ACADIA (ACAD) Q4 2025 Earnings Call Transcript

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DATE

Wednesday, February 25, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

• Chief Executive Officer — Catherine Owen Adams
• Chief Commercial Officer — Thomas Garner
• Executive Vice President, Head of Research and Development — Elizabeth Thompson, PhD
• Chief Financial Officer — Mark C. Schneyer

TAKEAWAYS

• Adjusted Total Revenue -- $298,000,000 for the quarter, representing 16% growth, and $1,080,000,000 for the year, up 14%.
• GAAP Total Revenue -- $284,000,000 for the quarter and $1,070,000,000 for the year.
• Adjusted NUPLAZID Net Sales -- $189,000,000 for the quarter and $692,000,000 for the year, growing 17% and 15%, respectively.
• NUPLAZID Volume Growth -- 13% for the quarter and 9% for the year, cited as underlying demand drivers.
• DAYBUE Net Product Sales -- $110,000,000 in the quarter and $391,000,000 for the year, delivering 13% and 12% growth.
• New NUPLAZID Prescriptions -- 18% year-over-year increase in the quarter, with 40% of fiscal-year prescribers new-to-brand.
• NUPLAZID Field Force Expansion -- 30% increase completed, expanding the commercial reach to approximately 11,000 writers.
• DAYBUE STIX Approval -- FDA approved the DAYBUE powder formulation in December; initial shipments began prior to broader Q2 commercial launch.
• DAYBUE Patient Uptake -- 1,070 global patients received shipments in the quarter, marking record highs in the U.S. and ex-U.S. markets.
• 2026 Revenue Guidance -- Projected total revenue between $1.22 billion and $1.28 billion.
• 2026 NUPLAZID Net Sales Guidance -- $760,000,000 to $790,000,000, reflecting 10%-14% growth over the prior year’s adjusted figure.
• 2026 DAYBUE Net Sales Guidance -- $460,000,000 to $490,000,000, for 18%-25% projected growth, excluding any EU commercial contribution.
• DAYBUE Persistency and Discontinuation Rates -- Discontinuations in the low single-digit range and annual consumption in the high-60% range, both described as stable.
• Gross-to-Net Adjustments -- NUPLAZID fourth quarter gross-to-net was 29.4% reported and 23.6% adjusted; DAYBUE at 19.5% in the quarter; full-year gross-to-net for NUPLAZID was 25.9% reported, 24.6% adjusted, and for DAYBUE 22.3% for the year.
• Operating Expenses -- R&D expense for the quarter was $85,000,000 (versus $101,000,000 prior year); SG&A reached $156,000,000 (up from $130,000,000), attributed to marketing and commercial expansion.
• One-Time Tax Benefit -- Release of valuation allowance on deferred tax assets produced a noncash income tax benefit of approximately $250,000,000.
• Cash Position -- $820,000,000 at year-end.
• EU Regulatory Update for Trofinetide -- Informed of a negative trend vote by the CHMP; plan to request reexamination, with a decision expected following a 120-day period.
• Peak Sales Outlook -- Management reaffirmed a $1,000,000,000 NUPLAZID 2028 sales target and a DAYBUE global 2028 net sales goal of $700,000,000, with EU contributing less than 15%.
• R&D Pipeline Disclosure -- Cited four unique molecules with a claimed peak sales potential of $11,000,000,000 combined; $4,000,000,000 specifically attributed to remlofenserin (ADP and LBDP indications).
• Upcoming Clinical Catalysts -- Phase 2 remlofenserin (ADP) top-line readout expected August–October; Phase 3 trofinetide in Japan initiated, with results targeted for late 2026 to early 2027; first-in-human study of ACP-271 set to begin before the end of Q1.
• Adjusted NUPLAZID Revenue Accounting Change -- A nonrecurring $20,000,000 reduction in net sales reflecting higher-than-anticipated CMS Medicare volume under the Inflation Reduction Act.
• Global DAYBUE Regulatory Status -- DAYBUE liquid now approved in three ex-U.S. markets, including Israel, with ongoing named patient supply programs in multiple countries.

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RISKS

• The CHMP issued a negative trend vote regarding trofinetide’s EU marketing application, and management expects the final opinion to be negative, potentially delaying EU commercial sales for DAYBUE.
• A nonrecurring $20,000,000 reduction in NUPLAZID net sales was required following higher-than-expected CMS Medicare volume indicated by Inflation Reduction Act invoices, driving an accounting change impacting financial comparability for fiscal 2025.
• 2026 DAYBUE sales guidance explicitly excludes any EU commercial sales due to uncertainties around EMA approval timing.

SUMMARY

ACADIA Pharmaceuticals (NASDAQ:ACAD) reported record adjusted annual revenue exceeding $1,000,000,000, with growth led by both NUPLAZID and DAYBUE. Management expects double-digit growth for both core brands in 2026, supported by new product launches, expanded field force, and pipeline catalysts. EU regulatory setbacks for trofinetide and an accounting change to NUPLAZID rebates present interim headwinds, but ex-U.S. programs and a robust R&D pipeline provide multiple avenues for long-term value creation.

• Management described the new DAYBUE STIX formulation as enabling incremental patient capture, estimating "over 400 patients" addressable, with impact projected across the next two to three years.
• DAYBUE field expansion now drives 76% of new patient starts from community-based physicians in the U.S.
• Management detailed that 18% year-over-year growth in NUPLAZID new prescriptions and a 30% field force expansion increased commercial reach from 7,000 to 11,000 prescribers.
• Executive Vice President Elizabeth Thompson confirmed that the pivotal Phase 2 remlofenserin study is powered for a "moderate effect size—so 0.4," with statistical significance at week six desired, and that placebo effect remains a key risk for clinical outcomes.
• The CFO clarified that, for NUPLAZID, the $108,000,000 Inflation Reduction Act cash payment was fully remitted in the quarter, and adjustments to net sales are noncash, reflecting accrual methodology changes for improved period comparability.

