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Luly said the phase-2a RSV trial will start (i.e. begin enrolling patients) in the current quarter.
A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model
https://clinicaltrials.gov/ct2/show/NCT03691623?term=enanta&rank=1
Recruitment Status : Not yet recruiting
First Posted : October 2, 2018
***********************
I will also note Enanta will release data (Clinical trials-phase 1) at an RSV conference November 1. This is the first day of the conference, possibly a poster event- doesn't appear to be a gran finale type oral presentation late breaker.
Still, it would appear that they are preparing to enter phase 2, which I *presume* means they were satisfied enough to post data at an RSV conference, and to continue setting up a Phase II trial. (as of less than a week ago)
Not a slam dunk, but generally positive indications.
The size of the trial may also be an indication; 114 participants demonstrates some degree of commitment.
Jay Luly-Enanta CEO- has mentioned RSV as a possible "go alone" possibility for ENTA- they could possibly do this without a partner.
Mavyret 9/28/18 script update: #msg-144060008.
The exercise price of a given option is whatever the market price was on the day the option grant was made.
Thanks Dew, so the exercise price of $34.70 is subject to change? How is that price derived?
Exercising options early, at a lower market price, has tax benefits compared to exercising later at a higher market price.
Mathematically, exercising options and paying the immediate portion of the tax bill in cash is tantamount to buying additional shares in the market price.
Dew, What is the advantage of exercising these shares now?
$120K* exercise-and-hold transaction by General Counsel:
https://www.sec.gov/Archives/edgar/data/1177648/000117764818000036/xslF345X03/edgar.xml
The exercised options did not expire until 2024.
*Market value of shares exercised and held.
GILD will launch Harvoni/Epclusa authorized generics for US market in Jan 2019; list price of these AGs will be $24K for 8 weeks—equivalent to the existing after-rebate net price of branded Harvoni/Epclusa, and close to the list prices of Mavyret and Zepatier:
http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=2368563
Any update today?
ABBV's Mavyret weekly NRx market share of the HCV market is at 52% (from 50% prior week) for the week ending 9/7.
ABBV's Mavyret weekly NRx market share of the HCV market is at 50% (from 52% the previous week) for the week ending 8/31.
ABBV's Mavyret weekly NRx market share of the HCV market is at 52% (from 49% the previous week) for the week ending 8/24.
New corporate slide set:
http://www.enanta.com/files/doc_presentations/2018/09/Corporate-Presentation-Sept-2018.pdf
ABBV's Mavyret weekly NRx market share of the HCV market is at 52% (from 49% the previous week) for the week ending 8/24.
ABBV's Mavyret weekly NRx market share of the HCV market is at 49% (from 52% the prior week) for the week ending 8/17.
The small amount of calendar-2Q18 Viekira royalty revenue ($1.2M or a little more, based on ~$41M of Viekira sales) is lost in the round-off error of the overall royalty calculation, where the inputs to the calculation have been rounded to the nearest million dollars.
Did anyone do the calculations? The 57.3 royalty comes close to what I calculated for Mav only (7.5 + 30 + 19.74 = 57.24 ). Should be another 1.4 to 1.8 million for the V Pak.
ENTA's EV is only $1.68B: #msg-142808471.
ENTA has disclosed the Mavyret/Glecaprevir royalty-rate tiers: #msg-142808661.
ENTA quarterly numbers ought to be viewed positively, IMO, given what we already knew about ABBV's Mavyret sales.
How is this viewed? I would think pretty positively...
ENTA FY3Q18 results—royalty revenue=$57.3M (+30% QoQ); GAAP EPS=$0.97:
https://www.enanta.com/investors/news-releases/press-release/2018/Enanta-Pharmaceuticals-Reports-Financial-Results-for-its-Fiscal-Third-Quarter-Ended-June-30-2018/default.aspx
Other PBMs haven't yet released their planned 2019 formularies, as far as I know.
ABBV has said all along that Mavyret's focus in the US market is on the government segment of the market, where PBMs play no role. So, even if CVS or another large PBM were to shun Mavyret in 2019, the damage wouldn't be that bad.
Good analysis. Have other PBMs released their 2019 formularies? I'm just wondering what are the chances that ESRX is not the only cockroach.
More on same subject:
Respectfully disagree. The ~15% (US) and <10% (WW) numbers I posted in this thread are pot'l %reductions in Mavyret's addressable mkt—not %reductions in ACTUAL SALES. If we presume that Mavyret wouldve gotten ~50% of ESRX biz, then %reduction in actual 2019 Mavyret sales is 3-4%.
— Roy Friedman (@DewDiligence) August 7, 2018
Well, OK,. that's not that big a difference. And gets to what I'm thinking about here, which is: are the PBMs lowering costs?
— Matthew Herper (@matthewherper) August 7, 2018
Musings on ENTA sell-off: #msg-142738244.
Bear in mind that the threshold for each Mavyret royalty tier is based on the 50% of Mavyret sales attributed to Glecaprevir. E.g., if we say, for the sake of discussion, that the threshold for the second royalty tier is $1B, then it would require $2B of cumulative Mavyret sales for the calendar year to get into that tier.
If the second tier is a billion in sales, we should have around 80% of Mav sales at a higher royalty. Any guess as to what the next level is?
ABBV/ENTA 2Q18 HCV sales=$973M (+6% QoQ)—$422M US; $551 ex-US:
https://finance.yahoo.com/news/abbvie-reports-second-quarter-2018-113800172.html
Poll re 2Q18 Mavyret sales:
https://twitter.com/DewDiligence/status/1020413905552723970
Background info re poll:
https://twitter.com/DewDiligence/status/1020445743893680128
Mavyret's US new-patient share hits 50.5%: #msg-142333374.
ABBV's Mavyret weekly NRx market share of the HCV market is at 48% (from 49% the prior week) for the week ending 7/6.
ABBV's Mavyret weekly NRx market share of the HCV market is at 49% (from 49% the prior week) for the week ending 6/29.
Thanks! I just retweeted it.
That was the whole post.
Twitter link to what I think was the source but you need a login id to actually read the story:
twitter link
Do you have a link?
Rocky made a post on IV a few days ago:
Headline from Japan Pharma email
"Maviret Sweeping Japan Hep C Market, 80% Share Snatched in Just 4 Months?"
Mavyret's NRx share is stuck just below 50% because MRK is hanging in with a 1.9% NRx share (according to IMS).
ABBV's Mavyret weekly NRx market share of the HCV market is at 49% (from 48% prior week) for the week ending 6/22
ABBV's Mavyret weekly NRx market share of the HCV market is at 48% (from 49% prior week) for the week ending 6/15.
ENTA’s CFO exercised options and held the resulting shares worth ~$800K:
https://www.sec.gov/Archives/edgar/data/1177648/000117764818000029/xslF345X03/edgar.xml
These options were due to expire in a few weeks.
ABBV's Mavyret weekly NRx market share of the HCV market is at 49% (from 47% the previous week) for the week ending 6/8.
Today's selloff is presumably related to GLMD's NASH data, which is not entirely logical, IMO.
Today's selloff is presumably related to GLMD's NASH data, which is not entirely logical, IMO.
Just the usual minor updates, as far as I can tell.
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