ACAD

It has been about a month since the last earnings report for Acadia Pharmaceuticals (ACAD). Shares have added about 0.5% in that time frame, outperforming the S&P 500. But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is Acadia due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers. Acadia reported second-quarter 2026 earnings of 18 cents per share, which surpassed the Zacks Consensus Estimate of 6 cents. The company had reported earnings of 16 cents per share in the year-ago quarter. Revenues of $308 million beat the Zacks Consensus Estimate of $294 million, reflecting a 16% year-over-year increase. Growth was supported by higher marketed product sales. Acadia’s revenues comprise net product sales from its two marketed drugs, Daybue and Nuplazid. Reported revenues increased from $264.6 million in the second quarter of 2025 to $308 million in the reported quarter. The company’s quarterly performance benefited from continued demand for both products. Daybue growth was supported by the uptake of the recently launched Daybue STIX formulation, while Nuplazid benefited from volume growth and increased new-patient prescriptions. Reported net product sales of Nuplazid were $183.2 million in the second quarter of 2026, up 9% from $168.5 million in the year-ago period. The drug is approved in the United States for treating hallucinations and delusions associated with Parkinson’s disease psychosis. Nuplazid sales beat the Zacks Consensus Estimate of $181.5 million. Management stated that Nuplazid’s growth was primarily volume-driven. New-patient prescriptions increased 20% year over year and reached their highest quarterly level since the first quarter of 2018. Acadia also continued to expand engagement with priority health care providers through its enlarged field force. Daybue reported net product sales of $124.8 million, up 30% from $96.1 million in the second quarter of 2025. Daybue is approved in the United States for treating Rett syndrome in adult and pediatric patients two years of age and older. The reported figure beat the Zacks Consensus Estimate of $111.3 million. Growth was driven largely by volume and strong uptake of Daybue STIX. Approximately 40% of U.S. Daybue patients were receiving STIX by the end of the quarter. The company also recorded a quarterly high in the number of patients returning to Daybue treatment. Acadia stated that around 60% of total referrals during the quarter came from treatment-naive patients, while 40% represented returning patients. For STIX specifically, 55% of patients switched from the oral solution, while the remaining 45% were new or returning patients. Research and development (R&D) expenses were $82 million in the second quarter of 2026, up 5% from $78 million in the year-ago period. Selling, general and administrative (SG&A) expenses increased 20% year over year to $160 million from $134 million. The increase reflected investments in expanding the Nuplazid and Daybue field forces and higher marketing spending to support both brands. Acadia had cash, cash equivalents and investment securities worth $956 million as of June 30, 2026, compared with $851 million as of March 31, 2026. Following the strong quarterly performance, Acadia raised its total revenue guidance for 2026 to a range of $1.24 billion to $1.30 billion. The previous guidance range was $1.22 billion to $1.28 billion. The company increased its Daybue global net product sales forecast to $480-$510 million from the prior range of $460-$490 million. The revised outlook reflects strong U.S. demand, uptake of STIX and expected contributions from international markets. Nuplazid net product sales guidance was maintained at $760-$790 million. Management expects the expanded field force to have a greater impact on Nuplazid’s performance later in the year as sales representatives deepen engagement with targeted physicians. Acadia now expects R&D expense in the range of $355-$380 million, down from the previous range of $385-$410 million. SG&A expenses continue to be expected between $660 million and $700 million. In the past month, investors have witnessed a upward trend in estimates review. The consensus estimate has shifted 59.62% due to these changes. At this time, Acadia has a nice Growth Score of B, however its Momentum Score is doing a bit better with an A. However, the stock was allocated a grade of C on the value side, putting it in the middle 20% for this investment strategy. Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending upward for the stock, and the magnitude of these revisions looks promising. Notably, Acadia has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Acadia belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Incyte (INCY), has gained 7.5% over the past month. More than a month has passed since the company reported results for the quarter ended June 2026. Incyte reported revenues of $1.67 billion in the last reported quarter, representing a year-over-year change of +37.7%. EPS of $3.09 for the same period compares with $1.57 a year ago. For the current quarter, Incyte is expected to post a loss of $3.31 per share, indicating a change of -246.5% from the year-ago quarter. The Zacks Consensus Estimate remained unchanged over the last 30 days. Incyte has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of A. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report ACADIA Pharmaceuticals Inc. (ACAD) : Free Stock Analysis Report Incyte Corporation (INCY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Image source: The Motley Fool. Tuesday, Aug. 4, 2026, at 4:30 p.m. ET Senior Vice President, Investor Relations and Corporate Development - Albert Kildani Chief Executive Officer - Catherine Owen Adams Chief Commercial Officer - Thomas Garner Executive Vice President, Head of Research and Development - Elizabeth Thompson Chief Financial Officer - Mark Schneyer Need a quote from a Motley Fool analyst? Email [email protected] Operator: Ladies and gentlemen, thank you for standing by. My name is Abby, and I will be your conference operator today. At this time, I would like to welcome everyone to ACADIA Pharmaceuticals Second Quarter 2026 Earnings Conference Call. [Operator Instructions] And I would now like to turn the conference over to Albert Kildani, Senior Vice President, Investor Relations and Corporate Development. Please go ahead. Albert Kildani: Good afternoon, and thank you for joining us on today's call to discuss ACADIA's second quarter 2026 financial results. Joining me on the call today from ACADIA are Catherine Owen Adams, our Chief Executive Officer, who will provide some opening remarks; followed by Tom 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 Schneyer, our Chief Financial Officer, who will review the financial highlights. Catherine will then provide some closing remarks before we open up the call for your questions. We are using supplemental slides, which are available on our website in 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 financial measures pertain only to NUPLAZID sales in 2025 and their impact on total revenues. All references to non-GAAP 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's website. Before proceeding, I'd 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, including 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'll now turn the call over to Catherine for opening remarks. Catherine Owen Adams: Thank you, Al. Good afternoon, everyone, and thank you for joining us today. I'm pleased to report that ACADIA delivered an outstanding second quarter, demonstrating strong commercial execution across both DAYBUE and NUPLAZID. We also continue to make important progress across our pipeline, led by remlifanserin in Alzheimer's disease psychosis. Let me start with our financial performance. We achieved total revenues of $308 million in the second quarter, representing 17% year-over-year growth on an adjusted basis. This performance reflects strong execution and continued demand for DAYBUE and NUPLAZID. Turning to DAYBUE. The brand delivered net sales of $125 million in the second quarter, representing 30% year-over-year growth. This strong performance was driven by meaningful uptake of DAYBUE STIX, our recently launched powder for oral solution, which is resonating with patients and caregivers in the U.S. The strong early adoption of DAYBUE STIX reinforces our confidence in this differentiated delivery option and supports the brand's continued growth trajectory. Based on these strong results, we are raising our 2026 guidance range for DAYBUE to $480 million to $510 million. I'm also delighted that we recently received a positive opinion from the CHMP following a re-examination process. This outcome represents a significant win for patients with Rett syndrome across Europe and reaffirms the value of DAYBUE as a foundational therapy. We're grateful to the CHMP for its thorough review and pleased to be moving closer to the opportunity to bring this therapy to patients in Europe. This positive opinion, along with strong DAYBUE STIX performance, reinforces our confidence to achieve our ambition of $700 million in DAYBUE sales in 2028. For NUPLAZID, the brand delivered net sales of $183 million in the second quarter, up 10% year-over-year on an adjusted basis. The underlying business remains strong, supported by continued demand growth, disciplined execution and impact from our expanded field force. We remain confident in our path to deliver approximately $1 billion in NUPLAZID net sales in 2028. Looking ahead, our most important near-term pipeline milestone is the upcoming Phase II readout for remlifanserin in Alzheimer's disease psychosis. We now expect to report top line results from this study in September to October of this year. If successful, remlifanserin has the potential to be transformational for ACADIA with peak sales potential of estimated $4 billion across Alzheimer's disease psychosis and Lewy body dementia psychosis. With that overview, let me now turn the call over to Tom to provide more detail on our commercial performance. Thomas Garner: Thank you, Catherine, and good afternoon, everyone. I'm excited to report another strong quarter for DAYBUE, which generated $125 million in net sales in the second quarter, representing 30% year-over-year growth, driven almost entirely by volume. Performance was led by continued strength in the U.S. business with additional contributions from our named patient supply programs. DAYBUE continues to strengthen its position as the foundational standard of care for Rett syndrome, and our second quarter results reflect what we believe to be the growing confidence that physicians, patients and caregivers have in the therapy. Demand trends accelerated during the quarter as we expanded the launch of DAYBUE STIX beyond center of excellence, which is engaging new patients and bringing previously discontinued patients back to therapy. Importantly, the number of patients returning to DAYBUE reached a record level during the second quarter. Of note, approximately 40% of all U.S. DAYBUE patients were receiving STIX by the end of the quarter. This rapid uptake highlights the significant value STIX is providing to patients and caregivers and reinforces its role as an important growth driver for the DAYBUE franchise. Turning to DAYBUE outside the United States. We achieved a major regulatory milestone late in the quarter with the receipt of positive CHMP opinion for the treatment of Rett syndrome, and we have already begun preparations for commercialization in the European Union following expected approval of DAYBUE by the European Commission. We've assembled a highly experienced team and remain on track to launch in Germany in early Q4. In parallel, we expect to submit pricing and market access submissions in our planned launch markets this year, positioning us for broader expansion across Europe as we work to secure reimbursement approvals. In addition, our named patient supply programs are expected to remain a meaningful contributor to growth through 2026, driven by increasing awareness of DAYBUE globally. Taken together, these trends reinforce our confidence in DAYBUE's increased guidance. And with that, let me turn to NUPLAZID. NUPLAZID delivered another strong quarter, generating $183 million in net sales, representing 10% year-over-year growth on an adjusted basis, driven primarily by volume. We were particularly encouraged by the continued momentum in new patient prescriptions, which have increased 20% year-over-year, representing the highest quarterly volume since the first quarter of 2018. Turning to our expanded field force. Execution remains on track, and we are beginning to see the early benefits of that investment emerge, consistent with the 6- to 9-month ramp period we anticipated. Since expanding the team, we have seen a significant increase in call activity and improve the depth and frequency of engagement with our highest priority customer segments. As a result, we have now reached over 12,000 priority health care providers since February, significantly expanding our presence across the clinicians