No­var­tis' Q4 earn­ings cloud­ed by reg­u­la­to­ry set­backs on in­clisir­an, Zol­gens­ma

When No­var­tis CEO Vas Narasimhan hops on the phone with in­vestors at 8 a.m. Tues­day, he will do so with his com­pa­ny al­ready 4 points in the red.

The cul­prit? Reg­u­la­to­ry de­lays and set­backs that have im­ped­ed two of the Swiss phar­ma’s ma­jor new drugs and made for a rocky Q4 re­port.

No­var­tis had planned to en­ter 2021 with an ap­proval in the bag for in­clisir­an, the RNAi heart drug they pur­chased for $9.7 bil­lion in 2019. In De­cem­ber, though, the FDA is­sued a sur­pris­ing com­plete re­sponse let­ter, which No­var­tis chalked up to “un­re­solved fa­cil­i­ty in­spec­tion-re­lat­ed con­di­tions.” They em­pha­sized that there were no safe­ty or ef­fi­ca­cy is­sues, cast­ing the re­jec­tion as an­oth­er ca­su­al­ty of the FDA’s in­abil­i­ty to con­duct on-site in­spec­tions in Eu­rope dur­ing the pan­dem­ic.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER