Great, I think we'll get started. Welcome everyone. Welcome to our sixth annual Biotechnology Conference at Guggenheim. I'm Evan Taddeo. I'm on the biotech team here. And for our next fireside session, I'd like to welcome the management team from Phathom Pharmaceuticals. From the company, we have Terrie Curran, CEO; Molly Henderson, the CFO; and Martin Gilligan, the CCO. Maybe I'll kick it over to Terrie. Could you maybe give us a, you know, a five-minute overview of where the company's at with its launch, clinical development, things like that, and some catalysts that we should be looking forward to? Thanks, Evan, and thank you, Guggenheim, for inviting Phathom to the conference. We're actually thrilled with the progress that we're making, as we begin the commercial execution of VOQUEZNA. As you know, VOQUEZNA is the first new mechanism entering into this very large marketplace for decades, with a differentiated profile. So it's the first potassium-competitive acid blocker that's entering the antisecretory category, the first compound that has demonstrated superiority versus the standard of care against PPIs. And we're executing the first two launches into erosive GERD and Helicobacter pylori. Very large marketplaces, more than 22 million patients that are diagnosed and treated with a prescription with GERD, so represents a very large commercial opportunity. Importantly, this is the first two indications that we're launching. We're just weeks into launch, and very pleased and excited with the reception that we're getting in the field and the response we're getting from physicians. Importantly, we have an additional indication. We have a PDUFA for non-erosive disease on July nineteenth, and that gives us the opportunity to enter into the largest segment within this space, with 15 million patients that are diagnosed and treated with a prescription with non-erosive disease. And then importantly, we have two other or three other programs that we'll pursue. One is in a very novel dosing regimen for non-erosive patients, and to as-needed treatment. And then the second is a pediatric program, and the third is we're looking at doing a Phase II eosinophilic esophagitis clinical program. Very excited that we have begun commercialization into this very large market where there's a significant unmet need, and we have a number of key catalysts going into 2024. Great, thank you for that. I do want to spend a good amount of time on the launch of VOQUEZNA, specifically some of the early feedback that you've been getting so far, given that it's in early stages of launch. So maybe can you help us contextualize, you know, what feedback you're getting from the doctors, and maybe a little bit more granularity on how we can be monitoring this from the script level? Given that, you know, we have numbers from IMS, but there's also this BlinkRx component, and we have less visibility into that, so we're just trying to figure out how to really understand, you know, how to kind of monitor the launch at this point. Sure. So I think I'll take that. So, I mean, I'll tell you, the launch is going well. There's a smile on my face. We're excited about the execution. I think everything we set out to do, we said we were gonna do, we've accomplished, and we're moving forward. Mm-hmm. From the physician standpoint, we're seeing scripts coming in. We're seeing doctors, you know, repeat, right, for additional patients. What seems to be resonating with them when I think about the sales call is, you know, we open up typically talking about the unmet need, and in other therapeutic areas I've worked in, you're kind of telling the doctor what their need is. Here, we introduce the discussion, and the physician is actually, they're kind of taking over the conversation, and they're agreeing, "Oh, I have patients cycling. I have patients who are dissatisfied," which makes a natural move to the mechanism of action. And right away, what we're seeing is that customers, they recognize it's different. They recognize it's not a PPI. They're seeing the data that plays out, the rapid, potent, and durable profile within the mechanism, and then when they see the superiority data, it almost makes sense, right? So it gives them the reason to prescribe. So we're starting to see that they're identifying patients, they're sending prescriptions in, and then to get to your point about IQVIA versus Blink, what we're then doing is saying: "Okay, doctor, when you're gonna write VOQUEZNA, you know, an opportunity or an option is to send that prescription to BlinkRx, and it gives you your best shot on call," right? So we're very early in the process of launch. We're really just weeks in. It wasn't until the middle of January that we had all of our sales force in place, and it's only, what, February seventh or eighth? It's really early in launch. So what those conversations look like is about the patient going to BlinkRx, and what they're doing there is they're identifying if the patient has two things: One, are they a commercial patient or a non-commercial? And then they're really drilling down on that commercial patient, and if you're a commercial patient, do you have coverage already, or do you not have coverage? And so if the patient has coverage, they will offer them the $25 copay and fulfill it through a retail pharmacy, and that's what you're seeing in IQVIA. So IQVIA includes anything that's going to any retail, CVS, Walgreens, independent, but it's also anything that's going to Blink that the patient