off enough of your accumulated position to have earned that starting position at no cost. Then just let it ride.

    This, of course, takes diligence and patience, but less than you may think. I simply look at my portfolio every day and if one of my stocks is way green or red I go and see what is up with it. Every couple weeks or so I perform an "unrealized gain/loss" scan on my holdings and evaluate to take profits or cut losses. Also, with big news events I re-evaluate my positions.
    This is how I invest in biotech stocks, I hope this helps you determine a strategy.
    Apr 14, 2010. 11:25 AM | Likes Like |Link to Comment
  • Antigenics Should Emerge From Dendreon's Shadow Soon [View article]
    They were cash flow positive for the year in 2008 and also 2 quarters of 2009 due to some milestone payments and licensing fees.
    Apr 14, 2010. 10:52 AM | Likes Like |Link to Comment
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