On November 5, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide,reported recent business highlights, anticipated upcoming milestones, and financial results for the third quarter and first nine months of 2020 (Press release, BeiGene, NOV 5, 2020, View Source [SID1234570085]).
"Our commercial teams continue to execute and sales of our recently launched internally developed products drove total product revenue to $91 million for the third quarter, a 39 percent increase compared to last quarter," said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene. "We believe that we are well-positioned to accelerate the development of our deep pipeline, further expand our portfolio in oncology and into other therapeutic areas, and continue to build our capabilities and operations for our products to serve more patients worldwide. In the remainder of 2020 and 2021, we look forward to key clinical readouts, as well as potential expanded commercial opportunities for our products through approvals in additional indications and geographic markets and by growing our commercial-stage portfolio in China to up to 12 products."
Howard Liang, Ph.D., Chief Financial Officer and Chief Strategy Officer, plans to retire from BeiGene following a transition period and the appointment of a new chief financial officer, which is expected to occur around the end of the first quarter of 2021.
"Howard has contributed greatly to our success since joining BeiGene in 2015. Since that time, Howard has been instrumental in each milestone and accomplishment as we expanded our footprint and became a truly global commercial organization with world-class research, development and manufacturing. We are grateful for everything he has done for BeiGene," said John V. Oyler.
Recent Business Highlights and Upcoming Milestones
Commercial Operations
•Generated $91.08 million in product revenue in the three months ended September 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 in China and BRUKINSA in China and the 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 the United States for the treatment of adult patients with MCL who have received at least one prior therapy; and approval in China in two indications – the treatment of adult patients with CLL/SLL who have received at least one prior therapy, and the treatment of adult patients with MCL who have received at least one prior therapy. BRUKINSA is under development globally for additional approvals.
•Received acceptance from the Center for Drug Evaluation (CDE) of the China 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 in Canada 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 (Free ASH Whitepaper) Annual Meeting being held virtually December 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;
•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 China in two indications – the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, and the treatment of patients with locally advanced or metastatic urothelial carcinoma with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Tislelizumab is under development globally for additional approvals.
•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) (Free ESMO Whitepaper) 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 (Free ESMO Whitepaper) 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
•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;
•Amgen has advised BeiGene that its applications to the Human Genetic Resources Administration of China (HGRAC) to obtain approval to conduct clinical studies in China 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 in China. 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 in China 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 (DKK1) protein, in development with Leap Therapeutics.
•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) Biopharmaceuticals Co., Ltd. and licensed to BeiGene outside of Greater China. DXP-593 and DXP-604 can potentially be used as a cocktail treatment option that could avoid resistance due to viral mutation.
•Initiated a Phase 1 clinical trial of healthy volunteers (NCT04532294) in Australia.
BA3071, a novel, investigational conditionally-active CTLA-4 inhibitor discovered by BioAtla, Inc.
•Announced an amended agreement with BioAtla to license in BA3071 globally.
Manufacturing Operations
•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 the Guangzhou High-tech Zone Technology Group Co., Ltd. (formerly Guangzhou GET Technology Development Co., Ltd.) ("GET"), an affiliate of Guangzhou 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, our Guangzhou biologics facility will become a wholly-owned subsidiary of BeiGene Hong Kong Co., Limited.
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 ended September 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 ended September 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 ended September 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 in China and the 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 ended September 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.
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 ended September 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 ended September 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 ended September 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 in China and the 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 ended September 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.
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