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SHANGHAI and CAMBRIDGE, Mass., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced financial results for the third quarter of 2022, along with recent product highlights and corporate updates.
“Zai Lab’s third quarter was marked by a new regional and highly synergistic collaboration, strong revenue growth across our commercial products, and significant progress toward achieving our remaining 2022 corporate priorities,” said Dr. Samantha Du, Founder, Chairperson and CEO, of Zai Lab. “The company’s strategic positioning with respect to its targeted disease areas provides a robust and synergistic platform to benefit patients in Greater China and around the world as we continue to increase our sales and developmental efforts. Looking ahead, we expect this momentum to be bolstered by our late-stage development candidates that are progressing through pivotal studies and regulatory submissions. As one example, we reached an agreement with the NMPA on the development plan for a bridging study for KarXT in schizophrenia in China. In addition, our recently announced strategic collaboration with Seagen for the license of TIVDAK strengthens our ability to address unmet medical needs in women’s cancer. TIVDAK is the first and only ADC approved in the U.S. for the treatment of adult patients with recurrent or metastatic cervical cancer. Zai Lab is progressing this asset in pivotal studies in China.”
Recent Product Developments 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 China as afirst-line maintenancemonotherapy for patients with advanced ovarian cancer, regardless of their biomarker status.
Recent Product Highlights
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 for the treatment of newly diagnosed and recurrent glioblastoma and malignant pleural mesothelioma.
Recent Product Highlight
Anticipated 2022 / Early 2023 Partner and Zai Milestones
QINLOCK® (Ripretinib)
QINLOCK is a 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 China for 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
Anticipated 2022 Zai Milestone
Adagrasib
Adagrasib 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 2022 Partner Milestones
Bemarituzumab
Bemarituzumab is a potential first-in-class antibody that is being developed in gastric and gastroesophageal junction (GEJ) cancer as a targeted therapy for tumors that overexpress FGFR2b.
Recent Product Highlight
Anticipated 2022 / Early 2023 Zai Milestone
Odronextamab
Odronextamab is a bispecific 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 2022 Zai Milestone
Anticipated 2022 Partner Milestone
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.
Recent Product Highlights
Anticipated Early 2023 Zai Milestone
CLN-081
CLN-081 is an orally available, irreversible epidermal growth factor receptor (EGFR) inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild type EGFR.
Anticipated 2022 Partner Milestone
BLU-945
BLU-945 is a selective and potent investigational inhibitor of the activating EGFR L858R mutation and on-target T790M and C797S resistance mutations, for the potential treatment of EGFR-driven NSCLC.
Recent Product Highlight
Autoimmune Disorders
VYVGART® (Efgartigimod)
Efgartigimod is an antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) autoantibodies 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 2022 / Early 2023 Zai Milestones
Anticipated Early 2023 Partner Milestone
Infectious Disease
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). Zai Lab led the China development and obtained approval by the NMPA in December 2021.
Anticipated 2022 Zai Milestone
Sulbactam-Durlobactam (SUL-DUR, Asia Pacific Rights)
Sulbactam-Durlobactam is a beta-lactam/beta-lactamase inhibitor combination that provides unique activity against Acinetobacter organisms, including carbapenem-resistant strains.
Anticipated 2022 / Early 2023 Zai Milestone
Neuroscience
KarXT
KarXT combines xanomeline, a novel muscarinic agonist, with trospium, an approved muscarinic antagonist. In November 2021, Zai partnered with Karuna Therapeutics, Inc. (Karuna) to develop KarXT in Greater China for the treatment of schizophrenia and possibly other indications like dementia-related psychosis.
Recent Product Highlights
Anticipated Early 2023 Partner Milestone
Global R&D Autoimmune Disorder Programs
ZL-1102 (IL-17 Human VH Antibody Fragment, Global Rights)
ZL-1102 is a novel 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).
Recent Product Highlight
Anticipated 2022 / Early 2023 Zai Milestone
Global R&D Oncology Programs
Recent Highlight
Corporate Updates
Third-Quarter 2022 Financial Results
Conference Call and Webcast Information
Zai Lab will host a live conference call and webcast tomorrow, November 10, 2022, 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/BI98db73679f254c8eb1024c9df5ea85a8
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 Company’s website at http://ir.zailaboratory.com.
