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Trend it was hard Hard for you to be a basher short on MannKind when you know the upside is there and 2014 will be the year of MannKind.
Glad you saw the light.
MannKind fans and critics line up for Sanofi's Afrezza pre-game show
November 26, 2014 | By Tracy Staton
Afrezza's inhaled insulin drug/device combination--Courtesy of Mannkind
Who doesn't like to watch a drug launch? It's pharma's version of a spectator sport, complete with cheerleaders (and boo-ers). And for Sanofi's ($SNY) upcoming rollout of Afrezza, the inhaled insulin developed by MannKind, the crowd is already assembling.
Two reasons: One, Afrezza's road to market was long, and MannKind ($MNKD) developed a host of enthusiastic fans and rabid critics as time went by. Two, Sanofi's diabetes business is under a spotlight, thanks to former CEO Chris Viehbacher's abrupt departure, not to mention the pessimistic forecasts he issued just before he left.
So, at Sanofi's investor confab late last week, a certain share of visitors zeroed right in on any comments about Afrezza--and any hints they might give about Sanofi's launch plans and their likelihood of success.
Some observers noted that Sanofi didn't trot out any physicians to talk up Afrezza, as it did with other soon-to-be-launched meds like Toujeo (the Lantus follow-up) and LixiLan (the Lantus-Lyxumia combo med). Bad sign, some said. Good sign, said others, noting that the docs discussed meds that aren't yet approved in the U.S.
Splitting hairs? Maybe. The hard and fast info on Afrezza's launch was scarce. Sanofi's Riccardo Perfetti, senior medical officer in diabetes, did say the company plans to target diabetic patients who don't want to start insulin therapy--and that's a lot of diabetics, given the fact that two-thirds of patients resist the move. On average, patients wait 5 years to add insulin to their oral meds.
Another target: Patients who are using a basal insulin like Lantus but need another insulin at mealtimes. Those patient populations, combined, could reach 3 million, RBC analyst Adnan Butt said in a recent investor note.
Selling points? No injections, obviously. As an inhaled insulin, Afrezza is an odd duck that could just possibly grow up to be a big-selling swan. According to Sanofi's market research, 39% of patients using oral meds didn't want to start insulin therapy specifically because they wanted to avoid injections. To about 60% of surveyed patients, Afrezza was a preferable alternative to a pen injector. Almost as many said they'd prefer to use Afrezza daily than add injections at mealtime.
Meanwhile, Sanofi is preparing to test other Afrezza dosing regimens, hoping to get some positive tweaks to the drug's official labeling. It's in negotiations with the FDA on post-approval studies. Launch date is still set for the first quarter of next year, regardless of change at the top of Sanofi.
Three simple rules for investing in MannKind or any stock.
1. Do research and due diligence on investment. Know as much as you can about product, management team, past experience and commitment to bring product to market. Study all the detail going back as far as you can the information on MannKind it is there In this case you have history of Founder and the fact he kept putting cash back into the company. Listen to past shareholder meetings and read annual reports. Who else is invested in the stock? What institutional investors are in it.
2. Invest what your comfort level might be. How long can you be? What happens it you lose your investment? Can you deal with the gyrations of ups and downs. Do you understand what it says in a company prospectus statement. If you lose your investment can you sleep at night ? If you can't deal with the + or - then stick with blue chips or ETF funds.
Buy shares on momentum but up and down as long as you know why it's moving in either direction.
3. Plan your exit plan from a stock. Is this something you want to hold long term or short term. When I invested in MannKind my view was it was a minimum of a 36 month investment as I saw and reviewed their history and thought the risk/ reward was inline with a long term hold.
I have lost a few that I should have gotten out of and won on many that should have been losers. I have ridden many stocks down to the single digits only to see them rise up to the three digit numbers. My horizon is not one year or five years but over 10 to 30 years. Look at the history of the Dow over the last 50 years and in 5 year segments. Quality investments have gyrations but do deliver long term. I have watched investors who are in their 80's and 90's who still invest and stick to these rules.
Comment from Afrezzauser. He was in the FDA trials. From a post he made on SA today.
