SHANGHAI & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the first quarter of 2024, along with recent product highlights and corporate updates.
“Our first quarter results demonstrate strong commercial execution and pipeline progress across our potential first- and best-in-class product portfolio,” said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer of Zai Lab. “The launch of VYVGART is off to an impressive start with $13.2 million of sales in the first quarter. Looking ahead, we expect to accelerate commercial performance for the remainder of the year and are preparing for three new potential launches in 2024. We are also excited by the progress of our late-stage pipeline and we are on track to achieve the objectives outlined in our five-year strategic plan, including significant revenue growth and profitability by the end of 2025.”
“Our net revenues grew 39% y-o-y or 43% y-o-y at CER in the first quarter, driven by strong execution with the launch of VYVGART and uptake of our existing portfolio,” said Josh Smiley, President and Chief Operating Officer of Zai Lab. “With VYVGART’s launch in gMG at the end of last year, and multiple new products and indications expected to launch over the near-term, we are now entering a period of robust growth for Zai Lab. Our significant growth, coupled with our focus on driving efficiencies and productivity across the organization, will drive the evolution of Zai Lab into a profitable, high growth business by the end of 2025. Furthermore, we will continue to focus on expanding our global portfolio through our internal discovery activities and strategic business development,” Mr. Smiley concluded.
First-Quarter 2024 Financial Results
Corporate Update
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
Repotrectinib
Tumor Treating Fields
ZL-1310 (DLL3 ADC)
Neuroscience, Autoimmune Disorders, and Infectious Diseases (NSAiID)
Efgartigimod (FcRn)
Sulbactam-Durlobactam (SUL-DUR)
Xanomeline-Trospium (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, May 9, 2024, at 8:00 a.m. ET (8:00 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/BIb8622a7cf98e46cd9bc9198a5f105c36
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.
1 Cash position includes cash and cash equivalents, current restricted cash, and short-term investments.
2 Mainland China, Hong Kong, Macau, and Taiwan (collectively, Greater China).
Zai Lab Limited Unaudited Condensed Consolidated Balance Sheets (in thousands of U.S. dollars ($), except for number of shares and per share data) | ||||||
|
|
March 31, |
|
December 31, | ||
Assets |
|
|
|
| ||
Current assets |
|
|
|
| ||
Cash and cash equivalents |
| 650,780 |
|
| 790,151 |
|
Restricted cash, current |
| 100,000 |
|
| — |
|
Short-term investments |
| — |
|
| 16,300 |
|
Accounts receivable (net of allowance for credit losses of $18 and $17 as of March 31, 2024 and December 31, 2023, respectively) |
| 60,422 |
|
| 59,199 |
|
Notes receivable |
| 15,363 |
|
| 6,134 |
|
Inventories, net |
| 37,851 |
|
| 44,827 |
|
Prepayments and other current assets |
| 24,224 |
|
| 22,995 |
|
Total current assets |
| 888,640 |
|
| 939,606 |
|
Restricted cash, non-current |
| 1,114 |
|
| 1,113 |
|
Long term investments |
| 14,109 |
|
| 9,220 |
|
Prepayments for equipment |
| 89 |
|
| 111 |
|
Property and equipment, net |
| 52,386 |
|
| 53,734 |
|
Operating lease right-of-use assets |
| 15,187 |
|
| 14,844 |
|
Land use rights, net |
| 3,034 |
|
| 3,069 |
|
Intangible assets, net |
| 12,398 |
|
| 13,389 |
|
Long-term deposits |
