Bluebird bio hasn’t yet made a sale of either of its recently approved gene therapies. But the Massachusetts-based biotechnology company has already turned two regulatory vouchers it received along with the approvals into nearly $200 million.
Known as priority review vouchers, these assets allow a drug developer to receive faster Food and Drug Administration review for an experimental medicine. They can also be sold or transferred to other companies, as Bluebird has now done. On Friday, Bluebird said Bristol Myers Squibb had bought the second of its vouchers for $95 million, a little more than a week after it completed the sale of the first to the Dutch biotech Argenx for $102 million.
The cash infusion is particularly important for Bluebird, which spent much of 2022 in financial difficulty. Last April, the company laid off 30% of its staff after warning investors of the risk it may not be able to stay solvent.
Its position has improved since, following the approvals of Zynteglo in August and Skysona in September. Neither of the two treatments — cleared for severe beta thalassemia and for a rare childhood brain disease — are expected to be big sellers, as there are relatively few patients eligible to receive them. Still, they will provide Bluebird with needed revenue, especially as the company priced them at $2.8 million and $3 million per patient, respectively.
“The sale of our second priority review voucher further bolsters our financial position and provides an important source of non-dilutive funding for the company,” Chris Krawtschuk, Bluebird’s newly appointed chief financial officer, said in a statement Friday.
Bluebird had $141 million in cash, equivalents and marketable securities as of Sept. 30, 2022, along with an additional $45 million in restricted cash. At the time it announced its third quarter earnings, it projected spending between $75 and $80 million in the fourth quarter to prepare for launching Zynteglo and Skysona, as well as preparing for post-approval regulatory commitments.
Assuming those numbers hold, the $197 million in proceeds from the regulatory voucher sales should roughly quadruple its available cash and liquid assets. Bluebird has said it plans early this year to provide guidance for its 2023 financial position.
In addition to launching Zynteglo and Skysona, Bluebird is also preparing to submit an approval application for a third gene therapy, lovo-cel, for sickle cell disease. The company recently resolved a partial FDA hold on clinical testing of the treatment, helping clear the way for its application and, if accepted by the agency, a potential approval decision.
Shares in Bluebird fell by more than 2% in Friday morning trading.