bluebird (BLUE) Larger than expected loss in T2, lower revenues Y / Y – August 9, 2021

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bluebird bio, Inc. (BLUE Free Report) reported a loss of $ 3.58 per share for the second quarter of 2021, larger than Zacks’ consensus estimate of a loss of $ 3.26. The company reported a loss of 36 cents per share in the quarter of last year.

The revenue of $ 7.5 million also missed Zacks’ consensus estimate of $ 17 million. Revenue declined significantly year over year due to a cumulative revenue catch-up adjustment recorded in May 2020.

Shares of the company were down on the pre-stock market on Monday after weaker-than-expected results were reported. Concurrent with the publication of the results, bluebird announced that the FDA has put a clinical stop on its elivaldogene gene therapy autotemcel for the treatment of cerebral adrenoleukodystrophy (“CALD”). He also said he would scale down his operations for the severe genetic disease sector in Europe and focus only on the US market. Investors are also very likely disappointed by these announcements, which caused the stock to drop on the pre-market.

The stock has plunged 42.1% so far this year against an industry increase of 1.8%.

Image source: Zacks Investment Research

Quarter in detail

Research and development costs decreased to $ 144.3 million from $ 156.3 million a year ago due to lower manufacturing expenses and lower clinical costs for pipeline development.

Selling, general and administrative expenses of $ 78.6 million were up from $ 68.6 million in the prior year quarter due to higher consulting fees for the upcoming separation of the operations of the company’s serious genetic diseases and oncology, as well as increased employee compensation and workforce expenses. .

Recent updates

Along with the publication of its results, bluebird announced that following a safety report, the FDA has suspended studies of its gene therapy, elivaldogene autotemcel (eli-cel, Lenti-D), which is ongoing. development for the treatment of CALD.

Subject to the resolution of the clinical suspension, the company plans to complete its continued Biologics License Application (BLA) submission to the FDA for eli-cel later in 2021.

Last month, the European Commission (“EC”) granted marketing authorization for Skysona (trade name for eli-cel in Europe) for the treatment of early CALD in patients under the age of 18 years of age with an ABCD1 genetic mutation and for whom a human leukocyte antigen -A matched hematopoietic (blood) stem cell donor is not available.

In July 2021, the Pharmacovigilance Risk Assessment Committee (“PRAC”) of the European Medicines Agency (“EMA”) issued a positive recommendation and concluded that the benefit / risk balance of medicinal products containing Zynteglo ( betibeglogene autotemcel gene therapy) remains favorable. At the time, the company informed the EMA that it was lifting the voluntary suspension of the marketing of Zynteglo. Along with the publication of the results, bluebird announced that the EMA Committee for Medicinal Products for Human Use has approved the PRAC’s positive recommendation for Zynteglo. A final decision is expected later in the third quarter of 2021 by the EC.

In June 2021, the FDA lifted the clinical suspension of the company’s clinical studies of gene therapies – LentiGlobin and betibeglogene autotemcel (beti-cel) – for the treatment of sickle cell anemia (“SCD”) and β-thalassemia-dependent. transfusions (“TDT”), respectively.

The company will now be able to resume the phase I / II HGB-206 and phase III HGB-210 studies on LentiGlobin (bb1111) for the treatment of adult and pediatric patients with sickle cell disease. It will also resume the phase III studies Northstar-2 (HGB-207) and Northstar-3 (HGB-212) on beti-cel for the treatment of adult, adolescent and pediatric patients with TDT. Bluebird remains on track to complete its ongoing BLA submission to the FDA in Q3 2021 for beti-cel.

We remind investors that in March 2021, bluebird, with its partner Bristol Myers (BMJ Free Report), obtained FDA approval for Abecma (idecabtagene vicleucel; ide-cel) as the first B cell maturation antigen (BCMA) directed by 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 revenue of $ 24 million in the United States, which the company shares equally with Bristol Myers.

Divestment

In January 2021, bluebird announced its intention 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 finalized in the fourth quarter of 2021.

Zacks rank and actions to consider

bluebird currently wears a Zacks Rank # 3 (Hold). Top-ranked stocks in the biotech sector include Repligen Corporation (RGEN Free report) and Spero Therapeutics, Inc. (SPRO Free Report), both currently carrying a Zacks Rank # 2 (Buy). You can see The full list of Zacks # 1 Rank (Strong Buy) stocks today here.

Repligen’s revenue estimates have been revised up 19% for 2021 and 14.8% up for 2022 in the past 60 days. The stock is up 30.8% since the start of the year.

Spero Therapeutics’ loss per share estimates have declined 1% for 2021 and 2% for 2022 in the past 60 days.


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