BeiGene Reports Second Quarter 2017 Financial Results
Aug 09, 2017 4:01 PM
“This quarter has been transformative for
“We expect to continue our momentum through the second half of the year. In the near-term, we will present updated Phase 1 monotherapy data on BGB-A317 and BGB-290 at the
Second Quarter 2017 and Recent Business Highlights
Clinical Programs:
BGB-3111, a potent and highly selective small molecule inhibitor of Bruton’s tyrosine kinase (BTK)
- Presented updated Phase 1 data on BGB-3111 in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and Waldenström’s macroglobulinemia (WM), as well as initial data from the combination trial of BGB-3111 and obinutuzumab, an anti-CD20 antibody, in CLL/SLL and follicular lymphoma (FL) at the 14th
International Conference on Malignant Lymphoma . - Initiated a Phase 2 trial of BGB-3111 in Chinese patients with non-germinal center B-cell-like diffuse large B-cell lymphoma.
- Continued enrollment in the following trials:
○ Global Phase 3 trial of BGB-3111 compared with ibrutinib in WM
○ Registrational trial of BGB-3111 in Chinese patients with relapsed/refractory mantle cell lymphoma
○ Registrational trial of BGB-3111 in Chinese patients with relapsed/refractory CLL/SLL
○ Dose-expansion phase of the global BGB-3111 Phase 1 monotherapy trial in B-cell malignancies
○ Dose-expansion phase of the global Phase 1 combination trial of BGB-3111 and obinutuzumab in B-cell malignancies
○ Phase 1 combination trial of BGB-3111 and BGB-A317 in B-cell malignancies inAustralia - Continued follow-up on patients enrolled in the Phase 1 monotherapy trial of BGB-3111 in Chinese patients with B-cell lymphoma.
BGB-A317, an investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1
- Presented initial data from the Phase 1 trial of BGB-A317 in combination with BGB-290 in advanced solid tumors at the 2017
American Society of Clinical Oncology (ASCO) Annual Meeting. - Presented preliminary Phase 1 data on BGB-A317 in hepatocellular carcinoma at the
European Society for Medical Oncology (ESMO) 19thWorld Congress on Gastrointestinal Cancer . - Initiated registrational trials of BGB-A317 in
China : one in relapsed/refractory classical Hodgkin lymphoma and another in previously treated, PD-L1-positive, locally advanced or metastatic urothelial cancer. - Initiated a Phase 2 trial of BGB-A317 in combination with chemotherapy for the first-line treatment of Chinese patients with locally advanced or metastatic esophageal, gastric, or gastroesophageal junction carcinoma.
- Continued enrollment in the following trials:
○ Dose-expansion phase of the global BGB-A317 Phase 1 monotherapy trial in advanced solid tumors
○ Phase 1 trial of BGB-A317 in Chinese patients with advanced solid tumors
○ Phase 1 combination trial of BGB-A317 and BGB-290 in advanced solid tumors inAustralia
○ Phase 1 combination trial of BGB-A317 and BGB-3111 in B-cell malignancies inAustralia
BGB-290, a potent and highly selective PARP inhibitor
- Presented initial data from the Phase 1 trial of BGB-290 in combination with BGB-A317 in advanced solid tumors at the 2017 ASCO Annual Meeting.
- Initiated a global Phase 1 trial of BGB-290 in combination with temozolomide in locally advanced or metastatic solid tumors.
- Initiated a global Phase 1b/2 trial of BGB-290 in combination with radiation therapy and/or temozolomide in glioblastoma.
- Continued enrollment in the following trials:
○ Dose-expansion phase of the BGB-290 Phase 1 monotherapy trial in advanced solid tumors in Australia
○ Phase 1 trial of BGB-290 in Chinese patients with advanced solid tumors
○ Phase 1 combination trial of BGB-290 and BGB-A317 in advanced solid tumors inAustralia .
Corporate Development:
- Entered into a strategic collaboration with Celgene Corporation. Upon closing,
BeiGene will acquire Celgene’s commercial operations inChina and assume commercial responsibility for Celgene’s approved therapies inChina (Abraxane®, Revlimid®, and Vidaza®) and pipeline agent CC-122. Celgene will gain exclusive rights to develop and commercialize BGB-A317 for solid tumors inthe United States , theEuropean Union ,Japan , and the rest of the world outside ofAsia .BeiGene will retain rights for solid tumors inAsia (ex-Japan ) and for hematological malignancies and internal combinations globally. Subject to closing,BeiGene will receive$413 million from Celgene in upfront licensing fees and an equity investment and will be eligible for up to$980 million in development, regulatory, and sales milestones, as well as royalties on future sales of BGB-A317. The transaction is expected to close in the third quarter of 2017.
Expected Upcoming Milestones
BGB-3111 (BTK Inhibitor)
- Present data from the Phase 1 combination trial of BGB-3111 with BGB-A317 in 2017.
- Present additional data from the dose-expansion phase of the Phase 1 monotherapy trial.
- Present additional data from the Phase 1 combination trial of BGB-3111 with obinutuzumab.
- Initiate global Phase 3 trial of BGB-3111 in comparison with bendamustine and rituximab in treatment naïve CLL/SLL
- Initiate global registrational Phase 2 trial of BGB-3111 and obinutuzumab in comparison with obinutuzumab alone in relapsed/refractory FL
BGB-A317 (PD-1 Antibody)
- Present updated Phase 1 monotherapy data at the ESMO 2017
Congress inMadrid, Spain ,September 8-12, 2017 . - Present data from the Phase 1 combination trial of BGB-A317 and BGB-3111 in 2017.
