Mannkind cannot rely on subject agreements that only holds Mannkind's new commercial partners to a Good Faith Effort expectation and need to have meat and potato's language that spells out clear strategies, goals and milestone timelines. Sanofi got away with under performing under their agreement with Mannkind, because it was based on a Good Faith Effort expectation that Sanofi can now argue is what they did. We all know Sanofi did little to nothing to promote and sell Afrezza in the United States, but Sanofi will argue they did exactly what was expected of them under a very subjective agreement. Mannkind needs to sign new tough agreements that holds their new partners to high standards of performance. JMO
Tweets & replies
Kevinmik @kevinmik 52m52 minutes ago
Why hasn't Mannkind done anything with MKC253: GLP-1/Technosphere ?
Kevinmik @kevinmik Feb 4
Is Mannind planning to have a booth at the American Diabetes Conference In June ? Thank you
Kevinmik @kevinmik Feb 3
Reach out and consider Vincent Mihalik Amylin's former Chief Commercial Officer,big pharma experienced selling diabetes drugs
Kevinmik @kevinmik Feb 2
Has Mannkind considered splitting the company into 2 separate companies to unlock value for its technology platform ? Kevinmik
Kevinmik @kevinmik Feb 2
MannKind Has $10 Billion Worth Of Marketable Inhabitable Insulin Acquired From Pfizer - Is It Still Usable ?
Pharmacokinetics and pharmacodynamics of inhaled GLP-1 (MKC253): proof-of-concept studies in healthy normal volunteers and in patients with type 2 diabetes.
MKC253 is glucagon-like peptide 1 (GLP-1, 7-36 amide) adsorbed onto Technosphere microparticles for oral inhalation. The pharmacokinetics of inhaled GLP-1 and the pharmacokinetic-pharmacodynamic (PK-PD) relationship between inhaled GLP-1 and insulin were analyzed in two trials, one in healthy normal volunteers and the other in patients with type 2 diabetes. Inhaled GLP-1 was absorbed quickly, with peak concentrations occurring within 5 min, and levels returned to baseline within 30 min. Inhaled GLP-1 appeared to produce plasma levels of GLP-1 comparable to those of parenteral administration and sufficient to induce insulin secretion resulting in attenuation of postmeal glucose excursions in subjects with type 2 diabetes. An E(max) (maximum effect) model described the relationship between GLP-1 concentration and insulin release. The variability in the E(max) may be due to differences in baseline glucose levels, differences resulting from genetic polymorphisms in GLP-1 receptors (GLP-1Rs), or the stage of diabetes of the patient.
PMID: 20592721 [PubMed - indexed for MEDLINE]
MKC253 is a formulation of GLP-1 (glucagon-like peptide) on Technosphere® particles that is delivered using our proprietary inhaler.
In initial clinical studies, MKC253 has shown a robust enhancement of insulin secretion without gastrointestinal (GI) intolerance.
Our hypothesis at present is that delivery of active GLP-1 to the arterial circulation, via the lung, avoids significant degradation by dipeptidyl peptidase-4 that occurs prior to the compound reaching the primary site of endocrine action. Thus, it may be possible to achieve a different response profile with pulmonary MCK253 than seen with subcutaneous or intravenous administration of GLP-1.
Moreover, the pulsatile administration of MKC253 achieved with the Technosphere® delivery technology appears to avoid the dose-limiting GI intolerance characteristically associated with GLP-1 and replaces the insulin response lost in patients with diabetes that cannot be replicated by other forms of GLP-1.
We believe that MKC253 represents a novel approach to the use of GLP-1 as a prandial therapy for diabetes, either alone or in combination with prandial insulin.
