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Zai Lab and Novocure Announce Results From the Phase 3 PANOVA-3 Trial of Tumor Treating Fields (TTFields) Therapy for Pancreatic Cancer to be Presented at 2025 ASCO Annual Meeting

Zai Lab and Novocure Announce Results From the Phase 3 PANOVA-3 Trial of Tumor Treating Fields (TTFields) Therapy for Pancreatic Cancer to be Presented at 2025 ASCO Annual Meeting

Yahoo31-05-2025
TTFields therapy concomitant with gemcitabine and nab-paclitaxel is the first treatment to show a clinically meaningful and statistically significant improvement in overall survival (OS) for patients with unresectable, locally advanced pancreatic adenocarcinoma in a Phase 3 trial
The OS benefit observed with TTFields therapy is supported by significantly improved quality of life and extended pain-free survival, a key outcome for patients with pancreatic cancer
Results from PANOVA-3 accepted as a late-breaking abstract for oral presentation at ASCO and simultaneous publication in the Journal of Clinical Oncology
SHANGHAI & CAMBRIDGE, Mass. & BAAR, Switzerland, May 31, 2025--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and Novocure (NASDAQ: NVCR) announced that results from the Phase 3 PANOVA-3 trial of Tumor Treating Fields (TTFields) therapy for pancreatic cancer will be presented today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and simultaneously published in the Journal of Clinical Oncology.
"The data presented today from the PANOVA-3 trial of Tumor Treating Fields show a clinically meaningful and statistically significant improvement in overall survival for people with locally advanced pancreatic cancer," said Vincent Picozzi, MD, MMM, medical oncologist and investigator in the PANOVA-3 trial. "Importantly, we also saw an extension in the duration of time before pain progressed. Pain is a hallmark of this disease, and as a clinician, the potential of this therapy to address this aspect of pancreatic cancer is very encouraging. These results illustrate the potential of Tumor Treating Fields therapy concomitant with gemcitabine and nab-paclitaxel to become a standard of care for unresectable, locally advanced pancreatic cancer."
The Phase 3 PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma compared to gemcitabine and nab-paclitaxel alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) for patients treated with TTFields.
"The encouraging data from the Phase 3 PANOVA-3 study demonstrate a meaningful improvement in outcomes for patients with unresectable, locally advanced pancreatic cancer—including pain reduction and a statistically significant improvement in overall survival," said Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "Pancreatic cancer remains one of the most challenging cancers to treat globally, with approximately 134,000 new cases diagnosed annually in China alone. Zai Lab participated in this trial and looks forward to continuing our collaboration with Novocure to bring this innovative therapy to patients in China as quickly as possible."
"Most people with pancreatic cancer are diagnosed with advanced disease, which is very difficult to treat and only about 1 in 10 people are alive five years after diagnosis," said Nicolas Leupin, MD, PhD, Chief Medical Officer, Novocure. "The results shared today at ASCO and in the Journal of Clinical Oncology demonstrate that Tumor Treating Fields therapy improved overall survival and pain-free survival in unresectable, locally advanced pancreatic cancer. We plan to submit these data to the FDA in the second half of 2025 to support a premarket approval for Tumor Treating Fields therapy."
Results from PANOVA-3
In the intent-to-treat population, patients treated with TTFields therapy concomitantly with gemcitabine and nab-paclitaxel had an mOS of 16.2 months compared to 14.2 months for patients treated with gemcitabine and nab-paclitaxel alone, a statistically significant 2.0-month improvement [hazard ratio (HR) 0.82; p=0.039 (N=571)].
TTFields therapy concomitant with gemcitabine and nab-paclitaxel demonstrated improvement in several secondary endpoints including the one-year survival rate and pain-free survival. Pancreatic cancer can cause significant pain as the disease progresses and managing pain is a key clinical challenge.
The one-year survival rate showed a statistically significant improvement in the TTFields concomitant with gemcitabine and nab-paclitaxel treated group with 68.1% [95% CI: 62.0–73.5] compared to those who received gemcitabine and nab-paclitaxel alone, 60.2% [95% CI: 54.2–65.7], p=0.029.
