01—Abstract
Summary
Summary of the 10-K filed February 23, 2023. Cited figures are marked; the original filing is the authoritative source.
Alnylam Pharmaceuticals, Inc. (ALNY) reported its 2022 financial and operational results in its Form 10-K filed on February 23, 2023.
The company demonstrated significant growth in net product revenues, primarily driven by its ATTR amyloidosis franchise, with ONPATTRO and AMVUTTRA generating substantial revenue. The company is strategically advancing its pipeline with a focus on both rare and prevalent diseases, highlighted by progress in late-stage investigational programs. Financially, Alnylam ended 2022 with a strong cash position of $2.19 billiona, supporting its operations and future development.
The company also successfully raised $1.04 billionb through convertible senior notes, with proceeds primarily used to repay existing debt. Alnylam remains committed to its P5x25 strategy, aiming to become a top-tier biotech company by 2025 through sustainable innovation and strong financial performance. Despite a reported net loss for the year, the company shows a positive trajectory with growing product revenues and a robust pipeline, positioning it for potential long-term value creation.
02—Key points
Key Highlights
- Strong growth in net product revenues, driven by ONPATTRO ($558M) and AMVUTTRA ($94M) for hATTR amyloidosis, and GIVLAARI ($173.1M) and OXLUMO ($69.8M) for rare hepatic diseases.
- Submitted supplemental New Drug Application (sNDA) for ONPATTRO for ATTR amyloidosis with cardiomyopathy, with FDA action date set for October 8, 2023.
- Received FDA approval for AMVUTTRA (vutrisiran) for the treatment of polyneuropathy of hATTR amyloidosis in adults.
- Advanced zilebesiran (ALN-AGT) for hypertension into Phase 2 clinical studies (KARDIA-1 and KARDIA-2), with topline results anticipated in mid-2023 and late 2023.
- Ended 2022 with $2.19 billion in cash, cash equivalents, and marketable securities, indicating a strong liquidity position.
- Issued $1.04 billion in convertible senior notes in September 2022 to strengthen the balance sheet and repay debt.
- Continued progress on the Alnylam P5x25 strategy, targeting over 0.5 million patients on its therapeutics, six or more marketed products, and over 20 clinical programs by the end of 2025.
03—One dollar
Follow one dollar
For each $1.00 of revenue in FY2022, Alnylam Pharmaceuticals, Inc. lost $1.09.
- Revenue$1.04B100.0%
- Cost of revenue−$140.2M13.5%
- Gross profit$897.2M86.5%
- Operating costs−$1.68B162.2%
- Operating income−$785.1M75.7%
- Interest, other & tax−$346.1M33.4%
- Net income−$1.13B109.0%
04—Financials
Financial Highlights
Figures from 10-KFY2022filed February 23, 2023Financial Statements
FY2022 against FY2021
| Line item | FY2022FY2021 | Change |
|---|---|---|
| Revenue | $1.04B$844.29M | +22.9% |
| Cost of Revenue | $140.17M$115.00M | +21.9% |
| Gross Profit | $897.24M$729.28M | +23.0% |
| R&D Expenses | $883.01M$792.16M | +11.5% |
| SG&A Expenses | $770.66M$620.64M | +24.2% |
| Operating Expenses | $1.82B$1.55B | +17.4% |
| Operating Income | -$785.07M-$708.65M | −10.8% |
| Interest Expense | $155.97M$143.02M | +9.1% |
| Net Income | -$1.13B-$852.82M | −32.6% |
| EPS (Basic) | $-9.30$-7.20 | −29.2% |
| EPS (Diluted) | $-9.30$-7.20 | −29.2% |
| Shares Outstanding (Basic) | 121.69M118.45M | +2.7% |
| Shares Outstanding (Diluted) | 121.69M118.45M | +2.7% |
05—Questions
Frequently Asked Questions
What were Alnylam's key product revenues in 2022?
Alnylam reported significant net product revenues in 2022: ONPATTRO generated $557.6 million, AMVUTTRA generated $93.8 million, GIVLAARI generated $173.1 million, and OXLUMO generated $69.8 million.
What is the status of ONPATTRO for ATTR amyloidosis with cardiomyopathy?
Alnylam submitted a supplemental New Drug Application (sNDA) to the FDA for ONPATTRO (patisiran) for the treatment of the cardiomyopathy of ATTR amyloidosis. The FDA accepted the sNDA for filing with an action date of October 8, 2023 and indicated plans for an advisory committee meeting.
How did Alnylam strengthen its financial position in 2022?
Alnylam ended 2022 with $2.19 billion in cash, cash equivalents, and marketable securities. Additionally, the company issued $1.04 billion in 1% Convertible Senior Notes due 2027, using the proceeds primarily to repay debt.
What is Alnylam's outlook for future growth?
Alnylam is executing its Alnylam P5x25 strategy, aiming to become a top-tier biotech company by 2025. This involves expanding its pipeline, launching new products, and growing its commercial infrastructure. Key drivers include advancing prevalent disease therapeutics like zilebesiran for hypertension and continuing to build upon its successful rare disease franchise.
06—Continue