Management View

• Catherine Owen Adams, CEO, highlighted a milestone year, stating, “We achieved adjusted total revenues of $298 million in the fourth quarter, up 16% from the prior year. And for the first time in our company’s history, annual revenues exceeded $1 billion, reaching $1.08 billion in adjusted 2025 revenue, which represented 14% growth from the prior year.” She noted this was driven by commercial execution, particularly in NUPLAZID and DAYBUE brands.
• Adams noted, “We expect NUPLAZID net sales of $760 million to $790 million, which would represent between 10% and 14% growth over 2025 adjusted net sales, placing the brand on a strong trajectory towards our expectation of achieving blockbuster status with $1 billion of net sales in 2028.”
• DAYBUE net product sales were reported at $110 million for the quarter and $391 million for the year, with Adams emphasizing the “expanded reach into the community physician setting in the U.S. and our ex-U.S. named patient supply programs.” She signaled excitement for DAYBUE STIX, a new powder formulation, and addressed a negative trend vote from the EU CHMP regarding trofinetide, but maintained the company’s commitment to advancing EU access.
• Adams projected, “For our 2026 DAYBUE guidance, we expect global net sales between $460 million and $490 million, which would represent between 18% and 25% growth over 2025.”
• Thomas Garner, Chief Commercial Officer, reported, “NUPLAZID delivered another outstanding quarter with adjusted net sales of approximately $189 million in the fourth quarter. Importantly, underlying quarterly volume growth remained exceptionally strong at 13%.” He described a 30% expansion of customer-facing teams and a new branded campaign to drive further growth.
• Garner reported DAYBUE’s Q4 sales at $110 million, and that “76% of new prescriptions originated from community-based physicians,” reflecting success in expanding beyond specialty care.
• Elizabeth Thompson, EVP and Head of R&D, noted an active pipeline, stating, “We anticipate initiating 5 additional Phase II or Phase III studies by the end of 2027.” She discussed the negative EU trend vote and the plan to request reexamination for trofinetide.
• CFO Mark Schneyer stated, “Fourth quarter total revenues were $284 million and for the full year were $1.07 billion on a GAAP basis.” He explained a nonrecurring $20 million adjustment due to higher-than-expected CMS IRA invoices, impacting NUPLAZID sales. Schneyer added, “Our cash balance at the end of 2025 was $820 million.”

Outlook

• Management expects total revenues for 2026 between $1.22 billion and $1.28 billion, with NUPLAZID net sales projected at $760 million to $790 million and DAYBUE net sales expected between $460 million and $490 million. Adams stated these projections support confidence in achieving long-term targets and blockbuster status for NUPLAZID by 2028.
• R&D expense for 2026 is forecast at $385 million to $410 million, and SG&A at $660 million to $700 million, reflecting foundational investments and field force expansions.
• No comparison to analysts’ estimates was provided due to insufficient data.

Financial Results

• Adjusted NUPLAZID net sales reached $189 million for Q4 and $692 million for the year, up 17% and 15% respectively, driven by prescription volume and a broadened prescriber base.
• DAYBUE net sales were $110 million in Q4 and $391 million for the year, with a gross to net adjustment of 19.5% for the quarter.
• R&D expenses for Q4 were $85 million, down from $101 million in Q4 2024, reflecting lower upfront payments. SG&A expenses for Q4 were $156 million, up from $130 million in the prior year, attributed to marketing investments and field expansion.
• A one-time noncash income tax benefit of approximately $250 million was recognized in Q4.

Q&A

• Tessa Romero, JPMorgan: Asked about ramp to 2028 global net sales targets. Adams indicated “we’re expecting low to mid-teens growth out to the $1 billion,” while Garner detailed confidence from recent metrics and field force expansion.
• Ritu Baral, TD Cowen: Inquired about remlifanserin data expectations. Thompson responded that the Phase II study is powered for a moderate effect size, aiming for “continued evidence that we are developing a molecule that’s in line with our target product profile.”
• Marc Goodman, Leerink: Asked about DAYBUE persistency and compliance. Garner confirmed “discontinuations remain in the pretty low single-digit range” and emphasized stability in consumption rates.
• Additional analysts queried the timeline for ADP trial progression, specifics on the EU regulatory situation, and competitive differentiation for pipeline assets. Management provided detailed but cautious responses, often stressing ongoing review and regulatory process adherence.

