BASEL, Switzerland, BEIJING, & CAMBRIDGE, Mass.–(BUSINESS WIRE)–$BGNE #BeiGene–BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today reported financial results from the second quarter of 2023 and business highlights.
“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
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;
|
| 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) |
|
| Tislelizumab |
|
| BAITUOWEI® (Goserelin Microspheres for Injection) |
|
Regulatory Submissions | BRUKINSA |
|
Clinical Activities | BRUKINSA |
|
Anticipated Upcoming Milestones
Category | Asset | Anticipated Milestone |
Approvals/Regulatory Updates | Tislelizumab |
|
Regulatory Submissions | Tislelizumab |
|
Clinical Activities/Data Readouts | BRUKINSA
|
|
| Tislelizumab |
|
| Sonrotoclax (BGB-11417, BCL-2 inhibitor)
|
|
| BTK CDAC (BGB-1663) |
|
| Ociperlimab (Anti-TIGIT) |
|
_________________________________ * Original PDUFA date deferred |
Scientific Congress Updates
Manufacturing Operations
Corporate Developments
Financial Summary | ||||||
|
|
|
| |||
| 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) | |||||||||||||||
| 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 |
|
1 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). |
About BeiGene
BeiGene is a global biotechnology company that is discovering and developing innovative oncology treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel; Beijing; and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.
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 the potential for BRUKINSA to become the BTK inhibitor of choice; the ability of BeiGene’s pipeline to drive growth; the potential for BeiGene to fulfill its mission of providing innovative cancer medicines and improving treatment options for more patients around the world; the expected continued decrease in net loss through 2023; the advancement of and anticipated clinical activities, regulatory submissions and approvals of BeiGene’s medicines and drug candidates; BeiGene’s plans and the expected events and milestones under the captions “Key Business and Pipeline Highlights” and “Anticipated Upcoming Milestones”; the expected capacities and completion dates for the Company’s manufacturing facilities under construction and the potential for such facilities to improve clinical and manufacturing capabilities; and BeiGene’s plans, commitments, aspirations and goals under the caption “About BeiGene”. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.
GAZYVA® is a registered trademark of Genentech, Inc.
BAITUOWEI® is a registered trademark of Luye Pharma Group, Ltd.
IMBRUVICA® is a registered trademark of Pharmacyclics LLC and Janssen Biotech. Inc.
Contacts
Investor
Liza Heapes
+1 857-302-5663
ir@beigene.com
Media
Kyle Blankenship
+1 667-351-5176
media@beigene.com
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