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Post by porkini on Aug 3, 2022 14:36:45 GMT -5
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Post by Clement on Aug 3, 2022 15:16:54 GMT -5
I just now read the EC transcript by motley fool. It was not the same as the actual EC.
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Post by oldfishtowner on Aug 3, 2022 15:51:25 GMT -5
I’m a bit surprised and confused by Martine’s comment on 50/50 split between DPI and nebulizer. My thoughts is maybe some later stage or those with an inability to use an inhaler properly for whatever reason (age, frail, can’t take a deep breath, etc) would benefit from the nebulizer where they don’t really have to do any work other than breath in the aerosol. Anyone have any better guesses? Martine went from 70% conversion to 50%, despite admitting it is more convenient and effective. Listen to the Jefferies Q&A from June. While the suitability of the delivery mechanism may play a role, UTHR also mentioned something about some patients/physicians will choose the nebulizer because of cost. It will be interesting to see what the difference in retail price is between the nebulizer and DPI. It may also give provide an idea of where LQDA will price its product if it ever gets to market.
Between the Jefferies conference and the earnings CC I get the impression UTHR is not going to push DPI, but market both products and let the providers/patients or reimbursers decide which to choose. I assume this choice will be based on the suitability for the patient as well as cost.
This seems to be inline with public concerns about inflation and the increased price consciousness among consumers that has percolated up to politicians and corporations.
By the way, at the Jefferies conference UTHR gave the DPI-nebulizer split as 60-40 for PAH and 50-50 for PAH-ILD. Now it seems to have migrated to 50-50 across the board.
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Post by mymann on Aug 3, 2022 16:13:45 GMT -5
"UTHR not pushing Tyvaso DPI"? Is that a hint that there is no 2nd molecule collaboration and secret royalty % for Tyvaso DPI is embarrassing to share with share holders?
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Post by peppy on Aug 3, 2022 16:19:55 GMT -5
"UTHR not pushing Tyvaso DPI"? Is that a hint that there is no 2nd molecule collaboration and secret royalty % for Tyvaso DPI is embarrassing to share with share holders? scroll up. to Neil. added indications. neil36United Therapeutics Corporation Reports Second Quarter 2022 Financial Results SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced its financial results for the quarter ended June 30, 2022. Total revenues in the second quarter of 2022 grew 5% year-over-year to $466.9 million, compared to $446.5 million in the second quarter of 2021. “I’m extraordinarily pleased with our business performance this past quarter,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “The FDA’s approval of our Tyvaso DPI medicine and recent major medical journal publications demonstrate our continuing product development success. I’m especially excited about our ongoing registration trials, such as PERFECT for assessing Tyvaso’s usefulness in COPD-associated pulmonary hypertension, ADVANCE OUTCOMES for studying whether once-daily ralinepag can reduce morbidity and mortality in pulmonary arterial hypertension, and TETON which is intended to demonstrate the disease-modifying potential of Tyvaso in idiopathic pulmonary fibrosis. Also very significant is our ARTISAN study, which will confirm whether Remodulin can be a short-term bridge to Orenitram when dosed rapidly to reduce right heart afterload and improve right ventricular structure and function.”“We ended the second quarter with a record number of patients on our treprostinil therapies, including the addition of approximately 500 Tyvaso patients this quarter,” said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics. “The recent approval and launch of Tyvaso DPI, coupled with the Medicare coverage decision for Tyvaso in PH-ILD, will provide additional momentum toward reaching our goal of 6,000 patients on Tyvaso by the end of the year.”
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Post by hopingandwilling on Aug 3, 2022 16:35:52 GMT -5
Dr. Rothblatt sure didn't help MNKDs cause today by making this statement during the Q&A session:
"Dr. Martine Rothblatt
Thank you, Jess, and really interesting questions, back to like kind of the heart of the business here. So, so cool. I'm going to maybe comment on your second question, and then I'm going to bounce it over to Mike on your first question. Our view is that there's going to be a, kind of, a leveling out at about 50-50 between nebulized and Tyvaso DPI. And you -- it's really very comparable to what we've seen over the years between subcu and IV in terms of parenteral.
