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You make some good points. However, I’m not yet convinced that ENTA is serious about remaining in the NASH hunt for the long haul, as they were in HCV.
It might be a mistake to interpret Luly’s comments on yesterday’s CC as the gospel truth. It’s more likely, IMO, that ENTA was stunned by the EDP-305 results and wasn’t fully prepared to level with investors about the consequences.
Oh, I'm in agreement that Viekira wasn't a bust either for the company or for investors. It (and several other compounds and therapies) weren't the first and final iteration of what has become (what appears to be) the final HCV treatment. (IMHO, if money wasn't the object, it could be further developed to become more effective, shorter TX, improvement for certain harder to treat groups, etc- it just isn't economically feasible to try. It becomes harder as you approach 100% cure rate))
"HCV is neither"
Yes, that is true today, but as little as 7 years ago they had a completely different MOA, didn't understand the relatively great difference in response in various groups, genotype, alleles, and resistant mutation issues or with the toxicity of the interferon based therapies. I think I heard about the abbvie multiple cocktail in 2011 or 12, soon thereafter Gilead bought Pharmasett, just for one asset (7977) to be used w/IFN/RBV therapy, then in an antiviral cocktail. It's fairly recent history. Established now for 5ish years.
"NASH is a multifactorial and poorly understood disease"
I agree completely. Even now they are even trying to figure out how to diagnose NASH or how to quantify response, or qualify NASH damage for trials without biopsy.
I guess I am saying that ENTA is one of those who does possess some of that understanding of the disease, and if you were to compare results to Gilead or Intercept I cannot tell who is ahead. I haven't had time to compare the 3, but my guess is that ENTA did as well the 2 much larger companies.(but not strongly differentiated)
Perhaps this is why ENTA wants to press ahead. I think they possess a longer view than investors.
Comparing to back to HCV MAY be instructive for comparison reference.
Those companies without the understanding were not able to successfully acquire HCV assets. They spent lots of $$$ and ultimately failed. Ultimately, they couldn't buy, and couldn't develop internally so they backed away.
I'm just saying, ENTA seems to be prepared to fail a bit more, if that's requisite to do the work necessary for success.
ENTA remains a company with a strong background of success in liver disease and virology.
Thx. I must be confusing some recently released HBV results with Enta. Agree on RSV. I thought they are good enough but market reaction was bearish for whatever reason. Perhaps the 305 itching AE's were too loud to be not noticed by longs with some knowledge of patients involved in trial.
Besides that FXR prospect, do you ascribe any value to the pipeline given so so results in RSV and HBV (if recollection serves).
Several points I'd make;
The price of the stock today shows market sentiment. It *seems* that there may be other compounds that are effective w/ fewer sides.
OTOH, I would argue that many of the players, like as was true in HCV, are still trying to sort NASH out. I still consider ENTA as having a fair amount of expertise in this area.
Given that..... I'm a little confused at Luly's response that the 2.5mg dose (or future undisclosed higher and lower dose, whatever they may be). It would seem that the community response it that the 2.5 dose is toast. Luly's response makes me feel ENTA hasn't discarded that. This leads me to feel that they still see it as potentially viable. I can't tell (from only having listened to it once) that they strongly favor one dose over the other. My thinking the 2.5 discontinuation rate makes it a non-player.
I harken back to viekira. What if ENTA had thrown in the towel after "failing" with that?
There seems like a disconnect in ENTA's response and the markets.
"I have not failed. I've just found 10,000 ways that won't work." Thos Edison
I'm not sure that ENTA is quite done with NASH (or FXR). I'm sure that several other companies probably are.
It is certainly true that both intercept and Gilead seemed positive with their results and the market was also very underwhelmed. My thinking is that the pros are less crushed by "failure" than the market. I have no clue. I only see the failure. Luly, ENTA and others who have expertise see the ares in which they succeeded and want to continue going to the next step.
The ultimate winner won't be the company that fails and quits. That may be the preferred course that many would take today. Fewer still are those who get it right on the first try.
Too bad about the itching at 2.5mg. The 1 mg doesn't look bad in comparison with OCA if the 12 week itching data doesn't get worse with time. Do you see any value as a combo with molecules from mdgl/vktx or others?
