bluebird bio, Inc. BLUE reported a loss of $3.58 per share for second-quarter 2021, wider than the Zacks Consensus Estimate of a loss of $3.26. The company reported a loss of 36 cents per share in the year-ago quarter.
Revenues of $7.5 million also missed the Zacks Consensus Estimate of $17 million. The top line declined significantly year over year due to a cumulative catch-up adjustment to revenues recorded in May 2020.
Shares of the company were down in pre-market trading on Monday following the announcement of the weaker-than-expected earnings results. Along with the earnings release, bluebird announced that the FDA has placed a clinical hold on its gene-therapy elivaldogene autotemcel for treating cerebral adrenoleukodystrophy (“CALD”). It also stated that it will scale back its operations for the severe genetic disease business in Europe and focus only on the U.S. market. Investors are also most likely disappointed by these announcements, which resulted in the stock to go down in pre-market trading.
The stock has plunged 42.1% so far this year against the industry’s increase of 1.8%.
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Quarter in Detail
Research and development expenses decreased to $144.3 million from $156.3 million recorded a year ago due to lower manufacturing expenses and decrease in clinical cost for pipeline development.
Selling, general and administrative expenses of $78.6 million were up from $68.6 million in the year-ago quarter due to higher consulting fees for the upcoming separation of the company’s severe genetic disease and oncology businesses, as well as increased employee compensation and headcount-related expenses.
Recent Updates
Along with its earnings release, bluebird announced that following a safety report, the FDA has placed a clinical hold on the studies of its gene therapy, elivaldogene autotemcel (eli-cel, Lenti-D), which is being developed for the treatment of CALD.
Subject to resolution of the clinical hold, the company plans to complete its rolling biologics license application (BLA) submission to the FDA for eli-cel later in 2021.
Last month, the European Commission (“EC”) granted marketing authorization of Skysona (eli-cel’s trade name in Europe) 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.
In July 2021, the European Medicines Agency's (“EMA”) Pharmacovigilance Risk Assessment Committee (“PRAC”) rendered a positive recommendation and concluded that the benefit-risk balance of medicinal products containing Zynteglo (betibeglogene autotemcel gene therapy) remains favorable. Back then, the company had informed the EMA that it is lifting the voluntary marketing suspension of Zynteglo. Along with the earnings release, bluebird announced that the EMA’s Committee for Medicinal Products for Human Use has endorsed the positive recommendation for Zynteglo by the PRAC. A final decision is expected later in the third quarter of 2021 by the EC.
In June 2021, the FDA lifted the clinical hold on the company’s clinical studies on gene therapies — LentiGlobin and betibeglogene autotemcel (beti-cel) — for treating sickle cell disease (“SCD”) and transfusion-dependent β-thalassemia (“TDT”), respectively.
The company will now be able to resume phase I/II HGB-206 and phase III HGB-210 studies on LentiGlobin (bb1111) for the treatment of adult and pediatric patients with SCD. It will also resume the phase III Northstar-2 (HGB-207) and Northstar-3 (HGB-212) studies on beti-cel for treating adult, adolescent and pediatric patients with TDT. Bluebird remains on track to complete its rolling BLA submission to the FDA in the third quarter of 2021 for beti-cel.
We remind investors that in March 2021, bluebird, along with partner Bristol Myers (NYSE:BMY) BMY, obtained an FDA approval for Abecma (idecabtagene vicleucel; ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma. In the second quarter of 2021, Abecma generated total revenues of $24 million in the United States, which the company shares equally with Bristol Myers.
Divestment
In January 2021, bluebird announced plans to separate its severe genetic disease and oncology businesses into two independent publicly traded companies (bluebird bio and 2seventy bio). The spin-off is expected to be completed in the fourth quarter of 2021.
Zacks Rank & Stocks to Consider
bluebird currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Repligen (NASDAQ:RGEN) Corporation RGEN and Spero Therapeutics (NASDAQ:SPRO), Inc. SPRO, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Repligen’s earnings estimates have been revised 19% upward for 2021 and 14.8% upward for 2022 over the past 60 days. The stock has rallied 30.8% year to date.
Spero Therapeutics’ loss per share estimates have narrowed by 1% for 2021 and 2% for 2022 over the past 60 days.
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Bristol Myers Squibb Company (BMY): Free Stock Analysis Report
Repligen Corporation (RGEN): Free Stock Analysis Report
bluebird bio, Inc. (BLUE): Free Stock Analysis Report
Spero Therapeutics, Inc. (SPRO): Free Stock Analysis Report
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