Q1 2024 2seventy bio Inc Earnings Call
Yeah.
Operator: Good day, and thank you for standing by. Welcome to the 2Seventy Bio First Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Jenn Snyder from 2Seventy Bio. Please go ahead.
Good day, and thank you for standing by.
Speaker Change: Welcome to the 270 bio first quarter 2024 earnings conference call. At this time, all participants are in a listen only mode.
Speaker Change: After the speaker's presentation, there will be a question and answer session to ask a question. During the session you will need to press star one on your telephone you will then hear an automated message advising your hand is free.
Speaker Change: Draw. Your question. Please press star one again.
Speaker Change: Be advised that today's conference is being recorded I would now.
Speaker Change: The conference over to your Speaker today, Jim Snyder was 270 bio. Please go ahead.
Jenn Snyder: Thank you, Shannon, and good morning, everyone. Thank you for joining us.
Jenn Snyder: Thank you Shannon and good morning, everyone. Thank you for joining US. This morning, we issued a press release on our first quarter 2024 financial results. The press release can be found in the investors and media section of the company's website at 270 bio Dot Com as a reminder, today's discussion will include forward looking statements related to 275.
Jenn Snyder: This morning, we issued a press release on our first quarter 2024 financial results. The press release can be found in the investors and media section of the company's website at 270bio.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 a BECMA, the timing and review of additional studies and regulatory applications for a BECMA, and statements regarding our financial condition, expectations, and future financial results, among others.
Jenn Snyder: 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 statements. On today's call, we are joined by Chip Baird, Chief Executive Officer, and Vicki Eatwell, Chief Financial Officer. Anna Truppel-Hartman, Chief Medical Officer, is also on the line for questions during the Q&A. And now I will turn it over to Chip. Chip.
Jenn Snyder: <unk> current plans and expectations, which are subject to certain risks and uncertainties. These forward looking statements include statements regarding <unk> regarding our strategic plans timelines and expectations with respect to sales efficacy and perceived therapeutic benefits of our beckmann, the timing and review of additional studies and regulatory.
Jenn Snyder: For Bachelor and statements regarding our financial condition expectation and future financial results among others.
Jenn Snyder: 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.
Jenn Snyder: 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 on today's call. We are joined by chip Baird.
William D. Baird: Chief Executive Officer, and Vickie, well, Chief Financial Officer, and Anna Triple Hartman, Chief Medical Officer is also on the line for questions. During the Q&A and now I will turn it over to chip chip.
William D. Baird: Thank you, Jenn, and thank you all for joining this morning. Today, we disclosed our first quarter 2024 financial results and recent business and operational updates. I'd like to walk through some of the business updates, and then Vicki Eatwell, our Chief Financial Officer, will go into detail on our financials. The first quarter of 2024 was an eventful one. We completed a major strategic realignment to focus exclusively on the back. To achieve this, we sold our oncology and autoimmune R&D programs to Regeneron.
William D. Baird: Thank you Jen and thank you all for joining this morning.
William D. Baird: Today, we disclosed our first quarter 2024 financial results and recent business and operational updates I'd like to walk through some of the business updates and then Vicky E Mail, our Chief Financial Officer, who will go into detail on our financials.
William D. Baird: As part of the sale, we transferred approximately 160 employees and approximately 67% of our real estate footprint to Regeneron. We think this is an ideal outcome for the science and these programs, and we look forward to seeing what the team can achieve in years to come. We also took the tough but necessary decision to reduce headcount by an additional 14% as part of the strategic refocus.
William D. Baird: First quarter of 2024 wasn't a Apple watch.
Speaker Change: We completed a major strategic realignment to focus exclusively on a background too.
Speaker Change: To achieve this we sold our oncology and auto immune R&D programs to regeneron.
Speaker Change: As part of the sale, we transferred approximately 100 160 employees at approximately 67% of our real estate footprint to regeneron.
Speaker Change: We think this is an ideal outcome for the science and these programs and we look forward to seeing what the team can achieve in years to come.
Speaker Change: We also took the tough but necessary decision to reduce head count.
