2Seventy Bio - Q4 2023

Transcript

Operator (participant)

Good day and thank you for standing by. Welcome to the 2seventy bio fourth quarter 2023 earnings conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, please press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker, Elizabeth Hicken, Head of Investor Relations. Please go ahead.

Elizabeth Hickin (Head of Investor Relations)

Thank you, operator, and good morning, everyone. Thank you for joining us. This morning, we issued a press release on our fourth quarter and full year 2023 financial results. The press release can be found in the Investors and Media section of the company's website at 2seventybio.com. As a reminder, today's discussion will include forward-looking statements related to 2seventy bio's current plans and expectations, which are subject to certain risks and uncertainties. These forward-looking statements include statements regarding our strategic plans, timelines, and expectations with respect to sales, efficacy, and perceived therapeutic benefits of Abecma, the timing and review of additional studies and regulatory applications for Abecma, and statements regarding our financial condition, expectations, and future financial results, among others.

Actual results may differ materially due to various risks, uncertainties, and other factors, including those described in the Risk Factors section of our most recent Form 10-K quarterly reports and other SEC filings. These forward-looking statements represent our views as of this call and should not be relied upon as representing our views as of any subsequent date. You are cautioned not to place any undue reliance on these forward-looking statements, and except as required by law, we undertake no obligation to update or revise any forward-looking statement. On today's call, we are joined by Chip Baird, Incoming Chief Executive Officer, and Vicki Eatwell, Incoming Chief Financial Officer. Anna Truppel-Hartmann, Head of Clinical Development, is also on the line for Q&A. And now I will turn it over to Chip. Chip?

Chip Baird (Incoming CEO)

Thank you, Liz, and thank you all for joining. This morning, we disclosed our fourth quarter and full year 2023 financial results and recent business and operational updates. I'd like to walk through some of the business updates, and then Vicki Eatwell, our Incoming Chief Financial Officer, will go into detail on the financials. First, as we announced in January, we have embarked on a new strategic path forward as an organization that will be wholly focused on Abecma. As part of this new path forward, we entered into an asset purchase agreement with Regeneron to acquire our research and development pipeline. I'm pleased to share that we've made good progress on the agreement and continue to believe we are on track to close within the first half of the year.

Turning to Abecma, we're looking forward to discussing our sBLA in the third-line at the upcoming ODAC meeting next week. As we've shared, FDA has said they are focused on the overall survival data from the KarMMa-3 study, which was presented at ASH and importantly showed a benefit in the Abecma arm when adjusted for crossover. We believe these data support the case to approve Abecma in this triple-class-exposed patient population. We're pleased to see regulators across other geographies respond positively, with third line-plus approvals in Japan and Switzerland, as well as a positive CHMP opinion in the E.U., which gives us confidence in a potential approval here in the U.S. Our clinical and regulatory teams at 2seventy bio and at BMS have been diligent and thorough in our preparation for the ODAC, and we look forward to the meeting next week.

From a commercial perspective, the approval in the third-line-plus setting is a key catalyst for Abecma returning to return to growth. To that end, we and BMS are prepared to meet the anticipated demand in earlier lines and, importantly, to continue to deliver Abecma on time and in spec for patients in need. These efforts are in addition to other ongoing efforts to expand site footprint and competitively differentiate Abecma's safety and efficacy profile with real-world data. We look forward to educating the community together with BMS on these data, and we remain excited about the potential for Abecma to transform the lives of patients living with myeloma. With these efforts and our extended cash runway, we believe 2seventy bio is strongly positioned to see Abecma return to growth this year and deliver for patients in need.

Before I close, I'd like to turn the call to Vicki to walk through some of our financials. Vicki, over to you.

Vicki Eatwell (Incoming CFO)

Thanks, Chip. As mentioned, fourth quarter Abecma U.S. revenues, as reported by Bristol Myers Squibb, were $56 million. The decline in fourth-quarter sales was due to ongoing competition from other BCMA-targeted therapies. We anticipate the commercial performance for the first part of 2024 will continue to be impacted by competitive dynamics until the potential expansion of the label to the third-line-plus setting, which will increase the addressable patient population. In the fourth quarter, 2seventy bio reported collaborative arrangement revenue of $2 million related to its collaboration with BMS for the three months ended December 31, 2023, and collaborative arrangement revenue of $50 million related to its collaboration with BMS for the 12 months ended December 31, 2023. We anticipate collaborative arrangement revenue to grow meaningfully as we see Abecma return to commercial growth.

