SHANGHAI and CAMBRIDGE, Mass., March 01, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced full-year 2022 financial results, along with recent product highlights and corporate updates.
“In 2022, our four marketed products each had substantial sales growth, and we made exciting progress across our pipeline globally,” said Dr. Samantha Du, Founder, Chief Executive Officer, and Chairperson of the Board of Directors of Zai Lab. “Our pipeline assets continued to demonstrate potential global best-in-class and/or first-in-class profile with numerous positive late-stage data readouts announced during the year, including adagrasib in non-small cell lung cancer, KarXT in schizophrenia, and efgartigimod in primary immune thrombocytopenia and generalized myasthenia gravis. We are also pleased to have contributed to several successful registrational studies, including the Tumor Treating Fields LUNAR study and the repotrectinib TRIDENT-1 study. We are also pleased to have added QINLOCK and NUZYRA to China’s National Reimbursement Drug List (NRDL) in 2023. We further deepened our women’s cancer franchise through our strategic collaboration with Seagen for TIVDAK. And, we continued to significantly enhance our talented global team.”
“Zai Lab is already a leading global biotech with relevant scale, a world-class pipeline, and a growing commercial portfolio in China. We expect to achieve commercial profitability this year, and we are preparing to launch at least 8 additional products and achieve overall corporate profitability by the end of 2025,” Dr. Du continued. “We will continue to invest in research and development as we seek to advance our product pipeline, including our internal discovery activities, and accelerate medicines to patients in need. We also aim to strengthen our portfolio and strategic positioning with potentially transformative assets and partnerships.”
“We believe that the global regulatory environment will continue to be supportive of innovative biopharmaceutical companies like Zai Lab,” Dr. Du concluded. “We will continue to build on our success in pursuit of our overall goal of improving human health, in China and globally.”
2023 Strategic Priorities
Zai Lab will focus on the following strategic priorities in 2023 to drive innovation in China and beyond:
Regulatory and Commercial
Research and Clinical Development
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 (FDA), the European Union (EMA), and mainland China (NMPA) as a first-line maintenance monotherapy for patients with advanced ovarian cancer, regardless of their biomarker status.
Recent Product Highlights
Anticipated 2023 Zai Milestone
Tumor Treating Fields
Tumor Treating Fields (TTFields) are electric fields that disrupt cancer cell division. Optune and Optune Lua, commercial TTFields devices, are approved or marketed in certain countries or regions, including the United States, Greater China (mainland China, Hong Kong, Macau, and Taiwan), Europe, and Japan, for the treatment of newly diagnosed and recurrent glioblastoma and malignant pleural mesothelioma.
Recent Product Highlights
Anticipated 2023 Partner and Zai Milestones
QINLOCK® (ripretinib)
QINLOCK is an orally administered switch-control tyrosine kinase inhibitor engineered to broadly inhibit KIT- and PDGFRα-mutated kinases. It is the only therapeutic approved in the United States and mainland China for the treatment of advanced gastrointestinal stromal tumor (GIST) patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting.
Recent Product Highlights
TIVDAK® (tisotumab vedotin)
TIVDAK is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed against cell surface tissue factor (TF) and Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody.
Recent Product Highlight
Anticipated 2023 Partner and Zai Milestone
Anticipated 2023 Partner Milestones
KRAZATI™ (adagrasib)
KRAZATI™ is a highly selective and potent oral small-molecule inhibitor of KRASG12C for treating KRASG12C-mutated NSCLC, colorectal cancer (CRC), pancreatic cancer and other solid tumors.
Recent Product Highlights
Anticipated 2023 Partner and Zai Milestones
Anticipated 2023 Partner Milestones
Bemarituzumab
Bemarituzumab is a potential first-in-class humanized monoclonal antibody that is in clinical development as a targeted therapy for gastric and gastroesophageal junction cancer patients whose tumors overexpress FGFR2b.
Recent Product Highlight
Anticipated 2023 Zai Milestones
Odronextamab
Odronextamab is an investigational 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).
Recent Product Highlight
Anticipated 2023 Zai Milestone
Anticipated 2023 Partner Milestones
Repotrectinib
Repotrectinib is an investigational next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and TRK A/B/C in TKI-naïve or TKI-pretreated cancer patients.
Anticipated 2023 Zai Milestones
Zipalertinib (previously CLN-081)
Zipalertinib is an orally available small molecule designed as a next-generation, irreversible epidermal growth factor receptor (EGFR) inhibitor in development for the treatment of patients with EGFR exon 20 insertion NSCLC.
Recent Product Highlight
MARGENZA™ (margetuximab)
MARGENZA is an investigational, immune-enhancing monoclonal antibody that targets human epidermal growth factor receptor 2 (HER2)-positive tumors, including certain types of breast and gastroesophageal cancers.
