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Post by dh4mizzou on Feb 25, 2021 10:00:20 GMT -5
PEDS TRIAL WILL START IN LATE 2021! Forgive the ignorance but how long should the trial take front to back including FDA approval? |
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Post by sellhighdrinklow on Feb 25, 2021 10:10:00 GMT -5
The FDA not being interested in Time In Range data w Arezzo use and CGMs is absurd. This is EVERYTHING that being a Type 1 is about.
Selling Danbury for 100 million and paying rent of 10 million is a 10% cap rate for the buyer. Not a very good deal for Mannkind imho
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Post by wmdhunt on Feb 25, 2021 10:15:26 GMT -5
Seems better to be in control of your physical plant than to be wrestling a landlord a lot of the time. Maybe I'm missing something here?
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Post by Clement on Feb 25, 2021 10:18:14 GMT -5
I had trouble hearing Mike. Did he say he expects a sumatriptan partner in the first half?
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Post by hellodolly on Feb 25, 2021 10:21:40 GMT -5
Seems better to be in control of your physical plant than to be wrestling a landlord a lot of the time. Maybe I'm missing something here?
Four renewable (5) year leases. I wonder who it is that has agreed, with a LOI, to buy the physical plant? UTHR? |
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Post by Chris-C on Feb 25, 2021 10:23:41 GMT -5
PEDS TRIAL WILL START IN LATE 2021! Forgive the ignorance but how long should the trial take front to back including FDA approval? I believe MC said they had discussed design with FDA and have most of the details worked out. He also mentioned that they are considering the top two Clinical Research Organization proposals to oversee the actual clinical trial. Once that is decided, patient recruitment gets underway and once complete, the study can begin. Once all is in order, this should be registered on the clinicaltrials.gov website so we we will able to track progress. I do not recall specifics of the study duration and specific phases, but probably safe to assume 6 months from study launch to conclusion. Assuming positive results and no issues, result would then be submitted to FDA with dosing recommendations for a label expansion based on results. My guess would be they are looking at 18 months-best case scenario for adding pediatric scripts to their revenue growth. Others may have a different view. |
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Post by geomean on Feb 25, 2021 10:37:00 GMT -5
The thing about sale leasebacks is that the owner/ future lessee realizes 100% on the investment capital in the sold/lease backed asset vs a % of the value if using a loan. Plus, the company avoids residual value risk. If the company can earn more on the capital by investing it in expanding it’s business it’s a prudent approach. Insofar as the cost of capital, the current Mid-Cap facility provides for a variable rate of 8.75% (6.75 plus a minimum of 2% which increases dollar for dollar if Libor exceeds 2% plus a back end 6% fee on the total borrowed. (It’s a 5 year term loan, so add 1.2 % per year to the 8.75% minimum, for a total minimum rate of 9.95%).. Here’s the MNKD description in its SEC filing on the transaction. “ On August 6, 2019 (the “Closing Date”), MannKind Corporation (“MannKind”) entered into a Credit and Security Agreement (the “MidCap Credit Facility”), by and among MannKind, MannKind LLC, MannKind’s wholly owned subsidiary (“MannKind LLC”, and together with MannKind, collectively, the “Company”), the lenders party thereto from time to time and MidCap Financial Trust (“MidCap”), as agent. The MidCap Credit Facility provides a secured term loan facility in an aggregate principal amount of up to $75.0 million. The Company borrowed the first advance of $40.0 million (“Tranche 1”) on August 6, 2019. Under the terms of the MidCap Credit Facility, the second advance of $10.0 million (“Tranche 2”) will be available to the Company until April 15, 2020, subject to the Company’s satisfaction of certain conditions described in the MidCap Credit Facility, including the Company achieving Afrezza Net Revenue (as defined in the MidCap Credit Facility) of at least $30.0 million on a trailing twelve month basis. Under the terms of the MidCap Credit Facility, the third advance of $25.0 million (“Tranche 3”) will be available to the Company until June 30, 2021, subject to the satisfaction of certain milestone conditions associated with Treprostinil Technosphere. Tranche 1 and, if borrowed, Tranche 2 and Tranche 3, each accrue interest at an annual rate equal to LIBOR plus 6.75%, subject to a LIBOR floor of 2.00%. Interest on each term loan advance is due and payable monthly in arrears. Principal on each term loan advance under Tranche 1 and Tranche 2 is payable in 36 equal monthly installments beginning September 1, 2021, until paid in full on August 1, 2024, and principal on each term loan advance under Tranche 3 is payable beginning on the later of (i) September 1, 2021, and (ii) the first day of the first full calendar month immediately following such term loan advance, in an amount equal to the outstanding term loan advance in respect of Tranche 3 divided by the number of full calendar months remaining before August 1, 2024. The Company has the