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willyw

02/04/19 8:21 PM

#223504 RE: DewDiligence #223494

Epclusa FDA approval in the USA; Jun 28, 2016
Mavyret; August 3, 2017. So roughly 13 months later than Epclusa approval.

I've seen estimates of 12-14 million HCV infected in China.
Gilead's Epclusa was approved in China roughly half way thru 2018

IF it were so that China approval of Mavyret lagged exactly 13 months, then China approval would be roughly July/August 2019. (I would think it should be a safe approval bet, and wonder if it could be further expedited for sooner approval)

So, one point is that 2019 estimates for Gilead must include a full year of China income; not so for Mavyret, and they may not be counting at all since approval hasn't happened yet.

My subtext is that just as investors may be surprised Mavyret guidance is still high for 2019 (recent Abbvie guidance) , it may continue to surprise in 2020.
People shouldn't be; both Gilead and Abbvie guided for stabilizing prices and long term treatment tails.

It's possible that HCV investors have seen short lived spans and expected the same; Telaprevir, victrelis, simeprevir, daclatasvir, zepatier, and perhaps even the Abbvie 2 and 3D programs, BUT all these programs had other programs with higher efficacy and shorter treatment durations nipping at their heels.
It is not so clear that anything is coming to replace the reigning HCV programs. It's hard to improve on efficacy or tolerability and both Epclusa and Mavyret are pan-genotypic.

I have not seen any antiviral in development that seems to potentially be superior to Gilead or Abbvie HCV programs.

One final proposition; if the Mavyret market share has slowly crept thru 2018 from a low percentage and has been slowly gaining over Gilead's programs, by the time China happens, could it gain a higher percentage of market share? What will be the Gilead/Abbvie HCV market share at 2019 year end? 2020 year end?

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DewDiligence

02/08/19 11:16 AM

#223571 RE: DewDiligence #223494

ENTA—Mavyret’s US new-patient share=56.6% in the week ending 2/1/18, as reported by IMS. GILD’s US new-patient share was 42.6%, and MRK’s was 0.9%.

In the same week: Mavyret’s US total-script share was 51.3%—despite Mavyret’s having a smaller average number of scripts per patient (i.e. a shorter average duration of treatment) than GILD’s HCV products; GILD’s US total-script share was 47.9%, and MRK’s was 0.8%.