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bluebird (BLUE) Posts Q4 Loss, Hit by Regulatory Pipeline Woes
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bluebird bio, Inc. (BLUE - Free Report) reported an adjusted loss (excluding restructuring expenses) of $1.82 per share from continued operations for the fourth quarter of 2021, in line with the Zacks Consensus Estimate but narrower than the year-ago quarter’s loss of $2.05.
Revenues from continued operations were $1.6 million, which missed the Zacks Consensus Estimate of $8 million. During the quarter under review, bluebird completed the separation of the oncology business into a separate independent entity called 2seventy bio, Inc. (TSVT - Free Report) . We note that TSVT has been listed on the NASDAQ since Nov 5, 2021. Following the separation, BLUE does not have any approved drug in the United States as Abecma, an FDA-approved multiple myeloma drug, is transferred to 2seventy bio.
Following the oncology business separation, BLUE is focusing on the severe genetic diseases business while 2seventy bio is focusing on research and development of its oncology pipeline as well as supporting the commercialization of Abecma.
Shares of bluebird have plunged 50% so far this year compared with the industry’s 18.3% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development expenses from continuing operations decreased to $79.4 million from $58.8 million recorded a year ago.
Selling, general and administrative expenses from continuing operations were $53.2 million, down from $80.6 million in the year-ago quarter.
Full-Year Results
bluebirdreported an adjusted loss of $7.86 per share from continued operations in 2021, narrower than the year-ago quarter's loss of $9.02.
Revenues from continued operations for the full year were $3.7 million. In the year-ago period, bluebird did not record any revenues from continued operations.
Recent Updates
bluebird bio announced that the FDA extended the review period of biologics licensing applications (BLAs) for betibeglogene autotemcel (beti-cel) and elivaldogene autotemcel (eli-cel) as treatments for β-thalassemia and cerebral adrenoleukodystrophy (CALD), respectively, by three months. The FDA cited that the delay is due the additional data submitted by bluebird on its request. The new PDUFA action dates for bluebird’s both lentiviral vector gene therapies are Aug 19, 2022 for beti-cel and Sep 16, 2022 for eli-cel.
In the past year, bluebird has suffered multiple regulatory setbacks for its pipeline. The FDA placing multiple clinical holds on BLUE’s pipeline programs does not bode well for the stock and has already been negatively impacting its prospects for sometime now. Moreover, BLUE’s decisions to wind down its European operations, a market where it already received an approval for beti-cel and eli-cel gene-therapies, do not go well with investors and is also one of the reasons for the stock’s downfall.
bluebird is in active communication with the FDA regarding the clinical hold placed by the latter on the studies of eli-cel for CALD since August 2021, following a safety report. Per management, the regulatory agency requested additional data from BLUE regarding safety events and monitoring the gene-therapy.
Earlier in January 2022, bluebird announced that it received written queries from the FDA with regard to the partial clinical hold placed by the regulatory body on lovotibeglogene autotemcel (lovo-cel) gene therapy in patients under the age of 18 with sickle cell disease (SCD). Following management’s assessment of the impact of this clinical hold, including the FDA’s review with written queries, bluebird reaffirms its plans to file a BLA for lovo-cel in first-quarter 2023 to treat SCD.
BioDelivery Sciences’ earnings per share estimates for 2022 have increased from 33 cents to 38 cents in the past 30 days. Shares of BDSI have surged 80.3% year to date.
Earnings of BioDelivery Sciences beat estimates in three of the last four quarters, missing the mark on a single occasion, the average surprise being 33.7%.
Vertex Pharmaceuticals’ earnings per share estimates for 2022 have increased from $14.33 to $14.52 in the past 30 days. Shares of VRTX have risen 8.7% year to date.
Earnings of Vertex Pharmaceuticals beat estimates in each of the last four quarters, the average being 10%.
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bluebird (BLUE) Posts Q4 Loss, Hit by Regulatory Pipeline Woes
bluebird bio, Inc. (BLUE - Free Report) reported an adjusted loss (excluding restructuring expenses) of $1.82 per share from continued operations for the fourth quarter of 2021, in line with the Zacks Consensus Estimate but narrower than the year-ago quarter’s loss of $2.05.
Revenues from continued operations were $1.6 million, which missed the Zacks Consensus Estimate of $8 million. During the quarter under review, bluebird completed the separation of the oncology business into a separate independent entity called 2seventy bio, Inc. (TSVT - Free Report) . We note that TSVT has been listed on the NASDAQ since Nov 5, 2021. Following the separation, BLUE does not have any approved drug in the United States as Abecma, an FDA-approved multiple myeloma drug, is transferred to 2seventy bio.
Following the oncology business separation, BLUE is focusing on the severe genetic diseases business while 2seventy bio is focusing on research and development of its oncology pipeline as well as supporting the commercialization of Abecma.
Shares of bluebird have plunged 50% so far this year compared with the industry’s 18.3% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development expenses from continuing operations decreased to $79.4 million from $58.8 million recorded a year ago.
Selling, general and administrative expenses from continuing operations were $53.2 million, down from $80.6 million in the year-ago quarter.
Full-Year Results
bluebirdreported an adjusted loss of $7.86 per share from continued operations in 2021, narrower than the year-ago quarter's loss of $9.02.
Revenues from continued operations for the full year were $3.7 million. In the year-ago period, bluebird did not record any revenues from continued operations.
Recent Updates
bluebird bio announced that the FDA extended the review period of biologics licensing applications (BLAs) for betibeglogene autotemcel (beti-cel) and elivaldogene autotemcel (eli-cel) as treatments for β-thalassemia and cerebral adrenoleukodystrophy (CALD), respectively, by three months. The FDA cited that the delay is due the additional data submitted by bluebird on its request. The new PDUFA action dates for bluebird’s both lentiviral vector gene therapies are Aug 19, 2022 for beti-cel and Sep 16, 2022 for eli-cel.
In the past year, bluebird has suffered multiple regulatory setbacks for its pipeline. The FDA placing multiple clinical holds on BLUE’s pipeline programs does not bode well for the stock and has already been negatively impacting its prospects for sometime now. Moreover, BLUE’s decisions to wind down its European operations, a market where it already received an approval for beti-cel and eli-cel gene-therapies, do not go well with investors and is also one of the reasons for the stock’s downfall.
bluebird is in active communication with the FDA regarding the clinical hold placed by the latter on the studies of eli-cel for CALD since August 2021, following a safety report. Per management, the regulatory agency requested additional data from BLUE regarding safety events and monitoring the gene-therapy.
Earlier in January 2022, bluebird announced that it received written queries from the FDA with regard to the partial clinical hold placed by the regulatory body on lovotibeglogene autotemcel (lovo-cel) gene therapy in patients under the age of 18 with sickle cell disease (SCD). Following management’s assessment of the impact of this clinical hold, including the FDA’s review with written queries, bluebird reaffirms its plans to file a BLA for lovo-cel in first-quarter 2023 to treat SCD.
bluebird bio, Inc. Price
bluebird bio, Inc. price | bluebird bio, Inc. Quote
Zacks Rank & Stocks to Consider
bluebird currently has a Zacks Rank #3 (Hold). A few better-ranked stocks in the overall healthcare sector are BioDelivery Sciences and Vertex Pharmaceuticals (VRTX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
BioDelivery Sciences’ earnings per share estimates for 2022 have increased from 33 cents to 38 cents in the past 30 days. Shares of BDSI have surged 80.3% year to date.
Earnings of BioDelivery Sciences beat estimates in three of the last four quarters, missing the mark on a single occasion, the average surprise being 33.7%.
Vertex Pharmaceuticals’ earnings per share estimates for 2022 have increased from $14.33 to $14.52 in the past 30 days. Shares of VRTX have risen 8.7% year to date.
Earnings of Vertex Pharmaceuticals beat estimates in each of the last four quarters, the average being 10%.