Vir Biotechnology提供企业最新情况并报告2023年第四季度和全年财务业绩-动脉网

Vir Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results

businesswire 等信源发布 2024-02-23 04:05

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SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2023.

旧金山--（商业新闻短讯）--Vir Biotechnology，Inc.（纳斯达克：Vir）今天提供了公司最新信息，并报告了截至2023年12月31日的第四季度和全年的财务业绩。

“Vir is poised to have a transformational year, with catalysts expected in the second and fourth quarters, which build off last year’s clinical trial progress in our chronic hepatitis delta and B programs. We believe these data readouts, notably the SOLSTICE delta update in the second quarter, hold tremendous promise for patients as we work towards solutions for these deadly diseases,” said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer.

“Vir将迎来一个转型的年份，预计第二季度和第四季度将产生催化剂，这将巩固去年我们慢性乙型肝炎三角洲和乙型肝炎项目的临床试验进展。我们相信这些数据读数，特别是第二季度的至日三角洲更新，在我们努力解决这些致命疾病的过程中，为患者带来巨大的希望。”Vir首席执行官、MBA博士、理学硕士玛丽安·德巴克（MarianneDeBacker）说。

“Our financial strength allows us to fund multiple clinical programs through major inflection points while enabling the flexibility to invest in external innovation opportunities.”.

“我们的财务实力使我们能够通过重大转折点为多个临床项目提供资金，同时能够灵活地投资于外部创新机会。”。

Pipeline Programs

管道项目

Chronic Hepatitis Delta (CHD)

慢性三角洲肝炎（CHD）

The Company presented initial SOLSTICE data from a small subset of participants in a late-breaker presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting in November 2023.

该公司在2023年11月美国肝病研究协会（AASLD）肝脏会议上的一次迟发性演讲中，展示了一小部分参与者的初始至日数据。

After 12 weeks of combination treatment with tobevibart and elebsiran, 5 out of 6 participants achieved undetectable HDV RNA and 6 out of 6 were below the lower limit of quantification.

在与tobevibart和elebsiran联合治疗12周后，6名参与者中有5名获得了不可检测的HDV RNA，6名参与者中有6名低于定量下限。

The SOLSTICE trial is ongoing with enrollment currently ahead of schedule for completion in the first quarter of 2024 due to the high level of physician and patient interest. This portion of the SOLSTICE trial is investigating the combination of tobevibart and elebsiran given every 4 weeks in one cohort, and tobevibart monotherapy given every 2 weeks in another cohort.

SOLSTICE试验正在进行中，由于医生和患者的兴趣很高，目前提前报名，预计将于2024年第一季度完成。SOLSTICE试验的这一部分正在研究一个队列中每4周给予一次tobevibart和elebsiran的组合，以及另一个队列中每2周给予一次tobevibart单药治疗。

Of the 30 participants anticipated to be enrolled in each cohort, approximately 44% have compensated cirrhosis..

在预计参加每个队列的30名参与者中，大约44%的人患有代偿性肝硬化。。

The Company expects to report data on a subset of participants in the second quarter: 12-week treatment data for 15 participants per regimen as well as 24-week data for 10 participants per regimen. Complete 24-week treatment data for 30 participants per regimen is expected in the fourth quarter of 2024..

该公司预计在第二季度报告一部分参与者的数据：每个方案15名参与者的12周治疗数据以及每个方案10名参与者的24周数据。预计2024年第四季度，每个方案将为30名参与者提供完整的24周治疗数据。。

Chronic Hepatitis B (CHB)

慢性乙型肝炎（CHB）

The Company presented new MARCH Part B data at AASLD The Liver Meeting in November 2023.

该公司在2023年11月的AASLD肝脏会议上提交了新的3月B部分数据。

The data demonstrated an approximately three-fold higher response rate when adding tobevibart to a regimen of elebsiran with or without peginterferon after 24 weeks of treatment (15.0% for tobevibart + elebsiran + peginterferon alpha and 14.3% for tobevibart + elebsiran).

数据显示，在治疗24周后，将tobevibart加入到有或没有聚乙二醇干扰素的elebsiran方案中时，反应率大约高出三倍（tobevibart+elebsiran+聚乙二醇干扰素α为15.0%，tobevibart+elebsiran为14.3%）。

The MARCH Part B trial is ongoing with 48-week end of treatment data expected in the fourth quarter of 2024.

三月B部分试验正在进行中，预计2024年第四季度将有48周的治疗结束数据。

The Phase 2 PREVAIL platform trial and its THRIVE/STRIVE sub-protocols are ongoing. The platform is evaluating combinations of tobevibart, elebsiran and/or peginterferon alpha in two CHB patient populations with the potential to evaluate other populations in the future. Initial data from this platform trial is expected in the first half of 2025..

