Enanta Pharmaceuticals Inc (ENTA)

[willyw]

Enta, Abbvie, Gilead, post earnings release.

Enanta has dropped from an opening thurs ($30.60) AM to a friday close of $29.19 on sub average volume.

Gilead opened at $99.61 on thurday and closed friday at $88.21 (on nearly triple volume)

In spite of Gilead dominating at EASL, how can it be it has fallen roughly 10% in 2 days?

What are the prospects for ENTA?
How are they as they relate to the Gilead HCV program(s)?

I highlighted interesting parts of the Gilead transcript
(apologies for length)

http://seekingalpha.com/article/3969438-gilead-sciences-gild-john-f-milligan-q1-2016-results-earnings-call-transcript?page=1

(milligan p. 2) "And in fact, we have treated close to 1 million patients with Sovaldi-based regimens since Sovaldi was first approved in late 2013. That's a remarkable achievement in just over two years."

Paul Carter on most of the following quotes;

"This was primarily driven by the continued opening of access across payer segments to allow for the treatment of patients with lower fibrosis scores as well as an increase in treatment by the VA during the second half of the quarter, as funding made its way to the various VA sites." (page 6)
For the Abbvie program fewer cirrhotics treated may mean greater share. In addition, Abbvie is now roughly 100% SVR rate in G-1b, even in C/P-A cirrhotics, riba free.

"The ability to treat for eight weeks notably is a strong competitive differentiation." (Page 6)
This should bode well for the Abbvie 2nd gen program.

"Qualitative feedback suggests that prescribing HCV physicians are encouraged by the fact that real-world outcomes mimic the experience in clinical trials. Several presentations of real-world data at EASL reinforce what has been seen in clinical practice" (page 6)
Those real world results also were very good for Abbvie; perhaps better since some thought it to be an inferior treatment to Gileads in G-1

"Despite the number of patients treated to date, there are still over 3 million patients in the U.S. who have yet to be treated. About half of these patients are undiagnosed."(page 6)
Plenty of market yet in the USA

(Japan) "30,000 patients were treated with Gilead products during the quarter, representing a market share greater than 90%." (P. 7)
NOT good news for Abbvie/ENTA 1st gen, although it could pick up. It should take some time to draw down.
I continue to wonder if once daily Viekira will be submitted/approved in Japan.

"so many different genotypes in China. Genotyping is not common in China, and this could provide a very good option for the people of China. So there's hope, but we can't guarantee of course that we can accelerate that approval beyond its current timeline, which is 2019".(p.11)
I have to wonder how much SOV/VEL with beat the Abbvie 2nd gen program in China; a year, 16 months?



"sofosbuvir/daclatasvir is a very expensive regimen. And the hope is that the cost of the genotype 3 treatment will come down somewhat after sof/vel comes onto the market, which is the PDUFA date is June 28." (p.11)
I see that combo diminishing in the USA w/ SOV/VEL approval. Abbvie 2nd gen will be quite comparable to SOV/VEL in efficacy and tolerability.


(this is really key, I thought)
"And then on the negotiation side, I think with real-world data, payers are tending now to really take a lot more time and put a lot more thought into evaluating the clinical profiles of the products. And until we see the clinical profiles of the new products, it's very hard to predict how competitive they are. If they're competitive, I think we have to anticipate prices will come down and we'll negotiate because we certainly don't want to lose any access to patients for our products, and we'll defend our market share vigorously." (14)
Perhaps referencing the Abbvie 2nd gen, which had a larger data reveal than merck or JNJ.
=========================

(my comments)

Gilead is going to see increased competition from Abbvie I think;

Abbvie/ Enta 2nd gen program is

Riba free
Once a day program
Pangenotypic
Tolerable + low AE;
Seems suited to other difficult treatment sub-groups

I'm not sure that the Gilead will be seen as superior, hands down. It may not even be as good as the A&E 2nd gen in some respects.

There is a lot of market left, but probably only for the best drugs; the bar seems to continue to be raised. Will other drugs fall off like Teleprevir did?

R. Gonzales said that Abbvie didn't cut the Viekira price drastically; I get the feeling that Gilead also tried to hold the line. MRK didn't; why?

I wonder if Merck is just getting what they can. I'm not sure they have a triple therapy that will be competitive; so they are getting what they can now, with what they've got.
Neither Gilead or Abbvie want to lower prices, because they have viable 2nd (or 3rd) gen programs. Maybe Merck doesn't care cause they aren't a long term player (I dunno; I wonder)
The price of sovaldi must stay high; it discourages other bolt on therapies from competitors, like daclatasvir or Merck doublet
.....and....
with the approval of SOF/VEL, I'm trying to think of the need for single agent sovaldi after approval (other than as a bolt on for competitors)

What do I think about the Gilead prospects?


The estimate a few years back was 180 million people in the world.
They have treated 1 million patients w/ Sovaldi based therapies.

I think that they may share more patients w/ Abbvie in the future, but I don't see them losing the lions share anytime soon.

I think it signals that there may not be any more $11 billion dollar HCV drugs buys in the near future. : )
Then again..... what if there was a drug that could replace GS-7977 (sovaldi), or had equal importance to Gileads nuke?

So far as ENTA.... IF the cyclophilin inhibitor were to be effective, it could end up replacing Sovaldi as the one compound needed in all treatments, or it could become a great partner for the (or a different) nuke.
What IF two compounds could treat all genotypes, sub-groups (TE, cirrhotics, etc) and in a shorter dosing period?