Moderna, Inc.

Reports third quarter revenue of $1.3 billion, GAAP net income of $0.2 billion and GAAP diluted EPS of $0.38

Increases 2026 expected revenue growth to 15%-25%, exceeding the previous expectation of up to 10% growth

Improves 2026 GAAP operating expense outlook by approximately $0.2 billion from previous estimate

Increases 2026 expected ending cash balance to $8.1-$8.3 billion

Highlights positive Phase 3 data for intismeran and U.S. FDA approval of mFLUSIVA, the Company's fifth approved product globally

Le Canada est le premier pays à autoriser à la fois le vaccin à ARNm de Moderna contre la grippe saisonnière, mFLUSIVA^®, et son vaccin combiné contre la grippe et la COVID-19, mCOFLU^®

Canada becomes the first country to authorize both Moderna's mRNA seasonal influenza vaccine, mFLUSIVA^®, and combination influenza and COVID-19 vaccine, mCOFLU^®

WHO Technical Advisory Group recommends mRNA-1469 for inclusion in efficacy study following encouraging Phase 1 clinical results

Initial Phase 1/2 data highlight the potential of Moderna's multiplexed mRNA approach in relapsed or refractory multiple myeloma

Juan Andres to Return to Moderna as Chief Operating Officer

Jerh Collins to Retire Following Four Years of Leadership at Moderna

Phase 3 data for intismeran autogene in the adjuvant treatment of patients with resected stage IIB-IV melanoma selected for presentation at a Presidential Symposium

Moderna to host an investor event via webcast on Saturday, October 24, at 7:00 PM CEST / 1:00 PM EDT

Proceeds to be utilized for general corporate purposes which may include the flexibility to invest in the growth of our oncology business and repayment of debt

Moderna has also purchased a hedge overlay intended to offset dilution up to a cap initially equal to a 175.0% premium to the stock price at pricing

Proceeds to be utilized for general corporate purposes which may include the flexibility to invest in the growth of our oncology business and repayment of debt

Moderna will also purchase a hedge overlay intended to offset dilution up to a cap initially equal to at least a 150% premium to the stock price at pricing

mFLUSIVA becomes Moderna's fifth approved product globally and fourth FDA-approved product

Company expects supply to be available in select retailers in the coming weeks

Phase 1 trial will evaluate safety and immune response for a strain of Ebola virus disease with no licensed vaccines indicated

Phase 1 trial is being conducted in Canada as part of our expanded collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), building on Moderna's prior filovirus research

L'essai de phase 1 évaluera l'innocuité et la réponse immunitaire pour une souche de la maladie à virus Ebola pour laquelle aucun vaccin n'est actuellement autorisé

L'essai de phase 1 est mené au Canada dans le cadre de notre collaboration élargie avec la Coalition pour les innovations en matière de préparation aux épidémies (CEPI), s'appuyant sur les recherches antérieures de Moderna sur les filovirus

Reports second quarter revenue of $0.1 billion, GAAP net loss of $(0.8) billion and GAAP EPS of $(1.97)

Reiterates plan to deliver up to 10% revenue growth in 2026

Improves 2026 GAAP operating expense outlook by approximately $0.2 billion from previous estimate and improves expected 2026 year-end cash balance to $4.7 - 5.2 billion

Anticipates potential approval of Moderna's fifth product with the August 5th PDUFA date for mFLUSIVA, the Company's seasonal influenza vaccine candidate

Announces that mRNA-1403, Moderna's norovirus vaccine candidate, did not meet statistical criteria for early success at the Phase 3 interim analysis and the Company is preparing to enroll an additional cohort

Former Biogen Chief Financial Officer brings more than 35 years of financial leadership and public company experience

Provides broad overview of Company's research and early development programs expected to continue to fuel future growth

Highlights validation of T-cell engager modality with mRNA-2808 in multiple myeloma, supporting rapid advancement of second T-cell engager mRNA-2151 in ovarian cancer

Introduces in vivo CAR-T modality with mRNA-6007 moving into early development for autoimmune diseases

FDA Prescription Drug User Fee Act (PDUFA) goal date remains August 5, 2026

Dr. Stephen Hoge, President of Moderna, to Assume an Expanded Role With Operational Oversight of the Company's Infectious Disease, Intismeran and Rare Disease Franchises

Ester Banque to Join Moderna as Chief Commercial Officer

Lynch syndrome is an inherited condition affecting 1 in 300 people that causes lifetime cancer risk of up to 80%^[1]

