Enanta Pharmaceuticals Inc (ENTA)

[DewDiligence]

Please see #msg-122248041.

[guyschmid]

Viekera sales:

Q1 16 US: 125m Intl: 289m Total: 414m

Q4 15 US: 197m Intl: 357m Total: 554m

Hmm - doesn't look that promising. Thoughts?

[DewDiligence]

ENTA FY2Q16 CC—5/9/16 4:30pm ET:

http://finance.yahoo.com/news/enanta-pharmaceuticals-host-conference-call-200500813.html

p.s. ABBV’s earnings report and CC are tomorrow morning.

[DewDiligence]

V-Pak without ribavirin approved by FDA/EMA for Child Pugh A cirrhotic patients:

#msg-122176850

[DewDiligence]

Global phase-3 program for ABT-493/ABT-530 (10 phase-3 trials, 2,500 patients):

#msg-122031014

[DewDiligence]

Twitter poll re ABBV's priority-review voucher:

Will $ABBV use its FDA priority-review voucher4 ABT-493/ABT-530-HCV combination?

— Roy Friedman (@DewDiligence) April 18, 2016

Please vote.

[DewDiligence]

ABT-493/ABT-530 data released today are as good as any investor could possibly have hoped for:

#msg-121968928

[willyw]

EASL- Real world results Abbvie 1st gen program

REAL-WORLD SAFETY AND EFFECTIVENESS OF OMBITASVIR/PARITAPREVIR/R ±
DASABUVIR ± RIBAVIRIN IN THE GERMAN HEPATITIS C REGISTRY (clear version)


http://www.natap.org/2016/EASL/EASL_19.htm

Please visit natap for many other EASL programs

"only 6 of 558 (1.1%) patients experienced virologic relapse"

=====================

See also

The Real-World Israeli experience of treating chronic hepatitis C (CHC), genotype 1 (GT1) patients with advanced fibrosis with paritaprevir/ritonavir/ombitasvir, dasabuvir with or without ribavirin (3D±R): a large multi-center cohort

http://www.natap.org/2016/EASL/EASL_16.htm

=========================

Analysis of the Real-World Effectiveness of Direct Acting Antiviral Treatments for Hepatitis C in a Large Population.

ANALYSIS OF THE REAL-WORLD EFFECTIVENESS OF DIRECT ACTING ANTIVIRAL TREATMENTS FOR HEPATITIS C IN A LARGE POPULATION

"Introduction: Documentation of the effectiveness of direct acting antiviral treatments for hepatitis C in a large real-world population is limited. We evaluated the effectiveness of simeprevir/sofosbuvir, ledipasvir/sofosbuvir, and ombitasvir/paritaprevir/ritonavir/dasabuvir for the treatment of hepatitis C patients within the United States Veterans Health Administration.

Material and Methods: Study patients were selected if they used one of the study treatments, completed treatment prior to September 1, 2015, and had a viral load test occurring at least 12 weeks after end-of-treatment. Treatment effectiveness was defined as having achieved a sustained virologic response at 12 weeks post-treatment. Effectiveness rates were estimated across all three treatments, and multivariate logistic analysis was employed to explore the impact of treatment type, controlling for patient and disease characteristics.

Results: A total of 9,604 patients met the study inclusion criteria. The unadjusted rates of effectiveness were 87.3% for simeprevir/sofosbuvir [N=3,068], 93.2% for ledipasvir/sofosbuvir [N=5,524], and 93.4% for ombitasvir/paritaprevir/ritonavir/dasabuvir [N=1,012]. Simeprevir/sofosbuvir yielded lower effectiveness rates than the other two study treatments (O.R.= 0.64, [0.49-0.85]). Other results from the logistic regression analysis found that patients with cirrhosis, decompensated cirrhosis or hepatocellular carcinoma at the start of treatment were less likely to achieve sustained virologic response. Black and male patients were less likely to achieve sustained virologic response, while co-infection with HIV, hepatitis B, diabetes and obesity had no impact on treatment effectiveness. There was some limited evidence that patients younger than 60 years of age were less likely to respond.

