•	Launched tislelizumab in China in March 2020 for patients with classical Hodgkin’s lymphoma (cHL) who have received at least two prior therapies;

•	Received approval from the China National Medical Products Administration (NMPA) for tislelizumab as a treatment for patients with previously treated locally advanced or metastatic urothelial carcinoma;

•	Generated $52.06 million in product revenue in the three months ended March 31, 2020;

•	As announced previously, the NMPA suspended the importation, sales and use of ABRAXANE® (nanoparticle albumin-bound paclitaxel) in China supplied to BeiGene by Celgene Corporation, a Bristol Myers Squibb (BMS) company. As a result, Celgene initiated a voluntary recall of ABRAXANE in mainland China; and

•	Received commercial insurance reimbursement for tislelizumab as a treatment for relapsed/refractory classical Hodgkin's lymphoma in Zhuhai, China.

•

Transition activities for the three Amgen commercial oncology medicines, XGEVA® (denosumab), KYPROLIS® (carfilzomib), and BLINCYTO® (blinatumomab) in China are on track. BeiGene is preparing to commence promotional activities for XGEVA in patients with giant cell tumor of bone in the third quarter of 2020. Regulatory activities for KYPROLIS and BLINCYTO are in progress, with new drug applications (NDAs) to the NMPA submitted in the fourth quarter 2019. Additionally, a supplemental NDA for XGEVA for an expanded indication in skeletal-related events in China was accepted by the NMPA; and

•	BeiGene is working with Amgen to advance the clinical-stage oncology assets in the collaboration pursuant to the global development plan.

•	Regulatory discussions are in progress and biologics license applications (BLAs) in China for both SYLVANT® (siltuximab) and QARZIBA®▼ (dinutuximab beta) are expected to be submitted in 2020.

•

Initiated a multi-center Phase 2 clinical trial (NCT04382586) evaluating zanubrutinib for the treatment of patients hospitalized for COVID-19 infection and pulmonary distress. The trial is designed to enroll approximately 42 patients, randomized to receive oral zanubrutinib at 320 mg once daily for 28 days plus supportive care, or placebo plus supportive care. An additional cohort of four to 10 patients on mechanical ventilation will all receive zanubrutinib plus

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•	Receive approvals in China for the treatment of patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) and R/R chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in the first half of 2020;

•	Announce top-line results from the SEQUOIA trial comparing zanubrutinib with bendamustine plus rituximab in patients with treatment-naïve CLL or SLL as early as the second half of 2020;

•	File a supplemental new drug application (sNDA) in China for Waldenström’s macroglobulinemia (WM) in 2020;

•	Discuss data from the Phase 3 ASPEN trial (NCT03053440) comparing zanubrutinib to ibrutinib in patients with WM with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in 2020;

•	Complete expanded enrollment in the Phase 3 ALPINE trial (NCT03734016) comparing zanubrutinib with ibrutinib in patients with R/R CLL/SLL in 2020; and

•	Present data from Phase 3 ASPEN trial comparing zanubrutinib to ibrutinib in patients with WM in an oral presentation at the 2020 ASCO Virtual Science Program being held May 29-31, 2020, and present three-year follow-up data of treatment-naïve and previously treated patients with WM.

•	Announced that the Center for Drug Evaluation (CDE) of the NMPA accepted an sNDA of tislelizumab in combination with two chemotherapy regimens for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC);

•

Announced that the pivotal Phase 3 trial (NCT03663205) of patients with first-line advanced non-squamous NSCLC met its primary endpoint at the planned interim analysis, demonstrating a statistically significant improvement in progression-free survival (PFS) for tislelizumab in combination with pemetrexed and platinum chemotherapy compared to pemetrexed and platinum chemotherapy alone as assessed by the independent review committee (IRC). The safety profile of tislelizumab in combination with pemetrexed and platinum chemotherapy was consistent with the known risks of each study treatment, and no new safety signals were identified;

•	Completed enrollment in the Phase 3 trial (NCT03358875) of tislelizumab versus docetaxel as a second- or third-line treatment in patients with NSCLC; and

•	Completed enrollment in the global Phase 3 trial (NCT03430843) of tislelizumab versus chemotherapy as a second-line treatment in patients with advanced esophageal squamous cell carcinoma (ESCC).

