Executive Summary

Solid first quarter: revenue rose 74% YoY to $205.8M on continued NUPLAZID growth ($129.9M, +10% YoY) and DAYBUE contributions ($75.9M), with GAAP diluted EPS of $0.10 and cash/investments of $470.5M .
DAYBUE sequentially declined 13% vs Q4 on seasonality and higher gross-to-net (10% fewer bottles, 3% lower net price), but management reported net patient adds in each of the last six weeks into early May and reiterated 2024 guidance, expecting quarterly growth from here .
FY24 guidance maintained: DAYBUE net sales $370–$420M; NUPLAZID $560–$590M; R&D $305–$325M; SG&A $455–$480M, unchanged from Feb. 27; cash balance increased $31.6M QoQ to $470.5M in a seasonally weak quarter .
Commercial and pipeline execution: ~1 in 4 diagnosed Rett patients have initiated DAYBUE; persistency at 9 months is 58% vs 47% in the clinical rollover cohort; ex-U.S. progress includes Canada priority review and EU PIP alignment; NUPLAZID continues to outpace the market and optimize cash flow .

What Went Well and What Went Wrong

What Went Well
- “Approximately 1 in 4 diagnosed Rett patients have initiated therapy with DAYBUE” with >650 prescribers and >80% of lives covered; real-world persistency ~10 pts above trial rollovers and dose compliance ~75–80% of label .
- NUPLAZID net sales $129.9M (+10% YoY), outperforming the PD market in both office-based and LTC channels; gross-to-net 33.1% in Q1 .
- International and pipeline momentum: Canada DAYBUE submission accepted with priority review; EU PIP agreed enabling anticipated filing in Q1 2025; Phase 3 PWS and seamless Phase 2/3 AD psychosis programs enrolling .
What Went Wrong
- DAYBUE net sales fell 13% QoQ on seasonality (fewer Rett clinic days, reauthorization processes) and higher gross-to-net; mix effects also drove a 10% bottle reduction and ~3% net price headwind .
- Early-launch dynamics led to an increase in numerical discontinuations during much of Q1 (lag effect from prior quarters’ starts), though management believes this has peaked and net adds resumed in recent weeks .
- Gross margin compressed sequentially given higher cost of product sales vs Q4 (mix and normalization post initial launch), and SG&A increased YoY to support DAYBUE annualization and ex-U.S. foundations .

Financial Results

Metric	Q3 2023	Q4 2023	Q1 2024
Revenue ($M)	$211.7	$231.0	$205.8
Cost of Product Sales ($M)	$14.6	$17.9	$23.0
Gross Profit ($M)	$197.1 (calc from rev–COGS using )	$213.1 (calc using )	$182.9 (calc using )
Gross Margin %	93.1% (calc using )	92.3% (calc using )	88.9% (calc using )
Income (Loss) from Operations ($M)	$(57.8)	$34.9	$15.2
Operating Margin %	(27.3)% (calc using )	15.1% (calc using )	7.4% (calc using )
Net Income (Loss) ($M)	$(65.2)	$45.8	$16.6
Net Income Margin %	(30.8)% (calc using )	19.8% (calc using )	8.0% (calc using )
Diluted EPS ($)	$(0.40)	$0.28	$0.10
Cash, Equivalents & Investments ($M, period-end)	$345.9	$438.9	$470.5

Segment/Product Sales

Product Net Sales ($M)	Q3 2023	Q4 2023	Q1 2024
NUPLAZID	$144.8	$143.9	$129.9
DAYBUE	$66.9	$87.1	$75.9
Total	$211.7	$231.0	$205.8

Operating Expense Detail

OpEx ($M)	Q3 2023	Q4 2023	Q1 2024
R&D	$157.0 (incl. $100M trofinetide rights)	$66.7	$59.7
SG&A	$97.9	$111.5	$108.0

Key KPIs and Commercial Drivers

KPI	Q3 2023	Q4 2023	Q1 2024
DAYBUE real-world persistency	4-mo persistency 75–81% vs 65% in LILAC-1 (framework)	6-mo persistency 70% (update)	9-mo persistency 58% vs 47% LILAC (10-pt delta)
DAYBUE compliance to dose	~75–80% of label	~75–80%	~75–80%
DAYBUE coverage	~80% lives covered by Nov	—	>80% lives covered
DAYBUE active patients	~800 on therapy (as of 9/30)	~860 on therapy at year-end; ~860 by Feb 27	862 active as of week ending May 3; net adds last 6 weeks
NUPLAZID gross-to-net	19.9% in Q3	27.5% in FY; 24.3% FY gross-to-net	33.1% in Q1

Notes: DAYBUE Q1 sequential decline: bottles –10% and net price –3% from higher gross-to-net .

YoY context: Q1 2024 revenue +74% YoY (press release) .

Guidance Changes

Metric	Period	Previous Guidance (2/27/24)	Current Guidance (5/8/24)	Change
DAYBUE Net Product Sales	FY 2024	$370–$420M	$370–$420M	Maintained
NUPLAZID Net Product Sales	FY 2024	$560–$590M	$560–$590M	Maintained
R&D Expense (GAAP)	FY 2024	$305–$325M	$305–$325M	Maintained
SG&A Expense (GAAP)	FY 2024	$455–$480M	$455–$480M	Maintained

Management reiterated all FY24 guidance on May 8 .