who care for patients living with Parkinson's disease psychosis. Our direct-to-consumer investments continue to be a meaningful driver of awareness, patient identification and activation. During Parkinson's awareness month in April, our NUPLAZID branded campaign, Mind Your Mind and the refreshed More to Parkinson's initiative delivered record audience reach and generated strong engagement across digital and social channels. More importantly, these efforts are translating into action as reflected in substantial sequential increases in both branded and unbranded patient conversion, reinforcing our ability to connect patients and caregivers with information about Parkinson's disease psychosis and the treatment options available to them. As we pair these awareness building efforts with our expanded field force, we are increasing both physician and patient recognition of NUPLAZID and further strengthening the foundation for sustainable growth. The leading indicators we are seeing across the market, including growing disease awareness, increased patient engagement and rising new prescriptions gives us confidence in the near- and long-term trajectory for NUPLAZID. And with that, I'll turn the call over to Liz. Elizabeth Thompson: Thank you, Tom, and good afternoon, everyone. Today, I'll provide a few brief updates across our clinical stage programs. Let me start with remlifanserin, which, as Catherine said, represents a potentially transformational opportunity for ACADIA. We recently announced several updates to this program. First and foremost, we have recently completed enrollment in the Phase II portion of our Alzheimer's disease psychosis program. And with this, we've tightened our range for top-line results, which we now expect to report in September to October. At the same time, we announced receipt of Fast Track designation from the FDA. This designation underscores the substantial unmet need in Alzheimer's disease psychosis, and we believe remlifanserin has the potential to become an important treatment option for patients and caregivers. Now that Phase II enrollment is complete, consistent with our operationally seamless Phase II, Phase III program design, we have commenced screening and enrollment in the Phase III studies. Beyond remlifanserin in Alzheimer's disease psychosis, our pipeline is robust and active with multiple studies underway today and several additional trial starts and data readouts expected over the next 18 months. Starting with the programs currently underway. First is our Phase III study of trofinetide ongoing in Japan. We continue to expect a readout between September and November. We're planning a regulatory submission in 2027, and we'll share more details about our potential filing strategy after we've selected our commercialization partner for the Japanese market. Now for other clinical programs. For remlifanserin, we also have a Phase II study underway in Lewy body dementia psychosis. And as mentioned, the 2 Phase III studies in Alzheimer's disease psychosis are now open for enrollment. We're also advancing ACP-211 in a Phase II study in major depressive disorder and ACP-711 and ACP-271 are progressing through their respective Phase I programs. Beyond this, by the end of 2027, we expect to have initiated 3 additional Phase II or Phase III studies. We also expect 4 Phase II or Phase III readouts over that same period. Of those, the readouts we have disclosed include the upcoming Phase II RADIANT results in Alzheimer's disease psychosis and trofinetide in Japan as well as ACP-211 in major depressive disorder. Together, this cadence of trial starts and readouts represents potential meaningful momentum across our pipeline. One final note before I hand over to Mark. We were very pleased to have achieved a positive CHMP opinion in the EU for trofinetide following the reexamination process. This represents a significant win for patients with Rett syndrome across the EU and brings us one step closer to making this foundational therapy available to patients in Europe. We anticipate a final decision from the European Commission later in Q3, and I'd like to thank the dedicated Acadian who worked so hard to achieve this outcome. In summary, our R&D organization is executing at a high level across multiple programs, positioning us to deliver important milestones that have the potential to create value for both patients and shareholders over the long term. And with that, I'll turn the call over to Mark to review our financial results. Mark Schneyer: Thank you, Liz, and good afternoon, everyone. I'm pleased to report strong financial results for the second quarter of 2026 that reflect the robust commercial execution Tom and Catherine described earlier. Total revenues for the second quarter were $308 million, representing 17% year-over-year growth on an adjusted basis. DAYBUE delivered net sales of $125 million in the second quarter, up 30% year-over-year, of which 27% came from volume. This exceptional volume growth was primarily driven by the strong uptake of the newly launched DAYBUE STIX formulation in the U.S. The gross to net adjustment for DAYBUE was 24.4% in the quarter. NUPLAZID generated net sales of $183 million in the second quarter, up 10% compared to the same period last year on an adjusted basis, driven by 8% volume growth, reflecting strong underlying demand for this important therapy. Our gross to net adjustment for NUPLAZID in the quarter was 23.9%. Turning to operating expenses. Our investments continue to be focused on advancing our pipeline and supporting our commercial growth. Research and development expenses for the quarter were $82 million compared to $78 million a year ago. SG&A expenses were $160 million for the quarter compared to $134 million a year ago. This increase reflects our investments to expand both the NUPLAZID and DAYBUE field forces and increased marketing investments supporting both brands. We ended the quarter with a cash position of $956 million. This healthy cash balance provides us with the financial flexibility to execute on our commercial plans, advance our pipeline and pursue business development opportunities that align with our strategic objectives. Turning to our full year 2026 guidance. We're raising our DAYBUE net sales outlook to $480 million to $510 million, up from $460 million to $490 million. This outlook reflects our strong performance in the first half of the year and includes all forms of trofinetide available globally, including our expectation for initial EU commercial sales in Q4. Our NUPLAZID net sales guidance remains unchanged at $760 million to $790 million. Taken together, we now expect total 2026 revenue of $1.24 billion to $1.3 billion. As we look to the rest of the year, let me provide a bit more color on expectation for each brand. For DAYBUE, we expect similar year-over-year growth rates for Q3 and Q4. And for NUPLAZID, we expect stronger year-over-year growth in Q4 relative to Q3 due to the greater impact of the expanded field force expected later in the year. Also for DAYBUE, we are slightly increasing the guidance range for gross to net to 23% to 25%. Lastly, on guidance, we are lowering our spend guidance for R&D and now expect R&D expenses in the range of $355 million to $380 million compared to the prior guidance range of $385 million to $410 million. The reduction to R&D guidance is primarily attributable to the shifting of a BD milestone to 2027 and selected portfolio prioritization decisions. All other guidance ranges for fiscal year 2026 are unchanged. With that financial overview, I'll turn the call back to Catherine for closing remarks. Catherine Owen Adams: Thank you, Mark. As we close, I want to reinforce why ACADIA is positioned for its next phase of growth, anchored by proven commercial execution, a transformational near-term pipeline opportunity and multiple value-driving milestones ahead. Turning first to commercial execution. Performance remains strong across both brands. We delivered an excellent second quarter led by DAYBUE. These results have led us to raise our DAYBUE guidance. Looking ahead, the upcoming European Commission decision represents another meaningful opportunity as we prepare to bring this foundational therapy to patients, beginning with our planned launch in Germany in the fourth quarter. NUPLAZID also continues to perform well, and we are beginning to see the benefits of our expanded field force as the team ramps and reaches more health care practitioners across specialties. Building on our commercial momentum, remlifanserin remains our most important near-term pipeline catalyst with Phase II data in Alzheimer's disease psychosis expected in the September to October time frame. Beyond remlifanserin, we're advancing ACP-211 and our broader pipeline with additional catalysts ahead, including top line Phase III trofinetide data from Japan later this year. Finally, we remain guided by our mission to turn scientific promise into meaningful innovation for underserved communities. Our second quarter performance and the milestones ahead reflect the progress we are making and reinforce our confidence in ACADIA's next phase of growth. Thank you all for your continued support of ACADIA. And with that, we're happy to take your questions. Operator? Operator: [Operator Instructions] And our first question comes from the line of Tess Romero with JPMorgan. Tessa Romero: So Liz, actually a question for you. Thinking through the outcome of the Phase II RADIANT trial, how should we think about scenarios around effect size here around your primary endpoint of the SAPS-H+D? And how should we think about the lower bounds of what could still have a path forward into Phase III? Or put another way, how much room do you think you have in your data to be able to execute on a Phase III plan that is derisked enough in ADP? Elizabeth Thompson: It's a great question, Tess, and obviously, one we've been giving a great deal of thought to of what would be really Phase III enabling data. And so I'll make a few comments there. First off, as I'm sure everyone on this call knows by now, we are 80% powered for a moderate effect size, 0.4 effect size on our SAPS-H+D. There is probably a little bit of flexibility around that in terms of what would still be a supportable and Phase III progressable asset. There is a lower level beyond which you start worrying about whether you'd be able to replicate the effect. But I think we've got a ways there. In general, we're going to be looking certainly at the impact on SAPS-H+D, but that's not going to be the only thing we're going to look for at an effect size perspective. We're going to look at responder analyses on SAPS-H+D. There are a number of other endpoints that we're considering as well. But broadly speaking, we're looking to see that we've got something that we think continues to align with what we think would be a meaningful drug in this space. And that's something that's going to be easy for patients to take, something they can take once a day with or without food, something that has evidence of efficacy, a supportive safety profile and some of the stuff we won't definitively answer in Phase II, of course. But we are going to want to feel good about the fact that we don't have negative cognitive impact or negative impact on motor, things like that. So there's a number of different considerations we're going to be looking at, but that hopefully gives you a little bit of a flavor for the thinking. Operator: Our next question comes from the line of Ritu Baral with TD Cowen. Ritu Baral: Two questions. One is actually a follow-up to Tess's and specifically, Liz, around the CGI-S. We had previously talked about how you intended to anchor the SAPS-H+D to the CGI-S. Can you talk to like what the NCID for CGI-S is and if you're going to release that data and if there's going to be sort of a correlative analysis with the top line data to the -- with your data announcement? And second, could you speak a little more to some of the presentations that I saw -- that our team saw at IRSF around from the Delphi consensus. They talked a fair bit about improved tolerability, I believe it's an independent group, but improved tolerability with STIX and improved DAYBUE tolerability with new titration regimens and how what they presented at IRSF is making an impact on DAYBUE commercially? Catherine Owen Adams: So I'll take a shot at the first part, certainly, and then probably we'll do some tag teaming on the second. So with respect to some of the CGI-S and how we may use that, first and foremost, this is our key secondary endpoint. I will say, I guess we should start with level setting with expectations around what's actually going to be put out at the time that we do our initial press release. I think it's probably to think in terms of what's going to be there for sure is going to be our primary efficacy endpoint and a comment on safety. Additional information, we're going to determine whether that is necessary and helpful at that time and some things we will certainly wait for future medical meetings. I would not anticipate that you're