$MNKD R&D: 2 EpiT & 4 TreT compounds progressing to PK profiling during 2Q16.
$MNKD R&D: To date, tested 2 EpiT, 6 TreT & 2 PalT compounds for aerodynamic performance and ambient temperature stability.
$MNKD R&D: In 2Q16, testing in process on Technosphere compounds for Epinephrine (EpiT), Treprostinil (TreT), and Palonosetron (PalT).
www.mannkindcorp.com/Collateral/Documents/English-US/MNKD%20Investor%20Call%202%203%2016%20v9.pdfSlide 11-16
12) Mannkind 3 Internal Technosphere Drugs In Development 2 Will Be Partnered & 1 Held By Mannkind
13) Epi Pen New Inhaled Drug Development Will Be Held By Mannkind & Has Huge Potential
14) Technopshere Future Drug Candidates Regulatory Path Will Be Quick Only Needing Bio-equivalency Trials
Former Mylan CMO Ray said,
"The last candidate I’d like to speak about is Epinephrine for the acute treatment of anaphylaxis. In the U.S. alone, Epinephrine used in anaphylaxis represents a market over $1 billion. Epinephrine is used as a drug of choice with initial treatment of suspected anaphylactic reactions. Patients with known allergies are often asked to carry Epinephrine auto injectors. These drug device auto injectors tend to be large and inconvenient to carry around.
They also involve an invasive procedure that is to say an injection into the lateral thigh. This has led to episodes where patients have postponed this injection leading to an adverse clinical outcome. We believe that the oral inhalation route will provide more than adequate levels of Epinephrine. In addition, this noninvasive step has the potential to prevent untoward outcomes secondary to delaying treatment for fear of an injection.
Epinephrine is in the early technical assessment phase. Preclinical work is expected to begin in the second quarter of this year followed by clinical trials beginning in the first quarter of 2017.
For those that may have questions whether an inhaled medication is suitable for use during the initial phase of an anaphylactic reaction, patients typically know when they are having the reaction. This is well before the full physiologic effects of anaphylaxis become apparent. This is when they typically take an antihistamine, for example, Benadryl because they do not want to inject themselves thinking that the Benadryl will help. Well, it doesn’t. This product will now offer them a noninvasive option.
Clearly, there is a very substantial U.S. and global market already for Epinephrine including millions of pediatric and young adult patients. The market is dominated by one player [Mylan]. We will be pursuing partners in which to penetrate this established market with a product that addresses a significant unmet medical need."
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Take Away's From The Conference Call
by kevinmik • 3 hours ago Flag
1) Sounds like a partnership deal (s) is being negotiated that's close to being announced raising cash
2) Afrezza will be relaunched in July
3) Afrezza packaging is now being produced under Mannkind's name
4) Both Sanofi & Mannkind Afrezza inventory will be sold in the 3Q
5) Mannkind Afrezza inventory only will be sold starting in the 4Q
7) 3Q Affrezza sales will be 35% from Sanofi inventory &100% from Mannkind inventory sold
8) Sales force will target 7,000 Endo's & Specialty doctors accounting for 70% of insulin sold in U.S.
9) Commercial Organization will cost approximately $22 million to be paid by cost saving cuts
10) 2 internal drug candidates advancing led by Epinephrine with IND filing in Jan 2017
11) Mannkind will have 6 abstracts and a commercial booth a the ADA Meeting in June
12) 7 out of 10 patients are getting pre-authorized approval for Afrezza
13) 1st Sanofi debt payment not due until 2024
14) Sales force will hit the market beginning in July
15) Sounds like Mannkind expects Afrezza sales to fund & support operations quickly
16) Sound like today's conference call was scaled back due to partnership deal (s) that were likely expected to close by now but still being worked on. Coming reals soon.
17) Today's call did not mirror in any way, shape or form all the activities going on at Mannkind. Looks like delayed partnership deal (s) are keeping a lid on what can be said and I believe it's also affected VDEX roll out.
18) There is clearly something going on behind the scene likely having to do with partnership, restructuring the company or selling the company. Who knows maybe investment banks hired by Mannkind are working on a buyout deal.
19) Only 2 analyst on the conference call today is very telling
20) $250,000 Receptor milestone payment received in 1Q and another one is due in the 4Q
21) missed 2016 cutoff for Medicare but will happen in 2017
Excerpt from today 10-Q Filing:
"Under the terms of the Sanofi Supply Agreement, in the event that Sanofi terminates the Sanofi License Agreement for various reasons (including the reasons cited in its notice of termination to the Company), then upon written notice from the Company within 30 days following the termination date, Sanofi is obligated to purchase up to $50 million of the Company’s insulin inventory as a percentage of each lot received or receivable by the Company (the “Insulin Put”). On April 14, 2016, the Company provided Sanofi with written notice that it was exercising the Insulin Put. The Company and Sanofi are currently discussing the schedule of purchases and deliveries pursuant to the Insulin Put."
