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Post by lakers on May 10, 2018 22:08:20 GMT -5
“We're also working on additional filings in other markets, and I hope to be able to share some of that information with you soon. Additionally, we have started negotiating term sheets for some other key markets which we will try to get done in second quarter but it could go into third quarter.”
Mike already said China, Mex. Mnkd needs To renegotiate with AMPH on the insulin contract anyway. IMHO, Mnkd may be filing in Mex by itself. Ditto Canada.
Cipla was an obvious choice given its strong presence in S Africa, UAE, Saudi Arabia, Oman, MENA. This would come handy for expansion to These regions as Mnkd saves supporting resource. One stone kills four birds. Cipla truly believes in inhaled insulin. They worked on it for years but failed to get approval. They really like that A is storage friendly, less intrusive, easy to use. Moreover, India, MENA ppl are needle phobic.
I suspect we will hear about Cipla again outside of India.
Takeda is pretty obvious for Japan, Australia, New Zealand, VN, APAC.
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Post by lakers on May 7, 2018 21:18:17 GMT -5
Economic Costs of Diabetes in the U.S. in 2017 Diabetes Care 2018 May; 41(5): 917-928. RESULTS The total estimated cost of diagnosed diabetes in 2017 is $327 billion, including $237 billion in direct medical costs and $90 billion in reduced productivity. For the cost categories analyzed, care for people with diagnosed diabetes accounts for 1 in 4 health care dollars in the U.S., and more than half of that expenditure is directly attributable to diabetes. People with diagnosed diabetes incur average medical expenditures of ∼$16,750 per year, of which ∼$9,600 is attributed to diabetes. People with diagnosed diabetes, on average, have medical expenditures ∼2.3 times higher than what expenditures would be in the absence of diabetes. Indirect costs include increased absenteeism ($3.3 billion) and reduced productivity while at work ($26.9 billion) for the employed population, reduced productivity for those not in the labor force ($2.3 billion), inability to work because of disease-related disability ($37.5 billion), and lost productivity due to 277,000 premature deaths attributed to diabetes ($19.9 billion). CONCLUSIONS After adjusting for inflation, economic costs of diabetes increased by 26% from 2012 to 2017 due to the increased prevalence of diabetes and the increased cost per person with diabetes. The growth in diabetes prevalence and medical costs is primarily among the population aged 65 years and older, contributing to a growing economic cost to the Medicare program. The estimates in this article highlight the substantial financial burden that diabetes imposes on society, in addition to intangible costs from pain and suffering, resources from care provided by nonpaid caregivers, and costs associated with undiagnosed diabetes. care.diabetesjournals.org/content/41/5/917?t=1&cn=ZmxleGlibGVfcmVjc18y&refsrc=email&iid=c791b8bc21064422a6c42d384cdaf83f&uid=2189122992&nid=244+293670920
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Post by lakers on Apr 24, 2018 21:07:59 GMT -5
• MannKind (NASDAQ:MNKD) is up 8.1% after hours following a letter from the FDA saying that the company's Afrezza inhalation treatment no longer needs a Risk Evaluation and Mitigation Strategy. • "We have determined that the communication plan is no longer necessary as an element of the REMS to ensure the benefits of Afrezza (insulin human) inhalation powder outweigh its risks because the communication plan has been completed and the most recent assessment demonstrated that the communication plan has met its goals," the FDA writes. • With that, a REMS is no longer required for the powder, the FDA says MannKind +8% as FDA clears risk hurdles for Afrezza www.seekingalpha.com/news/3348257
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Post by lakers on Apr 19, 2018 2:00:37 GMT -5
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Post by lakers on Apr 12, 2018 19:34:09 GMT -5
Mnkd announced Dr Kendall on 2/6/18 before 4Q17 ER on 2/27/18 when Mike broached the two term sheets. To reel in the CMO, Mike must have convinced him of Mnkd solvency, immediate international expansion, and tremendous upside.
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Post by lakers on Apr 12, 2018 18:05:40 GMT -5
I might add 6% negotiated Equity Stake by partner(s)? Any Unsolicited stake would cause the pps to spike which would be countered by Mnkd Selling ATM and/or trigger poison pill.
Any serious, long term partner would want Mnkd to stay solvent hence requiring an equity stake.
RLS Dronabinol Milestone payment if IND is filed, and/or CLS.
Brazil approval Milestone payment in 4Q18. Since the Brazil deal doesn’t have upfront, the deal could be heavily backend loaded with decent Milestones and royalty.
