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Manipulation by buying and selling to each other in PM is the most effective way to drive the share price down to create panic selling when market opens. Those living west coast having stop loss orders will be wiped out.
Why not? This is WS and this is why these analysts are hired for.
Bought more at $6.05 during pre-market. Shorts are getting crazy and desperate now.
And Google community
https://plus.google.com/u/0/communities/117562736659257887090/stream/8788aa3a-93f6-422e-9416-ed8874540b3b
That's what I have been trying to.
You should have set a sell when pps was above $7.
I am setting a BUY now and sell it back when it hit high.
Thanks Frosr6. Looking forward to the data in coming weeks.
I mean how long it take for this new prescribed drug to be refilled.
Let's say if there is 30 cartridges per pack and 3 cartridges per day, patient would have to refill within 10 days, i.e. RRx data should show up in between week 2 & 3, right?
I have no idea of the usual quantity a patient orders. Anyone?
Thanks. So when should we expect RRx for the prescriptions of week 1?
Weekly Total Rx = New Rx + Refills for the week.
My question is " Does the column of New Rx data reflect any new Rx or does the Total Rx give us any data of Refill Rx at all after subtract the New Rx data?" because as I look at the table, the Total Rx always has the same number of New Rx each week.
Am I reading the table right?
Why data is not covered for Feb 14-15?
Thanks. My suggestion is based on the assumption that SNY will market Afrezza as a complementary drug for diabetic treatment. If that is the case, we may see some kind of bundle sale arrangement (or recommendation) by SNY sales rep and as such, prescriptions of both drugs may have meaningful correlation, should patients see the benefits of having both as their treatment.
Just saying ...
Is It a Viable Suggestion that IMS Data Table be Expanded
to include that of Toujeo so that we can observe closely how both prescriptions correlated in order to make more meaningful sales projection for Afrezza in the future?
Just my 2 cents.
FDA approval of once-daily basal insulin Toujeo
Paris, France - February 26, 2015 - Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL), a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. Toujeo is expected to be available in the U.S. at the beginning of Q2 2015.
http://www.bioportfolio.com/news/article/2242359/Sanofi-Receives-FDA-Approval-of-Once-Daily-Basal-Insulin-Toujeo.html
What else may likely be happening in Q2 2015?
1) Additional 2 lines for manufacturing Afrezza will be up and running
2) FDA Approval of 12 Unit cartridge
SNY will be marketing Afrezza with Toujeo together as a premium diabetic treatment in the near future!
MannKind Corporation in Transition
By Motley Fool, February 25, 2015, 12:30:23 PM EDT
With one drug that just launched and plans to develop more in the works -- but not in the clinic yet -- MannKind is in a state of transition.
The biotech's inhaled insulin, Afrezza, launched earlier this month, so there weren't any sales in the fourth quarter to report. And on the conference call, management was understandably coy about the launch; it's hard to give an update on a two week-old launch especially since its partner Sanofi is in charge of sales and marketing.
MannKind earned two $25 million milestone payments associated with meeting obligations to manufacture commercial product. You can add those pre-launch milestones to the $150 million signing bonus as a sign of Sanofi's confidence in the drug-device. At the very least, the profits from Sanofi's 65% stake in Afrezza have to cover that $200 million.
There is another $725 million in potential milestone payments left to be earned. As most biotechs do, MannKind hasn't disclosed exactly what the thresholds for earning the milestones, but much of the remaining amount is probably tied to sales, so it's more of a profit sharing than an endorsement in Afrezza's potential since Sanofi won't have to pay it out if Afrezza is a flop.
MannKind is making progress toward getting a 12 unit cartridge approved by the FDA, which will be more convenient for patients that need more insulin; to get 12 units of insulin right now, patients have to take two puffs: one four-unit cartridge and one eight-unit cartridge. It's an incremental good sign, along with plans to triple the manufacturing capacity next quarter.
Sales still matter, though, and we won't get the first sales numbers until first quarter earnings reports in April or May.
Next drug(s)
MannKind has plans to develop other products using Technosphere, the inhalation technology that makes Afrezza possible, but still hasn't disclosed plans beyond announcing that the drugs will be used for pulmonary disease, pain, and oncology support.
