SOMERSET, N.J.--(BUSINESS WIRE)--Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported its first quarter 2024 unaudited financial results and key corporate highlights.

新泽西州萨默塞特（商业新闻短讯）--细胞治疗领域的全球领导者联想生物技术公司（纳斯达克：LEGN）（联想生物技术）今天报告了其2024年第一季度未经审计的财务业绩和主要公司亮点。

“Legend made great progress in the first quarter, culminating in our exciting announcements in recent weeks. We received label expansions for CARVYKTI in the U.S., Europe, and Brazil that have changed the treatment paradigm for multiple myeloma and will enable more patients to receive our transformative therapy earlier in the course of their disease,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech.

Legend Biotech首席执行官黄英博士说：“Legend在第一季度取得了巨大进展，最近几周我们发布了令人兴奋的公告。我们在美国、欧洲和巴西获得了CARVYKTI的标签扩展，这改变了多发性骨髓瘤的治疗模式，并将使更多患者在疾病早期接受我们的变革性治疗。”。

“With more patients needing access to CARVYKTI, we have increased our manufacturing capacity and have scaled up our operations to reach our goal of 10,000 annual doses by the end of 2025. The expansion of our partnership with Novartis demonstrates our commitment to ensuring every patient who needs CARVYKTI can access it.”.

“随着越来越多的患者需要使用CARVYKTI，我们已经提高了生产能力，并扩大了业务规模，以实现到2025年底达到每年10000剂的目标。我们与诺华的合作伙伴关系的扩大表明，我们致力于确保每一位需要CARVYKTI的患者都能使用它。”。

Regulatory Updates

法规更新

The U.S. Food and Drug Administration (FDA) approved CARVYKTI® for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and are refractory to lenalidomide following the Oncologic Drug Advisory Committee’s (ODAC) unanimous (11 to 0) vote recommending the approval of CARVYKTI®..

美国食品和药物管理局（FDA）批准CARVYKTI®用于治疗复发或难治性多发性骨髓瘤的成年患者，这些患者至少接受过一种先前的治疗方案，包括蛋白酶体抑制剂（PI）和免疫调节剂（IMiD），并且在肿瘤药物咨询委员会（ODAC）一致（11比0）投票建议批准CARVYKTI®后对来那度胺难治。。

The European Commission (EC) granted approval for the label expansion of CARVYKTI® for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide..

欧盟委员会（EC）批准了CARVYKTI®的标签扩展，用于治疗复发和难治性多发性骨髓瘤的成年患者，这些患者至少接受过一次治疗，包括免疫调节剂和蛋白酶体抑制剂，在最后一次治疗中显示出疾病进展，并且对来那度胺难治。。

The Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária), approved CARVYKTI® for the treatment of adult patients with multiple myeloma, who previously received a proteasome inhibitor and are refractory to lenalidomide, as well as adult patients with relapsed or refractory multiple myeloma, who previously received a proteasome inhibitor, an immunomodulatory agent and anti-CD38 antibody..

巴西卫生管理局ANVISA（Agência National de Vigilência Sanitária）批准CARVYKTI®用于治疗先前接受蛋白酶体抑制剂且对来那度胺难治的多发性骨髓瘤成年患者，以及先前接受蛋白酶体抑制剂，免疫调节剂和抗CD38抗体的复发或难治性多发性骨髓瘤成年患者。。

Key Business Developments

关键业务发展

Legend and Johnson & Johnson* entered into a Master Manufacturing and Supply Services Agreement with Novartis Pharmaceuticals Corporation to supplement our existing manufacturing capabilities and increase commercial supply of CARVYKTI®

联想和强生*与诺华制药公司签订了一份主要的制造和供应服务协议，以补充我们现有的制造能力，并增加CARVYKTI®的商业供应

Published inaugural Environmental, Social & Governance (ESG) report which aligns with the Sustainable Accounting Standards Board (SASB) Biotechnology and Pharmaceutical sector standards, shares ESG data collection and disclosure roadmap, and future growth strategy for good corporate citizenship

发布了符合可持续会计准则委员会（SASB）生物技术和制药行业标准的首届环境、社会和治理（ESG）报告，分享了ESG数据收集和披露路线图，以及良好企业公民身份的未来增长战略

* In December 2017, Legend Biotech entered into an exclusive worldwide collaboration and license agreement with Janssen Biotech, Inc., a Johnson & Johnson company, to develop and commercialize cilta-cel (the Janssen Agreement).

