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Post by compound26 on May 20, 2015 7:31:19 GMT -5
I wonder if the JDRF study would be considered empirical evidence by the FDA rather than anecdotal and whether this kind of evidence could lead to label revisions for Afrezza. I believe the following video link is related to that particular JDRF study. The study probably is in small scale. But I agree that it would be considered empirical evidence by the FDA rather than anecdotal. www.youtube.com/watch?v=GGgGjtM5ipg
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Post by compound26 on May 20, 2015 7:27:36 GMT -5
jdrf.org/2015/05/jdrf-top-research-advances-2/player.vimeo.com/video/1276277515:00 minute mark in the video for Afrezza GLUCOSE CONTROL The JDRF Glucose Control Program supports the development of novel insulin formulations and drugs that can be used in conjunction with insulin therapy to provide better control of blood-sugar levels. To learn more about JDRF’s glucose control research program, please click here. Mannkind’s Afrezza inhaled insulin shows promise as a good partner to AP system In summer 2014, JDRF industry partner Mannkind received FDA approval for Afrezza, a rapid acting inhaled insulin that can be used at the beginning of meals to more tightly control the rise in blood sugar levels that occur after eating. • A JDRF-supported study published in the Journal of Diabetes Science and Technology’s May 2015 issue showed that use of Afrezza as a mealtime bolus in conjunction with an experimental AP system significantly increased the percentage of time that people using the system stayed in ideal blood-glucose range. Thanks, harryx1. Great find. In the video, the commentator states that use of Afrezza as a mealtime bolus in conjunction with an experimental AP system " works really really well".
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Post by compound26 on May 19, 2015 16:26:01 GMT -5
I will sell my holdings of MNKD when its market cap hits 50B. Right now its market cap is at 1.8B. Long way to go.
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Post by compound26 on May 19, 2015 16:06:21 GMT -5
I added another 6,500 at 4.32 yesterday.
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Post by compound26 on May 16, 2015 11:19:00 GMT -5
If one multiplies the assumed penetration rate by four, then the assumptions in the original report will look like something below: Peak Afrezza sales of $12.8 billion. First-line insulin for 32% of type 2 patients failing oral drugs, worth $6.4b in peak U.S. sales. 12% and 24% penetration among type 1 and type 2 patients already on insulin, contributing $800m and $2.6b in U.S. sales.
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Post by compound26 on May 16, 2015 11:07:39 GMT -5
Here is the original report of Jefferies issued in August 2014, where you can see their assumptions of peak sales and market penetration rate. This will give context to Jefferies' latest comment "when MannKind does start advertising, the analyst expects the “eventual rate” of doctors who won’t prescribe Afrezza to fall to around 12%. Deepak added that the use numbers for this year through 2017 that are implied from their survey suggest that the penetration rate of the drug will be almost four times higher than what they previously estimated. The result would be a $37 per share price target." Jefferies Sees Peak Afrezza Sales of $3.2B, Starts MannKind (MNKD) at Buy August 27, 2014 7:30 AM EDT Jefferies initiated coverage on MannKind with a Buy rating and a price target of $10.00. Analyst Shaunak Deepak said he was taking a contrarian stance ahead of Afrezza launch. He sees peak Afrezza sales of $3.2 billion. "MNKD is off 33% since the Afrezza approval, reflecting negative Street sentiment about the Sanofi partnership and upcoming launch. Key concerns include docs not adopting Afrezza as a first-line insulin, aggressive counter-detailing from Novo and Lilly to protect their stake in the $6b+ mealtime insulin market, and a bad track record with the only other approved inhaled insulin, Exubera," said Deepak. "We believe Afrezza could address a major unmet need among patients poorly controlled with oral drugs that have not advanced to injectable agents. Surveys of insulin non-adherence suggest a not insubstantial portion of patients reject insulin due to reluctance to take shots. Accounting for other factors that influence patient avoidance of insulin, we believe Afrezza could be used as a first-line insulin for almost 8% of type 2 patients failing oral drugs, worth $1.6b in peak U.S. sales. We believe Sanofi would promote Afrezza as a first-line insulin to gain and retain patients for its $8b+ insulin franchise," he continued. "While Afrezza has shown non-inferiority to Novolog as a mealtime add-on in both type 1 and type 2 diabetics, we believe the significantly better A1c reductions with Novolog will be a challenge for marketing Afrezza. Compounding this is the Street’s memory of Exubera as a flop associated with lung cancer. We believe some patients only on basal insulin will be attracted to Afrezza’s benefits in hypoglycemia and weight gain, while some current mealtime insulin users will be drawn to reductions in injection burden and the whistle-like delivery device, which is more discrete than Exubera’s. We expect modest 3% and 6% penetration among type 1 and type 2 patients already on insulin, contributing $200m and $650m in U.S. sales. We see Sanofi as strongly motivated to promote Afrezza in this setting as its mealtime insulin, Apidra, only has a 3% share," he added. www.streetinsider.com/Analyst+Comments/Jefferies+Sees+Peak+Afrezza+Sales+of+$3.2B,+Starts+MannKind+(MNKD)+at+Buy/9785895.html
