Principal Investigator, Mnkd ProBoards
Apr 16, 2015 at 12:46pm
One of the Afrezza users reported taking 100,000 shots and is facing who knows how many more in their lifetime. New diabetics have to be looking at these first hand accounts and be intimidated. No wonder diabetics are reluctant to start treatments...and compliance once they do isn't great (with needles). I'm not afraid of needles...but 100,000 shots - no thanks!
2nd take away,
Afrezza users really need to be proactive when talking to their doctors (to get Afrezza) and take charge of it's usage. Doctors can't really prescribe proper Afrezza dosage (which is a stumbling block out the gate for Afrezza) but QoL should be much greater for patients that are motivated.
Sadly the brightest don't go to MD field which is protected by the AMA cartel. The brightest are EEs, CS who join Aapl, Goog, FB, Tsla, Twtr to revolutionize our lives. EEs, CS would be laid off if they fail to stay abreast with their knowledge and skills.
The Truth About Afrezza Inhalable Insulin A Chat with Al Mann
Al Mann, CEO of MannKind Corp., is something of a legend in his own time. He not only founded MiniMed, acquired by Medtronic, but also four other successful medical companies. He's a billionaire, with hisal-mann own Biomedical Engineering Institute at the University of Southern California (USC), so we can assume that he's not just championing the new inhalable insulin product Technosphere (brand name Afrezza) as some kind of pipe dream or get-rich-quick scheme.
The guy knows his stuff, but a lot of folks remain convinced that the odds are against Afrezza ever going very far. Today at DiabetesMine, a chat with Mr. Mann himself on the outlook for Afrezza:
DM) Mr. Mann, let's jump right in. How do you expect Afrezza to succeed in the aftermath of Exubera?
AM) Exubera was very inconvenient, it had absolutely no benefits clinically, and it was not as good as the other treatments on the market. Comparing Afrezza to Exubera is like saying that Rezulin — a bad drug that failed — is the same as Actos — a good drug with good outcomes.
What we have is a different form of insulin (from Exubera). It's powder so we deliver it into the lungs. But that's an advantage because it's delivered in the arterial blood system instead of the capillary system. We're actually delivering insulin monomers (molecules). Nobody ever did that before.
It behaves much like normal pancreatic insulin does. Normal people don't get hypos, and people taking Afrezza don't either, even if they dose and don't eat.
How is that possible?
Other insulins create an enormous period of hypoglycemia because there's an excess of insulin after you've digested your meal.
What happens is that if you eat a meal on regular insulins, Lantus and Humalog for example, 80% of the insulin remains in your body for up to 10-12 hours after your meal, which causes hypoglycemia.
With Afrezza, there's no complex meal titration. You take a set amount, matched to your body mass and insulin resistance, determined with your doctor. You take that same amount every time you eat a meal. Then it's not important whether you eat 50 grams of carbs or 100 grams or even zero. Afrezza essentially "turns off glucogenesis" so no glucose is secreted from the liver in reaction to food. Our trial studies are showing that patients are having no more glucose highs than normal non-diabetic people, and no more lows.
That sounds pretty magical. Does this work for Type 2s only, or is it an option for Type 1s now taking basal and bolus insulin?
Both could use it. Afrezza is for prandial control — mealtime only - not basal doses. For about 70% of Type 2s, all you'll need is a regular set dose of Afrezza. This will work for everyone except the "late-stage" Type 2s, who will need to take basal insulin as well.
It's different for Type 1's because there's a very big therapeutic window for them; their insulin needs are so differing. They can use Afrezza to cover meals, yes, but they'll still have the issue that if they dose and don't eat anything, they'll get hypo, and if they eat a large meal, they'll need a larger dose.
The advantage for all patients is that they won't have to do carb counting or anything, because Afrezza does not have to be so precisely matched to food intake.
So can you explain the details of dosing Afrezza?
The cartridges come in sizes of 15, 30, 45 and 60 units. Again, for Type 2s, their doctor wmannkind-logoill help them select a regular dose based on their body mass and level of insulin resistance. If a person is already on insulin, you'll multiply the amount of rapid-acting insulin analog you're now taking by three, and that's where you'll start for your original dose. You need about three times as much Afrezza as you do for an insulin injection.
Aren't most Type 2s currently treated with a basal insulin only, instead of mealtime dosing?
