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“We had a transformative year in 2017, highlighted by the collaboration with
“We also strengthened our balance sheet with an
Fourth Quarter 2017 and Recent Business Highlights
Zanubrutinib (BGB-3111), an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK)
- Presented preliminary clinical data from the Phase 1 trial of zanubrutinib in patients with non-Hodgkin’s lymphoma in an oral presentation at the 59th
American Society of Hematology(ASH) Annual Meeting in Atlanta;
- Presented updated Phase 1b data for the combination of zanubrutinib and GAZYVA® (obinutuzumab) in patients with chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL) and follicular lymphoma (FL) at the ASH annual meeting;
- Presented initial Phase 1b data for the combination of zanubrutinib and the Company’s investigational anti-PD-1 antibody, tislelizumab (BGB-A317), in patients with B-cell malignancies at the ASH annual meeting;
- Completed enrollment in the Phase 2 pivotal trial in
Chinain patients with CLL/SLL; and
- Initiated a Phase 1b/2 trial in
Chinaof zanubrutinib in combination with rituximab in patients with diffuse large B-cell lymphoma, FL, and marginal zone lymphoma.
Tislelizumab (BGB-A317), an investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1 under the collaboration with
- Presented preliminary results from the Phase 1 trial of tislelizumab in patients with urothelial carcinoma at the 2018 Genitourinary Cancers Symposium;
- Presented initial Phase 1b data for the combination of zanubrutinib and tislelizumab in patients with B-cell malignancies at the ASH annual meeting;
- Initiated the following trials:
-- Global Phase 3 trial of tislelizumab in patients with previously untreated advanced hepatocellular carcinoma (HCC); and
-- Global Phase 3 trial of tislelizumab in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma.
Pamiparib (BGB-290), an investigational small molecule PARP inhibitor
- Initiated a Phase 2 pivotal trial in
Chinaof pamiparib in patients with advanced ovarian cancer.
BGB-A333, an investigational humanized monoclonal antibody against the immune checkpoint receptor ligand PD-L1
- Initiated a global Phase 1/2 trial of BGB-A333 monotherapy and in combination with tislelizumab in advanced solid tumors.
- Received approval in
Chinafor a new indication for REVLIMID® (lenalidomide) in combination with dexamethasone as a treatment for adult patients with previously untreated multiple myeloma who are not eligible for transplant; and
- Initiated commercialization of VIDAZA® (azacitidine) in
- Entered an exclusive license agreement with
Mirati Therapeuticsfor the development, manufacturing and commercialization of Mirati’s sitravatinib, an investigational tyrosine kinase inhibitor targeting TAM family receptors (TYRO3, Axl, MER), split family receptors (VEGFR2, KIT) and RET, in Asia(excluding Japan), Australia and New Zealand; and
- Entered into a commercial supply agreement for tislelizumab with Boehringer Ingelheim.
Expected 2018 Milestones
- Present updated Phase 1 and
Chinapivotal trial data;
- Submit first NDA in
Chinafor mantle cell lymphoma;
- Complete enrollment in the global Phase 3 trial for Waldenstrom’s macroglobulinemia in Q3 2018; and
- Initiate a global head-to-head Phase 3 trial versus ibrutinib in relapsed/refractory CLL.
- 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 global and
China-focused pivotal trials.
- Present updated Phase 1 data;
- Initiate a global Phase 3 trial in gastric cancer in 1H 2018; and
- Initiate a Phase 3 trial in
Chinaas a maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer.
- Expand provincial reimbursement for ABRAXANE® (nanoparticle albumin-bound paclitaxel) in
Fourth Quarter and Full Year 2017 Financial Results
Cash, Cash Equivalents, and Short-Term Investments were $837.52 million as of December 31, 2017, compared to
- The increase of
$80.08 millionin the in the fourth quarter of 2017 was primarily due to the receipt of $170.95 millionfrom Celgeneas part of upfront licensing fees from the tislelizumab collaboration, offset by increased research and development spending and capital expenditures as we continue to advance our pipeline.
- The increase of
$469.35 millionfrom the prior year period was primarily due to cash received from Celgenefrom the tislelizumab collaboration, including upfront licensing fees of $263.00 millionand an equity investment of $150.00 million, and net proceeds of $188.52 millionfrom our August 2017follow-on public offering, offset by increased cash used in operations and for capital expenditures.
- Capital expenditures for the quarter and year ended December 31, 2017 were $18.93 million and
$58.73 million, compared to $8.06 million and $23.50 million, respectively, for the same periods in 2016, primarily attributable to increased investment in our manufacturing facilities in Guangzhouand Suzhou.
