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“We continue to make great progress launching new clinical trials on a global scale for patients with a wide variety of cancers, where we believe our investigational treatments can have a profound impact,” said
“Given the significantly reformed regulatory environment in
Recent Business Highlights
Zanubrutinib (BGB-3111), an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK)
- Completed enrollment in the Phase 2 pivotal trial in
Chinain patients with Waldenström macroglobulinemia (WM).
Tislelizumab (BGB-A317), an investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1
- Initiated the following trials:
• Global Phase 2 trial in patients with relapsed or refractory mature T- and natural killer (NK)-cell lymphomas; and
• Global Phase 2 trial in patients with previously treated hepatocellular carcinoma (HCC or liver cancer), under collaboration with
Celgene Corporationfor solid tumors.
Pamiparib (BGB-290), an investigational small molecule PARP inhibitor
- Presented preliminary Phase 1 clinical data in Chinese patients with ovarian or triple-negative breast cancer at the 2018
American Association for Cancer Research(AACR) Annual Meeting in Chicago.
- Continued to expand potential patient access to ABRAXANE® (nanoparticle albumin-bound paclitaxel) in
Chinaby obtaining inclusion in the provincial reimbursement drug list in Jiangsuand critical illness insurance in Zhejiang; and
- Launched a first-line indication of REVLIMID® (lenalidomide) in
Chinafollowing its regulatory approval by the China Foodand Drug Administration(CFDA) for the treatment of multiple myeloma (MM) in combination with dexamethasone in adult patients with previously untreated MM who are not eligible for transplant.
J. Samuel Su, former Vice Chairman of the Board of Directors of Yum! Brands, Inc.and Chairman and CEO of its Chinadivision, to the BeiGene Board of Directors;
- Appointed Dr.
Xiaobin Wuto the position of General Manager of Chinaand President of BeiGene, Ltd.;
Yifei Zhuto the position of China Co-Commercial Head, Sales and Market Access; and
- Appointed Dr.
Guillaume Vignonto the position of Senior Vice President, Business Development.
Expected Upcoming Milestones in 2018
- Present updated Phase 1 clinical data in patients with WM and pooled safety analysis in patients with hematologic malignancies at the 2018
European Hematology Association(EHA) Annual Congress in Stockholm, Sweden, June 14-17;
- Present other updated Phase 1 data and
Chinapivotal trial data;
- Submit first new drug application (NDA) in
Chinafor mantle cell lymphoma;
- Complete enrollment in the global Phase 3 trial for WM in Q3 2018; and
- Initiate a global head-to-head Phase 3 trial versus ibrutinib in relapsed/refractory chronic lymphocytic leukemia.
- Present updated Phase 1 data and
Chinapivotal trial data;
- Submit first NDA in
Chinafor Hodgkin’s lymphoma;
- Complete enrollment in the Phase 2 pivotal trial in
Chinafor urothelial carcinoma; and
- Initiate additional pivotal trials.
- Present updated Phase 1 data;
- Initiate a global Phase 3 trial in gastric cancer in Q2 or Q3 2018; and
- Initiate a Phase 3 trial in
Chinaas maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer.
- Continue to expand provincial reimbursement for ABRAXANE in
First Quarter 2018 Financial Results
Cash, Cash Equivalents, Restricted Cash and Short-Term Investments were $1,481.48 million as of March 31, 2018, compared to
Cash used in operations for the quarter ended
Revenues for the three months ended March 31, 2018 were
- Product revenue from sales of ABRAXANE, REVLIMID and VIDAZA® in
Chinatotaled $23.25 millionfor the first quarter 2018.
- Collaboration revenue totaled
$9.29 millionfor the first quarter 2018, reflecting $7.55 millionthat was recognized as research and development reimbursement revenue from Celgeneand $1.74 millionof deferred upfront fees from Celgenerecognized in the first quarter of 2018. In addition, unbilled receivables of $23.86 millionon the balance sheet reflect research and development reimbursement under the Celgenecollaboration for expenses incurred through the first quarter of 2018.
