Company to Host Conference Call and Webcast Today at 8:00 a.m. EDT
SHANGHAI and SAN FRANCISCO, May 10, 2021 (GLOBE NEWSWIRE) — Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, today announced financial results for the first quarter of 2021, along with recent product highlights and corporate updates.
�Zai Lab continued to execute well in all aspects of the business during the first quarter, said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. We entered into several strategic collaborations to further strengthen our gastric and lung cancer disease strongholds; significantly bolstered our autoimmune franchise with an exclusive agreement with argenx for efgartigimod, a pipeline-in-a-product opportunity; advanced numerous clinical programs toward key data readouts; gained approval of QINLOCK by the National Medical Products Administration (NMPA), our third innovative oncology product approval in the last 15 months in China and the first commercial product in what we expect to become a world-class gastric cancer franchise; and generated solid revenue growth, in part from increased volume of ZEJULA driven by its recent inclusion on the National Reimbursement Drug List (NRDL). In addition, we recently received encouraging news on several key assets from our partners. The Biologics License Application (BLA) filing of efgartigimod in generalized myasthenia gravis (gMG) was accepted by the U.S. Food and Drug Administration (FDA). The Phase 3 pivotal LUNAR trial of Tumor Treating Fields in non-small cell lung cancer (NSCLC) was recommended to continue with reduced sample size based on an accelerated interim analysis. Bemarituzumab was granted Breakthrough Therapy Designation by the FDA as first-line treatment for gastric cancer patients who overexpress FGFR2b.
With the completion of our recent global public offering with gross proceeds of nearly $860 million, we significantly strengthened our capital position. This new capital will allow us to accelerate our growth by entering into additional strategic partnerships, advancing our clinical development pipeline, and scaling our commercial and R&D organizations to drive strong revenue growth and enhance our global pipeline.
We remain on target to advance all stages of our product pipeline throughout 2021. We continue to expect approval of Nuzyra for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) by the NMPA. We plan to file margetuximab for Her2-positive breast cancer, Tumor Treating Fields for mesothelioma and ZEJULA for late-line ovarian cancer in China. We are engaging with the NMPA on the regulatory filing strategy for efgartigimod in gMG in China. And we anticipate numerous data readouts, including for Tumor Treating Fields in liver cancer and ovarian cancer, for QINLOCK in second-line GIST, for margetuximab in gastric cancer, for CLN-081 in NSCLC and for TPX-0022 in NSCLC and gastric cancer.
In our mission to address serious unmet medical needs for patients in China and around the world, we believe that we have built a sustainable platform that we can leverage, Dr. Du concluded. Our team continues to deliver on our aggressive growth objectives. I believe that the future of Zai Lab has never been brighter.
Recent Product Highlights and Anticipated Milestones
Oncology
ZEJULA® (niraparib)
ZEJULA is an oral, once-daily small-molecule poly ADP-ribose polymerase (PARP) 1/2 inhibitor. It is the only PARP inhibitor approved in the United States, the European Union and mainland China (hereinafter, China) as a monotherapy for patients with advanced ovarian cancer, regardless of their biomarker status.
Anticipated 2021 Zai Milestones
Tumor Treating Fields
Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and potentially causing cancer cell death.
Recent Product Highlights
Anticipated 2021 Zai Milestones
Anticipated 2021 Partner Milestones
QINLOCK® (ripretinib)
QINLOCK is a switch-control tyrosine kinase inhibitor engineered to broadly inhibit KIT- and PDGFR?-mutated kinases. It is the only therapeutic approved in the United States for advanced GIST patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting.
Recent Product Highlight
Anticipated 2021 Zai Milestones
Anticipated 2021 Partner Milestones
Odronextamab
Odronextamab is a bispecific monoclonal antibody designed to trigger tumor killing by linking and activating a cytotoxic T-cell (binding to CD3) to a lymphoma cell (binding to CD20).
Anticipated 2021 Zai Milestone
Anticipated 2021 Partner Milestones
Repotrectinib
Repotrectinib is a next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and TRK A/B/C, with the potential to treat TKI-naïve or TKI-pretreated patients.
Anticipated 2021 Zai Milestone
Anticipated 2021 Partner Milestones
MARGENZA (Margetuximab)
MARGENZA is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2).
Anticipated 2021 Zai Milestone
Anticipated 2021 Partner Milestones
Bemarituzumab
Bemarituzumab is a first-in-class antibody that is being developed in gastric and gastroesophageal junction cancer as a targeted therapy for tumors that overexpress FGFR2b.
Recent Product Highlight
Anticipated 2021 Zai Milestone
CLN-081
CLN-081 is an orally available, small-molecule, next-generation, irreversible epidermal growth factor receptor (EGFR) inhibitor designed to selectively target cells expressing mutant EGFR variants, including EGFR exon 20 insertions.
