2seventy bio Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
November 14, 2023

There are 10 speakers on the call.

Operator

Good day and thank you for standing by. Welcome to the 270 Bio Third Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. You will then hear an automated message advising your hand is raised.

Operator

Please be advised that today's conference is being recorded. I would now like to hand the conference over

Speaker 1

to your speaker, Elizabeth Hicken, Head

Operator

of Investor Relations. Please go ahead.

Speaker 1

Thank you, operator. This morning, 270 Bio issued a press release on our Q3 2023 financial results. The press release can be found in the Investors and Media of the company's website at 270bio.com. Speaking on the call today are Nick Leshle, Chief Chiro's Officer Chip Baird, Chief Operating Officer and Steve Bernstein, Chief Medical Officer. Philip Gregory, Chief Scientific Officer is also on the line for the Q and A section.

Speaker 1

As a reminder, today's discussion will include forward looking statements related to 270 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 and statements regarding our financial condition, expectations and other 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 ks 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 statements.

Speaker 1

At this time, I would like to turn the call over to Nick Leschley. Nick?

Speaker 2

Thank you, Liz. Good morning, everyone, and thank you for joining us as we discuss our Q3 results and business updates. While this quarter was challenging for 2 70 and the broader biotech markets, we continue to take actions to best position the business and our science for future success. In September, we made the difficult but necessary decision to reshape our organization to allow us to advance our pipeline and support our partners at BMS as they redouble their commercialization efforts with Abekma. Chip will discuss in more detail.

Speaker 2

We continue to support BMS in their efforts to return Abekma to growth and believe in the significant benefits it delivers for patients. We also look forward to presenting important data at the upcoming American Society Of hematology meeting, Steve will walk through what we saw in the abstracts from Karma III and Karma IIC presentations. In this environment, We have a sharp focus on the future, determining how to best ensure our important therapies become available to patients in need, drive value for our shareholders and continue to do what's best Our employees, we are evaluating all options to achieve these objectives. As always, I would like to thank our 270 team. I remain deeply grateful for our dedicated and talented employees who continue to go above and beyond to advance our programs and deliver for patients.

Speaker 2

I could not be more proud of the culture and the talent that we've built at 270. I will now hand it over to Chip to talk more about Abekma and our Q3 results.

Speaker 3

Thanks, Nick, and thanks to everyone for joining the call this morning. As our partners at BMS shared last month, the scheduled manufacturing plant maintenance and the competitive dynamics have impacted performance of Beqma. In the Q3, BMS reported $69,000,000 in U. S. Top line sales for Beqma for a total of $302,000,000 year to date.

Speaker 3

As a reminder, we are in a fifty-fifty COCO BMS for the U. S. At Backbone Business, we record collaboration arrangement revenue, which represents 50% of the operating profit of the U. S. Business.

Speaker 3

For the quarter ending September 30, 2023, we recorded $500,000 of collaboration revenue related to Abecma. The decline in collaboration revenue was primarily due to Abacma's top line performance. As Nick mentioned, this was A challenging quarter and we do expect competitive pressure for Abekma to continue in the Q4. That said, we and BMS continue to believe in the long term potential for Abekma to meaningfully impact the lives of patients with multiple myeloma. We're focused on supporting our partners at BMS and their efforts to get the program back on track, which include expanding the site footprint to enable more patients to access Abekma, educating physicians on the treatment sequencing and the emerging data The use of BCMA directed CAR Ts before other BCMA targeted therapies and competitively differentiated Beqma's Real world safety and efficacy profile.

Speaker 3

Steve will discuss this in greater detail later on the call. Nevertheless, the pressure on Abeka has had a meaningful downstream impact on 2 70s business. As a result, we have taken actions to reshape our organization. In In September, we announced a headcount reduction of approximately 40% and a streamlined approach to our pipeline, including pausing investment in our next generation AML program and gaining future investment in our BBT-three sixty nine program. The restructuring and cost savings actions are expected to achieve more than $130,000,000 in cost savings in 2024 2025.

Speaker 3

We also anticipate staying within our previously guided net cash spend range of $180,000,000 to 220,000,000 in 2023, and we will continue to carefully manage our cash to preserve financial runway. We believe the return To growth for Beccma will take some time and we are working closely with BMS on this effort. In the meantime, we're continuing to closely manage our balance sheet, operations and investments with a focus on doing what's best for the company and our stakeholders over the long term. With that, I'll hand it over to Steve to provide some additional detail on data that we will present at ASH. Over to you, Steve.

