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Post by buyitonsale on Jun 17, 2021 15:31:48 GMT -5
The "priced in" part is always dependent on what those who move the market for a specific stock want to do at the moment (options for example).
Also, the increase in the short position was largely a hedge by the investors of the convertible note... as we get closer to PDUFA date there should be covering and upward movement in share price, even if nothing else is announced...
I am a buyer at 4.31 or below from now on as I believe that October will bring in an approval and that is definitely NOT priced in...
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Post by oldfishtowner on Jun 17, 2021 15:48:50 GMT -5
If Tyvaso DPI gets approved in October, the conversion rate to Tyvaso DPI will be the key metric to watch. It isn’t out of the realm of possibility for the royalties from Tyvaso DPI to quickly surpass revenues from Afrezza. In the most recent quarter, MNKD reported just shy of $8.1 million in net revenue from Afrezza. (In the same quarter 2020, it was $8.0 million.) UTHR would need to see roughly $80 million in quarterly Tyvaso DPI sales in order to owe MNKD at least $8 million in royalties. In the most recent quarter, United reported Tyvaso sales of $123 million. Maybe, maybe not. I would like to see MNKD's participation in the Medicare Part D Senior Savings Model surprise everyone and double or triple scripts in 2022. But this probably requires that MNKD has to have a robust marketing program targeted to this segment, like ads in AARP's magazine, TV commercials targeted to seniors with Medicare Part-D, sales reps making sure that prescribers know that MNKD is participating in the program and what the cost is to patients, and maybe pamphlets distributed in physicians offices.
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Post by mnkdfann on Jun 17, 2021 19:36:57 GMT -5
During the latest conference they also commented that they expect 70% conversion from Tyvaso to Tyvaso DPI . You can then derive the 70% conversion to Tyvaso DPI and 10% royalty as a minimum. Fwiw, the 70% isn't gospel. It could be 50% or less, it could be 90% or more. So, sure, we can plan on 70%. But not with the certainty some seem to be citing it. UTHR is guessing. We developed Tyvaso, which was an easier way to take treprostinil inhaled, and then eventually got to Orenitram, which is obviously the simplest version of all of them. And so I look at DPI as really kind of fitting in. It's fitting kind of into that strategy of providing patient options. And so I would expect that with the DPI, you're going to have a significant number or majority of patients that are going to want to transition to the dry powder inhaler, and that's fantastic. You will have other patients that, for various reasons, may choose to stay on the nebulizer. And that's great.
We're going to continue to support that product. It's a great product. There is going to - I do think that there is going to be a patient type that is maybe better suited for that product over the DPI. Don't hold me to this. I think when the dust settles, you're probably looking at something of around a 70-30 split between dry powder and nebulizer. So we're going to continue to provide both options, support both options. And I think they're both great delivery devices for the right patient.
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there is some question, and I can't say one way or the other, that some patients with different indications might actually prefer a nebulized form. It might be a little bit easier for them to take and get a good dose versus the dry powder inhaler because they actually breathe in for the dry powder inhaler versus the nebulizer is a little bit more passive. |
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Post by buyitonsale on Jun 17, 2021 20:10:40 GMT -5
ir.unither.com/news/press-releases/press-release-details/2021/United-Therapeutics-Announces-FDA-Acceptance-of-Tyvaso-DPI-New-Drug-Application-For-Priority-Review/default.aspx "Primary safety and tolerability objective. Transition from Tyvaso Inhalation Solution to Tyvaso DPI was safe and well tolerated. Forty-nine out of 51 patients (96%) completed the treatment phase and there were no study drug related adverse events. Most adverse events experienced during the study were mild to moderate in severity and occurred at severities and frequencies consistent with those seen in other inhaled treprostinil studies in patients with PAH. Secondary objectives. Three weeks after switching from Tyvaso Inhalation Solution to Tyvaso DPI, patients in the BREEZE study demonstrated: Improvements in 6MWD compared to baseline. These improvements in 6MWD compared to baseline were sustained in the OEP through the data cut-off date. Improvements in overall satisfaction with the Tyvaso DPI inhaler compared to the Tyvaso Inhalation Solution nebulizer at baseline using an internally developed satisfaction and preference questionnaire. Improvement in patient-reported outcomes using the validated PAH-SYMPACT questionnaire. Optional extension phase. Subjects in BREEZE were given the opportunity to continue in an OEP. All subjects who completed the treatment phase (49/51) elected to continue in the OEP." My opinion - those to try it will switch.