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Post by compound26 on May 16, 2015 10:47:26 GMT -5
MannKind Corporation Surges On Results Of Afrezza SurveyMichelle Jones Posted date: May 15, 2015 03:43:41 PM MannKind shares surged today after one firm released the results from its physician survey of the company’s inhaled insulin, Afrezza. The stock climbed as much as 11.57% to $4.05 per share during regular trading hours. Prescription growth for Afrezza has been going slowly, as most analysts have expected, but the big question mark now is whether growth will pick up or if Afrezza will turn out to be a dud. Physicians respond favorably to Afrezza Jefferies analyst Shaunak Deepak said they surveyed 120 doctors regarding Afrezza, how often they prescribe it and how often they intend to prescribe it going forward. The survey covered both primary care doctors and endocrinologists. According to Deepak, more than one-third (35%) of the doctors they spoke to didn’t even know about Afrezza. However, the doctors that did about the inhaled insulin, said they expected to prescribe it more often than the analyst had previously expected, particularly in treating Type 1 diabetes. MannKind must educate Analysts at RBC Capital Markets have been keeping close tabs on weekly prescription numbers for MannKind’s only drug on the market. Progress has been very slow, although the firm has remained bullish on the insulin maker. Jefferies’ Deepak has now provided some reasons for the slowness, thanks to the survey. The analyst said the biggest problem MannKind faces in terms of getting Afrezza in the hands of patients is physician ignorance. According to Deepak, 8% of the doctors they surveyed don’t expect to prescribe the inhaled insulin. That, when combined with the 35% who didn’t know about it, indicates that nearly half of doctors who treat diabetes aren’t writing scripts for Afrezza. Just 12 of the doctors (or 10%) who were surveyed had actually written a prescription for Afrezza. Barriers to entry In addition to simply not knowing that Afrezza exists, the other big problem is the requirement for lung function testing before the inhaled insulin can be prescribed. Analysts knew from the start that this would be a problem for MannKind. According to Deepak, the doctors who didn’t own a spirometer (the tool used for lung function testing) rated the test a five out of five burden. On the other hand, doctors who did own a spirometer rated the issue a 2.5 out of five burden. Like RBC, Jefferies remains bullish on MannKind, with Deepak reiterating the firm’s Buy rating and $9 per share price target on the drug maker. The analyst said MannKind is aiming to “expand access to spirometers” and plans to begin advertising Afrezza in the third quarter. He sees these two plans as being positive catalysts. When MannKind does start advertising, the analyst expects the “eventual rate” of doctors who won’t prescribe Afrezza to fall to around 12%. Deepak added that the use numbers for this year through 2017 that are implied from their survey suggest that the penetration rate of the drug will be almost four times higher than what they previously estimated. The result would be a $37 per share price target, the analyst said. In the first quarter of this year, MannKind and marketing partner Sanofi sold about $1.1 million worth of Afrezza. www.valuewalk.com/2015/05/mannkind-corporation-surges-on-results-of-afrezza-survey/
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Post by compound26 on May 16, 2015 10:37:02 GMT -5
Why MannKind Stock Got New Life Breathed Into It TodayBy Brian Feroldi May 15, 2015 Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis. What: MannKind Corp. stock shot up 12% today on heavy trading volume after two pieces of news related to the company were released. So what: First, investment services group Jefferies affirmed its Buy rating on the stock with a $9 price target after conducting a survey of physicians about their use of MannKind's sole product on the market, an inhaled insulin called Afrezza. The survey found that 35% of physicians didn't even know that Afrezza was available for sale. In addition, providers confirmed that the lung function testing that management mentioned on the most recent conference call was indeed a reason for slow initial adoption, and they rated it as a 5 out of 5 burden for prescribing the drug when the office did not own a spirometer, which is the device needed to perform the prerequisite lung tests. Jefferies sees expanded access to spirometers and the start of advertising in the third quarter as near-term catalysts that will lift sales. Second, the FDA issued a warning that SGLT2 inhibitors for diabetes, which are competitors to Afrezza, may result in ketoacidosis, a serious condition that may require hospitalization. Brand name drugs mentioned in the report include Invokana, Farxiga, and Jardiance. The FDA is further investigating the safety issue and will determine if they need to alter the prescribing information for SGLT2 drugs. www.fool.com/investing/general/2015/05/15/why-mannkind-stock-got-new-life-breathed-into-it-t.aspx
