- BridgeBio Pharma has sold a voucher that speeds up Food and Drug Administration approval reviews to an undisclosed buyer for $110 million, adding to a string of licensing agreements and divestments meant to reduce expenses and extend its cash runway into 2024.
- The sale, announced by BridgeBio Friday, follows one day after the biotech licensed an experimental cancer drug to Bristol Myers Squibb for $90 million upfront. BridgeBio also sold a rare disease treatment approved in the U.S. last year to Sentynl Therapeutics in March and has marked another half dozen drugs in its pipeline for future partnering or out-licensing.
- The voucher was granted to BridgeBio by the FDA in February last year upon approval of that rare disease drug, called Nulibry. Known as priority review vouchers, these regulatory fast passes allow drug companies to shave four months off of FDA drug approval review times, to six months from a standard 10 months, and can be transferred.
Priority review vouchers have been regularly traded between biotech and pharmaceutical companies since 2014, when the first was sold by BioMarin Pharmaceutical to Sanofi and Regeneron. Their value has fluctuated since then as more have been awarded by the FDA to companies that win approval of drugs for certain rare or tropical diseases, as well as specific medical countermeasures.
Recently, however, they've regularly fetched prices between $100 and $110 million, with BridgeBio's sale at least the seventh since the end of 2020 to command around that amount. Y-mAbs Therapeutics, Rhythm Pharmaceuticals, Liminal BioSciences, Albireo Pharma, Mirum Pharmaceuticals and, most recently, BioMarin have all successfully sold off vouchers in that time period.
The price stability is good news for biotechs hoping to cash in on a voucher, most notably Bluebird bio, which has largely staked its financial future on selling two vouchers that it expects to receive in exchange for approval of two gene therapies now under FDA review.
The FDA has scheduled an advisory committee hearing for both therapies, which respectively treat rare blood and brain diseases, for early June. The agency previously extended its review of both drugs, known as beti-cel and eli-cel.
In the meantime, however, Bluebird has begun cutting costs, announcing plans to lay off about a third of its workforce and to reduce spending this year by between 35% to 40%. In March, the company warned investors there was "substantial doubt" about its ability to remain solvent through early 2023.
Sales of the vouchers, if Bluebird's therapies are approved, could help bolster the company's cash position. Bluebird has also said it is considering public or private equity financings, although the market for biotech company stocks has sunk significantly since last year, making it harder for companies to easily raise funds.
Along with Bluebird Bio, Marinus Pharmaceuticals has plans to sell a voucher it won with the March 2022 approval of its drug Ztalmy.
BridgeBio, for its part, in a tougher financial position than it had anticipated, after one of its top medicines failed in a closely watched clinical trial in December. That setback triggered layoffs and a restructuring that's continued with the some of the company's recent moves.
BridgeBio has also reached an agreed to amend a credit agreement, extending the interest-only period by two years and pushing out the principal repayment to November 2026.
"We believe this deal, coupled with our amended loan agreement, offers us the opportunity to read out more data within the duration of our debt and advance meaningful medicines to patients in need in the years to come," said BridgeBio CFO Brian Stephenson, in a statement.
Specifically, BridgeBio expects to have enough cash to fund operations into 2024, after a planned 30-month readout from the trial that delivered negative 12-month results in December.
Shares in BridgeBio rose by more than 10% in Friday morning trading.