- Continued rapid global growth with record total revenues of
$634 million in fourth quarter and $2.5 billion in full-year 2023,
increases of 67% and 74% from the prior-year periods
- Strengthened leadership in hematology with global BRUKINSA®
(zanubrutinib) sales of $413 million and $1.3 billion for the
quarter and full year, increases of 135% and 129%
- Progressed innovative hematology pipeline with initiation of
four registrational trials for sonrotoclax, including global Phase
3 study in treatment-naïve CLL, and two global expansion cohorts
for BTK CDAC in R/R CLL, R/R MCL
- Sustained growth with diverse product and geographic revenue
mix and improved operating leverage
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.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240226047170/en/
“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.
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:
- 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:
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
- 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
Category
Asset
Recent Milestones
Regulatory Approvals
BRUKINSA
- Received FDA approved label update to include superior PFS
results in adult patients with R/R CLL/SLL based on results from
the Phase 3 ALPINE trial
- Received approval from European Commission and authorization
from Health Canada for the treatment of adult patients with R/R FL
in combination with obinutuzumab who have received at least two
prior lines of systemic therapy
- Received regulatory approval in four additional markets for R/R
and treatment-naïve (TN) CLL
TEVIMBRA
- Received China National Medicinal Products Administration
(NMPA) approval as first-line treatment in patients with
unresectable hepatocellular carcinoma
- Received approval from the UK Medicines and Healthcare
Regulatory Agency (MHRA) as second-line treatment in patients with
advanced ESCC
Regulatory Submissions
Tislelizumab
- Received a positive opinion from the CHMP of the EMA
recommending approval as a treatment for NSCLC across three
indications
- Received NMPA acceptance of a supplemental Biologics License
Application (sBLA) submission for the treatment of previously
untreated extensive stage small cell lung cancer (ES-SCLC) in
combination with chemotherapy
- Received NMPA acceptance of a sBLA submission for treatment
plus platinum-based chemotherapy followed by adjuvant treatment of
adult patients with resectable Stage II or IIIA NSCLC
- Received EMA acceptance of submission for the treatment of
adult patients with first-line ESCC
Clinical Activities
BRUKINSA
- Announced positive follow-up data from the Phase 3 ALPINE study
in R/R CLL/SLL versus IMBRUVICA at ASH showing sustained PFS
benefit and persistently lower rates of cardiovascular events
Tislelizumab
- Enrolled first patient in a Phase 1 clinical trial evaluating
subcutaneous injection in the first-line treatment of patients with
advanced or metastatic NSCLC
Sonrotoclax (BGB-11417)
- FDA granted orphan designations for multiple myeloma (MM),
Waldenstrom’s macroglobulinemia (WM), acute myeloid leukemia (AML),
and mantle cell lymphoma (MCL)
- Enrolled first patient in a global pivotal trial in combination
with BRUKINSA in first-line CLL
- Presented data at ASH demonstrating:
- Sonrotoclax is safe and tolerable in combination with BRUKINSA
with deep and durable responses in TN CLL
- Encouraging data with potential to be first BCL2i approved in
MM with t(11,14)
- Promising single-agent activity in patients with R/R MZL
BTK CDAC (BGB-16673)
- Presented data at ASH from ongoing first-in-human study
demonstrating notable clinical responses and a tolerable safety
profile in heavily pretreated patients with B-cell malignancies,
including those with BTKi-resistant disease
- Enrolled first patients in R/R MCL expansion cohort with
potential for registration
- Fast Track and Orphan Drug designations received from FDA for
R/R MCL
Anti-LAG3 (LBL-0071)
- In partnership with Leads Biolabs, first subject enrolled in a
Phase 2 study as first-line treatment in patients with inoperable
locally advanced or metastatic ESCC in combination with
tislelizumab and chemotherapy
Early development
- Fully enrolled the first two cohorts in Phase 1 clinical trials
for NME BGB-43395 (CDK4 inhibitor)
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
Category
Asset
Anticipated Milestones
Anticipated Regulatory
Approvals
BRUKINSA
- Receive FDA approval in combination with obinutuzumab for the
treatment of adult patients with R/R FL who have received at least
two prior lines of systemic therapy in March 2024 and NMPA approval
in June 2024
Tislelizumab
- Receive FDA approval for the treatment of second-line ESCC in
first half of 2024
- Receive FDA approval for the treatment of first-line
unresectable, recurrent, locally advanced, or metastatic ESCC with
a target PDUFA in July 2024
- Receive EMA approval for the treatment of first line metastatic
NSCLC in combination with chemotherapy and second line metastatic
NSCLC as monotherapy in the first half of 2024
- Receive NMPA approval for the treatment of previously untreated
ES-SCLC in combination with chemotherapy in the third quarter of
2024
- Receive NMPA approval for the first-line treatment of
inoperable, locally advanced, or metastatic gastric or
gastroesophageal junction (G/GEJ) carcinoma in the second quarter
of 2024
Anticipated Regulatory
Submissions
BRUKINSA
- Submit an sNDA for a new tablet formulation with the EMA and
Health Canada in the first of half of 2024 and the FDA in the
second half of 2024
Tislelizumab
- Submit a marketing application with the Japan PMDA for the
treatment of first- and second-line ESCC in the first half of
2024
- Submit an sBLA with the EMA for the first-line treatment of