When I took Afrezza the first day I felt like I won a lottery and nobody in the world knew about it. Off course I would not want the world to know if I did. When it comes to Afrezza all diabetics and doctors have to know so that they can make a decision on what is best for them. How many times do I really speak of Afrezza being so great because I do not poke myself with needles? I hardly ever do! The speed of the insulin with no tail ends changed my life and not the needleless delivery. I know that you know this but at this point there are so many new people on this board it is worth repeating for others. Everyones knows a diabetic and I found this board to be very helpful to spread the word and my message.
Could the deal with MDT still out there?
Mannkind & Medtronic -- but not until February!
I (like many others on this board) continue to believe an announcement involving Medtronic is the third part of the deal that Greenhill was hired to negotiate. However, I believe it will not be announced until after MNKD's February BOD meeting.
Below are Hakan's public comments:
Hakan Edstrom
"Actually, we are right now in discussions with one of the major companies looking into kind of portfolio management. We want to make sure that beyond what we understand ourselves, our technology can accomplish that we look at significant unmet medical needs and we look at what are good business opportunities. So, we are just in the process of launching that and we'll have a discussion with our board in November and in February in regards to the areas that we think are our significant investment opportunities."
MNKD BOD November meeting was this week. I believe this meeting was mostly a status update on JAC activities and timelines with discussions about future technology opportunities. We should not assume that they will be making any announcements right after this meeting, as usual MNKD will be very conservative about future plans. Any announcement will be after the meeting Hakan spoke of in February as all the moving parts will finally be lined up!.
Medtronic's Covidien acquisition, remains on schedule to close in early calendar year 2015. Medtronic Inc. and Covidien plc announced that they will be holding special meetings with their respective shareholders. The meetings will be held so shareholders can vote for approval on the impending merger. The separate meetings are all scheduled for Tuesday, January 26, 2015, according to a joint press release.
Once Afrezza launches, technology will garner a great deal more attention than it is now. Less
where there is smoke there is fire
You just can't make this stuff up. Just when you thought nothing was up with additional partnerships could the marriage with Medtronics still be alive? If you remember last June 16th Sanofi and Medtronic's created a partnership / alliance to work together in diabetes. Could this partnership include MannKind? It was speculated back then and again in August that there was a marriage to be made with MDT and MannKind after the MDT inversion with Covidian. Is that still viable? Well look at MDT stated today about reshaping its diabetes business into 3 divisions 'focused on transforming diabetes care
I guess only time will tell but you have to think there is more to this press release and it might involve MannKind.
"Medtronic may also look to acquisitions to build out the non-intensive and service & solutions portions of its diabetes business"
Is Technosphere a consumable product?
Looking ahead does this writer see the future?
What Other Mergers Are Possible After The Halliburton-Baker Hughes Deal?
Paul Sigrist, Benzinga Staff Writer
Read more: http://www.benzinga.com/trading-ideas/long-ideas/14/11/5019622/what-other-mergers-are-possible-after-the-halliburton-baker-h#ixzz3JSdet8WW
Just do your due diligence on what MannKind and its Afrezza brings to Sanofi. Say what every you want but Sanofi who sold out of Exubera before it launched knows exactly what they get in potential sales with Afrezza. They didn't partner and pay 150,000,000 up front to lose. They know that it will be a winner and they will have a great new tool to help folks in the lost decade of dealing with Diabetes. Research what the lost decade is all about. Many of us fit that profile. Middle age boardline diabetic, overweight and not able to control with diet.
read this article as to why Exubera failed. Its telling why Afrezza will be a winner for Sanofi. Remember they didn't partner to lose.
http://dst.sagepub.com/content/2/3/518.full.pdf+html
So do you think that the Sanofi board went into this partnership blindly to fail with MannKind? I don't think so. They had their eyes wide open and have had over 6 years to study what Afrezza was all about and what it could and not do in the diabetes market place.
One more take away from the article:
Would the story of Exubera have ended differently if it
was not Pfizer but a different pharmaceutical company
that brought this product to the market? For most
diabetologists and patients with diabetes, Pfizer does not
have the reputation of being a “true” diabetes company.
