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bluebird bio (BLUE - Free Report) delivered a loss of 67 cents per share in the second quarter, narrower than the Zacks Consensus Estimate of a loss of 72 cents per share. The company had delivered a loss of $1.27 per share in the year-ago quarter (excluding restructuring expenses).
The company reported revenues of $6.9 million in the second quarter, up from $1.5 million in the year-ago quarter. The increase of $5.4 million was primarily due to product revenues from Skysona (elivaldogene autotemcel) and Zynteglo (betibeglogene autotemcel). Revenues, however, missed the Zacks Consensus Estimate of $9 million.
The FDA approved Zynteglo and Skysona for the treatment of beta-thalassemia in adult and pediatric patients requiring regular red blood cell transfusions and for treating early, active cerebral adrenoleukodystrophy on Aug 17, 2022 and Sept 16, 2022, respectively.
Shares of BLUE have plunged 43.8% so far this year compared with the industry’s 13.1% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development expenses declined by 33.8% to $42.3 million due to manufacturing costs related to Skysona and Zynteglo (now included in inventory and cost of product revenues), reduced employee compensation, benefit and other headcount-related expenses and a decrease in information technology and facility-related costs in 2023.
Selling, general and administrative expenses increased to $40.3 million from $36.7 million in the year-ago quarter due to commercial costs driven by marketing activities for Skysona and Zynteglo in the United States.
As of Jun 30, 2023, bluebird had cash and cash equivalents, marketable securities and a restricted cash balance of approximately $291 million, down from $364 million. Based on current operating plans, bluebird expects its cash, cash equivalents, restricted cash and marketable securities to be sufficient to meet its planned operating expenses and capital expenditure requirements into the fourth quarter of 2024. This runway includes approximately $45 million in restricted cash.
Excluding the same, bluebird estimates cash runway into the second quarter of 2024.
bluebird bio, Inc. Price, Consensus and EPS Surprise
In Jun 2023, bluebird bio announced that the FDA accepted for priority review the company’s biologics license application seeking approval for gene therapy lovotibeglogene autotemcel (lovo-cel) for patients with sickle cell disease. bluebird is pursuing FDA approval for lovo-cel for patients aged 12 and older who have a history of vaso-occlusive events. The regulatory body has set a target action date of Dec 20, 2023.
The priority review will shorten the FDA’s review of the application to six months from the time of filing versus a standard review timeline of 10 months. The company continues to anticipate a commercial launch in early 2024.
bluebird has made significant progress in the launch of Zynteglo with 11 patient starts (cell collections) for individuals suffering from beta-thalassemia. The first commercial infusion for Syksona was completed in March 2023. Cell collection has been completed for five patients to be treated with Skysona. bluebird continues to anticipate 5-10 patient starts this year.
Over the past 60 days, loss estimates for ACAD have narrowed to 41 cents from 56 cents for 2023. ACAD topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 20.33%.
Over the past 90 days, loss estimates for FOLD in 2023 have increased by 21 cents to 48 cents. FOLD topped earnings estimates in two of the last four quarters, missing the other two. Shares of Amicus have gained 13.5% in the year so far.
Over the past 30 days, loss estimates for DVAX have narrowed to 34 cents from 56 cents. Shares of Dynavax have gained 40% in the year so far.
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bluebird (BLUE) Q2 Earnings Top, Zynteglo & Skysona Fuel Revenues
bluebird bio (BLUE - Free Report) delivered a loss of 67 cents per share in the second quarter, narrower than the Zacks Consensus Estimate of a loss of 72 cents per share. The company had delivered a loss of $1.27 per share in the year-ago quarter (excluding restructuring expenses).
The company reported revenues of $6.9 million in the second quarter, up from $1.5 million in the year-ago quarter. The increase of $5.4 million was primarily due to product revenues from Skysona (elivaldogene autotemcel) and Zynteglo (betibeglogene autotemcel). Revenues, however, missed the Zacks Consensus Estimate of $9 million.
The FDA approved Zynteglo and Skysona for the treatment of beta-thalassemia in adult and pediatric patients requiring regular red blood cell transfusions and for treating early, active cerebral adrenoleukodystrophy on Aug 17, 2022 and Sept 16, 2022, respectively.
Shares of BLUE have plunged 43.8% so far this year compared with the industry’s 13.1% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development expenses declined by 33.8% to $42.3 million due to manufacturing costs related to Skysona and Zynteglo (now included in inventory and cost of product revenues), reduced employee compensation, benefit and other headcount-related expenses and a decrease in information technology and facility-related costs in 2023.
Selling, general and administrative expenses increased to $40.3 million from $36.7 million in the year-ago quarter due to commercial costs driven by marketing activities for Skysona and Zynteglo in the United States.
As of Jun 30, 2023, bluebird had cash and cash equivalents, marketable securities and a restricted cash balance of approximately $291 million, down from $364 million. Based on current operating plans, bluebird expects its cash, cash equivalents, restricted cash and marketable securities to be sufficient to meet its planned operating expenses and capital expenditure requirements into the fourth quarter of 2024. This runway includes approximately $45 million in restricted cash.
Excluding the same, bluebird estimates cash runway into the second quarter of 2024.
bluebird bio, Inc. Price, Consensus and EPS Surprise
bluebird bio, Inc. price-consensus-eps-surprise-chart | bluebird bio, Inc. Quote
Other Updates
In Jun 2023, bluebird bio announced that the FDA accepted for priority review the company’s biologics license application seeking approval for gene therapy lovotibeglogene autotemcel (lovo-cel) for patients with sickle cell disease. bluebird is pursuing FDA approval for lovo-cel for patients aged 12 and older who have a history of vaso-occlusive events. The regulatory body has set a target action date of Dec 20, 2023.
The priority review will shorten the FDA’s review of the application to six months from the time of filing versus a standard review timeline of 10 months. The company continues to anticipate a commercial launch in early 2024.
bluebird has made significant progress in the launch of Zynteglo with 11 patient starts (cell collections) for individuals suffering from beta-thalassemia.
The first commercial infusion for Syksona was completed in March 2023. Cell collection has been completed for five patients to be treated with Skysona. bluebird continues to anticipate 5-10 patient starts this year.
Zacks Rank and Stocks to Consider
bluebird currently has a Zacks Rank #3 (Hold).
Some top-ranked stocks in the healthcare sector include Acadia Pharmaceuticals (ACAD - Free Report) , Amicus Therapeutics (FOLD - Free Report) and Dynavax Technologies (DVAX - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, loss estimates for ACAD have narrowed to 41 cents from 56 cents for 2023. ACAD topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 20.33%.
Over the past 90 days, loss estimates for FOLD in 2023 have increased by 21 cents to 48 cents. FOLD topped earnings estimates in two of the last four quarters, missing the other two. Shares of Amicus have gained 13.5% in the year so far.
Over the past 30 days, loss estimates for DVAX have narrowed to 34 cents from 56 cents. Shares of Dynavax have gained 40% in the year so far.