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Post by lakers on Apr 10, 2018 3:35:56 GMT -5
Slide 26 Recap (almost complete) [first time it was worded like that, very interesting! no more PIPE this year? Partner equity stake? Upfronts? Milestones? Large Afrezza purchase by a national health care?]
It used to be:
Recapitalization (ongoing) Warrant Exchange Equity Raise Restructure/Reduce Debt Shareholder Vote to Increase Authorized Shares
A-One Investigator-Initiated Trial to finish this year, was originally slated for ADA 2018 but missed it.
Levin, ADD-1 trials will finish this year also. Apply for new labels which would attract more partners and spur sales?
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Post by lakers on Apr 9, 2018 19:57:23 GMT -5
Don't forget $6.25M due Deerfield 5/11/18, $2.77M due AMPH 6/15/18, and more. I believe, the China deal with AMPH will allow Mnkd to renegotiate the insulin payment term to AMPH.
$20M between 2 partners (India, China) has been bandied about by S.O. That seems to be low ball.
The wild cards are:
Equity stake by one or two partners: $50M for 10% stake might set the floor Pps to raise more money cheaply.
TreT licensing/partnership: After Phase I SAD study, Switch Study will start 1Q19, Pivotal PK Trial will start in 3Q19. Potential partner may emerge in 2019.
Co-promo International rev by Brazil, Mexico in 1H19, by India, China in 2H19.
Lower COGS due to higher volume.
Canada marketed by Mnkd, no NAFTA tariff, low shipping cost.
APAC: Japan, Australia, New Zealand, Vietnam by Takeda ?
MENA partnership?
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Post by lakers on Apr 9, 2018 12:42:29 GMT -5
Mike confirmed that they are working in India, China and Mexico markets and deals are forthcoming with upfront payments and future royalties.
Some here doubted about those markets and upfronts before this Conf. Glad Mike double confirmed that. I have said NAFTA countries are gimme, with no tariff, low shipping cost, ripe for Afrezza invasion. Mex’s 2018 population is 130,759,074. Canada is next. BRIC almost completes except R. APAC (Australia, Japan to start) will be targeted. MENA will probably be targeted before EU. This is the reverse of what other Pharmas would do. But Mnkd is not a normal Pharma. Exubera was approved in EU before the U.S. But it failed commercially. Maybe a different tack would make A successful.
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Post by lakers on Apr 8, 2018 13:11:19 GMT -5
The highly anticipated international deal might potentially be announced in the second week of May (ER week 5/7-10), before ASM 5/16 to quell SH revolt. Mnkd is in quiet period unless there is some material event. I wouldn’t rule out 4/9 either. Hope Mnkd gets $50M upfront minus HCW advisor fee. Who else? The play book also suggests HCW may reiterate Buy on Mnkd with new price target.
The easiest way to justify the needs for recent dilution would be providing more leverage for Mnkd to hammer out the deal details - assuring potential partners that Mnkd is determined to stay solvent at any cost. That’s what 140M shrs are partially for.
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Post by lakers on Apr 8, 2018 12:46:30 GMT -5
5:45AM PST or 8:45AM EST
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Post by lakers on Apr 7, 2018 0:42:11 GMT -5
My doctor has setup a spirometry lung test so that's a good sign that she will prescribe me Afrezza. The diabetes counselor said my cost for Afrezza is now $175 per month versus the $45 she originally quoted me the other day. She said $45 was the old price. Is there a coupon offered thru Mannkind that I can use for the first batch or two? Thanks www.activatethecard.com/afrezza7354/#
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Post by lakers on Apr 6, 2018 11:17:01 GMT -5
$6.25M due Deerfield 5/11 (shrs will be used before ER), $2.77M due AMPH 6/15. $2M/wk burn rate.
-2,116,424 cash 6/29. $25M covenant. 27M needed. Check S.O.
The ante raise is not a surprise. Ask yourself again, why raising just enough $26.3M (right on the dot) to last till 6/29? Doesn’t river have water?
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Post by lakers on Apr 6, 2018 10:50:33 GMT -5
“Mannkind has about $25 million as of March 31, which means a runway until June 30”
Ask yourself why Mnkd raised just enough until 6/30. Wait for the river card.
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Post by lakers on Apr 5, 2018 20:53:21 GMT -5
It gonna be interesting between 4/9-5/16, ER will be before 5/16. 1Q17 ER was on 5/10/17.
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