Given its limited resources -- MannKind ended the year with $120 million, not including the aforementioned $50 million from Sanofi -- and profits from Afrezza joint venture unlikely for the immediate future, MannKind plans to start initial work on one target at a time. That seems like a prudent move; let's just hope the next drug doesn't take as long to develop as Afrezza did.
Like insulin, MannKind is looking for drugs that have been on the market for awhile so their active ingredients are no longer covered by patents but that could use an improvement in rate of onset and/or the convenience of being inhaled -- both things that Technosphere can offer.
There's also potential to use Technosphere for drugs still covered by patents under an agreement with the companies that developed the drugs. Management hinted that it was exploring the possibility, but wasn't under liberty to disclose the potential partners just yet.
For the record, MannKind lost $198 million in 2014, slightly more than it did in 2013. None of that will matter if Afrezza is a success and MannKind is able to bring a second drug to market.
http://www.nasdaq.com/article/mannkind-corporation-in-transition-cm448468
How is "cash flow positive inside of their partnership" interpreted? Anyone here can shed some light? Does it imply upfront / milestone payments can be realized only when there is profit generated and distributed from selling Afrezza after taking relevant expenses incurred by Sanofi?
I already feel the heat, the passion of longs and diabetes. Glad I loaded up more at $6.50 yesterday morning.
MannKind Is Tripling Production To Meet Future Demand
Summary
MannKind and Sanofi's Afrezza has been on the market for two weeks.
Demand for Afrezza sample packages blows past expectations.
MannKind is set to triple manufacturing in Q2, 2015.
When will Afrezza materialize into profits for MannKind?
MannKind (NASDAQ:MNKD) recently released its Q4 and FY2014 earnings report and conference call. In my opinion it was as good of news as one could have hoped for MannKind. Anyone who was being a realist knew that MannKind would not come out and give us any direct sales numbers from Afrezza. If they did so at this point in time, the figures would probably be disappointing as a few weeks on the market is not enough time to create an impact. A good amount of people who have diabetes will need more than two weeks time just to make an appointment, let alone go through the tests necessary to be prescribed Afrezza. Hakan Edstrom did leave us with an idea of how strong the potential is there for a strong year, and even stronger future.
Afrezza Should Have Significant Sales Beginning Late FY 2015
No matter how much good news Afrezza has brought the company so far, none of it really matters until Afrezza can turn into a source of revenue. Sanofi (NYSE:SNY) and MannKind decided to do a slow rollout of the product since it is a new technology, and doctors will need to be educated on the drug before they are likely to prescribe it to patients. This is all stuff everyone has read before, but the conference call had some juicy information for MannKind bulls.
First off, when giving a round up of Afrezza, MannKind's CEO Hakam Edstrom, stated that Sanofi has been in touch requesting more sample packages as samples have blown past expectations. This tells us that word is getting out about Afrezza without any large marketing strategies directly to diabetes patients. This is good news because this presumably means the companies will have to spend less money on marketing and when they do market, diabetics will be largely accepting of Afrezza.
Secondly, Edstrom also noted that MannKind is ramping up production in Q2 2015, and this will triple their current output of insulin. This should be taken as the best news from the conference call! Sanofi and MannKind would not be tripling production of insulin if they did not have reasonable beliefs that they will be needing large supplies of insulin in Q3 2015, and later.
The two bits of information above were easily the most bullish points about MannKind, regarding Afrezza. Using these two tidbits of information, one can infer the MannKind and Sanofi both predict prescriptions of Afrezza to rapidly increase in Q3/Q4 2015. This will only continue to become more rapidly available to everyone in 2016 when lower-cost insurances will presumably cover the drug as its benefits are more highly known and studied. One benefit for insurance companies to cover Afrezza is that it will cause less hypoglycaemia events needing ambulatory or emergency room care, which can cost an insurance company a couple thousand dollars each event.
