Zai Lab Announces First Quarter 2024 Financial Results and Recent Corporate Updates
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) reported a strong first quarter of 2024 with net product revenue of $87.1 million, a 39% year-over-year growth. The company highlighted VYVGART® sales of $13.2 million, regulatory reviews ongoing for several products, and a robust balance sheet with $750.8 million in cash. With plans for new launches in 2024 and a focus on profitability by 2025, Zai Lab is poised for significant growth.
Zai Lab achieved a 39% year-over-year growth in net product revenue, reaching $87.1 million in the first quarter of 2024.
Strong VYVGART® sales of $13.2 million in the quarter indicate a successful launch and increased patient access.
The company maintains a healthy cash position of $750.8 million as of March 31, 2024, providing financial stability for future operations and growth.
Zai Lab's plans for new potential launches in 2024 and a focus on profitability by 2025 demonstrate a strategic vision for sustained growth and value creation.
Despite revenue growth, the net loss for the first quarter of 2024 was $53.5 million, reflecting increased expenses in research and development (R&D) and selling, general, and administrative (SG&A) functions.
R&D expenses grew to $54.6 million in the first quarter of 2024, primarily due to increased clinical trial expenses, impacting the company's bottom line.
Selling, general, and administrative expenses rose to $69.2 million in the quarter, driven by higher general selling expenses and headcount growth associated with the VYVGART launch, contributing to the overall net loss.
Insights
-
Net product revenue of
for the first quarter of 2024, representing$87.1 million 39% y-o-y growth;43% y-o-y growth at constant exchange rate (CER) -
VYVGART® (efgartigimod alfa injection) sales of
for the first quarter of 2024, driven by increased patient access; an estimated 2,700 new patients were treated with VYVGART in the first quarter of 2024$13.2 million - Regulatory reviews ongoing for sulbactam-durlobactam for ABC, efgartigimod SC for gMG, and repotrectinib for ROS1+ NSCLC; sBLA submitted for efgartigimod SC in CIDP
-
Strong balance sheet with a cash position1 of
as of March 31, 2024, compared to$750.8 million as of December 31, 2023$806.5 million - Company to host conference call and webcast on May 9, 2024, at 8:00 a.m. ET (8:00 p.m. HKT)
“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
“Our net revenues grew
First-Quarter 2024 Financial Results
-
Product revenue was
in the first quarter of 2024, compared to$87.1 million for the same period in 2023, representing$62.8 million 39% y-o-y growth and43% y-o-y growth at CER. This increase was primarily driven by increased sales volumes, including from the launch of VYVGART last September and decreased sales rebates to distributors resulting from price reductions in connection with listings on China’s National Reimbursement Drug List (NRDL) for certain products. This revenue growth included the following:-
ZEJULA®:
in the first quarter of 2024, an increase of$45.5 million 7% y-o-y from for the same period in 2023, driven by increased hospital sales in first-line ovarian cancer and increased duration of treatment and supported by the renewal of ZEJULA’s NRDL listing for the maintenance treatment of adult patients with first-line and recurrent ovarian cancer, effective January 1, 2024.$42.7 million -
VYVGART®:
in the first quarter of 2024, compared to nil for the same period in 2023, driven by positive physician and patient reception as well as increased patient access as VYVGART is added to hospital formularies. VYVGART was launched for the treatment of generalized myasthenia gravis (gMG) in September 2023 and was subsequently included for first-time NRDL listing effective, January 1, 2024.$13.2 million -
OPTUNE (Tumor Treating Fields):
in the first quarter of 2024, a decrease of$12.5 million 6% y-o-y from for the same period in 2023. Although revenue declined y-o-y for OPTUNE, it increased$13.3 million 49% versus the fourth quarter of 2023, with continued recovery of patient volume expected throughout 2024. -
QINLOCK®:
in the first quarter of 2024, an increase of$6.1 million 367% y-o-y from for the same period in 2023, driven by its inclusion in the NRDL in the first quarter of 2023 for the fourth-line treatment of advanced gastrointestinal stromal tumors (GIST).$1.3 million -
NUZYRA®:
in the first quarter of 2024, an increase of$9.9 million 81% y-o-y from for the same period in 2023, driven by the NRDL listings for the IV formulation of NUZYRA for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in the first quarter of 2023 and the oral formulation for these indications in the first quarter of 2024.$5.5 million
-
ZEJULA®:
-
Research and Development (R&D) expenses were
in the first quarter of 2024, compared to$54.6 million for the same period in 2023. This increase was primarily due to increased clinical trial expenses related to newly initiated studies and progress of existing studies, partially offset by a decrease in milestone fees for our licensed products.$48.5 million
-
Selling, General and Administrative expenses were
in the first quarter of 2024, compared to$69.2 million for the same period in 2023. This increase was primarily driven by higher general selling expenses and headcount growth associated with the VYVGART launch.$62.5 million
-
Net loss was
in the first quarter of 2024, or a loss per ordinary share attributable to common stockholders of$53.5 million (or loss per American Deposit Share (ADS) of$0.05 ), compared to a net loss of$0.55 for the same period in 2023, or a loss per ordinary share of$49.1 million (or loss per ADS of$0.05 ).$0.51
-
Cash and cash equivalents, short-term investments, and current restricted cash totaled
as of March 31, 2024, compared to$750.8 million as of December 31, 2023.$806.5 million
Corporate Update
-
In April 2024, Andrew Zhu joined Zai Lab as our Chief Commercial Officer in
Greater China 2. Mr. Zhu’s rich experience in building innovative business models and resource integration will help us further enhance our commercial operations and drive sales and profit growth acrossGreater China . He joins us from Simcere Zaiming, where he most recently served as Chief Operating Officer responsible for the commercial and pharmaceutical business. He previously served in various operational, sales, and marketing leadership roles at leading global biopharmaceutical companies, including AstraZeneca, Roche, Sanofi, and Bristol Myers Squibb (BMS).
Recent Pipeline Highlights
Below are key product updates since our last earnings release:
Oncology Pipeline
-
Tumor Treating Fields:
-
In March 2024, Zai Lab partner Novocure announced positive topline results from the Phase 3 METIS clinical trial for brain metastases from non-small cell lung cancer (NSCLC). The primary endpoint was met with Tumor Treating Fields therapy and supportive care demonstrating a significant improvement in time to intracranial progression versus supportive care alone (21.9 months median versus 11.3 months, respectively). These results will be presented as a late-breaking abstract at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in
Chicago on June 3. We are participating in theGreater China portion of the METIS trial.
-
In March 2024, Zai Lab partner Novocure announced positive topline results from the Phase 3 METIS clinical trial for brain metastases from non-small cell lung cancer (NSCLC). The primary endpoint was met with Tumor Treating Fields therapy and supportive care demonstrating a significant improvement in time to intracranial progression versus supportive care alone (21.9 months median versus 11.3 months, respectively). These results will be presented as a late-breaking abstract at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in
-
Bemarituzumab (FGFR2b):
-
We are enrolling patients in
Greater China for the global Phase 3 FORTITUDE-101 and FORTITUDE-102 studies:- FORTITUDE-101 is a Phase 3 study of bemarituzumab plus chemotherapy in first-line gastric cancer.
- FORTITUDE-102 is a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab in first-line gastric cancer.
-
We are enrolling patients in
-
Tisotumab Vedotin (Tissue Factor ADC):
-
In April 2024, Zai Lab partner Pfizer Inc. and Genmab A/S announced that the
U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) granting full approval for tisotumab vedotin (or TIVDAK®) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. We are participating in the global Phase 3 innovaTV 301 trial and extension study inGreater China .
-
In April 2024, Zai Lab partner Pfizer Inc. and Genmab A/S announced that the
-
Adagrasib (KRASG12C):
- We are evaluating the clinical data of the global Phase 3 KRYSTAL-12 study evaluating adagrasib in previously treated patients with KRASG12C-mutated NSCLC as we decide on next steps in the development of this product across indications.
