Alnylam Q4 2021 Earnings Report
Key Takeaways
Alnylam Pharmaceuticals reported a strong fourth quarter and full-year 2021, achieving global net product revenues of $199 million for the quarter and $662 million for the year, representing an 83% annual growth. The company is guiding for $900 million to $1 billion in combined net product revenues for 2022. Key milestones include the expected launch of vutrisiran and multiple clinical data readouts.
Achieved Q4 2021 global net product revenues of $199 million, reflecting significant annual growth.
Reported positive results from the HELIOS-A Phase 3 study of Vutrisiran.
Novartis received FDA approval for Leqvio, triggering a $25 million milestone payment to Alnylam.
Provided 2022 combined net product revenue guidance of $900 million to $1 billion.
Alnylam
Alnylam
Alnylam Revenue by Segment
Forward Guidance
Alnylam provided full year 2022 financial guidance, including combined net product revenues for ONPATTRO, GIVLAARI, OXLUMO and vutrisiran of $900 million - $1,000 million, net revenues from collaborations and royalties of $175 million – $225 million, GAAP R&D and SG&A expenses of $1,630 million – $1,750 million and Non-GAAP R&D and SG&A expenses of $1,400 million – $1,500 million.
Positive Outlook
- Combined net product revenues for ONPATTRO, GIVLAARI, OXLUMO and vutrisiran are expected to be $900 million – $1,000 million.
- Net revenues from collaborations and royalties are projected to be $175 million – $225 million.
- Launch vutrisiran in the U.S., assuming successful review and approval from the FDA, for the treatment of hATTR amyloidosis patients with polyneuropathy.
- Report results from the Phase 2 monotherapy study of cemdisiran in patients with IgA nephropathy.
- Vir Biotechnology plans to report results from its Phase 2 combination trials evaluating ALN-HBV02 (VIR-2218), an investigational RNAi therapeutic for the treatment of chronic hepatitis B virus (HBV) infection.
Challenges Ahead
- GAAP R&D and SG&A expenses are projected to be $1,630 million – $1,750 million.
- Non-GAAP R&D and SG&A expenses are expected to be $1,400 million – $1,500 million.
- Guidance is based upon January 31, 2022 FX rates
- Primarily excludes $230-$250 million of stock-based compensation expense from estimated GAAP R&D and SG&A expenses.
- There is no guarantee that any investigational therapeutics or expanded uses of commercial products will successfully complete clinical development or gain health authority approval.
Revenue & Expenses
Visualization of income flow from segment revenue to net income