Analyst Conference Summary

biotechnology

conference date: May 8, 2024
for quarter ending: March 31, 2024 (first quarter, Q1)

Forward-looking statements

Overview: Only therapy is now Abecma.

Basic data (GAAP):

Revenue was $12.4 million, up sequentially from $10.7 million, and down from from $41.6 million year-earlier.

Net income was negative $53 million, up sequentially from negative $56.8 million, and down from negative $47 million year-earlier.

Earning per share (EPS), diluted were negative $1.01, up sequentially from negative $1.11, and up from negative $1.08 year-earlier. [share count increased y/y]

Guidance:

Has cash runway beyond 2027.

Conference Highlights:

Chip Baird, incoming CEO, said "In the first quarter of 2024, we have successfully completed a strategic re-alignment to focus exclusively on Abecma, seeking to impact many more patients in earlier lines and return to commercial growth. In turn, we are focused on reaching financial sustainability and creating value for shareholders,. We have executed against the plan we described in January, completing the sale of our R&D business to Regeneron and obtaining FDA approval for Abecma in the earlier line setting. Going forward, we will have a streamlined cost structure that gives us time to return Abecma to growth with our partner, Bristol Myers Squibb. The recent FDA approval greatly expands the number of eligible patients for Abecma, and we believe that the KarMMa-3 data set demonstrates a competitive efficacy and safety profile in triple class exposed patients, a population for which there remains a high unmet need." We expect to achieve $150 million to $200 million per year in cash spend, following the realignment.

On April 4, 2024 Abecma received third line approval from the FDA for multiple myeloma. This is a much larger addressable population, but does not expect meaningful growth until H2. 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. In Q1 2024 the FDA approved suspension lentiviral vector (sLVV) for manufacturing Abecma. The transition to sLVV manufacturing will support anticipated increased demand in earlier lines.

Revenue by type: service $7.7 million; Abecma collaboration $4.7 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 $4.7 million in Q1, down sequentially from $7.3 million for Q4. That is based on Bristol Myers Q1 Abecma revenue of $82 million, down sequentially from $100 million, and from $147 million year-earlier..

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 its oncology and autoimmune research and development programs, clinical manufacturing capabilities, and related platform technologies. This closed in Q2 2024.

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

Operating expenses of $64 million consisted of: R&D $44 million; cost of manufacturing $3 million; SG&A $13 million; share of collaboration $1.2 million; restructuring $4.2 million; gain from fair value change $1.7 million. Loss from operations $51 million. Interest income $3 million. Other income $0.6 million. Loss on assets $5 million.

Analyst Q&A, selective:

Abecma profitality going forward, break even point? We had been in the fifth line setting. We need a return to growth to see a path to collaboration revenue and profitability. We have a high fixed manufacturing structure, so higher volumes should lower that cost per patient.

Suspension manufacturing approval will result in a build-out over time.

Launch competition, dynamics? No specifics yet, but it is a much larger market, so it would not take much to become meaningful. We are not supply constrained, and we can expand capacity if necessary.

2024 op ex should be about half what 2023 was, then 2025 should be one-third of 2023.

Feedback on label expansion? We see less competition in the third line setting. Bispecifics are not approved there. But it is early, we will have more feedback over time.

ODAC concern about Abecma PFS? 13 months v. just 4 months standard of care for PFS. Better data as the cutoff point was extended.

Type of treatment center? Academic centers have been the driver. Expanding the footprint to more remote locations will be important, showing them the new label and data.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: