Al "I can't comment on that, but stay tuned." could mean MDT, SNY may acquire 5% MNDK stake. As Al's retirement gift, Mnkd may announce MDT partnership too.
1/12/15 MNKD short interest goes down from 78,755,843 shares to 75,654,134. Days to cover from 22.07 to 18.15.
How Is Afrezza Supplied?
Afrezza is available in 2 strengths: 4 units (blue cartridge) and 8 units (green cartridge), both dispensed in foil packages:
• Each package contains 2 blister cards, with 15 cartridges per blister card (total of 30 cartridges). Patients will tear along a perforation, remove a strip (3 cartridges per strip), press on the individual cartridge to remove it from the strip, and insert the cartridge into the inhaler for use.
• If a patient requires mealtime insulin before 3 meals per day, then 1 strip will be used per day; however, if a patient uses fewer than 3 cartridges per day, any cartridge left on an open strip must be used within 3 days.
Alternatively, if the prescribed dose is greater than 8 units per meal, then the patient will need more than 1 cartridge. For example, if a patient requires 12 units before a meal, then 1 blue cartridge plus 1 green cartridge, with the same inhaler, will be used.
All cartridges (whether in blister packs or those on the strip being used for that day) should be kept refrigerated. However, cartridges and the inhaler should be at room temperature for 10 minutes before use.
Patients do have the option of keeping sealed blister cards and strips at room temperature; however, all of the cartridges must then be used within 10 days.
The Afrezza inhaler can be kept refrigerated or at room temperature in a clean, dry place but should be replaced after 15 days of use (use a calendar to keep track). The outside of the inhaler can be wiped with a clean, dry cloth if needed, but should not be washed for any reason.
Afrezza is administered via oral inhalation using the Afrezza inhaler, as a single inhalation at the beginning of a meal. If a meal is skipped, then the dose is skipped.
Insulin-naive patients: 4 units before each meal
Prandial SC insulin users: convert 1:1
Up to 4 units: one 4-unit cartridge
5-8 units: one 8-unit cartridge
9-12 units: one 4-unit and one 8-unit cartridge
13-16 units: two 8-unit cartridges
17-20 units: one 4-unit and two 8-unit cartridges
21-24 units: three 8-unit cartridges
For doses 24 units, combinations of different multiple cartridges can be used.
Premixed SC insulin users
Determine the mealtime injected dose by dividing one half of the total daily injected premixed insulin dose equally among 3 meals of the day. For example, if a patient injects a premixed insulin at 25 units SC twice daily (total daily dose, 50 units), divide 25 units by 3, to equal 8 units before each meal. This patient can then use one 8-unit green cartridge of Afrezza before to each meal. One half of the total daily injected premixed dose is administered as an injected basal dose.
Calculating the insulin-to-carbohydrate ratios of each meal can help guide motivated patients with how much rapid-acting insulin to administer before a meal. Because Afrezza is an ultra-rapid-acting insulin with early PPG control, patients initially may benefit from performing self-monitoring of blood glucose at 90-120 minutes to see whether another inhalation might be needed.
Selected Warnings and Precautions
Several key warnings should be emphasized:
Afrezza is contraindicated in persons with chronic lung disease (eg, asthma, chronic obstructive pulmonary disease) because acute bronchospasm has been reported in these patients. Spirometry to determine FEV1 and thus identify possible lung disease is recommended at baseline, 6 months, and 12 months and then yearly. If FEV1 drops ≥ 20% from baseline, consider discontinuation. If a patient experiences persistent shortness of breath, wheezing, or excessive coughing, consider more frequent pulmonary function monitoring. If symptoms continue, discontinue Afrezza.
Avoid use in patients with active lung cancer, a history of lung cancer, or those at risk for lung cancer.
Afrezza is not recommended for current smokers or those who have recently stopped smoking.
Afrezza is pregnancy category C and should not be used during pregnancy unless potential the benefit justifies the potential risk to the fetus.
