Analyst Conference Summary

biotechnology

conference date: March 5, 2024
for quarter ending: December 31, 2023 (fourth quarter, Q4)

Forward-looking statements

Overview: Refocussing on Abecma, with label expansion possible in 2024.

Basic data (GAAP):

Revenue was $10.7 million, down 11% sequentially from $12.0 million, and down 81% from from $56.2 million year-earlier.

Net income was negative $56.8 million, up sequentially from negative $72 million, and down from negative $23.1 million year-earlier.

Earning per share (EPS), diluted were negative $1.11, up sequentially from negative $1.40, and down from negative $0.60 year-earlier.

Guidance:

Cash runway beyond 2027. Could reach break-even in 2025.

Conference Highlights:

Chip Baird, incoming CEO, said "While Abecma experienced continued competitive headwinds in the fourth quarter, we and our partners at Bristol Myers Squibb are approaching critical milestones that we believe will shift Abecma back to growth, including the upcoming ODAC meeting next week to review our sBLA for Abecma in earlier lines. Given the strength of the KarMMa-3 data, which was presented at the American Society of Hematology Annual Meeting and Exposition last year, and the positive response from regulators in other geographies, we have confidence in the outcome of the ODAC meeting and potential for approval in the third line setting. With the potential for this expanded label and continuing commercial execution, in addition to the ongoing KarMMa-9 study in newly-diagnosed patients with inadequate response to transplant, we have confidence in Abecma’s role as an important treatment option for patients living with multiple myeloma." Decline in Abecma sales was due to competition with other BCMA based therapies.

Revenue by type: service $3.3 million; Abecma collaboration $7.3 million; royalty and other $0 million.

2seventy bio and Bristol Myers (BMY) share equally in all profits and losses related to development, manufacturing, and commercialization of Abecma in the U.S. 2seventy reported collaborative arrangement revenue of $7.3 million in Q4, up sequentially from $0.5 million for Q3. That is based on Bristol Myers Q4 Abecma revenue of $100 million, up sequentially from $93 million, but down 25% from $125 million year-earlier..

In response to the loss of income, in September 2seventy announced a restructuring program. Then in In January 2024, announced a strategic realignment of to focus solely on Abecma. 2seventy entered into an asset purchase agreement with Regeneron Pharmaceuticals to sell our oncology and autoimmune research and development programs, clinical manufacturing capabilities, and related platform technologies. This is on track for closing in 1H 2024. Expected to yield annual savings of approximately $150 million in 2024 and $200 million in 2025, inclusive of one-time cash restructuring costs of about $8 to 10 million

Abecma has received third-line approvals in Japan and Switzerland. It gained a positive CHMP opinion in the EU. Approval in the U.S. would signal a return to growth. Manufacturing capability is being prepared.

At the end of the quarter the balance of cash and equivalents (including marketable securities) was $222 million, down sequentially from $284 million.

Operating expenses of $71 million consisted of: R&D $51 million; cost of manufacturing $3 million; SG&A $16 million. Loss from operations $60 million. Interest income $4 million. Other expense $0.5 million.

Analyst Q&A, selective:

Abecma toxicity profile? On label. Commercially the profile becomes more important as we move to earlier line settings. Field experience is growing, including more Parkinsonism for other products than for Abecma.

ODAC key data? Overall survival data neutral unless crossover is accounted for. Bridging therapies also had an influence. It was a focus of Japanese and Swiss regulators, we are well prepared to talk about it.

Future competition from CARTs? Myeloma has never been a winner-take-all market. The market opportunity in the third line setting is large and not likely to be dominated by a single therapy. It will likely vary by patient population within the class. We think our safety and efficacy profile is competitive.

Real world Abecma data? We are seeing safety and efficacy that matches or exceeds the pivotal study. Abecma safety looks good comparted to other therapies.

We continue to increase the number of sites where Abecma is available for patients.

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