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bluebird bio Updates Plans for the Year Ahead

By Brian Orelli, PhD - Feb 22, 2018 at 6:07PM

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The gene therapy company is on the precipice of applying for approval for its first drug.

bluebird bio (BLUE 3.38%) released fourth-quarter earnings on Wednesday -- as it often does, without warning or holding a conference call. Nevertheless, the quarterly releases are a good time for investors to catch up with what's been happening with the gene therapy company.

And what a productive year it was. Cash, cash equivalents, and marketable securities jumped from $885 million in the fourth quarter of 2016 to $1.6 billion in the fourth quarter of 2017, a year-over-year change of 82%.

What happened with Bluebird this quarter?

  • Without any drugs on the market, Bluebird's revenue and earnings aren't particularly important at this point. For the record, the company had $4.2 million in revenue from partnerships with Celgene (CELG) and Novartis (NVS -0.20%) and lost $117.2 million in the fourth quarter.
  • More importantly, Bluebird's coffers increased substantially over 2017, thanks to secondary offerings in June and December. The capital raises diluted shareholders, but the hope is the cash will allow them to own a smaller slice of what will become a larger pie.
  • At the American Society of Hematology (ASH) Annual Meeting in December, Bluebird presented promising data for its updated manufacturing process for LentiGlobin, its gene therapy for transfusion-dependent beta-thalassemia (TDT) and sickle cell disease, as well as updated data for bb2121, its anti-BCMA chimeric antigen receptor (CAR) T-cell therapy being developed with Celgene.
  • Bluebird is continuing its foray into CAR T-cells through a partnership with TC BioPharm that was announced in December. The companies will develop CAR therapies using gamma delta T-cells, a platform that appears to be more flexible than the first-generation CAR T-cell technology.
  • In February, Celgene started the KarMMa trial, which the companies believe should be enough to get bb2121 approved by regulators.
Doctor listening to a boy's chest with a stethoscope

Image source: Getty Images.

What management had to say

Nick Leschly, who goes by the moniker "chief bluebird," laid out the company's plans for filing three marketing applications over the next two years: "We have an aggressive plan to file three programs with regulatory authorities in the next two years: LentiGlobin in TDT in 2018, Lenti-D in [cerebral adrenoleukodystrophy] in 2019 and, with our partners at Celgene, bb2121 in multiple myeloma, also in 2019."

Looking forward

In addition to the marketing applications that Leschly highlighted, investors can look forward to updated data from the phase 1 trial for bb2121, which should give investors confidence that the registration trial will be successful. Celgene also plans to start a phase 3 trial testing bb2121 in multiple myeloma patients who have failed two previous treatments this year. Data from a trial testing bb21217, the follow-on to bb2121, is expected at ASH in December.

For LentiGlobin, this year, Bluebird expects to lay out its plan for getting LentiGlobin approved for sickle cell disease, which will presumably be determined by data from the ongoing phase 1 HGB-206 trial that will read out more data at ASH in December. For LentiGlobin in TDT, investors can expect data at the European Hematology Association Annual Meeting in June. Bluebird is also developing another gene therapy for sickle cell disease that targets BCL11a suppression and fetal hemoglobin upregulation, which should enter the clinic this year.

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