Vir Biotechnology公布2024年第二季度财务业绩，并宣布战略重组，以优先考虑临床阶段的管道机会-动脉网

Vir Biotechnology Reports Second Quarter 2024 Financial Results and Announces Strategic Restructuring to Prioritize Clinical-Stage Pipeline Opportunities

businesswire 等信源发布 2024-08-02 02:02

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SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the second quarter ended June 30, 2024.

。

“The positive preliminary SOLSTICE Phase 2 study together with the recent FDA IND clearance and Fast Track designation for tobevibart and elebsiran for the treatment of chronic hepatitis delta infection highlight the encouraging momentum we’re building towards addressing the substantial unmet medical need for patients affected by this life-threatening disease,” said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer.

Vir首席执行官、工商管理硕士、医学博士玛丽安·德巴克（MarianneDeBacker）说：“积极的初步SOLSTICE 2期研究以及最近FDA的IND批准和tobevibart和elebsiran用于治疗慢性肝炎三角洲感染的快速通道指定，突显了我们正在为解决受这种威胁生命的疾病影响的患者的大量未满足的医疗需求而建立的令人鼓舞的势头。”。

“In addition, we are taking decisive steps to strategically restructure our organization and prioritize our resources to focus on the highest value near-term opportunities. These key strategic decisions will enable us to drive sustainable growth and accelerate patient impact as we advance in our mission of powering the immune system to transform lives.”.

“此外，我们正在采取决定性步骤，战略性地重组我们的组织，并优先考虑我们的资源，以专注于最高价值的近期机会。这些关键的战略决策将使我们能够推动可持续增长，并在我们推进免疫系统改造生活的使命时加速对患者的影响。”。

Pipeline Programs

管道项目

Chronic Hepatitis Delta (CHD)

慢性三角洲肝炎（CHD）

The Company presented positive preliminary Phase 2 chronic hepatitis delta SOLSTICE study data at the European Association for the Study of the Liver, EASL™ Congress 2024.

该公司在2024年欧洲肝脏研究协会EASL™大会上提交了阳性的2期慢性肝炎三角洲至日研究初步数据。

Tobevibart monotherapy and combination therapy with elebsiran achieved high virologic response and ALT normalization in people living with the hepatitis delta virus after 12 and 24 weeks of treatment.

。

Complete 24-week treatment data on the approximately 60 participants is on track to be reported in the fourth quarter of 2024.

关于大约60名参与者的完整24周治疗数据有望在2024年第四季度报告。

On June 26, the U.S. Food and Drug Administration (FDA) cleared the Company's investigational new drug (IND) application and granted Fast Track designation for the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection.

6月26日，美国食品和药物管理局（FDA）批准了该公司的研究性新药（IND）申请，并批准了tobevibart和elebsiran联合治疗慢性三角型肝炎感染的快速通道。

Chronic Hepatitis B (CHB)

慢性乙型肝炎（CHB）

The Phase 2 MARCH Part B study is fully enrolled with 48-week end of treatment data expected in the fourth quarter of 2024. The study is evaluating the safety, tolerability and antiviral activity of the combination of tobevibart and elebsiran with and without peginterferon alpha.

3月2日第二阶段B部分研究已全部登记，预计2024年第四季度将有48周的治疗结束数据。该研究正在评估托拜巴特和elebsiran联合使用和不使用聚乙二醇干扰素α的安全性、耐受性和抗病毒活性。

Initial data from the Phase 2 PREVAIL platform study and its THRIVE/STRIVE sub-protocols is expected in the first half of 2025. These studies are evaluating combinations of tobevibart, elebsiran and/or peginterferon alpha in two patient populations: immune-active but treatment-naïve and inactive carriers..

第二阶段PREVAIL平台研究及其STRIVE/STRIVE子协议的初始数据预计将于2025年上半年发布。这些研究正在评估tobevibart，elebsiran和/或聚乙二醇干扰素-α在两个患者人群中的组合：免疫活跃但未接受治疗和未接受治疗的携带者。。

Corporate Update

公司更新

As announced today, the Company signed an exclusive worldwide license agreement with Sanofi for multiple potential best-in-class clinical-stage T-cell engagers and exclusive use of the protease-cleavable masking platform, acquired by Sanofi from Amunix Pharmaceuticals. This license agreement is subject to the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Act Antitrust Improvements Act of 1976, as amended (HSR)..

