BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.
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.
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“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
- Product revenues for the quarter, $630.5 million, and full year, $2.2 billion, increased 86% and 75% from prior-year totals;
- Disciplined management of operating expense growth drove operating loss decreases of 18% and 33% on a GAAP basis and 28% and 47% on an adjusted basis for the quarter and full year;
- Solidified BRUKINSA’s position as a BTK inhibitor of choice with U.S. Food and Drug Administration (FDA) approval of a label update to include superior progression-free survival (PFS) results at a median follow up of 29.6 months from the Phase 3 ALPINE trial comparing BRUKINSA against IMBRUVICA® (ibrutinib) in previously treated patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL);
- Expanded global label for BRUKINSA with European Commission approval for the treatment of adult patients with R/R follicular lymphoma (FL) who have received at least two prior systematic treatments, making it the first BTK inhibitor ever approved in this indication and the BTK inhibitor with the broadest label in the class;
- Demonstrated leadership in hematology and strength of the Company’s pipeline with 25 abstracts presented at the American Society of Hematology (ASH) Annual Meeting in December, including:
- Updated results from the ALPINE trial demonstrating sustained PFS superiority at a median follow up of 39 months for BRUKINSA against IMBRUVICA for the treatment of adult patients with R/R CLL;
- Phase 1/2 trial data for sonrotoclax demonstrating safety and tolerability in combination with BRUKINSA with deep and durable responses in treatment-naïve CLL; promising single-agent activity in patients with R/R marginal zone lymphoma; and promising efficacy and safety in combination with dexamethasone in multiple myeloma (MM) with t(11,14); and
- First-in-human data for BTK CDAC BGB-16673 demonstrating notable clinical responses and a tolerable safety profile in heavily pretreated patients with B-cell malignancies, including those with BTKi-resistant disease.
- Expanded the global impact of anti-PD-1 antibody TEVIMBRA® (tislelizumab) with a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval as a treatment for non-small cell lung cancer (NSCLC) across three indications, EMA acceptance of submission for the treatment of adult patients with first-line esophageal squamous cell carcinoma (ESCC), and regulatory reviews ongoing in 10 markets, including the U.S. and Europe; and
- Advanced innovative R&D strategy by entering five New Molecular Entities (NMEs) into the clinic in 2023, including potential best-in-class CDK4 inhibitor BGB-43395.
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.
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Three Months Ended December 31, |
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Twelve Months Ended December 31, |
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(in thousands, except per share amounts) |
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2023 |
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2022 |
|
|
2023 |
|
|
2022 |
|
Net product revenues |
|
$ |
630,526 |
|
$ |
339,022 |
|
$ |
2,189,852 |
|
$ |
1,254,612 |
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Net revenue from collaborations |
|
$ |
3,883 |
|
$ |
41,073 |
|
$ |
268,927 |
|
$ |
161,309 |
|
Total Revenue |
|
$ |
634,409 |
|
$ |
380,095 |
|
$ |
2,458,779 |
|
$ |
1,415,921 |
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|
|
|
|
|
|
|
|
|
||||
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GAAP loss from operations |
|
$ |
(383,795) |
|
$ |
(468,622) |
|
$ |
(1,207,736) |
|
$ |
(1,789,665) |
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Adjusted loss from operations* |
|
$ |
(267,224) |
|
$ |
(372,480) |
|
$ |
(752,473) |
|
$ |
(1,420,225) |
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|
|
|
|
|
|
|
|
|
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* 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. |
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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:
- Global sales of BRUKINSA of $413.0 million and $1.3 billion for the fourth quarter and full year 2023, respectively, compared to $176.1 million and $564.7 million in the prior-year periods;
- Sales of tislelizumab of $128.0 million and $536.6 million for the fourth quarter and full year 2023, respectively, compared to $102.2 million and $422.9 million in the prior-year periods;
- Sales of Amgen in-licensed products of $51.1 million and $188.3 million for the fourth quarter and full year 2023, respectively, compared to $27.7 million and $114.6 million in the prior-year periods.
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:
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GAAP |
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Non-GAAP |
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(in thousands, except percentages) |
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Q4 2023 |
|
Q4 2022 |
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% Change |
|
Q4 2023 |
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Q4 2022 |
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% Change |
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|
Research and development |
|
$ |
493,987 |
|
$ |
446,023 |
|
11 % |
|
$ |
437,383 |
|
$ |
404,186 |
|
8% |
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Selling, general and administrative |
|
$ |
416,547 |
|
$ |
328,984 |
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27 % |
|
$ |
361,435 |
|
$ |
275,648 |
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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:
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GAAP |
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Non-GAAP |
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(in thousands, except percentages) |
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FY 2023 |
|
FY 2022 |
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% Change |
|
FY 2023 |
|
FY 2022 |
|
% Change |
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|
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 |
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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. |
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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.
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Cash, Cash Equivalents, and Restricted Cash |
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Year Ended December 31, |
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|
|
2023 |
|
2022 |
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|
(in thousands) |
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|
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) |
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Net cash provided by investing activities |
|
60,004 |
|
1,077,123 |
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Net cash provided by (used in) financing activities |
|
416,478 |
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(18,971) |
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Net effect of foreign exchange rate changes |
|
(8,082) |
|
(69,383) |
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Net decrease in cash, cash equivalents and restricted cash |
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(689,053) |
|
(507,850) |
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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
- Solidified BRUKINSA as a BTK inhibitor of choice with PFS superiority label update from the FDA, approvals in R/R FL in Europe and Canada
- Expanded TEVIMBRA global reach with pending regulatory submissions in 10 markets, including the U.S. and Europe
- Enrolled first patients in a Phase 3 global trial of sonrotoclax in first-line CLL and expansion cohorts with registration potential for BTK CDAC
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Category |
Asset |
Recent Milestones |
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Regulatory Approvals |
BRUKINSA |
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TEVIMBRA |
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Regulatory Submissions |
Tislelizumab |
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Clinical Activities |
BRUKINSA |
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Tislelizumab |
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Sonrotoclax |
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BTK CDAC |
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Anti-LAG3 |
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Early development
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Anticipated Upcoming Milestones
Key Highlights
- Secure FDA approval for BRUKINSA in combination with obinutuzumab in R/R FL, making it the BTK inhibitor with the broadest label in the class
- Receive FDA approval for tislelizumab in first- and second-line ESCC, demonstrating global expansion of innovative solid tumor portfolio
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Category |
Asset |
Anticipated Milestones |
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Anticipated Regulatory Approvals |
BRUKINSA |
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Tislelizumab |
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Anticipated Regulatory Submissions |
BRUKINSA |
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Tislelizumab |
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