twitterDOTcom/afrezzauser has a bunch of pictures
Father, Business Owner, Type 1 Diabetic. He was a Patient in the Afrezza Trials. FDA AdCom Speaker #1
Aria Vegas Sanofi Launch Speaker #1. He signed NDA. That's why he neither confirmed nor denied his testimonial there.
MannKind [Trend Analysis] could be the recipient of a short squeeze at present. As the chart below shows the percentage of the float currently being shorted is some 33% and has been steadily rising to this level since April 2014.
What is most interesting is that, as can be seen in the chart above, MannKind Corp (NASDAQ:MNKD) had its short interest peak at just above 40% in mid-March 2014 then it came crashing back down by the end of March and the stock sky rocketed as shorts had to cover with more buying and the stock ran up all the way from $4 to nearly $11.
Stocks that are heavily shorted are appealing to go long with, as mentioned above; this can lead to a sharp rise when good news comes as the shorts begin to cover their positions.
As such with MannKind reporting some fairly good news of late, the shorts must be starting to get worried. One such piece of good news is MannKind’s new product Afrezza, an inhalable form of insulin. Such a product is very exciting and certainly is great news for the company.
Holding MannKind Corp (NASDAQ:MNKD) down will be difficult if they keep releasing good news. If the short interest rises back up to the 40% levels, such a squeeze will most definitely put the thesis back on the table and coupled with good news, may well see the price rise a lot sharper.
Bode BW, Lorber DL, Gross J, et al. Reduced hypoglycemia risk with an inhaled insulin compared to injected prandial insulin in type 1 diabetes. Program and abstracts of the American Diabetes Association Annual Meeting; June 13-17, 2014; San Francisco, California. Abstract 127-OR.
Doheny K. Inhaled insulin: What to tell patients. WebMD Health News. July 1, 2014. medscapeDOTcom/viewarticle/830050 Accessed December 15, 2014.
Anne Peters: Advances in Diabetes, 2014
New Drugs, Old Drugs, and the In-Between
Patients have long dreamed of a way to take insulin without shots, and with the FDA's approval of the inhaled insulin Afrezza®, they will have the opportunity when Sanofi begins marketing the novel insulin next year.
The ultrarapid inhaled insulin has a peak action in 15-20 minutes, making it much faster than current rapid-acting injected forms, which take 45-90 minutes to peak. Afrezza also has some clinical benefits, including a lower risk for hypoglycemia and less weight gain in patients with type 1diabetes, plus a 0.4% improvement of A1c in patients with type 2 diabetes. But the biggest attraction may come from the lifestyle benefits of using the whistle-sized inhaler instead of giving injections.
Needle-phobic patients with type 2 diabetes needing mealtime insulin might prefer starting with an inhaled version, which could reduce treatment barriers. Patients with type 1 may prefer to inhale rather than inject while dining with others, for example.
It is worth noting that a sizable chunk of the short position was already in place before the company released its clinical trial results back in the summer of 2013. I think those who are still short believe that Afrezza will, in fact, be as big a failure as Exubera. For all the reasons discussed above, I think Afrezza is likely to fare much better than Exubera did, and, though I’m not predicting it with certainty, I do believe the odds are pretty good that it could end up becoming the mealtime insulin of choice as time goes by.
Ken: What else does MannKind have in their pipeline?
Nate: Although Afrezza has been the primary focus for both the company and investors alike for the past couple of years while the drug has moved from clinical trials to commercialization, I believe it is worth noting that Afrezza is actually just the first in what should eventually be a long line of drugs that will be brought to market using MannKind’s Technosphere drug-delivery platform, a proprietary system for formulating and delivering drugs to a patient’s bloodstream via the lungs in an extremely fast and convenient manner.
In particular, chronic pain medications and migraine medications have been mentioned by management in the past. In addition, drugs to treat conditions in the lungs would be obvious candidates, as would just about any other situation in which “lots of needle sticks” could be reduced or eliminated if an inhalable version was available instead.
Ken: Do you have any final thoughts you’d like to share?