Speaker Change: Additional 14% that's part of the strategic refocusing.
William D. Baird: The end result is that we have emerged with a leaner cost structure, cash runway beyond 2027, and time to get it back on track commercially. To that end, we have consistently said that the path to vecna growth hinges on earlier line approval. We have gone on quite a journey on this front, including an ODAC meeting in March to advise FDA on our supplemental BLA. The 2Seventy and BMS teams did an amazing job at the panel, and we were subsequently approved in the early-online setting, which opens a much larger addressable patient population.
Speaker Change: The end result is that we have emerged with a leaner cost structure cash run rate beyond 2027, and time to get it back right back on track commercially.
Speaker Change: To that end, we've consistently said that the path to that kind of growth hinges on earlier line approval.
Speaker Change: We traveled quite a journey on this front, including at <unk> meeting in March to advise FTA on our supplemental BLA for <unk>.
Speaker Change: 70, and BMS teams did an amazing job at the panel and were subsequently approved in the earlier line studies, which opens up a much larger addressable patient population.
William D. Baird: So it's been a great start to the year, and we are now singularly focused on getting Infection Back on Track. We're in the early days of launch, and expect that it'll take into the second half before we see meaningful growth. We've talked for some time now about known strengths for a backline, including strong efficacy that is reproducible in the real-world setting, a well-established and manageable safety profile, and consistent manufacturing turnaround time and high rates for InSpec products.
So it's been a great start to the year and we are now singularly focused on getting it back to back on track commercially.
Speaker Change: We are in the early days of launch and expect that it will take into the second half before we see meaningful growth.
Speaker Change: We've talked for some time now about known strengths for background, including strong efficacy that is reproduced in the real world setting.
Established and manageable safety profile and consistent manufacturing turnaround time at high rates of in spec product.
William D. Baird: With Karma 3 data in the label and real-world evidence that continues to mature, we believe we have a competitive profile in earlier-line, triple-class exposed patients, which is a population with high unmet needs. To be clear, multiple myeloma is a competitive market space, and a return to growth will take time. But we have a strong commercial organization and a launch strategy that we believe in, and we look forward to executing on them. I'm happy to talk about our strategy in the Q&A, but for now, we'll turn it over to our newly promoted CFO, Vicki Eatwell, to talk about the first quarter results.
Speaker Change: <unk> three data in the label and real World evidence that continues to mature. We believe we have a competitive profile in earlier line Triple class expose patients, which is a population with high unmet need.
Speaker Change: To be clear multiple myeloma is a competitive market space and a return to growth will take time.
Speaker Change: But we have a strong commercial organization and our launch strategy that we believe it and we look forward to executing on the plan.
CFO: I'm happy to talk about our strategy in the Q&A, but for now I will turn it over to our newly promoted CFO sticky eat well talk about the first quarter results Vicky. Thanks.
Vicki Eatwell: First quarter of ECMA U.S. revenues, as reported by Bristol-Myers Squibb, were $52 million, which was in line with our expectations and reflects ongoing competition in the late-line setting. As Chip stated, we are in the midst of a commercial launch following the recent FDA approval of abecma based on our CARMA 3 study, which greatly increases the addressable patient population. We look forward to delivering abecma to an increased number of patients and expect to see a return to growth in the second half of the year.
Vicki Eatwell: Thanks, Jeff.
Vicki Eatwell: First quarter U S revenues as reported by Bristol Myers Squibb for $52 million, which was in line with our expectation and reflects ongoing competition in the late line setting.
Vicki Eatwell: As Jeff stated we are in the midst of a commercial launch following the recent FDA approval of our backlog based on our Karma three study, which greatly increases the addressable patient population, we look forward to delivering it back led to an increased number of patients and expect to see a return to growth in the second half of the year as.
Vicki Eatwell: As a reminder, we share equally in the profits or losses of the U.S. Abecma business with BMS, and we record collaboration arrangement revenue or loss each quarter, which largely represents our 50% share of revenue, cost of goods sold, and selling expenses related to the U.S. business. In the first quarter, we reported a share of collaboration loss of $1.2 million related to our collaboration with BMS, driven by decreased patient demand in the late-line setting.