Earnings Call Themes & Trends

Topic	Q3 2023 (two quarters back)	Q4 2023 (prior quarter)	Q1 2024 (current)	Trend
DAYBUE demand and persistency	Surge at launch; 800+ patients; 4-mo persistency 75–81% vs 65% LILAC; access ~80% lives	Persistency improving at 4–6 months; reiterated linear growth trajectory post-surge	Seasonal dip in Q1; 9-mo persistency 58% vs 47% LILAC; net adds resumed; education on GI mgmt/titration	Stabilizing/improving persistency; sequential growth expected
DAYBUE GI management / titration	Emphasis on titration; label guidance; caregiver education	Continued messaging; 75–80% of label dose	Best practice push across COEs/community; manage early discontinuations	Execution scaling beyond COEs
Payer coverage / gross-to-net	Coverage policies accelerating (~80% lives)	Expect DAYBUE GTN ~20% in 2024; Q4 2023 at 15.4%	Q1 DAYBUE GTN slightly below 20% target; NUPLAZID GTN 33.1%	GTN normalizing upward
Seasonality / clinic days	First holiday season ahead flagged	December refills pull-ahead; January slowdown; Q1 guide given	Fewer Rett clinic days and reauths drove Q1; sequential growth expected going forward	Q1 seasonality digested
Ex-U.S. DAYBUE	Planning EU/Canada/Japan submissions	Canada NDS filing imminent; EU MAA H1’25 plan	Canada priority review accepted; EU PIP agreed; Japan PMDA meeting scheduled	Regulatory progress
NUPLAZID franchise	Share gains; strong cash flow	2024 guidance $560–$590M; GTN seasonality noted	Q1 sales $129.9M; outpaced market; optimize cash flow	Steady

Management Commentary

CEO on DAYBUE adoption: “Approximately 1 in 4 diagnosed Rett patients have initiated therapy with DAYBUE… We’ve established a very broad prescriber base with over 650 individual writers… and broad access with over 80% of Rett lives covered” .
COO on persistency: “Real-world persistency rate is 58% [at 9 months] compared with 47%… in LILAC… We believe the enduring population could be approximately half of patients who initiate therapy” .
CFO on Q1 drivers: “DAYBUE net product sales… a sequential decline of 13%… comprised of a 10% reduction in bottles sold and a 3% reduction in net price due to higher gross to net… net patient adds… now back… we are confident in our ability to grow DAYBUE sales on a quarter-by-quarter basis through the remainder of the year” .
Ex-U.S. plans: “PIP… has been agreed upon… paving the way for an anticipated filing in the first quarter of 2025 [EU]. In Japan… formal meeting scheduled with PMDA… In Canada… NDS accepted and granted priority review… potentially leading to an approval… around the end of this year” .

Q&A Highlights

Estimate/guidance confidence: Management reiterated FY24 guidance, citing net patient adds in each of the last six weeks, expecting positive net adds to continue .
Gross-to-net and COE vs community: DAYBUE gross-to-net trending toward 20% for 2024 (slightly below in Q1); persistency does not materially differ between COEs and non-COEs when GI strategies are applied .
Discontinuations cluster early: Discontinuations skew to first 2 fills; focus on titration/time-to-benefit and GI management to reduce early drop-offs .
NUPLAZID growth drivers: Real-world evidence education, increased new patient starts, and long-term care recovery underpin growth; investment level balanced to optimize cash flow .
Business development appetite: Active across early and late-stage; pre-commercial assets a sweet spot; environment more favorable for dealmaking; capital deployment opportunity-dependent .

Estimates Context

We attempted to retrieve S&P Global (Capital IQ) consensus for Q1 2024 revenue and EPS versus prior quarters but were unable to access due to a temporary request limit. As a result, comparisons versus Wall Street consensus are unavailable at this time (we will update upon access restoration). Values would be retrieved from S&P Global if available.

Key Takeaways for Investors

DAYBUE sequential dip looks transitory: Seasonality and gross-to-net drove Q1 softness, but leading indicators (net adds, coverage, persistency) and reiterated guide suggest a return to sequential growth from Q2 onward .
Persistence is tracking ahead of trials: With 9-month persistency ~10 pts above LILAC rollovers and focused GI/titration education, ACAD appears positioned to build an enduring DAYBUE patient base (~half of initiators over time) .
NUPLAZID remains a cash engine: Solid $129.9M Q1 sales, market share gains, and disciplined spend support funding pipeline and ex-U.S. DAYBUE launches .
Guidance unchanged: Maintaining all FY24 ranges boosts confidence in execution; watch DAYBUE bottle trends and GTN normalization as near-term stock drivers .
Upcoming catalysts: Canada DAYBUE decision (around YE 2024), EU filing in Q1 2025, and continued updates on PWS and AD psychosis programs; real-world DAYBUE evidence (e.g., LOTUS) continues to accumulate .
Balance sheet strength: Cash/investments of $470.5M (+$31.6M QoQ) provides flexibility for BD and pipeline without near-term financing needs .

Appendix: Additional Context and Data Points

Revenue and product detail: Q1 2024 total revenue $205.8M; NUPLAZID $129.9M (+10% YoY), DAYBUE $75.9M; “74% revenue growth year over year” .
Profitability: Q1 2024 net income $16.6M; diluted EPS $0.10; non-cash SBC $14.8M .
OpEx dynamics: R&D $59.7M (down YoY due to 2023 pre-approval trofinetide supply), SG&A $108.0M (annualization of DAYBUE and ex-U.S. investments) .
NUPLAZID market dynamics: Q1 GTN 33.1%; demand bottles +4% YoY; sell-in +6% YoY; growth in both office and LTC channels .
DAYBUE real-world data: Interim LOTUS findings reinforce caregiver-reported improvements (e.g., nonverbal communication, alertness, social interaction) and emphasize GI strategy education .

ACADIA PHARMACEUTICALS INC (ACAD)·Q1 2024 Earnings Summary