BeiGene Reports Third Quarter 2020 Financial Results
Nov 05, 2020 4:05 PM
“Our commercial teams continue to execute and sales of our recently launched internally developed products drove total product revenue to
“Howard has contributed greatly to our success since joining
Recent Business Highlights and Upcoming Milestones
Commercial Operations
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Generated
$91.08 million in product revenue in the three months endedSeptember 30, 2020 , representing an 81.6% increase compared to the comparable period of the prior year. Product revenue was driven by sales of our recently launched internally developed products tislelizumab inChina and BRUKINSA inChina andthe United States .
Development Programs
BRUKINSA® (zanubrutinib), a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects. BRUKINSA has received accelerated approval in
-
Received acceptance from the
Center for Drug Evaluation (CDE) of theChina National Medical Products Administration (NMPA) for a supplemental new drug application (sNDA) of BRUKINSA for the treatment of patients with Waldenström’s macroglobulinemia (WM) with priority review; -
Announced acceptance and priority review by
Health Canada of a New Drug Submission (NDS) for BRUKINSA in WM; a subsequent NDS for patients with MCL inCanada has been accepted; - Initiated patient enrollment in a Phase 1 trial (NCT04436107) of BRUKINSA in combination with lenalidomide, with or without rituximab, in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma; and
-
Received Fast Track designation in the
U.S. for patients with marginal zone lymphoma (MZL).
Expected Milestones for BRUKINSA
-
Present data from the pivotal Phase 2 MAGNOLIA trial (NCT03846427) in patients with R/R MZL, the pivotal Phase 2 trial in patients with WM in
China (NCT03332173), the Phase 2 trial (NCT04116437) in patients with R/R B-cell malignancies who are intolerant to ibrutinib or acalabrutinib, and from Arm C of the SEQUOIA trial (NCT03336333) in patients with treatment-naïve CLL or SLL with del(17p) at the upcoming 62nd ASH Annual Meeting being held virtuallyDecember 5-8, 2020 ; - Announce top-line results from the SEQUOIA trial (NCT03336333) comparing BRUKINSA with bendamustine plus rituximab in patients with treatment-naïve CLL or SLL as early as the first half of 2021;
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Continue to discuss data from the Phase 3 ASPEN trial (NCT03053440) comparing BRUKINSA to ibrutinib in patients with WM with the
U.S. Food and Drug Administration (FDA); and - Complete enrollment in the Phase 3 ALPINE trial (NCT03734016) comparing BRUKINSA with ibrutinib in patients with R/R CLL/SLL in 2020.
Tislelizumab, a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages; approved in
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Presented the first reported data from the Phase 3 RATIONALE 304 trial (NCT03663205) of tislelizumab combined with chemotherapy for the first-line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC) at the 2020
European Society for Medical Oncology (ESMO) Virtual Congress . Data from this trial were included in the supplemental biologics license application (sBLA) currently under review by the NMPA; - Began patient enrollment in a Phase 2 trial (NCT04401800) of tislelizumab in combination with lenvatinib in patients with hepatocellular carcinoma; and
- Completed patient enrollment in the Phase 3 clinical trial (NCT03924986) of tislelizumab combined with chemotherapy versus chemotherapy alone in recurrent or metastatic nasopharyngeal cancer.
Expected Milestones for Tislelizumab
- Announce top-line results from the global Phase 3 trial (NCT03358875) comparing tislelizumab versus docetaxel in second- or third-line patients with NSCLC and the global Phase 3 trial (NCT03430843) comparing tislelizumab versus chemotherapy in second-line patients with advanced esophageal squamous cell carcinoma (ESCC) before the end of 2020 or in 2021.
Pamiparib, an investigational selective small molecule inhibitor of PARP1 and PARP2
-
Presented data from the pivotal Phase 2 trial (NCT03333915) of pamiparib in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy, at the 2020
ESMO Virtual Congress . Data from this trial were included in the NDA currently under review by the NMPA.
Expected Milestones for Pamiparib
- Announce top-line results from the Phase 3 trial (NCT03519230) of pamiparib as a maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer (OC) before the end of 2020 or in 2021.
BGB-A1217, an investigational TIGIT monoclonal antibody
- Continued to enroll patients in the global Phase 1 clinical trial (NCT04047862) in combination with tislelizumab. The recommended Phase 2 dose has been determined and pivotal trials are in planning globally.