going to see any kind of correlation analyses between CGI-S and SAPS-H+D. I think when I referred to the anchoring before, what I was talking about is in the context of an eventual dossier to support the applicability of an endpoint for regulatory purposes, we do anticipate we would need to have a full dossier explaining the behavior of the instrument, the appropriateness of it, et cetera. And so that is one path that we could take to help support that is through an anchoring with the CGI-S. Generally speaking, it is considered that a change on CGI-S or CGI-I that those in and of themselves are clinically meaningful. And so that's helpful as you're trying to define meaningful change on another instrument. I think that covered everything around the CGI-S. With respect to some of the presentations at IRSF, taking the tolerability or the tolerability with titration piece first. What I will say is some of the information that we have from Lotus has suggested over time that there -- in patients who titrate that you certainly don't see onset of diarrhea with the same kind of rate. And so that can give an opportunity for patients and families to kind of get accustomed to the drug in context of many other tools that are in the toolbox, things that physicians are -- that we have encouraged physicians to make more use of is use of fiber, adequate water intake, making sure that they are discontinuing the antidiarrheals, et cetera. So there are a number of different tools that can help from a tolerability perspective. And I guess, Tom, I'll let you comment on how that is impacting physician use. Thomas Garner: Sure. So just a couple of things I would say. So first off, in terms of the Delphi consensus research that you mentioned, and yes, we did present a number of papers at IRSF. As a reminder, the Delphi consensus was actually conducted prior to the launch of STIX. So all of the information that you were seeing there relates to the oral solution. As it relates to STIX and the other experience that we're seeing, what we would say is -- at the moment, it seems to be on par with what we've seen historically with oral solution in terms of tolerability. Obviously, we're learning more as we go, this has only been the first full quarter where it's been in the hands of patients and caregivers beyond COEs. But what I would say is we've been very, very encouraged by the early start that we've made with STIX and have been pleased with the momentum that we're seeing across both COEs and non-COEs as we've moved into the community. Operator: And our next question comes from the line of Ash Verma with UBS. Ashwani Verma: I've got 2 on ADP as well. Maybe just on the Phase II, the effect size that you're shooting for the 0.4 that you mentioned about the powering. Just help us understand like the prior Study 19 pimavanserin data had shown a 0.2 that was using a different NPI scale, but in RADIANT, you are using SAPS-H+D. So, is that effectively comparable and not the effect size is? And then secondly, I saw that you've started the Phase III screening and enrolling the patients already, but we are waiting the data from Phase II. So if you are having to dose patients in the Phase III before we get the Phase II data, which dose would you be inclined to? Elizabeth Thompson: I'll just keep going. Okay. So with ADP, so just to ground a little bit in the pimavanserin data. So Study 19 was the Phase II study of pimavanserin in ADP. It was, as you rightly note, using a different endpoint. There are other differences from a population perspective. In our current study, we are, of course, requiring biomarker confirmation. But I will say on balance, we expect that most patients who were in the 019 study probably would have been biomarker positive as they were fairly advanced in their disease course, but we don't actually have biomarkers to be able to confirm that. And then probably another important thing to keep in mind is One of the things that we have seen in the data set is that there does appear to be a more significant impact in patients with greater baseline psychosis. And so, in the RADIANT trial, we are looking to move that patient population on balance to a somewhat more severe psychosis population than was in Study 019. And so with that context, yes, the Phase II of pimavanserin did have an effect size of about 0.32. We did power for remlifanserin for 0.4 for a couple of reasons. One, of course, is the endpoint where we've changed to something that we think is more sensitive to change, but also the fact that we have enriched for that more severe psychosis population, which if you look in Study 19, actually, if you look at the more severe psychosis population, your effect size goes up to more like 0.6. So we think that 0.4 is a defensible and appropriate powering assumption. And we think that if we meet that or in that vicinity, what we have is an agent that potentially could be meaningful for patients. And then I think the second piece was about Phase III. So yes, the design of our study is operationally seamless. And so what that does mean is that once enrollment completed in the Phase II portion, which we did announce recently, sites we're able to start screening and then enrolling for the Phase III portion. Right now, our Phase IIIs are designed very similarly to the Phase II study. The fact that these are statistically separate does mean we have the opportunity to analyze those data, which we are going to do in the September to October time frame and share those data, but also make modifications to the Phase III as needed. Right now, we are enrolling for both dosing arms, so there would be placebo, 30 and 60. There is a possible future where one of those dosing arms doesn't need to be taken care or need to be taken forward. But for now, we are continuing on with that. Operator: And our next question comes from the line of Marc Goodman with Leerink Partners. Marc Goodman: Yes. So now that it looks like DAYBUE Europe is going to happen, can you help quantify that opportunity for us? And you mentioned Germany in the fourth quarter. What other countries are you expecting to launch? And just give us a sense of how fast you think that ramp can be. Thomas Garner: Sure. I'll take that one, Marc. So thanks for the question. So I mean, first off, it goes without saying that we are very pleased that we've been able to turn around a negative opinion into a positive outcome for patients in Europe. And as I mentioned in the preparatory remarks, the team are geared up and ready to go. So we anticipate EC decision by the end of Q3, as Liz mentioned, and the team is going to be pretty quickly ready to go thereafter. Germany will be the launch market as we get out of the gates and you would then follow the normal cadence that you'd expect to see in terms of other early launch markets in the EU, which tends to be kind of Nordics and then others that we're working through Austria tends to be pretty quickly after Germany at the same time. In terms of the commercial opportunity, I mean, I go back to what we shared previously, which is as you look at the $700 million guidance for 2028, we estimate somewhere less than 15% of that number to come from Europe. So as you think about kind of cadence of the launch, it will be somewhat gradual through the end of Q4 as the patients who are receiving free drug today in Germany transition to paid treatment, and then you'll see it consistently come online through next year. So more information to come, but we are excited by the opportunity. I think as you think about the 3 pillars of growth for DAYBUE into the future, international expansion in Europe is certainly one, and we're really looking forward to pulling that through. Catherine Owen Adams: And just to sort of put a name on that, Marc, as you know, it takes years for countries to come online in Europe. So we will continue to follow the path that Tom laid out. But also in the meantime, where we can supply physician demand through our named patient programs, we will be honoring that as well. So both of those things will be happening depending on the country and what's going on and what the legal system allows. So just to continue that. Operator: Our next question comes from the line of Tazeen Ahmad with Bank of America. Tazeen Ahmad: To clarify, do you expect the discontinuation rate to change with the STIX formulations? And then secondly, on pricing in Europe for DAYBUE, on average, what percent discount do you think you'll have to take in the major European countries over time? Catherine Owen Adams: Thanks, Tazeen. I'll let Tom talk about STIX and the discontinuation rate. Thomas Garner: Sure. So I think as we've been monitoring kind of the STIX performance out of the gate, to date, as I mentioned earlier on, from the early data that we're seeing, it seems to be performing fairly similarly to what we have seen with the oral solution historically. Obviously, what's been very different, though, with the STIX launch is that we are now able to reengage patients who had previously discontinued the oral solution now that we have the new therapy. And it's clear that patients and caregivers, caregivers in particular, are willing to come back to DAYBUE given the efficacy that the brand offers. So we're continuing to monitor closely. What I would say overall, as you think about discontinuation rates, although we don't talk about them publicly as much as we did before, is they are largely in line with what we've shared in prior quarters. They remain under double digits, it remains very, very consistent. And as we see more patients move to the STIX therapy, and we're seeing that happen, that adoption happen somewhat quicker than we anticipated, we'll be sharing additional information on that. Catherine Owen Adams: In terms of pricing in Europe, I think for now, we're not guiding or giving any indication to prices in Europe. We will keep you updated as we move through those discussions with the individual national reimbursement authorities starting with Germany. And as you know, free pricing in Germany is for the first 6 months. And after that, we'll start our negotiation. So it won't be until the middle of next year that we start talking about that. Operator: And our next question comes from the line of Yigal Nochomovitz with Citigroup. Yigal Nochomovitz: Actually, just one more on pricing. You just mentioned the free pricing for the first 6 months. After that, what happens? Is there an accrual period where you estimate the expected negotiated price? And then once you get that price, then you move to the set price. And then with regard, again, back to the ADP readout, I'm wondering if you could just speak to the statistical test. I know I think for the prior study for pimavanserin in ADP, it was a T-test and -- but there was also in the PDP trial used MMRM. I'm just wondering if you could speak to those details. Catherine Owen Adams: I'll get Tom to talk about the discussion and Liz can move on. Thomas Garner: Yes. So thanks for the question, Yigal. So vis-a-vis Germany, we will be -- as soon as we have the approval, obviously, we'll be launching in Germany, as we said. During that free pricing period, essentially per the legislation that exists in Germany, we have the ability to price as we wish. At the same point, we will be working with AMNOG directly because we'll have submitted our pricing reimbursement dossier and that actually begins the process of negotiating what the price then becomes post that 6-month repricing period, at which point that becomes the price that's recognized on a GTM basis. So essentially for that first 6 months, we recognize the revenue at full price, whatever it may be set at. And then post that 6-month moratorium, that's when we start recognizing a different price from the publicly available price. SO, we will see. Elizabeth Thompson: We haven't talked a lot about the statistical considerations in terms of the Phase II study. But what I can say is that it is an MMRM analysis, and we are controlling for multiplicity as you would anticipate with a prespecified hierarchy. Operator: And our next question comes from the line of Malcolm Hoffman with BMO Capital Markets. Malcolm Hoffman: Congrats on the quarter. I was wondering if you could provide any color on whether you have seen a normalization of typical refill rates for NUPLAZID. I know you had mentioned new patient starts are really strong, but I just wanted to get a sense whether the scripts are back on track. And then for remlifanserin, can you comment on whether you have had to correct for any rate or drift throughout the study? I know maintaining the consistency of the rating throughout the trials is pretty critical here. Catherine Owen Adams: I'll let Tom start on NUPLAZID. Thomas Garner: Sure. So yes, NUPLAZID referral and restart rates are exactly where we expected them to be. In fact, if we look at Q2 of '26 versus Q2 of '25 in historical years, that's actually been a particularly good rebound versus prior year. So, I think the phenomenon that we saw in Q1 of this year clearly does seem to have been a one-off. Obviously, we'll