What Annexon, Inc. told the SEC could break it.

Annexon's corporate headquarters and laboratory facilities are concentrated in the San Francisco Bay Area (Brisbane, CA), which has experienced severe earthquakes and wildfires; the company carries no earthquake insurance, so a natural disaster could severely disrupt operations and materially harm the business.

“Our corporate headquarters and other facilities are located in the San Francisco Bay Area, which has experienced both severe earthquakes and the effects of wildfires. We do not carry earthquake insurance.”

Annexon has no approved products and no product revenue, has incurred net losses every year since inception ($206.7M in 2025) and had a $917.4M accumulated deficit and $238.3M cash at year-end 2025; it must keep raising capital — via $150M ATM programs with TD Cowen and warrant financings — and will need substantial additional funding to reach commercialization, exposing shareholders to dilution and funding risk.

“Our net losses were $206.7 million and $138.2 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $917.4 million”

Annexon owns no manufacturing, storage, distribution or testing facilities and contracts with third parties to manufacture its product candidates, and relies on third parties to conduct all preclinical studies and clinical trials; failure by these CMOs/CROs to deliver reliable, high-quality supply or meet regulatory/deadline obligations could delay launch or cause supply shortages.

“We do not currently own or operate facilities for product manufacturing, storage and distribution, or testing. We contract with third parties for the manufacture of our product candidates.”

Annexon's entire value depends on obtaining and maintaining FDA, EMA and comparable approvals; because pivotal tanruprubart GBS trials were conducted outside the U.S. (Bangladesh, the Philippines), the FDA may not accept that foreign data as the sole basis for U.S. marketing approval unless it is applicable to the U.S. population and practice, adding approval risk to its lead program.

“the FDA will not approve the application on the basis of foreign data alone unless those data are applicable to the United States population and United States medical practice, the trials were performed by clinical investigators of recognized competence and the data are considered valid”