Conclusion: Overall rates of effectiveness exceeded 87% across all three direct-acting antiviral treatments. Rates of treatment effectiveness for ledipasvir/sofosbuvir and ombitasvir/paritaprevir/ritonavir/dasabuvir were greater than 81% for all subgroups.

=====================
EASL saturday program

"DASABUVIR AND OMBITASVIR/PARITAPREVIR/RITONAVIR WITH OR WITHOUT RIBAVIRIN IN PATIENTS WITH HIV-HCV COINFECTION: REAL LIFE INTERIM ANALYSIS OF AN ITALIAN MULTICENTRE COMPASSIONATE USE PROGRAM"

[guyschmid]

Good data, but for me the question is whether the dominance of GILD (and the competition of Zeptier & others) can be overcome sufficiently for ENTA to be a candidate for ABBV to buy them?
The market is at the same time both fragmented and "block" like - with large patient blocks in GT 1a & b many of whose needs can be met well with Solvaldi and V-Pak..

For the next generation of DAA's the hurdle is high anyway, time to treat at either 12 or 8 weeks is not going to be the mega USP. So the question is does ABBV's next gen allow it to take share from GILD further? Or does it merely continue its current rate of sale as today.

Japan the big hope?

[DewDiligence]

Impressive ABBV/ENTA SVR rates for ABT-493/ABT-450 in patients who failed prior all-DAA therapy:

http://finance.yahoo.com/news/enanta-announces-abbvie-investigational-pan-051500346.html

Positive $ABBV MAGELLAN-1 data for ABT-493/ABT-530 in pts who have failed DAA regimens #ILC2016 #HepatitisC pic.twitter.com/1aTRVwEmj1

— Edny Inui (@DoctorEdny) April 15, 2016

[tmoney2555]

http://finance.yahoo.com/news/enanta-announces-high-svr-rates-051100649.html

[tmoney2555]

Cyclophilin data is presented tomorrow I believe

[NY1972]

Short interest down almost 1 million from 12/1

3/15/2016 3,379,406

[NY1972]

HIGH EFFICACY OF ABT-493 AND ABT-530 IN HCV GENOTYPE 1 INFECTED PATIENTS WHO HAVE FAILED DAA regimens

Arm A enrolment was stopped early to investigate higher doses of study drugs in other arms. Among patients with SVR12 data, SVR12 was achieved in 6/6 (100%) Arm A patients, 20/21 (95%) Arm B patients, and 19/20 (95%) Arm C patients. Two virologic failure swere observed; 1 relapse in a nArm Bpatient with baseline NS5A RAVs, and 1 breakthrough at treatment week 8 in Arm C
in a patient with Crohn’s disease on immune suppressant therapy

[DewDiligence]

ENTA +6% on ICL (EASL) abstracts:

http://finance.yahoo.com/news/enanta-pharmaceuticals-announces-hcv-data-110700338.html

[willyw]

This also looks very intriguing

Abstract GS11: HIGH EFFICACY OF ABT-493 AND ABT-530 IN HCV GENOTYPE 1 INFECTED PATIENTS WHO HAVE FAILED DIRECT-ACTING ANTIVIRAL-CONTAINING REGIMENS: THE MAGELLAN-I STUDY
(bold face my emphasis ~W)

[biotech_researcher]

Being drawn and quartered even at average volume is still not a bundle of enjoyment..

[willyw]

ABT-493 + ABT-530- Geno- 3 EASL Late Breaker

I cannot view the text of the complete abstract, but look at this presentation;

(type ABT-493 + ABT-530 into the search engine- red box
it will provide presentations; click on late breakers. ~W)

https://events.easl.eu/EventProgramme/ILC2016.aspx


16:00 - 16:15
Abstract LBO1: 100% SVR4 WITH ABT-493 AND ABT-530 WITH OR WITHOUT RIBAVIRIN IN TREATMENT-NAÏVE HCV GENOTYPE 3-INFECTED PATIENTS WITH CIRRHOSIS
Presenter:
Paul Y. Kwo (United States)

=============
This is a late breaker.
keep in mind that it is merely SVR-4,
so there is a possibility of a viral relapse, and it would be more likely in cirrhotics.
Nor do we know the sample size.

