bluebird bio Reports Third Quarter 2024 Results and Highlights Operational Progress and 2024 Guidance
bluebird bio (BLUE) reported Q3 2024 financial results with net revenue of $10.6 million, down from $12.3 million in Q3 2023. The company completed or scheduled 74 patient starts in 2024 across its portfolio, with 57 completed to date. Net loss improved to $60.8 million from $87.2 million year-over-year. Cash position stands at $118.7 million, including $48.0 million in restricted cash. The company expects to achieve quarterly cash flow break-even in H2 2025, contingent on scaling to approximately 40 drug product deliveries per quarter and securing additional funding. Management anticipates at least $25 million in net revenue for Q4 2024.
bluebird bio (BLUE) ha riportato i risultati finanziari del terzo trimestre 2024, con un fatturato netto di 10,6 milioni di dollari, in calo rispetto ai 12,3 milioni di dollari del terzo trimestre 2023. L'azienda ha completato o programmato 74 avvii di pazienti nel 2024 all'interno del suo portafoglio, di cui 57 già completati. La perdita netta è migliorata a 60,8 milioni di dollari, rispetto agli 87,2 milioni di dollari dell'anno precedente. La posizione di cassa ammonta a 118,7 milioni di dollari, di cui 48,0 milioni di dollari in contante vincolato. L'azienda prevede di raggiungere il pareggio di cassa trimestrale nella seconda metà del 2025, a condizione di aumentare le consegne di prodotti farmaceutici a circa 40 al trimestre e di garantire ulteriore finanziamento. La direzione prevede almeno 25 milioni di dollari di fatturato netto per il quarto trimestre 2024.
bluebird bio (BLUE) informó los resultados financieros del tercer trimestre de 2024, con ingresos netos de 10,6 millones de dólares, en comparación con los 12,3 millones de dólares del tercer trimestre de 2023. La compañía completó o programó 74 inicios de pacientes en 2024 en su cartera, de los cuales 57 se han completado hasta la fecha. La pérdida neta mejoró a 60,8 millones de dólares, frente a los 87,2 millones de dólares del año anterior. La posición de efectivo se sitúa en 118,7 millones de dólares, incluidos 48,0 millones de dólares en efectivo restringido. La compañía espera lograr el equilibrio del flujo de efectivo trimestral en la segunda mitad de 2025, condicionado a escalar aproximadamente 40 entregas de productos farmacéuticos por trimestre y asegurar financiación adicional. La dirección anticipa al menos 25 millones de dólares en ingresos netos para el cuarto trimestre de 2024.
블루버드 바이오 (BLUE)는 2024년 3분기 재무 결과를 보고하며, 순수익이 1,060만 달러로, 2023년 3분기 1,230만 달러에서 감소하였습니다. 회사는 2024년 포트폴리오 전반에서 74명의 환자 시작을 완료하거나 예정하였으며, 현재까지 57명이 완료되었습니다. 순손실은 지난해 8,720만 달러에서 6,080만 달러로 개선되었습니다. 현금 위치는 제한된 현금 4,800만 달러를 포함하여 1억 1,870만 달러입니다. 회사는 2025년 하반기에 분기 현금 흐름 손익 분기점을 달성할 것으로 예상하며, 연간 약 40개의 약품 제품 전달을 확대하고 추가 자금을 확보하는 조건입니다. 경영진은 2024년 4분기에 최소 2,500만 달러의 순수익을 예상하고 있습니다.
bluebird bio (BLUE) a annoncé les résultats financiers du troisième trimestre 2024, avec un chiffre d'affaires net de 10,6 millions de dollars, en baisse par rapport à 12,3 millions de dollars au troisième trimestre 2023. L'entreprise a réalisé ou prévu 74 démarrages de patients en 2024 dans son portefeuille, dont 57 ont été complétés à ce jour. La perte nette s'est améliorée à 60,8 millions de dollars, contre 87,2 millions de dollars d'une année sur l'autre. La position de trésorerie s'élève à 118,7 millions de dollars, dont 48,0 millions de dollars en espèces restreints. L'entreprise prévoit d'atteindre l'équilibre du flux de trésorerie trimestriel au second semestre 2025, sous réserve de passer à environ 40 livraisons de médicaments par trimestre et d'obtenir un financement supplémentaire. La direction s'attend à un chiffre d'affaires net d'au moins 25 millions de dollars pour le quatrième trimestre 2024.
