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Post by boca1girl on Nov 2, 2022 17:07:15 GMT -5
Tyvaso revenue from earnings statements: 2020 Q4 - $131M 2021 Q4 - $167M 2022 Q1 - $172M 2022 Q2 - $201M 2022 Q3 - $257M To guess, I'd say that gains in Q2 and Q3 provide a lowball estimate of DPI sales, including conversions. That's $83M. Gross sales to net is a 50% haircut or a little more. So maybe $5-6M in royalties for Q3? I'm not sure we ever knew what % of revenue manufacturing cost was. Anyone? Those quarterly numbers are net ..... not gross. See page 20 of the 10Q for Q3. d18rn0p25nwr6d.cloudfront.net/CIK-0001082554/5deaefa3-5c8c-4336-9fa4-4c7da8c53f06.pdfFrom a MNKD press announcement 11/19/20 MannKind remains entitled to receive low double-digit royalties on net sales of TreT. MannKind will also manufacture supplies of TreT for United Therapeutics and will earn a manufacturing margin. |
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Post by celo on Nov 2, 2022 18:28:07 GMT -5
Let's also keep in mind DPI sales really didn't take off until September the last month of the quarter, as according to the scripts posted. The uptick in revs is only a small fraction of what should be expected in future quarters.
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Post by porkini on Nov 2, 2022 18:35:57 GMT -5
So $257 million in Tyvaso revenue to UTHR in a quarter divided by thirteen weeks equals just under $20 million a week. If half of that consists of Tyvaso DPI, that would represent $10 million a week. At the lowest possible double-digit royalty, that would represent a million dollars a week to MNKD or $52 million a year, and that is not counting future growth or manufacturing costs plus. I'm trying to get my head around how the market could possibly see today's report as a negative for MNKD, other than the fact that IBB and much off the market had a late-day sell-off. UTHR, on the other hand, held on to most of its impressive gains. I'm thinking we have much brighter days ahead. Mebbe overthinkin' things a bit... NASDAQ off by -3.36%, MNKD off by -2.31%, MNKD had no news or public report to make like UTHR did. So today, MNKD +1.05% better than the exchange it is listed on. Something about lemons and lemonade... |
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Post by harryx1 on Dec 16, 2022 13:28:50 GMT -5
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher A Notice by the Food and Drug Administration on 12/14/2022 www.federalregister.gov/documents/2022/12/14/2022-27138/notice-of-approval-of-product-under-voucher-rare-pediatric-disease-priority-review-voucherSUMMARY: The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that TYVASO DPI (treprostinil), approved May 23, 2022, meets the criteria for redeeming a priority review voucher. EDIT: I think it was just a formality by the FDA that a voucher was used and approved. I thought initially it was a new voucher being issued but I don't think it is. |
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Post by jkendra on Dec 16, 2022 13:40:25 GMT -5
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher A Notice by the Food and Drug Administration on 12/14/2022 www.federalregister.gov/documents/2022/12/14/2022-27138/notice-of-approval-of-product-under-voucher-rare-pediatric-disease-priority-review-voucherSUMMARY: The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that TYVASO DPI (treprostinil), approved May 23, 2022, meets the criteria for redeeming a priority review voucher.
United Therapeutics Plans To Apply Priority Review Voucher To NDA For Tyvaso DPI
December 28, 2020 — 06:13 am EST
United Therapeutics Corporation (UTHR) has reached an agreement to acquire a Rare Pediatric Disease Priority Review Voucher for $105 million, which it plans to use with a forthcoming New Drug Application with the FDA. The PRV entitles the holder to designate an NDA for priority review. United Therapeutics plans to apply the PRV to its NDA for Tyvaso DPI, expected in the first half of 2021.
Michael Benkowitz, Chief Operating Officer, said: "Once approved, Tyvaso DPI with the innovative Dreamboat device is expected to be a major advancement in the delivery of inhaled treprostinil therapy, offering substantial convenience compared to the existing Tyvaso nebulizer."
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Post by boca1girl on Dec 16, 2022 13:44:20 GMT -5
I’m a bit confused since it is already approved. Can this be used on any future drug?