be monitoring very closely as we end 2026. But everything as it relates to demand and pull-through and patients returning is exactly where we anticipated it to be. Elizabeth Thompson: And as far as commenting on rater evaluation, potential for rater drift, et cetera, we have tried to be mindful of that. We have a rigorous process back in the day for our site and our rater selection, including proven experience in these kinds of trials and psychosis assessments, have extensive training calibration exercises and standardized scoring protocols. But probably most relevant to your question, we are on an ongoing basis, looking at blinded data and having sort of booster training of raters based on review of blinded data on an as-needed basis. Operator: Our next question comes from the line of Sean Laaman with Morgan Stanley. Sean Laaman: On DAYBUE STIX, so clearly an acceleration there. But can you quantify how much of the recent demand reflects entirely new patients versus improved compliance, persistence or conversion from the oral formulation? And where do you estimate the current treated patient population penetration stands in the U.S.? And how much untreated or underdiagnosed opportunity remains? Thomas Garner: Sean, it's Tom. So, thank you for the question. So let me just provide a little more color on kind of the dynamics that we saw in the quarter. So, if you look at kind of our overall mix in the quarter, both across STIX and the oral solution, around 60% of our referrals were coming from naive patients 40% were returning patients. And as we think about, again, future growth potential for the brand, obviously, naive will remain a focus. I think with STIX, we now have this additional opportunity to engage patients who have previously just discontinued. When we look at STIX in isolation, it's interesting there that we saw 55% of our existing patients on were switching from oral solution, 45% were either new or returning. So, kind of that gives you a little more flavor. We've also been particularly encouraged by just the momentum that we've seen through the quarter. So if we take June in isolation and we look across the entire business, 60% of all of our referrals in June alone for the STIX formulation. So I think that, that gives you a very clear direction of travel as we think about just the uptake of STIX the positive reaction that we've seen from both the clinical community and the patient community. We had a very strong IRSF meeting. And I think the momentum that we're building gives us a real sense of confidence that we can finish this year strong and really build further as we think about 2027. Catherine Owen Adams: Next question. Operator: And our next question comes from the line of Brian Abrahams with RBC Capital Markets. Nevin Varghese: This is Nevin on for Brian. So maybe just one on the DAYBUE opportunity in Japan. Can you remind us maybe what the Phase III trial design is there and what efficacy endpoints those regulators might require? And then just what the addressable Rett syndrome population is in Japan? Catherine Owen Adams: We'll start with the addressable and then we'll move to Liz just to give her an opportunity to take a breath. So Japan, we're looking to commercialize after we get our registrational study completed, which Liz can give you details on. The epidemiology of Rett around the world is similar. It's 1 in 10,000 to 1 in 15,000 live female births. We believe there's around 1,000 patients in Japan who have Rett syndrome, various different sources give slightly different numbers, but it's around that. And we're looking forward to our Phase III trial, which Liz can give you a little bit of a description. Elizabeth Thompson: It is a bit atypical as Phase IIIs go. I think it's important to think of this in the context of through discussions with PMDA. The primary support for an eventual indication should we get there, is going to be our LAVENDER data. The Phase III study that we're running in Japan is primarily to give some experience in Japanese patients. It is a very small trial, I think on the order of 20-ish patients. There is a placebo control, but obviously, it is in a very small number, again. We're looking at week 12 endpoints. We are looking at the same kinds of endpoints that we looked at in the trofinetide global program. Here, though, it is CGI-I as the primary with RSBQ as a key secondary endpoint. But again, the intent here is more to get experience in the Japanese population. There's no expectation that we would be able to hit a p-value, for example, with this kind of trial. So that's -- it will give us some sense of how the drug behaves there, and we think will be hopefully supportive for what is primarily going to be a LAVENDER-based package. Operator: And our next question comes from the line of Sumant Kulkarni with Canaccord Genuity. Sumant Kulkarni: I have 2, one on remlifanserin and one on peak sales potential. So it looks like Bristol's enrollment for ADEPT for ADP is going somewhat slower than that company initially expected. So given your experience with the ongoing ADP trial, do you think that space is something specific to their program? Or does it have wider implications for other ADP programs, including yours? Elizabeth Thompson: Probably should be careful on how much I'm speculating on somebody else's program. But I guess what I'd comment on there is essentially we took a while in enrollment because we were looking to make sure we were enrolling the right patient population. And so I think that anybody who is considering trials in this space should be thoughtful about how they are enrolling their patient population and ensuring that they have the patients enrolled that they're looking to. And so one of our versions there, of course, is the biomarker confirmation. But overall, we are being careful in that. Sumant Kulkarni: Got it. And given where you are today with your solid performance on NUPLAZID and you have now European approval for DAYBUE, do you have anything to add relative to your earlier $1.7 billion in peak global net sales in 2028 for those products? Catherine Owen Adams: I think we're talking about our confidence now of hitting those numbers as we move through the end of this year and we look at the continued uptake of STIX and we see how NUPLAZID ends the year, we will revisit that at that time. But for right now, both for the $1 billion on NUPLAZID and the $700 million on DAYBUE, we are confident that we will achieve those numbers during 2028. Operator: And our next question comes from the line of Rudy Li with Wolfe Research. Guofang Li: Congrats on a strong quarter for DAYBUE. Maybe just a quick follow-up to the patient dynamic for the STIX formulation. Can you maybe talk about the trend moving into July and August across different patient segments? And another question is based on your recent market research and physician feedback. How should we think about the market dynamic for Rett syndrome with potential gene therapies in the coming years? Catherine Owen Adams: Yes. I'm going to ask Tom to talk about July and August and then talk about our view on gene therapy. Thomas Garner: Yes. So a few things that I would say, and thanks for the question is as you look at kind of the momentum that we saw during Q2, and as I mentioned, 60% of our prescriptions at the end of June, we're already for STIX. And we are really now beginning to focus our team's efforts beyond the COEs as we think about pushing STIX more broadly. We feel pretty confident that the momentum that we saw during Q2 is going to continue into Q3. Early signs are indicating that way in addition to all of the additional programs that we have outside of the U.S. for inbound request name patient sales as well. So I think as you take that together, this gives us confidence in the guidance that we shared. Obviously, we have lifted both the bottom and the top as we think about the end of this year, and we feel good about where we're situated as we think about the remaining 5 months of 2026. Catherine Owen Adams: And in terms of gene therapy, just as a top line, we don't see any impact to our commercial forecast either in the short or long term with the potential introduction of a gene therapy, while we welcome any new option for patients with Rett syndrome. We believe that DAYBUE will remain the standard of care for patients with Rett syndrome, both in the U.S. and globally. Tom, I don't know if you want to talk any more about that. Thomas Garner: Yes. I mean I think, obviously, we're watching with a keen interest these first-generation gene therapies. I think there's optimism amongst certain patient types and certain members of the treating community. But again, we believe in the foundational standard of care that DAYBUE offers. Obviously, it can be used either pre or post gene therapy. And we think that, that inherent flexibility and the fact that you can use DAYBUE is completely reversible. We know the profile of the treatment very closely that DAYBUE will remain an important treatment for Rett syndrome moving forward. And I think the advent of DAYBUE STIX actually just makes us even more confident in that. Catherine Owen Adams: Next question. Operator: Our next question comes from the line of David Hoang with Deutsche Bank. David Hoang: Congrats on the quarter. I want to ask about the development of remlifanserin in ADP versus Lewy body. Is there any reason to think the probability of success would be different between those 2 indications? And then on the commercial side, I know you've talked about the $4 billion peak sales number there for remlifanserin across indications. Directionally, how should we think about how that might break out between ADP and Lewy body? Catherine Owen Adams: All right. I'll let Liz start on that one. I'll come up behind. Elizabeth Thompson: I was so busy writing things down. I may have missed the second part of the question. So broadly speaking, we are enthused about both the possibility in Alzheimer's as well as in Lewy body. These are both areas with tremendous unmet need and really nothing available for these patients. In broad terms, I don't think we see the probability as wildly different across the 2. We have more data in Alzheimer's with pimavanserin certainly, but the data that we do have in Lewy body, though in a smaller number of patients is pretty striking in its magnitude. So we're looking forward to the first readout coming in September to October. And while we haven't disclosed the Lewy body readout, we are looking forward to that in the future as well. Catherine Owen Adams: I think in terms of the commercial opportunity we've described before and so many others, the size of these markets, which are both considerable in the U.S. and beyond. I think in terms of how we see the $4 billion split out I would say it's roughly 60% ADP, 40% Lewy body. Obviously, that highly depends on the data, the competitive frame and who else is also on the market at the same time. So I would say we're sort of roughly around 60-40, but that will evolve as we get there. And let's cross the data threshold first. And with that, we'll take the next question. Operator: And our next question comes from the line of Jack Allen with Baird. Unknown Analyst: This is Chris on for Jack. Just turning back to DAYBUE. Regarding the STIX uptake, I heard you just mentioned that 45% of STIX users were either new or returning. Can you provide what percentage of that 45% were new -- and then are you seeing higher rates of uptake in a certain patient demographic age, for example? And if so, do you see that changing over time? Thomas Garner: Yes. So as you think about kind of the 45% that I mentioned, so if you kind of zoom in on STIX, it's roughly 60% were new, 40% were returning that we saw in the quarter. Again, as we go further into community, we anticipate that those dynamics may shift. I mean it's notable that we actually saw a very significant shift in Q2 to community prescriptions versus what we saw in Q1, which you'd expect because obviously, that's when we were actually talking to STIX more broadly beyond just the center of excellence. In terms of returning patients, I mean, we are seeing a very diverse mix. One of the things that has been different to what we had assumed before we launched is that it would primarily be patients who have discontinued due to formulation concerns that we return to the brand. We're actually seeing that a far broader group of patients are willing to return, which, again, I think just talks to the community's interest in trying DAYBUE again based upon the efficacy that they know that patients can see with this treatment. And I think the new formulation will potentially give us an avenue to unlock that opportunity further. Operator: And our next question comes from the line of Ananda Ghosh with H.C. Wainwright. Ananda Ghosh: Congrats on the quarter. I have 2 questions on ADP. The first one is where do enroll patients of RADIANT compared to prior trials, as mentioned, like the Ballard et al paper? And what instrument was chosen on that criteria? The second follow-up question is, we noted