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2seventy bio Reports Second Quarter Financial Results and Recent Operational Progress

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2seventy bio reported its second-quarter financial results and operational progress. Key highlights include:

1. Abecma generated $54 million in U.S. commercial revenue, reflecting significant demand growth.
2. Successfully completed the sale of its Hemophilia A and gene-editing technology to Novo Nordisk for up to $40 million.

Financial Metrics:

  • Net income: $24.9 million, compared to a net loss of $42.1 million in Q2 2023.
  • Total revenues: $9.0 million, down from $36.0 million in Q2 2023.
  • Cash reserves: $202 million, with a cash runway extending beyond 2027.

The company reduced operating expenses by 43% quarter-on-quarter due to the sale of its oncology R&D business to Regeneron.

2seventy bio aims for quarterly profitability by late 2025 and anticipates further revenue growth for Abecma in the third quarter of 2024.

2seventy bio ha riportato i risultati finanziari del secondo trimestre e i progressi operativi. I punti salienti includono:

1. Abecma ha generato 54 milioni di dollari in entrate commerciali negli Stati Uniti, riflettendo una crescita significativa della domanda.
2. Completata con successo la vendita della sua tecnologia per l'emofilia A e l'editing genetico a Novo Nordisk per un massimo di 40 milioni di dollari.

Metriche Finanziarie:

  • Utile netto: 24,9 milioni di dollari, rispetto a una perdita netta di 42,1 milioni di dollari nel Q2 2023.
  • Ricavi totali: 9,0 milioni di dollari, in calo rispetto ai 36,0 milioni di dollari del Q2 2023.
  • Riserve di cassa: 202 milioni di dollari, con una disponibilità di cassa che si estende oltre il 2027.

L'azienda ha ridotto le spese operative del 43% rispetto al trimestre precedente grazie alla vendita della sua divisione di R&S oncologiche a Regeneron.

2seventy bio punta a una redditività trimestrale entro la fine del 2025 e prevede una ulteriore crescita dei ricavi per Abecma nel terzo trimestre del 2024.

2seventy bio reportó sus resultados financieros del segundo trimestre y el progreso operativo. Los aspectos más destacados incluyen:

1. Abecma generó 54 millones de dólares en ingresos comerciales en EE. UU., reflejando un crecimiento significativo en la demanda.
2. Se completó con éxito la venta de su tecnología para la hemofilia A y la edición genética a Novo Nordisk por hasta 40 millones de dólares.

Métricas Financieras:

  • Ingresos netos: 24,9 millones de dólares, en comparación con una pérdida neta de 42,1 millones de dólares en el Q2 2023.
  • Ingresos totales: 9,0 millones de dólares, por debajo de los 36,0 millones de dólares en el Q2 2023.
  • Reservas de efectivo: 202 millones de dólares, con una disponibilidad de efectivo que se extiende más allá de 2027.

La empresa redujo los gastos operativos en un 43% trimestre a trimestre debido a la venta de su negocio de I+D en oncología a Regeneron.

2seventy bio tiene como objetivo una rentabilidad trimestral para finales de 2025 y anticipa un crecimiento adicional en los ingresos de Abecma en el tercer trimestre de 2024.

2seventy bio는 2분기 재무 결과와 운영 진행 상황을 보고했습니다. 주요 하이라이트는 다음과 같습니다:

1. Abecma는 미국에서 5,400만 달러의 상업 수익을 기록하여 수요가 크게 증가했습니다.
2. Novo Nordisk에 혈우병 A 및 유전자 편집 기술을 최대 4천만 달러에 성공적으로 판매했습니다.

재무 지표:

  • 순이익: 2,490만 달러로, 2023년 2분기에는 4,210만 달러의 순손실이었습니다.
  • 총 수익: 900만 달러로, 2023년 2분기 3,600만 달러에서 감소했습니다.
  • 현금 보유: 2억 2백만 달러로, 현금 런웨이는 2027년 이후까지 연장됩니다.

회사는 Regeneron에 온콜로지 연구개발 사업 부문을 판매함으로써 분기 대비 운영 비용을 43% 줄였습니다.

