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BioNTech SE

Case Details

Class Period: March 30, 2022 - October 13, 2023
Date Filed: January 12, 2024
Case Number: 2:24-cv-00337
Jurisdiction: Central District of California
icon-casetype Case Type: Securities Case
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Case Summary

BioNTech is a biotechnology company that develops and commercializes immunotherapies for cancer and other infectious diseases. The Company has developed and continues to develop, among other products and product candidates, Comirnaty, a COVID-19 vaccine, in collaboration with Pfizer Inc. (“Pfizer”). As part of BioNTech’s collaboration agreement with Pfizer, the two companies share gross profits from COVID-19 vaccine sales in their respective territories. In addition, Pfizer’s inventory write-offs for COVID-19 products reduce BioNTech’s gross profit share, thereby reducing BioNTech’s vaccine revenues.

During the Class Period, as the number of COVID-19 cases began to decline, one variant of the virus, namely, the Omicron XBB.1.5 subvariant, increasingly began to account for the majority of reported cases. Despite not yet having a version of Comirnaty approved by the U.S. Food and Drug Administration to treat this subvariant, BioNTech represented to the market and investors during the Class Period that Comirnaty remained relevant and in-demand.

The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) BioNTech overstated demand for Comirnaty and/or its commercial prospects; (ii) the Company and/or Pfizer had accumulated excess inventory of raw materials for Comirnaty, as well as COVID-19 vaccine doses adapted to other, non-XBB.1.5 variants that were produced at risk; (iii) accordingly, BioNTech was at an increased risk of recording significant inventory write-offs and other charges related to Comirnaty; and (iv) as a result, Defendants’ public statements were materially false and/or misleading at all relevant times.

On August 8, 2022, during pre-market hours, BioNTech issued a press release announcing the Company’s second quarter 2022 financial results, including, inter alia, earnings-per-share under generally accepted accounting principles of €6.45, missing consensus estimates by €0.63, and revenue of €3.2 billion, missing consensus estimates by €910 million, and representing a 39.7% year-over-year decrease. The Company attributed the result, in part, to the “dynamic” development of the pandemic, which “caus[ed] a re-phasing of orders and . . . le[d] to fluctuations in quarterly revenues.” According to BioNTech, “[t]his revenue fluctuation caused by the re-phasing of orders is expected to remain over the rest of the financial year with an uptake in demand in key markets in the fourth quarter of 2022 related to the Omicron-adapted bivalent vaccine, subject to regulatory approval.”

On this news, BioNTech’s American Depositary Share (“ADS”) price fell $13.81 per ADS, or 7.54%, to close at $169.30 per ADS on August 8, 2022.

On March 27, 2023, during pre-market hours, BioNTech issued a press release announcing the Company’s fourth quarter and full year 2022 financial results, which, among other things, forecasted approximately €5 billion in COVID-19 vaccine revenues for the 2023 financial year, significantly below market estimates of over €8 billion. As investment research firm Third Bridge noted, “the [C]ompany’s guidance for full year 2023 COVID-19 vaccine revenue of approximately EUR 5.0B is significantly below current consensus of over EUR $8.0B, reflecting the plummeting demand for population-wide levels of booster vaccinations[.]”

On this news, BioNTech’s ADS price fell $4.60 per ADS, or 3.59%, to close at $123.60 per ADS on March 27, 2023.

On Friday, October 13, 2023, during after-market hours, Pfizer issued a press release announcing, among other things, that “[d]ue to lower-than-expected utilization for our COVID products, Pfizer recorded a non-cash charge of $5.5 billion to Cost of Goods Sold in the third quarter of 2023 . . . related to [inter alia] . . . inventory write-offs and other charges for Comirnaty of $0.9 billion.” Pfizer further disclosed that it “is . . . reducing its full-year 2023 revenue expectations for Comirnaty by approximately $2.0 billion due to lower-than-expected vaccination rates.”

On Monday, October 16, 2023, during pre-market hours, BioNTech issued a press release announcing that, as a result of Pfizer’s inventory write-offs and other charges related to Comirnaty, BioNTech, too, would likely recognize up to €0.9 billion in inventory write-offs and other charges related to Comirnaty in the third quarter of 2023, which represents BioNTech’s half under the gross profit-sharing agreement with Pfizer, and that “[a]ny such write-offs will reduce the revenues the Company would report for 2023.” According to BioNTech, Pfizer informed that Company “that the majority of the write-offs relate to raw materials, mainly formulation-related lipids, purchased during the pandemic, as well as COVID-19 vaccine doses adapted to other, non-XBB.1.5 variants produced at risk.”

On this news, BioNTech’s ADS price fell $6.61 per ADS, or 6.38%, to close at $96.97 per ADS on October 16, 2023.

Then, on November 16, 2023, BioNTech issued a press release announcing its third quarter 2023 financial results. Among other items, the Company confirmed that “[i]nventory write-downs by BioNTech’s collaboration partner Pfizer . . . [in connection with Comirnaty] reduced BioNTech’s revenues by €507.9 million and €615.4 million for the three and nine months ended September 30, 2023, respectively.”

The Complaint alleges that, throughout the Class Period, Defendants’ wrongful acts and omissions, and the precipitous decline in the market value of the Company’s securities, Plaintiff and other Class members have suffered significant losses and damages.

Documents
Complaint