2seventy bio Reports Third Quarter Financial Results and Recent Operational Progress
2seventy bio reported third quarter financial results, highlighting a 42% increase in Abecma U.S. commercial revenue to $77 million compared to the second quarter. The company anticipates Abecma revenues between $240-$250 million for 2024. Additionally, discontinuing the KarMMa-9 study is expected to save over $80 million. Operating expenses were reduced by 24% from the previous quarter, with a net loss of approximately $10 million for Q3. Cash reserves stood at $192 million, expected to last beyond 2027. Total revenues for Q3 were $13.5 million, up from $12.0 million in Q3 2023. R&D expenses dropped significantly to $8.3 million from $51.3 million in Q3 2023. The company will discuss these results in a conference call today.
2seventy bio ha riportato i risultati finanziari del terzo trimestre, evidenziando un aumento del 42% delle entrate commerciali di Abecma negli Stati Uniti, arrivando a $77 milioni rispetto al secondo trimestre. L'azienda prevede entrate per Abecma comprese tra $240 e $250 milioni per il 2024. Inoltre, la sospensione dello studio KarMMa-9 dovrebbe comportare un risparmio di oltre $80 milioni. Le spese operative sono state ridotte del 24% rispetto al trimestre precedente, con una perdita netta di circa $10 milioni per il Q3. Le riserve di cassa ammontavano a $192 milioni, previste per durare oltre il 2027. Le entrate totali per il Q3 sono state di $13,5 milioni, in aumento rispetto ai $12,0 milioni del Q3 2023. Le spese per ricerca e sviluppo sono diminuite drasticamente a $8,3 milioni, rispetto ai $51,3 milioni del Q3 2023. L'azienda discuterà questi risultati in una chiamata di conferenza oggi.
2seventy bio informó los resultados financieros del tercer trimestre, destacando un aumento del 42% en los ingresos comerciales de Abecma en EE. UU., alcanzando los $77 millones en comparación con el segundo trimestre. La compañía anticipa ingresos de Abecma entre $240 y $250 millones para 2024. Además, se espera que la cancelación del estudio KarMMa-9 genere un ahorro de más de $80 millones. Los gastos operativos se redujeron en un 24% con respecto al trimestre anterior, con una pérdida neta de aproximadamente $10 millones para el Q3. Las reservas de efectivo se ubicaron en $192 millones, con expectativas de durar más allá de 2027. Los ingresos totales para el Q3 fueron de $13.5 millones, un aumento frente a los $12.0 millones en el Q3 de 2023. Los gastos en I+D disminuyeron significativamente a $8.3 millones desde los $51.3 millones en el Q3 de 2023. La compañía discutirá estos resultados en una conferencia telefónica hoy.
2seventy bio는 3분기 재무 결과를 보고하며, Abecma의 미국 상업 수익이 2분기 대비 42% 증가하여 7,700만 달러에 도달했다고 밝혔습니다. 이 회사는 2024년 Abecma 수익이 2억 4천만 달러에서 2억 5천만 달러 사이일 것으로 예상하고 있습니다. 또한 KarMMa-9 연구를 중단함으로써 8,000만 달러 이상의 비용 절감이 이루어질 것으로 기대하고 있습니다. 운영 비용은 이전 분기 대비 24% 감소하였고, 3분기에는 약 1,000만 달러의 순손실을 기록했습니다. 현금 준비금은 1억 9,200만 달러로 2027년 이후에도 사용할 수 있을 것으로 예상됩니다. 3분기 총 수익은 1,350만 달러로, 2023년 3분기의 1,200만 달러에서 증가했습니다. 연구 개발 비용은 5,130만 달러에서 830만 달러로 대폭 감소했습니다. 이 회사는 오늘 이러한 결과를 발표하는 컨퍼런스 콜을 진행할 예정입니다.
2seventy bio a publié les résultats financiers du troisième trimestre, mettant en avant une augmentation de 42 % des revenus commerciaux d'Abecma aux États-Unis, atteignant 77 millions de dollars par rapport au deuxième trimestre. L'entreprise anticipe des revenus pour Abecma compris entre 240 et 250 millions de dollars pour 2024. De plus, l'arrêt de l'étude KarMMa-9 devrait permettre d'économiser plus de 80 millions de dollars. Les dépenses opérationnelles ont été réduites de 24 % par rapport au trimestre précédent, avec une perte nette d'environ 10 millions de dollars pour le Q3. Les réserves de liquidités s'élevaient à 192 millions de dollars, prévues pour durer au-delà de 2027. Les revenus totaux pour le Q3 ont atteint 13,5 millions de dollars, en hausse par rapport à 12,0 millions de dollars au Q3 2023. Les dépenses de R&D ont chuté de manière significative à 8,3 millions de dollars, contre 51,3 millions de dollars au Q3 2023. L'entreprise discutera de ces résultats lors d'une conférence téléphonique aujourd'hui.
