bluebird bio Reports Second Quarter 2024 Results and Highlights Operational Progress and 2024 Guidance
bluebird bio (NASDAQ: BLUE) reported Q2 2024 results, highlighting 27 patient starts across its gene therapy portfolio. The company anticipates approximately 85 patient starts for 2024, with LYFGENIA launches accelerating in H2. Q2 net revenue was $16.1 million, up from $6.9 million in Q2 2023. Cash runway extends into Q2 2025.
Commercial progress includes favorable coverage for LYFGENIA, with over half of Medicaid-insured sickle cell patients in states affirming coverage. The company has activated 70+ Qualified Treatment Centers for LYFGENIA and ZYNTEGLO. bluebird expects 20-25% gross-to-net discounts across products in 2024.
James Sterling joined as CFO, and Michael Cloonan was appointed to the Board of Directors. The company is working to complete financial restatements for 2022 and 2023.
bluebird bio (NASDAQ: BLUE) ha riportato i risultati del secondo trimestre 2024, evidenziando 27 nuovi pazienti nel suo portafoglio di terapie geniche. L'azienda prevede circa 85 nuove iniziative terapeutiche per il 2024, con i lanci di LYFGENIA che dovrebbero accelerare nel secondo semestre. Il fatturato netto del secondo trimestre è stato di 16,1 milioni di dollari, in aumento rispetto ai 6,9 milioni di dollari del secondo trimestre 2023. La liquidità è prevista fino a Q2 2025.
I progressi commerciali includono una copertura favorevole per LYFGENIA, con oltre la metà dei pazienti affetti da anemia falciforme assicurati da Medicaid in stati che confermano la copertura. L'azienda ha attivato oltre 70 Centri di Trattamento Qualificati per LYFGENIA e ZYNTEGLO. bluebird si attende sconti lordi-netti tra il 20% e il 25% sui prodotti nel 2024.
James Sterling è stato nominato CFO e Michael Cloonan è stato eletto nel Consiglio di Amministrazione. L'azienda sta lavorando per completare le rettifiche finanziarie per il 2022 e il 2023.
bluebird bio (NASDAQ: BLUE) presentó los resultados del segundo trimestre de 2024, destacando 27 nuevos pacientes en su portafolio de terapia génica. La compañía anticipa aproximadamente 85 inicios de pacientes para 2024, con los lanzamientos de LYFGENIA acelerando en la segunda mitad del año. Los ingresos netos del segundo trimestre fueron 16,1 millones de dólares, un aumento desde los 6,9 millones de dólares en el segundo trimestre de 2023. La liquidez se extiende hasta Q2 2025.
Los avances comerciales incluyen una cobertura favorable para LYFGENIA, con más de la mitad de los pacientes con anemia de células falciformes asegurados por Medicaid en estados que ratifican la cobertura. La compañía ha activado más de 70 Centros de Tratamiento Calificados para LYFGENIA y ZYNTEGLO. bluebird espera descuentos brutos-netos del 20% al 25% en sus productos en 2024.
James Sterling se unió como CFO y Michael Cloonan fue nombrado para la Junta Directiva. La compañía está trabajando para completar las reemisiones financieras de 2022 y 2023.
블루버드 바이오 (NASDAQ: BLUE)가 2024년 2분기 실적을 발표하며, 유전자 치료 포트폴리오 내에서 27명의 환자 시작을 강조했습니다. 회사는 2024년 약 85명의 환자 시작을 예상하며, LYFGENIA 출시가 하반기에 가속화될 것으로 보입니다. 2분기 순수익은 1,610만 달러로, 2023년 2분기의 690만 달러에서 증가했습니다. 현금 유동성은 2025년 2분기까지 연장됩니다.
상업적 진행 상황은 LYFGENIA에 대한 유리한 보장을 포함하며, 의료보험에 가입된 겸상적혈구 환자의 절반 이상이 보장을 확인한 주에 거주하고 있습니다. 회사는 LYFGENIA와 ZYNTEGLO를 위해 70개 이상의 자격 치료 센터를 활성화했습니다. 블루버드는 2024년 제품 전반에 걸쳐 20-25%의 총액에서 순액 할인을 예상하고 있습니다.
