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Post by otherottawaguy on Nov 20, 2014 12:07:41 GMT -5
Using Sanofi numbers to extrapolate to world wide market potential:
3.1 Million is only for those that are resistant to adding Rapid acting insulin 2M are those that are being adequately serviced Giving a US ONLY market potential of 5M of a 30M current market of approx. 16% of entire market
This is where if gets interesting: EU Market = 300M population * 10% diabetic percentage * 16% = 4.8M ROW1 (Rest of World with means) = 500M * 10% * 16% = 8M ROW2 (without means) = 5000M * 10% * 16 * 10% (those with means) = 8M
Total US 5 + EU 4.8 + ROW1 8M + ROW2 8M = 25.8M potential users world wide or about 10% of the 300M worldwide diabetic population.
OOG
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Post by otherottawaguy on Nov 20, 2014 9:24:15 GMT -5
Current capacity with 1 line is 166K. Adding the next 2 updated lines will add another 365K bringing the grand total to 530k by the end of 2015 under the current capacity guidance. 1.5B in sales would mean an additional requirement for at least another line during 2015 making the 1.5B target possible in 2016
OOG
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Post by otherottawaguy on Nov 20, 2014 9:08:33 GMT -5
The way this guy is waxing on about Genzyme, we won't get to Afrezza until trading starts. They seem to be talking a lot more than showing slides, so unless I have missed it, the A presentation may shed some light (I hope).
OOG
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Post by otherottawaguy on Nov 18, 2014 9:03:49 GMT -5
from the magazine article:
WITH 40 PERCENT OF AMERICANS PREDICTED TO DEVELOP TYPE 2 WITH 40 PERCENT OF AMERICANS PREDICTED TO DEVELOP TYPE 2
diabetes in their lifetime, according to the Centers for Disease Control and Prevention’s latest fi ndings, it’s no wonder scientists are working around the clock to treat, manage and possibly even reverse the condition. Here’s a roundup of the latest breakthroughs. No more needles! This summer, the U.S. Food and Drug Administration (FDA) approved Afrezza, a rapid-acting inhaled insulin for adults with Type 1 and Type 2 diabetes, which is expected to hit the market in early 2015. The whistle-sized inhaler is used about 20 minutes prior to eating. Peak insulin levels are achieved within 15 minutes of the puff , compared to about an hour with traditional injected insulin. “This new delivery system is absorbed through the lungs, so it begins to work very quickly,” says Robert Ratner, MD, the American Diabetes Association’s (ADA) chief medical offi cer. “You can literally take it with the fi rst bite of the meal. It’s also out of the system faster, so there is less risk of low blood sugar.”
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Post by otherottawaguy on Nov 12, 2014 10:45:49 GMT -5
all we need is 1% of the entire float to disappear a week and away we go...
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Post by otherottawaguy on Nov 7, 2014 8:44:00 GMT -5
Was this broadcast anywhere?
This is that I found at the link, was hoping there might be more:
Services, San Mateo, California University of California, San Francisco, San Francisco, California 08:05 Keynote Speech: Toward a More Physiologic Insulin Therapy Alfred Mann, MS MannKind Corporation, Valencia, California Session 2: Wearable Devices for Diabetes
OOG
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Post by otherottawaguy on Nov 6, 2014 15:10:57 GMT -5
JPG:
I would agree with your observations. I am just trying to a conservative estimate based upon capacity and that is why I kept the P/E at 18. I have had others comment on this that using as much as a 50 P/E would be appropriate for an new up and comer. I have also over padded the share count by 20-30 million as well.
As to the launch, I am of the personal opinion, that if Sanofi make a concerted effort, we will see those machines firing on all cylinders (3? or more) by the end of 2015.
Taking these two facts into consideration, I am assuming that we are running at 30% capacity at launch and 100% (3 lines) by Dec 2015 giving us an annual average of 48%. Combining this with the lower PE estimate vs the 30-50 factor gives me the number that I am pretty much calculating.
Just for fun though, as I plan to hold this for another few years lets take the calculation that they will be built out to 12 lines at some point.