bluebird bio (BLUE) meldete Finanzzahlen für das dritte Quartal 2024 mit einem Nettoumsatz von 10,6 Millionen Dollar, ein Rückgang von 12,3 Millionen Dollar im dritten Quartal 2023. Das Unternehmen hat 2024 insgesamt 74 Patientenstarts in seinem Portfolio abgeschlossen oder geplant, von denen 57 bereits abgeschlossen sind. Der Nettoverlust verbesserte sich auf 60,8 Millionen Dollar im Vergleich zu 87,2 Millionen Dollar im Jahresvergleich. Die Cash-Position beläuft sich auf 118,7 Millionen Dollar, einschließlich 48,0 Millionen Dollar in eingeschränkten Mitteln. Das Unternehmen erwartet, in der zweiten Hälfte des Jahres 2025 einen Break-even im quartalsweisen Cashflow zu erreichen, abhängig von der Skalierung auf etwa 40 Lieferungen von Arzneimitteln pro Quartal und der Sicherstellung zusätzlicher Finanzierung. Das Management geht davon aus, dass im vierten Quartal 2024 mindestens 25 Millionen Dollar Nettoumsatz erzielt werden.
- Patient starts more than doubled from Q2 to Q3 2024
- 30 patient starts already scheduled for 2025
- More than 70 activated QTCs, with 40% having initiated or completed treatment
- Net loss improved by $26.4 million year-over-year
- R&D expenses decreased by $35.3 million year-over-year
- Q3 2024 revenue declined to $10.6M from $12.3M year-over-year
- Cost of product revenue increased to $11.8M from $9.1M year-over-year
- Current cash runway only extends into Q1 2025
- Company requires additional financing to reach cash flow break-even
- Operating at a significant net loss of $60.8M in Q3 2024
Insights
The Q3 results reveal significant operational challenges despite growing patient adoption. Net revenue of
The company's path to sustainability faces immediate hurdles. Current cash is only sufficient until Q1 2025, making additional financing crucial. The projected break-even in H2 2025 depends on scaling to 40 drug product deliveries per quarter and securing new funding. Cost reduction efforts show progress with R&D expenses down
Commercial traction shows promise with expanding treatment center network and improved insurance coverage. 70+ activated QTCs and favorable Medicaid coverage in key states provide a solid foundation for growth. The 30 patient starts scheduled for 2025 indicate strong forward momentum.
However, quarter-to-quarter revenue volatility and high operating costs present near-term risks. The anticipated
- 74 patient starts completed or scheduled to date in 2024 across bluebird’s commercial portfolio -
- Third quarter 2024 net revenue of
- Management to host conference call today, November 14, 2024 at 8:00 am ET -
“Patient starts more than doubled from our second to third quarter update, providing clear evidence that our commercial launches continued to accelerate,” said Andrew Obenshain, chief executive officer. “This momentum, coupled with steps we took in the third quarter to increase manufacturing capacity for ZYNTEGLO and optimize our cost structure, is propelling bluebird forward on our path to becoming a sustainable commercial gene therapy company. We remain focused on securing additional cash resources to extend our runway, which we believe would enable us to achieve this vision and reach cash flow break-even in the second half of 2025.”
COMMERCIAL LAUNCH UPDATES
Continued commercial momentum across the portfolio
- 57 patient starts completed to date in 2024 (35 ZYNTEGLO, 17 LYFGENIA, 5 SKYSONA).
- 17 additional starts scheduled through the remainder of 2024.
- Evidence of strong commercial demand, with 30 patient starts already scheduled in 2025, supporting the potential for cash flow breakeven in the second half of 2025.
-
More than 70 activated QTCs, with
40% having initiated or completed treatment for at least one patient.
Validated access and reimbursement strategy is driving favorable coverage landscape
- To date, more than half of all states have affirmed coverage for LYFGENIA through a preferred drug list or published coverage criteria.
-
Nearly
50% of Medicaid-insured individuals with sickle cell disease in theU.S. live in a state that has already completed prior authorization approval for the use of LYFGENIA for at least one patient. -
Multiple outcomes-based agreements are published and in place for LYFGENIA with national commercial payer organizations, representing more than 200 million
U.S. lives.