Sentiment Analysis

• Analysts focused on growth drivers, regulatory hurdles, and product expansion, with a generally positive but probing tone, seeking clarity on regulatory and trial outcomes.
• Management maintained a confident, forward-looking stance in prepared remarks, with Adams stating, “we feel very confident in that incremental growth that we see,” but provided more measured and sometimes cautious elaborations during Q&A, especially regarding regulatory challenges and clinical trial risks.
• Compared to the previous quarter, the tone remains confident but features more discussion of regulatory setbacks (EU negative trend vote) and detailed mitigation strategies.

Quarter-over-Quarter Comparison

• Management’s guidance for 2026 is more granular, with specific revenue and growth targets for both NUPLAZID and DAYBUE. This contrasts with the previous quarter, which focused on setting the stage for a strong year-end and field force expansion.
• Regulatory risks for DAYBUE in the EU have become more pressing, with a negative trend vote now publicly discussed, compared to optimistic launch readiness planning last quarter.
• Analyst focus remains on growth execution, but with increasing attention on regulatory developments and pipeline differentiation.
• Confidence in commercial execution persists, but with more explicit mentions of field force expansion and new product formulations.

Risks and Concerns

• The main challenge cited is the negative trend vote from the EU’s CHMP for DAYBUE (trofinetide), with management planning to request a reexamination and emphasizing the ongoing support through named patient supply programs.
• Nonrecurring accounting changes due to higher-than-expected CMS IRA invoices impacted NUPLAZID results.
• Pipeline risks and the need for successful trial outcomes were repeatedly referenced, with Thompson noting, “we do anticipate, throughout the process, we have gotten questions on things like the relevance of the endpoints… the clinical meaningfulness of the results…”

Final Takeaway

ACADIA Pharmaceuticals emphasized its achievement of surpassing $1 billion in annual revenues for the first time, with robust growth from NUPLAZID and DAYBUE and clear guidance for continued double-digit growth in 2026. The company is advancing key pipeline milestones, rolling out the DAYBUE STIX formulation, and expanding its commercial field force to drive further penetration. Despite regulatory setbacks in the EU for DAYBUE, management remains committed to maximizing global access and executing on long-term blockbuster sales targets, supported by a strong balance sheet and a diversified R&D pipeline.

Read the full Earnings Call Transcript

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Management View

• Catherine Owen Adams, CEO, reported “another strong quarter for ACADIA with solid execution across our commercial portfolio and continued momentum positions us well for a strong finish to 2025 as we lay the foundation for sustained growth into 2026 and beyond.” She highlighted total revenues of $278.6 million, up 11% year-over-year, emphasizing the strength of the commercial portfolio and execution on multiple fronts.
• Adams emphasized DAYBUE’s progress, noting “we achieved our largest sequential increase in referrals since launch” and shipped the highest number of DAYBUE bottles ever in a single quarter, reaching over 1,000 unique patients globally. Patient persistency remains stable.
• For NUPLAZID, Adams stated, “We delivered an exceptional quarter with net sales of $177.5 million, marking our strongest sales quarter ever.” She detailed plans for strategic investments in field force expansion and direct-to-consumer campaigns.
• Thomas Garner, Chief Commercial Officer, reported “DAYBUE sales were $101.1 million in Q3, representing our highest revenue and total prescription volume in any quarter to date since launch.” He noted 956 physicians have now written at least one prescription for DAYBUE, with 74% of new prescriptions coming from community-based physicians.
• Garner highlighted NUPLAZID’s 12% year-over-year growth, driven by 9% volume growth, a 21% increase in referrals, and a 23% rise in new prescription volumes compared to the prior year.
• Elizabeth Thompson, EVP and Head of R&D, announced the initiation of a Phase II study for ACP-204 in Lewy body dementia psychosis, a Phase III study of trofinetide in Japan, and anticipated initiation of a Phase II study for ACP-211 in Q4 2025. She projected “reporting results from 4 Phase II or Phase III studies between now and the end of 2027.”
• Mark Schneyer, CFO, stated, “We delivered an excellent quarter that underscores the robustness of our commercial portfolio, which enables us to generate strong revenue and cash flows while continuing to invest strategically in growth opportunities.”

