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Post by otherottawaguy on Apr 22, 2014 8:07:46 GMT -5
Not 100% sure but thought you were on the EXEL wagon as well?
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Post by otherottawaguy on Apr 16, 2014 15:18:33 GMT -5
MNKD Stock, Take Two: Volatility or Not, You Have to Like Afrezza MannKind Corporation has been on a roller coaster ride the past few days. Here's what to look for when the dust settles. By James Brumley, InvestorPlace Contributor | Apr 7, 2014, 9:36 am EDT
On Wednesday of last week, yours truly penned some less-than-flattering thoughts regarding MannKind Corporation (MNKD) … well, MNKD stock, not the company. The gist of the message was, although MannKind’s inhaled insulin, Afrezza, was highly likely to win the FDA’s approval on its original PDUFA date of April 15 — which we just learned has changed — it wasn’t a great buy at the then-inflated price. See, based on histories of other similarly hyped drugs, not only was MNKD stock apt to hit a major peak just a few minutes following any news of the drug’s approval, but the bulk of its near-term bullish “trading” potential had already been injected into the stock’s value. There was little short-term upside left to reward MNKD newcomers. It wasn’t a well-received idea, judging from the heated responses to my theory. There’s certainly no shortage of MannKind supporters out there who believe Afrezza could be a game-changer for the diabetes treatment world. And those supporters were anything but shy about using some … shall we say, “colorful” words to explain why I was wrong. That’s fine — I’ve got thick skin. But, I’m not going to change my bearish thesis. I will, however, add to that thesis making the long-term (and that’s the key distinction) bullish argument for MNKD stock on the heels of Afrezza’s approval. Afrezza Really Is a Game-Changer For those unfamiliar with the story, MannKind shares jumped nearly 75% last Wednesday following news that an advisory panel to the Food and Drug Administration recommended that the government’s drug authority approve Afrezza for type 1 and type 2 diabetes. If the FDA takes the panel’s advice – and it does about 75% of the time — Afrezza would become the market’s only inhaled insulin, circumventing the need for diabetics to continue poking themselves with a needle. The marketability of such a product is clear. Even those diabetics who have grown comfortable putting a needle into their own flesh, breathing something instead is a far more palatable option … even compared to the relatively pain-free ultra-thin needles some diabetics use to inject insulin. And in some regards, an inhaled insulin is a better-suited option for diabetics. The powder is dissolved from the lungs and absorbed into the bloodstream in 12 to 15 minutes, vs. 45 to 90 minutes for injected fast-acting insulins. While the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee was concerned about Afrezza’s safety and tempered efficacy compared to injected insulins, the decided outcome of the panel’s voting makes it pretty clear that the upside of Afrezza at least matches (if not exceeds) the downside. At stake for MannKind is an insulin market that was worth nearly $21 billion in 2012, and an insulin market that’s expected by some to be worth $32 billion by 2018. While, incredibly enough, there are no clear market-based studies that would indicate how much of that demand diabetics would direct toward an inhalable insulin, the blockbuster-level projections that were being thrown around the first time Afrezza was up for approval ranged anywhere from $2 billion to $5 billion per year. That’s a relatively modest and achievable 15% of the total insulin market, particularly given that the drug could mean the end of needles altogether for many diabetics. And, compared to MannKind Corporation’s current $2.5 billion market cap, that kind of revenue potential justifies an even higher MNKD stock price down the road. Potential Risks to MNKD Stock With all of that being said, no good discussion of MannKind and Afrezza can avoid pointing out that this isn’t the market’s first inhalable insulin. Pfizer (PFE) brought its inhalable insulin, Exubera, to the market in early 2007. By late 2007, after only producing $12 million in sales during the first three quarters of that year, Pfizer pulled the plug on the program. It wasn’t even selling close to well enough, with no real hope for improvement. Explanations for Exubara’s failure have been numerous, ranging from the ridiculous size of the inhaler to the cost of the drug compared to its efficacy. More specifically, the delivery device for Exubara was about a foot long (anything but convenient), and Exubera cost about 30% more than the going rate for insulin treatments at the time … still affordable, but tough to justify. Insurance companies weren’t jumping at a chance to pay a premium for the treatment either. While Exubera was ultimately a failure, Afrezza largely solves many of the problems that led to Exubara’s demise.
