Enanta Pharmaceuticals Inc (ENTA)

[DewDiligence]

That's the highest-ever weekly figure, according to IMS.

[guyschmid]

ABBV's Mavyret weekly NRx market share of the HCV market is at 55% (from 53% the prior week) for the week ending 11/30.

[DewDiligence]

ENTA’s General Counsel exercised and held $150K of stock today—the second such insider transaction recently:

https://www.sec.gov/Archives/edgar/data/1177648/000117764818000053/xslF345X03/edgar.xml

The exercised options did not expire until 2024.

[DewDiligence]

ENTA SVP exercised and held $150K of stock yesterday:

https://www.sec.gov/Archives/edgar/data/1177648/000117764818000051/xslF345X03/edgar.xml

The exercised options did not expire until 2024.

[guyschmid]

ABBV's Mavyret weekly NRx market share of the HCV market is at 53% (from 51% the prior week) for the week ending 11/23.

[DewDiligence]

ENTA’s enterprise value at current share price ~$1.44B: #msg-145176914.

[DewDiligence]

ENTA FY4Q18 CC transcript:

https://finance.yahoo.com/news/enanta-pharmaceuticals-inc-enta-q4-003433583.html

[DewDiligence]

ENTA FY4Q18 results—GAAP EPS=$1.30:

https://www.enanta.com/investors/news-releases/press-release/2018/Enanta-Pharmaceuticals-Reports-Financial-Results-for-its-Fiscal-Fourth-Quarter-and-Year-Ended-September-30-2018/default.aspx

“Enanta has never been in a stronger position from both a financial and clinical development perspective,” said Jay R. Luly, Ph.D. President and CEO, Enanta Pharmaceuticals.

“With the recent start of our Phase 2a study in RSV, we now have three Phase 2 studies ongoing in our wholly-owned development programs. Our momentum will continue into 2019, when we plan to initiate clinical testing of EDP-514, our first candidate to treat hepatitis B virus, and we expect Phase 2 data readouts in our other programs, starting with NASH and RSV studies.”

[DewDiligence]

ENTA’s latest corporate slides:

https://s22.q4cdn.com/306858242/files/doc_presentations/2018/10/Corporate-Presentation-Oct.-24-2018.pdf

The FY4Q18 earnings release and CC are tomorrow (11/26/18) after the close.

[guyschmid]

ABBV's Mavyret weekly NRx market share of the HCV market is at 54% (from 53% the prior week) for the week ending 11/9

[DewDiligence]

Mavyret data from AASLD:

#msg-144852424
#msg-144850948
#msg-144852305

[guyschmid]

ABBV's Mavyret weekly NRx market share of the HCV market is at 53% (flat to the prior week) for the week ending 11/2.

[guyschmid]

ABBV's Mavyret weekly NRx market share of the HCV market is at 53% (from 54% the prior week) for the week ending 10/26.

[DewDiligence]

ABBV 3Q18 results—HCV sales=$862M (vs ABBV’s $850M guidance):

https://investors.abbvie.com/static-files/184e032f-41e4-4324-a0c9-6683bbef9781

ABBV’s 3Q18 HCV sales were $444M US (+5% QoQ) and $418M ex-US (-24% QoQ). (The $418 ex-US total includes $23M of Viekira sales.)

[guyschmid]

ABBV's Mavyret weekly NRx market share of the HCV market is at 54% (from 52% the prior week) for the week ending 10/19.

[DewDiligence]

EDP-938 (RSV) update on phase-1/phase-2 trials:

https://finance.yahoo.com/news/enanta-pharmaceuticals-announces-positive-phase-113000203.html

Enanta Pharmaceuticals…today announced that dosing has begun in a Phase 2a study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-938 against respiratory syncytial virus infection in a human challenge study.

…up to 114 healthy adult subjects will be randomized into 1 of 3 arms (1:1:1) and will be dosed for 5 days. All subjects will be infected with RSV-A Memphis 37b virus, and approximately 76 subjects will receive EDP-938 and 38 subjects will receive placebo. Arm 1 will receive placebo, Arm 2 will receive a single 500 mg loading dose of EDP-938 followed by 300 mg BID, and Arm 3 will receive a daily 600 mg dose.

…EDP-938 is the only N-protein inhibitor in development today… we are targeting preliminary Phase 2a results in calendar 3Q19.

EDP-938 Phase 1 Results

The Phase 1 randomized, double-blind, placebo (PBO)-controlled, first-in-human study was conducted to evaluate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple- (7 days) ascending doses (SAD: 50 - 800 mg and MAD: 100 - 600 mg once daily and 300 mg twice daily) and food effect (FE) of EDP-938 in healthy subjects. In the SAD phase, 50 subjects [EDP-938 (n=38) and PBO (n=12)] were enrolled into 6 dose cohorts; in the MAD phase, 40 subjects [EDP-938 (n=30) and PBO (n=10)] were enrolled into 5 dose cohorts.