7.74 / 532 (current capacity) * 2184 (max cap) * 1/.91 (giving back time discount) = 34.94 per share (at some future date).
When this happens (and not if), I would assume that on the way there we would see a much high PE as you suggest.
Best wishes,
OOG
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Post by otherottawaguy on Nov 6, 2014 13:41:00 GMT -5
Can you paste the article in?
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Post by otherottawaguy on Nov 6, 2014 13:37:17 GMT -5
I would be interest to know how many shares the triggering entity picks up on one of these excursions?
Just looking at the action between the dip and the return to calm, it looks like they hit it with 975-1080 K on the way down and 1450K bought on the way back up.
Does that mean that there was a net exchange of shares of about 400K to the shorts advantage?
I would assume that there is no honour amongst thieves so triggering party may have only gotten 25-50 percent of the 400. Even at 200 K at 5.50, that is over a million for a mornings work. Lots of incentive to keep paying for the hit pieces, and to keep going back to the well.
OOG
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Post by otherottawaguy on Nov 6, 2014 13:24:43 GMT -5
Brentie:
I have always had issues with the capacity. 12 lines is what they have told us would be the max footprint at Danbury. They have also told us that this will produce enough annual dosages for 2 million customers, so I therefore have assumed 166k annual dosages per line.
As per the most recent CC and the statement that the lines are 10% faster this should bring the plant max capacity to 2.183M annual dosages.
Wish they would all be playing from the same deck of facts for all the hands.
OOG
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Post by otherottawaguy on Nov 6, 2014 13:17:32 GMT -5
So we now have the equivalent of 3.2 (1 old + 2 at 110% old capacity) lines firing at 166000 annual dosages.
3.2 * 166K = 531K
And to drag out my old formulae with the updated inputs:
Under current Danbury max production of 3.2 lines using your COGS and discounting for time: 531K (patients) * (2600- (45%* (2600) [COGS])) *.80[after pharma markup removed] * 35% [Royalty Rate] / 450M [Share Count w Warrants] * (1/(1.085 ^ 1.16)([discount to end of 2015] * PE =531k * 2600 * 0.55 * .80 * 0.35 / 450M * 0.910 * 18[P/E] =531k * $400 / 450M * 16.38 =532K * $0.00001456 =$7.74 pps (vs my previous estimate of $7.07)
So we gained about 10% on the added capacity and a shorter timeframe to the end of 2015. This assumes that all three lines are avail at 1 Jan and negates the effects of the old line that may or may not be running at 100% / 24h capacity. Adding an additional amount for the realization of the Lump Sums should probably push this to estimate of the current pps to over $8 per share.
Enjoy,
OOG
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Post by otherottawaguy on Nov 5, 2014 11:17:36 GMT -5
Afrezza Inhaled Insulin
The Fastest-Acting FDA-Approved Insulin on the Market Has Favorable Properties
David C. Klonoff, MD1 1Mills-Peninsula Health Services, San Mateo, CA, USA David C. Klonoff, MD, Mills-Peninsula Health Services, 100 S San Mateo Dr, Rm 5147, San Mateo, CA 94401, USA. Email: dklonoff@diabetestechnology.org inhaled insulin Afrezza diabetes pulmonary On June 27, 2014, the US Food and Drug Administration approved Afrezza (MannKind, Danbury, CT), an ultra-rapid-acting inhaled insulin to improve postprandial glycemic control in adults with diabetes mellitus.1 This is the only ultra-rapid-acting insulin on the market with faster pharmacokinetics and pharmacodynamics than the 3 rapid-acting insulin analogs currently on the market, which are insulin aspart, insulin glulisine, and insulin lispro.
