- Recorded product revenue of $192.5 million for the third
quarter, representing a 111% increase from $91.1 million in the
prior year period
- Received approvals for BRUKINSA® in two new indications in the
U.S. and approvals in six other markets
- Submitted first biologics license application (BLA) in the U.S.
for tislelizumab in collaboration with Novartis for patients with
advanced or metastatic esophageal squamous cell carcinoma following
prior systemic therapy
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global
biotechnology company focused on developing and commercializing
innovative medicines worldwide, today reported recent business
highlights, anticipated upcoming milestones, and financial results
for the third quarter and nine months ended September 30, 2021.
“We remain focused on translating science into highly impactful
medicines and making these medicines more affordable and accessible
to many more people with cancer around the world,” said John V.
Oyler, Co-Founder, Chairman and Chief Executive Officer of BeiGene.
“In the third quarter we had two new indications approved for
BRUKINSA in the United States, and recent BRUKINSA approvals in
Australia, Singapore, Brazil, Russia, and Chile as well as a
positive CHMP opinion for our first BRUKINSA filing in Europe.
Tislelizumab’s BLA for esophageal squamous cell carcinoma (ESCC)
has been accepted for review by the FDA, which is the first filing
for our internally developed anti-PD-1 medicine outside of China
and an important achievement in our collaboration with Novartis.
This is one of many global tislelizumab studies that comprise a
comprehensive PD-1 program that has enrolled over 5,600 patients in
more than 30 countries and regions and includes over 1,700 patients
from outside of China. We also continued to expand and strengthen
our strategic competitive advantages that we feel are critical to
transform the industry and bring innovative and accessible
medicines to billions more people around the world. These include
research, predominantly CRO-free global clinical development,
global commercial infrastructure, and internal manufacturing
capabilities.”
Recent Business Highlights and Upcoming
Milestones
Commercial Operations
- Product sales increased 111% in the third quarter of 2021
compared to the prior year period, primarily due to increased sales
of our internally developed products and in-licensed products from
Amgen;
- Global sales of BRUKINSA totaled $65.8 million in the third
quarter, representing a 320% increase compared to the prior year
period; U.S. sales of BRUKINSA totaled $33.7 million in the third
quarter compared to $5.7 million in the comparable prior year
period. U.S. sales continued to accelerate in the quarter, driven
by continued uptake in mantle cell lymphoma (MCL) and the recent
FDA approvals in Waldenstr�m’s macroglobulinemia (WM) and marginal
zone lymphoma (MZL). BRUKINSA sales in China totaled $32.1 million
in the third quarter, representing growth of 223% compared to the
prior year period, driven by a significant increase in all approved
indications, including chronic lymphocytic leukemia (CLL);
- Sales of tislelizumab in China totaled $77.0 million in the
third quarter, representing a 54% increase compared to the prior
year period. In the third quarter, new patient demand from broader
reimbursement and further expansion of our salesforce and hospital
listings continued to drive increased market penetration and market
share for tislelizumab;
- The commercial organization in China continued to demonstrate
its ability to bring new products to market, launching the second
product from the Amgen collaboration, BLINCYTO® (blinatumomab),
which contributed $5.0 million of sales in the third quarter. Two
additional new products are expected to be approved or launched by
the end of the year; and
- We are preparing for the upcoming National Reimbursement Drug
List (NRDL) negotiation in China for our eligible medicines,
including tislelizumab in first-line non-squamous non-small cell
lung cancer (NSCLC), first-line squamous NSCLC and second- or
third-line hepatocellular carcinoma (HCC), BRUKINSA in WM, and
pamiparib in germline BRCA (gBRCA) mutation-associated recurrent
advanced ovarian, fallopian tube, or primary peritoneal cancer who
have been treated with two or more lines of chemotherapy. The NRDL
negotiations are anticipated to be completed in the fourth quarter
of 2021.
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 the U.S., China,
Canada, Australia, and other international markets in selected
indications and under development for additional approvals
globally.