-
ZL-1310 (DLL3 ADC):
- In March 2024, Zai Lab presented findings from preclinical studies highlighting the therapeutic potential of ZL-1310 at the European Lung Cancer Congress (ELCC) 2024.
-
We are enrolling patients in
the United States andGreater China in the global Phase 1 study in relapsed and refractory second-line+ small cell lung cancer (SCLC) who have progressed after platinum-based treatment.
-
ZL-1218 (CCR8):
-
We are enrolling patients in
the United States ,Europe , andGreater China in the global Phase 1 study of ZL-1218 as a single agent and in combination with pembrolizumab in patients with advanced solid tumor malignancies.
-
We are enrolling patients in
Autoimmune Disorders, Infectious Disease, and Neuroscience Pipeline
-
Efgartigimod (FcRn):
- In April 2024, Zai Lab submitted an sBLA for efgartigimod SC for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) to the National Medical Products Administration (NMPA).
-
Xanomeline-Trospium (or KarXT) (M1/M4-agonist):
-
In April 2024, Zai Lab partner BMS presented new interim long-term data from the Phase 3 EMERGENT program at the Annual Congress of the Schizophrenia International Research Society (SIRS).
- In the new interim analysis of long-term efficacy data from the Phase 3 EMERGENT-4 open-label extension trial, KarXT was associated with significant improvement in symptoms of schizophrenia across all efficacy measures at 52 weeks.
- In the new pooled interim long-term safety and metabolic outcomes from the Phase 3 EMERGENT-4 and EMERGENT-5 trials, KarXT demonstrated a favorable long-term metabolic profile where most patients experienced stability or improvements on metabolic parameters over 52 weeks of treatment.
-
We are enrolling patients in a registrational bridging study in mainland
China .
-
In April 2024, Zai Lab partner BMS presented new interim long-term data from the Phase 3 EMERGENT program at the Annual Congress of the Schizophrenia International Research Society (SIRS).
Anticipated Major Milestones in 2024
Oncology
Repotrectinib
- Potential NMPA approval of our NDA for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.
Tumor Treating Fields
- Zai Lab to submit a Marketing Authorization Application (MAA) to the NMPA in second-line+ NSCLC, following progression on or after platinum-based therapy.
-
Novocure to provide a topline data readout from the Phase 3 PANOVA-3 clinical trial in locally advanced pancreatic cancer in the fourth quarter of 2024. We are participating in the study in
Greater China .
ZL-1310 (DLL3 ADC)
- Potential dose escalation data from the global Phase 1 study in relapsed and refractory second-line+ SCLC at the end of 2024 or early 2025.
Neuroscience, Autoimmune Disorders, and Infectious Diseases (NSAiID)
Efgartigimod (FcRn)
- Potential NMPA approval of the BLA for efgartigimod SC for gMG.
-
We plan to join in the registrational study of efgartigimod SC in Thyroid Eye Disease (TED) in
Greater China in the second half of 2024.
Sulbactam-Durlobactam (SUL-DUR)
- Potential NMPA approval of our NDA for infections caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (ABC).
Xanomeline-Trospium (KarXT) (M1/M4-agonist)
-
Zai Lab to complete patient enrollment in the
China bridging study in schizophrenia. -
Zai Lab to join the global Phase 3 ADEPT-2 and ADEPT-3 studies in Alzheimer’s disease with psychosis in
Greater China in mid-year. - BMS to report data from the EMERGENT-4 and EMERGENT-5 trials evaluating the long-term safety for treatment of schizophrenia in the second half of 2024.
ZL-1102 (IL-17 Humabody®)
- Zai Lab to initiate a global Phase 2 study in mild-to-moderate chronic plaque psoriasis in the second quarter of 2024.
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
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
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
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
Zai Lab Limited Unaudited Condensed Consolidated Balance Sheets
(in thousands of |
||||||
|
|
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 |
|
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 |
|
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240508997114/en/
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
Source: Zai Lab Limited
FAQ
What were Zai Lab's net product revenue and growth in the first quarter of 2024?
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What was Zai Lab's cash position as of March 31, 2024?