Early-Stage Proprietary Programs
-
Received acceptance of the investigational new drug (IND) submission in
China for BGB-11417 (BCL-2 inhibitor) for mature B-cell malignancies; and - Continued to advance our earlier-stage pipeline of internally-developed assets, including BGB-11417 (BCL-2 inhibitor in Phase 1 development for cancer), BGB-A445 (non-ligand competing OX40 monoclonal antibody in Phase 1 development in combination with tislelizumab for solid tumor), BGB-10188 (PI3Kδ inhibitor in Phase 1 development in combination with BRUKINSA or tislelizumab for cancer), and BGB-15025 (HPK1 inhibitor in preclinical development for cancer).
Collaboration Programs
Amgen
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Our collaboration with Amgen continues to progress, with ongoing commercial activities for XGEVA® (denosumab) in
China for patients with giant cell tumor of the bone (GCTB), as well as preparation for the launch of:- XGEVA® (120-mg denosumab) for the prevention of skeletal-related events in patients with bone metastases from solid tumors and in patients with multiple myeloma following potential approval expected in the fourth quarter 2020 or in early 2021;
- BLINCYTO® (blinatumomab) for the treatment of adult patients with R/R B-cell precursor acute lymphoblastic leukemia (ALL) following potential approval expected in the fourth quarter 2020 or in early 2021; and
- KYPROLIS® (carfilzomib) for patients with R/R multiple myeloma following potential approval expected in 2021;
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Amgen has advised
BeiGene that its applications to theHuman Genetic Resources Administration of China (HGRAC) to obtain approval to conduct clinical studies inChina for assets that are part of the Amgen-BeiGene Collaboration, including its application for sotorasib (AMG 510), a first-in-class investigational KRAS G12C inhibitor, are currently delayed. Approval from the HGRAC is required for the initiation of clinical trials involving the collection of human genetic materials inChina .BeiGene and Amgen continue to plan for the commencement of these clinical trials while Amgen awaits further information from HGRAC.BeiGene does not expect this to affect the conduct of the clinical trials inChina for its drug candidates other than assets that are part of the Amgen-BeiGene collaboration.
Zanidatamab (ZW25), a novel investigational Azymetric™ bispecific antibody against HER2 currently in late-stage clinical development with Zymeworks Inc.
- Began patient enrollment in a registration-enabling Phase 2 clinical trial (NCT04466891) in patients with advanced or metastatic HER2-amplified biliary tract cancers.
DKN-01, a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (
- Announced the first patient dosed in the DisTinGuish trial (NCT04363801), a Phase 2a clinical trial initiated by Leap, evaluating DKN-01 in combination with tislelizumab, with or without chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ).
DXP-593 and DXP-604, SARS-CoV-2 neutralizing antibody drug candidates identified by Singlomics (Beijing DanXu)
-
Initiated a Phase 1 clinical trial of healthy volunteers (NCT04532294) in
Australia .
BA3071, a novel, investigational conditionally-active CTLA-4 inhibitor discovered by
-
Announced an amended agreement with
BioAtla to license in BA3071 globally.
Manufacturing Operations
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Completed facility and process validation for the first plant of our biologics manufacturing facility in
Guangzhou ; -
Initiated expansion of the second and third plants of our biologics manufacturing facility in
Guangzhou to significantly increase manufacturing capacity and introduce new manufacturing technology platforms, expected to be completed by the end of 2020 and 2021, respectively; and -
Entered into an agreement to acquire the 5% equity interest in
BeiGene Biologics Co., Ltd. (“BeiGene Biologics”) held by theGuangzhou High-tech Zone Technology Group Co., Ltd. (formerlyGuangzhou GET Technology Development Co., Ltd. ) (“GET”), an affiliate ofGuangzhou Development District , and repay the related shareholder loan. Upon the update of the business license, which is expected to occur in the fourth quarter of 2020, ourGuangzhou biologics facility will become a wholly-owned subsidiary ofBeiGene Hong Kong Co., Limited .
COVID-19 Impact and Response
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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. Although the impact of COVID-19 on operations in
China lessened in the second and third quarters of 2020 compared to the first quarter of 2020, there remains uncertainty regarding the future impact of the pandemic both inChina andthe United States , as well as globally. The Company is striving to minimize delays and disruptions, and continues to execute on its commercialization, regulatory and clinical development goals globally.