DATA PRESENTATIONS AT ASH 2024
Updated data from the Company’s lentiviral vector (LVV) gene addition programs in patients with sickle cell disease who have a history of vaso-occlusive events and patients with beta-thalassemia who require regular blood transfusions will be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting will take place December 7-10, 2024 at the
SICKLE CELL DISEASE DATA
- Oral Presentation [#511]: An Update on Lovotibeglogene Autotemcel (lovo-cel) Clinical Trials for Sickle Cell Disease (SCD) and Analysis of Early Predictors of Response to Lovo-cel
- Presenting Author: Dr. Stacey Rifkin-Zenenberg (Hackensack)
- Date/Time: Sunday, December 8, 2024, 9:30 a.m. – 11:00 a.m. PT
- Poster Presentation [#3576]: Participants with a History of Stroke in Lovotibeglogene Autotemcel (lovo-cel) Clinical Trials
-
Presenting Author: Dr. Jen Jaroscak (The Medical University of
South Carolina ) - Date/Time: Sunday, December 8, 2024, 6:00 p.m. – 8:00 p.m. PT
BETA-THALASSEMIA DATA
- Poster Presentation [#2194]: Betibeglogene Autotemcel (beti-cel) Gene Addition Therapy results in durable Hemoglobin A (HbA) Production with up to 10 Years of Follow-Up in Participants with Transfusion-Dependent β-Thalassemia
-
Presenting Author: Dr. Alexis A Thompson (Children’s Hospital of
Philadelphia ) - Date/Time: Saturday, December 7, 2024, 5:30 p.m. – 7:30 p.m. PT
Abstracts outlining bluebird bio’s accepted data at ASH 2024 are available on the ASH conference website.
THIRD QUARTER FINANCIAL HIGHLIGHTS
-
Cash Position: The Company’s cash, cash equivalents and restricted cash balance was approximately
$118.7 million $48.0 million
bluebird and Hercules are engaging collaboratively as bluebird works to secure adequate cash runway to obtain additional financing and reach cash flow break-even. Based on current forecasts, which assume continued cost-saving initiatives, successfully renegotiating key contracts, and continued collaborative engagement from Hercules, we expect our existing cash and cash equivalents will enable us to fund our operations into the first quarter of 2025.
The Company anticipates quarterly cash flow break-even in the second half of 2025, assuming it scales to approximately 40 drug product deliveries per quarter and obtains additional cash resources to extend its runway.
-
Revenue, net: Total revenue, net was
$10.6 million $12.3 million
Revenue for the third quarter includes revenue from LYFGENIA, following the completion of the first infusion for sickle cell disease.
bluebird previously guided to an anticipated reduction of net revenue in the third quarter; the Company now anticipates net revenue of at least$25 million
-
Cost of Product Revenue: Cost of product revenue was
$11.8 million $9.1 million
-
SG&A Expenses: Selling, general and administrative expenses were
$39.8 million $40.8 million $1.0 million
-
R&D Expenses: Research and development expenses were
$23.2 million $58.5 million $35.3 million
-
Net income (loss): Net loss was
$60.8 million $87.2 million
CONFERENCE CALL DETAILS
bluebird will hold a conference call to discuss its third quarter 2024 results and business updates today, Wednesday, November 14, 2024, at 8:00 am ET.
To access the live conference call via telephone, please register at this link to receive a dial in number and unique PIN.
To access the live webcast, please visit the “Events & Presentations” page within the Investors & Media section of the bluebird bio website at http://investor.bluebirdbio.com. A replay of the webcast will be available on the bluebird bio website for 90 days following the event.
About bluebird bio, Inc.
bluebird bio is pursuing curative gene therapies to give patients and their families more bluebird days.
Founded in 2010, bluebird has been setting the standard for gene therapy for more than a decade—first as a scientific pioneer and now as a commercial leader. bluebird has an unrivaled track record in bringing the promise of gene therapy out of clinical studies and into the real-world setting, having secured FDA approvals for three therapies in under two years. Today, we are proving and scaling the commercial model for gene therapy and delivering innovative solutions for access to patients, providers, and payers.