This seems very bullish to me. To be clear, there will be other great presentations by competitors, but this looks very positive.

Genotype 3 looked a little iffy (from non-optimized dosing) to me from earlier posted data. Were I to guess it looks like 100% across all genotypes 12 weeks, and it looks as though it could be 8 weeks without riba as well.

More to come

[DewDiligence]

Jay Luly exercised and held ~$530K of stock today:

#msg-121079247

The options in question did not expire until 2021.

[willyw]

www.natap.org/2016/APASL/APASL_02.htm
per table 2 they are claiming for the higher dose;
100% SVR12 in GT1
100% SVR12 in GT2
97% SVR12 in GT3 (I'm going to have to look at this further; surprised me).

(FWIW) I saw 100% SVR rates for G-4 12 weeks too, and other studies G1-6 data.

I've been looking thru EASL abstracts. So far it's just titles.

Every year there are some interesting things, game changer things.

There are going to quite a few presentations of the Abbvie 1st gen program.

A fair number will be on the 2nd gen program. My interest/confusion of the SVR rates for G-3 was the way they were quantifying the SVR Rates. I think in trials if data is lost or there is stoppage, it's regarded as a failure. In the case of the 97% SVR rate, they (I think) are saying, yeah, a discontinuation, but a cure.....a SVR, never the less.

We will see how deep the data is, and of interest is what the higher dose optimized rates bring. IF they can bring in good cure rates I think they will will be quite competitive; amoung the highest cure rates, and using 2 compounds, not 3, such as we may see in GILD, JNJ or MRK. (SOV and VEL is 95% range)

By the way.... I belive they will present data comparing directly; ABT530/493 to the Sovaldi/Daclatasvir duo. It looks as though both Gilead and BMY have a lot of data on that combo in numerous groups. IF the 2nd gen is as good as it looks, it could be tops in dual therapy for G-3. I believe G-1 is coming in very good in 12 and 8 weeks as well.

Abstract THU-482: ENDURANCE-3: A PHASE 3, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED STUDY TO COMPARE EFFICACY AND SAFETY OF ABT-493/ABT-530 TO SOFOSBUVIR CO-ADMINISTERED WITH DACLATASVIR IN ADULTS WITH HCV GENOTYPE 3 INFECTION

Bottom line..... it appears to me that the ABBV/ENTA 2nd gen could be the most efficacious doublet out (if and when it is approved). IF a 3rd component, a nuke or a cyclophilin inhibitor were added it could be the highest efficacy and most effective RX for treating RAVs. I kinda wonder if a 3rd agent might be added at some point. I'm seeing a LOT of interest in treating past treatment failures.

Enanta will also present data on it's cyclophilin inhibitor.

When one starts looking thru all the presentations and concentration on RAVs, I think we may start seeing that the subject of resistance and RAVs will start becoming more prevalent.

Think perhaps how some infections no longer respond to a spectrum of antibiotics. This same thing may be happening in HCV. Exposure to for instance a NS5a or PI may be a bigger deal, or longer term issue than was thought. IF so..... the ENTA asset should generate some interest.
-------------------------------
(example)
Abstract THU-217: RETREATMENT OF HCV DAA FAILURES: HCV INFECTION MAY BE INCURABLE

Abstract THU-241: VIROLOGICAL FAILURES TO NEW DIRECT ACTING ANTIVIRALS IN A REAL LIFE SETTING MAY REQUIRE UNCONVENTIONAL REGIMENS FOR RE-TREATMENT
------------------------------------

Also spoiler..... there looks like there will be some presentations on the JNJ and MRK triple therapies with nukes. I think I also saw a JNJ new nuke in early early stage.

Meanwhile, GILD and MRK are in court this week over rights to nukes. Gilead saying they have the rights from purchasing Pharmasset, MRK alleging they had rights due to a prior short term partnership with Pharmasset. It's hard to imagine Gilead would spend 11+billion and not have it covered, but they are in court right now getting a ruling.

