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Post by uvula on Sept 1, 2022 8:47:01 GMT -5
I'm no expert on this, but I'm guessing the CEO will be sued by anyone who bought stock based on his comment and could be sued by the SEC also. |
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Post by phdedieu12 on Sept 1, 2022 10:10:25 GMT -5
Care to elaborate uvula??
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Post by uvula on Sept 1, 2022 10:27:48 GMT -5
Yesterday he said he was pleased with the ruling. I didn't listen to his conference call this morning.
The ruling hurts lqda.
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Post by akemp3000 on Sept 1, 2022 10:41:23 GMT -5
This may help explain why the Liquidia CEO perspective is polar opposite of most here. It seems he'll focus on the positive aspect of the ruling and will challenge the negative. UTHR will also challenge a part of the ruling. Regardless, there will be a further delay which is a big advantage to UTHR.
The commercial-stage biopharma Liquidia Corporation (NASDAQ:LQDA) dropped ~12% in the pre-market trading Thursday after Wedbush downgraded the stock to Underperform from Neutral, citing a delay for the commercial launch of its lead asset Yutrepia after a recent court decision.
In Nov. 2021, the FDA granted tentative approval for Yutrepia, a generic to Pulmonary Arterial Hypertension (PAH) therapy Tyvaso marketed by United Therapeutics (UTHR). The final approval and commercial launch of Yutrepia depend on the outcome of LQDA’s ongoing Hatch-Waxman Litigation with UTHR over patent rights for Tyvaso.
On Wednesday, a U.S. District Court Judge ruled in favor of LQDA on the ‘066 patent and ruled against it on the `793 patent, a split decision that both companies will likely appeal, Wedbush analysts Liana Moussatos and Andreas Argyrides argued.
“United has requested a rehearing of the '793 IPR decision and is likely to appeal if the PTAB decision is not reversed with the appeals process taking at least 1 yr,” the team added. They pushed back the projected timeline for full approval and the U.S. launch of Yutrepia to mid-2024 from Nov. 2022.
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Post by Thundersnow on Sept 1, 2022 13:06:25 GMT -5
United Therapeutics Prevails in Dry Powder Inhaler Patent Litigation United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the United States District Court for the District of Delaware issued an opinion in the pending litigation concerning United Therapeutics’ U.S. patents 9,593,066 (the ’066 patent) and 10,716,793 (the ’793 patent). This litigation concerns whether Liquidia Technologies, Inc.’s proposed treprostinil inhalation powder, YutrepiaTM, would infringe the ’066 and ’793 patents. The Court determined that Liquidia would induce infringement of various claims of the ’793 patent by marketing Yutrepia. The ‘793 patent relates to a method of administering treprostinil via inhalation. The Court also concluded that Liquidia failed to prove that any claim of the ’793 patent at issue is invalid. As a result of the Court’s decision, United Therapeutics expects the Court to enter an injunction barring the U.S. Food and Drug Administration from granting final approval for Yutrepia until expiration of the ’793 patent, May 14, 2027, as required by 35 U.S.C. § 271(e)(4)(A). I love that 3rd paragraph! 2027. So I see UTHR has 2 options regarding '793. They can prevent LQDA from getting final approval until '27 or they can enter into a royalty agreement and make money. |
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Post by pat on Sept 1, 2022 16:57:07 GMT -5
UTHR continues to impress, it is a well run company. I don’t expect them to buy out LQDA, but if they do then it’ll probably be the right move. And I’d be admittedly a bit envious if it happens, would rather see them buy MNKD, even though it would be a much lower number than we all used to envision. Interesting to see the share price action of UTHR, LQDA and MNKD starting about 2:30 today. arent you the one who said LFD is usually right and wasn’t it LFD who has been pro LQDA and trashes MNKD? |
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Post by agedhippie on Sept 1, 2022 22:48:27 GMT -5
Aged - courts are totally unpredictable but one thing seems certain and that it this is going to go on for at least another couple of years. Even if LQDA prevails UTHR will have taken control of the market and LQDA will have run out of money. It seems to me that at this point few will give them more money and they are doomed. I suspect they won't run out of money. They have $103M cash in bank and their burn rate is between $6M and $9M per qtr. That's more than enough to last 2 years without dilution. That said I suspect they will do a dilution round to cover manufacturing. |
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Post by cretin11 on Sept 2, 2022 1:56:43 GMT -5
UTHR continues to impress, it is a well run company. I don’t expect them to buy out LQDA, but if they do then it’ll probably be the right move. And I’d be admittedly a bit envious if it happens, would rather see them buy MNKD, even though it would be a much lower number than we all used to envision. Interesting to see the share price action of UTHR, LQDA and MNKD starting about 2:30 today. arent you the one who said LFD is usually right and wasn’t it LFD who has been pro LQDA and trashes MNKD? I don’t recall ever saying “LFD is usually right” and don’t think I’ve ever said or written that. And I’ve never read a LFD article about LQDA so have no idea what he thinks about that stock, nor do I care. (I’ve only read LFD’s articles about MNKD and of course lots of what he posts is accurate, because he regurgitates plenty of facts that are reported by MNKD itself. That’s part of what makes LFD’s articles so painful to read, the other part is how one-sided and over the top they are.) You might be confused because I’ve posted that Spencer Osbourne has been proven accurate on many things regarding MNKD. I have posted about hating on his articles for a long time, until finally seeing him be right (and me wrong) so often that I had to admit it. |
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Post by pat on Sept 2, 2022 5:51:59 GMT -5
