- Total revenues of $752 million in the first quarter, including
product revenue of $747 million, an 82% increase from the
prior-year period
- BRUKINSA revenue of $489 million, driven by growth in the U.S.
and Europe of 153% and 243%, respectively, from the prior-year
period; with recent fifth FDA approval, BRUKINSA now has the
broadest label in the BTKi class
- Rapidly advancing late-stage hematology pipeline; sonrotoclax
in development both as a monotherapy and in combination with
backbone therapy BRUKINSA; pivotal program initiated for BTK
CDAC
- Progressing potentially differentiated solid tumor programs
with ADC, degrader platforms and targeted therapies in priority
cancer types
- Significantly improved operating leverage and progress on path
to sustainable profitability
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
oncology company, today announced results from the first quarter
2024 and business highlights.
“We are pleased to present another quarter of strong financial
results. Supported by our tremendous global growth in revenue, we
have now ascended into the top 15 of global oncology innovators
based on total oncology sales. We also continue to make significant
improvement in our operating leverage as we progress to sustainable
profitability,” said John V. Oyler, Co-Founder, Chairman and CEO at
BeiGene. “We strengthened our hematology leadership with BRUKINSA,
now the BTK inhibitor with the broadest label in the class, as we
advance our innovative pipeline of therapies for hematologic
malignancies. With TEVIMBRA now approved for use in the U.S. and
Europe, we look forward to rapidly advancing our deep pipeline of
solid tumor therapies to match our leadership in hematology and
continue to solidify our reputation as a global oncology
innovator.”
Financial Highlights
(Amounts in thousands of U.S. dollars)
Three Months Ended March
31,
(in thousands, except
percentages)
2024
2023
% Change
Net product revenues
$
746,918
$
410,291
82
%
Net revenue from collaborations
$
4,734
$
37,510
(87
)%
Total Revenue
$
751,652
$
447,801
68
%
GAAP loss from operations
$
(261,348
)
$
(371,258
)
(30
)%
Adjusted loss from operations*
$
(147,341
)
$
(275,859
)
(47
)%
* 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)
- U.S. sales of BRUKINSA totaled $351 million in the first
quarter of 2024, representing growth of 153% over the prior-year
period, as BRUKINSA gained share in treatment-naïve (TN) chronic
lymphocytic leukemia (CLL), and emerged as the BTKi class leader in
new-patient share in relapsed or refractory (R/R) CLL; BRUKINSA
sales in Europe totaled $67 million in the first quarter of 2024,
representing growth of 243%, driven by continued gains in market
share and additional reimbursements including France, which
implemented reimbursement for BRUKINSA within CLL, Waldenstr�m’s
macroglobulinemia (WM) and marginal zone lymphoma for the first
time;
- Presented a new matching adjusted indirect comparison of the
efficacy of BRUKINSA versus acalabrutinib in R/R CLL based on data
from the Phase 3 ALPINE and Phase 3 ASCEND trials demonstrating a
progression-free survival and Complete Response (CR) advantage for
BRUKINSA versus acalabrutinib, as well as potentially improved
overall survival; and
- Received U.S. Food and Drug Administration (FDA) approval for
the treatment of adult patients with R/R follicular lymphoma, in
combination with the anti-CD20 monoclonal antibody obinutuzumab,
after two or more lines of systemic therapy.
TEVIMBRA® (tislelizumab)
- Sales of tislelizumab totaled $145 million in the first quarter
of 2024, representing growth of 26% compared to the prior-year
period;
- Announced European Commission approval as a treatment for
non-small cell lung cancer (NSCLC) across three indications,
including first- and second-line use;
- Received FDA approval for the treatment of second-line
esophageal squamous cell carcinoma (ESCC) after prior
chemotherapy;
- Received FDA acceptance of BLA for the treatment of first-line
gastric or gastroesophageal junction cancers; and
- The pending FDA approval for tislelizumab in first-line
unresectable, recurrent, locally advanced, or metastatic ESCC with
a target PDUFA action date of July 2024 may be deferred on account
of a potential delay in scheduling clinical site inspections.
Key Pipeline Highlights
Hematology
Sonrotoclax (BCL2 inhibitor)
- Received FDA fast track designation for R/R mantle cell
lymphoma (MCL); and
- Continued enrollment in R/R MCL and WM with registrational
intent as well as Phase 3 in TN CLL in combination with BRUKINSA;
more than 850 patients enrolled to date across the program.
BGB-16673 (BTK CDAC)
- Initiated expansion cohorts in R/R MCL (potential
registrational intent) and R/R CLL; more than 220 patients enrolled
to date across the program; and
- Expect to initiate Phase 3 clinical trial in R/R CLL by the end
of 2024.