Pfizer as a company also has no history and experience
with insulin therapy; it appeared as if Exubera was an
unusual product for their sales representatives (to phrase
it carefully). One clear lesson of the Exubera story is
that relying on a huge marketing machine (showing
specific advertisement spots for Exubera on TV!) and its
position as the world’s largest pharmaceutical company
(with its deep pockets) is not sufficient to make such a
product a success story. Pharmaceutical companies with
more history/reputation in insulin therapy and a sales
organization that is familiar with all the details of this
type of diabetes therapy probably would have done
somewhat better; however, the decisions made by Novo
Nordisk, Eli Lilly, and some years ago by Sanofi-Aventis
indicate that even such companies are not too sure about
their market success.
Even if Pfizer was probably not the ideal company to
bring the first such product to the market, Exubera would
have found at least some acceptance and place in diabetes
therapy if it would have been a real strong product with
many good properties. However, it was such a disaster
from a sales point of view that even Pfizer (with all the
bad effects of such a move on its image) could not keep
it in its portfolio. Put simply, the costs of keeping all the
support lines up and running that are mandatory for
such a product (about which most physicians, patients,
and insurance companies have no idea about) are so
high that even a big pharmaceutical company cannot
cover this over a prolonged period of time.
Clearly Pfizer, to be more precise, its marketing
department, was not able to convince either patients
or diabetologists about the opportunities that Exubera
offered during the unimpressive launch of this product
(see earlier discussion) and the time thereafter. Just having
a big booth at each diabetes congress is not sufficient.
Talking with the sales representatives at the booth quickly
revealed that they were trained to sell Exubera like
any other drug but had no in-depth understanding of
the advantages and disadvantages of this product. Also,
a number of symposia organized by Pfizer at which
experts (like myself) present only a positive view on
Exubera (which I always tried to avoid…) does not fit
anymore in a world in which physicians are able to
critically review clinical study data themselves and are
at the same time very cost sensitive. A more balanced
and fair presentation, describing the benefits on one side
while not ignoring potential risks and limitations
on the other, is more adequate nowadays. A lesson
for the pharmaceutical industry and their marketing
departments in general is that you are in trouble when
you cannot adequately convince your target population
about the advantages of your product. The conventional
approaches employed by the marketing people failed in
the case of Exubera. Without an adequate adjustment
of the marketing strategy, there is a high risk that this
story will be repeated with other novel products
The march is starting down the line to November 20, 2014 slowly but surely Sanofi is getting ready to launch. Just a couple of new things on it occuring.
Like this search on the Sanofi web site where it mentions and has links for Afrezza 16 time. Last week you couldn't even find anything on their website.
Another slide from the Sanofi web site announcing Afrezza.
An article from EuroBusinesss Media (EBM) and Sanofi CFO Jerome Contimine October 31, 2014
So you can bet that better days are just right around the corner for MannKind. Afrezza will be a great new drug for the diabetic and will eventually be a blockbuster seller. Maybe not overnight as it has be scaled up production wise as sales start to take off. But 2015 USA sales will prove that production sites in other countries will have to be set up as EMA,EU and UK sales will prove a need for a Europe production facility.
if one parent has it.
there is a 25 % chance of having it.
if both parents have it
there is an 80 % chance of having it.
Take A1C TEST ONCE A YEAR.
I have a friend who is in Endocrinologist who is not sure yet if he would prescribe. If a patient asked for it he would research and decide
If I needed to be prescribed to a insulin product I would ask my doctor to do it with that product. Fortunately I am healthy at this stage of my life. But my brother is prediabetic and would do it instead of insulin shots
Are you planning on trying AFREZZA ?
I do plan to ask my doctor if I should take AFREZZA
when it comes out.