第二阶段PREVAIL平台试验及其THRIVE/Strave子协议正在进行中。该平台正在评估两个CHB患者人群中托拜巴特，elebsiran和/或聚乙二醇干扰素-α的组合，并有可能在未来评估其他人群。该平台试验的初步数据预计将于2025年上半年发布。。

Human Immunodeficiency Virus (HIV)

人类免疫缺陷病毒（HIV）

The Phase 1 trial of VIR-1388, an investigational novel T cell vaccine for the prevention of HIV, remains ongoing with initial immunogenicity data expected in the second half of 2024.

VIR-1388是一种用于预防艾滋病毒的新型研究性T细胞疫苗，其第一阶段试验仍在进行中，预计2024年下半年将有初步的免疫原性数据。

The trial is supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Bill & Melinda Gates Foundation, and is being conducted by the HIV Vaccine Trials Network.

该试验得到了美国国立卫生研究院过敏与传染病研究所（National Institute of Allergy and Infectious Diseases）和比尔与梅琳达·盖茨基金会（Bill＆MelindaGates Foundation）的支持，目前正在由HIV疫苗试验网络进行。

In December, Nature Medicine recognized the Phase 1 trial of VIR-1388 as one of the “11 clinical trials that will shape medicine in 2024”.

12月，自然医学将VIR-1388的1期临床试验确认为“2024年将塑造医学的11项临床试验”之一。

COVID-19

新型冠状病毒肺炎

Later this year, the Company expects to file a health authority application to support a Phase 1 trial evaluating VIR-7229, a potential broadly neutralizing next-generation COVID antibody that has been AI-engineered to have increased potency, breadth and resistance to viral escape.

今年晚些时候，该公司预计将提交一份卫生局申请，以支持评估VIR-7229的第一阶段试验，VIR-7229是一种潜在的广泛中和的下一代新型冠状病毒抗体，已被人工智能设计为具有更高的效力，广度和对病毒逃逸的抵抗力。

The development of VIR-7229 has been supported in whole or in part with federal funds from the Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50122C00081..

VIR-7229的开发得到了卫生与公众服务部（HHS）的联邦资金的全部或部分支持；战略准备和应对管理局（ASPR）；生物医学高级研究与发展局（BARDA），其他交易号：75A50122C00081。。

Influenza

流感

The full analysis of data from the Phase 2 PENINSULA trial is expected in the second quarter in a scientific publication.

预计第二季度将在科学出版物中对第二阶段半岛试验的数据进行全面分析。

On February 21, 2024, the Company and GSK terminated their collaboration to research, develop and commercialize the Company’s monoclonal antibodies for the prevention, treatment, or prophylaxis of the influenza virus under the Definitive Collaboration Agreement established in May 2021 to reflect that Vir retains sole rights to continue advancing its investigational therapies for influenza independently or with other partners..

2024年2月21日，该公司与葛兰素史克终止了其研究、开发和商业化该公司用于预防、治疗、，或根据2021年5月建立的最终合作协议预防流感病毒，以反映Vir保留独立或与其他合作伙伴继续推进其流感研究疗法的唯一权利。。

The Company is actively pursuing external partnership opportunities for its next-generation influenza A and B antibodies and Antibody Drug Conjugates (ADCs).

该公司正在积极寻求下一代甲型和乙型流感抗体以及抗体-药物偶联物（ADC）的外部合作机会。

Preclinical Pipeline Candidates

临床前管道候选人

Vir is continuing to advance next-generation antibodies using its proprietary platform, which leverages dAIsYTM (data AI structure and antibody), an AI engine, allowing the Company to bring high-quality drug candidates to the clinic more efficiently.

Vir正在使用其专有平台继续推进下一代抗体，该平台利用AI引擎dAIsYTM（数据AI结构和抗体），使公司能够更有效地将高质量的候选药物带到诊所。

The Company expects the filing of multiple new INDs in the next 12-24 months, including:

公司预计在未来12-24个月内将提交多个新的IND，包括：

VIR-2981, an investigational neuraminidase-targeting mAb against both influenza A and B viruses.

VIR-2981是一种针对甲型和乙型流感病毒的单克隆抗体的研究性神经氨酸酶。

VIR-8190, an investigational mAb against respiratory syncytial virus (RSV) and human metapneumovirus.

VIR-8190，一种针对呼吸道合胞病毒（RSV）和人类偏肺病毒的研究性单克隆抗体。

VIR-1949, an investigational therapeutic T cell vaccine based on Vir’s human cytomegalovirus (HCMV) vector platform that is designed to treat precancerous lesions caused by the human papillomavirus.

VIR-1949是一种基于VIR人巨细胞病毒（HCMV）载体平台的研究性治疗性T细胞疫苗，旨在治疗由人乳头瘤病毒引起的癌前病变。

Corporate Update

公司更新

In December of 2023, the Company announced strategic imperatives to focus its capital allocation on programs with the highest potential for patient impact and value creation, which include:

2023年12月，该公司宣布了将资本分配重点放在对患者产生影响和创造价值潜力最大的项目上的战略要务，其中包括：

Closing R&D facilities in St. Louis, Missouri and Portland, Oregon in 2024. Research activities will continue at the Company’s sites in San Francisco, California and Bellinzona, Switzerland.

