Mann.ontop2....back in August Mannkind only had the August 11th 2Q conference call listed on their website until the wee early hours on Monday August 11th, when Mannkind and Sanofi issued a press release at 2:00 AM EST announcing their licensing deal and hosting a conference call at 8:30 AM EST to discuss the deal. The same thing could happen this coming Monday morning or possibly Sunday night with Mannkind issuing a press release that includes announcing an 8:30 AM EST conference call.
The press release announced in June 27th only states that Sanofi and Medtronic signed a memorandum of understanding to enter into a global strategic alliance in diabetes and I wonder if that understanding will become official on Monday that will also include Mannkind ? Here is the press release Sanofi and Medtronic issued. It looks like they may have been just waiting on Afrezza official approval to move forward.
Sanofi and Medtronic to Form Strategic Alliance in Diabetes to Improve Patient Experience and Outcomes
- Initial focus on insulin-device combinations and care management services -
Paris and Minneapolis, Minn. – June 14, 2014 – Sanofi (EURONEXT: SAN and NYSE: SNY) and
Medtronic, Inc. (NYSE: MDT) today announced that they have signed a memorandum of
understanding to enter into a global strategic alliance in diabetes, aimed at improving patient
experience and outcomes for people with diabetes around the world. The alliance will initially focus
on two key priorities: the development of drug-device combinations and delivery of care
management services to improve adherence, simplify insulin treatment, and help people with
diabetes better manage their condition.
The alliance will be structured as an open-innovation model, leveraging the capabilities, as well as
the human and financial resources, of both companies. Based on the success of the two initial
priorities, the companies may explore other areas for potential collaboration
Sanofi and Medtronic already have a diabetes partnership established entered into back in June 2014 and Alfred Mann's former company Minimed is still going strong under the umbrella of Medtronic ten years after Medtronic bought Minimed from Al. Could we see $20 - $25 Medtronic buyout on Monday with future additional payments based on sales milestone payments achieved for Afrezza. Bottom line Sanofi ends up with Afrezza and Inhaled GLP-1 and Medtronic gets Mannkind Technologies.
"Sanofi will be run for now by Serge Weinberg, a former venture capitalist, who previously served as chairman of Sanofi's board. Weinberg will oversee Sanofi just as two important new drugs make their way through regulators. The first is Genzyme's Lemtrada, a multiple sclerosis treatment that some think could have high nine-figure sales potential. The second, and arguably more important, is the FDA decision early next year for Sanofi's Lantus successor, Toujeo.
Lantus, a once-daily, long-acting insulin, is the globe's top-selling diabetes treatment, but it loses patent protection next year. That's got Wall Street worrying that a significant portion of Sanofi's sales could disappear by the end of 2016. To blunt that risk, Sanofi developed Toujeo as a Lantus alternative. In clinical trials, Toujeo did a better job than Lantus at controlling nighttime blood sugar levels
Sanofi is also likely to file for U.S. approval of its PCSK9 bad cholesterol busting drug alirocumab by the end of this year. That drug, which was developed by its partner Regeneron could have blockbuster sales potential given how widely used statins have become.
Weinberg will also be tasked with executing the launch of MannKind 's Afrezza, an inhaled insulin that had a circuitous path through regulators before winning FDA approval earlier this year. Sanofi agreed to partner with MannKind on Afrezza in August."
There is no FDA
There is no NDA (non-disclosure agreements)
There is no HSR
Mannkind hosted two conference calls on Monday August 11th, one at 8:30 AM to discuss the Sanofi licensing deal and another at 5:00 PM to discuss 2Q results. Let's see what happen this coming Monday November 3rd, when we already know the company is hosting a 5:00 PM conference call to discuss 3Q results and will they have another surprise announcement the morning of November 3rd for us like they did on August 11th ? Good luck to all longs.
Mannkind has zero R&D activities underway and they don't seem to be preparing or ready to advance any new R&D. Other than hiring key position for their Manufacturing Plant for commercial production, Mannkind hasn't advanced any new R&D programs since Afrezza was approved in June and they haven't hired any new senior leaders or employees to support the expansion of an R&D program. I think one of two things is going to happen. Mannkind it either going to sit tight and wait until Afrezza's launch in 2015 to finalize a buyout deal with Sanofi or in a bidding war with multiple companies or the company is going to split into two separate companies one that manages their diabetes franchise licensing agreements with Sanofi and a second new company will be created that will manage and advance their technology platform. You never know, we could get a press release this Sunday or early Monday morning announcing Mannkind is splitting the company in two separate companies and they host a separate conference call in the morning to talk about the details or cover it during their afternoon 3Q conference call. One thing is for sure something is up and we will hopefully find out soon what it is.
Afrezza is on the agenda and it will get a lot of coverage.
IR THEMATIC SEMINAR ON NEW MEDICINES
November 20, 2014
Sanofi will hold an IR Thematic Seminar on New Medicines at the Genzyme Headquarters in Cambridge, MA.
A live video webcast of the seminar will be available at
2:30 pm CET / 1:30 pm GMT / 8:30 am EST.
The event will be the first in a new series of events focusing on late-stage pipeline assets.
The agenda will consist of several deep dive sessions on new medicines and vaccines that we expect to launch in 2015, such as alirocumab, Dengue vaccine, Toujeo® and Afrezza®. A high level update on the next wave of innovative medicines and vaccines will also be provided.
