|
Post by mymann on Oct 30, 2023 21:29:02 GMT -5
Cool your jets. Because mnkd sp had a good day, the wild fantasy starts to fill our heads.
|
|
|
Post by porkini on Oct 30, 2023 21:56:15 GMT -5
Cool your jets. Because mnkd sp had a good day, the wild fantasy starts to fill our heads. For me it is just a mild fantasy. Maybe I just have more imagination for my wild fantasies. But then, this is a thread about UTHR and I'm slightly more than mildly pleased with my UTHR investment!
|
|
|
Post by kite on Oct 31, 2023 5:55:38 GMT -5
ir.unither.com/news/press-releases/press-release-details/2023/United-Therapeutics-Announces-First-Patient-Enrolled-in-Phase-3-TETON-PPF-Study-of-Nebulized-Tyvaso-in-Patients-with-Progressive-Pulmonary-Fibrosis/default.aspxUnited Therapeutics Announces First Patient Enrolled in Phase 3 TETON PPF Study of Nebulized Tyvaso in Patients with Progressive Pulmonary Fibrosis
Up to 60,000 patients in the United States may have PPF, with only one approved therapy available SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the first patient has enrolled in the registration-phase TETON PPFstudy, which will evaluate nebulized Tyvaso® (treprostinil) Inhalation Solution in 698 adult patients with progressive pulmonary fibrosis (PPF). This is in addition to two separate ongoing registration-phase studies, TETON 1 and TETON 2, of nebulized Tyvaso in patients with another type of pulmonary fibrosis (PF) known as idiopathic pulmonary fibrosis (IPF). The 52-week study will evaluate the impact of nebulized Tyvaso on a key prognostic indicator for PPF known as forced vital capacity (FVC). PPF is a progressive form of interstitial lung disease (ILD) characterized by the loss of the ability of the lungs to transfer oxygen into the blood, ultimately resulting in respiratory failure and death. Nebulized Tyvaso is currently approved by the U.S. Food and Drug Administration (FDA) to treat both pulmonary arterial hypertension and pulmonary hypertension (PH) associated with interstitial lung disease (PH-ILD). The PH-ILD indication, which includes patients with PH associated with IPF and PPF, was added to the nebulized Tyvaso label in March 2021 based on the successful results of the INCREASE study. Nebulized Tyvaso is only approved for use for PPF patients who may also have documented PH, to improve exercise capacity. The TETON PPF study seeks to evaluate the use of nebulized Tyvaso in PPF patients irrespective of whether or not they have PH. “The progressive pulmonary fibrosis phenotype represents a group of ILD patients who only have limited treatment options currently available to them,” said Steven Nathan, M.D., Medical Director of the Advanced Lung Disease and Lung Transplant Program at Inova Fairfax Hospital in Falls Church, Virginia, who is also chair of the TETON program steering committee. “The broader ILD data set from the INCREASE study showed improvements in FVC beyond just IPF patients, and the data provide the foundation for further study of inhaled treprostinil’s anti-fibrotic and disease modifying mechanism of action in patients with other forms of fibrotic lung disease like PPF.” “The initiation of the global TETON PPF study illustrates confidence in nebulized Tyvaso as a potential treatment option for patients with fibrotic lung disease,” said Natalie Breytenbach, Pharm.D., Associate Director, Global Product Development at United Therapeutics and the company’s lead for the TETON PPF study. “The expansion of TETON into the PPF patient population allows us to continue to evaluate inhaled treprostinil’s potential for treating this vulnerable group of patients in a robust global pivotal study.” The TETON program in IPF and PPF was prompted by data from the INCREASE study of nebulized Tyvaso for the treatment of PH-ILD, which demonstrated improvements in certain key parameters of lung function in pulmonary hypertension patients with fibrotic lung disease (improved absolute FVC and reduced exacerbations of underlying lung disease). Specifically, in the INCREASE study, treatment with nebulized Tyvaso resulted in significant improvements in percent predicted FVC at weeks 8 and 16, with subjects having an underlying etiology of IPF showing the greatest improvement (week 8: 2.5%; p=0.0380 and week 16: 3.5%; p=0.0147). In May 2022, data from the INCREASE open-label, long-term extension trial were presented at a medical conference, indicating that improvements in FVC were sustained for at least 64 weeks for PH-ILD patients with underlying IPF. For those patients who received placebo during the INCREASE study, marked improvements in FVC were observed following transition to nebulized Tyvaso during the open-label extension study. These data points, combined with substantial preclinical evidence of antifibrotic activity of treprostinil, suggest that nebulized Tyvaso may offer a treatment option for patients with IPF and PPF. Tyvaso DPI® (treprostinil) Inhalation Powder is not being evaluated in the TETON program, but United Therapeutics intends to seek FDA approval to expand the Tyvaso DPI label to include IPF and PPF, following completion of the TETON studies and any FDA-required bridging studies.
|
|
|
Post by ptass on Oct 31, 2023 9:35:06 GMT -5
Anyone have an educated guess on how long it will take to recruit the rest of the study participants?