Sanofi's premium pricing strategy for Afrezza killed a successful launch in the United States and I suspect it's the reason why Afrezza is not approved in Israel. Israel has a National Healthcare Program that is very cost conscious that likely keeps expensive drugs out of the system and that's why Afrezza priced at a premium by Sanofi is not available in Israel. Once Mannkind gets Afrezza back from Sanofi they will likely immediately, if they haven't already, make Afrezza available at a cost comparable to other diabetes drugs being sold in Israel to get an approval in Israel and they will either set up a licensing deal with a local Israel Company to sell Afrezza or Mannkind will sell licensing rights directly to the Israel Government, who will sell the drug themselves through their State subsidized drug program. JMO
Here are 2 links providing more interesting information about Ling Wong & Bill Gates Investments in start-up companies.
Investor and Entrepreneur
Seattle, Washington Venture Capital & Private Equity
Current Bill & Melinda Gates Foundation, World Economic Forum, Visterra Inc.
Previous Bill & Melinda Gates Foundation, Harvard University, MIT
Education Harvard University
Dr. Ling Wong currently serves as a Senior Program Officer in the Global Health Office of the President. Ling is focused upon opportunities and the strategic engagement with the biotechnology sector on behalf of the Office of the President. Ling also serves as a Program Investment Officer in the Program Related Investment group, $1.5B fund focused upon co-investing with private capital to develop technologies and products for Gates Foundation mission. Ling has participated in several investments including Genocea Biosciences, Visterra, Anacor Pharmaceuticals and Atreca and serves on the board of Visterra and Genocea.
Prior, Ling was at Harvard University where she developed an inhaled vaccine for tuberculosis. Passionate about working at the interface of technological innovation for applications in the developing world, Ling was instrumental in translation of this inhaled technology to a group in Pretoria, South Africa. Ling worked in the biotechnology sector with Professor Robert Langer at MIT. She was involved in start-up companies: Spherics, Inc and Sontra Medical, Inc. Ling is an advocate to foster science and technology innovation via work at the MIT Sloan School of Management and the US Senate.
Senior Program Officer
Bill & Melinda Gates Foundation
2013 – Present (3 years) - Office of the President
Advised leadership on strategy review and fund allocations.
Focused upon opportunities for company creation and strategic investments with the healthcare and technology sector including digital health, media/communications and mobile technologies.
The target market in 2030 should be every diabetic who would benefit using Afrezza and that will be a hell of a lot more than the 15 to 16 million you suggest. I would use your number as today's target market, but 14 years from now I expect Afrezza's superior efficacy, safety (including lungs) & patients compliance will be totally validated making Afrezza the #1 recommended treatment for all types of diabetes, from Pre-Diabetes, all Type II & Type I. JMO
"Diabetes is a chronic disease in which there are high levels of sugar in the blood. The World Diabetes Foundation estimates that there will be 438 million people with diabetes by the year 2030. The global market for products in the management of diabetes currently stands at $41 billion and is on pace to grow to over $114 billion by 2018. Oral anti-diabetics were the leading category of drugs in 2010 and showed a growth rate of 6.3% from the total global sales. The total sales for insulin products increased significantly as well."
So what if Afrezza over the next 10 years is shown to have superior health benefits vs all other diabetes treatments with no proven lung safety/side effect issues, what will things look like in 2030 ? If Aferzza is proven to be the best in class diabetes drug over the next 10 years, here is an estimated potential global revenue number that could driven by this paradigm changing diabetes drug in 2030 ?.
Potential Market Size = 438 million patients
Market Penetration Rate = 20%
Estimated Market Size = 87 million patients
Annual Drug Price = $2,000 per year
Peak Sales = $174 billion per year
Profit Sharing/Royalty Rate = 25%
Peak Annual Sales Revenues= $43 billion per year
gaizaboy... my mistake....you are correct the cumulative number is about $2.5 Billion, that would increase the tax benefit for future earning of $2.5 Billion getting a tax break of about $875 Million.
$2.5 Billion x 35% = $875 Million
Many including myself believe Andrea Leone-Bay joined Receptor Life Sciences as part of the licensing deal Mannkind negotiated with Receptor, when it could be Receptor recruited Andrea away from Mannkind and it was Andrea Leone-Bay who pushed and negotiated the licensing deal with Mannkind on behalf of her new company.