Overall, no safety concerns have been reported in 68 healthy subjects receiving a broad range of single and multiple doses of EDP-938. Headache was the most frequently reported AE during the SAD and MAD phases. There were no SAEs, and AEs were of mild intensity, with none leading to study drug discontinuation.

EDP-938 was rapidly absorbed and exposure increased with increasing single and multiple dosing, resulting in a PK profile suitable for once or twice daily oral dosing regardless of food. In the MAD phase, half-life ranged from 12.9 to 17.6 hours, and at doses comparable to those under study in the Phase 2a trial, mean trough levels were approximately 30x higher than the EC90 of EDP-938 against RSV-infected human cells.

There’s a poster presentation on these data tomorrow and an oral presentation on Thursday.

As I’m typing, both ENTA and XBI are down about 3%, so it’s hard to gauge investors’ reaction to the RSV info, specifically.

[guyschmid]

ABBV's Mavyret weekly NRx market share of the HCV market is at 52% (from 53% the prior week) for the week ending 10/12.

[Rocky3]

From the Japanese drug email list -


AbbVie’s hepatitis C drug Maviret (glecaprevir + pibrentasvir) was by far the best-selling medicine in Japan in April-September, but its sales appear to have already peaked out thanks to its own success. The shrinking market signals that the industry is on track to the elimination of the disease by 2030, as advocated by the WHO ...

[DewDiligence]

Mavyret’s US new-patient share=53.4%—the highest-ever weekly figure—in the week ending 10/5/18, as reported by IMS. GILD’s US new-patient share was 45.6%, and MRK’s was 1.0%.

Mavyret’s US total-script share was 47.2% in the week ending 10/5/18, slightly below the highest-ever weekly figure, as reported by IMS. GILD’s US total-script share was 51.6%, and MRK’s was 1.1%.

[willyw]

https://abbvie.referrals.selectminds.com/landingpages/sales-opportunities-at-abbvie-108

scroll down. This is sales, but there could also be other non-sales type jobs. I noticed what seemed to be about 11 such jobs-what seemed to be upper level positions. There could be less, or more as time goes by.

[DewDiligence]

...Abbvie is hiring people for the HCV China launch...

What is your source for that?

[willyw]

Seeing the trial set up (and fairly early into 4th quarter) is reassuring. : )

I am still holding ENTA.
Maybe I'm trying to remind myself better times are ahead.
I also noticed that Abbvie is hiring people for the HCV China launch, so that could be another bright spot coming in 2019.

I'm still pouring thru AASLD entries, trying to sift through NASH/HBV/HCV/PSC etc

[DewDiligence]

Luly said the phase-2a RSV trial will start (i.e. begin enrolling patients) in the current quarter.

[willyw]

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.

[DewDiligence]

Mavyret 9/28/18 script update: #msg-144060008.

[DewDiligence]

The exercise price of a given option is whatever the market price was on the day the option grant was made.

[Bickema]

Thanks Dew, so the exercise price of $34.70 is subject to change? How is that price derived?

[DewDiligence]

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.

[Bickema]

Dew, What is the advantage of exercising these shares now?

[DewDiligence]

$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.

[DewDiligence]

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

[tmoney2555]

Any update today?

[guyschmid]

ABBV's Mavyret weekly NRx market share of the HCV market is at 52% (from 50% prior week) for the week ending 9/7.

[guyschmid]

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.

[vinmantoo]

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.

It seems like ENTA goes down no matter what.

[DewDiligence]

New corporate slide set:

http://www.enanta.com/files/doc_presentations/2018/09/Corporate-Presentation-Sept-2018.pdf

[DewDiligence]

EDP-938 data to be presented at RSV conference:

https://www.enanta.com/investors/news-releases/press-release/2018/Enanta-Pharmaceuticals-to-Present-New-Data-on-its-RSV-Inhibitor-EDP-938-at-the-11th-International-Respiratory-Syncytial-Virus-Symposium/default.aspx

[guyschmid]

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.

[guyschmid]

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.

[DewDiligence]

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.

[DaveAu]

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.

[DewDiligence]

ENTA's EV is only $1.68B: #msg-142808471.

[DewDiligence]

ENTA has disclosed the Mavyret/Glecaprevir royalty-rate tiers: #msg-142808661.

[DewDiligence]

ENTA CC notes: #msg-142751191.

[DewDiligence]

ENTA quarterly numbers ought to be viewed positively, IMO, given what we already knew about ABBV's Mavyret sales.

[JK2016]

How is this viewed? I would think pretty positively...

[DewDiligence]

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

[DewDiligence]

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.

[DaveAu]

Good analysis. Have other PBMs released their 2019 formularies? I'm just wondering what are the chances that ESRX is not the only cockroach.

[DewDiligence]

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