|
|
Post by prcgorman2 on Nov 21, 2019 2:26:16 GMT -5
There's been a lot of discussion about Cash Flow Break Even (CFBE) which is a good focus for 2020 into some time into 2021. Maybe Afrezza sales will achieve CFBE in that time but I assume as many do it will take revenue from other sources too.
One of the sources not just for CFBE but actual positive earnings per share is royalties on sales of Trepostinil on Technosphere technology (TreT). Those TreT royalties might be fundamental as an important engine of growth for funding large scale trials of Afrezza and increasing the footprint of the salesforce, and potentially increasing ability to provide better PBM discounts on Afrezza thereby presumably improving insurance coverage. It takes money to make money.
What I don't know is what range of revenue (Future Cash Flow) can be reasonably expected from the TreT royalties?
The last UTHR income statement showed quarterly net income of about $590M. Royalties were stated to be in "low double digits" but of what? Gross proceeds? Net Revenue? If we can believe Dr. Rothblatt's assumption that TreT will enhance sales of Tyvaso, that would be worth estimating too.
|
|
|
|
Post by awesomo on Nov 21, 2019 2:37:57 GMT -5
|
|
|
|
Post by hellodolly on Nov 21, 2019 6:40:29 GMT -5
So, assuming low double digit royalties of 10%, it could potentially mean $10M per quarter or $40M a year, before the introduction of a new and improved TreT, if we use Tyvaso to make that forecast. . |
|
|
|
Post by pat on Nov 21, 2019 7:12:42 GMT -5
But Cretin said we’re going out of business...
I get so confused.
|
|
|
|
Post by cretin11 on Nov 21, 2019 7:33:50 GMT -5
But Cretin said we’re going out of business... I get so confused. Ha, good one Pat, but to clarify your apparent confusion, I’ve never stated or predicted that. I’ve stated my overall concern for things with the company, which is quite a different position than what you attribute to me. But getting back to the topic of this thread, thank you pcg for posting this question. I’d like to add a subpart to it, which is: when should we expect to start receiving royalties? |
|
|
|
Post by spikespiegel on Nov 21, 2019 8:20:25 GMT -5
it looks like UTHR will send a NDA (505(b)(2) Pathway in the H2 of 2020 after it has finished all the necessary Studies.
how long does the FDA Prozess take?
From the UTHR 10-Q
We commenced a clinical study (called BREEZE) in September 2019 to evaluate the safety and pharmacokinetics of switching PAH patients from Tyvaso to Treprostinil Technosphere. During the first half of 2020, we plan to commence a second clinical study in healthy volunteers to compare the pharmacokinetics of Treprostinil Technosphere to Tyvaso. The FDA has indicated that these two studies, if successful, will be the only clinical studies necessary to support FDA approval
|
|
|
|
Post by rfogel on Nov 21, 2019 8:51:13 GMT -5
it looks like UTHR will send a NDA (505(b)(2) Pathway in the H2 of 2020 after it has finished all the necessary Studies. how long does the FDA Prozess take? From the UTHR 10-Q We commenced a clinical study (called BREEZE) in September 2019 to evaluate the safety and pharmacokinetics of switching PAH patients from Tyvaso to Treprostinil Technosphere. During the first half of 2020, we plan to commence a second clinical study in healthy volunteers to compare the pharmacokinetics of Treprostinil Technosphere to Tyvaso. The FDA has indicated that these two studies, if successful, will be the only clinical studies necessary to support FDA approval Didn't Mannkind already do a study of TreT pharmacokinetics in healthy volunteers? |
|
|
|
Post by agedhippie on Nov 21, 2019 9:38:12 GMT -5
it looks like UTHR will send a NDA (505(b)(2) Pathway in the H2 of 2020 after it has finished all the necessary Studies. how long does the FDA Prozess take? From the UTHR 10-Q We commenced a clinical study (called BREEZE) in September 2019 to evaluate the safety and pharmacokinetics of switching PAH patients from Tyvaso to Treprostinil Technosphere. During the first half of 2020, we plan to commence a second clinical study in healthy volunteers to compare the pharmacokinetics of Treprostinil Technosphere to Tyvaso. The FDA has indicated that these two studies, if successful, will be the only clinical studies necessary to support FDA approval Didn't Mannkind already do a study of TreT pharmacokinetics in healthy volunteers? Yes, however the API was switched so it has to be rerun with the drug which will be used in production. |
|
|
|
Post by mango on Nov 21, 2019 9:49:39 GMT -5
