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ENTA FY2Q22* financials—royalty_revenue=$18.7M—3/31/22_cash=$322.5M (down from $347.7M at 12/31/21):
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-31
FY2Q22 R&D expenses were $42.1M, inline with prior guidance of $150-170M for FY2022; FY2Q22 SG&A expenses were $10.5M, very slightly above the annualized run rate of prior guidance of $35-41M for FY2022 (#msg-166871344).
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How ENTA’s Mavyret royalty is calculated
ENTA’s royalty rate on Mavyret sales from ABBV is tiered, as shown in the table in #msg-142808661. The royalty rate is applied to the 50% Glecaprevir component of Mavyret (a 2-drug combination). The royalty tiers reset at the start of each calendar year (like tax brackets), so ENTA’s royalty rate is highest in the fourth calendar quarter (ENTA’s fiscal* Q1) and is lowest during the first calendar quarter (ENTA’s fiscal* Q2).
During calendar 1Q22 (ENTA’s FY2Q22*), ABBV sold $380M of Mavyret (#msg-168696795), noting that HCV new-patient starts were still below pre-pandemic levels. In Feb 2022, ABBV issued calendar-2022 guidance for Mavyret sales of $1.7B (#msg-167728327). ABBV left this guidance unchanged in May 2022 after reporting 1Q22 results.
*ENTA’s fiscal year ends on September 30.
Paxlovid misses primary endpoint in post-exposure prophylaxis:
#msg-168706013
Thanks.
The response and use of the word "inoculation" makes more sense in that regard.
He’s using the word, inoculation to mean infection with the virus. I.e. he mistakenly thinks ENTA’s 'RSVP' trial is a “challenge” study.
As noted in my prior post here (and also on Twitter), the poster in question also does not understand the MoA of EDP-938.
I'm still just trying to unpack the first tweet?!?
Sounds like he's confused; he has a lot of followers on Twitter, but he's not a science person.
Use of a P-glycoprotein inhibitor (https://twitter.com/Biohazard3737/status/1519372525263802373 ). Can you comment on this? TIA
What technical details?
It seems to me that @Biohazard3737 (“Sheep of Wall Street”) is drawing a negative inference about EDP-235 based on the technical details of the potency assays used by ENTA without his considering alternative explanations for the way the assays were conducted. Only people inside ENTA would know the rationale for these details, as far as I can tell.
Regarding RSV, @Biohazard3737 evidently does not understand that the MoA of EDP-938 (an N-protein inhibitor) is intended to work later in the course of an infection than a fusion inhibitor. Of course, the RSVP trial might fail to meet its primary endpoint, but if that happens it won’t be for the reason cited by @Biohazard3737.
I read the guy’s dismissal of EDP-235 and it doesn’t make sense. He doesn’t state why it wouldn’t be an important drug if approved. Obviously we need efficacy data in Covid patients after safety data comes in this quarter. However, EDP-235 advantages would be significant as it would be only one pill a day and no need for a second drug to maintain Paxlovid levels high, and the drawbacks that has regarding other drugs.
My two replies (one re RSV and one re EDP-235) are within the same thread.
And what were your replies to those comments?
Tweet thread from a short:
https://twitter.com/Biohazard3737/status/1519372523892363266?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1519372523892363266%7Ctwgr%5E%7Ctwcon%5Es1_&ref_url=https%3A%2F%2Fpublish.twitter.com%2F%3Fquery%3Dhttps3A2F2Ftwitter.com2FBiohazard37372Fstatus2F1519372523892363266widget%3DTweet
I replied to two of the tweets in the thread.
Shionogi PR re COVID antiviral fails to mention teratogenicity!
https://www.businesswire.com/news/home/20220423005001/en
Shionogi is evidently acting like MRK did with Molnupiravir—i.e. pretending that a safety issue does not exist. In MRK’s case, the result was a product with essentially no demand because the FDA EUA restricts usage to patients “for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate” (#msg-167236732).
Wow, ENTA has been a roller coaster recently. I look forward to the rebound tomorrow.
Some_patients_may_need_longer_treatment_course_of Paxlovid, according_ to_anecdotal_info:
https://www.bostonglobe.com/2022/04/21/metro/puzzling-phenomenon-patients-report-rebound-covid-19-symptoms-after-taking-antiviral-paxlovid/
The FDA EUA specifies a 5-day treatment course because that’s what PFE tested in its clinical trials.
Ascletis’ ASC11 could be a serious competitor to EDP-235 based on the in vitro assays of potency described in the PR (https://finance.yahoo.com/news/ascletis-announces-3clpro-inhibitor-asc11-085000053.html ). However, the most consequential differentiators among agents from this drug class are safety and pharmacokinetics, and Ascletis’ PR is silent on these points. We’ll have to wait for Ascletis’ phase-1 data in late 2022 (or early 2023) to know how their drug actually stacks up.
Thoughts on the news from ASCLF today on a possible best in class competitor?
XBI was -4.8%, so today’s selloff was not ENTA-specific.
Why the purge today? Yikes.