제임스 스털링이 CFO로 합류하였고, 마이클 클루넌이 이사회에 임명되었습니다. 이 회사는 2022년 및 2023년의 재무 재표를 완료하기 위해 노력하고 있습니다.
bluebird bio (NASDAQ: BLUE) a publié les résultats du deuxième trimestre 2024, mettant en avant 27 nouveaux patients dans son portefeuille de thérapies géniques. L'entreprise anticipe environ 85 nouveaux patients pour 2024, avec des lancements de LYFGENIA qui devraient s'accélérer au second semestre. Le chiffre d'affaires net du deuxième trimestre s'est élevé à 16,1 millions de dollars, contre 6,9 millions de dollars au deuxième trimestre 2023. La liquidité est prévue jusqu'à Q2 2025.
Les progrès commerciaux incluent une couverture favorable pour LYFGENIA, avec plus de la moitié des patients atteints de drépanocytose assurés par Medicaid dans les États qui confirment la couverture. L'entreprise a activé plus de 70 Centres de Traitement Qualifiés pour LYFGENIA et ZYNTEGLO. bluebird s'attend à des remises brutes-nettes de 20 à 25% sur ses produits en 2024.
James Sterling a rejoint l'entreprise en tant que CFO, et Michael Cloonan a été nommé au Conseil d'Administration. L'entreprise travaille à finaliser les réévaluations financières pour 2022 et 2023.
bluebird bio (NASDAQ: BLUE) hat die Ergebnisse des zweiten Quartals 2024 veröffentlicht und dabei 27 neue Patientenstarts in seinem Gentherapie-Portfolio hervorgehoben. Das Unternehmen erwartet ungefähr 85 Patientenstarts für 2024, wobei die Markteinführungen von LYFGENIA in der zweiten Jahreshälfte beschleunigen werden. Der Nettoumsatz im zweiten Quartal betrug 16,1 Millionen US-Dollar, ein Anstieg gegenüber 6,9 Millionen US-Dollar im zweiten Quartal 2023. Die finanzielle Stabilität wird bis Q2 2025 gewährleistet.
Zu den kommerziellen Fortschritten gehört eine günstige Abdeckung für LYFGENIA, wobei mehr als die Hälfte der Medicaid-versicherten Patienten mit Sichelzellenanämie in den Bundesstaaten die Abdeckung bestätigen. Das Unternehmen hat über 70 qualifizierte Behandlungszentren für LYFGENIA und ZYNTEGLO aktiviert. bluebird erwartet Rabatte von 20-25% vom Bruttobetrag zum Nettobetrag für 2024.
James Sterling trat als CFO bei, und Michael Cloonan wurde in den Vorstand berufen. Das Unternehmen arbeitet daran, die finanziellen Neufeststellungen für 2022 und 2023 abzuschließen.
- 27 patient starts completed across portfolio in 2024, with 40+ additional patients scheduled
- Q2 2024 net revenue increased to $16.1 million from $6.9 million in Q2 2023
- Over 50% of Medicaid-insured sickle cell patients in states affirming LYFGENIA coverage
- 70+ Qualified Treatment Centers activated for LYFGENIA and ZYNTEGLO
- Anticipating approximately 85 patient starts across portfolio in 2024
- Cash runway only extends into Q2 2025
- Delayed filing of 2023 Form 10-K and Q1/Q2 2024 Form 10-Q due to financial restatements
- Gross-to-net discounts expected to be 20-25% of gross revenue in 2024
Insights
bluebird bio's Q2 2024 results show promising commercial progress, but financial challenges persist. Net revenue of
The projected 85 patient starts across the portfolio in 2024 is encouraging, but the company needs to accelerate revenue growth to achieve sustainability. The gross-to-net discount range of
Investors should monitor the company's ability to meet patient start targets and manage cash burn rate in the coming quarters.
bluebird bio's gene therapy portfolio is gaining traction, with 27 patient starts to date in 2024 across ZYNTEGLO, LYFGENIA and SKYSONA. The successful completion of manufacturing and release testing for the first commercial LYFGENIA patient is a significant milestone, potentially opening up a new revenue stream.
The company's progress in establishing a substantial Qualified Treatment Center (QTC) footprint, with over 70 activated centers for LYFGENIA and ZYNTEGLO, is important for scaling up patient access. The favorable coverage landscape, including positive Medicaid decisions and commercial payer agreements, should facilitate patient adoption.