2024年关闭密苏里州圣路易斯和俄勒冈州波特兰的研发设施。该公司位于加利福尼亚州旧金山和瑞士贝林佐纳的工厂将继续开展研究活动。

Eliminating approximately 12%, or 75 positions, including reductions from the Company’s discontinuation of its small molecule group which was initiated in the third quarter of 2023. The reductions will be substantially completed by the end of the first quarter of 2024.

取消了大约12%，即75个职位，包括公司于2023年第三季度开始停止其小分子集团的裁员。这些削减将在2024年第一季度末基本完成。

Through these actions, the Company expects to reduce its cost structure by at least $40 million annually.

通过这些行动，该公司预计每年至少减少4000万美元的成本结构。

On February 20, 2024, the Company announced that Executive Vice President and Chief Medical Officer, Phil Pang, M.D., Ph.D., has decided to step down to spend more time with his family. Dr. Pang’s last day will be March 31, 2024. The Company has initiated a search for a successor.

2024年2月20日，该公司宣布，执行副总裁兼首席医疗官Phil Pang医学博士已决定辞职，以便有更多时间陪伴家人。彭日成博士的最后一天将是2024年3月31日。该公司已开始寻找继任者。

Fourth Quarter and Full Year 2023 Financial Results

2023年第四季度和全年财务业绩

Cash, Cash Equivalents and Investments: As of December 31, 2023, the Company had approximately $1.63 billion in cash, cash equivalents and investments. Cash, cash equivalents and investments declined by approximately $108 million during the fourth quarter of 2023.

现金、现金等价物和投资：截至2023年12月31日，该公司拥有约16.3亿美元的现金、现金等价物和投资。2023年第四季度，现金、现金等价物和投资减少了约1.08亿美元。

Revenues: Total revenues for the quarter ended December 31, 2023 were $16.8 million compared to $49.4 million for the same period in 2022. Total revenues for the full year of 2023 were $86.2 million compared to $1.6 billion in 2022.

收入：截至2023年12月31日的季度总收入为1680万美元，而2022年同期为4940万美元。2023年全年的总收入为8620万美元，而2022年为16亿美元。

Revenues were comprised of the following components:

收入由以下组成部分组成：

Three Months Ended

截至三个月

December 31,

12月31日，

Year Ended

年末

December 31,

12月31日，

2023

2022

% Change

%更改

2023

2022

% Change

%更改

(in millions)

（单位：百万）

(in millions)

（单位：百万）

Collaboration revenue

协作收入

8.9

21.6

(58.8

37.3

1,505.5

(97.5

Contract revenue

合同收入

0.7

0.2

>100.0%

2.2

52.7

(95.8

License revenue from a related party

来自关联方的许可收入

—

22.3

(100.0

Grant revenue

赠款收入

7.2

27.6

(73.9

46.7

35.3

32.3

Total revenues

总收入

16.8

49.4

(66.0

86.2

1,615.8

(94.7

Note: Numbers may not add due to rounding.

注意：由于四舍五入，数字可能无法相加。

Collaboration revenue: The decrease in collaboration revenue for the fourth quarter and the full year of 2023 compared to the same periods in 2022 was driven by lower profit share from sales of sotrovimab under the Company’s 2020 GSK agreement.

合作收入：与2022年同期相比，2023年第四季度和全年的合作收入有所下降，这是由于公司2020年GSK协议下销售sotrovimab的利润份额降低所致。

Contract revenue: Contract revenue for the fourth quarter of 2023 and 2022 was nominal. The decrease in contract revenue for the full year of 2023 compared to 2022 was primarily driven by the recognition of deferred revenue related to GSK’s selection of RSV in the third quarter of 2022 under the Company’s 2021 GSK agreement..

合同收入：2023年和2022年第四季度的合同收入为名义收入。与2022年相比，2023年全年合同收入的下降主要是由于根据公司2021年葛兰素史克协议，葛兰素史克在2022年第三季度选择了RSV，因此确认了递延收入。。

License revenue from a related party: The decrease in license revenue for the full year of 2023 compared to 2022 was driven by certain revenues recognized under the collaboration with Brii Biosciences in the third quarter of 2022.

来自关联方的许可收入：与2022年相比，2023年全年许可收入的下降是由于2022年第三季度与Brii Biosciences合作确认的某些收入所致。

Grant revenue: The decrease in grant revenue for the fourth quarter of 2023 compared to the same period in 2022 and the increase in grant revenue for the full year of 2023 compared to 2022 were primarily driven by the timing of revenue recognized under the Company’s grant with BARDA supporting the Company’s Phase 2 PENINSULA trial of VIR-2482..

