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You are talking about TA trend.
Like I mentioned before. I am looking at a 6 month trend of RX's, not 7 or 10 weeks. Investors have to decide if they are long term investors or a short term traders, or a long term investor with core position and trading for short term gain.
The Afrezza Paradigm Shift very comprehensive. Enjoy!
(Need to click the link below at the bottom to read all the diagrams & pictures)
Update: This article was written in 2010 and I keep it up because most of the information here is still accurate to the best of my knowledge. I am not currently vested in MNKD (April 2013) because I believe it is overvalued ahead of the release of the 171/175 trial results in August.
This article encapsulates the reasons why Afrezza will bring about a fundamental change in the treatment of diabetes. Investors rely too much on analyst comments and published headlines from journalists that perform cursory due diligence at best. Smart investors who look at the underlying technology and the unmet need in the market will understand why Afrezza is such an advancement above the gold standards that exist today. There is a huge opportunity in the market to do a better job of controlling the disease that Afrezza addresses. It is estimated that 2 new diabetics are diagnosed every 10 seconds worldwide. If Afrezza can make the impact it should, it could become one of the biggest selling drugs of all time. Within this article I’ll cover what diabetes is, the problems with the existing standard of care for treating it, the facts on Afrezza and how it will bring about a shift to create a new standard of care, along with rebuttals to the common arguments presented by bear analysts that cover MannKind.
The Structure of Scientific Revolutions, written by Thomas Kuhn in 1962, is a historical look at science and how revolutionary advancements brought about change -- challenging the status quo at the time. He coined the phrase “Paradigm Shift,” describing what happens when the current framework of thought has to be re-written to account for a fundamental shift in an advancement of science. We are about to experience the next Paradigm Shift in the standard of care for treating diabetes but the market simply hasn’t yet realized it.
Insulin is an amazing hormone, produced in the pancreas, which is common among all animals (except a few bugs.) Even insulin produced by most animals would cause a clinical response in a human, including insulin produced from most fish! In a nutshell, insulin is one of the key hormones that tell our body what to do when metabolizing carbohydrates and fats after a meal. It is the central chemical signal for telling the body to take glucose from the blood and transfer it to the body’s cells. After you eat something and glucose or protein from the ingested meal hits the blood, the pancreas releases insulin which regulates glucose absorption into every cell, in every organ system in our body to be used as fuel. When there is too much glucose in the blood (because of the lack of insulin / insulin response) then Hyperglycemia occurs and when there is too much insulin in the body you get low-blood sugar and Hypoglycemia. Hypoglycemia can be mild, just causing you to feel bad but sometimes can be severe, resulting in a coma or even death. Hyperglycemia over-time can produce severe organ damage and it is the measurement of chronic hyperglycemia (too much glucose in the blood) that is used in the principle diagnosis of diabetes.
Glycosylated Hemoglobin (HbA1c) is a form of a metalloprotein in the red blood cells that exists in all vertebrates. It is what is used to quantify just how elevated plasma glucose has been over time, since free plasma glucose levels vary widely, but once HbA1c forms, its levels are relatively constant, and only vary with the formation and death of the red blood cells in which it is found. Measurements of HbA1c are therefore useful in the initial diagnosis of diabetes and in determining dietary compliance among patients. Your HbA1c level is basically an indicator of your average blood glucose concentration for the previous 1-3 months. According to the American Diabetes Association (ADA,) a HbA1c > 6.5 means you have diabetes. If it is between 5.7% - 6.4% then you are considered a pre-diabetic, at severe risk of becoming a Type 2 Diabetic. Drugs used to treat diabetes are evaluated on their ability to lower HbA1c levels.
Diabetes is classified as either Type 1 or Type 2. Type 1 results from the body’s inability to product insulin, which makes up somewhere between 5-10% of all diabetics. Type 2 Diabetes results from the body’s resistance to insulin, which makes up 90-95% of all diabetes cases. Insulin resistance most commonly affects your muscle and fat cells, which make up 2/3rds of your body. There is no cure for diabetes, either type 1 or 2, and for most it is a chronic disease. In the case of Type 2, the root cause in 80% of all cases is being overweight or obese, along with genetic predisposition. Through diet and exercise many Type 2’s could cure their disease, but most do not. The CDC estimates there are 56M Pre-diabetics, just a few pounds and a HbA1c point away from being classified as a full-blown diabetic. There are currently close to 28M diabetics in the US or 8% of the population and 6.5% of Europe is diabetic. According to a recent report from the CDC, a child born today has a 1 in 3 chance of becoming a diabetic in a few decades if things don’t change in our country and we could wind up with as many as 500M worldwide at the current rate of expansion. Outside of Obesity, there is no bigger cost to the world’s healthcare system.
Up to 75% of all deaths in Type 2 Diabetic patients are a result of Cardiovascular Disease (CVD.) There is a growing body of evidence that better control of post prandial glucose (PPG,) can substantially reduce CVD risk. Post prandial Glucose is the amount of glucose in the blood that exists after eating a meal, usually measured at 1-2 hours. In a study published in 2009, “Postprandial glucose - a potential therapeutic target to reduce cardiovascular mortality” (Peter R, Okoseime OE, Rees A, Owens DR. PMID: 19149642), the authors state, “There is now emerging evidence that postprandial glucose (PPG) contributes significantly to CVD risk, although to date there are no large scale interventional studies underway which test the hypothesis that targeting PPG will reduce CVD risk. Until recently, there was no consensus about the definition of postprandial hyperglycaemia. The International Diabetes Federation (IDF) has now developed new clinical guidelines for postprandial glucose and recommend that 2-hour post prandial glucose levels be kept <7.8 mmol/L. In the last few years more has become known about the cellular mechanisms triggered in response to glucose excursions which may explain this increased susceptibility to CVD. Recently, investigation into the contribution of PPG to HbA1c in subjects with T2DM, has shown that this is maximal in relatively well controlled diabetic subjects. Hence PPG is emerging as a legitimate therapeutic target to minimise CVD risk.” So not only is achieving a HbA1c under 6.5% an important treatment goal with managing diabetes, so is controlling post-prandial glucose levels in order to decrease the greatest risk of death among diabetics. The current standard of care for the treatment of diabetes primarily focuses on HbA1c reduction and not PPG.
To understand the impact of Afrezza, we must first look at the “normal science” for treating diabetes, both Type 1 and Type 2. Now before I go further, I am not a medical doctor or medical professional, just an investor that likes to understand the science behind what I may potentially invest in. My knowledge of diabetes, the treatment of diabetes and Afrezza all come through Internet-based research and conversation with other professionals.
The “Normal Science” of Treating Diabetes:
“Normal Science” is the term phrased by Kuhn to describe the accepted standard prior to the occurrence of a “Paradigm Shift.” There is a current “standard of care” for treating Diabetes which is generally followed by practitioners. For Type 1 patients, they have no choice but to receive Insulin through basal insulin injections and usually at mealtime to cover prandial needs. For Type 2’s, there are a number of options physicians can take to treat the disease but the American Diabetes Association and European Association for the Study of Diabetes has published consensus recommendations for initiating therapy.
