MANNKIND - 2013 endlich zum Überflieger?

konnte der ein oder andere hier noch überzeugt werden?!
der Kurs geht nun ja schön ab in den USA!  

Der Inhalator ist so groß wie ein USB Stick!

http://charts.stocktwits.com/production/...l_31759781.jpeg?1422296155  

Es geht in die richtige Richtung mit dem Kurs und hier Anwender fantastischen Afrezza, kein Puschen, Fakten durch Adcom Afrezza Trial Tester:

https://www.retailinvestor360.com/biotech/...arly-afrezza-launch.html  

ellogo zu diesem Artikel von heute würde mich mal deine Meinung interessieren,

mit den zwei meistverkauften "schnell wirksamen" Insulinpräparaten wurde in den USA 2013 ein Umsatz von 4,75 Milliarden Dollar gemacht,
genau auf diesen Markt zielt auch afrezza ab, daneben gibt es für afrezza noch weiteres Potential für jene die noch nicht Spritzen wollen und mit afrezza aber eine Alternative haben,

insgesamt ist dieser "fast acting Insulin" Markt wohl deutlich über 5 Milliarden Dollar schwer in den USA, weltweit wohl deutlich über 10 Milliarden Dollar, wohl eher in Richtung 15 Milliarden,

und nun kann jeder rechnen sollte mannkind von diesem Markt 15,20 oder 25% erobern,also für mich erscheint das realistisch,



A New Price Estimate Now That Afrezza Is Launching
Jan. 26, 2015 8:58 AM

People report that Afrezza is available at selected pharmacies.
Sanofi appears to be launching according to the stated schedule.
We have come up with a set of price targets based on historical unit and dollar sales figures for competing products.
In the comment section of my last article, several people posted reports saying that their local pharmacies now have MannKind Corp.'s (NASDAQ:MNKD) Afrezza in stock or on order. A screen shot was posted of Afrezza being listed as in stock at Cardinal Health. The discount web site, rxcut.com also displays a price for Afrezza which appears to be taken from a pharmacy benefit manager's database.

The pricing data that is emerging with these reports suggests that Afrezza is indeed priced to be competitive with other fast acting insulins. Prices reported for the 4 unit 90 cartridge (a 30-day supply) range from Cardinal Health's $215 to $269.99 at CVS.

If you compare this to the $303 to $423 retail price of Novolog FlexPens at Wal-Mart and CVS, as listed on GoodRx.com, you will see that Sanofi (NYSE:SNY) is pricing this new inhaled insulin aggressively. However, retail prices don't mean much when it comes to drugs, so we still have no real idea of what Sanofi will be paid by insurers and pharmacy benefit managers. All we know is that the retail price compares well with that of injected fast-acting insulins.

Estimating sales based on unit sales of fast-acting injected insulins

Since the retail pricing is in line, making Afrezza competitive with existing products, we can learn a lot by looking at historical sales data for the other fast acting insulins currently on the market.

Luckily for us, this data is available online in Drugs.com's list of the top 100 U.S. bestselling drugs of 2013. The main fast-acting insulins that dominate this niche, Novolog from Novo Nordisk (NYSE:NVO) and Humalog from Lilly (NYSE:LLY) appear on this list in both their vial and pen forms. So, we can quickly determine how many units they sold over the course of the year and what their total revenue was for those 2013 U.S. sales.

These are not all the fast-acting insulins on sale in the U.S. There is one more, Apidra, Sanofi's fast-acting insulin. But it is not a bestseller, so it did not appear on this list. The total worldwide sales for Apidra were reported (in Euros) in Sanofi's Annual report for 2013 along with what percentage of their total sales are attributable to the United States - 29%. Using those figures, it is possible to come up with a ballpark figure for Apidra's U.S. sales and add it into the mix.

Please note that I am only considering the sales of the expensive, patented analog fast-acting insulins. I am ignoring the regular human insulin preparations, Humulin and Novolin. These are much cheaper, but they are also much slower insulins and harder to use. They are usually prescribed to people with poor insurance coverage who would not be part of the target market for Afrezza at its current price point.

Here are the 2013 U.S. Sales numbers for these insulins. They include all the Drugs.com data for all forms of Humalog and Novolog with an additional estimated $108 million in U.S. sales for Apidra.

Total 2013 US Sales Dollars
All Analog Fast Acting Insulins
$4.76 Billion
Total 2013 Units
All Analog Fast Acting Insulin
38.46 Million
So, let's calculate what would happen if Afrezza were to take over one quarter of this market and sell 10 million units, at a price somewhere around $200 per unit (a unit being that 90 cartridge box). That could be a reasonable price given that LLY earned $203 per unit for the sales of its Humalog KwikPens in 2013.

That would generate sales of $2 billion, which is more than the dollar amount that 10 million units of these injected insulins earned. But for the moment, let's work out what that might mean for profits and stock price.

Assuming that there is a 30% margin for these insulin sales, a number that corresponds to the margin Novo Nordisk reports, a company that sells insulin as its main product, we come up with a profit from the sales of those 10 million units of $600 million.

MannKind's share of that profit according to the partnership terms would be 35%, or $210 million dollars. With 405.70 million shares outstanding (WSJ figures) that works out to $.52 per share. Assuming a modest 15 PE ratio, this level of U.S. sales would justify a price of $7.76.

A more conservative estimate based on dollar sales

However, given competitive pressures and the additional downward pressure on price that is becoming evident as pharmacy benefit managers become more aggressive about cost cutting, we have to heed the fact that the dollar sales figures reported for these other insulins show that they have on average been selling at unit prices closer to $125 than $200. So, we would do better to figure out a reasonable valuation for MNKD using the dollar amount that these other insulins actually earned in 2013 rather than the number of units they sold.

If Afrezza could capture $1 billion of those $4.8 billion insulin dollars, roughly one fifth of all sales, the numbers are much more modest. At a 30% margin, that $1 billion in sales would generate a profit of $300 million. MNKD's share of these profits would be $105 million dollars. That works out to $.26 per share, which at a PE of 15 would justify a price of only $3.90/share.

But wait! (As the TV hucksters say.) There's more!

Additional revenue from stealing market share from other injected drugs for type 2 diabetes

Before you sell your shares to a hungry short seller, remind yourself that Afrezza doesn't only compete with fast acting insulins. It also competes with several other blockbuster drugs prescribed to patients with Type 2 diabetes and it has a good chance of taking away a considerable chunk of their shares.

The most vulnerable of these drugs is the injected drug Victoza, made by Novo Nordisk. Victoza is on the list of the top 100 drugs sold in 2013. However, it causes very unpleasant side effects, including projectile vomiting, and while it is effective in a subset of patients who use it, a large majority of those who take it do not see significant improvements in their blood sugar.

What has relevance for those who claim that Afrezza's black box is a sales killer, is the fact that this top 100 drug comes with a black box warning that cites its potential for causing not one but two kinds of cancer. The warning section of the label also notes postmarketing reports "including fatal and non-fatal hemorrhagic or necrotizing pancreatitis." Nothing on the Afrezza label should raise anywhere near the concern that these fatal conditions listed on the Victoza label should raise.

So, doctors may decide that Afrezza might be a good choice for some of their patients who have been taking Victoza but still are seeing very poor blood sugars.

Victoza is a very expensive drug. There were 2.5 million Victoza prescriptions sold in 2013, earning drugmaker Novo Nordisk $1.08 billion dollars in sales. That works out to $432 per unit.

So, Afrezza should not only be cost competitive with Victoza but might provide better blood sugar control to people with Type 2 diabetes - even those who are not using basal insulin - with far fewer side effects and much less risk. That is because Victoza's mechanism primarily lowers post-meal blood sugars, as does Afrezza. It does not lower basal blood sugar.