INDUSTRY GLOSSARY

• Gross-to-net: The percentage reduction from gross sales to net sales due to discounts, rebates, and government programs.
• Inflation Reduction Act (IRA): U.S. legislation impacting pharmaceutical rebates and pricing, affecting net revenue calculations for Medicare-eligible products.
• CHMP: Committee for Medicinal Products for Human Use, the expert committee at the European Medicines Agency (EMA) that assesses marketing authorization applications.
• Named Patient Supply Programs: International framework allowing approved or investigational drugs to be provided to individuals before commercial availability in a given country.
• SAPS-H+D: The Scale for the Assessment of Positive Symptoms–Hallucinations and Delusions, a clinical endpoint used in psychosis trials.
• NPI-C: Neuropsychiatric Inventory–Clinician, a tool assessing neuropsychiatric symptoms, used as an exploratory endpoint in clinical studies.
• Master protocol: An adaptive clinical trial design allowing evaluation of multiple therapies or indications under a unified framework.
• GPR88 agonist: A compound targeting the GPR88 receptor, investigated for potential effects in neuropsychiatric disorders.
• Field force: Commercial sales and customer-facing teams responsible for product promotion and prescriber engagement.

Full Conference Call Transcript

Catherine Owen Adams, our Chief Executive Officer, who will provide some opening remarks, followed by Thomas Garner, our Chief Commercial Officer, who will discuss our commercial brands, DAYBUE and NUPLAZID. Also joining us today is Elizabeth Thompson, PhD, Executive Vice President, Head of Research and Development, who will provide an update on our pipeline programs, and Mark C. Schneyer, our Chief Financial Officer, who will review the financial highlights. Catherine will then provide some closing thoughts before we open up the call to your questions. We are using supplemental slides, available on our website under the Events and Presentations section.

On today's call, both GAAP and non-GAAP financial measures will be discussed, including non-GAAP NUPLAZID net sales and non-GAAP total revenues. The non-GAAP financial measures that are also referred to as adjusted measures are reconciled with the most directly comparable GAAP financial measures in our earnings press release and slide presentation, which has been posted on the Investors page of the company website. Before proceeding, I would like to remind you that during our call today, we will be making several forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

These forward-looking statements, goals, expectations, plans, prospects, growth potential, timing of events, future results, and financial guidance are based on current information, assumptions, and expectations that are inherently subject to change and involve several risks and uncertainties that may cause results to differ materially. These factors and other risks associated with our business can be found in our filings made with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of today's date, and we assume no obligation to update or revise these forward-looking statements as circumstances change, except as required by law. I will now turn the call over to Catherine for opening remarks.

Catherine Owen Adams: Thanks, Al, and good afternoon, everyone. I am pleased to report that ACADIA Pharmaceuticals Inc. delivered another strong quarter, capping off a milestone year for our company. We achieved adjusted total revenues of $298,000,000 in the fourth quarter, up 16% from the prior year, and for the first time in our company's history, annual revenues exceeded $1,000,000,000, reaching $1,080,000,000 in adjusted 2025 revenue, which represented 14% growth from the prior year. This achievement underscores the strength of our commercial execution and positions us for sustained growth in the coming years.

We are presenting adjusted revenues because during the fourth quarter, we received our Inflation Reduction Act invoices from CMS for NUPLAZID, which were higher than anticipated and required a nonrecurring accounting change in estimate that you see reflected in our financials. Mark will walk you through the details later in the call. As a result, we delivered adjusted NUPLAZID net sales of $189,000,000 in the fourth quarter and $692,000,000 for the full year. These results were up 17% and 15%, respectively, and in terms of volume represented 13% in the fourth quarter and 9% for the full year, together demonstrating the continued strength of NUPLAZID and further reinforcing our confidence in its long-term growth trajectory.

Now looking forward to 2026, we expect NUPLAZID net sales of $760,000,000 to $790,000,000, which would represent between 10% to 14% growth over 2025 adjusted net sales, placing the brand on a strong trajectory towards our expectation of achieving blockbuster status with $1,000,000,000 of net sales in 2028. Turning to DAYBUE, we delivered net product sales of $110,000,000 in the fourth quarter and $391,000,000 for 2025, representing 13% and 12%, respectively, year-over-year sales growth. This growth was driven primarily by our expanded reach into the community physician setting in the U.S., and our ex-U.S. named patient supply programs, including countries outside the European Union where we are seeing strong interest to access DAYBUE.

We are excited about the launch of DAYBUE STIX, our new powder formulation, which is still in the very early stages but already generating significant interest from both health care providers and caregivers. Tom will share more details on how this new formulation is being received and the opportunities we see ahead. I do want to briefly address the regulatory developments in the EU. As we shared, following our oral explanation to the Committee for Medicinal Products for Human Use, or CHMP, which we gave to support our trofinetide marketing application, we were informed that the outcome was a negative trend vote. Liz will provide details on our plan to request a reexamination, subject to the formal opinion.

Our commitment to advancing access to trofinetide in the EU remains unchanged. Importantly, our named patient supply programs remain active, ensuring patients maintain access to treatment as we move through the regulatory process. For our 2026 DAYBUE guidance, we expect global net sales between $460,000,000 and $490,000,000, which would represent between 18% to 25% growth over 2025, driven by contributions from the STIX launch in the U.S. and continued growth of our named patient supply outside the U.S. Due to the current status of our application within the EMA, this 2026 guidance does not include potential commercial sales that would result from this regulatory approval.

However, it does include contributions from our global named patient supply programs, including countries within the EU where we continue to see strong interest. Longer term, we continue to project 2028 global net sales for DAYBUE of $700,000,000 inclusive of the EU, and we'll update our expectations after clarity on the final EMA opinion. Just for perspective, of our projected $700,000,000 in 2028 sales, the EU sales represent less than 15% of the total, meaning we have ample opportunity for growth ahead under any scenario. Turning to our robust R&D pipeline, we are excited for the Phase 2 readout of remlofenserin in the August through October 2026 time frame, as this presents a key event for our company this year.

Beyond that, we see several important catalysts, which Liz will detail. Importantly, we have four unique molecules targeting large addressable markets with a combined full peak sales potential of $11,000,000,000. Approximately $4,000,000,000 of that potential is specifically attributable to remlofenserin across both the Alzheimer's disease psychosis and Lewy body dementia psychosis indications, highlighting the transformative potential this asset represents for ACADIA Pharmaceuticals Inc.'s future growth trajectory. I will now turn the call over to Tom for an update on our commercial brands.

