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Name | Symbol | Market | Type |
---|---|---|---|
BeiGene Ltd | NASDAQ:BGNE | NASDAQ | Depository Receipt |
Price Change | % Change | Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.73 | -0.45% | 162.54 | 158.70 | 167.80 | 165.50 | 161.70 | 163.82 | 101,487 | 05:00:08 |
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today reported financial results from the third quarter of 2023 and business highlights.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231109537270/en/
“Our BeiGene team delivered another strong quarter across our global product portfolio, driven by the ongoing successful launch of BRUKINSA, where we continue to see rapid uptake across all approved indications, including CLL,” said John V. Oyler, Chairman, Co-Founder and CEO at BeiGene. “We are excited to have regained the rights to TEVIMBRA worldwide, which is now approved in the EU and under regulatory review in 10 additional markets. We are now better positioned than ever before to execute on our global growth strategy while steadily improving operating leverage with moderate expense growth.”
Key Business and Pipeline Highlights
Third Quarter 2023 Financial Highlights
Total Revenue for the three months ended September 30, 2023, was $781.3 million, compared to $387.6 million in the same period of 2022, representing 101.6% growth, driven by growth in product revenue and the recognition of remaining deferred revenues from the Novartis collaborations. Total revenue by geographic area is presented as follows (amounts in thousands of U.S. dollars) (1):
Three Months Ended
Nine Months Ended
September 30,
September 30,
2023
2022
2023
2022
$
$
$
$
United States- total revenue
398,229
133,431
815,059
347,180
Product revenue
270,084
108,104
632,391
264,373
Collaboration revenue
128,145
25,327
182,668
82,807
China- total revenue
287,935
233,077
831,399
636,241
Product revenue
284,981
233,077
825,809
636,241
Collaboration revenue
2,954
—
5,590
—
Europe- total revenue
85,583
17,995
153,273
46,634
Product revenue
30,664
5,200
76,487
9,205
Collaboration revenue
54,919
12,795
76,786
37,429
Rest of world- product revenue
9,561
3,125
24,639
5,771
Total Revenue
781,308
387,628
1,824,370
1,035,826
(1)Net product revenues by geographic area are based upon the location of the customer, and net collaboration revenue is recorded in the jurisdiction in which the related income is expected to be sourced from.
Product Revenue for the three months ended September 30, 2023, was $595.3 million, compared to $349.5 million in the same period of 2022, representing 70.3% growth;
Gross Margin as a percentage of global product revenue for the third quarter of 2023 was 83.8%, compared to 78.1% in the prior-year period. The gross margin percentage increased primarily due to proportionally higher sales mix of global BRUKINSA compared to other products in the portfolio and compared to lower-margin sales of in-licensed products, as well as lower costs per unit for tislelizumab due to increased volume.
Operating Expenses for the three months ended September 30, 2023, were $819.0 million, compared to $749.4 million in the same period of 2022, representing 9.3% growth, primarily due to increased internal costs for research and development and sales and marketing costs in the U.S. and Europe, compared to the prior-year period. The Company expects product revenue growth to continue to meaningfully outpace operating expense growth, generating continued operating leverage.
Net Income for the quarter ended September 30, 2023, was $215.4 million compared to net loss of $557.6 million in the same period of 2022. The improvement in net income compared to the prior year period was primarily attributable to reduced operating losses and the non-operating gain of $362.9 million related to the BMS arbitration settlement. Operating loss improved $304.4 million compared to the prior-year period, as our product revenue growth and management of expenses is driving increased operating leverage. In addition, the reacquisition of the full global commercial rights to ociperlimab and TEVIMBRA resulted in the recognition of the remaining deferred collaboration revenue, which increased our total revenue.
For the quarter ended September 30, 2023, basic and diluted earnings per share were $0.16 and $0.15, respectively, and basic and diluted earnings per American Depositary Share (ADS) were $2.06 and $2.01, respectively. For the quarter ended September 30, 2022, net loss per share was $0.41 per share, and $5.39 per ADS.
Cash, Cash Equivalents, Restricted Cash, and Short-Term Investments were $3.2 billion as of September 30, 2023, and $4.5 billion as of December 31, 2022.