The name “Afrezza” refers to the drug/device combination product consisting of Technosphere insulin powder (known as TI), the inhaler, and the cartridges containing TI which is referred to as the Afrezza Inhalation System or the TI Inhalation System. TI is composed of recombinant human insulin and fumaryl diketopiperazine (FDKP), which is an inert excipient. Insulin powder particles are adsorbed onto uniform-sized (approximately 2 microns) carrier Technosphere particles which contain mostly crystallized FDKP. Upon inhalation, the Technosphere particles carry the insulin into the alveoli where the particles dissolve. Both the insulin and the FDPK are rapidly absorbed across the alveolar walls independently of each other. The insulin uptake into the blood stream is faster than that of any other approved insulin. The absorbed FDPK is not metabolized and is excreted in an inert form mostly by the kidneys.2
This approval was in response to the company’s third submission in 2013. After 2 previous cycles of review MannKind had received complete response letters on March 12, 2010, and January 18, 2011, because of multiple deficiencies identified by FDA in the prior applications.3 At one point in 2010, the company elected to drop their first generation delivery system (Medtone) and seek approval for their smaller second-generation delivery system (Gen2 also known internally as Dreamboat). FDA responded that a head-to-head comparison between the 2 inhalers would be needed, as well as a dose-proportionality study and a human factors study.2
The pharmacokinetic properties of TI are uniquely rapid of all approved insulins. The median time to maximum concentration in most subjects is 12-15 minutes. The PK of TI in subjects with type 1 diabetes, type 2 diabetes, and even smokers or those with chronic obstructive pulmonary disease is no different than that in unaffected controls. In asthmatic subjects insulin absorption may be decreased.4
Regarding the pharmacodynamics of TI, this drug has a more rapid onset of action and a shorter duration of action compared to rapid-acting insulin analogs. In glucose clamp studies, the maximum glucose infusion rate (tie of peak glucose-lowering activity) was 53 minutes for TI, 108 minutes for the analog insulin, and 3-4 hours for regular human insulin. The duration of Afrezza action is 2.5-3 hours.4
In their FDA submission, MannKind evaluated the safety and effectiveness of Afrezza in a total of 3017 subjects—1026 had type 1 diabetes and 1991 had type 2 diabetes. In 4 pivotal trials TI was either noninferior to comparator insulin in 2 of 3 trials and on the margin of noninferiority versus inferiority in 1 study (TI had a higher A1c than comparator with a 95% confidence interval as extreme as 0.40% worse than comparator with the prespecified noninferiority target set at <0.40%). In a placebo-controlled trial TI was superior to placebo.5
The most common adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough, and throat pain or irritation. In the approval, Afrezza was asked to print a boxed warning advising that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD). Regarding hypoglycemia, in all 3 active comparator-controlled trials of this drug, subjects had overall 20-65% less hypoglycemia, and based on an A1C stratification analysis, it turned out that the decreased hypoglycemia occurred irrespective of subjects’ A1C levels.2
The 2 most interesting trends in my opinion were the decreased postprandial excursions that were demonstrated with 7-point glucose curves and the decreased incidence of hypoglycemia in the trials where comparator insulin was used and in the placebo-controlled trials, the event rate for subjects on metformin plus sulfonylurea was the same as metformin plus TI.2 Although TI had PK/PD advantages compared to insulin aspart, these 2 benefits were not statistically significant. The early onset of action of Afrezza compared to insulin aspart likely helped control the postprandial rise in glucose and the early disappearance of Afrezza compared to insulin aspart likely led to less late postprandial hypoglycemia after a meal has been absorbed (Figure 1). This type of data would support the position that a valid effectiveness endpoint could be a reduction in such type of hypoglycemic events if a novel insulin or insulin delivery system is associated with ultra rapid absorption. At the same time, an ultra rapidly acting insulin like Afrezza might be expected to produce less hyperglycemia immediately after a meal and less hypoglycemia late after a meal and result in little decline in the A1C. Such a drug could still be helping not only to mitigate glycemic lows and highs, but to also decrease glycemic variability (GV), even though GV has not been proven to be a true problem requiring treatment.