The INTERCEPT-Lynch trial is part of a scientific collaboration between the University of Oxford and Moderna to advance a novel mRNA approach to cancer prevention

At a median 5-year (60.3 months) planned follow-up of the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, intismeran autogene in combination with KEYTRUDA demonstrated a 49% reduction in the risk of recurrence or death and a 59% reduction in the risk of distant metastasis or death compared to KEYTRUDA alone

Intismeran autogene in combination with KEYTRUDA demonstrated an encouraging trend toward overall survival in an exploratory analysis compared to KEYTRUDA alone (HR=0.471; [95% CI, 0.165-1.345])

Coalition for Epidemic Preparedness Innovations funding builds on Moderna's prior filovirus research and supports preclinical development and Phase 1 clinical evaluation

Regulatory filings are under review in the U.S., Europe, Canada and Australia, with potential approvals expected to begin in 2026

Reports first quarter revenue of $0.4 billion, with approximately 80% of revenue from international markets

Reports first quarter GAAP net loss of $(1.3) billion and GAAP EPS of $(3.40), including $0.9 billion non-recurring litigation settlement charge

Reiterates plan to deliver up to 10% revenue growth and GAAP operating expense reductions in 2026, excluding the non-recurring litigation settlement charge

Advanced infectious disease portfolio with key regulatory milestones in the EU, including approval of mNEXSPIKE and mCOMBRIAX, Moderna's flu plus COVID combination vaccine

Initiated Phase 3 clinical study evaluating intismeran autogene as monotherapy and in combination with KEYTRUDA QLEX for treatment of high-risk Stage 1 non-small cell lung cancer

Phase 3 study is supported by the Coalition for Epidemic Preparedness Innovations to help strengthen global preparedness against a significant pandemic threat

Moderna to host an investor event via webcast on Monday, June 1 at 6:15 PM CDT

mCOMBRIAX is the world's first flu plus COVID combination vaccine to receive marketing authorization and Moderna's fourth authorized product

mCOMBRIAX will be made available in the European Union, subject to national regulatory and access procedures

The U.S. FDA has granted Fast Track designation for mRNA-4359 in combination with pembrolizumab for the treatment of checkpoint inhibitor refractory unresectable or metastatic melanoma with PD-L1+ (TPS>1%)

Moderna to pay $950 million with no future royalties to resolve all global litigation; corresponding charge expected in Q1 2026

District Court's Section 1498 decision to be appealed to the Federal Circuit Court of Appeals with potential additional payment contingent on the outcome; no accrual recorded for potential additional payment as loss is not considered probable

2026 year-end cash and cash equivalents now expected to be in the range of $4.5 - $5.0 billion

mCOMBRIAX is the world's first flu plus COVID combination vaccine to receive a positive CHMP opinion recommending marketing authorization and represents Moderna's fourth vaccine to receive a positive CHMP opinion

mCOMBRIAX will be made available in the European Union, subject to final European Commission authorization and national regulatory and access procedures

Following a Type A meeting, the FDA's Center for Biologics Evaluation and Research has notified Moderna that its biologics license application for mRNA-1010 will proceed to review

Moderna has received a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026

mNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in Europe

Reports fourth quarter revenue of $0.7 billion, GAAP net loss of $(0.8) billion and GAAP EPS of $(2.11)

Reports full-year revenue of $1.9 billion, GAAP net loss of $(2.8) billion and GAAP diluted EPS of $(7.26)

Reiterates plan to deliver up to 10% revenue growth and GAAP operating expense reductions in 2026

Announces influenza vaccine filing accepted for regulatory review in the EU, Canada and Australia; Company received Refusal-to-File letter from U.S. FDA and has requested Type A meeting to understand path forward

Announces Norovirus Phase 3 trial fully enrolled with a data readout expected in 2026

Announces full enrollment of Phase 2 intismeran autogene trial in muscle invasive bladder cancer

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has requested a Type A meeting to understand the path forward

mRNA-1010 has been submitted and accepted for review in the EU, Canada and Australia

Company does not expect any impact on its 2026 financial guidance

Signed Memorandum of Understanding supports "Plan Mexico," Mexico's strategic initiative to build a local mRNA ecosystem and strengthen health security

Strategic agreement will enable access to Moderna's respiratory vaccine portfolio as well as a technology transfer to Laboratorios Liomont for domestic manufacturing of Moderna's COVID-19 vaccine

Moderna will continue to lead clinical development and manufacturing for mRNA-3927

Moderna to receive up to $160 million in upfront and near-term development and regulatory milestones, in addition to commercial and sales milestones and tiered royalties on net sales