Speaker 4

Thanks Chip and good morning everyone. Last week abstracts The ASH meeting went live, and I wanted to highlight 2 key Abekaem presentations that are scheduled for the meeting. The first is the final progression free survival analysis This is from our KARMA-three study. As a reminder, KARMA-three is our registrational study comparing Abekma to standard of care In triple class exposed patients with relapsed and refractory multiple myeloma who received 2 to 4 prior lines of therapy. This is the 1st controlled study comparing a BCMA targeted CAR T against standard of care.

Speaker 4

And last year, we announced that the study met its primary endpoint of progression free survival. The latest data to be presented at ASH shows that with additional follow-up, there is a deepening of responses in the Abekma arm. In addition, the significantly longer progression free survival of patients treated with Abekma compared to those treated with standard of care was maintained with further follow-up With the risk of progression or death reduced by 51% in the Abekma arm. Median PFS in the Abekma arm was 15.7 months compared to 4.4 months in the standard of care arm. And finally, the safety profile of the Beccra Remain consistent with previous reports with no reported Parkinsonian toxicity or Guillain Barre syndrome reported.

Speaker 4

An interim look at overall survival in this study will also be shared during the presentation of ASH. In addition to the K3 data, we'll also be presenting data from our Phase 2 KarMMa 2 cohort 2c study of vibecma. This is in clinically high risk Patients having an inadequate response to frontline autologous stem cell transplantation that's defined as patients having less And a very good PR to transplant. In the updated data, Abekma continued to demonstrate deep and durable responses With no new safety signals observed with extended follow-up. And importantly, none of the patients who receive lenalidomide maintenance after Abekma Experience disease progression.

Speaker 4

Indeed, these data are highly supportive of the registrational Karman-nine study And a similar patient population, which is currently open and enrolling. These data along with additional sub analyses Presented on patient reported outcomes and quality of life continue to reinforce the importance of the bekmir in the treatment armamentarium for patients relapsedrefractorymultiple myeloma and reinforce its manageable and well understood safety profile as well as its potential to play an important role in earlier lines of therapy against this relentless insidious disease. With that, I'll turn it back to Nick.

Speaker 2

Thank you, Steve. We appreciate everyone's time, and we will close by saying we remain committed to delivering for patients, Our employees, our translational science and our shareholders. Clearly, it has been a challenging period for our company and all our stakeholders. As I said at the outset of the call, we are focused on all options to deliver for our mission and for all stakeholders. With that, operator, you may now open the line for questions.

Operator

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

Speaker 5

Thanks for taking my questions. Maybe a couple of questions. Number 1, I guess Nick or Chip whoever wants to take it. You're mentioning that I think we'll take some time to return to growth for Abekma. Does that include the legal extension related And then secondly, on the OpEx side and profitability for the Abekma JV, now that K2 is open and obviously you're incurring more manufacturing Are you expecting Abekkma to be profitable, let's say, in Q4 and then next year as well, the Abekkma JV?

Speaker 5

Thank you.

Speaker 2

Thanks, Sharon. It's a little bit of a choppy line that you're on there, but we'll do our best to get after your questions. I think you had referenced We that we have said it might take some time for Abekima to restore. So I'll comment on that and then hand it to Chip for additional and then maybe you can speak to the profitability question. So, Yaron, I think it's just more of a generalized statement that's saying that those efforts at BMS and we're in support of, Those take time to get hold, right?

Speaker 2

This is an education piece. This is a data driven piece, but we do believe strongly in Abakma's place in the ecosystem As it continues to evolve with the data, the real world evidence as well as other factors that have to do with the safety profile balance with the APECMA Profile, which we think is certainly one that is has its place in that community. And so that's also where BMS is at. But these things don't happen overnight. So that is what we're in the midst of, and we're just trying to be as clear headed as we can about the timing that, that will take for it to settle more appropriately into the marketplace and the commercial setting.

Speaker 2

One of the key bits in that is certainly expansion of the centers and making sure that the availability is there and making sure the supply is there and we can deliver day in, day out. So, Ewen, all those things just take time, and that's what we're just indicating. Chip, if you want to add to that, feel free and then maybe address the second question.

Speaker 3

Yes. No, I think you said it well in terms of those dynamics on the return to growth, with regard to profitability, really this is going to be driven By patient volumes, by continued focus on operating leverage, particularly with regard to the cost and that we've seen good progress. And then of course, the clinical trial profile. So A number of the studies that were launched previously have are beginning to sell off. But at the same time, we as you know, we are standing up the CARMIN-nine study And that will be a cost.

Speaker 3

Net net, we expect Abacma to be a contributor to our business over the coming years. But what that looks like, the shape and how soon we see a return to growth, I think is something that we're continuing to sort.

