SAN MATEO, Calif. - Tuesday, 12. November 2024 AETOSWire
Continued
financial progress with $1 billion in quarterly total revenue, reduced
GAAP loss and second consecutive quarter of positive non-GAAP operating
income
Strengthened franchise leadership in chronic lymphocytic
leukemia (CLL) with foundational therapy BRUKINSA global revenue of $690
million, rapidly progressing pivotal programs for late-stage hematology
pipeline
Expanded oncology pipeline with four new molecular entities
(NMEs) entering the clinic this quarter (eight year-to-date);
reaffirmed on track to achieve goal to enter 10+ by end of year;
in-house innovative “Fast to Proof of Concept” strategy quickly explores
the clinical potential of molecules in parallel, with industry leading
speed of execution
(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE;
HKEX: 06160; SSE: 688235), a global oncology company, today announced
financial results and corporate updates from the third quarter of 2024.
“Our
exceptional third-quarter results underscore the Company’s global
oncology leadership driven by our unique R&D and clinical advantages
as well as the tremendous launch trajectory of BRUKINSA,” said John V.
Oyler, Co-Founder, Chairman and CEO at BeiGene. “In the U.S., BRUKINSA,
with the broadest label of any BTK inhibitor, is now the leader in new
patient starts in both frontline and relapsed/refractory (R/R) CLL in
addition to all other approved B-cell malignancies. As the cornerstone
of our hematology franchise, BRUKINSA shows tremendous promise for
patients as a monotherapy and as a backbone for best-in-class
combinations with our late-stage BCL2 inhibitor, sonrotoclax, and BTK
degrader BGB-16673. In the solid tumor area, we’re expanding access to
our PD-1 inhibitor, TEVIMBRA, for patients worldwide and building global
commercial capabilities to support our prolific pipeline of exciting
potential cancer medicines. We are laying the foundation for future
franchises in breast, lung, and gastrointestinal cancers across three
signature platform technologies including multi-specific antibodies,
protein degraders, and antibody-drug conjugates. This progress not only
highlights our achievements but also emphasizes our commitment to
positively impacting patients' lives globally, fostering hope and
advancements in the fight against cancer.”
Third Quarter 2024 Financial Snapshot
(Amounts in thousands of U.S. dollars and Unaudited)
Three Months Ended September 30,
Nine Months Ended September 30,
(in thousands, except percentages)
2024
2023
% Change
2024
2023
% Change
Net product revenues
$
993,447
$
595,290
67
%
$
2,661,511
$
1,559,326
71
%
Net revenue from collaborations
$
8,152
$
186,018
(96
)%
$
20,906
$
265,044
(92
)%
Total Revenue
$
1,001,599
$
781,308
28
%
$
2,682,417
$
1,824,370
47
%
GAAP loss from operations
$
(120,265
)
$
(133,968
)
(10
)%
$
(488,774
)
$
(823,941
)
(41
)%
Adjusted income(loss) from operations*
$
65,630
$
(16,339
)
502
%
$
(33,247
)
$
(485,249
)
(93
)%
*
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.
Key Business Updates
BRUKINSA®
(zanubrutinib) is an orally available, small molecule inhibitor of BTK
designed to deliver complete and sustained inhibition of the BTK protein
by optimizing bioavailability, half-life, and selectivity. With
differentiated pharmacokinetics compared with other approved BTK
inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation
of malignant B cells within a number of disease-relevant tissues.
BRUKINSA has the broadest label globally of any BTK inhibitor and is the
only BTK inhibitor to provide the flexibility of once or twice daily
dosing. The global BRUKINSA clinical development program includes about
6,000 patients enrolled in 30 countries and regions across more than 35
trials. BRUKINSA is approved in more than 70 markets, and more than
100,000 patients have been treated globally.
