EX-99.2 3 d307494dex992.htm EX-99.2 EX-99.2

Exhibit 99.2 A World Without Infectious Disease C o r p o r a t e O v e r v i e w F e b r u a r y 2 4 , 2 0 2 2 V I R B I O T E C H N O L O G Y , I N C . WHO: World Health Organization; HBV: Hepatitis B Virus; HIV: Human Immunodeficiency Virus


L E G A L D I S C L A I M E R Forward-Looking Statements Statements in this presentation that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding the near- term financial performance (including near-term collaboration revenue related to binding agreements for doses of sotrovimab) of Vir Biotechnology, Inc. (the “Company”), the timing and expected number of therapeutic doses of sotrovimab that the Company will be able to supply to patients, the ability of sotrovimab to maintain activity against circulating variants of concern and interest, including Omicron, the expected success, cost, and timing of the Company’s research and clinical development plans and clinical trials, the Company’s goals with respect to the prophylaxis or treatment of COVID-19, HBV, influenza A and HIV, the Company’s objectives, strategy, technology platform and clinical trial designs, the potential benefits of the Company’s collaborations, and the Company’s ability to complete certain milestones. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about the Company, including, without limitation, risks inherent in developing the Company’s products and technologies, future results from the Company’s ongoing and planned clinical trials such as unexpected data or clinical site activation rates or clinical trial enrollment rates that are lower than expected, difficulties arising from the Company’s collaborations, challenges in accessing adequate manufacturing capacity, the Company’s ability to obtain adequate financing to fund its planned clinical trials and other expenses, statements related to regulatory authorizations and approvals, trends in the industry, changes in the competitive landscape, delays or disruptions due to the COVID-19 pandemic, including supply chain disruptions, the legal and regulatory framework for the industry, unexpected litigation or disputes and future expenditures. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The actual results may vary from the anticipated results and the variations may be material. Other factors that may cause the Company’s actual results to differ from current expectations are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated in this presentation. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this presentation is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. The Company claims the protection of the safe harbor for forward- looking statements contained in the Private Securities Litigation Reform Act of 1995 for all forward-looking statements. This presentation discusses product candidates that are under clinical study, and which have not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of such products. Marketing Authorization/Emergency Use of Sotrovimab Sotrovimab has received marketing authorization in the European Union, Australia, Great Britain, Japan, and Saudi Arabia, and has been granted temporary authorization in multiple other countries, including Bahrain, Canada, Egypt, Kuwait, Qatar, Singapore, and the United Arab Emirates. In the United States, sotrovimab has not been approved, but has been authorized for emergency use by FDA under an EUA, to treat mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. The emergency use of sotrovimab is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization revoked sooner. © 2022 Vir Biotechnology, Inc. 02


2 0 2 1 : P R O V I N G O U R M E T T L E Delivered sotrovimab to patients around the world >750,000 doses sold, ~90% delivered, $917.2 million of sotrovimab collaboration revenue recognized IM trial achieved primary endpoint Stood up to Omicron and other tested variants Extended leadership in HBV functional cure development • Shared important new mono and combination therapy clinical data • Started three new Phase 2 combination trials Expanded GSK collaboration to include flu & other respiratory diseases Initiated first HIV trial using novel HCMV vaccine platform USG: US Government; IM: intramuscular; HBV: hepatitis B; HIV: human immunodeficiency virus; HCMV: human cytomegalovirus © 2022 Vir Biotechnology, Inc. 03


$ 917.2 million sotrovimab collaboration 1 revenues in 2021, more expected in 2022. Strong balance sheet. Resources to help save even more lives, build more value Pursuing a robust and diverse pipeline 2 in large infectious diseases: COVID-19, A pivotal Hepatitis B, Influenza and HIV, with multiple clinical value drivers in 2022 moment for VIR Validated and new technologies driving 3 innovation behind late-stage programs COVID-19: coronavirus disease 2019 © 2022 Vir Biotechnology, Inc. 04