2seventy bio hat die Finanzergebnisse des dritten Quartals veröffentlicht und hebt einen Anstieg der Abecma-U.S.-Umsätze um 42% auf 77 Millionen Dollar im Vergleich zum zweiten Quartal hervor. Das Unternehmen erwartet für 2024 Umsätze von Abecma zwischen 240 und 250 Millionen Dollar. Zudem wird erwartet, dass die Einstellung der KarMMa-9-Studie über 80 Millionen Dollar einspart. Die Betriebskosten wurden im Vergleich zum vorherigen Quartal um 24% gesenkt, mit einem Nettoverlust von etwa 10 Millionen Dollar für das Q3. Die Barreserven beliefen sich auf 192 Millionen Dollar und sollen über 2027 hinaus reichen. Die Gesamteinnahmen für das Q3 lagen bei 13,5 Millionen Dollar, ein Anstieg von 12,0 Millionen Dollar im Q3 2023. Die F&E-Ausgaben fielen erheblich auf 8,3 Millionen Dollar von 51,3 Millionen Dollar im Q3 2023. Das Unternehmen wird diese Ergebnisse heute in einer Telefonkonferenz besprechen.
- 42% increase in Abecma U.S. commercial revenue to $77 million.
- Expected Abecma revenues of $240-$250 million for 2024.
- 24% reduction in operating expenses from the previous quarter.
- Cash reserves of $192 million, expected to last beyond 2027.
- Significant reduction in net loss to approximately $10 million for Q3.
- Total revenues for Q3 were $13.5 million, compared to $12.0 million for Q3 2023.
- Significant drop in R&D expenses to $8.3 million from $51.3 million in Q3 2023.
Insights
The Q3 results show significant operational improvements. Abecma revenue grew 42% quarter-over-quarter to
The strong cash position of
The discontinuation of the KarMMa-9 study in newly diagnosed multiple myeloma patients represents a strategic pivot. While this limits potential market expansion, real-world evidence continues to support Abecma's differentiated safety profile. The emergence of myeloid neoplasms in
With 16,000 annual U.S. diagnoses of multiple myeloma and Abecma's established efficacy in later lines, there remains significant market opportunity despite increased competition. The focus on competitive differentiation through safety data and bridging therapy optimization is strategically sound.
Abecma generated
Decision in September to discontinue enrollment in KarMMa-9 study results in over
Ended quarter with approximately
Conference call today at 8:00 AM ET
“We are very pleased to report
ABECMA COMMERCIAL AND REGULATORY HIGHLIGHTS
-
Third quarter Abecma® (idecabtagene vicleucel; ide-cel)
U.S. revenues, as reported by Bristol Myers Squibb (BMS), were . The Company expects Abecma revenues of approximately$77 million -$240 for the full year of 2024.$250 million - 2seventy bio and BMS continue to focus on competitively differentiating Abecma’s safety and efficacy profile supported by the strength of the KarMMa-3 and real-world data.
- 2seventy bio, in partnership with study sponsor BMS, has discontinued enrollment in its ongoing Phase 3 KarMMa-9 study evaluating Abecma with lenalidomide maintenance versus lenalidomide maintenance alone in patients with newly diagnosed multiple myeloma (NDMM) who have suboptimal response to autologous stem cell transplant. 2seventy and BMS remain committed to expanding the reach of Abecma to as many multiple myeloma patients as possible.
-
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 approximately related to the collaboration with BMS for the three months ended September 30, 2024.$11 million
SELECT THIRD QUARTER FINANCIAL RESULTS
-
Total revenues were
for the three months ended September 30, 2024, compared to$13.5 million for the three months ended September 30, 2023. Total revenues were$12.0 million for the nine months ended September 30, 2024, compared to$34.9 million for the nine months ended September 30, 2023.$89.7 million -
Research and development expenses were
for the three months ended September 30, 2024, compared to$8.3 million for the three months ended September 30, 2023. Research and development expenses were$51.3 million for the nine months ended September 30, 2024, compared to$68.3 million for the nine months ended September 30, 2023.$179.5 million -
Selling, general and administrative expenses were
for the three months ended September 30, 2024, compared to$12.9 million for the three months ended September 30, 2023. Selling, general and administrative expenses were$13.0 million for the nine months ended September 30, 2024, compared to$35.4 million for the nine months ended September 30, 2023.$53.2 million -
Net loss was
for the three months ended September 30, 2024, compared to$9.9 million for the three months ended September 30, 2023. Net loss was$71.6 million for the nine months ended September 30, 2024, compared to$37.7 million for the nine months ended September 30, 2023.$160.7 million -
The Company reiterates its net cash spend range of
for 2024.$40 -60 million -
Cash, cash equivalents, and marketable securities totaled
as of September 30, 2024; the Company continues to expect to have cash runway beyond 2027.$192 million
Conference Call Information
2seventy bio will host a conference call and live webcast today, November 12 at 8:00 a.m. ET to discuss third 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
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.