Patients treated with TTFields concomitant with gemcitabine and nab-paclitaxel had a median pain-free survival of 15.2 months [95% CI: 10.3–22.8] compared to a median 9.1 months in the group treated with gemcitabine and nab-paclitaxel alone [95% CI: 7.4–12.7]; HR 0.74 [95% CI: 0.56–0.97], p=0.027. This is a statistically significant 6.1-month extension in pain-free survival. Pain-free survival was defined as the time from baseline until an increase of 20 or more points was reported by patients on a visual scale for pain or until death.
Quality of life was also measured as a secondary endpoint. Analyses were performed for all patients using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with the pancreatic cancer specific PAN26 addendum. Deterioration-free survival in global health status, pain and digestive problems were significantly improved in patients receiving TTFields therapy concomitant with gemcitabine and nab-paclitaxel compared to the gemcitabine and nab-paclitaxel alone group. Full analysis of the quality of life results in PANOVA-3 will be shared at a future scientific conference.
There was no statistically significant difference in additional secondary outcome measures of progression-free survival, local progression-free survival, objective response rate, puncture-free survival or tumor resectability rate between the TTFields with gemcitabine and nab-paclitaxel and the gemcitabine and nab-paclitaxel arms.
TTFields therapy was well-tolerated, no new safety signals were observed, and safety was consistent with prior clinical studies. Mild to moderate skin adverse events (AEs) were the most common device-related AEs.
Data Presentation & Publication Details
The PANOVA-3 data, (LBA 3500) Phase 3 study of Tumor Treating Fields (TTFields) with gemcitabine and nab-paclitaxel for locally advanced pancreatic ductal adenocarcinoma (LA-PAC), will be presented today by Dr. Picozzi in Hall D1 during the 3:00 – 6:00 p.m. Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary oral session.
The Phase 3 PANOVA-3 publication in the Journal of Clinical Oncology, Tumor Treating Fields with gemcitabine and nab-paclitaxel for locally advanced pancreatic adenocarcinoma: randomized, open-label, pivotal phase 3 PANOVA-3 study, will be available online at https://ascopubs.org/doi/10.1200/JCO-25-00746.
Novocure Investor Event
Novocure will host an investor event featuring Dr. Picozzi and Novocure leadership after the oral presentation. Event details and a link to a live webcast of the event are available on the investor relations page of www.novocure.com. For more information or to request in-person attendance, please contact Novocure investor relations at investorinfo@novocure.com.
Regulatory & Ongoing Clinical Study of TTFields for Pancreatic Cancer
Novocure plans to file for regulatory approval for use of TTFields therapy in unresectable, locally advanced pancreatic adenocarcinoma based on PANOVA-3 in the U.S. in the second half of 2025. The company also plans to file for regulatory approval in EU, Japan and other key markets.
Novocure continues to follow patients in its Phase 2 PANOVA-4 trial exploring the use of TTFields therapy together with atezolizumab, gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. PANOVA-4 has completed enrollment with data anticipated in the first half of 2026.
About PANOVA-3
PANOVA-3 is an international prospective, randomized, open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of Tumor Treating Fields (TTFields) therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment for locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone.
The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local progression-free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity.
The PANOVA-3 trial enrolled 571 patients who were randomized 1:1 and followed for a minimum of 18 months.
About PANOVA-4
PANOVA-4 is an international, multi-center, Phase 2 clinical trial designed to test the safety and efficacy of Tumor Treating Fields (TTFields) therapy together with atezolizumab, gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. The primary endpoint is disease control rate. Secondary endpoints include overall survival, progression-free survival, one-year survival rate, objective response rate, progression-free survival at six months, duration of response, and toxicity. The study is designed to enroll 76 patients and enrollment is complete.
About Pancreatic Cancer in China
Pancreatic cancer is one of the most common and deadliest cancers globally. In China, there were an estimated 134,374 new cases in 2022, and it is now the eighth most common cancer type1. The current median survival of patients with locally advanced, unresectable pancreatic cancer is nine to twelve months, and the five-year survival rate was 7.2%2, making it the malignancy with the lowest survival rate in China.
1 Xia C, Dong X, Li H et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl) 2022; 135: 584-590.
2 Hu JX, Zhao CF, Chen WB et al. Pancreatic cancer: A review of epidemiology, trend, and risk factors. World J Gastroenterol 2021; 27: 4298-4321.
About Tumor Treating Fields
Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.
To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.
About Zai Lab
Zai Lab 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 worldwide.
For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.X.com/ZaiLab_Global , www.twitter.com/ZaiLab_Global.
About Novocure
Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure's commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer.
