BeiGene Reports Fourth Quarter and Full Year 2019 Financial Results
“Despite challenges to our business in
Recent Business Highlights and Upcoming Milestones
- Received accelerated approval from the
U.S. Food and Drug Administration(FDA) of BRUKINSA™ (zanubrutinib) as a treatment for mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy; and launched within one week of approval;
- Received approval from the
China National Medical Products Administration(NMPA) of tislelizumab as a treatment for patients with classical Hodgkin’s lymphoma (cHL) who have received at least two prior therapies, with launch planned this month;
$222.60 millionin product revenue in the 12 months ended December 31, 2019, primarily from sales in Chinaof ABRAXANE®, REVLIMID®, and VIDAZA®, which represents a 70.1% increase compared to the same period in 2018. Revenue for the quarter ended December 31, 2019was $56.89 million. BeiGenemarkets ABRAXANE, REVLIMID, and VIDAZA in Chinaunder an exclusive license from Celgene Logistics Sàrl, a Bristol-Myers Squibb company;
- Submitted to the NMPA a supplemental new drug application (sNDA) for REVLIMID (lenalidomide), in combination with rituximab, for the treatment of patients with relapsed or refractory (R/R) indolent lymphoma (follicular lymphoma or marginal zone lymphoma). The sNDA has been accepted and granted priority review; and
- ABRAXANE was included in the
National Healthcare Security Administrationof China’s volume-based procurement list, effective in the second quarter of 2020.
BRUKINSA™ (zanubrutinib), a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects; approved in
- Announced results of the Phase 3 ASPEN trial (NCT03053440) comparing BRUKINSA to ibrutinib for the treatment of Waldenström’s macroglobulinemia (WM). While the primary endpoint of statistical superiority related to deep response (VGPR or better) was not met, zanubrutinib demonstrated more frequent VGPRs (28.4% vs. 19.2% in overall population) and advantages in safety and tolerability compared to ibrutinib.
ASPENis the largest Phase 3 trial in WM conducted to-date and the first comparative trial readout for BTK inhibitors;
- Completed enrollment in the Phase 2 MAGNOLIA trial (NCT03846427) in patients with R/R marginal zone lymphoma (MZL);
- Presented clinical data on BRUKINSA at the 61st
American Society of Hematology(ASH) Annual Meeting, including:
-- Initial results presented in an oral session of the SEQUOIA trial (NCT03336333) Arm C in patients with treatment-naïve (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with Del(17p);
-- Updated results presented in an oral session of the Phase 1/2 trial (NCT02343120) in patients with CLL or SLL;
-- Updated results presented in a poster from the Phase 1b trial (NCT02795182) of BRUKINSA in combination with tislelizumab in patients with previously treated B-cell lymphoid malignancies; and
- Initiated a Phase 1/2 clinical trial in
Japanof zanubrutinib in patients with mature B-cell malignancies.
Expected Milestones for Zanubrutinib
- Receive approvals in
Chinafor the treatment of patients with R/R MCL and R/R CLL/SLL in the first half of 2020;
- Announce top-line results from the SEQUOIA trial comparing zanubrutinib with bendamustine plus rituximab in patients with TN CLL or SLL as early as the second half of 2020;
- File an sNDA in
Chinafor WM in 2020;
ASPENdata with U.S. FDAand European Medicines Agency(EMA) and present Phase 3 ASPEN data at a major medical conference in 2020; and
- Complete expanded enrollment in the Phase 3 ALPINE trial comparing zanubrutinib 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 pivotal Phase 3 trial (NCT 03594747) of tislelizumab in combination with chemotherapy for the first-line treatment of patients with squamous non-small cell lung cancer (NSCLC) met the primary endpoint of improved progression-free survival (PFS) at the pre-planned interim analysis, as assessed by independent review committee (IRC). The safety profile of tislelizumab in both combinations in this trial was consistent with the known risks of each study treatment, and no new safety signals were identified;
- Received orphan-drug designation for tislelizumab from the
U.S.FDA for hepatocellular carcinoma (HCC) and esophageal squamous cell carcinoma (ESCC); and
- Announced updated clinical results presented at the ESMO Asia 2019
Congressfrom the Phase 2 trial (NCT03469557) of tislelizumab in combination with chemotherapy in patients with gastric/gastroesophageal junction (G/GEJ) adenocarcinoma or ESCC.
Expected Milestones for Tislelizumab
- Receive approval in
Chinafor the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) in 2020;
- Submit sNDA for the first-line treatment of patients with squamous NSCLC in
- Have regulatory discussions with health authorities based on preliminary results from the global Phase 2 trial (NCT03419897) of tislelizumab in second- or third-line patients with HCC in 2020;
- Announce top-line results from the Phase 3 trial (NCT03663205) comparing tislelizumab plus chemotherapy to chemotherapy alone in first-line patients with non-squamous NSCLC in
- Complete enrollment in the pivotal Phase 2 trial (NCT03736889) in
Chinaof patients with mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) solid tumors in 2020; and
- Complete enrollment in the global portion of the Phase 3 trial (NCT03358875) comparing tislelizumab with docetaxel in second-or third-line patients with NSCLC and in the global Phase 3 trial (NCT03430843) comparing tislelizumab with chemotherapy in second-line patients with advanced ESCC in early 2020 and announce top-line results in 2020 or early 2021.
Pamiparib, an investigational selective small molecule inhibitor of PARP1 and PARP2
- Disclosed plans to convert from Phase 3 to Phase 2 the clinical trial of pamiparib vs. placebo as maintenance therapy in patients with inoperable locally advanced or metastatic gastric cancer who have responded to platinum-based first line chemotherapy (NCT 03427814; also known as the BGB-290-303 trial). The Company plans to evaluate data from the Phase 2 trial to assess the potential of pamiparib in this indication and the potential next steps of development as a monotherapy or in combination with other therapies.
Expected Milestones for Pamiparib
- Have regulatory discussions based on preliminary results from the Phase 2 trial (NCT03333915) in Chinese patients with third or later line previously treated ovarian cancer (OC) harboring germline BRCA 1/2 mutations and potentially submit a new drug application (NDA) in
- Announce top-line results from the Phase 3 trial (NCT03519230) of pamiparib as a maintenance treatment in patients with platinum-sensitive recurrent OC in 2020 or first half of 2021; and
- Present updated data from the Phase 1 trial (NCT02660034) of pamiparib in combination with tislelizumab in patients with advanced solid tumors in 2020.
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 in
- Presented clinical data in an oral session at the
European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congressin December 2019from the Phase 1b trial (NCT03666143) of sitravatinib combined with tislelizumab in patients with platinum-resistant OC.
Expected Milestones for Sitravatinib
- Present additional Phase 1 clinical data on sitravatinib combined with tislelizumab at a medical meeting in 2020.
ZW25, a novel investigational Azymetric™ bispecific antibody currently in Phase 2 clinical development with Zymeworks, Inc.
Expected Milestones for ZW25
- 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; and
- Initiate a Phase 1b/2 trial investigating ZW25 in combination with chemotherapy with and without tislelizumab in patients with advanced HER2-positive breast cancer or gastric/gastroesophageal junction adenocarcinoma in early 2020.
Lifirafenib, an investigational RAF dimer inhibitor
Expected Milestones for Lifirafenib
- Publish Phase 1 data in a peer-reviewed journal in 2020.
BGB-A1217, an investigational TIGIT monoclonal antibody
Expected Milestones for BGB-A1217
- Present clinical data from the Phase 1 trial in 2020 or early 2021
BGB-A445, an investigational non-ligand competing anti OX40 agonistic monoclonal antibody
- Initiated a Phase 1 trial (NCT04215978) of BGB-A445 as monotherapy and in combination with tislelizumab in patients with advanced solid tumors.
