Shares of bluebird bio, Inc. BLUE were down 3.68% on Mar 30 after the company provided updates on the biologics license application (BLA) submission for experimental gene therapy lovo-cel for sickle cell disease (SCD) concurrent with the fourth-quarter results.
In early March, BLUE responded to feedback from the FDA on vector and drug product analytical comparability evaluations completed in December 2022 and submitted addition information related to CMC comparability analyses.
The company now states that it expects a response from the FDA within a matter of weeks and will expedite its BLA submission, pending alignment with the FDA on product comparability. The company has earlier guided that it will submit the BLA in the first quarter. The delay in BLA submission disappointed the investors and shares declined.
Concurrently, bluebird reported revenues of $0.06 million in the fourth quarter compared to $1.6 million in the year-ago quarter. Revenues missed the Zacks Consensus Estimate of $102 million. bluebird anticipates reporting commercial revenues in the first quarter of 2023.
The company reported earnings of 38 cents per share in the fourth quarter against a loss of $1.83 per share in the year-ago quarter.
Shares of BLUE have plunged 36.7% so far this year compared with the industry’s 14.7% decline.
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Quarter in Detail
Research and development expenses from continuing operations decreased to $45.9 million from $79.4 million a year ago. The decrease was primarily due to decreased employee compensation, benefits, other headcount-related expenses, information technology and facility-related costs, clinical trial and laboratory costs.
In November 2021, BLUE completed separating the oncology business into an independent entity called 2seventy bio, Inc. TSVT.
We note that TSVT has been listed on the Nasdaq since November 2021.
Selling, general and administrative expenses from continuing operations were $30.7 million, down from $53.2 million in the year-ago quarter. The decrease was primarily due to decreased employee compensation, benefit and other headcount-related expenses and reduced commercial readiness activities due to the company’s decision to focus its efforts on the U.S. market.
In the fourth quarter of 2022, the company recorded a gain of $102 million from the sale of priority review vouchers (PRV).
As of Dec 31, 2022, bluebird had cash and cash equivalents, marketable securities and restricted cash balance of approximately $227 million. Based on current operating plans, bluebird expects its cash, cash equivalents, restricted cash and marketable securities, including the net proceeds from the sale of its PRV of $93 million and net proceeds of $131 million from its public offering in January, will 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.
bluebird was granted two PRVs upon the FDA’s approval of Zynteglo (betibeglogene autotemcel) for the treatment of beta-thalassemia in adult and pediatric patients requiring regular red blood cell transfusions and Skysona (elivaldogene autotemcel) for the treatment of early, active cerebral adrenoleukodystrophy on Aug 17, 2022 and Sept 16, 2022, respectively.
The company entered into a definitive agreement to sell its first PRV for $102 million in November 2022. It entered a final agreement to sell its second PRV for $95 million in January 2023.
bluebird bio, Inc. Price, Consensus and EPS Surprise
bluebird bio, Inc. price-consensus-eps-surprise-chart | bluebird bio, Inc. Quote
bluebird has made significant progress in the launch of Zynteglo with five patient starts (cell collections) for patients with beta-thalassemia. As the launch progresses, the company plans to expand manufacturing capacity to meet the growing projected demand.
Cell collection has been completed for two patients to be treated with Skysona and the first commercial infusion has been completed. bluebird remains on track for 5-10 patient starts this year.
Zacks Rank and Other Stocks to Consider
bluebird currently has a Zacks Rank #2 (Buy). Other well-placed stocks in the overall healthcare sector are Novo Nordisk NVO and Ligand Therapeutics LGND. Both carry a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.20 to $4.43 and estimates for 2024 have gone up by 29 cents to $5.19.
Ligand’s earnings per share estimates for 2023 increased to $4.32 from $3.30 in the past 30 days. LGND beat earnings estimates in one of the last four reported quarters and missed in the remaining three.
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