*2017年12月，Legend Biotech与强生公司Janssen Biotech，Inc.签订了独家全球合作和许可协议，以开发和商业化cilta cel（Janssen协议）。

First Quarter 2024 Financial Results

2024年第一季度财务业绩

License Revenue: License revenue was $12.2 million for the first quarter of 2024 and consisted of the recognition of deferred revenue in connection with the global license agreement with Novartis Pharma AG to develop, manufacture, and commercialize LB2102 and other potential CAR-T therapies selectively targeting DLL3.

许可收入：2024年第一季度的许可收入为1220万美元，包括与诺华制药公司签订的全球许可协议相关的递延收入的确认，该协议旨在开发、制造和商业化LB2102和其他选择性针对DLL3的潜在CAR-T疗法。

Legend did not recognize any license revenue for the first quarter of 2023..

联想没有确认2023年第一季度的任何许可收入。。

Collaboration Revenue: Collaboration revenue was $78.5 million for the first quarter of 2024 compared to $36.3 million for the first quarter of 2023. The increase was primarily due to an increase in revenue generated from sales of CARVYKTI® in connection with the Janssen Agreement.

协作收入：2024年第一季度的协作收入为7850万美元，而2023年第一季度为3630万美元。增加的主要原因是与杨森协议有关的CARVYKTI®销售收入增加。

Collaboration Cost of Revenue: Collaboration cost of revenue was $49.1 million for the first quarter of 2024 compared to $35.6 million for the first quarter of 2023. The increase was primarily due to Legend Biotech’s share of the cost of sales in connection with CARVYKTI® sales under the Janssen Agreement..

收入协作成本：2024年第一季度的收入协作成本为4910万美元，而2023年第一季度为3560万美元。这一增长主要是由于联想生物技术在杨森协议项下CARVYKTI®销售相关的销售成本中所占份额。。

Cost of License and Other Revenue: Cost of license and other revenue for the three months ended March 31, 2024 was $5.6 million and consisted of costs in connection with the global license agreement with Novartis Pharma AG to develop, manufacture, and commercialize LB2102 and other potential CAR-T therapies selectively targeting DLL3.

许可成本和其他收入：截至2024年3月31日的三个月内，许可成本和其他收入为560万美元，包括与诺华制药公司签订的全球许可协议相关的成本，该协议旨在开发、制造和商业化LB2102和其他有选择地针对DLL3的潜在CAR-T疗法。

The Company did not incur any cost of license and other revenue for the three months ended March 31, 2023..

截至2023年3月31日的三个月内，公司没有产生任何许可证费用和其他收入。。

Research and Development Expenses: Research and development expenses were $101.0 million for the first quarter of 2024 compared to $84.9 million for the first quarter of 2023. The increase was primarily driven by continuous research and development activities in cilta-cel, including start up costs for clinical production in Belgium and continued investment in Legend’s solid tumor programs..

研发费用：2024年第一季度的研发费用为1.01亿美元，而2023年第一季度为8490万美元。这一增长主要是由于cilta cel的持续研发活动，包括比利时临床生产的启动成本以及对Legend实体瘤项目的持续投资。。

Administrative Expenses: Administrative expenses were $31.9 million for the first quarter of 2024 compared to $22.2 million for the first quarter of 2023. The increase was primarily due to the expansion of administrative functions and infrastructure to increase manufacturing capacity.

管理费用：2024年第一季度的管理费用为3190万美元，而2023年第一季度为2220万美元。增加的主要原因是扩大了行政职能和基础设施，以增加制造能力。

Selling and Distribution Expenses: Selling and distribution expenses were $24.2 million for the first quarter of 2024 compared to $18.0 million for the first quarter of 2023. The increase was primarily driven by costs associated with commercial activities for cilta-cel, including the expansion of the sales force and second line indication launch preparation..