Also, working in favor of MannKind is the Affordable Care Act. This allows lower-income citizens to receive health care at an affordable price. This could be huge; Afrezza has many new diabetics being prescribed insulin will not want to inject themselves, if given the choice of simply inhaling instead. Along with the superior activity of Afrezza, it should not surprise anyone if doctors push Afrezza to patients just beginning to take insulin for their diabetes. More universal health insurance to the lower class may also help Afrezza sales because many of them could have diabetes now, but simply can not afford to go to a doctor, or to be treated. Many lower-income families do not have the availability to fresh and quality foods, making their class one of the most likely to be diabetic due to poor eating habits.
At this point I can only see one argument from a bear's point of view. Will people, and more importantly insurance companies, give Afrezza a chance? Once a user tries Afrezza, there is no doubt, from information provided by current users of Afrezza, that they will feel better and love the new drug. But, often times with people, and Americans specifically, we have the attitude of "if something isn't broke, why fix it?" It could be this type of attitude that hurts Afrezza sales in the beginning.
http://seekingalpha.com/article/2949156-mannkind-is-tripling-production-to-meet-future-demand
MannKind's Accounting Is 'Murky,' MLV Analyst Says
MLV & Co. commented on MannKind Corporation following the company’s Q4 earnings report. The firm maintained a Hold rating and $7 price target.
Analyst Arlinda Lee noted that the company reported in line results but looked for data on NRx and TRx for Afrezza, as well emerging products in the pipeline, to be near-term catalysts for the stock.
Lee commented that the Afrezza inhaled-insulin product had only been on the market two weeks and that “impediments to the uptake of Afrezza include physician re-education and the necessity for prospective patients to make an appointment with a doctor for a pulmonary function test.”
The analyst note highlighted the company’s accounting and described it as “murky.” Lee explained that until the company’s profit-sharing partnership with Sanofi SA (ADR)
SNY 0.03%
becomes cash-flow positive, MannKind is unable to book upfront milestone revenues.
Lee thought investors should not expect to see revenues on the P&L until 2016 due to the accounting rules and limited availability of information on the product launch.
The company did mention the possibility that SNY, due to its reporting schedule, may disclose Afrezza sales earlier than MannKind.
Investors would receive more information as "early activity from the profit-share, including the recently earned $50 million in milestones, will be booked on MNKD's balance sheet, with some clarity on sales, profits or losses to be provided via MD&A disclosures in SEC filings,” according to Lee.
The $7 price target was based on a sum of the parts probability-weighted discounted earnings analysis. The firm expected fiscal 2015 to result in a loss per share of $0.28.
http://www.benzinga.com/analyst-ratings/analyst-color/15/02/5273657/mannkinds-accounting-is-murky-mlv-analyst-says
I must have missed this article. May I know when it was released?
MannKind Corp. US56400P2011
Frankfurt
6.225 (last price) up 0.335 or 5.69%
16/02/15 (Date)
6.147 (bid) 6.247 (ask)
39.08% (perf. 1 month) 28.54% (perf. 3 month) 53.89% (perf. 1 year)
7,979.58 (turnover in euro dollar)
1,000 shares traded only and has no significance to US, imho.
http://www.boerse-frankfurt.de/en/equities/mannkind+corp+US56400P2011
Thank you very much for the update. Very informative indeed.
MNKD mattress has the strongest springs
Maybe the immediate impact was 500K shares traded at $7.50 when ask was $7.30 at 11:34:24 this morning!
Exclusive: BlackRock to ramp up impact investing
BY JESSICA TOONKEL
Mon Feb 9, 2015 10:36am EST
(Reuters) - BlackRock Inc (BLK.N) is planning an array of new investment products that will allow clients to invest in addressing large societal issues, such as global hunger or poverty, an executive at the New York-based firm said.
BlackRock was set to announce on Monday a new initiative, called BlackRock Impact, to bring together its existing offerings that help clients invest in products with environmental and societal goals, as well as introduce new products, Rich Kushel, chief product officer and head of strategic product management group, told Reuters.
BlackRock has tapped Deborah Winshel, the former president and chief operating officer of The Robin Hood Foundation, to oversee the initiative.
Winshel, who begins her new role March 2 and will report to Kushel and BlackRock CEO Larry Fink, will work with BlackRock's portfolio managers globally to develop portfolios and tools to meet client demand and societal issues.
