BeiGene Reports Third Quarter 2017 Financial Results
Nov 13, 2017 4:05 PM
“BeiGene has achieved several important milestones since the beginning of the third quarter. Our strategic collaboration with Celgene Corporation has transformed us into a commercial-stage company in
“Looking ahead, we plan to present additional data on BGB-3111 at the 59th
Third Quarter 2017 and Recent Business Highlights
Clinical Programs:
BGB-3111, an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK)
• Completed enrollment in the pivotal Phase 2 trial in
• Initiated the following trials:
- Global Phase 3 trial of BGB-3111 compared to bendamustine and rituximab in treatment-naïve chronic lymphocytic leukemia / small lymphocytic lymphoma patients;
- Global pivotal Phase 2 trial of BGB-3111 in combination with GAZYVA® (obinutuzumab) in relapsed or refractory follicular lymphoma patients; and
- Pivotal Phase 2 trial in
China of BGB-3111 in Waldenström’s macroglobulinemia.
BGB-A317, an investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1
• Presented data from patients with gastric cancer, esophageal cancer, head and neck squamous cell carcinoma, and ovarian cancer enrolled in the global Phase 1 trial of BGB-A317 in patients with advanced solid tumors at the
• Presented preliminary Phase 1 data on BGB-A317 in Chinese patients with advanced tumors at the 20th Annual Meeting of the
• Completed enrollment in the pivotal Phase 2 trial of BGB-A317 in
• Completed enrollment in the global Phase 1a/1b trial of BGB-A317 in advanced tumors with a total of over 450 patients;
• Initiated the following trials:
- Phase 3 trial in
China of BGB-A317 as a second- or third-line treatment for patients with advanced lung cancer; - Pivotal Phase 2 trial in
China of BGB-A317 in previously treated, PD-L1-positive, locally advanced or metastatic urothelial cancer; - Phase 2 trial in
China of BGB-A317 in combination with chemotherapy as a first-line treatment for patients with advanced lung cancer; and - Phase 2 trial in
China of BGB-A317 in combination with chemotherapy as a first-line treatment for patients with locally advanced or metastatic esophageal, gastric, or gastroesophageal junction carcinoma.
BGB-290, an investigational small molecule PARP inhibitor
• Presented updated data from the global Phase 1 trial of BGB-290 in patients with advanced solid tumors at the ESMO 2017
• Initiated the following trials:
- Global Phase 1 trial of BGB-290 in combination with temozolomide in locally advanced or metastatic solid tumors; and
- Global Phase 1b/2 trial of BGB-290 in combination with radiation therapy and/or temozolomide in glioblastoma.
Corporate Development:
• Closed our global strategic collaboration with Celgene Corporation.
Expected Upcoming Milestones
BGB-3111 (BTK Inhibitor)
• Present additional Phase 1 data for BGB-3111 in non-Hodgkin’s lymphoma, updated Phase 1 data for the combination of BGB-3111 and Gazyva® (obinutuzumab), and initial Phase 1 data for the combination of BGB-3111 and BGB-A317 at the 59th
BGB-A317 (PD-1 Antibody)
• Present initial Phase 1 data for the combination of BGB-3111 and BGB-A317 at the 59th ASH Annual Meeting in
• Initiate Phase 3 trials of BGB-A317 in
BGB-290 (PARP Inhibitor)
• Initiate a pivotal trial in
Third Quarter 2017 Financial Results
Cash, Cash Equivalents, and Short-Term Investments were $757.44 million as of September 30, 2017, compared to $407.43 million as of
The Company consolidates the BeiGene Biologics joint venture in its consolidated financial statements. As of
Cash provided by operations for the three months ended September 30, 2017 was $6.60 million, compared to a use of cash of
Revenue for the three months ended September 30, 2017 was
R&D Expenses for the three months ended September 30, 2017 were $87.66 million, compared to
SG&A Expenses for the three months ended September 30, 2017 were $15.64 million compared to
Net Income attributable to
Financial Summary
Select Consolidated Balance Sheet Data ( | |||||||||
(Amounts in thousands of | |||||||||
September 30, 2017 (unaudited) | (audited) | ||||||||