Yes, but that's the wrong way around. The correct therapy should be a good prandial insulin and not long-term insulin — Afrezza in particular because it turns off glucose production and delivery from the liver. Our latest trials of 600 patients are showing even more significant benefits from the product than our original trials; the most recent trial appears to show that this should replace frontline treatment for all Type 2 patients.
That's a big statement for something so new. What about safety concerns? We hear that the FDA Endocrine Advisory Committee isn't even going to be scrutinizing this product...?
The FDA is already familiar with the kinetics of the product. We've done extensive safety studies, but not using Xrays like they did with Exubera. You can't detect lung cancer with Xrays. You have to do it in animals by sacrificing the animal at the end of the study, in order to examine every cell in the body and see if there's damage. That's how you find out if there's carcinogenicity.
We also did high-definition CT scans on the 600 patients in our study. That's the best you can do with people. We saw no change in their lungs, and some of them have been using the product for up to 5 years now.
How close are you to FDA approval then?
We've submitted all our data and recommendations, and our current review date is scheduled for January 16. That's when the committee will make their counter-proposal for the FDA label. The label says what you can use a drug for and what you can claim about it. We don't know what additional trials they might require to demonstrate superiority.
Getting back to usability, part of Exubera's problem was a form factor that simply wasn't liveable. Your tiny new Dreamboat inhaler looks amazing. Is this the delivery device we can expect at launch?
We hope so. Of course we did our clinical trials with the original MedTone inhaler - the little purple and white box you've seen in all the pictures. The new Dreamboat is pretty slick. We're hoping to get that approved by the dreamboat-mannkindtime the FDA approves Afrezza. We just have to do a short study with people using the two different inhalers, to show that the effect in the body is the same.
Are you worried that doctors will resist this new-fangled therapy, like they did with Exubera?
We actually did a survey of hundreds of endos and primary care physicians. Twenty-five percent said they would definitely recommend it for their patients.
Still, I ran into a doctor at a conference who thought it was nonsense to administer insulin with no complex meal titration. I tried to explain the science on which it was based... We'll have to give the doctors enough data so they understand and get comfortable with it. We believe Afrezza's going to change diabetes therapy, but it's going to take a little education to do it.
Won't it be difficult to teach patients how to use?
Not at all. We have an instructional DVD and a test device that people can use to learn it in a few minutes right in the doctor's office. There's no big risk of hypoglycemia, so it's not so worrisome that people might make mistakes.
The bottom line is always costs. Will patients get insurance coverage for Afrezza?
We're working with the reimbursement advisory panels to make sure we're within 5% of the current costs of Humalog and Novolog — so people will get essentially the same reimbursement they get now. We believe that we'll be covered by most mainstream health plans within six months of launch.
Don't forget this also saves a lot of money because you don't need nearly as many expensive test strips for fingersticks, by an order of magnitude. For Type 2s, maybe they'll just need a fasting test once a week. If you're Type 1, you will want to do a few more.
Afrezza: Dreamboat or shipwreck? Only time will tell. Meanwhile, you can't help but admire Al Mann's unwavering commitment to bringing a workable inhalable insulin to market. Thank you, Sir.
The Inside Truth about Exubera and Afrezza
For years, I’ve been saying the only thing in common between Exubera and Afrezza is that they were both inhaled. I recently decided to talk to the real experts about this issue-two people that have been on both insulins! They happen to also be in our Afrezza User Challenge to “Stay in Zone” and have firsthand experience with Exubera (which has been a perennial comparison for Afrezza), so I wanted to take the time to ask them some tough questions (separately) that I’m sure we would all like to know. What they said was more than I have ever learned from any other article.
The two individuals are L=Laureen (T1D since 1983) and B=Brian (T1D since 1999) and they had a lot to say about their experience and opinion of Exubera and Afrezza. This is where our interview begins.
Background Info: What was the deciding factor for you to begin Exubera, and how long were you on it for? Was it an easy transition for you?
(L) For me the deciding factor was reducing injections and gaining better control. In my lifetime, I have done over 100,000 injections, so having another way to administer a drug I needed to live was fantastic. The first 4-6 weeks took adjusting. Mainly because Exubera was dosed in mg and no doctor ever dosed insulin that way. Exubera also made my long acting (Levemir) more effective, so I had to reduce my basal level. I was on Exubera for 2 years.