BGB-3245, an investigational B-RAF inhibitor with activity against mutant monomeric and dimeric forms of B-RAF in pre-clinical studies. BGB-3245 is being developed by MapKure, which
- Initiated a Phase 1 clinical trial (NCT04249843) in patients with advanced or refractory tumors harboring specific v-RAF murine sarcoma viral oncogene homolog B (B-RAF) genetic mutations.
BGB-11417, an investigational small molecule Bcl-2 inhibitor
- Initiated study start-up for a Phase 1 trial in
Australiaand the United Statesin patients with mature B-cell malignancies.
Expected Milestones for BGB-11417
- Begin patient enrollment for the Phase 1 trial in mature B-cell malignancies in the first quarter or early in the second quarter of 2020.
- Received a drug manufacturing license for our
Guangzhoubiologics manufacturing facility in December 2019;
- Initiated tislelizumab manufacturing process validation; and
- Began Phase 2 expansion for additional manufacturing capacity at our
Guangzhoumanufacturing facility, expected to be completed by the end of 2020.
- Closed the global strategic collaboration with Amgen to commercialize XGEVA® (denosumab), KYPROLIS® (carfilzomib), and BLINCYTO® (blinatumomab) in
Chinaand jointly develop 20 Amgen oncology pipeline assets. Amgen purchased approximately $2.8 billionof BeiGene’s American Depositary Shares (ADS), representing an approximately 20.5% ownership interest;
- Announced an exclusive development and commercialization agreement with
EUSA Pharma (UK) Limitedfor the orphan biologic products SYLVANT® (siltuximab) in Greater Chinaand QARZIBA®▼ (dinutuximab beta) in mainland China; and
- Announced an exclusive option and license agreement with Leap Therapeutics, Inc. for the clinical development and commercialization of DKN-01, Leap's anti-Dickkopf-1 (
DKK1) antibody, in Asia(excluding Japan), Australia, and New Zealand.
Expected COVID-19 Impact
- The Company expects that the worldwide health crisis of COVID-19 will have a negative impact on its operations in
China, including commercial sales, regulatory interactions and inspections, and clinical trial recruitment and participation, particularly in the first quarter and possibly longer depending on the scope and duration of the disruption. The Company is working to minimize delays and disruptions and continues to execute on its commercialization, regulatory and clinical development goals in China.
Fourth Quarter and Full Year 2019 Financial Results
Cash, Cash Equivalents, Restricted Cash and Short-Term Investments were $985.50 million as of December 31, 2019, compared to
- Total cash and short-term investments decreased
$291.09 millionin the fourth quarter of 2019. Cash used in operating activities totaled $267.18 million. Capital expenditures were $15.46 million, and cash used for upfront license payments totaled $20.00 million.
- Total cash and short-term investments decreased
$823.72 millionfor the year ended December 31, 2019. Cash used in operating activities totaled $750.27 million. Capital expenditures were $89.61 million, and cash used for upfront license payments totaled $69.00 million.
Revenue for the fourth quarter and year ended December 31, 2019 was
- Product revenues totaled
$56.89 millionand $222.60 millionfor the fourth quarter and year ended December 31, 2019, respectively, compared to $37.76 millionand $130.89 millionfor the same periods in 2018.
- Collaboration revenue totaled nil and
$205.62 millionfor the fourth quarter and year ended December 31, 2019, respectively, compared to $20.91 millionand $67.34 millionfor the same periods in 2018. Included in the full year 2019 revenue was the $150 millionpayment in connection with the termination of the tislelizumab collaboration agreement with Celgene.
Expenses for the fourth quarter and year ended
- Cost of Sales for the fourth quarter and year ended
December 31, 2019were $17.98 millionand $71.19 million, respectively, compared to $9.19 millionand $28.71 millionin the same periods in 2018. Cost of sales related primarily to the cost of acquiring ABRAXANE, REVLIMID, and VIDAZA for distribution in China.