Thomas Garner: Thank you, Catherine. I am pleased to share the strong fourth quarter performance delivered by our commercial portfolio, beginning with NUPLAZID. NUPLAZID delivered another outstanding quarter with adjusted net sales of approximately $189,000,000 in the fourth quarter. Importantly, as Catherine mentioned, underlying quarterly volume growth remained exceptionally strong at 13%, accelerating the momentum we have built throughout the year. This growth was broad-based with strength across all channels. For the full year, volume increased 9%, reflecting sustained and durable demand for NUPLAZID. Several key metrics underscore this commercial momentum. New prescriptions led the way, growing 18% year over year in the fourth quarter.

This performance reflects continued traction in the marketplace and validates the effectiveness of our commercial strategy to improve awareness and diagnosis of Parkinson's disease psychosis, while positioning NUPLAZID as the preferred treatment option earlier in the course of the disease. This has been supported by a refined approach to targeting and segmentation. On the direct-to-consumer front, our new branded campaign launched in the fourth quarter, and we expect pull-through benefits to build throughout 2026. From an execution standpoint, we have now completed a 30% expansion of our customer-facing teams to better support our evolving prescriber base, with representatives now fully deployed in the field.

Based on our experience with DAYBUE, we expect a six- to nine-month ramp before the full impact of this investment is reflected in results. Our expanded team is now equipped with enhanced tools and resources to engage a broader and evolving prescriber base. Notably, 40% of NUPLAZID’s prescribers in fiscal year 2025 were new to brand. We are now even better positioned to meet the needs of this growing group of HCP writers. Overall, 2025 was a very strong year for NUPLAZID, and we are well positioned to build on this momentum in 2026 and beyond.

As reflected in our guidance, we expect another year of solid growth, and as Catherine noted, we remain confident in NUPLAZID’s path to approximately $1,000,000,000 in annual sales by 2028. Now turning to DAYBUE. We delivered another quarter of meaningful progress across multiple growth drivers. Fourth quarter sales were approximately $110,000,000 driven primarily by strong U.S. performance, with growing contributions from our rest-of-world programs. This represents 13% year-over-year sales growth, supported by 12% volume growth. In the fourth quarter, 1,070 patients received DAYBUE shipments globally, which represents record highs in both the U.S. and outside the U.S. This milestone highlights our continued success in reaching more patients who can benefit from therapy.

As the business matures, we expect to increasingly emphasize sales-based metrics over patient counts as our primary performance indicator. Core business fundamentals remain consistent with what we reported last quarter, including strong persistency, low discontinuation rates, and continued penetration within the approximately 6,000 diagnosed Rett syndrome patients in the United States, reinforcing the significant opportunity that remains. We continue to see growing momentum from our community expansion strategy. In the fourth quarter, 76% of new prescriptions originated from community-based physicians, validating our strategy of expanding access beyond specialty care centers and bringing DAYBUE closer to where patients receive their ongoing care. Now turning to DAYBUE STIX, one of our most exciting recent developments.

In December, the FDA approved this new formulation of DAYBUE, a powder for oral solution. We believe this represents a meaningful advancement in how we can serve patients and families. DAYBUE STIX has been developed based on the feedback we have heard directly from caregivers and HCPs. The powder formulation allows flexibility in mixing with different liquids and adjusting volume based upon patient preference. It requires no refrigeration, offers enhanced portability through compact packaging, and contains low sugar and carbohydrate content with no red dye or preservatives. Based on our analysis, we believe there is an incremental opportunity of over 400 patients, including treatment-naive, and those who have previously discontinued DAYBUE due to formulation concerns.

We have been very encouraged by the early response to the approval of DAYBUE STIX across the Rett community. Initial product is already in channel, and the first patients have already begun receiving shipments. Early patient mix is tracking in line with our expectations, and we remain on track for a broader commercial launch in early Q2 as we ensure appropriate inventory levels and a smooth transition for patients. Outside the United States, we continue to make progress expanding global access to trofinetide. DAYBUE liquid is now approved in three markets, including Israel, following recent approval by the Ministry of Health, further extending our international footprint.

Looking ahead, we see a strong growth outlook for DAYBUE reflected in our 2026 guidance. Key drivers include the U.S. launch of STIX, continued benefits from the expansion of our customer-facing teams, and ongoing contributions from the named patient supply programs internationally. Overall, the fundamentals of the DAYBUE business remain strong, with multiple demand drivers in the U.S., coupled with a runway for continued growth as we expand access globally. I would like to thank the ACADIA Pharmaceuticals Inc. Commercial Organization for their outstanding commitment to both NUPLAZID and DAYBUE in 2025. I look forward to further building on the strong momentum we have established as we head into 2026.

And with that, I will turn the call over to Liz.

Elizabeth Thompson: Thank you, Tom. I am pleased to have the opportunity to discuss progress on our robust R&D pipeline, where we continue to see real momentum building across multiple programs, and to provide some regulatory updates. As we updated last month, across our eight disclosed programs, we anticipate initiating five additional Phase 2 or Phase 3 studies by 2027, demonstrating the breadth and depth of our development portfolio. Over recent quarters, we have achieved several important milestones with new study initiations. Among these, we initiated a Phase 2 study of remlofenserin in Lewy body dementia psychosis, initiated a Phase 3 study of trofinetide in Japan, and launched our Phase 2 study of ACP-211 in major depressive disorder.

Soon, we expect to initiate our first-in-human study of ACP-271 in healthy volunteers, marking an important advance for this novel asset into clinical development. As a reminder, our current target indications are tardive dyskinesia and Huntington's disease. We continue to expect to deliver four Phase 2 or Phase 3 study readouts by 2027. The next milestone will be top-line results from our Phase 2 study of remlofenserin in Alzheimer's disease psychosis. Based on the pace of enrollment, we remain confident in the updated August to October 2026 timeline we shared last month. Recruitment in our remlofenserin study for Lewy body dementia psychosis is getting off to a solid start and is tracking in line with our expectations.

Turning to our trofinetide regulatory and international development updates, as we announced earlier this month, we were informed of a negative trend vote from the CHMP. We expect to receive the final opinion this week, which we expect will be adopted following the CHMP meeting currently taking place. Based on the trend vote, we do anticipate that final opinion to be negative. We are currently intending to follow the normal regulatory process for reexamination. In total, this process would be expected to take approximately 120 days from the adoption of the negative opinion. Assuming that timeline holds, we would expect the reexamination process to lead to a new final CHMP opinion around the end of Q2.

