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Post by compound26 on May 15, 2015 8:49:51 GMT -5
Jefferies affirms MannKind (Nasdaq: MNKD) at Buy with a price target of $9 folloinwg a recent Afrezza survey. Analyst Shaunak Deepak said Jefferies surveyed 56 endocrinologists and primary care physicians about their expected use of Afrezza for diabetes. Deepak commented, "In screening physicians, we found that 35 percent did not know about Afrezza. Those that did, however, expected to use Afrezza more frequently than we had expected, especially among Type 1 diabetics." On reasoning behind such a low launch, Deepak said, "Ignorance is a big factor: of the 120 physicians screened for this survey, 35 percent were not familiar with Afrezza. Combined with the 8 percent who knew about Afrezza but did not expect to prescribe it, this suggests nearly half of potential prescribers are not currently writing Afrezza scripts. Indeed, only 12 doctors surveyed had written a prescription for Afrezza. Separately, in keeping with MNKD’s 1Q commentary that lung function testing was a gating factor for Afrezza uptake, prescribers who did not own a spirometer rated the test a 5/5 burden, compared to a 2.5/5 burden for those who did." But, Deepak maintains a Buy rating, commenting, "Only a tenth of doctors screened had written an Afrezza script, we see MNKD’s efforts to expand access to spirometers and begin advertising in 3Q as key catalysts for uptake. With advertising, we expect the eventual rate of non-prescribers will fall closer to 12 percent. The 2015-2017 Afrezza use numbers implied by our survey suggest penetration rates nearly four times higher than we had previously modeled, and a $37 PT. To account for potential overreporting by surveyed physicians, we have discounted reported penetration rates by 70 percent and assumed that the reported 2017 penetration is a stand-in for peak." www.streetinsider.com/Analyst+Comments/Jefferies+Believes+Additional+Efforts+by+MannKind+%28MNKD%29+to+Expand+Afrezza+Could+Provide+Upside/10565885.htmlIt think they meant to say "Analyst Shaunak Deepak said Jefferies surveyed 56 endocrinologists and 64 primary care physicians about their expected use of Afrezza for diabetes" as the article refers to "120 physicians screened for this survey" later.
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Post by compound26 on May 14, 2015 18:52:23 GMT -5
jpg Im curious your thoughts on the study abstract itself. If you read the data, it suggests that it blows the competition away in terms of much less occasions of hypoglycemia, but the conclusion is worded at best, weak. Can they for some reason not say this? Other questions: When was this conducted? tripoley or someone commented that it may just be the data from the 171 study rehashed? Is this the type of data that SNY is presenting for label expansion without conducing new trials? It probably is using the data from the 171 study. The abstract refers to study ID# NCT01445951, which points to the 171 study. clinicaltrials.gov/ct2/show/study/NCT01445951
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Post by compound26 on May 14, 2015 18:35:23 GMT -5
Late Breaking Abstracts submitted to the AACE: am.aace.com/sites/all/files/Late-Breaking.pdfPage 12 Abstract #1220 REDUCED HYPOGLYCEMIA IS OBSERVED WITH INHALED INSULIN VERSUS SUBCUTANEOUS INSULIN ASPART IN PATIENTS (PTS) WITH TYPE 1 DIABETES MELLITUS (T1DM) Lawrence Blonde, MD1, Jasvinder Gill2, Elena Nikonova2, John Stewart3, Bruce Bode4 Discussion: These data show that the more rapid onset and offset of action with TI versus IA was not associated with greater supplemental dosing. There was a consistently lower hypoglycemia rate in pts with T1DM treated with TI versus IA, including those taking supplemental doses, and during dose adjustment and stable dosing. Conclusion: These data show that supplemental TI dosing does not result in an increased hypoglycemia risk Amazing stuff. This would deserve it's own tread. I obviously haven't seen the study but this is a very big deal. The first thing this does is give reason and an obligation for endos to acknowledge and think of Afrezza. It is now an obligation of competence to take Afrezza seriously. Again this is big. The second consequence is that it gives license or a reason for those who wanted to try it but didn't. Now there is a justification. Third it shows Mannkind and Sanofi know what they are doing. This is, as those who have followed my musings, is exactly what I was expecting and hoping (praying) for (but thinking ADA. This is even better! I might actually buy a few shares tomorrow... JPG, totally agree with your analysis above. It's 39 weeks from the time (August 11, 2014) when Mannkind and Sanofi announced their partnership. If this report results from a study that just finished (or finished a few weeks ago),which appears to be the case, that means this is a Phase III study on Afrezza sponsored by Sanofi. If that is the case, then that will be a strong piece of evidence of Sanofi's long-term commitment to the Mannkind and Sanofi partnership and to Afrezza. It will be a slap on the face to the shorts who have been claiming that Sanofi will drop Afrezza prematurely or that Sanofi is dragging its feet (making no efforts) to promote Afrezza.
