Executive Summary

Q4 2024 revenue surged 78% year over year to $1.13B, with gross margin expanding to 85.6%; adjusted operating income reached $78.6M, flipping from a loss in Q4 2023 .
BRUKINSA drove results: $828M global sales (+100% YoY), including $616M in the U.S., with ~$30M favorable order timing; TEVIMBRA delivered $154M (+20% YoY) amid approvals in the U.S. and EU .
2025 guidance maintained: total revenue $4.9–$5.3B, mid-80% GAAP gross margin, GAAP operating breakeven and positive operating cash flow; management flagged modest potential tariff cost impacts and seasonal phasing (Q2/Q4 stronger) .
Strategic catalysts: multiple 1H25 proof-of-concept readouts (CDK4, CDK2, B7H4 ADC), continued CLL leadership and BTK degrader progress (planned Phase 3 head-to-head vs pirtobrutinib), and pipeline expansion across solid tumors; patent settlement protects U.S. BRUKINSA to at least June 15, 2037 .

What Went Well and What Went Wrong

What Went Well

BRUKINSA momentum and class leadership in CLL new patient starts; CEO: “BRUKINSA is now the unequivocal leader in new CLL patient starts in the U.S., holds the broadest label of any BTK inhibitor” .
Significant operating leverage: product revenue grew >5x faster than expenses; adjusted operating income of $79M in Q4 and second consecutive quarter of positive operating cash flow .
Regulatory wins for TEVIMBRA (first-line gastric/GEJ adenocarcinoma U.S. approval; EC approvals in ESCC and gastric/GEJ), supporting solid tumor portfolio momentum .

What Went Wrong

Still GAAP net loss in Q4 ($151.9M) despite improvement; EPS was $(0.11) vs $(0.27) prior year .
OpEx increased (R&D +10% YoY; SG&A +21% YoY) driven by pipeline advancement and commercial investment; includes $60M R&D for MAT2A in-license in Q4 .
Collaboration revenue remains small ($9.8M in Q4), down sharply on a full-year basis vs 2023, reflecting lower milestone/royalty flows .

Financial Results

Metric	Q4 2023	Q4 2024
Total Revenue ($USD Millions)	$634.409	$1,127.824
YoY Revenue Growth (%)	—	78%
GAAP Loss from Operations ($USD Millions)	$(383.795)	$(79.425)
Adjusted Income (Loss) from Operations ($USD Millions)	$(267.224)	$78.603
GAAP Gross Margin (%)	83.2%	85.6%
Adjusted Gross Margin (%)	83.7%	87.4%
GAAP Net Loss ($USD Millions)	$(367.553)	$(151.881)
EPS (per share)	$(0.27)	$(0.11)
Cash from Operations ($USD Millions)	$(221.638)	$75.160
vs Estimates (Revenue, EPS)	N/A (S&P Global data unavailable)	N/A (S&P Global data unavailable)

Segment and Brand Mix (Q4 2024):

Segment/Brand	Q4 2024 ($USD Millions)	YoY Growth (%)
BRUKINSA (Global)	$828	100%
BRUKINSA U.S.	$616	97%
BRUKINSA Europe	$113	148%
TEVIMBRA (Global)	$154	20%
Amgen In-licensed Products	$101	98%
Collaboration Revenue	$9.789	152% vs Q4 2023

KPIs and Operating Metrics (Q4 2024):

KPI	Q4 2024
U.S. share of total revenue	55%
Europe share of total revenue	10%
GAAP Total Operating Expenses ($USD Millions)	$1,046.689
Adjusted Total Operating Expenses ($USD Millions)	$907.933
Cash, Cash Equivalents & Restricted Cash ($USD Millions)	$2,638.747

Non-GAAP Notes: Adjustments exclude share-based comp, depreciation and amortization. Reconciliation shows Q4 adjusted OpEx $907.9M vs GAAP $1,046.7M; adjusted operating income $78.6M vs GAAP operating loss $(79.4)M .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Total Revenue	FY2025	$4.9–$5.3B (unchanged)	$4.9–$5.3B	Maintained
GAAP Gross Margin %	FY2025	Mid-80% (unchanged)	Mid-80%	Maintained
GAAP Operating Expenses (R&D+SG&A)	FY2025	$4.1–$4.4B (unchanged)	$4.1–$4.4B	Maintained
GAAP Operating Income	FY2025	Breakeven to positive (unchanged)	Positive GAAP operating income	Maintained
Cash Flow from Operations	FY2025	Positive (unchanged)	Positive CFO	Maintained
FX Assumption	FY2025	Late Jan 2025 rates	Jan 31, 2025 rates	Maintained