With a dedicated focus on severe genetic diseases, bluebird has the largest and deepest ex-vivo gene therapy data set in the field, with industry-leading programs for sickle cell disease, β-thalassemia and cerebral adrenoleukodystrophy. We custom design each of our therapies to address the underlying cause of disease and have developed in-depth and effective analytical methods to understand the safety of our lentiviral vector technologies and drive the field of gene therapy forward.
bluebird continues to forge new paths as a standalone commercial gene therapy company, combining our real-world experience with a deep commitment to patient communities and a people-centric culture that attracts and grows a diverse flock of dedicated birds.
bluebird bio, LYFGENIA, ZYNTEGLO and SKYSONA are registered trademarks of bluebird bio, Inc. All rights reserved.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements, such as statements regarding future results of operations and financial position, including anticipated revenue for the fourth quarter; the number of anticipated patient starts across bluebird’s portfolio of therapies; the Company’s anticipated cash runway and path to cash flow breakeven in the second half of 2025, including the impact of continued cost-saving initiatives, bluebird’s ability to successfully renegotiate key contracts, and continued collaborative engagement from Hercules, and the Company’s ability to obtain additional cash resources; the Company’s expectations with respect to the commercialization of its products, including without limitation, patient demand, the timing and amount of revenue recognition; and the Company’s ability to establish favorable coverage for its therapies. Such forward-looking statements are based on historical performance and current expectations and projections about bluebird’s future goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond bluebird’s control and could cause bluebird’s future goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect bluebird bio’s business, particularly those identified in the risk factors discussion in bluebird bio’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by its subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. These risks and uncertainties include, but are not limited to: delays and challenges in bluebird’s commercialization and manufacturing of its products, including challenges in manufacturing vector for ZYNTEGLO and SKYSONA to meet current demand; the internal and external costs required for bluebird’s ongoing and planned activities, and the resulting impact on expense and use of cash, has been, and may in the future be, higher than expected, which has caused bluebird, and may in the future cause bluebird, to use cash more quickly than it expects or change or curtail some of its plans or both; substantial doubt exists regarding bluebird’s ability to continue as a going concern; bluebird’s expectations as to expenses, cash usage and cash needs may prove not to be correct for other reasons such as changes in plans or actual events being different than bluebird’s assumptions; the risk that additional funding may not be available on acceptable terms, or at all; risks related to bluebird's loan agreement, including the risk that operating restrictions could adversely affect bluebird's ability to conduct its business, the risk that bluebird will not achieve milestones required to access future tranches under the agreement, and the risk that bluebird will fail to comply with covenants under the agreement, including with respect to required cash and revenue levels, which could result in an event of default; the risk that the efficacy and safety results from bluebird’s prior and ongoing clinical trials will not continue or be seen in the commercial context; the risk that the QTCs experience delays in their ability to enroll or treat patients; the risk that bluebird experiences delays in establishing operational readiness across its supply chain ; the risk that there is not sufficient patient demand or payer reimbursement to support continued commercialization of the Company’s therapies; the risk of insertional oncogenic or other safety events associated with lentiviral vector, drug product, or myeloablation, including the risk of hematologic malignancy; the risk that bluebird’s products, including LYFGENIA, will not be successfully commercialized; and risks related to compliance with Nasdaq continued listing requirements. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, bluebird bio undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
