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I'm a value investor focused on buying companies trading below the intrinsic value. I've a back ground in engineering & finance. I'm also a Chartered Financial Analyst.
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  • 20 Reasons Why Mannkind's Afrezza Is Superior To Novolog/Humalog

    Mannkind's (MNKD) lead drug Afrezza is nearing the PDUFA date of 15-Apr-2014. Afrezza is an inhaled insulin for use during meal times. Mannkind has submitted the NDA for the 3rd time. Here are the 20 reasons why Afrezza is superior to its nearest competitors Novolog/Humalog. Novolog is marketed by Novo Nordisk (NVO) and Humalog by Eli Lily (LLY).

    1. Afrezza is ultra-rapid acting insulin with a pharmacokinetic profile that mimics endogenous secretion of insulin. In plain English, Afrezza works like body's natural secretion of insulin by pancreas during meal time. Novolog/Humalog are called rapid acting analogues and don't even come close. The reason for the ultra-rapid acting is due to the fact that Afrezza has monomeric insulin.

    2. Afrezza is delivered by a sleek device that is discreet, portable and easy to use. Novolog & Humalog are delivered by injections. The inhaler is disposable.

    3. Afrezza has lower post-prandial glucose excursions. Hence it results in lower long term diabetic complications.

    4. Afrezza requires little or no titration compared to Novolog/Humalog. There are no correctional dosages needed. The accurate card counting would be a thing of the past.

    5. Afrezza requires less blood glucose (BG) level testing. This is one of the major pain points of diabetics. A typical diabetic needs one or more correctional insulin shots after a heavy meal and 3-4 times BG testing.

    6. Afrezza reduces the stress on pancreas as it takes the load off the pancreas. The hyperglycemia is less pronounced for Afrezza users. (see pg. 7). Brief glucose excursions outside the normal physiological range are especially damaging to β-cells. Afrezza helps the pancreas live longer.

    7. Afrezza patients will show better compliance. This reduces the long term diabetic costs. Recent survey indicates that 1/3rd of patients fail to take insulin as prescribed.

    8. The physicians can initiate insulin therapy earlier with Afrezza.

    9. No injection site complications like lipodystrophy, pain, redness, irritation and no need to keep track of injection sites for rotation.

    10. No post meal snacking and weight gain with Afrezza. The post meal snacking is a feature of Novolog/Humalog that causes hypos due to long tail.

    11. Afrezza shows much lower incidences of hypoglycemia. According to this article, One in 20 people (an estimated 2-4 percent and 6 percent in patients younger than 40 years old) will perish from severe hypoglycemia.

    12. Afrezza offers lower costs in the long run if we consider the reduced BG tests, no correctional dosages, better compliance and reduced long term complications due to lack of hyperglycemia.

    13. The Griffin research mentioned earlier says that prophylactic use of Afrezza prevents type 2 diabetes. It is a hard sell to use deploy prophylactic use of Novolog/Humalog

    14. Survey of patients who participated in Afrezza trials reported higher satisfaction rates

    15. Anecdotal evidence from trial patients who used Afrezza reported better HbA1C. In some recent trials, Mannkind was able to show superiority in A1C. You can read more about the background on A1C in this article as well.

    16. Due to superior kinetics, Afrezza shuts off the hepatic secretion of glucose. The body needs less insulin during meal time.

    17. Patients need less training, Afrezza is easier to learn and use

    18. Obese patients will show better glucose clearance with Afrezza. Children who take meal time insulin will be less traumatized. The FDA has approved pediatric trials for Afrezza.

    19. Afrezza is a God sent for needle phobic patients.

    20. Afrezza is easier to use for visually impaired patients and for patients with various disabilities.

    Afrezza, if approved will give the current rapid acting analogues a run for its money. Al Mann, the CEO of Mannkind corp says that Afrezza will be the greatest medical product in history. The potential market size is just enormous. According to the recent Canaccord presentation, the potential patient population in U.S. alone includes

    · 3.2 million on prandial insulin

    · 1.9 million on basal insulin as the only insulin

    · 12.6 million on oral agents alone

    Disclosure: I am long MNKD, . I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

    Tags: LLY, NVO, MNKD, long-ideas
    Jan 07 11:11 AM | Link | 5 Comments
  • Mannkind: Timing The PDUFA Run-up

    Is it possible to profit from a PDUFA run-up? Is it less risky compared to a long term buy and hold strategy? The answer is a resounding yes, if you look at the past history of Mannkind's two PDUFA's. There is a lot of speculative activity around a PDUFA date of any small biotech company. Just take a look at the run-up for Arena's (ARNA) Belviq, Vivus's (VVUS) Qsymia, Orexigen's (OREX) Contrave prior to PDUFA date.

    First, a primer on Mannkind. Mannkind's lead product is called Afrezza. Afrezza is a device/ drug combination product. Afrezza delivers powder insulin from a proprietary inhaler. Afrezza was twice rejected by FDA. FDA has not cited any safety and efficacy issues. The odds are in favor of Mannkind to successfully complete the Phase 3 trials. If everything goes as planned, the FDA submission will be around mid to late 2013.

    The table given below captures the dates for the submissions.

    Afrezza

    Submission-1

    Submission-2

    Submission-3

    Submission date

    12-Mar-09

    29-Jun-10

    Around mid to late 2013

    PDUFA date

    16-Jan-10

    20-Dec-10

    Around late 2013 or early 2014

    Decision date

    12-Mar-10

    19-Jan-11

     

    I analyzed the past two run-ups prior to the PDUFA date. The X-axis is the "weeks before the decision date". The Y-axis shows the returns assuming that you sell on the decision date.

    The graph shows that buying shares 15-20 weeks before the PDUFA date yields great returns. The returns start diminishing as one starts buying near the PDUFA date. Of course, the past returns are no guarantee of future returns. But the run-up prior to the PDUFA date is unmistakable. The PDUFA trade avoids the dilution risk and Phase 3 trial issues. By selling near the PDUFA date, one avoids the FDA rejection risk.

    The long term buy and hold investor faces dilution risk from convertible debt, warrants & stock issuance and also FDA rejection risk. It is definitely a less risky option (with less upside) to trade around the PDUFA date.

    Disclosure: I am long MNKD. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

    Additional disclosure: The closing prices of Mannkind stock was downloaded from Yahoo! finance.

    Tags: ARNA, OREX, VVUS
    Jan 08 11:25 AM | Link | 1 Comment
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