U.S. sales of
BRUKINSA totaled $504 million in the third quarter of 2024, representing
growth of 87% over the prior-year period, with more than 60% of the
quarter over quarter demand growth coming from expanded use in CLL as
BRUKINSA continued to gain share in CLL new patient starts; BRUKINSA
sales in Europe totaled $97 million in the third quarter of 2024,
representing growth of 217%, driven by increased market share across all
major markets, including Germany, Italy, Spain, France and the UK;
Five-year follow-up results from cohort 1 of the Phase 3 SEQUOIA study
showed sustained progression-free survival (PFS) benefit (54-month PFS
rate of 80%) with BRUKINSA in patients with treatment-naïve (TN) CLL or
small lymphocytic lymphoma (SLL), with no new safety signals observed;
detailed data will be presented at the annual American Society of
Hematology (ASH) 2024 conference; and
Five-year follow-up data of
BOVen (zanubrutinib, obinutuzumab, venetoclax) study in TN CLL
demonstrates frequent unmeasurable minimal residual disease (uMRD) in
peripheral blood (96%) and bone marrow (92%), and uMRD was durable with a
median MRD-free survival of 34 months; detailed data will be presented
at the ASH 2024 conference.
TEVIMBRA® (tislelizumab) is a
uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed
cell death protein 1 (PD-1) monoclonal antibody with high affinity and
binding specificity against PD-1; it is designed to minimize binding to
Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s
immune cells to detect and fight tumors. TEVIMBRA is the foundational
asset of BeiGene’s solid tumor portfolio and has shown potential across
multiple tumor types and disease settings. The global TEVIMBRA clinical
development program includes almost 14,000 patients enrolled to date in
34 counties and regions across 66 trials, including 20
registration-enabling studies. TEVIMBRA is approved in 42 countries and
regions, and more than 1.3 million patients have been treated globally.
Sales of tislelizumab totaled $163 million in the third quarter of
2024, representing growth of 13% compared to the prior-year period;
Announced commercial availability in the U.S. for second-line
esophageal squamous cell carcinoma (ESCC) and in the first European
countries for second-line ESCC and first- and second-line non-small cell
lung cancer (NSCLC);
Received positive opinions from the
European Medicines Agency Committee for Medicinal Products for Human Use
(CHMP) as a first-line treatment for advanced/metastatic gastric or
gastroesophageal junction cancer and ESCC;
Received China National Medical Products Administration approval for neo-adjuvant/adjuvant NSCLC; and
Further expanded global footprint with new approvals in Brazil
(second-line NSCLC, second-line ESCC), Singapore (first- and second-line
NSCLC, second-line ESCC), Thailand (first- and second-line NSCLC,
first- and second-line ESCC and first-line gastric cancer) and Israel
(second-line ESCC).
Key Pipeline Highlights
BeiGene’s
portfolio strategy emphasizes rapid generation of early-stage clinical
proof-of-concept data enabled by its speed- and cost-advantaged (“Fast
to Proof of Concept”) approach to global clinical operations. The
Company’s in-house clinical operations team of 3,600 colleagues conducts
trials across five continents, ensuring rigorous data quality through
collaborations with regulators and investigators in over 45 countries.
This strategic approach maximizes resources by channeling data-gated
investments into the most promising clinically differentiated candidates
quickly and de-prioritizing others. With one of the largest oncology
research teams in the industry, BeiGene has demonstrated strengths in
translational small molecule and biologics discovery, including three
platform technologies: multi-specific antibodies, chimeric degradation
activation compounds (CDACs), and antibody-drug conjugates (ADCs). For
NMEs entering the clinic, BeiGene has industry leading preclinical, dose
escalation cohort and dose escalation to dose expansion timings. Two
examples of the Company’s speed advantage resulting from its internal
innovation at scale:
CDK4i entered the clinic in December 2023; 6.4 weeks on average for dose-escalation cohorts with more than 100 patients;
B7H4 ADC entered the clinic in April 2024; 6.6 weeks on average for dose-escalation cohorts with 30 patients enrolled.