Cash used in operations for the quarter ended September 30, 2023 totaled $78.2 million compared to $561.9 million in the prior-year period, driven by improved operating leverage.
For further details on BeiGene’s Third Quarter 2023 Financial Statements, please see BeiGene’s Quarterly Report on Form 10-Q for the third 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
TEVIMBRA
BAITUOWEI® (Goserelin Microspheres for Injection)
Regulatory Submissions
Tislelizumab
Clinical Activities
Tislelizumab
Sonrotoclax
(BGB-11417)
Early development
*Second generation
Anticipated Upcoming Milestones
CategoryAsset
Anticipated MilestoneApprovals/ Regulatory Updates
BRUKINSA
Tislelizumab
Regulatory Submissions
Tislelizumab
Clinical Activities/Data Readouts
BRUKINSA
Sonrotoclax
BTK CDAC (BGB-1663)
Ociperlimab (Anti-TIGIT)
Scientific Congress Updates
Manufacturing Operations
Corporate Developments
Financial Summary
Select Condensed Consolidated Balance Sheet Data (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)
As of
September 30,
December 31,
2023
2022
(unaudited)
(audited)
Assets:
Cash, cash equivalents, restricted cash and short-term investments
$
3,187,881
$
4,540,288
Accounts receivable, net
309,079
173,168
Inventories
316,929
282,346
Property, plant and equipment, net
1,178,038
845,946
Total assets
5,524,879
6,379,290
Liabilities and equity:
Accounts payable
341,857
294,781
Accrued expenses and other payables
505,824
467,352
Deferred revenue
300
255,887
R&D cost share liability
255,391
293,960
Debt
531,051
538,117
Total liabilities
1,761,645
1,995,935
Total shareholder’s equity
$
3,763,234
$
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
September 30,
Nine Months Ended
September 30,
2023
2022
2023
2022
(Unaudited)
(Unaudited)
Revenue:
Product revenue, net
$
595,290
$
349,506
$
1,559,326
$
915,590
Collaboration revenue
186,018
38,122
265,044
120,236
Total revenues
781,308
387,628
1,824,370
1,035,826
Expenses:
Cost of sales - products
96,309
76,543
274,088
212,953
Research and development
453,259
426,363
1,284,607
1,194,485
Selling, general and administrative
364,421
322,892
1,087,954
948,868
Amortization of intangible assets
1,287
187
1,662
563
Total expenses
915,276
825,985
2,648,311
2,356,869
Loss from operations
(133,968
)
(438,357
)
(823,941
)
(1,321,043
)
Interest income, net
26,649
12,759
57,735
34,261
Other income (expense), net
336,657
(125,640
)
291,142
(243,290
)
Income (loss) before income taxes
229,338
(551,238
)
(475,064
)
(1,530,072
)
Income tax expense
13,925
6,318
39,091
28,408
Net income (loss)
215,413
(557,556
)
(514,155
)
(1,558,480
)
Net income (loss) per share attributable to BeiGene, Ltd.:
Basic
$
0.16
$
(0.41
)
$
(0.38
)
$
(1.16
)
Diluted
$
0.15
$
(0.41
)
$
(0.38
)
$
(1.16
)
Weighted-average shares outstanding:
Basic
1,360,716,279
1,345,303,747
1,358,392,470
1,337,976,853
Diluted
1,390,331,833
1,345,303,747
1,358,392,470
1,337,976,853
Net income (loss) per ADS attributable to BeiGene, Ltd.:
Basic
$
2.06
$
(5.39
)
$
(4.92
)
$
(15.14
)
Diluted
$
2.01
$
(5.39
)
$
(4.92
)
$
(15.14
)
Weighted-average ADSs outstanding:
Basic
104,670,483
103,484,904
104,491,728
102,921,296
Diluted
106,948,603
103,484,904
104,491,728
102,921,296
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 LinkedIn and X (formerly known as Twitter).
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 ability of BeiGene to execute on its global growth strategy; 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 caption “Anticipated Upcoming Milestones”; the expected capacities and completion dates for the Company's manufacturing facilities under construction and the potential for such facilities to increase 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20231109537270/en/
Investor Liza Heapes +1 857-302-5663 ir@beigene.com
Media Kyle Blankenship +1 667-351-5176 media@beigene.com
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