销售和分销费用：2024年第一季度的销售和分销费用为2420万美元，而2023年第一季度为1800万美元。增加的主要原因是与cilta cel商业活动相关的成本，包括扩大销售队伍和二线指示发布准备。。

Net Loss: Net loss was $59.8 million for the first quarter of 2024, compared to a net loss of $112.1 million for the first quarter of 2023.

净损失：2024年第一季度净损失为5980万美元，而2023年第一季度净损失为11210万美元。

Cash Position: Cash and cash equivalents, time deposits, and short-term investments were $1.3 billion as of March 31, 2024.

现金状况：截至2024年3月31日，现金和现金等价物、定期存款和短期投资为13亿美元。

Webcast/Conference Call Details:

网络广播/电话会议详细信息：

Legend Biotech will host its quarterly earnings call and webcast today at 8:00 am ET. To access the webcast, please visit this weblink.

Legend Biotech将于美国东部时间今天上午8:00主持季度收益电话会议和网络广播。要访问网络广播，请访问此网络链接。

A replay of the webcast will be available on Legend Biotech’s website at https://investors.legendbiotech.com/events-and-presentations.

网络广播的重播将在Legend Biotech的网站上提供https://investors.legendbiotech.com/events-and-presentations.

About Legend Biotech

关于Legend Biotech

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogeneic chimeric antigen receptor T-cell, gamma-delta T cell and natural killer (NK) cell-based immunotherapy.

Legend Biotech是一家全球生物技术公司，致力于治疗和一天治疗威胁生命的疾病。总部位于新泽西州萨默塞特，我们正在开发各种技术平台的先进细胞疗法，包括自体和同种异体嵌合抗原受体T细胞，γδT细胞和基于自然杀伤（NK）细胞的免疫疗法。

From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of cutting-edge therapeutics for patients worldwide..

从我们在世界各地的三个研发基地，我们应用这些创新技术，为世界各地的患者探索尖端疗法。。

Learn more at https://legendbiotech.com and follow us on X (formerly Twitter) and LinkedIn.

了解更多信息，请访问https://legendbiotech.com并在X（前Twitter）和LinkedIn上关注我们。

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

关于前瞻性陈述的警示说明

Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives; statements relating to CARVYKTI®, including Legend Biotech’s expectations for CARVYKTI® and its therapeutic potential; statements relating to the potential approval of CARVYKTI® for earlier lines of therapy; statements related to Legend Biotech manufacturing expectations for CARVYKTI®; and the potential benefits of Legend Biotech’s product candidates.

本新闻稿中关于未来预期、计划和前景的声明，以及关于非历史事实的任何其他声明，构成1995年《私人证券诉讼改革法》所指的“前瞻性声明”。这些声明包括但不限于与联想生物技术的战略和目标有关的声明；有关CARVYKTI®的声明，包括联想生物技术公司对CARVYKTI®的期望及其治疗潜力；关于可能批准CARVYKTI®用于早期治疗的声明；与Legend Biotech对CARVYKTI®的制造期望有关的声明；以及Legend Biotech候选产品的潜在益处。

The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

“预期”，“相信”，“继续”，“可能”，“估计”，“预期”，“打算”，“可能”，“计划”，“潜力”，“预测”，“项目”，“应该”，“目标”，“将会”，“将会”和类似的表达旨在识别前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别词。

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to.

