– Net product revenue of $100.1 million for the second quarter
of 2024, representing 45% y-o-y growth; 47% y-o-y growth at
constant exchange rate (CER)
– VYVGART® (efgartigimod alfa injection) sales of $23.2 million
for the second quarter of 2024; raising full-year VYVGART revenue
guidance to exceed $80.0 million
– Expansion of Zai Lab’s global oncology pipeline with a next
generation ROR1 antibody-drug conjugate (ADC) program
– Three product approvals in China including XACDURO® for
HABP/VABP, efgartigimod SC for gMG, and AUGTYRO™ for ROS1+ NSCLC;
expect at least four regulatory submissions to the NMPA within next
12 months including KarXT for schizophrenia
– Strong balance sheet with a cash position1 of $730.0 million
as of June 30, 2024, compared to $750.8 million as of March 31,
2024
– Company to host conference call and webcast on August 7, 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 second quarter of 2024, along with recent
product highlights and corporate updates.
“In the second quarter, we achieved impressive commercial
growth, maintained financial discipline, and made significant
strides across our product portfolio, highlighting our capability
to execute on our strategic objectives,” said Dr. Samantha Du,
Founder, Chairperson, and Chief Executive Officer of Zai Lab. “The
success of VYVGART underscores the urgent need for effective and
safe treatments for patients living with generalized myasthenia
gravis. We will continue to prioritize resources and focus
investments on high-value initiatives with the potential to
significantly improve human health. Recently, we expanded our
global oncology pipeline with a next generation ROR1 ADC program,
ZL-6301. Additionally, the progress of our pipeline, including
efgartigimod, bemarituzumab, KarXT and our three global
clinical-stage assets, keeps us on track to achieve the goals
outlined in our five-year strategic plan.”
“Our net product revenues grew 45% y-o-y in the second quarter,
driven by the successful commercialization of VYVGART,” said Josh
Smiley, President and Chief Operating Officer of Zai Lab. “In 2024,
we will maintain our focus on the strong execution of VYVGART’s
launch in generalized myasthenia gravis while also preparing for
the anticipated launches of several new products and indications in
the near future. Our efforts to build a stronger and more efficient
organization, coupled with our innovative pipeline, position us for
substantial topline growth and set us on the path to achieve
profitability by the end of 2025.”
1
Cash position includes cash and cash
equivalents, current restricted cash, and short-term
investments.
Second-Quarter 2024 Financial Results
- Product revenue, net was $100.1 million in the second
quarter of 2024, compared to $68.9 million for the same period in
2023, representing 45% y-o-y growth and 47% y-o-y growth at CER.
This increase was primarily driven by increased sales for VYVGART
since its launch in September 2023 and China’s National
Reimbursement Drug List (NRDL) listing in January 2024, and
increased sales for ZEJULA and NUZYRA. Primary drivers of this
revenue growth included the following:
- ZEJULA®: $45.0 million in the second quarter of 2024, an
increase of 5% y-o-y from $43.0 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®: $23.2 million in the second quarter of 2024,
compared to $0.1 million for the same period in 2023, driven by its
NRDL listing for the treatment of generalized myasthenia gravis
(gMG) effective January 1, 2024 and 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
gMG in September 2023.
- NUZYRA®: $12.3 million in the second quarter of 2024, an
increase of 165% y-o-y compared to $4.6 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 $61.6
million in the second quarter of 2024, compared to $76.7 million
for the same period in 2023. This decrease was primarily due to
decreased milestone fees for our license and collaboration
agreements, partially offset by increased clinical trial expenses
related to newly initiated studies and progress of existing
studies.
- Selling, General and Administrative expenses were $79.7
million in the second quarter of 2024, compared to $67.9 million
for the same period in 2023. This increase was primarily driven by
higher general selling expenses and headcount growth primarily to
support VYVGART.
- Net loss was $80.3 million in the second quarter of
2024, or a loss per ordinary share attributable to common
stockholders of $0.08 (or loss per American Deposit Share (ADS) of
$0.82), compared to a net loss of $120.9 million for the same
period in 2023, or a loss per ordinary share of $0.13 (or loss per
ADS of $1.25).