Figure 1. View larger version: In this page In a new window Download to PowerPoint Slide Figure 1. Seven-point glucose profile at week 52 in T2DM subjects in a trial of Technosphere Insulin vs insulin comparator. Red square and red line = TI with each meal plus basal glargine insulin once daily. Purple circle and purple line = 70/30 insulin twice daily. This figure was adapted from data provided by Dr Anders Boss from a study by MannKind.7
The risk of lung cancer has been raised as a safety concern to the use of inhaled insulin. In the registration trials 2 heavy smokers developed lung cancer—1 while in a controlled comparative clinical trial and 1 while in an extension. This incidence of lung cancer (0.8 cases per 1000 patient-years)2 was felt by the company to be within the range of lung cancer observed in the general population (approximately 0.23-1.22 cases per 1000 patient-years, according to the American Lung Association).5 These incidences with Afrezza can be compared to the incidence of primary lung cancer and the mortality of primary lung cancer which were observed in a follow-up study of users of Exubera, another type of inhaled insulin that was available from September 2006 through October 2007. Comparing Exubera to comparator agents according to person-years of use, the relative increased lung cancer incidence and mortality with Exubera were 3.75 and 2.81 respectively and FDA classified pulmonary malignancies as adverse events of special interest for inhaled insulins.3 At the Afrezza panel hearing on April 1, 2014, the FDA reviewers raised the issue of whether inhaled insulin causes preexisting lung cancers to grow more quickly than they would otherwise grow, but neither FDA nor MannKind officials could think of a good way to prove or disprove that hypothesis.
The FDA is requiring the following postmarketing studies for Afrezza:1
•a clinical trial to evaluate pharmacokinetics, safety, and efficacy in pediatric patients
•a clinical trial to evaluate the potential risk of pulmonary malignancy with Afrezza (this trial will also assess cardiovascular risk and the long-term effect of Afrezza on pulmonary function)
•2 pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, 1 to characterize dose response and 1 to characterize within-subject variability.
Afrezza will fill a needed role for patients who do not wish to dose themselves for prandial insulin coverage with insulin from a needle injection. The rapid onset and offset of this insulin may well prove to be a great advantage in minimizing glucose fluctuations without much of the risk of late postinjection hypoglycemia. Now that MannKind signed a marketing agreement with the world’s largest insulin company, Sanofi,6 it is likely that Afrezza will soon be made available in many countries by way of a well-established distribution system. I look forward to seeing Afrezza used for mealtime insulin therapy in a closed-loop system and for many other situations where bolus insulin therapy is needed but late postprandial hypoglycemia is intolerable.
Next Section
Article Notes
Declaration of Conflicting Interests The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: DCK is a consultant to Google, Insuline, Roche, Sanofi, and Voluntis.
Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
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Post by otherottawaguy on Nov 4, 2014 15:19:24 GMT -5
Just so this guy stops getting a penny a click:
Diabetes Analyst: Sanofi CEO's Firing May Spell Trouble for MannKind Afrezza Partnership
By: Adam Feuerstein Follow | 11/04/14 - 01:40 PM EST
Stocks in this article: MNKDSNY
MannKind (MNKD) used its quarterly conference call Monday night to tamp down any concerns about the firing of Sanofi (SNY) CEO Chris Viehbacher causing problems for the Afrezza diabetes partnership ahead of the expected first quarter 2015 launch.
Not everyone shares MannKind's confidence. Diabetic Investor's David Kliff, a longtime Afrezza skeptic, believes Viehbacher was the driving force behind the MannKind partnership and pushed the deal against the wishes of others at Sanofi who didn't want anything to do with the inhaled insulin device. Now that Viehbacher is out at Sanofi, Kliff says the Afrezza commercial launch might be in trouble even before it starts.
Kliff, writing today to his subscribers:
With Viehbacher now gone and Sanofi expected to bring in a change agent with diabetes experience it's quite possible that this new person could reexamine the deal and decide it's just not worth the effort, not to mention the capital investment needed. A critical date here is November 20 when the company holds their analyst day, a day which according to MannKind management Afrezza will be big part of, the star of the show so to speak. Many observers believe that Sanofi will announce Viehbacher's replacement as early as this week. Given the timing of all these events it will be interesting to see if the new person, only in charge a short time, makes the first of several changes and knocks Afrezza out if it's starring role.