I mean, of course, most people would think -- hello? Yes. Of course, most people would think that subcu was so much more convenient than IV that everybody would go on subcu, but it doesn't really work that way. And the fact of the matter is, depending on people's particular medical conditions, IV is a better solution for them than subcu. And while we are super excited about DPI and confident that it is the most convenient way imaginable to take Tyvaso, I think because of people's particular medical conditions, long term, you're going to see about a 50-50 mix between the nebulized and DPI form of Tyvaso."
In fact, this ratio was mentioned at least twice during the call. UTHR continues to move lower the conversion numbers they expect to see over the coming months. Considering these are the numbers that UTHR is expecting just based on MNKD's DPI, if you factor in and assuming LQDA is going to get FDA approval--this means MNKD would be set to get royalty on less than 50% of current Tyvaso sales. If this 50/50 split actually happens, at some point UTHR must make the hard decision---do they want to promote converting to DPI. Then they don't have to pay outside royalty for Tyvaso--they keep 100% of the revenue and profit on their books. For Tyvaso DPI, they must pay 12% royalty to MNKD. By them merely paying MNKD a 5%+ margin on manufacturing, UTHR is looking at paying out 17% of their Tyvaso revenue. Already, UTHR has a manufacturing cost for Tyvaso, at what point is the royalty payment and manufacturing cost for DPI does not justify the revenue potential---when they admit that 50% is the expected cap for the conversion revenue. Just for example--say LQDA gets 25% of the Tyvaso conversion---in simple terms, is the 17% additional cost to UTHR worth the 25% of revenue for MNKDs DPI version? Think of the UTHR sales force--are they going to be out promoting the merits of a DPI product that will benefit their competitor with free adverting for the merits of DPI.
Now you can flame away--but just remember, the CEO of UTHR is telling you what to expect for the conversion to a DPI version. And the CEO explains to you why this is to be expected! As some might say--a 100% of 50% is worth more than 100% of 25%.
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Post by buyitonsale on Aug 3, 2022 16:59:04 GMT -5
Conversion to DPI metric is from existing Tyvaso patients.
There are roughly 4500 patients currently.
The new starts however should opt for a more convenient form of Tyvaso. That is going to be up to the doctor recommendation and patient preference. And those new starts are likely to stay on the same treatment .
What would be the valid reason for a newly starting patient to initially choose a nebulizer over a small inhaler ? To me, DPI has many advantages.
The number of new patients for PAH ILD and soon new indications will be in tens of thousands.
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Post by prcgorman2 on Aug 3, 2022 17:02:30 GMT -5
Dr. Rothblatt sure didn't help MNKDs cause today by making this statement during the Q&A session: "Dr. Martine Rothblatt Thank you, Jess, and really interesting questions, back to like kind of the heart of the business here. So, so cool. I'm going to maybe comment on your second question, and then I'm going to bounce it over to Mike on your first question. Our view is that there's going to be a, kind of, a leveling out at about 50-50 between nebulized and Tyvaso DPI. And you -- it's really very comparable to what we've seen over the years between subcu and IV in terms of parenteral. I mean, of course, most people would think -- hello? Yes. Of course, most people would think that subcu was so much more convenient than IV that everybody would go on subcu, but it doesn't really work that way. And the fact of the matter is, depending on people's particular medical conditions, IV is a better solution for them than subcu. And while we are super excited about DPI and confident that it is the most convenient way imaginable to take Tyvaso, I think because of people's particular medical conditions, long term, you're going to see about a 50-50 mix between the nebulized and DPI form of Tyvaso." In fact, this ratio was mentioned at least twice during the call. UTHR continues to move lower the conversion numbers they expect to see over the coming months. Considering these are the numbers that UTHR is expecting just based on MNKD's DPI, if you factor in and assuming LQDA is going to get FDA approval--this means MNKD would be set to get royalty on less than 50% of current Tyvaso sales. If this 50/50 split actually happens, at some point UTHR must make the hard decision---do they want to promote converting to DPI. Then they don't have to pay outside royalty for Tyvaso--they keep 100% of the revenue and profit on their books. For Tyvaso DPI, they must pay 12% royalty to MNKD. By them merely paying MNKD a 5%+ margin on manufacturing, UTHR is looking at paying out 17% of their Tyvaso revenue. Already, UTHR has a manufacturing cost for Tyvaso, at what point is the royalty payment and manufacturing cost for DPI does not justify the