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: Joey Stringer - Needham & Company - Analyst
: Thanks for a very helpful overview. Wanted to get into a little bit more detail on the regulatory interactions. Can you give us an overview -- I know
you touched on it a little bit, but give us an overview of that -- of your meeting with FDA, in terms of what the outcome was and what are your next
steps, you mentioned a resubmission.
Question: Joey Stringer - Needham & Company - Analyst
: In terms of data collection and or analysis processing, are you still collecting data such as stability data? How would that fit into resubmission?
Question: Joey Stringer - Needham & Company - Analyst
: In terms of the resubmission and the review process, what are the timelines for that? And when does the clock start, once you officially resubmit?
What's the process like there?
Question: Joey Stringer - Needham & Company - Analyst
: We've got a couple of questions on the -- how the interactions, the recent interactions with FDA have played out, and the fact that you seem to be
aligned resubmission and the stability data? And just in general, how would you classify the outcome in terms of what you think the FDA is signaling?
Does that give you more or less confidence in review process and potential approval?
Question: Joey Stringer - Needham & Company - Analyst
: You guys -- in terms of the manufacturing, if I have this right, had tweaked the reformulation a bit, just given the nitrosamine in theory. What about
the requirements for the new and improved, so to speak, reformulation? Does that mean you want to see bioequivalence studies or any additional
studies around that reformulation?
Question: Joey Stringer - Needham & Company - Analyst
: Okay. You mentioned that you're continuing to collect data stability, in particular, stability data. To the extent you can disclose, how is that stability
data tracking over time? And as far as you do projections based on how the data look, what's the latest update on that?
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APRIL 18, 2023 / 12:45PM, PHAT.OQ - Phathom Pharmaceuticals Inc at Needham Healthcare Conference
(Virtual)
Question: Joey Stringer - Needham & Company - Analyst
: What do you resubmit? What would be your next expected contact points from FDA?
Question: Joey Stringer - Needham & Company - Analyst
: In terms of providing updates to the market, what are your plans for that? Will it be a press release, part of the conference call, and how often would
you do that in terms of when are the right times to provide updates?
Question: Joey Stringer - Needham & Company - Analyst
: Great. Well, very helpful discussion upon that following process. I guess I am moving forward. I want to switch to the commercial aspect. You
mentioned that you have a potential approval decision by the end of the year. So let's talk about commercial infrastructure and salesforce. What
are your plans for -- just given how the regulatory process has played out, what are your plans for bringing on the salesforce? Will the salesforce
be brought on at full strength upon approval?
Question: Joey Stringer - Needham & Company - Analyst
: In terms of the commercial launch, have commercial infrastructure building up, you feel that your position was resourced to go full force at launching
the way you want to?
Question: Joey Stringer - Needham & Company - Analyst
: Great. In terms of access and conversations with payers, how are those progressing? And what are the, in particular, for the rest of subject is where
the expectations around access there?
Question: Joey Stringer - Needham & Company - Analyst
: What about pricing? What are your -- what's your latest thinking on pricing?
Question: Joey Stringer - Needham & Company - Analyst
: You mentioned that many are aware that the drug is approved the Takecab [ex US] in Japan, marketed by Takeda in Japan and some other countries.
In terms of you're looking at a comp for sales, is it a reasonable comp to look at what Takecab sales are [ex US] in terms of estimated peak sales
potential in the US on a population adjusted basis? Or understand that the market dynamics are different in the different countries, but maybe
just a little bit more perspective on that?
Question: Joey Stringer - Needham & Company - Analyst
: Great. You mentioned that just in terms of peak sales, I think it's close to $900 million run rate if you take the last quarter and sales. So it has done
extraordinarily well. Are there $900 million of annualized run rate? What's the breakdown in terms of the sales for -- Takecab is approved for a
couple of different indications, including erosive esophagitis and H. Pylori, so what's the relative breakdown of that $900 million, if you have that?
Question: Joey Stringer - Needham & Company - Analyst
: Thank you. That's very helpful. Martin, you did mention the other programs outside of E and H. Pylori have this non-erosive or NERD indication. For
those that aren't as familiar, there's two separate arms here to the program. There is the on-demand therapy and then there's the daily therapies.
Can you explain the difference between those two, and why the importance of each of those, and give us maybe a broad overview of the program?
Question: Joey Stringer - Needham & Company - Analyst
: Just to add onto that, when someone thinks of generic PPIs, they're not approved in the US for on-demand therapy, correct? And there's a distinction
there in terms of the differentiation?
Question: Joey Stringer - Needham & Company - Analyst
: Right. So they're moving on. There's this constant movement in the marketplace. It's really big market with a high level of dissatisfaction. So we
have the opportunity to intercede with a superior profile, and then with non-erosive with a differentiator for as-needed treatment. In terms of the
market opportunity for NERD relative -- what is the market opportunity relative to say erosive esophagitis?
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APRIL 18, 2023 / 12:45PM, PHAT.OQ - Phathom Pharmaceuticals Inc at Needham Healthcare Conference
(Virtual)
Question: Joey Stringer - Needham & Company - Analyst
: All right. That's very helpful. In terms of partnerships, two-part question, number one, can you outline what your current partnerships and royalty
obligations are for Vonoprazan? And second part is have you thought about ex-US partnerships, and what's your latest thinking on that?
Question: Joey Stringer - Needham & Company - Analyst
: There are a few late-stage competitor PCAB programs in development in the US for erosive esophagitis and GERD? Can you handicap the competitive
threat from those programs, and what potential impact it has on Phantom?
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APRIL 18, 2023 / 12:45PM, PHAT.OQ - Phathom Pharmaceuticals Inc at Needham Healthcare Conference
(Virtual)
Question: Joey Stringer - Needham & Company - Analyst
: Okay. Then, two last questions, financial related. What's your current cash position and what are your current expectations on cash runway?
Question: Joey Stringer - Needham & Company - Analyst
: Do you have any limitations to accessing your financing vehicles such as your term loan, and I guess, maybe you could remind us what those terms
are?
Question: Joey Stringer - Needham & Company - Analyst
: Thanks, Molly. Well, Terrie, thank you so much to you, and the rest of your team for participating. It was a very useful and great discussion.
Question: Joey Stringer - Needham & Company - Analyst
: Great, thank you. Thanks, everyone, for joining on the webcast. Have a good day and a good rest of the conference.
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