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Pfizer - Enanta Patent Case Looks like a very long timeline.
The following was posted yesterday at https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc
Judge Denise J. Casper: ELECTRONIC ORDER entered granting122 Joint MOTION for Extension of Time - Joint Motion to Modify Schedule. Deadline for substantial completion of document discovery by September 15, 2023. Close of fact discovery by November 17, 2023. Deadline for initial expert reports on issues as to which party bears the burden of proof by January 12, 2024. Deadline for rebuttal expert reports as to which party does not bear the burden of proof by March 1, 2024. Deadline for completion of expert depositions by April 12, 2024. Deadline for summary judgment motions and Daubert motions May 10, 2024. Deadline to file oppositions to summary judgment motions and oppositions to Daubert motions March 31, 2024. Deadline to file replies in support of summary judgment motions and replies in support of Daubert motions June 14, 2024. Status Conference set for 12/4/2023 02:45 PM in Courtroom 11 Related [+] before Judge Denise J. Casper. (Currie, Haley)
Done!! Incredibly curious what if anything will be shared update wise on the 235 project. Cheers to all for a wonderful Labor Day weekend. Off to northern Wisconsin & the UP of Michigan for a few days of fishing, kayaking, campfires and a few nice bottles of wine with friends. Peace….
rwwine,
Ha, ha, you just beat me to it. Why don't you post that on the Biotech Values site too?
Hopefully, they will be talking about developments in partnerships for EDP-235.
Enanta Pharmaceuticals to Participate in Investor Conferences in September
August 31, 2023, 7:00 AM EDT
WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, today announced that members of management will participate in four investor conferences being webcast in September and provide a business update:
Wells Fargo Securities Healthcare Conference: Fireside Chat at 2:15 p.m. ET on September 7, 2023
H.C. Wainwright 25th Annual Global Investment Conference: Presentation at 4:30 p.m. ET on September 12, 2023
Baird Global Healthcare Conference: Fireside Chat at 1:25 p.m. ET on September 13, 2023
2023 Cantor Global Healthcare Conference: Fireside Chat at 8:45 a.m. ET on September 26, 2023
A live webcast of each event will be accessible by visiting the “Events and Presentations” section on the “Investors” page of Enanta’s website at www.enanta.com. A replay of the webcasts will be available following the presentation and will be archived for at least 30 days.
About Enanta Pharmaceuticals, Inc.
Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections. Enanta’s research and development programs include clinical candidates for the following disease targets: respiratory syncytial virus (RSV), SARS-CoV-2 (COVID-19) and hepatitis B virus (HBV). Enanta is also conducting research on a single agent targeting both RSV and human metapneumovirus (hMPV).
Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing chronic hepatitis c virus infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230831535787/en/
Contacts
Media and Investors?Jennifer Viera?617-744-3848?jviera@enanta.com
Thank you. Is the reason you think it won't get approval at least not for a long time because Xocova is teratogenic like the thalidomide(Contergan) case? Good thing we talked this time :)
Shinogi's drug Ensitrelvir (Xocova) won't be getting approval in the US, at least not for a long time. The other drug is in phase 3 but no data is around yet and didn't meet primary endpoints in their 2021 phase 2 which had 1/3 of high risk patients yet you assume that will be approved next year.
https://www.fiercebiotech.com/biotech/atea-and-roche-s-covid-19-antiviral-flunks-phase-2-prompting-switch-will-delay-pivotal-data
I see you are another poster who has only made a small number of posts, all on the ENTA board. Nothing suspicious about that. /s
When Xocova and Atea's Sunrise comes out in U.S. market on 2024 or 2025. It will probably be before EDP-235's roll out.
Would it be weird thinking like one of each could substitute Paxlovid? Then EDP-235 wouldn't get as much market space to penetrate?
IMO, it is ritonavir that the most serious issue of Paxlovid. And both of them don't have ritonavir as far as I've seen.
Plus, EDP-514 has higher EC50 than Aligos drug, which means it has a less effective result as I understood. What do you think we could expect from this HBV treatment's result?
Many of_those points apply_to_the RSV program too:
With vaccine approvals for RSV for infants and seniors, and now at the time of pregnancy (congrats Pfizer), the final missing piece of this problem is an effective therapeutic. I had a good conversation with Jay Luly about this a couple of weeks ago. https://t.co/E1VY6gSpzK
— Brad Loncar (@bradloncar) August 21, 2023
I continue to have faith in Enanta for a few reasons;
1) While it has not been tested extensively EDP-235 still looks to be superior to Paxlovid and appears to be the best in class protease inhibitor.