Actually, we are ahead of schedule. Hakan said we'd have 3 lines cert'ed in first half 2015. $25 M bonus per line. The 3rd one has been built out at the same time as the 2nd one. Its cert is in progress. St expected $25M bonus 1Q15. Thus, $50 M beat expectations. Expect positive St reaction today.
Danbury area companies to watch in 2015
One of several pharmaceutical companies in the Danbury area, Mannkind got a big boost this past year when the company received U.S. Food and Drug Administration approval for its Afrezza, an inhalable form of insulin under development by the company as its main product candidate. Matt Pfeffer, the chief financial officer for the company, said recently that the company initially expects to produce up to 400 million units of the drug, the only inhalable insulin on the market today with FDA approval. The company also expects to hire as many as 100 employees as it ramps up production. Pfeffer said the company could generate close to $4 billion in sales annually out of the Danbury facility.
Shares of MannKind (NASDAQ:MNKD) were the recipient of unusually large options trading on Friday. Stock investors acquired 18,929 call options on the stock, StockRatingsNetwork reports. This is an increase of 443% compared to the typical volume of 3,485 call options.
Shares of MannKind (NASDAQ:MNKD) traded up 8.15% on Friday, hitting $5.64. The stock had a trading volume of 5,728,617 shares. MannKind has a 52-week low of $3.80 and a 52-week high of $11.48. The stock has a 50-day moving average of $5.70 and a 200-day moving average of $7.0. The company’s market cap is $2.236 billion.
Covidien-Medtronic Deal Moves Closer to the Finish Line
David Maung/Bloomberg News
Medtronic Inc.’s $43 billion acquisition of Ireland’s Covidien PLC moved one step closer to the finish line Thursday. The medical-device makers announced that they received clearance for the deal from the Chinese Ministry of Commerce.
The acquisition has also been cleared by the South Korean Fair Trade Commission, and the companies say all the necessary antitrust hurdles have now been cleared.
Now, the next big step is the shareholder vote on Jan. 6th. As there’s no reason to believe shareholders will shoot down the deal, which is structured as a tax inversion, analysts now expect the merger to close in early January rather than late January.
Investors had been concerned that this deal would be one of the casualties of the Treasury’s crackdown on inversions in September. A few other deals have fallen by the wayside since then. AbbVie, for instance, called off its $54 billion acquisition of Shire PLC in October.
Sean McDermott, an analyst at Evercore/ISI group, said investors have been wary of betting that the Covidien-Medtronic deal would close since the Shire-AbbVie merger was terminated.
Investors shouldn’t be worried anymore, Mr. McDermott wrote. “We see less then a 5% chance there will be any change to the U.S. tax code between now and the close of the merger in the current lame duck congressional session and zero interest from the Republicans in cooperating with Democrats on this issue.”
Meanwhile earlier this week, Medtronic raised $17 billion in debt to finance the deal. The bond offering was the largest by a company so far this year.
Edstrom said they are currently working with a consulting firm to determine the very best applications to apply the Technosphere technology to next. He concluded the session by stating that by February they hope to be able to give much more detail about the next application(s) of the Technosphere technology, and that they are hoping to be able to announce a signed contract by then.
MannKind Corporation (MNKD) COO Hakan Edstrom says his company is “looking closely” at expansion opportunities in the pain management market.
“If you get the medication into the bloodstream very quickly, you also have a relief of the pain much, much quicker. There are also nonopioid opportunities, where you may even be able to treat patients for their pain without having the risk of them getting into situations where they are dependent on the drug itself because of the side effects,” Edstrom says. “That’s one area that we are looking into right now, and there are some others that I, unfortunately for proprietary reasons, cannot necessarily speak on at this point in time.”
The combined Medtronic-Covidien entity, with a presence in more than 150 countries, is expected to drive more value and improve operational efficiency by offering various healthcare and diagnostic products and services as a package to its customers. Covidien generated over $10 billion in revenue in 2013 compared to Medtronic’s $17 billion, with about 50% of sales coming from outside the U.S.