•	Submit an sNDA in China for first-line treatment of patients with advanced non-squamous NSCLC in 2020 and present data at an upcoming medical conference;

•	Have regulatory discussions with health authorities based on preliminary results from the global Phase 2 trial (NCT03419897) in second- or third-line patients with hepatocellular carcinoma (HCC) in 2020;

•	Present data from the Phase 3 trial in patients with first-line advanced squamous NSCLC at the 2020 ASCO Virtual Scientific Program;

•	Announce top-line results from the Phase 3 trial (NCT03358875) comparing tislelizumab versus docetaxel in second-or third-line patients with NSCLC and in the global Phase 3 trial (NCT03430843) comparing tislelizumab versus chemotherapy in second-line patients with advanced ESCC in 2020 or early 2021;

•	Initiate a Phase 3 trial in China for patients with resectable Stage II or IIIA NSCLC; and

•	Complete enrollment in the pivotal Phase 2 trial (NCT03736889) in China of patients with mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) solid tumors in 2020.

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•	Completed enrollment in the Phase 2 clinical trial (NCT03575065) in China in patients with advanced HER2-negative breast cancer harboring germline BRCA mutation that have progressed despite standard therapy or for which no standard therapy exists.

•	Have regulatory discussions based on preliminary results from the Phase 2 trial (NCT03333915) in Chinese patients with third-line and above previously treated ovarian cancer (OC) harboring germline BRCA 1/2 mutations, and potentially submit an NDA in China in 2020;

•	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 the 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.

•	Published Phase 1 data in the Journal of Clinical Oncology.

•	Present clinical data from the Phase 1 trial in 2020 or early 2021.

•	Initiated patient enrollment for the Phase 1 trial (NCT04277637) of BGB-11417 in patients with mature B-cell malignancies. We intend to develop BGB-11417 both as a monotherapy and in combination with zanubrutinib.

•	Present additional Phase 1 clinical data on sitravatinib combined with tislelizumab at a medical meeting in 2020.

•	Initiated enrollment in a two-arm Phase 1b/2 trial (NCT04276493) evaluating ZW25 in combination with chemotherapy as a first-line treatment for patients with metastatic HER2-positive breast cancer and in combination with chemotherapy and tislelizumab as a first-line treatment for patients with metastatic HER2-positive gastroesophageal adenocarcinoma (GEA).

•	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.

•	Announced that the first patient has been dosed in Australia in the Phase 1 clinical trial (NCT04249843) in patients with advanced or refractory solid tumors. The U.S. FDA has allowed the Investigational New Drug (IND) application submitted for BGB-3245 to proceed, which will enable study expansion to U.S. sites.

•	Completed equipment validation and executed manufacturing process validation for the first phase of our manufacturing facility in Guangzhou; and

•	Began construction of the second phase of our manufacturing facility in Guangzhou to significantly increase manufacturing capacity, expected to be completed by the end of 2020.

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The Company expects that the worldwide health crisis of COVID-19 will have a negative impact on its operations, including commercial sales, regulatory interactions and inspections, and clinical trial recruitment and participation. The impact on the Company’s operations in China has started to alleviate, as much of the country gradually resumes regular business. The Company is working to continue to minimize delays and disruptions and continues to execute on its commercialization, regulatory and clinical development goals globally.

•	In addition to the clinical trial of zanubrutinib in COVID-19 patients, the Company announced plans to work with Atreca, Inc. and IGM Biosciences, Inc. to leverage the parties’ technology and expertise in an effort to discover, develop, and manufacture novel IgM or IgA antibodies targeting SARS-CoV-2 for the potential treatment of COVID-19.

•

Total cash and short-term investments increased $2.39 billion in the three months ended March 31, 2020, primarily due to the $2.78 billion of cash received from the sale of American Depositary Shares to Amgen in connection with the closing of the Amgen collaboration on January 2, 2020. In the three months ended March 31, 2020, cash used in operating activities totaled $341.94 million, capital expenditures were $21.53 million, and cash used for upfront license payments totaled $43.00 million.

•	Product revenues totaled $52.06 million for the three months ended March 31, 2020, compared to $57.42 million for the three months ended March 31, 2019, and were comprised of:

–	Product revenue of $20.53 million from sales of tislelizumab in China since its launch in March 2020, including launch inventory build at distributors. Despite the challenges posed by COVID-19, the China commercial team launched tislelizumab on plan in the first quarter through efforts in multiple channels including extensive online promotion;

–	Product revenue of $30.82 million from sales of ABRAXANE, REVLIMID and VIDAZA in China, compared to $57.42 million in the same period of the prior year. The decrease in revenues was due to the negative impact of the COVID-19 pandemic, increased generic competition, and the suspension of ABRAXANE sales in China by the NMPA in March 2020; and

–	Product revenue of $0.72 million from sales of BRUKINSA in the United States. Early launch indicators including new patient starts, reimbursement coverage, and physician perception have been encouraging.