- Cash and cash equivalents, short-term investments, and
current restricted cash totaled $730.0 million as of June 30,
2024, compared to $750.8 million as of March 31, 2024.
Corporate Updates
Below are key corporate updates since our last earnings
release:
- Business Development: In July 2024, Zai Lab entered into
a strategic partnership and global license agreement with MabCare
Therapeutics. Through this collaboration, the Company expanded its
global oncology pipeline with a next generation ADC targeting ROR1,
ZL-6301. ZL-6301 has the potential to be used in the treatment of
solid tumors where ROR1 is commonly expressed and in hematological
malignancies where ROR1 is a validated target. ZL-6301 has
demonstrated an encouraging pre-clinical profile, and it is
currently in the IND-enabling stage. Zai Lab plans to focus on
advancing its global development.
- Organizational Update: In June 2024, Zai Lab appointed
Dr. Rafael Amado as President, Head of Global Research and
Development, expanding his role to encompass R&D efforts across
all of our therapeutic areas upon the retirement of Dr. Harald
Reinhart at the end of June. This leadership transition allows for
continued momentum and a strategic focus on our pipeline.
Recent Pipeline
Highlights
Below are key product updates since our last earnings
release:
Oncology Pipeline
- Niraparib (PARP): In July 2024, Zai Lab announced that
data of a Zai-supported study published in Cell provides new
insights with potential to improve treatment of HRD-positive
ovarian cancers, including through neoadjuvant monotherapy with
niraparib and a combination of niraparib and ZL-1218, an
investigational CCR8 antibody.
– In June 2024, Zai Lab and partner Amgen
completed enrollment for the global Phase 3 FORTITUDE-101 study of
bemarituzumab plus chemotherapy in first-line gastric cancer.
– The enrollment is ongoing for the global
Phase 3 FORTITUDE-102 study of bemarituzumab plus chemotherapy and
nivolumab in first-line gastric cancer in mainland China, Hong
Kong, Macau, and Taiwan (collectively, Greater China).
- AUGTYRO™ (Repotrectinib) (ROS1/TRK):
– In May 2024, China’s National Medical
Products Administration (NMPA) approved the New Drug Application
(NDA) for repotrectinib for the treatment of adult patients with
locally advanced or metastatic ROS1-positive NSCLC. The approval
was based on the global TRIDENT-1 study that evaluated
repotrectinib in TKI naïve and TKI-pretreated patients with
ROS1-positive NSCLC. We participated in the Greater China portion
of this study.
– In June 2024, Zai Lab partner Bristol Myers
Squibb (BMS) announced that the U.S. Food and Drug Administration
(FDA) had granted accelerated approval of AUGTYRO for the treatment
of patients with NTRK-positive locally advanced or metastatic solid
tumors.
- ZL-1310 (DLL3 ADC): The enrollment in the United States
and Greater China is ongoing for the global Phase 1 study in
relapsed and refractory second-line+ small cell lung cancer (SCLC)
who have progressed on or after platinum-based chemotherapy.
- ZL-1218 (CCR8): The enrollment in the United States,
Europe, and Greater China is ongoing for the global Phase 1 study
of ZL-1218 as a single agent and in combination with pembrolizumab
in patients with advanced solid tumor malignancies.
Immunology, Neuroscience, and Infectious Disease
Pipeline
– In July 2024, the NMPA approved the
Biologics License Application (BLA) for efgartigimod alfa injection
(subcutaneous injection) (efgartigimod SC) as an add on to standard
therapy for the treatment of adult patients with gMG who are
anti-acetylcholine receptor (AChR) antibody positive. This approval
will provide additional flexibility and optionality for gMG
patients in mainland China.