If Afrezza could take only one third of the dollars currently spent on Victoza, it could earn another $356 million. With a 30% margin, that yields $106.9 profit, of which MNKD would earn $37 million.

And Victoza is only one of several very similar injected drugs for type 2 that might lose market share to Afrezza which share Victoza's steep price and worrisome, potentially fatal side effects. These other drugs are AstraZeneca's (NYSE:AZN) Bydureon and Byetta. I can't find U.S.-only sales numbers for these drugs, but analysts project worldwide sales of $384.3 for Byetta in 2015. Bydureon's sales have been extremely disappointing so far, possibly due to the fact it must be injected with a huge needle.

If Afrezza could capture 30% of those Byetta/Bydureon dollars we could add another $13 million to MNKD's profits.

When we do the math, the additional $50 million in the profits made by taking market share from Victoza and Byetta could add another $.123 to MNKD's earnings per share. That would bring them up to $.38 per share, justifying a price of $5.71 at a modest PE of 15.

Yet more revenue from replacing ineffective, expensive, and dangerous oral drugs for type 2

None of these numbers includes the patients with Type 2 who are taking no injected drugs at all. Many of these patients are taking Merck's (NYSE:MRK) Januvia. There were 9.2 million Januvia prescriptions sold in 2013, generating $2.77 billion dollars in U.S. sales.

An additional 3.7 million prescriptions of Janumet were sold. Janumet is a combo pill made up of Januvia and Metformin. Janumet brought in another $958 million from its U.S. sales alone.

Yet another similar drug, Onglyza, is not on the bestseller list, but it is selling a several hundred million dollars worth of prescriptions, worldwide.

These oral drugs also have significant side effects. The label for Januvia notes,

There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. There have been postmarketing reports of acute renal failure, sometimes requiring dialysis...serious allergic and hypersensitivity reactions in patients treated with JANUVIA such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.

And these drugs don't work very well for many people with type 2 diabetes. These are the patients who should be taking insulin. However, many have stayed with these pills out of fear of needles.

If Afrezza could capture 30% of the $3.73 billion currently spent on these Januvia drugs, those sales would add another $117 million to MNKD's profits, which would add another $.29 to its earnings, bringing them up to $.67 a share. That would justify a price of $10.04 at a conservative PE of 15.

Januvia is not a cheap drug, so the patients currently using it are those who have good insurance plans, plans that are either already covering Afrezza or are likely to do so within a year or so of the product launch. Note that I didn't even figure in additional units sold to patients currently using the very similar, equally expensive drug Onglyza.

And I am not even attempting to estimate how many other needle-phobic patients there might be out there who aren't taking any of these other drugs right now, due to contraindications or having had bad experiences with them in the past. They too are candidates to become Afrezza users.

One other group also could provide another big group of Afrezza customers. There were 40.5 million units of Lantus sold in the U.S. 2013 earning Sanofi $5.4 billion in U.S. sales alone. Many of these were bought by patients with type 2 diabetes who are using only basal insulin. They may have been avoiding fast-acting insulin because they don't want to have to carry around needles and worry about dosing. If only a small percentage of these people add Afrezza to their daily regimens, we could easily see another significant rise in earnings and share price.

And then there is the rest of the world

All these figures we have just reviewed are for sales made only in the United States. Since the United States represents 29% of Sanofi's worldwide sales, a successful Afrezza, sold worldwide, could triple profits and earnings, making a price near $30 quite possible, should the stock remain at a conservative PE of 15 and a lot more if investors become more enthusiastic about MNKD's future.

Caution: these numbers work only if the drug is a hit with doctors and patients

Obviously, these are best case numbers. Nothing we know now can tell us if doctors and patients will adopt Afrezza. But Afrezza is showing up on some formularies, and it appears that it is indeed priced competitively. It also appears to be rolling out to pharmacies, making it likely that the drug will launch very soon. Rumor has it that Sanofi has held its educational session for drug reps in Las Vegas this past week. This may mean they will be heading out to visit doctors soon.