2seventy bio는 2025년 말까지 분기 수익성을 목표로 하고 있으며, 2024년 3분기 Abecma의 추가 수익 성장을 예상합니다.

2seventy bio a publié ses résultats financiers et ses avancées opérationnelles pour le deuxième trimestre. Les points clés incluent :

1. Abecma a généré 54 millions de dollars de revenus commerciaux aux États-Unis, reflétant une croissance significative de la demande.
2. Vente réussie de sa technologie pour l'hémophilie A et l'édition génomique à Novo Nordisk pour un montant pouvant atteindre 40 millions de dollars.

Métriques Financières :

  • Revenu net : 24,9 millions de dollars, contre une perte nette de 42,1 millions de dollars au Q2 2023.
  • Revenus totaux : 9,0 millions de dollars, en baisse par rapport à 36,0 millions de dollars au Q2 2023.
  • Réserves de liquidités : 202 millions de dollars, avec une trésorerie s'étendant au-delà de 2027.

L'entreprise a réduit ses dépenses opérationnelles de 43 % d'un trimestre à l'autre grâce à la vente de son activité de recherche et développement en oncologie à Regeneron.

2seventy bio vise à atteindre la rentabilité trimestrielle d'ici fin 2025 et anticipe une nouvelle croissance des revenus pour Abecma au troisième trimestre de 2024.

2seventy bio hat seine finanziellen Ergebnisse und betrieblichen Fortschritte für das zweite Quartal bekannt gegeben. Die wichtigsten Highlights umfassen:

1. Abecma erzielte 54 Millionen Dollar an kommerziellen Einnahmen in den USA, was auf ein erhebliches Nachfragewachstum hinweist.
2. Erfolgreicher Abschluss des Verkaufs seiner Technologie zur Behandlung von Hämophilie A und zur Genbearbeitung an Novo Nordisk für bis zu 40 Millionen Dollar.

Finanzkennzahlen:

  • Nettoeinkommen: 24,9 Millionen Dollar, im Vergleich zu einem Nettoverlust von 42,1 Millionen Dollar im Q2 2023.
  • Gesamtumsatz: 9,0 Millionen Dollar, im Vergleich zu 36,0 Millionen Dollar im Q2 2023.
  • Bargeldreserven: 202 Millionen Dollar, mit einer finanziellen Laufzeit, die über 2027 hinausgeht.

Das Unternehmen hat die Betriebsausgaben im Quartalsvergleich um 43 % gesenkt, da es seine Onkologie-Forschungs- und Entwicklungsabteilung an Regeneron verkauft hat.

2seventy bio strebt bis Ende 2025 eine vierteljährliche Rentabilität an und erwartet für das dritte Quartal 2024 ein weiteres Umsatzwachstum für Abecma.

Positive
  • Abecma generated $54 million in U.S. commercial revenue.
  • Completion of Hemophilia A and gene-editing technology sale to Novo Nordisk for $40 million.
  • Net income of $24.9 million, a significant turnaround from a net loss of $42.1 million in Q2 2023.
  • 43% reduction in operating expenses.
  • Cash reserves of $202 million with a runway beyond 2027.
Negative
  • Total Q2 revenues dropped to $9.0 million from $36.0 million in Q2 2023.
  • Net loss of $27.8 million for the first six months of 2024, compared to $89.1 million in the same period in 2023.

Insights

2seventy bio's Q2 results show a significant transformation in their business model and financial position. The company reported $54 million in U.S. commercial revenue for Abecma, indicating modest growth. However, the most impactful changes come from their strategic decisions:

  • Sale of oncology R&D business to Regeneron, resulting in a 43% quarter-on-quarter reduction in operating expenses
  • Sale of Hemophilia A program and gene editing technology to Novo Nordisk for up to $40 million
  • Streamlined cost structure, with net cash spend range lowered to $40-60 million for 2024

These moves have strengthened their balance sheet, with $201.9 million in cash and equivalents as of June 30, extending their cash runway beyond 2027. The company's focus on Abecma and cost reduction puts them on track for potential quarterly profitability by end of 2025.