(B) I started taking Exubera because I hate to take shots. I took Exubera from its launch until about 2 1/2 years after it was discontinued. It was a very easy transition from injectable insulin. Inhaling insulin is WAY easier and WAY more convenient than injecting insulin.
What was your experience with Exubera: the 3 best things and the 3 worst things?
Ability to take insulin anywhere without the stares of needle phobs
Amazing control it gave me and reduction to one injection a day of Levemir
Size of inhaler – I had to buy a larger purse to carry around, a small price to pay, but it was gigantic
Determining dosage in mg
Adjusting back to Novolog once it was pulled off the market and my supply ran out
No shots for fast acting insulin.
Super easy and convenient to use. could throw in car and go, take doses while driving.
Can easily take multiple doses of insulin to adjust and correct, instead of a giant single dose like with injectable insulin.
The inhaler was very large.
People would think it was a Bong. Still was quick to use, so could do it more discreetly than a shot.
The properties of the insulin was lacking.
How did you feel when Exubera was pulled from the market, what did you do?
(L) I cried; I was absolutely devastated. I could not believe a drug company as large as Pfizer only gave this new drug a matter of months to take off. How could you expect to see sales with no advertising and when doctors didn’t even know about it. Exubera was my cure. As a type 1 diabetic, I don’t anticipate seeing an effective artificial pancreas or non invasive way to provide me with the insulin I need just to stay alive. Exubera gave me the freedom to feel like a normal person and inhale when I needed to without another injection. Injections keep my alive, but a world without them is one I didn’t think I would ever see, until Exubera.
(B) I felt completely outraged, it was not given a chance or enough time to succeed. It would have helped a lot of people with their control of diabetes. My wife called Exubera and complained. During their last week of business a 2 1/2 year supply showed up on my front porch.
What was the deciding factor to try Afrezza? How was your transition?
(L) I have been following Mannkind and Afrezza (formerly Afresa) since 2009, when Exubera was pulled off the market. I emailed Matt Pfeffer, from Mannkind, to get information on trials and FDA approval. In 2009-2010, Afrezza was in very early stages so I continued to follow it through the trials and FDA denial, then subsequent approval. I took trial information to my physician and as soon as it hit the market, I said, I want it. As with any change in medicine, there is a transition period, but so far it has been good. Determining proper dosing on Levemir and carb to Afrezza ratio has been the biggest challenge; but, I have found transitioning to Afrezza has been painless. The biggest issue so far is getting enough supply as to not run out.
(B) While using my 2.5 year supply of Exubera, I heard about Afrezza. I hoped my Exubera would last until Afrezza launched. Of course that didn’t happen, but it did allow me to follow Afrezza and be prepared for its launch. The transition this time was remarkable. In just 2 or 3 days I could see that I was going to have great control. I couldn’t believe how well it worked. I just wanted to not take shots. I knew from Exubera inhaling insulin is easier, I knew I would have better control but I had no idea my control was going to become ground breaking.
What has been your experience with Afrezza so far?
Afrezza works instantly. I have checked my blood sugar every 10 minutes after inhaling and eating to show no, I mean NO spike in BS, at all.
The life of it – since it is in and out in 1.5-2 hours, it makes life so easy. I don’t have to worry about if I still have Afrezza left from a previous dose (like I did on Novolog). I can eat a snack, like a normal person, and inhale Afrezza with no worries about a tail end overlapping and bottoming my BS out.
The Dreamboat – it is an amazing device. I am a woman, and we have very small pockets in our pants, but Afrezza slides right in!
Insurance coverage – This drug is FDA approved and the pre-authorizations and not getting comparable coverage to a bottle on insulin is an absolute crime.
Did I mention insurance coverage?
Medical professional’s lack of any actual data on this medicine. I have “argued” with Pharmacists and Doctors about the misperceptions they have on it because they are not educated. I get very frustrated when people say bad things about it with no solid data to go on.
The insulin itself works remarkably well. It has the ability to stop BG from rising. I can eat anything I want and it just wont allow my BG to rise, or rise very little. On the other hand if I do have a BG reading higher than I like it lowers my BG very gently. It took me while to figure that one out. People say 4 units is too much if your at 130, but that’s not true. Afrezza works so fast and stops working so fast 4 units just gets your BG moving down, by the time your at 100 its all done working.