Impact investing is not a new concept to Wall Street. A number of firms, like Goldman Sachs (GS.N), and Bank of America's (BAC.N) Merrill Lynch unit are involved with social impact bonds that address a specific need, like reducing recidivism at a state prison, while bringing returns for investors.
BlackRock is looking at ways to make impact investing more scalable to address a range of issues.
"What if you wanted to drive outcomes like poverty elimination or hunger elimination or the development of medicines?" Kushel said. He declined to elaborate on the products, but said he expects them to be launched "in the very near future."
BlackRock, with $4.65 trillion in assets under management, already has an array of funds and tools for clients looking to invest in a socially responsible way. For example, the world's largest asset manager manages more than $220 billion in values based mandates, which use screens to exclude securities based on clients' values.
Additionally, the firm has a suite of environmental, social and corporate governance-related products. In December, the firm launched the iShares MSCI ACWI Low Carbon Target Exchange-traded Fund (CRBN.P).
Winshel will also lead BlackRock's global philanthropic program.
http://www.reuters.com/article/2015/02/09/us-blackrock-impact-exclusive-idUSKBN0LD18W20150209?feedType=RSS&feedName=topNews&utm_source=twitter
Let's see if MNKD would be one of their targets.
Sounds good to me. Maybe we should expect more reports from institutional investors in the coming weeks.
Upgrade to the Nasdaq? Did the management mention or make any application yet? I would be great but it's gonna take some time to get approval, right?
I should have waited at least 2 more days before pulling my trigger and since this is a small investment here for me, so I just set the buy order at 0.229 and got filled to my surprise. GLTU
I am looking to buy a bit more at 0.200 - 0.205 level, if it ever reaches there.
I just bought back (at 0.229) the shares I sold at 0.3228.
Welcome Afrezza – Inhaled Insulin Gets Real!
Take a deep breath, Friends: the world’s first (seemingly) commercially viable inhalable insulin product is here. Today, Sanofi has officially launched MannKind’s long-awaited Afrezza, and we hear the product is already appearing in some pharmacies nationwide. Housed in a tiny, handy inhaler device, Afrezza is said to bring not only convenience, but also some new medical benefits to the world of rapid-acting insulin.
“I don’t know if it’s gonna be a blockbuster, but I do think it’s gonna have a niche,” says Dr. Steve Edelman of UC San Diego and TCOYD (a type 1 himself), who was one of the lead investigators on Afrezza clinical trials.
“I can say it has been shown in clinical trials to reduce hypoglycemia, but FDA won’t let (Sanofi) put that in the labeling. I was at the FDA public hearing in Washington, DC, and they spent all the time trying to refute the data instead of trying to understand it… It’s just a total shame FDA didn’t allow them to put that benefit in the label.”
“Afrezza really does work extremely well. I can see myself taking it for incidental hypers where subcutaneous insulin is way too slow and stays around in your system way too long,” he adds.
Whoa… aside from the obviously enormously superior design of the inhaler device itself over the previous Exubera fiasco, we’ve been skeptical about the practicality of Afrezza. After all, it’s just for prandial dosing, so even most type 2s would need a shot a day of long-acting insulin to complete their therapy, right? And how precise can inhaled dosing possibly be? Plus, it’s hard to get your head around how this stuff reduces hypoglycemia. Last not least, there are the issues of pricing and insurance reimbursement.
Read on… and please don’t miss the product Q&A at the end of this post.
Fewer Hypos
Edelman was kind enough to share with us a bunch of research data directly from his published review showing evidence of Afrezza’s edge over fast-acting Humalog insulin on core measures including pharmacokinetic (PK) and pharmacodynamic (PD), and GIR, or glucose infusion rate (the amount of glucose needed to counteract the insulin).
The bottom line is that Afrezza appears in the bloodstream faster and gets out quicker, so it’s much more likely to be peaking when your carbs are forcing a glucose spike, and to be out of your system rapidly enough to avoid lingering lows.
That’s why Edelman thinks Afrezza will be great for correction doses, even just a few hours after meals – you can bring down highs quickly without the risk of stacking insulin.
btw, for type 2 users who may not need it, it’s not requirement to be using a basal insulin alongside Afrezza, he says.
And the kicker: you also don’t gain as much weight as you may with subQ insulin, Edelman adds. Now those are some real-world advantages!
