- Recorded product revenue of $304.5 million for the second
quarter, representing a 120% increase from $138.6 million in the
prior year period
- BRUKINSA product revenue increased 203% globally versus the
second quarter of 2021, and 23% sequentially compared to the first
quarter of 2022, led by growth in U.S. and China
- New global clinical data support FDA and EMA filings under
review for BRUKINSA and tislelizumab
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company developing and commercializing innovative and
affordable oncology medicines to improve treatment outcomes and
access for far more patients worldwide, today reported financial
results for the second quarter of 2022, recent business highlights,
and anticipated upcoming milestones.
“We made significant progress in our mission to reach far more
cancer patients with innovative and affordable medicines, with
growth in product revenues across our portfolio, driven primarily
by our internally developed medicines, BRUKINSA and tislelizumab.
We have now expanded our approvals to more than 50 markets
globally, and BRUKINSA global revenue more than tripled on a
year-over-year basis,” said John V. Oyler, Co-Founder, Chairman and
Chief Executive Officer of BeiGene. “We continue to unlock
opportunity driven by our research and development engine and,
during the second half of this year, expect to share final analysis
data for our global Phase 3 ALPINE trial of BRUKINSA, including
progression-free survival in chronic lymphocytic leukemia as well
as topline data for tislelizumab as a first-line treatment for
patients with unresectable hepatocellular cancer.”
“BeiGene is well positioned for growth with momentum across our
commercial portfolio and geographies and a strong capital position.
We are continuing to execute with discipline and realize the
benefits of our strategic investments in research and commercial
capabilities,” said Julia Wang, Chief Financial Officer,
BeiGene.
Second Quarter 2022 Financial
Results
Cash, Cash Equivalents, Restricted Cash, and Short-Term
Investments were $5.7 billion as of June 30, 2022 and $6.6
billion as of December 31, 2021.
- In the three months ended June 30, 2022, cash used in operating
activities was $380.0 million, primarily due to our net loss of
$571.4 million, offset by a decrease in our net operating assets
and liabilities of $96.3 million, and by non-cash charges of $95.2
million. Net loss for the three months ended June 30, 2022 includes
$129.6 million of other losses due primarily to the strengthening
of the U.S. dollar and the related revaluation of foreign
currencies held by U.S. functional currency subsidiaries. Capital
expenditures were $50.3 million and cash used in financing
activities was $17.6 million. In addition, the impact of foreign
currency deposits being translated into the U.S. dollar negatively
impacted ending cash by $80.2 million in the three months ended
June 30, 2022 compared to a positive impact of $9.3 million in the
prior year period.
Revenue for the three months ended June 30, 2022 was
$341.6 million, compared to $150.0 million in the same period of
2021.
- Product revenue totaled $304.5 million for the three months
ended June 30, 2022, compared to $138.6 million in the same period
of 2021, including:
- Global sales of BRUKINSA of $128.7 million for the second
quarter of 2022, compared to $42.4 million in the prior year
period;
- Sales of tislelizumab in China of $104.9 million for the second
quarter of 2022, compared to $74.9 million in the prior year
period;
- Sales of Amgen in-licensed products in China of $29.5 million
for the second quarter of 2022, compared to $3.3 million in the
prior year period. Prior year period sales do not include sales of
BLINCYTO® and KYPROLIS®, which were launched in China in August
2021 and January 2022, respectively; and
- Sales of BMS in-licensed products in China of $23.4 million for
the second quarter of 2022, compared to $13.4 million in the prior
year period.
- Collaboration revenue for the three months ended June 30, 2022
was $37.1 million, resulting from partial recognition of the
upfront payments from Novartis of $650.0 million related to the
tislelizumab agreement and $300.0 million related to the
ociperlimab agreement, which were entered into in the first quarter
and fourth quarter of 2021, respectively. Collaboration revenue for
the three months ended June 30, 2021 was $11.4 million, resulting
from the partial recognition of revenue related to the tislelizumab
agreement.
Expenses for the three months ended June 30, 2022 were
$781.0 million, compared to $624.8 million in the same period of
2021.
- Cost of Sales for the three months ended June 30, 2022
were $71.2 million, compared to $36.3 million in the same period of
2021. Cost of sales increased primarily due to increased product
sales of tislelizumab and BRUKINSA, as well as BLINCYTO, which
commenced in August 2021, and KYPROLIS and POBEVCY®, which
commenced in January 2022.