Must Read: Warren Buffett's Top 10 Dividend Stocks
On its conference call last night, MannKind executives responded to questions about Sanofi's commitment to Afrezza post Viehbacher's exit.
"While certainly Viehbacher was a supporter of the Afrezza partnership, I have to say that the entire Sanofi organization has embraced this opportunity with much enthusiasm as we've seen in the U.S. and in France and in Germany. So we are still looking forward to a long and successful partnership. And yes, we have not seen any other impact on that," said MannKind President Hakan Edstrom.
As you'd expect, MannKind used most of the call to discuss steps it and Sanofi were taking to move Afrezza closer to launch early next year.
Kliff isn't buying MannKind's line:
Now for anyone out there who seriously is buying manure that's been spread about Afrezza and how it will become a mega-blockbuster, we suggest they go back and listen to Sanofi's last earnings call. We strongly suggest they pay close attention to the remarks made about insulin pricing. We then suggest they remember that Afrezza isn't cheap to make and all along Al Mann was touting how payors would pay a premium for this product. These are the same payors who have basically forced Sanofi to lower the price or increase rebates for Lantus...
Afrezza won't suffer the same fate as Exubera as it will see some sales. We do however believe that Sanofi could well suffer the same fate as Pfizer and that alone may cause the company, with a new CEO, new Chairman to pull the rug from under this ill-advised partnership before it's too late.
Just something else to watch as Sanofi chooses its next CEO and the Afrezza commercial launch draws closer.
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Post by otherottawaguy on Nov 4, 2014 9:28:09 GMT -5
GRIFFIN SECURITIES Member FINRA, SIPC
Keith A. Markey, Ph.D., M.B.A.
Stock Symbol NASDAQ: MNKD Current Price $5.92 12 mos. Target Price $16.25 Market Cap $2,382.1 mln MannKind Corp. BUY Company Update : Pharmaceuticals
Launch of Afrezza® Approaches
September financial results come in as expected. MannKind’s R&D expense for the quarter totaled $19.2 million, down 49% sequentially, and G&A costs were off 41% from the June quarter, at $19.1 million. The drop in expenditures was related to a decline in stock-based compensation performance awards, offset partly by legal expenses related to the Sanofi agreement. The downward trend should continue as Sanofi assumes more duties and MannKind focuses on building inventory. As a result, we estimate the per-share loss for the December quarter at $0.08, versus the $0.09 a share loss in the September period.
The Company has ample cash after receiving the $150 million upfront payment from Sanofi, $40 million from a debt agreement with Deerfield, and $17.3 million from warrant and stock option exercises. Another $70 million is available through Deerfield and $30 million, from The Mann Group. Also, MannKind should receive a $25 million manufacturing milestone in the near future.
Accounting issues related to the Sanofi deal remain undecided. MannKind and its auditors have not finalized how the upfront payment and milestones will be treated, other than to say they will be recognized once the Company is booking revenue and earnings are estimable. Treatment of MannKind’s share of losses generated by Afrezza’s rollout is another issue awaiting resolution. Hence, we are not providing 2015 estimates presently.
Sanofi has given hints about its marketing plans, though more information may be forthcoming on November 20th when it will hold a New Medicines seminar. We believe Afrezza’s launch will consist of two parts, one promoting it based on the benefits of prandial insulin for early-stage type 2 diabetics most of whom will probably require only a single dose of the current formulation. The other part of the marketing campaign will likely promote Afrezza and Sanofi’s new basal insulin, Toujeo®, for diabetics who are more advanced. A price break may even be offered to encourage use of both drugs.
We think investor interest in MannKind shares will rise in the months ahead as Afrezza begins to penetrate the diabetes market. However, the Company’s income statement may not be very informative initially, depending on how the upfront fee, milestone payments, and proportionate share of Afrezza losses are treated. MNKD stock remains on our BUY list.
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Post by otherottawaguy on Oct 28, 2014 11:13:50 GMT -5
Someone stated that he has been a the helm for the period where the share price has risen from 25 to 50 range. This squabble seems to have trimmed 10%.
OOG
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