However, the long-term efficacy and safety data for these gene therapies will be critical in determining their sustained success and market penetration. Investors should closely monitor real-world outcomes and any potential adverse events reported.
bluebird bio's market position in the gene therapy space is strengthening, with a focus on rare genetic disorders. The company's strategy of targeting multiple indications (sickle cell disease, beta-thalassemia and cerebral adrenoleukodystrophy) diversifies its market opportunities and risk.
The rapid acceleration projected for ZYNTEGLO following additional manufacturing capacity approval could be a significant growth driver. The company's success in securing favorable coverage and reimbursement, particularly with Medicaid and commercial payers, is important for market penetration.
However, competition in the gene therapy space is intensifying and bluebird bio must maintain its first-mover advantage. The appointment of experienced executives like James Sterling and Michael Cloonan could bring valuable industry insights and operational expertise to navigate this competitive landscape.
Investors should watch for potential market expansion opportunities and the company's ability to maintain its technological edge in the rapidly evolving gene therapy field.
- 27 patient starts to date in 2024 (19 ZYNTEGLO, 4 LYFGENIA, 4 SKYSONA); anticipate approximately 85 patient starts across the portfolio as LYFGENIA patient starts accelerate in the second half of 2024 -
- Second quarter 2024 net revenue of
- Cash runway into Q2 2025 based on current operating plans and cash on hand -
- Management to host conference call today, August 14, 2024 at 8:00 am ET -
“We are seeing clear evidence that our commercial launch is accelerating, with over 20 cell collections completed in sickle cell disease and beta-thalassemia to date in 2024, and more than 40 additional patients already scheduled to initiate the treatment journey for a bluebird gene therapy by the end of this year,” said Andrew Obenshain, chief executive officer, bluebird bio. “We are further encouraged by the commitment to provide patient access across both commercial and government payers, most recently conveyed through multiple positive Medicaid decisions and the growing number of published coverage policies for LYFGENIA, and we expect approximately 85 patient starts across our portfolio this year.”
COMMERCIAL LAUNCH UPDATES
LYFGENIA™ launch building (lovotibeglogene autotemcel); continued commercial momentum for ZYNTEGLO™ (betibeglogene autotemcel) and SKYSONA™ (elivaldogene autotemcel)
- 27 patient starts completed across portfolio to date in 2024 (19 ZYNTEGLO, 4 LYFGENIA, 4 SKYSONA).
- Launch momentum building with more than 40 additional patients scheduled for cell collection across commercial portfolio through year end.
- Successfully completed manufacturing and release testing for first commercial LYFGENIA patient and the first infusion is being scheduled.
- Rapid acceleration projected for ZYNTEGLO following the recent approval of additional manufacturing capacity.
Validated access and reimbursement strategy is driving favorable coverage landscape
-
Significant progress with formalized paths to market access. To date, more than half of Medicaid-insured individuals with sickle cell disease in the
U.S. live in a state that has affirmed coverage for LYFGENIA through a preferred drug list or published coverage criteria. -
Nearly
20% 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. - Timely access to ZYNTEGLO and SKYSONA has continued, with zero ultimate denials to date for either therapy across both Medicaid and commercial payers.
Substantial QTC footprint established
- bluebird has activated more than 70 total QTCs for LYFGENIA and ZYNTEGLO (defined as a signed MSA).
- Six centers are activated to administer SKYSONA for patients with cerebral adrenoleukodystrophy (CALD).
RECENT COMPANY UPDATES
James Sterling appointed as Chief Financial Officer
-
Effective June 10, 2024, James Sterling became Chief Financial Officer of bluebird bio. Mr. Sterling most recently served as chief financial officer of Renalytix plc, a diagnostics company focused on clinical management of kidney disease. Mr. Sterling was previously managing partner at Renwick Capital LLC, and managing director at investment banks Brock Capital Group LLC and Aleutian Capital Group. He also serves as a board director for a fund managed by Star Mountain Capital. Mr. Sterling has experience as a management consultant at Booz Allen Hamilton. He received his B.A. from
Boston University and an M.B.A. from Columbia Business School.