– In May 2024, the NMPA accepted the
supplemental Biologics License Application (sBLA) with priority
review for efgartigimod SC in chronic inflammatory demyelinating
polyneuropathy (CIDP). In June 2024, Zai Lab partner argenx
announced that the FDA approved VYVGART® Hytrulo (efgartigimod alfa
and hyaluronidase-qvfc) for this indication. We participated in the
global ADHERE Study, the largest clinical trial to date studying
CIDP.
- XACDURO® (Sulbactam-Durlobactam or SUL-DUR): In May
2024, the NMPA approved the NDA for XACDURO for the treatment of
adult patients with hospital-acquired bacterial pneumonia and
ventilator-associated bacterial pneumonia (HABP/VABP) caused by
susceptible isolates of Acinetobacter baumannii-calcoaceticus
complex.
- Xanomeline-Trospium (KarXT) (M1/M4-agonist): In July
2024, Zai Lab joined the global Phase 3 ADEPT-2 study in
Alzheimer’s disease with psychosis in Greater China.
- ZL-1102 (IL-17 Humabody®): In May 2024, Zai Lab dosed
the first patient in a global Phase 2 study evaluating the efficacy
and safety of ZL-1102 for the treatment of chronic plaque psoriasis
(CPP).
Anticipated Major Milestones in
2024 and the First Half of
2025
Potential Regulatory Submissions to the NMPA
- TTFields: Marketing Authorization Application (MAA)
submission in second-line+ NSCLC following progression on or after
platinum-based chemotherapy in the fourth quarter of 2024.
- Tisotumab Vedotin (Tissue Factor ADC): BLA submission in
recurrent or metastatic cervical cancer following progression on or
after chemotherapy.
- Repotrectinib (ROS1/TRK): supplementary NDA (sNDA)
submission in NTRK+ solid tumors.
- Xanomeline-Trospium (KarXT) (M1/M4-agonist): NDA
submission in schizophrenia.
Expected Clinical Development and Data Readouts
Efgartigimod (FcRn)
- Zai Lab to join the registrational study of efgartigimod SC
given by prefilled syringe in Thyroid Eye Disease (TED) in Greater
China in the fourth quarter of 2024.
- argenx to provide topline data from the Phase 2/3 ALKIVIA study
evaluating efgartigimod across three myositis subsets
(immune-mediated necrotizing myopathy (IMNM), anti-synthetase
syndrome (ASyS), and dermatomyositis (DM)) in the fourth quarter of
2024. Zai Lab to join the Phase 3 portion of this study in the
fourth quarter of 2024.
- Zai Lab to join the global registrational Phase 3 studies in
seronegative gMG and ocular MG in early 2025, aiming to expand the
label into broader MG populations.
Xanomeline-Trospium (KarXT) (M1/M4-agonist)
- Zai Lab to complete patient enrollment of the China
registrational bridging study in schizophrenia, with topline data
expected by the end of 2024.
- 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.
TTFields
- 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.
ZL-1218 (CCR8)
- Present the preliminary clinical PK and PD analysis of the
global Phase 1 study in solid tumors at 2024 European Society for
Medical Oncology (ESMO) in September 2024.