- R&D Expenses for the three months ended June 30,
2022 were $378.2 million, compared to $356.1 million in the same
period of 2021. The increase in R&D expenses was primarily
attributable to increases in headcount and costs related to
investment in our discovery and development activities, including
our continued efforts to internalize research and clinical
development activities, partially offset by decreased expense
related to upfront fees for in-process R&D. Upfront fees
related to in-process R&D for in-licensed assets totaled nil
and $45.0 million in the second quarters of 2022 and 2021,
respectively. Employee share-based compensation expense also
contributed to the overall increase in R&D expenses and was
$37.1 million for the three months ended June 30, 2022, compared to
$30.2 million for the same period of 2021.
- SG&A Expenses for the three months ended June 30,
2022 were $331.4 million, compared to $232.3 million in the same
period of 2021. The increase in SG&A expenses was primarily
attributable to increased headcount, largely related to the
expansion of our commercial teams, higher professional service fees
and higher external commercial expenses, including selling and
marketing, market access studies and promotional activities. The
overall increase in SG&A expenses was also attributable to
higher SG&A-related share-based compensation expense, which was
$44.2 million and $34.6 million for the second quarters of 2022 and
2021, respectively.
- Operating Loss for the three months ended June 30, 2022
decreased by $35.4 million, or 7.5% to $439.4 million, compared to
$474.8 million in the same period of 2021. The decrease in
operating loss for the quarter was driven by increased gross profit
on product sales, which exceeded the growth in operating
expenses.
- Net Loss for the quarter ended June 30, 2022 was $571.4
million, or $0.43 per share, and $5.56 per American Depositary
Share (ADS), compared to $480.3 million, or $0.40 per share, and
$5.23 per ADS in the same period of 2021. Net loss for the quarter
was negatively impacted by other non-operating expenses of $129.6
million, primarily related to foreign exchange losses resulting
from the strengthening of the U.S. dollar and the revaluation
impact of foreign currencies held in U.S. functional currency
subsidiaries.
Recent Business
Highlights
Commercial Operations
- Product sales increased 120% in the second quarter of 2022
compared to the prior year period, primarily due to increased sales
of our internally developed products, BRUKINSA and tislelizumab, as
well as increased sales of in-licensed products from Amgen;
- Global sales of BRUKINSA totaled $128.7 million in the second
quarter, representing a 203% increase compared to the prior year
period. U.S. sales of BRUKINSA totaled $88.4 million in the second
quarter, representing growth of 456% compared to the prior year
period, as the U.S. prescribing base continued to grow and as
clinician use increased within approved indications — mantle cell
lymphoma (MCL), Waldenstr�m’s macroglobulinemia (WM) and marginal
zone lymphoma (MZL). BRUKINSA sales in China totaled $36.7 million
in the second quarter, representing growth of 39% compared to the
prior year period, driven by a continued increase in all approved
indications; and
- Sales of tislelizumab in China totaled $104.9 million in the
second quarter, representing a 40% increase compared to the prior
year period. In the second quarter, we saw increased market
penetration and market share for tislelizumab across nine approved
indications, resulting from new patient demand from broader
reimbursement in additional National Reimbursement Drug List.
Development Programs
BRUKINSA® (zanubrutinib), a small molecule inhibitor of
Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy
and minimize off-target effects, approved in more than 50 markets
including the U.S., China, European Union (EU), Great Britain,
Canada, Australia, South Korea and Switzerland in selected
indications and under development for additional approvals
globally. The global BRUKINSA development program includes more
than 4,500 subjects enrolled to-date in more than 25 countries and
regions.
- Received approval in Mexico for BRUKINSA for the treatment of
adult patients with previously treated MCL;
- Received U.S. FDA fast track designation to investigate
zanubrutinib in combination with obinutuzumab, for the treatment of
adults with relapsed or refractory (R/R) follicular lymphoma (FL)
after two or more lines of systemic therapy;
- Received acceptance by Health Canada for supplemental new drug
submission (sNDS) for zanubrutinib in chronic lymphocytic leukemia
(CLL);
- Presented primary analysis of the global Phase 2 ROSEWOOD trial
(NCT03332017) of zanubrutinib plus obinutuzumab versus obinutuzumab
monotherapy in patients with R/R FL in an oral presentation at the
European Hematology Association (EHA) 2022 Congress as well as at
the 2022 American Society of Clinical Oncology (ASCO) Annual
Meeting. The ROSEWOOD trial met its primary endpoints of overall
response rate (ORR) and was generally well-tolerated, with safety
results consistent with previous studies of both medicines;
and
- Presented long-term follow-up safety and efficacy results from
the Phase 3 ASPEN trial (NCT03053440) of zanubrutinib versus
ibrutinib in patients with WM at the 2022 EHA Congress and ASCO
Annual Meetings, which showed that, at a median follow up of 43
months, zanubrutinib continued to demonstrate clinically meaningful
efficacy and a tolerable safety profile in patients with WM.
