- Net product revenue of $87.1 million for the first quarter of
2024, representing 39% y-o-y growth; 43% y-o-y growth at constant
exchange rate (CER)
- VYVGART® (efgartigimod alfa injection) sales of $13.2 million
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
- 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 $750.8 million as
of March 31, 2024, compared to $806.5 million as of December 31,
2023
- Company to host conference call and webcast on May 9, 2024, at
8:00 a.m. ET (8:00 p.m. HKT)
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
- Product revenue was $87.1 million in the first quarter
of 2024, compared to $62.8 million for the same period in 2023,
representing 39% y-o-y growth and 43% 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®: $45.5 million in the first quarter of 2024, an
increase of 7% y-o-y from $42.7 million 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.
- VYVGART®: $13.2 million 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.
- OPTUNE (Tumor Treating Fields): $12.5 million in the
first quarter of 2024, a decrease of 6% y-o-y from $13.3 million
for the same period in 2023. Although revenue declined y-o-y for
OPTUNE, it increased 49% versus the fourth quarter of 2023, with
continued recovery of patient volume expected throughout 2024.
- QINLOCK®: $6.1 million in the first quarter of 2024, an
increase of 367% y-o-y from $1.3 million 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).
- NUZYRA®: $9.9 million in the first quarter of 2024, an
increase of 81% y-o-y from $5.5 million 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.
- Research and Development (R&D) expenses were $54.6
million in the first quarter of 2024, compared to $48.5 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.
- Selling, General and Administrative expenses were $69.2
million in the first quarter of 2024, compared to $62.5 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.
- Net loss was $53.5 million in the first quarter of 2024,
or a loss per ordinary share attributable to common stockholders of
$0.05 (or loss per American Deposit Share (ADS) of $0.55), compared
to a net loss of $49.1 million for the same period in 2023, or a
loss per ordinary share of $0.05 (or loss per ADS of $0.51).
- Cash and cash equivalents, short-term investments, and
current restricted cash totaled $750.8 million as of March 31,
2024, compared to $806.5 million as of December 31, 2023.
Corporate Update
- In April 2024, Andrew Zhu joined Zai Lab as our Chief
Commercial Officer in Greater China2. 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 across Greater 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 the Greater China portion of the METIS
trial.
- 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.
- 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 in Greater
China.
- 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 and Greater
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, and
Greater 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.
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.
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
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, 2024
December 31,
2023
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.
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
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