Hematology
Sonrotoclax (BCL2 inhibitor)
More than 1,300 patients enrolled to date across the program;
Continued enrollment in global Phase 2 trial in Waldenström’s
macroglobulinemia (WM) and global Phase 3 CELESTIAL trial in combination
with BRUKINSA in TN CLL with enrollment completion estimated in the
first quarter of 2025;
Anticipate enrolling first subjects in
global Phase 3 programs in R/R CLL and R/R mantle cell lymphoma (MCL) in
the first half of 2025; and
Announced upcoming oral presentation
at ASH 2024 of Phase 1 study in combination with BRUKINSA for patients
with TN CLL/SLL highlighting continued deep and durable responses and
manageable tolerability.
BGB-16673 (BTK CDAC)
More
than 350 patients enrolled to date across the program; continued to
enroll potentially registration enabling expansion cohort in R/R CLL;
Anticipate initiation of Phase 3 trial in R/R CLL in the first half of 2025; and
Granted US FDA Fast Track Designation for R/R CLL/SLL.
Solid Tumors
Lung Cancer
BG-T187 (EGFR x MET trispecific antibody): Initiated dose escalation;
EGFR and MET dual targeting to address large EGFR-mutated NSCLC
population and other EGFR- or MET-driven populations such as colorectal
cancer; differentiated MET biparatopic design with optimal MET
inhibitory activity to pursue best-in-class opportunity;
BGB-58067 (MTA-cooperative PRMT5 inhibitor): on track to enter the
clinic in the fourth quarter of 2024; selectively kills MTAP-deletion
tumor cells that are present in approximately 15% of all tumor types;
designed to avoid on-target hematological toxicity seen with
first-generation inhibitors; best-in-class potential with high potency,
selectivity, and brain penetrability; and
BG-60366 (EGFR CDAC):
on track to enter the clinic in the fourth quarter of 2024:
differentiated degrader mechanism to completely abolish EGFR signaling;
highly potent across osimertinib-sensitive and resistant EGFR mutations;
strong preclinical efficacy data with oral and daily dosing;
Breast and Gynecologic Cancers
BGB-43395 (CDK4 inhibitor): continued dose escalation in monotherapy
and in combination with fulvestrant and letrozole in the anticipated
efficacious dose range; more than 100 patients enrolled to date;
BG-68501 (CDK2 inhibitor) and BG-C9074 (B7H4 ADC): continued monotherapy
dose escalation, with pharmacokinetics as expected and no dose-limiting
toxicities observed; and
Four abstracts accepted for
presentation at San Antonio Breast Cancer Symposium (SABCS), including
preclinical characterization and data from first-in-human Phase 1 dose
escalation study of BGB-43395.
Gastrointestinal Cancers
NMEs entered into the clinic in the third quarter include:
BGB-B2033 (GPC3 x 4-1BB bispecific antibody): initiated dose escalation
in GPC3 highly expressing tumors; best-in-class potential due to highly
potent 4-1BB agonist antibody via simultaneous binding to two 4-1BB
molecules for better receptor clustering and T-cell activation;
BG-C477 (CEA ADC): highly expressed tumor-associated antigen in
multiple cancer types; differentiated ADC design enables broad targeting
including in patients with medium to low target expression; potent
anti-tumor activity in preclinical models of colorectal and gastric
cancer and NSCLC; and
BGB-B3227 (MUC-1 x CD16A bispecific
antibody): initiated dose expansion for MUC-1 highly upregulated tumors,
including lung, gastrointestinal and breast cancers; differentiated
MUC-1 antibody targeting SEA domain to reduce sink effect of soluble
MUC-1; potential first-in-class natural killer (NK) cell engager acting
through CD16A, an NK activating receptor highly expressed in MUC-1
positive tumors;
NMEs on track to enter the clinic in the fourth quarter of 2024:
BGB-53038 (PanKRAS inhibitor): highly potent and selective with broad
activity against KRAS mutations in multiple tumor types; limits toxicity
by sparing other RAS proteins; and
BG-C137 (FGFR2b ADC):
potential first-in-class ADC for a validated target in upper
gastrointestinal and breast cancers; potential superior efficacy
compared to leading monoclonal antibody in both high- and
medium-expression models.
Inflammation and Immunology
BGB-45035
(IRAK4 CDAC): Currently in dose escalation in both SAD and MAD cohorts;
potent and selective degrader that targets both kinase and scaffold
functions of IRAK4 for complete target degradation; deep and fast
degradation that leads to stronger cytokine inhibition and superior
efficacy in vivo.