Tislelizumab, a humanized IgG4 anti-PD-1 monoclonal
antibody specifically designed to minimize binding to FcγR on
macrophages; approved in China in nine indications and under
development for additional approvals globally. The global
tislelizumab clinical development program includes more than 11,000
subjects enrolled to-date in 30 countries and regions.
- Received approval from the China National Medical Products
Administration (NMPA) for tislelizumab in combination with
chemotherapy as a first-line (1L) treatment for patients with
recurrent or metastatic nasopharyngeal cancer (NPC);
- Announced acceptance by the Center for Drug Evaluation (CDE) of
the NMPA for a supplemental biologics application (sBLA) for
tislelizumab in combination with chemotherapy as a 1L treatment for
patients with advanced or metastatic gastric or gastroesophageal
junction adenocarcinoma whose tumors express PD-L1;
- Notification of successful dossier validated from Australia’s
Therapeutic Goods Administration (TGA) for the new drug application
of tislelizumab in 1L and second-line (2L) non-small cell lung
cancer (NSCLC) and 2L esophageal squamous cell carcinoma
(ESCC);
- In collaboration with Novartis, the United Kingdom Medicines
and Healthcare products Regulatory Agency (MHRA) has validated the
tislelizumab submission for review as a treatment for 1L and 2L
NSCLC and 2L ESCC in Great Britain;
- Presented a late-breaking oral presentation at the 2022
European Society for Medical Oncology (ESMO) World Congress on
Gastrointestinal Cancer on new data from RATIONALE 306
(NCT03783442), a global Phase 3 trial which showed overall survival
benefit for tislelizumab plus chemotherapy versus chemotherapy
alone in 1L advanced or metastatic ESCC; and
- Presented updated results in an oral plenary session from the
global Phase 3 RATIONALE 309 trial (NCT03924986) of tislelizumab in
1L patients with NPC, and in a poster session reviewed clinical
outcomes associated with tislelizumab in patients with advanced
hepatocellular carcinoma (HCC) who have previously been treated
with sorafenib or lenvatinib in RATIONALE 208 (NCT03419897) at the
2022 ASCO Annual Meeting.
Early-Stage Programs
- Presented two posters from dose escalation studies of BGB-11417
(NCT04277637 and NCT04771130), a highly selective investigational
BCL2 inhibitor in CLL, non-Hodgkin's lymphoma and acute myeloid
leukemia (AML) at the EHA 2022 Congress;
- Initiated tumor-specific dose expansion cohorts in Phase 1
trial (NCT04215978) in patients with solid tumors of BGB-A445, an
investigational non-ligand competing OX40 monoclonal antibody, as
monotherapy;
- Initiated patient dosing in the Phase 1 trial (NCT05381909) in
patients with advanced or metastatic solid tumors for BGB-24714, an
investigational second mitochondrial-derived activator of caspase
(SMAC) mimetic;
- Continued to advance our early-stage clinical pipeline of
internally developed product candidates at dose escalation stage,
including:
- BGB-15025: an investigational hematopoietic progenitor kinase 1
(HPK1) inhibitor as monotherapy or in combination with tislelizumab
in solid tumors;
- BGB-10188: an investigational PI3Kδ inhibitor as monotherapy or
in combination with BRUKINSA in hematology malignancies, or in
combination with tislelizumab in solid tumors; and
- BGB-23339: a potent, allosteric investigational tyrosine kinase
2 (TYK2) inhibitor.
Amgen Milestones
- In collaboration with Amgen, launched BLINCYTO (blinatumomab)
for injection for the treatment of pediatric patients with R/R
CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL);
and
- Entered into a clinical trial collaboration and supply
agreement with Amgen, in which Amgen provides KYPROLIS for a
combination study conducted by BeiGene of BGB-11417 plus
dexamethasone and carfilzomib in R/R multiple myeloma.
Zymeworks Milestones
- In collaboration with Zymeworks, presented preliminary results
from two Phase 1b/2 studies at the ASCO 2022 Annual Meeting
evaluating zanidatamab:
- In combination with docetaxel as a 1L therapy for patients with
advanced HER2-positive breast cancer; and
- In combination with chemotherapy and tislelizumab as a 1L
therapy for patients with HER-2 positive gastric/gastroesophageal
junction adenocarcinoma.