Meanwhile, hold on to your hats and expect to see some serious volatility in the price. There were, as of December 31, 2014, some 75.6 million shares sold short. There are a lot of people being paid to raise fear and doubt in the minds of stockholders to shake loose the shares those shorts need to buy to close out their positions.  

@ franz22 sowohl die Marge für Afrezza wurde von MNKD höher angegeben, als auch das KGV ist mit 15 sehr niedrig angesetzt. Da wäre also noch Luft nach oben, wenn man sonst alle Schätzungen beibehält im obigen Artikel http://www.ariva.de/forum/...m-Ueberflieger-477322?page=15#jumppos379 .

@ellogo2 im Beitrag http://www.ariva.de/forum/...m-Ueberflieger-477322?page=14#jumppos369 erwähnst du die niedrige Wirkung auf HbA1c. .

"Mein Ansatz ist nur, dass ich es für nicht wirklich Therapierelevant halte, weil es insgesamt nicht zu besseren Hba1c-Werten führt."

Ich weiss nicht ob dir bekannt ist, dass man nach Ende der Studie noch eine Einzelfallanalyse durchgeführt hat. Dabei kam man zu dem Ergebnis, dass ein erklecklicher Anteil der Probanden Afrezza so wie das gewohnte Insulin vor der Mahlzeit eingenommen hat, so dass die Wirkung zum überwiegenden Teil zeitlich falsch eingesetzt hat. Bei richtiger Anwendung ist Afrezza also wirksamer als man auf den ersten Blick auf die Studiendaten annehmen würde.

Aus diesem Interview

http://www.diabetesincontrol.com/articles/...er-and-ceo-mannkind-corp

stammt dieses Zitat von Al Mann "

AM: I don't know the largest drop, but many Afrezza patients achieved HbA1cs under 7% and quite a large number even under 6.5%. Frankly part of the problem in the trials was that from experience with other insulins the fasting glucose was generally not lowered as it should have been; had that been done the A1c results would have been much better.

SF: Was that when you changed to the new device?

AM: No, I think that a problem during the trials was that some patients took their dose of Afrezza even before starting to eat. The trial protocols called for Afrezza to be dosed "at the beginning of the meal," but sometimes it was taken even before. We need to do additional trials to gain more experience with optimized dosing times. Actual ingestion of food in most meals in the United States except in restaurants takes only about 30 minutes, so I believe that the first Afrezza dose really ought to be taken ten or fifteen minutes after starting to eat."

Bedienungsfehler haben auch zur ersten Ablehnung durch die FDA geführt. Bei der grossen Studie mit 5000 Patienten fällt auf dass einige davon eine Ketoazidose bekommen haben, also die Zuckerwerte völlig aus dem Ruder gelaufen sind. Heisst das, dass Afrezza hier überhaupt nicht gewirkt hat? Nein. Aber der ursprüngliche Medtone Inhaler musste gereinigt werden, was einige Patienten versäumt und damit einen verstopften Inhalator benutzt haben. Deswegen die zwingende Umstellung auf einen Inhalator der nach zwei Wochen weggeworfen wird.

Eine Frage: da du anscheinend vom Fach bist würde mich interessieren ob diese Aussagen auch irgendwo in medizinischen Datenbanken zu den Studien vermerkt sind. Bis jetzt habe ich dafür nur die Aussagen von Al Mann und Mannkind. Ich glaube ihnen das auch, würde es aber gerne schriftlich in einem offiziellen Dokument nachlesen. Hast du auf solche Datenbanken Zugang?

 

ich glaube nicht, dass damit ein so hoher Anteil am "fast acting Markt" zu erziehlen ist.
Wie ich schon früher erwähnte....vielleicht 10%, an mehr glaube ich nicht.  

Deine Überlegung ist natürlich korrekt.
Wenn der Zeitpunkt der Applikation nicht stimmt, hat man nicht die optimale Wirkung.
Ich habe auch nur von den Studiendaten gesprochen, wie sie sind.
Werben können sie im Vertrieb nur mit den Daten, die sie haben.
Der Aussendienst kann nicht beim Arzt sitzen und sagen..."ja, die Daten Zeigen etwas anderes, aber eigentlich kann Afrezza mehr."