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Post by ryster505 on Jun 17, 2021 21:00:53 GMT -5
ir.unither.com/news/press-releases/press-release-details/2021/United-Therapeutics-Announces-FDA-Acceptance-of-Tyvaso-DPI-New-Drug-Application-For-Priority-Review/default.aspx "Primary safety and tolerability objective. Transition from Tyvaso Inhalation Solution to Tyvaso DPI was safe and well tolerated. Forty-nine out of 51 patients (96%) completed the treatment phase and there were no study drug related adverse events. Most adverse events experienced during the study were mild to moderate in severity and occurred at severities and frequencies consistent with those seen in other inhaled treprostinil studies in patients with PAH. Secondary objectives. Three weeks after switching from Tyvaso Inhalation Solution to Tyvaso DPI, patients in the BREEZE study demonstrated: Improvements in 6MWD compared to baseline. These improvements in 6MWD compared to baseline were sustained in the OEP through the data cut-off date. Improvements in overall satisfaction with the Tyvaso DPI inhaler compared to the Tyvaso Inhalation Solution nebulizer at baseline using an internally developed satisfaction and preference questionnaire. Improvement in patient-reported outcomes using the validated PAH-SYMPACT questionnaire. Optional extension phase. Subjects in BREEZE were given the opportunity to continue in an OEP. All subjects who completed the treatment phase (49/51) elected to continue in the OEP." My opinion - those to try it will switch. Looks there like 90% to moi… |
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Post by hellodolly on Jun 20, 2021 8:15:04 GMT -5
The high retention is unsurprising if you watch a Tyvaso promotional video. The current nebulizer is the size of a small bong with numerous parts to assemble and disassemble with every use and must but be sufficiently charged for each use. Also, the carrying case is the size of a small suitcase. If over 5% of current patients chose to stay with nebulizer over Dreamboat I would be shocked... I am talking night and day difference in convenience of platforms. As if the increased performance of drug would not be enough. I agree and believe this will play a big role into patients currently prescribed Tyvaso and why they will prefer the Cricket and/or Blue Hale devices. The last MNKD press release mentioned UT was working with MNKD in some capacity to roll out the Blue Hale device. As for new patients, doctors may present them with a choice but it's pretty easy to see what's more convenient to carry and use. I tend to lean towards the camp that believes the old Tyvaso will fade away over the next five years or so and the newer DPI formulation will be the only choice UT will provide. |
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Post by liane on Jun 20, 2021 17:40:58 GMT -5
I created a separate thread for all the off topic posts. Please keep this thread on topic. Any further transgressions will be deleted permanently.
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Post by morfu on Jun 21, 2021 18:03:16 GMT -5
I created a separate thread for all the off topic posts. Please keep this thread on topic. Any further transgressions will be deleted permanently. Thank you, Liane, sorry for causing so much trouble  |
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Post by beardawg on Jun 21, 2021 19:09:08 GMT -5
Is FDA reviewing the Afrezza black box warning and PFT requirement? Would be great to get rid of those, but I don’t recall any news along those lines. MC indicated recently they were working with FDA on making the spirometry optional instead of required. Afrezza BBW has nothing to do with Tyvaso and likely will not be affected by it. We all know the BBW is completely unwarranted and not a cause of concern.      Foot Fracture? Stress? Injection site rash/mass pain? How can these things be taken seriously? |
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Post by beardawg on Jun 21, 2021 19:25:30 GMT -5
An updated near-term development list 🥭 Afrezza Peds Phase 3 this year Anybody know if the Afrezza Peds trial is doing it on inferiority or if it is to prove superiority? |
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Post by peppy on Jun 21, 2021 20:58:08 GMT -5
An updated near-term development list 🥭 Afrezza Peds Phase 3 this year Anybody know if the Afrezza Peds trial is doing it on inferiority or if it is to prove superiority? I recall the trial is going for superior. I think there is a thread. mango |
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Post by sr71 on Jun 23, 2021 14:22:13 GMT -5
UTHR announced today that they are discontinuing their injectable-treprostinil partnership program with Medtronic for PAH patients: d18rn0p25nwr6d.cloudfront.net/CIK-0001082554/b7518a51-9c7b-45fb-8b51-6e8ef50c42ce.htmlHere's the text from the 8K: "On June 22, 2021, United Therapeutics Corporation (the “Company”) and Medtronic, Inc. (“Medtronic”) agreed to discontinue further efforts to develop and commercialize the Implantable System for Remodulin® (“ISR”). By way of background, the ISR has been developed over the past 12 years in collaboration with Medtronic to deliver Remodulin (treprostinil) Injection for patients with pulmonary arterial hypertension (“PAH”) via an implantable system developed by Medtronic. On February 25, 2019, Medtronic and the Company entered into a Commercialization Agreement governing the parties’ collaboration to commercialize the ISR in the United States (the “Commercialization Agreement”). Despite approval by the U.S. Food and Drug Administration (“FDA”) of Medtronic’s premarket approval application (“PMA”) for the ISR in December 2017, commercial launch of the product required Medtronic, as the applicant, to satisfy certain conditions to its PMA approval. Based on the evolution of treatment options and paradigms in PAH over the past few years, and the anticipated efforts required to satisfy the FDA’s conditions of approval, the Company and Medtronic have decided to discontinue further efforts to develop and commercialize the ISR. The Company and Medtronic plan to work together on a mutually-agreed approach to wind-down the development program, and to support patients already enrolled in clinical studies of the ISR, at the Company’s sole expense. Effective June 22, 2021, the parties mutually agreed to terminate the Commercialization Agreement. There were no penalties associated with the termination of the Commercialization Agreement." This should reinforce the commitment for the Treprostinil DPI partnership with Mannkind. |
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Post by uvula on Jun 23, 2021 20:47:21 GMT -5
They must be very optimistic to break up before the inhaled stuff is approved.
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Post by akemp3000 on Jun 24, 2021 4:34:21 GMT -5
Considering UTHR's CEO put up over $100M to accelerate the approval process, it's easy to recognize the optimism and anticipated approval of an improved delivery method for a drug that's been widely used for years and was recently approved by the FDA for a new indication. There's obviously no guarantee but this is probably as close as it gets.
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Post by georgethenight2 on Jun 24, 2021 5:46:39 GMT -5
Considering UTHR's CEO put up over $100M to accelerate the approval process, it's easy to recognize the optimism and anticipated approval of an improved delivery method for a drug that's been widely used for years and was recently approved by the FDA for a new indication. There's obviously no guarantee but this is probably as close as it gets. And yet we are flounder at less than $5 a share. The winds of change will soon be blowing hard. |
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