The Abecma market dynamics present a mixed picture. While Q2 revenue was modest at $54 million, there's a promising uptick in demand, measured by new patients undergoing apheresis. This suggests potential revenue growth in Q3. Key factors to watch:

  • Execution of third-line launch in H2 2024
  • Competitive differentiation based on Abecma's safety and efficacy profile
  • Impact of KarMMa-3 and real-world data on market perception

The collaboration with Bristol Myers Squibb, sharing profits and losses equally, adds stability but also complexity to revenue forecasting. The recent regulatory approval for earlier line treatment could expand Abecma's market potential, potentially driving future growth. However, investors should monitor the competitive landscape closely, as the CAR-T therapy market for multiple myeloma is becoming increasingly crowded.

The clinical implications of 2seventy bio's Q2 results are noteworthy. Abecma's approval for earlier line treatment in multiple myeloma is a significant advancement. This expansion could potentially benefit more patients and improve outcomes. Key clinical considerations include:

  • Safety profile: Monitoring of cytokine release syndrome (CRS) and neurologic toxicities remains crucial
  • Efficacy data: Real-world evidence will be vital to support the KarMMa-3 trial results
  • Patient selection: Identifying suitable candidates for CAR-T therapy in earlier treatment lines

The company's focus on Abecma allows for concentrated efforts in optimizing its use and potentially expanding indications. However, the reported cases of secondary malignancies, particularly myeloid neoplasms, warrant careful long-term follow-up and risk assessment. This aspect could influence treatment decisions and regulatory considerations moving forward.

Following regulatory approval in the earlier line setting this quarter, Abecma generated $54 million U.S. commercial revenue and saw meaningful growth in demand

Recent completion of Hemophilia A and gene editing technology sale to Novo Nordisk for up to $40 million reinforces exclusive focus on Abecma with streamlined cost structure

Approximately $28 million (43%) quarter-on-quarter reduction in operating expenses due to completion of sale of R&D business to Regeneron on April 1, 2024

Ended quarter with approximately $202 million cash, cash equivalents, and marketable securities; cash runway beyond 2027

Conference call today at 8:00 AM ET

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- 2seventy bio, Inc. (Nasdaq: TSVT), today reported financial results and recent highlights for the second quarter ended June 30, 2024.

“This year has been transformative for 2seventy, and we enter the second half in a strong financial and operational position, poised for commercial growth,” said Chip Baird, CEO. “We dramatically reduced our cost structure and strengthened our balance sheet with the completion of the sale of our oncology R&D business to Regeneron and the sale of our Hemophilia A program and gene editing technology to Novo Nordisk. These changes move us closer to achieving quarterly profitability by the end of 2025. We were pleased to see that Abecma turned a corner in the second quarter, recording modest growth in revenue in the U.S. Importantly, we saw a meaningful increase in patients undergoing apheresis, which we expect to translate to additional revenue growth in the third quarter. We look forward to the continued execution of our third line launch in the second half of 2024 and a continued return to growth for Abecma.”

ABECMA COMMERCIAL AND REGULATORY HIGHLIGHTS

  • Second quarter Abecma® (idecabtagene vicleucel; ide-cel) U.S. revenues, as reported by Bristol Myers Squibb (BMS), were $54 million. Demand, as measured by new patients undergoing apheresis in the quarter, saw meaningful growth.
  • In order to restore growth for Abecma, 2seventy bio and BMS are focused on competitively differentiating Abecma’s safety and efficacy profile supported by the strength of the KarMMa-3 and real-world data, and anticipates continued growth in the second half of 2024.
  • 2seventy bio and BMS share equally in all profits and losses related to development, manufacturing, and commercialization of Abecma in the U.S. The Company reported collaborative arrangement revenue of $4.4 million related to the collaboration with BMS for the three months ended June 30, 2024.