Novocure's global headquarters is located in Baar, Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter.
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements about future expectations, plans, and prospects for Zai Lab, including, without limitation, statements regarding the prospects of and plans for developing and commercializing TTFields therapy, the potential benefits of TTFields therapy, and the potential treatment of pancreatic cancer. These forward-looking statements may contain 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 statements of historical fact or 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. Actual results may differ materially from those indicated by such 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 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 the SEC's website at www.sec.gov.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250531848054/en/
Contacts
For more information, please contact: Zai Lab Investor Relations: Christine Chiou / Lina Zhang+1 (917) 886-6929 / +86 136 8257 6943christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com Zai Lab Media: Shaun Maccoun / Xiaoyu Chen+1 (857) 270-8854 / +86 185 0015 5011shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com Novocure Investors: Ingrid Goldberginvestorinfo@novocure.com Novocure Media: Catherine Falcettimedia@novocure.com
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Funding costs were RMB142.1 million (US$19.8 million), compared to RMB161.3 million in the same period of 2024 and RMB122.7 million in the prior quarter. The year-over-year decrease was primarily due to lower average costs of ABS issuance, partially offsetting by the increase in fundings from ABS. The sequential increase was mainly due to the increase in fundings from ABS. Sales and marketing expenses were RMB662.7 million (US$92.5 million), compared to RMB366.4 million in the same period of 2024 and RMB591.5 million in the prior quarter. The year-over-year increase was primarily due to the increase in the allocation of marketing resources to embedded finance channels and content feed advertisements to generate more effective leads. The sequential increase was primary due to proactive user acquisition effort, partially offset by improved efficiency in acquiring new users. General and administrative expenses were RMB175.9 million (US$24.6 million), compared to RMB95.1 million in the same period of 2024 and RMB196.5 million in the prior quarter. The year-over-year and sequential changes mainly reflected the change in share-based compensations. Provision for loans receivable was RMB773.8 million (US$108.0 million), compared to RMB849.5 million in the same period of 2024 and RMB823.2 million in the prior quarter. The year-over-year and sequential decreases were mainly due to the reversal of prior quarters' provision in this quarter, offset by the increase in loan origination volume of on-balance-sheet loans. The changes reflected the Company's consistent approach in assessing provisions commensurate with its underlying loan profile. Provision for financial assets receivable was RMB66.6 million (US$9.3 million), compared to RMB70.2 million in the same period of 2024 and RMB39.9 million in the prior quarter. The year-over-year decrease was primarily due to the reversal of prior quarters' provision in this quarter, offset by the increase in capital-heavy loan facilitation volume. The sequential increase was mainly due to the increase in capital-heavy loan facilitation volume. The changes reflected the Company's consistent approach in assessing provisions commensurate with its underlying loan profile. Provision for accounts receivable and contract assets was RMB79.9 million (US$11.2 million), compared to RMB123.8 million in the same period of 2024 and RMB68.4 million in the prior quarter. The year-over-year and sequential changes reflected the Company's consistent approach in assessing provisions commensurate with its underlying loan profile. The year-over-year decrease was also partly due to the decrease in capital-light loan facilitation volume. Provision for contingent liability was RMB397.6 million (US$55.5 million), compared to RMB-213.3 million in the same period of 2024 and RMB159.3 million in the prior quarter. The year-over-year and sequential increases were mainly due to the increases in capital-heavy loan facilitation volume and reflected the Company's consistent approach in assessing provisions commensurate with its underlying loan profile. Income from operations was RMB2,136.2 