Alnylam's Triple-Digit Revenue Growth Driven by AMVUTTRA Uptake and Strong Pipeline Progress
Record TTR Franchise Growth Sets New Benchmarks for Alnylam
Alnylam Pharmaceuticals’ third quarter of 2025 showcased a remarkable surge, with total net product revenues leaping 103% year-over-year to $851 million. The centerpiece: AMVUTTRA’s global success in ATTR-CM, posting $685.3 million in revenue, a 165% jump from the same quarter last year. TTR franchise revenues reached $724.4 million—up 135%—reflecting not just higher patient demand, but widespread adoption of AMVUTTRA, including first-line use for new-to-treatment patients and those progressing on stabilizers.
The continued clinical validation of AMVUTTRA’s benefits was spotlighted in recent HELIOS-B Phase 3 study results, showing a 37% reduction in risk of death or first cardiovascular event in the overall population versus placebo. As CEO Dr. Yvonne Greenstreet noted, these results support broad payer coverage and convenient dosing as key growth drivers, enabling the company to increase full-year 2025 guidance for TTR net product revenues to $2.48-$2.53 billion.
| Metric | Q3 2025 | Q3 2024 | Change (%) |
|---|---|---|---|
| Total Net Product Revenue | $851M | $420.15M | 103 |
| AMVUTTRA Revenue | $685.3M | $258.59M | 165 |
| TTR Franchise Revenue | $724.4M | $308.88M | 135 |
| GAAP Net Income | $251.08M | ($111.57M) | - |
| Non-GAAP Net Income | $396.18M | ($64.20M) | - |
| Royalty Revenue | $46.20M | $23.39M | 98 |
Broadening Access, Clinical Success, and First-Line Adoption for AMVUTTRA
AMVUTTRA’s clinical profile and broad reimbursement—most patients paying $0 out-of-pocket—enabled significant momentum. Notably, patient demand for AMVUTTRA approximately doubled quarter-over-quarter, signaling continued rapid adoption in both new and switch patients. Further, new analyses from HELIOS-B presented at leading conferences revealed significant cardiovascular benefit and a lower rate of GI adverse events versus placebo, bolstering confidence in its long-term role.
Pipeline Expansion and Key Trials Add to Investor Confidence
While commercial momentum takes center stage, Alnylam continues to build out a robust RNAi pipeline. Two new Phase 3 studies have been launched: ZENITH for zilebesiran in hypertension (partnered with Roche, expected to enroll 11,000 patients globally), and TRITON-PN for nucresiran in hATTR-PN. The company also advanced earlier-stage trials, including mivelsiran for Alzheimer's disease and ALN-5288 targeting tauopathies.
Regeneron’s positive Phase 3 data for cemdisiran in generalized myasthenia gravis—and plans for U.S. regulatory submission—demonstrate growing validation of RNAi therapeutics beyond rare disease, further supporting Alnylam’s long-term vision. Additionally, the company’s royalty and milestone income (highlighted by $300 million from Roche this quarter) offers important balance sheet support as R&D and SG&A expenses increase with portfolio growth.
Financial Highlights Show Shift to Sustainable Profitability
The transformation in Alnylam’s financial position is evident: Q3 2025 delivered a GAAP net income of $251.08 million and a non-GAAP net income of $396.18 million, compared to net losses in Q3 2024. This shift is supported by strong cash balances ($2.7 billion as of September 30), despite debt repayments and investments in pipeline expansion.
Cost of goods sold rose to 23.2% of net product revenues (from 19.5%), reflecting higher AMVUTTRA royalties. SG&A and R&D expenses increased year-over-year with expanded headcount and marketing, but revenue growth far outpaced these costs, yielding strong operating leverage.
| Operating Expense (Q3 2025) | 2025 | 2024 | Change (%) |
|---|---|---|---|
| Cost of Goods Sold | $197.23M | $81.98M | 141 |
| GAAP R&D Expense | $358.81M | $270.93M | 32 |
| GAAP SG&A Expense | $322.08M | $220.99M | 46 |
2025 Outlook Raised: Guidance Reflects Confidence in Pipeline and Commercial Execution
Management’s raised 2025 revenue guidance—to $2.95-$3.05 billion in total net product revenues—represents a projected 79-85% increase from 2024. Guidance for TTR franchise revenues increased by $275 million at midpoint, underscoring expectations of sustained momentum for AMVUTTRA. The company anticipates achieving full-year non-GAAP operating profitability, reaffirming Alnylam’s maturation into a top-tier profitable biotech.
| 2025 Financial Guidance (Updated) | Prior Range | Current Range | Change |
|---|---|---|---|
| Total TTR Net Product Revenues | $2,175M–$2,275M | $2,475M–$2,525M | + $275M (midpoint) |
| Total Net Product Revenues | $2,650M–$2,800M | $2,950M–$3,050M | + $300M (midpoint) |
| Net Product Revenue Growth (YoY) | 61%–70% | 79%–85% | Increased |
Key Takeaways for Investors
Alnylam’s third quarter confirms a business firing on all cylinders: AMVUTTRA’s performance, expanded indications, robust pipeline progression, and improved financial discipline set a solid course for continued growth and profitability. Investors may want to follow upcoming results from HELIOS-B at AHA 2025 and monitor the launch and reimbursement trajectory for AMVUTTRA, as these will further test the sustainability of Alnylam’s newfound momentum.
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