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bluebird bio Flies Forward

By Brian Orelli, PhD - May 8, 2019 at 8:12AM

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An approval for Zynteglo is imminent.

Development-stage biotech bluebird bio (BLUE 3.80%) released first-quarter earnings without much fanfare given the lack of a product on the market. Fortunately, the biotech is on the cusp of having an approved drug and plans to hold an analyst day this week where investors can get a little more insight into its plans.

Bluebird results: The only number that really matters

Metric

Q1 2019

Q1 2018

Quarter-Over-Quarter Cash Burn

Cash, cash equivalents, and marketable securities

$1.73 billion

$1.89 billion

$0.16 billion

Data source: bluebird bio.

What happened with Bluebird this quarter?

  • For the record, Bluebird lost $164 million in the quarter, a substantial increase from the $115 million in the year-ago quarter. The biotech spent more on research and development, as its pipeline has matured into larger clinical trials. General and administrative expenses also jumped as it prepares to launch Zynteglo, which used to go by the name LentiGlobin.
  • Speaking of Zynteglo, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approving the drug for transfusion-dependent thalassemia (TDT) patients who do not have a beta 0/beta 0 genotype who can't find a matched stem cell donor. The European Commission should give an official approval in the coming months.
  • Bluebird and partner Celgene (CELG) published data from the phase 1 study testing idecabtagene vicleucel (ide-cel), which used to go by bb2121, in patients with multiple myeloma in The New England Journal of Medicine.
Doctor talking to a patient in an exam room.

Image source: Getty Images.

What management had to say

As the company is wont to do, management didn't hold a conference call for the first-quarter results, but Nick Leschly, who goes by the title of chief bluebird, hinted that more information about the launch of Zynteglo would be presented on May 9: "We look forward to providing more detail on our commercial plans and launch expectations at our upcoming analyst day, including how our initial country-by-country launch in TDT will lay the foundation for our future launches."

Leschly also highlighted the company's pipeline: "While the research and commercial engines are revving, our clinical development programs continue to progress at full speed, with the next data from our programs in TDT and sickle cell disease anticipated in mid-year, and studies in earlier lines of multiple myeloma adding to the robust ide-cel (bb2121) development plan."

Looking forward

On Thursday, management will present an update on its research and commercial strategies. It's not clear if there will be any new clinical trial data presented or if management just plans to lay out its development strategy. Either way, the commercial side of the company's plans should be useful as Bluebird prepares to submit a marketing application with the FDA for Zynteglo by the end of the year.

As it typically does, Bluebird will likely present substantial data at the American Society of Hematology's annual meeting in December. Look for data for Zynteglo in TDT patients with the harder-to-treat beta 0/beta 0 genotypes, as well as LentiGlobin in sickle cell disease and ide-cel and its follow-on, bb21217, in multiple myeloma.

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Stocks Mentioned

bluebird bio, Inc. Stock Quote
bluebird bio, Inc.
BLUE
$3.28 (3.80%) $0.12
Celgene Corporation Stock Quote
Celgene Corporation
CELG

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