million (US$298.2 million), compared to RMB1,985.0 million in the same period of 2024 and RMB1,974.7 million in the prior quarter. Non-GAAP income from operations was RMB2,254.7 million (US$314.7 million), compared to RMB2,021.9 million in the same period of 2024 and RMB2,104.3 million in the prior quarter. Operating margin was 41.0%. Non-GAAP operating margin was 43.2%. Income before income tax expense was RMB2,172.0 million (US$303.2 million), compared to RMB2,076.6 million in the same period of 2024 and RMB2,220.2 million in the prior quarter. Income taxes expense was RMB441.5 million (US$61.6 million), compared to RMB700.1 million in the same period of 2024 and RMB423.6 million in the prior quarter. Net income was RMB1,730.5 million (US$241.6 million), compared to RMB1,376.5 million in the same period of 2024 and RMB1,796.6 million in the prior quarter. Non-GAAP net income was RMB1,849.0 million (US$258.1 million), compared to RMB1,413.4 million in the same period of 2024 and RMB1,926.2 million in the prior quarter. Net income margin was 33.2%. Non-GAAP net income margin was 35.4%. Net income attributed to the Company was RMB1,734.0 million (US$242.1 million), compared to RMB1,380.5 million in the same period of 2024 and RMB1,800.2 million in the prior quarter. Non-GAAP net income attributed to the Company was RMB1,852.5 million (US$258.6 million), compared to RMB1,417.4 million in the same period of 2024 and RMB1,929.8 million in the prior quarter. Net income per fully diluted ADS was RMB12.76 (US$1.78). Non-GAAP net income per fully diluted ADS was RMB13.63 (US$1.90). Weighted average basic ADS used in calculating GAAP net income per ADS was 132.92 million. Weighted average diluted ADS used in calculating GAAP and non-GAAP net income per ADS was 135.92 million. Ordinary shares outstanding as of June 30, 2025 was 264,857,728. 12 'Financing income' is generated from loans facilitated through the Company's platform funded by the consolidated trusts and Fuzhou Microcredit, which charge fees and interests from borrowers. 30 Day+ Delinquency Rate by Vintage and 180 Day+ Delinquency Rate by Vintage The following charts and tables display the historical cumulative 30 day+ delinquency rates by loan facilitation and origination vintage and 180 day+ delinquency rates by loan facilitation and origination vintage for all loans facilitated and originated through the Company's platform. Loans under 'ICE' and total technology solutions are not included in the 30 day+ charts and the 180 day+ charts: Semi-Annual Dividend for the First Half of 2025 The board of directors of the Company (the 'Board') has approved a dividend of US$0.38 per Class A ordinary share, or US$0.76 per ADS for the first half of 2025 to holders of record of Class A ordinary shares and ADSs as of the close of business on September 8, 2025 Hong Kong Time and New York Time, respectively, in accordance with the Company's dividend policy. For holder of Class A ordinary shares, in order to qualify for the dividend, all valid documents for the transfers of shares accompanied by the relevant share certificates must be lodged for registration with the Company's Hong Kong branch share registrar, Computershare Hong Kong Investor Services Limited, at Shops 1712-1716, 17th Floor, Hopewell Centre, 183 Queen's Road East, Hong Kong no later than 4:30 p.m. on September 8, 2025 (Hong Kong Time). The payment date is expected to be on September 25, 2025 for holders of Class A ordinary shares and around September 30, 2025 for holders of ADSs. Update on Share Repurchase On November 19, 2024, the Board approved a share repurchase plan (the '2025 Share Repurchase Plan') whereby the Company is authorized to repurchase up to US$450 million worth of its ADSs or Class A ordinary shares over the next 12 months starting from January 1, 2025. As of August 14, 2025, the Company had in aggregate purchased approximately 7.1 million ADSs on the open market for a total amount of approximately US$277 million (inclusive of commissions) at an average price of US$38.9 per ADS pursuant to the 2025 Share Repurchase Plan. Business Outlook As macro-economic uncertainties persist, the Company intends to maintain a prudent approach in its business planning for the rest of 2025. Management will continue to focus on enhancing efficiency of the Company's operations. As such, for the third quarter of 2025, the Company expects to generate a net income between RMB1.52 billion and RMB1.72 billion and a non-GAAP net income*13 between RMB1.60 billion and RMB1.80 billion, representing a year-on-year decline between 2% and 13%. This outlook reflects the Company's current and preliminary views, which is subject to material changes. 