BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.–(BUSINESS WIRE)–$BGNE #BeiGene—BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today reinforced its continued global expansion, rapid global and U.S. revenue growth, and innovative R&D strategy with the presentation of results from the fourth quarter and full year 2023 and business highlights.
“BeiGene made great progress in the fourth quarter and full year 2023 toward our goal to become an impactful next-generation oncology innovator. We have solidified our leadership in hematology with the continued success of BRUKINSA’s global launch, led by U.S. and Europe,” said John V. Oyler, Chairman, Co-Founder and CEO at BeiGene. “Our cost advantaged research and development and manufacturing have enabled us to build one of the largest and most exciting oncology pipelines in the industry. We look forward to a transformative year for BeiGene as we continue to deliver on operational excellence propelled by outstanding growth in revenue across new and existing geographies.”
Key Business and Pipeline Highlights
Fourth Quarter and Full Year 2023 Financial Highlights
Revenue for the fourth quarter and full year 2023 was $634.4 million and $2.5 billion, respectively, compared to $380.1 million and $1.4 billion in the prior-year periods. The increase in total revenue in the quarter compared to the prior year is primarily attributable to product sales growth in the Company’s major markets. For the fourth quarter and full year 2023, the U.S. was the largest market the Company derived revenue from, with revenue of $313.2 million and $1.1 billion, respectively, compared to $155.4 million and $502.6 million in the prior-year periods. The Company expects this trend to continue in 2024 as U.S. sales of BRUKINSA continue to grow.
|
| Three Months Ended December 31, |
| Twelve Months Ended December 31, | ||||||||
(in thousands, except per share amounts) |
|
| 2023 |
|
| 2022 |
|
| 2023 |
|
| 2022 |
Net product revenues |
| $ | 630,526 |
| $ | 339,022 |
| $ | 2,189,852 |
| $ | 1,254,612 |
Net revenue from collaborations |
| $ | 3,883 |
| $ | 41,073 |
| $ | 268,927 |
| $ | 161,309 |
Total Revenue |
| $ | 634,409 |
| $ | 380,095 |
| $ | 2,458,779 |
| $ | 1,415,921 |
|
|
|
|
|
|
|
|
| ||||
GAAP loss from operations |
| $ | (383,795) |
| $ | (468,622) |
| $ | (1,207,736) |
| $ | (1,789,665) |
Adjusted loss from operations* |
| $ | (267,224) |
| $ | (372,480) |
| $ | (752,473) |
| $ | (1,420,225) |
|
|
|
|
|
|
|
|
| ||||
* For an explanation of our use of non-GAAP financial measures, refer to the “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. |
Product Revenue totaled $630.5 million and $2.2 billion for the fourth quarter and full year 2023, respectively, compared to $339.0 million and $1.3 billion in the prior-year periods, and include:
Gross Margin as a percentage of global product sales for the fourth quarter and full year 2023 was 83.2% and 82.7%, respectively, compared to 78.3% and 77.2% in the prior-year periods. The gross margin percentage increased in both the quarter-over-quarter and year-over-year period due to a proportionally higher product sales mix of global BRUKINSA compared to other products in our portfolio and compared to lower margin in-licensed products, as well as lower costs per unit for both BRUKINSA and tislelizumab.
