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 for the first quarter 2023, recent business highlights, and upcoming milestones.
“Our two cornerstone medicines, BRUKINSA and tislelizumab, achieved significant global growth in the first quarter as we continue to advance our pipeline of innovative therapies for patients with cancer,” said John V. Oyler, Co-Founder, Chairman and CEO at BeiGene. “The strong uptake of BRUKINSA following recent global approvals in CLL speaks to the importance of a BTKi that has demonstrated superior efficacy and safety to IMBRUVICA®. We are committed to bringing our impactful medicines to more patients around the world.”
“Our first-quarter results demonstrate BeiGene’s progress in operational excellence and financial discipline to bring affordable and accessible medicines to more patients globally,” said Julia Wang, Chief Financial Officer at BeiGene. “With product revenues continuing to grow meaningfully faster than operational expenses, BeiGene is well positioned for future growth.”
First Quarter 2023 Financial Results
Revenue for the three months ended March 31, 2023, was $447.8 million, compared to $306.6 million in the same period of 2022.
– Global sales of BRUKINSA of $211.4 million for the first quarter of 2023, compared to $104.3 million in the prior-year period;
– Sales of tislelizumab in China of $114.9 million for the first quarter of 2023, compared to $87.6 million in the prior-year period; and
– Sales of Amgen in-licensed products in China of $36.4 million for the first quarter of 2023, compared to $29.9 million in the prior-year period.
Cost of Product Sales for the first quarter of 2023 was $81.8 million, compared to $65.2 million in the prior-year period. Cost of sales increased primarily due to increased product sales of BRUKINSA and tislelizumab, as well as sales of XGEVA® and POBEVCY®.
Gross Margin as a percentage of global product sales for the first quarter of 2023 was 80.1%, compared to 75.1% 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 sales compared to other products in the portfolio and compared to lower-margin sales of in-licensed products.
Operating Expenses for the three months ended March 31, 2023, were $737.3 million, compared to $684.7 million in the same period of 2022.
Net Loss for the quarter ended March 31, 2023, was $348.4 million, or $0.26 per share, and $3.34 per American Depositary Share (ADS), compared to $435.2 million, or $0.33 per share, and $4.25 per ADS in the same period of 2022. The decrease in net loss is primarily attributable to improved operating leverage due to growing product revenues exceeding operating expense growth. The company expects this trend to continue through 2023.
Cash, Cash Equivalents, Restricted Cash, and Short-Term Investments were $3.8 billion as of March 31, 2023, and $4.5 billion as of December 31, 2022.
In the three months ended March 31, 2022, cash used in operating activities was $236.6 million, primarily due to our net loss of $435.2 million, partially offset by non-cash charges within net loss of $80.9 million. Net operating assets and liabilities contributed $117.7 million of cash due to the collection of the $300 million upfront fee from Novartis for ociperlimab, partially offset by seasonality of working capital due to compensation-related payments. Capital expenditures were $45.1 million, and cash used in financing activities was $11.3 million.
Recent Business Highlights
Commercial Operations
Regulatory Progress and Development Programs
BRUKINSA® (zanubrutinib), a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects, approved in more than 65 markets including the U.S., China, European Union, Great Britain, Canada, Australia, South Korea and Switzerland in selected indications and under development for additional approvals globally. The global BRUKINSA development program includes more than 4,900 subjects enrolled to-date in 29 countries and regions.
Tislelizumab, a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages; approved in China in 10 indications and under development for additional approvals globally. The global tislelizumab clinical development program includes more than 12,100 subjects enrolled to date in 31 countries and regions.
Ociperlimab (BGB-A1217), an investigational anti-TIGIT monoclonal antibody with competent Fc function. The global ociperlimab development program includes 20 countries and regions, and more than 1,700 subjects have been enrolled.
BGB-11417, an investigational, highly selective and highly potent inhibitor of BCL-2, being developed as monotherapy or in combination with zanubrutinib +/- obinutuzumab in B-cell malignancies, in combination with azacytidine in AML and MDS and as monotherapy and in combination with dexamethasone and in combination with carfilzomib in multiple myeloma. The global BGB-11417 development program includes seven countries and regions, and more than 430 subjects have been enrolled.
BGB-A445, an investigational non-ligand competing OX40 monoclonal antibody, being developed as monotherapy or in combination with tislelizumab.
Early-Stage Programs
Continued to advance our early-stage clinical pipeline of internally developed product candidates at dose-escalation stage, including:
Collaboration Programs
Manufacturing Operations
Corporate Developments
Expected Milestones
BRUKINSA
Tislelizumab
– Australia’s TGA review of BLA for tislelizumab in first- and second-line NSCLC and second-line ESCC, with a decision expected in the second half of 2023, as well as New Zealand’s Medsafe review of BLA for tislelizumab in first- and second-line NSCLC and second-line ESCC; and
– South Korea Ministry of Food and Drug Safety review of BLA for tislelizumab in second-line ESCC; and
– Brazil’s Anvisa review of BLA for tislelizumab in first- and second-line NSCLC and second-line ESCC;
– Ongoing U.S. FDA review of the BLA submission in second-line ESCC, with a decision expected in 2023;
– EMA review of marketing authorization applications for tislelizumab in first- and second-line NSCLC and second-line ESCC, with a decision expected in 2023;
– Medicines and Healthcare products Regulatory Agency review of tislelizumab for treatment of first- and second-line NSCLC and second-line ESCC in Great Britain;
– Swissmedic review of marketing authorization applications for tislelizumab in second-line ESCC and second-line NSCLC;
– Support U.S. FDA regulatory submission by Novartis in 2023 for first-line gastric cancer and first-line unresectable ESCC; and
– Submit BLA to Japan’s Pharmaceutical and Medical Devices Agency in 2023 for first- and second-line ESCC.
