Moderna, Inc. (MRNA) Earnings

Management highlights

### Pipeline Milestones - **Respiratory vaccines**: mRNA-1010 (seasonal flu) received a positive unanimous recommendation from the FDA VRBPAC advisory committee, with an August 5, 2026 PDUFA date in the U.S., and is under review in the EU, Canada, and Australia. Phase 3 efficacy/safety results are published in the New England Journal of Medicine. - mRNA-1403 (norovirus vaccine) did not meet statistical criteria for early success at its interim phase 3 analysis; the study remains blinded, and the company is preparing to enroll an additional fourth cohort to accrue more cases. - **Oncology pipeline**: Presented 5-year durable clinical benefit data for individualized neoantigen therapy Intismoran (in combination with Keytruda) for adjuvant melanoma at ASCO 2026, confirming induction of de novo neoantigen-specific T-cells. Dosing has begun for two new cancer antigen therapy programs: Phase 1-2 mRNA-4194 in Lynch syndrome and Phase 1 mRNA-4200 in solid tumors. The Phase 3 adjuvant melanoma study of Intismoran is fully enrolled, with an interim analysis expected in H2 2026. Multiple other Intismoran studies across tumor types are advancing, with renal cell carcinoma (fully enrolled 2025 Q2) potentially reading out in 2026 or 2027, and muscle invasive bladder cancer (enrolled earlier 2026) expected to read out in 2027. - **Rare diseases**: The registrational Phase 3 study for propionic acidemia (PA) is fully enrolled, with data expected in 2026. A decision on a pivotal trial for methylmalonic acidemia (MMA) is deferred until the PA readout. ### Commercial Updates - COVID: Spikevax and MNEX Spike have been updated to target the XFG strain selected by U.S. and European health authorities for the 26-27 season. MNEX Spike is now approved in Japan and Taiwan, adding to existing approvals in the U.S., EU, Canada, and Australia. 2025-2026 real-world data shows 59% adjusted vaccine effectiveness against COVID hospitalization for adults 65+, and 67% for adults 75+, with numerical advantages over competitor products, and captured 24% of the U.S. retail COVID market (34% among adults 65+). - RSV: MRESVIA is approved in 44 countries, most recently Mexico (for all adults 60+ and high-risk adults 18-59), with a label expansion to high-risk 18-59 year olds in Australia. New real-world effectiveness data against RSV hospitalization has been published. - Combo vaccines: mCombrax is approved in the EU, and under review in Canada, Australia, and Japan; the company awaits U.S. standalone flu approval before taking next steps for the combo in the U.S. The company signed a joint procurement contract with the European Commission for up to 24 million doses of MRESVIA across six countries. ### Corporate Updates - Expanded partnership with CEPI to develop an Ebola vaccine, reinforcing commitment to global pandemic preparedness. - Named Time magazine's world's most impactful company for pioneering mRNA science. - Appointed Esther Bank as new Chief Commercial Officer, a 30+ year healthcare commercial leader, to lead the global commercial organization ahead of multiple upcoming product launches. Appointed Michael McDonald, former Biogen CFO, to Moderna's Board of Directors. - Moderna will host its Analyst Day on November 12, 2026 in Cambridge.

Guidance

- Full year 2026 total revenue growth is maintained at up to 10% YoY, with a 50-50 expected revenue split between U.S. and international markets. Third quarter revenue is expected to represent ~55% of second half 2026 revenue. Guidance assumes no 2026 revenue from the flu vaccine mRNA-1010 and mCombrax, and accounts for projected declines in COVID vaccination rates. - 2026 cost of sales guidance is lowered by $0.1 billion to $1.7 billion, which includes a $0.9 billion charge for the previously announced litigation settlement (the $950 million payment will be reflected in Q3 2026 cash). The downward revision reflects additional manufacturing efficiency gains. - 2026 R&D expense guidance is lowered by $0.1 billion to $2.9 billion, driven by operational efficiencies. - 2026 SG&A expense guidance is maintained at approximately $1 billion, flat YoY, with commercial spend heavily weighted to the second half due to vaccine seasonality. - Excluding the $0.9 billion litigation charge, 2026 GAAP operating expenses are expected to be $4.7 billion, and cash costs (excluding stock-based compensation, depreciation, and amortization) are expected to be $4 billion. This represents a $0.2 billion total improvement versus prior guidance. - 2026 capital expenditure guidance is maintained at $0.2-$0.3 billion. End-of-year 2026 cash and investments are projected to be between $4.7 billion and $5.2 billion, improved from prior guidance due to lower cash cost projections.