C L I N I C A L D E V E L O P M E N T P I P E L I N E Antibody siRNA T cell Disease Area Product Candidate Treatment / Prophylaxis Preclinical Phase 1 Phase 2 Phase 3 Authorized Collaborator † Sotrovimab Treatment (Early-IV) COVID-19 mAb GlaxoSmithKline † Sotrovimab Treatment (Early-IM) GlaxoSmithKline Sotrovimab Treatment (Hospitalized) GlaxoSmithKline Sotrovimab Prophylaxis GlaxoSmithKline VIR-7832 Treatment mAb GlaxoSmithKline VIR-2218 Treatment HBV siRNA Alnylam VIR-2218 + PEG-IFN-⍺ Treatment siRNA Alnylam VIR-3434 Treatment mAb VIR-2218 + VIR-3434 Treatment siRNA Alnylam VIR-2218 + BRII-179 Treatment siRNA Alnylam, Brii Biosciences 1 2 VIR-2218 + TLR8 + PD-1 Treatment siRNA Alnylam, Gilead Influenza A VIR-2482 Prophylaxis HIV VIR-1111* Prophylaxis Bill & Melinda Gates Foundation *Vaccine designed to establish proof of concept in Phase (Ph) 1 clinical trial to determine whether unique immune response observed in non-human primates can be replicated in humans; ultimately, any candidates we advance as a potential HIV vaccine will require modifications to VIR-1111 before further clinical development. Sotrovimab and VIR-2482 incorporate Xencor’s XtendTM technology. VIR-7832 and VIR- 3434 incorporate Xencor’s XtendTM and other Fc technologies. PEG-IFNα: peginterferon alfa-2a 1: GS-9688; 2: nivolumab †sotrovimab for early treatment by IV currently has marketing approval, temporary authorization or emergency use authorization © 2022 Vir Biotechnology, Inc. in >40 countries and an application has been submitted to the FDA requesting an amendment to the EUA for sotrovimab to 05 include IM administration.


COVID-19 A S P I R I N G T O M A K E C O V I D H I S T O R Y © 2022 Vir Biotechnology, Inc. 06


S O T R O V I M A B COVID-19 unmet needs ~429M ~6M Cases to date globally Deaths to date globally https://coronavirus.jhu.edu/map.htm © 2022 Vir Biotechnology, Inc. 07 As of February 23, 2022


S O T R O V I M A B Reaching patients Working to enable broader patient access by: around the world Sotrovimab currently has marketing approval, Increasing 1H2022 supply to 2 million temporary authorization or emergency use 1 doses, additional doses in 2H2022 authorization in >40 countries ~1.7 million sotrovimab doses sold* to date 2 Filed IM EUA amendment with FDA 2021: >750,000 1Q2022: ~1 million (inc. 600,000 to US Government)* Conducting trials to address unmet 3 needs in high-risk prophylaxis and hospitalized patients *Doses secured through binding agreements © 2022 Vir Biotechnology, Inc. 08


W H A T ’ S N E X T ? Preparing for the next wave and for future pandemics SMALL MOLECULE THAT ANTIBODIES THAT ARE PAN-CORONAVIRUS TREATS MULTIPLE EVEN BROADER AND VACCINE DESIGNED TO RESPIRATORY DISEASES: MORE POTENT THAN BE VARIANT PROOF COVID, FLU, ETC SOTROVIMAB Manufacturing initiated Initial proof-of-concept achieved Initial proof-of-concept achieved + © 2022 Vir Biotechnology, Inc. 09 04


Hepatitis B I N P U R S U I T O F A F U N C T I O N A L C U R E © 2022 Vir Biotechnology, Inc. 10