Super easy and convenient to use. I can use it any time, anywhere. I can take a dose while driving alone down a winding road in the dark. Its too easy, and the inhaler is super small. I do it right in front of people all the time and they don’t think anything of it. It attracts 0 attention.
Taking multiple doses is huge. With shots you have to guess how much your going to eat, how much you plan on exercising, your current BG and if its rising or falling, then take your best guess at how much to shoot up. With Afrezza because your inhaling it, you can take a smaller dose, then take more later, as often as necessary. All the people I know who take injections try to do it in one dose, and if they didn’t guess their dose just right they tend to wait until their next shot. This makes them high for a long time. The body does not digest all Carbs at the same rate, so taking multiple doses makes more sense to coincide with digestion.
The only bad thing I’ve experienced is that for some reason there are folks out there determined to bash it. It doesn’t matter what evidence I provide, they have made up their minds to be against it. It’s a new drug, people are just starting to use it. How can you be against something that hasn’t had a chance to prove itself. It’s like they are walking up to a person who is 6’6 and saying they don’t think they can play basketball, without ever seeing them play…In my opinion its like they’re saying it to Michael Jordan!
How do you think Exubera and Afrezza stack up against one another—are they comparable and is it a fair comparison?
(L) This is difficult as they are different drugs. In general they appear to be comparable, but the advantage of Afrezza is the “quickness” of it. It is in so quickly and out quickly after covering food and never increasing BS. Exubera stayed in a bit longer and I would have to think more about if I had a tail left before inhaling more. The other glaring piece to me is the powder in Afrezza is much more effective. With Exubera, I took 7mg at a time. The mg comparison to what I take with Afrezza is 1.4mg (for 2, 8 u cartridges). So you need a lot less powder than with Exubera.
(B) It’s not a fair comparison, they are similar in how easy they are to use and the fact that you can take multiple doses. I don’t get real bent out of shape when they are compared because Exubera would have helped people. The decision to pull it off the market was the cause of its failure, otherwise it could have been successful. On the other hand Afrezza would have caused its demise due to the fact that Afrezza works so much better.
What would you say to someone who was on exubera and now thinking about taking Afrezza?
(L) Do it. Don’t ask your doctor, demand a sample to try it. It will change your life. If your doctor says no, find a new doctor. We must be in charge of our own health and if a doctor refuses to look at the data and see how this is changing lives, then a new doctor is in order.
(B) Do it!
How long have you been on Afrezza and what is your opinion-has your life changed at all—can you give a few examples?
(L) I am going on 4 weeks. I had a sample pack then ran out and had to go back to Novolog for a week before I could get re-supplied. The instant effect of Afrezza on food intake is amazing and honestly unbelievable. If I didn’t check my BS so often to prove it, I wouldn’t believe it myself. I was 93 at dinner, ate pasta and had a glass of wine, inhaled 2, 8u cartridges, and one hour later, 90, 2 hours later, 105. There is no spike in bs. I am a normal person!
(B) I started Afrezza about at its launch, within a few days. Has my life changed? Ya, bigtime. My pre Afrezza A1c was 10.1. My first A1c on Afrezza only I expect to be around 5.5. I’m no longer sick from Diabetes. With Afrezza I don’t ever have high BG anymore and I don’t have lows either. I don’t consider myself a diabetic anymore. Not health wise anyways.
What do you think is keeping most doctors from prescribing Afrezza? How encouraging and knowledgeable was your doctor to prescribe it?
(L) Doctors are confused about the dosing as well as prescribing info. I went to my doctor with the information and told her I wanted it, but she wasn’t sure how much I should use and was confused about only 2 options for dosing. Now, those 2 options work very well, but there needs to be better education on the pharmacology to physicians and pharmacists. I had been bringing my doctor information on it for 2 years. She was knowledgeable about it, but leery of the dosing.
(B) My Dr. knew about it because I called her the first day I heard about it a few years ago and I have been waiting ever since. I forced the conversation. I spearheaded the Dr. to learn about it. I was crushed a couple weeks ago when my cousin who is a T1 came back from her Endo appointment and told me her Dr. wouldn’t prescribe it to her. Her Dr. told her it’s only for T2’s and that I must be a T2 or else I was misdiagnosed. I would laugh at that, except for that Dr. compromised my cousins health and made statements that are way out there. I’ve been a T1 for 16 years by the way. I think there is a total meltdown in regards to Dr.s and their current knowledge and understanding of Afrezza. This is a area that needs to be addressed and fixed .