already has commercial coverage. Now, keep in mind, we're weeks into launch. We always said we anticipated our coverage at this point to be very low, and it will grow as we move into the year. So now that other group of non-covered patients, they offer VOQUEZNA at a discounted cash price that's affordable for most patients. And what they do is then they provide that by mail to the patient, and then the good thing for the doctor is they're not hearing complaints back, and when there's a refill, they'll keep scanning for commercial coverage. Those scripts are not communicated through IQVIA, because they're not a retail channel, so IQVIA does not pick it up. So then what we look at is we step back, and then when we have our earnings or our quarterly updates, we'll provide a combination of what is the IQVIA scripts- Mm-hmm. - What are the Blink scripts, and pull that all together so you can get a good vision of demand. Got it. And just kind of focusing on the Blink for a second, what is the timeline from script to the patient actually getting the drug if they're going through the Blink system? And how does that kinda compare, you know, broadly across the board? So, you're asking is, by the time Blink receives it, how long until the patient actually gets it? Yes. Yeah, I would say. So I've actually done it. I've tested it out. So it's anywhere from four to seven days. So what we do is we provide samples to the physician's office, but we're not providing volumes that it's substituting for scripts. I mean, it really is just a start. And it's all dependent upon the patient. So the patient will get notified by Blink right away. From the time that patient says, "Yes, I'm getting my prescription, and here's my credit card for the copay," or whatever it might be, it's then shipped directly to the patient. Mm-hmm. It typically takes anywhere from when that patient does that exercise four to seven days. What's really nice about it is it communicates them along the way. So, "I've got your prescription. On Blink, I have your prescription. Now, next thing, here's what you need to do. Okay, it is now shipped." And literally, within minutes, and I found this out by chance, when it's delivered to your home, within minutes, you get a text to say it's actually sitting in your mailbox or at the front door. Hmm. Got it. Yeah, it seems quite convenient. Yeah. So in terms of... I don't know what you can tell us in great detail so far, but, in terms of, like, the patient mix that you're seeing so far, can you give us any color there? Just trying to understand- Yeah ... basically, what's kind of giving you confidence, that- Yeah ... you're gonna see broad uptake kind of across the patient spectrum? Yeah. Especially in EE. Yeah. So, you know, what we always said prior to launch was everything was telling us, and everything being the customers, including payers, that this was not gonna be limited to a subset of patients or more severe patients, and that's early days is exactly what we're seeing. So I'll give you an example. I spent a couple days last week out riding with sales reps, calling on physicians. And never did I hear the doctor communicating more severe patient, C/D patient. What I heard them communicating was a more broad base and very fitting with our strategy, the patient who has experience on a PPI, and that's exactly what our conversations with the payer are right now. Mm-hmm. As that patient step through a PPI, not because of the label- Mm-hmm ... but for utilization management from a payer perspective, and it makes sense to the physician. You know, I'll go back to my earlier comments about the unmet need. They're leading that dialogue for us. They, they know, they live the unmet need, so they see those patients continually, and it's the rapid, potent, durable profile. The data and C/D almost pays that off. Mm-hmm. But they see the patient cycling through, and that's it. It's a broad base. Got it. And then, so in terms of, you know, the initial stages of launch, of course, you've guided for this coming quarter to be kind of negligible revenue, but for the current quarter, I'd love to kind of gauge your comfort level on the Street's numbers for the initial quarter, sitting around $3 million-$4 million. Yeah. So what we've always indicated going into launch is that the first couple quarters will be nominal. So we anticipated Q4 to represent stocking, inventory build, Q1 to be the sell-through of that inventory build, start to have the discussions with payers, and then really see the momentum starting in later part Q2, and then thereafter, from an inflection standpoint. So our position is to really reinforce that position, that we expect very nominal revenues for the first couple quarters, and then see the inflection thereafter. Understood. And then, how do you layer in kind of gross-to-net on top- Yeah ... of that in coverage? Yeah, so going into launch, we anticipated relatively higher gross-to-net for the first two quarters. We've signalled around the 75% range, and then on a steady state, 50%-65%. We don't anticipate providing further guidance on that, as we negotiate with payers. Got it. Of course, we, you know, we've been able to see how well this type of drug does in another market, right, in Japan, as TAKECAB. Now, of course, there are some crucial differences between the Japanese and U.S. markets, so, maybe if you can kind of help us, you know, frame those differences in the market and how well of a comp that market is to the U.S. Is that something