BeiGene Reports Second Quarter 2020 Financial Results
“We have made tremendous progress since the start of the second quarter, with approvals for tislelizumab and BRUKINSA for three indications in
Recent Business Highlights and Upcoming Milestones
- Received approval from the
National Medical Products Administration(NMPA) for BRUKINSA® (zanubrutinib) in Chinain June for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy, and for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Subsequently launched BRUKINSA in these indications in Chinawithin 12 days of approval;
- Received approval from the NMPA and launched tislelizumab in
Chinain April for the treatment of patients with previously treated locally advanced or metastatic urothelial carcinoma (bladder cancer);
- Began commercializing XGEVA® (denosumab) in
Chinaon July 1for the treatment of giant cell tumor of bone (GCTB), following its earlier approval by the NMPA in May 2019and subsequent launch by Amgen. This marks the first Amgen product that has been transitioned to BeiGenefor commercialization in Chinasince the commencement of our global strategic oncology collaboration in January 2020;
$65.64 millionin product revenue in the three months ended June 30, 2020, representing a 13% increase compared to the comparable period of the prior year, despite the suspension and recall of ABRAXANE® in Chinain March 2020. Product revenue was driven by sales of our newly launched internally developed products tislelizumab and BRUKINSA; and
- Received supplemental medical insurance coverage in
Hainanprovince, Chinafor tislelizumab for patients with classical Hodgkin’s lymphoma (cHL), BRUKINSA for patients with CLL/SLL, and XGEVA for patients with GCTB.
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
- Announced the acceptance of a marketing authorization application (MAA) by the
European Medicines Agency(EMA) for BRUKINSA for the treatment of patients with Waldenström’s Macroglobulinemia (WM) who have received at least one prior therapy or as first-line treatment for patients unsuitable for chemo-immunotherapy;
- Presented clinical data from the Phase 3 ASPEN trial comparing BRUKINSA to ibrutinib for the treatment of patients with WM at the 2020
American Society of Clinical Oncology (ASCO) Virtual Scientific Program;
- Announced an exclusive distribution agreement with
Medison Pharma Ltd.in Israeland the acceptance of a new drug application (NDA) in Israelfor BRUKINSA for the treatment of patients with MCL who have received at least one prior therapy; and
- Filed and received acceptance of two NDAs by the
Australia Therapeutic Goods Administration(TGA) for BRUKINSA in relapsed/refractory (R/R) MCL and WM.
Expected Milestones for BRUKINSA
- File a supplemental new drug application (sNDA) in
Chinafor WM in 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 second half of 2020;
- 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) in 2020; and
- Complete expanded 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
- Announced that the NMPA accepted a sNDA for tislelizumab in combination with chemotherapy for first-line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC);
- Announced that the NMPA accepted a sNDA for tislelizumab for the treatment of patients with previously treated unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer;
- Presented results from a Phase 3 clinical trial evaluating tislelizumab in combination with standard chemotherapy for the first-line treatment of patients with advanced squamous NSCLC at the 2020 ASCO Virtual Scientific Program. Data from this trial were included in the sNDA currently under review by the NMPA;
- Initiated patient enrollment in a Phase 3 trial (NCT04379635) in
Chinacomparing tislelizumab plus chemotherapy to placebo plus chemotherapy in patients with resectable Stage II or IIIA NSCLC;
- Completed enrollment in the pivotal Phase 2 trial (NCT03736889) in
Chinaof patients with mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) solid tumors; and
- Entered into a clinical collaboration agreement with
Hutchison China MediTech Limited(Chi-Med) to evaluate the safety, tolerability and efficacy of combining tislelizumab with two of Chi-Med’s drug candidates, Elunate® (fruquintinib) and surufatinib, for the treatment of various solid tumor cancers in the United States, Europe, China, and Australia.
Expected Milestones for Tislelizumab
- Present data from the Phase 3 trial (NCT03663205) of tislelizumab combined with chemotherapy for the first-line treatment of patients with advanced non-squamous NSCLC at the 2020
European Society for Medical Oncology (ESMO) Virtual Congress. Data from this trial were included in the sNDA currently under review by the NMPA; and
- 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) in 2020 or early 2021.
