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Post by lakers on Nov 16, 2019 12:17:42 GMT -5
“On Brazil they just got the product of customs a couple of weeks ago, so I don't want to comment yet on their launch plans. I know they're finishing up pricing negotiations with the government, I think until all that happens, we're just -- we know there's a lot of excitement down there, but I think we need another month or so to get the feedback on how that flows out but otherwise product down there has gone through customs. It's in the warehouse.”.
Feb is more likely.
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Post by lakers on Nov 10, 2019 23:40:16 GMT -5
spencerosborne
44m
$MNKD stop sending messages that say Deerfield is gone. Deerfield has rights to sales milestones on Afrezza. There is $75m worth of milestones to pay out. The Amphastar deal has $93m in commitments. Thus there are liabilities of $168m that any potential buyer of afrezza must consider. This is, in part, what makes selling afrezza a bit of a challenge. The other issue is poor sales in general.
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Post by lakers on Nov 10, 2019 1:00:22 GMT -5
CG: Christer Gardell, Founder, managing partner of Cevian Capital, Backed by Carl Icahn JE: Jeffrey Eberwein, Founder & CEO of Lone Star Value Management www.carriedin.com/activist-investors/ |
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Post by lakers on Nov 9, 2019 21:20:33 GMT -5
UTHR. PE: Private Equity fund, Activist Investor. SO mentioned initials of activist investors CG, JE.
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Post by lakers on Nov 9, 2019 14:36:49 GMT -5
Time tested adage: When things don’t go well, execs tend to fall back to what worked for them in the past.
David Kendal : former Lilly CMO, Cialis -inhaled Tadalafil
James Shanon: former GSK CMO, Mnkd Board, Imitrex - inhaled Sumatriptans, Aloxi- inhaled Palonosetron CINV
It’s hard to keep a pill down when you want to vomit.
Global Chemotherapy-induced Nausea and Vomiting (CINV) Market Will Reach $2,659 million by 2022 with Top Key Players GlaxoSmithKline plc, Helsinn Holding S.A., Heron Therapeutics, Inc., Merck & Co., Inc., and Tesaro, Inc
KEY FINDINGS OF THE CINV MARKET STUDY
The Aloxi segment generated highest revenue in the global market in 2015, accounting for over half of the total market.
The Netupitant-Palonosetron FDC segment is the fastest growing segment at a CAGR of 10.8%.
The North American market has witnessed a significant growth in the recent years. Presently, it is the largest regional market for CINV drugs and an its market share is anticipated by 2022. Asia-Pacific is the fastest growing market due to increase in number of cancer population, high incidences of gastroenteritis and other diseases that lead to nausea and vomiting. This region boosts up the demand for antiemetic drug due to growth in demand for CINV drugs and is expected to fuel the market growth in this region.
”they are advanced into an animal PK study that will help us get some additional information as we think about dosing in animals and how that's going to correlate to bioavailability of the current available formulations. So, our pipeline slide here has been updated in orange to talk about the two next pipeline slides that went to non-clinical pharmacology, that will help us get better understanding of the absorption through the lungs and really help us understand the dosage form as we continue to progress these in development. We will expect this data pretty much by the end of the year, but full study outcomes in Q1.
UT has not made a decision on the undisclosed compound as they have a right to opt in for a certain period of time, and they are completing a market assessment before making any decisions.”
