They know big things are going to happen including a transformation of Mannkind's financial statements (income statement, balance sheet & cash flow statement) that are going to show huge improvement.
A week or two after filing the HSR, the Federal Trade Commission would have mailed a letter to Mannkind acknowledging receipt of the application and they would have included the expiration date for the HSR waiting period. Provided the Federal Trade Commission has no further questions about the HSR application, the HSR will expire on the expiration date @ 11:59 PM listed in the letter. Matthew Pfeffer knows exactly when the HSR expires.
I did call Mannkind IR over a week ago and spoke with Roberta to ask the question about the HSR expiration date and said she said she would look into it and call me back. Well she did call me back and said the company expects the HSR to expire mid-September and I expect she likely got the answer from Matt Pfeffer. Please also note that Alfred Mann remained silent and conducted no interviews since August 11th when the Sanofi deal was announced and he ended his his silence this past Monday September 15th, giving a full interview that we have all discussed at length. Lastly Sanofi posted two new job openings specifically for Afrezza on September 15th, which all together tell me the HSR has already expired. I did call back Mannkind IR this week to find out about getting information about the actual expiration date, but I never got a call back. I don't believe Mannkind is going to issue a press release about the HSR and the next news to drop will coincide with the company's 3Q reporting and conference call. Hopefully we get an early press release and conference call for 3Q results sometime in October and Mannkind doesn't decide to wait until November to issue a 10Q & 8K filing and host a call to discuss both. Thanks Kevinmik
Pub. No.: WO/2014/144895 International Application No.: PCT/US2014/029491
Publication Date: 18.09.2014 International Filing Date: 14.03.2014
Applicants: MANNKIND CORPORATION [US/US]; 28903 North Avenue Paine Valencia, CA 91355 (US)
Disclosed herein are DKP microcrystals made by an improved method where they do not irreversibly self-assemble into microparticles. The microcrystals can be dispersed by atomization and re-formed by spray drying into particles having spherical shell morphology. Active agents and excipients can be incorporated into the particles by spray drying a solution containing the components to be incorporated into microcrystalline diketopiperazine particles. In particular, the microcrystalline particle compositions are suitable for pulmonary drug delivery of one or more peptides, proteins, nucleic acids and/or small organic molecules.
Griffin Securities Research Report Excerpt:
"But research suggests that intervention with insulin in newly diagnosed Type 2 diabetic patients may slow or prevent the disease’s progression, and a related theory suggests that intervention at the prediabetic stage may prevent the disease entirely for some individuals. Is Afrezza a therapy capable of halting disease progression or providing an environment for the body to heal itself? Those questions will be answered in due course, most likely with support of a major partner."
The facility in Danbury when fully build-out is designed to produce 2 billion cartridges annually that will serve about 1 million diabetics. For the launch, Mannkind expects to have 3 finished lines up an running that will produce about 375 million cartridges, but have the ability to add capacity very quickly. The plant is also designed to product products for future new drugs. Even at fully capacity the Danbury Plant will only be able to meet demand only in United States and they may need to expand even further if the number of U.S. diabetics using Afrezza exceed 1 million. Manufacturing for sales outside the United States will require new plants be constructed or converted in countries outside the United States and I expect they could have as many as 4 to 5 new manufacturing plants around the world producing Afrezza.
The milestones are going to become transparent when Mannkind issues an 8K SEC filing that will provide details of the agreement including the milestone payment structure and I expect over 1/2 of the milestone payments or about $500 million will come from almost guaranteed development & regulatory goals. I also expect most of the milestones will be completed earned within 2 years of Afrezza's U.S. launch, so as far as I am concerned, I am already banking on Mannkind delivering close to a $1 billion in revenues over the next two years, which combined with their low cost structure coming from the licensing deal will having Mannkind generating profits and posting positive earnings. It's all good news....
June 30, 2014 ending cash = $41.2 million
July 18, 2014 Deerfield Trache #4 Payment = $40 million
September 2014 Sanofi Upfront Payment ? = $150 million
3Q 2014 Expenses = ($45 million)
September 30, 2014 ending cash = $186 million
Addition sources of cash
Sales of Tranche B notes to Deerfield = $70 million
Available borrowings The Mann Group = $30 million
Total Cash Avalable = $100 million
Sanofi future milestone cash payments = $775 million
*Sanofi licensing being in full force will cut Mannkind's costs that is currently coming out of Danbury to virtually nothing that will allow their cash position to cover operating costs for several years.
Just check out their website:
Rxneed-FDA approves Afrezza to treat type 2 diabetes-A fast-acting inhalable diabetes medication
FDA approves Afrezza to treat type 2 diabetes-A fast-acting inhalable diabetes medication
The U.S. Food and Drug Administration today approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal.
More New Products
This must mean early demand and possibly preorder are very strong and Sanofi wants to start selling and shipping Afrezza asap. I would not be surprised if Sanofi starts selling Afrezza and stocking pharmacy shelf's ahead of the official launch and they will certainly start distributing Afrezza samples to doctors & hospitals in the 4Q 2014. Sales will start happening sooner than expected.
"For clarity, the Form 13D is a required filing by any entity that becomes a 5% holder. This filing must be made at the time (within 10 days) the holder crosses the 5% threshold. Form 13G is the same form, but used when the person or entity is making the purchase for "investment" only.) Additional purchases by this holder do not have to be reported on Forms 3, 4, or 5, until the holder crosses the 10% threshold."
Sanofi would need to own about 20 million shares of Mannkind to report a 13D filing for 5% and 40 million shares to report 3.4.5 filings for over 10%.
Good luck longs.
Sanofi is buying Mannkind stock....Period and JMO
August 11th = $52.09
September 18th = $56.93 / 10% Growth
August 11th = $10.08
September 18th - $6.17 / (40%) Loss
3 things should tell you he will eventually sell Mannkind.
1) his prior history of selling his company's
2) his age and current activity that has him unloading his holdings likely for estate reasons
3) Recent large stock options/rsu's issued to Mannkind's leadership team & no company expansion to bring in new senior leaders to guide the company's future. .
Sanofi is already on-board with Afrezza and market acceptance of Afrezza will get them on-board with inhaled GLP-1 as well. Going forward, Sanofi is going to put much of the resources behind Toujeo, Afrezza & Technosphere GLP-1 that will drive growth for the company for decades to come. Eventually Sanofi will likely add Mannkind Tecnologies through a buyout to drive growth.
Over the years Zacks has been pretty negative about Mannkind, but it now seems the magic of Technosphere and Dreamboat has changed that opinion to become fans of Mannkind. Took them long enough to get there, but at least they are now on-board recognizing the huge paradigm change that's about to happen in the way diabetes is treated and the way other diseases and disorders are treated using a novel new inhaled delivery device system.
Sanofi has already stated how impressed they are with Afrezza's unique delivery device and if Afrezza's launch out of the gate is strong and demonstrates a huge demand for the drug, I fully expect Sanofi will aggressively move forward to purchase Mannkind Inc. I think they already have an idea based on pre-launch market survey's and pre-orders how well Afrezza will do and from their comments they expect a huge demand for the drug which is why they are instituting a controlled launch until they have additional manufacturing capacity to produce more Afrezza to meet ongoing demand. IMO strong sales results in the 1H 2015, will set the stage for a Sanofi buyout of Mannkind. The last thing Sanofi wants to see is real world demand for Afrezza and that will validate and justify a buyout.
I agree crs also because of Medallion Inc.
It seems to me if Sanofi is going to buyout the entire company which will also include technology platform.