Other Developments
-
Announced the appointment of
Corsee Sanders , Ph.D. to the Company’s Board of Directors and the Audit and Scientific Advisory Committees of the Board; -
Announced a license, distribution, and supply agreement with Bio-Thera Solutions, Ltd., to develop, manufacture, and commercialize BAT1706, an investigational biosimilar to Avastin® (bevacizumab), in
China , includingHong Kong ,Macau , andTaiwan ; and -
Announced the inclusion of the Company’s ordinary shares, which trade on the
Hong Kong Stock Exchange , in the Shanghai-Hong Kong Stock Connect and Shenzhen-Hong Kong Stock Connect programs and the Hang Seng Composite Index (HSCI).
Third Quarter 2020 Financial Results
Cash, Cash Equivalents, Restricted Cash, and Short-Term Investments were
-
In the three months ended
September 30, 2020 , cash used in operating activities totaled$346.24 million and capital expenditures were$28.68 million , compared to$265.01 million and$30.87 million , respectively, in the prior year period. Cash used in operating activities for the three months endedSeptember 30, 2020 includes$36.56 million of accrued interest paid to GET in connection with the repayment of the Shareholder Loan.
Revenue for the three months ended
-
Net product revenues for the three months ended
September 30, 2020 were comprised of:-
$49.94 million from sales of tislelizumab inChina , compared to none in the prior year period; -
$15.66 million from sales of BRUKINSA inChina andthe United States , compared to none in the prior year period; -
$22.43 million from sales of BMS in-licensed products inChina , compared to$50.14 million in the same period of the prior year. The decrease was primarily due to decreased product sales of ABRAXANE® following the suspension by the NMPA and voluntary recall by BMS inMarch 2020 ; and -
$3.05 million from sales of XGEVA®, the first product transferred toBeiGene from the Amgen collaboration, whichBeiGene commenced sales and marketing inChina in the third quarter of 2020.
-
Expenses for the three months ended
-
Cost of Sales for the three months ended
September 30, 2020 were$21.12 million , compared to$20.11 million in the same period of 2019. Cost of sales primarily included costs of tislelizumab and BRUKINSA that were sold during the period, as well as acquisition costs for supply of Amgen and BMS in-licensed products that were sold during the period inChina . -
R&D Expenses for the three months ended
September 30, 2020 were$349.07 million , compared to$236.97 million in the same period of 2019. The increase in R&D expenses was primarily attributable to continued increases in spending on our ongoing and newly initiated late-stage pivotal clinical trials, R&D expense related to upfront license payments for our in-licensed assets, development expenses associated with the Amgen collaboration, the preparation for additional regulatory submissions, and manufacturing costs related to pre-commercial activities and supply. In-process R&D expense for in-licensed assets totaled$66.5 million in the three months endedSeptember 30, 2020 , compared to none in the prior year period. Our co-funding obligation for the development of the pipeline assets under the Amgen collaboration for the three months endedSeptember 30, 2020 was$60.85 million , of which$30.80 million was recorded as R&D expense. The remaining$30.05 million was recorded as a reduction of the R&D cost share liability. R&D-related share-based compensation expense was$25.41 million for the three months endedSeptember 30, 2020 , compared to$20.67 million for the same period of 2019. -
SG&A Expenses for the three months ended
September 30, 2020 were$160.84 million , compared to$105.00 million in the same period of 2019. The increase in SG&A expenses was primarily attributable to increased headcount, primarily related to the expansion of our commercial team to support the distribution of our products inChina andthe United States , as well as higher professional service fees and costs to support our growing operations. SG&A-related share-based compensation expense was$24.89 million for the three months endedSeptember 30, 2020 , compared to$16.14 million for the same period of 2019. -
Net Loss for the three months ended
September 30, 2020 was$425.22 million , or$0.37 per share, and$4.81 per American Depositary Shares (ADS), compared to$307.36 million , or$0.39 per share, and$5.11 per ADS in the same period of 2019.
Financial Summary
Select Condensed Consolidated Balance Sheet Data (
(Amounts in thousands of
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As of |
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2020 |
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2019 |
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(unaudited) |
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(audited) |
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Assets: |
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Cash, cash equivalents, restricted cash and short-term investments |
$ |
4,724,015 |
|
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$ |
985,503 |
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Accounts receivable, net |
60,266 |
|
|
70,878 |
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Working capital |
4,320,015 |
|
|
862,384 |
|
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Property and equipment, net |
291,218 |
|
|
242,402 |
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Total assets |
5,566,390 |
|
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1,612,289 |
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Liabilities and equity: |
|
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Accounts payable and accrued expenses |
425,588 |
|
|
286,044 |
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Debt [1] |
201,773 |
|
|
240,695 |
|
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Research and development cost share liability |
531,538 |
|
|
— |
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Total liabilities |
1,269,876 |
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|
633,934 |
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Noncontrolling interest |
9,020 |
|
|
16,150 |
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Total equity |
$ |
4,296,514 |
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$ |
978,355 |
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[1] Total debt includes the shareholder loan balance from our joint venture partner of nil and
Condensed Consolidated Statements of Operations (
(Amounts in thousands of
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Three Months Ended
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Nine Months Ended
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2020 |
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2019 |
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2020 |
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2019 |
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(Unaudited) |
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(Unaudited) |
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Revenue: |
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Product revenue, net |
$ |
91,080 |
|
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$ |
50,141 |
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$ |
208,774 |
|
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$ |
165,704 |
|
Collaboration revenue |
— |
|
|
— |
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|
— |
|
|
205,616 |
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Total revenues |
91,080 |
|
|
50,141 |
|
|
208,774 |
|
|
371,320 |
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Expenses: |
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|
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Cost of sales |
21,123 |
|
|
20,106 |
|
|
49,579 |
|
|
53,206 |
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Research and development [1] |
349,070 |
|
|
236,968 |
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|
939,340 |
|
|
644,079 |
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Selling, general and administrative |
160,837 |
|
|
105,002 |
|
|
391,967 |
|
|
244,895 |
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Amortization of intangible assets |
187 |
|
|
331 |
|
|
658 |
|
|
994 |
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Total expenses |
531,217 |
|
|
362,407 |
|
|
1,381,544 |
|
|
943,174 |
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Loss from operations |
(440,137) |
|
|
(312,266) |
|
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(1,172,770) |
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(571,854) |
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Interest (expense) income, net |
(614) |
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|
2,206 |
|
|
7,184 |
|
|
9,569 |
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Other income (expense), net |
5,711 |
|
|
(1,817) |
|
|
29,368 |
|
|
(967) |
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Loss before income taxes |
(435,040) |
|
|
(311,877) |
|
|
(1,136,218) |
|
|
(563,252) |
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Income tax benefit |
(8,423) |
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|
(3,217) |
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(8,344) |
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(569) |
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Net loss |
(426,617) |
|
|
(308,660) |
|
|
(1,127,874) |
|
|
(562,683) |
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Less: Net loss attributable to noncontrolling interest |
(1,393) |
|
|
(1,303) |
|
|
(3,713) |
|
|
(2,116) |
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Net loss attributable to |
$ |
(425,224) |
|
|
$ |
(307,357) |
|
|
$ |
(1,124,161) |
|
|
$ |
(560,567) |
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Net loss per share attributable to |
$ |
(0.37) |
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|
$ |
(0.39) |
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$ |
(1.07) |
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$ |
(0.72) |
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Weighted-average shares outstanding, basic and diluted |
1,148,973,077 |
|
|
781,482,459 |
|
|
1,052,940,583 |
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777,938,599 |
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Net loss per ADS attributable to |
$ |
(4.81) |
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$ |
(5.11) |
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$ |
(13.88) |
|
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$ |
(9.37) |
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Weighted-average ADSs outstanding, basic and diluted |
88,382,544 |
|
|
60,114,035 |
|
|
80,995,429 |
|
|
59,841,431 |
|
[1] Research and development expense for the third quarter 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 product candidates and approvals of its products; 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 drugs and drug candidates; the success of BeiGene’s commercialization efforts and revenue growth; plans to expand the Company’s portfolio in oncology and other therapeutic areas and to expand the Company’s capabilities and operations for its products to serve more patients worldwide; the impact of the COVID-19 pandemic on the Company’s clinical development, commercial and other operations; and BeiGene’s plans and the expected events and milestones under the caption “Recent Business Highlights and Upcoming Milestones”. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including
ABRAXANE® is a registered trademark of
XGEVA® and BLINCYTO® are registered trademarks of Amgen.
Avastin® is a registered trademark of
View source version on businesswire.com: https://www.businesswire.com/news/home/20201105006167/en/
Investor Contact
+1 857-302-5189
ir@beigene.com
Media Contact
+1 857-302-5663 or +1 857-302-7596
media@beigene.com
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