that Study 19 was using NPI-NH, both for screening as well as on the endpoint determination. But the RADIANT, I think the screening tool is different than the endpoint. And what's the rationale behind that? Catherine Owen Adams: So Anand, the first part of your question was a little bit unclear. So maybe we'll get to start the Study 19 response and then you can reask it so that we can answer the right question. Elizabeth Thompson: Sure. So what I'll say is on the screening criteria that we used -- well, let me phrase this carefully. So when we are considering patients that we're including in the analysis, we're taking into account both the NPI-NH values as well as the SAPS-H+D values in terms of who qualifies for the primary analysis. So we are actually including a component of the endpoint as well as another criterion. And again, the goal here is to sort of edge up that overall population level psychosis severity because we do think that slightly more severe patient population does seem to have a greater effect size that's shown. Catherine Owen Adams: The first part of the question was around enrolled patients, but perhaps you could just ask it again so we can understand it properly. Ananda Ghosh: Yes. No, that was helpful. So I think this answers a part of that question. My question was, given that one of the ideas from the Study 19 was that you need to have much more severe patients. So given the baseline of RADIANT, where do they sit with respect to the overall Study 19 population? That was the question. Elizabeth Thompson: So we're not, at this point, disclosing what baseline characteristics of the population look like. So what I can say is we did have enrollment criteria that should be consistent with edging up that overall population level of severity, but we're not currently disclosing what the actual baseline values are. Operator: And our next question comes from the line of Uy Ear with Mizuho. Uy Ear: Congrats on the quarter. Just going back to the RADIANT study. I was wondering if you can provide a little more color in terms of the number of patients enrolled and whether all the patients have been dosed? And what are the gating factors, I guess, to getting the data in September versus October? And my second question is, are you able to share for which program the milestone payment in R&D was shifted to 2027? Elizabeth Thompson: Sure. So again, hopefully, I got all my notes down here. In terms of complete enrollment in the RADIANT program, in particular, in the Phase II portion of it, that was 363 patients that were enrolled. The main gating factor between September and October is going to be the 30-day safety follow-up if patients don't roll over. The study is still -- it is still ongoing. Everybody has gotten past randomization, but there are still patients on study. So I cannot answer today whether all patients are going to go into the open-label extension or whether we may need that 30-day follow-up, which would move us out later. In terms of the milestone question, so sorry. So as we have been -- as we've been progressing 711 forward, one of the things that we've been pleased actually is from both a -- from a nonclinical perspective, we found that we both have the ability from a tox perspective and also the potential benefit of higher dosing. And so accordingly, we added in some additional higher dosing that we're going to be exploring in Phase I before we go into Phase II. That did shift out our timing a little bit such that the milestone is not going to hit this year. I do look forward to updating more with some specifics around time lines and study impact as we get through that Phase I dosing, but we wanted to reflect reality of when we thought milestone would hit. Operator: And our next question comes from the line of Paul Matteis with Stifel. Julian Hung: This is Julian on for Paul. In thinking about DAYBUE STIX with the reversal of the CHMP opinion, you sort of set this like 15% threshold for contribution. Just thinking about like the peak opportunity, I guess, is that a reasonable sort of like benchmark? Or do you have any analogs that you can point to in the rare disease space that can sort of set expectations to what contribution ex U.S. that DAYBUE could potentially have to your franchise? And then one quick question also on remlifanserin. There have been some studies published out there that -- from independent authors that suggest that pimavanserin at approved doses can get to 90% receptor occupancy after only a couple of weeks of dosing. I guess just with the improvements to your molecule, what do you think is -- is it fair to expect that it's going to be driving greater efficacy due to receptor occupancy? Or is it going to be elucidating an effect due to the improvements you made to the clinical trial? Catherine Owen Adams: Thanks, Julian. I'll just make a quick comment around the peak opportunity for DAYBUE outside the U.S. As we talked about already, we've guided to $700 million in 2028. That is definitely not the peak opportunity that we see. That is the 2028 number, just to be clear about that. And right now, we're talking about around 15% of those sales to be from outside the U.S. That's obviously highly dependent on the reimbursement decisions that we get as we move through the reimbursement discussions that we've already sort of talked about. I would say that's an average analog for other rare disease opportunities. As we progress through the reimbursement discussions and we get those decisions and we get the first view of prices in the EU, we will be better able to articulate what percentage of our 2028 sales as well as further future peak opportunities would be. But I think for right now, that's a fairly normal analog for rare disease. But as rare disease is very heterogeneous. There is really not a normal analog. So it's one that we are sticking with for right now, and we will update you as we go through. And I'm going to hand the other question back to Liz. Elizabeth Thompson: Yes. Briefly, I suspect that the data that you were referring to is in young healthy volunteers because that's where most of the receptor occupancy information is. And I'll say that, that is true that we get to near full receptor occupancy even with pimavanserin at marketed doses. It is our expectation and belief that in elderly and diseased patients, this is a bit of a different animal and higher levels are going to be necessary to get to the same receptor occupancy. And to sort of support this, I would point again to the exposure response analyses that we've done out of prior data sets in both Alzheimer's and Lewy body that do suggest that levels that are higher than what you can get to with the marketed dose of pimavanserin on average do seem to be associated with higher efficacy. So again, I think that, that is a strong reason to believe there's a potential for greater efficacy. But I will say that even if the degree of efficacy we saw with remlifanserin winds up being more similar to what we've seen with pimavanserin, we're structuring our programs in such a way by being focused on the individual diseases and properly powered such that I think that we have an increased likelihood of technical and regulatory success even if the effect were to be similar to the pimavanserin in terms of its scope. Operator: Ladies and gentlemen, that concludes our question-and-answer session. I will now turn the conference back over to Catherine Owen Adams for closing remarks. Catherine Owen Adams: I'd just like to thank you all for your questions and continued support of ACADIA and look forward to reporting on our next quarter where we will have an exciting set of results for remlifanserin. Thank you all for your attention today. Operator: This concludes today's call, and we thank you for your participation. You may now disconnect. Before you buy stock in Acadia Pharmaceuticals, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Acadia Pharmaceuticals wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $411,427!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,335,252!* That performance is why people listen. With a track record of beating the S&P 500 by 4x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 11, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Acadia Pharmaceuticals (ACAD) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Acadia Pharmaceuticals (ACAD) appears an attractive pick given a noticeable improvement in the company's earnings outlook. The stock has been a strong performer lately, and the momentum might continue with analysts still raising their earnings estimates for the company. Analysts' growing optimism on the earnings prospects of this drugmaker is driving estimates higher, which should get reflected in its stock price. After all, empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements. Our stock rating tool -- the Zacks Rank -- has this insight at its core. The five-grade Zacks Rank system, which ranges from a Zacks Rank #1 (Strong Buy) to a Zacks Rank #5 (Strong Sell), has an impressive externally-audited track record of outperformance, with Zacks #1 Ranked stocks generating an average annual return of +25% since 2008. Consensus earnings estimates for the next quarter and full year have moved considerably higher for Acadia Pharmaceuticals, as there has been strong agreement among the covering analysts in raising estimates. The chart below shows the evolution of forward 12-month Zacks Consensus EPS estimate: The company is expected to earn $0.15 per share for the current quarter, which represents a year-over-year change of -42.3%. Over the last 30 days, the Zacks Consensus Estimate for Acadia has increased 18.02% because four estimates have moved higher compared to no negative revisions. The company is expected to earn $0.40 per share for the full year, which represents a change of -52.4% from the prior-year number. In terms of estimate revisions, the trend for the current year also appears quite encouraging for Acadia. Over the past month, three estimates have moved higher compared to no negative revisions, helping the consensus estimate increase 6.57%. The promising estimate revisions have helped Acadia earn a Zacks Rank #2 (Buy). The Zacks Rank is a tried-and-tested rating tool that helps investors effectively harness the power of earnings estimate revisions and make the right investment decision.You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Our research shows that stocks with Zacks Rank #1 (Strong Buy) and 2 (Buy) significantly outperform the S&P 500. Acadia shares have added 10.8% over the past four weeks, suggesting that investors are betting on its impressive estimate revisions. So, you may consider adding it to your portfolio right away to benefit from its earnings growth prospects. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report ACADIA Pharmaceuticals Inc. (ACAD) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Acadia Pharmaceuticals ACAD reported second-quarter 2026 earnings of 18 cents per share, which surpassed the Zacks Consensus Estimate of 6 cents. The company had reported earnings of 16 cents per share in the year-ago quarter. Revenues of $308 million beat the Zacks Consensus Estimate of $294 million, reflecting a 16% year-over-year increase. Growth was supported by higher marketed product sales. Acadia’s revenues comprise net product sales from its two marketed drugs, Daybue (trofinetide) and Nuplazid (pimavanserin). Reported revenues increased from $264.6 million in the second quarter of 2025 to $308 million in the reported quarter. The company’s quarterly performance benefited from continued demand for both products. Daybue growth was supported by the uptake of the recently launched Daybue STIX formulation, while Nuplazid benefited from volume growth and increased new-patient prescriptions. Reported net product sales of Nuplazid were $183.2 million in the second quarter of 2026, up 9% from $168.5 million in the year-ago period. The drug is approved in the United States for treating hallucinations and delusions associated with Parkinson’s disease psychosis. Nuplazid sales beat the Zacks Consensus Estimate of $181.5 million. Management stated that Nuplazid’s growth was primarily volume-driven. New-patient prescriptions increased 20% year over year and reached their highest quarterly level since the first quarter of 2018. Acadia also continued to expand engagement with priority health care providers through its enlarged field force. Daybue reported net product sales of $124.8 million, up 30% from $96.1 million in the second quarter of 2025. Daybue is approved in the United States for treating Rett syndrome in adult and pediatric patients two years of age and older. The reported figure beat the Zacks Consensus Estimate of $111.3 million. Growth was driven largely by volume and strong uptake of Daybue STIX, a powder formulation for oral solution. Approximately 40% of U.S. Daybue patients were receiving STIX by the end of the quarter. The company also recorded a quarterly high in the number of patients returning to Daybue treatment. Acadia stated that around 60% of total