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bluebird (BLUE) Stock Down 19% on Q3 Earnings & Revenue Miss
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bluebird bio, Inc. (BLUE - Free Report) reported an adjusted loss of $2.93 per share for third-quarter 2021, wider than the Zacks Consensus Estimate of a loss of $2.72. The company incurred an adjusted loss of $2.94 per share in the year-ago quarter.
Revenues of $22.7 million also missed the Zacks Consensus Estimate of $56 million. Nonetheless, the top line increased 17.7% year over year due to an increase in revenues from the collaboration arrangement with Bristol Myers (BMY - Free Report) for Abecma. Abecma received FDA approval in March 2021 for the treatment of adult patients with relapsed or refractory multiple myeloma.
Shares of the company were down 19.4% on Friday, following the announcement of weaker-than-expected earnings. The stock has plunged 69.6% so far this year in comparison with the industry’s 12.4% decline.
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Quarter in Detail
Research and development expenses decreased to $131.4 million from $140.4 million recorded a year ago due to a decline in expenses recognized by the company under the collaboration agreement with Bristol Myers.
Selling, general and administrative expenses of $68.3 million were up from $68 million in the year-ago quarter due to higher consulting fees for the separation of the company’s severe genetic disease and oncology businesses as well as increased employee compensation and headcount-related expenses.
Completion of Separation of Oncology business
It completed the separation of the oncology business into a separate independent entity, 2seventy bio, Inc. (TSVT - Free Report) , which is listed on the NASDAQ since Nov 5, 2021. Following the separation, it will focus on the severe genetic diseases business. We note that following the separation, bluebird does not have any approved drug in the United States as Abecma has been transferred to 2seventy.
Recent Updates
bluebird completed the submission of a rolling biologics license application (BLA) with the FDA for beti-cel to treat transfusion-dependent β-thalassemia (TDT) in September 2021. The company expects to receive acceptance of the BLA from the FDA by November 2021.
Meanwhile, the FDA has placed a clinical hold on the studies of its gene therapy, eli-cel, which is being developed for the treatment of CALD. The company is in active communication with the FDA and subject to resolution of the clinical hold, it anticipates BLA submission to the FDA for eli-celby 2021-end.
To wind down the European business, the company plans to withdraw the regulatory marketing authorization for Skysona in the European Union (EU). Earlier in July, the European Commission granted marketing authorization of Skysona for the treatment of early CALD in patients aged less than 18 years with an ABCD1 genetic mutation and for whom a human leukocyte antigen-matched sibling hematopoietic (blood) stem cell donor is not available. The company has already withdrawn the marketing application seeking approval for Skysona in CALD in the U.K.
It expects to withdraw the marketing authorizations for Zynteglo (beti-cel’s trade name in Europe) from both the EU and the U.K. by early 2022. Zynteglo is approved in the U.K. and EU for the treatment of patients aged 12 years and above having TDT.
Alkermes’ earnings per share estimates for 2021 have increased from $0.61 to $0.68 in the past 60 days. The same for 2022 has risen from $1.06 to $1.11 in the past 60 days. The stock has rallied 52% in the year so far.
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bluebird (BLUE) Stock Down 19% on Q3 Earnings & Revenue Miss
bluebird bio, Inc. (BLUE - Free Report) reported an adjusted loss of $2.93 per share for third-quarter 2021, wider than the Zacks Consensus Estimate of a loss of $2.72. The company incurred an adjusted loss of $2.94 per share in the year-ago quarter.
Revenues of $22.7 million also missed the Zacks Consensus Estimate of $56 million. Nonetheless, the top line increased 17.7% year over year due to an increase in revenues from the collaboration arrangement with Bristol Myers (BMY - Free Report) for Abecma. Abecma received FDA approval in March 2021 for the treatment of adult patients with relapsed or refractory multiple myeloma.
Shares of the company were down 19.4% on Friday, following the announcement of weaker-than-expected earnings. The stock has plunged 69.6% so far this year in comparison with the industry’s 12.4% decline.
Quarter in Detail
Research and development expenses decreased to $131.4 million from $140.4 million recorded a year ago due to a decline in expenses recognized by the company under the collaboration agreement with Bristol Myers.
Selling, general and administrative expenses of $68.3 million were up from $68 million in the year-ago quarter due to higher consulting fees for the separation of the company’s severe genetic disease and oncology businesses as well as increased employee compensation and headcount-related expenses.
Completion of Separation of Oncology business
It completed the separation of the oncology business into a separate independent entity, 2seventy bio, Inc. (TSVT - Free Report) , which is listed on the NASDAQ since Nov 5, 2021. Following the separation, it will focus on the severe genetic diseases business. We note that following the separation, bluebird does not have any approved drug in the United States as Abecma has been transferred to 2seventy.
Recent Updates
bluebird completed the submission of a rolling biologics license application (BLA) with the FDA for beti-cel to treat transfusion-dependent β-thalassemia (TDT) in September 2021. The company expects to receive acceptance of the BLA from the FDA by November 2021.
Meanwhile, the FDA has placed a clinical hold on the studies of its gene therapy, eli-cel, which is being developed for the treatment of CALD. The company is in active communication with the FDA and subject to resolution of the clinical hold, it anticipates BLA submission to the FDA for eli-celby 2021-end.
To wind down the European business, the company plans to withdraw the regulatory marketing authorization for Skysona in the European Union (EU). Earlier in July, the European Commission granted marketing authorization of Skysona for the treatment of early CALD in patients aged less than 18 years with an ABCD1 genetic mutation and for whom a human leukocyte antigen-matched sibling hematopoietic (blood) stem cell donor is not available. The company has already withdrawn the marketing application seeking approval for Skysona in CALD in the U.K.
It expects to withdraw the marketing authorizations for Zynteglo (beti-cel’s trade name in Europe) from both the EU and the U.K. by early 2022. Zynteglo is approved in the U.K. and EU for the treatment of patients aged 12 years and above having TDT.
bluebird bio, Inc. Price
bluebird bio, Inc. price | bluebird bio, Inc. Quote
Zacks Rank & Stock to Consider
bluebird currently has a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Alkermes (ALKS - Free Report) , which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes’ earnings per share estimates for 2021 have increased from $0.61 to $0.68 in the past 60 days. The same for 2022 has risen from $1.06 to $1.11 in the past 60 days. The stock has rallied 52% in the year so far.