🔹 Revenue: $108M (est. $110.3M) 🔴; -35% YoY
🔹 Adj. EPS: -$2.52 (est. -$3.18) 🟢; vs. -$3.07 YoY
FY25 Guidance
🔹 Revenue: $1.5B–$2.5B (est. $2.13B) 🟡
🔹 R&D Expenses: ~$4.1B (est. $4.09B) 🟡
🔹 SG&A Expenses: ~$1.1B
🔹 Cost of Sales: ~$1.2B
🔹 CapEx: ~$0.4B
🔹 YE Cash & Investments: ~$6B
🔹 Tax: Minimal
Long-Term Cost Outlook
GAAP OpEx:
🔹 FY26: $5.4B–$5.7B (prior: $5.9B)
🔹 FY27: $4.7B–$5.0B
🔸 Expected OpEx savings of $1.4B–$1.7B by FY27
Other Q1 Metrics:
🔹 Net Loss: -$971M
🔹 R&D Expenses: $856M; -19% YoY
🔹 SG&A Expenses: $212M; -23% YoY
🔹 Operating Loss: -$1.05B
🔹 Cash & Investments: $8.4B (vs. $9.5B at FY24-end)
🔹 Spikevax Sales: $84M (US: $29M | Intl: $55M)
🔹 mRESVIA Sales (RSV): $2M
Strategic Highlights
🔸 Advancing up to 10 products toward approval; oncology focus intensifies
🔸 FDA PDUFA Dates:
• mRNA-1283 (Next-gen COVID): May 31, 2025
• mRNA-1345 (RSV, high-risk adults): June 12, 2025
🔸 Phase 3 Readouts Expected:
• CMV, Norovirus, and Seasonal Flu
🔸 RSV vaccine now approved in Australia, UK, Switzerland, Taiwan
🔸 COVID demand expected to skew heavily to H2
🔸 Flu/COVID combo (mRNA-1083) for 18–49 deprioritized
Oncology & Rare Disease Pipeline Progress
🔸 mRNA-4157 (intismeran autogene) in Phase 3 (Melanoma, NSCLC, RCC, Bladder)
🔸 mRNA-4359 (Checkpoint AIM-T) added to pipeline; Phase 2 enrolling
🔸 PA (mRNA-3927): Phase 1/2 registrational; early MDE reduction seen
🔸 MMA (mRNA-3705): START program participant; pivotal trial starts 2025
CEO Stéphane Bancel Commentary
🔸 “We are executing with financial discipline and sharpening focus on oncology. We reiterate our 2025 framework and expect to reduce our cost base by up to $1.7B by 2027. With multiple Phase 3 readouts ahead, we are confident in Moderna’s long-term outlook.”