Well, listen, thank you all for joining us. It's nice to have one of my SMid companies become commercial stage. It doesn't happen so often these days, so congratulations to you guys on the approvals. I felt like it was a little long time coming based on some of the stuff which some of it was just self-created by folks, but either way. Well, a lot of that is behind us. We're not gonna waste any time on that. There's a lot to talk about. Maybe let me turn it to you, Terrie, first, to kick things off, and we'll jump right into some nuances.
Great. So thanks for having us here, Umair. It's really exciting to now be a commercial-stage company, and launching the first new mechanism into a very large category, antisecretory category. So it's a potassium-competitive acid blocker. We are currently launching into two indications, Erosive GERD and the eradication of H. pylori. We were able to achieve very broad labels for both indications. In Erosive GERD, we have an indication for healing, as well as maintenance of healing, in all grades of Erosive GERD.
And importantly, we were able to demonstrate superiority in the more severe patients in the first two weeks, a very rapid onset of healing of the erosions, and then, most importantly, in terms of the maintenance of healing at 24 weeks, we showed superiority in both the Cs and Ds, as well as all patients, by the end of the maintenance period. So very exciting to be in this position and be launching those two indications. We have also filed for a non-erosive indication, and we anticipate that to be approved Q3 of 2024. And we're in the process of finalizing a novel protocol for on-demand utilization of VOQUEZNA. We had a positive phase II, and we will finalize the phase III protocol design and initiate that in 2024.
In addition to that, we're finalizing the protocol for an Eosinophilic Esophagitis phase II, and that's in its final stages of devising that protocol with the FDA. So an exciting milestone for the company to be commercializing the first PCAB into this very large market.
Excellent. Just before we begin, there's a lot of stuff to go through. Maybe if I may ask you, Terrie, where does Takeda stand right now on their equity ownership, and has there been conversations? I know this was a topic very near and dear to Molly's heart as well. On their Like, where are they with their plans around continuing ownership of Phathom or not, and any involvement in your launch in any way, or is that not the case?
Yeah, so they continue to be an important partner to Phathom. So right now, they hold a little less than 15% ownership in the company. At this point, we haven't gotten any indication otherwise, but I know from a commercial standpoint, they continue to be important, as well as a CMC standpoint to us.
Got it. To the extent Takeda was— So we'll talk about the launch and how the launch progresses, but to the extent Takeda is interested in perhaps trimming their position further, would they, in future, do that in open market, or would it be part of some sort of a secondary offering? Just because I feel like it's been a very relevant topic to investors previously.
Yeah. Certainly can't speak for Takeda, but our understanding is that they would be responsible. They understand the impact that would have, and I think that's our belief, that they would do it responsibly.
Right. Also, it's very rare to see a setup like this, where it's a blockbuster product for a big pharma outside of U.S., and now it's you guys launching it in U.S. for them. Even if Takeda is not launching the drug here, I would imagine from a pharmacovigilance and from safety database accumulation perspective, there must have to be a fair amount of communication. Is there any involvement from their front, from a commercial perspective whatsoever or no?
No, no. So we've got the licenses for the U.S., Europe, and Canada. So for all of the safety, quality monitoring, we better do them internally. Obviously, we have a very close relationship with Takeda, as some of our team that are in the R&D team came from Takeda, and so there's a very close relationship there in terms of reporting and, particularly with Martin in launching into the U.S., a close collaboration with them to really understand why they've been as successful as they have in Japan. I mean, they're generating revenue in Japan alone of more than $850 million, and they're currently market leader with 35% share, and so we wanted to kind of take some of the lessons from their book, and see if we could apply those into the U.S. market as well.
We've got a very close collaboration with them.
Excellent. So I realize there's several layers to a drug launch: digital promotion, payer negotiations, BlinkRx and those, also sales force hiring, actual commercial launch. I guess, could you catch us up on some of those components, where we are on each?
Sure. So let's start with physician promotion, and maybe I'll go chronologically.
Mm-hmm.
So we received approval for Erosive GERD on November 1st, and on November 2nd, we turned on digital promotion to physicians. So what does that mean? That means where a physician searches for information, where they go on their social sites, if they were one of our targets, which is 52,000 physicians, they were getting some type of VOQUEZNA message. And-
What are these sites, typically, just so we understand?
What are they? What?
What type of sites are these? Like, up-to-date or-
Yeah. So they're... So they're different levels. So the physicians are GI and primary care, and then if you really tier it, there's—it's a mix of just advertising, and then there's just a deeper layer of education, which might be a KOL video talking about VOQUEZNA.
Right. But what type of sites would you find these physicians?
Yeah, so you would. So that's always the case. So you would find that on things such as Doximity or any site that a physician might go to.
Okay, got it.
And we've targeted knowing... You get the profile of those physicians, and then you can also target where are the common sites that they go to.