In the 2009 study published in Diabetes Care, “Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy -- A consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes” (David M. Nathan, MD, John B. Buse, MD, PHD, Mayer B. Davidson, MD, Ele Ferrannini, MD, Rury R. Holman, FRCP, Robert Sherwin, MD, and Bernard Zinman, MD,) the study concludes that “Many patients may be managed effectively with monotherapy; however, the progressive nature of the disease will require the use of combination therapy in many, if not most, patients over time, to achieve and maintain glycemia in the target range.” “Self-monitoring of blood glucose (SMBG) is an important element in adjusting or adding new interventions and, in particular, in titrating insulin doses.” “Mounting evidence suggests that aggressive lowering of glycemia, especially with insulin therapy, in newly diagnosed diabetes can result in sustained remissions, i.e., normoglycemia without need for glucose-lowering medications. Type 2 diabetes is a progressive disease, and patients should be informed that they are likely to require the addition of glucose-lowering medications over time.”
As you can see from the above treatment options, insulin therapy has the best advantages to any therapy but the currently available insulin therapies have important disadvantages with them, namely 1-4 shots per day, self-monitoring of blood glucose, weight gain and risk of hypoglycemia. In an article published by Irl Hirsch, M.D. (Univ of Washington School of Medicine) on 11/16/2005 entitled “Optimal Initiation of Insulin in Type 2 Diabetes,” Dr. Hirsch writes about the impact insulin therapy can have on Type 2 Diabetics and the optimal initiation plan to use insulin. Dr. Hirsch states that “it can be anticipated that most patients will eventually require insulin therapy to achieve and maintain glycemic control.” Regarding the ADA’s goal of maintaining a HbA1c < 6.5%, “Such stringent levels of glucose control cannot generally be maintained with oral antidiabetic drugs (OADs) alone. However, overall rates of insulin use for type 2 diabetes in the United States are very low. Approximately 11% of patients are treated with a combination of insulin plus OADs and another 16% receive insulin monotherapy. An A1C < 7.0% is only achieved in 36% of patients. Higher rates of glycemic control have been reported among patients with type 2 diabetes who are receiving care from endocrinology practices (61%) and may in part be due to a higher rate of insulin use.”
Dr. Hirsch’s description of the barriers to insulin therapy is spot-on in my opinion, “delays in initiating insulin may stem from both physician and patient barriers. Negative patient perceptions regarding insulin include fear of injections and hypoglycemia. In some cases, patients may perceive insulin as
a sign of their personal failure to control the disease. Clinician concerns include hypoglycemia, weight gain, and the misconception that elevated insulin increases cardiovascular risks. In addition, both clinicians and patients may consider insulin therapy to be complicated and labor-intensive.”
The graphic below shows the current recommended treatment plan for diabetics.
Diabetes Treatment Initiation, recommended Standard of Care:
When lifestyle changes and Metformin aren’t enough, the recommended approach is to either try a sulfonylurea or basal insulin next. Physicians generally reach for basal over prandial insulin first because you are only looking at 1 injection per day, rather than 3 in the case of prandial therapy, which patients are less resistant to. Once those aren’t doing the job by themselves, more intensive insulin therapy is recommended, including the use of a prandial (RAA - Rapid Acting Analog) insulin. The other agents available have their place with some patients but all have their own side effects to consider in relation to their modest reduction in HbA1c and control of post prandial glucose excursions. The earlier introduction of insulin into a patient’s treatment plan is the most effective therapy for controlling HbA1c and PPG but in order for that to happen, insulin must overcome the high barriers preventing wide-spread adoption.
Insulin as a treatment is basically a commodity. Insulin is Insulin is Insulin -- it has been used for treating diabetes for 90 years. The differentiation in the market is around the delivery device and kinetics. Sanofi-Aventis will say that Lantus basal insulin is better than Novo Nordisk’s Levemir basal insulin. Novo Nordisk will say their NovoRapid is better than Eli Lilly’s Humalog Rapid Acting insulin. For the most part, Basal insulin is Basal insulin and Rapid Acting Analogs are Rapid Acting Analogs. They are all injected, have comparable onset of action and remain in the body for similar periods of time. They all have the same barriers to entry for introducing them into the patient’s treatment plan. Think of Ford vs. GM; they both make cars and are competing for the same market share across the same set of consumers, but there is little difference among the vehicles themselves and it simply boils down to personal preference. The same is true for the current mix of insulin providers. This will change with the introduction of Afrezza. It is like bringing a new car to the market that costs the same as the current cars available but the new car can also fly and uses half the fuel.
The arrival of Afrezza Ultra-Rapid insulin on the market will usher in a new change in the standard of care that I will describe below.
Dispelling myths and supplying factual detail about Exubera and Afrezza
Before moving on to the Afrezza Paradigm Shift, I’d like to clear up the often misconstrued comparison between Exubera and Afrezza. The only common element between both products is that they are both delivered the pulmonary route. Rather than invoke my opinion into the matter, I’ll simply state the facts about each product and let you the reader, draw your own conclusions as to the ability to forecast the market for Afrezza based on the experience from Exubera.
Exubera Facts:
Pfizer’s Exubera was one of the biggest failures in the history of biotech. Originally projected to do over $2B a year in sales, it was a complete flop when introduced and Pfizer took a $2.8B charge to write-off the program. MannKind’s detractors and skeptics continue to point to the dismal sales of Exubera as an indicator for the future of Afrezza. Here are the facts about Exubera, which ultimately led to its failure.
· Exubera offered absolutely no medical benefit whatsoever to Rapid Acting Analogs (RAA.) None.
· The only benefit of Exubera is that you inhaled it and could prevent mealtime injections, but the kinetics and side effects were similar to regular RAA.
· Exubera had very complex dosing requirements, unique to the product and not linear to standard insulin units. You still had to perform dose titration before a meal and continue to administer Self-Monitoring Glucose Tests.
· Prescribers hated it. It offered no advantage as a therapy, had complex dosing and therefore took a lot of time to explain its use to patients. Patients were often confused by how to use it, which took up a lot of time for physicians and their staff.
· Exubera was priced 20% higher than RAA so Payers didn’t want to cover it.
· The device itself was very inconvenient.
· Despite a popular myth, Exubura did not cause an increase in lung cancer risk.
It is no wonder that Exubera was such a dud in the market given the facts above. The question is why did Pfizer even bother with it? The ‘other’ company’s efforts at inhaled insulin were ceased after Exubera’s failure. Every single one of those programs was a ‘me too’ effort offering no medical benefit, just like Exubera.
Now here are the facts about MannKind’s Afrezza.
Afrezza Facts:
· Afrezza is the world’s first Ultra-Rapid Insulin.
· Afrezza mimics the normal insulin response to a meal that a healthy person would have.
· Afrezza greatly reduces the risk of hypoglycemia
· Afrezza is weight-neutral.
· Afrezza results in lower fasting glucose levels.
· Afrezza inhaler is convenient and easy to use, tested for patients as young as 4 years old.
· Afrezza causes no clinically meaningful impact to pulmonary function (1.7% on the Medtone device and about .5% on the Gen2 inhaler.)
· The Device is disposed of every 2 weeks, eliminating concerns of cleaning or long-term durability.