Check out this video of Dr. Edelman discussing – and using! – Afrezza:
https://www.youtube.com/watch?v=TkJ10Nq1xmM
Clearer Dosing?
Stefan Schwarz, Sanofi’s US Afrezza Lead, tells us that the whole system of dosing is much improved too.
“A dose of Exubera was not expressed in equivalent measure to subcutaneous units. Afrezza is equivalent, and has linear dosing, so an 8-unit cartridge is the same as two cartridges of 4 units.”
But given those set dose sizes of 4 or 8 units, it’s still murky to us how physicians will know to set dosing, i.e. for a large versus a small meal (assuming precise carb-counting doesn’t come into play here)? The company’s official response:
“Physicians should adjust dosing based on a person's metabolic needs, blood glucose monitoring results and goals for glycemic control. Physicians may also need to adjust the dosing based on changes such as a person's level of activity or meal patterns, such as nutrient content or timing.”
OK, can’t wait to see that in action.
Who’s Eligible?
Contrary to what’s been stated in some media coverage, FDA approval is for all adults with both type 1 and type 2 diabetes. Of course patients can’t have any “contraindications” that would compromise their lungs, like COPD or asthma, or if you’re a smoker, you’re out. (See Prescribing Info, PDF)
It is not yet approved for pediatric patients, but Sanofi says it’s actively working with FDA to define the protocol for a study in children.
Interestingly, every patient who wants to get approved for an Afrezza prescription will first have to take a lung test called FEV1 (Forced Expiratory Volume test), Edelman tells us. Despite the scary name, it’s a simple breath test doctors can do right in the office, if they have the machinery.
Edelman says most primary care physicians do have an FEV1 device right in their office, but he doesn’t know any endos who have one.
“It’s not expensive, and it’s a big improvement over the Pulmonary Function test you had to get before prescribing Exubera – which was expensive and required patients to go to a special lab… Who knows? Maybe Sanofi will start providing (FEV1 tests) to doctors?” he adds.
Who Will Want Afrezza / “An Unmet Need”
While it may be hard for most of us type 1s to imagine patients flocking to Afrezza as they run screaming from needles, apparently there is quite a large segment of PWDs who could really benefit -- type 2s on oral drugs who still qualify as “uncontrolled” and those on basal insulin who need it, but are just not yet willing to add mealtime insulin shots, according to Sanofi’s Schwarz.
Leading endo Dr. Edelman agrees. “Resistance to taking insulin is PERSISTENT. I see so many patients who just won’t take it – even one military vet who’s been shot at, says to me, ‘you could shoot me through the head before I take that injection,” he says.
Well, there’s some great anecdotal evidence that this easy-to-use no-needles product indeed fills an “unmet need.”
Availability and Cost
This is where the big controversy lies, it seems: will enough people be willing to pay for it? Of course, as a new drug Afrezza won’t be covered by many insurance plans at launch, and at a “tier” with higher copays for those that do.
Sanofi’s Schwarz wouldn’t offer pricing details in advance of shipping, but says Sanofi will have tools in place to help patients in need access the drug, including copay cards.
We did some of our own informal research by calling our local Walgreens, CVS and Kroger pharmacies and were told that they don’t yet stock Afrezza on their shelves, but if you can obtain a doctor’s prescription, those pharmacies can order it for you now from a nearby distribution center, which usually fill orders in just 24 hours.
CVS wasn't hip to sharing prices without an Rx, but Walgreens and Kroger both quoted a cost of $334 out-of-pocket cash price for a box of 30 4-unit cartridges + 60 of the 8-unit cartridges.
We also checked with insurer Anthem BCBS that currently pays 50% of our insulin costs; they would do the same for Afrezza, they say, so our price would be $130.80 for a box of 60 of the 4-units that should last a month. So yes, it’s comparable to our current insulin prices – and even potentially a bit less than what many pay for a month's worth of Humalog or Novolog currently.
A well-known investor-blogger over at Seeking Alpha notes that “cost conscious insurers often wait for a year after a product is launched to cover it.”
User Chronicles
Some of you may have already discovered the blog and twitter feed of Sam Finta (@afrezzauser), a type 1 who took part in Afrezza’s clinical trials and participated in the FDA Advisory Committee hearing for the product.