- Received FDA approvals in two new indications, including full
approval for the treatment of adult patients with WM, and
accelerated approval for the treatment of adult patients with
relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have
received at least one anti-CD20-based regimen;
- Received a positive opinion from the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA), recommending approval for the treatment of adult patients
with WM who have received at least one prior therapy or first-line
treatment for patients unsuitable for chemo-immunotherapy;
- Was granted a cohort Temporary Authorization for Use (cATU), an
early access program, for patients with WM by the French National
Agency for Medicines and Health Products Safety (ANSM);
- Received acceptance of the marketing authorization application
(MAA) from Swissmedic and the Medicines and Healthcare products
Regulatory Agency (MHRA) in the UK for patients with WM;
- Received approval in Australia for the treatment of adult
patients with MCL who have received at least one prior therapy and
for patients with WM who have received at least one prior therapy
or in first line treatment for patients unsuitable for
chemo-immunotherapy; and
- Continued to advance BRUKINSA in new markets. BRUKINSA is now
approved in Australia, Russia, Singapore, Brazil, Chile, Israel,
and UAE for patients with MCL who have received at least one prior
therapy. There currently are more than 20 marketing authorization
applications in multiple indications under review around the
world.
Expected Milestones for BRUKINSA
- Receive EMA approval for treating adult patients with WM who
have received at least one prior therapy or first-line treatment
for patients unsuitable for chemo-immunotherapy in 2021;
- Report results from the Phase 3 SEQUOIA trial (NCT03336333)
comparing BRUKINSA with bendamustine plus rituximab in patients
with treatment-naïve CLL or small lymphocytic lymphoma (SLL); and
early results from Arm D in patients with del(17p) in combination
with venetoclax in two oral presentations at the 63rd American
Society of Hematology (ASH) Annual Meeting taking place December
11-14, 2021;
- Continue to discuss Phase 3 clinical trial results in CLL with
regulatory agencies in the U.S., Europe, and other countries;
- Report additional results from the Phase 3 ALPINE trial
(NCT03734016) in 2022; and
- Continue to expand BRUKINSA’s registration program globally in
new geographies and indications, including potential additional
approvals in 2021 and the first half of 2022 for certain patients
with MCL in APAC, the Middle East and South America.
Tislelizumab, a humanized IgG4 anti-PD-1 monoclonal
antibody specifically designed to minimize binding to FcγR on
macrophages; approved in China in selected indications and under
development for additional approvals globally.
- Received acceptance by the FDA of a BLA for tislelizumab in
collaboration with Novartis as a treatment for patients with
unresectable recurrent locally advanced or metastatic ESCC after
prior systemic therapy. The Prescription Drug User Fee Act (PDUFA)
target action date is July 12, 2022;
- Received acceptance by the Center for Drug Evaluation (CDE) of
the China National Medical Products Administration (NMPA) of a
supplemental BLA (sBLA) in combination with chemotherapy as a
first-line treatment for patients with recurrent or metastatic
nasopharyngeal cancer (NPC);
- Received approval from the NMPA in a new indication, for
front-line squamous NSCLC with nab-paclitaxel and carboplatin;
and
- Reported data at the European Society for Medical Oncology
(ESMO) Congress 2021 including:
– RATIONALE 304 (NCT03663205): Tislelizumab
plus chemotherapy vs. chemotherapy alone as first-line treatment
for non-squamous NSCLC in patients who are smokers vs. non-smokers;
and
– RATIONALE 307 (NCT03594747): Tislelizumab
plus chemotherapy vs. chemotherapy alone as first-line treatment
for advanced squamous NSCLC in patients who were smokers vs.
non-smokers.
Expected Milestones for Tislelizumab
- Receive approvals in China for the four sBLAs currently under
review in first-line NPC, second- or third-line NSCLC, second-line
ESCC, and second- or third-line MSI-High solid tumors in 2022.
Pamiparib, a selective small molecule inhibitor of PARP1
and PARP2 conditionally approved in China for the treatment of
patients with germline BRCA mutation-associated advanced ovarian,
fallopian tube, or primary peritoneal cancer who have been treated
with two or more lines of chemotherapy.
Expected Milestones for Pamiparib
- Report topline results from the Phase 3 trial (NCT03519230) of
pamiparib as a maintenance treatment in patients with
platinum-sensitive recurrent ovarian cancer, in 2021 or the first
half of 2022.
Ociperlimab (BGB-A1217), an investigational anti-TIGIT
monoclonal antibody with competent Fc function
- Initiated patient enrollment in the Phase 2 AdvanTIG-206 trial
(NCT04948697) of ociperlimab in combination with tislelizumab plus
Bio-Thera’s POBEVCY® (BAT1706), a biosimilar to bevacizumab
(Avastin®), as first-line treatment in patients with advanced
HCC.
Expected Milestones for ociperlimab
- Initiate patient enrollment in the global Phase 2 AdvanTIG-205
trial (NCT05014815) in frontline stage IV NSCLC, in 2021.