We ended the year with $221.8 million of cash, cash equivalents, and marketable securities. With the changes to the cost structure resulting from restructuring measures and following the close of the asset purchase agreement with Regeneron, we expect annual savings of approximately $150 million in 2024, and approximately $200 million in 2025, inclusive of one-time cash restructuring costs of approximately $8 million-$10 million. We now expect our cash runway to go beyond 2027 and see a path to potential breakeven by 2025, obviating the need to seek funding from the capital markets in the foreseeable future. With that, I'll turn it back to Chip.

Chip Baird (Incoming CEO)

Thanks, Vicki. Before we close, I'd like to thank the team at 2seventy bio for continuing to navigate these challenging waters and not losing sight of the mission and the clear task at hand. With key milestones coming in the near term, close with the APA, with Regeneron, ODAC, and PDUFA soon thereafter, we feel we are well-positioned to emerge from the first quarter in a much stronger position. We look forward to continuing to support our partners at BMS as they bring Abecma to myeloma patients in need. With that, we're happy to take your questions. Operator, over to you.

Operator (participant)

Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. We ask that you please limit yourself to one question. Please stand by while we compile the Q&A roster. Our first question comes from the line of Daina Graybosch with Leerink Partners. Your line is now open.

Daina Graybosch (Senior Research Analyst)

Yeah, I'd like to ask a question about toxicity profile. I think you've often spoken in the past that the lack of delayed neurotoxicity, whether the more severe or the less severe forms of that, are a potential advantage, but you're still, you know, not necessarily seeing that in the revenue numbers. I wonder how your conversations with doctors in the field are going, and whether you expect toxicity to be a major point of discussion at the ODAC.

Chip Baird (Incoming CEO)

Thanks, Daina. It's a good question, and that's one that's been known and on the label for some time. I would comment broadly at a commercial perspective that the tox profile becomes increasingly important as we move towards earlier line settings, when there are other treatment options available and when the kind of benefit risk profile just is inherently different. So I think that will be an important factor as we move into this third line-plus setting. But we'll turn it to Anna to comment from a clinical perspective, an MD perspective. Anna?

Anna Truppel-Hartmann (Head of Clinical Development)

Thank you, Chip, and thank you, Daina. It is also important to note that real world experience is growing as well, in the field, which also has an impact onto you. So with all the real-world evidence that has been published, in the last month or so, at last ASH, there was a wealth of data. We can see that there is lots of delayed neurotoxicity, such as Parkinsonism, for some other products, not for, not as much for Abecma. And I think these kind of data will also influence how treating physicians see the toxicity profile for the product.

Operator (participant)

Thank you. Our next question comes from the line of Salveen Richter with Goldman Sachs. Your line is now open.

Lydia Erdman (Biotech Equity Research Analyst)

Hi, this is Lydia on for Salveen. Thanks so much for taking our question. Just on the upcoming ODAC meeting, what key piece of data do you think best supports the overall survival data? Thanks so much.

Chip Baird (Incoming CEO)

Yeah, Anna, do you want to comment on that one?

Anna Truppel-Hartmann (Head of Clinical Development)

Yes, thank you very much for the question. So the overall survival data has a key confounding factor, which is the crossover. We have used a very patient-centric study design, and therefore we haven't seen a difference between the standard of care on Abecma in the overall survival. But when adjusting for crossover, as mentioned by Chip before, then it really seems to favor Abecma. So this is kind of an important point when looking at overall survival data. In addition to that, we have had discussions around bridging therapies as well for the ITT population.

Due to the impact of bridging therapies and the importance of bridging therapies, we've seen some of either imbalance in the early part of the couple months, but overall, overall survival seems to be really favoring ide-cel when adjusting for the crossover.

Chip Baird (Incoming CEO)

Yeah, Anna, and the only thing I'd add there is overall survival was a focus of, as we said before, the regulatory discussions in Japan and in Europe and with the Swiss regulatory authorities. So, you know, this is a topic that we've had experience talking to regulators about. The team has been diligent in the prep for the meeting, and so we look forward to discussions next Friday.

Operator (participant)

Thank you. Our next question comes from the line of Yaron Werber with TD Cowen. Your line is now open.

Speaker 9

Hi, this is Jana on for Yaron. Thanks for taking our question. You're only facing a lot of competition from Carvykti in biospecifics, but looking further ahead, do you think that Abecma's lead to market is going to be sufficient to be competitive, even with newer CAR-T's in development, like Arcellx Gilead's anito-cel or Novartis' PHE885? Or do you think demand is gonna be increasing enough as CAR-T moves upstream to make room for several CAR-T to coexist?

Chip Baird (Incoming CEO)

Yeah, no, it's thanks for the question. You know, I think the history of myeloma has always been never a winner-take-all scenario. This is a huge market. It's a complex market. Patients progress through different lines of therapies in a myriad of different ways. And again, as we expand from the current label to this expanded third line-plus setting, the market opportunity is significant. It will be difficult for any one manufacturer to meet that demand.