bluebird bio, Inc. Condensed Consolidated Statements of Operations (in thousands, except per share data) (unaudited) |
|||||||||||||||
|
For the three months ended September 30, |
|
For the nine months ended September 30, |
||||||||||||
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
(As Restated) |
|
|
|
(As Restated) |
||||||||
Revenue: |
|
|
|
|
|
|
|
||||||||
Product revenue, net |
$ |
10,612 |
|
|
$ |
12,281 |
|
|
$ |
45,274 |
|
|
$ |
21,414 |
|
Other revenue |
|
— |
|
|
|
111 |
|
|
|
12 |
|
|
|
249 |
|
Total revenues |
|
10,612 |
|
|
|
12,392 |
|
|
|
45,286 |
|
|
|
21,663 |
|
Cost of product revenue |
|
11,781 |
|
|
|
9,126 |
|
|
|
66,591 |
|
|
|
21,335 |
|
Gross margin |
|
(1,169 |
) |
|
|
3,266 |
|
|
|
(21,305 |
) |
|
|
328 |
|
Operating expenses: |
|
|
|
|
|
|
|
||||||||
Selling, general and administrative |
|
39,765 |
|
|
|
40,771 |
|
|
|
136,479 |
|
|
|
118,700 |
|
Research and development |
|
23,174 |
|
|
|
58,501 |
|
|
|
73,408 |
|
|
|
131,536 |
|
Restructuring expenses |
|
2,811 |
|
|
|
— |
|
|
|
2,811 |
|
|
|
— |
|
Total operating expenses |
|
65,750 |
|
|
|
99,272 |
|
|
|
212,698 |
|
|
|
250,236 |
|
Gain from sale of priority review voucher, net |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
92,930 |
|
Loss from operations |
|
(66,919 |
) |
|
|
(96,006 |
) |
|
|
(234,003 |
) |
|
|
(156,978 |
) |
Interest income |
|
1,640 |
|
|
|
2,454 |
|
|
|
7,056 |
|
|
|
7,961 |
|
Interest expense |
|
(5,778 |
) |
|
|
(4,311 |
) |
|
|
(16,875 |
) |
|
|
(12,331 |
) |
Other income, net |
|
10,191 |
|
|
|
10,631 |
|
|
|
31,782 |
|
|
|
30,177 |
|
Loss before income taxes |
|
(60,866 |
) |
|
|
(87,232 |
) |
|
|
(212,040 |
) |
|
|
(131,171 |
) |
Income tax (expense) benefit |
|
58 |
|
|
|
— |
|
|
|
37 |
|
|
|
80 |
|
Net loss |
$ |
(60,808 |
) |
|
$ |
(87,232 |
) |
|
$ |
(212,003 |
) |
|
$ |
(131,091 |
) |
Net loss per share - basic |
$ |
(0.31 |
) |
|
$ |
(0.80 |
) |
|
$ |
(1.10 |
) |
|
$ |
(1.23 |
) |
Net loss per share - diluted |
$ |
(0.31 |
) |
|
$ |
(0.80 |
) |
|
$ |
(1.10 |
) |
|
$ |
(1.23 |
) |
Weighted-average number of common shares used in computing net loss per share - basic: |
|
193,893 |
|
|
|
109,098 |
|
|
|
193,588 |
|
|
|
106,924 |
|
Weighted-average number of common shares used in computing net loss per share - diluted: |
|
193,893 |
|
|
|
109,098 |
|
|
|
193,588 |
|
|
|
106,924 |
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
||||||||
Other comprehensive income (loss), net of tax benefit (expense) of |
|
611 |
|
|
|
137 |
|
|
|
285 |
|
|
|
1,843 |
|
Total other comprehensive income (loss) |
|
611 |
|
|
|
137 |
|
|
|
285 |
|
|
|
1,843 |
|
Comprehensive loss |
$ |
(60,197 |
) |
|
$ |
(87,095 |
) |
|
$ |
(211,718 |
) |
|
$ |
(129,248 |
) |
|
|
|
|
|
|
|
|
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bluebird bio, Inc. Condensed Consolidated Balance Sheets (in thousands, except per share data) (unaudited) |
||||||
|
As of September 30, 2024 |
|
As of December 31, 2023 |
|||
Cash and cash equivalents |
$ |
70,651 |
|
|
$ |
221,755 |
Restricted cash |
|
48,001 |
|
|
|
52,842 |
Total assets |
|
465,056 |
|
|
|
619,161 |
Total liabilities |
|
470,842 |
|
|
|
424,624 |
Total stockholders’ equity |
|
(5,786 |
) |
|
|
194,537 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20241114895294/en/
Investors & Media
Investors:
Courtney O’Leary, 978-621-7347
coleary@bluebirdbio.com
Media:
Jess Rowlands, 857-299-6103
jess.rowlands@bluebirdbio.com
Source: bluebird bio, Inc.
FAQ
What was bluebird bio's (BLUE) revenue in Q3 2024?
How many patient starts did BLUE complete in 2024?
When does BLUE expect to reach cash flow break-even?
What is BLUE's current cash position as of Q3 2024?