About Zai Lab
Zai Lab Limited (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, including our products, business activities and partnerships, research, and other events or developments, 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; 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 collaboration partners’ products and of our pipeline therapies; the anticipated benefits and potential of investments, collaborations, and business development activities; our future financial and operating results; financial guidance, including our projections for the number of marketed products we will have in the future; key data readouts and regulatory filings across our entire portfolio; and our plans to initiate or continue existing clinical trials for our other products and product candidates. 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 novel coronavirus (COVID-19) pandemic, including any government actions or lockdown measures taken in response, on our business and general economic, regulatory, and political conditions, (6) risks related to doing business in China, and (7) 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. 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
lina.zhang@zailaboratory.com
Media: Christine Drury / Xiaoyu Chen
+1 (317) 385-9227 / +86 185 0015 5011
christine.drury@zailaboratory.com / xiaoyu.chen@zailaboratory.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) | ||||||
| September 30, 2022 | December 31, 2021 | |||||
| $ | $ | |||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | 1,119,476 | 964,100 | ||||
| Short-term investments | — | 445,000 | ||||
| Accounts receivable (net of allowance for credit loss of $8 and $11 as of September 30, 2022 and December 31, 2021, respectively) | 27,736 | 47,474 | ||||
| Notes receivable | 10,251 | 7,335 | ||||
| Inventories, net | 29,131 | 18,951 | ||||
| Value added tax recoverable - current | 1,080 | — | ||||
| Prepayments and other current assets | 22,157 | 18,021 | ||||
| Total current assets | 1,209,831 | 1,500,881 | ||||
| Restricted cash, non-current | 803 | 803 | ||||
| Long term investments (including the fair value measured investment of $3,316 and $15,383 as of September 30, 2022 and December 31, 2021, respectively) | 3,316 | 15,605 | ||||
| Prepayments for equipment | 4,068 | 989 | ||||
| Property and equipment, net | 50,528 | 43,102 | ||||
| Operating lease right-of-use assets | 20,269 | 14,189 | ||||
| Land use rights, net | 6,824 | 7,811 | ||||
| Intangible assets, net | 1,540 | 1,848 | ||||
| Long-term deposits | 1,329 | 870 | ||||
| Value added tax recoverable | 6 | 23,858 | ||||
| Total assets | 1,298,514 | 1,609,956 | ||||
| Liabilities and shareholders’ equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | 90,112 | 126,163 | ||||
| Current operating lease liabilities | 6,980 | 5,927 | ||||
| Other current liabilities | 58,456 | 60,811 | ||||
| Total current liabilities | 155,548 | 192,901 | ||||
| Deferred income | 23,205 | 27,486 | ||||
| Non-current operating lease liabilities | 13,892 | 9,613 | ||||
| Total liabilities | 192,645 | 230,000 | ||||
| Commitments and contingencies | ||||||
| Shareholders’ equity | ||||||
| Ordinary shares (par value of $0.000006 per share; 5,000,000,000 shares authorized; 961,829,720 and 955,363,980 shares issued as of September 30, 2022 and December 31, 2021, respectively; 959,724,940 and 954,981,050 shares outstanding as of September 30, 2022 and December 31, 2021, respectively) | 6 | 6 | ||||
| Additional paid-in capital | 2,877,361 | 2,825,948 | ||||
| Accumulated deficit | (1,799,591 | ) | (1,418,074 | ) | ||
| Accumulated other comprehensive income (loss) | 39,549 | (23,645 | ) | |||
| Treasury Stock (at cost, 2,104,780 and 382,930 shares as of September 30, 2022 and December 31, 2021, respectively) | (11,456 | ) | (4,279 | ) | ||
| Total shareholders’ equity | 1,105,869 | 1,379,956 | ||||
| Total liabilities and shareholders’ equity | 1,298,514 | 1,609,956 | ||||
| Zai Lab Limited Unaudited condensed consolidated statements of operations (In thousands of U.S. dollars ("$") except for number of shares and per share data) | ||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||
| $ | $ | $ | $ | |||||||||
| Revenues: | ||||||||||||
| Product revenue, net | 56,963 | 43,103 | 150,633 | 100,141 | ||||||||
| Collaboration revenue | 577 | — | 1,806 | — | ||||||||
| Total revenues | 57,540 | 43,103 | 152,439 | 100,141 | ||||||||
| Expenses: | ||||||||||||
| Cost of sales | (20,044 | ) | (12,162 | ) | (53,094 | ) | (30,535 | ) | ||||
| Research and development | (99,524 | ) | (55,144 | ) | (219,462 | ) | (401,220 | ) | ||||
| Selling, general, and administrative | (66,555 | ) | (59,002 | ) | (186,947 | ) | (149,254 | ) | ||||
| Loss from operations | (128,583 | ) | (83,205 | ) | (307,064 | ) | (480,868 | ) | ||||
| Interest income | 3,872 | 713 | 5,235 | 1,171 | ||||||||
| Other income (expenses), net | (36,479 | ) | (13,580 | ) | (79,467 | ) | (12,401 | ) | ||||
| Loss before income tax and share of loss from equity method investment | (161,190 | ) | (96,072 | ) | (381,296 | ) | (492,098 | ) | ||||
| Income tax expense | — | — | — | — | ||||||||
| Share of loss from equity method investment | — | (340 | ) | (221 | ) | (548 | ) | |||||
| Net loss | (161,190 | ) | (96,412 | ) | (381,517 | ) | (492,646 | ) | ||||
| Net loss attributable to ordinary shareholders | (161,190 | ) | (96,412 | ) | (381,517 | ) | (492,646 | ) | ||||
| Loss per share - basic and diluted | (0.17 | ) | (0.10 | ) | (0.40 | ) | (0.53 | ) | ||||
| Weighted-average shares used in calculating net loss per ordinary share - basic and diluted | 959,085,960 | 950,354,320 | 957,439,910 | 921,748,380 | ||||||||
| Loss per American Depositary Shares (“ADS”) - basic and diluted | (1.68 | ) | (1.01 | ) | (3.98 | ) | (5.34 | ) | ||||
| Weighted-average ADSs used in calculating net loss per ADS - basic and diluted | 95,908,596 | 95,035,432 | 95,743,991 | 92,174,838 | ||||||||
Note: Basic and diluted net loss per ordinary share, weighted average number of ordinary shares forthe three and nine months ended September 30, 2021, respectively, 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 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 September 30, | Nine Months Ended September 30, | |||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||
| $ | $ | $ | $ | |||||||||
| Net loss | (161,190 | ) | (96,412 | ) | (381,517 | ) | (492,646 | ) | ||||
| Other comprehensive income (loss), net of tax of nil: | ||||||||||||
| Foreign currency translation adjustments | 35,062 | 1,741 | 63,194 | (600 | ) | |||||||
| Comprehensive loss | (126,128 | ) | (94,671 | ) | (318,323 | ) | (493,246 | ) | ||||