revenue potential---when they admit that 50% is the expected cap for the conversion revenue. Just for example--say LQDA gets 25% of the Tyvaso conversion---in simple terms, is the 17% additional cost to UTHR worth the 25% of revenue for MNKDs DPI version? Think of the UTHR sales force--are they going to be out promoting the merits of a DPI product that will benefit their competitor with free adverting for the merits of DPI. Now you can flame away--but just remember, the CEO of UTHR is telling you what to expect for the conversion to a DPI version. And the CEO explains to you why this is to be expected! As some might say--a 100% of 50% is worth more than 100% of 25%. Couple things. Your post (and now mine) doesn't belong in the Volume thread. Second thing. No flames needed for your sophistry. IIRC, the treprostinil patent expired and MNKD did a phase 1 trial on their own of what we now call Tyvaso DPI. So UTHR kept more money by partnering with MNKD than if they ignored the DPI product. UTHR spent well over $250 million between developing and attempting the acceleration of approval of Tyvaso DPI. That ain't chump change. (Watch the movie "Barbarians at the Gate" with James Garner.) The conversion of existing Tyvaso users isn't the key. It's the new Rx for Tyvaso especially for expanded indications. Anyway you slice it, they're serious about selling the product they paid more than a quarter of a billion dollars to get developed and approved, and manufacturing costs and royalties will accrue to MNKD. i.e,. Tyvaso DPI is a cash cow, not a goose that lays golden eggs. It helps MNKD, not makes MNKD.
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Post by prcgorman2 on Aug 3, 2022 17:10:30 GMT -5
Thank you Liane and/or porkini (or other moderator)!
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Post by Chris-C on Aug 3, 2022 20:12:02 GMT -5
This may have been posted elsewhere on the board, so my apologies if it is a duplicate. The UTHR earnings release announcement arrived in my inbox this morning at 5:00am. I thought a couple of paragraphs were interesting and relevant to the discussion above (plus this thread is titled 2nd quarter financial results! And, the comments have relevance to MNKD's upcoming earning's report since they clearly show that patients have been using DPI and United is adding more patients to its Tyvaso product. To wit:
“We ended the second quarter with a record number of patients on our treprostinil therapies, including the addition of approximately 500 Tyvaso patients this quarter,” said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics. “The recent approval and launch of Tyvaso DPI, coupled with the Medicare coverage decision for Tyvaso in PH-ILD, will provide additional momentum toward reaching our goal of 6,000 patients on Tyvaso by the end of the year.”
Later in the earnings release:
"Net product sales from our treprostinil-based products (Tyvaso, Remodulin, and Orenitram) grew by $42.2 million for the second quarter of 2022, as compared to the same period in 2021. The growth in Tyvaso revenues resulted primarily from an increase in quantities sold, reflecting an increased number of patients following the label expansion to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD). The decrease in Unituxin revenues resulted primarily from a decrease in quantities sold, partially offset by a price increase. The decrease in quantities sold was primarily due to the timing of orders by our distributors and does not precisely reflect trends in underlying patient demand. The decrease in Adcirca revenues resulted primarily from higher gross-to-net deductions and, to a lesser extent, a decline in bottles sold as a result of generic competition for Adcirca."
Then, further down the release :
RESEARCH AND DEVELOPMENT UPDATE
Updates on select later-stage programs are below.
"Tyvaso in IPF — TETON 1 and TETON 2. We are enrolling a phase 3 study called TETON 1, which is a U.S. study of Tyvaso for the treatment of idiopathic pulmonary fibrosis (IPF). The primary endpoint of this study is the change in absolute forced vital capacity (FVC) from baseline to week 52. We are in the process of commencing an additional phase 3 study of Tyvaso in IPF patients that will be similar to TETON 1, called TETON 2, but will be conducted outside of the United States.
The TETON program was prompted by data from the INCREASE study which demonstrated improvements in certain key parameters of lung function in pulmonary hypertension patients with fibrotic lung disease. Specifically, in the INCREASE study, treatment with Tyvaso resulted in significant improvements in percent predicted FVC at weeks 8 and 16, with subjects having underlying etiologies of idiopathic interstitial pneumonias showing greater improvement. Consistent positive effects were also observed in patients with chronic hypersensitivity pneumonitis and environmental/occupational lung disease. These data points, combined with substantial preclinical evidence of antifibrotic activity of treprostinil, suggest that Tyvaso may offer a treatment option for patients with fibrotic lung disease."