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Post by lakers on Nov 9, 2019 14:21:38 GMT -5
spencerosborne 8/9/19, 10:08 AM $MNKD I see the monthly MidCap minimum afrezza net revenue covenants as critical. The way I see it, it is very important for net revenue from Brazil to come in. In a perfect world, relying on Brazil would not be an issue. On US sales, I estimate that MNKD falls out of compliance by $1m in November, and is $3m out of compliance by the march 31 test. If that is the case, the $10m for tranche 2 cannot happen, and the interest rate on the $40m loan goes up by 2 points. By my estimation, a ramp in US sales is needed as well as a very good Brazil launch. Dont hate.. I am simply being realistic. MC already conceded that “I believe we have a strong relationship with MidCap, and we will successfully work together to resolve any issues that may rise throughout the term of our loan.” IMHO, MidCap is merely a bridge loan which tides Mnkd over until after 12/27/19 when the toxic 1.6 Warrants expire. Then UT, PEs like CG, JE May take an equity stake in Mnkd. They don’t want to be diluted by Warrants. MidCap loan may be used as a leverage in such negotiations. That could be why MC seems unconcerned, almost cavalier about covenants. Lone Star Value Management JE is Jeffrey Eberwein Founder & CEO United States Old Greenwich, CT Mnkd’s Danbury plant is in CT, 34.6 mi away from JE’s Office. He knows Mnkd. Cevian Capital is a Swedish investment firm founded in 1996 by Christer Gardell and Lars Förberg, both of whom serve as managing partners. Backed by Carl Icahn, it is the largest activist investment firm in Europe. It has offices in Stockholm, Zurich, and London. Hakan Edstrom, former Mnkd CEO, is a Swedish also. Read more: mnkd.proboards.com/thread/11488/spencer-scripts-latest-wainwright-conference?page=2#ixzz64oc5X2Px |
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Post by lakers on Nov 9, 2019 11:10:49 GMT -5
charlieL
11/8/19, 05:20 PM
$MNKD afrezza should be promoted as a maintanace insulin not a mealtime insulin. they are used for both but the fact is you can correct your blood sugar at anytime. come on mike this you should know
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Post by lakers on Nov 9, 2019 11:05:52 GMT -5
spencerosborne
11/7/19, 01:37 PM
@herewithpopcorn CG and JE are potential actavist investors. If they were making a play, they would have already done their buying by now. If we get to Thanksgiving and there is no actavist announcement. It's all moot.
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Post by lakers on Nov 9, 2019 5:20:14 GMT -5
Just noticed that Spencer said that "CG" is a "potential"activist investor:  CG is Carlyle Group, a well known hedge fund, activist investor. CG can also be: Cevian Capital Christer Gardell, a Swedish like Hakan Co-Founder & Managing Partner Europe Stockholm, Sweden Cevian Capital is a Swedish investment firm founded in 1996 by Christer Gardell and Lars Förberg, both of whom serve as managing partners. Backed by Carl Icahn, it is the largest activist investment firm in Europe. It has offices in Stockholm, Zurich, and London. Formerly called Amaranth, Cevian has invested in such companies as ABB, Danske Bank, ThyssenKrupp, Volvo , G4S, TeliaSonera, and Lindex, and played a major role in the sale of Skandia to Old Mutual Lone Star Value Management
JE is Jeffrey Eberwein
Founder & CEO United States Old Greenwich, CT
Mnkd’s Danbury plant is in CT, 34.6 mi away from JE’s Office. He knows Mnkd. An activist shareholder is a shareholder that uses an equity stake in a corporation to put pressure on its management.[1] A fairly small stake (less than 10% of outstanding shares) may be enough to launch a successful campaign. Shareholder activism can take any of several forms: proxy battles, publicity campaigns, shareholder resolutions, litigation, and negotiations with management. Daniel Loeb, head of Third Point Management, is notable for his use of sharply written letters directed towards the CEOs of his target companies. fintel.io/i/lone-star-value-management-llcwww.carriedin.com/activist-investors/ |
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Post by lakers on Nov 8, 2019 2:45:42 GMT -5
spencerosborne
05:36 PM
$MNKD $10m for tranche 2 of credit facility is available until April 15th. Because mannkind is very likely to miss covenants, the company will need to negotiate some new terms (if it wants to draw the cash). Those terms could include shares, added covenants, warrants, converts, etc. Mannkind describes MidCap as "friendly". That does not mean MidCap will simply ignore terms. It really only means that MidCap wont call the loan. Likely they will keep the leash tight though. No banker worth their salt gives concessions. I would venture to say midcsp knew darn well that a covenant miss was likely when the deal was first structured. It virtually guaranteed the extra 2% interest. Tranche 3 of $25m is available til june 30, 2021.