My doctor is in charge of the Diabetic Wing of a hospital the San Francisco Bay area .
not short MNKD
not long MNKD
here is where my BIOTECH money is
I play them all
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=107988607
Copy of posting on MannKind board
An article from 2008 that is worth reading again today to restore you confidence in why Sanofi decided to partner with MannKind on Afrezza. the title of the article is: THE FAILURE OF EXUBERA: ARE WE BEATING A DEAD HORSE? by Lutz Heinemann in the Diabetes Science technology Journal. Which is the same group where Alfred Mann spoke to this AM.
http://dst.sagepub.com/content/2/3/518.full.pdf+html
If you don't read the long transcript perhaps this is the biggest take away point:
In hindsight, it was a smart decision by Sanofi-Aventis to step out of the cooperation
with Pfizer and to cash a huge amount of money for the world’s second largest
insulin plant in Germany and their share in Exubera
development. It is most likely that Sanofi-Aventis had
anticipated correctly the problem with the European
health care systems (see later). As a result, the only
company that is still active and that has a late phase of
clinical development is MannKind. A direct consequence
of this development is that other companies that are
developing inhaled insulin formulations appear to have
issues in finding adequate partners/investors in view
of the billions of dollars burned by inhaled insulin
(i.e., Nektar). The fate of inhaled insulin most likely also
hampers the development of all other alternative routes
of insulin administration (ARIA).
So do you think that the Sanofi board went into this partnership blindly to fail with MannKind? I don't think so.
There are no earnings yet as the product has not even been launched. Perhaps we will see some exciting things in the next 12 month and perhaps not. But I know one thing and that is you can bash away all you want. MannKind is a company with a product that will be selling in the USA 1st Quarter and then in other countries perhaps 120 of them within the next 2 to 5 years.
You can chase all your penny stock fantasies that you follow as a basher but lets check back this time next year and see if your contribution to mankind is better than Al Mann's contribution to MannKind. I am putting my money on Alfred Mann vs. a schill.
New survey on the impact of Snsulin Injections. You can see why Afrezza will be a big seller based on what this independant report is tell you about injections. This report was not commissioned by either MannKind or Sanofi. Again it shows why Afrezza will be a big seller for MannKind and the partnership with Sanofi will be a good one.
Injection Impact Report
http://www.injectionimpact.com/
New Survey Explores the Impact of Insulin Injections and Communications between Patients and Healthcare Providers
The American Association of Diabetes Educators (AADE) has just released results from an innovative new survey entitled the “Injection Impact Report” that highlights the level of communication between patients and healthcare providers relating to insulin injections and also spotlights how those injections can impact patients’ daily lives and treatment adherence.
According to the survey results, 33 percent of respondents have experienced some level of dread relating to insulin injections (eight percent strongly agreed/25 percent somewhat agreed), 14 percent of individuals surveyed felt that the insulin injections had a negative impact on their life (three percent experience a major negative impact/11 percent experience a moderate negative impact) and more than 29 percent of individuals surveyed felt that injecting insulin was the hardest aspect of their diabetes care (eight percent strongly agree/21 percent somewhat agree). However, even though insulin injections had such an impact on these individuals, 52 percent do not proactively discuss their concerns regarding the physical and emotional aspects of injecting with their healthcare provider.
http://www.injectionimpact.com/images/HCP_Guide.pdf
Gotta keep up the good fight . Our day is coming soon. Enjoy you great posts on the light side. F 16 retarded is still spewing his crap daily. What do you make of Trend. Is he a short? My suspension was lifted and I get more than one post a day. So I will post more often there.
We will find out more details about the Launch date on November 20, 2014 when Sanofi Chairman Serge Weinberg has his Investor Relations Conf Call from their Genzyme HQ in Boston. You can watch this online by going to the Sanofi IR section of their web site. I am sure the detailed information of Afrezza will be equal or better than their diabetes presentation from June 2014 which you can also see these slides on line.
Their introduction of Afrezza® I am sure will be another milestone that will increase the share price in a positive direction.