Speaker 2

Thanks, Jerome.

Operator

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

Speaker 6

Hey, good morning. Thanks for taking my question. I guess, first, on Abak bookkeeping there. I guess, Could you just remind us the status of Karma 9? And then separately on the MAGE A 4 program, I guess, could you remind us what Are there

Speaker 1

is there specific solid tumors that are being enrolled in the China study and maybe thoughts around the activity signal so far kind of mainly

Speaker 3

Yes. Just Chip, do you

Speaker 2

want to jump in on the first one?

Speaker 3

Yes. KARMR-nine is That study has initiated and we're beginning the process of enrolling patients. So that's very exciting. And again, that's targeted towards A frontline label for patients with the suboptimal response to transplant. We think that's an important unmet need And that newly diagnosed population, and more to come on that one, but that one's up and underway, which is a big milestone.

Speaker 3

On the MAGE A 4 stuff, so as you know, we have a collaboration with JW to put that into the clinic. That's obviously on track still. So we're excited to get that clinic bound very shortly. In terms of indications, obviously, this is a very target centric So the primary goal is to make sure the patients enrolled are MAGE A 4 positive. And at least initially, we don't have a We're not sort of singling out a particular indication to focus on in the initial studies.

Speaker 3

So we're largely looking at this from an initial safety and efficacy We're establishing the initial safety and efficacy of the MAGE A 4 program. To remind you, this is not a naked TCR, so to speak. It's actually a potency enhanced one that uses our approach to turning TGF beta signaling into a positive driver of T cell proliferation.

Speaker 2

Just one comment on that. This is Nick. More broadly, I think the JW collaboration is one that we're super excited about, and MAGE is certainly the front runner and also demonstrated what they can do In actually engaging in manufacturing and getting ready to translationally deploy in China, so we can sort of understand this target. So the proof Concept model is one that we're excited about. We will be extending further into our relationship on the Regeneron front as well as our own Sort of aspirations on other targets.

Speaker 2

So that's something that from an execution point of view, timing and a cost point of view is very beneficial to the company and the mission that we're on just for a broader context. Next question?

Operator

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

Speaker 1

Good morning. This is Anumeet on for Salveen. Thanks for taking our question. Just on Abekma, I guess, what gives you confidence that the same headwinds won't play out in the earlier line setting? Thank you.

Speaker 2

So I'm not 100% clear on your question. Can you just clarify a little bit more detail about what you're asking? Or maybe you can't. So what maybe you guys can help me understand. What's the question, what makes us think that a better model will play the same way?

Speaker 2

Yes, go ahead.

Speaker 1

Sorry, I was just sorry, I think my eye got cut off. I'm just, I guess, what gives you confidence that when Abecma is approved in the 3rd line setting, The bispecifics won't come in to play there to be used ahead of Abekma in that setting as well as just competitive headwinds from other BCMA CAR Ts?

Speaker 2

Well, I'll start with an overall and then I think Steve can jump in and provide a little bit on the clinical side. First of all, the myeloma market It's never been a winner takes all market and that's never really existed. And also the supply chain doesn't really support that and the sequencing of therapy does So I think on a sort of first principles level, that's not how we see it playing out. It's also not in the interest of myeloma. This is still an incurable disease and no one has been able to cure it.

Speaker 2

So I think there's going to be room for a number of us, number of CAR Ts as well as bispecifics and others. And over time, the clinical base as well as the data that will come out will figure out the best way to use these medicines. This has always been the case, Steve can speak to that because I think that's part of what he's done in his first part of his career at But that's why we are quite confident in the data that has been and continues to come out on Abekma and how it delivers for patients in a consistent, meaningful as well as safe, Predictable way. So Steve, maybe you can add a little bit of color on your thoughts on Abekmo over time.

Speaker 4

Yes. I think as Nick mentioned, with all the different therapies, A lot of emphasis has been on how do you optimally sequence these. And I think that the data to date is really supporting the fact That if you get a CAR after you got a prior BCMA targeted therapy like a TCE or an ADC, You don't do nearly as well as if you got your BCMA CAR before having such A BCMA targeted therapy. And I think there's no reason to think that that paradigm is going to be different as you move to earlier lines of therapy. So I do think that there's an advantage in both clinical efficacy as well again as having rapid deep Responses with a single therapy that's going to make the BCMA CAR, I.