正如今天宣布的那样，该公司与赛诺菲签署了一项全球独家许可协议，涉及多个潜在的一流临床阶段T细胞参与者，并独家使用赛诺菲从Amunix Pharmaceuticals收购的蛋白酶可切割掩蔽平台。根据1976年《哈特·斯科特·罗迪诺法案反托拉斯改进法案》（HSR）的规定，本许可协议的适用等待期到期或终止。。

The Company initiated a strategic restructuring to advance the development of its hepatitis programs and focus on the highest near-term value opportunities. The organizational realignment and optimization include phasing out programs in influenza, COVID-19, and the Company’s T cell-based viral vector platform, as well as a workforce reduction of approximately 25% or approximately 140 employees.

该公司启动了战略重组，以推进其肝炎项目的发展，并专注于近期价值最高的机会。组织调整和优化包括逐步取消流感，新型冠状病毒肺炎和该公司基于T细胞的病毒载体平台的计划，以及减少约25%或约140名员工的劳动力。

The Company expects to end 2024 with approximately 435 employees, a decrease of approximately 200 from its peak headcount in the second quarter of 2023. This includes the Sanofi employees who are expected to join Vir following receipt of HSR clearance..

该公司预计到2024年底将拥有约435名员工，比2023年第二季度的高峰人数减少约200人。这包括赛诺菲的员工，他们预计在收到高铁许可后加入Vir。。

“This decision was not taken lightly yet is essential to ensure that our resources are aligned with our evolving strategy and that Vir is positioned for sustainable growth and long-term success,” said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer. “I am grateful for every Vir employee who has helped to progress our journey to bring life-saving therapies to patients and their families.”.

Vir首席执行官Marianne De Backer（医学硕士、博士、工商管理硕士）表示：“这一决定并非易事，但对于确保我们的资源与我们不断发展的战略相一致，确保Vir能够实现可持续增长和长期成功至关重要。”。“我感谢每一位Vir员工，他们帮助我们的旅程取得了进展，为患者及其家人带来了挽救生命的疗法。”。

As a result of this strategic restructuring and prioritization the Company anticipates:

由于这一战略重组和优先次序，公司预计：

Approximately $50 million of annual workforce cost savings starting in 2025. Combined with the strategic actions taken in December 2023, the Company lowered its cost structure by approximately $90 million since its peak in 2023, part of which will be redeployed to the newly anticipated key personnel from Sanofi..

从2025年开始，每年节省劳动力成本约5000万美元。。。

Cost savings of $50 million through the end of 2025 due to the phasing out of certain programs. These savings will substantially be reinvested in the newly licensed programs from Sanofi following closing of the transaction.

由于某些项目的逐步取消，到2025年底可节省5000万美元的成本。交易结束后，这些节省下来的资金将大量再投资于赛诺菲新授权的项目。

Restructuring expenses estimated at $11 million to $13 million, primarily related to employee severance cash payouts. The Company expects to recognize most of these expenses in the second half of 2024.

重组费用估计为1100万至1300万美元，主要与员工遣散费现金支出有关。该公司预计在2024年下半年确认其中大部分费用。

The Company will host a virtual R&D Day in late November 2024.

该公司将于2024年11月下旬举办虚拟研发日。

On May 29, 2024, the Company announced the appointment of Mark D. Eisner, M.D., M.P.H. as Executive Vice President and Chief Medical Officer, effective June 3, 2024. Dr. Eisner brings extensive late-stage clinical development expertise and deep knowledge in the fields of immunology and infectious disease..

2024年5月29日，公司宣布任命Mark D.Eisner，M.D.，M.P.H.为执行副总裁兼首席医疗官，自2024年6月3日起生效。艾斯纳博士在免疫学和传染病领域拥有广泛的晚期临床开发专业知识和深厚的知识。。

On April 18, 2024, the Company announced that founding board members Phillip Sharp, Ph.D. and Robert Perez would not stand for reelection. Effective May 29, 2024, two new independent directors were elected in their place, including Norbert Bischofberger, Ph.D., who brings close to 40 years of biotech leadership experience and Ramy Farid, Ph.D., whose pioneering work applying advanced computational methods to drug discovery has enabled high-quality, novel molecules for drug development and materials applications..

2024年4月18日，该公司宣布创始董事会成员PhillipSharp博士和RobertPerez不支持连任。自2024年5月29日起，两位新的独立董事当选，其中包括拥有近40年生物技术领导经验的Norbert Bischofberger博士和Ramy Farid博士，他们将先进的计算方法应用于药物发现的开创性工作为药物开发和材料应用提供了高质量的新型分子。。

Second Quarter 2024 Financial Results

2024年第二季度财务业绩

Cash, Cash Equivalents and Investments: As of June 30, 2024, the Company had approximately $1.43 billion in cash, cash equivalents and investments. Cash, cash equivalents and investments declined by approximately $78 million during the second quarter of 2024.