· Afrezza’s meal-escalation study demonstrated that there was no increased risk of hypoglycemia from Zero up to 150 grams of carbohydrates during a meal. Very little if any need for complex meal titration.
· Afrezza eliminates the need for painful shots, a major concern for new patients requiring insulin therapy and a complaint for those already on insulin therapy.
· Afrezza breaks down all of the existing barriers for introducing insulin therapy to a patient!
In a study published early this year entitled, “Effect of Technosphere Inhaled Insulin on Quality of Life and Treatment Satisfaction” (Mark Peyrot, Richard R. Rubin. Diabetes Technology & Therapeutics. January 2010, 12(1): 49-55. doi:10.1089/dia.2009.0115,) the authors explain that, “research suggests that insulin-naive patients offered an option of taking inhaled insulin are much more likely to initiate insulin therapy than those offered an option of subcutaneous insulin. Thus, availability of the Technosphere insulin system might contribute to reduced delay in the initiation of insulin therapy, a goal suggested by recent clinical guidelines. In addition, research suggests that inhaled insulin is preferred to subcutaneous insulin. Most (85%) patients who received an inhaled insulin during the main phase of a clinical trial chose to continue doing so during the open-label extension phase, and 75% of patients using subcutaneous insulin during the parallel group phase chose to switch to the inhaled insulin.”
The graph below shows the superior kinetics of Afrezza, practically mimicking a normal person’s insulin response to a meal. This is the key for reducing Hypoglycemia and improving post prandial glucose levels.
Afrezza greatly reduces the risk of Hypoglycemia compared to standard RAA insulin
Because Afrezza works fast without the long tale that exists with existing prandial insulin options, the risk of Hypoglycemia is greatly reduced. This is clear when the data from the Phase 2/3 trials is pooled and analyzed.
It is too early to make the claim, but one can hypothesize that Afrezza could potentially halt the progression of Type 2 diabetes. Patients Beta-cell function in the Pancreas has often declined by 50% even before they are diagnosed with diabetes. Under the current standard of care, insulin is introduced later in the treatment plan, on average after patients have had a HbA1c level > 7% for 10 years and over HbA1c levels > 8% for 5 years, while the pancreatic function has declined even further during those 15 years. It is theorized that Patient’s ß-cell function continues to decline 5% annually.
Meal-time insulin control is the first problem that diabetics experience with keeping glucose levels in check. Today, basal insulin is first introduced because it is typically a single daily injection, but it doesn’t adequately control mealtime glucose needs, which continue to stress the pancreas. Through early use of a prandial insulin (instead of basal,) pancreatic stress can be reduced, with the potential to dramatically extend the organ’s lifespan.
The Afrezza “Paradigm Shift” of Treating Diabetes:
Once patients are no longer achieving their therapeutic target HbA1c levels through, lifestyle changes + Meformin, then a 2nd line treatment needs to be added. Under the current standard, RAA insulin isn’t added until after basal insulin has been introduced. The reason for that primarily is that a patient would much prefer to have 1 shot of basal a day then 3 shots of RAA insulin. In a 2008 study published in The Lancet (doi:10.1016/S0140-6736(08)60485-7), “Once-daily basal insulin glargine versus thrice-daily prandial insulin lispro in people with type 2 diabetes on oral hypoglycaemic agents (APOLLO): an open randomised controlled trial,” the findings were that both basal and prandial insulin were equally as good at controlling HbA1c, but prandial was better at controlling post-prandial glucose excursions throughout the day (now shown to substantially reduce CVD risk) and the conclusion was: “A therapeutic regimen involving the addition of either basal or prandial insulin analogue is equally effective in lowering haemoglobin A1c. We conclude that insulin glargine provides a simple and effective option that is more satisfactory to patients than is lispro for early initiation of insulin therapy, since it was associated with a lower risk of hypoglycaemia, fewer injections, less blood glucose self monitoring, and greater patient satisfaction than was insulin lispro.”
These conclusions are consistent with other studies I have read and my own opinion for user acceptance. Now, look at the comparison between Afrezza and existing basal or prandial therapies. Early introduction of Afrezza therapy can help lower the risk of long-term cardiovascular disease risk. It may eventually be proven to reduce the stress on the pancreas and preserve ß-cell function, thereby arresting or slowing the progression of the disease. Afrezza may in fact add a decade or more to the expected lifespan of those suffering from diabetes.
Today, Diabetics on insulin therapy have to maintain a vigorous blood glucose monitoring regime to calculate their mealtime injection dosage requirements and adjust with correcting doses if necessary. For most patients on Afrezza, this will potentially no longer be the case. In a meal escalation study conducted by MannKind and presented as a poster at this year’s ADA, the researchers demonstrated that once a patient is on their optimal dose of Afrezza, just some basic carbohydrate estimates will be needed to ensure their normal dose is adequate. In this study, MannKind tested the effect of eating a meal containing varying levels of carbohydrates with the effect of the post-prandial glucose excursions. This test included eating double the expected amount of carbohydrates, half the expected amount and completely skipping the meal together. All 4 scenarios resulted in PPG Excursions that were well under the recommendations of the ADA, without increased risk of hypoglycemia. This is a complete Paradigm Shift for diabetics on insulin therapy.
Alfred Mann discussed this study in their conference call held on February 1st, 2010 and had this to say about it: ““The objective of this study was to demonstrate conclusively that complex meal titration is not needed. Almost from the beginning of the AFREZZA program, I have expected a very wide therapeutic window for AFREZZA, and especially so in type 2. But I was surprised when the subject(s) had no hypo problems at all, even if they ate absolutely nothing. Let me be more specific. Both prandial excursions for the type 2 patients were within plus or minus 35 milligrams per deciliter, no matter what they ate, even if they ate nothing. The patients all achieved good glycemic control by taking a standard dose of AFREZZA, no matter what they ate and without the risk of hypo. And if there is no need for titration and little risk of hypos, there would be little need for regular prandial glucose [measurement] regimens. We will need to conduct more of these studies in order to demonstrate these findings on a larger scale.”
Afrezza breaks-down the existing barriers to entry for the introduction of Insulin Therapy for both patients and physicians.
Afrezza addresses the primary barriers from patients and physicians for introducing insulin therapy. These are:
· Fear of Injections
· Risk of Hypoglycemia
· Weight Gain
· Complicated and labor intensive
With these barriers broken down, you will see Afrezza rapidly gain market acceptance from patients on existing RAA therapies and patients that should be on insulin but aren’t. Overtime, you will see Afrezza used far earlier in the treatment for Type 2 than you have seen in the past with injected insulin.
The graph below is what may happen over the next few years as Afrezza gains market acceptance.
Afrezza opens up a new world for Endocrinologists and Primary Care Physicians to treat Diabetes. Insulin has been the most effective tool at controlling HbA1c but patients have been reluctant to use it for fear of needles and weight gain. Afrezza’s superior absorption kinetics over existing therapies, combined with its ease of use and convenience, will usher in a new era of diabetes management that may have a dramatic impact to the long term health of those suffering from the disease.
To fully appreciate Afrezza and the value of MannKind, you must understand the unique underlying system that makes Ultra-Rapid Acting insulin possible.