Cash, cash equivalents and short‑term investments | $ | 757,435 | $ | 368,174 | |||||
Unbilled receivable | 170,950 | — | |||||||
Prepaid expenses and other current assets | 33,945 | 6,225 | |||||||
Property and equipment, net | 55,322 | 25,977 | |||||||
9,421 | — | ||||||||
Total assets | 1,049,059 | 405,813 | |||||||
Accounts payable | 35,168 | 11,957 | |||||||
Accrued expenses and other payables | 46,991 | 22,297 | |||||||
Deferred revenue | 38,609 | — | |||||||
Bank loan | 18,036 | 17,284 | |||||||
Shareholder loan | 140,311 | — | |||||||
Noncontrolling interest | 14,349 | — | |||||||
Total equity | $ | 764,489 | $ | 352,907 | |||||
Consolidated Statements of Operations ( | |||||||||||||
(Amounts in thousands of | |||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||
Revenue | |||||||||||||
Product revenue, net | $ | 8,822 | $ | — | $ | 8,822 | $ | — | |||||
Collaboration revenue | 211,391 | — | 211,391 | 1,070 | |||||||||
Total revenues | 220,213 | — | 220,213 | 1,070 | |||||||||
Expenses: | |||||||||||||
Cost of sales – products | (1,944 | ) | — | (1,944 | ) | — | |||||||
Research and development | (87,660 | ) | (30,106 | ) | (177,678 | ) | (69,100 | ) | |||||
Selling, general and administrative | (15,641 | ) | (4,722 | ) | (35,187 | ) | (11,760 | ) | |||||
Amortization of intangible assets | (63 | ) | — | (63 | ) | — | |||||||
Total expenses | (105,308 | ) | (34,828 | ) | (214,872 | ) | (80,860 | ) | |||||
Income (loss) from operations | 114,905 | (34,828 | ) | 5,341 | (79,790 | ) | |||||||
Interest (expense) income, net | (1,785 | ) | (75 | ) | (3,581 | ) | 336 | ||||||
Changes in fair value of financial instruments | — | — | — | (1,514 | ) | ||||||||
(Loss) gain on sale of available-for-sale securities | — | (137 | ) | 10 | (1,077 | ) | |||||||
Other income (expense), net | 1,103 | (327 | ) | 1,531 | 732 | ||||||||
Income (loss) before income taxes | 114,223 | (35,367 | ) | 3,301 | (81,313 | ) | |||||||
Income tax benefit (expense) | 3,061 | (127 | ) | 2,680 | (306 | ) | |||||||
Net income (loss) | $ | 117,284 | $ | (35,494 | ) | $ | 5,981 | (81,619 | ) | ||||
Less: Net loss attributable to noncontrolling interest | (102 | ) | — | (237 | ) | — | |||||||
Net income (loss) attributable to | $ | 117,386 | $ | (35,494 | ) | $ | 6,218 | (81,619 | ) | ||||
Net income (loss) attributable to common shareholders per ADS, basic | $ | 2.79 | $ | (1.08 | ) | $ | 0.15 | (2.77 | ) | ||||
Net income (loss) attributable to common shareholders per ADS, diluted | $ | 2.54 | $ | (1.08 | ) | $ | 0.14 | (2.77 | ) | ||||
Weighted-average number of ADS outstanding - basic | 42,118,973 | 32,933,655 | 40,563,845 | 29,497,875 | |||||||||
Weighted-average number of ADS outstanding - diluted | 46,200,975 | 32,933,655 | 43,172,139 | 29,497,875 | |||||||||
Consolidated Statements of Comprehensive Income (Loss) ( | ||||||||||||
(Amounts in thousands of | ||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||
Net income (loss) | $ | 117,284 | $ | (35,494 | ) | $ | 5,981 | $ | (81,619 | ) | ||
Other comprehensive income (loss), net of tax of nil: | ||||||||||||
Foreign currency translation adjustments | 341 | 377 | 985 | (13 | ) | |||||||
Unrealized holding gain, net | 51 | 121 | 58 | 857 | ||||||||
Comprehensive income (loss) | 117,676 | (34,996 | ) | 7,024 | (80,775 | ) | ||||||
Less: Comprehensive loss attributable to noncontrolling interests | (70 | ) | — | (178 | ) | — | ||||||
Comprehensive income (loss) attributable to | $ | 117,746 | $ | (34,996 | ) | $ | 7,202 | $ | (80,775 | ) | ||
About
Forward-Looking Statements
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 financial condition; results of operations and business outlook; the momentum of its business, as well as the advancement of, and anticipated clinical development and regulatory milestones and plans related to BeiGene’s drug candidates and clinical trials, including commencing new trials and providing data readouts and updates for its drug candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including risks related to
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