On August 2, 2023 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported financial results from the second quarter of 2023 and business highlights (Press release, BeiGene, AUG 2, 2023, View Source [SID1234633639]).
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"Our strong second quarter results highlight the continued execution of our global commercial teams and the success of our two cornerstone medicines, BRUKINSA and tislelizumab. As demonstrated by the growing prescriber use for patients with CLL, BRUKINSA is becoming the BTK inhibitor of choice, driven by compelling efficacy and safety data across indications, including superiority versus IMBRUVICA in relapsed/refractory (R/R) CLL," said John V. Oyler, Co-Founder, Chairman and CEO at BeiGene. "Our robust pipeline, highlighted at our recent investor R&D Day and fueled by one of the largest and most productive oncology research teams in the industry, will continue to drive our short- and long-term growth as a science-based organization, and allow us to fulfill our mission of providing innovative cancer medicines and improving treatment options for more patients around the world."
Key Business and Pipeline Highlights
Received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for tislelizumab as a monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy;
Announced U.S. Food and Drug Administration (FDA) acceptance of a supplemental new drug application (sNDA) for BRUKINSA in combination with GAZYVA (obinutuzumab) as a treatment for patients with R/R follicular lymphoma (FL) with a target action date in the first quarter of 2024, under the Prescription Drug User Fee Act;
Announced Health Canada approval of BRUKINSA for the treatment of adult patients with CLL, and Australia Therapeutic Goods Administration (TGA) approval of BRUKINSA for the treatment of treatment-naïve (TN) and R/R CLL/small lymphocytic lymphoma (SLL);
Announced new regulatory approvals for BRUKINSA, including China National Medicinal Products Administration (NMPA) approval of two sNDAs for TN adults with CLL or SLL and Waldenström’s macroglobulinemia (WM), and two sNDAs for conversions from conditional approval to regular approval for certain patients with R/R CLL/SLL and R/R WM;
Held investor R&D Day, highlighting the Company’s growing and diverse pipeline of innovative therapies. For webcast replay and more information from the event, visit the investors section of the BeiGene website at View Source; View Source; or View Source;
Announced an agreement with DualityBio for BeiGene to acquire an exclusive option for a global clinical and commercial license to an investigational, preclinical Antibody Drug Conjugate (ADC) therapy for patients with select solid tumors to complement the Company’s initial internally discovered ADC assets, and;
Announced a partnership with The Max Foundation, a global nonprofit organization dedicated to accelerating health equity by delivering medication, technology, and supportive services to patients worldwide, and the BeiGene Foundation, to provide access to BRUKINSA for the treatment of adult patients with CLL in 29 countries over the next three years, enabling the Company’s mission to treat more patients globally.
Second Quarter 2023 Financial Highlights
Product Revenue for the three months ended June 30, 2023, was $553.7 million, compared to $304.5 million in the same period of 2022, representing 81.8% growth;
Product sales increased $249.2 million in the second quarter of 2023 compared to the prior-year period, primarily due to increased sales of our internally developed products, BRUKINSA and tislelizumab, as well as increased sales of in-licensed products from Amgen;
U.S. sales of BRUKINSA totaled $223.5 million in the second quarter, representing growth of 152.9% over the prior-year period, as adoption for adult patients with CLL/SLL accelerated and use across all FDA-approved indications continued to expand. BRUKINSA sales in China totaled $48.5 million, representing growth of 32.2% over the prior-year period, driven by increases in all approved indications as the Company continues to increase market value share as the BTK leader in China;
Sales of tislelizumab in China totaled $149.5 million for the second quarter of 2023, representing growth of 42.5% compared to the prior-year period. Continued increase in new patient demand from reimbursement of new indications and further expansion of our salesforce efficiency and hospital listings continued to drive increased market penetration and leading PD-1 inhibitor market share for tislelizumab, and;
Total product revenues by geographic area are presented as follows (amounts in thousands of U.S. dollars):
Three Months Ended
Six Months Ended
June 30,
June 30,
2023
2022
2023
2022
$
$
$
$
China
293,919
212,429
540,828
403,164
United States
223,540
88,381
362,307
156,269
Rest of world
36,286
3,701
60,901
6,651
Total
553,745
304,511
964,036
566,084
Gross Margin as a percentage of global product revenue for the second quarter of 2023 was 82.7%, compared to 76.6% in the prior-year period. The gross margin percentage increased primarily due to lower costs per unit for both BRUKINSA and tislelizumab, as well as a proportionally higher sales mix of global BRUKINSA compared to other products in the portfolio and compared to lower-margin sales of in-licensed products.
Operating Expenses for the three months ended June 30, 2023, were $818.0 million, compared to $709.8 million in the same period of 2022, representing 15.2% growth in comparison to 81.8% product revenue growth in the quarter, driving significant operating leverage.
Net Loss for the quarter ended June 30, 2023, was $381.1 million, or $0.28 per share, and $3.64 per American Depositary Share (ADS), compared to $565.7 million, or $0.42 per share, and $5.50 per ADS in the same period of 2022. The decrease in net loss is primarily attributable to improved operating leverage due to product revenue growth exceeding operating expense growth. The Company expects this trend to continue through 2023. Net loss for the quarter was negatively impacted by other non-operating expenses of $63.8 million, primarily related to foreign exchange losses resulting from the strengthening of the U.S. dollar and the revaluation impact of foreign currencies held in U.S. functional currency subsidiaries. Non-operating expenses were $129.6 million in the same period of 2022.
Cash, Cash Equivalents, Restricted Cash, and Short-Term Investments were $3.5 billion as of June 30, 2023, and $4.5 billion as of December 31, 2022.
For further details on BeiGene’s Second Quarter 2023 Financial Statements, please see BeiGene’s Quarterly Report on Form 10-Q for the second quarter of 2023 filed with the U.S. Securities and Exchange Commission.
Regulatory Progress and Development Programs
Category
Asset
Recent Milestones
Approvals/Regulatory Updates
BRUKINSA (zanubrutinib)
Health Canada approval for the treatment of adult patients with CLL/SLL
Australia TGA approval for the treatment of TN and R/R CLL/SLL
China NMPA approval of:
sNDA for the treatment of TN adult patients with CLL/SLL
sNDA for the treatment of adult patients with TN WM
sNDA for the conversion from conditional to regular approval for the treatment of adult patients with R/R CLL/SLL
sNDA for the conversion from conditional to regular approval for the treatment of adult patients with R/R WM
Tislelizumab
EU CHMP positive opinion for tislelizumab as a monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic ESCC after prior platinum-based chemotherapy
China NMPA approval of:
sNDA for the treatment of adult patients with first-line gastric cancer (PD-L1+)
sNDA for the treatment of adult patients with first-line ESCC
BAITUOWEI (Goserelin Microspheres for Injection)
In partnership with Luye Pharma, China NMPA approval for the treatment of patients with prostate cancer requiring androgen deprivation therapy
Regulatory Submissions
BRUKINSA
Received U.S. FDA acceptance of sNDA for the treatment of adult patients with R/R FL
Received EMA acceptance of marketing authorization application for the treatment of adult patients with R/R FL
Clinical Activities
BRUKINSA
First subject enrolled in a Phase 3 clinical trial for primary membranous nephropathy
Anticipated Upcoming Milestones
Category Asset Anticipated Milestone
Approvals/Regulatory Updates
Tislelizumab
In partnership with Novartis, approval for second-line ESCC in U.S.* and EU
Regulatory Submissions
Tislelizumab
First-line extensive stage small cell lung cancer (ES-SCLC) submission in China
In partnership with Novartis for first-line ESCC in U.S. and EU
In partnership with Novartis to first-line gastric cancer in U.S. and EU
In partnership with Novartis for first- and second-line ESCC in Japan
Clinical Activities/Data Readouts
BRUKINSA
Announce additional follow-up data from the Phase 3 ALPINE study versus ibrutinib in R/R CLL
Tislelizumab
Announce results from the Phase 3 RATIONALE-315 trial in neoadjuvant and adjuvant non-small cell lung cancer (NSCLC)
Sonrotoclax (BGB-11417, BCL-2 inhibitor)
Initiate global pivotal trial in combination with BRUKINSA in first-line CLL in the second half of 2023
Initiate global potential registration enabling trial in R/R WM in the second half of 2023
Announce additional data from Phase 1 studies
BTK CDAC (BGB-1663)
Announce updated data readouts from Phase 1 studies in B-cell malignancies
Ociperlimab (Anti-TIGIT)
Complete enrollment in the Phase 3 AdvanTIG-302 trial in first-line NSCLC in 2023
Announce data for multiple Phase 2 studies, including:
For second-line ESCC in patients whose tumors express PD-(L)1
For first-line hepatocellular carcinoma (HCC)
For first-line NSCLC
_________________________________
* Original PDUFA date deferred
Scientific Congress Updates
Present results from the Phase 3 RATIONALE-312 trial investigating tislelizumab with or without chemotherapy as a treatment for extensive-stage small cell lung cancer as an oral presentation at the 2023 World Conference on Lung Cancer in September;
Present eight accepted abstracts, including data from the tislelizumab, ociperlimab and other Solid Tumor programs, at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting in October;
Presented clinical results for BRUKINSA at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and European Hematology Association (EHA) (Free EHA Whitepaper) congress, including Phase 1 results in R/R diffuse large B-cell lymphoma (DLBCL) and updated results from the Phase 3 ROSEWOOD study in combination with GAZYVA in R/R FL;
Presented two abstracts for tislelizumab at the ASCO (Free ASCO Whitepaper) Annual Meeting, including additional analyses from the Phase 3 RATIONALE-301 trial versus sorafenib in first-line unresectable HCC;
Presented results from a Phase 1 study of internally discovered OX40 agonist BGB-A445, with or without tislelizumab, in patients with advanced solid tumors at ASCO (Free ASCO Whitepaper); and
In partnership with Zymeworks, presented updated results from the Phase 2b HERIZON-BTC trial of zanidatamab in previously treated, HER2-amplified biliary tract cancer as an oral presentation at ASCO (Free ASCO Whitepaper).