赠款收入：2023年第四季度赠款收入与2022年同期相比减少，2023年全年赠款收入与2022年相比增加，主要是由于公司赠款确认收入的时间安排，BARDA支持公司VIR-2482的第二阶段半岛试验。。

Cost of Revenue: Cost of revenue for the fourth quarter of 2023 was nominal compared to $6.0 million for the same period in 2022. Cost of revenue for the full year of 2023 was $2.8 million compared to $146.3 million in 2022. The decreases were due to lower third-party royalties owed on the sales of sotrovimab..

收入成本：2023年第四季度的收入成本为名义成本，而2022年同期为600万美元。2023年全年的收入成本为280万美元，而2022年为1.463亿美元。减少的原因是，索罗维玛销售所欠的第三方特许权使用费减少。。

Research and Development Expenses (R&D): R&D expenses for the fourth quarter of 2023 were $111.9 million, which included severance charges of $2.6 million and $16.5 million of non-cash stock-based compensation expense, compared to $155.2 million for the same period in 2022, which included $13.4 million of non-cash stock-based compensation expense.

研发费用（R＆D）：2023年第四季度的研发费用为1.119亿美元，其中包括260万美元的遣散费和1650万美元的非现金股票补偿费用，而2022年同期为1.552亿美元，其中包括1340万美元的非现金股票补偿费用。

The decrease was primarily driven by the wind down of clinical studies involving VIR-2482 in the fourth quarter of 2023. R&D expenses for the full year of 2023 were $589.7 million, which included $62.7 million of non-cash stock-based compensation expense, compared to $474.6 million in 2022, which included $53.2 million of non-cash stock-based compensation expense.

减少的主要原因是2023年第四季度涉及VIR-2482的临床研究逐渐减少。2023年全年的研发费用为5.897亿美元，其中包括6270万美元的非现金股票补偿费用，而2022年的研发费用为4.746亿美元，其中包括5320万美元的非现金股票补偿费用。

The increase was primarily driven by the Phase 2 PENINSULA trial of VIR-2482 and related manufacturing costs and, to a lesser extent, the advancement of our CHB and CHD clinical programs..

增加的主要原因是VIR-2482的2期半岛试验和相关的制造成本，以及在较小程度上我们的CHB和CHD临床计划的进步。。

Selling, General and Administrative Expenses (SG&A): SG&A expenses for the fourth quarter of 2023 were $43.1 million, which included $1.9 million of severance charges and $11.8 million of non-cash stock-based compensation expense, compared to $38.7 million for the same period in 2022, which included $11.5 million of non-cash stock-based compensation expense.

销售、总务和管理费用（SG＆A）：2023年第四季度的SG＆A费用为4310万美元，其中包括190万美元的遣散费和1180万美元的非现金股票补偿费用，而2022年同期为3870万美元，其中包括1150万美元的非现金股票补偿费用。

SG&A expenses for the full year of 2023 were $178.0 million, which included $48.6 million of non-cash stock-based compensation expense, compared to $161.8 million in 2022, which included $48.9 million of non-cash stock-based compensation expense. The increase for both the fourth quarter and full year were primarily driven by higher personnel-related costs..

2023年全年的SG＆A费用为1.78亿美元，其中包括4860万美元的非现金股票补偿费用，而2022年的SG＆A费用为1.618亿美元，其中包括4890万美元的非现金股票补偿费用。第四季度和全年的增长主要是由较高的人事相关成本推动的。。

Other Income (Loss): Other income for the fourth quarter of 2023 was $18.3 million compared to other loss of $(1.1) million for the same period in 2022. The increase was primarily due to higher foreign exchange loss incurred in the fourth quarter of 2022, partially offset by higher unrealized loss of equity investments in the same period of 2023.

其他收入（损失）：2023年第四季度的其他收入为1830万美元，而2022年同期的其他损失为110万美元。增加的主要原因是2022年第四季度发生的外汇损失增加，部分被2023年同期未实现的股权投资损失所抵消。

Other income for the full year of 2023 was $56.1 million compared to other loss of $(78.8) million in 2022. The increase was primarily due to higher unrealized loss of equity investments incurred in 2022 and higher interest income earned in 2023..

2023年全年的其他收入为5610万美元，而2022年的其他损失为7880万美元。增加的主要原因是2022年发生的未实现股权投资损失增加以及2023年获得的利息收入增加。。

Benefit from (Provision for) Income Taxes: Benefit from income taxes for the fourth quarter of 2023 was $4.8 million compared to $50.0 million for the same period in 2022. Benefit from income taxes for the year of 2023 was $13.1 million compared to a provision for income taxes of $(238.4) million in 2022.