arent you the one who said LFD is usually right and wasn’t it LFD who has been pro LQDA and trashes MNKD? I don’t recall ever saying “LFD is usually right” and don’t think I’ve ever said or written that. And I’ve never read a LFD article about LQDA so have no idea what he thinks about that stock, nor do I care. (I’ve only read LFD’s articles about MNKD and of course lots of what he posts is accurate, because he regurgitates plenty of facts that are reported by MNKD itself. That’s part of what makes LFD’s articles so painful to read, the other part is how one-sided and over the top they are.) You might be confused because I’ve posted that Spencer Osbourne has been proven accurate on many things regarding MNKD. I have posted about hating on his articles for a long time, until finally seeing him be right (and me wrong) so often that I had to admit it. july 25 at 2:43pm. “…not easy admitting LFD was right”. You’ve repeatedly written that. I don’t have the patience to pull each instance. LFD has been incredibly critical of MNKD and technosphere. I have always suspected your motives and continue to. |
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Post by sportsrancho on Sept 2, 2022 7:38:09 GMT -5
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Post by sayhey24 on Sept 2, 2022 8:26:05 GMT -5
Aged - courts are totally unpredictable but one thing seems certain and that it this is going to go on for at least another couple of years. Even if LQDA prevails UTHR will have taken control of the market and LQDA will have run out of money. It seems to me that at this point few will give them more money and they are doomed. I suspect they won't run out of money. They have $103M cash in bank and their burn rate is between $6M and $9M per qtr. That's more than enough to last 2 years without dilution. That said I suspect they will do a dilution round to cover manufacturing. Do they have a manufacturing facility? I thought they are basically running the development/trials out of a "lab" facility similar to what MNKD did back in the day. If they need to develop such a facility $100m is not going to go very far. Who in their right mind is going to give this company $200m to build a manufacturing facility for a drug which is caught up in a lawsuit and could very well lose. If they win then they will need to go up against the market leader who has a drug which has a 2 year head start and an existing sales team and the drug is as good or better than theirs. I wish them luck. As far as MNKD I don't see LQDA impacting Tyvaso DPI sales for at least several years. Hopefully that will give Mike more than enough time develop a plan for afrezza and start executing it in the T2 market. If and when he does Tyvaso DPI revenue to MNKD will be insignificant. |
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Post by Clement on Sept 2, 2022 9:12:40 GMT -5
I suspect they won't run out of money. They have $103M cash in bank and their burn rate is between $6M and $9M per qtr. That's more than enough to last 2 years without dilution. That said I suspect they will do a dilution round to cover manufacturing. Do they have a manufacturing facility? I thought they are basically running the development/trials out of a "lab" facility similar to what MNKD did back in the day. If they need to develop such a facility $100m is not going to go very far. Who in their right mind is going to give this company $200m to build a manufacturing facility for a drug which is caught up in a lawsuit and could very well lose. If they win then they will need to go up against the market leader who has a drug which has a 2 year head start and an existing sales team and the drug is as good or better than theirs. I wish them luck. As far as MNKD I don't see LQDA impacting Tyvaso DPI sales for at least several years. Hopefully that will give Mike more than enough time develop a plan for afrezza and start executing it in the T2 market. If and when he does Tyvaso DPI revenue to MNKD will be insignificant. Liquidia's proprietary PRINT technology was developed and built in-house, beginning back in the days when Joe Desimone was at UNC. PRINT technology is how they make very small particles (powder) with a very tight size distribution. I think that manufacturing of all their Treprostinil powder occurs at their facilities in RTP. Their inhaler looks like they simply buy a stock item from a plastics manufacturer. Having said that, I agree that it could be tough for LQDA to hang on. It appears the only revenue stream is distributing generic Treprostinil (not in powder form) and that's not a big revenue generator. |
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Post by harryx1 on Sept 2, 2022 9:42:24 GMT -5
IMO, this is how I see things playing out the next week or so...
LQDA will drift a little higher then UTHR will submit their final judgement and ask that the judge uphold the 793 as valid and infringed and then request an injunction on Yutrepia for the life of the patent.
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Post by cretin11 on Sept 2, 2022 10:25:22 GMT -5
I don’t recall ever saying “LFD is usually right” and don’t think I’ve ever said or written that. And I’ve never read a LFD article about LQDA so have no idea what he thinks about that stock, nor do I care. (I’ve only read LFD’s articles about MNKD and of course lots of what he posts is accurate, because he regurgitates plenty of facts that are reported by MNKD itself. That’s part of what makes LFD’s articles so painful to read, the other part is how one-sided and over the top they are.) You might be confused because I’ve posted that Spencer Osbourne has been proven accurate on many things regarding MNKD. I have posted about hating on his articles for a long time, until finally seeing him be right (and me wrong) so often that I had to admit it. july 25 at 2:43pm. “…not easy admitting LFD was right”. You’ve repeatedly written that. I don’t have the patience to pull each instance. LFD has been incredibly critical of MNKD and technosphere. I have always suspected your motives and continue to. Thanks for confirming my memory on this was accurate. |
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Post by agedhippie on Sept 2, 2022 10:57:06 GMT -5
IMO, this is how I see things playing out the next week or so... LQDA will drift a little higher then UTHR will submit their final judgement and ask that the judge uphold the 793 as valid and infringed and then request an injunction on Yutrepia for the life of the patent. I agree. If Liquidia appeal then the stay will remain in place pending appeal, and if they don't I think UTHR will get an injunction to formalize it. |
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