13 Non-GAAP net income represents net income excluding share-based compensation expenses. Conference Call Preregistration Qfin Holdings' management team will host an earnings conference call at 8:30 PM U.S. Eastern Time on Thursday, August 14, 2025 (8:30 AM Beijing Time on Friday, August 15, 2025). All participants wishing to join the conference call must pre-register online using the link provided below. Registration Link: Upon registration, each participant will receive details for the conference call, including dial-in numbers and a unique access PIN. Please dial in 10 minutes before the call is scheduled to begin. Additionally, a live and archived webcast of the conference call will be available on the Investor Relations section of the Company's website at About Qfin Holdings Qfin Holdings is a leading AI-empowered Credit-Tech platform in China. By leveraging its sophisticated machine learning models and data analytics capabilities, the Company provides a comprehensive suite of technology services to assist financial institutions and consumers and SMEs in the loan lifecycle, ranging from borrower acquisition, preliminary credit assessment, fund matching and post-facilitation services. The Company is dedicated to making credit services more accessible and personalized to consumers and SMEs through Credit-Tech services to financial institutions. For more information, please visit: Use of Non-GAAP Financial Measures Statement To supplement our financial results presented in accordance with U.S. GAAP, we use Non-GAAP financial measure, which is adjusted from results based on U.S. GAAP to exclude share-based compensation expenses. Reconciliations of our Non-GAAP financial measures to our U.S. GAAP financial measures are set forth in tables at the end of this earnings release, which provide more details on the Non-GAAP financial measures. We use Non-GAAP income from operation, Non-GAAP operating margin, Non-GAAP net income, Non-GAAP net income margin, Non-GAAP net income attributed to the Company and Non-GAAP net income per fully diluted ADS in evaluating our operating results and for financial and operational decision-making purposes. Non-GAAP income from operation represents income from operation excluding share-based compensation expenses. Non-GAAP operating margin is equal to Non-GAAP income from operation divided by total net revenue. Non-GAAP net income represents net income excluding share-based compensation expenses. Non-GAAP net income margin is equal to Non-GAAP net income divided by total net revenue. Non-GAAP net income attributed to the Company represents net income attributed to the Company excluding share-based compensation expenses. Non-GAAP net income per fully diluted ADS represents net income excluding share-based compensation expenses per fully diluted ADS. Such adjustments have no impact on income tax. We believe that Non-GAAP income from operation, Non-GAAP operating margin, Non-GAAP net income, Non-GAAP net income margin, Non-GAAP net income attributed to the Company and Non-GAAP net income per fully diluted ADS help identify underlying trends in our business that could otherwise be distorted by the effect of certain expenses that we include in results based on U.S. GAAP. We believe that Non-GAAP income from operation and Non-GAAP net income provide useful information about our operating results, enhance the overall understanding of our past performance and future prospects and allow for greater visibility with respect to key metrics used by our management in its financial and operational decision-making. Our Non-GAAP financial information should be considered in addition to results prepared in accordance with U.S. GAAP, but should not be considered a substitute for or superior to U.S. GAAP results. In addition, our calculation of Non-GAAP financial information may be different from the calculation used by other companies, and therefore comparability may be limited. Exchange Rate Information This announcement contains translations of certain RMB amounts into U.S. dollars at specified rates solely for the convenience of the reader. Unless otherwise noted, all translations from RMB to U.S. dollars are made at a rate of RMB 7.1636 to US$1.00, the exchange rate set forth in the H.10 statistical release of the Board of Governors of the Federal Reserve System as of June 30, 2025. Safe Harbor Statement Any forward-looking