Anticipated 2021 Zai Milestone
Anticipated 2021 Partner Milestone
TPX-0022
TPX-0022 is an orally bioavailable, multi-targeted kinase inhibitor with a novel three-dimensional macrocyclic structure that inhibits the MET, CSF1R (colony stimulating factor 1 receptor) and SRC kinases.
Anticipated 2021 Partner Milestones
Tebotelimab
Tebotelimab is an investigational, first-in-class, bispecific, tetravalent DART molecule targeting PD-1 and LAG-3.
Anticipated 2021 Zai and Partner Milestone
Retifanlimab
Retifanlimab is an investigational monoclonal antibody that inhibits PD-1.
Recent Product Highlight
Autoimmune Diseases
Efgartigimod
Efgartigimod is an antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) antibodies and block the IgG recycling process. Efgartigimod binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG antibodies from degradation.
Recent Product Highlight
Anticipated 2021 Zai Milestones
Anticipated 2021 Partner Milestones
Infectious Disease
NUZYRA® (omadacycline)
NUZYRA is a once-daily oral and intravenous antibiotic for the treatment of adults with CABP and ABSSSI.
Anticipated 2021 Zai Milestone
Sulbactam-Durlobactam (SUL-DUR)
Sulbactam-Durlobactam is a beta-lactam/beta-lactamase inhibitor combination that provides unique activity against Acinetobacter organisms, including carbapenem-resistant strains.
Anticipated 2021 Zai and Partner Milestone
Internal Programs with Global Rights
ZL-2309 (CDC7)
ZL-2309 is an orally active, selective and ATP-competitive cell division cycle 7 (CDC7) kinase inhibitor.
Anticipated 2021 Zai Milestone
ZL-1102 (IL-17)
ZL-1102 is a novel human nanobody targeting IL-17 with high affinity and avidity. Unlike other anti-IL-17 products, ZL-1102 is being developed as a topical treatment for chronic plaque psoriasis (CPP).
Anticipated 2021 Zai Milestone
Business Development Updates
Corporate Updates
First-Quarter 2021 Financial Results
Conference Call and Webcast Information
Zai Lab will host a live conference call and webcast today, May 10, 2021, at 8:00 a.m. ET. Listeners may access the live webcast by visiting the Companys website at http://ir.zailaboratory.com. Participants must register in advance of the conference call. Details are as follows:
Registration Link: http://apac.directeventreg.com/registration/event/2374839
Conference ID: 2374839
All participants must use the link provided above to complete the online registration process in advance of the conference call. Upon registering, each participant will receive a dial-in number, Direct Event passcode and a unique access PIN, which can be used to join the conference call.
A replay will be available shortly after the call and can be accessed by visiting the Companys website at http://ir.zailaboratory.com.
About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company focused on developing and commercializing therapies that address medical conditions with unmet needs in oncology, autoimmune disorders and infectious disease. To that end, our experienced team has secured partnerships with leading global biopharmaceutical companies in order to generate a broad pipeline of innovative marketed products and product candidates. We have also built an in-house team with strong product discovery and translational research capabilities and are establishing a pipeline of proprietary product candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to impact human health worldwide.
For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.
Zai Lab Forward-Looking Statements
This press release contains references to statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements regarding our ability to advance our product pipeline and further demonstrate our commercial and discovery capabilities, anticipated milestones for our approved products and product candidates and other statements containing words such as aim, anticipate, believe, estimate, expect, intend, may, plan, predict, project, seek, target, potential, will, would, could, should, continue, contemplate 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 neither historical facts nor assurances of future performance. Forward-looking statements are based on Zai Labs expectations and assumptions that Zai Lab believes are reasonable 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. Actual results of operations, financial condition and liquidity and the development of the industry in which Zai Lab operates may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Labs ability to successfully commercialize and generate revenue from its approved products; (2) Zai Labs ability to finance its operations and business initiatives and obtain funding for such activities, (3) Zai Labs results of clinical and pre-clinical development of its product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Labs product candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on general economic, regulatory and political conditions and (6) other factors discussed in Zai Labs Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed on March 1, 2021, and its other filings with the Securities and Exchange Commission. Zai Lab anticipates that subsequent events and developments will cause Zai Labs expectations and assumptions to change and undertakes 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 Zai Labs views as of any date subsequent to the date of this press release.
For more information, please contact:
ZAI LAB CONTACTS:
Zai Lab
Billy Cho, CFO
+86 137 6151 2501
billy.cho@zailaboratory.com
Media: Ryo Imai / Robert Flamm, Ph.D.