I pointed out the likely miss of covenants on the day the MidCap facility was announced. I also stated it would be as early as november
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Post by lakers on Nov 8, 2019 2:43:15 GMT -5
spencerosborne
05:46 PM
$MNKD clarity on an item. I still believe undisclosed molecule is Adcirca (tadalifil). Uthr owns only the PAH indication. As I have written before, mnkd has not licensed ED rights. Is the company serious about making "Puff n Stuff"? Not sure. Announcing intent could be a good way to get Lilly to the table. Even to assist in working to getting UTHR better terms on adcirca fees and royalties. Time will tell. I have previously discussed these dynamics in depth.
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Post by lakers on Nov 4, 2019 15:31:12 GMT -5
Agree Slugworth. A 5% stake announcement by UTHR could turn MNKD's world right side up immediately. No one knows what UTHR might be thinking but considering Martine's latest positive comments about the Mannkind collaboration at the 3Q report, it could happen in a heartbeat. No prediction here. Just agreeing it could happen and would not be that surprising. Only After 12/27/19 1.6 convertible note to avoid diluting themselves. |
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Post by lakers on Oct 14, 2019 23:22:35 GMT -5
United Therapeutics Looks To Develop Inhaled Adcirca - A Deeper Look Mar. 13, 2019 7:46 PMUnited Therapeutics Corporation (UTHR)ARNA, LQDA, MNKD Summary It appears that the undisclosed compound in the deal between United Therapeutics and MannKind is Adcirca. Adcirca is used to treat PAH. Adcirca has the same active ingredient as Cialis. When United Therapeutics (NASDAQ:UTHR) signed a deal with MannKind (MNKD) for a dry powder inhaled form of Treprostinil, the company also contracted an undisclosed compound within the PAH space. With United's most recent update of its pipeline page, it appears that the undisclosed compound is Adcirca. www.google.com/amp/s/seekingalpha.com/amp/article/4248602-united-therapeutics-looks-develop-inhaled-adcirca-deeper-lookRespira Reacquires Full Rights Over RT234 for As-Needed PAH Symptom Relief pulmonaryhypertensionnews.com/2019/10/14/respira-reacquires-full-rights-over-rt234-for-pah-symptom-relief/This follows the decision of its partner United Therapeutics to terminate the collaboration with Respira, which was established in April 2017 RT234 is an inhaled therapy being developed to provide symptom relief in people with PAH. It is thought to help improve exercise tolerance and reduce breathlessness and fatigue related to PAH. The therapeutic combo combines the potent vasodilator vardenafil — available in the United States in an oral form for the treatment of erectile dysfunction — with Respira’s dry-powder inhaler technology AOS-DPI. In contrast to available PAH therapies that are administrated under a specific treatment regimen, RT234 was designed to be taken when necessary (on-demand use). In April, RT234 received orphan drug designation by the U.S. Food and Drug Administration for the treatment of PAH. www.webmd.com/hypertension-high-blood-pressure/news/20090529/new-use-for-cialis-active-ingredientAdcirca, which will be available in August, is made by the drug company Lilly, which also makes Cialis. Adcirca will be marketed in the U.S. by United Therapeutics Corporation. The FDA approved Adcirca based on a clinical trial in which pulmonary arterial hypertension patients either took Adcirca (given as two daily tablets, with each tablet containing 20 milligrams of tadalafil) or a placebo pill for 16 weeks. At the end of the study, the patients walked for six minutes; during that time, patients taking Adcirca walked 33 meters farther than patients in the placebo group. Patients taking Adcirca also had less clinical worsening of their pulmonary arterial hypertension during the study than patients taking the placebo, according to a news release from United Therapeutics. |
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Post by lakers on Oct 11, 2019 0:50:23 GMT -5
Thanks Matt, aka Matt_PK: “The official CMED price lists are updated monthly. The most recent update on October 1st did not contain pricing for Afrezza. There may be another way that CMED can communicate a final decision to Biomm itself during the month, but I am not aware of any other method that is publicly viewable.” MannKind: Q3 Afrezza Sales In The Books - Brazil Launch Pending $MNKD seekingalpha.com/article/4295537Wed Oct 9, 2019, 10:44A |
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Post by lakers on Oct 9, 2019 20:01:27 GMT -5
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