One fewer serious competitor for EDP-235.
https://www.bloomberg.com/news/articles/2022-04-13/shionogi-falls-most-in-decade-on-birth-defect-risk-of-covid-pill
"The pill’s [shionogi's covid antiviral] chance of commercial success fell to 5% from 50% after the report tying it to birth defects, which may make it less competitive, said Stephen Baker, an equities analyst at Jefferies & Co."
also
" Demand for drugs to treat Covid is fierce as the world transitions to an endemic state and the focus shifts to easy-to-take medications."
--------------
Enanta's covid candidate EDP-325 is expected to finish it's Phase 1 MAD and SAD dosing in the 2nd quarter and commence phase 2 in Q3
ENTA’s EDP-235 presentation slides and poster at the ASBMB* annual meeting:
https://www.enanta.com/wp-content/uploads/2022/04/Enanta_EDP-235-ASBMB-Annual-Meeting-Seminar_Final.pdf
https://www.enanta.com/wp-content/uploads/2022/04/EDP-235-2022-ASBMB-Annual-Meeting-Poster-Final.pdf
*American Society for Biochemistry and Molecular Biology.
(ENTA)—PFE acquires private RSV-therapeutics company for undisclosed up-front and $525 biobucks:
https://www.businesswire.com/news/home/20220407005081/en/
https://www.evaluate.com/vantage/articles/news/deals-snippets/pfizer-doubles-down-respiratory-syncytial-virus
Reviral (the private company being acquired) has an RSV fusion inhibitor, Sisunatovir, in phase-2 trials for hospitalized infants (https://www.businesswire.com/news/home/20210616005103/en ) and immune-comprised adults, with data from both expected in 2H23. Reviral also has an N-protein inhibitor in phase-1.
As ENTA’s Jay Luly has mentioned on many occasions, RSV fusion inhibitors, which seek to prevent the virus from entering cells, haven’t worked especially well for patients who have a high viral load at treatment start. That’s why ENTA’s lead RSV compound is the N-protein inhibitor, EDP-938. ENTA expects to report phase-2b (‘RSVP’) data for EDP-938 during 2Q22; the phase-2a data were recently published in NEJM (#msg-167916018).
ENTA also has a second RSV compound, EDP-323, an L-protein inhibitor; this is an MoA no other company is pursuing (yet), as far as I know.
PFE hits_goal_of_shipping_6M_courses*_of Paxlovid during_1Q22:
https://finance.yahoo.com/news/1-pfizer-made-6-mln-214629742.html
The company's targets for 2Q22 and full-year 2022 are 24M and 100M courses, respectively. Demand is not an issue—PFE does not expect to have any problem whatsoever in selling as many courses as it can produce.
*Each course of treatment consists of 20 tablets of Paxlovid and 10 tablets of ritonavir.
New Covid Variant XE Found In UK, More Transmissible Than Omicron: WHO
https://www.ndtv.com/world-news/new-covid-variant-xe-found-in-uk-more-transmissible-than-omicron-who-2858643
Continued need for ENTA’s anti-viral candidate.
ENTA’s EDP-235 featured in C&EN:
https://cen.acs.org/business/next-generation-COVID-19-antivirals/100/i11
ALGS discontinues another HBV candidate:
https://finance.yahoo.com/news/aligos-discontinues-development-antisense-oligonucleotide-120000830.html
There are many possibilities, much depending upon the trajectory of covid, new variants and abilities for vaccines to adapt to new strains.
I'm hopeful that speed to approval is maintained. IF Enanta does indeed have a best in class PI antiviral a speedy approval via EUA should be a plus.
After the SOTU last night it seemed to me that addressing covid was still very much an interest by the Biden administration.
True on both counts.
Maybe, but sales to the government for free distribution to patients generally come with substantial price concessions.
I think Joe Biden's SOTU address last night may influence Enanta. Joe said that Paxlovid reduced (from memory) hospitalizations 90% and that he was going to make it available free and immediately after a positive covid DX. (availability will presumably continue to ramp up)
1) One could infer that the next best in class antiviral might see the same treatment- such as Enanta's covid antiviral (EDP-325).
2) We might also assume that since Joe's presidency hinges (in part) on getting past covid that the EUA use may be prolonged long enough for Enanta to get a more rapid approval in order to provide a non-RTV boosted once daily covid theraputic.
3) Joe also mentioned that being a part of the international community meant making our superior vaccines available- and one could extrapolate if we had a best in class approved antiviral that it could even be construed as an excellent means to reinforce our diplomatic relations with other countries as well as the right thing to do.
4) Joe Biden -- whether you are dem or republican, love him or hate him - is still president for approximately 3 more years and policies may extend beyond presidencies.
What I heard last night seemed positive for covid biotech- perhaps especially for Enanta.
It's a hypothesis - but based somewhat in the context of what Biden referred to last night at the SOTU as well as in Obama's pandemic preparedness systems.
A strong covid response could be a part of Biden's legacy and potentially aid the world in covid recovery.
