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Post by caesar on May 3, 2023 9:09:17 GMT -5
Appears that United reported that Tyvaso on sequential quarters dropped by about $4 million. Their stock is trading down by about$10.00. I thought that Tyvaso DPI was going to grow their market share. Cost of sales, excluding share-based compensation. Cost of sales for the three months ended March 31, 2023 increased as compared to the same period in 2022, primarily due to an increase in Tyvaso DPI royalty expense and product costs, following the commercial launch of the product in June 2022. It's all good - transitioning from Nebulizer to TyvasoDPI accelerating and sales growing within expected parameters.
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Post by anderson on May 3, 2023 9:31:19 GMT -5
Appears that United reported that Tyvaso on sequential quarters dropped by about $4 million. Their stock is trading down by about$10.00. I thought that Tyvaso DPI was going to grow their market share. From the call it sounds like specialty pharmacies cut back on orders of Tyvaso nebulizer(to much stock on hand) and were not able to order the desired levels of Tyvaso DPI. This is supposedly not affecting the patients, just inventory build up. Which lead to an overall decline in Tyvaso revenue. Tyvaso DPI is surprisingly more popular than the nebulizer. Also combined this with the number of Tyvaso DPI patients in the UTHR PAP program and revenue suffers.
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Post by jkendra on May 3, 2023 12:49:55 GMT -5
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Post by porkini on May 3, 2023 20:34:02 GMT -5
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Post by peppy on May 4, 2023 2:43:49 GMT -5
Thank you porkini for the links and the sorting of information. Your call link allowed me to listen to the call. No wonder MNKD price jumped like it did. Another Tyvasso DPI line in Danbury by 2024. Another facility being built by UTHR for Tyvasso DPI manufacturing expansion. weehaw. I look for MNKD share price to continue up.
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Post by liane on May 4, 2023 17:49:04 GMT -5
Good Read!
A Factory of Unlimited Organs
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Post by casualinvestor on May 9, 2023 9:31:39 GMT -5
"Second, we're seeing a higher level of PAP utilization for Tyvaso DPI than we expected. We believe this is a short-term phenomenon and will subside to a large degree when the Medicare changes that are part of the inflation reduction at go into effect starting next year."
PAP utilization is their assistance program that generates little revenue. I believe this is the drag on $$, along with the usual Q1 insurance woes. It will also drag on MNKD royalty revenue.
MNKD increasing production will help, as they are not currently making enough product:
"First, our partner, MannKind, is activating a second production line and additional kitting capacity from which we expect to see increased DPI supply as soon as this quarter. Second, and in parallel, MannKind is also on track to significantly expand manufacturing capacity in the first half of next year to support up to 25,000 Tyvaso DPI patients a year."
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Post by uvula on May 9, 2023 10:00:41 GMT -5
Why would PAP drag down mnkd royalties? Don't we get paid per unit delivered to uthr?
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Post by Clement on May 9, 2023 11:12:40 GMT -5
Why would PAP drag down mnkd royalties? Don't we get paid per unit delivered to uthr? UTHR pays manufacturing cost plus when delivered to UTHR. UTHR pays royalties when sold to patient.
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Post by Clement on Jun 14, 2023 6:40:06 GMT -5
new distribution center and warehouse -- net zero energy (geothermal, photovoltaic, and battery storage) "Dubbed "Phase Five," the new building is the second site net zero building on the company’s Research Triangle Park Campus, and the fifth overall in its sustainable portfolio. The 55,000-square-foot facility features a new warehouse designed to meet current good manufacturing practices (cGMP) for pharmaceutical products and boasts a microgrid-based electrical system designed to run without any fossil fuels via battery backup using two Tesla Megapacks. Among other things, the facility will be used to store and distribute the company’s newest drug-device combination product, Tyvaso DPI®, which was launched last year." "As far as we are aware, this is the first cGMP warehouse designed to meet site net zero energy standards." finance.yahoo.com/news/united-therapeutics-unveils-net-zero-100000315.html
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Post by neil36 on Jun 20, 2023 16:32:51 GMT -5
Facebook Post June 15, 2023:
Ah yes, only in America: Three weeks ago, I transitioned from Tyvaso nebulizer to Tyvaso DPI for my main PH med. it’s a small disposable inhaler system that’s far easier to use and take with me than the old, bulky nebulizer and associated supplies and meds. Because I was at the re-order phase for the nebulizer med, they made me place a reorder of that med before they would let me order the DPI med. Keep in mind, each medication is roughly the same price, and my insurance is billed around $25,000 for each refill. So I had to deal with the copay for both.
The reason for this was that if the DPI didn’t work as well, or I had severe side effects, they wanted to make sure I still had my nebulizer meds on hand. The side effects have been minimal, and the med is just as effective. So me, calling the pharmacy and insurance to see what to do with the nebulizer medication…. And the response was….. “just throw it away. We can’t take it back, just dispose of the medication, the supplies AND the nebulizers”
I can tell you from personal experience that the time I had to send a nebulizer back because it shorted out… they tried to charge me $30,000 for the nebulizer…. I have three on hand, and they just told me to toss them in the trash like a dirty diaper.
