We are happy to inform you of the recent news about the U.S. Food and Drug Administration (FDA)’s decision to grant approval for Roche’s novel bispecific antibody for the treatment of neovascular or wet age-related macular degeneration (nAMD) and diabetic macular edema (DME).
XOMA now enters an exciting new stage in its evolution.
This is the first asset under our royalty aggregator business model to receive approval from the FDA. Over the next year, we expect XOMA will begin to receive payments from Roche based on net sales in the U.S. We look forward to further announcements from Roche regarding potential additional markets. As a team, we worked diligently to acquire these commercial payment rights from the previous license holder, and we’re beginning to see the prospects of these efforts bearing fruit.
XOMA acquired a 0.5 percent commercial payment stream on net sales associated with this asset from Affitech SA in October 2021. Per our agreement, we will pay Affitech a $5.0 million milestone based upon this U.S. marketing approval.
Sincerely,
Jim Neal
Chairman and Chief Executive Officer
Forward-Looking Statements/Explanatory Notes
Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the timing and amount of potential commercial payments to XOMA and other developments related to the Roche asset, and the potential of XOMA’s portfolio of partnered programs and licensed technologies generating substantial milestone and royalty proceeds over time. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will,” “would,” “could,” or “should,” the negative of these terms or similar expressions. These forward-looking statements are not a guarantee of XOMA’s performance, and you should not place undue reliance on such statements. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry, including those related to the fact that our product candidates subject to out-license agreements are still being developed, and our licensees may require substantial funds to continue development which may not be available; we do not know whether there will be, or will continue to be, a viable market for the products in which we have an ownership or royalty interest; if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, our third-party licensees will not be able to market them, and the impact to the global economy as a result of the COVID-19 pandemic. Other potential risks to XOMA meeting these expectations are described in more detail in XOMA’s most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA’s prospects. Any forward-looking statement in this press release represents XOMA’s beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law.
EXPLANATORY NOTE: Any references to “portfolio” in this letter refer strictly to milestone and/or royalty rights associated with a basket of drug products in development. Any references to “assets” in this letter refer strictly to milestone and/or royalty rights associated with individual drug products in development.
As of the date of this letter, with the exception of the Roche asset, all assets in XOMA’s milestone and royalty portfolio are investigational compounds, and their efficacy and safety have not been established. There is no guarantee that any of these assets will become commercially available or will be commercially successful after receiving marketing approval.