- Present data from the Phase 1 trial in Chinese patients with advanced solid tumors in 2017.
BGB-290 (PARP Inhibitor)
- Present updated Phase 1 monotherapy data at the ESMO 2017
Congress inMadrid, Spain ,September 8-12, 2017 .
Second Quarter 2017 Financial Results
Cash, Cash Equivalents, and Short-term Investments were $407.43 million as of June 30, 2017, compared to $368.17 million as of December 31, 2016. The increase was due primarily to proceeds from an equity investment in and a shareholder loan to BeiGene Biologics by
Cash used in operations for the three months ended June 30, 2017 was $51.89 million, compared to $19.26 million for the same period in 2016. The increase was primarily attributable to higher research and development (R&D) and general and administrative (G&A) expenses in support of our clinical trials and the expansion of our workforce, as further detailed below. Capital expenditures for the quarter ended June 30, 2017 were $13.62 million, compared to $5.46 million for the same period in 2016. The increase was primarily attributable to increased investment in our manufacturing capabilities.
Revenue for the three months ended June 30, 2017 was nil, compared to $0.39 million in the same period in 2016. The decrease in revenue in the period was due to the completion of R&D service deliverables under our collaboration agreement for BGB-283.
R&D Expenses for the three months ended June 30, 2017 were $47.25 million, compared to
G&A Expenses for the three months ended June 30, 2017 were $10.78 million compared to
Net Loss Attributable to
Financial Summary
Select Consolidated Balance Sheet Data ( | ||||||
(Amounts in thousands of | ||||||
(unaudited) | (audited) | |||||
Cash, cash equivalents and short‑term investments | $ | 407,430 | $ | 368,174 | ||
Prepaid expenses and other current assets | 11,261 | 6,225 | ||||
Property and equipment, net | 33,770 | 25,977 | ||||
Total assets | 473,975 | 405,813 | ||||
Accounts payable | 24,419 | 11,957 | ||||
Long-term bank loan | 17,701 | 17,284 | ||||
Shareholder loan | 135,027 | — | ||||
Noncontrolling interest | 14,419 | — | ||||
Total equity | $ | 270,172 | $ | 352,907 | ||
Consolidated Statements of Operations ( | ||||||||||||
(Amounts in thousands of | ||||||||||||
Three Months Ended | Six Months Ended | |||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||
Collaboration revenue | $ | — | $ | 393 | $ | — | $ | 1,070 | ||||
Operating expenses: | ||||||||||||
Research and development | (47,245 | ) | (21,117 | ) | (90,018 | ) | (38,994 | ) | ||||
General and administrative | (10,777 | ) | (3,904 | ) | (19,546 | ) | (7,038 | ) | ||||
Total operating expenses | (58,022 | ) | (25,021 | ) | (109,564 | ) | (46,032 | ) | ||||
Loss from operations | (58,022 | ) | (24,628 | ) | (109,564 | ) | (44,962 | ) | ||||
Interest (expense) income, net | (1,982 | ) | 121 | (1,796 | ) | 411 | ||||||
Changes in fair value of financial instruments | — | — | — | (1,514 | ) | |||||||
Gain (loss) on sale of available-for-sale securities | 2 | (228 | ) | 10 | (940 | ) | ||||||
Other (expense) income, net | (477 | ) | 746 | 428 | 1,059 | |||||||
Loss before income tax expense | (60,479 | ) | (23,989 | ) | (110,922 | ) | (45,946 | ) | ||||
Income tax expense | (201 | ) | (135 | ) | (381 | ) | (179 | ) | ||||
Net loss | $ | (60,680 | ) | $ | (24,124 | ) | $ | (111,303 | ) | $ | (46,125 | ) |
Less: Net loss attributable to noncontrolling interest | (135 | ) | — | (135 | ) | — | ||||||
Net loss attributable to | $ | (60,545 | ) | $ | (24,124 | ) | $ | (111,168 | ) | $ | (46,125 | ) |
Net loss attributable to common shareholders per ADS, basic and diluted | $ | (1.52 | ) | $ | (0.73 | ) | $ | (2.80 | ) | $ | (1.66 | ) |
Weighted-average number of ADS used in net loss per ADS calculation - basic and diluted | 39,820,287 | 32,903,593 | 39,773,393 | 27,761,107 | ||||||||
Consolidated Statements of Comprehensive Loss ( | ||||||||||||
(Amounts in thousands of | ||||||||||||
Three Months Ended | Six Months Ended | |||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||
Net loss | $ | (60,680 | ) | $ | (24,124 | ) | $ | (111,303 | ) | $ | (46,125 | ) |
Other comprehensive loss, net of tax of nil: | ||||||||||||
Foreign currency translation adjustments | 554 | (486 | ) | 644 | (390 | ) | ||||||
Unrealized holding gain, net | 19 | 275 | 7 | 736 | ||||||||
Comprehensive loss | (60,107 | ) | (24,335 | ) | (110,652 | ) | (45,779 | ) | ||||
Less: Comprehensive loss attributable to noncontrolling interests | (108 | ) | — | (108 | ) | — | ||||||
Comprehensive loss attributable to | $ | (59,999 | ) | $ | (24,335 | ) | $ | (110,544 | ) | $ | (45,779 | ) |
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 expected closing of the strategic transaction with Celgene and the benefits of that transaction; the sufficiency of its cash, cash equivalents and short-term investments; plans for its manufacturing joint venture; and 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 registrational and combination 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 the proposed strategic transaction with Celgene;
Investor/Media ContactSource:Lucy Li , Ph.D. +1 781-801-1800 ir@beigene.com media@beigene.com