Operating Expenses
The following table summarizes operating expenses for the fourth quarter 2023 and 2022, respectively:
|
| GAAP |
|
|
| Non-GAAP |
|
| ||||||||
(in thousands, except percentages) |
| Q4 2023 |
| Q4 2022 |
| % Change |
| Q4 2023 |
| Q4 2022 |
| % Change | ||||
Research and development |
| $ | 493,987 |
| $ | 446,023 |
| 11 % |
| $ | 437,383 |
| $ | 404,186 |
| 8% |
Selling, general and administrative |
| $ | 416,547 |
| $ | 328,984 |
| 27 % |
| $ | 361,435 |
| $ | 275,648 |
| 31% |
Amortization(1) |
| $ | 1,838 |
| $ | 188 |
| 878 % |
| $ | — |
| $ | — |
| NM |
Total operating expenses |
| $ | 912,372 |
| $ | 775,195 |
| 18 % |
| $ | 798,818 |
| $ | 679,834 |
| 18% |
The following table summarizes operating expenses for the full year 2023 and 2022, respectively:
|
| GAAP |
|
|
| Non-GAAP |
|
| ||||||||
(in thousands, except percentages) |
| FY 2023 |
| FY 2022 |
| % Change |
| FY 2023 |
| FY 2022 |
| % Change | ||||
Research and development |
| $ | 1,778,594 |
| $ | 1,640,508 |
| 8% |
| $ | 1,558,960 |
| $ | 1,474,919 |
| 6% |
Selling, general and administrative |
| $ | 1,504,501 |
| $ | 1,277,852 |
| 18% |
| $ | 1,284,689 |
| $ | 1,077,977 |
| 19% |
Amortization(1) |
| $ | 3,500 |
| $ | 751 |
| 366% |
| $ | — |
| $ | — |
| NM |
Total operating expenses |
| $ | 3,286,595 |
| $ | 2,919,111 |
| 13% |
| $ | 2,843,649 |
| $ | 2,552,896 |
| 11% |
(1) Relates to BMS product distribution rights intangible asset that was fully amortized as of December 31, 2023, when the rights reverted back to BMS under the terms of the Settlement Agreement. |
Research and Development (R&D) Expenses increased for the fourth quarter and full year 2023 compared to the prior-year periods on both a GAAP and adjusted basis primarily due to investing in new platforms/modalities to advance preclinical programs into the clinic and early clinical programs into late stage. Upfront fees related to in-process R&D for in-licensed assets totaled $31.8 million and $46.8 million in the fourth quarter and full year 2023, respectively, compared to $48.7 million and $68.7 million in the prior-year periods.
Selling, General and Administrative (SG&A) Expenses increased for the fourth quarter and full year 2023 compared to the prior-year periods on both a GAAP and adjusted basis due to continued investment in the global commercial launch of BRUKINSA primarily in the U.S. and Europe.
Net Loss
GAAP net loss improved for the fourth quarter and full year 2023, as compared to the prior-year periods, primarily attributable to reduced operating losses and the non-operating gain of $362.9 million related to the BMS arbitration settlement for full year 2023.
For the fourth quarter of 2023, net loss per share was $0.27 per share and $3.53 per ADS, compared to $0.33 per share and $4.29 per ADS in the prior-year period. Net loss for full year 2023 was $0.65 per share and $8.45 per ADS, compared to $1.49 per share and $19.43 per ADS in the prior-year period.
Cash, Cash Equivalents, and Restricted Cash | ||||
| Year Ended December 31, | |||
|
| 2023 |
| 2022 |
| (in thousands) | |||
Cash, cash equivalents and restricted cash at beginning of period | $ | 3,875,037 | $ | 4,382,887 |
Net cash used in operating activities |
| (1,157,453) |
| (1,496,619) |
Net cash provided by investing activities |
| 60,004 |
| 1,077,123 |
Net cash provided by (used in) financing activities |
| 416,478 |
| (18,971) |
Net effect of foreign exchange rate changes |
| (8,082) |
| (69,383) |
Net decrease in cash, cash equivalents and restricted cash |
| (689,053) |
| (507,850) |
Cash, cash equivalents and restricted cash at end of period | $ | 3,185,984 | $ | 3,875,037 |
Cash Used in Operations in fourth quarter and full year 2023 was $221.6 million and $1.2 billion, respectively, compared to $318.2 million and $1.5 billion in the prior-year periods, driven by improved operating leverage.
For further details on BeiGene’s 2023 Financial Statements, please see BeiGene’s Annual Report on Form 10-K for the year of 2023 filed with the U.S. Securities and Exchange Commission.
Regulatory Progress and Development Programs
Key Highlights
Category | Asset | Recent Milestones |
Regulatory Approvals | BRUKINSA |
|
TEVIMBRA |
| |
Regulatory Submissions | Tislelizumab |
|
Clinical Activities | BRUKINSA |
|
Tislelizumab |
| |
Sonrotoclax |
| |
BTK CDAC |
| |
Anti-LAG3 |
| |
Early development
|
|
Anticipated Upcoming Milestones
Key Highlights
Category | Asset | Anticipated Milestones |
Anticipated Regulatory Approvals | BRUKINSA |
|
Tislelizumab |
| |
Anticipated Regulatory Submissions | BRUKINSA |
|
Tislelizumab |
| |
Zanidatamab2 |
| |
Anticipated Clinical Activities | Sonrotoclax |
|
Ociperlimab |
| |
Tarlatamab3 |
| |
Early development |
| |
1 Leads Biolabs collaboration; BeiGene has commercial rights excluding China | ||
2 Jazz/Zymeworks collaboration; BeiGene has commercial rights in APAC (excluding Japan), Australia, New Zealand | ||
3 Amgen collaboration; BeiGene will have commercial rights in China and tiered mid-single digit royalties on net sales outside of China | ||
4 XmAb® is a registered trademark of Xencor, Inc. |
Manufacturing Operations
Corporate Developments
Financial Summary | |||||
Select Condensed Consolidated Balance Sheet Data (U.S. GAAP) | |||||
(Amounts in thousands of U.S. Dollars) | |||||
| As of | ||||
| December 31, |
| December 31, | ||
|
| 2023 |
|
| 2022 |
| (audited) | ||||
Assets: |
|
|
| ||
Cash, cash equivalents, restricted cash and short-term investments | $ | 3,188,584 |
| $ | 4,540,288 |
Accounts receivable, net |
| 358,027 |
|
| 173,168 |
Inventories, net |
| 416,122 |
|
| 282,346 |
Property, plant and equipment, net |
| 1,324,154 |
|
| 845,946 |
Total assets | $ | 5,805,275 |
| $ | 6,379,290 |
Liabilities and equity: |
|
|
| ||
Accounts payable | $ | 315,111 |
| $ | 294,781 |
Accrued expenses and other payables |
| 693,731 |
|
| 467,352 |
Deferred revenue |
| 300 |
|
| 255,887 |
R&D cost share liability |
| 238,666 |
|
| 293,960 |
Debt |
| 885,984 |
|
| 538,117 |
Total liabilities |
| 2,267,948 |
|
| 1,995,935 |
Total equity | $ | 3,537,327 |
| $ | 4,383,355 |
Condensed Consolidated Statements of Operations (U.S. GAAP) | |||||||||||
(Amounts in thousands of U.S. dollars, except for shares, American Depositary Shares (ADSs), per share and per ADS data) | |||||||||||
| Three Months Ended December 31, |
| Twelve Months Ended December 31, | ||||||||
|
| 2023 |
|
| 2022 |
|
| 2023 |
|
| 2022 |
| (unaudited) |
| (audited) | ||||||||
Revenue |
|
|
|
|
|
|
| ||||
Product revenue, net | $ | 630,526 |
| $ | 339,022 |
| $ | 2,189,852 |
| $ | 1,254,612 |
Collaboration revenue |
| 3,883 |
|
| 41,073 |
|
| 268,927 |
|
| 161,309 |
Total revenues |
| 634,409 |
|
| 380,095 |
|
| 2,458,779 |
|
| 1,415,921 |
Cost of sales – products |
| 105,832 |
|
| 73,522 |
|
| 379,920 |
|
| 286,475 |