Anticipated 2023 Zai Milestone
BLU-945
BLU-945 is a potential next-generation investigational oral EGFR inhibitor designed to selectively target the EGFR L858R activating mutation as well as C797X and T790M on-target resistance mutations, while being highly selective against wild-type EGFR. BLU-945 is in development for the potential treatment of EGFR-mutant NSCLC.
Anticipated 2023 Partner Milestone
Retifanlimab
Retifanlimab is an investigational monoclonal antibody that inhibits PD-1.
Recent Product Update
Internal Oncology R&D Programs (Global Rights)
Recent Update
Anticipated 2023 Zai Milestone
Autoimmune Disorders
VYVGART® (efgartigimod)
Efgartigimod is an investigational antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) antibodies and block the IgG recycling process. It binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG from degradation.
Recent Product Highlights
Anticipated 2023 Zai Milestones
Anticipated 2023 Partner Milestones
ZL-1102 (IL-17 Human VH Antibody Fragment, Global Rights)
ZL-1102 is a human VH antibody fragment (Humabody®) targeting the IL-17A cytokine with high affinity and avidity. Unlike other anti-IL-17 products, ZL-1102 is being developed as a topical treatment for mild-to-moderate chronic plaque psoriasis (CPP).
Anticipated 2023 Zai Milestone
Infectious Disease
Sulbactam-Durlobactam (SUL-DUR, Asia Pacific rights)
Sulbactam-Durlobactam is a combination of a beta-lactam antibiotic (sulbactam) and a beta-lactamase inhibitor (durlobactam) for the treatment of serious infections caused by Acinetobacter, including multi-drug and carbapenem-resistant strains.
Recent Product Highlights
Anticipated 2023 Partner Milestone
NUZYRA® (omadacycline)
NUZYRA is a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in both hospital and community settings.
Recent Product Highlight
Neuroscience
KarXT
KarXT (xanomeline-trospium) is an oral, investigational M1/M4-preferring muscarinic acetylcholine receptor agonist in development for the treatment of psychiatric and neurological conditions, including schizophrenia and dementia-related psychosis.
Anticipated 2023 Zai Milestone
Anticipated 2023 Partner Milestones
Corporate Updates
Financial Results for Full-Year 2022
Conference Call and Webcast Information
Zai Lab will host a live conference call and webcast tomorrow, March 2, 2023, at 8:00 a.m. ET. 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/BI7e1f2dd4243c461585564c4b7dd866a6.
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 focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world. Our goal is to leverage our competencies and resources to positively impact human health worldwide.
For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.
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; capital allocation and investment strategy; 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. 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) the effects of the COVID-19 pandemic on our business and results of operations; (6) risks related to doing business in China; and (7) other factors identified in our most recent annual report filed with the U.S. Securities and Exchange Commission. 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.
For more information, please contact:
Investor Relations: Lina Zhang
+86 136 8257 6943
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Media: Christine Drury / Xiaoyu Chen
+1 (317) 385-9227 / +86 185 0015 5011
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Zai Lab Limited Consolidated balance sheets (In thousands of U.S. dollars (“$”) except for number of shares and per share data) | ||||||
December 31, 2022 | December 31, 2021 | |||||
$ | $ | |||||
Assets | ||||||
Current assets | ||||||
Cash and cash equivalents | 1,008,470 | 964,100 | ||||
Short-term investments | — | 445,000 | ||||
Accounts receivable (net of allowance for credit loss of $11 as of December 31, 2022 and 2021, respectively) | 39,963 | 47,474 | ||||
Notes receivable | 8,608 | 7,335 | ||||
Inventories | 31,621 | 18,951 | ||||
Prepayments and other current assets | 35,674 | 18,021 | ||||
Total current assets | 1,124,336 | 1,500,881 | ||||
Restricted cash, non-current | 803 | 803 | ||||
Long-term investments (including the fair value measured investment of $6,431 and $15,383 as of December 31, 2022 and 2021, respectively) | 6,431 | 15,605 | ||||