“My experience says it’s definitely a ‘life changer’ and my observation is you’ll never go back to your old regimen,” he writes.
As Seeking Alpha noted, bloggers are going to be key for this product, as “word of mouth will do what no amount of paid pharmacy reps can do!” Amen to that.
PRODUCT Q&A
On that note, we had some very specific questions from a day-to-day user perspective, submitted to Sanofi’s Schwarz. Here’s what we learned:
DM) Can the inhaler/device be recycled?
SS) No, the inhaler should be discarded after 15 days of use and replaced with a new one to maintain drug delivery.
Can the insulin cartridge be recycled?
No, used cartridges should be discarded in the regular household trash. You can tell when a cartridge is used, the white cup has moved to the center of the cartridge.
How much insulin in one puff on the inhaler? Is one unit one puff?
Cartridges come in two dosing strengths, 4 units (.35 mg of insulin) and 8 units (.7 mg of insulin). One cartridge is one dose administered with one inhalation. For patients who require doses exceeding 8 units, patients may use a combination of 4 unit and 8 unit cartridges.
How will a patient know that they've inhaled the whole puff?
Patients are able to deliver their full dose with a normal inhalation.
What sort of container or carrying case will be provided? i.e. how will patients carry Afrezza around?
Afrezza is available as 4 unit and 8 unit single-use cartridges. Three cartridges are contained in a single cavity of a blister strip. Each card contains 5 blister strips separated by perforations for a total of 15 cartridges. Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package). The perforation allows users to remove a single strip containing 3 cartridges, which can be carried in a pocket or a purse.
At this time, there is no manufacturer carrying case for the inhaler. Third-party companies often design and offer those. And we continue to evaluate patient needs to determine if any additional support here should be considered.
Disclaimer: Content created by the Diabetes Mine team. For more details click here.
http://www.healthline.com/diabetesmine/welcome-afrezza-inhaled-insulin-gets-real#1
I bought back at $6.31, 6.32 yesterday & 6.45 today. Still looking for re-entry point.
Yes ... ART I read about it. I am currently holding a small position. GLTA.
Why it's up? Any good news is being expected?
Ultra Rapid-Acting Inhaled Insulin Afrezza Now Available in some US Pharmacies
Sanofi and MannKind's ultra rapid-acting inhaled-insulin Afrezza for type 1 and type 2 diabetes is now available in some US pharmacies! Though Sanofi has not officially announced its availability, Afrezza can now be picked up at retail outlets like CVS and Walgreens – we’d note that a special pharmacy order may be required, meaning you can pick it ~1-2 days after you turn the prescription in.
From speaking with pharmacists, it seems that Afrezza’s cash price costs are comparable to those of Novolog and Humalog insulin pens; it’s still unclear how much patients with insurance will need to pay for Afrezza. Given Sanofi’s expertise in selling insulin, we assume pricing will be patient-friendly.
We’ve been monitoring the twitter feed of Sam Finta (@afrezzauser), a type 1 patient who took part in Afrezza’s clinical trials and participated in the FDA Advisory Committee hearing for Afrezza, to hear his experience in these early days. The word so far is certainly very positive and we expect the product’s ease of use will appeal to doctors and nurses too. Afrezza could be an especially good option for type 2 patients that are not achieving their goals on pills, as well as any patient that dislikes injections, those struggling to manage mealtime blood sugars, and those who experience lots of hypoglycemia after meals. The inhaled insulin only comes in two sizes right now, equivalent to 4- or 8-units of injected rapid-acting insulin; it will be interesting to see how it is used in type 1. [Some may choose to use it for particularly high carb meals or to correct a very high blood sugar.] For more on Afrezza, please see our coverage of its FDA approval and partnership with Sanofi.