Gross profit |
| 528,577 |
|
| 306,573 |
|
| 2,078,859 |
|
| 1,129,446 |
Operating expenses |
|
|
|
|
|
|
| ||||
Research and development |
| 493,987 |
|
| 446,023 |
|
| 1,778,594 |
|
| 1,640,508 |
Selling, general and administrative |
| 416,547 |
|
| 328,984 |
|
| 1,504,501 |
|
| 1,277,852 |
Amortization of intangible assets |
| 1,838 |
|
| 188 |
|
| 3,500 |
|
| 751 |
Total operating expenses |
| 912,372 |
|
| 775,195 |
|
| 3,286,595 |
|
| 2,919,111 |
Loss from operations |
| (383,795) |
|
| (468,622) |
|
| (1,207,736) |
|
| (1,789,665) |
Interest income, net |
| 16,274 |
|
| 18,219 |
|
| 74,009 |
|
| 52,480 |
Other income (expense), net |
| 16,749 |
|
| 19,438 |
|
| 307,891 |
|
| (223,852) |
Loss before income taxes |
| (350,772) |
|
| (430,965) |
|
| (825,836) |
|
| (1,961,037) |
Income tax expense |
| 16,781 |
|
| 14,370 |
|
| 55,872 |
|
| 42,778 |
Net loss |
| (367,553) |
|
| (445,335) |
|
| (881,708) |
|
| (2,003,815) |
|
|
|
|
|
|
|
| ||||
Net loss per share | $ | (0.27) |
| $ | (0.33) |
| $ | (0.65) |
| $ | (1.49) |
Weighted-average shares outstanding—basic and diluted |
| 1,353,005,058 |
|
| 1,348,916,108 |
|
| 1,357,034,547 |
|
| 1,340,729,572 |
|
|
|
|
|
|
|
| ||||
Net loss per American Depositary Share (“ADS”) | $ | (3.53) |
| $ | (4.29) |
| $ | (8.45) |
| $ | (19.43) |
Weighted-average ADSs outstanding—basic and diluted |
| 104,077,312 |
|
| 103,762,778 |
|
| 104,387,273 |
|
| 103,133,044 |
Note Regarding Use of Non-GAAP Financial Measures
BeiGene provides certain non-GAAP financial measures, including Adjusted Operating Expenses and Adjusted Operating Loss and certain other non-GAAP income statement line items, each of which include adjustments to GAAP figures. These non-GAAP financial measures are intended to provide additional information on BeiGene’s operating performance. Adjustments to BeiGene’s GAAP figures exclude, as applicable, non-cash items such as share-based compensation, depreciation and amortization. Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred. BeiGene maintains an established non-GAAP policy that guides the determination of what costs will be excluded in non-GAAP financial measures and the related protocols, controls and approval with respect to the use of such measures. BeiGene believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of BeiGene’s operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of the Company’s historical and expected financial results and trends and to facilitate comparisons between periods and with respect to projected information. In addition, these non-GAAP financial measures are among the indicators BeiGene’s management uses for planning and forecasting purposes and measuring the Company’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies.
RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP MEASURES | ||||||||||||
(in thousands, except per share amounts) | ||||||||||||
(unaudited) | ||||||||||||
|
| Three Months Ended December 31, |
| Twelve Months Ended December 31, | ||||||||
|
|
| 2023 |
|
| 2022 |
|
| 2023 |
|
| 2022 |
Reconciliation of GAAP to adjusted cost of sales – products: |
|
|
|
|
|
|
|
| ||||
GAAP cost of sales – products |
| $ | 105,832 |
| $ | 73,522 |
| $ | 379,920 |
| $ | 286,475 |
Less: Depreciation |
|
| 1,898 |
|
| — |
|
| 8,578 |
|
| — |
Less: Amortization of intangibles |
|
| 1,119 |
|
| 781 |
|
| 3,739 |
|
| 3,225 |
Adjusted cost of sales – products |
| $ | 102,815 |
| $ | 72,741 |
| $ | 367,603 |
| $ | 283,250 |
|
|
|
|
|
|
|
|
| ||||
Reconciliation of GAAP to adjusted research and development: |
|
|
|
|
|
|
|
| ||||
GAAP research and development |
| $ | 493,987 |
| $ | 446,023 |
| $ | 1,778,594 |
| $ | 1,640,508 |
Less: Share-based compensation expenses |
|
| 39,424 |
|
| 34,966 |
|
| 163,550 |
|
| 139,348 |
Less: Depreciation |
|
| 17,180 |
|
| 6,871 |
|
| 56,084 |
|
| 26,241 |
Adjusted research and development |
| $ | 437,383 |
| $ | 404,186 |
| $ | 1,558,960 |
| $ | 1,474,919 |
|
|
|
|
|
|
|
|
| ||||
Reconciliation of GAAP to adjusted selling, general and administrative: |
|
|
|
|
|
|
|
| ||||
GAAP selling, general and administrative |
| $ | 416,547 |
| $ | 328,984 |
| $ | 1,504,501 |
| $ | 1,277,852 |
Less: Share-based compensation expenses |
|
| 53,328 |
|
| 43,160 |
|
| 204,038 |
|
| 163,814 |
Less: Depreciation |
|
| 1,784 |
|
| 10,176 |
|
| 15,774 |
|
| 36,061 |
Adjusted selling, general and administrative |
| $ | 361,435 |
| $ | 275,648 |
| $ | 1,284,689 |
| $ | 1,077,977 |
|
|
|
|
|
|
|
|
| ||||
Reconciliation of GAAP to adjusted operating expenses |
|
|
|
|
|
|
|
| ||||
GAAP operating expenses |
|
| 912,372 |
|
| 775,195 |
|
| 3,286,595 |
|
| 2,919,111 |
Less: Share-based compensation expenses |
|
| 92,752 |
|
| 78,126 |
|
| 367,588 |
|
| 303,162 |
Less: Depreciation |
|
| 18,964 |
|
| 17,047 |
|
| 71,858 |
|
| 62,302 |
Less: Amortization of intangibles |
|
| 1,838 |
|
| 188 |
|
| 3,500 |
|
| 751 |
Adjusted operating expenses |
| $ | 798,818 |
| $ | 679,834 |
| $ | 2,843,649 |
| $ | 2,552,896 |
|
|
|
|
|
|
|
|
| ||||
Reconciliation of GAAP to adjusted loss from operations: |
|
|
|
|
|
|
|
| ||||
GAAP loss from operations |
| $ | (383,795) |
| $ | (468,622) |
| $ | (1,207,736) |
| $ | (1,789,665) |
Plus: Share-based compensation expenses |
|
| 92,752 |
|
| 78,126 |
|
| 367,588 |
|
| 303,162 |
Plus: Depreciation |
|
| 20,862 |
|
| 17,047 |
|
| 80,436 |
|
| 62,302 |
Plus: Amortization of intangibles |
|
| 2,957 |
|
| 969 |
|
| 7,239 |
|
| 3,976 |
Adjusted loss from operations |
| $ | (267,224) |
| $ | (372,480) |
| $ | (752,473) |
| $ | (1,420,225) |
|
|
|
|
|
|
|
|
|
Contacts
Investor Contact
Liza Heapes
+1 857-302-5663
ir@beigene.com
Media Contact
Kyle Blankenship
+1 667-351-5176
media@beigene.com
SEOUL, SOUTH KOREA - Media OutReach Newswire - 6 November 2024 - On World Pathology…
KUALA LUMPUR, MALAYSIA - Media OutReach Newswire - 31 October 2024 - E-brokerage is a…
Strategic alliance poised to create new growth avenues in Thailand, Japan, and beyond. BANGKOK, THAILAND…
Leonteq announced today that it has enabled its Shari’a-compliant structured product offering on its digital…
Revolutionizing Home and Commercial Cleaning with Aqueous Ozone Solutions that are hypoallergenic & eco-friendly QUEENSLAND,…
Enjoy up to 10% rebate and chance to win business class round trip to Tokyo…