Burns McClellan, on behalf of Zai Lab
212-213-0006 ext. 315 / 364
rimai@burnsmc.com / rflamm@burnsmc.com
Investors: Mike Zanoni
Endurance Advisors, on behalf of Zai Lab
610-442-8570
mzanoni@enduranceadvisors.com
Zai Lab Limited
Zai Lab Limited | ||||||
Unaudited Condensed Consolidated Balance Sheets | ||||||
(In thousands of U.S. dollars (“$”) except for number of shares and per share data) | ||||||
As of | ||||||
March 31, 2021 | December 31, 2020 | |||||
$ | $ | |||||
Assets | ||||||
Current assets: | ||||||
Cash and cash equivalents | 1,013,420 | 442,116 | ||||
Short-term investments | – | 744,676 | ||||
Accounts receivable (net of allowance of $2 and $1 as of March 31, 2021 and 2020, respectively) | 8,815 | 5,165 | ||||
Inventories | 12,629 | 13,144 | ||||
Prepayments and other current assets | 14,321 | 10,935 | ||||
Total current assets | 1,049,185 | 1,216,036 | ||||
Restricted cash, non-current | 743 | 743 | ||||
Investments in equity investees | 1,473 | 1,279 | ||||
Prepayments for equipment | 244 | 274 | ||||
Property and equipment, net | 29,016 | 29,162 | ||||
Operating lease right-of-use assets | 16,652 | 17,701 | ||||
Land use rights, net | 7,784 | 7,908 | ||||
Intangible assets, net | 1,585 | 1,532 | ||||
Long term deposits | 910 | 862 | ||||
Value added tax recoverable | 23,698 | 22,141 | ||||
Total assets | 1,131,290 | 1,297,638 | ||||
Liabilities and shareholders’ equity | ||||||
Current liabilities: | ||||||
Accounts payable | 41,415 | 62,641 | ||||
Current operating lease liabilities | 5,602 | 5,206 | ||||
Other current liabilities | 45,639 | 30,196 | ||||
Total current liabilities | 92,656 | 98,043 | ||||
Deferred income | 16,657 | 16,858 | ||||
Non-current operating lease liabilities | 12,307 | 13,392 | ||||
Total liabilities | 121,620 | 128,293 | ||||
Commitments and contingencies (Note 18) | ||||||
Shareholders’ equity | ||||||
Ordinary shares (par value of $0.00006 per share; 500,000,000 shares authorized, 88,519,172 and 74,666,725 shares issued and outstanding as of March 31, 2021 and 2020, respectively) | 5 | 5 | ||||
Additional paid-in capital | 1,967,802 | 1,897,467 | ||||
Accumulated deficit | (946,513 | ) | (713,603 | ) | ||
Accumulated other comprehensive loss | (11,624 | ) | (14,524 | ) | ||
Total shareholders’ equity | 1,009,670 | 1,169,345 | ||||
Total liabilities and shareholders’ equity | 1,131,290 | 1,297,638 | ||||
Zai Lab Limited | |||||||
Unaudited Condensed Consolidated Statements of Operations | |||||||
(In thousands of U.S. dollars (“$”) except for number of shares and per share data) | |||||||
Three Months Ended March 31, | |||||||
2021 | 2020 | ||||||
$ | $ | ||||||
Revenue | 20,103 | 8,218 | |||||
Expenses: | |||||||
Cost of sales | (7,505 | ) | (2,084 | ) | |||
Research and development | (203,852 | ) | (33,742 | ) | |||
Selling, general and administrative | (35,838 | ) | (18,714 | ) | |||
Loss from operations | (227,092 | ) | (46,322 | ) | |||
Interest income | 214 | 1,655 | |||||
Interest expenses | – | (59 | ) | ||||
Other expense, net | (6,227 | ) | (3,125 | ) | |||
Loss before income tax and share of gain (loss) from equity method investment | (233,105 | ) | (47,851 | ) | |||
Income tax expense | – | – | |||||
Share of gain (loss) from equity method investment | 195 | (137 | ) | ||||
Net loss | (232,910 | ) | (47,988 | ) | |||
Net loss attributable to ordinary shareholders | (232,910 | ) | (47,988 | ) | |||
Loss per share – basic and diluted | (2.64 | ) | (0.66 | ) | |||
Weighted-average shares used in calculating net loss per ordinary share – basic and diluted | 88,374,928 | 72,956,538 | |||||
Zai Lab Limited | |||||||
Unaudited Condensed Consolidated Statements of Comprehensive Loss | |||||||
(In thousands of U.S. dollars (“$”) except for number of shares and per share data) | |||||||
Three Months Ended March 31, | |||||||
2021 | 2020 | ||||||
$ | $ | ||||||
Net loss | (232,910 | ) | (47,988 | ) | |||
Other comprehensive income, net of tax of nil: | |||||||
Foreign currency translation adjustments | 2,900 | 3,539 | |||||
Comprehensive loss | (230,010 | ) | (44,449 | ) |
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