Text: Slowly, Rhee
Bluebird Biology, a star company in gene therapy, has repeatedly behaved abnormally.
Recently, the bluebird bio has repeatedly appeared in the spotlight, and a series of "big moves" have been questioned.
With the release of its 2021 financial report, the poor data has caused the public to worry about its financial situation and ability to continue to operate.
The news that the chief financial officer (CFO) is leaving has ignited negative sentiment in the market. On the day, the stock fell more than 10%.
In addition, several gene therapies that Bluebird Biology is "proud of" have also appeared frequently in recent years, which has cast a layer of haze on its development prospects.
Today, on the one hand, plagued by safety issues such as clinical setbacks, and on the other hand, the commercial difficulties have made it more and more difficult, where will the darlings in the field of gene therapy go in the past?
01
A stone stirring up a thousand layers of waves?
CFO leaves Share price performance is subdued
On March 7, EST, Bluebird Announced the resignation of its Chief Financial Officer, Gina Consylman, effective April 3; CBO Jason F. Cole will take over the position.
Founded on April 16, 1992, Bluebird Biology is a clinical biotechnology company headquartered in Cambridge, Massachusetts, dedicated to developing potential gene therapies for severe genetic diseases and cancers. Its comprehensive product platform includes gene therapy, cancer immunotherapy and gene editing. Its product lines include Lenti-D, LentiGlobin, BCL11A shRNA, bb2121 and BB21217.
It is worth noting that the departure time node of the chief financial officer of Bluebird Biology is slightly strange.
Previously, Bluebird Bio released its 2021 annual results. The company had a net loss of $562.6 million and revenue of just $3.7 million in 2021, compared to a net loss of $561.1 million in 2020.
As of December 31, 2021, Bluebird Bio's cumulative loss was $3.72 billion.
In addition, a few days before the resignation of the chief financial officer (March 4), Bluebird Bio had said that it was "doubtful of its ability to continue to operate for the next year.".
As a result, the resignation of the chief financial officer has stirred up thousands of waves, and investors cannot help but associate the two.
In terms of stock market performance, BlueBird Bio continued to fall from March 1 to 7. It reached its lowest peak on March 7, falling more than 10%. On March 8, the stock recovered from the previous day, but remained relatively depressed, closing at $4.450 per share.
Screenshot source: Oriental Fortune
02
Confined to commercial difficulties
Repeated declines in performance are not satisfactory
The decline in the performance of Bluebird Bio is not unrelated to its commercial difficulties. Despite repeated searches for change, it is becoming more and more difficult.
At the beginning of last year (January 2021), Bluebird Bio announced plans to split its severe genetic disease and oncology business, and in the future the company will continue to focus on severe genetic diseases (SGD) while launching its oncology business as a new entity.
It is reported that these two major businesses have been "hit hard" before. Bluebird CEO Nick Leschly said both businesses have clear goals and will benefit from independent leadership.
However, the final performance was still unsatisfactory.
Bluebird Said it has seen a decline in cash, cash equivalents and securities since it divested its oncology business. As of December 31, 2021, that total was $396.6 million, down 22 percent from about $507.2 million at the time of the Bluebird spin-off, although the latter included restricted cash.
Meanwhile, Bluebird Bio said it expects "cash consumption" or spending of less than $400 million in 2022, with operating losses and negative operating cash flow expected in the future, as well as the need for additional funding to support its planned operations. In other words, the ability to continue to do business is questionable.
In addition, due to the setback in the listing of its product Zynteglo in the European market, Bluebird Bio began the pace of layoffs in April 2021 and plans to "reduce and reshape" its workforce in parts of Germany.
In addition to the impact of its own business divestiture, Bluebird Bio has also encountered setbacks in other aspects.
03
Gene therapy is regulated, clinically shelved...
How did the Blue Bird creature reverse its current disadvantage?
For Bluebird Biology, Chengye gene therapy and defeat gene therapy.
In 2021, BlueBird Biology has had several gene therapy setbacks.
In February 2021, in the Phase 1/2 trial of gene therapy LentiGlobin, two patients with sickle cell anemia developed acute myeloid leukemia and myelodystic hyperplasia, and Bluebird immediately called off LentiGlobin's phase 1/2 (HGB-206) and phase 3 (HGB-210) clinical studies. Affected by this, the company's stock price fell nearly 38% on the day.
In addition to the stock price, Bluebird Biologics' gene therapy drug Zynteglo was also affected, and since Zynteglo was the same viral vector as the above test, the company decided to suspend sales of it.
- In July 2021, Zynteglo returned to the European blood disease treatment market, and the European Commission on Pharmacovigilance Risk Assessment (PRAC) re-approved the drug because it decided that the benefits of Zynteglo's treatment outweighed the risks.
- In August 2021, Bluebird Biogene Therapy elivaldogene autotemcel (eli-cel, Lenti-D™) was also ordered to abort the test by the FDA for suspected of causing the patient's myelodysplastic syndrome.
- In October 2021, Bluebird withdrew its regulatory marketing authorization for gene therapy Skysona from the European Union, as well as its marketing application for Skysona from the UK Medicines and Health Products Authority.
- At the end of December 2021, Bluebird Biolovotibeglogene Autotemcel (lovo-cel, bb1111) was clinically shelved by the US FDA. Due to persistent non-transfusion-dependent anemia developed in a juvenile patient after receiving disposable love-cel therapy, the FDA partially shelved clinical studies for the treatment of patients with sickle cell disease under the age of 18, and adult enrollment was not affected.
In January, the U.S. FDA extended the review period for licensing applications for biologics for Zynteglo (betibeglogene autotemcel, beti-cel) for the treatment of β thalassemia and Skysona (elivaldogene autotemcel, eli-cel) for the treatment of cerebral adrenoleukodystrophy.
Judging from the latest developments, Bluebird Biological Beti-cel is about to face FDA approval, and if approved, it is expected to become the first in vitro hematopoietic stem cell gene therapy in the United States.
It is worth mentioning that when Beti-cel was approved in Europe, the treatment price of about $1.8 million made it the second market drug to price more than $1 million, second only to Novartis' Zolgensma gene therapy (about $2.1 million).
Whether Betti-ce can successfully break through the barrier this time may be related to whether the BlueBird creature can reverse the current disadvantage.