SELECT SECOND QUARTER FINANCIAL RESULTS

  • Total revenues were $9.0 million for the three months ended June 30, 2024, compared to $36.0 million for the three months ended June 30, 2023. Total revenues were $21.4 million for the six months ended June 30, 2024, compared to $77.7 million for the six months ended June 30, 2023.
  • Research and development expenses were $16.0 million for the three months ended June 30, 2024, compared to $60.0 million for the three months ended June 30, 2023. Research and development expenses were $59.9 million for the six months ended June 30, 2024, compared to $128.2 million for the six months ended June 30, 2023.
  • Selling, general and administrative expenses were $9.9 million for the three months ended June 30, 2024, compared to $19.5 million for the three months ended June 30, 2023. Selling, general and administrative expenses were $22.5 million for the six months ended June 30, 2024, compared to $40.2 million for the six months ended June 30, 2023.
  • Restructuring expenses were $7.4 million for the three months ended June 30, 2024, and $11.6 million for the six months ended June 30, 2024. There were no restructuring expenses in the comparable three- and six-month periods in 2023.
  • The Company recognized a $48.0 million one-time gain on sale to Novo Nordisk for the three months ended June 30, 2024. Additionally, the Company recognized a $5.0 million one-time loss on assets held for sale to Regeneron for the six months ended June 30, 2024.
  • Net income was $24.9 million for the three months ended June 30, 2024, compared to net loss of $42.1 million for the three months ended June 30, 2023. Net loss was $27.8 million for the six months ended June 30, 2024, compared to net loss of $89.1 million for the six months ended June 30, 2023.
  • The Company has lowered its net cash spend range to $40-60 million for 2024.
  • Cash, cash equivalents, and marketable securities totaled $201.9 million as of June 30, 2024; the Company continues to expect to have cash runway beyond 2027.

Conference Call Information
2seventy bio will host a conference call and live webcast today, August 7 at 8:00 a.m. ET to discuss second quarter 2024 financial results and recent business highlights. Participants can access the conference call live via webcast which is available on the Investors and Media page of the company’s website at https://ir.2seventybio.com. Participants who wish to ask a question may register here to receive dial-in numbers and a unique pin to join the call.

A replay of the webcast may be accessed from the “News and Events” page in the Investors and Media section of our website at https://ir.2seventybio.com/ and will be available for 30 days following the event.

ABECMA U.S. INDICATION
ABECMA is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

U.S. Important Safety Information

BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED CYTOPENIA and SECONDARY HEMATOLOGICAL MALIGNANCIES

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
  • Neurologic Toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed.
  • Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities.
  • Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA.
  • T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA
  • ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS.

Warnings and Precautions:

Early Death: In KarMMa-3, a randomized (2:1), controlled trial, a higher proportion of patients experienced death within 9 months after randomization in the ABECMA arm (45/254; 18%) compared to the standard regimens arm (15/132; 11%). Early deaths occurred in 8% (20/254) and 0% prior to ABECMA infusion and standard regimen administration, respectively, and 10% (25/254) and 11% (15/132) after ABECMA infusion and standard regimen administration, respectively. Out of the 20 deaths that occurred prior to ABECMA infusion, 15 occurred from disease progression, 3 occurred from adverse events and 2 occurred from unknown causes. Out of the 25 deaths that occurred after ABECMA infusion, 10 occurred from disease progression, 11 occurred from adverse events, and 4 occurred from unknown causes.

Cytokine Release Syndrome (CRS): CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA. Among patients receiving ABECMA for relapsed refractory multiple myeloma in the KarMMa and KarMMa-3 studies (N=349), CRS occurred in 89% (310/349), including ≥ Grade 3 CRS (Lee grading system) in 7% (23/349) of patients and Grade 5 CRS in 0.9% (3/349) of patients. The median time-to-onset of CRS, any grade, was 1 day (range: 1 to 27 days), and the median duration of CRS was 5 days (range: 1 to 63 days). In the pooled studies, the rate of ≥Grade 3 CRS was 10% (7/71) for patients treated in dose range of 460 to 510 x 106 CAR-positive T cells and 5.4% (13/241) for patients treated in dose range of 300 to 460 x 106 CAR-positive T cells.

