- September 29, 2022
We are happy to inform you of the recent news about the European Commission (EC)’s decision to grant approval for VABYSMO® (faricimab-svoa), Roche’s novel bispecific antibody for the treatment of neovascular or wet age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME).
We believe our October 2021 transaction with Affitech marked an important point in the advancement of XOMA’s royalty monetization strategy. Recently, we saw evidence of this with the receipt of our first royalty-style payment of over $500,000 earned during the first five months of commercialization of VABYSMO in the U.S. and initial sales in Japan.
This is the first asset to reach commercialization stage since we launched our royalty aggregator business model. To date, Roche has received commercialization approval from the U.S. Food and Drug Administration, the EU, and Japan’s Ministry of Health, Labour, and Welfare. We look forward to further announcements from Roche regarding potential additional markets.
In October 2021, XOMA acquired a 0.5 percent commercial payment stream on net sales associated with this asset from Affitech SA. Per our agreement, we will pay Affitech a $3.0 million milestone based upon this EC 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 VABYSMO®, 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-Q 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 VABYSMO, 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.