SHANGHAI & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for full-year 2023, along with recent product highlights and corporate updates.
“We made excellent progress on several key strategic priorities in 2023, notably the launch of VYVGART in China for generalized myasthenia gravis (gMG) in September and the drug’s successful inclusion on China’s NRDL for this indication effective January 1, 2024,” said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer of Zai Lab. “The launch is off to an impressive start with more patients treated with VYVGART in January than the last four months of 2023 combined, fueled by high physician adoption and increased patient access as hospitals add VYVGART to formularies. Looking ahead, we expect strong commercial performance across our portfolio this year, and are preparing for three new potential launches in 2024. We are also excited by the progress of our late-stage pipeline and our growing global early-stage development efforts. We are on track to achieve the objectives outlined in our five-year strategic plan and to position Zai Lab as a high-growth, profitable and innovative biotech company.”
“We are focused on achieving three corporate objectives,” said Josh Smiley, President and Chief Operating Officer of Zai Lab. “First, we seek to accelerate top-line growth supported by multiple launches of new products and indications over the next two to three years. Second, we aim to reach corporate profitability by the end of 2025 through revenue growth and continued focus on efficiency and productivity. Third, we are committed to building a global portfolio through our internal discovery activities and strategic business development. These corporate objectives capture our vision for Zai Lab, where we lead with innovation, grow with purpose, and deliver on our mission of improving patient lives globally,” Mr. Smiley concluded.
Full-Year 2023 Financial Results
Key Highlights by Commercial Products
ZEJULA®
VYVGART®
OPTUNE®
QINLOCK®
NUZYRA®
2024 Strategic Priorities
Zai Lab will focus on the following strategic priorities in 2024 to drive innovation in China and beyond:
Commercial Execution
Clinical Data and Regulatory Actions
Clinical Development
1 Mainland China, Hong Kong, Macau, and Taiwan (collectively, Greater China).
Recent Pipeline Highlights
Below are key product updates since our last earnings release:
Oncology Pipeline
Autoimmune Disorders, Infectious Disease, and Neuroscience Pipeline
Anticipated Major Milestones in 2024
Oncology
Tumor Treating Fields
Repotrectinib (ROS1/TRK)
Adagrasib (KRASG12C)
Tisotumab Vedotin (Tissue Factor ADC)
Neuroscience, Autoimmune Disorders, and Infectious Diseases (NSAiID)
Efgartigimod (FcRn)
Sulbactam-Durlobactam (SUL-DUR)
Xanomeline-Trospium (or KarXT) (M1/M4-agonist)
ZL-1102 (IL-17 Humabody®)
Conference Call and Webcast Information
Zai Lab will host a live conference call and webcast tomorrow, February 28, 2024, at 8:00 a.m. ET (9:00 p.m. HKT). Listeners may access the live webcast by visiting the Company’s website at http://ir.zailaboratory.com. Participants must register in advance of the conference call.
Details are as follows:
Registration Link: https://register.vevent.com/register/BIa1fd72e50c9e4117b696c49bdfa9f83b
All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.
A replay will be available shortly after the call and can be accessed by visiting the Company’s website.
About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, autoimmune disorders, infectious diseases, and neuroscience. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide.
For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.
Non-GAAP Measures
In addition to results presented in accordance with GAAP, we disclose growth rates that have been adjusted to exclude the impact of changes due to the translation of foreign currencies into U.S. dollars, which are non-GAAP measures. We believe that these non-GAAP measures are important for an understanding of the performance of our business operations and financial results and provide investors with an additional perspective on trends. Although we believe the non-GAAP financial measures enhance investors’ understanding of our business and performance, these non-GAAP financial measures should not be considered an exclusive alternative to accompanying GAAP financial measures.
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements relating to our strategy and plans; potential of and expectations for our business and pipeline programs; our goals, objectives, and priorities and our expectations under our growth strategy (including our expectations regarding our commercial products and launches, clinical stage products, revenue growth, profitability, and cash flow); clinical development programs and related clinical trials; clinical trial data, data readouts, and presentations; risks and uncertainties associated with drug development and commercialization; regulatory discussions, submissions, filings, and approvals and the timing thereof; the potential benefits, safety, and efficacy of our products and product candidates and those of our collaboration partners; the anticipated benefits and potential of investments, collaborations, and business development activities; our future financial and operating results; and financial guidance, including with respect to our planned sources and uses of cash and our expected path to profitability. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products; (2) our ability to obtain funding for our operations and business initiatives; (3) the results of our clinical and pre-clinical development of our product candidates; (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates; (5) risks related to doing business in China; and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.SEC.gov.