The most common manifestations of CRS (greater than or equal to 10%) included pyrexia (87%), hypotension (30%), tachycardia (26%), chills (19%), hypoxia (16%). Grade 3 or higher events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, ARDS, atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, coagulopathy, renal failure, multiple organ dysfunction syndrome and HLH/MAS.

Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.

Of the 349 patients who received ABECMA in clinical trials, 226 (65%) patients received tocilizumab; 39% (135/349) received a single dose, while 26% (91/349) received more than 1 dose of tocilizumab. Overall, 24% (82/349) of patients received at least 1 dose of corticosteroids for treatment of CRS. Almost all patients who received corticosteroids for CRS also received tocilizumab. For patients treated in dose range of 460 to 510 x 106 CAR-positive T cells, 76% (54/71) of patients received tocilizumab and 35% (25/71) received at least 1 dose of corticosteroids for treatment of CRS. For patients treated in dose range of 300 to 460 x 106 CAR-positive T cells, 63% (152/241) of patients received tocilizumab and 20% (49/241) received at least 1 dose of corticosteroid for treatment of CRS.

Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or symptoms of CRS and monitor patients for signs or symptoms of CRS for at least 4 weeks after ABECMA infusion. At the first sign of CRS, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated. Ensure that a minimum of 2 doses of tocilizumab are available prior to infusion of ABECMA. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.

Neurologic Toxicities: Neurologic toxicities, including immune-effector cell-associated neurotoxicity (ICANS), which may be severe or life- threatening, occurred concurrently with CRS, after CRS resolution, or in the absence of CRS following treatment with ABECMA.

In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, CAR T cell-associated neurotoxicity occurred in 40% (139/349), including Grade 3 in 4% (14/349) and Grade 4 in 0.6% (2/349) of patients. The median time to onset of neurotoxicity was 2 days (range: 1 to 148 days). The median duration of CAR T cell-associated neurotoxicity was 8 days (range: 1 to 720 days) in all patients including those with ongoing neurologic events at the time of death or data cut off. CAR T cell-associated neurotoxicity resolved in 123 of 139 (88%) patients and median time to resolution was 5 days (range: 1 to 245 days). One-hundred and thirty four out of 349 (38%) patients with neurotoxicity had CRS. The onset of neurotoxicity during CRS was observed in 93 patients, before the onset of CRS in 12 patients, and after the CRS event in 29 patients. The rate of Grade 3 or 4 CAR T cell-associated neurotoxicity was 5.6% (4/71) and 3.7% (9/241) for patients treated in dose range of 460 to 510 x 106 CAR-positive T cells and 300 to 460 x 106 CAR-positive T cells, respectively. The most frequent (greater than or equal to 5%) manifestations of CAR T cell-associated neurotoxicity include encephalopathy (21%), headache (15%), dizziness (8%), delirium (6%), and tremor (6%).

At the safety update for KarMMa-3 study, one patient developed fatal neurotoxicity 43 days after ABECMA. In KarMMa, one patient had ongoing Grade 2 neurotoxicity at the time of death. Two patients had ongoing Grade 1 tremor at the time of data cutoff.

Cerebral edema has been associated with ABECMA in a patient in another study in multiple myeloma. Grade 3 myelitis and Grade 3 parkinsonism have occurred after treatment with ABECMA in another study in multiple myeloma.

Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or symptoms of neurologic toxicities and monitor patients for signs or symptoms of neurologic toxicities for at least 4 weeks after ABECMA infusion and treat promptly. Rule out other causes of neurologic symptoms. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. Counsel patients to seek immediate medical attention should signs or symptoms occur at any time.

Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, HLH/MAS occurred in 2.9% (10/349) of patients. All events of HLH/MAS had onset within 10 days of receiving ABECMA, with a median onset of 6.5 days (range: 4 to 10 days) and occurred in the setting of ongoing or worsening CRS. Five patients with HLH/MAS had overlapping neurotoxicity. The manifestations of HLH/MAS include hypotension, hypoxia, multiple organ dysfunction, renal dysfunction and cytopenia.