[DewDiligence]

GILD's HCV sales in Japan are running at an annualized rate of $5B(!), so this is a lucrative market indeed.

[willyw]

Enta G-1b market in Japan: Comparisons to other Therapies

There is a lot of info in here. More than I can wrap my head around at once. Generally, to my way of thinking, this looks encouraging for Abbvie/ENTA

They seem to have a therapy which has very high cure rates, once per day dosing, lower end of Adverse Events (AE)

ANY therapy with RBV has a higher rate of discontinuations and AE's

Here is the LINK. I'd appreciate any feedback

http://www.natap.org/2016/APASL/APASL_20.htm

==================
a note..... I can't tell (can't confirm) which form of Abbvie HCV that they are comparing. One might think that since they mention Asian that it may be the therapy now approved in Japan, but it seems to me that the sites providing that data do not use the HCV drug combo offered in Japan (which eliminated the 2X daily dosing of Dasabuvir.

Here however is one link to the Japan therapy and SVR rates; roughly 95%.
http://www.natap.org/2016/APASL/APASL_07.htm

What we do know is that the Gilead therapies are going well in Japan. If the efficacy and ease of treatments are similar w/ Abbvies program, we may see good income for ABBV and ENTA.

One other thing I think I notice. Look at the rate of AE's comparing HVN (Harvoni) to VKR.
It looks to me as though when RBV is removed from the equation, that the Abbvie TX may be slightly more tolerable (or equal to Harvoni).

Hard to say; far more SOV based data than VKR. If the data is from Viekira, I would think that the tolerability could only improve when dasabuvir is removed.

I am also going to note that this may be a more aged group than the usual HCV infected aggregate. In older or in groups with more co-morbidities the safety of a treatment may be more important than in younger markets. I have the general impression that some people who did simeprevir suffered sides which lasted long after treatment, and some who the treatment (SOV/SIM) *may* have caused edema, possibly de-compensation.
Bottom line; in spite of these being listed here, I wonder if some would be more dangerous on the more aged and more cirrhotic Japanese demographic. If you cause someone to de-compensate due to a harsh treatment, you haven't saved any money; no matter what you paid for the treatment.

Also note; this is not Abbvie sponsored. Seems to be a comparison of what we are seeing out of trials in the real world.

Final note: it appears that some of the ABBV data was still ongoing, so all ABBV data wasn't in, or so it appears; much of the other looks to be substantially complete and in some cases w/ a fair sized subject sample.

My recollection is that the GILD SVR rates turned in were very good; towards 100%. It will be interesting to see the real world results between the two therapies, and what size this turns out to be for the two companies.

Better than nothing. : )

[willyw]

Positive catalysts for ENTA, possible negatives.

http://finance.yahoo.com/news/enanta-pharmaceuticals-announces-chmp-positive-145200533.html

Today's is chmp positive opinion for treating g-1b without RBV
The FDA is doing the same. Some time this year ENTA (abbv) will likely be treating more cirrhotics. It will also serve to dispel the notion that the drug combo wasn't safe. The labeling change is for compensating cirrhotics; not de-compensating, and pertains to Genotype 1b; not 1a.

At some point this year Viekira will be approved for once daily in the US, possibly this year in the EU as well.

There are a large number of genotype 1b's in the world.
http://www.natap.org/2016/HCV/021916_01.htm
These are markets just starting to open up.

Data on Japan should bring in additional royalties, higher royalty rates, and higher royalty tiers.

http://www.natap.org/2016/APASL/APASL_13.htm

The labeling for Viekira will presumably only improve in the US and Ex US markets; somewhat broader labeling, and easier once a day dosing.

It is likely that the Merck regimen will impact on sales in the US, and later in EU. The Merck program will erode some Abbvie market share and will influence pricing of programs. Gild doesn't expect huge cuts, it may nick Abbvie's more.