Again, our intention to request reexamination is based on our current understanding of the trend vote, but we will need to review the final opinion to determine our optimal path forward. While we look to bring trofinetide to patients in the EU, we continue to make progress on other fronts. In Japan, as I mentioned, we recently initiated our Phase 3 study, which represents an exciting opportunity to bring trofinetide to Japanese patients with Rett syndrome. We anticipate results from this pivotal study between Q4 2026 and Q1 2027, which would position us for a potential regulatory submission in 2027 in this important market.

The strength and diversity of our pipeline continues to position ACADIA Pharmaceuticals Inc. for sustained growth, with multiple potential opportunities to bring truly meaningful innovation to underserved patients living with rare and neurological diseases. 2025 was a milestone year for ACADIA Pharmaceuticals Inc. in many ways, and I am particularly proud of what the R&D team has done to continue to move our science and our pipeline forward. And with that, I will hand the call over to Mark. Thank you, Liz.

Mark C. Schneyer: I am pleased to walk you through our strong financial performance for the fourth quarter and full year 2025. Fourth quarter total revenues were $284,000,000, and for the full year were $1,070,000,000 on a GAAP basis. Turning to NUPLAZID, fourth quarter GAAP net product sales were $174,000,000, and for the full year 2025, $680,000,000. We are also reporting results on a non-GAAP basis to adjust for the accounting impact on NUPLAZID from receiving our first invoices for inflation cap rebates under the Inflation Reduction Act, or IRA.

While we have been accruing for inflation cap rebates since Q4 2022, based upon historical data that we received from the federal government and our customers, the invoices we received from CMS indicated that our Medicare volume for NUPLAZID was higher than we had been accruing for. This volume difference required us to make a change in estimate for our IRA rebate accruals in fiscal year 2025, which is accounted for as an increase in gross-to-net and resulted in a nonrecurring $20,000,000 reduction in net sales. A reconciliation from our GAAP results to non-GAAP adjusted NUPLAZID net sales and total company revenues is presented on slide 15.

The adjusted net sales methodology apportions the previously described $20,000,000 change in estimate to the years in which the applicable NUPLAZID net sales volumes occurred. As you can see on this slide, the change in estimate is only a modest change in net sales when looking over the entire four fiscal year period. For the fourth quarter, adjusted NUPLAZID net sales were $189,000,000, up 17% year over year. For fiscal year 2025, our adjusted NUPLAZID net sales were $692,000,000, up 15% year over year. For the quarter, gross-to-net for NUPLAZID was 29.4% on a reported basis and 23.6% on an adjusted basis.

Our gross-to-net for NUPLAZID for the full year was 25.9% on a reported basis and 24.6% on an adjusted basis. For DAYBUE, we achieved $110,000,000 in net sales in Q4, up 13% year over year, demonstrating continued strong momentum in this brand. The gross-to-net adjustment for DAYBUE in the quarter was 19.5%. Full year DAYBUE net sales were $391,000,000, up 12% year over year. DAYBUE gross-to-net was 22.3% for the year. Turning to our operating expenses, R&D expenses for the fourth quarter were $85,000,000, down from $101,000,000 in 2024. The decrease was primarily attributable to the $28,000,000 upfront payment for ACP-711 in 2024.

SG&A expenses for the fourth quarter were $156,000,000, up from $130,000,000 in 2024, primarily driven by increased marketing investments to support NUPLAZID and from our DAYBUE field expansion and marketing investments. With regard to taxes, we released the valuation allowance on the company's deferred tax assets, resulting in a one-time noncash income tax benefit of approximately $250,000,000 in the fourth quarter. Our cash balance at the end of 2025 was $820,000,000. Looking ahead to fiscal year 2026, I am pleased to provide our financial guidance, which reflects our confidence in the continued growth trajectory of both NUPLAZID and DAYBUE.

While we will be making some foundational SG&A investments this year, we expect them to deliver meaningful top-line and operating income growth as we move forward into 2027 and 2028. For total revenues, we expect to achieve between $1.22 billion and $1.28 billion, representing meaningful year-over-year growth that builds upon our strong 2025 performance. For NUPLAZID, we are guiding to net sales between $760,000,000 and $790,000,000. Sales growth is primarily expected to be driven by expanding volume. Gross-to-net is expected to be in the range of 22% to 24%, and this aligns with the Medicare volume mix implied by our IRA inflation cap invoices received from CMS.

For DAYBUE, we are guiding to net sales in the range of $460,000,000 to $490,000,000, driven by DAYBUE STIX and continued growth in our named patient supply programs. Given the delay to any potential EMA approval, this guidance range does not assume EU commercial sales. Gross-to-net is expected to be in the range of 22% to 24%. We expect R&D expense to be between $385,000,000 and $410,000,000. The increase in R&D spend expected in 2026 compared to 2025 is primarily attributable to an increase in clinical and personnel cost as we advance and have broadened our R&D portfolio. Our R&D expense guidance assumes our remlofenserin program continues into the Phase 3 portion of the program.

We expect SG&A expense to be between $660,000,000 and $700,000,000 for the full year. The growth in SG&A year over year is primarily due to our expansion of customer-facing personnel and marketing investments for NUPLAZID and increased spend to support the launch of DAYBUE STIX, as well as the annualization of our DAYBUE field force expansion that took place in Q2 2025. This guidance reflects our confidence in the underlying strength of our business and positions us well for continued growth as we advance towards our 2028 objectives. And with that, I will turn the call back to Catherine. Thank you, Mark.

Catherine Owen Adams: Looking ahead, in addition to the strong revenue growth we have highlighted on this call, we have a series of exciting milestones to support our growth in 2026 and beyond. Our most significant catalyst arrives later this year, with top-line results from the Phase 2 study of remlofenserin in Alzheimer's disease psychosis, expected between August and October, an opportunity with the potential to meaningfully shift our long-term growth profile. We also plan to initiate our first-in-human study of ACP-271 before the end of the first quarter. With a strong balance sheet, we also have the flexibility to pursue business development opportunities that complement and support our future growth.

Taken together—our commercial execution, advancing pipeline, and financial strength—ACADIA Pharmaceuticals Inc. is well positioned to sustain growth and value creation. And with that, I will turn the call back to the operator to begin our Q&A session.