And as Anna alluded to before, as we look at the real-world evidence and as we understand more and more about these therapies, not outside the strict confines and controlled setting of a clinical study, but actually in their use and application in the real world, differences emerge, and our understanding of what's the best product for the best patient population evolves, and we think that's going to play out over a very long time. I think the outside world is, has taken somewhat of a winner take all kind of mindset, and that's that's convenient, and that's a but we think it's a simple, it's an oversimplification of the nuance between these different products.

And as we said, we like the benefit-risk profile of Abecma. We like the safety and efficacy profile. We think it's competitive, and we look forward to educating on that in the third-line-plus setting throughout the balance of this year.

Operator (participant)

Thank you. Our next question comes from the line of Kelsey Goodwin with Guggenheim Securities. Your line is now open.

Kelsey Goodwin (VP)

Oh, hey. Good morning. Thank you for taking my question. I guess on the real-world evidence that's being generated, could you just remind us what are the major key areas of differentiation for Abecma that that's arising with the real-world data? And then maybe quickly, follow up on increasing the site footprint. Could you maybe just expand a bit there? I guess, are these sites that already have existing CAR T infrastructure, and how will that build out look? Thank you so much.

Chip Baird (Incoming CEO)

Sure. Thanks, Kelsey. Maybe I'll take the site footprint question first, and then we can talk about the points of differentiation that are emerging in the real world evidence and real world setting. From a site footprint perspective, we've, as we've described before, we continue to increase the number of sites where Abecma is available for patients in a large market like the U.S. That's really important for patients, particularly later line patients for whom extended travel is difficult. So again, we started in larger cities and larger academic centers where the catchment was just larger and that made a lot of sense. But as we've increased the footprint, that's gonna make Abecma available for more and more patients.

You know, we have plans to continue to expand that footprint over time. So, you know, that's an important commercial driver, but I think the main one is gonna be our ability to describe and articulate both the safety profile and the efficacy, the competitive efficacy profile of Abecma in the third-line-plus setting. In terms of what we're seeing and some of those competitive differentiators in the real-world evidence, you know, again, it's both safety and I think a closing of the gap from the efficacy perspective, but Anna, I think, would be best to comment on that.

Anna Truppel-Hartmann (Head of Clinical Development)

Yes. Thank you, Chip. The real-world evidence data is wonderful to see that the wealth of data is increasing with Abecma being available now for a while commercially. And what we really can see is that whatever data set that is looked at in the data are reproducible from the KarMMa pivotal study. So any data set has shown either same efficacy or even better efficacy. And of note, many of those patients that are treated in real-world wouldn't have been eligible for the pivotal study. So this is very encouraging to see that the real-world evidence data seem to be very beneficial for Abecma with regards to efficacy, but also with regards to safety.

I do think there was also a lot of data around safety profile of the new agents approved in myeloma, and also Abecma looks very, very good compared to the other profiles with regards to non-relapse mortality or infections or delayed neurotoxicities, et cetera. So I do think we are very pleased to see how the body of evidence in real-world evidence is showing positive results.

Operator (participant)

Thank you. Our next question comes from the line of Samantha Semenkow with Citi. Your line is now open.

Samantha Semenkow (VP)

Hi, good morning. Thanks for taking our question. I'm wondering if you're able to share any insights on Abecma's utilization trends over the last several months or quarters. You know, and what types of patients are receiving, continuing to receive Abecma? You know, how are physicians making the decision to utilize Abecma versus their competitive BCMA options? Where types of centers are you seeing Abecma used? You know, any insight you're able to provide would be helpful. Thank you.

Chip Baird (Incoming CEO)

Hi, Sam. Yeah, thanks for the question. I would say it's really site specific in terms of how it's being used. So again, we don't tend to think of Abecma being, you know, niched for, you know, a given type of patient. So really, I think it depends on the site in terms of whether it's an Abecma-only site, whether it's an Abecma and a T-cell engager site, or whether they have multiple CAR-Ts. Those are all different factors that I think impact how Abecma is being deployed. But certainly as we think about both the fifth line and looking forward to the third line plus setting, we don't see Abecma as like a niche to, you know, a given subset of patients.

Anna, anything from a clinical perspective to add?

Anna Truppel-Hartmann (Head of Clinical Development)

No, thanks. Thank you. I think you're good.

Operator (participant)

Thank you. I'm showing no further questions at this time. I'd like to hand the call back over to Chip Baird for closing remarks.

Chip Baird (Incoming CEO)

Thank you, everyone, for making time for the call today. We look forward to sharing more updates, and I'm sure we'll be talking again on the other side of the ODAC meeting this week. With that, wish everyone a great day. Thank you.

Operator (participant)

This concludes today's conference call. Thank you for your participation. You may now disconnect.