Technosphere is the MannKind proprietary technology that delivers Afrezza and is the crown jewel of the company. It is the platform that serves as a carrier for drugs into the deep lung – whose carrier particles are immediately liquefied allowing the drug to hit the bloodstream almost instantaneously. In fact, the absorption kinetics with Technosphere delivery is just as fast as if you delivered the drug through an injection directly into an artery. The pharmacokinetics of this platform opens up a new world for drug innovation that allows ultra rapid absorption to achieve a desired clinical response. Any small molecule drug, peptide or protein could be delivered via Technosphere particles. In addition to diabetes drugs you could see drugs delivered via Technosphere particles for a broad range of therapies such as cardiovascular disease, migraines, osteoporosis, oncology, fertility and infectious diseases.
For drugs like Afrezza to treat a recurring or chronic condition, you would use a color-coded device for each drug.
MannKind has also developed single-use; disposable inhalers (think vaccines or military applications.) Just push in the button and take a breath. Imagine stockpiling anthrax vaccines in disposable inhalers for immediate distribution in the event of a bio-terrorism attack or members of our military carrying them for quick inoculation in the event of biological warfare.
Technosphere creates a huge competitive advantage not only for Afrezza but for other drugs that will take advantage of the platform. Once Afrezza’s Gen2 inhaler is approved, it will create the precedent for using the same approved platform for delivery of other agents. MannKind already has a mechanism in place to license out the platform to other pharmaceutical companies to take advantage of. You will see more licensing of the technology once the first FDA approval happens utilizing the Technology for Afrezza. Over time, Technosphere could generate hundreds of millions, if not a billion dollars or more in licensing revenue.
Afrezza Valuation:
As I stated in my earlier article “Afrezza’s Market Potential and the Future Value of MannKind” (http://seekingalpha.com/article/236516-afrezzas-market-potential-and-the-future-value-of-mannkind ,) you cannot value Afrezza based on the existing market for Rapid-Acting insulin. I think it is a given that Afrezza will consume the RAA market as evidenced by 75% of patients voluntarily choosing to switch to Afrezza in one of the studies. The key is the earlier adoption of insulin among diabetics AND the migration of Afrezza as the first choice in insulin therapy over basal insulin for use earlier in the treatment plan. This shift magnifies the market exponentially. Afrezza will cost around $2,000 per patient per year, within 5% of existing RAA options. There are approximately 27% of diabetics that are currently on insulin therapy, which equates to about 7.5M patients in the US. As studies show, earlier introduction of insulin therapy is recommended and Afrezza will enable this change. The most recent survey results showed that physicians would prescribe Afrezza to 25% of their patients, which would equal 7M patients just in the US, many of whom most likely aren’t already on insulin therapy.
MannKind’s production capacity for Afrezza in their sole plant will be enough to support 2M patients annually (400K at launch.) At full capacity, that equals $4B in annual Afrezza sales just from this one facility. If Afrezza creates the Paradigm Shift I think it will, they will need several more plants to support worldwide demand. This is a good problem to have if you are MannKind and an investor with a long-term horizon.
The speed by which Afrezza gains market acceptance will be largely determined by the partner that MannKind chooses. I hope the partner is either already a leader in the diabetes field or a big pharma who is hungry to drive a new diabetes portfolio for growth. As a sales person, Afrezza is a dream product to sell. It has clear medical benefits over the competition; it is unique, attractive and has an overall great value proposition for both physicians and patients. With an aggressive sales force and a properly developed marketing campaign, I have no doubt that Afrezza will be a huge success.
Fear, Uncertainty and Doubt:
The purpose of this article is to demonstrate why Afrezza will cause a Paradigm Shift in the treatment of diabetes, which I think I’ve clearly shown. I’d like to also address each of the most common arguments that Bears present when it comes to Afrezza. I find it amazing that all of the fear and doubt about Afrezza comes from the financial community and not from practitioners and patients. The most recent marketing surveys clearly show the demand, and the science proves it is a better solution – knocking down all of the existing barriers to entry for introducing insulin therapy. So why do some analysts and journalists continue to forecast an Afrezza failure in the market?
· Exubera Comparison: This one is a tired story that is easily dispelled simply by looking at the facts. I laid out all of the facts above and if you still think Exubera foreshadows the failure of Afrezza, then you probably shouldn’t be investing in biotechnology companies.
· No Advisory Committee: Analysts have backed off this one a bit but some still say the lack of an Advisory Committee means that the FDA won’t approve Afrezza by this PDUFA date. It isn’t surprising at all that an Advisory Committee wasn’t required for Afrezza. There is already precedent for pulmonary delivery of insulin with the approval of Exubera – who had their own advisory committee in 2005 where the expert panel members voted 7-2 in favor of approval. That Advisory Committee was to discuss the efficacy of Exubera and the pulmonary delivery of insulin. Afrezza is a far better product than Exubera for all of the facts described earlier and the FDA knows this. Advisory committees are usually called when there is a Risk vs. Benefit discussion that needs to take place with feedback from outside experts or if the drug under review is a new, novel compound. Afrezza is simple insulin carried on completely inert particles. Afrezza had no serious safety flags through dozens of trials and 5,000 patients that would require a Risk vs. Benefit discussion. There is absolutely nothing with Afrezza that would warrant an Advisory Committee. If one was deemed necessary by the FDA, it would have been called during the initial review in 2009.
· Patient Acceptance: Diabetics are ‘used’ to taking multiple shots a day and won’t want to change. Are you kidding me? This is one of the most asinine statements that I’ve heard on numerous occasions. Now, while this may be true for some, it will be the exception and not the rule. This was even demonstrated in the Quality of Life study referenced earlier, where when given the choice of continuing to use injected RAA insulin or switching to Afrezza, 75% chose to switch. Now think about the millions of diabetics who should be on insulin therapy but resist it. Taking shots is the most widely referenced barrier to entry for beginning insulin therapy. MannKind presented a poster presentation at the 2010 ADA conference to discuss a survey conducted directly to almost 1,100 Type 2 Diabetics regarding the interest of inhaled insulin given the medical benefits laid out in the survey – over 68% of responders said they would be interested in it, and that is before they see commercials on TV or hear about it from their physician. Most of the reasons for the interest expressed by patients were better control of high blood sugar after a meal, avoiding the discomfort and inconvenience of shots along with less weight gain.
· FDA won’t allow MannKind to switch Delivery Devices: In order to switch Delivery Devices, bio-equivalency must be shown between the devices to validate that the previous study data captured still applies with the new device. MannKind conducted extensive studies based on feedback for trial-design from the FDA and recommended assays, which clearly show bio-equivalency between the Medtone and Gen2 devices. Gen2 is just a simpler, more efficient form of the Medtone device. The FDA, despite their recent risk-averse nature, will look at the bio-equivalency data and if it meets their goals of showing bio-equivalency and the device data addresses their concerns which arose with the Medtone device, then they will approve it. Believe it or not, the FDA wants better drugs to hit the market to benefit patients, but they want to ensure they are safe and without undue risk. That is exactly what Afrezza with the Gen2 inhaler is. There is absolutely no reason why any new trials would be needed if bio-equivalency was clearly proven in the studies included with the resubmission. These studies include a Pediatric proof-of-concept study that showed the Gen2 device could be used in children as young as 4 years of age.
