Adithya Jayaraman

Adi Jayaraman asked about the adjuvant melanoma program, specifically how Moderna anticipates its use across the broader PD-1/PD-L1 class or primarily only with pembrolizumab. She also inquired about the impact of subcutaneous pembrolizumab and other options on regimen selection, logistics, or ultimately uptake for INTKINAV.

Answer

Stephen Hoge, President, expects INT's label to broadly apply to other PD-1/PD-L1 inhibitors approved for adjuvant melanoma, beyond just pembrolizumab, to maximize patient access. He believes subQ pembro's impact is a 'within the PD-1 class question' and wouldn't relate to INT, which would be a 'category of one,' providing benefit regardless of the PD-1 administration route.

Adithya Jayaraman asked if a similar Q4 to Q1 new prescription (NRX) jump observed for tafamidis in prior years should be modeled for AMVUTTRA®, considering factors like IRA Part D modifications or normal seasonality.

Answer

Tolga Tanguler, Chief Commercial Officer, stated it's still early, awaiting competitor reports, but emphasized that the ATTR cardiomyopathy category growth is accelerating due to underdiagnosis. He highlighted Alnylam's strong positioning, differentiation, robust HELIOS-B outcomes data, and continued investment in real-world evidence to become a market leader.

Adithya Jayaraman, on behalf of Corey Kazimoff at Evercore, asked if a similar new prescription (NRX) jump from Q4 to Q1, as observed with tafamidis in previous years, should be modeled for AMVUTTRA, considering factors like IRA Part D modifications or normal seasonality. He also inquired about overall category growth expectations.

Answer

Tolga Tanguler, Chief Commercial Officer, noted it was too early to draw firm conclusions on Q4 to Q1 NRX jumps for AMVUTTRA, as only one competitor had reported. He emphasized that the ATTR cardiomyopathy category growth is accelerating due to underdiagnosis and undertreatment, and the polyneuropathy category is also growing faster with new competition. Tanguler asserted AMVUTTRA's strong positioning as a market leader due to its differentiated mechanism, robust HELIOS-B outcomes, and ongoing investment in real-world evidence.