Our price estimate for Medtronic’s stock is currently around $64, which is about 10% below the market price.
See our full analysis for Medtronic Inc.
Financial Benefits: With the Covidien acquisition, Medtronic expects synergies related to optimization of their global back-office, manufacturing and supply-chain infrastructure to result in savings of at least $850 million by FY 2018. It is also likely to benefit from potential revenue synergies with the addition of Covidien’s offerings to Medtronic’s existing product portfolio, in addition to gains from a reduction in its tax liabilities considering that Ireland’s corporate tax rate is 12.5% compared to 35% in the U.S. The medical device maker stated earlier that it expects the transaction to be accretive to its cash earnings in FY 2016 and to GAAP earnings by FY 2018.
Strategic Benefits: Covidien is a global healthcare products company with over 38,000 employees in 70 countries and products being sold in more than 150 countries. It sells a diverse range of products, primarily medical devices and medical supplies. Its medical devices include surgical products, vascular products as well as respiratory and monitoring products. Its medical supplies include monitoring and operating room products, needles and syringes, nursing care, skincare products, hydrogels and animal health products. 
Apart from certain vascular and surgical products, there is little product overlap between the two companies. We believe the Covidien acquisition should help Medtronic expand its presence in the minimally-invasive surgical market. Covidien is also likely to help Medtronic in expanding operations in emerging markets, where it has an extensive R&D and manufacturing presence. Medtronic has reported robust sales growth from its emerging market operations in the last few quarters, but there is still considerable room for improvement. Emerging markets including Asia-Pacific, South Asia, Africa and the Middle East currently contribute about 13% of its overall revenues, and this deal is likely to help improve their contribution going forward.
Now that Medtronic Inc. (NYSE: MDT) has received approval from the U.S. Federal Trade Commission and the European Commission, the only real obstacle is a Jan. 6 shareholder meeting.
While it isn't a guarantee the company's shareholders will approve the $42.9 billion acquisition, analysts are pretty confident. If the deal is approved, it could be finalized by late January or early February.
"It's a positive deal for both companies," said Jeffrey Loo, an analyst with S & P Capital IQ.
Loo said industry expectations were always for the deal to be approved. And once it is completed, the device industry could begin to change even more.
"Medtronic is going to become a much bigger player in the industry, which will be helped by the lower tax rate," Loo says. "Whether or not that will be a catalyst for additional transactions is yet to be seen. But there will probably be further consolidation in the (device) sector."
Both commissions approved the deal contingent upon Medtronic divesting Covidien's drug-coated balloon catheter product. Plans were already in place to sell that business to The Spectranetics Corporation. That deal, estimated to be worth around $30 million, is expected to be completed shortly after the acquisition closes. Medtronic will also move its official headquarters to Ireland, where Covidien is based, a plan that could lead to eventual changes in the U.S. tax code.
Despite the planned move of Medtronic's headquarters, Jeff Windau, an analyst with Edward Jones, said Medtronic's Memphis spinal division could actually stand to gain attention for investment once the deal is completed.
"One thing this does highlight is if there's a sound business rationale for making the deal, companies can make these work in current conditions," Windau said. "Spinal is still important for Medtronic overall."
FTC and EC grant clearance for Medtronic acquisition of Covidien
Medtronic recently announced it has received clearance from the Federal Trade Commission and conditional clearance from the European Commission for its proposed acquisition of Covidien.
Clearance from the FTC comes on the heels of Medtronic and Covidien’s agreement to a proposed consent order, which included a commitment to divest certain Covidien assets to The Spectranetics Corporation — an allocation that will take place following the finalization of the proposed acquisition and the factor upon which the EC’s conditional clearance hinges, according to a company press release. The acquisition of Covidien is expected to close early in 2015 following additional clearances from the shareholders of both companies, as well as a sanction from the High Court of Ireland.