Outlook

• The company updated its full-year 2025 guidance, with NUPLAZID now expected to deliver $685 million to $695 million in net sales, up from the previous $665 million to $690 million range.
• DAYBUE guidance was modified to include named patient supply programs, narrowing the range to $385 million to $400 million, compared to prior U.S.-only guidance of $380 million to $405 million.
• R&D expenses are now guided to $335 million to $345 million, and SG&A to $540 million to $555 million.
• Adams stated, “our commitment to finishing 2025, getting over $1 billion in total revenues, positioning ACADIA for continued growth in 2026 and beyond.”

Financial Results

• Total revenues for Q3 were $278.6 million, up 11% year-over-year.
• DAYBUE net sales reached $101.1 million, representing 11% year-over-year growth, driven entirely by volume.
• NUPLAZID net sales were $177.5 million, a 12% increase year-over-year, with 9% attributable to volume growth.
• Gross-to-net adjustment for DAYBUE was 22%, and for NUPLAZID, 25%.
• Operating expenses included R&D at $87.8 million, up from $66.6 million in Q3 2024, and SG&A at $133.4 million, essentially flat with the prior year.
• The company ended the quarter with $847 million in cash, compared to $762 million at the end of Q2.

Q&A

• Ritu Baral, TD Cowen: Asked about the NUPLAZID field force expansion. Garner explained investments are targeting both community and long-term care settings, “investing slightly more on a percentage basis in the community, but at the same time, we are going to be modestly increasing our LTC team.”
• Yigal Nochomovitz, Citigroup: Inquired about clinical endpoints for ACP-204. Thompson explained the primary endpoint and trial design, noting, “we’re looking for roughly a moderate effect size, a 0.4 effect size on SAPS-H+D.”
• Tessa Romero, JPMorgan: Queried about DAYBUE referral growth and patient starts. Garner indicated continued growth is expected through Q4 and into 2026.
• Brian Abrahams, RBC: Asked about ACP-204 trial conduct and safety. Adams emphasized focus on appropriate patient selection and ongoing DSM-V monitoring.
• So Youn Shim, UBS: Asked about peak sales guidance. Adams stated the company now aspires to $11 billion in peak sales for the portfolio, and $1.5 billion to $2 billion for NUPLAZID and DAYBUE.
• Additional questions covered NUPLAZID pricing, European DAYBUE launch readiness, investment in NUPLAZID field force, reimbursement strategies in Europe, and pipeline differentiation.

Sentiment Analysis

• Analysts focused on sustainability of momentum, field force expansion, and guidance specificity. The tone was generally positive, with questions delving into growth levers and pipeline opportunities.
• Management maintained a confident and upbeat tone in prepared remarks, using phrases such as “we are confident” and “we believe these trends are an important leading indicator of future prescribing behavior.” During Q&A, management remained detailed, occasionally shifting to a more cautious or nuanced stance when discussing competitive dynamics and pipeline risks.
• Compared to the previous quarter, both management and analysts showed increased confidence and specificity regarding commercial execution and pipeline progress.

Quarter-over-Quarter Comparison

• Q3 guidance for NUPLAZID was raised at both ends, reflecting accelerating momentum; DAYBUE guidance was narrowed and expanded to include international contributions.
• DAYBUE surpassed 1,000 global patients, up from 987 in Q2, and achieved its highest-ever quarterly net sales and prescription volume.
• Persistency rates and prescriber breadth continued to improve, notably with community-based physicians representing a growing majority of new DAYBUE prescriptions.
• The company reiterated and elaborated on its multi-year pipeline milestones, highlighting increased clarity on timing and expected readouts.
• Management’s tone was even more confident than the previous quarter, with a greater focus on near-term and 2026 growth, while analysts maintained an inquisitive but positive approach.

Risks and Concerns

• Management noted that overall market penetration for DAYBUE remains relatively low, at approximately 40% in the U.S. and 27% in the community setting, representing both a risk and an opportunity.
• Thompson acknowledged the unsuccessful outcome of the COMPASS Prader-Willi syndrome study, indicating ongoing knowledge-sharing from the trial.
• Reimbursement in Europe and IRA price negotiations for NUPLAZID were raised as potential future challenges, with management outlining ongoing engagement with payers and regulatory agencies.