H E P A T I T I S B UNMET NEEDS VIR’S ANSWER In pursuit of a functional We are developing multiple combination therapies ~300M cure intended to both suppress Approximately 300 million people in the world live with chronic Hepatitis B the virus (“remove the brake”) and stimulate the immune system (“step on the gas”) <7% Recent presentations at Current therapies either require life-long EASL and AASLD therapy or have poor tolerability with functional cure* rates less than 7% demonstrate the breadth of our approach https://www.hepb.org/what-is-hepatitis-b/what-is-hepb/facts-and-figures/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8309973/ *Functional cure: undetectable hepatitis B virus surface antigen (HBsAg), defined as less than 0.05 international units per milliliter, as well as HBV DNA less than the lower limit of quantification, in the blood six months after the end of therapy © 2021 Vir Biotechnology, Inc. © 2022 Vir Biotechnology, Inc. 11


H E P A T I T I S B Broad portfolio in pursuit of a functional cure VIR-2218 PHASE 2 DATA ONGOING PHASE 2 COMBINATION TRIALS WITH VIR-2218 Potential Best-In-Class siRNA as “backbone” of therapy VIR-3434 mAb 1 2 PEG-IFN-⍺ GS-9688 TLR-8 agonist 3 Nivolumab PD-1 antagonist Placebo 20 mg 50 mg 100 mg 200 mg 4 BRII-179 T cell vaccine 1 Substantial, Durable, and Dose Dependent Reduction of HBsAg through 48 weeks HBsAg: hepatitis B virus surface antigen © 2022 Vir Biotechnology, Inc. 1. Gane E, et al. Oral presentation at: The International Liver Congress – EASL; June 25, 2021; Virtual. 12 Mean Change in Log 10 HBsAg (IU/mL)


M A R C H T R I A L Evaluating functional cure potential from combinations Part B*: additional cohorts to determine dose, length of treatment, and evaluate Part A: short treatment courses designed to rapidly evaluate safety, PK, and HBsAg suppression, when VIR-3434 is given weekly triple cocktails, when VIR-3434 is given every 4 weeks WEEK WEEK 00 04 08 12 16 20 24 28 32 36 40 44 48 00 04 08 12 16 20 24 28 32 36 40 44 48 Regimen 3 Regimen 1 VIR-2218 Q4W VIR-2218 Q4W VIR-3434 Q4W VIR-3434 QW Regimen 2 Regimen 4 VIR-2218 Q4W VIR-2218 Q4W VIR-3434 Q4W VIR-3434 QW Regimen 5 Initial data expected 1H2022 VIR-2218 Q4W VIR-3434 Q4W PEG-IFNα QW Each regimen will enroll up to 30 participants with chronic HBV infection who are virally suppressed on NRTI therapy Participants will be followed for at least 48 weeks post-treatment and be assessed for safety and efficacy VIR-3434 18-75mg dosing in Part A, dosing TBD for Part B; VIR-2218 200mg dose in Part B; PEG-IFNα 180mcg dose in Regimen 5 MARCH: Monoclonal Antibody siRNA Combination against Hepatitis B; QW: weekly; Q4W, every 4 weeks; NRTI: nucleos(t)ide reverse transcriptase inhibitor *Not exhaustive - additional cohorts may be added © 2022 Vir Biotechnology, Inc. 13


Influenza, HIV and Innovation M O V I N G T H E F I G H T F O R W A R D © 2022 Vir Biotechnology, Inc. 14


I N F L U E N Z A UNMET NEED VIR’S ANSWER Working to Antibodies intended to provide overcome the meaningfully higher levels of protection for ~500K the most vulnerable: e.g., the elderly with COPD or CHF limitations Deaths from influenza globally each year V I R - 2482: of current • Covers all major strains of influenza A since the 1918 Spanish flu pandemic vaccines based on preclinical data - don’t need 10-60% to guess which strain of influenza will be circulating Vaccines are only 10-60% effective, depending on the year • Designed to provide consistent protection for entire flu season - no immune response required • Phase 2 start expected in 2H2022 A d d i t i o n a l a n t i b o d i e s t h a t a l s o https://www.who.int/teams/global-influenza-programme/surveillance-and-monitoring/burden-of-disease c o v e r i n f l u e n z a B i n p r e c l i n i c a l https://www.webmd.com/lung/news/20200902/how-effective-is-the-flu-vaccine COPD: Chronic obstructive pulmonary disease; CHF: chronic heart failure d e v e l o p m e n t © 2021 Vir Biotechnology, Inc. © 2022 Vir Biotechnology, Inc. 15