Operator: Thank you. The floor is now open for questions. If you have dialed in and would like to ask a question, please press 1 on your telephone keypad to raise your hand and join the queue. If you are called upon to ask a question and are listening via loudspeaker or device, please pick up your handset to ensure that your phone is not on mute when asking your question. Your first question comes from the line of Tessa Thomas Romero of J.P. Morgan. Your line is open.

Tessa Thomas Romero: Good afternoon, Catherine and team. Thanks so much for taking our questions this evening. So how should we be thinking about ramp to your 2028 global net sales targets that you outlined at our conference last month? Any additional color you can give us now that your 2026 guidance has been outlined for both DAYBUE and NUPLAZID? Thank you.

Catherine Owen Adams: Thanks, Tess. I will give you a top-line view, and then maybe I will ask Tom to add some specifics. So if we take NUPLAZID and we look at our mid guidance for 2026 at July, that is about 12% above this year's growth on the adjusted basis, and so would indicate, you know, we are expecting low- to mid-teens growth out to the billion, so we feel very confident in that incremental growth that we see, and Tom will explain maybe a bit more about how that tracks through to the marketing execution.

And then for DAYBUE, at the mid of our guidance, 21% over last year, again, expecting for next year and out to 2028 sort of low-20% growth to continue. So those are how we bridge between today and our guidance to 2028. Overall, the company's CAGR during that time will be about 16%. But, Tom, in terms of the confidence to ramp, perhaps you would add some stuff for us. Sure.

Thomas Garner: So good afternoon, Tess. Hope you are doing well. As you can see by our results through 2025, both brands are coming off a very strong year. And just looking at NUPLAZID and, in particular, our Q4 performance, you can see the acceleration that we actually saw in some of our metrics through Q4. This gives us real confidence going into 2026. Now with our 30% expansion of the field force in place, we can really begin to further capitalize upon the underlying demand that we are seeing in the market for NUPLAZID. We are really positioning NUPLAZID earlier in the treatment paradigm for these patients with PDP. We are continuing to focus on our unbranded efforts.

We think awareness for this patient population is incredibly important. And as we begin to tap into just some of the underlying dynamics that we see on a weekly and a monthly basis, especially as it relates to our expanding new writer base, it gives us real confidence that our strategy moving forward is going to continue to pay dividends for us. Turning to DAYBUE, we got the approval for DAYBUE STIX back in December. We have been really encouraged by the early signals that we are seeing through January. Just recall, we are not anticipating a full launch for that formulation until Q2.

What we are seeing already, I think, really underpins the excitement that we had leading up to and through that approval, given the encouraging stories we are hearing both from caregivers and HCPs and their interest in continuing to use DAYBUE and try the new formulation, either for those patients who are naive to therapy or potentially may have discontinued due to formulation concerns. There are two big opportunities that we see for DAYBUE in the U.S. Outside of the U.S., it is going to be a continuation as we further bolster our named patient supply programs, and we continue to see plenty of inbound interest from across the various countries where those programs are available.

We will support those patients where we can.

Albert Kildani: Thanks, Tess.

Operator: Your next question comes from the line of Ritu Subhalaksmi Baral of TD Cowen. Your line is open.

Ritu Subhalaksmi Baral: Good afternoon, guys. Thanks for taking the question. I wanted to ask the team what good remlofenserin ADP data will look like later this year. What are you hoping to show on the primary endpoint—that is SAPS-H+D at week six? And if you could go through some of the powering. And in the January presentation, you noted a key exploratory endpoint of the NPI-C. Is there anything in particular that you are looking for in that exploratory endpoint of note that sort of fills out the clinical story of what remlofenserin’s benefit in this population could be? And then I have a quick follow-up. Oh, sure.

Catherine Owen Adams: I will get Liz to give you her response.

Elizabeth Thompson: Sure. Thanks for the question, Ritu. So, broadly speaking, what we are looking for in our Phase 2 study with remlofenserin is continued evidence that we are developing a molecule that is in line with our target product profile—what we think a drug really needs to be to be meaningful in this patient population—and that has a number of different components to it, and then I promise I will come to your questions about powering. Some of the components are, we think it is important here to have a drug that is going to be easy for people to take and easy for them to be with, particularly in this patient population.

You can imagine the challenges in having people take their medicine appropriately and the potential big impact if they do not. So something that is once a day, something that can be taken with or without food, something that does not have significant DDIs with other medicines—those are all things we think are important that we feel pretty good about with remlofenserin today. We think it is going to be important, obviously, to show efficacy and a good safety profile, and frankly, if we see something that is in line with the established NUPLAZID safety profile, I think we will be very pleased with that.

Finally, we are not going to answer this just with this Phase 2 trial, but we think it is going to be important to see data that is directionally supportive of other things that we think matter—that we are not going to have a negative impact on motor, for example, that we are not going to have a negative impact on cognition. Those are all the kinds of things that we are going to be looking for in this study. In particular around powering and the SAPS-H+D, from a primary endpoint perspective, what we have powered for here is a moderate effect size—so 0.4, in particular.

We will be pleased, of course, if we see statistical significance on that at week six. Around NPI-C, we are not really ready at this point to comment on specifics of what we are looking for there. That is a more recently added endpoint, and so we certainly did not power the study around that. So it is more exploratory in nature, and that is reflected in where it is in our hierarchy at this point.

Albert Kildani: Thanks, Ritu.

Operator: Thank you. Next question comes from the line of Marc Harold Goodman of Leerink. Your line is open.

Marc Harold Goodman: Yes. Can you just give us a sense of what is going on behind the scenes with DAYBUE and just the persistency and how patients are being compliant with the drug—just how that has changed? We have not heard you talk about that at all today. Thanks.

Catherine Owen Adams: Yes. I think Tom talked to it at a high level in his comments. Tom, do you want to add any more color for Marc?

Thomas Garner: Yes. Essentially, Marc, everything is in line with what we shared in previous quarters. Our discontinuations remain in the low single-digit range. They have really stabilized. Consumption remains as we have shared before, which I think for the full year was in the high-60% range. Our story now is we have stabilized the business and are back on a growth trajectory. We are seeing the benefits from the expansion that we made back in Q2, and our strategy to expand into community is working for us. It is now a case of utilizing STIX to unlock that next wave of growth, and that is what we anticipate doing as we head into 2026.

Marc Harold Goodman: So it is just continuation of the—it has been single digits all year. Is that what you are saying? All four quarters?