Having taken both, what would you tell everyone? What are you going to tell your doctor when you see him next? and what is your recommendation about Afrezza-do you think it will be a success or go the way of Exubera?
(L) Afrezza is as close to a cure for Type 1 diabetics as we will ever get. I get there are insulin pumps, but I refuse to walk around with a tube attached to my body all day. If you are type 2, and didn’t want to take injections, then you will love this. This drug is amazing, it gives you freedom and peace of mind. My doctor will hear all about my great blood sugars. I will also tell her to give my contact information out to others who want a firsthand account of it. Exubera being pulled devastated me, so I only hope that health care professionals, Insurance Companies and Physicians open their mind to a non-injectable form of insulin. Once they see the real life results, they will see there is more than one way to manage this disease, a much less invasive way.
(B) I’d tell any diabetic to consider it or better yet, try it. It doesn’t work like any other insulin, so it really can’t be compared to other insulins. If diabetics try it I am convinced they will have results just like mine.When I see my Dr. next time I’m not going to say anything. She will read my graphs from my CGM. They speak for themselves. So will my A1C. I think Afrezza will be a success. With Exubera we didn’t have CGM,s to prove the results, it didn’t work even close to how well Afrezza works, and there was no social networks to share the data. Nowadays I can post my results online in a minute. Others can see the results nearly real-time. I have a lot of people interested in it. I know the demand is there. The two biggest hurdles Afrezza faces is lack of Dr’s who are knowledgeable, and lack of insurance that covers it appropriately. Right now the only people using Afrezza are the ones who demanded it and went through all the work to get it. It shouldn’t be that hard to get. My Dr. was totally onboard with it and my Insurance also covered it prior to launch, and yet it still took many phone calls from me to my Dr. to my Insurance and to my Pharmacy to get the Rx written by Dr. just right so the insurance company could cover it and the Pharmacy could order it. This is a issue that needs to be fixed.
Anything you want to say/add not asked or covered?
(L) Fight for what you want and for what works for you. Write to medical directors and go through appeals processes because this drug is worth the fight. This is your life, your body and you have to live with any complications so do not let anyone tell you this drug doesn’t work. It does, I can prove it.
(B) When you have control of your diabetes, your life does change. Your health gets better immediately. Afrezza will give Diabetics total control of their BG.
Thank you so much Laureen and Brian for sharing your experiences and opinions with me and also the world. Grateful for all you are doing for diabetics everywhere and also taking control and going on the “offensive” against your diabetes to have a longer and healthier life with your family and friends. Wishing you both an easier journey now that you have Afrezza.
I am surprised that none listened to Amph Webcast at Needham HealthCare Conf 4/15/15 to get the latest scoop on Mnkd, then post its Synopsis here. Too bad you have to research another co. To figure out Mnkd who is mute as a clam.
Also we will see sales increases on our insulin API business due to our sales to MannKind. As you know, we have a contract with MannKind where we will supply them with insulin for their Afrezza product. And that contract has minimum purchase quantities at fixed prices. The majority of our insulin sales in the fourth quarter were to MannKind, and it should be noted that these sales in 2014 count toward their 2015 minimum. Remember that the MannKind contract, like most of our insulin contracts, are denominated in euros because nearly all of our expenses for that business are also euro-based, as are the payments that we make to Merck as part of the purchase price for that business.
We had previously estimated that we would see approximately $32 million in sales per year for MannKind, but due to the declining dollar versus the euro, the dollar value of sales has declined closer to $25 million per year. Likewise, our expenses and payment obligations to Merck have declined by the same percentage.
Bill reported, enoxaparin pricing continued to decline; however, we expect this decline to be more than offset by strong growth of our other products and our insulin sales to MannKind.
In the fourth quarter, we scaled up production at our French subsidiary AFP to meet MannKind's demand for recombinant human insulin API. I'm happy to report that we're now selling such API to MannKind, and although the value of the euro has declined since signing the agreement with MannKind, all of our costs at AFP are in euros, as well as our payment obligations to Merck. Therefore, as Bill discussed, we have a natural currency hedge in place.