option to prepay the term loans, in whole or in part, subject to early termination fees in an amount equal to 3.00% of principal prepaid if prepayment occurs on or prior to the first anniversary of the Closing Date, 2.00% of principal prepaid if prepayment occurs after the first anniversary of the Closing Date but on or prior to the second anniversary of the Closing Date, and 1.00% of principal prepaid if prepayment occurs after the second anniversary of the Closing Date and prior to or on the third anniversary of the Closing Date. In connection with execution of the MidCap Credit Facility, the Company paid MidCap a $375,000 origination fee. Upon termination of the MidCap Credit Facility, the Company is required to pay an exit fee equal to 6.00% of the principal amount of all term loans advanced to the Company under the MidCap Credit Facility. The Company’s obligations under the MidCap Credit Facility are secured by a security interest on substantially all of its assets, including intellectual property. Additionally, the Company’s future subsidiaries, if any, may be required to become co-borrowers or guarantors under the credit facility.” From investors.mannkindcorp.com/node/16541/htmlSo the cap rate being discussed appears to be reasonable, and better than the “Mid-Cap” facility in that there’s greater leverage. |
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Post by MnkdWASmyRtrmntPlan on Feb 25, 2021 10:59:08 GMT -5
Hohum, I was unimpressed with the annual conf call, and so was the stock price, which is maintaining its current plateau of $5.80, but it is continuing its nice long-term steady upward drive. The last 5 years (since Al's passing and Mike's joining) has been in slow-motion in my perception. So, it doesn't look like there is any sharp drop, which is a good thing. But, also no buying opportunities - just buy when you can. The recording is on MNKD website: 2020 Conference Call |
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Post by mango on Feb 25, 2021 12:18:03 GMT -5
Absolutely insane setup for this year, folks.
✅ Afrezza Pediatric Phase 3 THIS YEAR
✅ Sumatriptan Phase 1 THIS YEAR
✅ Clofazimine Phase 1 THIS YEAR
✅ Royalties kicking in with Thyquidity co-promote ALREADY STARTED
✅ Tyvaso DPI FDA approval THIS YEAR
Guys, it doesn’t get much better than this, but we KNOW it will!
Everything’s right, so hold on tight
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Post by itellthefuture777 on Feb 25, 2021 12:58:06 GMT -5
The thing about sale leasebacks is that the owner/ future lessee realizes 100% on the investment capital in the sold/lease backed asset vs a % of the value if using a loan. Plus, the company avoids residual value risk. If the company can earn more on the capital by investing it in expanding it’s business it’s a prudent approach. Insofar as the cost of capital, the current Mid-Cap facility provides for a variable rate of 8.75% (6.75 plus a minimum of 2% which increases dollar for dollar if Libor exceeds 2% plus a back end 6% fee on the total borrowed. (It’s a 5 year term loan, so add 1.2 % per year to the 8.75% minimum, for a total minimum rate of 9.95%).. Here’s the MNKD description in its SEC filing on the transaction. “ On August 6, 2019 (the “Closing Date”), MannKind Corporation (“MannKind”) entered into a Credit and Security Agreement (the “MidCap Credit Facility”), by and among MannKind, MannKind LLC, MannKind’s wholly owned subsidiary (“MannKind LLC”, and together with MannKind, collectively, the “Company”), the lenders party thereto from time to time and MidCap Financial Trust (“MidCap”), as agent. The MidCap Credit Facility provides a secured term loan facility in an aggregate principal amount of up to $75.0 million. The Company borrowed the first advance of $40.0 million (“Tranche 1”) on August 6, 2019. Under the terms of the MidCap Credit Facility, the second advance of $10.0 million (“Tranche 2”) will be available to the Company until April 15, 2020, subject to the Company’s satisfaction of certain conditions described in the MidCap Credit Facility, including the Company achieving Afrezza Net Revenue (as defined in the MidCap Credit Facility) of at least $30.0 million on a trailing twelve month basis. Under the terms of the MidCap Credit Facility, the third advance of $25.0 million (“Tranche 3”) will be available to the Company until June 30, 2021, subject to the satisfaction of certain milestone conditions associated with Treprostinil Technosphere. Tranche 1 and, if borrowed, Tranche 2 and Tranche 3, each accrue interest at an annual rate equal to LIBOR plus 6.75%, subject to a LIBOR floor of 2.00%. Interest on each term loan advance is due and payable monthly in arrears. Principal on each term loan advance under Tranche 1 and Tranche 2 is payable in 36 equal monthly installments beginning September 1, 2021, until paid in full on August 1, 2024, and principal on each term loan advance under Tranche 3 is payable beginning on the later of (i) September 1, 2021, and (ii) the first day of the first full calendar month immediately following such term loan advance, in an amount equal to the outstanding term loan advance in respect of Tranche 3 divided by the number of full calendar months remaining before August 1, 2024. The Company has the option to prepay the term loans, in whole or in part, subject to early termination fees in an amount equal to 3.00% of principal