Executive Summary

Q3 2025 revenue rose 14% y/y to $116.1M, but missed S&P Global consensus of $138.0M; EPS (ADS) was -$0.33 vs -$0.27 consensus, reflecting a softer-than-expected top line and continued investment; FY25 revenue guidance cut to at least $460M from $560–$590M. *
Commercial highlights: VYVGART revenue grew sequentially to $27.7M despite a one-time $2.4M price adjustment ahead of NRDL; ZEJULA declined y/y amid PARPi competition; NUZYRA and XACDURO grew, with the latter constrained by supply.
Operating loss improved 28% y/y to $48.8M and adjusted operating loss improved 42% y/y to $28.0M; cash and equivalents were $817.2M at quarter end, providing operational flexibility.
Pipeline remains the key medium-term catalyst: DLL3 ADC “zoci” (ZL-1310) entered a global registrational study in 2L+ ES-SCLC with best-in-class potential; KarXT added to China’s schizophrenia guidelines with launch prep underway.

What Went Well and What Went Wrong

What Went Well

Zoci (DLL3 ADC) advanced to a global registrational trial with compelling Phase 1 data (ORR 68% at 1.6 mg/kg; 80% intracranial ORR in untreated brain metastases; Grade ≥3 TRAEs 13%), supporting first- and best-in-class potential. “We are demonstrating the speed, scientific rigor, and global ambition of our R&D engine.”
VYVGART commercial durability improved: average vials per patient increased >30% YTD; nearly 21,000 patients treated to date; updated MG guidelines catalyzing movement toward maintenance therapy.
Cost discipline: R&D down to $47.9M (from $66.0M y/y) and adjusted operating loss improved 42% y/y to $28.0M.

What Went Wrong

Top-line miss vs consensus: Total revenue $116.1M vs $138.0M consensus, driven by VYVGART price adjustment (-$2.4M) and measured adoption curve; ZEJULA continued y/y pressure from competitive dynamics. *
Profitability timing pushed out: Management now expects profitability beyond Q4 2025 given a lower revenue base, from prior “on track to Q4 profitability” stance in Q2.
XACDURO supply constraints limited upside despite robust demand; ZEJULA share gains delayed as VBP timing and generics dynamics remained choppy.

Financial Results

Summary P&L (Actuals)

Metric	Q1 2025	Q2 2025	Q3 2025
Total Revenues ($M)	$106.49	$109.98	$116.10
Product Revenue ($M)	$105.65	$109.09	$115.36
Collaboration Revenue ($M)	$0.84	$0.89	$0.73
EPS (ADS, diluted) ($)	-$0.45	-$0.37	-$0.33
Loss from Operations ($M)	-$56.31	-$54.90	-$48.82
Adjusted Loss from Operations ($M)	-$37.05	-$34.19	-$28.00

Note: Adjusted loss excludes depreciation, amortization, and share-based compensation.

Q3 2025 vs S&P Global Consensus

Metric	Consensus	Actual	Surprise ($)	Surprise (%)	# of Est.
Total Revenues ($M)	$138.00*	$116.10	-$21.90	-15.9%	1*
EPS (ADS, diluted) ($)	-$0.27*	-$0.33	-$0.06	n/a	3*

Values marked with * retrieved from S&P Global.

Operating Expenses and Cash

Metric	Q1 2025	Q2 2025	Q3 2025
R&D Expense ($M)	$60.73	$50.61	$47.93
SG&A Expense ($M)	$63.42	$71.04	$70.11
Cash, Cash Equivalents, ST Investments & Current Restricted Cash ($M)	$857.3 (3/31)	$832.3 (6/30)	$817.2 (9/30)

Product Sales Breakdown

Product Revenue ($M)	Q1 2025	Q2 2025	Q3 2025
VYVGART (incl. Hytrulo)	$18.1	$26.5	$27.7 (incl. -$2.4 price adj.)
ZEJULA	$49.5	$41.0	$42.4
XACDURO	—	$4.6	$6.4
NUZYRA	$15.1	$14.3	$15.4

KPIs and Commercial Indicators

KPI	Q3 2025
VYVGART patients treated to date	~21,000
VYVGART penetration in gMG	~12%
Avg vials/patient	>30% YTD increase vs 2024
VYVGART sequential volume	Mid-teens growth QoQ
VYVGART Hytrulo price adjustment impact	-$2.4M in Q3

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Total Revenues	FY 2025	$560–$590M (Q1 and Q2 reaffirmations)	≥$460M	Lowered

Management also signaled profitability (non-GAAP) now expected beyond Q4 2025 vs “on track for Q4” in Q2.