Additionally, in January 2015, we entered into a supply option agreement with MannKind, pursuant to which, MannKind will have the option to purchase recombinant human insulin API in addition to the amounts specified in the July 2014 supply agreement. Under the option agreement, MannKind has the option to purchase additional insulin API in calendar years
Eli Lilly has Forteo (an expensive, daily injectable (e-coli derived) recombinant PTH for bone density and pagetts disease. It works to increase bone formation instead of halting resorption as all the bisphosphonates like Fosomax, Actonel, Boniva, etc. do. Unigene (Bkpt- IP and assets now in a new company beginning with 'E' can't remember) had a PII next gen enteric coated oral PTH that looked good, but partner GSK backed out, variable bioavailability was always suspected but not clear that was an issue any more.
This market is the osteoporosis, osteo-athritis space. BIG.
Sequential subcutaneous PTH injection therapy (repeated 14 days of PTH administration and a subsequent treatment pause for a few weeks) is known to increase bone mineral density in patients with osteopenic disorders. Alternative methods of drug delivery may be beneficial in increasing compliance. A pilot study was performed in 10 healthy volunteers (4 female/6-male, age: 25.6 +/- 3.5 years, BMI: 22.3 +/- 2.4 kg/m 2, mean +/- SD) to assess the pharmacokinetic profiles of 1600 IU of PTH(1 - 34) using the pulmonary Technosphere drug delivery system in comparison to a subcutaneous injection of 400 IU. The treatments were administered in the morning after an overnight fast and blood samples for measurement of PTH(1 - 34), PTH(1 - 84), and calcium and calcitonin were taken over a period of 6 hours. Both injection and pulmonary application of PTH(1 - 34) were well tolerated. After pulmonary administration of Technosphere/PTH(1 - 34), PTH(1 - 34) appeared in the serum with a faster concentration increase (T max: pulmonary 10 +/- 5 min vs. subcutaneous 28 +/- 8 min, p less than 0.001) and with higher maximal concentrations (C max : pulmonary 309 +/- 215 pmol/l vs. subcutaneous 102 +/- 45 pmol/l, p less than 0.05) as compared to the subcutaneous injection. The relative bioavailability of pulmonary Technosphere/PTH(1 - 34) was calculated to be 48 %.
Amphastar France Pharmaceuticals
■Recombinant Human Insulin (RHI)
−Signed supply agreement with MannKind to supply RHI for Afrezza®
−Agreement specifies minimum annual sales of 24 million euros annually for 5 years from 2015 - 2019
−Further amounts may be purchased
−Several other customers currently purchasing R&D quantities for filings outside of the US
−One customer buying production quantities outside of the US
−Signed Option Agreement to supply additional quantities in 2016-2019
−Supply Merck with porcine insulin with their animal health business with a 5 year supply agreement
−Other porcine customers with potential sales
−If MannKind chooses not to exercise its option, they pay a cancelation fee
13 Generic Product Candidates Pipeline
Delivery Technology: Inhalation
Number of Candidates: 6
Therapeutic Area: Respiratory
Our applied technical capabilities have led to our strong product pipeline
■Filed three ANDAs
■Injectable ANDA’s target IMS Sales of over $5 Billion
■Inhalation ANDA’s target IMS Sales of over $9 Billion
Six additional proprietary product candidates with target indications
Pilot study with technosphere/PTH(1-34)--a new approach for effective pulmonary delivery of parathyroid hormone (1-34) to increase bone mineral density in patients with osteopenic disorders. That's a BIG market!
This is the best part:
"No differences were seen between pulmonary and subcutaneous application with regard to the PTH(1 - 84), calcitonin and calcium concentrations. In conclusion, pulmonary application of Technosphere/PTH(1 - 34) appears to be an effective and thus attractive candidate for PTH substitution therapy in osteoporosis and other conditions leading to a decrease in bone mineral density."
Amphastar Investor Presentation April 2015 pdf file, slides 9, 14, 15 of 25
Apr 15, 2015
12:10 PM ET
14th Annual Needham Healthcare Conference Webcast
Cramer: Finding stocks that signal a raging buy
Jim Cramer has decided to reveal the methods to his madness by opening his toolbox and arming investors with the techniques he uses to determine when a stock is just begging to be bought.
"What I am teaching you are really what I call tells-they are signals that a stock might be worth owning-that it is worth your time and effort to go through the often boring process of reading through the conference call transcripts and quarterly process," the "Mad Money" host said.
First, Cramer uses the new-high list to determine what should be on his radar. Another signal that he looks for is to buy stocks that have had a big run, along with substantial insider buying. Insider buying indicates that the people running the company believe the stock is headed higher, and if they believe, you should believe, too.