所得税收益（准备金）：2023年第四季度所得税收益为480万美元，而2022年同期为5000万美元。2023年的所得税收益为1310万美元，而2022年的所得税准备金为2.384亿美元。

The benefit from income taxes in the fourth quarter and the year of 2023 was primarily due to a pre-tax loss and our ability to carry back the R&D credit to 2022. The benefit from income taxes in the fourth quarter of 2022 was primarily due to the Company’s pre-tax loss. The swing from a provision for income taxes in 2022 to a benefit from income taxes in 2023 was due to the higher collaboration revenue from sotrovimab sales that resulted in pre-tax income in 2022..

第四季度和2023年所得税的收益主要是由于税前亏损以及我们将研发信贷转回2022年的能力。2022年第四季度所得税的收益主要是由于公司的税前亏损。从2022年的所得税拨备到2023年的所得税收益的转变，是由于sotrovimab销售带来的更高的合作收入导致了2022年的税前收入。。

Net (Loss) Income: Net loss attributable to Vir for the fourth quarter of 2023 was $(116.0) million, or $(0.86) per share, basic and diluted, compared to a net loss of $(101.6) million, or $(0.76) per share, basic and diluted, for the same period in 2022. Net loss attributable to Vir for the year of 2023 was $(615.1) million, or $(4.59) per share, basic and diluted, compared to a net income of $515.8 million, or $3.89 per share, basic and $3.83 per share, diluted, in 2022..

净（亏损）收入：2023年第四季度归属于Vir的净亏损为（1.16）亿美元，或每股（0.86）美元，基本和稀释，而2022年同期的净亏损为（1.016）亿美元，或每股（0.76）美元，基本和稀释。2023年归属于Vir的净损失为（6.151）亿美元，或每股（4.59）美元，基本和摊薄，而2022年的净收入为5.158亿美元，或每股（3.89美元），基本和摊薄分别为3.83美元。。

2024 Financial Guidance

2024年财务指南

Vir is providing full year 2024 guidance below (in millions):

Vir将提供以下2024年全年指南（单位：百万）：

GAAP combined R&D and SG&A expense range:

GAAP综合研发和销售及管理费用范围：

650

到

680

The following expenses are included in the GAAP combined R&D and SG&A expense range:

以下费用包括在GAAP综合研发和SG＆A费用范围内：

Stock-based compensation expense

股票补偿费用

115

到

105

Restructuring charges*

重组费用*

到

* Restructuring charges are primarily non-cash expenditures, related to the closing of two R&D sites previously announced on December 13, 2023.

*重组费用主要是非现金支出，与之前于2023年12月13日宣布关闭的两个研发基地有关。

Approximately three to four percent of the GAAP combined R&D and SG&A expense will be funded by grants. These grants are recognized as revenue.

大约3%至4%的GAAP合并研发和SG＆A费用将由赠款资助。这些赠款被确认为收入。

The GAAP combined R&D and SG&A 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..

GAAP合并研发和SG＆A费用指南不包括由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 fourth quarter and full year 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，讨论第四季度和全年业绩。在线直播将于https://investors.vir.bio/并将在www.vir.bio上存档30天。

About Tobevibart

关于Tobevibar

Tobevibart is an investigational subcutaneously administered antibody designed to block entry of hepatitis B and hepatitis delta viruses into hepatocytes 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 potentially function as a T cell vaccine against hepatitis B virus and hepatitis delta virus, as well as to have an extended half-life.

Tobevibart是一种皮下注射的研究性抗体，旨在阻止乙型肝炎和三角洲肝炎病毒进入肝细胞，并降低血液中病毒粒子和亚病毒颗粒的水平。Tobevibart结合了Xencor的Xtend™和其他Fc技术，已被设计为潜在的抗乙型肝炎病毒和三角洲肝炎病毒的T细胞疫苗，并具有延长的半衰期。

Tobevibart was identified using Vir’s proprietary mAb discovery platform..

Tobevibart是使用Vir专有的单克隆抗体发现平台鉴定的。。

About Elebsiran

关于Elebsiran

Elebsiran is an investigational subcutaneously administered hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) that Vir believes has the potential to stimulate an effective immune response and have direct antiviral activity against hepatitis B virus and hepatitis delta virus. 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是一种皮下注射的乙型肝炎病毒，靶向小干扰核糖核酸（siRNA），Vir认为它有可能刺激有效的免疫反应，并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。这是临床上第一个包括增强稳定化学加（ESC+）技术的siRNA，以增强稳定性并最小化脱靶活性，这可能导致治疗指数增加。

Elebsiran is the first asset in the Company’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials..

Elebsiran是该公司与Alnylam Pharmaceuticals，Inc.合作进入临床试验的第一笔资产。。

About VIR-2482

关于VIR-2482

VIR-2482 is an investigational hemagglutinin targeting, intramuscularly administered influenza A-neutralizing monoclonal antibody. In vitro, it has been shown to cover all major strains of influenza A that have arisen since the 1918 flu pandemic. VIR-2482 is designed as a prophylactic for influenza A.