Corporate Updates
Strengthened global
leadership team with appointments of Matt Shaulis as General Manager of
North America and Shalini Sharp to Board of Directors.
Third Quarter 2024 Financial Highlights
Revenue
for the three months ended September 30, 2024, was $1,002 million,
compared to $781 million in the same period of 2023, driven primarily by
growth in BRUKINSA product sales in the U.S. and Europe of 87% and 217%
respectively. The reacquisition of the full global commercial rights to
ociperlimab and TEVIMBRA in the third quarter of 2023 resulted in the
recognition of the remaining deferred revenues from the former Novartis
collaborations, which contributed $183 million of the total revenue in
the prior year period.
Product Revenue for the three months ended
September 30, 2024, was $993 million, compared to $595 million in the
same period of 2023, representing an increase of 67%. The increase in
product revenue was primarily attributable to increased sales of
BRUKINSA. For the three months ended September 30, 2024, the U.S. was
the Company’s largest market, with product revenue of $504 million,
compared to $270 million in the prior year period. In addition to
BRUKINSA revenue growth, product revenues were positively impacted by
growth from in-licensed products from Amgen and tislelizumab.
Gross
Margin as a percentage of global product revenue for the third quarter
of 2024 was 83%, compared to 84% in the prior-year period on a GAAP
basis and 85%, compared to 84% in the prior-year period on an adjusted
basis. The GAAP gross margin percentage decrease compared to the
prior-year period was the result of accelerated depreciation expense of
$17 million resulting from the move to more efficient, larger scale
production lines for tislelizumab, and with a similar amount to be
incurred in the fourth quarter related to this move. The adjusted gross
margin percentage, which does not include the accelerated depreciation,
increased primarily due to proportionally higher sales mix of global
BRUKINSA compared to other products in the portfolio.
Operating Expenses
The following table summarizes operating expenses for the third quarter 2024 and 2023, respectively:
GAAP
Non-GAAP
(unaudited, in thousands, except percentages)
Q3 2024
Q3 2023
% Change
Q3 2024
Q3 2023
% Change
Research and development
$
496,179
$
453,259
9
%
$
405,545
$
396,146
2
%
Selling, general and administrative
$
455,223
$
365,708
24
%
$
380,737
$
308,493
23
%
Total operating expenses
$
951,402
$
818,967
16
%
$
786,282
$
704,639
12
%
The following table summarizes operating expenses for the year-to-date period ended September 30, 2024 and 2023, respectively:
GAAP
Non-GAAP
(unaudited, in thousands, except percentages)
Q3 YTD 2024
Q3 YTD 2023
% Change
Q3 YTD 2024
Q3 YTD 2023
% Change
Research and development
$
1,411,283
$
1,284,607
10
%
$
1,193,494
$
1,121,577
6
%
Selling, general and administrative
$
1,326,379
$
1,089,616
22
%
$
1,116,805
$
923,254
21
%
Total operating expenses
$
2,737,662
$
2,374,223
15
%
$
2,310,299
$
2,044,831
13
%
Research
and Development (R&D) Expenses increased for the third quarter of
2024 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. Upfront fees and milestone
payments related to in-process R&D for in-licensed assets totaled $5
million in the third quarter of 2024, compared to $15 million in the
prior-year period. Included within GAAP research and development expense
for the third quarter of 2024 is $24.9 million of accelerated
depreciation expense related to the move of clinical production to
larger, more efficient production lines with approximately $2.0 million
remaining to be incurred in the fourth quarter.
Selling, General
and Administrative (SG&A) Expenses increased for the third quarter
of 2024 compared to the prior-year period on both a GAAP and adjusted
basis due to continued investment to support the global commercial
launch of BRUKINSA, primarily in the U.S. and Europe. SG&A expenses
as a percentage of product sales were 46% for the third quarter of 2024
compared to 61% in the prior year period.