ENTA reports phase-2a NASH data for EDP-305: #msg-151356515.
EDP-938 oral presentation at IDWeek* on 10/3/19:
https://www.enanta.com/investors/news-releases/press-release/2019/New-Data-from-Enantas-Phase-2a-Human-Challenge-Study-of-EDP-938-for-RSV-to-be-Presented-at-IDWeek-2019/default.aspx
https://www.idsociety.org/events2/events/2019/October/idweek-2019/
*Conference sponsored by Infectious Diseases Society of America (IDSA).
New slide set (for today’s Baird webcast):
https://s22.q4cdn.com/306858242/files/doc_presentations/2019/08/September-4-2019-Corporate-Presentation.pdf
USPSTF recommends HCV screening for essentially all US adults:
#msg-150806950
ENTA FY3Q19 results:
https://www.enanta.com/investors/news-releases/press-release/2019/Enanta-Pharmaceuticals-Reports-Financial-Results-for-its-Fiscal-Third-Quarter-Ended-June-30-2019/default.aspx
FY3Q19 royalty revenue=$44.4M, up from $39.6M in FY2Q19 (Jan-Mar 2019).
ENTA’s royalty rate from ABBV resets to the lowest tier at the start of each calendar year; the royalty tiers applicable to the 50% Glecaprevir component of Mavyret are shown in #msg-142808661.
ENTA’s 6/30/19 cash balance=$389.2M.
FY3Q19 GAAP EPS=$0.33 (including an $0.04 tax credit).
EDP-305 cannot logically be worse than OCA on safety/tolerability; it is not a bile acid.
thx. If recollection serves, OCA complications were itching and raising of cholesterol. Could 305 be worse IYO? Even if so, seems a lot of negativity is already priced in. Although it could still be a rough ride technically if 60 is broken. I had an alert triggered today via execution of single put being sold. Now I am waiting for the final bloodletting. Trump is determined get this over with in a hurry.
I would agree on the granular level. However, as a group, IMO the data is useful even if the timing is inaccurate. Eg. I got lucky in selling July credit spreads in ENTA (expired OTM) although option pricing had the direction right two weeks after expiration. Another recent example was FGEN, timing there was off by ~4 weeks but the stock did dive after MACE data release. That was a nice opp to add and many of us did either via rich put premiums or directly on data release. Looks like there will be an opp here upon OCA data release.
(Dew Wrote)
Option pricing was prescient in the way the stock has moved. Looks like it will get into the 60's. One sdev band now ~ 55-83.
How does the newly EMA approved shorter treatment regiment impact ENTA royalties?
Enanta’s HCV Collaboration Partner AbbVie receives Approval by the European Commission for MAVIRET™ (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks for Treatment-Naïve HCV Patients with Compensated Cirrhosis
August 02, 2019
https://www.enanta.com/investors/news-releases/press-release/2019/Enantas-HCV-Collaboration-Partner-AbbVie-receives-Approval-by-the-European-Commission-for-MAVIRET-glecaprevirpibrentasvir-to-Shorten-Treatment-Duration-to-Eight-Weeks-for-Treatment-Nave-HCV-Patients-with-Compensated-Cirrhosis/default.aspx
MAVIRET™ is now available as a shorter, 8-week, once-daily option for treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT)1, 2, 4, 5 or 6
Marketing authorization is supported by 97.9 percent cure* rate across this group of patients with no reported virologic failures
Analysis evaluating MAVIRET as an 8-week, once-daily treatment option for treatment-naïve, compensated cirrhotic, GT3 HCV patients is ongoing
Glecaprevir, is one of the two direct-acting antivirals (DAAs) in MAVIRET and is Enanta’s second protease inhibitor developed and commercialized by AbbVie
(visit the link for the full text) ~W
I was diagnosed in 2003. Back then the cure rate was less than 50% after a year of chemotherapy like symptoms. Some people suffered lasting serious disorders from the treatment; brain fog, auto-immune disorders, chronic fatigue, and other disorders which defied diagnosis or treatment. Through it all cirrhotics have remained the most difficult to treat. 8 weeks seems like a miracle to those of us who saw many treat repeatedly and fail, or those who kept waiting for a treatment and were lost before one came.