Final Takeaway

ACADIA’s management reiterated its confidence in surpassing $1 billion in total revenues for 2025, underpinned by record performance from DAYBUE and NUPLAZID, continued investment in commercial expansion, and a robust R&D pipeline with four major study readouts expected by 2027. The company remains focused on leveraging its commercial momentum, expanding global access, and advancing multiple late-stage clinical programs to drive sustained growth and value for stakeholders.

Read the full Earnings Call Transcript

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San Diego, California-based Acadia (NASDAQ:ACAD) lost ~13%, while Soleno (NASDAQ:SLNO), whose PWS candidate is currently in late-stage development, added ~14%.

Citing topline data from its Phase 3 COMPASS PWS trial, the company said that its intranasal PWS therapy, carbetocin, designed to treat the excessive sense of hunger seen with the disease, didn’t reach the study’s main goal with a statistically significant effect.

The effects in those who received carbetocin failed to show any differentiation from patients treated with placebo on any secondary endpoint, Acadia (NASDAQ:ACAD) added, noting that the safety and tolerability of the drug were consistent with its prior clinical trials.

Given the setback, the company has decided to drop intranasal carbetocin from its pipeline.

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Management View

• Catherine E. Owen Adams, CEO, stated that “Our second quarter performance reinforces the momentum we’re building across all facets of our business from commercial strength to our clinical pipeline and global expansion.” She highlighted total revenue of $264.6 million, with $96.1 million from DAYBUE and $168.5 million from NUPLAZID. Adams emphasized that DAYBUE “has now passed stabilization, moved into growth and is entering a new phase, expansion and acceleration,” and noted the impact of patient support and field expansion efforts. For NUPLAZID, Adams pointed to litigation wins that “validate our long-term strategy and reinforce our ability to deliver NUPLAZID to patients through 2038.”
• Thomas Andrew Garner, Chief Commercial Officer, noted DAYBUE’s Q2 sales of $96.1 million and the increase in unique U.S. patients to 987, up from 954 in Q1. He said long-term persistency remains strong with an 18-month persistency rate above 45%. Garner reported that “one of the most promising indicators in the second quarter is a meaningful uptick in our proportion of new referrals coming outside of Centers of Excellence,” and the direct-to-consumer campaign for DAYBUE launched in July is seeing “positive signs of early engagement.”
• Mark C. Schneyer, CFO, stated, “The second quarter was strong across the board with $264.6 million in total revenues, up 9% year-over-year.” Schneyer announced, “We are raising the low end of our NUPLAZID guidance range, reflecting the strength of the business and its performance to date. We now expect NUPLAZID net product sales for the year to be between $665 million and $690 million.” He added, “We are reiterating all other prior guidance ranges from our Q1 call.”
• Elizabeth H. Z. Thompson, EVP, Head of R&D, described pipeline momentum with “9 disclosed programs in development and 5 Phase II or Phase III data readouts expected through 2027.” Thompson highlighted upcoming milestones, including a Phase II study of ACP-204 in Lewy body dementia psychosis and a Phase III study of trofinetide in Japan beginning in Q3 2025, and top line COMPASS PWS Phase III data for ACP-101 in early Q4 2025.

Outlook

• Management increased 2025 full-year NUPLAZID net product sales guidance to a range of $665 million to $690 million, up from previous guidance of $650 million to $690 million.
• U.S.-only total revenue guidance was adjusted to reflect the change in NUPLAZID guidance. All other prior guidance ranges from Q1 were reiterated.
• The company expects continued acceleration in DAYBUE new patient starts toward the end of the year as field force expansion and DTC campaigns gain traction.
• Thompson stated, “Between 2025 and 2027, we expect 5 Phase II or Phase III readouts.”

Financial Results

• Total revenue for Q2 2025 was reported at $264.6 million, a 9% year-over-year increase.
• DAYBUE net product sales totaled $96.1 million, representing 14% year-over-year growth and 12% volume growth.
• NUPLAZID net product sales reached $168.5 million, a 7% year-over-year increase, with 5% attributable to volume.
• Gross to net adjustment for DAYBUE was 23.3%, and for NUPLAZID was 24.6%.
• R&D expenses were $78 million, up from $76.2 million in Q2 2024; SG&A expenses were $133.5 million, up from $117.1 million in Q2 2024, reflecting increased investment in U.S. commercial operations.
• Cash balance at quarter end was $762 million, up from $681.6 million at Q1 end.