Thomas Garner: Yes. Yep. Yep.

Operator: Thank you. Your next question comes from the line of Rudy Lee of Wolfe Research. Your line is open.

Rudy Lee: Hi. Thanks for taking my question. I have a follow-up question for this upcoming Phase 3 trial in ADP. Can you maybe just talk about the timeline—how long it would take you to start and finish the trial? And a second question regarding the EU opinion for DAYBUE. What is supposed to be the concern regarding the pathway, and how do you plan to fix that with the upcoming request for reexamination? Thanks.

Catherine Owen Adams: Liz, that is clarity on the ADP Phase 2 to Phase 3 enrollment timeline, and then you can fill them in on EU. Sure. Hi, Rudy. Welcome, and thanks.

Elizabeth Thompson: So first, on the remlofenserin Phase 2 to Phase 3. When we originally designed this program, we were building it on a wealth of information from pimavanserin, and so we took an assertive approach to clinical development where we have a combined program—a master protocol—that includes the Phase 2 and two Phase 3s. The advantage of this is that they are statistically separate, so I have been talking about how we are going to provide top-line results on the Phase 2 in the August to October timeframe. But they are operationally seamless.

What that means is that as soon as we stop enrolling in the Phase 2 portion of the ADP program, sites can start enrolling in the Phase 3 portion of the ADP program. We look to move from Phase 2 to Phase 3 enrollment later in the course of this year. Switching over to the reexamination, we do not have the final opinion in hand. We expect that to show up over the course of the coming days, so I cannot tell you exactly what is going to be in it.

What I can say is that we do anticipate, throughout the process, we have gotten questions on things like the relevance of the endpoints to the patient population, the clinical meaningfulness of the results that we saw on our endpoints, the duration of therapy, and the mechanism of action of DAYBUE and how that could be extrapolated to the kind of impact you might expect to have on the disease.

Those are the types of things that we anticipate we are going to see in the final opinion, but again, that is going to come in the following days, and we will put out a press release that provides more information on it when we have more information on it to share. In terms of what we might do differently this time around, some of that is going to depend on the nature of the questions that we actually wind up seeing. I will say in terms of reason to believe, there is precedent for reexaminations taking a negative opinion and turning it into a positive opinion.

If you look over the last five years, depending on how you cut it, you get something like 20% to 30% of reexaminations resulting in a positive opinion. There are a number of factors that can go into this. Certainly part of the process is that you do have a new rapporteur and co-rapporteur. You have an opportunity to come in specifically addressing only those grounds that are the grounds for refusal of the application. We have an opportunity to potentially bring some new voices into it. We are really committed to the EU patient population and are looking for ways to navigate this regulatory process.

Catherine Owen Adams: Thanks, Liz, and thanks, Rudy.

Operator: Thank you. Your next question comes from the line of Yigal Nochomovitz of Citi.

Caroline (for Yigal Nochomovitz): Hi. This is Caroline on for Yigal. Could you tell us how remlofenserin is differentiated from KarXT, which has upcoming Phase 3 readouts in ADP this year? Thanks.

Elizabeth Thompson: Sure. Mechanistically, these are different approaches to addressing psychosis. Overall, psychosis is really the result of an excessive ratio of your serotonergic versus your cholinergic signaling neurotransmission pathways, and we come at that from different angles of the seesaw, if you want to think of it that way—one is taking down one side versus increasing the other side. There is reason to think that either could be impactful in psychosis. Certainly there are going to be a number of differentiators in terms of how the drugs are taken.

We have a good understanding of what the dosing paradigm looks like for remlofenserin, as well as what it is likely to look like for KarXT, and you need to think about the profile of each of these in the context of an elderly, frail patient population. We think that remlofenserin could be a good treatment for patients if we see a safety profile that continues to be consistent with what we have seen for NUPLAZID.

Albert Kildani: Thanks, Caroline.

Operator: Your next question comes from the line of Sean Laaman of Morgan Stanley. Your line is open. Good afternoon, Catherine and team. Hope everyone is well, and thank you for taking my question.

Sean Laaman: As DAYBUE STIX rolls out more broadly in early—I think it is early Q2 2026, you said—should we think about net new patient capture versus switching? And do you think STIX meaningfully expands addressable Rett population over time?

Thomas Garner: Yes. Good afternoon, Sean. Thanks for the question. First, just to reiterate, we have been really encouraged by the early excitement that we are seeing from the Rett community regarding STIX. As we mentioned on the call, by our own internal estimates, we think there are around 400-plus patients we could unlock in addition to just having liquid on the market with the STIX formulation. That is made up of both patients who are naive and those that may have discontinued or maybe never started due to formulation concerns. Taken in totality, we believe there is clearly additional upside that we can capture over the next few years.

It is worth noting that the 400 patients we are talking about—we do not think we are going to see all of them in 2026. We anticipate unlocking those over the next two to three years. Taken together, coupled with all of the efforts that we deployed in 2025—expanded field team, more direct-to-consumer, significant education especially as we move into the community setting—we believe there is an opportunity to further penetrate the Rett marketplace with DAYBUE and potentially continue to expand it further. We now estimate that there are around 6,000 Rett patients diagnosed in the U.S., which is a modest increase from what we shared previously. Taken together, absolutely, we believe in the long-term growth outlook for DAYBUE.

Catherine Owen Adams: Thanks, Sean. We are excited about STIX and getting patient stories in already with a few patients now in the channel and look forward to really giving you a full insight into DAYBUE STIX at our next call.

Operator: Thank you. Your next question comes from the line of Brian Corey Abrahams of RBC Capital Markets. Your line is open. Hi, everyone. This is Nevin on for Brian. Thank you for taking our questions.

Nevin (for Brian Corey Abrahams): Just a couple of questions on 204 remlofenserin. At the R&D Day last year, you had shown that there was a dose-dependent exposure signal with pimavanserin in the ADP and Lewy body patients, where some of that higher exposure had correlated to greater symptom reduction. So, I guess, what drives your confidence that the 30 mg and 60 mg doses of remlofenserin would reproduce that exposure-response relationship in the same way? And is there any way to maybe quantify that target gap or target efficacy gap versus pimavanserin marketed dose based on some of the preclinical and Phase 1 PK data that you have?

Catherine Owen Adams: So, alright. Let me think how to come at this one.