Conclusion:
The street has no idea of the profoundly positive impact Afrezza will have in the world of diabetes therapies. Once Afrezza is approved and once the absorption kinetics of it is understood by healthcare providers and patients, Afrezza will become the new “normal science” for treating diabetes. Afrezza will overtake basal insulin as the first course of insulin therapy for type 2 diabetics going onto insulin therapy (earlier in the treatment plan) and will replace existing RAA options for a majority of patients already on prandial insulin. When this happens, not only will Afrezza reach “mega-blockbuster” status but it could become the most valuable drug of our time. The Paradigm Shift of Afrezza is inevitable -- improving the health and Quality of Life for millions of diabetics.
http://klljinvestments.blogspot.fr/p/afrezza-paradigm-shift.html
If that's the case GS report is probably rewritten with NEUTRAL.
I do not expect any statistical significance of Script numbers with less than 6 month (at least 24 weeks) data.
Goldman Downgrade Makes MannKind A Buy
On the day I published “Afrezza’s Initial Sales Create Buying Opportunity” MannKind closed at $6.52. Less than a week later Goldman Sachs downgraded MannKind to a sell with a target price of $3. With MannKind now starting to recover from the downgrade, now is a good time to buy the stock if you have a 3 year investment horizon.
Goldman is a powerful investment bank and their opinion definitely moved the stock price. The thing is that Goldman’s investment horizon, like most of Wall Street’s, is shorter than 3 years. Goldman’s recommendation to sell may be the right call for short-term traders, but it creates a buying opportunity for those who can give the company a reasonable amount of time to rollout Afrezza, it’s new inhalable insulin.
Afrezza was launched about 6 weeks ago by MannKind’s marketing partner Sanofi. The main reason initial sales have been disappointing is that Afrezza’s label does not allow Sanofi to claim it as being superior to existing insulin pens. The best that can be said is that Afrezza is not inferior.
Those who thought Afrezza sales would rocket out of the gate were expecting that Sanofi would be able to market Afrezza as a medically superior alternative to traditional insulin pens.
While Afrezza has a different pharmacokinetic profile than other insulins, it has not yet been proven that that this will result in reduced complications. It’s going to take years of additional clinical experience with Afrezza before doctors can tell whether there is indeed a reduction in complications.
In the meantime, Afrezza can still succeed as a non-inferior alternative to needles. The appeal of “no needles” rates high with patients but in a recent survey of 100 diabetics on Research Now’s diabetes panel, 91% of respondents were not even aware of Afrezza.
To understand Afrezza’s appeal, watch both of these videos.
In my view, the appeal of “no needles” is not enough for doctors to proactively switch patients from successful therapies to one that is only non-inferior. However, I think Afrezza will succeed over the next year as patients learn that they can take their mealtime insulin discretely and with no needles.
Sales will really take off when MannKind and Sanofi have the data to prove that Afrezza reduces complications, but in MannKind’s last conference call they did not even provide a timeframe for presenting this data.
Buying high potential biotech stocks after disappointing initial sales has proven to be a sound strategy for more than one Marketocracy Master. Here’s why.
At this point, the risk that the drug doesn’t work has been resolved and the risk that the FDA won’t grant approval has been eliminated. The risk has been reduced to marketing, a normal business risk with which lots of people have firsthand experience, while the upside is as big as ever.
MannKind has already weathered a downgrade from the most influential firm on the street. Other Wall Street firms could downgrade the stock, but their impact will be less than Goldman’s.
I am not waiting until MannKind hits Goldman’s $3 target price. When first quarter sales are announced, I have no doubt they will be low, but I think Goldman’s downgrade has already baked that into the price. However, I believe the odds are pretty good that sales will start to show a nice ramp by the end of the year and since Wall Street is short over 30% of the float, the positive impact of such news could be surprisingly swift.
Be prepared for a rocky ride, but if you have a 3 year investment horizon, you have enough time for an investment in MannKind to work out.
http://www.forbes.com/sites/kenkam/2015/03/20/goldman-downgrade-makes-mannkind-a-buy/
If you have done your DD, you would not repeatedly ask this question and draw pre-mature conclusion without looking for facts before hand.
Spot on! eom.
Mannkind: Is There Value In A Goldman Sachs "SELL" Recommendation?
As a seasoned investor, having made my first stock purchase at the age of 19 and having worked as an Investment Representative upon graduation from college, I've long had an interest in investments and have followed the stock market closely for over 27 years.
Over this period of time, I've only grown more cynical with each passing year and with each personal observation. Why? Mostly because I consider myself a value investor and it seems I've developed an uncanny ability to purchase stocks in companies just before downgrades. Over time I've learned to trust my instincts and, instead of panic selling, have attempted to embrace these downgrades as a sign that I'm (mostly) succeeding in my attempt to buy stocks near their bottom... thus completing one-half of every investors goal: buy low.
For this particular article, I wanted to focus on The Evil Empire Goldman Sachs as they recently downgraded a company that I've long followed from a distance but only recently bought into.
That company is Mannkind Corporation (NASDAQ:MNKD). I first bought into MNKD on Jan 21 of 2015 after noticing huge purchases taking place in the Feb 4.5 calls. The open interest, in just a matter of weeks, had climbed from essentially nothing to 52,900 contracts. I went long at $5.39. Three weeks later, on Feb 10th, MNKD hit $7.88 intraday representing a greater than 44% gain.
The wind seemed to be at MNKD's back once again. MNKD was in the midst of a 4.5 month uptrend after suffering through a brutal three month selloff that witnessed it's shares falling over 57% from a peak of $10.96 on Jun 30 to $4.61 on Oct 13... commencing only days after the FDA's approval of Afrezza on June 27th of 2014, MNKD's novel drug and delivery system to treat diabetes.
Then along came Goldman Sachs
On Mar 3, 2015, with MNKD having closed at $6.64 the previous day, Goldman Sachs decided it was time to update their opinion. Goldman downgraded MNKD to SELL with a $3 target.
This quickly brought MNKD's attempt at a full recovery to an end. It was a brutal downgrade considering their previous target had been $6. Volume swelled to 22 million shares (4x average) and the stock has not had a green day since... trading down for 5 consecutive days thus far. Most recent close: $5.34, representing a 19.5% loss since downgrade.
To most longs, the downgrade simply didn't add up as Goldman Sachs had increased their own position in MNKD by 400,182 shares (by a whopping 176%) during the quarter end 12/31/14. Also during the quarter: institutions added a net 10,208,339 shares, new positions came in at 7,690,822 shares, while institutions that exited their positions entirely was represented by only 878,623 shares.
Goldman based their downgrade on both a supposed concern about the slow roll-out of Afrezza (which had only been on the market for one month) and pricing discount concerns. Goldman then extrapolated these numbers all the way out to 2025 to arrive at their current valuation of $3. Meanwhile, other investment firms trumpeted these same Afrezza sales numbers as signs of success.
So, is my skepticism of the MNKD downgrade from Goldman Sachs warranted here? To answer that question, I simply go back to my own personal experiences with Goldman.
