Decision from US Court of Appeals

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anonymous

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What does everyone think about the decision that came down from the US Court of Appeals yesterday? Seems like HE patents are valid until 2029 but IBS-D patents were deemed invalid. The appellate court upheld the district court’s decision. Thoughts?
 












Depends. It seems like IBS-D patents are invalid. Seems open to interpretation in my view. It seems like the patents aren’t valid which means a generic version could be manufactured. 14 days/42 pills/550 mg.
 






Based on my understanding they affirmed the HE ruling and remanded the IBS-D ruling back to lower courts to reconsider. That ruling coupled with the Amneal lawsuit puts the B&L spin-off in jeopardy I would think.
 












anonymous said:
Completely agree. I read the lower court decision and I don’t see how Salix can win. It is what it is and just rolling with it.
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What makes you think this is such a bad ruling? I believe your interpretation is wrong. In order for anyone to pursue the IBS-D indication they have to jump through major hoops with trials, etc. and spend lots of $$ - it would be close to 2028-2029 by the time they get all of that done. It wouldnt make any sense because the current patents will be expiring by then. Its unfoefunate that our corporate communications cant put together a clear, positive press release.
 






Did you read the full opinion and lower court decision? I would read all of that before you make that statement. The patents are invalid for IBS-D. That says we don’t have a valid patent to protect generic companies from filing NDA’s to make the 550 mg dose x 14 days. The FDA will then have to determine if they will approve the NDA. It’s not a definite lock for an approval BUT it could get a lot of generic companies to starting trying to get it approved. Possibly hoping to get a settlement from us not to go to market? Other companies have settled. My concern with that is can we afford to settle? We have a lot of debt so how do we pay for these settlements. Just trying to point some things out and not stress anyone out. Just don’t want to see anyone blindsided.
 






This right here. The patents are invalid so everyone is free to make a generic. That coupled with the Amneal lawsuits really puts the future of Bauch into a precarious position. I don't see how they can effectively spin-off BLCO. I think that is what investors are seeing also. The stock has dropped 25% in the last month, and put options are up. Will be interesting to see what happens. Bausch's problem is they have nothing in the pipeline. How can they be solvent in 4 years, with 20 billion in debt coming due?
 












anonymous said:
This right here. The patents are invalid so everyone is free to make a generic. That coupled with the Amneal lawsuits really puts the future of Bauch into a precarious position. I don't see how they can effectively spin-off BLCO. I think that is what investors are seeing also. The stock has dropped 25% in the last month, and put options are up. Will be interesting to see what happens. Bausch's problem is they have nothing in the pipeline. How can they be solvent in 4 years, with 20 billion in debt coming due?
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Thats absolutely incorrect. The patent for IBS-D was determined not to be valid. A generic company can pursue that indication; however, in order to do so they have to conduct studies that show bioequivalence. The patents will almost be expired by the time those studies are completed - and they are expensive to conduct- no company is going to risk that much money for such a short period of time.
 






anonymous said:
Did you read the full opinion and lower court decision? I would read all of that before you make that statement. The patents are invalid for IBS-D. That says we don’t have a valid patent to protect generic companies from filing NDA’s to make the 550 mg dose x 14 days. The FDA will then have to determine if they will approve the NDA. It’s not a definite lock for an approval BUT it could get a lot of generic companies to starting trying to get it approved. Possibly hoping to get a settlement from us not to go to market? Other companies have settled. My concern with that is can we afford to settle? We have a lot of debt so how do we pay for these settlements. Just trying to point some things out and not stress anyone out. Just don’t want to see anyone blindsided.
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Yes - I understand the full ruling. Do you understand what is required of the generic companies to pursue the IBS-D indication? They would have to conduct full bioequivalency trials - timely and costly, by the time they are completed the patents will almost be expired. Thats why this was a positive decision. We are lucky they initially went after both indications otherwise it might have been ugly .
 