For instance, Afrezza is delivered via a palm-sized inhaler, and while the question of cost has yet to be answered, some observers expect Afrezza to cost about 10% to 20% more than the typical price of injectable insulin. That’s a very modest premium to pay for the needle-adverse. On that note… While self-injections might seem like a miserable way of life for non-diabetics, many onlookers would agree (and bear in mind, hindsight is 20/20) that Pfizer simply overestimated how miserable insulin needles were for diabetics. Many of them don’t mind using needles, now that ultrafine syringes make the injection process a minimally-painful experience. Efficacy and safety and price and complexity really aren’t the issue. The core of the issue is the needle, or lack thereof. Still, in that regard, the scale tips slightly in MannKind’s favor. Bottom Line for MannKind So I’m ready to change the bearish stance on MNKD stock that I took on Wednesday, now that I’m seeing the insulin’s upside? Nope, at least not yet, and probably not for a while … a even longer while, now that the FDA’s final decision date has been pushed back from April 15 to July 15. As I said then, my expectation for a pullback from this stock beginning right around the time of an approval for Afrezza on July 15 is neither a judgment call on the company nor a judgment call on the drug. It’s a judgment call on how traders think and act when they get more than a little too euphoric.
Eventually, the dust will settle, and the value of MNKD stock will roughly reflect the potential of Afrezza. It’s the “in the meantime” that could dole out some pain. And how does the postponed PDUFA date change the dynamics here? Not a lot. If there’s any impact to stem from the delay, it would probably be to the stock’s disadvantage, as the market’s interpretation of the postponement will likely lead some traders to think the FDA still has a problem with the drug despite the advisory panel’s recommendation. That might be the current read given MNKD’s double-digit decline at today’s open. More likely, though, the delay is more of a procedural one than a true red flag, and will become somewhat irrelevant in July. Oh, some of the recent buyers will drop out of their positions between now and then simply because holding MNKD stock for three extra months was never part of their plan. But by and large, anybody who was willing to stick with MannKind shares through April 15 still will be willing to take on those same risks three months from now. In any case, my critics were quick to point out that any post-approval weakness is just going to be a little volatility, and won’t matter later … especially when and if a partner steps up to the plate. Those are good points. But, post-approval responses to other similarly hyped drugs have shown that little bit of volatility might not be so little. Indeed, it might be big enough to rattle even the staunchest of shareholders. Moreover, one can’t assume a partner is waiting on the wings, ready to swoop in with a bag of cash a few moments after any approval. Interested partners have been few and far between thus far. Could I be wrong? Sure. From my risk-vs.-reward perspective, however, even for long-term shareholders there seems to be too much risk and not enough reward left to justify paying the current frothy price of MNKD stock, let alone any price appreciation we see between now and July 15. After July 15, however — and after any sizable pullback — that risk-reward ratio starts to favor the stock again for the long haul, as Afrezza is still a good-looking solution. And in this game, risk management is half the battle. As of this writing, James Brumley did not hold a position in any of the aforementioned securities.
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Post by otherottawaguy on Apr 11, 2014 11:59:03 GMT -5
Just hate seeing articles disappear...with no way to reference them in the future.
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Post by otherottawaguy on Apr 11, 2014 8:40:20 GMT -5
Took a quick look through it. Saw that the directors have benn compensated in Cash to the tune of about $40 since 2011. This does nt include , shares, options, fees! or the like. I understand that our price tag for development is approaching $2B, with half of that coming since the last CRL. If that is the case looks like we are paying these guy about 4-5% of funds to date.
Wow, would love to be on that gravy train.