This is not a 5K but it's a Ultra Marathon. It's only started. We are in only the 2nd month of a 12 to 24.month run. Any can happen on every single lap so we just have to be read for the up's and down's. There will be many that will test our will but we will prevail. Pay attention to milestones. The next one is Sanofi Investor Relations call introducing Afrezza November 20, 2014 at the Genzyme headquarters in Boston. By the way Sanofi liked Genzyme so much the bought the company. Hmm why have this introduction at the Genzyme facility vs the Sanofi North American HQ in New Jersey?
Sanofi has a unique way of partnerships. just remember REGN and ALNY. first partners then 24 months later buying into REGN. In the case of ALNY they bought in 16 months. Go figure. Goldman gave the neutral rating so that they wouldn't look like a little piggy when the stock explodes. There was a hidden message that was ACUMULATE NOW. I stated before this was a + or - rating. They are slick smart whores in the game of screwing the small investor.
The Ultra Marathon will run for a long time. One of my favorite tunes for the Marathon is DREAMBOAT ANNIE by Heart. I guess that is fitting.
Heading out this morning into the sun
Riding on the diamond waves, little darlin' one
Warm wind caress herr
Her lover it seems
Oh, annie
Dreamboat annie my little ship of dreams
Going down the city sidewalk alone in the crowd
No one knows the lonely one whose head's in the clouds
Sad faces painted over with those magazine smiles
Heading out to somewhere won't be back for a while.
I bet we close today close to 6. Folks are getting nervous as the know anything could happen between now and the end of 2014 with Sanofi. Keep pounding the retard pilot.
My guess is Sanofi plan will be revealed on Nov 20.
No No No this is not supposed to be happening. We are reversing course and heading back into the wild blue sky.
Where is my pilot? did he retire? Oh no can we go it alone.
Glad that DMC and Martin are hear and have my backside covered...
On a bad day for the market MannKind Trades over 16,544,000 shares. Say it's not so. This is not in the long term plan that the shorts had in mind for us. Oh well. I think they future is pretty bright for MannKind. Let’s watch the product get launched at the November 20, 2014 Investor relations meeting that Sanofi is having and then sales begin in early 2015. I guess that we are at $15.00 this time next year we can claim a victory. If we hit that figure sooner than it’s a great investment.
Shortly we will know if we are a POS or a winner. My money is on us being a winner if your long in MannKind.
This is for shares trading today over 13,000 units.
Who is buying these shares? anybody care to guess?
be sure and join us on this board IHUB for Friends of MannKind
http://investorshub.advfn.com/Friends-of-MannKInd-28962/
What will we learn at the Sanofi Investor Relations presentation on November 2014 in Boston? Good new on the product launch?
Same here but at the end of the day a few stock went green. my bank stocks really have tanked.
I guess that this POS might take off soon. Glad to see it start flying. There must be some chum in the water for such a up date on a bad Day for the market.
Yeah it is. I'm definitely getting annihilated everywhere else!
10% up in a bloodbath market....I'll take it.
My thoughts on where we are today. Why they silence from both companies. Is Mannkind gearing up more production lines at the factory in Connecticut? To handle demand if the product sales take off when released to the USA market.
What about EMA !and UK release?
You can bet the lines are planned and the equipment will be in and ready to go to coincide EMA approval. They will have their timing right for production. The line might even be installed at a Sanofi plant in France. some EU countries might require this for distribution.
We know that eventually that there will be a 2nd production site. Europe or in China. Sanofi has several insulin plants there. I am sure that once Sanofi gets its insulin approved for use with Afrezza that whatever Sanofi plant produces that insulin will be the plant for the Afrezza production line. This is why it makes sense for Sanofi to take either a stock investment interest in MannKind like they did with REGN & ALNY. Or perhaps a complete buyout of MannKind.
One has to beleive that Afrezza will prove to be a blockbuster drug with 480,000,000 diabetics world wide. Do you really think Sanofi wants to be a partner with MannKind or the owner? Insulin is a cheap highly profitable drug. One of the most prescribed drugs. They want to own it as its a cash cow. Today approved in America. Mid 2015 EMA, UK approval. Then 120 possible nations for usage. Do you really think they want a partner?