H I V UNMET NEED VIR’S ANSWER On a mission P R E V E N T I O N : to prevent HCMV-based vaccine intended to “program” ~1.5M unique T cell responses against HIV New cases per year and cure* V I R -1111 High unmet need for a vaccine for • Currently in phase 1 the billions of individuals who are or • No safety signals reported to date may become sexually active • Plan to share additional clinical data in 1H2022 C U R E : Antibodies engineered to enhance ~38M T cell responses in preclinical Infected globally development High unmet need for a cure for the millions who don’t want to take antiretroviral therapy in perpetuity *In collaboration with the Bill & Melinda Gates Foundation https://www.unaids.org/en/resources/fact-sheet © 2021 Vir Biotechnology, Inc. © 2022 Vir Biotechnology, Inc. 16


I N N O V A T I O N Deploying our technologies to create enduring medicines C U R R E N T T E C H N O L O G Y P L A T F O R M S Broadly-neutralizing antibodies that can treat today’s and tomorrow’s variants A N T I B O D I E S T C E L L T cell immunomodulators for the prevention and cure of chronic infections I N N A T E I M M U N I T Y s i R N A Universal vaccines to protect against future diseases N E W A R E A S O F I N N O V A T I O N Broad spectrum host-directed oral antivirals impervious to resistance B C E L L A I / M A C H I N E L E A R N I N G B cell factories that continuously deliver antibodies siRNA: small interfering ribonucleic acid © 2021 Vir Biotechnology, Inc. © 2022 Vir Biotechnology, Inc. 17


Catalysts L O O K I N G A H E A D T O 2 0 2 2 © 2022 Vir Biotechnology, Inc. 18


2 0 2 2 A N T I C I P A T E D C A T A L Y S T S COVID-19 HBV INFLUENZA HIV F I R S T H A L F S E C O N D H A L F Sotrovimab (mAb) VIR-7832 (mAb) F i l e D a t a BLA (Early Treatment, IV, IM) Phase 1b add’l clinical data (Early Treatment, AGILE) VIR-2218 (siRNA) + VIR-3434 (mAb) Sotrovimab (mAb) D a t a * D a t a Prophy Phase 2 (MARCH trial) Phase 3 (Prophylaxis, COMET-STAR) Sotrovimab (mAb) VIR-2218 (siRNA) +/- PEG-IFN-⍺ D a t a D a t a Prophy Phase 3 (Hospitalized, RECOVERY) Phase 2 additional clinical data VIR-2218 (siRNA) + BRII-179 VIR-3434 (mAb) D a t a D a t a Phase 2 Phase 1 additional clinical data VIR-1111 (T cell) VIR-2482 (mAb) D a t a S t a r t Phase 1 additional clinical data Phase 2 *The analysis of the primary endpoint in the COMET-STAR trial will be event driven, and could be as early as the second half of 2022. © 2022 Vir Biotechnology, Inc. 19


F o u r t h q u a r t e r a n d F Y 2 0 2 1 f i n a n c i a l o v e r v i e w E P S T O T A L R E V E N U E 4Q2021: $812.7M 4Q2021: FY2021: $1.1B $4.01 per share, basic $3.92 per share, diluted FY2021: S O T R O V I M A B $4.07 per share, basic C O L L A B O R A T I O N R E V E N U E $3.96 per share, diluted 4Q2021: $809.5M S H A R E S O F C O M M O N S T O C K FY2021: $917.2M I S S U E D & O U T S T A N D I N G ~131M N E T I N C O M E C A S H , C A S H E Q U I V A L E N T S 4Q2021: $525.3M A N D I N V E S T M E N T S * FY2021: $528.6M ~$909.5M * Excludes restricted cash © 2022 Vir Biotechnology, Inc. 20