Solid Tumors
Lung Cancer
- Enrolled last subject in a Phase 3 clinical trial for
ociperlimab (anti-TIGIT) for first-line PD-L1 high NSCLC;
- Multiple tislelizumab lung cancer combination cohorts with
BGB-A445 (anti-OX40), LBL-007 (anti-LAG3) and BGB-15025 (HPK1
inhibitor) expected to read out in 2024; and
- Pan-KRAS and MTA-cooperative PRMT5 inhibitors and EGFR CDAC on
track to enter the clinic in the second half of 2024.
Breast Cancer
- BGB-43395 (CDK4 inhibitor): Initiated fourth dose level of
monotherapy, which is in the efficacious dose range with no dose
limiting toxicities observed; and initiated dosing of combination
with fulvestrant just over four months from first monotherapy
dose.
- BG-68501 (CDK2 inhibitor): Initiated second dose level of
monotherapy in first-in-human study, with clinical pharmacokinetics
as expected and no dose limiting toxicities observed.
- BG-C9074 (B7H4 ADC): First patient dosed in Australia in global
first-in-human Phase 1 study.
Gastrointestinal Cancers
- Multiple tislelizumab combination cohorts with LBL-007
(anti-LAG3) and BGB-A445 (anti-OX40) reading out in 2024;
- Plan to submit a BLA with the NMPA for zanidatamab for the
treatment of second-line biliary tract cancer; and
- CEA-ADC and FGFR2b-ADC on track to enter the clinic in the
second half of 2024.
Other Business
Highlights
- The U.S. Patent and Trademark Office (USPTO) granted the
Company’s petition for post-grant review of the Pharmacyclics’
patent asserted against the Company in a patent infringement suit,
stating that the Company has shown that it is more likely than not
that the patent is invalid; The USPTO is expected to issue a final
decision on the validity of the patent within 12 months;
- Published the 2023 Responsible Business & Sustainability
Report which details the Company’s commitment to providing
equitable benefit to patients, business and society; and
- Anticipate opening of state-of-the-art biologics manufacturing
facility and clinical R&D center at the Princeton West
Innovation Campus in Hopewell, New Jersey, in July.
First Quarter 2024 Financial
Highlights
Revenue for the three months ended March 31, 2024, was
$752 million, compared to $448 million in the same period of 2023,
driven primarily by growth in BRUKINSA product sales in the U.S.
and Europe of 153% and 243% respectively.
Product Revenue for the three months ended March 31,
2024, was $747 million, compared to $410 million in the same period
of 2023, representing an increase of 82%. The increase in product
revenue was attributable to increased sales of our internally
developed products, BRUKINSA and tislelizumab. For the three months
ended March 31, 2024, the U.S. was the Company’s largest market,
with product revenue of $351 million, compared to $139 million in
the prior year period.
Gross Margin as a percentage of global product revenue
for the first quarter of 2024 was 83%, compared to 80% in the
prior-year period. The gross margin percentage increased primarily
due to proportionally higher sales mix of global BRUKINSA compared
to other products in the portfolio.
Operating Expenses
GAAP
Non-GAAP
(in thousands, except
percentages)
Q1 2024
Q1 2023
% Change
Q1 2024
Q1 2023
% Change
Research and development
$
460,638
$
408,584
13
%
$
405,440
$
361,696
12
%
Selling, general and administrative
$
427,427
$
328,499
30
%
$
372,146
$
283,154
31
%
Amortization
$
—
$
187
(100
)%
$
—
$
—
NM
Total operating expenses
$
888,065
$
737,270
20
%
$
777,586
$
644,850
21
%
Research and Development (R&D) Expenses increased for
the first 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 $35 million in the first
quarter of 2024, compared to nil in the prior-year period.
Selling, General and Administrative (SG&A) Expenses
increased for the first quarter of 2024 compared to the prior-year
period 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. SG&A expenses as a percentage of
product sales were 57% for the first quarter of 2024 compared to
80% in the prior year period.
Loss from Operations in the first quarter of 2024
decreased 30% on a GAAP basis and 47% on an adjusted basis compared
to the prior-year period. The decrease is driven by significantly
improved operating leverage associated with substantial revenue
growth and expense discipline as we make significant progress on
the path to sustainable profitability.
GAAP Net Loss improved for the quarter ended March 31,
2024, compared to the prior-year period, as our product revenue
growth and management of expenses is driving increased operating
leverage.
