We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
bluebird (BLUE) Misses on Q4 Revenues, Provides Portfolio Updates
Read MoreHide Full Article
bluebird bio (BLUE - Free Report) reported revenues of $7.8 million in the fourth quarter, up from $0.1 million recorded in the year-ago quarter but missing the Zacks Consensus Estimate of $17 million.
Revenues were $29.5 million in 2023, up from $3.6 million in 2022. The increase was primarily due to product revenues from Skysona and Zynteglo.
Of the total revenues, $16.7 million were attributable to Zynteglo and $12.4 million were attributable to Skysona, with gross-to-net discounts of approximately 19% across both products.
The FDA approved Zynteglo for the treatment of beta-thalassemia in adult and pediatric patients requiring regular red blood cell transfusion on Aug 17, 2022, and Skysona for treating early, active cerebral adrenoleukodystrophy (CALD) on Sept 16, 2022.
The FDA recently approved its third gene therapy, lovotibeglogene autotemcel (lovo-cel), under the brand name Lyfgenia, for the treatment of sickle cell disease (SCD) in patients aged 12 years and older with a history of vaso-occlusive events.
Shares of BLUE have plunged 72.2% in the past year compared with the industry’s 8.4% decline.
Image Source: Zacks Investment Research
bluebird ended 2023 with cash, cash equivalents and restricted cash balance of approximately $275 million, including restricted cash of approximately $53 million.
Earlier in the month, bluebird bio announced that it has received a $175 million five-year, term loan facility from Hercules Capital, Inc. (HTGC - Free Report) . The funding will extend bluebird’s cash runaway by two years.
Per the terms of the agreement, bluebird will get the term loans in four tranches. The first tranche of $75 million was drawn upon the closing of the transaction. BLUE will be eligible to draw two additional tranches of $25 million each, subject to the achievement of commercial milestones.
If all three tranches totaling $125 million are executed, the funding, along with BLUE’s existing cash balance, is expected to extend its cash runway through the first quarter of 2026. It will be based on current plans and the launch trajectory of its three gene therapies.
The agreement also states that a fourth tranche of up to $50 million may be available at the sole discretion of Hercules.
BLUE also announced that it entered into a factoring agreement in the fourth quarter of 2023, which is accelerating cash collection related to patient starts across its portfolio of approved therapies.
The company is restating its financial statements for 2022 and for the first three quarters of both 2022 and 2023.
Other Updates
bluebird also disclosed 20 patient starts completed for Zynteglo in 2023 and seven patient starts since the beginning of 2024.
For Skysona, six patient starts were completed in 2023 and two patient starts have been completed so far in 2024.
bluebird expects patient start for Lyfgenia shortly. Multiple patients have enrolled and started preparing for treatment across qualified treatment centers (QTC) networks.
bluebird anticipates 85 to 105 patient starts (cell collections) combined across all three of its FDA-approved therapies (Lyfgenia, Zynteglo, Skysona) in 2024.
bluebird bio, Inc. Price, Consensus and EPS Surprise
The company expects to recognize revenues from its first infusion of Lyfgenia in the third quarter of 2024.
bluebird has activated 62 QTCs for Zynteglo and 49 centers are already receiving referrals for Lyfgenia. Five centers are also activated to administer Skysona for patients with CALD.
Enrollment is ongoing for the HGB-210 study evaluating lovo-cel for patients under the age of 12 and is expected to be completed by the fourth quarter.
Our Take
While bluebird’s progress with its portfolio is encouraging, gaining market share in the challenging gene therapy field will be a daunting task. The stock has been under pressure, particularly after the FDA recently approved Lyfgenia because of the boxed warning of hematologic malignancy issued with Lyfgenia’s label. Some patients developed blood cancer after being treated with Lyfgenia.
Hence, bluebird will need to monitor patients closely for evidence of malignancy through complete blood counts, at least every six months, and integration site analysis at months six, 12 and as warranted.
Moreover, the FDA concurrently approved Vertex Pharmaceuticals (VRTX - Free Report) and CRISPR Therapeutics’ (CRSP - Free Report) exagamglogene autotemcel, a CRISPR/Cas9 genome-edited cell therapy, for the treatment of SCD in patients aged 12 years and older with recurrent vaso-occlusive crises.
Exagamglogene autotemcel was approved under the brand name Casgevy, making it the first FDA-approved treatment to utilize a type of novel genome editing technology.
Approval of another gene therapy for the same indication will make it challenging for bluebird to gain market shares.
Also, BLUE has priced Lyfgenia at $3.1 million per dose. Vertex and CRISPR's gene therapy will cost $2.2 million each for every dose.