“This regulatory clearance represents an important milestone in bringing our companies together,” Omar Ishrak, chairman and CEO of Medtronic, said in the release. "We continue to make good progress in planning for the integration of these two companies which will unite them under a single mission: to alleviate pain, restore health and extend life for patients with chronic disease around the world.”
Kevin is 100% correct. No doubt. TS M&A will happen after MDT, Covident inversion happens late Jan. The new entity is no longer about med device only. This coincides with Mnkd promised to announce TS portfolio mgmt by Feb.
Update: Mann Sells Two Local Biomedical Parks
By ELLIOT GOLAN
Thursday, November 20, 2014
Editor's Note: The story has been corrected from the version published at 2:32 p.m. Nov. 20. MannKind Corp. is not headquartered in the Mann Biomedical Park and Advanced Bionics has moved from it.
The long anticipated sale of the Mann Biomedical Park in Valencia has finally closed.
The 120-acre park owned by billionaire Alfred Mann was sold to Intertex Cos. in Valencia with financial backing from L.A. investment firm Oaktree Capital Management LP
In addition, the joint venture purchased the nearly 10-acre Sylmar Biomedical Park, which houses other Mann-affiliated companies.
“Rarely does an opportunity become available to buy such high-quality, unique real estate of this size in the Santa Clarita Valley,” said Intertex President Dale Donohoe, in a statement.
Market sources have pegged the Santa Clarita deal, first reported by the Business Journal in September, at about $100 million. Intertex did not release financial details on either acquisition.
Tenants at the 600,000-square-foot Santa Clarita park include the Alfred Mann Foundation and Bioness Inc., which makes medical devices for people with multiple sclerosis, traumatic brain injury and cerebral palsy. The park was formerly the headquarters of Advanced Bionics AG, a maker of cochlear hearing implants that Mann founded in 1993 and later sold.
Tenants at the 180,000-square-foot Sylmar park include Mann’s Second Sight Medical Products Inc. and advanced battery maker Quallion LLC, which he sold last year.
Santa Clarita City Manager Ken Striplin said he’s excited about what the sale could bring to Santa Clarita. He noted that Intertex President Dale Donohoe has a long history in the area.
“Dale Donohoe has built several excellent projects in Santa Clarita including the Bridgeport Marketplace, and we look forward to his future plans for the Mann Biomedical park to bring new businesses and new jobs to our community,” he said in an email.
The 16-buiding office and industrial park off the 5 Freeway is more than just an investment play for Intertex. The park is entitled for nearly 900,000 square feet of additional building development that can include office/flex and industrial/flex.
Mann purchased the park in 2002 from Legacy Partners of Foster City. Prior to that, it was owned by aerospace and defense giant Lockheed Martin of Bethesda, Md., which operated its advanced development Skunk Works program there.
Biotech industry insiders have said Mann could be selling off his real estate to raise capital to reinvest into his companies, which would make the timing impeccable; the deal closed the day before one of Mann’s companies at his Sylmar park went public.
Second Sight had a smash debut on the Nasdaq Wednesday in its first day of trading, with the stock more than doubling. Mann has a roughly 33 percent stake in the company, now worth about $195 million.
Mann was represented in the two sales by Kevin Shannon, Craig Peters, Ken White, Doug Sonderegger and Laura Stumm of CBRE. Bank of America provided debt financing, which was procured by CBRE’s Val Achtemeier.
MNKD short interest goes down from 79,738,493 shares to 79,738,493. Days to cover from 22.00 to 20.07.
Short Interest Rises in Facebook (FB), Google (GOOG), Tesla (TSLA); Falls in 31% in Apple (AAPL)
9:09 AM 12/26/2014 - StreetInsider
On Christmas Even, NASDAQ released short interest data for the two-week period ended December 15, 2014. Overall, short interest in all 2,910 NASDAQ securities totaled 8,441,763,186 shares at the December 15, 2014 settlement date, compared with 2,910 issues and 8,507,937,827 shares at the end of the previous reporting period.
