Executive Summary

Q1 2025 total revenues were $897.8M, down 0.5% YoY and below consensus ($984.0M), while non-GAAP EPS of $1.68 missed consensus ($4.66) due to a $172M Xyrem antitrust settlement charge booked in SG&A; GAAP LPS was $(1.52) . Revenue Consensus Mean: $983.8M*, Primary EPS Consensus Mean: $4.66*; Primary EPS - # of Estimates: 16*, Revenue - # of Estimates: 17*. Values retrieved from S&P Global.
Neuroscience strength continued: Xywav +9% YoY to $344.8M and Epidiolex +10% YoY to $217.7M; oncology was softer (Rylaze −8% YoY, Zepzelca −16%) given protocol changes and competition .
2025 guidance: Total revenue affirmed at $4.15–$4.40B; SG&A (non-GAAP) raised to $1.47–$1.53B and R&D (non-GAAP) raised to $760–$810M to reflect Chimerix acquisition; non-GAAP ANI lowered to $250–$350M (from $1.4–$1.5B prior) given $885M acquired IPR&D related to Chimerix and the litigation settlements .
Catalysts: ASCO oral presentation for Zepzelca 1L ES-SCLC maintenance data (June), HERIZON‑GEA‑01 top-line in 2H25, and dordaviprone PDUFA on Aug 18, 2025; management reiterated confidence in 2025 revenue outlook and minimal direct tariff impact in 2025 .

What Went Well and What Went Wrong

What Went Well

Xywav and Epidiolex delivered growth: Xywav +9% YoY to $344.8M and Epidiolex +10% YoY to $217.7M; management cited robust demand and patient adds, with ~14,600 active Xywav patients exiting Q1 (≈450 net adds) .
Pipeline/regulatory progress: sNDA submitted for Zepzelca 1L ES‑SCLC maintenance; CHMP positive opinion for zanidatamab in 2L BTC; HERIZON‑GEA‑01 PFS readout expected 2H25 .
Chimerix acquisition completed, adding near-term commercial opportunity (dordaviprone) with Priority Review and Aug 18, 2025 PDUFA date .

What Went Wrong

Oncology softness: Rylaze −8% YoY to $94.2M (COG protocol timing) and Zepzelca −16% YoY to $63.0M (competition, delayed progression to 2L), driving overall oncology net sales down 11% YoY .
Litigation impact: $172.0M SG&A charge tied to Xyrem antitrust settlements reduced non-GAAP EPS by $2.34 and GAAP by $2.38; GAAP net loss was $(92.5)M .
Top-line miss vs Street: Revenue ($897.8M) and non-GAAP EPS ($1.68) missed consensus, partly reflecting seasonality (Epidiolex inventory burn) and one fewer U.S. oncology shipping week in the quarter .

Financial Results

Metric	Q1 2024	Q3 2024	Q4 2024	Q1 2025
Total Revenues ($USD Millions)	$902.0	$1,055.0	$1,088.2	$897.8
GAAP EPS ($)	$(0.23)	$3.42	$3.11	$(1.52)
Non-GAAP EPS ($)	$2.63	$6.61	$6.60	$1.68
Gross Margin % (GAAP)	88.7%	88.7%	87.4%	87.5%
Gross Margin % (Non-GAAP)	92.4%	92.6%	91.6%	91.7%

Segment/Product Revenues ($USD Millions)

Product	Q3 2024	Q4 2024	Q1 2025
Xywav	$388.5	$401.0	$344.8
Xyrem	$58.1	$49.3	$37.2
Epidiolex/Epidyolex	$251.6	$275.0	$217.7
Rylaze/Enrylaze	$98.8	$101.5	$94.2
Zepzelca	$85.8	$78.3	$63.0
Defitelio/defibrotide	$65.8	$57.7	$40.7
Vyxeos	$34.3	$53.2	$29.5
Ziihera (zanidatamab)	—	$1.1	$2.0
High‑sodium oxybate AG royalties	$58.2	$55.3	$48.9

Key KPIs

KPI	Q3 2024	Q4 2024	Q1 2025
Active Xywav patients (approx.)	13,625	14,150	14,600
Net Xywav patient adds	~400	~525	~450
IH patients (subset of active Xywav)	~3,550	~3,900	~4,225

Estimate Comparison (Street vs Actual) – Q1 2025

Metric	Consensus	Actual	# of Estimates
Revenue ($USD)	$983.8M*	$897.8M	17*
Primary EPS ($)	$4.66*	$1.68	16*

Values retrieved from S&P Global.

