Steven Basta
Analyst · Evercore
Thank you, Eric, and thank you to everyone joining us today. I'll start with an overview of our financial and commercial highlights this quarter and then provide commentary on our shift to a greater gastroenterology focus and our current operating priorities. First, I wish to welcome 2 new Phathom leadership team members. Joining me on the call today is Sanjeev Narula, our new Chief Financial and Business Officer. Sanjeev brings to Phathom a proven track record of building successful profitable pharmaceutical businesses of significant scale. His experience and insights will be important to driving our growth. I'm delighted to have Sanjeev as a partner in building Phathom. I'm also pleased to announce that Nancy Phelan has recently joined Phathom as our new SVP of Marketing and Analytics. Nancy brings a wealth of experience in technology-driven marketing, tactical implementations of marketing to integrate with sales activities and both HCP and consumer promotion in the pharmaceutical industry. Nancy has successfully led marketing for several successful drugs. We have a solid commercial and financial team in place. Starting today with our financial highlights for Q3. Really pleased to report at the end of Q3, we've delivered 25% growth this quarter while reducing operating expenses by 43% and therefore significantly reducing our cash usage. We beat expectations on the revenue and on the operating expenses, and we're executing effectively throughout the organization on the plan that we set out 6 months ago. Net revenue for Q3 was $49.5 million, which represents 25% growth quarter-over-quarter. This is ahead of expectations of approximately $47 million and is in line with our revenue guidance for the year. As a result of the strength this quarter, we are narrowing our full year guidance to the top half of the previously communicated range. While growing revenue significantly, our cash operating expenses were $49.3 million this quarter, which is meaningfully better than our previously stated target of getting below $60 million in cash OpEx for Q3. You may recall in May, we set a target for the year of bringing our operating expenses on a quarterly basis below $55 million by Q4 of 2025. I'm pleased to report that we've achieved that milestone early in Q3. We've cut our cash OpEx by nearly 50% since Q1 while growing revenues ahead of expectations. We're quite pleased with the performance that the entire team has delivered through the course of the past 6 months. Our cash usage was less than $15 million for Q3. That's down 77% versus the Q2 cash usage number. One note for Q4. Our operating expenses for Q4 will be somewhat higher than in Q3, primarily due to the start of the EoE Phase II trial. But we do still expect to operate at below $55 million cash OpEx as we've previously stated, even with the additional clinical trial expense. My sincere thanks go to the entire Phathom team for their dedicated efforts to deliver both our continued revenue growth and our operating expense discipline throughout this period. I'm most impressed every day by the extraordinary talent and dedication of our team. A few notes on commercial performance for the quarter that might be helpful for folks. Launch-to-date, we have 790,000 filled prescriptions as of October 17. That's approximately 36% growth since our Q2 call. In Q3, we had 221,000 filled prescriptions. Of these 221,000 prescriptions in Q3, 144,000 were covered scripts, which grew approximately 23% quarter-over-quarter. For everyone who looks at our financials, recall this is the growth category that drives our revenue. We also had 77,000 cash prescriptions that were filled, growing approximately 38% quarter-over-quarter. The growth here includes the impact of having turned on Medicare patient availability on a cash-pay -- for the cash-pay program as of April. As we've previously noted, 70% of our prescriptions launched to-date have come from gastroenterologists. During the recent quarter, we are seeing stable payer coverage and expect that moving forward for VOQUEZNA. We've pivoted in the last 6 months to focus on gastroenterology target prescribers as our core growth strategy. The intent of this shift is to really target depth rather than breadth of writing. That is we want to get physicians who adopt VOQUEZNA to write prescriptions more and more frequently and grow their utilization of our product as the clear path to driving our growth. In alignment with that strategy, we have communicated that and have taken several steps over the past 6 months to align our sales activities to enable that greater focus on the gastroenterology customer. In May, we announced the strategic shift. Step one, which actually occurred in May as well in Q2, was to adjust our incentive compensation plan for our sales reps to more reasonably balance and focus on gastroenterologists who were previously had been focused on the primary care call point. Step 2, which we implemented in July, was to reset the sales territory target list to include all of the gastroenterology customers and take out unproductive primary care physicians from those target lists. That allowed the sales force to start spending more time in gastroenterology practices. We also implemented in July a modified incentive comp plan, which focused on growth of total prescriptions rather than focusing on growth of the new writer base. So it really is aligned with that strategy of driving depth rather than breadth of