由于各种重要因素的影响，实际结果可能与此类前瞻性声明所显示的结果存在重大差异。联想生物技术的预期可能会受到新药品开发中涉及的不确定性等因素的影响；意外的临床试验结果，包括对现有临床数据或意外的新临床数据进行额外分析的结果；意外的监管行动或延迟，包括要求额外的安全性和/或有效性数据或数据分析，或一般的政府监管；由于我们的第三方合作伙伴采取的行动或未能采取行动而导致的意外延误；挑战产生的不确定性。

LEGEND BIOTECH CORPORATION

联想生物技术公司

CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS

简明合并损益表

Three Months Ended

截至三个月

March 31,

3月31日，

2024

2024

2023

2023

US$’000, except share and per share data

000美元，股票和每股数据除外

(Unaudited)

（未经审计）

(Unaudited)

（未经审计）

REVENUE

收入

License revenue

许可证收入

12,181

12,181

—

—

Collaboration revenue

协作收入

78,481

78,481

36,280

36,280

Other revenue

其他收入

3,329

3,329

56

56

Total revenue

总收入

93,991

93,991

36,336

36,336

Collaboration cost of revenue

收入的协作成本

(49,101

(49,101

)

)

(35,613

(35,613

)

)

Cost of license and other revenue

许可成本和其他收入

(5,638

(5,638

)

)

—

—

Other income and gains

其他收入和收益

64,091

64,091

8,199

8,199

Research and development expenses

研发费用

(100,964

(100,964

)

)

(84,889

(84,889

)

)

Administrative expenses

管理费用

(31,929

(31,929

)

)

(22,205

(22,205

)

)

Selling and distribution expenses

销售和分销费用

(24,223

(24,223

)

)

(17,954

(17,954

)

)

Other expenses

其他费用

(540

(540

)

)

(10,734

(10,734

)

)

Fair value gain of warrant liability

权证负债公允价值收益

—

—

20,000

20,000

Finance costs

财务成本

(5,475

(5,475

)

)

(5,113

(5,113

)

)

LOSS BEFORE TAX

税前亏损

(59,788

(59,788

)

)

(111,973

(111,973

)

)

Income tax expense

所得税费用

(5

(5

)

)

(128

(128

)

)

LOSS FOR THE PERIOD

本期亏损

(59,793

(59,793

)

)

(112,101

(112,101

)

)

Attributable to:

归因于：

Ordinary equity holders of the parent

母公司普通股股东

(59,793

(59,793

)

)

(112,101

(112,101

)

)

LOSS PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY HOLDERS OF THE PARENT

归属于母公司普通股股东的每股亏损

Basic

基本

(0.16

(0.16

)

)

(0.34

(0.34

)

)

Diluted

稀释

(0.16

(0.16

)

)

(0.34

(0.34

)

)

ORDINARY SHARES USED IN LOSS PER SHARE COMPUTATION

每股损失计算中使用的普通股

Basic

基本

364,010,429

364,010,429

330,497,072

330,497,072

Diluted

稀释

364,010,429

364,010,429

330,497,072

330,497,072

LEGEND BIOTECH CORPORATION

联想生物技术公司

CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

简明合并财务状况报表

March 31, 2024

2024年3月31日

December 31, 2023

2023年12月31日

US$’000

千美元

US$’000

千美元

(Unaudited)

（未经审计）

(Audited)