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Post by otherottawaguy on Apr 11, 2014 8:30:44 GMT -5
MNKD excerpt from article:
TLSR: This makes me think of a name in your active coverage— MannKind Corp. (MNKD:NASDAQ), with its inhalable insulin product Afrezza (human insulin of recombinant DNA origin delivered via Technosphere particles). It had an AdCom meeting on April 1 and the PDUFA date is now set at July 15. Sometimes the FDA doesn’t have an AdCom meeting, but in the case of Afrezza, I’m thinking it was necessary because the agency made MannKind jump through so many hoops during the drug approval process, including extra trials and years of added development. Do you think that’s the FDA’s reason for holding an AdCom meeting? To finally pull all that information together? KM: Yes. It’s a rather complex drug application. Insulin is a biologic, and we clearly know how it functions, but it’s being delivered attached to a unique particle MannKind calls Technosphere, through a route of administration that is not typical—pulmonary absorption. Also, the inhalation delivery device, called Gen-2 or Dreamboat, is brand new, as it had to be specifically created for this particular drug. I suppose the FDA felt that this AdCom was the best way to be certain that all factors and data were being addressed. And indeed, that was the case—the advisory committee weighed the merits of the drug thoroughly. I think the experts’ near-unanimous support of Afrezza for both type 1 and type 2 diabetes was a strong signal to the FDA in favor of approval. TLSR: Keith, no one could deny that the approval vote on Afrezza was anything but a positive event. Yet, looking at the relative strength of MannKind shares over the past six months, I get the feeling that some investors are looking at opportunities to sell. What do you think? KM: I hate to say it, but that attitude certainly exists. There are a number of people who have made a fair amount of money shorting MannKind stock over the years, partly because of the amount of time that it’s taken to develop the drug and take it over the various hurdles of the regulatory process. There are still a number of people out there who are betting against it, simply because they have made a fair amount of money on it in the past, and probably feel that they can do the same again. It’s hard to know exactly where the stock is going to be when the next news breaks, but it’s possible that there could be corrections along the way to commercialization. TLSR: Your target price on MannKind is $13/share. That’s more than a 100% implied return on this stock. At this point, and given what you’ve just said, are we now looking at MannKind as a market penetration and revenue story?
KM: It depends on how far out you’re looking. I think a couple of things are going to have to take place before we get to a true revenue-and-earnings story. We still have to get FDA approval, and we expect to see MannKind partner with a major drug company to market the product. It will need to be a company with a strong and experienced sales force dedicated to the family/general practitioner (GP) segment of the medical community. The last time I spoke with Al Mann, MannKind founder and CEO, he said that his goal would be to find a good partner experienced in promoting drugs to the GP. Al knows that most diabetics are going to be treated first in the primary care setting, whether they are type 1 or type 2 diabetics. The more difficult cases will obviously be handed off to endocrinologists, who will be the key opinion leaders on uptake of the drug. For that reason, I think it will be equally crucial for MannKind to have some success penetrating that specialty-clinician market. After finding a marketing partner, it will probably take about six months from approval to launch. So, if we get the approval by July 15, the PDUFA date, that would place the launch in Q4/14 or early 2015.
In that interim, between approval and launch, we may have a relatively quiet period. The two companies—the partner pharma and MannKind—will start to work together while inventory builds. But that kind of work doesn’t really generate any news, and so investors will probably just have to sit tight for the actual revenue-and-earnings story to begin. TLSR: Back in 2007, Pfizer Inc. (NYSE:PFE) didn’t even last a year with its inhalable insulin product Exubera (recombinant human insulin with particle diameters between1–5mm), which was developed by Nektar Therapeutics (NKTR:NASDAQ). Exubera’s inhalation device was an inconvenient and cumbersome bonglike device that was not really usable in a public place such a restaurant, and Pfizer eventually dumped the product and gave it back to Nektar. Clearly, MannKind’s palm-size Dreamboat inhalation device, designed for Afrezza, is a huge improvement over Exubera’s delivery device. But could Exubera’s failure be an overhang on MannKind’s shares? KM: To a certain extent, I think it has been an overhang, because when people in the investment community hear “inhalable insulin,” they immediately think of Exubera. It has taken a fair amount of time to educate some investors about the difference. I imagine there’s also an overhang within some of the other major pharmaceutical companies that have watched Afrezza’s development, but remember what happened with Pfizer and Exubera. I don’t know exactly where MannKind is in the partnering process, but I know that it has been talking to multinational corporations and some regional companies in various parts of the world, and it may have had to overcome some reluctance to even discuss Afrezza. We may also see some overhang in the adoption by the medical community. The important thing is, I don’t think that the individual consumer—the diabetic patient—is going to care one iota about what happened with Pfizer and Exubera seven or eight years ago. I imagine, in their eyes, Afrezza offers a distinctly new approach to treating this chronic disease.