prepaid if prepayment occurs on or prior to the first anniversary of the Closing Date, 2.00% of principal prepaid if prepayment occurs after the first anniversary of the Closing Date but on or prior to the second anniversary of the Closing Date, and 1.00% of principal prepaid if prepayment occurs after the second anniversary of the Closing Date and prior to or on the third anniversary of the Closing Date. In connection with execution of the MidCap Credit Facility, the Company paid MidCap a $375,000 origination fee. Upon termination of the MidCap Credit Facility, the Company is required to pay an exit fee equal to 6.00% of the principal amount of all term loans advanced to the Company under the MidCap Credit Facility. The Company’s obligations under the MidCap Credit Facility are secured by a security interest on substantially all of its assets, including intellectual property. Additionally, the Company’s future subsidiaries, if any, may be required to become co-borrowers or guarantors under the credit facility.” From investors.mannkindcorp.com/node/16541/htmlSo the cap rate being discussed appears to be reasonable, and better than the “Mid-Cap” facility in that there’s greater leverage. This land lease loan came from "The Founder" movie...maybe they watched it..took a few pointers..."you're not in the drug business..your in the real estate business!" "Franchise Franchise Franchise" Mannkind..says the world..humannkind.. |
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Post by sayhey24 on Feb 25, 2021 14:52:59 GMT -5
Absolutely insane setup for this year, folks. ✅ Afrezza Pediatric Phase 3 THIS YEAR ✅ Sumatriptan Phase 1 THIS YEAR ✅ Clofazimine Phase 1 THIS YEAR ✅ Royalties kicking in with Thyquidity co-promote ALREADY STARTED ✅ Tyvaso DPI FDA approval THIS YEAR Guys, it doesn’t get much better than this, but we KNOW it will! Everything’s right, so hold on tight I liked Mike's comments about RLS. We have waited a long time for this and I sure hope they start making a number of near-term announcements as Mike indicated. |
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Post by apidistra on Feb 25, 2021 15:11:42 GMT -5
I'm very happy with the conference call. Less debt, higher net revenue, products of superb efficacy in market niches, a doubling of Afrezza TrX in three years despite the efforts to crush it and Covid, many studies on several products which will all prove to be successes in time and apparently top talent finally on board. I see MC on track, fulfilling many goals no one thought he could overcome and tried to fire him for and fighting hard and smart every day. As one of our friends likes to say 😉, that's my take on it.
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Post by longliner on Feb 25, 2021 15:32:23 GMT -5
I'm very happy with the conference call. Less debt, higher net revenue, products of superb efficacy in market niches, a doubling of Afrezza TrX in three years despite the efforts to crush it and Covid, many studies on several products which will all prove to be successes in time and apparently top talent finally on board. I see MC on track, fulfilling many goals no one thought he could overcome and tried to fire him for and fighting hard and smart every day. As one of our friends likes to say 😉, that's my take on it. This blew away any other MNKD Company communication that has occcured since I began investing in Mannkind! I was surprised to hear of the Fosun partnership (without a PR) as they are approximately 3 times the market cap of UTHR. If indeed a partnership materializes with Roche (a 168 Billion dollar Company) and Fosun with similar terms as UTHR we go from unprofitable to holy s--t we have profit!! I believe that only leaves 7 or 8 other compounds being explored for potential production! Once the market digests this news the upgrades will be interesting. |
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Post by apidistra on Feb 25, 2021 15:56:50 GMT -5
I'm very happy with the conference call. Less debt, higher net revenue, products of superb efficacy in market niches, a doubling of Afrezza TrX in three years despite the efforts to crush it and Covid, many studies on several products which will all prove to be successes in time and apparently top talent finally on board. I see MC on track, fulfilling many goals no one thought he could overcome and tried to fire him for and fighting hard and smart every day. As one of our friends likes to say 😉, that's my take on it. This blew away any other MNKD Company communication that has occcured since I began investing in Mannkind! I was surprised to hear of the Fosun partnership (without a PR) as they are approximately 3 times the market cap of UTHR. If indeed a partnership materializes with Roche (a 168 Billion dollar Company) and Fosun with similar terms as UTHR we go from unprofitable to holy s--t we have profit!! I believe that only leaves 7 or 8 other compounds being explored for potential production! Once the market digests this news the upgrades will be interesting. Fosun? The Chinese pharma company. That would be terrible! MNKD stay away from China!!! My past business life was there. There is no future there for us. |
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Post by longliner on Feb 25, 2021 15:58:39 GMT -5
Sorry, I stepped away to buy 3,000 shares!  |
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