Elizabeth Thompson: Yes, first off, part of our reason to believe is based on the fact that with PIM we did see what appears to be an exposure response from an efficacy perspective, and in neither ADP nor Lewy body do we appear to be at the maximum or near-maximum plateau level of that efficacy. I will say that, frankly, even if we were able to just reproduce similar levels of efficacy with remlofenserin that were seen with 34 mg of pimavanserin and do it in a more robust study that is focused specifically on the Alzheimer's population, we think that would be meaningful in and of itself. Additional efficacy would be the cherry on top.

We think there are good reasons to believe that exposure-response relationship is true and will play out when we are able to test it with two different doses, but we do have to do that test. Even if we do not see as much of a differentiation between the 30 and the 60 as you might expect based on that exposure response, we still could have a meaningful therapy here in the context of a more robust, more specifically designed trial.

Catherine Owen Adams: Excellent.

Operator: Your next question comes from the line of Ashwani Verma of UBS. Your line is open.

Ashwani Verma: Great. Thanks for taking our questions. So as we think about the increase in the OpEx this year, does that mostly now enable you to get to your 2028 goals, or is there more incremental investments coming in the subsequent years that will be key to delivering that? And then secondly, I know on KarXT, there has been a lot of focus on the irregularities that they saw in terms of clinical trial execution. Can you give us some confidence when you look at your study execution that you do not see any type of issue like that?

Mark C. Schneyer: Thanks, Ash, for the question. From an SG&A standpoint, you will see incremental increases from here. This is the foundational investment that we are making to achieve our goals in 2027, 2028, and beyond. From an R&D standpoint, it depends on how the portfolio advances as it continues to be successful. With a broader and bigger portfolio, it can increase, and if we see normal rates of attrition, it will increase less. We do think our margin achievement will significantly expand from here, and our expectations—really depending upon how the R&D portfolio evolves—are that we could see mid-teens operating margins.

If you think about normal rates of attrition in the R&D portfolio, you would be in the low-20% operating margin in 2028.

Elizabeth Thompson: As far as the question about the BMS situation and the irregularities, like everyone else, we do not know the specifics of the irregularities that were seen in the BMS situation. That said, on an ongoing basis, we do look at blinded data in a number of ways. At this point, we are not aware of any substantial irregularities that suggest that we have a problem. Obviously, this is an ongoing thing. We are very committed to good clinical practice, and we do continue to look on an ongoing basis, but so far, so good.

Albert Kildani: Okay.

Operator: Thank you. Your next question comes from the line of Evan Seigerman of BMO Capital Markets. Your line is open.

Nakhung (for Evan Seigerman): Hi. I am Nakhung. I am on for Evan. Thanks for taking our question. I know this study is early, but can you take a second to talk about what you are looking to see from the Phase 1 ACP-271 healthy volunteers study you expect to initiate this quarter? Given the mechanism and preclinical work, it seems obviously you want to see improved levels of sedation relative to the VMAT2 inhibitors. I just want to get a sense whether there are other key measures you are looking to assess here.

Elizabeth Thompson: This is very exciting. This may be the first 271 question I have gotten, well, maybe ever. Thank you for the question. It is early here, but what I will say is this is some of the most novel biology we have in the pipeline. Part of it is the first step of a GPR88 agonist into humans in clinical trials, so we are interested in overall how that behaves in humans. We are interested in understanding PK and to whatever extent we can, the PK/PD disconnect that we did seem to see in some of our animal models suggesting the potential for a long PD effect that outlasts the PK—so some initial exploration there.

And, yes, understanding what this looks like from an adverse event potential profile is going to be important in terms of the degree to which it bears out our hypothesis of how this could work in people. Thank you for your interest. Looking forward to talking more about this as we go through the coming months and years.

Catherine Owen Adams: Thank you.

Operator: Thank you. Your next question comes from the line of Sumant Kulkarni of Canaccord Genuity. Your line is open. Good afternoon. Thanks for taking our questions.

Sumant Kulkarni: I know you mentioned a couple of times today that you are running two Phase 3 trials for ACP-204 in Alzheimer's disease psychosis. But what does the FDA's recent publication of its official position on needing one robust pivotal trial plus confirmatory evidence mean for ACP-204 in ADP and Lewy body dementia psychosis, especially if your Phase 2 data turn out to be, quote, unquote, very good?

Elizabeth Thompson: That is a great question. We are excited to see any regulatory innovation that could mean that safe and effective products could get to patients faster. There is a lot that, at this point, has been discussed in a journal article and in some presentations. There are a lot of questions that we do not know the answer to yet that make it hard to know exactly what this could mean for ACADIA Pharmaceuticals Inc.'s future development program, so we are watching this very closely. Things like what the impact is on the required safety database, as an example.

Of course, we always do have to think of this in terms of globally acceptable development programs, so there is a fair bit to work through there. That said, I would always want, in a situation where one had amazing data, to think about whether there were ways to bring something to patients faster. I think this gives us a little bit of additional reason to think we should try having those conversations, if nothing else.

Catherine Owen Adams: That is great. Just to reiterate, as we come through our top-line results between August and October, and Liz and team develop the Phase 3 protocol from those results, we will continue to inform you how those Phase 3 trials will be redesigned or designed according to what is happening in the policy environment as well as what is driven by the data. Thank you.

Operator: Your next question comes from the line of David Timothy Hoang of Deutsche Bank. Your line is open.

David Timothy Hoang: Hi there. Thanks for taking my question. Maybe first, just one on remlofenserin commercial opportunity. I think you have mentioned a potential $4,000,000,000 peak sales number for ADP and LBDP combined previously. Could you help put some arms around that number in terms of what would be the split between ADP and Lewy body? Is that just the U.S. market? Does that contemplate competition from KarXT? What would ramp to peak sales potentially look like? And then to come back on the IRA rebate accrual for NUPLAZID, could you help reconcile what is actually cash versus noncash for the quarter and full year? And is this a situation that may repeat in the future and would require another reconciliation? Thanks.

Catherine Owen Adams: Let me talk to ADP and LBDP in terms of the $4,000,000,000, and then we will move to the next part of the question. We have not disclosed the split that we see exactly between the two indications, but we have said that they are roughly equally weighted. Obviously, the populations are slightly different in the U.S., and the unmet need is different, as well as the population fragility, so there are some differences between the two indications that we will work through both commercially and financially as we come through our clinical trials. Overall, we feel this is a very strong opportunity for us in much larger markets than we are in now.

