With attention focused on their recently approved drugs for transthyretin amyloid cardiomyopathy (ATTR-CM), there was a serendipitous timeliness to Alnylam and BridgeBio presenting their quarterly updates on consecutive days.
While BridgeBio blew away analyst projections on Wednesday, reporting sales of $37 million for Attruby in its first full quarter on the market, Alnylam countered with positive news as well for Amvuttra on Thursday.
Since Amvuttra earned its FDA label expansion to treat patients with ATTR-CM so late in the first quarter on March 20, there were no significant sales to report for the indication. But the company is pointing to encouraging signs in its uptake.
“Our first priority out of the gate was the access setup and we’re pleased to say it’s progressing exactly to plan, enabling the second half growth story that we have portrayed,” Tolga Tanguler, Alnylam’s chief commercial officer, said during a conference call.
Tanguler explained that 80% of TTR volume in the U.S. flows through 170 health systems, and that the company had gained formulary placements of Amvutta within four weeks of the label expansion at more than half of the systems. He added that a “majority” have initiated Amvuttra treatment for ATTR-CM patients.
Tanguler also reported early feedback from patients and doctors indicates “excitement for a new mechanism of action in ATTR-CM.”
“What we’re hearing from prescribers is that the Amvuttra’s disruptive value proposition resonates and is enabling this early encouraging launch momentum,” Tangular said.
Alnylam and BridgeBio are challenging powerhouse Pfizer, which has dominated the market with its booming Vyndaqel franchise. In 2024, the Pfizer treatments achieved sales of $5.4 billion, which was up from $3.3 billion in 2023.
Alnylam CEO Yvonne Greenstreet, M.D., said there is plenty of room for new options for ATTR-CM patients.
“We really are in a category growth story,” Greenstreet said. “What we’re seeing is continued evidence of a large, growing, and frankly, unsatisfied market and I think we’re very excited to be able to participate.”
Alnylam points to its experience with treating patients with polyneuropathy caused by hereditary transthyretin amyloidosis (hATTR-PN). The company earned approvals for Onpattro (2018) and Amvuttra (2022) to treat the condition.
“We are finding that in categories where the majority of patients remain untreated, more treatment options mean more voices helping to raise disease awareness ultimately accelerating category growth and increasing the number of patients on therapy,” Tanguler said. “We believe about 80% of the addressable patient population remains untreated. This bodes well for the opportunity ahead in ATTR-CM.”
In the first quarter, sales for Amvuttra and Onpattro came in at $310 million and $49 million, which were up a combined 37% year over year and 4% sequentially. The combined $359 million TTR franchise sales were in line with the analysts' forecast of $355 million.
In 2024, sales of the two treatments were at $1.22 billion. With the new indication for Amvuttra, the company is sticking to its previously announced guidance for the pair to generate between $1.6 billion and $1.725 billion in 2025.
For the company overall, revenue was up in the quarter 20% to $594 million. Alnylam is guiding to overall sales of between $2.05 billion and $2.25 billion, which would be a 31% increase year over year at midpoint.