that we can kind of rely on in terms of overall market opportunity? Yeah, so we see a lot of similarities in this, I'll say, the setup or leading into the market and then afterwards. So what looks the same, right? Unmet need, which I mentioned a couple times already, same in Japan. I mean, it's been 30 years for both countries where there's been no new mechanism. I mean, that's incredible. So no new mechanism in the market, entering- Mm-hmm ... a generic market, entering with the same profile of rapid, potent, and durable- Mm-hmm ... and coming in in that generic market with a branded premium price. So there, you have tremendous similarities. I think where I'll say we have an advantage compared to Japan is, first of all, in our label. We did our own studies here in the U.S. to pull through that rapid, potent, durable profile. We saw superiority versus standard of care PPI. And in that traditional therapy, we saw this superiority that all of the data is listed in our label- Mm-hmm. as well as, and this is unusual, the word superiority three times. So, and I think on the—what I've heard from customers last week is they're actually talking about it as being a superior product. "I told my patient I'm putting you on this, I believe it's better." So I think we have that advantage. The other thing is, this is a very symptom-driven market, which makes it a very consumer-driven market, and there is no DTC in Japan. Whereas we all know in the U.S. from turning on television- Mm-hmm ... or our devices, we see a lot of pharma ads. So that will be a trigger, you know, as we progress through the launch that we can turn on. So we can really learn from Japan. Their $850 million was their last annual sales, which in Japan- Mm-hmm ... is a blockbuster. But we have those two additional levers, obviously a bigger market and a higher price market. Got it. And speaking of outside of the U.S., how are you thinking of kind of the ex-U.S. opportunity for VOQUEZNA? Yeah, since we got approval of erosive GERD back in November, there's been an inbound amount of interest. So certainly we're in early discussions with several different parties. I think as setting expectations as the year progresses, we'll have a better sense on the economics and the strategic value of going ex-U.S., but I'd still say it's early stages at this point. Got it. Then, moving away from EE and HP, transition to NERD. Can you give us an overview of where that program stands and how you're thinking about the market opportunity in NERD, relative to, you know, what you're building in EE and in HP? Sure. So, so we have filed for the non-erosive indication with the intent to get that indication in Q3 of this year. The PDUFA is July nineteenth. We see this as being a significant opportunity beyond erosive GERD. There's 15 million patients in the U.S. that are diagnosed and treated with a script for non-erosive disease. We anticipate, like erosive GERD, that the unmet need is very similar, as is the patient journey, with a large number of patients being dissatisfied with the standard of care or PPIs. Our field force, the core point is identical, so we'll leverage the existing field footprint. And so with this increased size in the population, we see a meaningful positive inflection in uptake in Q3 of this year. Got it. And then kind of double-clicking on that a little bit more. Can you—how are you thinking about the, the launch in NERD, given that at this point, VOQUEZNA will be on the market for a bit, docs will have some, you know, you know, experience with it, maybe building some comfort? Should we expect a similar, similar dynamics in terms of launch, for NERD, or can—is there gonna be more of an inflection? Like, how should we think about that? Yeah. So we will launch the new indication immediately post-approval. We already have we'll have the field- Mm-hmm ... in place, unlike EE, where we had to build the field over December and January. So we'll be able to leverage that existing footprint. As I mentioned, we're targeting exactly the same physicians, the high-prescribing PPI physicians. So we will have similar promotional tactics, both with the field as well as digital promotion and campaigns. What's gonna be a little bit different for the non-erosive indication is that both the EE or erosive GERD and non-erosive, from a payer perspective, will be the same presentation of 30 tablets in the bottle. So we're currently in the process of negotiating contracts with PBMs to secure access for the bottle, and that will be the same presentation flow through to the non-erosive indication. So larger population, launching straight away as soon as we get the indication approved, and then the decisions that are being made now will apply to the label more broadly. So we anticipate seeing a significant inflection in uptake in Q3 of 2024. Got it. Maybe moving on to your unique dosing paradigm in NERD. Can you give us an update on where the on-demand dosing program is, and when you expect to start that trial, and maybe some expectations around that? Sure. So we're in final negotiations and discussions with the FDA on the Phase III design. As you know, we completed a successful Phase II. We will initiate that program during the year. The patients as well as physicians are very excited about the potential to utilize VOQUEZNA in an as-needed or on-demand fashion. What's important to note is that PPIs are not approved in this way, and because of the differences of mechanism cannot be utilized in that way. So this will be