Arvid Necander

Arvid Necander asked for concrete details on amendments made to ongoing production lines following the CRL and if the facility is now operating at full capacity for approved products. He also questioned the R&D spend, noting it's trending higher than the initial full-year guidance, and asked if a meaningful step down is anticipated for Q4.

Answer

Joseph McClellan, Chief Operating Officer, elaborated on the observations, which included manufacturing controls, investigations, laboratory controls, and documentation practices. He confirmed over 180 actions were committed to, such as strengthening microbial controls, visual inspection, airflow, and gowning procedures, and that manufacturing for Q4 deliveries is ongoing. Linda Jónsdóttir, Chief Financial Officer, confirmed elevated R&D in Q2 and Q3 due to clinical/manufacturing activities and launch preparations, with an expected lower R&D spend in Q4 compared to Q2 and Q3.

Arvid Necander from DNB Carnegie noted that R&D spend appears to be trending higher than the initial full-year guidance of $160 million-$165 million and asked if a meaningful step down is anticipated for Q4.

Answer

Linda Jónsdóttir, CFO, confirmed elevated R&D levels in Q2 and Q3 due to timing of clinical and manufacturing activities, launch preparations, and facility improvement-related impacts. She stated that lower R&D is expected in Q4 compared to Q2 and Q3, but it will still be impacted by improvement costs.