Moderna Q1 Earnings Call Highlights

Key Points

• Moderna reported Q1 revenue of $400 million, up $300 million year-over-year and driven roughly 80% by international deliveries under long-term strategic partnerships (notably the U.K.), and reiterated an expectation of up to 10% revenue growth in 2026 with Q2 guidance of $50–100 million.
• A large litigation settlement (Arbutus/Genevant) drove a GAAP net loss of $1.3 billion in Q1—$878 million was recognized in cost of sales—with Moderna appealing and noting a planned $950 million lump-sum payment in Q3 2026 and a potential additional payment of up to $1.3 billion if liability is affirmed; excluding the settlement, Q1 net loss would have been about $0.5 billion.
• Regulatory and pipeline progress includes EU approvals for mNEXSPIKE (12+) and mCOMBRIAX (50+), which management expects to contribute to revenue beginning in 2027; the U.S. flu candidate mRNA‑1010 has a PDUFA date of Aug. 5, 2026, and key clinical readouts for norovirus Phase III and a propionic acidemia pivotal study are expected in 2026.

Moderna NASDAQ: MRNA reported first-quarter 2026 revenue of $400 million, topping the company’s guidance and rising $300 million from the prior-year period, as management pointed to deliveries under long-term strategic partnerships as a key driver. On the company’s earnings call, executives also highlighted two new European Union approvals in its respiratory portfolio and provided updates across late-stage programs in oncology, infectious disease, and rare disease.

Revenue lift driven by international deliveries; 2026 growth target reiterated

Chief Executive Officer Stéphane Bancel said Moderna “grew year-over-year revenues significantly to $0.4 billion, driven primarily by execution of our long-term strategic partnership with the U.K. government,” and reiterated the company’s expectation for “up to 10% growth in 2026.”

Chief Financial Officer Jamey Mock said roughly 80% of first-quarter revenue came from international markets and 20% from the U.S., with the international performance “primarily driven from deliveries under our long-term strategic partnerships.” For the second quarter, Mock guided to revenue of $50 million to $100 million, “evenly split between U.S. and international markets,” implying first-half 2026 revenue of approximately $440 million to $490 million.

In the question-and-answer session, management provided more detail on the U.K. timing. The company said the first-quarter delivery was for the U.K.’s spring booster campaign and that “a 2nd campaign is planned for the fall, the 3rd and 4th quarter of this year, and that would be an additional delivery later this year.”

Litigation settlement drove GAAP loss; cost cuts and cash position emphasized

Moderna posted a first-quarter net loss of $1.3 billion, or $3.40 per share, compared with a $1.0 billion net loss, or $2.52 per share, a year earlier. Mock said the year-over-year change was “primarily driven by the litigation settlement.” Excluding the settlement item, net loss would have been $0.5 billion, or $1.18 per share, which Mock said was “down over 50% versus the prior year.” Bancel similarly cited a net loss of $0.5 billion excluding the settlement, or $1.3 billion on a GAAP basis.

Cost of sales for the quarter was $955 million, including $878 million related to the Arbutus and Genevant settlement. Excluding that item, cost of sales was $77 million, down 14% year over year on a non-GAAP basis, which Mock attributed to lower unutilized capacity costs, fewer losses on purchase commitments, and fewer inventory write-downs, partially offset by higher sales volume.

Mock described the settlement terms, including a planned lump-sum payment of $950 million in the third quarter of 2026, with $878 million recognized in first-quarter cost of sales and $72 million to be amortized over three years. He added that Moderna will appeal to the Federal Circuit on its government contractor immunity defense under federal statute 1498. If Moderna prevails, “no further payments will be due,” but if liability under Section 1498 is affirmed, Moderna has agreed to an additional payment of up to $1.3 billion. Mock said the company concluded a loss related to that pending proceeding is “not probable,” and “no charge has been recorded.” In Q&A, management said it believes the matter could be resolved “perhaps late 2027, maybe into 2028,” though it called the timeline a moving target.

Management also emphasized reduced spending. Research and development expense fell 24% to $649 million, which Mock attributed to lower clinical development and manufacturing costs as large phase III respiratory programs and a CMV phase III study wind down, partially offset by higher post-marketing commitments for COVID products. SG&A declined 18% to $173 million, which Mock said reflected continued cost discipline.

Bancel said Moderna’s cost-reduction work produced a 26% year-over-year reduction in adjusted cash cost in the quarter, excluding the litigation settlement, and he said the company remains on track for approximately $4.2 billion in adjusted cash cost for 2026.

Moderna ended the quarter with $7.5 billion in cash and investments, down from $8.1 billion at the end of 2025. Mock said the decrease was “primarily driven by operating losses as we continue to invest in R&D and advance our pipeline,” noting the settlement did not affect first-quarter cash since payment is due in the third quarter.

2026 framework: higher cost of sales outlook due to settlement; no flu or combo revenue assumed

Moderna reiterated its expectation for total revenue to grow up to 10% in 2026, with an expected geographic mix of roughly 50% U.S. and 50% international. Mock said the outlook incorporates potential declines in COVID vaccination rates, offset by increased penetration of mNEXSPIKE and revenue from long-term strategic partnerships.