Okay, got it.
And so that's why you get the different levels of degree of education at each one.
... So since November 2nd, so digital started. I'm sorry.
Yep.
Okay.
And then we're rolling in virtual speaker programs, which will turn to live speaker programs in January, and that's delivered by KOLs who are familiar with the product and the profile, and they're sharing the data. The sales force is probably the next piece, so we're gonna have 320 sales reps. More than half of them have started. They were trained in the month of November, and as of this week, more than half of the 320 are calling on physicians, which coincided with product being available in pharmacy starting yesterday. So reps are actively calling on physicians. They're talking about the profile, the uniqueness of our label, differentiator profile, safety aspects, and how to access drug.
Excellent. So the formal launch started now-
Yes.
- which let's call it-
Correct
... beginning of December.
Yep, and then we'll roll in, in December, pretty much the rest of the 300. They'll do their training in December, so by early first two weeks of January, we should have the entire sales force in place calling on physicians.
Got it. Okay, makes sense. Now, another very important aspect of this launch, and I feel like I've talked about this with Molly and with Terrie for a couple of years at this point, as well as with yourself, which is, we've seen examples in derm space.
Mm-hmm.
We've seen examples in CGRP neuroscience space, headache space, where if a lot of drug was basically made available for free-
Mm-hmm
... to a large primary care-like population, you could get fair amount of utilization, and that could sometimes be leveraged into important payer conversations and be turned-
Yeah
... into a...
Yeah.
... a real sales potential as well, and we saw Biohaven do that very successfully-
Yeah.
... for example. Now, granted, for that, you also need a fair amount of financial resources-
Yeah.
... sort of allocated towards that. Could you walk us through your thought process on learnings from some of those?
Yeah.
... and also how you thought about BlinkRx versus a bridge program?
Yeah.
Mm-hmm.
Yeah, so I think what's important there is everything you just described was either a specialty, very high cost, or hypercompetitive. So I came from a dermatology space, so a way a lot of those programs started was they needed specialty pharmacy support because the reimbursement hurdles were really big. And then they also ran a situation where a new mechanism came in, and they knew there was a follower coming in X number of months, right? six, eight months. So they had to capture as many patients as possible 'cause it was hypercompetitive market. And if you take a look at the migraine space, I think, oh, it's, you know, eight tablets is over $1,000, right? So we're talking about a very different market where this will be...
It's an oral molecule, it's at the retail channel, it's at a cost that's not at that high level, and then there's no competition in the marketplace. So when we looked at this, what we're expecting, which is critically important to your question, is one step through a PPI. And having come from the derm space, as soon as you hear a step, you're like: "Oh, no, how do we get around it?" In this space, again, no competition, really large market, a step is very reasonable. We don't see any issue with that. So, why did we look at Blink? We wanted to provide some support, especially during that period, 'cause access is gonna roll in. It just, as you all know, doesn't turn on right away.
So we wanted something that was gonna support the patient through the process, and then also help patients get drug if they needed it, and we didn't want physician to be turned off because of rejections. So when a product goes into Blink, we looked at a digital fulfillment center, such as Blink. The prescription comes in, and we tell doctors I should back up, right? It's available at retail. You can get it at CVS, Walgreens, independent, but an option is to go to Blink where patient services rest. If that comes in and it's covered by the plan, it will go through one of the retail partners, so it'll go right through retail.
If for some reason it's not covered yet, and it's a commercial patient, they'll be offered a discounted cash price, and what that does is a couple of things: it gets patient on drug. But from our perspective, what it also does is every time that patient needs a refill, they do a recheck, and as soon as that coverage is triggered, they move over to the traditional retail flow.
Got it. So I was running some math, thinking about what expectations now heading into the new year. I think the consensus numbers are about $3.5 million for 1Q.
Mm-hmm.
I asked myself, what does that imply for TRX?
Mm-hmm.
Again, you have to assume there's patients that might be getting the prescription at about a 25%-30% gross on it, or they might be on BlinkRx-
Mm-hmm.
... and we can assume certain ratios, but give or take, I was thinking, you know what? You need over 10,000 TRX-
Mm-hmm.
... in one queue-
Mm-hmm
... to get to a sales number of $3.5 million.
Mm-hmm.
Which implies like perhaps, I don't know, 6,000-7,000 patients that are on therapy at that point.
Mm-hmm.
Is that too, like, I felt like that sounded like a lot to me so early in the launch.
Yeah.
I realize it's a very big target population, but I also realize there's a lot of barriers from an insurance perspective early on in the launch.
Yeah.
How should we think about the cadence of several thousand patients per quarter of launch?