referrals during the quarter came from treatment-naive patients, while 40% represented returning patients. For STIX specifically, 55% of patients switched from the oral solution, while the remaining 45% were new or returning patients. Year to date, Acadia shares have gained 1.7% compared with the industry’s 2.6% growth. Image Source: Zacks Investment Research Research and development (R&D) expenses were $82 million in the second quarter of 2026, up 5% from $78 million in the year-ago period. Selling, general and administrative (SG&A) expenses increased 20% year over year to $160 million from $134 million. The increase reflected investments in expanding the Nuplazid and Daybue field forces and higher marketing spending to support both brands. Acadia had cash, cash equivalents and investment securities worth $956 million as of June 30, 2026, compared with $851 million as of March 31, 2026. Following the strong quarterly performance, Acadia raised its total revenue guidance for 2026 to a range of $1.24 billion to $1.30 billion. The previous guidance range was $1.22 billion to $1.28 billion. The company increased its Daybue global net product sales forecast to $480-$510 million from the prior range of $460-$490 million. The revised outlook reflects strong U.S. demand, uptake of STIX and expected contributions from international markets. Nuplazid net product sales guidance was maintained at $760-$790 million. Management expects the expanded field force to have a greater impact on Nuplazid’s performance later in the year as sales representatives deepen engagement with targeted physicians. Acadia now expects R&D expense in the range of $355-$380 million, down from the previous range of $385-$410 million. SG&A expenses continue to be expected between $660 million and $700 million. Acadia completed enrollment in the phase II portion of the RADIANT program evaluating remlifanserin in Alzheimer’s disease psychosis (ADP). The study enrolled 363 patients, and top-line results are expected between September and October 2026. The company has also started screening and enrollment in two phase III studies of remlifanserin in ADP. The candidate received Fast Track designation from the FDA for treating hallucinations and delusions associated with ADP. A separate phase II study of remlifanserin is underway in Lewy body dementia psychosis. Acadia is also evaluating ACP-211 in a phase II study for major depressive disorder, while ACP-711 and ACP-271 are progressing through phase I development. Acadia also received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending authorization of Daybu for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. If approved, Daybu would become the first authorized treatment for Rett syndrome in the EU. A final European Commission decision is expected later in the third quarter of 2026. ACADIA Pharmaceuticals Inc. price-consensus-eps-surprise-chart | ACADIA Pharmaceuticals Inc. Quote Acadia currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY, Repligen RGEN and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share have risen from $3.20 to $3.33, while estimates for 2027 have increased from $3.64 to $3.87 during the same time. HRMY shares have gained 3.5% year to date. Harmony Biosciences’ earnings missed estimates in three of the trailing four quarters and beat on the remaining occasion, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.62 during the same time. RGEN shares have declined 8.6% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 156.2% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report ACADIA Pharmaceuticals Inc. (ACAD) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

This article first appeared on GuruFocus. Total Revenue: $308 million in Q2 2026, representing 17% year-over-year growth on an adjusted basis. Debut (trofinetide) Net Sales: $125 million in Q2 2026, up 30% year-over-year, driven almost entirely by volume (27% from volume). Nuplazid (pimavanserin) Net Sales: $183 million in Q2 2026, up 10% year-over-year on an adjusted basis, driven by 8% volume growth. Gross-to-Net Adjustments: 24.4% for Debut and 23.9% for Nuplazid in the quarter. R&D Expenses: $82 million in Q2 2026, compared to $78 million a year ago. SG&A Expenses: $160 million in Q2 2026, compared to $134 million a year ago. Cash Position: $956 million at the end of the quarter. FY 2026 Guidance: Debut net sales raised to $480 million to $510 million; Nuplazid net sales unchanged at $760 million to $790 million; total revenue expected at $1.24 billion to $1.3 billion. FY 2026 R&D Guidance: Lowered to $355 million to $380 million, from prior guidance of $385 million to $410 million. Warning! GuruFocus has detected 9 Warning Signs with ACAD. Is ACAD fairly valued? Test your thesis with our free DCF calculator. Release Date: August 04, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. ACADIA Pharmaceuticals Inc (NASDAQ:ACAD) delivered strong Q2 2026 results with total revenues of $308 million, a 17% year-over-year increase on an adjusted basis. Debut (trofinetide) net sales grew 30% year-over-year to $125 million, driven by strong uptake of the new Debut Stix formulation, leading to raised 2026 guidance to $480-$510 million. Nuplazid (pimavanserin) net sales grew 10% year-over-year to $183 million, with new patient prescriptions up 20% year-over-year, the highest quarterly volume since Q1 2018. Received a positive CHMP opinion for trofinetide in the EU, paving the way for European launch in Germany in Q4 2026, expanding the commercial opportunity. The pipeline is advancing, with the Phase 2 readout for remlifanserin in Alzheimer's disease psychosis expected in September-October 2026, and the program has received FDA Fast-Track designation. The company maintains a strong cash position of $956 million, providing financial flexibility for commercial and pipeline investments. Nuplazid's growth is modest at 10% year-over-year, and the company kept its 2026 guidance unchanged at $760-$790 million, indicating a slower ramp. SG&A expenses increased significantly to $160 million (up from $134 million a year ago) due to expanded field forces and marketing, pressuring near-term profitability. The company lowered its R&D guidance for 2026 due to a shifted BD milestone and portfolio prioritization, which may delay some pipeline progress. The upcoming Phase 2 readout for remlifanserin carries significant risk; the company is powering for a 0.4 effect size, and failure could derail the $4 billion peak sales potential. European launch of trofinetide will face pricing and reimbursement negotiations, with initial sales expected to be gradual and subject to discounts, potentially limiting near-term contribution. The company faces potential competition from gene therapies for Rett syndrome, though it downplays the impact, and from other ADP programs like Bristol's, which may affect market dynamics. Q: How should we think about scenarios around effect size for the Phase II RADIANT trial's primary endpoint (SAPS H&D), and what would be the lower bound that could still support a de-risked path forward into Phase 3?A: Elizabeth Thompson, EVP, Head of R&D: The Phase 2 study is 80% powered for a moderate effect size of 0.4 on SAPS H&D. While there is some flexibility, we will look beyond just the primary endpoint, including responder analyses and other endpoints. The key is ensuring we have a drug that is easy to take, has evidence of efficacy, a supportive safety profile, and no negative cognitive or motor impact. We are not disclosing baseline characteristics, but enrollment criteria were designed to edge up overall population severity, as prior data suggests a greater effect size in more severe psychosis patients. Q: Can you help quantify the European opportunity for DAYBUE following the positive CHMP opinion, and what is the expected launch cadence and ramp?A: Thomas Garner, Chief Commercial Officer: We anticipate a final European Commission decision by the end of Q3, with Germany as the first launch market in early Q4, followed by the Nordics and Austria. The ramp will be gradual, with patients transitioning from free drug programs. We estimate that less than 50% of our $700 million 2028 DAYBUE sales guidance will come from Europe. Catherine Owen-Adams, CEO, added that named patient programs will continue to supply physician demand in countries where legal systems allow. Q: Can you provide more color on the dynamics of DAYBUE STIX uptake, specifically the mix of new versus returning patients, and how this is impacting the overall franchise?A: Thomas Garner, Chief Commercial Officer: In Q2, approximately 60% of overall referrals were naive patients and 40% were returning patients. For STIX specifically, 55% of existing patients switched from oral solution, while 45% were either new or returning. By the end of June, 60% of all referrals were for the STIX formulation. We are seeing a broader group of patients willing to return to therapy than initially anticipated, which is driving record-level patient returns. Q: Regarding the Phase 2/3 program for remlifanserin in Alzheimer's disease psychosis, how does the effect size compare to prior pimavanserin data, and how are you managing the Phase 3 enrollment while awaiting Phase 2 results?A: Elizabeth Thompson, EVP, Head of R&D: The prior Study 19 showed an effect size of about 0.32 using a different endpoint. We powered for 0.4 because we changed to a more sensitive endpoint (SAPS H&D) and enriched for a more severe psychosis population, where the effect size in Study 19 was closer to 0.6. The Phase 3 studies are now open for enrollment, and we are currently enrolling both dosing arms (30mg and 60mg). We will analyze Phase 2 data in September-October and may modify the Phase 3 design if needed. Q: Can you comment on the statistical methods used for the RADIANT trial, and how are you managing rater drift or consistency throughout the study?A: Elizabeth Thompson, EVP, Head of R&D: The Phase 2 study uses an MMRM analysis with multiplicity control via a pre-specified hierarchy. We have a rigorous rater selection process, including proven experience in psychosis trials, extensive training, and calibration exercises. We are continuously reviewing blinded data and providing booster training to raters on an as-needed basis to maintain consistency. Q: What is the status of the DAYBUE Phase 3 trial in Japan, and what is the addressable Rett syndrome population there?A: Catherine Owen-Adams, CEO: We estimate around 1,000 patients with Rett syndrome in Japan. Elizabeth Thompson, EVP, Head of R&D: The Phase 3 trial is small (~20 patients) and primarily designed to gather experience in Japanese patients, with the LAVENDER data serving as the primary support for regulatory approval. The trial uses CGI-I as the primary endpoint with RSBQ as a key secondary, but there is no expectation of hitting a p-value given the small sample size. Q: Given the strong performance of DAYBUE and NUPLAZID, do you have any updates on your earlier $1.7 billion peak global net sales guidance for 2028?A: Catherine Owen-Adams, CEO: We remain confident in achieving $1 billion in NUPLAZID net sales and $700 million in DAYBUE net sales during 2028. We will revisit these targets as we move through the end of this year and assess the continued uptake of STIX and NUPLAZID's performance. Q: How should we think about the probability of success for remlifanserin in Alzheimer's disease psychosis versus Lewy body dementia psychosis, and how might the $4 billion peak sales potential be split?A: Elizabeth Thompson, EVP, Head of R&D: We do not see the probability of success as wildly different across the two indications. We have more data in Alzheimer's, but the Lewy body data, though in smaller numbers, is striking in magnitude. Catherine Owen-Adams, CEO: The $4 billion peak sales potential is roughly split 60% for Alzheimer's disease psychosis and 40% for Lewy body dementia psychosis, though this will evolve based on data and competitive dynamics. Q: Can you provide more detail on the pricing and reimbursement process for DAYBUE in Germany, and what should we expect regarding the gross-to-net impact?A: Thomas Garner, Chief Commercial Officer: In Germany, we will have free pricing for the first six months post-launch. During this period, we will submit our pricing and reimbursement dossier to AMNOG, and after the six-month period, the negotiated price will be recognized on a gross-to-net basis. Catherine Owen-Adams, CEO: We are not currently guiding on European pricing and will provide updates as we progress through negotiations with national reimbursement authorities. Q: Can you comment on the discontinuation rates for DAYBUE with the STIX formulation, and how does this compare to the oral solution?A: Thomas Garner, Chief Commercial Officer: Early data suggests STIX is performing similarly to the oral solution in terms of tolerability. Discontinuation rates remain under double-digits and are consistent with prior quarters. The key difference is that For the complete transcript of the earnings call, please refer to the full earnings call transcript.

