- Second quarter total revenues increased 42% to $1.3 billion versus second quarter 2024
- Global BRUKINSA revenues increased 49% to $950 million versus second quarter 2024
- Reported diluted GAAP Earnings per American Depositary Share (ADS) of $0.84, non-GAAP diluted Earnings per ADS of $2.25
- Anticipate 20+ milestones in next 18 months across hematology and solid tumor pipeline
(BUSINESS WIRE) -- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced financial results and corporate updates from the second quarter of 2025.
“Our strong second quarter performance reinforces our trajectory as a global oncology powerhouse and underscores our proven ability to deliver sustainable, long-term growth,” said John V. Oyler, Co-Founder, Chairman and CEO of BeOne. “We are executing with purpose and advancing our mission to deliver transformative medicines to more patients worldwide. BRUKINSA, the backbone of our hematology franchise, continues to set the standard as the best-in-class BTK inhibitor with the most approved indications and market leader in the US, a position earned from superior efficacy, favorable safety, and positive patient outcomes across its five indications. Building on this momentum, our two additional Phase 3 hematology assets, BCL2 inhibitor sonrotoclax and BTK CDAC BGB-16673, have the potential to further expand our franchise leadership with pivotal data readouts and new trial initiations anticipated in the near-term. At our recent Investor R&D Day, we outlined a bold path forward with more than 20 expected R&D milestones in the next 18 months. This includes potentially promising advances across our expansive solid tumor pipeline, where we are building future global franchises targeting a range of highly prevalent cancers.”
(Amounts in thousands of U.S. dollars and unaudited)
|
|
|
Three Months Ended June 30,
|
|
|
|
Six Months Ended June 30,
|
|
|
|
|
|
2025
|
|
2024
|
|
% Change
|
|
2025
|
|
2024
|
|
% Change
|
|
Net product revenues
|
|
$
|
1,302,076
|
|
$
|
921,146
|
|
|
41
|
%
|
|
$
|
2,410,606
|
|
$
|
1,668,064
|
|
|
45
|
%
|
|
Net revenue from collaborations
|
|
$
|
13,224
|
|
$
|
8,020
|
|
|
65
|
%
|
|
$
|
21,973
|
|
$
|
12,754
|
|
|
72
|
%
|
|
Total revenue
|
|
$
|
1,315,300
|
|
$
|
929,166
|
|
|
42
|
%
|
|
$
|
2,432,579
|
|
$
|
1,680,818
|
|
|
45
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP income (loss) from operations
|
|
$
|
87,885
|
|
$
|
(107,161
|
)
|
|
182
|
%
|
|
$
|
98,987
|
|
$
|
(368,509
|
)
|
|
127
|
%
|
|
Adjusted income (loss) from operations*
|
|
$
|
274,945
|
|
$
|
48,464
|
|
|
467
|
%
|
|
$
|
414,302
|
|
$
|
(98,877
|
)
|
|
519
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net income (loss)
|
|
$
|
94,320
|
|
$
|
(120,405
|
)
|
|
178
|
%
|
|
$
|
95,590
|
|
$
|
(371,555
|
)
|
|
126
|
%
|
|
Adjusted net income (loss)*
|
|
$
|
252,822
|
|
$
|
23,294
|
|
|
985
|
%
|
|
$
|
388,959
|
|
$
|
(122,602
|
)
|
|
417
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP basic EPS per ADS
|
|
$
|
0.87
|
|
$
|
(1.15
|
)
|
|
176
|
%
|
|
$
|
0.89
|
|
$
|
(3.56
|
)
|
|
125
|
%
|
|
Adjusted basic EPS per ADS*
|
|
$
|
2.33
|
|
$
|
0.22
|
|
|
959
|
%
|
|
$
|
3.61
|
|
$
|
(1.17
|
)
|
|
409
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP diluted EPS per ADS
|
|
$
|
0.84
|
|
$
|
(1.15
|
)
|
|
173
|
%
|
|
$
|
0.85
|
|
$
|
(3.56
|
)
|
|
124
|
%
|
|
Adjusted diluted EPS per ADS*
|
|
$
|
2.25
|
|
$
|
0.22
|
|
|
923
|
%
|
|
$
|
3.48
|
|
$
|
(1.17
|
)
|
|
397
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Free Cash Flow*
|
|
$
|
219,772
|
|
$
|
(205,538
|
)
|
|
207
|
%
|
|
$
|
207,447
|
|
$
|
(670,688
|
)
|
|
131
|
%
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* For an explanation of our use of non-GAAP financial measures refer to the “Note Regarding Use of Non-GAAP Financial Measures” section later in this press release and for a reconciliation of each non-GAAP financial measure to the most comparable GAAP measures, see the table at the end of this press release.
|
Second Quarter 2025 Financial Results
Revenue for the second quarter of 2025 was $1.3 billion, compared to $929 million in the prior-year period driven primarily by growth in BRUKINSA (zanubrutinib) product sales in the U.S. and Europe.
Product Revenue totaled $1.3 billion for the second quarter of 2025 compared to $921 million in the prior-year period. The increase in product revenue was primarily attributable to increased sales of BRUKINSA. The U.S. continued to be the Company’s largest market, with product revenue of $685 million compared to $479 million in the prior-year period. In-licensed products from Amgen and TEVIMBRA (tislelizumab) also contributed to product revenue growth.
-
U.S. sales of BRUKINSA totaled $684 million in the second quarter of 2025, representing growth of 43% over the prior-year period driven primarily by robust demand growth across all indications and modest benefit due to net pricing. BRUKINSA continues to maintain its leading new patient share across the BTKi class due to its differentiated, best-in-class clinical profile. BRUKINSA sales in Europe totaled $150 million in the second quarter of 2025, representing growth of 85% compared to the prior-year period, driven by increased market share across all major European markets, including Germany, Italy, Spain, France and the UK.
