Replies to post #196270 on Biotech Values

[mr_o]

The was I understand it, ENTA will receive $30 million in Q4 and $80million on 2-gen approval. With approximately $250 million in cash the current EV is $200 million. Is this correct?

[dewophile]

ENTA

It was not entirely clear from the FDA warning that these events occurred exclusively in patients with decompensated cirrhosis - to the contrary the warning suggested that at least some of these SAEs were in pts with compensated cirrhosis:

http://www.fda.gov/Drugs/DrugSafety/ucm468634.htm

Our review of adverse events reported to the FDA Adverse Event Reporting System (FAERS) database and to the manufacturer of these medicines, AbbVie, identified cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines. Some of these events resulted in liver transplantation or death. These serious outcomes were reported mostly (i.e. not exclusively) in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it..

If indeed pretty much only decompensated cirrhotics are affected, as suggested by the ABBV PR, then i agree w you totally

[jbog]

Moreover, I don’t think the V-Pak label change will materially alter ABBV’s exclusive contract with ESRX. ABBV would have a strong legal case, IMO, if ESRX tried to change the terms of the contract other than to ensure that V-Pak isn’t given to patients where it’s now contraindicated.

You sound like this is the first contract these guys wrote and signed. Companies of this size certainly would have a remedy included for many unforeseen situations. Unfortunately, we have no clue what is in the agreement.

[tmoney2555]

Well said! NASH program also a potential catalyst.

[jbog]

Gilead market position strengthened after Viekira Pak warning, says Leerink

After speaking with two hepatitis C virus specialists, Leerink analyst Seamus Fernandez believes the FDA warning of serious liver injury risk with AbbVie (ABBV) and Enanta's Viekira Pak strengthens Gilead's market position. The specialists believe the FDA warning letter could scare off some physicians from prescribing Viekira Pak in any cirrhotic patients, regardless of Child-Pugh class, Fernandez tells investors in a research note. This should firm up Gilead's position in the market given the "impressive" safety and efficacy seen with Sovaldi-containing regimens across almost all patient subsets, the analyst contends.

[lgonber]

Good post.COngrats for you purchase at $20. As an investor in GILD and ACHN, yesterday´s news favored my portfolio. I am considering a purchase in ENTA in case it goes back to the levels you bought. My only concern is if doctors are reluctant to prescribe V-pack to all cirrhotic patients (just in case) which is about 25% of patients with hepatitis C. DO you think this could happen? and if so, would that impact in ENTA royalties significantly?
thank you

[DewDiligence]

(ENTA)—GILD’s COO John Milligan (on 3Q15 CC) said HCV payer contracts for 2016 are already solidified, and hence Milligan sees no effect on payer contracts from the recent V-Pak label change.

[DewDiligence]

ESRX CC: No change expected in V-Pak utilization due to revised FDA label.

[DewDiligence]

Pretty fast 40% gain on Oct22 ENTA buy (#msg-117918952, #msg-117924201).

[DewDiligence]

Re: ABBV/ENTA next-gen HCV regimen

A phase-3 trial of ABT-493/ABT-530 in non-cirrhotic GT1 patients, called ENDURANCE-1, is now listed on clinicaltrials.gov:

https://clinicaltrials.gov/ct2/show/NCT02604017

Comments:

• There are two arms: one for 12 weeks and one for 8 weeks.

• Only one dose of ABT-493 and ABT-530 is being tested, but the dose size is not (yet) listed. Both drugs are given once daily.

• ABT-493 and ABT-530 are the only drugs in the regimen. (No ribavirin and no PI booster.)

• The enrollment target is 600 patients (300 per arm); 60 trial sites (including US and ex-US) are already listed.

• Expected completion (for SVR12 reporting) is Jan 2017.

[DewDiligence]

IMS forecasts $45-55B worldwide HCV-drug sales in 2020:

http://www.statnews.com/2015/11/18/pharmalot-global-spending-drugs/

[DewDiligence]

ENTA receives $30M milestone from ABBV for HCV launch in Japan:

http://www.sec.gov/Archives/edgar/data/1177648/000119312515382975/d214977d8k.htm

[DewDiligence]

ENTA FY4Q15* CC notes:

• EDP-494 cyclophilin inhibitor for HCV will start phase-1 monotherapy trials in calendar 1Q16. ENTA’s eventual plan to is pair EDP-494 with an in-house nuke to make a 2-DAA HCV regimen for patients who are hard to treat due to the presence of RAVs from prior DAA treatment.

• ENTA’s FXR agonist for NASH will start phase-1 during 2016. This is the same drug class as ICPT’s OCA (#msg-111502128).

• During FY4Q15 (which predates any ABBV HCV sales in Japan), ENTA received V-Pak/Technivie/Viekirax royalties from ABBV at an annualized rate of $57M.

• ENTA’s pro forma cash balance at 9/30/15 was $253.8M. (This is comprised of $209.4M cash on hand; $14.4M in royalties earned but not yet received from ABBV; and the $30M milestone payment from ABBV for Viekirax approval in Japan.)

• ENTA expects to spend $40-50M on R&D during FY2016; however, inasmuch as ENTA is profitable and has an ample cash balance (see above), there are no plans to raise capital.

--
ENTA’s FY4Q15* PR:
http://finance.yahoo.com/news/enanta-pharmaceuticals-reports-financial-results-210100660.html

*ENTA’s fiscal year ends on Sep 30.