| 1,480 |
|
| 1,209 |
|
Total assets |
| 988,437 |
|
| 1,036,295 |
|
Liabilities and shareholders’ equity |
|
|
|
| ||
Current liabilities |
|
|
|
| ||
Accounts payable |
| 88,121 |
|
| 112,991 |
|
Current operating lease liabilities |
| 7,536 |
|
| 7,104 |
|
Short-term debts |
| 48,273 |
|
| — |
|
Other current liabilities |
| 48,176 |
|
| 82,972 |
|
Total current liabilities |
| 192,106 |
|
| 203,067 |
|
Deferred income |
| 26,297 |
|
| 28,738 |
|
Non-current operating lease liabilities |
| 7,540 |
|
| 8,047 |
|
Other non-current liabilities |
| 325 |
|
| 325 |
|
Total liabilities |
| 226,268 |
|
| 240,177 |
|
Commitments and contingencies |
|
|
|
| ||
Shareholders’ equity |
|
|
|
| ||
Ordinary shares (par value of $0.000006 per share; 5,000,000,000 shares authorized; 978,197,710 and 977,151,270 shares issued as of March 31, 2024 and December 31, 2023, respectively; 973,285,510 and 972,239,070 shares outstanding as of March 31, 2024 and December 31, 2023, respectively) |
| 6 |
|
| 6 |
|
Additional paid-in capital |
| 2,993,282 |
|
| 2,975,302 |
|
Accumulated deficit |
| (2,249,451 | ) |
| (2,195,980 | ) |
Accumulated other comprehensive income |
| 39,168 |
|
| 37,626 |
|
Treasury Stock (at cost, 4,912,200 shares as of both March 31, 2024 and December 31, 2023) |
| (20,836 | ) |
| (20,836 | ) |
Total shareholders’ equity |
| 762,169 |
|
| 796,118 |
|
Total liabilities and shareholders’ equity |
| 988,437 |
|
| 1,036,295 |
|
Zai Lab Limited Unaudited Condensed Consolidated Statements of Operations (in thousands of $, except for number of shares and per share data) | ||||||
|
| Three Months Ended March 31, | ||||
|
| 2024 |
|
| 2023 |
|
|
|
|
|
| ||
Revenue |
| 87,149 |
|
| 62,797 |
|
Expenses |
|
|
|
| ||
Cost of sales |
| (33,619 | ) |
| (21,337 | ) |
Research and development |
| (54,645 | ) |
| (48,472 | ) |
Selling, general, and administrative |
| (69,194 | ) |
| (62,510 | ) |
Loss from operations |
| (70,309 | ) |
| (69,522 | ) |
Interest income |
| 9,658 |
|
| 10,232 |
|
Interest expenses |
| (113 | ) |
| — |
|
Foreign currency (losses) gains |
| (2,068 | ) |
| 8,912 |
|
Other income, net |
| 9,361 |
|
| 1,234 |
|
Loss before income tax |
| (53,471 | ) |
| (49,144 | ) |
Income tax expense |
| — |
|
| — |
|
Net loss |
| (53,471 | ) |
| (49,144 | ) |
Loss per share – basic and diluted |
| (0.05 | ) |
| (0.05 | ) |
Weighted-average shares used in calculating net loss per ordinary share – basic and diluted |
| 973,145,760 |
|
| 961,444,780 |
|
Zai Lab Limited Unaudited condensed consolidated statements of comprehensive loss (in thousands of $) | ||||||
|
| Three Months Ended March 31, | ||||
|
| 2024 |
|
| 2023 |
|
Net loss |
| (53,471 | ) |
| (49,144 | ) |
Other comprehensive income, net of tax of nil: |
|
|
|
| ||
Foreign currency translation adjustments |
| 1,542 |
|
| (8,413 | ) |
Comprehensive loss |
| (51,929 | ) |
| (57,557 | ) |
Zai Lab Limited Non-GAAP Measures (in thousands of $) | ||||||||||||
|
| Three Months Ended March 31, |
| Year over Year % Growth | ||||||||
|
| 2024 |
|
| 2023 |
|
| As reported |
| At CER* | ||
Revenue |
| 87,149 |
|
| 62,797 |
|
| 39 | % |
| 43 | % |
Loss from operations |
| (70,309 | ) |
| (69,522 | ) |
| 1 | % |
| 3 | % |
* The growth rates at CER were calculated assuming the same foreign currency exchange rates were in effect for the current and prior year periods.
Contacts
For more information, please contact:
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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