Shares of Alnylam Pharmaceuticals are sliding in morning trading despite the news that the company’s revenues grew by 83% in 2021 compared to the previous year.
Alnylam CEO Dr. Yvonne Greenstreet/courtesy Alnylam Pharmaceuticals
Shares of Alnylam Pharmaceuticals are sliding in morning trading despite the news that the company’s revenues grew by 83% in 2021 compared to the previous year. Some investors appear to be put off by company losses, which grew to $852 million for the year.
Investors have been stepping back from biotech stocks for some time, particularly as interest rates are expected to increase. Over the past six months, the Nasdaq Biotechnology Index has declined more than 20%, while Alnylam’s stock price has declined more than 27% during the same period.
Despite the sliding stock price, Alnylam’s product portfolio continues to increase revenue returns for the Cambridge, Mass.-based company. In all, the company’s assets generated $662 million in global sales. As the company looks into the remainder of 2022, Alnylam is predicting its total sales to increase by 44% to between $900 million and $1 billion in combined net product revenues.
Alnylam’s revenues were driven by Onpattro (patisiran), an RNAi therapeutic used to treat hereditary transthyretin-mediated (hATTR) amyloidosis in adults. Onpattro generated $475 million in revenue for the year, a 55% growth in sales over 2020.
Other drivers for Alnylam include Givlaari (givosiran) and Oxlumo (lumasiran), which brought in $128 million and $60 million for the year, respectively.
Dr. Yvonne Greenstreet, Alnylam’s recently-tapped chief executive officer, said 2021 was a year of remarkable growth at the company. In addition to the 83% revenue growth, Greenstreet said the company has made significant gains in its pipeline, which includes the Phase III asset vutrisiran, a subcutaneously administered investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis and Stargardt disease. In the Phase III HELIOS-A study, vutrisiran demonstrated statistically significant improvements in the progression of neuropathy. The drug also improved quality of life, gait speed and overall disability compared to placebo.
Alnylam submitted a New Drug Application for vutrisiran last year. The FDA has a PDUFA date of April 14. If approved, Greenstreet indicated that it could be administered to patients shortly afterward.
In addition to vutrisiran, Alnylam is assessing Oxlumo to treat primary hyperoxaluria type 1 (PH1). The company posted positive topline results from the ILLUMINATE-C Phase III study in patients with advanced PH1. Alnylam is also studying the drug to treat recurrent kidney stone disease. The company initiated a Phase II study for this indication.
Another investigational RNAi therapeutic in development for the treatment of complement-mediated diseases is cemdisiran. Alnylam’s partner Regeneron initiated Phase III studies of cemdisiran and pozelimab combination in myasthenia gravis and paroxysmal nocturnal hemoglobinuria.
The company also announced a Phase I study of ALN-APP, an investigational RNAi therapeutic targeting amyloid precursor protein (APP) to treat early-onset Alzheimer’s disease. Alnylam said ALN-APP represents the first-ever RNA interference (RNAi) therapeutic to be evaluated in a disease impacting the central nervous system. In a brief note, Alnylam said it hopes to leverage its pioneering RNAi platform to potentially make an impact in a disease setting where the unmet medical need is profound.
“We believe this strong commercial execution and impressive clinical development progress underscores the promise of our company to deliver self-sustainable innovation from our highly productive, organic platform, setting us up well to execute on our Alnylam P5x25 strategy,” Greenstreet said.
Alnylam P5x25 is the company’s five-year strategy to become top-five biotech based on market cap within the next five years. In an interview with BioSpace earlier this year, Greenstreet said Alnylam P5x25 is a “roadmap for how we’re going to serve … at least half a million patients around the world, as well as bring forward more marketed medicines—six plus—and continue to build this rich clinical pipeline.”
