|
Post by savzak on Dec 21, 2014 8:44:58 GMT -5
Dec. 2014 issue of "Pharmacy Practice News"... m.pharmacypracticenews.com/Article.aspx?d=Clinical&d_id=50&i=December+2014&i_id=1130&a_id=29015Afrezza Approval Makes Splash Although SGLT2 inhibitors and GLP-1 RAs are important additions to clinicians’ armamentarium, “the biggest news in diabetes treatment is the approval of the pulmonary insulin, Afrezza [MannKind],” stressed Dr. Campbell. “It begins working within minutes, peaks within 15 minutes, and is associated with few instances of hypoglycemia,” he said. The failed launch of Pfizer’s Exubera, another inhaled insulin that was approved by the FDA in 2006 and quickly removed from the market due to low sales, may not bode well for Afrezza. But in Dr. Campbell’s view, differences between the two agents make it more likely that Afrezza will be widely adopted into clinical practice. “Afrezza has greater pulmonary absorption and requires less patient education,” he said. “Patients needed half an hour of training to understand how to use Exubera. Afrezza, in contrast, requires one minute of training.”
|
|
|
Post by gwb on Dec 21, 2014 14:41:58 GMT -5
New from Fools . Now just Pricing is the ? But there is a nice map of us for last 30 years , in 10 year periods . Interesting changes in TX and southern states, growing much faster !
www.nasdaq.com/article/could-the-next-generation-of-diabetes-treatments-be-found-in-this-illegal-drug-cm425555
Could the Next Generation of Diabetes Treatments Be Found in This Illegal Drug?
By Motley Fool, December 21, 2014, 11:41:03 AM EDT
Heart disease and cancer may be the two most common direct causes of death in the United States, but a chronic disease that now affects 29.1 million people in this country and is a prime risk factor for heart disease, cancer, and a number of other serious ailments is rightfully beginning to draw a lot of attention. This growing concern is none other than diabetes.
Diabetes prevalence within the U.S. Source: Centers for Disease Control and Prevention.
A growing problem Diabetes comes in two forms: type 1 and the considerably more common type 2.
Type 1 diabetes is a genetic disorder that manifests during childhood and destroys the cells responsible for insulin production. Insulin is a key component required for us to absorb glucose in order to produce energy. Type 1 diabetes makes up about 5%-10% of all diabetic diagnoses and the disease itself is not preventable.
On the other hand, type 2 diabetes can develop at any age and is the result of the body not understanding how to properly use insulin, resulting in glycemic imbalances that can be dangerous over the long run. Unlike type 1 diabetes, type 2 diabetes is potentially preventable or at least its progression can be dramatically slowed by maintaining a healthy lifestyle, eating properly, and maintaining a healthy weight.
However, with more than a third of the U.S. population considered obese, and around two-thirds overweight based on body mass index, it's no wonder we've seen a rise in diabetes diagnoses over time. Estimates from the Centers for Disease Control and Prevention note that there are 86 million cases of prediabetes just waiting in the wings, and that a frightening one in four diabetics has no clue they have diabetes.
It's a serious long-term disease that clearly needs immediate attention.
Source: MannKind.
Even the "little guy" is getting in on the action. After a complete response letter rejection in 2011, MannKind received approval from the Food and Drug Administration for its inhalable type 1 & type 2 diabetes drug Afrezza in August. From a convenience factor the possibility of diabetics no longer having to inject themselves with insulin could be very desirable, although questions on pricing remain prior to its expected launch in the first-quarter of 2015 with licensing partner Sanofi .