The last sentence below say's it all....NOL has value as a Mannkind write-off or to an acquirer who will end up buying Mannkind for more than just the NOL.....
"The Section 382 Limitation
Since a net operating loss can be used to directly reduce the amount of taxable income, it can be considered a valuable asset. If a business acquires an entity that has an NOL, the reason for doing so should not be the presence of the NOL, for the Internal Revenue Service has placed a restriction on the use of an acquired NOL. The restriction is documented in section 382 of the Internal Revenue Code. Section 382 states that:
If there is at least a 50% ownership change in a business that has an NOL,
The acquirer can only use that portion of the NOL in each successive year that is based on the long-term tax-exempt bond rate multiplied by the stock of the acquired entity.
Despite this restriction, the presence of a large NOL can impact the price paid by an acquirer to the shareholders of an acquiree, since it impacts the net-of-tax cash flows that an acquirer will derive from the ongoing results of an acquiree."
U.S. Corporate Tax Rate is approximately 35% that will create a tax savings of over $500 million when Mannkind's NOL is applied to earnings either by Mannkind or by an acquiring company. IMO Mannkind's current market cap does nothing more than reflect the value of Mannkind's NOL and completely ignores all the other intrnsic value the company's has owning a blockbuster approved diabetes drug, innovative technology platform, state of the art manufacturing plant and intellectual properties well protected by patents. Bottom-line Mannkind's current market cap greatly under values the company. $1.5 Billion NOL x .35 Corporate Tax Rate = $525 Million Tax Savings
Sanofi included Afrezza in their Pre-Quarterly Results Press Release Dated 1/18/16
Paris, January 18, 2016
Pre-quarterly Results Communication
Sanofi (EURONEXT: SAN and NYSE: SNY) has compiled the following items for consideration to assist in the financial modeling of the Group?s Q4 2015 results. As a reminder, in order to align your models with Sanofi?s new sales reporting structure, historical sales of GBUs by geographic region and product are available on the Investor Relations section of Sanofi?s website. Sanofi will report Q4 2015 sales on February 9, 2016 using the existing format and will start using the new GBU format from Q1 2016 onwards.
As previously communicated on October 29, 2015, Sanofi expects its global diabetes sales to be down 6% to 7% at constant exchange rates in 2015. In the first nine months of 2015, sales for the Diabetes division declined 4.6% at constant exchange rates to #$%$5,677 million. As expected, a glargine biosimilar was launched in several European countries as well as in Japan in Q3 2015.
Sanofi is still assessing the effect of the termination of the MannKind agreement on its 2015 financial results.Sanofi current estimate is that the total after-tax impact is expected to be around -#$%$100 million on business net income, impacting ?other current operating expenses? and ?net financial expenses? lines. The termination of the MannKind agreement does not change Sanofi?s Diabetes outlook for 2015-2018.
Let's see if Sanofi provides greater transparency on February 9th about Afrezza's Termination Agreement. I'm betting they will !!!
ANNUAL RESULTS 2015
February 09, 2016
Annual results 2015 will be reviewed by management during a conference call with the financial community. The presentation will be followed by a Q&A session.
In order to facilitate analysts’ forecasts on Q4 results 2015, Sanofi would like to highlight the following items:
Pre-quarterly Results Communication
7:30 am CET / 1:30 am EST: Press Release
2:30 pm CET / 8:30 am EST: Live audio webcast of the conference call - please register here
They don't need to keep to the old script announcing the release dates for their quarterly & full year financial results a week before they happen and should put out the information much earlier. JMO
Only a paper loss that I have experienced many times over my investment history. The good news is the drop in price allowed me to convert my Traditional Rollover IRA to a Roth IRA, that will have a huge tax advantage for me when I actually start using these funds in another 7 years when I get ready to retire or for my estate that will benefit my wife and children. All my previous paper losses ultimately turned out to be huge real gains when the company's I invested in where either bought out or turned around and I expect my investment in Mannkind will do even better.