GAAP Income (Loss) from
Operations in the third quarter of 2024 operating loss decreased 10%
compared to the prior-year-period primarily due to increased operating
leverage. On an adjusted basis, we generated operating income of $66
million, an increase of $82 million from the prior year period. GAAP and
adjusted loss from operations in the prior year period benefited from
the recognition of the remaining deferred revenues from the Novartis
collaboration agreements.
GAAP Net Loss for the quarter ended
September 30, 2024 was $121 million, compared to net income of $215
million in the prior-year period. Net income in the prior year period
benefited from the non-operating gain of $363 million (pre and
after-tax) related to the BMS arbitration settlement and the recognition
of the remaining deferred revenues from the Novartis collaboration
agreements. Net loss in the period continued to improve sequentially, as
our product revenue growth and management of expenses is driving
increased operating leverage.
For the quarter ended September 30,
2024, net loss per basic ordinary share was $(0.09) and net loss per
basic American Depositary Share (ADS) was $(1.15), compared to net
income per basic ordinary share of $0.16 and net income per basic ADS of
$2.06 in the prior-year period.
Cash Provided by Operations for
the quarter ended September 30, 2024 was $188 million, an increase of
$267 million over the prior-year period. The improvement in operating
cash flows in the period was primarily driven by improved non-GAAP
operating income and favorability in the period from working capital
seasonality.
For further details on BeiGene’s Third Quarter 2024
Financial Statements, please see BeiGene’s Quarterly Report on Form 10-Q
for the third quarter of 2024 filed with the U.S. Securities and
Exchange Commission.
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 nearly 11,000 colleagues spans five continents. To learn more about
BeiGene, please visit www.beigene.com and follow us on LinkedIn, X
(formerly known as Twitter), Facebook and Instagram.
BeiGene
intends to use the Investors section of its website, its X (formerly
known as Twitter) account at x.com/BeiGeneGlobal, its LinkedIn account
at linkedin.com/company/BeiGene, its Facebook account at
facebook.com/BeiGeneGlobal, and its Instagram account at
instagram.com/BeiGeneGlobal to disclose material information and to
comply with its disclosure obligations under Regulation FD. Accordingly,
investors should monitor BeiGene’s website, its X account, its LinkedIn
account, its Facebook account, and its Instagram account in addition to
BeiGene’s press releases, SEC filings, public conference calls,
presentations, and webcasts.
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 the expansion of
TEVIMBRA for patients worldwide; the future and success of BeiGene’s
pipeline; 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 quarterly report on Form 10-Q, 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.
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
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
(Unaudited)
(Unaudited)
Revenues
Product revenue, net
$
993,447
$
595,290
$
2,661,511
$
1,559,326
Collaboration revenue
8,152
186,018
20,906
265,044
Total revenues
1,001,599
781,308
2,682,417
1,824,370
Cost of sales - products
170,462
96,309
433,529
274,088
Gross profit
831,137
684,999
2,248,888
1,550,282
Operating expenses:
Research and development
496,179
453,259
1,411,283
1,284,607
Selling, general and administrative
455,223
365,708
1,326,379
1,089,616
Total operating expenses
951,402
818,967
2,737,662
2,374,223
Loss from operations
(120,265
)
(133,968
)
(488,774
)
(823,941
)
Interest income, net
10,643
26,649
40,028
57,735
Other income, net
11,318
336,657
1,096
291,142
(Loss) income before income taxes
(98,304
)
229,338
(447,650
)
(475,064
)
Income tax expense
23,046
13,925
45,255
39,091
Net (loss) income
(121,350
)
215,413
(492,905
)
(514,155
)
(Loss) earnings per share
Basic
(0.09
)
0.16
(0.36
)
