The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: David Steinberg - Jefferies Group LLC - Analyst
: So Terrie, good morning. Thanks for joining us. First question. You recently released the HP data. It shows statistical significance I think on six points,
and it showed superiority to the standard of care. So all very good. Given there was a lot of information to sift through, in your view, what are the
most important aspects of the results that you would like to enforce with investors on the call this morning?
Question: David Steinberg - Jefferies Group LLC - Analyst
: Okay, fair enough. My next question is while there was significant separation between vonoprazan and lansoprazole groups, vonoprazan didn't
quite get to the 90% eradication rate established in Japan where you did -- where Takeda did multiple clinical trials. Do you have any views on this
aspect of the Phase III data?
Question: David Steinberg - Jefferies Group LLC - Analyst
: Fair enough, okay. And I had one follow-up on H. pylori. So a company called RedHill launched a competing product called Talicia -- I hope I
pronounced that correctly -- about a year ago. Do you have any views on the rollout of that product and are there any [reintrudes] for vonoprazan
assuming FDA approval in terms of payer and physician receptivity, unmet need, things like that? And also, given the declining overall eradication
rates in the US and around the world, why do you think that Talicia hasn't done better than it has today?
Question: David Steinberg - Jefferies Group LLC - Analyst
: Okay, Martin. Thank you. That was very comprehensive. So I think that's it for H. pylori. So let's move on to the next opportunity for vonoprazan,
which is in GERD. And arguably GERD is a much larger opportunity. I think there are 6 billion-plus doses of PPIs taken by patients last year. So the
upcoming Phase III is more important, in a way, than the HP data. Now prior to the HP Phase III data, all the information generated thus far was
from Japan. The HP data was the first non-Japan data.
Was there anything instructive in the recent data that you would like to share that you think perhaps offers a higher likelihood of positive data in
the GERD readout from what we just saw in HP? I think [as you alluded] to it with any further expansion and that would be very great -- very good.
Question: David Steinberg - Jefferies Group LLC - Analyst
: Okay. Great. So, several months ago you disclosed another new major clinical program at your Investor Day. And that would be NERD, not GERD.
Can you outline -- I think people -- I think investors are much more familiar with GERD. But NERD sounds like a pretty big opportunity if not a major
opportunity. So Terrie, could you outline this opportunity for us and the key aspects of the clinical trial design?
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JUNE 01, 2021 / 2:00PM, PHAT.OQ - Phathom Pharmaceuticals Inc at Jefferies Healthcare Conference (Virtual)
Question: David Steinberg - Jefferies Group LLC - Analyst
: Got it. Thank you. So let's now talk a little bit about the commercial opportunity for vonoprazan, assuming it receives approval here in the US. So,
in the past, you've discussed the success in Japan, I believe it's called TAKECAB, as a possible indicator of future success here in the US.
And also the commercial success of DEXILANT, which is the only remaining branded PPI, serves as another reason why there is significant demand
for another acid-reducing agent despite the wide availability of OTCs, including Prilosec and Nexium.
So has anything changed with the revenue trajectory of either product that would give you pause on the commercial opportunity of vonoprazan
in the US? Either to the plus or the minus? And can you remind us what you think peak sales might be for vonoprazan, assuming it gets approved
in both HP and in GERD?
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JUNE 01, 2021 / 2:00PM, PHAT.OQ - Phathom Pharmaceuticals Inc at Jefferies Healthcare Conference (Virtual)
Question: David Steinberg - Jefferies Group LLC - Analyst
: Thanks, Martin. That's a perfect segue into my next question, which has to do with managed care contracting and discounting, things like that. So
Takeda in the United States -- we talked earlier about the last PPI in the market and they've used a contracting strategy to promote DEXILANT, and
gross net rebates are fairly significant for the product.
In your market research and dialogue with the payers, do have a sense of how you might be able to price vonoprazan? And then secondly, do you
think the current dynamics in the market will force you to aggressively contract the payers? And does having both the H. pylori and GERD indications
actually make pricing a bit more tricky for you?
Question: David Steinberg - Jefferies Group LLC - Analyst
: Okay. Fair enough. We have a couple minutes left. Once your GERD data reads out -- well, I guess the NERD data will come next year. But after the
GERD data reads out, you're going to file -- assuming it's positive, you'll file an NDA for both indications. So focus will shift to your commercial
preparization -- prep for the launch. And I know you recently brought in some key managers, head of sales, head of market access and others.
Can you share with us a bit more about your go-to-market strategy, plans for commercial sales force build, awareness building among KOLs? And
also, do you expect to -- obviously all the companies that sold PPIs were large pharma companies. Is part of your plan potentially to out license
vonoprazan to a company with a larger reach who can hit thousands of GPs beyond the current GI-focused sales force that you're building?
Question: David Steinberg - Jefferies Group LLC - Analyst
: Okay. One quick question for you. We have a minute left. Vonoprazan is your only asset. Looks like a great asset, but it's your only asset. Does it
make sense to add additional product candidates to your portfolio? Are you considering any on-market opportunities that could help accelerate
the building of your commercial team?
Question: David Steinberg - Jefferies Group LLC - Analyst
: That makes a lot of sense. And with that, we are just out of time. So I'd like to thank Terrie, Martin, Azmi and Todd for joining us. Thanks for an
excellent and comprehensive presentation. And thanks for everyone on the line for listening in today. And I hope everyone has a great conference
and a great day.
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