Speaker 4

E. Abekma Preferable to a BCMA TCE in earlier lines of therapy is the initial treatment of choice. So just additional comments, this

Speaker 2

is Nick again, is that I do think just broadly speaking, we and BMS believe that Sort of the data convergence is happening and is happening in the real world evidence as we'll see it over time from an efficacy point of view. And we remain, As Steve mentioned earlier, very confident around the safety profile of Abacma, which does bode well as you get into earlier lines. Last thing I'd say, I think you're also going to see a subsetting of patient populations over time in The practical use of this as you start to also overlay supply chain capabilities and scale that also take a number of years to get into its full, Let's say capacity setup, which we certainly are not at us and anyone else in the space. So overall, we think Beqima has a place and it needs to sort of Get back on track as it relates to that. And BMS, we know, is certainly committed to that, and we are as well.

Operator

Thank you. Our next question comes from the line of Dana Graybosch with Leerink Partners. Your line is now open.

Speaker 7

Hi. Thanks for the question. And if you guys could talk more about the competitive profile that you're seeing. You're talking a lot about T cell engagers. You're not mentioning the other competing CAR T by name.

Speaker 7

And the other competing CAR T hasn't seen a decline in their sales. So I guess the question is, why do you think it's the T cell engagers taking away share versus a choice at the limited centers to date Going forward, the competing CAR T, and could you help us understand the share insights where both CAR Ts are available versus the sharing sites where only Beccma is available versus T cell engagers.

Operator

Thanks.

Speaker 2

This is Nick. I can comment and then Chip will jump in. We have no problem saying CARVICTI by name, just to be clear, because it is a very important medicine that is Making a major difference for myeloma, our only comment here is that the CAR dynamic is also being interfaced with the T cell engager dynamic when you have A line out the door and that was what we were commenting on, which is that's what comes in and it perhaps is settled into a place where it's not necessarily data driven. At that point, it was more Cality driven, which is if you have a patient and you believe there's no supply available, then you do what you got to do if you're a clinician and they should do that. That is what we're saying will evolve and settle and has not yet settled.

Speaker 2

We do see that Abekma will continue to do and there are many sites where Abekma is alone, if you will. CARVERICTI Still ramping up. It's not surprising to me that their sales quote aren't down, but also they're in a ramp up phase. You recall, we've been out in the marketplace for considerably Longer than they have, etcetera. So I think we've spoken to that, and I don't think today's dynamic is necessarily going to be the dynamic 6 to 12 months from now.

Speaker 2

That's our view. That's BMS's view. And that's what we're settled into, and we're going to go deliver in the marketplace. And we believe the real world data as well as over time, the earlier line data will support That and a shared utilization of those medicines across myeloma. Any additional comments, Chip?

Speaker 3

No, I think it's well said. I think commercially, we think about competition from 2 angles, Certainly for the T cell engagers and that utilization in the community setting was probable and particularly when CAR Ts were more constrained in terms of the capacity relative to the label. Today, as CAR T capacity increases, we think and the evidence from a clinical perspective suggests That using a BCMA directed CAR T before a T cell engager ensures the optimal outcome for patients. So that's an important message With regard to that side of the competition, with regard to other CAR Ts, for a long time, we were And BMS was in more of a constrained environment now that that's less true. We're out there doing commercial things.

Speaker 3

And I think that He is talking about the profile from an efficacy perspective, importantly, a safety perspective and important differences there in terms of neurotox, And then a manufacturing perspective in terms of turnaround time and out of spec rates and things of that sort. So all of those things go into it, all of those things We're out there with a message in the field, but those opinions and perceptions and beliefs can take time to change.

Speaker 2

And one other thing that I think is sort of lost on some people is it's this is not a market that is saturated. This is not a market where there's full education and utilization throughout the myeloma market. Our estimates and BMS' estimates is that there's pretty close to 50% are not getting an advanced treatment at this point in time. So There's a huge opportunity for BACMA CARVICTI and the T cell engagers to make sure that we access everyone who can benefit from this. And That's the bigger picture in here.

Speaker 2

And then you can sit and compare us versus CARVICTI in a very specific way. I actually think that's missing the point over the long term And where it will settle in ultimately to be part of that orumeterium, and we think our data and the development plan will support that. And that's hence where the I think the additional centers That we're standing up and BMS is charging at is quite impressive and certainly exceeds the other drug you were mentioning, if you will. But at that point in time, that's where we can actually start to have the real conversations, have the supply to deliver and let it settle over time. But that's what Chip mentioned earlier in his script, We'll take some time to actually settle in.

Speaker 2

Thanks, Jamie.

Operator

Thank you. Our next question comes from the line of Samantha Simyko with Citi, your line is now open.

