While the approval of Leqembi Iqlik bodes well for Biogen and Eisai’s planned application for a subcutaneous induction regimen next year, its financial impact remains “uncertain,” as potentially higher revenues from the injection could be offset by steeper costs of production, according to Jefferies.
The FDA signed off Friday on a subcutaneous formulation of Biogen and Eisai’s anti-amyloid Alzheimer’s therapy Leqembi, opening up at-home administration for patients who have been treated with the drug for 18 months. The partners will market the injection as Leqembi Iqlik.
In a note to investors on Monday, Jefferies analysts wrote that the approval is “in line with expectations, but good news nonetheless.” Still, the firm remains “uncertain” about the financial impact of Leqembi Iqlick, given the likely higher costs that the companies will incur to produce the subcutaneous injection.
Biogen and Eisai have set Leqembi Iqlik’s wholesale acquisition cost at $375 per autoinjector, dosed weekly, coming out to a total of $19,500 per year. This pricing “is considerably higher than the average ~$13-14,000 annual cost of maintenance IV therapy,” Jefferies wrote.
“Therefore, all else equal, adoption of IQLIK will boost revenue,” though such an increase might not be reflected in the bottom line, the analysts concluded. The drug formulation itself requires 120% greater antibodies than the intravenous version, according to Jefferies, and the autoinjector device will likewise add to the cost of producing Iqlik.
“This approval may have a small positive impact on revenue, because revenue per patient will rise, but profits per patient may decline on higher COGS [cost of goods sold],” Jefferies wrote. Nevertheless, Friday’s approval could bode well for the partners’ plan to file for a subcutaneous initiation formulation of Leqembi next year, the firm added.
BMO Capital Markets agreed, writing in a Monday note that revenues from the approval are likely to be “incremental” for Biogen and Eisai, though Leqembi Iqlik “could expand access” to the therapy “as more patients push into longer term treatment.”
Beyond its financial impact for the companies, Leqembi Iqlik’s approval represents a “crucial step toward making Leqembi more accessible for patients,” Howard Fillit, co-founder and chief science officer at the Alzheimer’s Drug Discovery Foundation, said in a statement on Friday. “Subcutaneous delivery is more than an upgrade—it’s a gateway to the next generation of Alzheimer’s care.”
Leqembi Iqlik is specifically approved for maintenance treatment, meaning it can only be used in patients who have completed 18 months of induction with the originally approved intravenous formulation of the therapy. The injection is designed to be used weekly, versus the biweekly infusion schedule of its intravenous maintenance counterpart.
Friday’s approval was supported by data from subcutaneous substudies of the Phase III Clarity AD open-label extension trial. Results showed that transitioning to weekly injections maintained clinical and biomarker benefits as compared with intravenous maintenance. Safety profiles were also comparable between formulations, with amyloid-related imaging abnormalities occurring at similar frequencies.
Meanwhile, recent long-term data from Clarity AD, presented in July at the Alzheimer’s Association International Conference, showed that over three and four years of treatment, intravenous Leqembi can delay disease progression and keep patients in the early stages of Alzheimer’s disease, as compared with the condition’s natural course.