|
|
|
Post by castlerockchris on Oct 31, 2023 10:54:59 GMT -5
Cool your jets. Because mnkd sp had a good day, the wild fantasy starts to fill our heads. Not a wild speculation, just a statement of fact on how quickly I would act if UTHR decided to offer MNKD shareholders the same premium. I don't believe it is going to happen, just wishing it would. Here is wild speculation - MNKD 101 shows excellent early results in the Phase II/III trail by late in 2024. UTHR decides it is potentially another $1b+ drug they could own. Looks at the royalties and manufacturing costs it will be paying for T-DPI for all indications over the next decade (2-3 billion), and says that is enough and buys MNKD for a 100% premium while the stock is hovering around $6.50. That is only 3.7 billion (assumes 284.5mm shares outstanding), of which potentially $200mm+ annually will fall directly to their bottom line. It will be accretive and have the potential to launch another orphan lung drug all within a year. Assuming they save the $200mm in royalties in the first year, at their current PE ratio of 12.5 that is a 2.5 billion dollar boost to their market cap. They only need to find another 1.2 billion in value for the remainder of the purchase price in order to justify it to share holders. Peds trial coming to a near term conclusion? Plus favorable MNKD 101 early results? Plus existing Afrezza business? The deal is half cash, half stock and assumes existing cash (MNKD's remaining cash on hand and some UTHR cash) is used to extinguish MNKD's debt. Seems like a good deal to me. Here is some even wilder speculation. UTHR does the above and immediately sells the insulin business and pipeline, minus MNKD 101 back to Mike and his team for $750mm - $1B. They allow the new MNKD to keep the manufacturing facility and continue to manufacture T-DPI until UTHR's Death Star factory comes on line in 2027 - 2028, as part of the deal. There, that is wild speculation! Or is it?
|
|
|
Post by peppy on Nov 1, 2023 7:49:07 GMT -5
|
|
|
Post by cretin11 on Nov 1, 2023 8:52:31 GMT -5
castlerock your speculation is indeed wild, but fun to ponder. I like the sound of it. But I don’t think the last part would be viable (UTHR selling the insulin division etc back to mike and his team). Mike’s made a boatload of $$$ off MNKD but not that much! And I don’t think he’d find any backing at that price level. But stranger things have happened so who knows!
|
|
|
Post by MnkdWASmyRtrmntPlan on Nov 1, 2023 8:52:38 GMT -5
third-quarter 2023 earnings of $5.38 per share beat the Consensus Estimate of $4.89 by +10% Earnings rose 10% year over year on the back of higher product sales.
Revenues in the reported quarter were $609.4 million, beating the Consensus Estimate of $576.5 million. Revenues rose 18% year over year, driven by Tyvaso sales.
Quarter in Detail Tyvaso sales totaled $325.8 million, up 26% year over year, which beat the Consensus Estimate of $305 million. Tyvaso revenues included $205.1 million in sales from the Tyvaso dry powder inhalation (DPI) formulation, and $120.7 million in sales from nebulized Tyvaso. Sales of Tyvaso DPI rose 225% in the quarter, driven by higher volumes and continued growth in utilization by patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Sales of nebulized Tyvaso declined 38% due to lower volumes following patient switch to Tyvaso DPI.
Which all sounds good to me. Alas, after a half-hour of trading today, MNKD has dropped from yesterday's close of $4.29 to $4.23. Go figure.
|
|
|
Post by dh4mizzou on Nov 1, 2023 9:21:13 GMT -5
And yet UTHR is DOWN 4% so far today. WTF is going on?
|
|
|
Post by peppy on Nov 1, 2023 9:39:49 GMT -5
|
|
|
Post by Clement on Nov 1, 2023 9:59:23 GMT -5
In the call, UTHR said that, until January, there are some reimbursement problems with T-DPI. Mike B also said to expect ratio of TDPI/Tneb to increase beginning in January because those problems will go away.
On another topic, the PAP was not mentioned. (Patient Assistance Program)
|
|
|
Post by MnkdWASmyRtrmntPlan on Nov 1, 2023 10:20:54 GMT -5
UTHR Net product sales of Tyvaso DPI - Three Months Ended:March 31, June 30, September 30, December 31, March 31, June 30, September 30, 2022 2022 2022 2022 2023 2023 2023 $ — $3.0 $63.1 $92.2 $118.7 $193.6 $205.1 (source = UTHR 2023 Q3 Finances) MNKD 2Q 2023 Tyvaso DPI royalties =~ $19M (source = MNKD 2023 Q2 Finances) *So, MNKD's estimated Royalty-Percent =~ 9.81% *And, MNKD's 3Q 2023 calculated Tyvaso-DPI royalties =~ $20.1M (+5.8%)
|
|
|
Post by peppy on Nov 1, 2023 11:36:39 GMT -5
UTHR share price coming back up on heavy volume for UTHR $222.115 -0.745 (-0.33%) Bid: $221.86 x 105 Ask: $222.35 x 36 Volume: 553,937
|
|
|
Post by MnkdWASmyRtrmntPlan on Nov 1, 2023 13:26:07 GMT -5
UTHR Net product sales of Tyvaso DPI - Three Months Ended:March 31, June 30, September 30, December 31, March 31, June 30, September 30, 2022 2022 2022 2022 2023 2023 2023 $ — $3.0 $63.1 $92.2 $118.7 $193.6 $205.1 (source = UTHR 2023 Q3 Finances) MNKD 2Q 2023 Tyvaso DPI royalties =~ $19M (source = MNKD 2023 Q2 Finances) *So, MNKD's estimated Royalty-Percent =~ 9.81% *And, MNKD's 3Q 2023 calculated Tyvaso-DPI royalties =~ $20.1M (+5.8%) Correction: I should not have used the word "estimated" above. I should have used the word "approximate". The Royalty-Percent was not estimated; it was calculated. However, I do not believe the "$19M" number is very accurate (even though it is directly from the Mannkind 2023 Q3 Financial Information Results).
|
|
|
Post by joeypotsandpans on Nov 1, 2023 14:24:39 GMT -5
UTHR share price coming back up on heavy volume for UTHR $222.115 -0.745 (-0.33%) Bid: $221.86 x 105 Ask: $222.35 x 36 Volume: 553,937 Huge outside day, nice recovery, let's see how it closes in 35 minutes 😉
|
|