Bluebird's Lyfgenia launch gains traction, but shares tumble with report of accounting errors

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来源: FiercePharma

Accounting errors related to leasing agreements with contract manufacturers will force the company to refile its financial statements for 2022 and the first three quarters of 2023, bluebird bio said. The mistakes are not expected to affect the cash position or revenue of the company, bluebird bio Chief Financial Officer Chris Krawtschuk said.

While bluebird bio reported details on the progress of its launch of three gene therapies on Tuesday, the Massachusetts biopharma also said it will have to refile its financial statements from 2022 and the first three quarters of 2023 because of accounting errors.

“The restatement relates to the application of our accounting policies for contracts with our contract manufacturing organizations and suppliers,” Chris Krawtschuk, bluebird’s chief financial officer, said in a conference call.

The errors were found by bluebird’s financial team during preparation of its 2023 financial statement. Bluebird estimates that its understatement of lease assets and lease liabilities will fall between $100 million and $200 million for 2022 and between $30 million and $125 million for each of the first three quarters of last year.

“The restatement is not expected to have any impact on our cash position or revenue,” Krawtschuk added.

The company said it expects to refile the financial statements by April 16.

With the news, bluebird’s share price tumbled by 16% by mid-morning on Tuesday.

Last week, the company reported agreeing to a $175 million loan from Hercules Capital which helps the company launch its new sickle cell disease (SCD) gene therapy Lyfgenia, which was approved three months ago. The loan extends bluebird’s cash runway to the first quarter of 2026.

In 2024, Bluebird expects to have between 85 and 105 patient starts for its three gene therapies. For Lyfgenia, multiple patients are enrolled in the program with its first start “imminent,” the company said. Bluebird expects to recognize revenue from its first dosing in the third quarter, for the treatment which is priced at $3.1 million.

Mizuho Securities analyst Salim Syed noted that bluebird's launch of Lyfgenia is progressing similarly to that of its SCD gene therapy rival Casgevy, which was approved the same day. Its sponsors, Vertex and CRISPR, recently said they also expect infusions and revenue in the back half of 2024.

As for bluebird, seven patients have started this year on its gene therapy Zynteglo, adding to the 20 starts bluebird logged for the beta thalassemia therapy in 2023. Six patients started last year on bluebird’s cerebral adrenoleukodystrophy treatment Skysona and two more are underway this year.

Bluebird has activated 62 qualified treatment centers for Zynteglo, with 49 already receiving referrals for Lyfgenia. Five centers are also activated to administer Skysona.

Bluebird’s revenue in the fourth quarter came to $7.8 million, bringing its 2023 figure to $29.5 million, with Zynteglo accounting for $16.7 million and Skysona coming in at $12.4 million.

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