The presentations will be followed by a Q&A session.
Clearly Sanofi's Board of Directors are 100% behind the licensing deal that was signed with Mannkind. It seems one of the issues Sanofi's Board of Directors had with their CEO was his inability to manage an effective sales process to promote product sales and growth and the new CEO they bring might actually be a positive for Afrezza. We may see Sanofi increase their sales focus and process for the new drugs they are launching including Afrezza.
1) Will have no impact on Mannkind
2) Will give Mannkind the opportunity to hire Sanofi ex CEO to run Mannkind
3) Will have Sanofi move aggressively to complete a total buyout of Mannkd
* Sanofi's now former CEO seemed more inclined to establish collaboration/licensing deals like the one they structured with Mannkind instead of M&A and it could be Sanofi's Board of Directors specifically its Chairman rather go directly to M&A to get new drugs and technologies in-house and avoid having to share control with another company.
Pierre was the Senior Executive who joined Mannkind during their August 11th conference call announcing the licensing deal. Sanofi's exiting CEO may have given his blessing to the Mannkind deal, but I have to believe Pierre was actively involved in getting the deal done to add Mankind's novel diabetes drugs Afrezza and eventually possibly Inhaled GLP-1 to his Sanofi Diabetes Portfolio. Pierre is the guy who will drive Afrezza's success and that hasn't changed. I also expect Pierre will be the spokes person during Sanofi's November 20th IR Conference Call to talk about Afrezza's launch strategy. Here is what Pierre said back on August 11th about the Afrezza.
"Afrezza is an innovative drug-device combination product consisting of a dry formulation of human insulin delivered through a small, discreet inhaler," said Pierre Chancel, Sanofi Senior Vice President Diabetes Division. "Afrezza is a further addition to our growing portfolio of integrated diabetes solutions. It is uniquely positioned to provide patients with another insulin therapy option to manage their diabetes but does not require multiple daily injections."
Thanks to Technosphere Inhaled drug delivery is going to go from servicing a niche market to having an expanded role delivery drugs for all types of diseases and disorders. It's one thing to put a value on a diabetes drug like Afrezza that is going to create a paradigm change in diabetes care, but when you start talking about putting a value on a technology that will create a paradigm change in the entire healthcare industry you are then looking at really big bucks.
Sanofi will introduce Afrezza during the early part of the 1Q 2015, using a control launch until Toujeo is approved later in the 1Q 2015, at which time the company will unleash a massive marketing campaign promoting the combination use of Toujeo & Afrezza offering lower hypoglycemic events, weight neutral (weight loss ?) and Afrezza's elegant super convenient inhaled device dreamboat. The dynamic duo working together will allow Sanofi to retain its #1 ranking and keep its market dominance for long acting insulin that they currently enjoy with Lantus and it will allow Sanofi to gain a #1 ranking and attain market dominance for the first time in the rapid acting insulin space. I expect Toujeo will match Lantus peak annual sales of $7 billion dollar for dollar and I expect Afrezza will actually eventually exceed Toujeo's annual sales of $7 billion and generate global sales exceeding $10 billion. I think Sanofi knows Afrezza is actually the real golden goose that will deliver bigger sales for the company over the long term coming from combination sales with Toujeo, combination sales with other long acting insulin products and a huge return coming from the virgin Type II market that injected insulin hasn't been able to penetrate for over 80 years. Ultimately Sanofi's diabetes franchise of Toujeo and Afrezza could generate $15 billion in annual sales for the company and that doesn't include Technosphere GLP-1, which will be added gravy. This is only what Mannkind's diabetes franchise is going to do for Sanofi and you can imagine what additional upside Sanofi will see once they get their hands on Mannkind's Technosphere Technology and Novel Delivery Devices and apply them to a host of other diseases, disorders and new drug candidates. The combination of Sanofi and Mannkind is going to be big and a paradigm change in the making. It's really great to be an investor in Mannkind before the real action begins with the stock price :)
It's going to be hard for other company's to compete against Sanofi's diabetes triple threat Toujeo, Afrezza & Technosphere GLP-1.
Sanofi will soon take partial or complete ownership of Mannkind's Technosphere Inhaled GLP-1 drug candidate either though another licensing deal or by buying out Mannkind. Sanofi made sure they included a right of first refusal for Mannkind Inhaled Technosphere GLP-1 in the Afrezza licensing deal and they did it for a very good reason. Mannkind Technosphere Inhaled GLP-1 is another great innovative product that will help ensures the future growth of Sanofi's diabetes franchise.
These crooks will soon have to return the 9 million shares they borrowed from Mannkind that they've been shorting against for the past few years. Wouldn't be surprised these shares are being naked shorted as well.
Insulin is insulin and what makes Afrezza different, better and special is the technology behind it Technosphere, Dreamboat Device & a state of the art Manufacturing facility and process in Danbury. Sanofi believes in Afrezza, but they are even bigger believers in Technosphere and Dreamboat.
Mike... Wrong ? Obviously my post was about Mannkind's valuable assets being acquired by Sanofi through a buyout.
Sanofi is going to rely on Afrezza & Inhaled GLP-1 to support the company's diabetes franchise growth and they will also need Mannkind Technology Platform (Technosphere & Novel Device) & Oncology Platform to diversify and expand the company's revenue stream away from diabetes and into other disease/disorder areas's. Looks like Sanofi/Mannkind are past the courting stage and they will soon be married to each other officially.