Image: Bigstock
bluebird (BLUE) Misses on Q4 Revenues, Provides Portfolio Updates
bluebird bio (BLUE - Free Report) reported revenues of $7.8 million in the fourth quarter, up from $0.1 million recorded in the year-ago quarter but missing the Zacks Consensus Estimate of $17 million.
Revenues were $29.5 million in 2023, up from $3.6 million in 2022. The increase was primarily due to product revenues from Skysona and Zynteglo.
Of the total revenues, $16.7 million were attributable to Zynteglo and $12.4 million were attributable to Skysona, with gross-to-net discounts of approximately 19% across both products.
The FDA approved Zynteglo for the treatment of beta-thalassemia in adult and pediatric patients requiring regular red blood cell transfusion on Aug 17, 2022, and Skysona for treating early, active cerebral adrenoleukodystrophy (CALD) on Sept 16, 2022.
The FDA recently approved its third gene therapy, lovotibeglogene autotemcel (lovo-cel), under the brand name Lyfgenia, for the treatment of sickle cell disease (SCD) in patients aged 12 years and older with a history of vaso-occlusive events.
Shares of BLUE have plunged 72.2% in the past year compared with the industry’s 8.4% decline.
Image Source: Zacks Investment Research
bluebird ended 2023 with cash, cash equivalents and restricted cash balance of approximately $275 million, including restricted cash of approximately $53 million.
Earlier in the month, bluebird bio announced that it has received a $175 million five-year, term loan facility from Hercules Capital, Inc. (HTGC - Free Report) . The funding will extend bluebird’s cash runaway by two years.
Per the terms of the agreement, bluebird will get the term loans in four tranches. The first tranche of $75 million was drawn upon the closing of the transaction. BLUE will be eligible to draw two additional tranches of $25 million each, subject to the achievement of commercial milestones.
If all three tranches totaling $125 million are executed, the funding, along with BLUE’s existing cash balance, is expected to extend its cash runway through the first quarter of 2026. It will be based on current plans and the launch trajectory of its three gene therapies.
The agreement also states that a fourth tranche of up to $50 million may be available at the sole discretion of Hercules.
BLUE also announced that it entered into a factoring agreement in the fourth quarter of 2023, which is accelerating cash collection related to patient starts across its portfolio of approved therapies.
The company is restating its financial statements for 2022 and for the first three quarters of both 2022 and 2023.
Other Updates
bluebird also disclosed 20 patient starts completed for Zynteglo in 2023 and seven patient starts since the beginning of 2024.
For Skysona, six patient starts were completed in 2023 and two patient starts have been completed so far in 2024.
bluebird expects patient start for Lyfgenia shortly. Multiple patients have enrolled and started preparing for treatment across qualified treatment centers (QTC) networks.
bluebird anticipates 85 to 105 patient starts (cell collections) combined across all three of its FDA-approved therapies (Lyfgenia, Zynteglo, Skysona) in 2024.
bluebird bio, Inc. Price, Consensus and EPS Surprise
bluebird bio, Inc. price-consensus-eps-surprise-chart | bluebird bio, Inc. Quote
The company expects to recognize revenues from its first infusion of Lyfgenia in the third quarter of 2024.
bluebird has activated 62 QTCs for Zynteglo and 49 centers are already receiving referrals for Lyfgenia. Five centers are also activated to administer Skysona for patients with CALD.
Enrollment is ongoing for the HGB-210 study evaluating lovo-cel for patients under the age of 12 and is expected to be completed by the fourth quarter.
Our Take
While bluebird’s progress with its portfolio is encouraging, gaining market share in the challenging gene therapy field will be a daunting task. The stock has been under pressure, particularly after the FDA recently approved Lyfgenia because of the boxed warning of hematologic malignancy issued with Lyfgenia’s label. Some patients developed blood cancer after being treated with Lyfgenia.
Hence, bluebird will need to monitor patients closely for evidence of malignancy through complete blood counts, at least every six months, and integration site analysis at months six, 12 and as warranted.
Moreover, the FDA concurrently approved Vertex Pharmaceuticals (VRTX - Free Report) and CRISPR Therapeutics’ (CRSP - Free Report) exagamglogene autotemcel, a CRISPR/Cas9 genome-edited cell therapy, for the treatment of SCD in patients aged 12 years and older with recurrent vaso-occlusive crises.
Exagamglogene autotemcel was approved under the brand name Casgevy, making it the first FDA-approved treatment to utilize a type of novel genome editing technology.
Approval of another gene therapy for the same indication will make it challenging for bluebird to gain market shares.
Also, BLUE has priced Lyfgenia at $3.1 million per dose. Vertex and CRISPR's gene therapy will cost $2.2 million each for every dose.
bluebird currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.