With the confidence that we have behind the design of remlofenserin for these specific populations, we feel like, if the data bears out, it is going to make a huge difference for the patient population and provide us a robust value story for both our health care environment and patients more broadly, both in the U.S. and hopefully beyond the U.S. In terms of NUPLAZID and the IRA, do you want to talk a little bit more about that?

Mark C. Schneyer: Sure. Thanks for the question. As far as cash versus noncash, we did pay our invoice in the quarter, and for the first two years of the program, that was a $108,000,000 payment that went out. Over the course of the year, if we factor in the payment plus additional accruals that we made, it was a net cash flow over the year of about $30,000,000. The adjustments that we made to net sales are all noncash adjustments, but they are meant to be reflective of our operational performance so you can compare periods.

When we shared the data going back to 2022, if we had full information, these were the accruals that we would have made, rather than needing to make the change in estimate that we made now that we got the information from CMS for the first time this year.

Catherine Owen Adams: Hope we answered the questions, David. Thank you.

Operator: Your next question comes from the line of Jason Nicholas Butler of Citizens. Your line is open.

Jason Nicholas Butler: Just understanding it is still early, any initial comments you can speak to on the increased NUPLAZID field force? And how are you, on an ongoing basis, assessing ROI on the full commercial investment for NUPLAZID, specifically the non–field force components?

Catherine Owen Adams: I am going to get Tom to talk to you about the sales force, but just to reiterate that we assess ROI on our marketing and commercial mix on a very regular basis. That is the basis of how we manage the business and the decisions that we make in order to ensure that our investments are driving both efficiency and growth. In terms of the team, Tom, why do you not share a little bit more about how it is going?

Thomas Garner: Sure. As we mentioned, Jason, we fully completed the expansion of the field team in January. I am pleased to announce that the team is now out in the field. We have been encouraged that they have hit the ground running, probably earlier than we thought, quite honestly. We are already seeing a nice uptick in their activity. With this expansion, we are able to meet the needs of around 60% of the overall PDP market in terms of prescribers. We have increased our target universe from about 7,000 writers to about 11,000 writers.

We believe that the additional 4,000 to 5,000 that we are now targeting is really going to help us unlock the incremental growth that we anticipate seeing through 2026, 2027, and 2028. We are very pleased with the early activity and metrics we are seeing. We are following our top-of-the-funnel metrics very tightly, as you would imagine, and we are already beginning to see a noticeable increase in referral volumes. We are excited to see that carry on through the year and look forward to the continued impact of that expansion and investment over the next two to three years.

Catherine Owen Adams: Just to reiterate, you can see the step-up in SG&A for 2026 versus 2025, and that is contributed by both the annualization of the DAYBUE expansion as well as the NUPLAZID expansion. As Mark said on a previous question, we do not expect that to continue to ramp at the same rate. We expect a step-up this year and then a more incremental increase as we head into 2028. We feel like we have a good base right now, and this will be our base with minor adjustments moving forward. Again, just to reiterate that point in terms of the OpEx to support this incremental growth.

Operator: Your next question comes from the line of Jack Allen of Baird. Your line is open.

Jack Allen: Thanks for taking the questions and congrats on the progress made over the course of the quarter. I wanted to ask on DAYBUE and the $700,000,000 sales expectations by 2028. Can you help us understand a little bit more about the assumptions that are going into that number? Does that include ex-U.S. sales? And what are your thoughts around potential competition for gene therapies within that period?

Catherine Owen Adams: I will answer at a high level, and then maybe either Tom or Liz can respond on gene therapy. The $700,000,000 consists mainly of the U.S. business, driven through growth of STIX and liquid and expanding the patient population from where we are now into the community. It does include global sales from the named patient program, where we have the ability, legally and through the regulatory framework, to supply the named patient program, and it does include EU commercial sales for now. Our current assumption is that we will have an EU approval before 2028. However, once we get the final decision from EMA, we will re-guide for that 2028 number.

To reiterate, the EU commercial sales within that $700,000,000 number is less than 15%. I hope that is a good explanation, and then I can make a couple of comments. And then, if there is anything you want to add, Tom.

Elizabeth Thompson: Generally, there are a couple of components to your gene therapy question. One is it is probably better for you to ask the gene therapy companies when they are speculating that they are coming to market. I will note that their development milestones do take some time to mature, so whether that is going to feature into 2028 or not, we should leave for them to comment. In terms of whether there is room for more than one type of agent out there, the data we have seen so far suggests that while we all wish these would be cures, I do not think the data so far suggests that they are.

The predominant likelihood is that patients are going to require more than one aspect to their care.

Catherine Owen Adams: Thanks, Liz.

Operator: Your next question comes from the line of Paul Matteis of Stifel. Your line is open.

Julian (for Paul Matteis): Hey there. This is Julian on for Paul. Thanks for taking our question. Wondering what you think is the biggest risk to the ACP-204 readout. Are there different indication-specific considerations for ADP versus LBD that you have thought of? Any chance that you plan on sharing baseline information ahead of the Phase 2, or anything else that you could share would be helpful? Thank you.

Elizabeth Thompson: A few things here. We are not currently anticipating that we would be sharing baseline information prior to the readout, so just to get that out there. In terms of ADP versus Lewy body, there are a few things we think about. One, of course, is that psychosis is impactful in both patient populations, but it is very frequent in Lewy bodies, so we do see that being a more substantial proportion of that patient population. That is important to keep in mind.

While in both cases you are generally dealing with an elderly population, it is also considered that the Lewy body population may be a bit more frail, and so we are especially mindful of appropriate safety profiles in that patient population. In terms of biggest risks, we have done a great deal to build upon pimavanserin in terms of how we put the molecule together and how we put the program together. In these kinds of spaces, you always have to be concerned about placebo effect.

We are doing what we can to manage it in terms of good training of investigators, looking for outliers, all that good stuff, but that is something you always have to be mindful of in these kinds of trials.

Operator: Thank you. We have run out of time for any further questions. I will now turn the conference back over to Albert Kildani for closing remarks.

Albert Kildani: Thank you, everyone, for joining us today. We look forward to speaking to you on our next conference call.

Operator: This concludes today's conference call. You may now disconnect.

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