Below are some notable short interest updates for several notable and heavily shorted NASDAQ stocks (NOTE: We added three biotechs to the list to track - GILD, BIIB, CELG - although the days coverage doesn't include the recent biotech rout.)
HIGHER SHORT INTEREST:Facebook (NASDAQ: FB) short interest goes up from 34,210,393 shares to 34,842,204. Days to cover from 1.40 to 1.37.Google (NASDAQ: GOOG) short interest goes up from 2,303,569 shares to 2,876,401. Days to cover from 1.38 to 1.49. NOTE: Google (NASDAQ: GOOGL) short interest goes down from 2,374,772 shares to 2,363,748. Days to cover from 1.38 to 1.03.Tesla (NASDAQ: TSLA) short interest goes up from 22,613,117 shares to 23,474,178. Days to cover from 5.15 to 3.45.Biogen Idec (NASDAQ: BIIB) short interest goes up from 2,482,567 shares to 2,848,915. Days to cover from 1.61 to 1.26.BlackBerry (NASDAQ: BBRY) short interest goes up from 111,375,334 shares to 111,509,772. Days to cover from 9.12 to 11.43.Keurig Green Mountain (NASDAQ: GMCR) short interest goes up from 10,558,122 shares to 6,156,295. Days to cover from 2.11 to 3.71.GoPro, Inc. (NASDAQ: GPRO) short interest goes up from 10,558,122 shares to 12,755,375. Days to cover from 1 to 1.92.First Solar (NASDAQ: FSLR) short interest goes up from 8,451,951 shares to 8,939,981. Days to cover from 3.93 to 4.08.El Pollo Loco (NASDAQ: LOCO) short interest goes up from 2,242,902 shares to 2,910,539 shares. Days to cover from 1.00 to 1.87.SolarCity (NASDAQ: SCTY) short interest goes up from 17,384,965 shares to 18,643,049. Days to cover from 7.51 to 7.57.Zynga (NASDAQ: ZNGA) short interest goes up from 64,113,958 shares to 70,485,894. Days to cover from 6.87 to 7.04.Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) short interest goes up from 2,162,189 shares to 2,370,067. Days to cover from 4.97 to 4.29.
LOWER SHORT INTEREST:Apple (NASDAQ: AAPL) short interest goes down from 78,182,668 shares to 53,673,391. Days to cover from 1.69 to 1.00.Microsoft (NASDAQ: MSFT) short interest goes down from 67,099,529 shares to 58,708,012. Days to cover from 2.35 to 2.06.Gilead Sciences (NASDAQ: GILD) short interest goes down from 56,571,917 shares to 55,467,752. Days to cover from 3.49 to 3.97.Celgene (NASDAQ: CELG) short interest goes down from 11,165,661 shares to 10,373,953. Days to cover from 3.22 to 2.20.Netflix (NASDAQ: NFLX) short interest goes down from 6,002,352 shares to 5,997,113. Days to cover from 2.75 to 3.22.Micron (NASDAQ: MU) short interest goes down from 91,013,63 shares to 88,342,760. Days to cover from 5.23 to 4.74.lululemon athletica (NASDAQ: LULU) short interest goes down from 23,433,941 shares to 23,349,907. Days to cover from 9.05 to 4.26.SodaStream International (NASDAQ: SODA) short interest goes down from 3,412,532 shares to 3,064,343. Days to cover from 7.27 to 4.86.Groupon (NASDAQ: GRPN) short interest goes down from 89,267,776 shares to 86,567,261. Days to cover from 6.73 to 6.43.MannKind (NASDAQ: MNKD) short interest goes down from 79,738,493 shares to 79,738,493. Days to cover from 22.00 to 20.07.Plug Power (NASDAQ: PLUG) short interest goes down from 36,553,762 shares to 78,755,843. Days to cover from 7.36 to 4.79.
The prior period's short interest report can be found here.