Didn't Mannkind already do a study of TreT pharmacokinetics in healthy volunteers? Yes, however the API was switched so it has to be rerun with the drug which will be used in production. I must have missed this. Was this discussed in a CC or something? What was it switched from and to? Switched from Treprostinil to...? |
|
|
|
Post by anderson on Nov 21, 2019 10:07:11 GMT -5
Yes, however the API was switched so it has to be rerun with the drug which will be used in production. I must have missed this. Was this discussed in a CC or something? What was it switched from and to? Switched from Treprostinil to...? I was mentioned on the board a while ago. It is the same as reason MNKD is not using the Pfizer insulin in storage and has to use the Amphastar's (merck) insulin (that api was used in the trials). UT probably just wants to use their own supplier instead of who ever MNKD got theirs from for the trial. MNKD needs to do the same thing in the future when they get cash so they can build their own insulin plant. It also means UT will have a backup source for the API. |
|
|
|
Post by mango on Nov 21, 2019 10:42:05 GMT -5
I must have missed this. Was this discussed in a CC or something? What was it switched from and to? Switched from Treprostinil to...? I was mentioned on the board a while ago. It is the same as reason MNKD is not using the Pfizer insulin in storage and has to use the Amphastar's (merck) insulin (that api was used in the trials). UT probably just wants to use their own supplier instead of who ever MNKD got theirs from for the trial. MNKD needs to do the same thing in the future when they get cash so they can build their own insulin plant. It also means UT will have a backup source for the API. Ah ok, that makes sense. Thank you I still don’t understand why they’d need to conduct the study over just because the supplier changed. The API is still Treprostinil. What am I missing? Is it that every time a pharma companies supplier changes they must conduct a new clinical trial? That doesn’t even make sense 🤷🏻♂️ |
|
|
|
Post by rfogel on Nov 21, 2019 14:46:14 GMT -5
I must have missed this. Was this discussed in a CC or something? What was it switched from and to? Switched from Treprostinil to...? I was mentioned on the board a while ago. It is the same as reason MNKD is not using the Pfizer insulin in storage and has to use the Amphastar's (merck) insulin (that api was used in the trials). UT probably just wants to use their own supplier instead of who ever MNKD got theirs from for the trial. MNKD needs to do the same thing in the future when they get cash so they can build their own insulin plant. It also means UT will have a backup source for the API. Is there a source for this information? I've never heard of needing to redo a trial because of a different API source and google isn't helping me. It's also strange to me that they are doing the healthy trial after the tyvaso sitch to TreT trial -- it seems like the healthy trial to establish pharmacokinetics should have been first. |
|
|
|
Post by agedhippie on Nov 21, 2019 16:07:46 GMT -5
I was mentioned on the board a while ago. It is the same as reason MNKD is not using the Pfizer insulin in storage and has to use the Amphastar's (merck) insulin (that api was used in the trials). UT probably just wants to use their own supplier instead of who ever MNKD got theirs from for the trial. MNKD needs to do the same thing in the future when they get cash so they can build their own insulin plant. It also means UT will have a backup source for the API. Is there a source for this information? I've never heard of needing to redo a trial because of a different API source and google isn't helping me. It's also strange to me that they are doing the healthy trial after the tyvaso sitch to TreT trial -- it seems like the healthy trial to establish pharmacokinetics should have been first. You can find the information on the board. I think it was Matt that posted the definitive reply. The reason why is that not all APIs are created equal so source matters. |
|
|
|
Post by ktim on Nov 21, 2019 17:42:22 GMT -5
But Cretin said we’re going out of business... I get so confused. Quick... someone grab the fire extinguisher, Pat's pants are on fire. |
|
|
|
Post by cretin11 on Nov 21, 2019 17:56:55 GMT -5
So are we collectively comfortable with a prediction of around $10M royalties per quarter, to hopefully hit our bottom line within a time frame of maybe the next 24 months? Just putting it out there for folks to weigh in (on either side of that model). To prcgorman's initial point, it is relevant to predicting when/if we'll get to CFBE and beyond.
|
|