very unique to VOQUEZNA and offer patients an ability to treat their symptoms either in a daily regimen, or as needed or on demand when they need to have resolution of their symptoms. Got it. And you had mentioned some interesting data you showed in Phase II. What's, you know, what would be a win for you in Phase III? And is there an instance, like in other indications where we've seen we would expect maybe some detriment in the efficacy, or is it pretty consistent from, you know, Phase II to III? Yeah, we anticipate it being very consistent between Phase II and Phase III. We've looked at some of the data from the daily dosing trial, and what's unique about that trial and daily dosing that we extended beyond the six months, and we saw over time, actually, an increase in efficacy beyond that six-month time point. And we've looked at some of the potency, the rapid, potent, and durable, some of the endpoints we'd like to see play out in the on-demand trial so that we can, with that foundation that we've built with the other indications, can then be translated into the on-demand, as-needed regimen. ... Got it. And because this is a little bit of a unique situation, there's not a clear bar, right? Because PPIs are not approved here. You know, is there an actual benchmark? You know, what are you hearing from, you know, from the physicians that you've talked to so far? Is there something specific they would like to see? Or is basically just, they just need to see that it works technically for them to, to- Right. I think the Phase II, the positive Phase II is very reassuring, and that the FDA is very pleased to engage with us, and physicians have seen that data and are very excited to have an opportunity to utilize a treatment that they can use both daily dose, daily or as needed. So I think the bar for us is making sure that we engage with the FDA and are aligned on the protocol, which is progressing really well, and then we execute the Phase III. And then last question on NERD. Given that you could eventually have, you know, two different dosing paradigms within the same indication, how is that? What does that patient journey look like? How is that going to work? Mm. How would docs decide between putting a patient on, you know, consistent daily dosing versus putting a patient on, you know, your drug every now and again? Yeah. I'll answer that. So I think the way to frame this is the daily dosing, which unto itself, physicians are attracted to, right? Mm-hmm. So we don't need the as-needed to be successful, and I'll explain how the as-needed- Yeah ... fits in. The unique thing, as Terrie mentioned, is we have six extra months of efficacy data there, which would be, we've submitted for our label, and if it's in our label, it would be a key differentiator. That's probably the, there's a lot of patients who just need maintenance, right? So they need to be on long term, and that's a fit for them. We also know that there's patients who don't need to be on as frequently. So that might be, you know, instead of the maintenance patient, this might be more of the symptomatic relief patient, and that's what the market doesn't address today. Now, is it used sometimes with PPIs? Yes. But what we hear from physicians is this profile is perfect for that because it's rapid, and it works, and then it lasts. From our Phase II data, not only work quickly, but it lasts for the full day. So what we hear is, number one, for, patients, this is a must-have. Like, they would like, "I would love to have this. I've been waiting for this." From a physician perspective, what they like is, or what they tell us: "I will now... It causes me, if you have the as-needed, I'm gonna use it on daily, it's great. But if you have as-needed, it's gonna be another motivator for me to put more patients on VOQUEZNA. Mm-hmm. So what I'll probably do is I will start you, the patient, on a daily dosing. After I do my check with you, you know, six-eight weeks, whatever it is, later, say, 'Okay, you're doing really well. You have two options: You can continue on, on maintenance, or you have the opportunity to do the as-needed dosing.' Now, as-needed dosing between you and I could look very different. Mm-hmm. It could be six days a week for you, and it could be one day a week for me. That's- Mm ... that's the beauty of it. It's as-needed." So we we think it's really gonna fill that VOQUEZNA funnel even larger, larger because of the differentiation. Got it. Okay, I lied. One more question on NERD. Okay, so in terms of coverage, what are the implications of having those two different paradigms and the interplay between those? In terms of payer coverage? Yes. Yeah. So, first of all, it's early 'cause we have to do Phase III. Mm. We don't see that it creates any new hurdles or challenges, right? So again, it will be in the same bottle. It just might be that my bottle of 30 count might be gone in 30 days, and your bottle of 30 count might be done in, I don't know, 60 days, name a day, right? So we don't envision that this is gonna create some unique or unwanted situation that's gonna limit utilization for patients. Got it. Then finally, turning over to Molly, can you remind us what your cash runway is, and kind of where it gets you in terms of the upcoming launches? Sure. Between the cash we have on hand, plus our debt facility, we anticipate that our runway gets us through 2026. Got it. Those are all the questions I have. Thank you very much. Appreciate it. All right. Thank you. Thanks. Thanks, Evan.