Conference Call and Webcast
Information
Zai Lab will host a live conference call and webcast tomorrow,
August 7, 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/BIaccafead4b094cf191720bf5d03048c6
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, immunology, neuroscience, and infectious disease. 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
Unaudited Condensed Consolidated Balance Sheets
(in thousands of U.S. dollars ($), except for number of
shares and per share data)
June 30, 2024
December 31,
2023
Assets
Current assets
Cash and cash equivalents
630,048
790,151
Restricted cash, current
100,000
—
Short-term investments
—
16,300
Accounts receivable (net of allowance for
credit losses of $20 and $17 as of June 30, 2024 and December 31,
2023, respectively)
69,635
59,199
Notes receivable
8,102
6,134
Inventories, net
41,846
44,827
Prepayments and other current assets
20,292
22,995
Total current assets
869,923
939,606
Restricted cash, non-current
1,116
1,113
Long term investments
4,073
9,220
Prepayments for equipment
46
111
Property and equipment, net
50,613
53,734
Operating lease right-of-use assets
13,102
14,844
Land use rights, net
2,991
3,069
Intangible assets, net
44,063
13,389
Long-term deposits
1,441
1,209
Total assets
987,368
1,036,295
Liabilities and shareholders’
equity
Current liabilities
Accounts payable
127,344
112,991
Current operating lease liabilities
7,581
7,104
Short-term debt
70,298
—
Other current liabilities
46,495
82,972
Total current liabilities
251,718
203,067
Deferred income
25,343
28,738
Non-current operating lease
liabilities
5,803
8,047
Other non-current liabilities
325
325
Total liabilities
283,189
240,177
Commitments and contingencies
Shareholders’ equity
Ordinary shares (par value of $0.000006
per share; 5,000,000,000 shares authorized; 986,310,340 and
977,151,270 shares issued as of June 30, 2024 and December 31,
2023, respectively; 981,398,140 and 972,239,070 shares outstanding
as of June 30, 2024 and December 31, 2023, respectively)
6
6
Additional paid-in capital
3,011,964
2,975,302
Accumulated deficit
(2,329,728
)
(2,195,980
)
Accumulated other comprehensive income
42,773
37,626
Treasury Stock (at cost, 4,912,200 shares
as of both June 30, 2024 and December 31, 2023)
(20,836
)
(20,836
)
Total shareholders’ equity
704,179
796,118
Total liabilities and shareholders’
equity
987,368
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 June
30,
Six Months Ended June
30,
2024
2023
2024
2023
Revenues
Product revenue, net
100,106
68,864
187,255
131,661
Collaboration revenue
398
—
398
—
Total revenues
100,504
68,864
187,653
131,661
Expenses
Cost of product revenue
(35,148
)
(23,763
)
(68,767
)
(45,100
)
Cost of collaboration revenue
(85
)
—
(85
)
—
Research and development
(61,625
)
(76,682
)
(116,270
)
(125,153
)
Selling, general, and administrative
(79,710
)
(67,920
)
(148,904
)
(130,430
)
Gain on sale of intellectual property
—
10,000
—
10,000
Loss from operations
(76,064
)
(89,501
)
(146,373
)
(159,022
)
Interest income
9,330
10,090
18,988
20,321
Interest expense
(492
)
—
(605
)
—
Foreign currency losses
(4,108
)
(40,079
)
(6,176
)
(31,167
)
Other (expenses) income, net
(8,943
)
(1,405
)
418
(171
)
Loss before income tax
(80,277
)
(120,895
)
(133,748
)
(170,039
)
Income tax expense
—
—
—
—
Net loss
(80,277
)
(120,895
)
(133,748
)
(170,039
)
Loss per share - basic and diluted
(0.08
)
(0.13
)
(0.14
)
(0.18
)
Weighted-average shares used in
calculating net loss per ordinary share - basic and diluted
975,937,790
964,817,310
974,541,780
963,140,360
Zai Lab Limited
Unaudited Condensed Consolidated Statements of Comprehensive
Loss
(in thousands of $)
Three Months Ended June
30,
Six Months Ended June
30,
2024
2023
2024
2023
Net loss
(80,277
)
(120,895
)
(133,748
)
(170,039
)
Other comprehensive income, net of tax of
nil:
Foreign currency translation
adjustments
3,605
34,908
5,147
26,495
Comprehensive loss
(76,672
)
(85,987
)
(128,601
)
(143,544
)
Zai Lab Limited
Non-GAAP Measures
(in thousands of $)
Three Months Ended June
30,
Year over Year %
Growth
Six Months Ended June
30,
Year over Year %
Growth
2024
2023
As reported
At CER*
2024
2023
As reported
At CER*
Product revenue, net
100,106
68,864
45
%
47
%
187,255
131,661
42
%
45
%
Loss from operations
(76,064
)
(89,501
)
(15
)%
(15
)%
(146,373
)
(159,022
)
(8
)%
(8
)%
* 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/20240806076148/en/
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
Zai Lab (NASDAQ:ZLAB)
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