Case Study #1: Community Health Systems (NYSE:CYH)
CYH is one of the nations largest hospital chains. On April 11, 2011, Tenet Healthcare (NYSE:THC) sued CYH alleging that CYH was admitting patients for needless stays and bilking the U.S. government and private insurers in the process. Obviously, this also peaked the interest of the federal government who then launched their own series of investigations.
What brought me into the stock was a combination of things: the resulting carnage to their stock price, CYH's denial, and the not so coincidental timing of the charges... which came almost immediately after a third failed hostile attempt by CYH to purchase THC.
The day before the above lawsuit was filed by THC, CYH closed at $40.30. The following day it dropped 35.7% to close at $25.89. The stock then continued it's downtrend for another five months before finally bottoming out at $16.40 on Oct 11. Afterwards, the stock found its footing and began a 4.5 week uptrend.
Then along came Goldman Sachs
On Nov 3, 2011, with CYH having closed at $19.51 the previous day, Goldman Sachs decided it was time to update their opinion. Goldman downgraded CYH to SELL with a $17 target.
Immediate Results:
After the downgrade, CYH slowly drift lower and continued to do so for another 2.5 months until its Oct lows could be tested again. Post downgrade, the lowest low occurred on Jan 13, 2012 with CYH closing at $16.70, representing a 14.4% loss.
01 Months after downgrade: (3.3%) ($19.51 to $18.77)
02 Months after downgrade: (11.7%) ($19.51 to $17.22)
03 Months after downgrade: + 2.5% ($19.51 to $20.01)
04 Months after downgrade: + 23.9% ($19.51 to $24.18)
05 Months after downgrade: + 19.86% ($19.51 to $23.19)
Intermediate Results:
06 Months after downgrade: + 24.3% ($19.51 to $24.26)
12 Months after downgrade: + 51.2% ($19.51 to $29.51)
18 Months after downgrade: + 133.8% ($19.51 to $45.62)
24 Months after downgrade: + 124.4% ($19.51 to $43.79)
30 Months after downgrade: + 102.3% ($19.51 to $39.47)
36 Months after downgrade: + 184.1% ($19.51 to $55.43)
* On Mar 21, 2012, CYH would be completely exonerated of the charges alleged by THC.
* On May 1, 2012, with CYH having closed at $24.34 the previous day (less than 4 months after their initial downgrade to sell), Goldman Sachs upgraded CHY back to neutral and tacked $10 onto its previous estimate with a new $27 price target.
* On Oct 8, 2013, with CYH having closed at $43.44 the previous day, Goldman Sachs "assumes coverage" of CYH with a neutral rating and tacks $21 onto their previous neutral estimate with a new $48 price target. Stated differently, Goldman had now added $31 onto is original $17 SELL target for CYH.
Case Study #2: Western Union (NYSE:WU)
Western Union is an industry leader in domestic and global payment services and money transfers. On Oct 31 of 2012, WU had the rugged pulled out from under it when they reported earnings that disappointed the street. The stock fell 29% from a previous close of $17.93 to $12.73, its biggest one-day drop since the company was spun off from First Data Corp in 2006. The stock would bottom out only a few days later at $11.95 on Nov 2.
On Dec 10, 2012 the company was able to raise $750 million dollars by selling senior unsecured notes maturing in 3-5 years at rates ranging from 2.375% to 2.875%. It was this bit of news that had me buying the Jan'15 $10 LEAPS for $3.30. The fact that they could raise that much money, at such low rates, told me all I needed to know about the health of the company.
Then along came Goldman Sachs
On Jan 9, 2013 with WU having closed at $13.67 the previous day, Goldman Sachs decided it was time to update their opinion. Goldman downgraded WU to SELL with a $12 target.
Immediate Results:
Post downgrade, the lowest low occurred only seven trading days later on Jan 18 when WU closed at $13.41, representing a 1.9% loss.
1 Month after downgrade: + 7.2% ($13.67 to $14.66)
2 Month after downgrade: + 7.0% ($13.67 to $14.63)
3 Month after downgrade: + 8.2% ($13.67 to $14.80)
4 Month after downgrade: + 17.7% ($13.67 to $16.10)
5 Month after downgrade: + 21.7% ($13.67 to $16.65)
Intermediate Results:
06 Month after downgrade: + 25.8% ($13.67 to $17.21)
12 Month after downgrade: + 24.7% ($13.67 to $17.06)
18 Month after downgrade: + 27.2% ($13.67 to $17.39)
24 Month after downgrade: + 31.1% ($13.67 to $17.93)
* On May 1, 2013, with WU having closed at $14.81 the previous day, Goldman Sachs reiterated their SELL rating but raised their price target from $12 to $13.
* On July 8, 2014, with WU having closed at $17.31 the previous day, Goldman Sachs "resumed" coverage of WU with a SELL rating and a price target of $17.
Case Study #3: Teva Pharmaceutical (NYSE:TEVA)
Teva Pharmaceutical is one of the worlds largest pharmaceutical companies. After having their stock peak in Mar of 2010 at $64.54, the stock began a long 18-month downtrend, finally bottoming out on Sep 23, 2011 at $35.26. Four months later the stock recovered to $45 and largely held this price for three more months before giving away again in Apr'12. The floor that had been put in Sep'11 was then tested again in Dec'12, Jan'13, and Feb'13... but successfully held its ground each time never closing below $36.
Then along came Goldman Sachs
On July 30, 2013, with TEVA having closed at $39.90 the previous day, Goldman decided it was time to update their opinion. Goldman downgraded TEVA to SELL with a $40 target.
Immediate Results: Post downgrade, the lowest low occurred on Nov 11, when TEVA closed at $36.59, representing a 8.2% loss.
Immediate Results:
1 Month after downgrade: (4.2%) ($39.90 to $38.22)
2 Month after downgrade: (5.2%) ($39.90 to $37.78)
3 Month after downgrade: (5.5%) ($39.90 to $37.70)
4 Month after downgrade: + 2.1% ($39.90 to $40.76)
5 Month after downgrade: + 0.4% ($39.90 to $40.09)
Intermediate Results:
06 Month after downgrade: + 14.2% ($39.90 to $45.58)
12 Month after downgrade: + 37.5% ($39.90 to $54.88)
18 Month after downgrade: + 42.8% ($39.90 to $56.86)
* On Mar 19, 2014, with TEVA having closed at $49.91 the previous day, Goldman Sachs performed a 180 degree turn and upgraded the stock to BUY with a $52 target.
How the Mannkind story will end:
Based on my experience alone, it seems to me that Goldman Sachs tends to issue SELL recommendations on companies sometime (usually several months or more) after they've managed to put in some sort of "V" shaped bottom. After the downgrade, more times than not, the stock then tends to gravitate back towards the price that represented the bottom of its "V" pattern. To recap:
CYH: V-bottom: $16.40, Goldman induced bottom: $16.70
WU: V-bottom: $11.95, Goldman induced bottom: $13.41
TEVA: V-bottom: $35.26, Goldman induced bottom: $36.59
MNKD: V-bottom: $4.61, Goldman induced bottom: TBD
As a result, and based solely on my own experiences, my best guess is that MNKD will mostly likely find its bottom somewhere between its current price of $5.34 and $4.68.