In KarMMa-3, one patient had Grade 5, two patients had Grade 4 and two patients had Grade 3 HLH/MAS. The patient with Grade 5 HLH/MAS also had Grade 5 candida sepsis and Grade 5 CRS. In another patient who died due to stroke, the Grade 4 HLH/MAS had resolved prior to death. Two cases of Grade 3 and one case of Grade 4 HLH/MAS had resolved.

In KarMMa, one patient treated in the 300 x 106 CAR-positive T cells dose cohort developed fatal multi-organ HLH/MAS with CRS. In another patient with fatal bronchopulmonary aspergillosis, HLH/MAS was contributory to the fatal outcome. Three cases of Grade 2 HLH/MAS resolved.

HLH/MAS is a potentially life-threatening condition with a high mortality rate if not recognized early and treated. Treatment of HLH/MAS should be administered per institutional guidelines.

ABECMA REMS: Due to the risk of CRS and neurologic toxicities, ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS. Further information is available at www.AbecmaREMS.com or contact Bristol-Myers Squibb at 1-866-340-7332.

Hypersensitivity Reactions: Allergic reactions may occur with the infusion of ABECMA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) in ABECMA.

Infections: ABECMA should not be administered to patients with active infections or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after ABECMA infusion.

In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, infections (all grades) occurred in 61% of patients. Grade 3 or 4 infections occurred in 21% of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 7%, bacterial infections in 4.3%, and fungal infections in 1.4% of patients. Overall, 15 patients had Grade 5 infections (4.3%); 8 patients (2.3%) with infections of pathogen unspecified, 3 patients (0.9%) with fungal infections, 3 patients (0.9%) with viral infections, and 1 patient (0.3%) with bacterial infection.

Monitor patients for signs and symptoms of infection before and after ABECMA infusion and treat appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to standard institutional guidelines.

Febrile neutropenia was observed in 38% (133/349) of patients after ABECMA infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

Viral Reactivation: Cytomegalovirus (CMV) infection resulting in pneumonia and death has occurred following ABECMA administration. Monitor and treat for CMV reactivation in accordance with clinical guidelines. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against plasma cells. Perform screening for CMV, HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice.

Prolonged Cytopenias: In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, 40% of patients (139/349) experienced prolonged Grade 3 or 4 neutropenia and 42% (145/349) experienced prolonged Grade 3 or 4 thrombocytopenia that had not resolved by Month 1 following ABECMA infusion. In 89% (123/139) of patients who recovered from Grade 3 or 4 neutropenia after Month 1, the median time to recovery from ABECMA infusion was 1.9 months. In 76% (110/145) of patients who recovered from Grade 3 or 4 thrombocytopenia, the median time to recovery was 1.9 months. Five patients underwent stem cell therapy for hematopoietic reconstitution due to prolonged cytopenia. The rate of Grade 3 or 4 thrombocytopenia was 62% (44/71) and 56% (135/241) for patients treated in dose range of 460 to 510 x 106 CAR-positive T cells and 300 to 460 x 106 CAR-positive T cells, respectively.

Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support according to local institutional guidelines.

Hypogammaglobulinemia: In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, hypogammaglobulinemia was reported as an adverse event in 13% (46/349) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 37% (130/349) of patients treated with ABECMA.

Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in 45% (158/349) of patients treated with ABECMA. Forty-one percent of patients received intravenous immunoglobulin (IVIG) post-ABECMA for serum IgG <400 mg/dL.

Monitor immunoglobulin levels after treatment with ABECMA and administer IVIG for IgG <400 mg/dl. Manage appropriately per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.

Use of Live Vaccines: The safety of immunization with live viral vaccines during or after ABECMA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during ABECMA treatment, and until immune recovery following treatment with ABECMA.

Secondary Malignancies: Patients treated with ABECMA may develop secondary malignancies. In KarMMa-3, myeloid neoplasms (four cases of myelodysplastic syndrome and one case of acute myeloid leukemia) occurred in 2.2% (5/222) of patients following treatment with ABECMA compared to none in the standard regimens arm at the time of the safety update. The median time to onset of myeloid neoplasm from ide-cel infusion was 338 days (Range: 277 to 794 days). Three of these five patients have died following the development of myeloid neoplasm. One out of the five cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy.

