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

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– Prior data from the Phase 2 SOLSTICE trial in chronic hepatitis delta participants demonstrated that after only 12 weeks of combination therapy, 100% (6/6) of participants had HDV RNA less than the lower limit of quantification –

– Phase 2 SOLSTICE trial on track to complete enrollment ahead of schedule with initial data expected in the second quarter; greater than 90% of participants dosed –

– Prior Phase 2 MARCH Part B chronic hepatitis B data demonstrated that tobevibart may play an important role in achieving a functional cure; 48-week end of treatment data readout on track for the fourth quarter –

– $1.63 billion in cash, cash equivalents and investments as of December 31, 2023 –

– Conference call scheduled for February 22, 2024 at 1:30 p.m. PT / 4:30 p.m. ET –

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.


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

Pipeline Programs

Chronic Hepatitis Delta (CHD)

Chronic Hepatitis B (CHB)

Human Immunodeficiency Virus (HIV)

COVID-19

Influenza

Preclinical Pipeline Candidates

Corporate Update

Fourth Quarter and Full Year 2023 Financial Results

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.

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.

Revenues were comprised of the following components:

 

Three Months Ended
December 31,

 

 

 

Year Ended

December 31,

 

 

 

2023

 

2022

 

% Change

 

2023

 

2022

 

% Change

 

(in millions)

 

 

 

(in millions)

 

 

Collaboration revenue

$

8.9

 

$

21.6

 

(58.8

)%

 

$

37.3

 

$

1,505.5

 

(97.5

)%

Contract revenue

 

0.7

 

 

 

0.2

 

 

>100.0%

 

 

2.2

 

 

 

52.7

 

 

(95.8

)%

License revenue from a related party

 

—

 

 

 

—

 

 

—

%

 

 

—

 

 

 

22.3

 

 

(100.0

)%

Grant revenue

 

7.2

 

 

 

27.6

 

 

(73.9

)%

 

 

46.7

 

 

 

35.3

 

 

32.3

%

Total revenues

$

16.8

 

 

$

49.4

 

 

(66.0

)%

 

$

86.2

 

 

$

1,615.8

 

 

(94.7

)%
 

Note: Numbers may not add due to rounding.

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.

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. 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. 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.

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. 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.

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. 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.

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. 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.

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.

2024 Financial Guidance

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

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

$

650

to

$

680

 

 

 

 

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

 

 

 

 

 

Stock-based compensation expense

$

115

to

$

105

Restructuring charges*

$

35

to

$

25
 

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

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.

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.

Conference Call

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.

About Tobevibart

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 was identified using Vir’s proprietary mAb discovery platform.

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

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

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.

About 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. 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.

About 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.

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

About 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.

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.

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

About 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.

About 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. 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.

Forward-Looking Statements

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. 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. 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 manufacturing capacity; clinical site activation rates or clinical trial enrollment rates that are lower than expected; successful development and/or commercialization of alternative product candidates by Vir’s competitors; changes in expected or existing competition; delays in or disruptions to Vir’s business or clinical trials, Vir’s use of artificial intelligence and machine learning in its efforts to engineer next-generation proteins and in other research and development efforts; the timing and amount of actual expenses, including, without limitation, Vir’s anticipated combined GAAP R&D and SG&A expenses; geopolitical changes or other external factors; and unexpected litigation or other disputes. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product.

Contacts

Media
Carly Scaduto

Senior Director, Media Relations

cscaduto@vir.bio
+1 314-368-5189

Investors
Richard Lepke

Senior Director, Investor Relations

rlepke@vir.bio
+1 978-973-9986

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