writing. Step 3, which we just implemented in October, just in the last couple of weeks, is a realignment of our sales territory geographies to enable better balance and better focus on our gastroenterology target call point. Let me describe that evolution for you a little bit in terms of the sales force structure. Prior to our October restructuring, we had approximately 280 sales representatives in place. But they were situated in territories that had been mapped at launch around total PPI volume, which is basically mapping them around primary care PPI volume because that was our prior strategy prior to the restructuring in May. As of 2 weeks ago, what we've done is we have realigned the base territory maps so that we consolidated territories that did not have enough gastroenterologists to focus the reps' time appropriately on those customers, and we created new territories where there was a high concentration of gastroenterologists. The transition of territories does create a bit of disruption in the field during this quarter. At full strength by Q1 when we filled the open territories, we expect to have approximately 300 sales representatives in place. The net effect at the end of this transition is to create territories that are better balanced to enable us to call on every target gastroenterologist with the desired frequency. This realignment in the sales force territories could have some temporary impact in Q4, which we've considered in updating our revenue guidance for this quarter and setting our updated guidance for the year. We believe the sales force realignment can accelerate our growth during 2026. It may take some time to see the full impact of the sales force realignment activity. The gastroenterology opportunity for VOQUEZNA includes a target universe of approximately 24,000 gastroenterology writers. And that includes 17,000 physicians and about 7,000 affiliated nurse practitioners and physicians' assistants. Collectively, those 24,000 GI targets write about 20 million PPI prescriptions every year. That's our opportunity set. At our current prescription run rate in GI, we believe we've converted approximately 3% of the GI PPI prescribing market opportunity of 20 million prescriptions a year. If we are able over time to convert 20% to 30% of that 20 million prescription volume, we believe that that penetration could potentially reach or exceed $1 billion in revenue per year within the gastroenterology target universe alone. Obviously, there's a much bigger opportunity than that, and that opportunity resides in primary care. And we do believe that in future years, our expansion back into more depth and time in primary care clinics could potentially drive revenue to an even higher number, possibly reaching $2 billion or more in revenue. A quick update on our clinical program. We have recently initiated our Phase II clinical trial in Eosinophilic Esophagitis. Screening of patients is currently underway in that study. So we've initiated study sites. We've initiated screening patients with the first subject enrolled in the study expected in Q4, as we previously communicated. Just as a quick reminder, the rationale for this study is twofold. First, in terms of market opportunity, PPI therapy is currently first-line therapy for EoE patients. There is an opportunity for VOQUEZNA, therefore, to play an important role in EoE treatment, potentially displacing some portion or a meaningful portion of that PPI usage in EoE patients if the trial is successful and if the program overall is successful. Second, if this Phase II study is successful, we believe that we have an opportunity or may have an opportunity to receive a written request from the FDA to conduct a Phase III study that includes pediatric patients, and that creates the potential for us to extend our regulatory exclusivity by an additional 6 months. That will be determined at the end of the Phase II trial as we have conversations with FDA at that time. We expect to report top line results from this study in 2027. As we're on the topic of regulatory exclusivity, just a quick reminder for everyone. We've updated the Orange Book or FDA rather, has updated the Orange Book to indicate that we have exclusivity through May of 2032. The mechanics of how that works actually provides us exclusivity into 2033 because an ANDA filing is not permitted until that May of 2032 date. So with a 10- to 18-month typical ANDA review timeline, we believe generic entry is unlikely until 2033. A note on the VOQUEZNA TRIPLE PAK update that we've previously discussed. We've had good progress here working with our supplier of the TRIPLE PAKs. You may recall from our update in August that there has been some risk of disruption to the availability of the clarithromycin component in our TRIPLE PAK from the supplier of that product. We have not to-date experienced any disruption in TRIPLE PAK availability and based upon recent communications, do not anticipate any near-term interruption, although there is still some uncertainty in this area. We will continue to monitor this closely and provide any updates that are needed. We are executing at Phathom with discipline and momentum to implement our GI-focused strategy. The financial picture of the company is in order with solid execution on our plan. We have a talented and engaged team throughout Phathom driving our revenue growth. I'll turn it over at this point to Sanjeev to provide more detail on the financials and the outlook for the year.