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 & Q2)	Current Period (Q3 2025)	Trend
VYVGART launch dynamics	Q1: rebound after seasonal dip; NRDL in effect; building access . Q2: record utilization; July MG guidelines bolster acute and maintenance use .	Durable growth drivers: more patients, longer duration; ~21k treated; ~12% penetration; mid-teens sequential volume; $2.4M price adjustment headwind in Q3 .	Positive underlying demand/duration; pricing/NRDL optics near term.
ZEJULA competition	Q1: leading PARPi in hospitals . Q2: y/y pressure; awaiting VBP/generics dynamics .	Sequential improvement; y/y still softer; share gains expected as VBP and generics settle .	Mixed near term; potential share gains into 2026.
XACDURO supply	Q2: launch traction .	Demand robust but supply constraints limit upside; normalization targeted by year-end .	Near-term constrained; improving into 2026.
Profitability timeline	Q1/Q2: on track for Q4 non-GAAP profitability .	Now pushed beyond Q4 due to lower revenue base .	Slower path; still improving.
Zoci (DLL3 ADC)	Q1/Q2: ASCO data; Fast Track; registrational start 2H25 .	Registrational study initiated; strong efficacy/safety including intracranial activity .	Accelerating; high conviction asset.
KarXT China	Q2: pending approval; prep for launch .	Included in national guidelines; targeted launch plan; NRDL aim in 2027 .	Readying launch; meaningful 2026–27 driver.
Regulatory/macro (NRDL)	Q2: MG guidelines (July) supportive .	VYVGART Hytrulo price alignment ahead of NRDL; guidelines aiding maintenance adoption .	Structural tailwind for duration; near-term pricing effects.

Management Commentary

“Zai Lab is entering the next phase of our growth, powered by the rapid advancement of our global pipeline and supported by a commercially profitable and scalable business in China.” — Dr. Samantha Du, CEO
“In gMG, we are seeing steady new patient starts and increasing treatment duration… While adoption is building gradually, physician confidence continues to grow and reinforces the long-term potential of VYVGART.” — Josh Smiley, President/COO
“Loss from operations improved 28%... adjusted loss from operations… was $28 million… While we expect meaningful quarter-over-quarter improvement… we now expect profitability to shift beyond the fourth quarter.” — Yajing Chen, CFO
“At the 1.6 mg/kg dose, we observed an overall response rate of 68%… and 80% in untreated brain metastases… Grade ≥3 TRAEs 13%… positioning zoci as an ideal candidate for first-line combinations.” — Dr. Rafael Amado, President & Head of Global R&D

Q&A Highlights

Guidance reset and path to profitability: Lower revenue base (slower VYVGART treatment duration ramp; ZEJULA dynamics; XACDURO supply) pushes profitability beyond Q4; China business remains commercially profitable; 2026 update forthcoming.
VYVGART trajectory: Focus on moving patients to at least three cycles with guidelines support; expecting low-teens sequential volume growth into 2026.
ZL-1503 (IL-13/IL-31R) expectations: First-in-human program across healthy volunteers and AD patients; potential for brisk, sustained efficacy; initial data in 2026.
KarXT launch setup: Concentrated institutional deployment; significant unmet need given no new mechanisms in ~70 years; approval hoped near term, launch in 2026, NRDL in 2027.
Bema (bemarituzumab) update: After Amgen disclosures, management views China approval path as “very challenging”; evaluating resource reallocation.

Estimates Context

Q3 2025 missed S&P Global consensus on revenue ($116.10M vs $138.00M*) and EPS (ADS) (-$0.33 vs -$0.27*), with limited estimate coverage (Rev: 1; EPS: 3), suggesting potential model dispersion. *
Factors behind the miss: one-time -$2.4M VYVGART Hytrulo price adjustment, measured ramp to maintenance dosing, ZEJULA class pressures, and XACDURO supply constraints.
Forward adjustments: Consensus likely to move lower for FY25 and modestly for early FY26; offset by rising conviction in zoci timelines (registrational underway) and KarXT launch trajectory.