Personally the quiet is maddening. It's Drip Drip Drip. What will we learn between now and the end of 2014 from either MannKind or Sanofi. The best we can expect is on November 20, 2014 at the Sanofi Investor Relations conference. SNY is controlling the tone at the top. Is that surprising?
Personally I hate the % of value that I have lost since approval. Foolishly ??I kept buying shares. Should had waited for a lower price. I have averaged down my cost basis. have not sold a single share. I will not sell a single share. Perhaps I will be buying more. The potential for a big upside is enough of a incentive to stay long and see what happens. There 78,000,000 shorts know that there is blood in the water and have done a great job of chumming the water. SHORTLY we will see who wins.
Very good post. Imho
MannKind: A Very Favorable Risk/Reward Profile
Oct. 8, 2014 10:25 AM ET | 1 comment | About: MannKind Corporation (MNKD), Includes: SNY
Disclosure: The author is long MNKD. (More...)
Summary
•MannKind's share price dropped after the Sanofi deal and has continued to drop since.
•In this current range, MannKind's risk to reward profile is very favorable.
•Investors should take a chance on MannKind because, though the risks are a reality, the potential reward far outweighs those risks.
This article was sent to 17,884 people who get email alerts on MNKD.
(For those of you who already know all there is to know about MannKind (NASDAQ:MNKD), you can skip the background section and go to the analysis section.)
Shares in biotechnology company MannKind have been on a wild ride in 2014. From a low of nearly $4 a share in March to a high of $11.48 in June and a Monday closing price of $5.44, the share price has been unpredictable to say the least.
(click to enlarge)
MNKD stock chart for 2014
StockChart.com
The year has included FDA approval for MNKD's inhaled insulin product Afrezza on June 27th and a partnership with French pharmaceutical company Sanofi (NYSE:SNY) to market and sell Afrezza. SNY has experience in the diabetes market with its blockbuster drug Lantus, which generates billions in profit annually. The basic terms of the partnership are that MNKD will receive $150 million upfront and maximum additional payments of up to $775 million if the drug performs well. SNY and MNKD will also split profit and loss on marketing and selling the drug, with SNY receiving 65% and MNKD the other 35%. The companies have announced that Afrezza will go on the market in the first quarter of 2015, so meaningful sales numbers won't be available until mid to late 2015. Now that we have the basic facts out of the way let's move to some analysis.
Analysis: Bull vs Bear
(click to enlarge)
Mannkind
MannKind's Technosphere
MNKD is a very controversial stock. Opinions on how the company will fare in the future range from blowout success to crushing disaster, but both sides of the coin have good points. Bulls claim that Afrezza is a novel product that will garner huge success in the diabetes market and that the Technosphere inhaler, which allows for inhalation of a drug in dry powder form, will provide future applications beyond Afrezza. Bears claim that labeling will be an issue because the FDA demanded that diabetes patients receiving Afrezza get lung function tests done before taking Afrezza, six months after the initial lung function test and then annually from then on. Bears also claim that Afrezza will not perform well because doctors will be hesitant to change prescriptions from more stable injectable treatments to inhaled treatments, which historically have a higher probability of causing pulmonary issues.
Now this article will not address which side is right because no one will know until the drug hits the market and sales data is released. Bulls, no matter how confident they are that the company will succeed, must admit that Afrezza's labeling is less than optimal and that inhaled treatments are always more heavily scrutinized. Bulls must admit that these facts may affect sales. Additionally, bears, no matter how confident they are that the company will fail, must acknowledge the innovative nature of Afrezza, and acknowledge that there is a chance that the drug has blockbuster potential because of the sheer size of the diabetes market.
This article will talk about the risk/reward profile of MNKD because that is where the investment decision should be made. Examining the stock in this way reveals that MNKD is a great opportunity because the potential reward far outweighs the risk.
Analysis: Risk/Reward Profile
I'll start out by examining some facts. By 2013 estimates, there are approximately 382 million people on Earth living with diabetes. That number is expected to increase to 592 million by 2035, showing that the number of people with diabetes is expected to grow rapidly. The following chart shows the number of diabetes cases (in millions) at two year intervals.