And the stock price is soaring because of it. If it was such a positive decision, Appio wouldn't have put out the statement he put out. Bottom line is this company is on the tail-end of its lifecycle.
 






I00% agree with the statement above. Stock price is going down, down, down. Street does not like that they are hearing. If people have options for other positions, they should take them.
 






anonymous said:
And the stock price is soaring because of it. If it was such a positive decision, Appio wouldn't have put out the statement he put out. Bottom line is this company is on the tail-end of its lifecycle.
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Have you not seen how T.A. communicates? Its no surprise that his email was confusing. Unfortunately you have to rely on analysts for an understanding of what is going on. The stock price should raise after the May earnings call.
 






anonymous said:
I00% agree with the statement above. Stock price is going down, down, down. Street does not like that they are hearing. If people have options for other positions, they should take them.
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Its crazy how clueless some people are about this scenario. Unless you are an Integra rep you have zero reason to go anywhere.
 






anonymous said:
Its crazy how clueless some people are about this scenario. Unless you are an Integra rep you have zero reason to go anywhere.
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Wow - that is so awesome to read this comment!

From “Clueless Person” - You obviously have not been listening the earnings calls or the recent fireside chat. Senior leaders literally responded to questions about plans for the future after Xifaxan goes generic in 2029 (you know the drug that keeps this company afloat) with the statements like “we won’t see a launch for Rifaximin SSD until next century!” What this means is that in 5 short years there won’t be a need for ANY tower. Also - reps will be 5 years older and, pharma generally likes to hire them young and train them “their” way. I was just saying that everyone should be looking for new opportunities IF they need the income that this job provides them. If not, then definitely ride it out. That is my plan. That’s because I don’t “need” this job.

Would feel terrible if someone actually needed the income and passed on an opportunity because they chose to just listen to management and not actually do research (on the company, etc) for himself/herself.
Good luck to you.
 






anonymous said:
Wow - that is so awesome to read this comment!

From “Clueless Person” - You obviously have not been listening the earnings calls or the recent fireside chat. Senior leaders literally responded to questions about plans for the future after Xifaxan goes generic in 2029 (you know the drug that keeps this company afloat) with the statements like “we won’t see a launch for Rifaximin SSD until next century!” What this means is that in 5 short years there won’t be a need for ANY tower. Also - reps will be 5 years older and, pharma generally likes to hire them young and train them “their” way. I was just saying that everyone should be looking for new opportunities IF they need the income that this job provides them. If not, then definitely ride it out. That is my plan. That’s because I don’t “need” this job.

Would feel terrible if someone actually needed the income and passed on an opportunity because they chose to just listen to management and not actually do research (on the company, etc) for himself/herself.
Good luck to you.
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Sorry , you lost all credibility be quoting "we wont see a launch of SSD until the next century" that has NEVER been said, and I think most people in pharma would easily take 5 (more) years at one company , making decent money as a positive in this industry. Also, the pharma that pays big $$ doesnt care if you are young, those days have long sailed, they care if you have documented performance, P Clubs, etc. Thanks for the good luck , but I'm in a good spot .
 






Oh my bad- I meant “decade” not century lol. Again - listen to the last fireside chat and you will find that decade is correct. Totally happy that you are in a good spot. There are people that are not and that is who I am trying to help. Just info,
 






anonymous said:
Oh my bad- I meant “decade” not century lol. Again - listen to the last fireside chat and you will find that decade is correct. Totally happy that you are in a good spot. There are people that are not and that is who I am trying to help. Just info,
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Anyone who confuses “century” for “decade” should not be offering any career advice or direction.
 






Salix is dead. The B&L people told us exactly how this would go nine years ago when Valeant bought us. Single digit growth. Drug prices shooting through the roof. Leadership all eliminated and replaced with Valeant turds. No new investment in research or new products. Just keep squeezing existing brands and raising prices. It was always going to be like this. And now a significant generic challenge to X550. Does anyone think this ends well for us?
 






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