If the $4.60 area fails to hold, then my next best guess (final answer) would be that the bottom is found somewhere between $4.10 and $4.60... being that $4.03 represents the next most recent closing low from Mar 31, 2014.
For the record, I am a big believer in the MNKD product, it's unique and easy (and non-frightening) delivery system, and its vast potential with new formulations of existing drugs. As I read elsewhere, Mannkinds' Technosphere Dry Powder Delivery System could do for MNKD what the K-cup did for the Keurig Green Mountain Corporation (NASDAQ:GMCR). I don't believe that's a far-fetched statement either. Of course, it won't happen overnight, but it should be a fun ride. Initially turbulent, but smoother every year thereafter.
Final Thoughts
Don't be discouraged by the above analysis. Instead, embrace it! In all three examples (CYH, WU, TEVA), the longest it took to recoup your investment after a Goldman Sachs downgrade was 4 months. After that, there was no looking back. 18 months later, these same stocks were up 133%, 27%, and 42% respectfully. Additionally, even after the downgrades, none of them succumbed to prices below their previously established lows.
That being said, don't misinterpret what I'm saying. Just because a downgrade is issued does not mean I suddenly want to purchase shares in a particular company. For example, if the company is in an industry I consider to be on its last legs (such as coal companies that haven't declared bankruptcy yet and gotten a fresh start), then I have no interest in buying into that company regardless of how cheap the shares might get. In other words, I have to like the company before I'm willing to ride out a downgrade.
Lastly, always be weary of any information you get from analyst and especially if that information cost you nothing. Before taking the information at face value, always try to ask yourself questions such as...
"Why are they telling me this?" -and- "Why do they want to help me for free?" -and- "Why did they wait for the stock to drop 50% before downgrading?" -or- "Why did they wait for the stock to rise 50% before upgrading?"
It's my belief that, more times than not, brokerage and investment firms are simply "talking their book". If they want in a stock, they'll first try spooking the masses out in order to shake some shares loose and get a better price. If they want out of a stock, they'll talk it up so they can drum up demand and exit their positions at a premium. Just another tool they have at their disposal to keep their batting averages at perfect.
Okay, I'll go ahead shut up now before I say too much and The Evil Empire and/or their government henchmen come looking for me.
(nervous laughter)
Disclosure: The author is long MNKD.
Additional disclosure: Note: This article was written on March 9th but, due to technical glitches with the SA spellcheck feature, we've only now resolved the issue. Additionally, it was originally submitted as an article but SA denied publication due to it being of "technical analysis" rather than "fundamental analysis".
http://seekingalpha.com/instablog/173357-the-linch-scale/3836186-mannkind-is-there-value-in-a-goldman-sachs-sell-recommendation
I do not understand what you are trying to tell us.
MKND is going to need a lot of insulin because the bioavailability of Afrezza is so low compared to injected insulin. the low bioavailability of Afrezza is one of the reasons the product is a dubious business proposition
Could you elaborate the significance of lower level of bioavailability between injected insulin and inhaled insulin? What impact has been evidenced to patients taking Afreeza as far as any study concluded? Why FDA still approved Afrezza if it is a dubious business proposition?
We may have to struggle for a couple more days before the correction is completed. Shorts here will have to work so much harder than SNY's sales rep to get the share price down. They are getting worried approaching every Friday!
Agree. eom
A reply from DickyD to AF in the following gives us more details about the effect of DILUTION:
You cant do math. The note converts at 6.80, not todays stock price, even if you wanted to spin it that way. The note holders will take equity because they know the value of what they are getting and they also know how it has been held down by the likes of GS, The Street, you, and anchored by BoA.
You fail to mention that before the 15.7 mil shares (not the bigger number you quote - Ashame your editor cant figure that out) does get added to the float, 9mil of it is pulled out because thats what the note holder owes MNKD. The net impact will be 5.7mil shares of dilution, or ONLY 1.4% of the float, which isnt bad considering it eliminates 100 mil of debt.
So you see, the note holder DOES want equity, because they knew they were playing both sides of the coin. And low and behold, the share price will finish below $5.50 so that everyone is happy. Then the shorts will start to accumulate, and when they've accumulated enough will flip the switch. Jimmy Olsen from the Daily Planet will change his price target and rating, and the stock will go higher. And once again, you'll be in a position where you're wrong.
The difference between you and them is obvious: You've been wrong every step of the way. They're wrong so long as it takes for them to make money. But at the end of the day you'll be what you are, someone who has a personal grudge, cant get over it, and who was wrong every step of the way.
http://www.thestreet.com/story/13082829/2/mannkinds-financial-health-complicated-by-looming-100m-debt-payment.html
This is just some noise to me. I believe if script numbers continues to pick up, more revenue will be generated, including milestone payments. Cash flow, top line and bottom line will be improving, not to mention any potential partnership payments from TS collaboration.
Discussions of Afrezza on Diabetes.co.uk among T1
http://www.diabetes.co.uk/forum/threads/afrezza-inhaled-fast-acting-insulin.73664/
LETTER TO Sanofi SHAREHOLDERS
Sanofi and MannKind Corporation announced that Afrezza®, a new rapid- acting inhaled insulin, is now available by prescription in U.S. retail pharmacies.
A NEW OPTION FOR PATIENTS
Afrezza® is approved in the United States to control high blood sugar in adults with type 1 and type 2 diabetes1. Now, patients have another option to control their blood sugar with a rapid-acting insulin that is not injected.
Administered at the beginning of a meal, Afrezza® dissolves rapidly upon inhalation to the lung and delivers insulin quickly to the bloodstream.
AN IMPORTANT ADDITION TO OUR DIABETES PORTFOLIO
By adding Afrezza® to Sanofi’s Diabetes portfolio of integrated, personalized solutions, we are demonstrating our continued commitment to recognizing and meeting the diverse and complex needs of people living with this disease.
A WORLDWIDE EXCLUSIVE LICENSING AGREEMENT
Sanofi and MannKind have entered into a worldwide exclusive licensing agreement to develop and commercialize Afrezza®. Sanofi is responsible for global commercial, regulatory and development activities.
http://en.sanofi.com/Images/38551_Letter_to_shareholders_N40_EN.pdf
But probably good from shorts' perspective! Just saying ....
You are right. I'd rather spend more time following diabetes' comments using Afrezza.
"The only way to forecast is to include historical data". Pete, you are ONLY half right and true about making a forecast.
One cannot ignore to build forward looking assumptions based on historical performance to arrive a meaningful forecast.
Couldn't help but bought more at $5.44 just now....GLTA
Also Mannkind Adcom morning
Part 1:
Pete, why a drop of share price from $11.48 to $5.70 means or results in dilution? Your comments always seem to have attached negativity without grounds.
Yes, please keep us posted and if possible let your doctor go thru those tweets and tudiabetes.org forum. Hopefully it will help him get more perspectives.
Interesting read from these TWEETS about Afrezza experiences:
https://twitter.com/mikemj23/with_replies
&
https://twitter.com/Myabetes/with_replies
Increase of the concentration of insulin does not necessarily lead to more EFFECTIVE prandial (meal time) glucose control for diabetics but the sound bite sure sounds "attractive". Just saying...
