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After four consecutive quarters in which revenue topped 5 billion euros ($5.1 billion)—nearly all of it attributed to sales of its Pfizer-partnered COVID-19 vaccine—BioNTech is coming to grips with a decline in demand for the shot, known commercially as Comirnaty.

And the fall is coming quicker than expected. On Monday, the German company reported revenue of 3.2 billion euros ($3.3 billion) for the second quarter. It was a 40% decline from the same period last year and nearly a 50% drop from the company's first quarter revenue figure of 6.4 billion euros.

The performance was significantly shy of Wall Street’s second quarter revenue expectation of 3.96 billion euros. With the news, BioNTech's share price dropped 8% by mid-morning.

“The development of the pandemic has been and remains dynamic, causing a rephasing of orders, with this leading to fluctuations in quarterly revenue,” chief financial officer Jens Holstein said on a conference call.

Much of the shortfall can be attributed to delays in vaccine deliveries to the European Union, the company said. In May, BionTech and Pfizer said they were pushing deliveries due for June through August to beyond September.

As for the United States, BioNTech's chief strategy officer Ryan Richardson said that an additional vaccine order “will be heavily weighted" in the fourth quarter of 2022.

Despite the performance, BioNTech is not adjusting its 2022 projection for Comirnaty and still expects sales to reach between 13 billion and 17 billion euros. The company projects an uptick in sales later this year with autumn booster campaigns, combined with expected approval of the company’s pair of omicron-adapted vaccines.

BioNTech has begun manufacturing those omicron-tweaked shots, CEO Uğur Şahin said during the call. This month the company expects to begin trials of its vaccine geared to omicron’s BA.4/5 variant, targeting its approval in October.

While the FDA is primarily focused on a BA.4/5-tweaked vaccine, the European Medicines Agency hopes to employ it along with a BA.1-tweaked shot, Sahin said.

Lee Brown, the global sector lead for healthcare at Third Bridge, says much will depend on the new versions of the vaccine.

“The forthcoming launches of the updated COVID-19 vaccines are important, especially for the higher-risk cohorts of the population," Brown wrote. “The U.S. booster market potentially could represent over $7 billion annually for the next several years, even if ongoing booster shots only focus on the 50 and older cohort and other higher risk groups. As such, the COVID-19 vaccine tailwind is expected to continue.”

Contrary to the drop in sales, BioNTech said it is gaining market share. In January of this year, Comirnaty sales accounted for 52% of the worldwide market. But now the figure is 63%, the company said. Over the same period in developed markets, there’s been a rise from 59% to 68% in market share.

Of the 9.6 billion euros ($9.8 billion) revenue figure the company achieved in the first half, 5.4 billion euros ($5.5 billion) were accumulated in net profit. This came despite a rise in operating costs in the second quarter due to 400 million euros ($408 million) in inventory write-offs.

“That is something we had to swallow in Q2,” Holstein said. “It will remain a topic we will have to keep a view on depending on how the pandemic evolves.”

BioNTech isn't alone in having to write off COVID-19 vaccine inventory. Moderna last week recorded a $499 million charge for unused doses amid the global demand slump.

https://www.fiercepharma.com/pharma/covid-vaccine-demand-free-fall-biontech-sees-revenue-drop-nearly-50-second-quarter