Pamiparib, an investigational selective small molecule inhibitor of PARP1 and PARP2
- Announced that the NMPA accepted and subsequently granted priority review of an NDA for pamiparib for the treatment of 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.
Expected Milestones for Pamiparib
- Present data from the Phase 1/2 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; and
- 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) in 2020 or the first half of 2021.
Early-Stage Clinical Development Programs
- Continued to advance our earlier-stage pipeline of internally-developed assets, including BGB-A1217 (monoclonal antibody against TIGIT in Phase 1/2 development for cancer in combination with tislelizumab), BGB-11417 (BCL-2 inhibitor in Phase 1 development for cancer), BGB-A445 (non-ligand competing OX40 monoclonal antibody in Phase 1 development for solid tumors in combination with tislelizumab), BGB-10188 (PI3Kδ inhibitor in Phase 1 development for cancer in combination with BRUKINSA or tislelizumab), and BGB-15025 (HPK1 inhibitor in preclinical development for cancer); and
- Identified a recommended Phase 2 dose in the Phase 1 trial (NCT04047862) of BGB-A1217 (TIGIT monoclonal antibody) in combination with tislelizumab in advanced solid tumors.
Zanidatamab (ZW25), a novel investigational Azymetric™ bispecific antibody against HER2 currently in Phase 2 clinical development with Zymeworks Inc.
- Began the manufacturing technology transfer to our biologics facility in
Expected Milestones for Zanidatamab
- Support clinical development and enrollment of the planned registration-enabling trials in refractory HER2-positive biliary tract cancer in 2020 and first-line HER2-positive gastroesophageal adenocarcinomas in late 2020 or early 2021.
BGB-3245, an investigational RAF dimer inhibitor with activity against mutant monomeric and dimeric forms of B-RAF in preclinical studies; being developed by MapKure, which is jointly owned by
- Initiated patient enrollment in
the United Statesand Australiain the Phase 1 clinical trial (NCT04249843) of BGB-3245 in patients with advanced or refractory solid tumors.
Expected Milestones for BGB-3245
- Initial clinical data from the Phase 1 study expected in 2021.
- Completed equipment validation and continued manufacturing process validation for the first phase of our biologics manufacturing facility in
- Initiated expansion of the second phase of our biologics manufacturing facility in
Guangzhouto significantly increase manufacturing capacity and introduce new manufacturing technology platforms, expected to be completed by the end of 2020.
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 and inspections, and clinical trial recruitment and participation. Although the impact of COVID-19 on operations in
Chinalessened in the second quarter of 2020 compared to the first quarter of 2020, there remains uncertainty regarding the future impact of the pandemic both in Chinaas 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.
- Announced the closing of a registered direct offering of 145,838,979 ordinary shares, at a price of
$14.2308per share ( $185per American Depositary Share (ADS)), resulting in gross proceeds of approximately $2.08 billionand net proceeds, after estimated offering expenses, of approximately $2.07 billion.
- Announced a license and collaboration agreement with Assembly Biosciences, Inc. in
Chinafor its portfolio of three clinical-stage chronic hepatitis B virus (HBV) core inhibitor candidates ABI-H0731, ABI-H2158, and ABI-H3733, for the treatment of patients with HBV infection; and
- Announced the appointment of
Angus Grant, Ph.D. as Chief Business Executive. Dr. Grantwill oversee business development and alliance management and help drive external innovation and investment to guide our global growth strategy.
Second Quarter 2020 Financial Results
Cash, Cash Equivalents, Restricted Cash, and Short-Term Investments were $3.16 billion as of
- In the three months ended
June 30, 2020, cash used in operating activities totaled $263.00 millionand capital expenditures were $32.61 million, compared to $46.10 millionand $21.45 million, respectively, in the prior year period.
Revenue for the three months ended
- Product revenues totaled
$65.64 millionfor the three months ended June 30, 2020, compared to $58.14 millionfor the same period in 2019, comprised of:
$29.42 millionfrom sales of tislelizumab in China, in its first full quarter of sales following its launch in March 2020;
$6.97 millionfrom sales of BRUKINSA in Chinaand the United States, including the launch inventory build at distributors following approval in Chinain June 2020;
$29.01 millionfrom sales of REVLIMID® and VIDAZA® in China, compared to $23.41 millionin the same period of the prior year; and
$0.24 millionfrom ABRAXANE, which was comprised of reversals of rebate accruals subsequent to the suspension of sales and recall of ABRAXANE in March 2020, compared to $34.73 millionin the same period of the prior year.
- Collaboration revenue was nil for the three months ended
June 30, 2020, compared to $185.20 millionfor the same period in 2019. Collaboration revenue for the three months ended June 30, 2019included a termination fee of $150 millionfrom the termination of the Celgene collaboration agreement for tislelizumab, as well as $25.74 millionof research and development service revenue and $9.46 millionof reimbursed research and development costs under the agreement, both of which were recognized prior to termination of the agreement.
Expenses for the three months ended
- Cost of Sales for the three months ended
June 30, 2020were $14.31 million, compared to $17.84 millionin the same period of 2019. Cost of sales primarily included acquisition costs for supply of REVLIMID and VIDAZA that was sold during the period in China, as well as the post-approval costs of tislelizumab and BRUKINSA that was sold during the period.
- R&D Expenses for the three months ended
June 30, 2020were $285.97 million, compared to $228.76 millionin 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, development expenses associated with the Amgen collaboration, the preparation for additional regulatory submissions, and manufacturing costs related to pre-commercial activities and supply. Our co-funding obligation for the development of the pipeline assets under the Amgen collaboration for the three months ended June 30, 2020was $55.94 million, of which $28.34 millionwas recorded as R&D expense. The remaining $27.61 millionwas recorded as a reduction of the R&D cost share liability. R&D-related share-based compensation expense was $23.71 million for the three months ended June 30, 2020, compared to $18.15 millionfor the same period of 2019.
- SG&A Expenses for the three months ended June 30, 2020 were $124.05 million, compared to
$82.25 millionin the same period in 2019. The increase in SG&A expenses was primarily attributable to increased headcount, including the expansion of our commercial team to support the distribution of our products in Chinaand 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 $21.76 million for the three months ended June 30, 2020, compared to $14.45 millionfor the same period of 2019.
- Net Loss for the three months ended
June 30, 2020was $335.20 million, or $0.33per share, or $4.31per ADS, compared to $85.57 million, or $0.11per share, or $1.43per ADS in the same period in 2019.
Select Condensed Consolidated Balance Sheet Data (
(Amounts in thousands of
|Cash, cash equivalents, restricted cash and short-term investments||$||3,157,643||$||985,503|
|Accounts receivable, net||61,663||70,878|
|Property and equipment, net||258,106||242,402|
|Liabilities and equity:|
|Accrued expenses and other payables||207,921||163,556|
|Research and development cost share liability||561,594||—|
Condensed Consolidated Statements of Operations (
(Amounts in thousands of
|Three Months Ended
||Six Months Ended|
|Product revenue, net||$||65,635||$||58,142||$||117,694||$||115,563|
|Cost of sales||14,307||17,839||28,456||33,100|
|Research and development||285,968||228,760||590,270||407,111|
|Selling, general and administrative||124,049||82,248||231,130||139,893|
|Amortization of intangible assets||188||332||471||663|
|Loss from operations||(358,877||)||(85,833||)||(732,633||)||(259,588||)|
|Interest income, net||1,108||2,886||7,798||7,363|
|Other income (expense), net||19,976||(878||)||23,657||850|
|Loss before income taxes||(337,793||)||(83,825||)||(701,178||)||(251,375||)|
|Income tax (benefit) expense||(1,475||)||2,129||79||2,648|
|Less: Net loss attributable to noncontrolling interest||(1,116||)||(384||)||(2,320||)||(813||)|
|Net loss attributable to
|Net loss per share attributable to
|Weighted-average shares outstanding, basic and diluted||1,010,230,470||777,509,102||1,007,967,904||776,137,299|
|Net loss per ADS attributable to
|Weighted-average ADSs outstanding, basic and diluted||77,710,036||59,808,392||77,535,993||59,702,869|
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 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
|Investor Contact||Media Contact|
|+1 857-302-5189||+1 857-302-5663 or +1 857-302-7596|
ABRAXANE® is a registered trademark of
XGEVA® is a registered trademark of Amgen.
ELUNATE® is a registered trademark of
Source: BeiGene, LTD.