However, Cramer warned that these signals alone are not a good reason to buy a stock. At the end of the day, there is no avoiding doing the homework on a company. That means checking the fundamentals and making sure the company has a story that you can get behind.
There is also one other scenario that indicates the stock is a raging buy. That is when Cramer sees that a stock has heavy short- selling, meaning investors have borrowed shares that they don't own, sold them and are waiting for the stock to go lower before buying them back. Short sellers are looking to collect the difference between the high price where they sold them, and the low price where they bought back the shares.
"You can think of shorting as like regular investing, only in reverse. We try to buy low and sell high. Shorts just turn that around, selling high and then later buying low," Cramer added.
Why is short-selling important?
Short-selling is an indication to Cramer that the investor who sold short really believes the stock is headed lower. After all, the potential downside is infinite with short-selling so they are taking a lot of risk on themselves.
Another thing to watch for on a stock that has a lot of short-sellers is that if there are a lot of them, and all of a sudden good news comes out, the stock could surge because the short-sellers then panic and scramble to cover their short positions-this is called a short squeeze.
Even better, when there is a heavy short-position on a stock sometimes the people who run the company will start to buy shares for themselves.
It is the equivalent of management drawing a line in the sand and saying "our stock goes this low, and no lower."
"This is an explosive combination, and one that often leads to a short squeeze that sends the stock much higher," Cramer said.
Usually short-sellers usually don't know any more about a business than the insiders who run it. So, if a lot of people are shorting a stock and management is buying it back in large quantities, this means you need to start doing your homework because you might want to side with management on that one.
Another bullish signal is when a heavily shorted company announces a huge buyback, bigger than the previous one. This is another approach that management will take to stop the short-sellers.
But be careful!
Read more from Mad Money with Jim Cramer
Cramer Remix: A stock star was born
Cramer: Big money about to flow here
Cramer: Google must play ball...or else
Cramer warned that short-sellers can seriously damage a stock. So, don't just go out there and start buying any old stock with a heavy short balance. One general rule he uses is to buy those stocks that have a large dividend.
This is because when you borrow shares, you are required to pay the owner of the shares the dividend. Therefore the best protection is to use the dividend as a deterrent from those who abuse short-selling.
"Insider buying plus heavy short interest can equal a raging buy, as long as you avoid situations where the shorts are determined to crush the stock at any cost."
I heard here that Toujeo ads was already on NEJM 2 wks ago. Afrezza Ads and articles reflecting AU 30-strong annecdotal evidences on NEJM will in effect improve label on many MD's minds. Otherwise, it's take 2 more yes to get FDA to change the label.
MannKind (MNKD) Stock Is Met With Heavy Support
MannKind Stock NewsMannKind Corporation (NASDAQ: MNKD)
MannKind stock has had a rough time in the market recently, there’s no doubt about that. However, when you look at the reason for the declines we’ve seen, and the technical side of the equation, it looks like the stock should be coming back any time now. Here’s why…
MNKD Declines Are Unfounded In The First Place
If we look back to the beginning of the drop, we can see the reason the stock is falling in the first place; Goldman Sachs downgraded it in a very controversial move. The reality is that the analyst that downgrade the stock formed his opinion mainly around his expectations for Afrezza…
Unfair Opinion Of Afrezza – Afrezza is a new insulin created by MNKD that allows users to inhale it rather than deal with a needle. Physician feedback has been great, but the launch didn’t go as well as Goldman Sachs wanted to see. The only thing is, they formed that opinion 3 weeks after Afrezza hit the market.
When it comes to Afrezza, there are legal reasons the MNKD can’t claim that it is a superior insulin to other options. However, physicians seem to think it’s better than what they’ve seen in the past. As a matter of fact, since the GS downgrade, there have been a few analyst upgrades based on physician feedback of Afrezza.
MannKind Stock Has Hit A Technical Floor
At this point, there’s strong support in the market just below the price. Looking at the MNKD stock chart, you’ll see that the stock has traded relatively flat along this floor since March 9th. The truth is that at the current price, MNKD is a steel; and the 17 calls for every put we’ve seen lately say they feel the same!
Any Form Of Good News Could Send This Thing Soaring
At this point, bulls are anxiously waiting for a reason to push MNKD higher. All we need is a little bit of good news. So, I’ve set my Google News Alerts to let me know of anything that’s going on with this one. I’m waiting for the breakout!