Management noted seasonality (Q2 and Q4 typically strongest) and modest potential cost impacts from new U.S. tariffs, mitigated by U.S. manufacturing footprint for BRUKINSA .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2)	Previous Mentions (Q-1)	Current Period (Q4 2024)	Trend
AI/Technology & R&D efficiency	Not available	Not available	Internal 3,700+ clinical team; speed/cost advantages; multiple POC catalysts in 2025	Strengthening
Supply chain / Tariffs	Not available	Not available	Regional manufacturing footprint; modest tariff impact expected	Resilient
Product performance (BRUKINSA)	Not available	Not available	U.S. revenue surpassed Calquence; class leadership in CLL new starts	Leadership expanding
Regional trends	Not available	Not available	U.S. 55% of revenue; Europe 10%; Europe nearly tripled in 2024	Broadening mix
Regulatory/legal	Not available	Not available	TEVIMBRA approvals in U.S./EU; BRUKINSA patent settlement—U.S. generic no earlier than 2037	Positive updates
R&D execution	Not available	Not available	CELESTIAL Phase 3 enrollment completed in ~14 months; late-stage plans for degrader	Accelerating

Note: Prior quarter (Q3/Q2 2024) documents were not found in our retrieved set; trends reflect current call commentary.

Management Commentary

CEO strategic message: “We believe that we've reached an inflection point… BRUKINSA U.S. revenue exceeded Calquence for the first time in the fourth quarter… proposed name change to BeOne and redomiciliation to Switzerland” .
Hematology franchise outlook: “We have a once-in-a-lifetime opportunity to build life-changing combinations and the preeminent franchise in the $12 billion+ CLL market” .
CFO on operating leverage: “Product revenue growing more than 5x faster than expenses… $79M adjusted income from operations… second consecutive quarter of positive operating cash flow” .
Guidance framing: “We project revenue to be between $4.9B to $5.3B… GAAP gross margin in the mid-80% range… modest tariff impact given U.S. manufacturing… achieve full year GAAP operating breakeven and positive CFO” .

Q&A Highlights

Medicare Part D redesign and pricing: Q1 seasonality and redesign effects offset by specified small manufacturer designation; net pricing relatively stable .
IRA negotiation dynamics: Manageable indirect impacts; differentiation vs IMBRUVICA and acalabrutinib emphasized; continued leadership in new starts .
Fixed-duration doublets (AMPLIFY) vs continuous BTK: Management critical of efficacy/safety; sees opportunity for BRUKINSA+sonrotoclax to deliver deeper MRD and sustained PFS .
Patent settlement: Generic BRUKINSA entry no earlier than June 15, 2037; franchise durability through combinations and later-stage assets .
Pipeline timing: CELESTIAL event-driven PFS readout to take time; ASCO H1 2025 data for CDK4/CDK2; head-to-head BTK degrader vs pirtobrutinib planned .

Estimates Context

Wall Street consensus (S&P Global) for Q4 2024 revenue and EPS was unavailable due to access limits at the time of this analysis; therefore, estimate comparisons cannot be provided. We will update when S&P Global data is retrievable.

Key Takeaways for Investors

Revenue and margin acceleration: $1.13B Q4 revenue (+78% YoY) with GAAP gross margin 85.6%; adjusted operating income turned positive—evidence of operating leverage .
BRUKINSA is the engine: $828M in Q4 with U.S. new patient share leadership; expect ongoing mix benefits and global expansion (Europe, Japan) .
Watch seasonality and order timing: Q4 benefited from ~$30M order timing; management flagged Q2 and Q4 as stronger quarters; incorporate phasing in models .
Guidance maintained: $4.9–$5.3B FY25 revenue, mid-80% gross margin, positive GAAP operating income and CFO; mild tariff headwind expected to be manageable .
Non-GAAP adjustments matter: Share-based comp and D&A materially impact GAAP vs adjusted results; adjusted operating income at $78.6M vs GAAP loss $(79.4)M in Q4 .
Pipeline catalysts near term: Multiple 1H25 POC readouts (CDK4/CDK2/B7H4 ADC) and solid tumor programs advancing; hematology late-stage programs (sonrotoclax; BTK degrader) set up multi-year growth .
Strategic durability: Patent settlement supports BRUKINSA exclusivity to at least 2037 in U.S.; combinations and wholly owned assets extend franchise beyond covalent BTK .
Trading implications: Near-term momentum supported by maintained guidance, margin expansion, and BRUKINSA share gains; monitor ASCO readouts and any competitive fixed-duration approvals for sentiment shifts .

Appendix: Source Coverage and Document Retrieval Notes

Q4 2024 8-K and press release (Exhibit 99.1) read in full .
Q4 2024 earnings call transcript read in full .
Other Q4 2024 press releases not found in our document set for ONC during 2024-10-01 to 2024-12-31 [Search returned none].
Prior two quarters (Q3 and Q2 2024) earnings documents were not found in our document set; trend analysis relies on Q4 vs prior-year comparisons and management’s commentary [Search returned none].

BeiGene, Ltd. (ONC)·Q4 2024 Earnings Summary