With the broader market hovering near record highs, many investors may be looking to healthcare stocks for their historically defensive characteristics, making medical companies that are also delivering standout earnings results especially attractive. Strong commercial execution, expanding product portfolios, and improving operational performance have helped several healthcare companies deliver meaningful earnings beats. That said, here are three medical stocks that are standing out after crushing Q2 EPS expectations this week. Acadia Pharmaceuticals ACAD) delivered one of the biggest earnings surprises in the biotech space, with its focus being on the development of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders and rare diseases. The biotech firm reported Q2 adjusted earnings of 18 cents per share, easily topping consensus estimates of 6 cents. The resulting 200% earnings surprise marked another quarter of solid execution. Revenue climbed 16% year over year to $307.96 million, which easily surpassed expectations of $293.82 million. Growth was fueled by continued momentum from both of Acadia's commercial products. DAYBUE generated 30% sales growth thanks to strong patient demand and adoption of its recently launched STIX formulation, while NUPLAZID sales increased roughly 9%. Management also intrigued investors by raising its 2026 revenue guidance to between $1.24-$1.3 billion (+15% growth), reflecting confidence in continued commercial momentum. The combination of a triple-digit earnings surprise, accelerating product sales, and higher guidance makes Acadia one of healthcare's standout earnings winners this quarter. Image Source: Zacks Investment Research CVS Health (CVS) continued its impressive turnaround story with another massive earnings beat. The healthcare giant reported Q2 adjusted earnings of $2.58 per share, exceeding Wall Street’s expectations of $1.87 by 71 cents and representing a nearly 38% EPS surprise. This came as revenue increased more than 7% YoY to $106.09 billion, comfortably ahead of expectations of $100.17 billion. Results were driven by significantly improved profitability in CVS's insurance business, where the medical benefit ratio declined to 87.4% from 89.9% a year earlier. CVS also generated double-digit operating income growth in its Health Services segment, which includes its pharmacy benefit management operations. Reassuringly, CVS raised its full-year adjusted EPS guidance to between $7.90-$8.10 (+17% growth), highlighting confidence that operational improvements remain intact despite ongoing insurance reimbursement and regulatory pressures. Image Source: Zacks Investment Research Eli Lilly LLY) once again demonstrated why it remains one of the premier growth stories in healthcare. The pharmaceutical giant reported Q2 adjusted earnings of $8.38 per share, exceeding the consensus estimate of $6.01 by $2.37 and producing a 39% EPS surprise. Lilly’s revenue surged 48% YoY to roughly $23 billion and blasted expectations of $20.26 billion, driven by exceptional demand for its blockbuster diabetes and obesity franchise. Both of Lilly’s flagship products significantly outperformed expectations, with Mounjaro generating $9.94 billion in sales and Zepbound contributing $4.93 billion. Management also increased its full-year revenue guidance to between $85 billion-$87 billion (+31% growth) as manufacturing capacity continues to expand to meet robust global demand. Lilly's ability to deliver another sizable earnings beat while maintaining extraordinary revenue growth underscores the strength of its competitive position in obesity and diabetes therapeutics. Image Source: Zacks Investment Research For investors looking to the medical sector for companies executing at a high level, these three stocks are certainly worthy of consideration. To that point, as investors look to balance growth opportunities with defensive positioning, Acadia Pharmaceuticals, CVS Health, and Eli Lilly stand out as healthcare names combining resilient business models with strong earnings momentum. Keeping that in mind, CVS and Lilly could soon join Acadia stock in regard to receiving a buy rating as analysts are likely to raise their earnings estimates in the coming weeks. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Eli Lilly and Company (LLY) : Free Stock Analysis Report CVS Health Corporation (CVS) : Free Stock Analysis Report ACADIA Pharmaceuticals Inc. (ACAD) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Interested in ACADIA Pharmaceuticals Inc.? Here are five stocks we like better. Second-quarter revenue rose 17% year over year to $308 million, driven by DAYBUE sales of $125 million (+30%) and NUPLAZID sales of $183 million (+10%). ACADIA raised its 2026 DAYBUE sales outlook to $480 million-$510 million while maintaining NUPLAZID guidance of $760 million-$790 million. DAYBUE STIX adoption reached approximately 40% of U.S. patients, supporting new and returning patient growth, while ACADIA expects initial European sales in the fourth quarter following a favorable regulatory opinion. Remlifanserin phase II Alzheimer’s disease psychosis results are expected between September and October; the program has FDA Fast Track designation and has already begun phase III enrollment. ACADIA ended the quarter with $956 million in cash and now expects 2026 total revenue of $1.24 billion-$1.30 billion. Acadia Pharmaceuticals: A Mid-Cap Biotech Making Large Moves ACADIA Pharmaceuticals (NASDAQ:ACAD) reported second-quarter 2026 revenue of $308 million, representing 17% year-over-year growth on an adjusted basis, as sales of its Rett syndrome therapy DAYBUE and Parkinson’s disease psychosis treatment NUPLAZID increased. Chief Executive Officer Catherine Owen Adams said the quarter reflected strong commercial execution across both brands, while the company also advanced its pipeline, led by remlifanserin for Alzheimer’s disease psychosis. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control DAYBUE generated $125 million in second-quarter net sales, up 30% from a year earlier. NUPLAZID produced $183 million in net sales, up 10% year over year on an adjusted basis. ACADIA raised its full-year DAYBUE sales outlook while maintaining its NUPLAZID guidance. DAYBUE growth was driven primarily by volume, including adoption of DAYBUE STIX, the company’s powder-for-oral-solution formulation. Chief Commercial Officer Thomas Garner said approximately 40% of U.S. DAYBUE patients were receiving STIX by the end of the quarter. → Financials Hit Record Highs as the AI Trade Unravels—Can They Keep Leading? Garner said the expanded launch beyond Centers of Excellence helped engage new patients and bring previously discontinued patients back to therapy. The number of patients returning to DAYBUE reached a record during the quarter, he said. Of referrals during the quarter across DAYBUE formulations, about 60% came from treatment-naive patients and 40% from returning patients, according to Garner. Looking specifically at STIX users, he said 55% of existing patients were switching from the oral solution, while 45% were new or returning patients. Among that latter group, approximately 60% were new patients and 40% were returning patients. → Why Rare Earth Processing Could Be the Real 2027 Opportunity ACADIA raised its 2026 DAYBUE net sales guidance to $480 million to $510 million, from a prior range of $460 million to $490 million. The outlook includes expected initial European commercial sales in the fourth quarter. The company recently received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, for trofinetide, the active ingredient in DAYBUE, following a re-examination process. ACADIA expects a European Commission decision later in the third quarter and plans to launch in Germany in early fourth quarter, followed by other European markets as reimbursement approvals are obtained. Garner said ACADIA expects less than 50% of its stated $700 million DAYBUE sales target for 2028 to come from Europe. The company said it currently expects roughly 15% of 2028 DAYBUE sales to come from outside the U.S., subject to reimbursement decisions and pricing negotiations. NUPLAZID’s adjusted 10% sales growth was primarily volume-driven, with volume up 8% year over year. Garner said new patient prescriptions increased 20% from a year earlier and reached their highest quarterly level since the first quarter of 2018. The company has expanded its commercial field force and said it is beginning to see benefits from that investment, which it had expected to take six to nine months to ramp. Since February, the expanded team has reached more than 12,000 priority healthcare providers, according to Garner. ACADIA also cited direct-to-consumer awareness efforts, including its “Mind Your Mind” and “More to Parkinson’s” campaigns during Parkinson’s Awareness Month in April. Garner said the campaigns produced record audience reach and increased branded and unbranded patient conversion sequentially. NUPLAZID refill and restart rates were in line with the company’s expectations, Garner said in response to an analyst question. ACADIA maintained its 2026 NUPLAZID net sales guidance of $760 million to $790 million and expects stronger year-over-year growth in the fourth quarter than in the third quarter as the field-force expansion gains traction. ACADIA completed enrollment in the phase II portion of its RADIANT study of remlifanserin in Alzheimer’s disease psychosis. Executive Vice President and Head of Research and Development Elizabeth Thompson said top-line results are now expected between September and October. The Food and Drug Administration granted Fast Track designation to remlifanserin for Alzheimer’s disease psychosis. ACADIA has also begun screening and enrollment in its phase III studies under an operationally seamless phase II/phase III program design. Thompson said the phase II portion enrolled 363 patients and is powered at 80% to detect a 0.4 effect size on the Scale for the Assessment of Positive Symptoms Hallucinations and Delusions, or SAPS H&D. The phase III studies are currently enrolling placebo, 30-milligram, and 60-milligram dosing arms, with the company retaining the ability to modify the phase III program after reviewing phase II data. ACADIA estimates remlifanserin could have $4 billion in peak sales potential across Alzheimer’s disease psychosis and Lewy body dementia psychosis. Management said it currently views that opportunity as roughly 60% attributable to Alzheimer’s disease psychosis and 40% to Lewy body dementia psychosis, though the split will depend on clinical data and the competitive environment. Elsewhere in the pipeline, ACADIA expects phase III trofinetide data from Japan between September and November and plans a potential regulatory submission in Japan in 2027. The Japanese trial includes roughly 20 patients and is intended primarily to provide experience in Japanese patients, with ACADIA’s prior LAVENDER data expected to serve as the primary basis of a future filing package. Research and development expense was $82 million in the quarter, compared with $78 million a year earlier. Selling, general and administrative expense rose to $160 million from $134 million, reflecting investments in the DAYBUE and NUPLAZID field forces and marketing support for both brands. Chief Financial Officer Mark Schneyer said ACADIA ended the quarter with $956 million in cash. The company now expects 2026 total revenue of $1.24 billion to $1.3 billion. ACADIA lowered its expected 2026 R&D expense range to $355 million to $380 million, from prior guidance of $385 million to $410 million. Schneyer said the reduction reflected a business-development milestone shifting to 2027 and selected portfolio prioritization decisions. Other fiscal-year guidance ranges were unchanged. ACADIA Pharmaceuticals Inc is a biopharmaceutical company focused on the development and commercialization of innovative therapies for central nervous system (CNS) disorders. Established in 1993 and headquartered in San Diego, California, ACADIA's research centers concentrate on conditions with significant unmet medical needs, including Parkinson's disease psychosis, Alzheimer's disease psychosis, and schizophrenia. The company utilizes a range of scientific platforms, including selective receptor modulation and precision-targeted compounds, to advance its portfolio of small-molecule therapeutics. The company's flagship product, NUPLAZID® (pimavanserin), received U.S. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "ACADIA Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Viatris VTRS, a global healthcare company, is scheduled to report second-quarter 2026 results on Aug. 6, before the opening bell. The Zacks Consensus Estimate for second-quarter revenues is pegged at $3.68 billion, while the same for earnings is pinned at 62 cents per share. The company reports under four segments based on geography — Developed Markets, Emerging Markets, Japan, Australia and New Zealand (“JANZ”) and Greater China. Developed Markets sales are expected to rise, though growth in North America may be tempered by the Indore manufacturing facility import alert. Solid growth in EpiPen, Creon and Viatris’ thrombosis portfolio is likely to have enabled it to partially absorb the anticipated competition for Dymista. Incremental revenues from new products, such as iron sucrose, are likely to have boosted the quarterly top line. Following an inspection of Viatris' oral finished dose manufacturing facility in Indore, India, in June 2024, the company received a warning letter and import alert from the FDA in December 2024. The import alert affected 11 actively distributed products, including lenalidomide and everolimus. The Zacks Consensus Estimate for revenues from Developed Markets is pinned at $2.18 billion. Sales from Emerging Markets are expected to have experienced growth, driven by branded business in Turkey, Mexico and certain Asian markets. The generic business is likely to have seen growth due to the stabilization of supply for certain lower-margin ARB products. The Zacks Consensus Estimate for revenues from this geography is pegged at $558.5 million. Viatris shares have surged 41.6% year to date against the industry’s 1.1% decline. Image Source: Zacks Investment Research Sales in JANZ are likely to have been adversely impacted by lower net sales of existing products in Japan and Australia due to government price reductions and additional competition. The Zacks Consensus Estimate for revenues from the JANZ markets is pinned at $285.1 million. Sales in Greater China might have increased due to strong growth across multiple channels, including e-commerce, retail and private hospitals, as a result of higher marketing and selling efforts. The Zacks Consensus Estimate for revenues from this geography is pegged at $631.7 million. Viatris also reports revenues under two divisions (in terms of product category) — brands and generics. The brand business comprises the majority of the company’s portfolio. Brand performance is likely to have benefited from strong performance in Greater China and Emerging Markets, in addition to growth in certain key brands in Developed Markets. However, the generics business is likely to have been negatively impacted by inspection at the Indore facility and competition for Wixela, partially offset by continued growth in Yupelri and Breyna in North America, strong performance across key European markets, and slight volume growth in JANZ. On the profitability front, gross margin is likely to have been stable. Total operating expenses in the second quarter of 2026 are likely to have declined as a result of the planned cost-saving initiatives. Viatris’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 10.04%. In the last reported quarter, VTRS beat on earnings by 13.46%. Our proven model does not conclusively predict an earnings beat for VTRS this time around.  