VIR-2482是一种研究性血凝素靶向，肌内给药的甲型流感中和单克隆抗体。在体外，它已被证明涵盖了自1918年流感大流行以来出现的所有主要甲型流感病毒株。VIR-2482被设计为甲型流感的预防药物。

VIR-2482 incorporates Xencor’s Xtend™ and was identified using Vir’s proprietary mAb discovery platform..

VIR-2482结合了Xencor的Xtend™并使用VIR专有的单克隆抗体发现平台进行了鉴定。。

The PENINSULA trial has been supported in whole or in part with federal funds from the Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50122C00081..

半岛试验得到了卫生与公众服务部（HHS）联邦资金的全部或部分支持；战略准备和应对管理局（ASPR）；生物医学高级研究与发展局（BARDA），其他交易号：75A50122C00081。。

About VIR-2981

关于VIR-2981

VIR-2981 is an investigational neuraminidase-targeting monoclonal antibody against influenza viruses. It targets a region of the neuraminidase protein that is highly conserved across influenza A and B strains and is designed to inhibit the influenza neuraminidase, a key viral protein that facilitates release of new viruses in infected individuals.

VIR-2981是一种针对流感病毒的研究性神经氨酸酶靶向单克隆抗体。它靶向神经氨酸酶蛋白的一个区域，该区域在甲型和乙型流感病毒株中高度保守，旨在抑制流感神经氨酸酶，这是一种关键的病毒蛋白，可促进受感染个体释放新病毒。

Preclinical data demonstrate the antibody’s breadth and potency against all major strains of seasonal and pandemic influenza viruses and support the potential of this antibody in the prevention of influenza illness. VIR-2981 was identified using Vir’s proprietary mAb discovery platform..

临床前数据表明该抗体对所有主要季节性和大流行性流感病毒株的广度和效力，并支持该抗体在预防流感疾病中的潜力。使用VIR专有的单克隆抗体发现平台鉴定了VIR-2981。。

About VIR-1388

关于VIR-1388

VIR-1388 is a preclinical subcutaneously administered HIV T cell vaccine based the T cell-based viral vector platform and has been designed to elicit abundant T cells that recognize HIV epitopes with the goal of creating a safe and effective HIV vaccine.

VIR-1388是基于T细胞的病毒载体平台的临床前皮下施用的HIV T细胞疫苗，其被设计用于引发识别HIV表位的丰富T细胞，目的是产生安全有效的HIV疫苗。

About Sotrovimab

关于Sotrovimab

Sotrovimab is an investigational SARS-CoV-2 neutralizing monoclonal antibody that was developed in collaboration with GSK. The antibody binds to an epitope on SARS-CoV-2 shared with SARS-CoV-1 (the virus that causes SARS). Sotrovimab, which incorporates Xencor, Inc.’s Xtend™ technology, has been designed to achieve high concentration in the lungs to achieve optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

Sotrovimab是与GSK合作开发的一种研究性SARS-CoV-2中和单克隆抗体。该抗体与SARS-CoV-1（引起SARS的病毒）共有的SARS-CoV-2表位结合。Sotrovimab结合了Xencor，Inc.的Xtend™技术，旨在实现肺部高浓度，以实现对受SARS-CoV-2影响的气道组织的最佳渗透，并延长半衰期。

Sotrovimab was identified using Vir’s proprietary mAb discovery platform. Sotrovimab is currently not authorized in the US..

Sotrovimab是使用Vir专有的mAb发现平台鉴定的。Sotrovimab目前未在美国获得授权。。

About VIR-7229

关于VIR-7229

VIR-7229 is an investigational next generation COVID-19 monoclonal antibody with a distinct combination of potency, breadth and viral inescapability. VIR-7229 is designed as a prophylactic for COVID-19 and was identified using Vir’s proprietary mAb discovery platform. VIR-7229 incorporates Xencor, Inc.’s Xtend™ technology and is affinity matured using machine learning to increase its effectiveness in binding to SARS-CoV and SARS-CoV-2 variants..

VIR-7229是一种研究性的下一代COVID-19单克隆抗体，具有效力，广度和病毒不可避免性的独特组合。VIR-7229被设计为新型冠状病毒肺炎的预防药物，并使用VIR专有的单克隆抗体发现平台进行鉴定。VIR-7229结合了Xencor，Inc.的Xtend™技术，并通过机器学习进行了亲和力成熟，以提高其与SARS-CoV和SARS-CoV-2变体结合的有效性。。

About VIR-8190

关于VIR-8190

VIR-8190 is an investigational dual specificity monoclonal antibody that has the ability to potently neutralize both respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) strains. RSV and HMPV are recognized as significant causes of lower respiratory tract disease in high-risk populations, including infants and immunocompromised individuals.

VIR-8190是一种研究性双特异性单克隆抗体，具有有效中和呼吸道合胞病毒（RSV）和人类偏肺病毒（hMPV）菌株的能力。RSV和HMPV被认为是高危人群（包括婴儿和免疫功能低下的个体）下呼吸道疾病的重要原因。

VIR-8190 was identified using Vir’s proprietary mAb discovery platform..