2nd gen program

Here is a bit more data at a recent conference

http://www.natap.org/2016/APASL/APASL_02.htm
per table 2 they are claiming for the higher dose;
100% SVR12 in GT1
100% SVR12 in GT2
97% SVR12 in GT3 (I'm going to have to look at this further; surprised me).
We must also keep in mind that this is shallow data. There should be a larger sampling with the higher dosing regimen in upcoming months. This could be unexpected by the markets, but keep in mind it could cut both ways. We will see what the studies show, but this *looks* encouraging.

ABBV has deeper data on this than they have shown.
They should be able to release decent data by mid year and could have preliminary data at EASL. By the way; the data on GT-4's is good too, per my recollection.

They are also conducting 8 week trials in GT1, and I expect high SVR rates there as well.

AS they year time rolls on these therapies will pay more and more attention to RAVs. The 2nd gen program may look even better when seen how it stacks up in that area.

What the Abbvie 2nd gen program really needs is another compound to add to it. It could be a nuke. It *could* be a cyclophillin inhibitor.

Frankly, if the ENTA compound is as good is it appears, it could be used as a stand alone add on to any program; Abbvie's, Gilds, Merck's. IF Enta can find a nuke to partner with 494 it could also become a larger player in HCV. I am uncertain as to the time table ...if if and whens on entering into clinic for a proof of concept for the cyclophillin asset, but it seems quite effective on RAVs. It will be interesting to see the data on it.

Possible up or downsides;
What will the year bring from the JNJ nuke program? The Merck nuke program? RGLS?

Time will tell, but progress is an uphill fight. We haven't seen strong data on the nukes. We recently saw encouraging efficacy from RGLS, but we also saw some very worrisome AE's in small numbers. Perhaps worse, there wasn't much comment on them, to the best of my knowledge.
If these 3 HCV programs were to be problematic or less than successful it could turn into a race between GILD and ABBV. I think we may see the viability of some of these programs this year.
I think we are starting to see that development in HCV could soon end as the cure rates climb and prices drift downward. Whoever is on top may stay on top

[NY1972]

Senior Center Based Hepatitis C Screening in Baltimore

HCV prevalence in our population was an order of magnitude higher than national estimates. This can be in part explained by high rates of IDU in Baltimore City (prevalence of injection drug use of 336/10,000 population aged 15-64).[13] High rates of hepatitis C in those born before 1945 may also partly be explained by introduction of heroin use into Baltimore in the 1950s.

https://www.researchgate.net/publication/290221608_Senior_Center_Based_Hepatitis_C_Screening_in_Baltimore

[NY1972]

Comparing Cyclophilin A and miR-122

CyPA is involved in diverse pathological processes of cancer development. Specifically, it has been reported that overexpressed CyPA in many cancers: (1) helps cancer proliferation,73 (2) regulates cell cycle progression,74 (3) blocks apoptosis,75 and (4) promotes cell migration/invasion.76


http://www.nature.com/cddis/journal/v4/n10/full/cddis2013410a.html


miR-122 levels are frequently reduced in hepatocellular carcinoma (HCC) compared to normal liver, and low miR-122 levels correlate with poor prognosis.[15][16] Overexpression of miR-122 reduces tumorigenic properties in HCC cell lines, suggesting that it functions as a tumor suppressor gene, and increases the response of cells to the chemotherapeutic drugs sorafenib and doxorubicin.

https://en.wikipedia.org/wiki/MiR-122#Role_in_cancer

[NY1972]

Some notes from RGLS CC:

1. 1 SAE deemed drug related by investigator, required hospitalization

2. SVR24 will be required by FDA as RG101's effect lasts 12 weeks, why 2nd injection on day 29?

3. RG101 targets host factor miR-122, compared to host protein cyclophilin targeted by EDP-494

[DewDiligence]

ENTA—Small open-market purchase by independent director last Friday:

http://www.sec.gov/Archives/edgar/data/1177648/000090866216000460/xslF345X03/edgar.xml

[NY1972]

More hypes from RGLS, never in ENTA PR

RG-101 Containing Regimen Has Potential to Reduce Harvoni®, Olysio®, or Daklinza™ Rx to 4 Week Duration -
- Regulus to Accelerate Development of RG-101 as Backbone Therapy in HCV

[DewDiligence]

ENTA—The S-8 filing is not for a public offering, but rather to register 562K shares for future grants under the company’s Equity Incentive Plan. The $24.50 price listed in the S-8 filing is simply the market price at the time of the filing.