Revenue for the fourth quarter and year ended December 31, 2017 was
- Product revenue from sales of ABRAXANE and REVLIMID in
Chinatotaled $15.61 millionand $24.43 millionfor the fourth quarter and from August 31, 2017(the closing of the Celgenetransaction) to December 31, 2017, respectively.
- Collaboration revenue totaled
$2.57 millionand $213.96 millionfor the fourth quarter and year ended December 31, 2017, respectively, reflecting recognition of the upfront licensing fees from Celgenein the third quarter and deferred upfront fees recognized in the fourth quarter.
Expenses for the fourth quarter and year ended
- Cost of sales for the fourth quarter and from
August 31 to December 31, 2017were $3.03 millionand $4.97 million, respectively. Cost of sales relates to the cost of acquiring ABRAXANE and REVLIMID for distribution in China.
- R&D Expenses for the fourth quarter and year ended December 31, 2017 were $91.34 million and
$269.02 million, respectively, compared to $28.93 millionand $98.03 millionin the same periods in 2016. The increase in R&D expenses was primarily attributable to increased spending on our ongoing late-stage clinical trials, increased manufacturing costs for our drug candidates due to expansion of ongoing clinical programs, and increased employee compensation expense as a result of increased headcount to support our clinical programs. Additionally, R&D-associated share-based compensation expense was $10.95 million and $30.61 millionfor the fourth quarter and year ended December 31, 2017, respectively, compared to $2.90 millionand $8.08million for the same periods in 2016, due to increased headcount and a higher share price.
- SG&A Expenses for the fourth quarter and year ended December 31, 2017 were $27.42 million and
$62.60 million, respectively, compared to $8.34 millionand $20.10 millionin the same periods in 2016. 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 related to the Celgenetransaction and patent prosecution activities, and costs to support our growing operations. In addition, SG&A-associated share-based compensation expense was $5.51 million and $12.25million for the fourth quarter and year ended December 31, 2017, respectively, compared to $1.05 millionand $2.55 millionfor the same periods in 2016.
Net Loss for the fourth quarter and year ended December 31, 2017 was $99.28 million and
|Select Consolidated Balance Sheet Data (U.S. GAAP)|
|(Amounts in thousands of U.S. Dollars)
|December 31, 2017||December 31, 2016
|Cash, cash equivalents and short‑term investments||$||837,516||$||368,174|
|Property and equipment, net||62,568||25,977|
|Consolidated Statements of Operations (U.S. GAAP)|
|(Amounts in thousands of U.S. Dollars, except for number of American Depositary Shares (ADSs) and per ADS data)|
|Three Months Ended
|Twelve Months Ended
|Product revenue, net||$||15,606||$||—||$||24,428||$||—|
|Cost of sales – products||(3,030)||—||(4,974)||—|
|Research and development||(91,340)||(28,933)||(269,018)||(98,033)|
|Selling, general and administrative||(27,415)||(8,337)||(62,602)||(20,097)|
|Amortization of intangible assets||(187)||—||(250)||—|
|Loss from operations||(103,798)||(37,270)||(98,457)||(117,060)|
|Interest (expense) income, net||(527)||47||(4,108)||383|
|Changes in fair value of financial instruments||—||—||—||(1,514)|
|Gain (loss) on sale of available-for-sale securities||34||(338)||44||(1,415)|
|Other income (expense), net||9,926||(289)||11,457||443|
|Loss before income taxes||(94,365)||(37,850)||(91,064)||(119,163)|
|Income tax (expense) benefit||(4,915)||252||(2,235)||(54)|
|Less: Net loss attributable to noncontrolling interest||43||—||(194)||—|
|Net loss attributable to BeiGene, Ltd.||$||(99,323)||$||(37,598)||$||(93,105)||(119,217)|
|Net Loss per ADS, basic and diluted||$||(2.19)||$||(1.05)||$||(2.23)||$||(3.84)|
|Weighted-average number of ADSs outstanding – basic and diluted||45,402,681||35,663,284||41,783,497||31,047,650|
|Consolidated Statements of Comprehensive Income (Loss) (U.S. GAAP)|
|(Amounts in thousands of U.S. Dollars)|
|Three Months Ended
|Twelve Months Ended
|Other comprehensive (loss) income, net of tax of nil:|
|Foreign currency translation adjustments||(134)||(232)||851||(245)|
|Unrealized holding gain, net||(354)||251||(296)||1,108|
|Less: Comprehensive loss attributable to noncontrolling interests||73||—||(105)||—|
|Comprehensive loss attributable to BeiGene, Ltd.||$||(99,841)||$||(37,579)||$||(92,639)||$||(118,354)|
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 2018 Milestones”. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including
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