2seventy bio Reports Second Quarter Financial Results and Recent Operational Progress
Following regulatory approval in the earlier line setting this quarter, Abecma generated
Recent completion of Hemophilia A and gene editing technology sale to Novo Nordisk for up to
Approximately
Ended quarter with approximately
Conference call today at 8:00 AM ET
“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
ABECMA COMMERCIAL AND REGULATORY HIGHLIGHTS
-
Second quarter Abecma® (idecabtagene vicleucel; ide-cel)
U.S. revenues, as reported by Bristol Myers Squibb (BMS), were . Demand, as measured by new patients undergoing apheresis in the quarter, saw meaningful growth.$54 million - 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 related to the collaboration with BMS for the three months ended June 30, 2024.$4.4 million
SELECT SECOND QUARTER FINANCIAL RESULTS
-
Total revenues were
for the three months ended June 30, 2024, compared to$9.0 million for the three months ended June 30, 2023. Total revenues were$36.0 million for the six months ended June 30, 2024, compared to$21.4 million for the six months ended June 30, 2023.$77.7 million -
Research and development expenses were
for the three months ended June 30, 2024, compared to$16.0 million for the three months ended June 30, 2023. Research and development expenses were$60.0 million for the six months ended June 30, 2024, compared to$59.9 million for the six months ended June 30, 2023.$128.2 million -
Selling, general and administrative expenses were
for the three months ended June 30, 2024, compared to$9.9 million for the three months ended June 30, 2023. Selling, general and administrative expenses were$19.5 million for the six months ended June 30, 2024, compared to$22.5 million for the six months ended June 30, 2023.$40.2 million -
Restructuring expenses were
for the three months ended June 30, 2024, and$7.4 million for the six months ended June 30, 2024. There were no restructuring expenses in the comparable three- and six-month periods in 2023.$11.6 million -
The Company recognized a
one-time gain on sale to Novo Nordisk for the three months ended June 30, 2024. Additionally, the Company recognized a$48.0 million one-time loss on assets held for sale to Regeneron for the six months ended June 30, 2024.$5.0 million -
Net income was
for the three months ended June 30, 2024, compared to net loss of$24.9 million for the three months ended June 30, 2023. Net loss was$42.1 million for the six months ended June 30, 2024, compared to net loss of$27.8 million for the six months ended June 30, 2023.$89.1 million -
The Company has lowered its net cash spend range to
for 2024.$40 -60 million -
Cash, cash equivalents, and marketable securities totaled
as of June 30, 2024; the Company continues to expect to have cash runway beyond 2027.$201.9 million
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
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 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
2seventy bio, Inc. |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
||||||||||||||||
(unaudited) |
||||||||||||||||
(in thousands) |
||||||||||||||||
|
|
|
|
|
||||||||||||
|
|
For the three months ended
|
|
For the six months ended
|
||||||||||||
|
|
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 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240807192042/en/
Investors and Media:
Vicki Eatwell, CFO
vicki.eatwell@2seventybio.com
Kelli Koenig
kkoenig@realchemistry.com
Source: 2seventy bio, Inc.