statements contained in this announcement are made under the 'safe harbor' provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as 'will,' 'expects,' 'anticipates,' 'future,' 'intends,' 'plans,' 'believes,' 'estimates' and similar statements. Among other things, the business outlook and quotations from management in this announcement, as well as the Company's strategic and operational plans, contain forward-looking statements. Qfin Holdings may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission ('SEC'), in announcements made on the website of The Stock Exchange of Hong Kong Limited (the 'Hong Kong Stock Exchange'), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including the Company's business outlook, beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, which factors include but not limited to the following: the Company's growth strategies, changes in laws, rules and regulatory environments, the recognition of the Company's brand, market acceptance of the Company's products and services, trends and developments in the credit-tech industry, governmental policies relating to the credit-tech industry, general economic conditions in China and around the globe, and assumptions underlying or related to any of the foregoing. Further information regarding these and other risks and uncertainties is included in Qfin Holdings' filings with the SEC and announcements on the website of the Hong Kong Stock Exchange. All information provided in this press release is as of the date of this press release, and Qfin Holdings does not undertake any obligation to update any forward-looking statement, except as required under applicable law. For more information, please contact: Qfin Holdings E-mail: ir@ Unaudited Condensed Consolidated Balance Sheets(Amounts in thousands of Renminbi ('RMB') and U.S. dollars ('USD')except for number of shares and per share data, or otherwise noted) December 31, June 30, June 30, 2024 2025 2025 RMB RMB USD ASSETS Current assets: Cash and cash equivalents 4,452,416 5,287,926 738,166 Restricted cash 2,353,384 2,924,500 408,244 Short term investments 3,394,073 4,904,581 684,653 Security deposit prepaid to third-party guarantee companies 162,617 223,177 31,154 Funds receivable from third party payment service providers 462,112 353,931 49,407 Accounts receivable and contract assets, net 2,214,530 2,318,783 323,690 Financial assets receivable, net 1,553,912 1,630,038 227,545 Amounts due from related parties 8,510 2,761 385 Loans receivable, net 26,714,428 34,927,339 4,875,669 Prepaid expenses and other assets 1,464,586 1,561,791 218,018 Total current assets 42,780,568 54,134,827 7,556,931 Non-current assets: Accounts receivable and contract assets, net-noncurrent 27,132 16,114 2,249 Financial assets receivable, net-noncurrent 170,779 213,939 29,865 Amounts due from related parties 51 28 4 Loans receivable, net-noncurrent 2,537,749 2,507,609 350,049 Property and equipment, net 362,774 496,825 69,354 Land use rights, net 956,738 946,376 132,109 Intangible assets 11,818 11,023 1,539 Goodwill 42,414 42,392 5,918 Deferred tax assets 1,206,325 1,289,151 179,959 Other non-current assets 36,270 96,667 13,494 Total non-current assets 5,352,050 5,620,124 784,540 TOTAL ASSETS 48,132,618 59,754,951 8,341,471 LIABILITIES AND EQUITY Current liabilities: Payable to investors of the consolidated trusts-current 8,188,454 5,894,433 822,831 Accrued expenses and other current liabilities 2,492,921 2,799,439 390,787 Amounts due to related parties 67,495 92,351 12,892 Short term loans 1,369,939 1,463,522 204,300 Guarantee liabilities-stand ready 2,383,202 2,481,731 346,436 Guarantee liabilities-contingent 1,820,350 1,895,076 264,542 Income tax payable 1,040,687 885,592 123,624 Other tax payable 109,161 56,427 7,877 Total current liabilities 17,472,209 15,568,571 2,173,289 Non-current liabilities: Deferred tax liabilities 439,435 588,634 82,170 Payable to investors of the consolidated trusts-noncurrent 5,719,600 14,106,000 1,969,122 Convertible senior notes - 4,857,243 678,045 Other long-term liabilities 255,155 527,042 73,572 Total non-current liabilities 6,414,190 20,078,919 2,802,909 TOTAL LIABILITIES 23,886,399 35,647,490 4,976,198 TOTAL QFIN HOLDINGS INC EQUITY 24,190,043 24,058,376 3,358,421 Noncontrolling interests 56,176 49,085 6,852 TOTAL EQUITY 24,246,219 24,107,461 3,365,273 TOTAL LIABILITIES AND EQUITY 48,132,618 59,754,951 8,341,471 Unaudited Condensed Consolidated Statements of Operations(Amounts in thousands of Renminbi ('RMB') and U.S. dollars ('USD')except for