For a development-stage biotech, bluebird bio 's (NASDAQ: BLUE) fourth-quarter earnings weren't anything to get excited about, but the quarterly report still offers a good opportunity for investors to check in on the cash runway and expectations for the year ahead.
Bluebird results: The only number that really matters
|Metric||Q4 2018||Q4 2017||Year-Over-Year Change|
|Cash, cash equivalents, and marketable securities||$1.9 billion||$1.6 billion||17%|
Data source: bluebird bio.
What happened with Bluebird this quarter?
- Bluebird certainly has plenty of cash to get it past the drug-approval finish line. The increase in its bank account didn't come from Bluebird making money in 2018 -- in fact, it lost over $555 million for the year -- but rather about $600 million from a secondary offering in July, $100 million from an investment by Regeneron Pharmaceuticals (NASDAQ: REGN) in August connected to their deal to develop cancer therapies, and almost $50 million in January 2018 as part of an overallotment tied to another secondary offering in December 2017.
- The capital raises resulted in 54.7 million shares outstanding, around 8 million more than last year, but that's the cost of doing business for biotechs. It dilutes shareholders, but the hope is that they'll own a smaller slice of a much larger pie.
- At the American Society of Hematology meeting in December, Bluebird presented data for its gene therapy LentiGlobin in patients with transfusion-dependent beta-thalassemia (TTD) as well as sickle cell disease (SCD). With its partner Celgene (NASDAQ: CELG) , Bluebird also presented data for its follow-on multiple myeloma CAR-T called bb21217.
- Celgene and Bluebird completed enrollment in the pivotal clinical trial for the first CAR-T in the program, confusingly called bb2121, putting the therapy on track for approval in the second half of 2020.
- In January, Bluebird struck another CAR-T deal, licensing technology from Inhibrx to help with targeting of CAR-T therapies to the cancerous cells.
What management had to say
Nick Leschly, who goes by the title chief bluebird, pointed out the busy plans for the company over the next few years for LentiGlobin in TTD and SCD, bb2121 for multiple myeloma, and Lenti-D in cerebral ALD. "We have an unprecedented opportunity in front of us where we anticipate that all four lead programs will have an initial filing or launch by 2022, and we are developing a deep pipeline enabled by our core technologies and our partnerships," Leschly said.
Bluebird expects a European approval for LentiGlobin in TDT by the end of the year. It also expects to file for approval with the FDA at the end of this year, setting up a potential approval next year. The approvals will initially come in TDT patients with non-beta 0/beta 0 mutations, but there's potential to expand the approvals to patients with beta 0/beta 0 mutations if data from the Northstar-3 study, which is expected later this year, is positive.
SCD is farther behind, but Bluebird expects to start the final clinical trial before approval for that disease by the end of the year.
Finally, in multiple myeloma, investors should look for data from the aforementioned pivotal trial for bb2121 as well as earlier-stage data for bb21217 later this year.
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