BGB-11417, an investigational BCL-2 inhibitor
- Initiated patient enrollment in a Phase 1 trial (NCT04973605)
in patients with multiple myeloma with t (11;14) translocation, in
2021.
Expected Milestones for BGB-11417
- Begin patient enrollment in pivotal trials, in 2022.
Early-Stage Programs
- Continued to advance our early-stage clinical pipeline of
internally-developed product candidates at dose escalation stage,
including BGB-A445 (an investigational non-ligand competing OX40
monoclonal antibody as monotherapy or in combination with
tislelizumab in solid tumors), 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);
- BGB-16673 (an investigational Chimeric Degradation Activating
Compound, or CDAC, targeting BTK) received investigational new drug
(IND) clearance and permission to proceed from the FDA. Patient
dosing in the first Phase 1 trial (NCT05006716) in patients with
B-cell malignancies is expected to begin in 2021; and
- BGB-A425 (an investigational TIM3 monoclonal antibody) study
advanced to the Phase 2 portion of the Phase 1/2 trial
(NCT03744468) in combination with tislelizumab.
Collaboration with Amgen
- Secured approval by the Hainan BoAo government for early access
to LUMAKRAS® (sotorasib, a KRAS G12C inhibitor) in designated
hospitals in the province.
Other Collaboration Programs
- Announced that the NMPA granted QARZIBA® (dinutuximab beta)
conditional approval for the treatment of high-risk neuroblastoma
in patients aged 12 months and above who have previously received
induction chemotherapy and achieved at least a partial response,
followed by myeloablative therapy and stem cell transplantation, as
well as patients with a history of R/R neuroblastoma with or
without residual disease. QARZIBA is a targeted immunotherapy
licensed by EUSA Pharma to BeiGene in mainland China;
- Received notification by BMS-Celgene of its intent to terminate
a license and supply agreement with respect to ABRAXANE®
(nanoparticle albumin-bound paclitaxel) in China. BeiGene contests
this action, as it believes that the reasons provided by
BMS-Celgene are not valid bases for terminating the agreement with
respect to ABRAXANE. Arbitration proceedings are ongoing between
the parties regarding BMS-Celgene’s failure to ensure the
continuity and adequacy of its supply of ABRAXANE under the
agreement in accordance with Good Manufacturing Practices (GMP);
and
- Received results from the Phase 2 trial (NCT04551898)
evaluating investigational SARS-CoV-2 neutralizing antibody
BGB-DXP593 in patients with mild to moderate COVID-19, licensed
from Singlomics outside of China. The trial did not meet the
primary efficacy endpoint of viral load change in nasopharyngeal
swabs at Day 8. The license rights of the two Singlomics candidates
(DXP593 and DXP604) outside of the U.S. and the development rights
of the candidates in the U.S. have been returned to Singlomics
under a reversion agreement signed by the parties, with BeiGene
retaining U.S. commercial rights.
Sitravatinib, an investigational tyrosine kinase
inhibitor of receptor tyrosine kinases (RTKs), including TAM family
receptors (TYRO3, Axl, MER), split family receptors (VEGFR2, KIT)
and RET, licensed from Mirati Therapeutics Inc. (Mirati), in Asia
(excluding Japan), Australia, and New Zealand.
- Reported data at the European Society for Medical Oncology
(ESMO) Congress 2021:
− Sitravatinib + tislelizumab in patients
with anti-PD-(L)1 refractory/resistant metastatic NSCLC
(NCT03666143); and
− Sitravatinib + tislelizumab in patients
with metastatic NSCLC (NCT03666143).
Zanidatamab, (ZW25) an investigational bispecific HER2
antibody targeting HER2 in late-stage clinical development with
Zymeworks, Inc.
Expected Milestones for Zanidatamab
- Initiate a Phase 3 clinical trial in first-line HER2+ gastric
cancer, in 2021.
Manufacturing Operations
- Continued efforts to secure geographically diverse
manufacturing and supply chain redundancy with the previously
announced plans to build a new commercial-stage manufacturing and
clinical R&D campus at Princeton West Innovation Park in
Hopewell, New Jersey. The acquisition of the property is expected
to close in 2021;
- Continued construction on the new small molecule manufacturing
campus in Suzhou, China. Phase 1 of construction will bring over
50,000 square meters and 600M solid preparation capacity and is
expected to be completed in 2023. Once completed, the total
production capacity is expected to increase BeiGene's small
molecule manufacturing capability in China by up to six times the
current capacity; and
- Two additional 2,000L bioreactors at Boehringer Ingelheim’s
facility are available to support commercial production of
tislelizumab’s expanding indications in China. This is in addition
to BeiGene’s 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 expected to bring
total capacity to 64,000 liters, and to be completed by the end of
2022.