What We Can Expect Moving Forward
As I’ve said time and time again, I’m expecting to see strong growth from MannKind in the long run. The reality is that when Afrezza does start to take off, investors are going to realize how unfounded the Goldman Sachs downgrade really was.
What has been your experience with Afrezza so far?
•Afrezza works instantly. I have checked my blood sugar every 10 minutes after inhaling and eating to show no, I mean NO spike in BS, at all.
•The life of it – since it is in and out in 1.5-2 hours, it makes life so easy. I don’t have to worry about if I still have Afrezza left from a previous dose (like I did on Novolog). I can eat a snack, like a normal person, and inhale Afrezza with no worries about a tail end overlapping and bottoming my BS out.
•The Dreamboat – it is an amazing device. I am a woman, and we have very small pockets in our pants, but Afrezza slides right in!
•Insurance coverage – This drug is FDA approved and the pre-authorizations and not getting comparable coverage to a bottle on insulin is an absolute crime.
•Did I mention insurance coverage?
•Medical professional’s lack of any actual data on this medicine. I have “argued” with Pharmacists and Doctors about the misperceptions they have on it because they are not educated. I get very frustrated when people say bad things about it with no solid data to go on.
•The insulin itself works remarkably well. It has the ability to stop BG from rising. I can eat anything I want and it just wont allow my BG to rise, or rise very little. On the other hand if I do have a BG reading higher than I like it lowers my BG very gently. It took me while to figure that one out. People say 4 units is too much if your at 130, but that’s not true. Afrezza works so fast and stops working so fast 4 units just gets your BG moving down, by the time your at 100 its all done working.
•Super easy and convenient to use. I can use it any time, anywhere. I can take a dose while driving alone down a winding road in the dark. Its too easy, and the inhaler is super small. I do it right in front of people all the time and they don’t think anything of it. It attracts 0 attention.
4) Large addressable market. The initial portfolio is focused on pulmonary
disease, pain, and cancer supportive, with development efforts expected
in sequence to contain costs and a start in 2015. Though the Street has
taken its eyes off of inhaled GLP-1 in response to a question MNKD did
not rule out its possibility.
Upcoming news flow:
• Afrezza 12U cartridge sBLA approval in 2Q:15
• Afrezza post-approval study details, since timelines have implications
for both label expansion and overall program costs in 1H:15
• Earlier stage pipeline with either partnering or advancement of one or
more proprietary programs in 2015.
Target price/base case
We value MNKD at $13 per share, which includes US and
EU profit/expense splits for Afrezza with Sanofi. We assume
a US launch in 2015 and EU in 2017. MNKD will retain
manufacturing responsibilities while Sanofi is responsible for
commercial efforts. We forecast peak Afrezza sales of more
than $7B WW with peak profit split ~$1.7B for sales in the US
and outside the US.
Our upside scenario includes $33 in value for the US and EU
opportunity. We assume market penetration of ~50%+ and
peak Afrezza sales of ~$9B in the US and a penetration rate
of ~36% outside the US and peak Afrezza sales of ~$7B. This
results in profit split revenue of over $4B. Other assumptions
are unchanged from the base case, so the larger numbers
and higher valuation are driven by a higher assumed market
penetration for Afrezza.
Our $5/share downside scenario assumes that Afrezza will
have a lower market penetration due to either a perceived
lack of equivalent efficacy to an injected insulin, safety
overhang from the prior Exubera (Pfizer) experience, or dosing
complexity. Under this scenario we assume a US market
penetration of ~12.5% and an ex-US penetration of less than
8%, resulting in worldwide Afrezza sales of under $3B.
Potential catalysts for the stock
• EU filing plans in 2015. MNKD will count on Sanofi for an
MAA filing where visibility on approval would be a positive.
• Afrezza post-approval study details, timelines have
implications for label expansion
• Launch trajectory over the next 12–18 months.
Approval of a
12U cartridge is expected in 2Q:15 (filed by SNY in 4Q:14) and there is
the potential for a lower dose for pediatric patients in the future. Pipeline
progress will leverage MNKD’s technosphere platform and pursue specific
disease areas based on: 1) Addressing a serious unmet need, 2) Short
development time or low costs to develop, 3) Inhaled delivery, and
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