Segment performance

Moderna does not break out formal product segment financial performance in this call. Total Q2 2026 revenue was $145 million, a 2% increase year-over-year (YoY), with a geographic mix of 60% U.S. and 40% international. For the first half (H1) of 2026, total revenue was $0.5 billion, with 31% from the U.S. and 69% from international markets, driven by long-term strategic partnerships. Q2 2026 cost of sales was $93 million, a 22% decrease YoY driven by lower unutilized manufacturing capacity costs and improved efficiency. R&D expenses were $651 million, a 7% decrease YoY due to lower clinical costs after winding down late-stage programs. SG&A expenses were $216 million, a 6% decrease YoY reflecting ongoing cost discipline. Net loss for Q2 was $782 million, a 5% improvement YoY; loss per share was $1.97 compared to $2.13 YoY. Cash and investments totaled $6.9 billion at the end of Q2.

Risks & headwinds

- The norovirus vaccine mRNA-1403 phase 3 study failed to meet statistical criteria for early success at interim analysis, requiring additional cohort enrollment and extending the development timeline, with slower-than-expected endpoint case accumulation due to unexpected norovirus strain epidemiology. - Event-driven oncology and rare disease trial readout timelines are uncertain: renal cell carcinoma readout could occur in 2026 or 2027, and bladder cancer readout in 2027, depending on the pace of event accrual. There is no guarantee of positive efficacy data for Intismoran across tumor types, particularly in indications where checkpoint inhibitors do not work (such as pancreatic cancer). - COVID vaccination rates are projected to decline, which creates downside risk to full year 2026 U.S. revenue if declines are larger than expected. - Late strain selection for flu vaccines would require accommodation from global public health bodies (FDA, CDC, WHO), and discussions around this capability are still in early stages, even though Moderna has the manufacturing capability to update strains in under two months. - Market access for new products in Europe requires completion of pricing negotiations, HTA assessments, and (in some cases) public health body recommendations, so full commercial contribution from newly approved products is not expected until 2028 at the earliest.

Analyst Q&A

• Q: If the Phase 3 Intismoran adjuvant melanoma study passes its first interim, how should results and disclosure be interpreted, and what is the read-through for efficacy in other tumor types like lung cancer? /

  A: Management did not disclose pre-planned statistical thresholds for early efficacy or exact disclosure details. The study is designed to characterize the full commercial profile of the product, even if early efficacy criteria are not met at interim, the study will continue to accrue events to final analysis. For read-through to other tumor types, positive efficacy in melanoma would increase confidence for other tumors where checkpoint inhibitors work (like lung and bladder cancer), while efficacy in less responsive tumors like pancreatic remains unproven, which is why those are still in earlier stage trials. Positive mechanism of action data from ASCO confirms neoantigen-specific T-cell induction that supports the approach across indications.

• Q: If flu vaccine is approved, what potential pricing strategy does Moderna expect, and can you share additional details on the norovirus interim analysis outcome? /

  A: Pricing discussions are ongoing and contingent on final approval, but based on Phase 3 data showing relative efficacy versus standard dose flu vaccines and lack of egg adaptation, Moderna positions mRNA-1010 in the enhanced vaccine category, and will characterize its value with payers based on health economics before setting final pricing. For norovirus, the study remains blinded, so no details on effect size can be shared; the additional cohort is being added to accrue more endpoint cases, as case accumulation has been slower than expected due to prior seasons of off-target strain outbreaks.

• Q: What are the top priorities for the new Chief Commercial Officer over the next six months, as Moderna prepares for upcoming product launches? /

  A: CCH Esther Bank is leading preparation for multiple near-term product launches: potential flu approval in H2 2026, the 2027 launch of the flu-COVID combo vaccine, and commercial launch of Intismoran if Phase 3 data is positive (working hand-in-hand with partner Merck). A key priority is preparing for geographic expansion, particularly in Europe, where Moderna's pandemic-era exclusive partnership is set to expire in 2026, opening up a large new market that requires tailored commercial strategies across individual European countries. She will also support preparation for the potential launch of the propionic acidemia rare disease asset, should trial data be positive. The commercial organization restructuring supports Moderna's transition to a multi-product, geographically diversified growth-stage company.

• Q: For full year 2026 10% revenue growth guidance, what are the main puts and takes across geographies, and where are the key risks/upsides? /

  A: H1 2026 revenue hit $0.5 billion, up almost $300 million YoY, so even if H2 2026 is flat YoY, full year growth will exceed 10%. H1 2026 was 70% international, so the full year 50-50 target means most variable growth will come from the U.S. in the second half. The guidance already accounts for an expected decline in U.S. COVID vaccination rates; if the decline is smaller than projected, there is upside to full year revenue, while a larger decline would create downside. International growth is mostly locked in via existing strategic partnership contracts, with new volumes from UK and other partnerships that were not present in 2025 H2 offsetting projected U.S. declines.