Analyst Conference Summary

biotechnology

conference date: May 3, 2023
for quarter ending: March 31, 2023 (first quarter, Q1)

Forward-looking statements

Overview: Good revenue ramp, still in the red.

Basic data (GAAP):

Revenue was $41.6 million, well up from from $8.4 million year-earlier.

Net income was negative $47.0 million, up from negative $85.7 million year-earlier.

Earning per share (EPS), diluted were negative $1.08, up from negative $3.20 year-earlier.

Guidance:

Believes on track for upper end of prior 2023 guidance. Cash runway to 2026.

Conference Highlights:

Nick Leschly said "We have had an incredibly strong start to the year, with a sharp focus on timely execution across our commercial business, clinical programs, and research pipeline. Abecma revenue remains on a strong growth trajectory as we continue to successfully execute with Bristol Myers on manufacturing scale-ups to deliver Abecma to myeloma patients. The successful steps taken to date to increase vector and drug product manufacturing support the achievement of the upper end of our U.S. revenue guidance range. With the recent FDA acceptance of our Abecma sBLA based on our KarMMa-3 study, we look forward to the opportunity to offer this transformational product to patients in earlier lines of treatment and, if approved, will enable us to serve thousands of additional patients in the U.S. We have made significant progress across our pipeline, and we plan to share initial clinical data from our SC-DARIC33 program for acute myeloid leukemia at the ASGCT Annual Meeting." Abecma was cash-flow positive, and moving towards overall cash-flow positive in the next few years.

Revenue by type: service $10.8 million; collaboration $29.4 million; royalty and other $1.4 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 $23.0 million for Q1, and share of collaboration loss of $5.4 million. Abecma was cash-flow positive in Q1 and 2seventy expects the collaboration to be cash flow positive throughout 2023 and to generate between $200 and $300 million of operating income for 2seventy bio during the 2024-2025 period.

In Q1 expanded manufacturing capabilities and made progress toward FDA approval for sLVV manufacuring comparability to adherent lentiviral vector method.

In Q1 The FDA has accepted the sBLA for Abecma in adult patients with triple-class exposed relapsed or refractory multiple myeloma. The FDA assigned a PDUFA date of December 16, 2023.

The joint 2seventy bio and Novo Nordisk collaborative program focused on an in vivo gene editing treatment for hemophilia A achieved positive proof of concept data, triggering a $15 million milestone payment to 2seventy bio.

2seventy bio will have 5 presentations at American Society of Gene & Cell Therapies (ASGCT) annual meeting.

By the end of 2023 2seventy bio expects: a data update from Phase I CRC-403 study of bbT369 in patients with relapsed and/or refractory B cell non-Hodgkin lymphoma (B-NHL). A data update from Phase I PLAT-08 study of SC-DARIC33 in patients with acute myeloid leukemia. Submission of an IND for the MUC-16 program in ovarian cancer, in partnership with Regeneron. Led by JW Therapeutics, initiation of an investigator-initiated study in China of 2seventy bio's potency enhanced MAGE-A4 T cell receptor (TCR) program in solid tumors.

2seventy bio will host a virtual R&D Deep Dive on Friday, May 19, at 10:00 a.m. ET.

At the end of the quarter the balance of cash and equivalents (including marketable securities) was $341 million, up sequentially from $268 million. 2seventy bio successfully raised approximately $117 million in net proceeds from an equity raise in Q1 2023.

Operating expenses of $93 million consisted of: R&D $68 million; cost of manufacturing $4 million; SG&A $21 million, cost of royalties $0.6 million. Loss from operations $52 million. Interest income $2 million. Other income $3 million.

Analyst Q&A, selective:

Peak sales opportunity of $2 to $3 billion, timeline? Predicated on clinical evolution in the marketplace, manufacturing, and label extension to earlier lines of therapy. In 2024 we should transition to suspension vector. We expect to be supply constrained for years.

Most relevent data points for commercial decision making? Real world analysis of Abecma is very positive.

So far treatment sites have not been a capacity constraint.

We hope to see continued improvement in multiple myeloma data as we address earlier lines of therapy.

369 positioning? There is a big need in lymphoma, despite a good percentage of patients getting a good response on current therapies. We believe the hurdles are high for 369.

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