Centers for Disease Control and Prevention
There are also 29 million people in the United States alone suffering from diabetes, which is 1 out of every 10 adults. It is predicted that by 2050 that number will drastically increase and 1 in 3 U.S. adults will suffer from diabetes.
Additionally, studies show that people don't like needles. In all seriousness though, common sense would dictate that, if all other side effects and risks were the same, diabetes patients would choose inhaled powder over an injection before every meal. This is especially true for new diabetes patients who will surely elect to take inhaled insulin over injected insulin, whereas one might be able to make the argument that current diabetes patients would rather stick with the injection (pun not intended) that they've been using, rather than switch to inhaled insulin which is something they're not used to (though if you made that argument I'd be skeptical).
Another thing to consider is that Sanofi's backing gives Afrezza more credibility than if MannKind had decided to go it alone. While you can say that since the drug got FDA approval, it would be seen as legitimate even if MannKind hadn't partnered with Sanofi, having a big pharmaceutical name with experience in the diabetes market backing your product makes for a smoother experience for the diabetes patients taking the drug and for the doctors prescribing the drug. More importantly though, Sanofi's sales and marketing professionals know how to get the word out about Afrezza and how to get people to buy it. This is an invaluable resource for MNKD, which would otherwise have to hire and train people to create its own sales and marketing network, which would be very expensive.
So with those facts, we have established that Afrezza most likely has 1) a huge existing and future market in which to establish sales 2) a willing consumer base and 3) a partner that can successfully market the drug among the population, including among the otherwise skeptical or hesitant. When taking into account the size of the diabetes market, the demand for Afrezza and Sanofi's sales and marketing expertise, the potential reward is evident.
Evaluating Afrezza's Potential (in the U.S.)
Afrezza is now approved to treat diabetes mellitus type 1 and type 2. For type 2 diabetes patients, taking Afrezza alone is enough, but for type 1 diabetes, Afrezza must be taken along with a long-acting insulin product (such as SNY's Lantus). The U.S. diabetes market is, as of 2013, about $17 billion and is expected to rise to $25 billion by 2020. Afrezza is a rapid-acting insulin product, meaning its main competitors are other injected rapid-acting insulin products. To determine what Afrezza's potential sales might be, we have to look at the sales generated by these currently available injected insulin products. In the US, Novo Nordisk's (NYSE:NVO) rapid-acting insulin Novolog generated $1.3 billion in 2013, Eli Lilly's (NYSE:LLY) rapid-acting insulin Humalog generated $1.15 billion in 2013 and sales of both have been increasing steadily every year. Afrezza can also be utilized by type 2 diabetes patients as an alternative to oral treatments, which may cause hypoglycemia, and injectable treatments, which people unfamiliar with insulin are unlikely to want. U.S. type 2 diabetes patients represent about 90% of diabetes cases and the market is estimated to be about $1.6 billion, bringing Afrezza's total sales potential to about $4 billion annually. Now I will examine the different scenarios that we may see when Afrezza sales data is released, and I will estimate sales of Afrezza in each scenario.
In my opinion, there are four ways in which sales of Afrezza can play out in the first few years of being on the market: 1) Sales completely flop because of an unforeseen issue that either turns patients off from using the drug or turns doctors off from prescribing the drug 2) Inhaled insulin becomes a niche market because many people simply aren't convinced about the efficacy or safety of the drug and sales are around $200-300 million 3) Sales are healthy and Afrezza generates around $600-$1 billion annually and 4) Sales skyrocket past expectations and exceed $1 billion annually. Now I won't try and pretend that I'm not bullish on MNKD, because I am. But even a bear must admit that the reward here substantially outweighs the risk, and even if that bear thinks that the reward is not likely to materialize, the potential is there. Let's look at each scenario more in depth and analyze the likelihood that each will occur.
Scenario #1: Sales completely flop
Because Afrezza has successfully endured clinical trials, the FDA advisory committee and FDA approval without causing any significant health problems, the idea that the drug will go on the market and be immediately pulled because of some detrimental side effect is mostly unfounded. This scenario is the only one where MNKD and investors lose completely, but, in my opinion, this scenario is also the least likely to occur.