2) Other larger pharmas continue development in the space and COVID is not going away. A best in class drug should have a good profitable run.
3) As in the past, new variants continue to arrive, have potential for evading vaccines which cannot keep pace with the continuous COVID adaptations.
4) Issues (opportunities) with long COVID, rebound, prophylaxis are still needing a solution.
5) Per my earlier post a large number of Americans are vaccine hesitant. The government is no longer supplying free pandemic vaccinations and so we will see reduced compliance and higher and more serious outcomes than are necessary.
-You do not need a "delta" variant to require the need for an improved antiviral; just new variants and lower compliance coupled with vaccines which are imperfectly suited to newer variants.
Obviously, all of this is my humble opinion, and the above pertain ONLY to COVID.
They only address the present need for an improved PI.
6) If Enanta has a good follow on COVID candidate that can be effective and has a different MOA it could possibly have two profitable COVID drugs and a longer deeper pipeline.
That is why I mentioned it because the annual flu vaccine is still required. It is not clear if the two are being treated differently because the disease risk is different, or if it is because the vaccine risk is different.
What about the flu vaccine at Michigan? You suggested the requirements for the Covid vaccine was being treated differently than those for influenza vaccines, Berkeley treats them the same.
Michigan Medicine has updated its COVID-19 vaccination policy, no longer requiring the vaccine or an approved exemption as a condition of employment. ... The change aligns with the policies at other health systems and comes in advance of the upcoming release of an updated COVID-19 vaccine.
The message does not say anything about requiring the updated vaccine when it is available.
Do you know that universities and their hospitals across America are not requiring any COVID vaccine or boosters for their employees, but they do continue to require yearly flu vaccines?
It is difficult to say that the change in policy is due to employee pushback.
This poll seems small but legit.
I also think it somewhat describes the current landscape of vaccines but particularly Covid.
So far as Enanta it suggests that Covid might last longer and have deeper consequences (for those unvaccinated).
https://www.kff.org/coronavirus-covid-19/poll-finding/kff-health-misinformation-tracking-poll-pilot/
There is an important link on methodology at the article's bottom.
Also that there WILL be those may be RSV vaccine resistant to vaccination.
I arrived at this poll from a Yahoo article entitled; "A third of adults believe COVID-19 vaccines caused thousands of sudden deaths: Poll"
https://www.yahoo.com/news/third-adults-believe-covid-19-090000023.html
(RE; Covid) " 65% of respondents heard or read the false claim; "The COVID-19 vaccines have caused thousands of sudden deaths in otherwise healthy people."
Percent who say the false claim is definitely or probably true: 34%
Percent who have both heard or read the false claim and say it is definitely or probably true: 29%"
I'm actually hesitant to post this since it has a Alice in Wonderland surreal quality to it.
But it explains a lot IMHO, if true.
ENTA’s pro forma cash @6/30/23=$221.2M—treating_ENTA’s_deferred-royalty_obligations_as debt (as is done under GAAP [#msg-172603887]—but see note at bottom of this post). The $212.2M figure consists of:
• $380.3M of net current assets on the 6/30/22 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017023039754/enta-20230630.htm#consolidated_balance_sheets );
• $5.9M of marketable securities on the 6/30/23 balance sheet designated as long-term (e.g. bonds with a time to maturity greater than one year) (ibid); and
• ($165.0M) deferred long-term liabilities relating to the Omers royalty agreement. ($36.7M of liabilities relating to the Omers agreement are booked as current liabilities and hence are included in the $380.3M figure in the first bulleted item.)
Note: Excluding the “debt” associated with the Omers royalty agreement, ENTA’s pro forma net cash at 6/30/23 was $422.9M ($221.2M + $165.0M + $36.7M).
ENTA’s fully-diluted share count @6/30/23=26.09M—a decrease of 0.07M since 3/31/23.
The 26.09M figure above consists of: 21.06 basic shares on the 6/30/23 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017023039754/enta-20230630.htm#consolidated_balance_sheets ); and 5.03M options and unvested restricted-stock shares and equivalents (whether or not exercisable) (ibid, p.10).
COVID BA.2.86 strain is worrying some experts:
https://finance.yahoo.com/news/explainer-eris-ba-2-86-120000468.html
I read it and you are wrong. They have the $200 million cash and they aren’t paying anything out of their pockets. It is coming out of future revenues. It is an accounting mechanism. Are you really saying they got the money but can’t use it for anything? That makes no sense.
Agree. I wasn’t meaning it’s a $3 stock this year or next but at some point unless a deal is struck. On the positive side there is also the patent litigation with PFE that could yield positive results as well.