Manufacturing Operations
- Construction has begun on the U.S. flagship commercial-stage
manufacturing and clinical R&D campus at the Princeton West
Innovation Campus in Hopewell, N.J. The property has more than one
million square feet of developable real estate for potential future
expansion;
- Continued construction on our new small molecule manufacturing
campus in Suzhou, China. Phase 1 of construction is expected to
bring more than 52,000 square meters and expand production capacity
to 600 million tablets/capsules and be completed in 2023. Once
completed, qualified, and approved, the total production capacity
is expected to increase our small molecule manufacturing capability
in China by up to a total of ten times capacity; and
- Continued construction on our state-of-the-art biologics
facility in Guangzhou, China, which currently is approved for 8,000
liters of biologics capacity, with an additional Phase of
construction to bring total capacity to 64,000 liters expected to
be completed and GMP-ready by the end of 2022.
Corporate Developments
- Announced a strategic research collaboration with InnoRNA to
jointly discover mRNA therapies, under which we will hold exclusive
global development and commercialization rights; and
- Appointed Chan Lee as General Counsel. Mr. Lee will serve on
our Executive Committee and report directly to John V. Oyler.
Expected Milestones
BRUKINSA
- Continue to support ongoing FDA review of the sNDA for
CLL/small lymphocytic lymphoma, which has a PDUFA target action
date of January 2023;
- Continue to support the European Medicines Agency (EMA) review
of new indication applications for CLL and MZL;
- Continue to support Health Canada review of sNDA for CLL;
- Announce final analysis data for the global Phase 3 ALPINE
trial (NCT03734016) including progression-free survival in 2022;
and
- Continue to expand BRUKINSA’s registration program globally in
new geographies and indications, including potential launches in
2022 in more than 10 markets.
Tislelizumab
- Continue to support NMPA review of BLA application for
tislelizumab in combination with chemotherapy as a 1L treatment for
patients with advanced or metastatic gastric or gastroesophageal
junction adenocarcinoma whose tumors express PD-L1;
- Continue to support Australia’s TGA review of NDA for
tislelizumab in 1L/2L NSCLC and 2L ESCC;
- In collaboration with Novartis, continue to support UK MHRA
review of tislelizumab for treatment of 1L/2L NSCLC and 2L ESCC in
Great Britain;
- In collaboration with Novartis, continue to support the EMA
review of marketing authorization applications for tislelizumab in
NSCLC and 2L ESCC;
- In collaboration with Novartis, continue to support the ongoing
FDA review of the BLA submission in 2L ESCC to facilitate
scheduling the required inspections as soon as possible. In the
FDA’s general advice letter communicating the deferral of action,
the FDA cited only the inability to complete inspections due to
restrictions on travel as the reason for the deferral and did not
provide a new anticipated action date as they continue to monitor
the public health situation and travel restrictions;
- Continue to support planned regulatory submissions by Novartis
for 1L gastric cancer, 1L and localized ESCC, and 1L HCC in the
U.S. in 2023. No additional submissions planned in the U.S. in
2022;
- Announce topline results from the global Phase 3 clinical trial
(NCT03412773) of tislelizumab as a 1L treatment for patients with
HCC in Q3 2022; and
- Present clinical data at 2022 World Conference on Lung Cancer
including final analysis of the global, Phase 3 RATIONALE 303 trial
(NCT03358875) with tislelizumab monotherapy compared to
chemotherapy in previously treated advanced NSCLC and Phase 1 data
on tislelizumab in combination with ociperlimab in metastatic NSCLC
(NCT04047862); with sitravatinib in PD-L1+, locally
advanced/metastatic, non-squamous NSCLC (NCT03666143); and with
sitravatinib in PD-L1+, locally advanced/metastatic, squamous NSCLC
(NCT03666143).
Ociperlimab
- Initiate additional pivotal clinical trials in 2022; and
- Announce data from Phase 1 trial (NCT04047862) cohorts in
various solid tumor types in 2022.
BGB-11417 (BCL-2)
- Initiate pivotal trials in 2022; and
- Present Phase 1 clinical data for non-Hodgkin's lymphoma, CLL,
AML and multiple myeloma (MM) (NCT04883957, NCT04277637,
NCT04771130, and NCT04973605) at a medical congress in late
2022.
Early Stage Programs
- In collaboration with Leads Biolabs, initiate patient dosing of
LBL-007, a novel investigational antibody targeting the LAG-3
pathway, in combination with tislelizumab and surzebiclimab (TIM3)
in 2022.