BGB-11417 (BCL-2 inhibitor)
Ociperlimab (anti-TIGIT)
– For second-line ESCC in patients whose tumors express PD-(L)1 (NCT04732494);
– For first-line hepatocellular carcinoma (NCT04948697); and
– For first-line NSCLC (NCT05014815).
BGB-16673 (BTK CDAC)
BGB-A445 (anti-OX 40)
BGB-15025 (HPK 1)
Collaboration Programs
COVID-19 Impact and Response
We are continuing to monitor the impact of the effects of the COVID-19 pandemic on our business. It is possible that the COVID-19 pandemic continues to have a negative impact on our operations, including commercial sales, regulatory interactions, inspections, filings, manufacturing, and clinical trial recruitment, participation, and data readouts. We are striving to minimize delays and disruptions, have put protocols and procedures in place, and continue to execute on our commercial, regulatory, manufacturing, and clinical development goals globally.
Financial Summary
Select Condensed Consolidated Balance Sheet Data (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)
|
|
|
| ||
| As of | ||||
| March 31, |
| December 31, | ||
| 2023 |
| 2022 | ||
| (unaudited) |
| (audited) | ||
Assets: |
|
|
| ||
Cash, cash equivalents, restricted cash and short-term investments | $ | 3,837,823 |
| $ | 4,540,288 |
Accounts receivable, net |
| 309,628 |
|
| 173,168 |
Inventories |
| 296,995 |
|
| 282,346 |
Property and equipment, net |
| 925,404 |
|
| 845,946 |
Total assets |
| 5,956,775 |
|
| 6,379,290 |
Liabilities and equity: |
|
|
| ||
Accounts payable |
| 241,360 |
|
| 294,781 |
Accrued expenses and other payables |
| 417,922 |
|
| 467,352 |
Deferred revenue |
| 222,822 |
|
| 255,887 |
R&D cost share liability |
| 276,562 |
|
| 293,960 |
Debt |
| 488,106 |
|
| 538,117 |
Total liabilities |
| 1,799,469 |
|
| 1,995,935 |
Total equity | $ | 4,157,306 |
| $ | 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 March 31, | ||||||
|
| 2023 |
|
|
| 2022 1 |
|
| (Unaudited) | ||||||
Revenue: |
|
|
| ||||
Product revenue, net | $ | 410,291 |
|
| $ | 261,573 |
|
Collaboration revenue |
| 37,510 |
|
|
| 45,053 |
|
Total revenues |
| 447,801 |
|
|
| 306,626 |
|
Expenses: |
|
|
| ||||
Cost of sales – products |
| 81,789 |
|
|
| 65,237 |
|
Research and development |
| 408,584 |
|
|
| 389,915 |
|
Selling, general and administrative |
| 328,499 |
|
|
| 294,573 |
|
Amortization of intangible assets |
| 187 |
|
|
| 188 |
|
Total expenses |
| 819,059 |
|
|
| 749,913 |
|
Loss from operations |
| (371,258 | ) |
|
| (443,287 | ) |
Interest income (expense), net |
| 16,016 |
|
|
| 10,071 |
|
Other (loss) income, net |
| 18,303 |
|
|
| 11,967 |
|
Loss before income taxes |
| (336,939 | ) |
|
| (421,249 | ) |
Income tax expense |
| 11,492 |
|
|
| 13,949 |
|
Net loss |
| (348,431 | ) |
|
| (435,198 | ) |
|
|
|
| ||||
Net loss per share attributable to BeiGene, Ltd.: |
|
|
| ||||
Basic and diluted | $ | (0.26 | ) |
| $ | (0.33 | ) |
Weighted-average shares outstanding: |
|
|
| ||||
Basic and diluted |
| 1,354,164,760 |
|
|
| 1,332,017,262 |
|
|
|
|
| ||||
Net loss per ADS attributable to BeiGene, Ltd.: |
|
|
| ||||
Basic and diluted | $ | (3.34 | ) |
| $ | (4.25 | ) |
Weighted-average ADSs outstanding: |
|
|
| ||||
Basic and diluted |
| 104,166,520 |
|
|
| 102,462,866 |
|
1 We 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 our previously filed financial statements in the first 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 March 31, 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 9,400 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 Statemen
Contacts
Investor
Kevin Mannix
+1 857-302-5189
ir@beigene.com
Media
Kyle Blankenship
+1 667-351-5176
media@beigene.com
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