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Post by otherottawaguy on Apr 9, 2014 15:06:22 GMT -5
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Post by otherottawaguy on Apr 9, 2014 13:55:04 GMT -5
Settlement Date Short Interest Avg Daily Share Volume Days To Cover 3/14/2014 63,558,514 6,342,384 10.021234 2/28/2014 59,244,446 8,143,101 7.275416 March Disemination Dates Period, Report By, Disemination Date 3/14/2014 3/18/2014 3/25/2014 3/31/2014 4/02/2014 4/09/2014 (after 4 p.m., ET)Saw this over on YMB, website purports to be able to estimate the interperiod change in short count: www.shortanalytics.com/getshortchart.php?tsymbol=MNKDTodays Chart for: 09 Apr 2014: Attachment DeletedGuess we'll soon see. OOG
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Post by otherottawaguy on Apr 9, 2014 13:42:05 GMT -5
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Post by otherottawaguy on Apr 9, 2014 12:49:50 GMT -5
Aren't these the guys that we supposedly licensed that Cancer indication sidejob to? OOG
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Post by otherottawaguy on Apr 9, 2014 10:36:04 GMT -5
Possibly the "Extension Funding" bringing Mr Mann's ownership back up to pre Deerfield / ATM (x2) levels?
Think it was previously at 47%, corrects welcomed...
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Post by otherottawaguy on Apr 8, 2014 8:29:05 GMT -5
SilentBob:
Just hate seeing articles disappear or drop behind a pay wall as we have seen in the past.
Hope you don't mind me riding your tailcoat,
OOG
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Post by otherottawaguy on Apr 8, 2014 8:27:32 GMT -5
Market Outperform Admin April 8, 2014 Brinson Patrick Initiates MannKind Corp at Market Outperform2014-04-08T12:06:13+00:00 Rating Changes, United States No Comment In a report published today, Brinson Patrick Initiated Coverage on shares of MannKind Corp (MNKD) with a Market Outperform rating and a price target of $12.00 “We would be buyers on recent weakness from the FDA’s decision to extend the PDUFA date for Afrezza to July 15, 2014. Recall, the AdCom voted 13 – 1 and 14 – 0 in favor of approving Afrezza for type-1 and type-2 diabetes, respectively. While the FDA is under no obligation to follow these recommendations, we have a high level of conviction for approval. We view the votes and recommendations as a best-case-scenario for Afrezza, and envision a major partnership announcement soon.” Brinson Patrick said “We see little risk to approval, despite the PDUFA extension. With much of the approval risk behind Afrezza, we see investor focus shifting to labeling, commercial partnership, and successful launch. With initial sales beginning in 1Q:15, we model 2025 Afrezza sales of $3.6B, driven by use in earlier-stage T2D. We expect the initial demand for Afrezza to be high considering statements made by the panel and open public hearing about its efficacy, safety, pharmacokinetics, and attractive size.” it added Shares of MannKind Corp (MNKD) closed at $6.32 on Monday.
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Post by otherottawaguy on Apr 8, 2014 8:26:50 GMT -5
MannKind Corp MNKD Brinson Patrick Market Outperform $12.00
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Post by otherottawaguy on Apr 8, 2014 8:25:30 GMT -5
4/8/2014 Brinson Patrick Initiated Coverage Outperform $12.00
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Post by otherottawaguy on Apr 7, 2014 13:04:27 GMT -5
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