number of shares and per share data, or otherwise noted) Three months ended June 30, Six months ended June 30, 2024 2025 2025 2024 2025 2025 RMB RMB USD RMB RMB USD Credit driven services 2,912,205 3,565,549 497,732 5,928,487 6,676,415 931,992 Loan facilitation and servicing fees-capital heavy 151,073 460,858 64,333 394,839 890,633 124,328 Financing income 1,690,110 2,204,963 307,801 3,225,096 4,022,184 561,475 Revenue from releasing of guarantee liabilities 972,586 805,272 112,412 2,138,604 1,583,494 221,047 Other services fees 98,436 94,456 13,186 169,948 180,104 25,142 Platform services 1,247,858 1,650,346 230,380 2,384,759 3,230,177 450,915 Loan facilitation and servicing fees-capital light 524,405 326,829 45,624 1,027,120 700,538 97,791 Referral services fees 623,491 986,396 137,696 1,172,315 1,991,018 277,935 Other services fees 99,962 337,121 47,060 185,324 538,621 75,189 Total net revenue 4,160,063 5,215,895 728,112 8,313,246 9,906,592 1,382,907 Facilitation, origination and servicing 722,160 781,029 109,027 1,458,186 1,495,521 208,767 Funding costs 161,302 142,118 19,839 317,265 264,775 36,961 Sales and marketing 366,388 662,685 92,507 782,005 1,254,180 175,077 General and administrative 95,054 175,879 24,552 201,469 372,361 51,980 Provision for loans receivable 849,508 773,849 108,025 1,697,429 1,597,036 222,938 Provision for financial assets receivable 70,166 66,631 9,301 169,169 106,494 14,866 Provision for accounts receivable and contract assets 123,766 79,905 11,154 235,239 148,350 20,709 Provision for contingent liabilities (213,267) 397,614 55,505 103,397 556,957 77,748 Total operating costs and expenses 2,175,077 3,079,710 429,910 4,964,159 5,795,674 809,046 Income from operations 1,984,986 2,136,185 298,202 3,349,087 4,110,918 573,861 Interest income, net 45,987 73,265 10,227 96,045 141,039 19,688 Foreign exchange gain 160 108,449 15,139 242 110,572 15,435 Fair value change of derivatives - (170,407) (23,788) - (170,407) (23,788) Other income, net 45,430 24,509 3,421 157,398 200,109 27,934 Income before income tax expense 2,076,563 2,172,001 303,201 3,602,772 4,392,231 613,130 Income taxes expense (700,055) (441,521) (61,634) (1,066,120) (865,152) (120,771) Net income 1,376,508 1,730,480 241,567 2,536,652 3,527,079 492,359 Net loss attributable to noncontrolling interests 4,020 3,514 491 8,163 7,090 990 Net income attributable to ordinary shareholders of the Company 1,380,528 1,733,994 242,058 2,544,815 3,534,169 493,349 Net income per ordinary share attributable to ordinary shareholders of Qfin Holdings, Inc. Basic 4.54 6.52 0.91 8.27 12.93 1.80 Diluted 4.46 6.38 0.89 8.10 12.59 1.76 Net income per ADS attributable to ordinary shareholders of Qfin Holdings, Inc. Basic 9.08 13.04 1.82 16.54 25.86 3.60 Diluted 8.92 12.76 1.78 16.20 25.18 3.52 Weighted average shares used in calculating net income per ordinary share Basic 303,761,387 265,842,311 265,842,311 307,894,289 273,358,655 273,358,655 Diluted 309,495,756 271,838,718 271,838,718 314,244,423 280,821,385 280,821,385 Unaudited Condensed Consolidated Statements of Cash Flows(Amounts in thousands of Renminbi ('RMB') and U.S. dollars ('USD')except for number of shares and per share data, or otherwise noted) Three months ended June 30, Six months ended June 30, 2024 2025 2025 2024 2025 2025 RMB RMB USD RMB RMB USD Net cash provided by operating activities 1,961,616 2,622,004 366,018 3,919,883 5,427,689 757,676 Net cash used in investing activities (980,403) (8,191,142) (1,143,439) (4,118,578) (11,431,328) (1,595,752) Net cash (used in) provided by financing activities (767,607) 1,995,605 278,576 1,007,802 7,444,676 1,039,237 Effect of foreign exchange rate changes 2,115 (29,290) (4,090) 4,210 (34,411) (4,804) Net increase (decrease) in cash and cash equivalents 215,721 (3,602,823) (502,935) 813,317 1,406,626 196,357 Cash, cash equivalents, and restricted cash, beginning of period 8,156,593 11,815,249 1,649,345 7,558,997 6,805,800 950,053 Cash, cash equivalents, and restricted cash, end of period 8,372,314 8,212,426 1,146,410 8,372,314 8,212,426 1,146,410 Unaudited Condensed Consolidated Statements of Comprehensive Income/(Loss)(Amounts in thousands of Renminbi ('RMB') and U.S. dollars ('USD')except for number of shares and per share data, or otherwise noted) Three months ended June 30, 2024 2025 2025 RMB RMB USD Net income 1,376,508 1,730,480 241,567 Other comprehensive income, net of tax of nil: Foreign currency translation adjustment 1,890 (119,202) (16,640) Other comprehensive income (loss) 1,890 (119,202) (16,640) Total