- R&D Expenses for the fourth quarter and year ended
December 31, 2019were $283.26 millionand $927.34 million, respectively, compared to $257.46 millionand $679.01 millionin the same periods in 2018. The increase in R&D expenses was primarily attributable to increased spending related to ongoing enrollment and expansion of pivotal clinical trials for zanubrutinib and tislelizumab, preparation for additional regulatory submissions of our late-stage drug candidates, manufacturing costs related to pre-commercial activities and supply, as well as increases in spending related to our preclinical-stage programs. Employee share-based compensation expense also contributed to the overall increase in R&D expenses, and was $21.69 million and $76.29 millionfor the fourth quarter and year ended December 31, 2019, respectively, compared to $16.09 millionand $54.38 millionfor the same periods in 2018, due to increased headcount and a higher share price.
- SG&A Expenses for the fourth quarter and year ended December 31, 2019 were $143.35 million and
$388.25 million, respectively, compared to $72.49 millionand $195.39 millionin the same periods in 2018. The increase in SG&A expenses was primarily attributable to increased headcount, including the expansion of our commercial teams to support the distribution of our commercial products in Chinaand in the United States, increased commercial activities as well as higher professional service fees and costs to support our growing operations. The overall increase in SG&A expenses was also attributable to higher SG&A-related share-based compensation expense, which was $16.65 million and $57.86 millionfor the fourth quarter and year ended December 31, 2019, respectively, compared to $9.87 millionand $32.74 millionfor the same periods in 2018, due to increased headcount and a higher share price.
- Net Loss for the fourth quarter and year ended
December 31, 2019was $388.06 million and $948.63 million, or $0.49and $1.22per share, or $6.39and $15.80per ADS, respectively, compared to $268.26 millionand $673.77 million, or $0.35and $0.93per share, or $4.52and $12.15per ADS, respectively, in the same periods in 2018.
Select Condensed Consolidated Balance Sheet Data (
(Amounts in thousands of
|Cash, cash equivalents, restricted cash and short-term investments ||$||985,503||$||1,809,222|
|Property and equipment, net||242,402||157,061|
|Liabilities and equity:|
|Accrued expenses and other payables||163,556||100,414|
 Cash, cash equivalents, restricted cash and short-term investments as of
Condensed Consolidated Statements of Operations (
(Amounts in thousands of
|Three Months Ended
||Twelve Months Ended
|Product revenue, net||$||56,892||$||37,762||$||222,596||$||130,885|
|Cost of sales - products||(17,984||)||(9,193||)||(71,190||)||(28,705||)|
|Research and development ||(283,259||)||(257,464||)||(927,338||)||(679,005||)|
|Selling, general and administrative||(143,354||)||(72,490||)||(388,249||)||(195,385||)|
|Amortization of intangible assets||(332||)||(331||)||(1,326||)||(894||)|
|Loss from operations||(388,037||)||(280,808||)||(959,891||)||(705,769||)|
|Interest (expense) income, net||(438||)||5,950||9,131||13,947|
|Other income (expense), net||8,141||(396||)||7,174||1,993|
|Loss before income taxes||(380,334||)||(275,254||)||(943,586||)||(689,829||)|
|Income tax (expense) benefit||(7,561||)||8,544||(6,992||)||15,796|
|Less: Net income (loss) attributable to noncontrolling interest||166||1,545||(1,950||)||(264||)|
|Net loss attributable to
|Net loss per share attributable to
|Weighted-average shares outstanding, basic and diluted||788,899,247||771,982,215||780,701,283||720,753,819|
|Net loss per ADS attributable to
|Weighted-average ADSs outstanding, basic and diluted||60,684,557||59,383,247||60,053,945||55,442,601|
 Research and development expense for the fourth quarter and year ended
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 the encouraging clinical data for BeiGene’s product candidates and product revenue for its products; the conduct of late-stage clinical trials and expected data readouts; the potential commercial launches of BeiGene’s product candidates; the advancement of and anticipated clinical development, regulatory milestones and commercialization of BeiGene’s products and drug candidates; the impact of the coronavirus 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||+ 1 857-302-7596|
i ABRAXANE® is a registered trademark of
ii XGEVA® is a registered trademark of Amgen.
Source: BeiGene, LTD.