Michael Cloonan appointed to bluebird bio’s Board of Directors
- On June 20, 2024, Michael Cloonan was appointed to bluebird bio’s Board of Directors. Mr. Cloonan is currently President and Chief Executive Officer of Sionna Therapeutics. He was previously Chief Operating Officer at Sage Therapeutics leading all business and G&A functions. During his four years with Sage, he helped lead the growth of the organization through multiple capital raises, the launch of the company’s first product, and execution of a transformational, multi-billion-dollar collaboration. An experienced and respected global biotech leader, Mr. Cloonan has over 20 years of biopharma experience across global organizations in various business and commercial roles.
2024 GUIDANCE
- The Company anticipates approximately 85 patient starts (cell collections) combined across its portfolio of three FDA approved therapies (LYFGENIA, ZYNTEGLO, SKYSONA) in 2024. Consistent with previous quarters, bluebird plans to provide quarterly updates on patient starts by indication for each of its therapies.
-
The Company continues to anticipate gross-to-net discounts across all three products to be in the range of
20% to25% of gross revenue in 2024 and expects they will fluctuate based on product and payer mix, as well as utilization of outcomes-based agreements for LYFGENIA and ZYNTEGLO. - Based on projected timelines from cell collection to infusion, the Company anticipates recognizing revenue from its first infusion of LYFGENIA in the third or fourth quarter of 2024.
SECOND QUARTER FINANCIAL HIGHLIGHTS
-
Cash Position: The Company’s cash, cash equivalents and restricted cash balance was approximately
$193 million $49 million
Based on current operating assumptions, bluebird expects its cash and cash equivalents as of June 30, 2024 will be sufficient to fund its operations into the second quarter of 2025i, not accounting for the cash minimums required under the Company’s loan agreement with Hercules Capital, Inc. and excluding receipt of any future tranches under the agreement.
The Company has also renegotiated certain terms of its loan agreement with Hercules Capital, Inc. and is eligible to receive two future tranches totaling$50 million
-
Revenue, net: Total revenue, net was
$16.1 million $6.9 million $9.2 million
On March 26, 2024, bluebird announced that it will restate its consolidated financial statements as of and for the year ended December 31, 2022, and for each of the first three quarters of 2022 and 2023 in its Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Form 10-K"). The restatements relate to the identification of leases and the treatment of non-lease components contained in lease agreements. The restatement is not expected to impact the Company’s cash position or revenue. As a result of the restatement, the Company is delayed in filing its 2023 Form 10-K and its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2024 (the “Q1 2024 Form 10-Q") and June 30, 2024 (the “Q2 2024 Form 10-Q”). The Company is continuing to work expeditiously to complete these filings.
The financial results included in this press release represent the most current information available to the Company’s management. The Company expects that its actual results to be reported in its Q2 2024 Form 10-Q will not differ materially from the results included herein, however, these results are subject to change following the completion of the Company’s financial close procedures and the review of its consolidated financial statements for the quarter ended June 30, 2024.
CONFERENCE CALL DETAILS
bluebird will hold a conference call to discuss its second quarter 2024 results and business updates today, Wednesday, August 14, 2024, at 8:00 am ET.
To participate in the conference call, please dial +1 (800) 715-9871 (
The live webcast of the call may be accessed by visiting the “Events & Presentations” page within the Investors & Media section of the bluebird website at http://investor.bluebirdbio.com. A replay of the webcast will be available on the bluebird 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 the number of anticipated patient starts across bluebird’s portfolio of therapies; the Company’s anticipated cash runway; the Company’s expectations regarding its ability to maintain compliance with, and access future tranches under, its term loan facility; the Company’s expectations with respect to the commercialization of its products, including without limitation, the acceleration of patient starts, the timing of revenue recognition, anticipated gross-to-net discounts; and the Company’s ability to establish favorable coverage for its therapies; and expectations regarding the Company’s restatement of certain historical financial statements and the timing for filing of its 2023 Form 10-K, Q1 2024 Form 10-Q and Q2 2024 Form 10-Q. 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, 2022, 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, including our Prospectus Supplement, dated December 19, 2023. 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.
i Taking into account the minimum cash requirements under the Company’s loan agreement with Hercules Capital, Inc., bluebird expects its cash and cash equivalents will be sufficient to fund its operations into the first quarter of 2025.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240814882522/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.
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