The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. That is not the case here, as you will see below. Earnings ESP:Viatris has an Earnings ESP of -0.81% as the Most Accurate Estimate of 61 cents per share is just shy of the Zacks Consensus Estimate of 62 cents. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter. Zacks Rank:VTRS currently carries a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank stocks here. Viatris Inc. price-consensus-eps-surprise-chart | Viatris Inc. Quote Here are some stocks worth considering from the healthcare space, as our model shows that these have the right combination of elements to beat on earnings this reporting cycle. ACADIA Pharmaceuticals ACAD has an Earnings ESP of +25.00% and a Zacks Rank #2 at present. Shares of ACAD have lost 4.1% year to date. The company’s earnings beat estimates in three of the trailing four quarters and missed on the remaining occasion, delivering an average surprise of 20.83%. Acadia is scheduled to report second-quarter results on Aug. 4, after market close. Arcutis Biotherapeutics ARQT has an Earnings ESP of +52.94% and a Zacks Rank #2 at present. Shares of ARQT have lost 10.7% year to date. The company’s earnings beat estimates in three of the trailing four quarters but missed in the remaining quarter, delivering an average surprise of 42.78%. ARQT is scheduled to report second-quarter results on Aug. 5. BridgeBio Pharma BBIO has an Earnings ESP of +13.69% and a Zacks Rank #3 at present. Shares of BBIO have risen 4.5% year to date. BridgeBio Pharma’s earnings missed estimates in each of the trailing four quarters, delivering an average negative surprise of 18.94%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Viatris Inc. (VTRS) : Free Stock Analysis Report ACADIA Pharmaceuticals Inc. (ACAD) : Free Stock Analysis Report BridgeBio Pharma, Inc. (BBIO) : Free Stock Analysis Report Arcutis Biotherapeutics, Inc. (ARQT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

- Second quarter DAYBUE® GAAP net sales of $125 million, up 30% year-over-year driven by strong uptake of DAYBUE STIX - Second quarter NUPLAZID® GAAP net sales of $183 million, up 10% year-over-year on a non-GAAP adjusted basis - Increased full year 2026 total revenue guidance to $1.24 to $1.30 billion, reflecting higher DAYBUE guidance of $480 to $510 million and reaffirmed NUPLAZID guidance of $760 to $790 million - Topline results from the Phase 2 remlifanserin study in Alzheimer’s disease psychosis anticipated September to October 2026 SAN DIEGO, August 04, 2026--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its financial results for the second quarter ended June 30, 2026. "Acadia delivered an outstanding second quarter, highlighted by strong commercial execution across both DAYBUE and NUPLAZID, resulting in total revenue growth of 17% year-over-year on an adjusted basis," said Catherine Owen Adams, Chief Executive Officer of Acadia. "For DAYBUE, continued patient demand and robust uptake of STIX drove another quarter of strong performance. For NUPLAZID, we continued to see strong momentum, especially in new-to-brand prescriptions as our recently expanded sales force gained traction in the field. We remain confident that both franchises are on track to achieve our long-term ambition of approximately $1.7 billion in annual net sales in 2028. Looking ahead, we are excited about the anticipated topline results from our Phase 2 program evaluating remlifanserin in Alzheimer's disease psychosis in the September to October timeframe, which we believe represents a potentially transformational opportunity for Acadia." Company Updates Completed enrollment in the Phase 2 portion of the RADIANT program evaluating remlifanserin in Alzheimer's disease psychosis and initiated Phase 3 screening and enrollment; topline Phase 2 results are expected in September to October 2026. Received FDA Fast Track designation for remlifanserin for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis, recognizing its potential to address a significant unmet medical need. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization for DAYBU® (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. If approved by the European Commission, DAYBU would become the first authorized treatment for Rett syndrome in the European Union. Financial Results Revenues GAAP total revenues, comprised of net product sales from NUPLAZID and DAYBUE, were $308 million for the second quarter of 2026, up 16% as compared to GAAP total revenues of $265 million in the second quarter of 2025, and up 17% as compared to non-GAAP adjusted total revenues of $262 million in the second quarter of 2025. GAAP net product sales of NUPLAZID were $183 million for the second quarter of 2026, up 9% compared to GAAP net product sales of $168 million for the second quarter of 2025, and up 10% as compared to non-GAAP adjusted net product sales of $166 million for the second quarter of 2025. Net product sales of DAYBUE were $125 million for the second quarter of 2026, an increase of 30% as compared to $96 million for the second quarter of 2025. A reconciliation of NUPLAZID non-GAAP adjusted net product sales and non-GAAP adjusted total revenues is provided in Table 1. A description of these adjustments is included under ‘Non-GAAP Financial Measures.’ Research and Development Research and development expenses for the second quarter of 2026 were $82 million, compared to $78 million for the same period of 2025. Selling, General and Administrative Selling, general and administrative expenses for the second quarter of 2026 were $160 million, compared to $134 million for the same period of 2025. Net Income For the second quarter of 2026, Acadia reported net income of $32 million, or $0.18 per diluted share, compared to a net income of $27 million, or $0.16 per diluted share, for the same period in 2025. Cash and Investments At June 30, 2026, Acadia’s cash, cash equivalents, and investment securities totaled $956 million, compared to $820 million at December 31, 2025. Full Year 2026 Financial Guidance (GAAP): Acadia is updating its 2026 guidance: Total revenues revised to a range of $1.24 to $1.30 billion, up from the previous range of $1.22 to $1.28 billion. NUPLAZID net product sales in the range of $760 to $790 million. DAYBUE (including all forms of trofinetide) global net product sales in the range of $480 to $510 million, up from the previous range of $460 to $490 million. R&D expense in the range of $355 to $380 million, down from the previous range of $385 to $410 million. SG&A expense in the range of $660 to $700 million. Conference Call and Webcast Information Acadia will host a conference call to discuss the second quarter 2026 results today, Tuesday, August 4, 2026 at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed by registering for the call here. Once registered, participants will receive an email with the dial-in number and unique PIN number to use for accessing the call. About NUPLAZID® (pimavanserin) Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID. About DAYBUE® (trofinetide) Trofinetide is a synthetic version of a naturally occurring molecule known as the tripeptide glycine-proline-glutamate (GPE). The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown. Trofinetide was approved for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older by the U.S. Food and Drug Administration in March 2023 under the trade name DAYBUE or DAYBUE STIX. About Acadia Pharmaceuticals Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference. For more information, visit us at acadia.com and follow us on LinkedIn and X. Non-GAAP Financial Measures This press release contains the following financial measures that do not comply with U.S. generally accepted accounting principles (GAAP): non-GAAP adjusted net product sales for NUPLAZID for the second quarter of 2025 and non-GAAP adjusted total revenues for the second quarter of 2025. In preparing these non-GAAP financial results, the Company includes adjustments made to reflect the impact of a change in estimate related to NUPLAZID IRA rebate accruals. Please refer to our press release dated February 25, 2026, for additional details. These non-GAAP financial measures complement GAAP results and are used by management to analyze financial performance and evaluate period-to-period changes. Management believes these non-GAAP financial measures are useful to investors and other users of the Company’s financial statements to facilitate period-to-period comparability. These non-GAAP financial measures are not meant to be considered as a substitute for comparable GAAP measures; should be read in conjunction with the Company’s consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are unlikely to be comparable with non-GAAP disclosures released by other companies. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and can be identified by terms such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "potential," "guidance," "continue" and similar expressions (including the negative thereof) intended to identify forward-looking statements. Forward-looking statements contained in this press release, include, but are not limited to, statements about: (i) our business strategy, objectives and opportunities, including support for and innovations in our pipeline assets and business development opportunities, sales growth for DAYBUE and uptake in DAYBUE STIX, and potential for enhanced shareholder value; (ii) the momentum and expectations for NUPLAZID with the expanded sales force, (iii) the FDA’s potential review of a new drug application for remlifanserin as a treatment for Alzheimer’s disease psychosis, (iv) the receipt and timing of the topline results of the RADIANT Phase 2 study, the transformational opportunity of those results, and the enrollment of the Phase 3 portion of the RADIANT development program, (v) potential approval of DAYBU (trofinetide) in the European Union, (vi) plans for, including timing, development and progress of commercialization or regulatory timelines for our products and our product candidates; (vii) benefits to be derived from and efficacy of our products, including the potential advantages of our products; and (viii) our estimates regarding our future financial performance, profitability, capital requirements or expenses, including our full year 2026 financial guidance and anticipated net product sales by the end of 2028. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. Such risks, uncertainties and other factors include, but are not limited to: our dependency on the continued successful commercialization of our products and our ability to maintain or increase sales of our products; the success of our plans to continue commercial growth; the costs of our commercialization plans and development programs, and the financial impact or revenues from any commercialization we undertake; our ability to obtain necessary regulatory approvals for our product candidates and, if and when approved, market acceptance of our products; the risks associated with clinical trials and their outcomes, including risks of unsuccessful enrollment and negative or inconsistent results; our dependence on third-party collaborators, clinical research organizations, manufacturers, suppliers and distributors; the impact of competitive products and therapies; our ability to generate or obtain the necessary capital to fund our operations; our ability to grow, equip and train our specialized sales forces; our ability to manage the growth and complexity of our organization; our ability to maintain, protect and enhance our intellectual property; and our ability to continue to stay in compliance with applicable laws and regulations. Given the risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of these and other risks, uncertainties and other factors that may cause our actual results, performance or achievements to differ, please refer to our annual report on Form 10-K for the year ended December 31, 2025 as well as our subsequent filings with the Securities and Exchange Commission from time to time. The forward-looking statements contained herein are made as of the date hereof, and we undertake no obligation to update them after this date, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260804047448/en/ Contacts Investor Contact: Acadia Pharmaceuticals Inc.Al Kildani(858) [email protected] Acadia Pharmaceuticals Inc.Jessica Tieszen(858) [email protected] Media Contact: Acadia Pharmaceuticals Inc.Deb Kazenelson(818) [email protected]

Acadia Pharmaceuticals (ACAD) came out with quarterly earnings of $0.18 per share, beating the Zacks Consensus Estimate of $0.06 per share. This compares to earnings of $0.16 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +200.00%. A quarter ago, it was expected that this drugmaker would post earnings of $0.04 per share when it actually produced earnings of $0.02, delivering a surprise of -50%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Acadia, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $307.96 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 4.81%. This compares to year-ago revenues of $264.57 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Acadia shares have lost about 4.1% since the beginning of the year versus the S&P 500's gain of 11%. While Acadia has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Acadia was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.13 on $328.06 million in revenues for the coming quarter and $0.39 on $1.24 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 42% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, MaxCyte, Inc. (MXCT), is yet to report results for the quarter ended June 2026. The results are expected to be released on August 12. This company is expected to post quarterly loss of $0.12 per share in its upcoming report, which represents no change from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 14.3% lower over the last 30 days to the current level. MaxCyte, Inc.'s revenues are expected to be $6.5 million, down 23.6% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report ACADIA Pharmaceuticals Inc. (ACAD) : Free Stock Analysis Report MaxCyte, Inc. (MXCT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research