Kelly Close is on the scene covering the Afrezza news, check out this video below of Sam Finta using Afrezza!
http://diatribe.org/ultra-rapid-acting-inhaled-insulin-afrezza-now-available-some-us-pharmacies
Shantha Biotechnics, a Sanofi company, will set up a `460-crore manufacturing facility
SHANTHA TO SET UP `460-CR FACILITY
METRO NEWS / HYDERABAD : Shantha Biotechnics, a Sanofi company, will set up a `460-crore manufacturing facility where Insuman, a human insulin product from Sanofi's range of diabetes treatment will be manufactured. Sanofi will make an investment of `460 crore in the facility. This will be Sanofi's second plant apart from its existing Insuman manufacturing plant in Frankfurt. The construction of the 13,400 square-metre building will begin immediately, with the site fully operational by 2019.
Harish Iyer, CEO, Shantha Biotechnics said, “For the first time, we will be able to manufacture insulin – in cartridges here. The new high technology facility will benefit from our existing biotechnology production expertise. This state-of-the-art facility will have the capability to ramp up manufacturing volumes to 60 million Insuman cartridges per year, within two to three years of commercial manufacturing.”
Shailesh Ayyangar, managing director - India and vice president - South Asia, Sanofi said, “The technology transfer and a successful collaborative effort within the Sanofi Group, underline our commitment to investing and ‘making in India’. Many more diabetic patients in India can have easier access to better disease management and quality of life post completion of the facility.” Type 2 Diabetes is a prominent Non Communicable Disease. Globally, diabetes afflicts close to 382 million people with India alone accounting for over 65 million cases.
The number of people with diabetes in India is expected to rise to 109 million by 2035. Out of the estimated 42 million patients on insulin in India, 3.3 million patients are prescribed Regular Human Insulin for diabetes management and control. The production of Insuman in this facility is expected to meet local and international demand.
http://metroindia.com/Details.aspx?id=60537
Hyderabad-based Shantha Biotechnics, a subsidiary of French pharmaceutical company Sanofi, is setting up an insulin manufacturing plant at an investment of Rs 460 crore near here. The plant is expected to be operational by 2019.
The facility will manufacture Insuman, a human insulin product from the portfolio of Sanofi’s diabetes treatments. This will be the French global pharma major’s second Insuman manufacturing plant in the world. Chief minister K Chandrasekhar Rao today laid the foundation stone for the plant. The project is coming up in his home constituency of Gajwel in the neighbouring Medak district.
KI Varaprasada Reddy, founder and chairman of Shantha, said this would be a new technology facility where insulin would be manufactured in cartridges. According to him, it has a capacity to ramp up manufacturing volumes to 60 million cartridges a year in 2-3 years of commercial manufacturing. The cartridges manufactured in this plant will be priced at Rs 11 per day. Sanofi India launched Insuman cartridges in 2011.
Sanofi Pasteur Holding acquired Shantha in 2009 as the homegrown vaccine maker’s products complement the former’s portfolio. Four of Shantha’s licensed vaccines, including pentavalent vaccine (Shan5), are WHO-qualified. Further, Sanofi Pasteur and Shantha are also developing a new paediatric combination vaccine based on Shan5 paediatric vaccine incorporating Sanofi Pasteur’s inactivated polio vaccine in order to secure polio eradication, according to the company.
http://www.business-standard.com/article/companies/sanofi-subsidiary-to-set-up-rs-460-cr-insulin-manufacturin-facility-in-telangana-115012901055_1.html
Over 47,437 views thus far.
Took some profits at $6.65, 6.62 & 6.60 by selling 15% of my holding this morning.
Does that lead to general hospitals in the US will also use Afrezza soon as well?
Watch MannKind Closely, A Short Squeeze Could Be Nearing
Summary
MNKD achieves milestone payment of $50M.
Al Mann steps down as CEO with company at a jumping off point.
With 33% of float short and the stock compressed, a squeeze isn't out of the question.
By Parke Shall
Our last piece on MannKind indicated that we may have been losing patience with the speed in which the company was conducting the rollout of its inhaled insulin product, Afrezza. Before that, we wrote about MannKind (NASDAQ:MNKD) a couple of months ago, where we asked the question of whether or not a short squeeze was possible. We talked about the appeal of going long stocks that are heavily shorted and we concluded that we'd continue waiting for more price compression before considering MannKind as a long investment.
Since then, the price has been compressed and we think the short squeeze thesis is back on the table. As you can see, even with the price compressed, the short interest in MNKD has steadily climbed over the past 12 months. We believe that this has to reach a tipping point, and with MannKind's recent developments, we believe the company could be close to flushing out some shorts.