comprehensive income 1,378,398 1,611,278 224,927 Comprehensive loss attributable to noncontrolling interests 4,020 3,514 491 Comprehensive income attributable to ordinary shareholders 1,382,418 1,614,792 225,418 Six months ended June 30, 2024 2025 2025 RMB RMB USD Net income 2,536,652 3,527,079 492,359 Other comprehensive income, net of tax of nil: Foreign currency translation adjustment 3,900 (134,565) (18,785) Other comprehensive income (loss) 3,900 (134,565) (18,785) Total comprehensive income 2,540,552 3,392,514 473,574 Comprehensive loss attributable to noncontrolling interests 8,163 7,090 990 Comprehensive income attributable to ordinary shareholders 2,548,715 3,399,604 474,564 Unaudited Reconciliations of GAAP and Non-GAAP Results(Amounts in thousands of Renminbi ('RMB') and U.S. dollars ('USD')except for number of shares and per share data, or otherwise noted) Three months ended June 30, 2024 2025 2025 RMB RMB USD Reconciliation of Non-GAAP Net Income to Net Income Net income 1,376,508 1,730,480 241,567 Add: Share-based compensation expenses 36,909 118,484 16,540 Non-GAAP net income 1,413,417 1,848,964 258,107 GAAP net income margin 33.1% 33.2% Non-GAAP net income margin 34.0% 35.4% Net income attributable to shareholders of Qfin Holdings, Inc. 1,380,528 1,733,994 242,058 Add: Share-based compensation expenses 36,909 118,484 16,540 Non-GAAP net income attributable to shareholders of Qfin Holdings, Inc. 1,417,437 1,852,478 258,598 Weighted average ADS used in calculating net income per ordinary share for both GAAP and non-GAAP EPS - diluted 154,747,878 135,919,359 135,919,359 Net income per ADS attributable to ordinary shareholders of Qfin Holdings, Inc. - diluted 8.92 12.76 1.78 Non-GAAP net income per ADS attributable to ordinary shareholders of Qfin Holdings, Inc. - diluted 9.16 13.63 1.90 Reconciliation of Non-GAAP Income from operations to Income from operations Income from operations 1,984,986 2,136,185 298,202 Add: Share-based compensation expenses 36,909 118,484 16,540 Non-GAAP Income from operations 2,021,895 2,254,669 314,742 GAAP operating margin 47.7% 41.0% Non-GAAP operating margin 48.6% 43.2% Six months ended June 30, 2024 2025 2025 RMB RMB USD Reconciliation of Non-GAAP Net Income to Net Income Net income 2,536,652 3,527,079 492,359 Add: Share-based compensation expenses 81,554 248,098 34,633 Non-GAAP net income 2,618,206 3,775,177 526,992 GAAP net income margin 30.5% 35.6% Non-GAAP net income margin 31.5% 38.1% Net income attributable to shareholders of Qfin Holdings, Inc. 2,544,815 3,534,169 493,349 Add: Share-based compensation expenses 81,554 248,098 34,633 Non-GAAP net income attributable to shareholders of Qfin Holdings, Inc. 2,626,369 3,782,267 527,982 Weighted average ADS used in calculating net income per ordinary share for both GAAP and non-GAAP EPS - diluted 157,122,212 140,410,693 140,410,693 Net income per ADS attributable to ordinary shareholders of Qfin Holdings, Inc. - diluted 16.20 25.18 3.52 Non-GAAP net income per ADS attributable to ordinary shareholders of Qfin Holdings, Inc. - diluted 16.72 26.94 3.76 Reconciliation of Non-GAAP Income from operations to Income from operations Income from operations 3,349,087 4,110,918 573,861 Add: Share-based compensation expenses 81,554 248,098 34,633 Non-GAAP Income from operations 3,430,641 4,359,016 608,494 GAAP operating margin 40.3% 41.5% Non-GAAP operating margin 41.3% 44.0%

Why Swatch Is Facing Tough Times
Why Swatch Is Facing Tough Times

Bloomberg

time2 hours ago

  • Bloomberg

Why Swatch Is Facing Tough Times

The Swatch brand is credited with having saved a Swiss watch industry that had been laid low by the so-called quartz revolution. Back in the 1970s and 1980s, these less expensive and more accurate watches from an ascendant Japan upended European mechanical watchmaking. Swatch's response? Tap into the '80s zeitgeist with colorful, low-priced designs—funky, artistic, eclectic and made for collectors along with a whole new demographic that saw them as fashion, not function. Swatch used its skyrocketing revenue to support its more staid, traditional brands while acquiring new ones. But fast forward to today, and the market's changed: phones and smartwatches have undercut low-cost watches, leaving luxury as the main engine for growth. In this Bloomberg Originals mini-documentary, we show how that change hasn't favored Swatch. And a new set of problems, from low sales in China to Donald Trump's tariffs, have made matters even worse.

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