Phathom Pharmaceuticals, Inc.

Hello and welcome to the Fathom Pharmaceuticals fourth quarter and full year 2024 earnings results call. At this time, all participants are in a listen-only mode. After the presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's call is being recorded. With that, I would like to turn the conference over to Eric Chiarelli, Fathom's Head of Investor Relations. Please go ahead.

Thank you, operator. Hello, everyone, and thank you for joining us this morning to discuss Fathom's fourth quarter and full year 2024 results. This morning's presentation will include remarks from Terry Curran, our President and CEO, Martin Gilligan, our Chief Commercial Officer, and Molly Henderson, our Chief Financial Officer. Osmeen Abusi, our Chief Operating Officer, will also be joining the team during the Q&A portion of today's call. Just a couple of logistical items before we get started. Earlier this morning, we issued a press release detailing the results we will be discussing during the call. A copy of that press release can be found under the news releases section of our corporate website. Further, the recording of today's webcast can be found under the events and presentation section of our corporate website. Before we begin, Let me remind you that we will be making a number of forward-looking statements throughout today's presentation. These forward-looking statements involve risks and uncertainties, many of which are beyond FADM's control. Actual results can materially differ from the forward-looking statements. Any such risk can materially adversely affect the business, the results of operations, and the trading prices for FADM's common stock. A discussion of these statements and risk factors is available on the current Safe Harbor slide, as well as in the risk factors section of today's Form 10-K. All forward-looking statements made on this call are based on the beliefs of Fathom as of this date, and Fathom disclaims any obligation to update these statements. With that, I will now turn the call over to Terri Curran, Fathom's President and CEO, to kick us off. Terri?