I believe I became infected in the 90's via surgery. I had zero damage in 2002, and by 2013 I was on the verge of cirrhosis, in spite of doing everything I could to stay healthy. I was able to get cured in a Gilead trial, but if I had to have waited for approvals either drug approval or insurance approval I have no doubt I would have been among those who became cirrhotic or who passed waiting for a treatment that could cure me.
This is a great treatment and close to a miracle for many people.
At current stock price, options no longer skewed like last week so perhaps this news was anticipated. One sdev move still 65 to 95 for Aug expiration.
ABBV’s 2Q19 HCV sales=$784M—2019 guidance lowered $3.3B—>$3.1B:
https://finance.yahoo.com/news/abbvie-reports-second-quarter-2019-114200464.html
I reposted with full URLs.
I couldn't open it.
Give me the 5 cent tour :)
EDP 305 Argon 1 Phase 2 initial Dara due 3q 2019
ENTA starts phase-1 of EDP-514 for treatment of HBV:
#msg-149783907
ENTA’s General Counsel exercised and held ~$270K of stock today:
https://www.sec.gov/Archives/edgar/data/1177648/000117764819000033/xslF345X03/edgar.xml
The options in question did not expire until 2025.
Today’s transaction is in addition to the $250K exercise-and-hold in Mar 2019 (#msg-147373277) and the $150K exercise-and-hold in Jan 2019 (#msg-146329304).
On today’s CC, ABBV reiterated its guidance for 2019 Mavyret sales of $3.3B.
ABBV's Mavyret weekly NRx market share of the HCV market is at 49% (from 50% the prior week) for the week ending 6/14.
JNJ’s failure in RSV has no bearing on ENTA: #msg-149405176.
Musings on the EDP-938 data: #msg-149396106.
ENTA reports EDP-938 phase-2 data…
PR:
https://www.enanta.com/investors/news-releases/press-release/2019/Enanta-Pharmaceuticals-Announces-Topline-Results-Showing-EDP-938-Achieved-its-Primary-and-Secondary-Endpoints-in-its-Phase-2a-Human-Challenge-Study-in-Healthy-Adults-Infected-with-Respiratory-Syncytial-Virus-RSV/default.aspx
CC slides:
https://s22.q4cdn.com/306858242/files/doc_presentations/2019/06/SLIDES-EDP-938-Challenge-TOPLINE-DATA-FINAL.pdf
ABBV's Mavyret weekly NRx market share of the HCV market is at 51% (from 49% the prior week) for the week ending 5/31.
ENTA’s EV (fully-diluted) ~$1.6B: #msg-149160816.
ABBV's Mavyret weekly NRx market share of the HCV market is at 49% (from 51% the prior week) for the week ending 5/24.
ABBV's Mavyret weekly NRx market share of the HCV market is at 51% (from 50% the prior week) for the week ending 5/17.
ABBV's Mavyret weekly NRx market share of the HCV market is at 50% (from 48% the prior week) for the week ending 5/10.
ABBV's Mavyret weekly NRx market share of the HCV market is at 48% (from 52% the prior week) for the week ending 5/3.
ENTA FY2Q19 results:
https://www.enanta.com/investors/news-releases/press-release/2019/Enanta-Pharmaceuticals-Reports-Financial-Results-for-its-Fiscal-Second-Quarter-Ended-March-31-2019/default.aspx
FY2Q19 royalty revenue was $39.6M, down from $69.9M in FY1Q19 (Oct-Dec 2018). ENTA’s royalty rate from ABBV resets to the lowest tier at the start of each calendar year, so ENTA’s fiscal 2Q (Jan-Mar) will always have the lowest royalty tier for a given fiscal year.
(The royalty tiers applicable to the 50% Glecaprevir component of Mavyret are shown in #msg-142808661.)
ENTA’s cash balance at 3/31/19 was $387M.
FY2Q19 GAAP EPS was $0.20, due to a tax benefit.
ABBV's Mavyret weekly NRx market share of the HCV market is at 52% (from 54% the prior week) for the week ending 4/26.
Pediatric HCV is a small market, which is why this announcement didn't cause a bigger buzz.
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