现金、现金等价物和投资：截至2024年6月30日，该公司拥有约14.3亿美元的现金、现金等价物和投资。2024年第二季度，现金、现金等价物和投资减少了约7800万美元。

Revenues: Total revenues for the quarter ended June 30, 2024, were $3.1 million compared to $3.8 million for the same period in 2023.

收入：截至2024年6月30日的季度总收入为310万美元，而2023年同期为380万美元。

Cost of Revenue: Cost of revenue was nominal for the second quarter of 2024 and 2023.

收入成本：2024年和2023年第二季度的收入成本是名义上的。

Research and Development Expenses (R&D): R&D expenses for the second quarter of 2024 were $105.1 million, which included $13.1 million of non-cash stock-based compensation expense, compared to $168.1 million for the same period in 2023, which included $17.1 million of non-cash stock-based compensation expense.

研发费用（R＆D）：2024年第二季度的研发费用为1.051亿美元，其中包括1310万美元的非现金股票补偿费用，而2023年同期为1.681亿美元，其中包括1710万美元的非现金股票补偿费用。

The decrease was primarily driven by lower clinical development costs and manufacturing costs associated with VIR-2482, lower contract manufacturing costs associated with the Company's hepatitis programs, and lower personnel costs related to cost savings initiatives implemented during the second half of 2023..

减少的主要原因是与VIR-2482相关的临床开发成本和制造成本降低，与公司肝炎项目相关的合同制造成本降低，以及与2023年下半年实施的成本节约举措相关的人员成本降低。。

Selling, General and Administrative Expenses (SG&A): SG&A expenses for the second quarter of 2024 were $30.3 million, which included $9.1 million of non-cash stock-based compensation expense, compared to $45.5 million for the same period in 2023, which included $13.5 million of non-cash stock-based compensation expense.

销售、总务和管理费用（SG＆A）：2024年第二季度的SG＆A费用为3030万美元，其中包括910万美元的非现金股票补偿费用，而2023年同期为4550万美元，其中包括1350万美元的非现金股票补偿费用。

The decrease was primarily related to cost savings initiatives implemented during the second half of 2023..

下降主要与2023年下半年实施的成本节约举措有关。。

Restructuring, long-lived assets impairment and related charges: Restructuring, long-lived assets impairment and related charges for the second quarter of 2024 was $26.3 million compared to $5.4 million for the same period in 2023. The increase was primarily related to impairment charges related to closing our St.

重组、长期资产减值和相关费用：2024年第二季度的重组、长期资产减值和相关费用为2630万美元，而2023年同期为540万美元。增加的主要原因是与关闭我们的St相关的减值费用。

Louis, Missouri facility previously announced on December 13, 2023..

密苏里州路易斯工厂之前于2023年12月13日宣布。。

Other Income: Other income for the second quarter of 2024 was $18.7 million compared to $17.6 million for the same period in 2023.

其他收入：2024年第二季度的其他收入为1870万美元，而2023年同期为1760万美元。

Benefit from Income Taxes: Benefit from income taxes for the second quarter of 2024 was $1.5 million compared to $2.8 million for the same period in 2023.

所得税收益：2024年第二季度所得税收益为150万美元，而2023年同期为280万美元。

Net Loss: Net loss attributable to Vir for the second quarter of 2024 was $(138.4) million, or $(1.02) per share, basic and diluted, compared to a net loss of $(194.8) million, or $(1.45) per share, basic and diluted for the same period in 2023.

净损失：2024年第二季度归属于Vir的净损失为（1.384）亿美元，或每股（1.02）美元，基本和稀释，而2023年同期净损失为（1.948）亿美元，或每股（1.45）美元，基本和稀释。

2024 Financial Guidance

2024年财务指南

The Company is lowering its operating expense guidance for the full-year 2024, inclusive of its recently announced transaction with Sanofi and strategic restructuring. This reduction is primarily due to savings from workforce restructuring and phasing out of influenza, COVID-19, and the Company’s T cell-based viral vector platform programs, as well as other ongoing cost saving efforts:.

。

GAAP operating expense range:

GAAP营业费用范围：

580

到

610

The following expenses are included in the GAAP operating expense range:

以下费用包含在GAAP运营费用范围内：

Stock-based compensation expense

股票补偿费用

到

Restructuring charges*

重组费用*

到

* Restructuring charges include employee severance cash payouts, as well as non-cash expense related to the closing of two R&D sites previously announced on December 13, 2023.