Zai Lab Limited Consolidated Balance Sheets (in thousands of U.S. dollars (“$”), except for number of shares and per share data) | ||||||
|
| December 31, | ||||
|
| 2023 |
| 2022 | ||
Assets |
|
|
|
| ||
Current assets |
|
|
|
| ||
Cash and cash equivalents |
| 790,151 |
|
| 1,008,470 |
|
Short-term investments |
| 16,300 |
|
| — |
|
Accounts receivable (net of allowance for credit loss of $17 and $11 as of December 31, 2023 and 2022, respectively) |
| 59,199 |
|
| 39,963 |
|
Notes receivable |
| 6,134 |
|
| 8,608 |
|
Inventories, net |
| 44,827 |
|
| 31,621 |
|
Prepayments and other current assets |
| 22,995 |
|
| 35,674 |
|
Total current assets |
| 939,606 |
|
| 1,124,336 |
|
Restricted cash, non-current |
| 1,113 |
|
| 803 |
|
Long-term investments |
| 9,220 |
|
| 6,431 |
|
Prepayments for equipment |
| 111 |
|
| 1,396 |
|
Property and equipment, net |
| 53,734 |
|
| 57,863 |
|
Operating lease right-of-use assets |
| 14,844 |
|
| 19,512 |
|
Land use rights, net |
| 3,069 |
|
| 6,892 |
|
Intangible assets, net |
| 13,389 |
|
| 1,511 |
|
Long-term deposits |
| 1,209 |
|
| 1,396 |
|
Total assets |
| 1,036,295 |
|
| 1,220,140 |
|
Liabilities and shareholders’ equity |
|
|
|
| ||
Current liabilities |
|
|
|
| ||
Accounts payable |
| 112,991 |
|
| 65,974 |
|
Current operating lease liabilities |
| 7,104 |
|
| 7,050 |
|
Other current liabilities |
| 82,972 |
|
| 66,818 |
|
Total current liabilities |
| 203,067 |
|
| 139,842 |
|
Deferred income |
| 28,738 |
|
| 21,360 |
|
Non-current operating lease liabilities |
| 8,047 |
|
| 13,343 |
|
Other non-current liabilities |
| 325 |
|
| — |
|
Total liabilities |
| 240,177 |
|
| 174,545 |
|
Commitments and contingencies |
|
|
|
| ||
Shareholders’ equity |
|
|
|
| ||
Ordinary shares (par value of $0.000006 per share; 5,000,000,000 shares authorized, 977,151,270 and 962,455,850 shares issued as of December 31, 2023 and 2022, respectively; 972,239,070 and 960,219,570 shares issued and outstanding as of December 31, 2023 and 2022, respectively) |
| 6 |
|
| 6 |
|
Additional paid-in capital |
| 2,975,302 |
|
| 2,893,120 |
|
Accumulated deficit |
| (2,195,980 | ) |
| (1,861,360 | ) |
Accumulated other comprehensive income |
| 37,626 |
|
| 25,685 |
|
Treasury stock (at cost, 4,912,200 and 2,236,280 shares as of December 31, 2023 and 2022, respectively) |
| (20,836 | ) |
| (11,856 | ) |
Total shareholders’ equity |
| 796,118 |
|
| 1,045,595 |
|
Total liabilities and shareholders’ equity |
| 1,036,295 |
|
| 1,220,140 |
|
Zai Lab Limited Consolidated Statements of Operations (in thousands of $, except for number of shares and per share data) | |||||||||
| Year Ended December 31, | ||||||||
| 2023 |
| 2022 |
| 2021 | ||||
Revenues |
|
|
| ||||||
Product revenue, net | 266,719 |
| 212,672 |
| 144,105 |
| |||
Collaboration revenue | — |
| 2,368 |
| 207 |
| |||
Total revenues | 266,719 |
| 215,040 |
| 144,312 |
| |||
Expenses |
|
|
| ||||||
Cost of sales | (95,816 | ) | (74,018 | ) | (52,239 | ) | |||
Research and development | (265,868 | ) | (286,408 | ) | (573,306 | ) | |||
Selling, general and administrative | (281,608 | ) | (258,971 | ) | (218,831 | ) | |||
Gain on sale of intellectual property | 10,000 |
| — |
| — |
| |||
Loss from operations | (366,573 | ) | (404,357 | ) | (700,064 | ) | |||
Interest income | 39,797 |
| 14,582 |
| 2,190 |
| |||
Foreign currency (loss) gain | (14,850 | ) | (56,403 | ) | 4,661 |
| |||
Other income (expense), net | 7,006 |
| 3,113 |
| (10,201 | ) | |||
Loss before income tax and share of loss from equity method investment | (334,620 | ) | (443,065 | ) | (703,414 | ) | |||
Income tax expense | — |
| — |
| — |
| |||
Share of loss from equity method investment | — |
| (221 | ) | (1,057 | ) | |||
Net loss | (334,620 | ) | (443,286 | ) | (704,471 | ) | |||
Loss per share — basic and diluted | (0.35 | ) | (0.46 | ) | (0.76 | ) | |||
Weighted-average shares used in calculating net loss per ordinary share — basic and diluted | 966,394,130 |
| 958,067,140 |
| 929,921,120 |
|
Contacts
For more information:
Investor Relations:
Christine Chiou / Lina Zhang
+1 (917) 886-6929 / +86 136 8257 6943
christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com
Media:
Shaun Maccoun / Xiaoyu Chen
+1 (415) 317-7255 / +86 185 0015 5011
shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com
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