01—Abstract
Summary
Summary of the 10-K filed February 15, 2024. Cited figures are marked; the original filing is the authoritative source.
Alnylam Pharmaceuticals, Inc. (ALNY) reported its 2023 financial and operational results, showcasing significant revenue growth driven by its expanding portfolio of RNAi therapeutics.
The company's net product revenues reached $1.24 billiona, up 39% year-over-year, primarily due to the strong performance of AMVUTTRA and continued growth in GIVLAARI and OXLUMO, partially offset by a decline in ONPATTRO sales as patients transitioned to AMVUTTRA. Collaboration revenues also saw a substantial increase, largely from the new agreement with Roche for zilebesiran and increased royalties from Novartis on Leqvio. Alnylam continues to invest heavily in research and development, with expenses increasing by 14% to $1.0 billion, reflecting progress in its pipeline, including the development of zilebesiran for hypertension and ALN-APP for Alzheimer's disease.
The company ended the year with $2.44 billionb in cash, cash equivalents, and marketable securities, providing a solid liquidity position. Despite a net loss of $440 million, Alnylam is progressing towards its P5x25 strategic goals, aiming for profitability and a leading biotech profile by the end of 2025.
02—Key points
Key Highlights
- Total revenues increased by 76% to $1.83 billion in 2023, driven by a 39% rise in net product revenues to $1.24 billion and a significant increase in collaboration revenues to $546 million.
- AMVUTTRA sales grew substantially to $558 million, while ONPATTRO sales declined to $355 million, indicating a product franchise shift.
- GIVLAARI and OXLUMO demonstrated solid growth, with revenues reaching $219 million and $110 million, respectively.
- Research and development expenses increased by 14% to $1.0 billion, reflecting continued investment in pipeline advancement, particularly for zilebesiran and ALN-APP.
- The company ended 2023 with $2.44 billion in cash, cash equivalents, and marketable securities, providing a strong liquidity foundation.
- Alnylam advanced its key pipeline programs, including reporting positive topline results for zilebesiran's KARDIA-1 Phase 2 study and positive interim results for ALN-APP's Phase 1 study.
- The FDA issued a Complete Response Letter (CRL) for ONPATTRO's sNDA for ATTR amyloidosis with cardiomyopathy, indicating that clinical meaningfulness was not established for this indication.
03—One dollar
Follow one dollar
For each $1.00 of revenue in FY2023, Alnylam Pharmaceuticals, Inc. lost $0.24.
- Revenue$1.83B100.0%
- Cost of revenue−$268.2M14.7%
- Gross profit$1.56B85.3%
- Operating costs−$1.84B100.8%
- Operating income−$282.2M15.4%
- Interest, other & tax−$158.1M8.6%
- Net income−$440.2M24.1%
04—Financials
Financial Highlights
Figures from 10-KFY2023filed February 15, 2024Financial Statements
FY2023 against FY2022
| Line item | FY2023FY2022 | Change |
|---|---|---|
| Revenue | $1.83B$1.04B | +76.2% |
| Cost of Revenue | $268.22M$140.17M | +91.3% |
| Gross Profit | $1.56B$897.24M | +73.9% |
| R&D Expenses | $1.00B$883.01M | +13.7% |
| SG&A Expenses | $795.65M$770.66M | +3.2% |
| Operating Expenses | $2.11B$1.82B | +15.8% |
| Operating Income | -$282.18M-$785.07M | +64.1% |
| Interest Expense | $121.22M$155.97M | −22.3% |
| Net Income | -$440.24M-$1.13B | +61.1% |
| EPS (Basic) | $-3.52$-9.30 | +62.2% |
| EPS (Diluted) | $-3.52$-9.30 | +62.2% |
| Shares Outstanding (Basic) | 124.91M121.69M | +2.6% |
| Shares Outstanding (Diluted) | 124.91M121.69M | +2.6% |
05—Questions
Frequently Asked Questions
What was Alnylam's net product revenue in 2023 and what drove the changes?
Alnylam's net product revenues increased by 39% to $1.24 billion in 2023. This growth was primarily driven by the launch and strong performance of AMVUTTRA ($558 million in sales), which benefited from patient transitions from ONPATTRO. GIVLAARI ($219 million) and OXLUMO ($110 million) also contributed with solid growth. ONPATTRO sales decreased to $355 million, largely due to the shift to AMVUTTRA.
How did Alnylam's collaboration revenues perform, and what are the key partnerships?
Alnylam's collaboration revenues increased significantly to $546 million in 2023, primarily due to a $338 million revenue recognition from the new collaboration with Roche for zilebesiran and increased milestone and royalty payments from Novartis for Leqvio. Other key collaborations include those with Regeneron and Sanofi.
What is the status of Alnylam's key pipeline programs, particularly vutrisiran for ATTR amyloidosis with cardiomyopathy and zilebesiran?
Alnylam's HELIOS-B Phase 3 study of vutrisiran for ATTR amyloidosis with cardiomyopathy is expected to report topline results in late June or early July 2024. Regarding zilebesiran, the company reported positive topline results from the KARDIA-1 Phase 2 study and completed enrollment in the KARDIA-2 study. Furthermore, the FDA issued a Complete Response Letter (CRL) for ONPATTRO's sNDA for ATTR amyloidosis with cardiomyopathy, stating that clinical meaningfulness was not established for this indication.
What is Alnylam's financial position, including cash reserves and overall profitability?
Alnylam ended 2023 with a strong liquidity position, reporting $2.44 billion in cash, cash equivalents, and marketable securities. Despite this, the company reported a net loss of $440 million for the year, continuing its trend of losses as it invests heavily in R&D and commercial infrastructure. Alnylam is working towards achieving financial self-sustainability by the end of 2025 as part of its P5x25 strategy.
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