(0.38
)
Diluted
(0.09
)
0.15
(0.36
)
(0.38
)
Weighted-average shares outstanding—basic
1,376,751,873
1,360,716,279
1,361,216,763
1,358,392,470
Weighted-average shares outstanding—diluted
1,376,751,873
1,390,331,833
1,361,216,763
1,358,392,470
(Loss) earnings per American Depositary Share (“ADS”)
Basic
(1.15
)
2.06
(4.71
)
(4.92
)
Diluted
(1.15
)
2.01
(4.71
)
(4.92
)
Weighted-average ADSs outstanding—basic
105,903,990
104,670,483
104,708,982
104,491,728
Weighted-average ADSs outstanding—diluted
105,903,990
106,948,603
104,708,982
104,491,728
Select Unaudited Condensed Consolidated Balance Sheet Data (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)
As of
September 30,
December 31,
2024
2023
(unaudited)
(audited)
Assets:
Cash, cash equivalents and restricted cash
$
2,713,428
$
3,185,984
Accounts receivable, net
569,047
358,027
Inventories
431,676
416,122
Property, plant and equipment, net
1,562,965
1,324,154
Total assets
5,830,860
5,805,275
Liabilities and equity:
Accounts payable
307,532
315,111
Accrued expenses and other payables
717,343
693,731
R&D cost share liability
187,052
238,666
Debt
1,051,316
885,984
Total liabilities
2,394,787
2,267,948
Total equity
$
3,436,073
$
3,537,327
Select Unaudited Condensed Consolidated Statements of Cash Flows (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)
Three Months Ended
September 30,
2024
2023
(unaudited)
Cash, cash equivalents and restricted cash at beginning of period
$
2,617,931
$
3,421,574
Net cash provided by (used in) operating activities
188,369
(78,150
)
Net cash used in investing activities
(133,882
)
(186,275
)
Net cash provided by (used in) financing activities
12,662
(76,782
)
Net effect of foreign exchange rate changes
28,348
525
Net increase (decrease) in cash, cash equivalents, and restricted cash
95,497
(340,682
)
Cash, cash equivalents and restricted cash at end of period
$
2,713,428
$
3,080,892
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
(Amounts in thousands of U.S. Dollars)
(unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2024
2023
2024
2023
Reconciliation of GAAP to adjusted cost of sales - products:
GAAP cost of sales - products
$
170,462
$
96,309
$
433,529
$
274,088
Less: Depreciation
19,589
2,320
24,618
6,680
Less: Amortization of intangibles
1,186
981
3,546
2,620
Adjusted cost of sales - products
$
149,687
$
93,008
$
405,365
$
264,788
Reconciliation of GAAP to adjusted research and development:
GAAP research and development
$
496,179
$
453,259
$
1,411,283
$
1,284,607
Less: Share-based compensation cost
47,670
44,150
141,121
124,126
Less: Depreciation
42,964
12,963
76,668
38,904
Adjusted research and development
$
405,545
$
396,146
$
1,193,494
$
1,121,577
Reconciliation of GAAP to adjusted selling, general and administrative:
GAAP selling, general and administrative
$
455,223
$
365,708
$
1,326,379
$
1,089,616
Less: Share-based compensation cost
66,933
51,969
192,890
150,710
Less: Depreciation
7,475
3,959
16,606
13,990
Less: Amortization of intangibles
78
1,287
78
1,662
Adjusted selling, general and administrative
$
380,737
$
308,493
$
1,116,805
$
923,254
Reconciliation of GAAP to adjusted operating expenses
GAAP operating expenses
$
951,402
$
818,967
$
2,737,662
$
2,374,223
Less: Share-based compensation cost
114,603
96,119
334,011
274,836
Less: Depreciation
50,439
16,922
93,274
52,894
Less: Amortization of intangibles
78
1,287
78
1,662
Adjusted operating expenses
$
786,282
$
704,639
$
2,310,299
$
2,044,831
Reconciliation of GAAP to adjusted income (loss) from operations:
GAAP loss from operations
$
(120,265
)
$
(133,968
)
$
(488,774
)
$
(823,941
)
Plus: Share-based compensation cost
114,603
96,119
334,011
274,836
Plus: Depreciation
70,028
19,242
117,892
59,574
Plus: Amortization of intangibles
1,264
2,268
3,624
4,282
Adjusted income (loss) from operations
$
65,630
$
(16,339
)
$
(33,247
)
$
(485,249
)
View source version on businesswire.com: https://www.businesswire.com/news/home/20241112799807/en/
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