Scenario #2: Inhaled insulin becomes a niche market ($200-300 million)
Inhaled insulin is not something to be brushed off as a niche market opportunity. Diabetics, especially those with type 1 diabetes, use rapid-acting injections because there are no alternatives. Efficacy and safety have been proven throughout Afrezza's approval process, and barring some massively successful smear campaign by companies that have injected insulin products on the market, such as NVO and LLY, doctors and patients alike will see Afrezza's benefits and it will gain a reputation as a safe and effective alternative to injected treatments. I think that with SNY's marketing prowess and the drug's novelty, Afrezza will not become a niche market. But if this situation does develop, then, using $250 million of sales profit as a benchmark, MannKind will receive about 35% of this number, which translates to about $87.5 million annually. With these numbers MNKD, with a market cap of about $2 billion, looks a bit overvalued. But as I stated before, this situation is unlikely to occur.
Scenario #3: Sales of Afrezza Are Successful ($600-$1 billion)
This scenario is the one we are most likely to see when sales of Afrezza are released in mid to late 2015. As is always true with a new, innovative drug, adoption takes time and sales will probably come out of the gate at a jog and increase as time goes on to a steady run. Using a benchmark of $800 million in sales profit for this scenario, MannKind will receive about $280 million of this, which would make the stock much more fairly valued, if not undervalued. Also, the longer the drug is on the market and helping diabetes patients avoid injections, the more widespread adoption will become, increasing sales at a steady pace.
Scenario #4: Sales Blow Expectations Out of the Water ($1 billion+)
While this scenario is definitely possible, I think it's too optimistic to think Afrezza will sweep over and change the diabetes market immediately after the drug is put on the market. If Scenario #3 occurs, then I believe sales will eventually reach this level (of $1 billion+), but hoping for this much success before Afrezza takes a couple years to prove itself in the market is too much to ask for. However, if this situation was to occur, then, at its current stock price, MNKD would be very undervalued, indicating huge potential reward for investors.
Conclusion
Where the stock is now, with a Monday close of $5.44 and a market cap of $2.22 billion, the reward heavily outweighs the risk because for the most likely outcomes, MNKD is in position for future gains. Maybe sales of Afrezza won't vindicate MNKD's valuation right away, but the stock will be in a position to outperform. I acknowledge that the risks exist, but at current valuation the risk is acceptable because of the huge potential reward.
MannKind Announces Receipt of $150 Million Licensing Upfront Payment
VALENCIA, Calif., Sept. 29, 2014 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) today announced that it had received a $150 million upfront payment in connection with an exclusive worldwide collaboration and licensing agreement with Sanofi for development and commercialization of Afrezza® (insulin human) Inhalation Powder, a new rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes.
About MannKind Corporation
MannKind Corporation (Nasdaq:MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. MannKind maintains a website at www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.
CONTACT: Company Contact:
Matthew J. Pfeffer
Chief Financial Officer
661-775-5300
mpfeffer@mannkindcorp.com
MannKind Corporation Logo
Let's create a better place here. Click on moderator position. That way we remain in control. I can only post once a day on the other board. I also will not pay for a membership so I can't private message anymore. Can read them but not respond.
I have had it with the MNKD board.
Glad you here on a positive MannKind board.
Interesting read on northwest bio regarding Adam Feuerstein and hedge fund scams.
http://smithonstocks.com/northwest-biotherapeutics-washington-post-calls-for-investigation-of-hedge-fund-stock-trading-practices/
Glad you made it over to the Darkside. It's a friendly place for MannKind followers. Add yourself as a moderator if you are interested.
Links to slides and videos of Afrezza trial patient testimonials for ADCOM.
diatribe.org/issues/63/new-now-next/1
Nice board! Good spot to post valuable info. MNKD board has turned into yahoo which is why I don't post. I'm just in a holding position and waiting til next year. I've been adding using the profit on all my flips as pps drops. So loaded!
For disagreeing with a flaming poster who is stalking folks on the MNKD board.
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