Abeona sells speedy drug review voucher for $155M
Abeona Therapeutics has quickly cashed in on a recent drug approval, agreeing on Monday to sell a so-called priority review voucher awarded by the Food and Drug Administration to an undisclosed buyer for $155 million.
Abeona earned the voucher two weeks ago, when the FDA cleared a cell therapy called Zevaskyn for a form of epidermoloysis bullosa, a rare skin condition. That approval, Abeona's first, was critical for its future prospects, as the company is counting on drug sales to help it break even financially next year. Like many other small drugmakers, Abeona is struggling with a depressed stock price that makes it difficult to raise equity.
The voucher Abeona won is one tool it can use to bolster its cash holdings. These vouchers help speed up drug reviews and are regularly sold for $100 million or more. On a conference call last month discussing Zevaskyn's approval, company executives expressed urgency in completing a deal, given the uncertainty about the future of the FDA program governing these regulatory fast passes.
On that call, CEO Vishwas Seshadri noted how the last four priority review voucher sales each totaled $150 million or more, and the company anticipated interest to 'remain strong.' Since November, Zevra Therapeutics, Acadia Pharmaceuticals and PTC Therapeutics all sold vouchers for $150 million, while Ipsen got slightly more, at $158 million, in a deal last August.
'We're confident that there is demand, and we will prioritize speed over any other further price optimization,' Seshadri said.
In a statement, Abeona Chief Financial Officer Joe Vazzano said the voucher sale leaves the company with enough cash to operate for more than two years without the need for additional funding or accounting for any Zevaskyn sales. Abeona expects to become profitable 'in early 2026,' according to Vazzano.
Abeona's cell therapy should be available in the third quarter. The company is competing for market share with Krystal Biotech, which sells a topical gel for a form of epidermolysis bullosa that's administered weekly. Zevaskyn, by comparison, is a one-time treatment made from a person's own skin cells.
Analysts at the investment firm Jefferies have estimated Zevaskyn could generate $460 million in yearly sales at its peak. Abeona executives have said to expect gradual growth in uptake, with 10 to 15 patients likely treated this year and an acceleration afterwards.
Abeona shares climbed 10% in early trading Monday, to about $6 apiece.
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