Nate: One of the most valuable lessons I’ve learned over the years is that it almost always pays to “follow the smart money”… and, in this case, I am more than happy to have my own money invested alongside Al Mann’s $960 million.
Not only do I believe Afrezza has the potential take a serious bite out of the existing mealtime insulin market, but future applications of the Technosphere platform have the potential to be game changers as well.
Nate: While it remains to be seen exactly where MannKind’s marketing partner Sanofi (NYSE:SNY) decides to price Afrezza, MannKind has been saying all along that it believes it will priced competitively with the existing “pens” that are on the market… and early indications suggest that this is, in fact, the price range that the product is starting to show up in at pharmacies around the country.
As far as “paying for convenience” goes, I think it is important to keep a couple of things in mind when looking at Afrezza through the eyes of an insurance company. While the idea of “no needles” can be thought of as merely being a convenience, the bottom line is that paying for the complications that arise when diabetics are not taking their insulin properly is far more expensive than simply providing them with insulin in a form that increases the odds they will use it correctly… and I have been hard pressed to find anyone who has said they would prefer a needle over a deep breath. Naturally, if folks are more willing to stay on top of their insulin needs, they are less likely to suffer the complications that arise from poor blood sugar control.
So, assuming Afrezza does, in fact, get priced competitively versus existing delivery systems… but also ends up promoting better patient compliance (which, in turn, means fewer complications)… I believe it will end up being a winner in the eyes of insurance companies.
Ken: There is a rather large short position in the stock – 75 million shares out of the roughly 400 million that are outstanding. In my experience, short sellers generally don’t bet big unless they think they’ve got a sure thing. What are the shorts looking at?
Nate: While it looks like 75 million shares are short against 400 million outstanding, roughly 40% of the stock is held by Al Mann, so the short interest is actually even quite a bit larger that it first appears relative to the available float.
Ken: What makes you think Afrezza is not going to suffer the same fate?
Nate: What really sets Afrezza apart from other existing meal-time insulins is the fact that it enters and leaves the body in a manner that is much more similar to how the body actually produces and uses insulin, than anything else currently on the market. In contrast, Exubera had the same PK profile as existing mealtime insulins already on the market. I believe this “fast in, fast out” mechanism of action is going to allow diabetics to achieve a much higher degree of success in controlling their blood sugar levels… and this is a big deal not only for patients and their quality of life, but also for physicians and insurance companies as well.
In addition, it should be noted that Exubera’s delivery device was the size of a small fire extinguisher – it was hardly convenient to carry around, and definitely not the sort of thing that anyone would want to whip out in public. Afrezza’s delivery device is roughly the size of a small whistle and requires virtually no effort to load and use. Putting these two pieces together – the convenience factor and especially the improved PK profile – I think there is a good chance Afrezza could quickly and quietly become the mealtime insulin of choice.
Ken: How many patients are there who could benefit from Afrezza?
Nate: The general consensus is that roughly 350-400 million people around the world have been diagnosed with either Type 1 or Type 2 diabetes, and this number is currently forecast to grow to over 550 million in the next 20 years. Not everyone who is diagnosed with diabetes ends up needing to take insulin to control their condition, but we are still talking about a very large potential patient population.
Ken: I am guessing that with the new technology involved, manufacturing Afrezza can’t be cheap – won’t pricing be an issue? And will insurance companies be willing to pay for “convenience”?
Ken: Why is Afrezza better than insulins currently sold by market leaders Novo Nordisk (NYSE:NVO) and Eli Lilly (NYSE:LLY)
Nate: To be sure, the advantage that gets talked about first – and usually with the most enthusiasm – is the fact that it is inhaled rather than injected, and while this will admittedly play a bigger role with newly diagnosed diabetics going forward, than it will with existing patients who are already used to injecting themselves several times a day, my own very small (and admittedly unscientific) survey suggests that a sizable portion of this patient population would also be more than happy to skip the injections, despite the fact that the needle sticks have become ‘tolerable’ as smaller and smaller needles have become available over the years.
In addition, a number of people I have spoken with have expressed excitement at the thought of being able to take their insulin during lunchtime meetings (or any other restaurant situation, for that matter) by simply taking a discrete puff on their inhaler, rather than leaving the table to give themselves an injection or playing the old “jab their leg under the table” game in order to spare others from watching the injection.
However, along with this “ease of use” feature, I believe an even more important piece of the puzzle is Afrezza’s pharmacokinetic (PK) profile, something we can talk about a little later in the interview.
Ken: If memory serves me correctly, there was another inhalable insulin on the market a few years ago, and it failed badly.
Nate: Well the last attempt at an inhalable insulin, Exubera, which was marketed by Pfizer (NYSE:PFE) did, in fact, go down as perhaps one of the greatest flops of all-time in pharmaceutical history. Pfizer pulled the plug on the product after it generated only $12 million in sales in its first nine months on the market! Needless to say, its resounding failure has been a cloud hanging over MannKind ever since.
Picx of Pricing on computer screen to prove it.
MannKind Corporation MNKD 5.39% is up over 5 percent on Monday.
Aside from a positive analyst upgrade, another theory for the move is this: Reports that Afrezza is available at some pharmacies.
Photos of the product and packaging were posted online from a Los Angeles pharmacy. It is being reported that the set costs $278 without insurance.
$mnkd $sny @FiercePharma from a LA pharmacy Cash price in a full service non-discount pharmacy. 90ct 4u 278.00 pic.twitterDOTcom/Zg06CvhLbk
— LF (@kcphaeton) January 26, 2015
Mannkind's partner in the launch is Sanofi SNY 0.32%.
Mannkind stock is also breaking out of resistance levels formed over the last three months.
The stock had been in a downward trend ever since receiving approval in the middle of last year. The stock is currently holding above its 50 and 200-day moving averages, and the MACD has turned positive.
MannKind Corporation MNKD 5.39% shares are trading higher $0.28 at $6.03 in Monday’s session. The rally is being attributed to a First Call rating upgrade earlier this morning.
The recommendation is accompanied by a $9.75 price target, according to 9 analysts in consensus.
The issue, which has had many false starts in the past, is back above $6.00 for the first time since November 28, when it ended that session at $6.15.
With a short interest of nearly 22 percent of float, any positive developments on the research and development front may ignite a furious rally.
It's possible the Street is anticipating some much-needed good news regarding the company's rapid acting inhaled insulin drug, Afrezza.
Joel Elconin , Benzinga Staff Writer
January 26, 2015 3:28pm
I think so. Sanofi could be acquiring 5% Mnkd first, before taking the whole.
There’s been plenty of ballyhoo surrounding Afrezza, the inhaled insulin product that Sanofi is planning to launch later this year in conjunction with MannKind. The fact that Afrezza still doesn’t have an official launch date, in particular, has stoked whispers that Sanofi isn’t all that excited for the product.
But that’s all a bunch of nonsense, according to Witz. "We are focusing on the two [insulin] products, but they're different,” she said. “Toujeo is the new golden standard insulin glargine, and that's a market in which we have more of a ground today. This is really our field, if you like."
Toujeo is the highly-anticipated next-gen insulin that’s expected to bolster Sanofi’s sales just as its flagship Lantus falls off the patent cliff. But it’s not just about bigger sales with a fresh product, Witz says—there’s a real potential to help diabetes patients avoid the disastrous downstream consequences of the condition.
"[D]espite Lantus, despite insulin glargine, half of diabetic patients still aren't at their goal…There are 60 amputations per day [in the U.S.] due to the consequences of diabetes."
But it could be difficult to convince a certain class of patients that a long-acting and powerful med like Toujeo is the right way to go—particularly those who are averse to injections in any form. And that’s where Afrezza enters the picture.
"Afrezza, inhaled insulin, as much as we work on convincing patients to move into insulin, some patients are very resistant to insulin," said Witz. An inhaled (and eminently portable) inhaled option like Afrezza could at least convince diabetics to try out insulin, and perhaps even convince them to eventually transition to a stronger product like Toujeo.
"We're very optimistic about [Afrezza], but it's new in the field."
BioPharma Dive sat down for an interview with Pascale Witz, EVP, Global Divisions and Strategic Development at Sanofi.