Thank you, Eric, and thank you to all those joining us on today's call. I'm excited to report on the great progress we made during 2024 and the work that's underway to ensure 2025 is a year of strong growth. throughout our first full year of product availability, we reported many accomplishments and consistently exceeded expectations. Most noteworthy, we secured broad commercial access, launched a full-scale consumer campaign, and received FDA approval for non-erosive GERD. As I reflect on the past year, it's clear that we've built a strong foundation with each of our accomplishments serving as key building blocks. Feedback from physicians, testimonials from patients and continued demand give us confidence that Equestria is a game-changing product and they were successfully bringing it to market. We're proud of the work we've done so far, but this is just the beginning. We'll continue building off this strong foundation and focus on pivotal growth drivers in 2025. We fully believe Equestria can reach blockbuster status. Importantly, our launch data reinforced this story. Commercial coverage has held consistently above 120 million lives, with the majority of these lives being able to access the Quesna after stepping through only one generic PTI prescription, a pre-satisfied criteria for most acid reflux patients. And with over 300,000 prescriptions filled to date, the pull-through from this coverage is evidence. Without a doubt, the non-erosive approval sparked an inflection in our launch, and we believe that momentum will continue throughout 2025 and beyond. Looking more broadly at Fathom's future, there is so much to be excited about related to our ongoing launch and upcoming development goals. On the commercial front, we will continue to invest with the objective of making McQuesna a household name, the product physicians and patients think of when they think of heartburn. In fact, I'm pleased to share that we'll soon be rolling out an exciting new consumer campaign, expanding upon the Kresnik and Kixom acid, and aimed at further enhancing brand awareness. In parallel, our sales force will be focused on reaching primary care physicians who are the largest group of GERD treaters. We've built amazing awareness with GI, but PCPs are where we can make a big difference. Every year, there are hundreds of thousands of PCPs who write PPIs for their patients. We think adding the Quesna to their toolkit can materially help the way they treat GERD. For now, we're focused on driving growth by calling on the highest volume PCPs with increased frequency. Our reps are working to ensure these physicians recognise that the Quesna brand understand the clinical benefits and know that the access process is often as easy as checking a box. We believe this is a path to displacing PPIs, and Martin will share more on these efforts later in the call. On the development front, we've always viewed Equestria as a pipeline and a product, and we believe eosinophilic esophagitis, or EOE, can be the next indication to expand the label. In fact, we recently finalized a phase two design with the FDA. This is a space we're excited about because we think that Kresna can make a difference. EOE is a chronic inflammatory condition of the esophagus, which is drawing increased attention from the medical community as both the incidence and prevalence have grown in recent years. Although compared to GERD, EOE is a smaller market, we believe it could be a unique opportunity given the importance of the condition, the need for lifelong management, and the overlap with the gastroenterology market. Patients with EOE usually present with heartburn symptoms and difficulty swallowing. The unmet need is significant, given the current treatment options are limited. Although an approved corticosteroid and biologic offer two options, PPIs continue to be first-line therapy, despite not being approved this indication. The rationale is that PPIs are meant to reduce esophageal inflammation and neutralize acid reflux symptoms. Based on this, we believe the potency of the Quesna may potentially provide an alternative first-line therapy ahead of PPIs, biologics, and corticosteroids. Our study will be the first large, well-controlled study in EOE for either acid secretory class, PPIs, or PCAPs. It will include approximately 150 subjects with both adult and adolescent segments. Equestria's efficacy will be compared to placebo, and we anticipate the top-line readout in 2027. Although data on the efficacy of PCADs for EOE is limited, reviews of retrospective data from Japan show promise that it will present potential impact. Recently, we've also been working on the development of an orally disintegrating tablet, or ODT formulation for Equestria. This is another key pillar to our development strategy, that complements the work we are doing at EOE. Once available, an ODT formulation could present a route of administration more desirable for patients with difficulty swallowing, which is the core symptom among those suffering from EOE and also common among pediatric and elderly patients. Additionally, an ODT formulation offers the opportunity for new intellectual property, potentially further protecting the brand. An OTC formulation could be a longer-term source of differentiation for an over-the-counter Equestria product. In fact, we believe Equestria is uniquely suited for prescriptions over-the-counter or OTC switch. Such an effort could create a long-term durable revenue stream. The total OTC asset control market generates approximately $3 billion in annual sales. PPI specifically account for roughly a third of those sales with branded products making up about 35% of the corresponding PPI unit volume. We believe that Quesna's rapid, potent and durable asset suppression profile supports the potential to capture market share by providing rapid and complete heartburn relief as needed. However, there's work to be done before we can achieve that vision. Throughout 2025, we'll be analyzing the OTC market opportunity and developing our long-term strategy. Separately, we're exploring real-world data to understand the prevalence of GERD symptoms among the increasing wave of GLP-1 users and the utilization of acid suppressants to relieve such symptoms. Our review will help us to determine if further efforts are warranted to evaluate the potential of EQUESMA to provide relief to those patients. Before turning the call over to Martin, I'd like to take a moment to mention our active citizen petition to the FDA and potential outcomes. On December 11, 2024, we submitted a citizen petition, or CP, to the FDA requesting that they update the Orange Book to reflect a 10-year period of new chemical entity exclusivity for our 10 milligram and 20 milligram bottles based on the fact that the underlying drug substance across all the Quezna products contains the same new active moiety, phenoprazine. We continue to feel confident in the strength of our legal position as outlined in the CP. We are now just about halfway through the 180-day period for the FDA to review and provide a response. If the FDA grants our CP on or before the June deadline, we expect the Orange Book to be quickly updated to reflect regulatory exclusivity through May 2032 for all Vaquedina products. However, even in the case where the FDA rules against our CP request, we are equally confident in our patent position. Our composition of matter patent is strong and we expect its expiry will be extended to at least mid 2030 pending the granting of our requested patent term extension under the Hatch Waxman Act. Additionally, we have a separate patent for Venoprazan's formulation. Lastly, on the financial side, Molly will further detail our fourth quarter 2024 results later in the call, for which we reported net revenues of $29.7 million and ended with $297 million in cash. We remain confident that our balance sheet and the available capital under our debt agreement can support the investments needed to pursue our launch and development plans. In 2024, we built a strong foundation. We are now leveraging our commercial and development expertise to grow the launch and continue exploring new opportunities for the Bequesna franchise. We here at Fathom are passionate, resilient and determined to deliver on Bequesna's blockbuster potential. We're just getting started and I'm excited by the opportunities that lie ahead in 2025. I'll now turn the call over to Martin to provide further details on our recent commercial updates. Martin.