Yeah. So I'm not... You know, I, I don't know the details of your math, but I understand your point. So what I would say is, it's a market that's moving. It's, it moves fast, and it moves... Well, it moves fast, and it's moving in large bounds. So as an example, we know from a claims database, is that within 90 days of someone starting on a PPI, they switch to another PPI. So it's a big market that's moving, so it's, it's not unrealistic that the 52,000 physicians that we're targeting are seeing patients on a daily basis. Patients are moving through. Matter of fact, those 52,000 physicians, on a per month basis, they're each responsible on average for 122 prescriptions.
Mm.
That means... I mean, that's - it's one of the largest volume therapeutic care categories that there is. So, we do expect-
5 million, so 6 million prescriptions off of these physicians alone?
Probably, yes. Probably, yeah.
... Got it. I guess, one of the implicit assumptions in my analysis in going from 3.5 million to calculating a few thousand patients-
Mm-hmm.
-was that half the volume will be BlinkRx.
Mm-hmm.
Is that a little much?
Uh..
Or is that realistic? Has to be early in the launch, no?
Yeah, I think time will tell us. I think that's not out of the question.
Okay.
I mean, we're on day three, right, day two right now, our product being in the market.
Yeah.
So I think we're gonna learn over the past couple-
But if I-
next couple weeks and months.
... If I take a BlinkRx prescription right now, I pay, that's $75 coming to Phathom, correct? And I pay, I pay $75, you get $75.
Yeah. So I'm not sure where $75 comes from, but let me explain to you how it works. So, as I said, if it comes through, the patient will be offered a discounted price. Now, that's an agreement between Blink and the patient. What we do know, what I can share is that, that is gonna be what the patient will pay out of pocket, is within the range of a traditional commercial copay for a preferred or non-preferred brand. So that range would be $40-$90, but we're gonna be much closer, on the $40 side, versus that $75 or $90 side.
$40-$90 is what patient pays out of pocket?
For a typical prescription, without using a copay card, for anything that's covered. So you have a preferred or non-preferred brand. All of our health plan, we have Cigna. If I had got a prescription today, and it was a branded prescription, either preferred or non-preferred, and I went to the pharmacy and didn't use a copay card, if that drug costs $300-$400, whatever it is, dollars, my, my cost to me might be $40-$90. That's typically what the math works out to be-
Okay.
...with health plans. And so what Blink will do is they will offer that at a much discounted price to that. So it'll be somewhere between $40-$90. $650 WAC, Blink's gonna offer it at a cash price much lower, which will fall between that $40 and $90, much closer to the 40-dollar side than it is the $75 or $90.
Okay.
Does that..
Just to be clear.
That clear?
So if I have insurance right now... I have Aetna, I go into a pharmacy, and I'm collecting a prescription, I pay $40 out of pocket, or let's say I pay $40 out of pocket-
Yeah.
and insurance covers the rest.
Mm-hmm.
If I didn't have insurance, Blink would let me pick it up for also for $40. Is that, is that what you said?
Yeah. So I just wanna... let me just re-clarify. If you already have coverage and they say: "Oh, VOQUEZNA is covered," they're gonna put you through a typical retail, pay your copay. If you don't have coverage yet, you—I think you said Aetna, right? If you don't have Aetna, what they would say is: "Okay, there's no coverage for this. You know, Mr. Jones, this would cost $650, but we're prepared to offer you at a discounted price." And that price is gonna be in the range closer to $40, and that's an agreement between Blink and that patient.
I see. Okay. Is Blink making it available to everybody that comes in?
If you are a-
Or if they have insurance?
... if you're a commercially insured patient for the cash discount, but they can support any prescription that goes through. I mean, they're a fulfillment center, so they can, you know, cover any. They can flow any product out.
I remember I was having this conversation with you guys previously. What's the most successful drug Blink has launched? What's a successful drug launch which used Blink?
Yeah, so I can't-
Recently-
... I can't speak to all of their launch.
I mean, I'm sure they market it-
Yeah
... you guys for sure.
Yeah.
So-
So I think I would put them in the category of Phil Rx, which is also another digital pharmacy. I can't speak to who all of the clients are for both companies, but two most recent launches, I think, Phil Rx, and it's the same concept. I believe they did Yervoy.
Okay, okay.
Yeah.
They're real drugs there.
Yeah.
Okay.
And then in for BlinkRx, now I know, Bausch + Lomb is using them for their new eye care product, which seems to be high volumes-
Got it
... going out. Yeah.
Okay, got it. All right, excellent. Now, sampling, will that be happening separate from the Blink and the actual prescriptions?
Yeah. So, starting, you know, late December or definitely in January, reps will carry samples. Just wanna be really clear what that means, though. We are not sampling to a volume to replace a prescription, right? So what we'll be doing is, we'll be offering samples for the physician to get experience-
Like a blister pack for seven days?
Yeah, so each package will be five tablets, which is five days.
Mm-hmm.
