Summary
Alnylam Pharmaceuticals, Inc. reported strong growth in product revenues for the third quarter and first nine months of 2019, primarily driven by its first commercial product, ONPATTRO®. Total revenues saw a substantial increase year-over-year. Despite this revenue growth, the company continues to incur significant operating losses, consistent with its business model focused on research and development of novel RNAi therapeutics. The company has a robust pipeline with several late-stage investigational programs, notably givosiran, for which an NDA was accepted by the FDA with Priority Review and an MAA filed with the EMA. Financially, Alnylam bolstered its cash position through a significant public offering and a strategic collaboration with Regeneron, which included a substantial upfront payment and stock purchase. The company's cash reserves remain strong, providing ample runway to fund its ongoing development and commercialization efforts under its Alnylam 2020 strategy. Management believes current resources are sufficient for multiple years, though continued investment in R&D and commercial capabilities is expected.
Financial Highlights
47 data points| Revenue | $70.06M |
| Cost of Revenue | $5.21M |
| Gross Profit | $64.85M |
| R&D Expenses | $160.80M |
| SG&A Expenses | $120.35M |
| Operating Expenses | $286.36M |
| Operating Income | -$216.30M |
| Interest Expense | $0 |
| Net Income | -$208.53M |
| EPS (Basic) | $-1.92 |
| Shares Outstanding (Basic) | 108.70M |
Key Highlights
- 1ONPATTRO® (patisiran) net product revenues significantly increased to $46.1 million in Q3 2019 and $110.6 million for the first nine months of 2019, a substantial jump from the prior year.
- 2Total revenues grew by 3,286% in Q3 2019 and 175% year-to-date, reflecting the commercialization of ONPATTRO® and collaboration revenues.
- 3Givosiran received FDA Priority Review with a PDUFA date of February 4, 2020, and its Marketing Authorisation Application (MAA) was validated by the EMA.
- 4The company secured significant funding through a $400 million upfront payment and $400 million stock purchase from Regeneron as part of a broad strategic collaboration.
- 5Alnylam's cash position strengthened, ending Q3 2019 with $925.75 million, boosted by a $381.9 million net proceeds from a public offering and the Regeneron collaboration.
- 6Research and development expenses increased by 15% for the quarter and 21% year-to-date, reflecting continued investment in pipeline advancement, including clinical trials and license fees.
- 7Despite revenue growth, the company reported net losses of $208.5 million for Q3 2019 and $609.9 million for the first nine months of 2019, with an accumulated deficit of $3.45 billion, which is typical for a biopharmaceutical company at this stage.