inoperable, locally advanced, or metastatic G/GEJ carcinoma in the
first quarter of 2024
Zanidatamab2
- In partnership with Jazz Pharmaceuticals and Zymeworks, submit
a BLA with the NMPA for treatment of HER2-amplified inoperable and
advanced or metastatic biliary tract cancer in the second half of
2024
Anticipated Clinical Activities
Sonrotoclax
- Complete enrollment in a global Phase 2 trial in R/R MCL with
potential for registration in the second quarter of 2024
Ociperlimab (Anti-TIGIT)
- Complete enrollment in the Phase 3 AdvanTIG-302 trial in
first-line NSCLC in the first quarter of 2024
Tarlatamab3 (DLL3 x CD3 bispecific T-cell
engager)
- In partnership with Amgen, begin China enrollment in a global
Phase 3 trial in limited-stage small cell lung cancer in the second
half of 2024
Early development
- Initiate first-in-human trials for at least 10 NMEs in 2024,
including pan-KRAS inhibitor, MTA cooperative PRMT5 inhibitor, EGFR
degrader, CDK2 inhibitor, ADCs, and bispecific immune cell
engagers
- In partnership with Amgen3, enroll first patient in China in a
Phase 1 study in metastatic castration-resistant prostate cancer
for xaluritamig (AMG 509, STEAP1 x CD3 XmAb® T-cell engager
molecule4) in the first half of 2024
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
- Neared completion of $800 million U.S. flagship biologics
manufacturing and clinical R&D facility at the Princeton West
Innovation Campus in Hopewell, New Jersey, which is expected to be
operational in July 2024; the property has more than 1 million
square feet of total developable real estate, allowing for future
expansion;
- Completed construction on new small molecule manufacturing
campus in Suzhou, China. Phase 1 of construction added more than
559,000 square feet and expanded production capacity to 1 billion
solid dosage form units annually; and
- Completed construction of a 250,000-square-foot ADC production
facility and additional 170,000-square-foot biologics clinical
production capabilities at our state-of-the-art biologics facility
in Guangzhou, China, which brings the total capacity to 65,000
liters.
Corporate Developments
- Acquired an exclusive global license to a differentiated CDK2
inhibitor from Ensem Therapeutics, Inc., complementing the
Company’s early development pipeline in breast cancer and other
solid tumors.
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)
Please note that the figures presented above
may not sum exactly due to rounding
About BeiGene
BeiGene is a global oncology company that is discovering and
developing innovative treatments that are more affordable and
accessible to cancer patients worldwide. With a broad portfolio, we
are expediting development of our diverse pipeline of novel
therapeutics through our internal capabilities and collaborations.
We are committed to radically improving access to medicines for far
more patients who need them. Our growing global team of more than
10,000 colleagues spans five continents, with administrative
offices in Basel, Beijing, and Cambridge, U.S. To learn more about
BeiGene, please visit www.beigene.com and follow us on LinkedIn and
X (formerly known as Twitter).
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
and other federal securities laws, including statements regarding
BeiGene’s progress towards becoming an impactful next-generation
oncology innovator; the future of BeiGene’s oncology pipeline;
BeiGene’s ability to grow revenue across new and existing
geographies, particularly in the U.S.; the expected capacities and
completion dates for the Company’s manufacturing facilities under
construction and the potential for such facilities to increase
manufacturing capabilities; BeiGene’s anticipated regulatory
approvals, submissions and clinical activities; and BeiGene’s
plans, commitments, aspirations and goals under the caption “About
BeiGene”. Actual results may differ materially from those indicated
in the forward-looking statements as a result of various important
factors, including BeiGene’s ability to demonstrate the efficacy
and safety of its drug candidates; the clinical results for its
drug candidates, which may not support further development or
marketing approval; actions of regulatory agencies, which may
affect the initiation, timing and progress of clinical trials and
marketing approval; BeiGene’s ability to achieve commercial success
for its marketed medicines and drug candidates, if approved;
BeiGene's ability to obtain and maintain protection of intellectual
property for its medicines and technology; BeiGene’s reliance on
third parties to conduct drug development, manufacturing,
commercialization, and other services; BeiGene’s limited experience
in obtaining regulatory approvals and commercializing
pharmaceutical products; BeiGene’s ability to obtain additional
funding for operations and to complete the development of its drug
candidates and achieve and maintain profitability; and those risks
more fully discussed in the section entitled “Risk Factors” in
BeiGene’s most recent annual report on Form 10-K, as well as
discussions of potential risks, uncertainties, and other important
factors in BeiGene’s subsequent filings with the U.S. Securities
and Exchange Commission. All information in this press release is
as of the date of this press release, and BeiGene undertakes no
duty to update such information unless required by law.
IMBRUVICA® is a registered trademark of Pharmacyclics LLC.
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version on businesswire.com: https://www.businesswire.com/news/home/20240226047170/en/
Investor Contact Liza Heapes +1 857-302-5663
ir@beigene.com
Media Contact Kyle Blankenship +1 667-351-5176
media@beigene.com
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