COVID-19 Impact and Response
- The Company expects that the worldwide health crisis of
COVID-19 will continue to have a negative impact on its operations,
including commercial sales, regulatory interactions, inspections,
filings, and clinical trial recruitment, participation, and data
read outs. There remains uncertainty regarding the future impact of
the pandemic globally. The Company is striving to minimize delays
and disruptions, and continues to execute on its commercial,
regulatory, manufacturing, and clinical development goals
globally.
Corporate Developments
- Listing of the Company’s ordinary shares on the Science and
Technology Innovation Board (STAR Market) of the Shanghai Stock
Exchange is expected to be completed in 2021, subject to market
conditions and additional regulatory approvals; and
- Received inclusion in several FTSE Russell indices, including:
the FTSE Global Equity Index Large Cap; the FTSE All-World (LM);
the FTSE All-Cap (LMS); and the FTSE Total-Cap (LMSµ). In addition,
BeiGene was included in the FTSE Developed ESG Low Carbon Select
Index, and the FTSE Asia ex Japan ESG Low Carbon Select Index,
reflecting the Company’s commitment to sustainability.
Third Quarter 2021 Financial
Results
Cash, Cash Equivalents, Restricted Cash, and Short-Term
Investments were $3.9 billion as of September 30, 2021,
compared to $4.4 billion as of June 30, 2021, and $4.7 billion as
of December 31, 2020.
- In the three months ended September 30, 2021, cash used in
operating activities was $495.7 million, primarily due to our net
loss of $413.9 million and a $89.4 million increase in our net
operating assets and liabilities, offset by non-cash charges of
$7.5 million; capital expenditures were $67.0 million; and cash
provided by financing activities was $109.2 million, consisting
primarily of $50 million in proceeds from the sale of shares to
Amgen, as well as the exercise of employee share options.
Revenue for the three months ended September 30, 2021 was
$206.4 million, compared to $91.1 million in the same period of
2020.
- Product revenue totaled $192.5 million for the three months
ended September 30, 2021, compared to $91.1 million in the same
period of 2020, including:
– Sales of tislelizumab in China of $77.0
million, compared to $49.9 million in the prior year period;
– Sales of BRUKINSA of $65.8 million,
compared to $15.7 million in the prior year period;
– Sales of XGEVA® (denosumab), the first
product transferred to BeiGene from the Amgen collaboration, in
China of $15.7 million, compared to $3.1 million in the prior year
period. BeiGene commenced sales and marketing in China in July
2020;
- Collaboration revenue for the three months ended September 30,
2021 was $14.0 million, resulting from the partial recognition of
previously deferred revenue associated with the upfront payment
received from Novartis in the first quarter of 2021. There was no
collaboration revenue in the prior year period.
Expenses for the three months ended September 30, 2021
were $668.8 million, compared to $531.2 million in the same period
of 2020.
- Cost of Sales for the three months ended September 30,
2021 were $47.4 million, compared to $21.1 million in the same
period of 2020. Cost of sales increased primarily due to increased
product sales of tislelizumab, BRUKINSA, and XGEVA.
- R&D Expenses for the three months ended September
30, 2021 were $351.9 million, compared to $349.1 million in the
same period of 2020. The increase in R&D expenses was primarily
attributable to increases in headcount and external costs related
to our investment in discovery and development activities,
including our continued efforts to internalize research and
clinical trial activities, partially offset by decreased spending
on clinical trials related to BRUKINSA, as well as decreased
expense related to upfront fees related to in-process R&D.
Additionally, R&D-related share-based compensation expense was
$31.7 million for the three months ended September 30, 2021,
compared to $25.4 million for the same period of 2020.
- SG&A Expenses for the three months ended September
30, 2021 were $269.2 million, compared to $160.8 million in the
same period of 2020. The increase in SG&A expenses was
primarily attributable to increased headcount and increased
external expenses related to the growth of our global commercial
organization, as we continued to build our worldwide footprint.
SG&A-related share-based compensation expense was $35.4 million
for the three months ended September 30, 2021, compared to $24.9
million for the same period of 2020.