Expenses for the quarter ended
- Cost of sales for the first quarter were
$4.55 million, compared to nil in the first quarter of 2017. Cost of sales relates to the cost of acquiring ABRAXANE, REVLIMID and VIDAZA for distribution in China.
- R&D Expenses for the three months ended
March 31, 2018were $109.70, compared to $42.77 millionin the same period in 2017. The increase in R&D expenses was primarily attributable to increased spending on our ongoing late-stage clinical trials and increased employee compensation expense as a result of increased headcount to support our clinical programs. Also contributing to the increase was the up-front license fee of $10 millionpaid to Mirati Therapeuticsfor the license of sitravatinib in Asia(excluding Japan), Australia and New Zealand. R&D-associated share-based compensation expense was $12.05 million for the three months ended March 31, 2018, compared to $4.53 millionfor the same period in 2017, due to increased headcount and a higher share price.
- SG&A Expenses for the three months ended
March 31, 2018 were $28.92 million, compared to $8.77 millionin the same period in 2017. The increase in SG&A expenses was primarily attributable to increased headcount, including employees transferred from Celgene China in connection with the license agreement for Celgene’s commercial products in China, as well as higher professional service fees and costs to support our growing operations. SG&A-associated share-based compensation expense was $5.34 million for the three months ended March 31, 2018, compared to $1.46 millionfor the same period in 2017, due to increased headcount and a higher share price.
- Net Loss for the first quarter of 2018 was $105.12 million, or
$2.03per American Depositary Share (ADS), compared to a net loss of $50.62 million, or $1.27per ADS in the same period in 2017.
Select Consolidated Balance Sheet Data (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)
|March 31,||December 31,|
|Cash, cash equivalents, restricted cash and short-term investments||$||1,481,475||$||837,516|
|Property and equipment, net||76,990||62,568|
|Accrued expenses and other payables||55,712||49,598|
Consolidated Statements of Operations (U.S. GAAP)
(Amounts in thousands of U.S. Dollars, except for number of American Depositary Shares (ADSs) and per ADS data) (unaudited)
|Three Months Ended|
|Product revenue, net||$||23,250||$||—|
|Cost of sales - product||(4,550||)||—|
|Research and development||(109,700||)||(42,773||)|
|Selling, general and administrative||(28,915||)||(8,769||)|
|Amortization of intangible assets||(188||)||—|
|Loss from operations||(110,809||)||(51,542||)|
|Interest income, net||1,552||186|
|Other income, net||729||913|
|Loss before income tax expense||(108,528||)||(50,443||)|
|Income tax benefit (expense)||3,412||(180||)|
|Less: net loss attributable to noncontrolling interests||(520||)||—|
|Net loss attributable to BeiGene, Ltd.||$||(104,596||)||$||(50,623||)|
|Net loss per ADS, basic and diluted||$||(2.03||)||$||(1.27||)|
|Weighted-average number of ADSs outstanding – basic and diluted||51,577,739||39,725,977|
Consolidated Statements of Comprehensive Loss (U.S. GAAP)
(Amounts in thousands of U.S. Dollars) (unaudited)
|Three Months Ended|
|Other comprehensive loss, net of tax of nil:|
|Foreign currency translation adjustments||272||90|
|Unrealized holding gain (loss), net||329||(12||)|
|Less: comprehensive loss attributable to noncontrolling interests||(456||)||—|
|Comprehensive loss attributable to BeiGene, Ltd.||$||(104,059||)||$||(50,545||)|
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 BeiGene’s advancement of, and anticipated clinical development, regulatory milestones and commercialization of its drugs and drug candidates, the potential for the Company’s drugs and drug candidates, and the expected milestones under the caption “Expected Upcoming Milestones in 2018”. 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|
|Lucy Li, Ph.D.||Liza Heapes|
|+1 781-801-1800||+ 1 857-302-5663|
i ABRAXANE®, REVLIMID®, and VIDAZA® are registered trademarks of