I'M not saying the pipeline doesn't have value, but Wall Street clearly hasn't assigned any value to it therefore if ENTA continues to burn cash and the assigned value is based on the cash, it only makes sense to me that as the on hand cash goes lower, the stock price does as well.
ENTA market value is already below cash and you are predicting it will drop 10x below cash. When? Are you saying the pipeline has zero value?
The Street isn't giving much (if any) value to the pipeline. The $15/share price is reflective of only the 393M on hand cash which decreases on a monthly basis with the expected burn rate. With the sale of the royalties, the amount coming in from Abbvie isn't replacing and/or adding to the cash on hand. In summary, with each passing month, the on hand cash decreases and the stock price goes along with it. Correct me if I am wrong....?
Anyone have an educated guess as to the likelihood of a partner for 235 or 938? If low, what in the pipeline would keep this from being a $1-$3 stock?
There's no particular benefit to the accounting treatment; it's simply the proper way to handle a deferred liability under GAAP.
Thank you. Is the impetus for this accounting method tax efficiency?
Is it likely that the general market does not understand the accounting method being used, or is otherwise using this accounting method as an excuse to knock Enanta a little harder?
Does this accounting benefit Enanta through other mechanisms such as retaining eligibility for some government and oversight programs?
Thank you again!
On page 8 of the same 10-Q document, there’s a heading that says, “amounts in thousands, except per share data.” This header applies to all of the notes to the financial statements that follow, so the “$200,000” in the excerpt I posted means $200 million.
Re: Accounting treatment of the Omers transaction
Here’s the explanation from ENTA’s FY3Q23 10-Q (p.12):
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017023039754/enta-20230630.htm
I would like to propose a benefit of the doubt for the poor performing stock and attribute the decline in price to an expectation of the masses that the entire market is going to decline.
This poor stock is taking the hit upfront because it is strictly a provider of research and development.
I do not understand the accounting methods for the sale of a portion of the HCV revenue. I do understand the terms of the agreement, I do not understand the accounting practice, i.e., recording it as debt.
Please correct me if I am wrong and I am thankful for any explanation that can be provided.
Like you know me.
Good humor
10 out of 10.
I made a song and dance about it. I admit.
Still nothing informative.
Well, I am not sure if you read it or not.
Firstly, what I said is not Paxlovid has better data than EDP-235.
In fact, I was asking from what perspective EDP-235 is better
Secondly, I understand EDP-235, 938, 514, 323 are the names of inhibitors. I am not entirely sure if people call them a pipeline or not. I thought we call them a pipeline.
If I were wrong, you could say in detail.
Not just blaming. I think you should study how to speak to people. The way you use is so violent and rude. I am not sure whether it derives from your arrogance or pride or whatever.
I have never said you've told me the wrong 2Q revenue. You just ignore what you wrongly thought.
I am sensitive. YES. Because I try to think and understand others' perspectives. Not like you.
IMHO, someone who has better sympathy is a better person.
I can not get any informative information from your writing.
I will end discuss with you. It is hard to say this is a discussion, though. Bye. Enjoy your smart investment.
Oh I see. That makes sense :)
Thank you.
The most recent quarter was fiscal Q3 because ENTA's fiscal years run from Oct 1 to Sep 30 (#msg-172537414).
Mother of god!
I know it is the 2Q conference call.
THE REASON I write Q3 is the company use that term. Go to the website or go to Seeking alpha, and you could easily find it. I don't know why they write down Q3 but it says so. I thought you must go to enanta's homepage or something. But I was wrong.
What kind of person are you making me.
I listened conference call and watched the slides
How do you think I know the name of company's pipeline.
'Waste water'wise
I couldn't find it in google yet because it needs context of this company.
I know it is not that great to ask everything
But I studied this company 7hours yesterday. And I will study more for a while.
But no worries at least I will find it finally at some point.
I do not know how long you followed Enanta.
And I don't know how well educated you are.
But this attitude is not that nice of you as a person.
You could just say what it is.
You DO NOT HAVE TO BUT.
And there is someone who claim about Paxlovid's 2Q revenue. You can easily find him
That person is Not You though
You did NOT say about Q2's Paxlovid revenue.
Please Think before you write.
I see. You think it is still a big opportunity for ENTA, don't you? I understand it. Compared to its Market Cap. it is huge, isn't it?
What I meant about transition is PFE says one of the reasons for poor revenue on Paxlovid is they are changing their method of sales to commercial markets rather than to government deals. That's what I understood from their recent conference call. I was asking you guys' opinion on it. Whether it would be better for PFE's Paxlovid sales or not.
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