*重组费用包括员工遣散费现金支出，以及与之前于2023年12月13日宣布关闭两个研发基地有关的非现金费用。

The revised guidance excludes the accounting impact of the upfront payment and an escrowed milestone payment in connection with the Sanofi agreement. The Company will incorporate any associated impact to its guidance in its third quarter 2024 earnings press release.

修订后的指南不包括与赛诺菲协议相关的预付款和托管里程碑付款的会计影响。该公司将在2024年第三季度收益新闻稿中纳入任何相关影响。

Approximately three percent of the GAAP operating expense will be funded by grants. These grants are recognized as revenue.

大约3%的GAAP运营费用将由赠款资助。这些赠款被确认为收入。

Except for the pending transaction with Sanofi, the GAAP operating expense guidance does not include the effect of GAAP adjustments caused by events that may occur subsequent to the publication of this guidance, including, but not limited to, business development activities, litigation, in-process R&D impairments, and changes in the fair value of contingent considerations..

除与赛诺菲的未决交易外，GAAP运营费用指南不包括本指南发布后可能发生的事件引起的GAAP调整的影响，包括但不限于业务发展活动、诉讼、过程中研发减值以及或有对价公允价值的变化。。

Conference Call

电话会议

Vir will host a conference call to discuss the second quarter results at 1:30 p.m. PT / 4:30 p.m. ET today. A live webcast will be available on https://investors.vir.bio/ and will be archived on www.vir.bio for 30 days.

Vir将于美国东部时间今天下午1:30/4:30召开电话会议，讨论第二季度业绩。在线直播将于https://investors.vir.bio/并将在www.vir.bio上存档30天。

About Tobevibart (VIR-3434)

关于托韦巴特（VIR-3434）

Tobevibart is an investigational subcutaneously administered antibody designed to inhibit entry of hepatitis B and hepatitis delta viruses into hepatocytes, neutralize both hepatitis B virus and hepatitis delta virus virions and to reduce the level of virions and subviral particles in the blood. Tobevibart, which incorporates Xencor’s Xtend™ and other Fc technologies, has been engineered to have an extended half-life and was identified using Vir’s proprietary monoclonal antibody discovery platform..

Tobevibart是一种研究性皮下给药抗体，旨在抑制乙型肝炎和三角洲肝炎病毒进入肝细胞，中和乙型肝炎病毒和三角洲肝炎病毒粒子，并降低血液中病毒粒子和亚病毒粒子的水平。Tobevibart结合了Xencor的Xtend™和其他Fc技术，已被设计为具有延长的半衰期，并使用Vir专有的单克隆抗体发现平台进行了鉴定。。

About Elebsiran (VIR-2218)

关于Elebsiran（VIR-2218）

Elebsiran is an investigational subcutaneously administered hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Vir believes it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus.

Elebsiran是一种研究性皮下注射乙型肝炎病毒，靶向小干扰核糖核酸（siRNA），旨在降解乙型肝炎病毒RNA转录本并限制乙型肝炎表面抗原的产生。Vir认为它有可能对乙型肝炎病毒和三角洲肝炎病毒具有直接的抗病毒活性。

It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially could result in an increased therapeutic index. Elebsiran is the first asset in the Company’s collaboration with Alnylam Pharmaceuticals, Inc.

这是临床上第一个包括增强稳定化学加（ESC+）技术的siRNA，以增强稳定性并最大程度地降低脱靶活性，这可能导致治疗指数增加。Elebsiran是该公司与Alnylam Pharmaceuticals，Inc.合作的第一笔资产。

to enter clinical studies..

进入临床研究。。

About Vir Biotechnology, Inc.

关于Vir Biotechnology，Inc。

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Vir’s clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections.

Vir Biotechnology，Inc.是一家临床阶段的生物制药公司，专注于通过发现和开发治疗严重传染病和癌症的药物来增强免疫系统以改变生活。Vir的临床阶段投资组合包括针对慢性三角型肝炎和慢性乙型肝炎感染的传染病计划。

Vir also has a preclinical portfolio of programs across a range of other infectious diseases. Vir routinely posts information that may be important to investors on its website..