For the quarter ended March 31, 2024, net loss per share was
$(0.19) and $(2.41) per American Depositary Share (ADS), compared
to $(0.26) per share and $(3.34) per ADS in the prior year
period.
Cash Used in Operations for the quarter ended March 31,
2024, totaled $309 million compared to $564 million in the
prior-year period, driven by improved operating leverage.
For further details on BeiGene’s First Quarter 2024 Financial
Statements, please see BeiGene’s Quarterly Report on Form 10-Q for
the first 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 more than
10,000 colleagues spans five continents. To learn more about
BeiGene, please visit www.beigene.com and follow us on LinkedIn, X
(formerly known as Twitter) and Facebook.
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 ability to advance its pipeline of therapies for
hematologic malignancies and rapidly advance its pipeline of solid
tumor therapies to solidify its reputation as a global oncology
innovator; BeiGene’s anticipated clinical activities and read outs;
the opening date of BeiGene’s biologics manufacturing facility and
clinical R&D center in Hopewell, New Jersey; BeiGene’s progress
towards sustainable profitability; 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
March 31,
2024
2023
(Unaudited)
Revenues
Product revenue, net
$
746,918
$
410,291
Collaboration revenue
4,734
37,510
Total revenues
751,652
447,801
Cost of sales - products
124,935
81,789
Gross profit
626,717
366,012
Operating expenses:
Research and development
460,638
408,584
Selling, general and administrative
427,427
328,499
Amortization of intangible assets
—
187
Total operating expenses
888,065
737,270
Loss from operations
(261,348
)
(371,258
)
Interest income, net
16,160
16,016
Other income (expense), net
1,762
18,303
Loss before income taxes
(243,426
)
(336,939
)
Income tax expense
7,724
11,492
Net loss
(251,150
)
(348,431
)
Net loss per share, basic and diluted
$
(0.19
)
$
(0.26
)
Weighted-average shares outstanding—basic
and diluted
1,355,547,626
1,354,164,760
Net loss per ADS, basic and diluted
$
(2.41
)
$
(3.34
)
Weighted-average ADSs outstanding—basic
and diluted
104,272,894
104,166,520
Select Condensed Consolidated
Balance Sheet Data (U.S. GAAP)
(Amounts in thousands of U.S.
Dollars)
As of
March 31,
December 31,
2024
2023
(unaudited)
(audited)
Assets:
Cash, cash equivalents, restricted cash
and short-term investments
$
2,807,436
$
3,188,584
Accounts receivable, net
435,294
358,027
Inventories
447,345
416,122
Property, plant and equipment, net
1,417,992
1,324,154
Total assets
5,667,681
5,805,275
Liabilities and equity:
Accounts payable
356,575
315,111
Accrued expenses and other payables
569,438
693,731
R&D cost share liability
225,530
238,666
Debt
1,025,992
885,984
Total liabilities
2,307,320
2,267,948
Total equity
$
3,360,361
$
3,537,327
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
March 31,
2024
2023
( in thousands)
Reconciliation of GAAP to adjusted cost
of sales - products:
GAAP cost of sales - products
$
124,935
$
81,789
Less: Depreciation
2,345
2,180
Less: Amortization of intangibles
1,183
799
Adjusted cost of sales - products
$
121,407
$
78,810
Reconciliation of GAAP to adjusted
research and development:
GAAP research and development
$
460,638
$
408,584
Less: Share-based compensation
expenses
38,045
34,028
Less: Depreciation
17,153
12,860
Adjusted research and development
$
405,440
$
361,696
Reconciliation of GAAP to adjusted
selling, general and administrative:
GAAP selling, general and
administrative
$
427,427
$
328,499
Less: Share-based compensation
expenses
50,669
41,360
Less: Depreciation
4,612
3,985
Adjusted selling, general and
administrative
$
372,146
$
283,154
Reconciliation of GAAP to adjusted
operating expenses
GAAP operating expenses
$
888,065
$
737,270
Less: Share-based compensation
expenses
88,714
75,388
Less: Depreciation
21,765
16,845
Less: Amortization of intangibles
—
187
Adjusted operating expenses
$
777,586
$
644,850
Reconciliation of GAAP to adjusted loss
from operations:
GAAP loss from operations
$
(261,348
)
$
(371,258
)
Plus: Share-based compensation
expenses
88,714
75,388
Plus: Depreciation
24,110
19,025
Plus: Amortization of intangibles
1,183
986
Adjusted loss from operations
$
(147,341
)
$
(275,859
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240508878785/en/
Investor Liza Heapes +1 857-302-5663 ir@beigene.com
Media Kyle Blankenship +1 667-351-5176
media@beigene.com
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