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;
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
The most common manifestations of CRS (greater than or equal to
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 (
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
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
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
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
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,
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
Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in
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
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
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
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 regarding expected ABECMA (ide-cel)
2seventy bio, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (in thousands, except per share data) |
|||||||||||||||
For the three months ended
|
|
For the nine months ended
|
|||||||||||||
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
Revenue: | |||||||||||||||
Service revenue |
|
2,850 |
|
|
4,948 |
|
|
15,192 |
|
|
20,796 |
|
|||
Collaborative arrangement revenue |
|
10,684 |
|
|
5,859 |
|
|
19,744 |
|
|
64,265 |
|
|||
Royalty and other revenue |
|
- |
|
|
1,227 |
|
|
- |
|
|
4,642 |
|
|||
Total revenues |
|
13,534 |
|
|
12,034 |
|
|
34,936 |
|
|
89,703 |
|
|||
Operating expenses: | |||||||||||||||
Research and development |
|
8,320 |
|
|
51,315 |
|
|
68,264 |
|
|
179,541 |
|
|||
Cost of manufacturing for commercial collaboration |
|
5,768 |
|
|
4,408 |
|
|
12,490 |
|
|
11,672 |
|
|||
Selling, general and administrative |
|
12,884 |
|
|
13,004 |
|
|
35,400 |
|
|
53,213 |
|
|||
Share of collaboration loss |
|
- |
|
|
- |
|
|
1,230 |
|
|
- |
|
|||
Restructuring expenses |
|
503 |
|
|
8,614 |
|
|
12,131 |
|
|
8,614 |
|
|||
Cost of royalty and other revenue |
|
- |
|
|
551 |
|
|
- |
|
|
2,099 |
|
|||
Change in fair value of contingent consideration |
|
- |
|
|
54 |
|
|
(2,415 |
) |
|
180 |
|
|||
Goodwill impairment charge |
|
- |
|
|
12,056 |
|
|
- |
|
|
12,056 |
|
|||
Total operating expenses |
|
27,475 |
|
|
90,002 |
|
|
127,100 |
|
|
267,375 |
|
|||
Loss from operations |
|
(13,941 |
) |
|
(77,968 |
) |
|
(92,164 |
) |
|
(177,672 |
) |
|||
Interest income, net |
|
2,855 |
|
|
3,626 |
|
|
8,243 |
|
|
8,765 |
|
|||
Other income, net |
|
1,153 |
|
|
2,704 |
|
|
3,233 |
|
|
8,159 |
|
|||
Gain on sale of assets to Novo Nordisk |
|
- |
|
|
- |
|
|
47,987 |
|
|
- |
|
|||
Loss on assets held for sale to Regeneron |
|
- |
|
|
- |
|
|
(5,026 |
) |
|
- |
|
|||
Loss before income taxes |
|
(9,933 |
) |
|
(71,638 |
) |
|
(37,727 |
) |
|
(160,748 |
) |
|||
Income tax (expense) benefit |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|||
Net Loss |
|
(9,933 |
) |
|
(71,638 |
) |
|
(37,727 |
) |
|
(160,748 |
) |
|||
Net loss per share - basic and diluted |
|
(0.19 |
) |
|
(1.40 |
) |
|
(0.72 |
) |
|
(3.31 |
) |
|||
Weighted-average number of common shares used in computing net loss per share - basic and diluted |
|
52,263 |
|
|
51,179 |
|
|
52,176 |
|
|
48,566 |
|
2seventy bio, Inc. Condensed Consolidated Balance Sheet Data (unaudited) (in thousands) |
|||||||
As of September 30,
|
|
|
As of December 31,
|
||||
Cash, cash equivalents and marketable securities |
$ |
192,399 |
|
|
$ |
221,805 |
|
Total assets |
|
503,846 |
|
|
565,426 |
||
Total liabilities |
|
275,744 |
|
|
|
310,126 |
|
Total stockholders' equity |
|
228,102 |
|
|
|
255,300 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20241112435270/en/
Investors and Media:
Vicki Eatwell, CFO
vicki.eatwell@2seventybio.com
Morgan (
Morgan.adams@2seventybio.com
Source: 2seventy bio, Inc.
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