|
|
|
Post by kc on Dec 22, 2014 12:26:54 GMT -5
The hits just keep on coming. New article in the fool. Yep! We are burning down with the house. Are you a bottom feeder? I guess that I am www.fool.com/investing/general/2014/12/22/is-buying-these-3-stocks-like-making-a-bet-in-a-bu.aspx Buying These 3 Stocks Is Like Making a Bet in a Burning HouseBargain hunters are often attracted to beaten-down biotech stocks because they sometimes rebound in astonishing fashion. That said, it can be extremely difficult to separate the wheat from the chaff when mulling over such companies, with many of them having little to no hope of ever reliving their glory days. As such, they are likely garnering interest from so-called "bottom feeders" looking to pick up shares on the cheap. My view on their prospects moving forward, though, is that investing in them is more akin to making a bet in a burning house. Here's why. MannKind's Afrezza must start strong MannKind shareholders are always eager to tout the company's newly approved inhaled-insulin product Afrezza as a "game-changer" destined for blockbuster status. According to Afrezza's label, though, it looks more like an add-on product for certain types of diabetics needing more insulin, or as an alternative to needles for patients not yet taking injected insulin. Such a niche market could indeed be profitable given the immense size of the insulin market. The issue, however, is that MannKind has already amassed a market cap of $2.2 billion and, as per the terms of a marketing partnership with Sanofi, is only in line to receive a 35% cut from Afrezza's profits, which translates into about 25% of total sales. If Sanofi were somehow able to gain favorable reimbursement status with payers sooner rather than later, I think a really strong launch would still only rake in about $200 million in its first year on the market. That puts MannKind on track to recognize a mere $50 million in Afrezza sales. Under even this rosy scenario, MannKind shares would be trading at 44 times 12-month, trailing revenue -- excluding any further milestone payments and assuming shares trade sideways. Put simply, it would take a blockbuster launch just to make MannKind shares look reasonably valued at current levels. Given that payers may end up balking at covering a medically unnecessary product such as Afrezza (it can't replace other insulins), there is a serious risk that this product stumbles -- instead of roars -- out of the gate
Are any of these stocks worth the risk? Beleaguered shareholders of the three companies may be holding out hope against hope that a turnaround is on the way. In each case, though, I think the odds aren't in their favor.
Another Hit me with your best shot article. Budwell spins the hits for us on Christmas.
|
|
|
Post by dreamboatcruise on Dec 22, 2014 12:42:53 GMT -5
Articles are a lot easier to ignore when they have such glaring factual errors as "it can't replace other insulins". The good FUD writers manage to misrepresent and spin fear without actually having glaring factual errors. Someone needs to gently recommend that this guy go back to FUD school, in the holiday spirit of giving... advice to the intellectually needy.
|
|
|
Post by kc on Dec 22, 2014 12:46:55 GMT -5
I added my two cents for all its worth. One more comment why are Formulary providers adding Afrezza to their offerings even before knowing what the details are of the product as Regence RX did in October 2014. Did they go out on a limb for a new offering that is not going to help their patients? Regence RX Pharmacy Benefit Manager for Blues of ID,OR,UT WA have Afrezza on the books for 2015. blue.regence.com/trgmedpol/drugs/dru371.pdf Medication Policy Manual Policy No: dru371 Topic: Afrezza®, inhaled insulin Date of Origin: October 21, 2014 Committee Approval Date: November 13, 2014 Next Review Date: May 2015 Effective Date: November 13, 2014
|
|
|
Post by dreamboatcruise on Dec 22, 2014 13:26:44 GMT -5
My take on the Regence... though it's more a wishful guess, is that it is just a placeholder because there was some hard date (committee meeting, printing date for material, etc.) where they needed something to place in the guide. I guess the only clue is a review date that seems very quick. Hopefully there is a real prospect of it being giving better formulary placement after they negotiate pricing with SNY, which I would assume had not been done back in Oct-Nov.
I don't really see it as going out on a limb in any way... they knew the FDA approved it after all.
|
|
|
Post by brentie on Dec 22, 2014 21:42:28 GMT -5
|
|
|
Post by jpg on Dec 22, 2014 23:14:18 GMT -5
Interesting and well thought out analysis but, in my opinion, very conservative sales rampup estimates. The conservstive projected sales rampup doesn't fit well with other recent diabetic drug launches. MDs don't know (for good reason) what to give as second line after Metformin because the logical next step is insulin and patients are more then reticent to go there quickly. Doctors therefor prescribe what is available without injection even though many MDs aren't convinced they are doing their patients a great service with many of these pills. if Sanofi can tap into this Afrezza will do very well and probably much faster then our RBC analyst models. JPG
|
|
|
Post by gwb on Dec 23, 2014 0:23:31 GMT -5
Thanks Brentie , I believe if it wasn't for SNY we would never have gotten any play from RBC . I also have to believe that RBC is getting a good read from folks inside SNY.