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Post by compound26 on May 15, 2015 14:30:34 GMT -5
MANNKIND CORP CMN 56400P201 2,930 561,914 SH DFND 1 561,914 0 0 MANNKIND CORP CMN 56400P201 1,021 195,800 SH Put DFND 1 195,800 0 0 MANNKIND CORP CMN 56400P201 971 186,200 SH Call DFND 1 186,200 0 0 MANNKIND CORP CMN 56400P201 337 64,599 SH MANNKIND CORP CMN 56400P201 4,415 849,057 SH DFND 1 849,057 0 0 MANNKIND CORP CMN 56400P201 4,710 905,700 SH Put DFND 1 905,700 0 0 MANNKIND CORP CMN 56400P201 10,096 1,941,500 SH Call DFND 1 1,941,500 0 0 MANNKIND CORP CMN 56400P201 133 25,648 SH Goldman Sachs, after a downgrade, accumulates another 40% position, from 627k to 875k shares. Further, they increase their call position by over 1000% from $900k to over $10,000,000 So typical of GS. They do it again and again. They short (downgrade) something, but buy a ton of it themselves (at a lower price as of a result of their shorting (downgrading)). In the financial crisis, they promoted/sold subprime mortgage and then shorted it and made a killing.
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Post by compound26 on May 15, 2015 14:05:27 GMT -5
Gustavo Basualdo @guasaman 3rd day pump free!Finally stabilizing. Turns out #afrezza+glargine=easier basal control than pump for me #incredible twitter.com/guasaman Great. I will add that.
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Post by compound26 on May 15, 2015 14:00:46 GMT -5
By his own admission, he was off 400% on projections. Idiots. This is a good example of why it is best to ignore other people's opinion and come up with your own in the biotech world. We should give him credit for doing his due diligence (at least he based on his opinion on a survey of the physicians; unlike GS, who would just come out with a price target out of thin air). And also note that this time, Jefferies actually surveyed 120 physicians. 120 physicians is not such a small sample. Note that last time (in March 2015), they only surveyed 16 physicians. See the report below. Analyst: MannKind Afrezza Estimates Are Being Changed 'Based On Physician Feedback' Javier Hasse , Benzinga Staff Writer March 24, 2015 In a report issued Tuesday morning, Jefferies analyst Shaunak Deepak adjusted his estimates for MannKind Corporation 's Afrezza based on physician feedback, in spite of early IMS scripts. According to the analyst, the feedback has made the firm more confident in the long-term sales potential of the rapid acting inhaled insulin. Timeline Jefferies maintained its peak penetration estimates across all subgroups, but is now working under the assumption that Afrezza trajectory will take ten years, rather than six. "As a result of this more gradual sales ramp," they lowered their price target from $10 to $9, while reiterating a Buy rating. Speaking With Experts The research firm spoke with 16 endocrinologists, "none of whom had prescribed Afrezza as of early March. However, feedback suggested strong interest in the drug," so they spoke to two physicians at diabetes centers who had prescribed the drug six and four times, respectively. "Collectively, the feedback suggested that Afrezza could be a desirable option as a first insulin or an alternative to injectable mealtime insulin, but that it will likely take additional time to educate physicians to use Afrezza to its full potential." Read more: www.benzinga.com/analyst-ratings/analyst-color/15/03/5352295/analyst-mannkind-afrezza-estimates-are-being-changed-bas#ixzz3aEcAXBBF
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Post by compound26 on May 15, 2015 12:57:38 GMT -5
I spent some time assembling a summary of the advantages of Afrezza and patients' feedback in the social media. This is very crude right now. Please provide your input and I will update it as appropriate. Hopefully, with your input, we can make it useful (even a little bit help will be better than none, I guess, to Mannkind and Sanofi for their marketing, advertising and product improvement efforts. Gee, not easy to be an investor of Mannkind. Seems like I am turning myself into a unpaid data collector/analyst for Mannkind. Attachment Deleted
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Post by compound26 on May 15, 2015 9:40:33 GMT -5
Really like the fact they actually surveyed 120 physicians. Also note their comment regarding the Spirometry test.
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.
Mannkind commented in their conference call that only 30% of the endos have spirometers. Hope Sanofi and Mannkind can find ways to help alleviate the Spirometry test burden for the endos soon.
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Post by compound26 on May 15, 2015 9:22:39 GMT -5
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Post by compound26 on May 15, 2015 8:53:45 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.htmlReally like their report. Note that last paragraph: 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.
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