Guidance Changes

Metric	Period	Previous Guidance (Feb 25, 2025)	Current Guidance (May 6, 2025)	Change
Total Revenues ($B)	FY 2025	$4.15–$4.40	$4.15–$4.40	Maintained
Gross Margin % (GAAP)	FY 2025	88%	88%	Maintained
Gross Margin % (Non-GAAP)	FY 2025	92%	92%	Maintained
SG&A ($M, Non-GAAP)	FY 2025	$1,250–$1,310	$1,470–$1,530	Raised (Chimerix + settlements)
R&D ($M, Non-GAAP)	FY 2025	$720–$770	$760–$810	Raised (dordaviprone programs)
Effective Tax Rate (Non-GAAP)	FY 2025	13%–15%	35%–45%	Raised (mix/adjustments)
Net Income (GAAP)	FY 2025	$560–$720	$(615)–$(450)	Lowered (to loss: AIPR&D + settlements)
GAAP EPS ($)	FY 2025	$9.15–$11.50	$(10.00)–$(7.50)	Lowered
Net Income (Non-GAAP)	FY 2025	$1,400–$1,500	$250–$350	Lowered (AIPR&D + settlements)
Non-GAAP EPS ($)	FY 2025	$22.50–$24.00	$4.00–$5.60	Lowered
Acquired IPR&D ($M)	FY 2025	—	$870–$900	Added (Chimerix)

Note: Guidance updates explicitly incorporate the Chimerix acquisition (closed Apr 21) and $172M Xyrem antitrust settlements; the combined impact is ~$1.0B pre-tax adjustments, driving lower GAAP and non-GAAP ANI .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q3 2024)	Previous Mentions (Q4 2024)	Current Period (Q1 2025)	Trend
Tariffs/macro & supply chain	Noted general macro; no direct impact quantified	No direct 2025 tariff impact discussed; inventory strength	Sufficient U.S. inventory for 2025; de minimis direct tariff impact; U.S. CMO capacity for oxybate	Stable/Prepared
Oxybate market dynamics	Xywav growth; AG royalties up; Xyrem erosion	Xywav record Q4; warned 2026 generic dynamics	Xywav +9% YoY; majority adds new-to-oxybate; IH growth; LUMRYZ IH path blocked by patent/injunction	Positive for Xywav
Zepzelca competitive landscape	Announced positive 1L maintenance trial	Filing plan in 1H25; 2L remains leader	2L pressure from Imdelltra; 1L maintenance expected to be practice-changing; NCCN inclusion targeted	Mixed near-term; improving on 1L
Rylaze protocol impact	Temporary revenue timing shift	Normalization expected early 2025	Normalization expected in Q2; AYA education underway	Improving
Zanidatamab program (Ziihera)	Pan-tumor and GEA Phase 3 ongoing	EmpowHER-BC-303 initiated; $2B+ multi‑indication potential	CHMP positive opinion in 2L BTC; HERIZON‑GEA‑01 top-line in 2H25	Building momentum
Regulatory/legal	Routine forward-looking risk	Epidiolex settlements “late 2030s” runway	Xyrem antitrust class settlement booked ($172M); GAAP loss	Overhang reduced
Corporate development	2030 notes; share buybacks	Active BD, delevered balance sheet	Chimerix acquisition completed; dordaviprone PDUFA 8/18	Accretive pipeline

Management Commentary

“Our focus on execution and operational excellence resulted in solid commercial performance, led by Epidiolex and Xywav… We are affirming our 2025 total revenue guidance range of $4.15–$4.40 billion” — Bruce Cozadd (CEO) .
“We saw strong Epidiolex demand… expect it to reach blockbuster status in 2025” — Renée Galá (President & COO) .
“We completed the submission of an sNDA to expand Zepzelca… results have the potential to be practice-changing” — Rob Iannone (EVP, R&D) .
“This $172M charge… reduced our adjusted net income by $146M and our GAAP and non-GAAP EPS by $2.38 and $2.34 per share” — Phil Johnson (CFO) .

Q&A Highlights

Tariffs/supply chain: Management expects no direct 2025 financial impact; sufficient U.S. inventory and optionality with U.S. oxybate CMO; flexibility to shift manufacturing if needed .
Zepzelca vs Imdelltra: 2L pressure noted; 1L maintenance expansion seen as practice-changing with larger patient pool and longer duration; aim for NCCN inclusion .
Rylaze normalization and AYA strategy: Protocol impact to normalize in Q2; ongoing education to drive AYA usage despite longer ramp vs pediatrics .
Dordaviprone: Priority Review; no AdCom expected; ACTION Phase 3 enrolling; potential to transform care in H3 K27M-mutant diffuse glioma .
Oxybate/IH: Majority narcolepsy adds are new-to-oxybate; IH competitive path for LUMRYZ blocked by patent/injunction through 2036; continued payer coverage (>90% commercial lives) .

Estimates Context

Q1 2025 results were below Street: Revenue $897.8M vs $983.8M*, and non-GAAP EPS $1.68 vs $4.66* (Primary EPS). The miss primarily reflects the $172M Xyrem antitrust settlement charge impacting both GAAP and non-GAAP, seasonality (Epidiolex inventory burn), and one fewer U.S. oncology shipping week (~7.7% fewer) .
Outlook: With guidance revised to include $885M acquired IPR&D and higher SG&A/R&D, Street models should recalibrate 2025 non-GAAP ANI/EPS and tax rate to the updated ranges; revenue guidance was affirmed .