Prepayments for equipment | 1,396 | 989 | ||||
Property and equipment, net | 57,863 | 43,102 | ||||
Operating lease right-of-use assets | 19,512 | 14,189 | ||||
Land use rights, net | 6,892 | 7,811 | ||||
Intangible assets, net | 1,511 | 1,848 | ||||
Long-term deposits | 1,396 | 870 | ||||
Value added tax recoverable | — | 23,858 | ||||
Total assets | 1,220,140 | 1,609,956 | ||||
Liabilities and shareholders’ equity | ||||||
Current liabilities | ||||||
Accounts payable | 65,974 | 126,163 | ||||
Current operating lease liabilities | 7,050 | 5,927 | ||||
Other current liabilities | 66,818 | 60,811 | ||||
Total current liabilities | 139,842 | 192,901 | ||||
Deferred income | 21,360 | 27,486 | ||||
Non-current operating lease liabilities | 13,343 | 9,613 | ||||
Total liabilities | 174,545 | 230,000 | ||||
Commitments and contingencies | ||||||
Shareholders’ equity | ||||||
Ordinary shares (par value of $0.000006 per share; 5,000,000,000 shares authorized, 962,455,850 and 955,363,980 shares issued as of December 31, 2022 and 2021, respectively; 960,219,570 and 954,981,050 shares issued and outstanding as of December 31, 2022 and 2021, respectively) | 6 | 6 | ||||
Additional paid-in capital | 2,893,120 | 2,825,948 | ||||
Accumulated deficit | (1,861,360 | ) | (1,418,074 | ) | ||
Accumulated other comprehensive income (loss) | 25,685 | (23,645 | ) | |||
Treasury stock (at cost, 2,236,280 and 382,930 shares as of December 31, 2022 and 2021, respectively) | (11,856 | ) | (4,279 | ) | ||
Total shareholders’ equity | 1,045,595 | 1,379,956 | ||||
Total liabilities and shareholders’ equity | 1,220,140 | 1,609,956 |
Zai Lab Limited Consolidated statements of operations (In thousands of U.S. dollars (“$”) except for number of shares and per share data) | |||||||||
Year Ended December 31, | |||||||||
2022 | 2021 | 2020 | |||||||
$ | $ | $ | |||||||
Revenues | |||||||||
Product revenue, net | 212,672 | 144,105 | 48,958 | ||||||
Collaboration revenue | 2,368 | 207 | — | ||||||
Total revenues | 215,040 | 144,312 | 48,958 | ||||||
Expenses | |||||||||
Cost of sales | (74,018 | ) | (52,239 | ) | (16,736 | ) | |||
Research and development | (286,408 | ) | (573,306 | ) | (222,711 | ) | |||
Selling, general and administrative | (258,971 | ) | (218,831 | ) | (111,312 | ) | |||
Loss from operations | (404,357 | ) | (700,064 | ) | (301,801 | ) | |||
Interest income | 14,582 | 2,190 | 5,120 | ||||||
Interest expenses | — | — | (181 | ) | |||||
Foreign currency (loss) gain | (56,403 | ) | 4,661 | 21,659 | |||||
Other income (expenses), net | 3,113 | (10,201 | ) | 7,417 | |||||
Loss before income tax and share of loss from equity method investment | (443,065 | ) | (703,414 | ) | (267,786 | ) | |||
Income tax expense | — | — | — | ||||||
Share of loss from equity method investment | (221 | ) | (1,057 | ) | (1,119 | ) | |||
Net loss | (443,286 | ) | (704,471 | ) | (268,905 | ) | |||
Loss per share — basic and diluted | (0.46 | ) | (0.76 | ) | (0.35 | ) | |||
Weighted-average shares used in calculating net loss per ordinary share — basic and diluted | 958,067,140 | 929,921,120 | 776,677,430 | ||||||
Loss per American Depositary Shares (“ADS”) - basic and diluted | (4.63 | ) | (7.58 | ) | (3.46 | ) | |||
Weighted-average ADSs used in calculating net loss per ADS - basic and diluted | 95,806,714 | 92,992,112 | 77,667,743 |
Note: Basic and diluted net loss per ordinary share, weighted average number of ordinary shares for the year ended December 31, 2021 have been retrospectively adjusted as a result of the Share Subdivision and the ADS Ratio Change that became effective on March 30, 2022. The Share Subdivision and ADS Ratio Change did not result in any change to the number of outstanding ADSs of the Company.
Zai Lab Limited Consolidated statements of comprehensive loss (In thousands of U.S. dollars (“$”) except for number of shares and per share data) | ||||||||
Year Ended December 31, | ||||||||
2022 | 2021 | 2020 | ||||||
$ | $ | $ | ||||||
Net loss | (443,286 | ) | (704,471 | ) | (268,905 | ) | ||
Other comprehensive income (loss), net of tax of nil: | ||||||||
Foreign currency translation adjustments | 49,330 | (9,121 | ) | (19,144 | ) | |||
Comprehensive loss | (393,956 | ) | (713,592 | ) | (288,049 | ) |
Last Trade: | US$19.85 |
Daily Change: | 0.21 1.07 |
Daily Volume: | 303,954 |
Market Cap: | US$1.980B |
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