COVID-19 Impact and Response
We expect that the worldwide health crisis of COVID-19 will
continue to have a negative impact on our operations, including
commercial sales, regulatory interactions, inspections, filings,
manufacturing, and clinical trial recruitment, participation, and
data readouts. There remains uncertainty regarding the future
impact of the pandemic both globally and specifically in China due
to outbreaks and restrictions and potential impact on clinical,
manufacturing and commercial operations. We are striving to
minimize delays and disruptions, have put protocols and procedures
in place, and continue to execute on our commercial, regulatory,
manufacturing, and clinical development goals globally.
Financial Summary
Select Condensed Consolidated Balance Sheet Data (U.S.
GAAP)
(Amounts in thousands of U.S. Dollars)
As of
June 30,
December 31,
2022
2021
(unaudited)
(audited)
Assets:
Cash, cash equivalents, restricted cash
and short-term investments
$
5,707,963
$
6,624,849
Accounts receivable, net
172,259
483,113
Property and equipment, net
633,100
587,605
Total assets
7,378,207
8,645,949
Liabilities and equity:
Accounts payable
234,355
262,400
Accrued expenses and other payables
454,183
558,055
Deferred revenue
330,966
407,703
R&D cost share liability
344,779
390,362
Debt
565,936
629,678
Total liabilities
2,075,663
2,402,962
Total equity
$
5,302,544
$
6,242,987
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 June
30,
Six Months Ended June
30,
2022
2021
2022
2021
(Unaudited)
(Unaudited)
Revenue:
Product revenue, net
$
304,511
$
138,624
$
566,084
$
244,741
Collaboration revenue
37,061
11,368
82,114
511,123
Total revenues
341,572
149,992
648,198
755,864
Expenses:
Cost of sales - products
71,173
36,263
136,410
68,948
Research and development
378,207
356,091
768,122
676,817
Selling, general and administrative
331,403
232,289
625,976
414,395
Amortization of intangible assets
188
187
376
375
Total expenses
780,971
624,830
1,530,884
1,160,535
Loss from operations
(439,399
)
(474,838
)
(882,686
)
(404,671
)
Interest income (expense), net
11,431
(4,866
)
21,502
(9,045
)
Other loss, net
(129,617
)
(867
)
(117,650
)
(4,990
)
Loss before income taxes
(557,585
)
(480,571
)
(978,834
)
(418,706
)
Income tax expense (benefit)
13,864
(230
)
26,889
(4,860
)
Net loss
(571,449
)
(480,341
)
(1,005,723
)
(413,846
)
Net loss per share attributable to
BeiGene, Ltd.:
Basic and diluted
$
(0.43
)
$
(0.40
)
$
(0.75
)
$
(0.35
)
Weighted-average shares outstanding:
Basic and diluted
1,336,463,026
1,194,071,476
1,334,252,648
1,191,521,766
Net loss per ADS attributable to BeiGene,
Ltd.
Basic and diluted
$
(5.56
)
$
(5.23
)
$
(9.80
)
$
(4.52
)
Weighted-average ADSs outstanding:
Basic and diluted
102,804,848
91,851,652
102,634,819
91,655,520
About BeiGene
BeiGene is a global biotechnology company that is developing and
commercializing innovative and affordable oncology medicines to
improve treatment outcomes and access for far more 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 8,500 colleagues spans five
continents, with administrative offices in Beijing, China;
Cambridge, U.S.; and Basel, Switzerland. To learn more about
BeiGene, please visit www.beigene.com and follow us on Twitter at
@BeiGeneGlobal.
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
clinical data for BeiGene’s drug candidates and approvals of its
medicines; the conduct of late-stage clinical trials and expected
data readouts; additional planned product approvals and launches;
the advancement of and anticipated clinical development, regulatory
approvals and other milestones and commercialization of BeiGene’s
medicines and drug candidates; the success of BeiGene’s
commercialization efforts and revenue growth; the expected
capacities and completion dates for the Company’s manufacturing
facilities under construction; the impact of the COVID-19 pandemic
on the Company’s clinical development, regulatory, commercial,
manufacturing, and other operations; BeiGene’s plans and the
expected events and milestones under the captions “Recent Business
Highlights” and “Expected Milestones”; 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 and its ability to obtain additional
funding for operations and to complete the development of its drug
candidates and achieve and maintain profitability; the impact of
the COVID-19 pandemic on BeiGene’s clinical development,
regulatory, commercial, manufacturing, and other operations, as
well as 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.
BLINCYTO® and KYPROLIS® are registered trademarks of Amgen.
POBEVCY® is a registered trademark of Bio-Thera Solutions,
Ltd.
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Investor Contact Kevin Mannix +1 857-302-5189
ir@beigene.com
Media Contact Emily Collins +1 201-201-4570
media@beigene.com
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