I am floored by the waste. $20k+ in meds, plus, apparently $90k in medical hardware that they just want me to chuck out. The meds I can understand, at least to a degree, but the machinery? Jesus….. or they aren’t nearly as expensive to produce as they like to make people believe… in any case they made me order my meds to toss them, and I’m offering 3 $30k nebulizers for $60k to anyone that wants them, a great deal! 😂*
*not really, I’m probably not legally allowed to resell them, but if anyone wants to dig through my trash and make a donation, let me know. 😂
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Post by peppy on Jul 10, 2023 13:15:11 GMT -5
United Therapeutics Corporation (UTHR) 221.19. +9.37 (+4.42%)
MNKD 4.0950. +0.1850 (+4.7315%)
just looking.
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Post by Clement on Jul 10, 2023 15:25:13 GMT -5
High volume today for UTHR. Volume today was 718K shares. Ave volume (3M) is 378K shares. Share price up 5.3%.
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Post by wyattdog on Jul 24, 2023 10:51:12 GMT -5
tUnited Therapeutics Wins Appeal in Dry Powder Inhaler Patent Litigation 11:45 AM ET, 07/24/2023 - Business Wire SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Jul. 24, 2023--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the United States Court of Appeals for the Federal Circuit affirmed the district court decision in the patent litigation United Therapeutics brought against Liquidia Technologies, Inc. The Federal Circuit affirmed that Liquidia’s proposed Yutrepia™ product infringes a United Therapeutics’ patent, U.S. Patent No. 10,716,793 (the ’793 patent). As a result, the U.S. Food and Drug Administration (FDA) cannot grant Liquidia final approval for its Yutrepia product until expiration of the ’793 patent, May 14, 2027, except in certain circumstances discussed below.
The Federal Circuit affirmed the district court’s decision that Liquidia would induce infringement of various claims of the ’793 patent by marketing Yutrepia and that Liquidia failed to prove any claim of that patent invalid. The ‘793 patent relates to a method of administering treprostinil via inhalation.
The Federal Circuit also affirmed the district court’s decision that certain claims of another United Therapeutics patent, U.S. Patent No. 9,593,066 (the ’066 patent), are either invalid or not infringed by Liquidia. The ’066 patent relates to a method of making treprostinil, the active pharmaceutical ingredient in both Tyvaso® (treprostinil) Inhalation Solution and Tyvaso DPI® (treprostinil) Inhalation Powder.
“Today’s decision vindicates our position, as confirmed earlier by the district court, that Yutrepia is an infringing product. We will continue to vigorously defend our intellectual property,” said Shaun Snader, Vice President and Associate General Counsel – IP and Litigation at United Therapeutics.
Both parties have the opportunity to request rehearing by the Federal Circuit with respect to the adverse portions of the Federal Circuit’s affirmance.
Last year, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office issued a final written decision in an inter partes review (IPR) of the ’793 patent initiated by Liquidia finding all claims of the patent to be unpatentable. United Therapeutics appealed that decision to the Federal Circuit, and that appeal is pending. United Therapeutics expects that the PTAB decision will not affect the district court’s order barring FDA from granting final approval for Yutrepia unless all claims Liquidia was found to infringe are found invalid following exhaustion of all appeals.
United Therapeutics: Enabling Inspiration
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Post by jkendra on Jul 24, 2023 11:07:52 GMT -5
finance.yahoo.com/news/united-therapeutics-wins-appeal-dry-154500068.htmlUnited Therapeutics Wins Appeal in Dry Powder Inhaler Patent LitigationMon, Jul 24, 2023, 11:45 AM EDT SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C., July 24, 2023--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the United States Court of Appeals for the Federal Circuit affirmed the district court decision in the patent litigation United Therapeutics brought against Liquidia Technologies, Inc. The Federal Circuit affirmed that Liquidia’s proposed Yutrepia™ product infringes a United Therapeutics’ patent, U.S. Patent No. 10,716,793 (the ’793 patent). As a result, the U.S. Food and Drug Administration (FDA) cannot grant Liquidia final approval for its Yutrepia product until expiration of the ’793 patent, May 14, 2027, except in certain circumstances discussed below. The Federal Circuit affirmed the district court’s decision that Liquidia would induce infringement of various claims of the ’793 patent by marketing Yutrepia and that Liquidia failed to prove any claim of that patent invalid. The ‘793 patent relates to a method of administering treprostinil via inhalation. The Federal Circuit also affirmed the district court’s decision that certain claims of another United Therapeutics patent, U.S. Patent No. 9,593,066 (the ’066 patent), are either invalid or not infringed by Liquidia. The ’066 patent relates to a method of making treprostinil, the active pharmaceutical ingredient in both Tyvaso® (treprostinil) Inhalation Solution and Tyvaso DPI® (treprostinil) Inhalation Powder. "Today’s decision vindicates our position, as confirmed earlier by the district court, that Yutrepia is an infringing product. We will continue to vigorously defend our intellectual property," said Shaun Snader, Vice President and Associate General Counsel – IP and Litigation at United Therapeutics. Both parties have the opportunity to request rehearing by the Federal Circuit with respect to the adverse portions of the Federal Circuit’s affirmance. Last year, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office issued a final written decision in an inter partes review (IPR) of the ’793 patent initiated by Liquidia finding all claims of the patent to be unpatentable. United Therapeutics appealed that decision to the Federal Circuit, and that appeal is pending. United Therapeutics expects that the PTAB decision will not affect the district court’s order barring FDA from granting final approval for Yutrepia unless all claims Liquidia was found to infringe are found invalid following exhaustion of all appeals.
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