- Net Loss for the three months ended September 30, 2021
was $413.9 million, or $0.34 per share, and $4.46 per American
Depositary Share (ADS), compared to $425.2 million, or $0.37 per
share, and $4.81 per ADS in the same period of 2020.
Financial
Summary
Select Condensed Consolidated Balance
Sheet Data (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)
As of
September 30,
December 31,
2021
2020
(unaudited)
(audited)
Assets:
Cash, cash equivalents, restricted cash
and short-term investments
$
3,923,313
$
4,658,730
Accounts receivable, net
129,584
60,403
Working capital
3,128,400
3,885,491
Property and equipment, net
450,788
357,686
Total assets
5,286,334
5,600,757
Liabilities and equity:
Accounts payable
206,203
231,957
Accrued expenses and other payables
389,874
346,144
Deferred revenue
124,898
—
R&D cost share liability
420,001
502,848
Debt
643,278
518,652
Total liabilities
1,929,261
1,731,514
Total equity
$
3,357,073
$
3,869,243
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,
2021
2020
2021
2020
(Unaudited)
(Unaudited)
Revenue:
Product revenue, net
$
192,461
$
91,080
$
437,202
$
208,774
Collaboration revenue
13,979
—
525,102
—
Total revenues
206,440
91,080
962,304
208,774
Expenses:
Cost of sales - products
47,413
21,123
116,361
49,579
Research and development [1]
351,937
349,070
1,028,754
939,340
Selling, general and administrative
269,227
160,837
683,622
391,967
Amortization of intangible assets
188
187
563
658
Total expenses
668,765
531,217
1,829,300
1,381,544
Loss from operations
(462,325)
(440,137)
(866,996)
(1,172,770)
Interest (expense) income, net
(2,230)
(614)
(11,275)
7,184
Other income, net
31,477
5,711
26,487
29,368
Loss before income taxes
(433,078)
(435,040)
(851,784)
(1,136,218)
Income tax benefit
(19,223)
(8,423)
(24,083)
(8,344)
Net loss
(413,855)
(426,617)
(827,701)
(1,127,874)
Less: Net loss attributable to
noncontrolling interest
—
(1,393)
—
(3,713)
Net loss attributable to BeiGene, Ltd.
$
(413,855)
$
(425,224)
$
(827,701)
$
(1,124,161)
Net loss per share attributable to
BeiGene, Ltd.:
Basic and diluted
$
(0.34)
$
(0.37)
$
(0.69)
$
(1.07)
Weighted-average shares outstanding:
Basic and diluted
1,205,971,284
1,148,973,077
1,196,391,201
1,052,940,583
Net loss per ADS attributable to BeiGene,
Ltd.
Basic and diluted
$
(4.46)
$
(4.81)
$
(8.99)
$
(13.88)
Weighted-average ADSs outstanding:
Basic and diluted
92,767,022
88,382,544
92,030,092
80,995,429
[1] Research and development expense for the three and nine
months ended September 30, 2021 includes upfront fees related to
in-process research and development of in-licensed assets totaling
nil and $53.5 million, respectively, compared to $66.5 million and
$109.5 million in the comparable prior year periods.
About BeiGene
BeiGene is a global, science-driven biotechnology company
focused on developing innovative and affordable medicines to
improve treatment outcomes and access for patients worldwide. With
a broad portfolio of more than 40 clinical candidates, we are
expediting development of our diverse pipeline of novel
therapeutics through our own capabilities and collaborations. We
are committed to radically improving access to medicines for two
billion more people by 2030. BeiGene has a growing global team of
over 7,700 colleagues across five continents. 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
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
timeline for the Company to complete its proposed public offering
and listing on the STAR Market of the Shanghai Stock Exchange, if
at all; the impact of the COVID-19 pandemic on the Company’s
clinical development, regulatory, commercial and other operations;
BeiGene’s plans and the expected events and milestones under the
caption “Recent Business Highlights and Upcoming Milestones”; and
BeiGene’s plans, commitments, aspirations and goals under the
captions “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 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 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.
XGEVA®, BLINCYTO®, and LUMAKRAS® are registered trademarks of
Amgen.
ABRAXANE® is a registered trademark of Abraxis Bioscience LLC, a
Bristol Myers Squibb company.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211104006165/en/
Investor Contact Gabrielle Zhou +86 10-5895-8058 or +1
857-302-5189 ir@beigene.com
Media Contact Liza Heapes +1 857-302-5663
media@beigene.com
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