Vir还拥有一系列其他传染病的临床前项目组合。Vir定期在其网站上发布对投资者可能很重要的信息。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “should,” “could,” “may,” “might,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的前瞻性声明。诸如“应该”、“可能”、“可能”、“可能”、“将要”、“计划”、“潜力”、“目标”、“期望”、“预期”、“有希望”等词语和类似表达（以及引用未来事件、条件或情况的其他词语或表达）旨在识别前瞻性陈述。

These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding anticipated expenditures and annual savings in connection with the restructuring; the anticipated timing of such cost impacts; Vir’s cash balance; Vir’s financial guidance; Vir’s future financial and operating results and its expectations related thereto; Vir’s ability to realize the anticipated benefits from the exclusive worldwide license agreement with Sanofi (the “Agreement”); difficulties or unanticipated expenses in connection with the Agreement, and the potential effects on Vir’s earnings; the risk that Vir’s investment in connection with the Agreement will lose value for any number of reasons; the ability of the parties to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from studies, including those involving SAR446309 (AMX-818), SAR446329 (AMX-500) and SAR446368, and any additional programs that may become subject to the Agreement; the potential clinical effects, potential benefits, safety and efficacy of the investigational products that are the subject of these programs; data from ongoing studies evaluating such investigation.

这些前瞻性声明基于截至本新闻稿发布之日，Vir的预期和假设。本新闻稿中包含的前瞻性声明包括但不限于与重组有关的预期支出和年度节省的声明；此类成本影响的预期时间；Vir的现金余额；Vir的财务指导；Vir未来的财务和经营业绩及其相关预期；Vir从与赛诺菲的独家全球许可协议（“协议”）中实现预期收益的能力；与协议有关的困难或意外费用，以及对Vir收入的潜在影响；Vir与本协议相关的投资因多种原因而失去价值的风险；双方在目前预期的时间表内或根本没有时间启动，进展或完成临床试验的能力，以及研究可能产生不利结果的可能性，包括涉及SAR446309（AMX-818），SAR446329（AMX-500）和SAR446368的研究，以及可能受协议约束的任何其他计划；作为这些计划主题的研究产品的潜在临床效果，潜在益处，安全性和有效性；正在进行的评估此类调查的研究数据。

VIR BIOTECHNOLOGY, INC.

VIR生物技术公司。

Condensed Consolidated Balance Sheets

简明合并资产负债表

(in thousands, except share and per share data)

（单位：千，股份和每股数据除外）

(unaudited)

（未经审计）

June 30,

6月30日，

2024

December 31,

12月31日，

2023

ASSETS

资产

CURRENT ASSETS:

流动资产：

Cash and cash equivalents

现金及现金等价物

296,864

241,576

Short-term investments

短期投资

849,833

1,270,980

Restricted cash and cash equivalents, current

限制性现金和现金等价物，流动

13,946

13,268

Equity investments

股权投资

4,368

9,853

Prepaid expenses and other current assets

预付费用和其他流动资产

40,729

52,549

Total current assets

流动资产总额

1,205,740

1,588,226

Intangible assets, net

无形资产净值

18,899

22,565

Goodwill

商誉

16,937

Property and equipment, net

财产和设备净值

66,063

96,018

Operating lease right-of-use assets

经营租赁使用权资产

62,266

71,182

Restricted cash and cash equivalents, noncurrent

非流动受限现金和现金等价物

6,366

6,448

Long-term investments

长期投资

279,992

105,275

Other assets

其他资产

13,292

12,409

TOTAL ASSETS

总资产

1,669,555

1,919,060

LIABILITIES AND STOCKHOLDERS’ EQUITY

负债和股东权益

CURRENT LIABILITIES:

Accounts payable

应付账款

4,389

6,334

Accrued and other liabilities

应计负债和其他负债

75,321

104,220

Deferred revenue, current

递延收入，当期

16,702

64,853

Total current liabilities

流动负债合计

96,412

175,407

Operating lease liabilities, noncurrent

经营租赁负债，非流动

95,018

111,673

Contingent consideration, noncurrent

或有对价，非流动

30,600

25,960

Other long-term liabilities

其他长期负债

13,855

15,784

TOTAL LIABILITIES

负债总额

235,885

328,824

Commitments and contingencies (Note 8)

承诺和或有事项（附注8）

STOCKHOLDERS’ EQUITY:

股东权益：

Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of June 30, 2024 and December 31, 2023; no shares issued and outstanding as of June 30, 2024 and December 31, 2023

优先股，面值0.0001美元；截至2024年6月30日和2023年12月31日授权的10000000股；截至2024年6月30日和2023年12月31日，未发行股票

—

Common stock, $0.0001 par value; 300,000,000 shares authorized as of June 30, 2024 and December 31, 2023; 136,590,097 and 134,781,286 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively

普通股，面值0.0001美元；截至2024年6月30日和2023年12月31日授权的300000000股；截至2024年6月30日和2023年12月31日，分别发行了136590097股和134781286股

Additional paid-in capital

额外实收资本

1,878,013

1,828,862

Accumulated other comprehensive loss

累积其他综合损失

(2,879

)

(815

)

Accumulated deficit