-
Sales of TEVIMBRA totaled $194 million in the second quarter of 2025, representing growth of 22% compared to the prior-year period.
Gross Margin as a percentage of global product sales for the second quarter of 2025 was 87.4% compared to 85.0% in the prior-year period on a GAAP basis. The gross margin percentage increased due to a proportionally higher sales mix of global BRUKINSA compared to other products in our portfolio. Gross margin also benefited from cost of sales productivity improvements for both BRUKINSA and TEVIMBRA. On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of product sales increased to 88.1% for the second quarter of 2025, compared to 85.4% in the prior-year period.
Operating Expenses
The following table summarizes operating expenses for the second quarter of 2025:
| |
|
|
|
|
|
|
|
|
|
|
|
GAAP
|
|
|
|
Non-GAAP
|
|
|
|
(unaudited, in thousands, except percentages)
|
|
Q2 2025
|
|
Q2 2024
|
|
% Change
|
|
Q2 2025
|
|
Q2 2024
|
|
% Change
|
|
Research and development
|
|
$
|
524,896
|
|
$
|
454,466
|
|
15
|
%
|
|
$
|
444,057
|
|
$
|
382,509
|
|
16
|
%
|
|
Selling, general and administrative
|
|
$
|
537,913
|
|
$
|
443,729
|
|
21
|
%
|
|
$
|
441,655
|
|
$
|
363,922
|
|
21
|
%
|
|
Total operating expenses
|
|
$
|
1,062,809
|
|
$
|
898,195
|
|
18
|
%
|
|
$
|
885,712
|
|
$
|
746,431
|
|
19
|
%
|
The following table summarizes operating expenses for the first half of 2025:
| |
|
|
|
|
|
|
|
|
|
|
|
GAAP
|
|
|
|
Non-GAAP
|
|
|
|
(unaudited, in thousands, except percentages)
|
|
Q2 YTD 2025
|
|
Q2 YTD 2024
|
|
% Change
|
|
Q2 YTD 2025
|
|
Q2 YTD 2024
|
|
% Change
|
|
Research and development
|
|
$
|
1,006,783
|
|
$
|
915,104
|
|
10
|
%
|
|
$
|
865,252
|
|
$
|
787,949
|
|
10
|
%
|
|
Selling, general and administrative
|
|
$
|
997,201
|
|
$
|
871,156
|
|
14
|
%
|
|
$
|
837,166
|
|
$
|
736,068
|
|
14
|
%
|
|
Total operating expenses
|
|
$
|
2,003,984
|
|
$
|
1,786,260
|
|
12
|
%
|
|
$
|
1,702,418
|
|
$
|
1,524,017
|
|
12
|
%
|
Research and Development (R&D) Expenses increased for the second quarter of 2025 compared to the prior-year period on both a GAAP and adjusted basis primarily due to advancing preclinical programs into the clinic and early clinical programs into late stage, and offset by lower development upfront and milestone fees. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled $0.5 million and $12 million in the second quarter of 2025 and 2024, respectively.
Selling, General and Administrative (SG&A) Expenses increased for the second quarter of 2025 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment in global commercial expansion, primarily in the U.S. and Europe. SG&A expenses as a percentage of product sales were 41% for the second quarter of 2025, compared to 48% in the prior-year period.
Net Income/(Loss) and GAAP/Non-GAAP Earnings Per Share
GAAP net income for the second quarter of 2025 was $94 million, an increase of $215 million over the prior-year period loss, primarily attributable to revenue growth and improved operating leverage.
For the second quarter of 2025, basic and diluted earnings per share was $0.07 and $0.06 per share and $0.87 and $0.84 per American Depositary Share (ADS), respectively, compared to basic loss of $0.09 per share and $1.15 per ADS in the prior-year period.
Free Cash Flow for the second quarter of 2025 was $220 million, an increase of $425 million over the prior-year period.
For further details on BeOne’s Second Quarter 2025 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the second quarter of 2025 filed with the U.S. Securities and Exchange Commission.
Full Year 2025 Guidance
BeOne has updated its full year 2025 revenue guidance and maintained its expense guidance. Guidance is summarized below:
|
|
Prior FY 2025 Guidance1
|
Current FY 2025 Guidance1
|
|
Total Revenue
|
$4.9 - $5.3B
|
$5.0 - $5.3B
|
|
GAAP Operating Expenses
(R&D and SG&A)
|
$4.1 - $4.4B
|
$4.1 - $4.4B
|
|
GAAP Gross Margin %
|
Mid-80% range
|
Mid to high-80% range
|
|
GAAP Operating Income
|
Positive FY 2025
|
Positive FY 2025
|
|
Cash Flow
|
Positive FY 2025
cash flow from operations
|
Positive FY 2025
free cash flow
|
|
1 Does not assume any potential new, material business development activity or unusual/non-recurring items. Assumes June 30, 2025 foreign exchange rates.
|
BeOne’s total revenue guidance for full year 2025 of $5.0 billion to $5.3 billion includes expectations for strong revenue growth driven by BRUKINSA’s U.S. leadership position and continued global expansion in both Europe and other important rest of world markets. Gross margin percentage is expected to be in the mid- to high-80% range due to mix and production efficiencies as compared to 2024. BeOne’s guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth in both commercial and research at a pace that continues to deliver meaningful operating leverage. Non-GAAP operating expenses, which exclude costs related to share-based compensation, depreciation and amortization expense, are expected to track with GAAP operating expenses, with reconciling items unchanged from existing practice. Operating expense guidance does not assume any potential new, material business development activity or unusual/non-recurring items.
|