Speaker 8

Hi, good morning. Thanks for taking our questions. Just 2 for me. So at ASH, you noted you're expecting to present the interim overall survival data for PRIMAL-three. As we head into the upcoming PDUFA for Beqma, Can you share whether the FDA has requested to see the OS data as a part of their review?

Speaker 8

And assuming we get approval next month for third line Myeloma, how quickly can you and BMS begin providing treatment slots to patients that fall under the expanded label? Thank you.

Speaker 2

Thanks. Good question. And I'll kick it over to Steve here in a second. But just so you know, given the closeness and the engagement with the FDA, we don't comment on Sort of the ongoing PDUFA conversation as it relates to that, but we certainly can speak to what we anticipate to see at ASH at a high level where I think maybe you Speak to that, Steve, what we'll be presenting?

Speaker 4

Yes. I don't want to say anything more than the abstract, obviously to preclude the presentation. There isn't a lot in the abstract on overall survival except that we are going to present data with that. So you'll see the data there. Remember, it's important To keep in mind that the design of this study was a patient centric design, so that it did allow for patients who did progress on standard of care To go ahead and get ABECMA and there were 56% of patients that actually Crossed over from the standard of care arm to the Abekma arm, and obviously that always will confound the survival data.

Speaker 4

But I encourage you to go to the presentation at ASH and you'll see more detail on the survival data.

Speaker 2

Thanks, Steve. It's always awkward. Next question please.

Operator

Our next question comes from the line of John Newman with Canaccord Genuity. Your line is now open.

Speaker 9

Hi, guys. Thanks for taking the question. It's interesting listening to the comments that you've made on the call today regarding the competitive dynamic. I can't help but think that we are still in a market where all CAR Ts are still constrained by supply to some extent. And what I'm curious about is if you could talk about the transition that I think you're still planning to make To suspension vector, which I believe you said will happen early in 2024 and just how that might play into Increasing the supply or sort of exactly where you see that benefiting Abekma?

Speaker 9

Thanks.

Speaker 2

This is Nick. Good question. I think Chip will comment on this as well. But I think the constraint is less around the vector side of the equation. I think as we move towards suspension, which you're right, is the plan that will Perhaps help us and certainly will help us in cost of goods and also over time make sure that we never have a constraint as it relates to Vector.

Speaker 2

But where the constraint traditionally has been is in the drug product, and that is where BMS has gone after, maybe Chip can comment on a pretty significant Increase to make sure that as we get access to more patients and we open up more sites that we can deliver on all the demand that we believe is out there for CAR Ts in this setting. I'll let Chipy, if you have anything extra to add as it relates to that.

Speaker 3

No. It's pretty well said. The suspension will help us with Cost of treating patients, cost of goods sold, will take Factor largely off the table as a potential future supply constraint, but really The market and the growth in the market will be governed by how quickly we and others in the field Can ramp the drug product capacity and there we've made good progress both in terms of capacity as well as continued high level performance on Turnaround time and in spec manufacturing rates, all of those contribute ultimately to the true capacity that you can deliver And just

Speaker 2

on that, I think supply is certainly important and I think that keeps, let's say, more players in the game more consistently because when you're dealing with a patient that doesn't have a lot of time You want to intervene, then you're going to make the choices as a provider that you need to get the patient help. But I think it's going to rapidly get more complicated already is, is what's Safety profile, what's the specific of this patient, right? What are the things like? Can they travel? Can they not travel?

Speaker 2

There is A lot of factors. When I order it, do I actually get it consistently, right? Can I predict the safety profile? We're already seeing that on a sort of center by center basis. And in some cases, I've gone from being a backma users to CARVICTI users to the other way around, going from CARVICTI users to a backma users.

Speaker 2

And we're going to anticipate See that as people get used to both medicines in which populations they're either comfortable due to their own personal experiences and maybe an institutional experience. So That we're seeing on the ground, if you will, and that's just beginning. And I'll come back to the point that we've made earlier, which is there's still a huge way to go to tap into this entire population that's eligible over time. And that is going to settle, but that's not going to settle until we get more centers spread out over the country up and running across all these Medicines and then I think, each of us will have, I think, certainly a share, if you will, and a contribution to hopefully Getting myeloma beat into the cure category.

Operator

Thank you. And I'm currently showing no further questions at this time. I'd like to Turn the call back over to Nick Leshle for closing remarks.

Speaker 2

Thank you very much. I appreciate everyone taking the time. And if you have any So more detailed questions or anything we said was not clear, then please feel free to follow-up with Liz or our folks here, and then we'll be happy to get back to you. Thank you very much. Have a great day.

Operator

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

Powered by Quartr
Earnings Conference Call
2seventy bio Q3 2023
00:00 / 00:00