[biotech_researcher]

This Registration Statement covers an aggregate of 561,505 shares of the Registrant’s Common Stock, par value $0.01 per share (the “Common Stock”), that may be issued pursuant to awards granted under the Registrant’s 2012 Equity Incentive Plan. In addition, pursuant to Rule 416(a) under the Securities Act of 1933, as amended (the “Securities Act”) this Registration Statement also covers such additional shares of Common Stock as may be issued to prevent dilution from stock splits, stock dividends and similar transactions.
(2) Pursuant to Rules 457(c) and 457(h)(1) under the Securities Act, the proposed maximum offering price per share and the maximum aggregate offering price for the shares have been calculated solely for the purpose of computing the registration fee on the basis of the average high and low prices of the Common Stock as reported by the Nasdaq Global Select Market on February 11, 2016 to be $25.97 and $23.03, respectively.

[DewDiligence]

CC-31244 is a non-nucleoside polymerase inhibitor—not the class of drug ENTA is looking to procure (#msg-120481433).

[NY1972]

CC-31244 is highly potent and active against all genotypes (1-6) with no cytotoxicity in various cell systems

http://content.equisolve.net/_68c9316e16870b3792e01db165af63fd/cocrystalpharma/db/109/302/pdf/Cocrystal+Pharma+Inc.+AASLD+Poster+11-16-15.pdf

[NY1972]

VL levels around the proposed clinical thresholds show significant inter-assay and intra-patient variability.


http://cid.oxfordjournals.org/content/early/2016/02/09/cid.ciw061.short?rss=1

[NY1972]

Canada trying to save a few bucks with 8 weeks of Z?

8 weeks of therapy – $40,200
12 weeks of therapy – $60,300
16 weeks of therapy – $80,400


people with genotype 1b who do not have severe liver injury and who have not been previously treated – Zepatier treatment lasts for eight weeks

http://www.catie.ca/en/catienews/2016-01-29/zepatier-hepatitis-c-approved-canada

[NY1972]

Express Scripts' Miller likes price for Merck hepatitis drug

Will he like RAV screening and 16 week + RIBA for GT1a?

Still, Miller doesn’t foresee Merck taking much market share this year, since there are contracts in place for drugs already on the market from Gilead and AbbVie Inc. Gilead and AbbVie have divided up the market by locking up deals with insurers and pharmacy benefit managers, offering discounts to ensure their medications are the first choice.
“What you’ll see is the Merck team doing a lot of negotiating this year, and you’ll see the drug gain traction next year,” Miller said.

http://www.bloomberg.com/news/articles/2016-02-12/express-scripts-giving-extra-scrutiny-to-valeant-prescriptions?cmpid=yhoo.headline

[biotech_researcher]

Fidelity sold a little ENTA, down to 3.93% in a filing today..

[DewDiligence]

Sounds like a non sequitur.

[NY1972]

Shorts' most favorite analyst?

Barclays PT 16
Viekira Pak’s Place in Hep C Landscape Should Diminish
Pipeline Programs – Too Early to Impact Story in 2016

Sounds like a jilted lover?

[NY1972]

Shorts got shorter, must be convinced Z = Harvoni or low low tide coming

1/29/2016 Short Interest = 4,214,173

[DewDiligence]

The FY1Q16 10-Q has been filed:

http://www.sec.gov/Archives/edgar/data/1177648/000119312516455395/d106818d10q.htm

[Rocky3]

I think that the focus should be on the quarter ending 6/30/16, not 3/30/16.

US sales will be down again next quarter. V-Pak script counts are down 20% QOQ at this point. I would expect Europe should be strong again, but the real growth should be in Japan in the following quarter. The way that HCV sales have grown so far is that it takes a few quarters for the new scripts to translate into total scripts. It happened with Sovaldi and then with Harvoni. I expect GILD Japan revenue to be up significantly in the March quarter, and then to decline in the June quarter, mostly because of mandated price reductions.

