2seventy bio, Inc. (TSVT) is a cell and gene therapy company that has established itself as a key player in the treatment of multiple myeloma. The company's flagship product, Abecma, is a CAR-T therapy approved for the treatment of adult patients with relapsed or refractory multiple myeloma. 2seventy bio's journey has been marked by both challenges and successes, as it navigates the dynamic multiple myeloma market and works to maximize the potential of Abecma.

Business Overview and History

2seventy bio was incorporated in Delaware in April 2021 as a cell and gene therapy company, emerging from the separation of the oncology portfolio and programs from bluebird bio, Inc. The company's name, "2seventy bio," reflects its mission to work at the maximum speed of translating human thought into action – 270 miles per hour – to give the people it serves more time.

The separation from bluebird bio was part of a strategic plan to create two independent public companies, each focusing on different aspects of gene therapy. In connection with the separation, 2seventy bio entered into several agreements with bluebird bio to govern their relationship going forward. These agreements included a separation agreement, tax matters agreement, employee matters agreement, intellectual property license agreement, and transition services agreements.

Prior to the separation, all of bluebird bio's outstanding shares of common stock were owned by 2seventy bio. Following the completion of the separation and distribution in 2021, 2seventy bio and bluebird bio began operating as independent public companies, with bluebird bio no longer owning any shares of 2seventy bio's common stock.

2seventy bio's focus is on the research, development, and commercialization of transformative treatments for cancer, combining its expertise in T cell engineering technology, lentiviral vector gene delivery approaches, and a suite of technologies. This specialized focus allows the company to concentrate its resources and efforts on advancing innovative therapies in the oncology field.

In March 2013, bluebird bio had entered into a collaboration agreement with Bristol-Myers Squibb (BMS) for the development and commercialization of ide-cel, marketed as Abecma. This collaboration agreement was assumed by 2seventy bio in connection with the separation. Under the collaboration, 2seventy bio and BMS share equally in the profits and losses related to the development and commercialization of Abecma in the United States.

Financial Snapshot

Financials 2seventy bio's financial performance has been heavily influenced by the commercialization of Abecma. In 2024, the company reported U.S. Abecma sales of approximately $242 million, within its previously issued guidance range of $240 million to $250 million. While fourth quarter revenue was impacted by higher deferrals of infusions into 2025, the overall trend of Abecma's growth in the third-line setting has been encouraging.

For the fiscal year 2023, 2seventy bio reported total revenue of $100.39 million, with a net loss of $217.57 million. The company's operating cash flow for 2023 was negative $166.86 million, and free cash flow was negative $180.72 million. In the most recent quarter (Q3 2024), revenue was $13.53 million, representing a year-over-year growth of 12.4% compared to Q3 2023. The net loss for Q3 2024 was $9.93 million.

For the nine months ended September 30, 2024, the company recognized $15.05 million in collaborative arrangement revenue from the Abecma U.S. collaboration, as well as $2.63 million in reimbursement from BMS for 2seventy bio's costs of commercial manufacturing and activities. However, the company also incurred $1.23 million in share of collaboration loss during this period.

Liquidity

The company's net cash burn in the fourth quarter of 2024 was $9 million, and it ended the year with approximately $184 million in cash, cash equivalents, and marketable securities. 2seventy bio's path to quarterly breakeven is expected by the end of 2025, reflecting the company's focus on streamlining its cost structure and maximizing the profitability of Abecma.

As of September 30, 2024, 2seventy bio had $192.40 million in cash, cash equivalents, and marketable securities. The company's debt-to-equity ratio stands at 1.08, while both its current ratio and quick ratio are 4.95. 2seventy bio expects its current cash position to be sufficient to fund planned operations for at least the next twelve months.

For 2024, 2seventy bio expects net cash spend in the range of $40 million to $60 million and projects a cash runway beyond 2027. The company is aiming to reach breakeven operations potentially as soon as 2025, with the breakeven point estimated to be around $300 million in total U.S. Abecma sales.

Operational Highlights and Challenges

In 2024, 2seventy bio took several strategic actions to sharpen its focus on Abecma and improve its financial position. The company entered into an asset purchase agreement with Regeneron Pharmaceuticals, selling its oncology and autoimmune research and development programs, clinical manufacturing capabilities, and related platform technologies. This transaction, which closed in April 2024, allowed 2seventy bio to streamline its operations and redirect resources towards the continued commercialization of Abecma.

Additionally, in June 2024, 2seventy bio announced the completion of an asset purchase agreement with Novo Nordisk, selling its Hemophilia A program and rights to its in vivo gene editing technology outside of oncology and autoimmune disease. This divestiture further supported the company's strategic shift towards Abecma. As part of this agreement, 2seventy bio received $38 million in upfront consideration, plus up to an additional $2 million that will be held back by Novo for 12 months and may be used to settle certain indemnification claims.

One notable challenge faced by 2seventy bio in 2024 was the decision, in partnership with BMS, to discontinue enrollment in the Phase 3 KarMMa-9 study. This study was evaluating Abecma with lenalidomide maintenance versus lenalidomide maintenance alone in patients with newly diagnosed multiple myeloma who had a suboptimal response to autologous stem cell transplantation. The decision to discontinue the study was driven by the company's focus on financial discipline and a desire to streamline its cost structure, ultimately resulting in over $80 million in anticipated cost savings over the next several years.

The strategic realignment and asset sales have allowed 2seventy bio to focus exclusively on the development and commercialization of Abecma. However, the company has incurred significant one-time restructuring expenses, including $12.13 million in the nine months ended September 30, 2024, primarily related to severance, retention packages, and costs associated with BMS's early exit from a commercial manufacturing and supply agreement for Abecma.

Competitive Landscape and Outlook

The multiple myeloma treatment landscape continues to evolve, with 2seventy bio and Abecma facing competition from other CAR-T therapies and novel modalities. However, the company believes Abecma has a well-established and differentiated safety profile, as well as a competitive efficacy profile, particularly when patients receive effective bridging therapy prior to treatment.

Looking ahead, 2seventy bio is committed to expanding Abecma's reach to as many multiple myeloma patients as possible. The company will continue to compete commercially, while also working to optimize the cost structure of Abecma to increase operating margins and cash flow from the business. Alongside its partner BMS, 2seventy bio is actively exploring ways to streamline expenses across clinical, manufacturing, and commercial operations.

For 2024, 2seventy bio expects U.S. Abecma revenues to be approximately $240 million to $250 million. The company anticipates that Q4 2024 Abecma revenues will be impacted by continued competition and a reduction in CAR-T infusions during the U.S. holiday season. Despite these challenges, 2seventy bio is working to optimize the cost structure of Abecma to increase the operating margin and cash flow from the business.

As 2seventy bio approaches 2025, it is one step closer to reaching breakeven, which the company believes will create strategic optionality for the future. The company's unwavering focus on delivering for patients and creating value for shareholders will remain its guiding principle as it navigates the evolving multiple myeloma landscape.

Conclusion

2seventy bio's journey has been marked by both challenges and successes as it has navigated the dynamic multiple myeloma market. The company's flagship product, Abecma, has been at the forefront of its efforts, with the therapy's continued expansion into earlier lines of treatment and strong commercial performance in 2024 highlighting its potential.

By streamlining its operations and sharpening its focus on Abecma, 2seventy bio has positioned itself for a path to profitability, expected by the end of 2025. As the company continues to compete in the evolving multiple myeloma landscape, its commitment to delivering transformative treatments for cancer patients and creating value for shareholders will be crucial to its long-term success.