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bluebird bio (BLUE - Free Report) delivered a loss of 66 cents per share in the third quarter, narrower than the Zacks Consensus Estimate of a loss of 69 cents per share. The company delivered a loss of $92 per share in the year-ago quarter (excluding restructuring expenses).
The company reported revenues of $12.4 million in the third quarter, up from $0.1 million in the year-ago quarter, beating the Zacks Consensus Estimate of $11 million. The increase of $5.4 million was primarily due to product revenues from Skysona (elivaldogene autotemcel) and Zynteglo (betibeglogene autotemcel).
The FDA approved Zynteglo for the treatment of beta-thalassemia in adult and pediatric patients requiring regular red blood cell transfusion on Aug 17, 2022 and Skysona for treating early, active cerebral adrenoleukodystrophy on Sept 16, 2022.
Shares of BLUE have plunged 51.6% so far this year compared with the industry’s 21% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development expenses declined 14.4% to $45.5 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 21.9% to $40.7 million in the year-ago quarter due to commercial costs driven by marketing activities for Skysona and Zynteglo in the United States.
As of Sep 30, 2023, bluebird had cash and cash equivalents, marketable securities and a restricted cash balance of approximately $227 million, down from $291 million at the end of the previous quarter. Based on current operating plans, bluebird expects its cash, cash equivalents and marketable securities, including anticipated cash flows from operations and excluding $53 million of restricted cash, to be sufficient for its planned operating expenses and capital expenditure requirements into the second quarter of 2024.
bluebird bio, Inc. Price, Consensus and EPS Surprise
In June 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 ages 12 and older. In August, the FDA communicated that an advisory committee meeting would not be scheduled for lovo-cel. The regulatory body has set a target action date of Dec 20, 2023.
In October 2023, bluebird entered into an agreement to sell a Rare Pediatric Disease Priority Review Voucher (“PRV”), if received, in connection with the potential approval of lovo-cel for sickle cell disease. Under the terms of the agreement, bluebird will receive $103 million upon closing of the sale, which is contingent upon the FDA’s approval of lovo-cel and granting of the PRV.
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 16 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 six patients to be treated with Skysona. bluebird continues to anticipate 5-10 patient starts this year.
Dynavax’s loss per share estimates for 2023 have narrowed from 23 cents to 15 cents for 2023 in the past 30 days. During the same period, earnings estimates for 2024 rose from 3 cents to 12 cents. Year-to-date, shares of DVAX have gained 8.6%.
Earnings estimates for Ligand Pharmaceuticals’ 2023 earnings per share have increased from $5.09 to $5.10 in the past thirty days. During the same period, earnings estimates for 2024 rose from $4.56 to $4.59.
Ligand beat earnings estimates in three of the last four quarters and missed the mark on one occasion. The company has delivered an earnings surprise of 52.47%, on average.
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bluebird (BLUE) Q3 Earnings Top; Zynteglo, Skysona Fuel Sales
bluebird bio (BLUE - Free Report) delivered a loss of 66 cents per share in the third quarter, narrower than the Zacks Consensus Estimate of a loss of 69 cents per share. The company delivered a loss of $92 per share in the year-ago quarter (excluding restructuring expenses).
The company reported revenues of $12.4 million in the third quarter, up from $0.1 million in the year-ago quarter, beating the Zacks Consensus Estimate of $11 million. The increase of $5.4 million was primarily due to product revenues from Skysona (elivaldogene autotemcel) and Zynteglo (betibeglogene autotemcel).
The FDA approved Zynteglo for the treatment of beta-thalassemia in adult and pediatric patients requiring regular red blood cell transfusion on Aug 17, 2022 and Skysona for treating early, active cerebral adrenoleukodystrophy on Sept 16, 2022.
Shares of BLUE have plunged 51.6% so far this year compared with the industry’s 21% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development expenses declined 14.4% to $45.5 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 21.9% to $40.7 million in the year-ago quarter due to commercial costs driven by marketing activities for Skysona and Zynteglo in the United States.
As of Sep 30, 2023, bluebird had cash and cash equivalents, marketable securities and a restricted cash balance of approximately $227 million, down from $291 million at the end of the previous quarter. Based on current operating plans, bluebird expects its cash, cash equivalents and marketable securities, including anticipated cash flows from operations and excluding $53 million of restricted cash, to be sufficient for its planned operating expenses and capital expenditure requirements 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 June 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 ages 12 and older. In August, the FDA communicated that an advisory committee meeting would not be scheduled for lovo-cel. The regulatory body has set a target action date of Dec 20, 2023.
In October 2023, bluebird entered into an agreement to sell a Rare Pediatric Disease Priority Review Voucher (“PRV”), if received, in connection with the potential approval of lovo-cel for sickle cell disease. Under the terms of the agreement, bluebird will receive $103 million upon closing of the sale, which is contingent upon the FDA’s approval of lovo-cel and granting of the PRV.
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 16 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 six 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).
A couple of better-ranked stocks in the overall healthcare sector are Dynavax Technologies (DVAX - Free Report) and Ligand Pharmaceuticals (LGND - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Dynavax’s loss per share estimates for 2023 have narrowed from 23 cents to 15 cents for 2023 in the past 30 days. During the same period, earnings estimates for 2024 rose from 3 cents to 12 cents. Year-to-date, shares of DVAX have gained 8.6%.
Earnings estimates for Ligand Pharmaceuticals’ 2023 earnings per share have increased from $5.09 to $5.10 in the past thirty days. During the same period, earnings estimates for 2024 rose from $4.56 to $4.59.
Ligand beat earnings estimates in three of the last four quarters and missed the mark on one occasion. The company has delivered an earnings surprise of 52.47%, on average.