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Post by compound26 on May 14, 2015 15:36:51 GMT -5
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Post by compound26 on May 14, 2015 15:04:47 GMT -5
I think I saw Sam responding to someone regarding this and said something like if he participated in such program, he would be limited on what he can say (something to that effect).
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Post by compound26 on May 14, 2015 14:38:59 GMT -5
When I swag this, i use 25% still in SNY inventory, 50% in doctor inventory, and 25% dispersed to end users. That will be a reasonable assumption. Using such assumption, and assuming each patient get just one 10-day supply of samples, then I will arrive at my scenario 1 estimate.
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Post by compound26 on May 14, 2015 13:21:02 GMT -5
This would be 6-7 sample packs per patient, which is very unlikely unless patient has multiple visits? 2 or 3 packs/patient/visit sounds more reasonable to me. Agree. The assumptions are just there for easier calculations. Some assumptions may turn out to be too conservative while others may turn out to be on the aggressive side. More likely their effects cancel out each other.
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Post by compound26 on May 14, 2015 13:01:52 GMT -5
I would think (hope) we see closer to 1K in scripts real soon. I would thinks so. My above post was just for entertainment and for poking your mind. My above post also does not include any natural growth we should and would have based on more public awareness of the drug, doctors getting more willing to prescribe the drug after seeing positive feedback, insurance giving better coverage, etc. So I believe the actual prescriptions will be more than what I stated above if we fast forward a few weeks ahead. However, in the meantime, if other factors do not kick in as fast as we would expect, I think the above estimate would be the floor of the prescriptions solely based on the samples effect.
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Post by compound26 on May 14, 2015 12:47:39 GMT -5
Follow members, just for your entertainment, a very rough back-of-the-envelope guess of the samples to prescriptions conversion. 54,00 boxes / 1.600,000 carts of samples in total. Scenario 1: Assuming each patient uses 10 carts per day and each got two times the 10-day supply of samples, 1.600,000 will go to 8,000 patients. Assuming the doctors have given out half of the samples, then will reach 4,000 patients. Assuming 50% of the patients who got samples will ask for a prescription, that’s 2,000 patients. Assuming we have already seen 1,000 of such patients, there are 1,000 patients to arrive. Assuming these patients will get prescriptions within the next 12 weeks, that’s 80 each week. Adding 80 to the 250/300 TRx we have currently, it is likely we will see TRx at 335-450/week in the coming weeks. Scenario 2: Assuming each patient uses 10 carts per day and each got one 10 day supply of samples, 1.600,000 will go to 16,000 patients. Assuming the doctors have given out half of the samples, then will reach 8,000 patients. Assuming 50% of the patients who got samples will ask for a prescription, that’s 4,000 patients. Assuming we have already seen 1,000 of such patients, there are 3,000 patients to arrive. Assuming these patients will get prescriptions within the next 12 weeks, that’s 250 each week. Adding 250 to the 250/300 TRx we have currently, it is likely we will see TRx at 500-600/week in the coming weeks. Average of the two estimates above, it is likely we will see TRx at 425-525/week in the coming weeks .