T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes.

Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol-Myers Squibb at 1‑888‑805‑4555 for reporting and to obtain instructions on collection of patient samples for testing of secondary malignancy.

Effects on Ability to Drive and Operate Machinery: Due to the potential for neurologic events, including altered mental status or seizures, patients receiving ABECMA are at risk for altered or decreased consciousness or coordination in the 8 weeks following ABECMA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

Adverse Reactions: The most common nonlaboratory adverse reactions (incidence greater than or equal to 20%) include pyrexia, CRS, hypogammaglobulinemia, infections – pathogen unspecified, musculoskeletal pain, fatigue, febrile neutropenia, hypotension, tachycardia, diarrhea, nausea, headache, chills, upper respiratory tract infection, encephalopathy, edema, dyspnea and viral infections.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

About Bristol Myers Squibb and 2seventy bio
Abecma is being jointly developed and commercialized in the U.S. as part of a Co-Development, Co-Promotion, and Profit Share Agreement between Bristol Myers Squibb and 2seventy bio. Bristol Myers Squibb assumes sole responsibility for Abecma drug product manufacturing and commercialization outside of the U.S. The companies’ broad clinical development program for Abecma includes ongoing and planned clinical studies (KarMMa-2, KarMMa-3, KarMMa-9) in earlier lines of treatment for patients with multiple myeloma. For more information visit clinicaltrials.gov.

About 2seventy bio
Our name, 2seventy bio, reflects why we do what we do - TIME. Cancer rips time away, and our goal is to work at the maximum speed of translating human thought into action – 270 miles per hour – to give the people we serve more time. With a deep understanding of the human body’s immune response to tumor cells and how to translate cell therapies into practice, we’re applying this knowledge to deliver the first FDA-approved CAR T cell therapy for multiple myeloma to as many patients as possible. Importantly, we remain focused on accomplishing our mission by staying genuine and authentic to our “why” and keeping our people and culture top of mind every day. For more information, visit www.2seventybio.com.

Follow 2seventy bio on social media: X (Twitter) and LinkedIn.

2seventy bio is a trademark of 2seventy bio, Inc.

Cautionary Note Regarding Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of applicable laws and regulations. These statements include, but are not limited to: statements about our plans, strategies and expectations with respect to the commercial launch of ABECMA (ide-cel) in additional indications and in earlier line settings, including potential demand; statements regarding expected ABECMA U.S. revenue; statements regarding expected benefits from our strategic collaboration with BMS; statements about the efficacy and perceived therapeutic benefits of ABECMA; statements regarding the anticipated benefits of the sale of our oncology and autoimmune research and development programs, clinical manufacturing capabilities, and related platform technologies to Regeneron; statements regarding the anticipated benefits of the sale of our Hemophilia A program and gene editing technology to Novo; statements about our strategic realignment and expected cost savings; statements regarding our financial condition, expenses, results of operations, expectations regarding use of capital, cash runway, net cash spend and other future financial results; and statements about our ability to execute our strategic priorities. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, our limited independent operating history and the risk that our accounting and other management systems may not be prepared to meet the financial reporting and other requirements of operating as an independent public company; the risk that Abecma will not be as commercially successful as we may anticipate; the risk that our strategic realignment to focus on the development and commercialization of Abecma may not be as successful as anticipated, may fail to achieve the anticipated cost savings, and may cause disruptions in our business that could make it difficult to achieve our strategic objectives; and the risk that we are unable to manage our operating expenses or cash use for operations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our annual Report on Form 10-K for the year ended December 31, 2023, as supplemented and/or modified by any other filings that we will make with the Securities and Exchange Commission in the future. All information in this press release is as of the date of this release, and we undertakes no duty to update this information unless required by law.