Q&A

• Tessa Thomas Romero, JPMorgan: Asked about ACP-101 top line details and risk management in clinical trials. Thompson responded that the focus would be on the primary endpoint and key safety/tolerability overview, with robust monitoring of assessment variability.
• Ritu Subhalaksmi Baral, TD Cowen: Inquired about DAYBUE community growth and HCP writers. Garner said “the number of referrals that were coming directly from our non-COE accounts actually grew to about 3/4 of our overall number… up from about 2/3 the quarter before.” For new writers, “the vast majority… fell outside of the COEs.”
• Michael H. Riad, Morgan Stanley: Asked about DAYBUE patient growth trajectory. Garner indicated expectations for acceleration as the new customer model takes effect, aiming for continued increases in new patient starts.
• Jason Nicholas Butler, Citizens JMP: Questioned NUPLAZID investment strategy. Adams explained that DTC spend will continue to focus on the short-to-medium term, with longer-term strategy under consideration, supported by ongoing campaign success.
• Brian Corey Abrahams, RBC: Asked about DAYBUE persistency and physician education. Garner reported “12-month persistency remains well above 50%… our 18-month persistency… is above 45%.”
• Ami Fadia, Needham: Sought color on NUPLAZID volume and DAYBUE persistency outside COEs. Garner confirmed “NBRx volume was kind of reflected across all channels,” and real-world 18-month persistency stands at about 45%.
• Marc Harold Goodman, Leerink: Asked about DAYBUE discontinuations and inventory. Garner said discontinuations were “well below 10%.” Schneyer noted no significant inventory changes.
• Ashwani Verma, UBS: Inquired about NUPLAZID IRA eligibility and ACP-101 formulation. Schneyer said “2029 will be the first year that NUPLAZID is eligible for negotiation unless there’s changes in the legislation.”
• Additional questions covered pipeline prioritization, growth drivers for 2026, and upcoming clinical milestones. Management provided detailed responses without deflections, emphasizing confidence in commercial momentum and pipeline breadth.

Sentiment Analysis

• Analysts focused on persistency, patient growth, community penetration, and pipeline milestones, reflecting a slightly positive and constructive tone, with several congratulatory remarks on quarterly progress.
• Management maintained a confident and upbeat tone in both prepared remarks and responses, frequently highlighting momentum and execution. Adams stated, “Our teams are executing with urgency and precision,” and Thompson described pipeline progress as “tangible.”
• Compared to the previous quarter, both analysts and management demonstrated increased confidence and optimism, with less focus on operational risks or competitive threats.

Quarter-over-Quarter Comparison

• The current quarter saw a raised NUPLAZID guidance and a clear acceleration in DAYBUE patient growth, compared to stable guidance and steady growth in Q1 2025.
• Management’s language shifted from a focus on stabilization and foundation-building to expansion, acceleration, and global growth.
• Analysts in Q2 asked more about execution on new field force models and persistency trends, versus earlier questions on post-stabilization growth and guidance sustainability.
• Key metrics such as DAYBUE patient count and persistency rates continued to improve, with stronger topline results and higher cash balances reported.

Risks and Concerns

• Management acknowledged gross to net adjustments, increased SG&A and R&D spending, and ongoing regulatory processes as factors to monitor.
• Questions on IRA price negotiation eligibility for NUPLAZID and trial conduct for ACP-101 indicated continued vigilance on policy and trial execution risks.
• No new material risks or negative surprises were disclosed during the quarter.

Final Takeaway

ACADIA Pharmaceuticals delivered a second quarter marked by revenue growth, improved patient persistency, and expanding community penetration for DAYBUE, alongside increased guidance for NUPLAZID sales. Management highlighted progress across its clinical pipeline with multiple late-stage readouts anticipated through 2027, while maintaining a strong balance sheet and disciplined investment. The company expressed confidence in sustaining commercial momentum and advancing its portfolio, positioning itself for further growth in the second half of 2025 and beyond.

Read the full Earnings Call Transcript

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