The company's short interest is still massive, with about 33% of the float held short. With recent milestones, we believe a short squeeze could once again be in play for MannKind.
If you recall, the company earned $50M from Sanofi last week as a product of their agreement and Afrezza manufacturing metrics. There's still $725M that can be brought in, in the form of other milestones for sales and regulatory achievements. As many investors already know, MannKind will be entitled to part of the profits from Afrezza, as well. As these items unfold, the top line at MannKind should see a boost.
With MNKD seemingly able to fly on its own at this point, 88 year old billionaire Al Mann has stepped down from the company's CEO role and is transitioning the position to Hakan Edstrom, who is currently the President of the company. A copy of that press release is available here.
With a $2.19B market cap, we believe MNKD to be a bit less overvalued than it was months ago when we spoke about our initial short term doubts about the company's performance. For us, the concept of Afrezza always seemed like it had long term potential for success, and we continue to believe that story. With Mr. Mann stepping down from his role and the company achieving the first of hopefully ((OTCPK:MANY)) milestones, we believe that MNKD could be finding itself at a jumping off point.
With the stock compressed as much as it has been over the last year, and the current short interest, any further traction from MNKD could potentially ignite the match that incites a short squeeze. If you're looking for some exposure to biotech that's a bit less risky than speculative companies without FDA approval, MNKD could be a nice company to consider.
We continue to emphasize our point that the MannKind/Sanofi deal could potentially be a long-term success. We have no position in MNKD, but we are reassured by the company's $50M award. In order to consider a potential investment, we'd like to see continued signs of strength from the top We'll continue to keep a close eye on the company moving forward.
http://seekingalpha.com/article/2816355-watch-mannkind-closely-a-short-squeeze-could-be-nearing
Update: A Dangerous Time To Be Short MannKind
by Trevor Lowenthal
Summary
Last week, MannKind announced that it received a $50 million milestone payment from Sanofi.
I reiterate my bullish thesis on MannKind.
As expected, MannKind is positioned for the Q1 2015 launch of Afrezza. There is a significant short position, but optimal uptake of Afrezza could trigger a short squeeze.
Last year, I took a lot of heat from long investors for writing a bullish article on MannKind (NASDAQ:MNKD) with a thesis stating that FDA approval of Afrezza was already priced into the stock. Shortly thereafter, I wrote a second article expressing my concerns about the risks of going long on MannKind well before the Q1 2015 launch of Afrezza - at a time when the stock traded at a 50 percent premium. Last week, however, we learned that MannKind received a $50 million milestone payment pursuant to the terms of the partnership with Sanofi (NYSE:SNY). While this event was anticipated by shareholders, I believe it marks the beginning of a positive year for MannKind as we head closer to the Afrezza launch. As a result, I reiterate my bullish thesis.
Some key highlights from MannKind's latest announcement are as follows:
[MannKind] earned a total of $50 million in milestone payments in connection with the satisfaction of manufacturing milestones specified in its collaboration and licensing agreement with Sanofi.
Pursuant to the agreement, MannKind previously received a $150 million upfront payment.
[The company] is eligible to earn up to $725 million in further development, regulatory and sales milestones, and is also eligible to receive a share of profits on sales of Afrezza.
While there are significant risks to MannKind through the Afrezza launch this quarter, I believe they are largely reflected in the current stock price. After all, it is important to remember that the stock traded around $10 before Afrezza even received FDA approval. This warrants my belief that any positive development, namely optimal uptake of Afrezza, should trigger a significant uptrend. Moreover, I believe the potential for a significantly higher stock price is amplified by the fact that there remains a substantial short interest (78,755,843 shares) in MannKind, with roughly 20 days to cover as of writing. Thus, I suspect any positive development could trigger a short squeeze, prompting my conclusion that shorting MannKind does not seem to be an advisable investment strategy. On the other hand, considering many analysts project Afrezza to generate over a billion in annual revenue, I believe the best way for an investor to capitalize on any potential upside is through purchasing a long call option.
http://seekingalpha.com/article/2812645-update-a-dangerous-time-to-be-short-mannkind