使用VIR专有的单克隆抗体发现平台鉴定了VIR-8190。。

About VIR-1949

关于VIR--1949

VIR-1949 is an investigational therapeutic vaccine based the T cell-based viral vector platform that is designed to treat HPV-related high-grade squamous epithelial pre-cancer lesions (HSIL) and cancers. This vaccine uses HCMV as the vaccine vector. Based on preclinical data, HCMV vectors have the potential to induce high frequencies of antigen-specific, tissue-localizing effector memory T cells..

VIR-1949是一种基于T细胞的病毒载体平台的研究性治疗性疫苗，旨在治疗HPV相关的高级鳞状上皮癌前病变（HSIL）和癌症。该疫苗使用HCMV作为疫苗载体。根据临床前数据，HCMV载体有可能诱导高频率的抗原特异性组织定位效应记忆T细胞。。

About Vir Biotechnology, Inc.

关于Vir Biotechnology，Inc。

Vir Biotechnology, Inc. is an immunology company focused on powering the immune system to transform lives by treating and preventing infectious diseases and other serious conditions, including viral-associated diseases. Vir has assembled two technology platforms that are designed to modulate the immune system by exploiting critical observations of natural immune processes.

Vir Biotechnology，Inc.是一家免疫学公司，专注于通过治疗和预防传染病和其他严重疾病，包括病毒相关疾病，为免疫系统提供动力，以改变生活。Vir已经组装了两个技术平台，旨在通过利用对自然免疫过程的关键观察来调节免疫系统。

Its current clinical development pipeline consists of product candidates targeting hepatitis delta and hepatitis B viruses and human immunodeficiency virus. Vir has several preclinical candidates in its pipeline, including those targeting influenza A and B, COVID-19, RSV/MPV and HPV. Vir routinely posts information that may be important to investors on its website..

其目前的临床开发流程包括针对三角洲肝炎病毒、乙型肝炎病毒和人类免疫缺陷病毒的候选产品。Vir有几个临床前候选药物，包括针对甲型和乙型流感，新型冠状病毒，RSV/MPV和HPV的候选药物。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 “may,” “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“可能”、“将”、“计划”、“潜在”、“目标”、“期望”、“预期”、“有希望”等词语和类似表达（以及其他涉及未来事件、条件或情况的词语或表达）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 Vir’s strategy and plans; Vir’s cash balance; Vir’s financial guidance; Vir’s future financial and operating results and its expectations related thereto; potential of, and expectations for, Vir’s pipeline; Vir’s clinical and preclinical development programs, clinical trials, including the enrollment of Vir’s clinical trials, and the expected timing of data readouts and presentations; the potential benefits, safety, and efficacy of Vir’s investigational therapies; and risks and uncertainties associated with drug development and commercialization.

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有关Vir战略和计划的声明；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管道的潜力和期望；Vir的临床和临床前开发计划，临床试验，包括Vir临床试验的注册，以及数据读取和演示的预期时间；Vir研究疗法的潜在益处，安全性和有效性；以及与药物开发和商业化相关的风险和不确定性。

Many important factors may cause differences between current expectations and actual results, including uncertainty as to whether the anticipated benefits of the BARDA collaboration can be achieved; unexpected safety or efficacy data or results observed during clinical trials or in data readouts; the timing and outcome of Vir’s planned interactions with regulatory authorities; difficulties in obtaining regulatory approval; uncertainty as to whether the anticipated benefits of Vir’s collaborations with other companies can be achieved; difficulties in collaborating with other companies; challenges in accessing man.

许多重要因素可能会导致当前预期与实际结果之间的差异，包括是否可以实现BARDA合作的预期收益的不确定性；在临床试验或数据读数中观察到意外的安全性或有效性数据或结果；Vir计划与监管机构互动的时间和结果；难以获得监管部门的批准；Vir与其他公司合作的预期收益是否能够实现的不确定性；与其他公司合作困难；接触人类的挑战。

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）

December 31,

12月31日，

2023

2022

ASSETS

资产

CURRENT ASSETS:

流动资产：

Cash and cash equivalents

现金及现金等价物

241,576

848,631

Short-term investments

短期投资

1,270,980

1,521,517

Restricted cash and cash equivalents, current

限制性现金和现金等价物，流动

13,268

12,681

Equity investments

股权投资

9,853

31,892

Prepaid expenses and other current assets

预付费用和其他流动资产

52,549

104,356

Total current assets

流动资产总额

1,588,226

2,519,077

Intangible assets, net

无形资产净值

22,565

32,755

Goodwill

商誉

16,937

Property and equipment, net

财产和设备净值

96,018

105,609

Operating right-of-use assets

经营使用权资产

71,182

82,557

Restricted cash and cash equivalents, noncurrent

非流动受限现金和现金等价物

6,448

6,656

Long-term investments

长期投资

105,275

23,927

Other assets

其他资产

12,409

14,570

TOTAL ASSETS

总资产

1,919,060

2,802,088

LIABILITIES AND STOCKHOLDERS’ EQUITY

负债和股东权益

CURRENT LIABILITIES:

