BeiGene Reports Third Quarter 2021 Financial Results
BeiGene reported a remarkable third quarter with product revenue reaching $192.5 million, up 111% from $91.1 million year-over-year. Key approvals for BRUKINSA in the U.S. include new indications, while the FDA accepted the first BLA for tislelizumab targeting esophageal cancer. Total revenue for the quarter was $206.4 million, with a net loss of $413.9 million. Cash and equivalents totaled $3.9 billion. The company continues to expand its global footprint, emphasizing affordability and accessibility for cancer treatments.
- Product revenue increased by 111% year-over-year to $192.5 million.
- BRUKINSA sales reached $65.8 million, a 320% increase compared to the prior year.
- FDA accepted BLA for tislelizumab, extending its market reach.
- Net loss of $413.9 million in Q3 2021, slightly improved from $425.2 million in Q3 2020.
- Cash reserves decreased from $4.4 billion in Q2 2021 to $3.9 billion by end of Q3 2021.
- Operating expenses rose significantly to $668.8 million, up from $531.2 million in the prior year.
-
Recorded product revenue of
for the third quarter, representing a$192.5 million 111% increase from in the prior year period$91.1 million -
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
“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
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
in the third quarter, representing a$65.8 million 320% increase compared to the prior year period;U.S. sales of BRUKINSA totaled in the third quarter compared to$33.7 million in the comparable prior year period.$5.7 million U.S. sales continued to accelerate in the quarter, driven by continued uptake in mantle cell lymphoma (MCL) and the recent FDA approvals in Waldenström’s macroglobulinemia (WM) and marginal zone lymphoma (MZL). BRUKINSA sales inChina totaled in the third quarter, representing growth of$32.1 million 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 in the third quarter, representing a$77.0 million 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 of sales in the third quarter. Two additional new products are expected to be approved or launched by the end of the year; and$5.0 million -
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
- 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 theUK 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 , andUAE 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 placeDecember 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 andSouth America .
Tislelizumab, a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages; approved in
-
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 theChina 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
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 mainlandChina ; -
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 theU.S. and the development rights of the candidates in theU.S. have been returned to Singlomics under a reversion agreement signed by the parties, withBeiGene retainingU.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
-
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 inHopewell, 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 increaseBeiGene's small molecule manufacturing capability inChina 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 inGuangzhou, 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
-
In the three months ended
September 30, 2021 , cash used in operating activities was , primarily due to our net loss of$495.7 million and a$413.9 million increase in our net operating assets and liabilities, offset by non-cash charges of$89.4 million ; capital expenditures were$7.5 million ; and cash provided by financing activities was$67.0 million , consisting primarily of$109.2 million in proceeds from the sale of shares to Amgen, as well as the exercise of employee share options.$50 million
Revenue for the three months ended
-
Product revenue totaled
for the three months ended$192.5 million September 30, 2021 , compared to in the same period of 2020, including:$91.1 million
– Sales of tislelizumab in
– Sales of BRUKINSA of
– Sales of XGEVA® (denosumab), the first product transferred to
-
Collaboration revenue for the three months ended
September 30, 2021 was , 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.$14.0 million
Expenses for the three months ended
-
Cost of Sales for the three months ended
September 30, 2021 were , compared to$47.4 million in the same period of 2020. Cost of sales increased primarily due to increased product sales of tislelizumab, BRUKINSA, and XGEVA.$21.1 million -
R&D Expenses for the three months ended
September 30, 2021 were , compared to$351.9 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$349.1 million for the three months ended$31.7 million September 30, 2021 , compared to for the same period of 2020.$25.4 million -
SG&A Expenses for the three months ended
September 30, 2021 were , compared to$269.2 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$160.8 million for the three months ended$35.4 million September 30, 2021 , compared to for the same period of 2020.$24.9 million -
Net Loss for the three months ended
September 30, 2021 was , or$413.9 million per share, and$0.34 per American Depositary Share (ADS), compared to$4.46 , or$425.2 million per share, and$0.37 per ADS in the same period of 2020.$4.81
Financial Summary
Select Condensed Consolidated Balance Sheet Data (
(Amounts in thousands of |
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|
As of |
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|
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 ( |
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(Amounts in thousands of |
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|
Three Months Ended
|
|
Nine Months Ended
|
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|
2021 |
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2020 |
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2021 |
|
2020 |
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|
(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 |
$ |
(413,855) |
|
|
$ |
(425,224) |
|
|
$ |
(827,701) |
|
|
$ |
(1,124,161) |
|
|
|
|
|
|
|
|
|
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Net loss per share attributable to |
|
|
|
|
|
|
|
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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 |
|
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|
|
|
|
|
|
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Net loss per ADS attributable to |
|
|
|
|
|
|
|
||||||||
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
About
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
XGEVA®, BLINCYTO®, and LUMAKRAS® are registered trademarks of Amgen.
ABRAXANE® is a registered trademark of
View source version on businesswire.com: https://www.businesswire.com/news/home/20211104006165/en/
Investor Contact
+86 10-5895-8058 or +1 857-302-5189
ir@beigene.com
Media Contact
+1 857-302-5663
media@beigene.com
Source:
FAQ
What were BeiGene's product revenues in Q3 2021?
How much did BRUKINSA sales increase in Q3 2021?
What is the significance of the FDA's acceptance of the BLA for tislelizumab?
What was BeiGene's net loss for Q3 2021?