So for the March quarter, I would hope that the ABBV gross HCV sales should be up, but not by a huge amount. The change in the royalty payments should help even more. The real increase I would expect in the June quarter, assuming that ABBV/ENTA does as well in Japan as it has done in Europe. JMO.

[NY1972]

Will Japan 2D regiment bring in 200M next Q? 1/7 of GILD's number + $554M = $3B run rate next Q.

4Q15 V-Pak sales $554M (+18% vs 3Q15): $197M US (-19% vs 3Q15); $357M ex-US (+57% vs 3Q15)

And so we're looking, we're really looking forward to how things start to roll out in Japan. Gilead has obviously had tremendous success there this last quarter, which I think was their first full quarter pulling in, I think it was about $1.4 billion in Japan alone, so stay tuned, and we'll see how it goes.

[DewDiligence]

The word, unfortunately in that context means unfortunately for MRK.

[NY1972]

Luly's Unfortunate view on Merck's label:

So if those RAVs are present and it's recommended that you have that testing then it's recommended that you have 16 weeks of therapy not 12 and it's recommended that you add ribavirin on top of that. Unfortunately you need to do that RAV testing in order to determine that.

More color on their potential Pujols for the world that thinks the game is over:

We will aim to have a Phase 1 data later this year and to initiate a proof-of-concept study. Before then, we will present additional preclinical data on EDP-494 at EASL in April.

[DewDiligence]

It helps that the expected tax rate in FY2016 is only 27% (#msg-120398905).

[Rocky3]

P/E = 5???

And what in it on '16 earnings?

Looks like Yahoo says that calendar year earnings are estimated at ~.30/sh and '17 earnings negative. Sure seems to low to me. If 3/31/16 quarter can repeat 12/31/15 royalty (and I think that they should be higher due to Japanese sales more than replacing the decline in the US, which is down ~20% QOQ at this point), there should be >.20/sh income. Even with increased expenses going forward, the expenses are very low. And the potential Japanese sales are very meaningful, but we don't really know how much market share it will take. Hopefully, we will get some numbers as the quarter matures. It will also be interesting to get MRK script numbers and to see how GILD and ABBV numbers are changed - I think there not be much change.

I still think that ENTA can earn ~$1/sh+ in calander '16, but the real issue is how much share the next generation can get world-wide. The market is saying that the earnings are going away sooner than later. Place your bets.

[DewDiligence]

ENTA FY1Q16 EPS=$1.36—cash*=$254.5:

http://finance.yahoo.com/news/enanta-pharmaceuticals-reports-financial-results-210200818.html

CC at 4:30pm ET.

*Includes $17.9M of royalties earned (but not yet received) from ABBV.

[NY1972]

P/E = 5

Luly should feel like Rodney Dangerfield today.

[biotech_researcher]

Remicade, Humira and Enbrel work by blocking an inflammation-causing protein called Tumor Necrosis factor (TNF). Raymond said more than 60 other anti-TNF biosimilars are in development and could commoditize the drug class much sooner than thought.

https://www.yahoo.com/news/fda-reviewers-support-celltrions-biosimilar-remicade-125940029--finance.html

No place to hide...

[NY1972]

What will be ZEPATIER real world cure rate in Canada if RAV screening is not required?

From Canadian PRODUCT MONOGRAPH:

GT1a SVR was achieved in 98% (432/439) of subjects without baseline NS5A polymorphisms and 55% (16/29) of subjects with baseline NS5A polymorphisms that confer greater than 5-fold reduction of elbasvir antiviral activity in vitro. Among treatment experienced subjects, SVR was achieved in 99% (291/295) of subjects without baseline NS5A polymorphisms and 50% (13/26) of subjects with baseline NS5A polymorphisms

Genotype 1b SVR was achieved in 100% (223/223) of subjects without baseline NS5A polymorphisms and 86% (31/36) of subjects with baseline NS5A polymorphisms