Ich glaube, die Ärzte werden Afrezza natürlich ausprobieren, keine Frage.
Wenn es dann gut funktioniert und das Handling für die Patienten keine Probleme darstellt, dann wirds auch laufen.

Wichtig für den Behandler ist, du musst ihm eine sichere, praktikable Lösung anbieten, mit der er auf Dauer möglichst wenig Arbeit hat.

Eine positive selbstgemachte Erfahrung ist das Beste, was da passieren kann.

Also, warten wir´s mal ab, geht ja sicher bald los.

 

langfristig halte ich deine Aussage dass nicht mehr als 10% des Marktes zu erreichen seine als nicht realistisch an, würde mich da dann auch mal auf ein paar Argumente freuen,

wie ich bereits ausgeführt hatte besitzt afrezza ein paar deutliche Vorteile gegenüber der Insulin Spritze ein Marktanteil von zumindest rund 25% am fast acting Markt ist für mich absolut realistisch,

vor allem bei der Kundengruppe die Neu in den Markt kommen (müssen)  

Argumente?
Nun, wir haben hier doch die letzten Wochen reichlich Argumente ausgetauscht.
Wenn ich mir alle "Fürs" und "Wieders" vor Augen führe, glaube ich eben an nicht mehr.

Ich spreche von max. 10% der Patienten, die Mahlzeiteninsulin bekommen.

Da es ja einen Tick teurer ist, ist das im Umsatzvergleich natürlich etwas mehr als 10%.  

Der Markt fällt, Mannkind steigt, Afrezza wird weltweit ein Blockbuster und auf 1-2 Jahre gesehen, steigt Mannkind um das Vielfache von heute, nur meine bescheidene Meinung!  

Ellogo, der Sekptische, wenn er Recht hat und Afrezza weltweit nur 10 % Marktanteil erhält, haben wir hier einen Tenbagger!  

http://us.rd.yahoo.com/finance/external/forbes/...d/?partner=yahootix  

"Afrezza will become the mealtime Insulin of choise", wow, das sagt die Biotechlegende aus dem obigen Forbes Artikel!



 

Auszug aus dem Forbes Bericht:

In addition, with the abnormally large short position that exists in the stock, I believe there is far more upside potential than downside risk in the stock from current price.  In fact, I?ll go so far as to say that for someone with a three- to five-year time horizon, I believe we?re looking at losing $2-$4 on the downside, if things don?t work out, but making $25-$40 (or more?) on the upside, if things do go our way. I like that set-up a lot.

Honest-to-goodness short squeezes do not come along all that often on Wall Street, but when they do, they can be spectacular indeed.  Putting this observation together with my belief that the price action we have seen in MannKind?s stock over the past six months may represent one of the most extreme examples of an ?inefficient market? that I have seen in my 26 years of following the biotech sector, and I think it will only take a piece or two of good news to really set this stock on fire.

I consider MNKD a strong buy under $6 and a buy under $9.
 

Vor ein paar Tagen in den hr3 Nachrichten : Sanofi sucht im Raum Frankfurt neue Mitarbeiter im 3-stelligen Bereich um dort ein "neues" Diabetesmittel herzustellen. Der Name des Mittels wurde nicht genannt.

Bin hier seit Jahren investiert und möchte mich bei Euch für die fundierten Infos bedanken!  

Interessant, Afrezza wird in ein paar Jahren weltweit das Mealtime Insulin der Wahl, und ich freue mich schon Leute fröhlich den Miniinhalator zu benutzen ob beim Baden, im Stadion, in der Arbeit, im Restaurant....anstatt sich auf dem WC zu spritzen, Unterschied wie Tag und Nacht!  

