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bluebird bio Prepares Its "Transition to a Commercial Company"

By Brian Orelli, PhD - Aug 6, 2018 at 2:47PM

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The biotech expects to file a marketing application with EU regulators by the end of the year.

As this development-stage drugmaker typically does, bluebird bio (BLUE 0.60%) issued a second-quarter earnings report that offered an opportunity for investors to get caught up on the biotech's happenings during the quarter.

Bluebird results: The only number that really matters

Metric

Q2 2018

Q4 2017

Year-to-Date Change

(Loss)

Cash, cash equivalents, and marketable securities

$1.46 billion

$1.61 billion

($0.15 billion)

Data source: Bluebird.

What happened with Bluebird this quarter?

  • Without any drugs on the market, GAAP revenue and earnings aren't particularly important for Bluebird. What really matters is that the company has plenty of cash to get its first drug approved. In fact, the company raised an additional $600.6 million through a secondary offering after the close of the quarter, boosting its nest egg even more, and extending its runway into 2022.
  • Bluebird's gene therapy LentiGlobin was granted accelerated assessment by European regulators for the treatment of transfusion-dependent beta-thalassemia (TDT). Management reiterated that it plans to submit a marketing application in the EU this year. Updated data presented at the annual congress of the European Hematology Association (EHA) showed that the drug continues to help patients out to three years.
  • The company also presented data at EHA for LentiGlobin in patients with sickle cell disease, showing the new manufacturing protocol produced cells with more anti-sickling hemoglobin.
  • At the American Society of Clinical Oncology meeting, Bluebird and its partner Celgene (CELG) presented updated data from the phase 1 trial for bb2121 in patients with multiple myeloma, showing long-lasting responses for the CAR-T therapy.
Normal and sickled red blood cells

bluebird bio aims to fight sickle cell disease. Image source: Getty Images.

What management had to say

Nick Leschly, who goes by the title "chief bluebird," highlighted the company's potential to ramp up sales quickly: "As we prepare to make this important transition to a commercial company, with the potential for three initial product approvals by the end of 2020, our readiness and implementation plans are well underway. We are also investing and building for our next phase of growth through a sustainable innovation engine, and a strong development and commercial infrastructure to allow us to bring more transformative therapies to patients."

Looking forward

The submission of the EU marketing application for LentiGlobin in TDT -- and the eventual approval -- is the biggest near-term event for Bluebird. But the bigger potential lies ahead, especially for LentiGlobin for sickle cell disease, which is a larger market than TDT; and for bb2121, which should be quickly adopted as a last-line therapy for multiple myeloma, and could advance to earlier-stage disease.

To keep track of Bluebird's progress, investors should keep an eye out for data for both drugs at the American Society of Hematology meeting. Late-breaking abstract submissions are due at the end of October, but the meat of the data will likely be held for the meeting in early December.

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Stocks Mentioned

bluebird bio, Inc. Stock Quote
bluebird bio, Inc.
BLUE
$3.35 (0.60%) $0.02
Celgene Corporation Stock Quote
Celgene Corporation
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