Pete, have you really been hearing both positive and negative side of MNKD? I believe you have, from the sentiments and nature of the posts you made in the past few days.
Besides, I am sure we do have many accredited investors on this board who are well-versed in making investment decision. You are not alone.
Summary of recommendations
http://www.nasdaq.com/symbol/mnkd/recommendations
We have in this investment world more than GS. Also others that cover this stock:
http://www.investors.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-analysts
Let's put aside the "issues" of deal and user friendly for a moment.
Since you are so sure the pps will hit $3, will you sell all your shares and / or long PUT or short call today to possibly achieve a profit of over $2? This seems to be a smart move, right?
I think as a prudent investor, he or she should do his/her own due diligence than to solely rely on analyst to make a few bucks here and there.
There have been more than enough investment analysts, financial analysts, business analysts, M&A analysts in the market. Who you gonna trust when one says strong buy and the other says strong sell?
Trend, please be more specific about your doctor and the kind of risk of cancer(s). Just too general to validate the content.
Pete, what makes you so certain that the stock will hit to $3 for you to average down?
I believe shorts and bashers (here) do not give up so easily. It's still 3 days until Friday. I think we still have chance to get cheap shares between $5.20 to 5.30, imo
Just bought more at $5.33, thanks shorts.
I just want to hold my buy order for a few more minutes to see if the 450k sortable shares from IB are still available before pulling my trigger.
https://www.interactivebrokers.com/en/index.php?key=mnkd&cntry=usa&tag=United+States&ib_entity=llc&ln=&asset=&f=4587&conf=am&amref=1
Want to know more about the failure of Exubera?
Why compare the sales data lone with Exubera? Do you want to compare it also with advertising expenses spent in the same period to make it more relevant?
I really wouldn't use "disaster" to describe the first 5 week Rx, given that it has been a soft launch by SNY.
SNY has long indicated to us that it would be a Controlled launch and would have another marketing launch later. Now that more sample packs were requested. Therefore, I have no reasons not to believe Sanofi has all the calculated steps in its ways to market this product.
Using Afrezza inhaled insulin with a CGM
Listen to what a early clinical trial participant and Dr. Jay Skyler has to say.
Afrezza GO LIVE LIFE 2
Any breaking news for the spike? I bought a small position not long ago based on the TA only.
Forget Biased Analysts, Diabetics Love MannKind's Afrezza
Summary
-The days of unbridled FUD are over.
-Investors can now focus on ACTUAL diabetics usage of Afrezza.
-Fact: diabetics are loving Afrezza.
-The number of negative articles will increase as reality envelopes shorts.
-The future could not be brighter for MNKD.
-The MannKind (ticker "MNKD") story/plot continues to thicken
Over the past several years, investors, both long and short, have had to rely on trial data, and the opinions of analysts to guide their investment decisions. This led to a messy set of views and considerable swings in the stock price. Those days are now over.
The reason is simple, diabetics now have access to Afrezza, and thus, we can get the information directly from the "horses mouth." And what we are witnessing, is that diabetics are absolutely loving Afrezza. This isn't one analysts opinion, but fact, and the results diabetics are enjoying are far superior to what was observed in the clinical trials.
The number of investors that are on the short side of MannKind, those who believe the company is worth less than the current price, are now beginning to realize they are wrong. However, in order to exit the position in an orderly manner, they need to push the stock price down. This is why we will see additional negative articles in the short-term. If it wasn't for these articles and targeted analyst reports, the price would quickly rise, hurting the $500M position that has been wrongly wagered, in the hopes of poor results by Afrezza.
Historically, investors in biotech companies have had to endure dramatic swings in the stock price. The reasons are straight-forward: biotechnology is a complex field, results are generally binary, and because novel drugs carry significant uncertainty, volatility ensues.
However, at some point, the proverbial "rubber hits the road", and the success/failure, is no longer determined by clinical trials, and biased opinions, but by actual patients, and their experience/results on the given drug. This is precisely where we are today.
Al Mann, Chairman of MannKind, has been claiming for years, that Afrezza is vastly superior to current insulin therapy. He knew it wasn't able to be properly conveyed in the clinical trials due to the inherently restrictive protocols, but as soon as diabetics began using Afrezza, it would bare out. Every benefit Al Mann touted over current insulin is being enjoyed by those early adopters using Afrezza today.
Word is spreading about Afrezza due to the positive experience that diabetics are enjoying. No marketing has been done by MannKind or Sanofi. Zero. And yet, they are running low on sample kits, and already planning on expanding their manufacturing capacity. This is not wishful thinking on the part of Sanofi, they are seeing the results.
Actual prescription numbers do not signify what analysts want you to believe currently. In fact, it's the polar opposite. The prescription figures being touted as underwhelming is actually very encouraging. Since there is zero marketing ongoing, diabetics are learning of Afrezza solely from other diabetics, currently utilizing Afrezza, and word is spreading fast.
It's only been officially available for 25 days and yet, celebrities are making their own online videos extolling the positive benefits of Afrezza; and not because someone is paying them too, but because they are diabetic, understand all the difficulties that other diabetics are going through, and are genuinely excited for the future of diabetes care, all thanks to Afrezza.
Now, with modern online/social media, we have the ability to track, in virtually real time, how diabetics experience Afrezza, compared to other insulin therapies they historically utilized. The results, which anyone can follow, have been nothing short of spectacular. Diabetics, especially T1's, have been glowing about the results they are enjoying. The results are so superior, that diabetics themselves (the ones not yet on Afrezza) are in disbelief, as many have their HbA1c's (a closely followed measure) at levels never before enjoyed. Some such as Sam Finta (as well as numerous others now posting their results on Twitter), have the levels to a point where it's nearly the same as non-diabetics. This is impossible on any other insulin therapy. But that doesn't stop people from making false claims….
For years, some reporters and analysts have been very negative on MannKind, telling everyone the sky is falling. Before, few could tell if they are right or wrong. Now, we have proof. The sky is clearing, and a ray of light has broken through the clouds. They continue to push the same story, but people no longer believe. And rightly so, they have access to the same information, directly from diabetics, and they understand what Afrezza is now truly capable of.
Over the next few days, you will see a considerable increase in the volume of shares trading. Coupled with negative stories, shorts will try to push the stock price down so they can cover (shorts must buy shares to close their position). It may work, but I believe that people have already figured out that they have the story all wrong, and shares will be appreciably higher in the near term.
Everyone has an agenda, but there is one major exception: diabetics, whose lives are literally on the line every day and every time the use insulin. They are seeing real, significant improvement in their lives as a result of Afrezza. Why would you ignore their overwhelmingly positive experience, and believe some analyst telling you they won't like it?
Analysts and reporters have absolutely zero bearing on how Afrezza will do. It is only what diabetics think and experience that will determine the fate of Afrezza. As such, we continue to believe that Afrezza will be the best selling drug in history. As always, do your own research and analysis.
http://seekingalpha.com/article/2968416-forget-biased-analysts-diabetics-love-mannkinds-afrezza