2seventy bio, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(unaudited)

(in thousands)

 

 

 

 

 

 

 

For the three months ended
June 30,

 

For the six months ended
June 30,

 

 

2024

 

2023

 

2024

 

2023

Revenue:  
Service revenue  

$

4,621

 

$

5,022

 

$

12,342

 

$

15,848

 

Collaborative arrangement revenue  

 

4,346

 

 

29,034

 

 

9,060

 

 

58,406

 

Royalty and other revenue  

 

-

 

 

1,992

 

 

-

 

 

3,415

 

Total revenues  

 

8,967

 

 

36,048

 

 

21,402

 

 

77,669

 

Operating expenses:  
Research and development  

 

16,013

 

 

59,980

 

 

59,944

 

 

128,226

 

Cost of manufacturing for commercial collaboration  

 

3,453

 

 

3,610

 

 

6,722

 

 

7,264

 

Selling, general and administrative  

 

9,857

 

 

19,489

 

 

22,516

 

 

40,209

 

Share of collaboration loss  

 

-

 

 

-

 

 

1,230

 

 

-

 

Restructuring expenses  

 

7,398

 

 

-

 

 

11,628

 

 

-

 

Cost of royalty and other revenue  

 

-

 

 

907

 

 

-

 

 

1,548

 

Change in fair value of contingent consideration  

 

(685

)

 

53

 

 

(2,415

)

 

126

 

Total operating expenses  

 

36,036

 

 

84,039

 

 

99,625

 

 

177,373

 

Loss from operations  

 

(27,069

)

 

(47,991

)

 

(78,223

)

 

(99,704

)

Interest income, net  

 

2,527

 

 

3,090

 

 

5,388

 

 

5,139

 

Other income, net  

 

1,434

 

 

2,812

 

 

2,080

 

 

5,455

 

Gain on sale to Novo Nordisk  

 

47,987

 

 

-

 

 

47,987

 

 

-

 

Loss on assets held for sale to Regeneron  

 

-

 

 

-

 

 

(5,026

)

 

-

 

Income (loss) before income taxes  

 

24,879

 

 

(42,089

)

 

(27,794

)

 

(89,110

)

Income tax (expense) benefit  

 

-

 

 

-

 

 

-

 

 

-

 

Net income (loss)  

$

24,879

 

$

(42,089

)

$

(27,794

)

$

(89,110

)

Net income (loss) per share - basic  

$

0.48

 

$

(0.83

)

$

(0.53

)

$

(1.89

)

Net income (loss per share - diluted  

$

0.45

 

$

(0.83

)

$

(0.53

)

$

(1.89

)

Weighted-average number of common shares used in computing net income (loss) per share - basic  

 

52,186

 

 

50,966

 

 

52,129

 

 

47,238

 

Weighted-average number of common shares used in computing net income (loss) per share - diluted  

 

55,011

 

 

50,966

 

 

52,129

 

 

47,238

 

2seventy bio, Inc.

Condensed Consolidated Balance Sheet Data

(unaudited)

(in thousands)

   
  As of June 30,
2024
As of December 31,
2023
Cash, cash equivalents and marketable securities  

$

201,873

$

221,805

Total assets  

 

517,896

 

565,426

Total liabilities  

 

283,092

 

310,126

Total stockholders' equity  

 

234,804

 

255,300

 

Investors and Media:

Vicki Eatwell, CFO

vicki.eatwell@2seventybio.com

Kelli Koenig

kkoenig@realchemistry.com

Source: 2seventy bio, Inc.

FAQ

What revenue did Abecma generate in the second quarter of 2024?

Abecma generated $54 million in U.S. commercial revenue in the second quarter of 2024.

What was 2seventy bio’s net income for Q2 2024?

2seventy bio reported a net income of $24.9 million for the second quarter of 2024.

What were 2seventy bio’s total revenues for Q2 2024?

The total revenues for 2seventy bio in Q2 2024 were $9.0 million.

How has 2seventy bio reduced its operating expenses?

2seventy bio reduced its operating expenses by 43% through the sale of its oncology R&D business to Regeneron.

What is 2seventy bio’s cash runway as of Q2 2024?

2seventy bio has cash reserves of $202 million, with a cash runway extending beyond 2027.

2seventy bio, Inc.

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