流动负债：

Accounts payable

应付账款

6,334

6,422

Accrued and other liabilities

应计负债和其他负债

104,220

489,090

Deferred revenue, current

递延收入，当期

64,853

15,517

Total current liabilities

流动负债合计

175,407

511,029

Deferred revenue, noncurrent

递延收入，非流动

1,526

53,207

Operating lease liabilities, noncurrent

经营租赁负债，非流动

111,673

123,837

Contingent consideration, noncurrent

或有对价，非流动

25,960

24,937

Other long-term liabilities

其他长期负债

14,258

11,115

TOTAL LIABILITIES

负债总额

328,824

724,125

Commitments and contingencies (Note 10)

承诺和或有事项（附注10）

STOCKHOLDERS’ EQUITY:

股东权益：

Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of December 31, 2023 and 2022, respectively; no shares issued and outstanding as of December 31, 2023 and 2022

优先股，面值0.0001美元；截至2023年和2022年12月31日分别授权10000000股；截至2023年和2022年12月31日，未发行股票

—

Common stock, $0.0001 par value; 300,000,000 shares authorized as of December 31, 2023 and 2022, respectively; 134,781,286 and 133,236,687 shares issued and outstanding as of December 31, 2023 and 2022, respectively

普通股，面值0.0001美元；截至2023年和2022年12月31日分别授权300000000股；截至2023年和2022年12月31日，分别发行134781286股和133236687股

Additional paid-in capital

额外实收资本

1,828,862

1,709,835

Accumulated other comprehensive loss

累计其他综合损失

(815

)

(9,122

)

(Accumulated deficit) retained earnings

（累积赤字）留存收益

(237,824

)

377,237

TOTAL STOCKHOLDERS’ EQUITY

股东权益合计

1,590,236

2,077,963

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

总负债和股东权益

1,919,060

2,802,088

VIR BIOTECHNOLOGY, INC.

VIR生物技术公司。

Condensed Consolidated Statements of Operations

简明合并经营报表

(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）

Three Months Ended

截至三个月

December 31,

12月31日，

Year Ended

年末

December 31,

12月31日，

2023

2022

2023

2022

Revenues:

收入：

Collaboration revenue

协作收入

8,858

21,609

37,266

1,505,469

Contract revenue

合同收入

744

180

2,228

52,714

License revenue from a related party

来自关联方的许可收入

—

22,289

Grant revenue

赠款收入

7,185

27,621

46,686

35,325

Total revenues

总收入

16,787

49,410

86,180

1,615,797

Operating expenses:

营业费用：

Cost of revenue

收入成本

798

5,996

2,765

146,319

Research and development

研究与开发

111,915

155,173

589,671

474,648

Selling, general and administrative

销售、一般和管理

43,090

38,743

178,049

161,762

Total operating expenses

营业费用合计

155,803

199,912

770,485

782,729

(Loss) income from operations

经营（亏损）收入

(139,016

)

(150,502

)

(684,305

)

833,068

Other income (loss):

其他收入（损失）：

Change in fair value of equity investments

股权投资公允价值变动

(992

)

8,879

(21,888

)

(111,140

)

Interest income

利息收入

20,736

16,172

86,990

28,092

Other (expense) income, net

其他（费用）收入净额

(1,485

)

(26,187

)

(8,991

)

4,260

Total other income (loss)

其他收入（损失）合计

18,259

(1,136

)

56,111

(78,788

)

(Loss) income before benefit from (provision for) income taxes

所得税（准备金）收益前的（亏损）收入

(120,757

)

(151,638

)

(628,194

)

754,280

Benefit from (provision for) income taxes

所得税收益（准备金）

4,784

50,035

13,077

(238,443

)

Net (loss) income

净（亏损）收入

(115,973

)

(101,603

)

(615,117

)

515,837

Net loss attributable to noncontrolling interest

非控股权益净损失

—

(56

)

—

Net (loss) income attributable to Vir

归属于Vir的净（亏损）收入

(115,973

)

(101,603

)

(615,061

)

515,837

Net (loss) income per share attributable to Vir, basic

归属于Vir的每股净（亏损）收入，基本

(0.86

)

(0.76

)

(4.59

)

3.89

Net (loss) income per share attributable to Vir, diluted

归属于Vir的每股净（亏损）收入，摊薄

(0.86

)

(0.76

)

(4.59

)

3.83

Weighted-average shares outstanding, basic

加权平均流通股，基本

134,608,811

133,154,960

134,130,924

132,606,767

Weighted-average shares outstanding, diluted

加权平均流通股，摊薄

134,608,811

133,154,960

134,130,924

134,810,908

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