•	Collaboration revenue totaled nil for the three months ended March 31, 2020, compared to $20.41 million for the three months ended March 31, 2019.

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•	Cost of sales for the three months ended March 31, 2020 were $14.15 million, compared to $15.26 million in the same period of 2019. Cost of sales primarily includes acquisition costs related to the amount of ABRAXANE, REVLIMID and VIDAZA that was sold during the period in China, as well as the post-approval cost of tislelizumab and BRUKINSA that was sold during the period.

•

R&D Expenses for the three months ended March 31, 2020 were $304.30 million, compared to $178.35 million in the same period of 2019. The increase in R&D expenses was primarily attributable to continued increases in spending on our ongoing and newly initiated late-stage pivotal clinical trials, development expenses associated with the Amgen collaboration, the preparation for additional regulatory submissions, and manufacturing costs related to pre-commercial activities and supply. R&D expense in the three months ended March 31, 2020 also included $43.00 million of expense related to upfront license payments, compared to $10.00 million in the same period of 2019. Our co-funding obligation for the development of the pipeline assets under the Amgen collaboration for the three months ended March 31, 2020 was $56.00 million, of which $28.37 million was recorded as R&D expense. The remaining $27.63 million was recorded as a reduction of the R&D cost share liability. R&D-related share-based compensation expense was $20.40 million for the three months ended March 31, 2020, compared to $15.77 million for the same period of 2019.

•

SG&A Expenses for the three months ended March 31, 2020 were $107.08 million, compared to $57.65 million in the same period in 2019. The increase in SG&A expenses was primarily attributable to increased headcount, including the expansion of our commercial team to support the distribution of our commercial products in China and the United States, as well as higher professional service fees and costs to support our growing operations. SG&A-related share-based compensation expense was $17.86 million for the three months ended March 31, 2020, compared to $10.62 million for the same period of 2019.

•	Net Loss for the three months ended March 31, 2020 was $363.74 million, or $0.36 per share, or $4.70 per American Depositary Share (ADS), compared to $167.64 million, or $0.22 per share, or $2.81 per ADS in the same period in 2019.

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		Exhibit 99.1

Financial Summary

Select Condensed Consolidated Balance Sheet Data (U.S. GAAP)

(Amounts in thousands of U.S. Dollars)

	As of
	March 31,				December 31,
	2020				2019
	(unaudited)				(audited)
Assets:
Cash, cash equivalents, restricted cash and short-term investments	$	3,376,915			$	985,503
Accounts receivable, net	65,620				70,878
Working capital	3,143,390				862,384
Property and equipment, net	240,331				242,402
Total assets	4,067,212				1,612,289
Liabilities and equity:
Accounts payable	98,364				122,488
Accrued expenses and other payables	179,331				163,556
Bank loan	81,913				83,311
Shareholder loan	157,278				157,384
Research and development cost share liability	589,200				—
Total liabilities	1,240,156				633,934
Noncontrolling interest	14,842				16,150
Total equity	$	2,827,056			$	978,355

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		Exhibit 99.1

Condensed Consolidated Statements of Operations (U.S. GAAP)

(Amounts in thousands of U.S. dollars, except for shares, American Depositary Shares (ADSs), per share and per ADS data)

	Three Months Ended March 31,
	2020				2019
	(Unaudited)
Revenue:
Product revenue, net	$	52,059			$	57,421
Collaboration revenue	—				20,412
Total revenues	52,059				77,833
Expenses:
Cost of sales - products	14,149				15,261
Research and development	304,302				178,351
Selling, general and administrative	107,081				57,645
Amortization of intangible assets	283				331
Total expenses	425,815				251,588
Loss from operations	(373,756		)		(173,755		)
Interest income, net	6,690				4,477
Other income, net	3,681				1,728
Loss before income taxes	(363,385		)		(167,550		)
Income tax expense	1,554				519
Net loss	(364,939		)		(168,069		)
Less: Net loss attributable to noncontrolling interest	(1,204		)		(429		)
Net loss attributable to BeiGene, Ltd.	$	(363,735	)		$	(167,640	)
Net loss per share attributable to BeiGene, Ltd., basic and diluted	$	(0.36	)		$	(0.22	)
Weighted-average shares outstanding, basic and diluted	1,005,347,581				774,750,255
Net loss per ADS attributable to BeiGene, Ltd., basic and diluted	$	(4.70	)		$	(2.81	)
Weighted-average ADSs outstanding, basic and diluted	77,334,429				59,596,173

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Investor Contact		Media Contact
Craig West		Liza Heapes or Vivian Ni
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