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Post by compound26 on May 14, 2015 9:53:03 GMT -5
Pretty lame podcast. Anyone who read the Wikipedia entry could have provided a better summary of Al Mann's career. No real explanation of Afrezza's benefits beyond that it is inhaled. Take out the meaningless banter and this could have been compressed from 16 minutes to less than 5. The thesis is that MNKD has invested heavily in Afrezza due to 2 CRL's, and uptake is slow. Extrapolate the current numbers and you get sales that do not support a higher market cap. In the end the question is the same as it has always been. Will Afrezza be a blockbuster and a paradigm change in diabetes treatment or just a more convenient form of parandial insulin? The science and the early results from diabetics say paradigm shift in diabetes treatment. The early sales figures say just another treatment option. I say that the story remains the same. MNKD is still on the path to success and they will get there. It just always takes more time than expected. Agree. Not much information from the video at all. Based on the podcast's rationale, you should not invest in Apple until iphone is clearly proven to be a blockbuster and you should not invest in google until it has dominated the internet search and soundly beaten Microsoft. So based on this podcast's view, those early investors in apple and google are all stupid investors.
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Post by compound26 on May 12, 2015 18:57:58 GMT -5
Thanks, JPG. I think they refer to the same report (which I believe came out yesterday). One website quoted yesterday and the other quoted today. MannKind 'Facing Low Profitability And Delayed Profits' As Afrezza Ramp Fizzles, Goldman Says Javier Hasse , Benzinga Staff Writer May 11, 2015 3:35pm MannKind Corporation shares fell 5 percent Monday after JP Morgan downgraded the stock from Neutral to Underweight. The demotion followed last Friday’s earnings release, which disappointed many investors and analysts. Jefferies analyst Shaunak Deepak maintained a Buy rating and $9 price target. Analysts at Goldman Sachs reiterated a Sell and trimmed their price target from $3.00 to $2.00, to account for challenging headwinds. The News According to the research note, MannKind's share (Sanofi is a partner) of the Afrezza first quarter loss amounts to $12.4 million, “which was financed by a $175mn loan facility with Sanofi which now stands at $15.4mn. MNKD acknowledged that Afrezza sales were lower than expected and described plans to address certain headwinds including a black box warning on the label that requires spirometry testing and managed care hurdles such as prior authorization. Separately, management anticipates DTC advertising to begin this summer.” The Implications As Goldman Sachs has said in previous occasions, they believe MannKind “is facing low profitability and delayed profits based on a slow ramp of Afrezza, patient-driven market dynamics requiring heavy SG&A spending, and challenging deal terms with Sanofi.” Concerned that Afrezza the sales targets it is required by MannKind (to cover milestone payments to Sanofi), the firm lowered its sales and earnings estimates. They now expect a net loss of $(0.28) per share for 2015, $(0.12) per share for 2016, and $(0.04) per share for 2017. Read more: www.benzinga.com/analyst-ratings/analyst-color/15/05/5498649/mannkind-facing-low-profitability-and-delayed-profits-as#ixzz3ZyItptnV
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Post by compound26 on May 12, 2015 18:26:25 GMT -5
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Post by compound26 on May 12, 2015 13:40:37 GMT -5
Yes. I think Sanofi has confirmed that: Sanofi has also warned that Afrezza's launch wasn't likely to be quick or easy. " The initial rollout of Afrezza is targeted and focused on building awareness behind the product and appropriate usage," the company told the Los Angeles Times. "Because of requirements imposed by the FDA for starting patients on this therapy and the necessary time to gain market access, it will take time for Afrezza to demonstrate its potential." www.fiercepharma.com/story/analysts-skeptical-sanofi-can-turn-around-afrezza-launch-dtc-ads-are-coming/2015-05-12
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Post by compound26 on May 11, 2015 18:52:54 GMT -5
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Post by compound26 on May 11, 2015 17:13:48 GMT -5
One thing that Exubera could and probably does help Afrezza is that overtime, substantially, if not all, of the satisfied patients of Exubera will be patients of Afrezza. While there are not so many, there are still some out there. If I recall correctly, Exubera has all together 80,000 prescriptions and 24,000 patients. Not sure those numbers were for US or globally, but I would guess we should at least catch most of these patients in the US to the extent they liked inhaled insulin. That will help at least during the early stages of the launch.
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