Mock also underscored what the guidance excludes, saying it assumes no revenue from the company’s flu vaccine or Comirnaty.

Cost of sales guidance increased from $0.9 billion to $1.8 billion, reflecting inclusion of the $0.9 billion litigation settlement charge. Excluding that charge, Mock said the cost-of-sales outlook would have been unchanged from prior guidance and reflects expectations for gross margin improvement from manufacturing efficiency and volume leverage.

Additional 2026 expectations included:

• R&D expense: approximately $3.0 billion, with spending timing “slightly weighted more to the second half of the year.”
• SG&A expense: approximately $1.0 billion, flat year over year, with commercial spending more heavily weighted to the second half due to seasonality.
• Capital expenditures: $0.2 billion to $0.3 billion.
• Year-end cash and investments:

Mock also said the company did not see any material impacts from the ongoing conflict in the Middle East on its 2026 financial outlook, while noting Moderna would continue monitoring geopolitical developments.

Regulatory milestones in Europe; U.S. flu PDUFA set for August

Moderna highlighted multiple regulatory developments in its respiratory portfolio. Bancel said the company achieved “an important milestone with the approval of mCOMBRIAX in the European Union,” describing it as the first flu-plus-COVID combination vaccine approved globally and noting it marked Moderna’s fourth approved product. He also said the company secured EU approval for Spikevax.

President Stephen Hoge said Moderna received EU approvals for mNEXSPIKE for individuals 12 and older and for mCOMBRIAX for adults 50 and above, which he said positions Moderna in what he called a “large $1.8 billion annual European respiratory vaccines market.” Hoge said Moderna expects both products to contribute to revenue growth beginning in 2027.

In the U.S., Moderna’s seasonal flu vaccine candidate mRNA-1010 has a PDUFA date of Aug. 5, 2026. In response to questions about the FDA review and leadership changes at CBER, Hoge said the review was proceeding in what he described as “a pretty normal course,” and he said Moderna generally does not interact with senior CBER leadership during reviews, emphasizing engagement with the review staff in the Office of Vaccines. He said Moderna did not expect any impact on the flu review from the new acting CBER director.

Pipeline updates: intismeran expansion, norovirus data expected in 2026, rare disease readout ahead

In oncology, Moderna discussed continued expansion of intismeran, its individualized cancer therapy developed with Merck. Bancel said Moderna initiated a new phase III trial in non-small cell lung cancer for patients with high-risk stage 1 disease, calling it the company’s first phase III study evaluating intismeran in a monotherapy arm in early-stage disease. Hoge said the new lung cancer phase III is the third phase III in lung cancer for intismeran and includes a monotherapy evaluation, following a previously announced monotherapy study in non-muscle invasive bladder cancer.

Addressing investor questions on the strategy, management said the rationale centers on the therapy’s safety profile and the stage 1 treatment landscape, where standard care is often surgery followed by watchful waiting. Management said the phase III trial will evaluate intismeran monotherapy versus surgery and watchful waiting, and also assess whether adding Keytruda provides incremental benefit.

On the phase III adjuvant melanoma study, management maintained that an interim analysis is expected in 2026 but declined to narrow timing further. Management also said the interim does not include a built-in futility assessment; rather, it can lead to early success or continuation toward later analyses. Executives said Moderna plans to present a five-year update from its phase II adjuvant melanoma study at ASCO, including relapse-free survival (RFS), distant metastasis-free survival, and overall survival trend data.

Beyond intismeran, management discussed mRNA-4359, described as a cancer antigen therapy that is in phase II, with cohorts enrolling in first-line metastatic melanoma and first-line metastatic non-small cell lung cancer. Bancel said Moderna presented new clinical data for mRNA-4359 at AACR.

In infectious disease, Hoge said Moderna’s phase III norovirus vaccine study is fully enrolled in its second Northern Hemisphere season, and based on case accrual to date, Moderna continues to expect data in 2026. In response to a question on what success would look like, management said it views statistical significance as the bar and cited a desire for meaningful vaccine efficacy, “north of 50%,” while noting there is currently no approved norovirus vaccine.

Moderna also said its pandemic flu program, mRNA-1018, initiated a phase III study with support from CEPI.

In rare diseases, Hoge said the propionic acidemia (PA) program is fully enrolled in a potentially registrational study, and Moderna continues to expect pivotal data later in 2026. He added that Moderna decided to defer starting a registrational trial for methylmalonic acidemia (MMA) until after receiving the PA pivotal readout.

About Moderna NASDAQ: MRNA

Moderna, Inc is a biotechnology company headquartered in Cambridge, Massachusetts, specializing in messenger RNA (mRNA) therapeutics and vaccines. The company's platform leverages synthetic mRNA to instruct cells to produce proteins that can prevent or treat diseases. Since its founding in 2010, Moderna has advanced from early-stage research into a broad pipeline of vaccine and therapeutic candidates designed to address infectious diseases, rare genetic disorders and chronic illnesses.

Moderna's flagship product is its mRNA-based COVID-19 vaccine, which was the first of its kind to receive emergency use authorization and later full approval in multiple jurisdictions.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.