Italien spricht schon vom revolutionären Afrezza, geil:

http://us.lrd.yahoo.com/....it/2015/01/28/tecnosfere-afrezza-diabete/  

aktuelle Erbebnisse, sensationell:

https://us.lrd.yahoo.com/...71039/**https%3A//twitter.com/afrezzauser  

hallo ellogo, bin gerade auf die Aktie von dexcom gestoßen weil ein Diabetiker die Nutzung von dexcon in Kombination mit afrezza als hervorragend beschrieb,

dexcon stellt Geräte her mit der man dank eines Chips am Körper den Blutzucker ohne Einstich messen kann, dachte das sei eigentlich noch nicht am Markt,

damit könnte das (unglaubliche) echt Realität werden, nämlich dass Diabetiker weder zum Messen noch für das Insulin mehr Spritzen oder Stechen müssen, diese Kombination würde verdammt viel Freiheit bedeuten muss ich mal sagen!!!

http://www.dexcom.com/de

http://www.comdirect.de/inf/aktien/detail/...amp;ID_NOTATION=11672337

 

Stimmt, die kontinuierliche Blutzuckermessung ist ne feine Sache, aber durchaus schon bekannt.

Deine Behauptung, dass es ohne Einstich misst, ist nicht ganz korrekt.
Der Patient muss die Sonde in die Haut stechen.
Aber ist sicher angenehmer, als sich täglich mehrfach in den Finger zu pieksen.  

Afrezza is now available in certain US pharmacies. The product is provided in packs of 90 doses for 30 days supply at a price of USD ~270-334. (Close Concerns, ?29 January 2015)
Comment: Afrezza comes in two dose strengths: a 10 U (blue) cartridge and a 20 U (green) cartridge, equivalent to ~4 U and ~8 U of injected insulin, respectively. The 30-day supply packs contain two Dreamboat inhalers and three different combinations of dose strengths. The monthly cost of Afrezza is slightly below or similar to oral DPP-4 and SGLT2 inhibitors. Compared to injectable prandial insulin analogues in prefilled devices, Afrezza is priced at a 80-160% premium per unit.

Sanofi positions Afrezza as mealtime therapy for add-on to OADs in T2DM
The primary target group for Afrezza is T2DM patients suboptimally treated due to reluctance to initiate or intensify injectable therapy. The product is approved for the treatment of adult patients with T1DM or T2DM, however with several limitations of use including contraindications in patients who smoke and patients with asthma or COPD.
Sanofi estimates a potential patient base of ~3 million in the US. Afrezza has an ultra-fast PK profile with time to peak plasma concentration of ~12-15 min. Promotional messaging focuses on the small size and simplicity of the Dreamboat inhaler, distinctly different from Pfizer's Exubera which was withdrawn from the market in 2007.

Post-marketing trials for label updates to be initiated in 2015
Afrezza's label contains efficacy data on its use as add-on to OADs in T2DM, but not as add-on to basal insulin. The AFFINITY-2 trial of Afrezza added to OADs showed a modest HbA1c change of -0.4% vs placebo. Post-marketing requirements include a 5-year outcomes trial in T2DM patients (n=8,000-10,000) to evaluate the potential risks of lung cancer and cardiovascular disease, and the long-term effect on pulmonary function. Following inlicensing Afrezza from MannKind in August 2014, Sanofi is responsible for all commercial, regulatory and development activities. Regulatory submissions in other countries may follow the US launch.
 

www.afrezza.com jetzt online!  

Afrezza, offizieller Launch:

http://us.lrd.yahoo.com/...lin-now-available-in-the-us-20150203-00013  

Was ist das für eine Webpräsenz.

Da steht doch nur, wann man Afrezza nicht einnehmen darf.

Ob das schlau ist, soviel vor dem eigenen Produkt zu warnen  

Das ist eine normale Pressemeldung, Werbung für Afrezza wird ganz anders ausschauen!
Allein die sozialen Medien mit Facebook, Twitter.... werden Afrezza sehr sehr bekannt machen wenn die Diabetiker begeistert sind!