Depending upon your decile as a physician, if you're a decile 10, which means really high volume, we have a ratio, you'd be getting more versus a decile five physician.
Okay.
Our recommendation to the physician is: "Listen, this is to get someone started. Give them one, two sets, which is 5-10 days, and give them the prescription at the same time.
Got it. Isn't that problematic for H. pylori? What's... Isn't that 14 days-
So this is... Yeah, so thank you for clarifying. This is for GERD.
That's also-
We will not be sampling for H. pylori.
But how do you know they don't give it to HP?
Well, they would, but then they would have to couple that with-
Okay, but they'll-
... the antibiotics
have to do that stuff on their own.
Yeah.
Which-
Yeah
... no one
Yeah
wants to do the work.
For everyone, H. pylori is a 14-day treatment. It's an acute therapy, unlike GERD, which is a long-term therapy.
Correct.
We've got the commercial coverage there of 65% already for HP.
Got it. Okay. Any early experience, I know you're day two or day three-
Mm
... to the launch?
Day two.
Day two?
Day two with product in the market, yeah.
Got it. But any early experience in terms of-
Yeah, so-
feedback you're hearing?
Yeah. I'm hearing good stuff.
You're smiling.
Yeah, yeah, yeah.
Terrie's laughing.
I'm here-
Molly's smiling, too.
I'm hearing everything we planned for is happening. Physicians are... They hear it's a new mechanism. They totally relate to the unmet need that they need something new. They hear the rapid potent durable profile, "This is what I've been waiting for." We are hearing that the data is resonating. We are hearing that they really like the being able to take it with or without food, which is important because PPIs are restricted to work effectively that way. And then the other thing we're hearing is, you know, we have reps, they're new to Phathom, but they have experience, and so they have some relationships.
Reps have gone into the office, and they've talked to the doctor in the morning, and because of those relationships, the office is calling them that afternoon and saying, "I just saw a patient, and I wrote a prescription.
Okay.
So now we're in really early days.
Okay, absolutely.
But all's very exciting.
That's great.
Yeah.
Just before we wrap up, I know SG&A run rate, $75 million from prior year. You talked about, you've talked about sort of a, a hundred rep- sorry, you- we've talked about the sort of $100 million dollars for reps from the 300 plus. We've talked about some DTC, which could be, I don't know, $75 million or so. So in my mind, I was thinking $75 million was the underlying SG&A, $100 million for reps, maybe another $75 million for digital spend, so that's $250 million. Is that an appropriate number to think about for next year?
Yeah, and to your point, what we've mentioned is that sales reps, that Martin mentioned, you know, all in is about $100 million incremental, which is the number you're referring to, which is correct, as well as our current run rate. And then the one component, as you mentioned, was DTC. That is somewhat gated based upon how we're performing throughout the year. So if we're seeing strong momentum and early access, you know, we'll move that up. If that looks a little bit slower in the year, we'll delay it. So I'd say that's one lever that we have in our belts that we could manage-
Got it.
in 2024.
I guess, as we just wrap it up, Terrie, if I may ask you, I feel like, outside of getting the approval and getting over some of the Zantac spillover effects that you had to deal with, the other big issue you've had to navigate has been the cash situation of the company. So I would say it wouldn't be inaccurate to say that while, we're now here, launch is starting, and you guys are adequately funding the launch, but it's not perhaps funded to the extent you would've thought when you first joined Phathom a few years ago. And I guess my question is, to the extent some of the early feedback comes in as strong as some of the early indications are, do you think there's more opportunities to actually put more resources into this launch?
Yeah, no, I would say that we're funded, yeah, as well as we should be at this point in the launch. I think, you know, we had made a decision to go into this launch with a full complement of reps, as well as funding prior to launch, functions such as market access, market research, as well as the payer team, which has really set us up for-
Mm
... a great launch. And having the early access on HP reinforces the access strategy. So I think we're really well funded going into this launch. And as Molly mentioned, we've got capital that will get us through to the end of 2025, and that's without raising additional capital through the various facilities we have access to. And then I think we'll just gauge the launch, and see whether there's opportunities to invest even more in DTC. It's a very consumer responsive marketplace.
We've seen that from other launches in this category, and so if there is an area of ROI, then I think direct-to-consumer will be one that we could potentially invest in, particularly when we have the larger indication approved in Q3, which I think is, you know, largely not accounted for in many of the investors' analysis, that we will have the NERD approval if all goes according to plan in Q3.
Got it.
At that point in time that the bottle presentation is reimbursed for both EE as well as non-erosive. So we should see an uptick in or acceleration in revenue in Q3 of 2024.
Excellent. Fantastic. Well, thank you guys for being here. Good luck, and-
Thank you
... I hope the launch continues as you're hoping it does.
Great.
Thank you.
Excellent.
Thanks.