Executive Summary

Q4 2024 total revenues rose 66% year over year to $109.1M, with net product revenue at $108.5M; operating loss narrowed 45% YoY to $67.9M as commercial momentum from VYVGART, ZEJULA, and NUZYRA offset costs .
Management issued first-time FY2025 revenue guidance of $560–$590M and reiterated a target to achieve non-GAAP operating profitability in Q4 2025; guidance was framed as ahead of Street per Q&A, a potential stock catalyst .
VYVGART net sales reached $30.0M in Q4 (full-year $93.6M), driven by NRDL inclusion and expanding physician adoption; non-NRDL status for Hytrulo/CIDP limits near-term impact but builds optionality .
Pipeline catalysts: ZL-1310 (DLL3 ADC) showed 74% ORR in Phase 1 and received US FDA Orphan Drug Designation, with an accelerated-approval pathway under discussion and pivotal initiation targeted in 2025 .
Note: CFO commentary cited $839.7M cash at quarter-end vs. $879.7M in the release, likely a slip—press release/8-K detail cash, ST investments, and restricted cash totaling $879.7M as of Dec 31, 2024 .

What Went Well and What Went Wrong

What Went Well

VYVGART’s first full year: $93.6M FY revenue, $30.0M in Q4; prescriber base expanded (>2,000), maintenance-phase utilization increasing; hospital listings achieved at targeted sites (~65% market potential) .
Operating discipline: loss from operations improved 45% YoY in Q4 (non-GAAP adjusted loss from operations down 53% YoY), reflecting expense control and revenue scale .
Pipeline momentum and regulatory progress: ZL-1310 74% ORR and FDA Orphan Drug Designation; KarXT NDA accepted in China; TTFields PANOVA-3 met OS primary endpoint; multiple China submissions planned in 1H25 .

Management quote: “2024 was a defining year… 2025 is set to be a transformative year with VYVGART’s continued momentum, three new product launches, progress with ZL-1310, and potential regulatory milestones” — CEO Dr. Samantha Du .

What Went Wrong

EPS and net loss remained negative in Q4 as interest income declined and FX losses rose; Q4 net loss was $81.7M, loss per ordinary share $(0.08) (ADS $(0.80)) .
Hytrulo/CIDP growth constrained near term: CIDP and Hytrulo not on NRDL in 2025, limiting impact to supplemental insurance/cash-pay channels .
SG&A remained elevated (flat YoY in Q4; up for the year) due to commercialization, partially offset by declines in other selling and G&A categories .

Financial Results

Consolidated Results vs. Prior Periods

Metric	Q2 2024	Q3 2024	Q4 2024
Total Revenues ($USD Millions)	$100.504	$102.265	$109.070
Product Revenue, Net ($USD Millions)	$100.106	$101.847	$108.512
Loss from Operations ($USD Millions)	$(76.064)	$(67.853)	$(67.891)
Net Loss ($USD Millions)	$(80.277)	$(41.671)	$(81.684)
Loss per Ordinary Share (Basic & Diluted)	$(0.08)	$(0.04)	$(0.08)
Adjusted Loss from Operations (Non-GAAP) ($USD Millions)	N/A	$(48.187)	$(47.621)

Notes:

Year-over-year Q4 growth: total revenues +66% YoY; product revenue +65% YoY .
EBIT Margin % (computed from loss from operations ÷ total revenues): Q2 -75.7% ; Q3 -66.3% ; Q4 -62.2% .
FX impact: Q4 foreign currency loss $(23.418)M vs. gain in Q3 .

Product Revenue Breakdown

Product	Q2 2024	Q3 2024	Q4 2024
VYVGART (incl. Hytrulo) ($USD Millions)	$23.2	$27.3	$30.0
ZEJULA ($USD Millions)	$45.0	$48.2	$48.4
NUZYRA ($USD Millions)	$12.3	$10.0	$11.0

Drivers:

VYVGART growth supported by NRDL listing (effective Jan 1, 2024) and expanding prescriber base .
ZEJULA maintained leadership in hospital sales for ovarian cancer in China .
NUZYRA growth aided by IV (Jan 2023) and oral (Jan 2024) NRDL inclusion; IV NRDL renewed Jan 2025 .

KPIs and Operating Metrics

KPI	Q3 2024	Q4 2024	Commentary
Physicians prescribing VYVGART	N/A	>2,000	Breadth/depth expanding; top 300 prescribers engaged
Hospital listings coverage (gMG potential)	N/A	~65%	Targeting next wave to ~85%
Maintenance-phase return rate	~40% of Q3 starters returned in Q4	~40%	Supports multi-cycle adherence
New patient initiations	N/A	~1,000 per month	Growing maintenance-phase starts
Market size / penetration	gMG ~170,000; penetration <10%	~170,000; <10%	Significant runway

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Total Revenue	FY 2025	None (first-time total revenue guidance)	$560M–$590M	Initiated guidance
Profitability (Non-GAAP Operating Income)	Q4 2025	“Path to profitability by end of 2025” (prior commentary)	Achieve profitability in Q4 2025	Clarified timeline
Product-specific guidance (VYVGART/ZEJULA/NUZYRA, OpEx, tax)	FY 2025	Not provided	Not provided	N/A