（已审核）

NON-CURRENT ASSETS

非流动资产

Property, plant and equipment

物业、厂房和设备

105,278

105,278

108,725

108,725

Advance payments for property, plant and equipment

物业、厂房和设备预付款

563

563

451

451

Right-of-use assets

使用权资产

80,179

80,179

80,502

80,502

Time deposits

定期存款

4,387

4,387

4,362

4,362

Intangible assets

无形资产

3,152

3,152

4,061

4,061

Collaboration prepaid leases

协作预付租赁

166,344

166,344

151,216

151,216

Other non-current assets

其他非流动资产

1,412

1,412

1,493

1,493

Total non-current assets

非流动资产合计

361,315

361,315

350,810

350,810

CURRENT ASSETS

流动资产

Collaboration inventories

协作库存

22,146

22,146

19,433

19,433

Trade receivables

贸易应收款

3,307

3,307

100,041

100,041

Prepayments, other receivables and other assets

预付款、其他应收款和其他资产

85,603

85,603

69,251

69,251

Financial assets at fair value through profit or loss

以公允价值计量且其变动计入当期损益的金融资产

150,449

150,449

663

663

Pledged deposits

质押存款

359

359

357

357

Time deposits

定期存款

254,357

254,357

30,341

30,341

Cash and cash equivalents

现金及现金等价物

897,571

897,571

1,277,713

1,277,713

Total current assets

流动资产总额

1,413,792

1,413,792

1,497,799

1,497,799

Total assets

总资产

1,775,107

1,775,107

1,848,609

1,848,609

CURRENT LIABILITIES

流动负债

Trade payables

贸易应付款

39,485

39,485

20,160

20,160

Other payables and accruals

其他应付款和应计项目

136,012

136,012

132,802

132,802

Government grants

政府补助金

538

538

68

68

Lease liabilities

租赁负债

3,116

3,116

3,175

3,175

Tax payable

应交税费

7,273

7,273

7,203

7,203

Contract liabilities

合同责任

63,251

63,251

53,010

53,010

Total current liabilities

流动负债合计

249,675

249,675

216,418

216,418

NON-CURRENT LIABILITIES

非流动负债

Collaboration interest-bearing advanced funding

合作生息预付款

286,396

286,396

281,328

281,328

Lease liabilities long term

长期租赁负债

45,174

45,174

44,169

44,169

Government grants

政府补助金

6,664

6,664

7,305

7,305

Contract liabilities

合同责任

23,109

23,109

47,962

47,962

Other non-current liabilities

其他非流动负债

30

30

56

56

Total non-current liabilities

非流动负债合计

361,373

361,373

380,820

380,820

Total liabilities

负债总额

611,048

611,048

597,238

597,238

EQUITY

股权

Share capital

股本

36

36

36

36

Reserves

储量

1,164,023

1,164,023

1,251,335

1,251,335

Total ordinary shareholders’ equity

普通股股东权益合计

1,164,059

1,164,059

1,251,371

1,251,371

Total equity

总股本

1,164,059

1,164,059

1,251,371

1,251,371

Total liabilities and equity

负债和权益合计

1,775,107

1,775,107

1,848,609

1,848,609

LEGEND BIOTECH CORPORATION

联想生物技术公司

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW

简明合并现金流量表

Three Months Ended March 31,

截至3月31日的三个月，

US$’000

千美元

2024

2024

2023

2023

(Unaudited)

（未经审计）

(Unaudited)

（未经审计）

LOSS BEFORE TAX

税前亏损

(59,788

(59,788

)

)

(111,973

(111,973

)

)

CASH FLOWS FROM/ (USED IN) OPERATING ACTIVITIES

经营活动产生/（使用）的现金流量

15,518

15,518

(139,215

(139,215

)

)

CASH FLOWS FROM/ (USED IN) INVESTING ACTIVITIES

投资活动产生/（使用）的现金流量

(396,148

(396,148

)

)

16,032

16,032

CASH FLOWS FROM/ (USED IN) FINANCING ACTIVITIES

融资活动产生/（使用）的现金流

831

831

(444

(444

)

)

NET DECREASE IN CASH AND CASH EQUIVALENTS

现金及现金等价物净减少额

(379,799

(379,799

)

)

(123,627

(123,627

)

)

Effect of foreign exchange rate changes, net

汇率变动的净影响

(343

(343

)

)

(2,354

(2,354

)

)

Cash and cash equivalents at beginning of the period

期初现金及现金等价物

1,277,713

1,277,713

786,031

786,031

CASH AND CASH EQUIVALENTS AT END OF THE YEAR

年末现金及现金等价物

897,571

897,571

660,050

660,050

ANALYSIS OF BALANCES OF CASH AND CASH EQUIVALENTS

现金及现金等价物余额分析

Cash and bank balances

现金和银行余额

1,156,674

1,156,674

670,065

670,065

Less: Pledged deposits

减：质押存款

359

359

1,283

1,283

Time deposits

定期存款

258,744

258,744

8,732

8,732

Cash and cash equivalents as stated in the statement of financial position

财务状况表中所述的现金和现金等价物

897,571

897,571

660,050

660,050

Cash and cash equivalents as stated in the statement of cash flows

现金流量表中所列的现金和现金等价物

897,571

897,571

660,050

660,050