|
|
|
Post by spiro on Dec 23, 2014 10:07:54 GMT -5
IMO, the RBC Capital revenue estimate is way off. If the first 3 production lines can produce 400,000,000 cartilages and each patient would require around 1,100 per year, the 3 lines could treat somewhere near 364,000 patients. Assuming a $2,000 per year cost, that would indicate over $700,000 million in revenue. Production lines 4,5 and 6, because of the increased efficiency will produce around 500,000 cartridges per year. If the Danbury factory was built out to the 12 line capacity, the plant could generate near $2 billion in revenue.
|
|
|
Post by cybergym66 on Dec 23, 2014 10:32:06 GMT -5
IMO, the RBC Capital revenue estimate is way off. If the first 3 production lines can produce 400,000,000 cartilages and each patient would require around 1,100 per year, the 3 lines could treat somewhere near 364,000 patients. Assuming a $2,000 per year cost, that would indicate over $700,000 million in revenue. Production lines 4,5 and 6, because of the increased efficiency will produce around 500,000 cartridges per year. If the Danbury factory was built out to the 12 line capacity, the plant could generate near $2 billion in revenue. Yes, the low-ball revenue estimate raised my eyebrows too. I also agree that the analyst didn't do enough DD or he would have known that each new line will be "X" faster than the previous one so MNKD can produce more accordingly. I think the big wake up for the analysts will be when the first reported numbers come out and they realize how far off they were in their predictions. Right now I think most of us will agree that Weather Forecaster and Stock Analysts are synonymous!
|
|
|
Post by noonen on Dec 23, 2014 10:46:02 GMT -5
IMO, the RBC Capital revenue estimate is way off. If the first 3 production lines can produce 400,000,000 cartilages and each patient would require around 1,100 per year, the 3 lines could treat somewhere near 364,000 patients. Assuming a $2,000 per year cost, that would indicate over $700,000 million in revenue. Production lines 4,5 and 6, because of the increased efficiency will produce around 500,000 cartridges per year. If the Danbury factory was built out to the 12 line capacity, the plant could generate near $2 billion in revenue. i think rbc is sandbagging on patient #'s and rev/patient, and i like it. $1200-$1400/patient in revs? and they still get to $13 target? good. From rbc revs and patient assumptions (page 3 of report): revs 350,000,000 450,000,000 patients 250,000 350,000 rough rev/patient 1,400 1,286 I don't understand the discount game in pharma, but it seems a bit steep that the partnership would have to give up $400-$1000 per patient (reducing the $1800-$2200 numbers that are thrown out there a lot) to get into those programs.
|
|
|
Post by mannmade on Dec 23, 2014 11:15:13 GMT -5
They really are a bunch of FOOLS or just hired hacks, either way...
From the Motley Fool
MannKind's Afrezza must start strong MannKind shareholders are always eager to tout the company's newly approved inhaled-insulin product Afrezza as a "game-changer" destined for blockbuster status. According to Afrezza's label, though, it looks more like an add-on product for certain types of diabetics needing more insulin, or as an alternative to needles for patients not yet taking injected insulin.
Such a niche market could indeed be profitable given the immense size of the insulin market. The issue, however, is that MannKind has already amassed a market cap of $2.2 billion and, as per the terms of a marketing partnership with Sanofi, is only in line to receive a 35% cut from Afrezza's profits, which translates into about 25% of total sales.
If Sanofi were somehow able to gain favorable reimbursement status with payers sooner rather than later, I think a really strong launch would still only rake in about $200 million in its first year on the market. That puts MannKind on track to recognize a mere $50 million in Afrezza sales.
Under even this rosy scenario, MannKind shares would be trading at 44 times 12-month, trailing revenue -- excluding any further milestone payments and assuming shares trade sideways. Put simply, it would take a blockbuster launch just to make MannKind shares look reasonably valued at current levels.
Given that payers may end up balking at covering a medically unnecessary product such as Afrezza (it can't replace other insulins), there is a serious risk that this product stumbles -- instead of roars -- out of the gate.
|
|
|
Post by brentie on Dec 23, 2014 11:59:39 GMT -5
|
|
|
Post by bradleysbest on Dec 23, 2014 12:04:37 GMT -5
Low estimates are fine with me. The cream will rise to the top & only make the share price jump that much faster! Excitng times ahead but don't spending your anticpated "winnings" on XMAS just yet..... HAPPY HOLIDAYS
|
|