Manufacturing Operations
Continued construction at the $700+ million U.S. flagship manufacturing and clinical R&D facility at the Princeton West Innovation Campus in Hopewell, N.J. The property has more than 1 million square feet of total developable real estate, allowing for future expansion; the site will be ready in 2024;
Continued construction on our state-of-the-art biologics facility in Guangzhou, China, which has a current total capacity of 64,000 liters, including both single-use and stainless-steel technologies; the site continues the construction of an ADC production facility and additional biologics clinical production to be completed in 2024; and
Continued construction on our new small molecule manufacturing campus in Suzhou, China. Phase 1 of construction is expected to add more than 559,000 square feet and expand production capacity to 600 million tablets/capsules per year, and to be completed in 2023; once completed, qualified and approved, it is expected to increase the current small molecule manufacturing capacity in China by more than 5 times; the site also started construction of a new R&D center that will improve both clinical and manufacturing capabilities, to be completed in 2024.
Corporate Developments
BeiGene regained full, global rights to develop, manufacture and commercialize investigational TIGIT inhibitor ociperlimab as the result of a mutual decision with Novartis to terminate the Option, Collaboration and License Agreement with Novartis pursuant to which BeiGene granted Novartis an exclusive time-based option to receive such rights in North America, Europe, and Japan, and;
In partnership with Luye Pharma, launched BAITUOWEI (Goserelin Microspheres for Injection) for the treatment of patients with prostate cancer requiring androgen deprivation therapy in China, which broadens our footprint in urological malignancy indications.
Financial Summary
Select Condensed Consolidated Balance Sheet Data (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)
As of
June 30,
December 31,
2023
2022
(unaudited)
(audited)
Assets:
Cash, cash equivalents, restricted cash and short-term investments
$
3,527,267
$
4,540,288
Accounts receivable, net
299,282
173,168
Inventories
321,333
282,346
Property, plant and equipment, net
1,031,938
845,946
Total assets
5,728,736
6,379,290
Liabilities and equity:
Accounts payable
266,975
294,781
Accrued expenses and other payables
454,950
467,352
Deferred revenue
183,310
255,887
R&D cost share liability
271,291
293,960
Debt
628,478
538,117
Total liabilities
1,930,177
1,995,935
Total equity
$
3,798,559
$
4,383,355
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
June 30,
Six Months Ended
June 30,
2023
2022 1
2023
2022 1
(Unaudited)
(Unaudited)
Revenue:
Product revenue, net
$
553,745
$
304,511
$
964,036
$
566,084
Collaboration revenue
41,516
37,061
79,026
82,114
Total revenues
595,261
341,572
1,043,062
648,198
Expenses:
Cost of sales – products
95,990
71,173
177,779
136,410
Research and development
422,764
378,207
831,348
768,122
Selling, general and administrative
395,034
331,403
723,533
625,976
Amortization of intangible assets
188
188
375
376
Total expenses
913,976
780,971
1,733,035
1,530,884
Loss from operations
(318,715
)
(439,399
)
(689,973
)
(882,686
)
Interest income, net
15,070
11,431
31,086
21,502
Other expense, net
(63,818
)
(129,617
)
(45,515
)
(117,650
)
Loss before income taxes
(367,463
)
(557,585
)
(704,402
)
(978,834
)
Income tax expense
13,674
8,141
25,166
22,090
Net loss
(381,137
)
(565,726
)
(729,568
)
(1,000,924
)
Net loss per share attributable to BeiGene, Ltd.:
Basic and diluted
$
(0.28
)
$
(0.42
)
$
(0.54
)
$
(0.75
)
Weighted-average shares outstanding:
Basic and diluted
1,360,224,377
1,336,463,026
1,357,211,308
1,334,252,648
Net loss per ADS attributable to BeiGene, Ltd.:
Basic and diluted
$
(3.64
)
$
(5.50
)
$
(6.99
)
$
(9.75
)
Weighted-average ADSs outstanding:
Basic and diluted
104,632,644
102,804,848
104,400,870
102,634,819
The Company revised certain prior period financial statements for an error related to the valuation of net deferred tax assets, the impact of which was immaterial to its previously filed financial statements in the second quarter of 2022 (see "Notes to the Condensed Consolidated Financial Statements, Note 1. Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies" and "Note 2. Revision of Prior Period Financial Statements" included in our Quarterly Report on Form 10-Q for the period ended June 30, 2023, filed with the SEC).