Tyvaso in PH-COPD — PERFECT. Enrollment is ongoing for the phase 3 PERFECT study evaluating Tyvaso for the treatment of WHO Group 3 pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD). Recently, we decided to trigger a pre-specified transition and convert the PERFECT study from a crossover study into a single treatment period of 12 weeks. While this increased the size of the study from 136 patients to 314 patients, we believe this decision may increase site and subject participation with a simpler, shorter, and more traditional study design.
QUESTION FOR OUR FDA Experts: If Tyvaso is approved for additional indications based on these studies, does FDA label expansion automatically qualify the DPI version? Or do data need to be collected on these disease specific uses in another application?
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Post by oldfishtowner on Aug 3, 2022 23:16:19 GMT -5
"UTHR not pushing Tyvaso DPI"? Is that a hint that there is no 2nd molecule collaboration and secret royalty % for Tyvaso DPI is embarrassing to share with share holders? In the context of my statement I meant that UTHR is not going to prefer or push DPI over the nebulizer. My take is that UTHR will market each product with the same effort and let the market choose between them.
I believe the 50-50 split was intended as an estimate of the initial reception of the two products by the market. My recollection is that earlier UTHR remarks suggest UTHR does believe DPI is the better product in terms of delivering treprostinil to the lungs, and that eventually DPI will gain more of the market. And perhaps the latter is what the original estimates represent.
I can understand the business decision. UTHR likely wants to capture as many new patients as as quickly as possible before LQDA gains a foothold in the event LQDA gets the nod from the court and the FDA. UTHR is taking the path of least resistance for the market and not wasting time or money trying to steer patients to one drug or the other. This is the reality of the market and a smart business decision to deal with this reality in a way that enhances the probability of reaching their revenue and earnings goals and reducing risk. So no, I don't think that this means UTHR will not exercise its option to develop a second or even a third molecule with MNKD. But frankly, I do not expect UTHR to make decision until sometime next year.
I am not at all concerned about this.
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Post by sr71 on Aug 4, 2022 1:52:17 GMT -5
Chris-C,
I’m no FDA expert, but Martine appears to generally use term “Tyvaso” in a non-specific inclusive manner.
I believe this is intentional to keep competitors (such as Liquidia) guessing the details, especially with unresolved litigation in play.
This is fine with me since I consider Martine to be in the same league as Al Mann, whom I also have trusted.
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Post by Clement on Aug 4, 2022 8:29:46 GMT -5
"UTHR not pushing Tyvaso DPI"? Is that a hint that there is no 2nd molecule collaboration and secret royalty % for Tyvaso DPI is embarrassing to share with share holders? In the context of my statement I meant that UTHR is not going to prefer or push DPI over the nebulizer. My take is that UTHR will market each product with the same effort and let the market choose between them.
I believe the 50-50 split was intended as an estimate of the initial reception of the two products by the market. My recollection is that earlier UTHR remarks suggest UTHR does believe DPI is the better product in terms of delivering treprostinil to the lungs, and that eventually DPI will gain more of the market. And perhaps the latter is what the original estimates represent.
I can understand the business decision. UTHR likely wants to capture as many new patients as as quickly as possible before LQDA gains a foothold in the event LQDA gets the nod from the court and the FDA. UTHR is taking the path of least resistance for the market and not wasting time or money trying to steer patients to one drug or the other. This is the reality of the market and a smart business decision to deal with this reality in a way that enhances the probability of reaching their revenue and earnings goals and reducing risk. So no, I don't think that this means UTHR will not exercise its option to develop a second or even a third molecule with MNKD. But frankly, I do not expect UTHR to make decision until sometime next year.
I am not at all concerned about this.
Bingo!
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Post by veritasfiliatemporis on Aug 4, 2022 9:05:14 GMT -5
Questionable...If I recall correctly 48 out of 50 patient at the end of the trial remained on Tyvaso DPI all " very satisfy and not willing to switch back". It has high potential, why UTHR should not run for Tyvaso DPI? Do not forget has been approved without black box warning, this could drive a change for black box policy even for Afrezza. I don't see the point here.
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Post by wyattdog on Aug 4, 2022 10:38:51 GMT -5
-Oppenheimer Adjusts United Therapeutics Price Target to $325 From $300, Maintains Outperform Rating 10:01 AM ET, 08/04/2022 - MT Newswires
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