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Post by peppy on Dec 16, 2022 13:52:46 GMT -5
I’m a bit confused since it is already approved. Can this be used on any future drug? adding an indication? |
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Post by porkini on Dec 16, 2022 13:54:51 GMT -5
"Pediatric" is what caught my attention as jkendra went back and highlighted for us. |
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Post by jkendra on Dec 16, 2022 14:14:07 GMT -5
What are TYVASO and TYVASO DPI? TYVASO (treprostinil) Inhalation Solution and TYVASO DPI (treprostinil) Inhalation Powder are prescription medicines used in adults to treat: Pulmonary arterial hypertension (PAH; WHO Group 1), which is high blood pressure in the arteries of your lungs. TYVASO or TYVASO DPI can improve the ability to exercise. Your ability to exercise decreases 4 hours after taking TYVASO or TYVASO DPI. It is not known if TYVASO or TYVASO DPI is safe and effective in children under 18 years of age. |
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Post by celo on Dec 16, 2022 14:24:17 GMT -5
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Post by sayhey24 on Dec 16, 2022 14:56:18 GMT -5
Now here is a WIN! Tyvaso DPI for the kids. A new market and no cost to MNKD just profits. Thank you Martine! Soon we will have Afrezza for kids.
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Post by Thundersnow on Dec 16, 2022 15:31:55 GMT -5
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher A Notice by the Food and Drug Administration on 12/14/2022 www.federalregister.gov/documents/2022/12/14/2022-27138/notice-of-approval-of-product-under-voucher-rare-pediatric-disease-priority-review-voucherSUMMARY: The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that TYVASO DPI (treprostinil), approved May 23, 2022, meets the criteria for redeeming a priority review voucher.
United Therapeutics Plans To Apply Priority Review Voucher To NDA For Tyvaso DPI
December 28, 2020 — 06:13 am EST
United Therapeutics Corporation (UTHR) has reached an agreement to acquire a Rare Pediatric Disease Priority Review Voucher for $105 million, which it plans to use with a forthcoming New Drug Application with the FDA. The PRV entitles the holder to designate an NDA for priority review. United Therapeutics plans to apply the PRV to its NDA for Tyvaso DPI, expected in the first half of 2021.
Michael Benkowitz, Chief Operating Officer, said: "Once approved, Tyvaso DPI with the innovative Dreamboat device is expected to be a major advancement in the delivery of inhaled treprostinil therapy, offering substantial convenience compared to the existing Tyvaso nebulizer."
Does anyone know the duration of the PEDS Trial? |
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Post by Thundersnow on Dec 17, 2022 1:19:28 GMT -5
United Therapeutics Plans To Apply Priority Review Voucher To NDA For Tyvaso DPI
December 28, 2020 — 06:13 am EST
United Therapeutics Corporation (UTHR) has reached an agreement to acquire a Rare Pediatric Disease Priority Review Voucher for $105 million, which it plans to use with a forthcoming New Drug Application with the FDA. The PRV entitles the holder to designate an NDA for priority review. United Therapeutics plans to apply the PRV to its NDA for Tyvaso DPI, expected in the first half of 2021.
Michael Benkowitz, Chief Operating Officer, said: "Once approved, Tyvaso DPI with the innovative Dreamboat device is expected to be a major advancement in the delivery of inhaled treprostinil therapy, offering substantial convenience compared to the existing Tyvaso nebulizer."
Does anyone know the duration of the PEDS Trial? I meant to say - Does anyone know how long the DPI PEDS Trial will take for FDA Approval. |
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Post by agedhippie on Dec 17, 2022 13:58:09 GMT -5
Does anyone know the duration of the PEDS Trial? I meant to say - Does anyone know how long the DPI PEDS Trial will take for FDA Approval. A couple of years? They haven't filed the papers to for the trial yet as far as I can see on the trials site (I stand to be corrected). So they have the recruitment phase which is probably 6 months at least, the trial which will be about a year elapsed time for everyone to finish, and six months to a year to process the numbers and file with the FDA. That feels like a fairly typical trial timeline. There may be some papers published when they are processing the numbers to prime the doctors. |
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DPI news.
Dec 17, 2022 15:11:20 GMT -5
via mobile
Post by radgray68 on Dec 17, 2022 15:11:20 GMT -5
Anybody know how compassionate use laws apply to kids? Or, any chance of a quick confirmatory trial with orphan/fast track conditions? Probably still 18 months or more knowing how it usually goes, would be my guess.
Did Martine add a pediatric application with the last request/delay from the FDA? They could be about to talk trial design already. How cool would that be?
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