Earnings Call Themes & Trends

Topic	Q2 2024 (Previous Mentions)	Q3 2024 (Previous Mentions)	Q4 2024 (Current)	Trend
VYVGART commercial ramp	NRDL-driven ramp; raised full-year VYVGART to >$80M	“Blockbuster” trajectory; $27.3M Q3	$30.0M Q4; >2,000 prescribers; 40% maintenance returns; targeting ~85% hospital coverage	Accelerating
Hytrulo/CIDP launch	NMPA accepted sBLA; global ADHERE data context	NMPA approval for CIDP; Hytrulo SC for gMG	Not on NRDL 2025; limited near-term impact; building access via supplemental channels	Build optionality; near-term constrained
ZL-1310 (DLL3 ADC)	Enrollment ongoing; end-2024/early-2025 data expected	74% ORR preliminary; best-in-class potential	Orphan Drug Designation; pivotal start 2025; accelerated approval discussions; 2027 approval path	De-risking; advancing
KarXT (schizophrenia)	China bridging study progressing; NDA expected	Bridging study positive; NDA early 2025	NDA accepted (Jan 2025); commercial plan for China	Toward launch
TTFields (pancreatic/NSCLC)	PANOVA-3 topline H2 2024 expected	—	PANOVA-3 met OS; China filing H2 2025	Positive data; filing planned
Revenue guidance	No total revenue guidance	No total revenue guidance	First-time total revenue guidance $560–$590M	New transparency

Management Commentary

CEO strategic framing: “2024 was a defining year… 2025 is set to be a transformative year with VYVGART’s continued momentum, three new product launches, progress with ZL-1310, and potential regulatory milestones for key assets” — Dr. Samantha Du .
Commercial outlook: “We expect substantial topline growth… targeting $2 billion in revenue by 2028… and advancing towards our goal of achieving profitability in the fourth quarter of 2025” — Josh Smiley .
Pipeline confidence: “We think we have an opportunity to achieve accelerated approval [for ZL-1310]… other DLL3 products are much earlier… we could be the first ones to be approved” — Dr. Rafael Amado .
China launch strategy for KarXT: focus on ~150 sales reps in major treatment centers; unmet need vs. atypical antipsychotics .

Q&A Highlights

Guidance vs. consensus: Analysts noted FY2025 revenue guidance ahead of consensus; management expects faster growth in VYVGART vs. base business, with contributions from ZEJULA, NUZYRA, AUGTYRO, and XACDURO .
VYVGART trajectory: Expect stronger H2 ramp driven by maintenance-phase cycles, guideline update tailwinds, and hospital access expansion; seasonal fluctuations possible .
ZL-1310 regulatory path: Accelerated approval pathway under discussion; pivotal start in 2025; competitive positioning vs. tarlatamab and B7-H3 agents discussed, with higher ORR cited .
CIDP/Hytrulo commercialization: Not NRDL-listed in 2025; limited impact expected; focus remains IV gMG while enabling access via supplemental channels .
Pove (IgAN) timeline: China enrollment ongoing; aim for accelerated approval; positioning on dosing (q4 weeks) and global data breadth .

Estimates Context

S&P Global consensus (EPS and revenue) for Q4 2024 was unavailable due to data access limits during retrieval; therefore, explicit consensus figures and beat/miss calculations cannot be provided. The call noted FY2025 revenue guidance “came in ahead of consensus,” suggesting potential upward estimate revisions for topline growth .
Expect analysts to adjust models for: VYVGART maintenance-phase persistence, Hytrulo/CIDP limited near-term contribution, ZEJULA/NUZYRA steady growth, and incremental launches (AUGTYRO, XACDURO) .

Key Takeaways for Investors

Commercial engine is scaling: VYVGART momentum and multi-cycle maintenance use underpin sustained revenue growth; ZEJULA and NUZYRA provide reliable base strength .
First-time FY2025 revenue guidance ($560–$590M) and a more precise profitability timeline (Q4 2025) improve visibility; the guidance was framed as above consensus in Q&A, a potential sentiment catalyst .
ZL-1310 is a high-impact, near-term pipeline asset with 74% ORR, ODD status, and an accelerated pathway being pursued; pivotal initiation in 2025 could reset the narrative around global innovation .
Near-term drag: CIDP/Hytrulo not NRDL-listed in 2025 tempers contribution; focus remains gMG IV while building access programs, implying a back-half weighted revenue ramp .
Balance sheet robust for execution: $879.7M cash/ST investments/current restricted cash at year-end supports launches and pivotal development; note discrepancy vs. CFO remark ($839.7M) on call .
2025 catalysts: KarXT China review and commercialization setup; TTFields China filing; bemarituzumab Phase 3 readouts/NMPA submission; ZL-1310 monotherapy/combo updates and pivotal start .
Trading implication: Expect estimate momentum to follow guidance and VYVGART adoption signals; watch ASCO/major medical conference for ZL-1310 updates as a binary catalyst and potential multiple expansion driver .

Zai Lab Ltd (ZLAB)·Q4 2024 Earnings Summary