(written but not posted Valentines day Monday 2/14)
I know that the posts are merely observing that money is moving out of covid; Molnupiravir, Moderna, Pfizer, Novamax. I guess that Mr. Market has spoken and the market is always right. : )
I have to wonder if covid is over. I have to wonder if this is an opportunity.
The news with Molnupiravir shows us that a superior antiviral will beat out an inferior one. So....how long will it be till the Pfizer is replaced by a non-boosted one? A once a day antiviral instead of a twice a day?
I guess the market thinks covid is departing. But is it?
Even without a new variant, there is no reason to think that Delta or Omicron will magically leave. They will stay and still have lots of un vaxxed and unboosted to infect.
https://www.mayoclinic.org/coronavirus-covid-19/vaccine-tracker
So I wouldn't celebrate too fast.
And we are seeing that boosting only lasts so long.
Covid can revisit the past infected, the un vaxxed and underboosted.
So for me, it looks like a time to bet that it isn't ending, that it will continue. Is the USA still populated with the old, the overweight? Diabetics? People with multiple co-morbidities? Cancer patients/ people w/ compromised immune systems? People who eschew vaccinations, boosters, masks and mandates?
Were I to guess we may have a series of descending waves- but we are FAR from over. Perhaps the tremendous years Pfizer has had may be decreasing, but I have a sense of optimism about the next best in class antivirals.
Finally..... what if there is yet another variant?
And it appears that there IS yet another variant.
Even as many proclaim that the pandemic is over.
Right or wrong I have been adding as the share price dropped.
A new drug shows promise against respiratory virus, study shows
By Brenda Goodman, CNN
Updated 1:39 PM ET, Thu February 17, 2022
A 3-year-old patient in the hospital receives medication via an inhalation mask to treat Respiratory Syncytial Virus (RSV).
A 3-year-old patient in the hospital receives medication via an inhalation mask to treat Respiratory Syncytial Virus (RSV).
(CNN)A new antiviral medication against respiratory syncytial virus, or RSV, appears to be safe and lowered viral levels and symptoms significantly more than a placebo, according to the results of a study published Wednesday in The New England Journal of Medicine.
The study is unusual in that it is based on a two-part human challenge trial, where researchers purposefully infect people with a pathogen to test a new therapy. Challenge studies speed up research because scientists don't have to wait for their study participants to get sick out in the real world. They can also enroll fewer people, knowing that participants will inevitably catch a germ. But they're also risky and only considered ethical when the need for a new treatment or therapy is thought to outweigh the potential risks to study participants.
Comments on ALGS' ALGS-097111: #msg-167924816.
ENTA’s phase-2a RSV trial published in NEJM:
https://www.nejm.org/doi/full/10.1056/NEJMoa2108903
And the dosing begins with expected read out Q2.
ENTA’s fully-diluted share count @12/31/21=24.7M—an increase of 0.3M since 9/30/21 (#msg-166903176).
The 24.7M figure above consists of: 20.5M basic shares on the 12/31/21 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017022001018/enta-20211231.htm p.2 ); and 4.2M options outstanding at 12/31/21 (whether or not exercisable) (ibid, p.11).
ENTA’s pro forma cash @12/31/21=$377.7M—a decrease of $13.6M since 9/30/21 (#msg-166903163).
The $377.7M figure above consists of: $289.1M of net current assets on the 12/31/21 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017022001018/enta-20211231.htm p.2); and $88.7M of marketable securities on the 12/31/21 balance sheet designated as long-term (e.g. bonds with a time to maturity greater than one year).
Dang; BMY's Daclatasvir
Yes, thanks for the transcript Dew. I sometimes have trouble hearing and need the transcripts to affirm what I thought I heard.
So far as some derisking - both the RSV and Covid phase 1 data at the 54:25 minute mark Luly mentioned both will be complete next Q.
EDP-325 phase 2/3 covid should start in the 2nd half.
RE: EDP 514, it almost appears that Enanta is in no hurry to partner with sub-optimal HBV compounds that stand lesser chances of success.
Gilead's HCV program succeeded due to several shrewd acts;
1) They were willing to pay more than anyone for the best nuke.
2) They partnered, then abandoned Merck'sDaclatasvir as a second combination agent (with their own in house NS5a Ledipasvir), thus retaining 100% of the HCV sales from the start.
I have to suspect that this is what Enanta would like to do with HBV. I'd guess that they are trying hard to find another/create another MOA or agent to combine EDP-514 with. That act of not partnering may show some confidence in what they have (EDP-514) and -perhaps- confidence that they can create a 2nd compound in house.
IMHO, this also rather explains also WHY the L- inhibitor in RSV.
IF Enanta can have a total lock on RSV from the get go they may reduce the enticement for others to follow in with vaccines or anti-virals.
SURE- many tried with HCV.... but how many succeeded? Still trying? Few- very few.
Time will tell if that could repeat with RSV and HBV.
Thanks Dew. Good to hear that EDP-235 will begin phase I trials this month. Plenty of room for and money to be made with a best-in-class Covid protease inhibitor.
I will feel even better when another HepB drug is chosen for trials for future combination with EDP-514.
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