Vicki Eatwell: As a reminder, we share equally in the profits or losses in the U S. At backflip business with Sienna and we record collaboration arrangement revenue or loss each quarter, which largely represents our 50% share of revenue cost of goods sold and selling expenses related to the U S business.
Vicki Eatwell: In the first quarter, we reported share of collaboration loss of $1 $2 million related to our collaboration with BMS driven by decreased patient demand in the late line setting.
Vicki Eatwell: Turning briefly to our cost structure, and as a reminder, the sale of our R&D pipeline to Regeneron, combined with our cost-saving actions, is expected to achieve $150 to $200 million of cost savings in 2024 and 2025, respectively. We anticipate staying within our previously guided net cash spend range of $80 to $100 million in 2024, and we are committed to carefully managing our spend to preserve cash runway. As we reported last quarter, we expect our runway to go beyond 2027 and see a path to potential breakeven by 2025 as VECMA returns to growth. With that, I'll turn it back.
Vicki Eatwell: Turning briefly to our cost structure and as a reminder, the sale of our R&D pipeline to Regeneron combined with our cost saving action is expected to achieve 150 to 200 million of cost savings in 2024, and 2025, respectively. We anticipate staying within our previously guided net cash spend range of 82.
Vicki Eatwell: $100 million in 2024, and we are committed to carefully managing our spend to preserve cash runway.
Vicki Eatwell: As we reported last quarter, we expect our runway to go beyond 2027.
Vicki Eatwell: Your path to potential breakeven by 2025 as the backroom of returns to growth with that I'll turn it back to chip.
William D. Baird: Thanks, Vicki. I'll close with two thoughts. First, we've been through a lot of change in the first quarter, but one thing that is unchanged is our patient focus. We believe in the potential of Vecma to make a meaningful impact for patients in the early reliance setting and are singularly focused on delivering more time for every myeloma patient we are able to serve. Together with our partners at VMS, this will be a top priority.
William D. Baird: Thanks Vicki.
William D. Baird: Closer to two thoughts first we've been through a lot of change in the first quarter, but one thing that is unchanged our patient focus.
William D. Baird: We believe in the potential of background to make a meaningful impact for patients in the earlier line setting and are singularly focused on delivering more time for every myeloma patient we were able to serve together with our partners at BMS. This will be a top priority second.
William D. Baird: Second, we're focused on being careful stewards of investor capital, staying focused on reaching breakeven and profitability and driving value for shareholders. Together with Vicki, Anna, Jess, and the rest of the team, we will continue to focus on these priorities to drive value. And with that, we're happy to take questions. Operator. Thank you.
William D. Baird: Second we're focused on being careful stewards of investor capital staying focused on reaching breakeven in profitability and driving value for shareholders together with Vicki on adjusting the rest of the team. We will continue to focus on these priorities to drive value and with that we're happy to take questions operator.
Operator: Thank you. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. We ask that you please limit yourself to one question. Please stand by. Our first question comes from the line of Daina Graybosch with Lee Ring Partners. Your line is now open.
William D. Baird: Thank you as a reminder to ask a question. Please press star one wanted to telephone and wafer name to be announced.
To withdraw your question. Please press star one again, we exited you please limit yourself to one question.
Speaker Change: Please standby will compile the Q&A roster.
Speaker Change: Our first question comes from the line of Dana <unk> with Leerink Partners. Your line is now open.
Rabib: Hi, this is Rabib on behalf of Dana. Thank you for the question; is the question related to Becma profitability? How should we think about Becma collaboration profitability going forward? Is there a threshold revenue above which the program will be consistently profitable given flat sales over the last three quarters? You know, what is driving this fluctuation in profitability and collaboration loss from quarter to quarter? And can we better anticipate these fluctuations in our model? And then there's a short follow-up after that.
Speaker Change: Hi, This is <unk> on for Dana. Thank you for the question.
Or the question is related to backlog profitability.
Speaker Change: How should we think about a backpack collaboration profitability going forward.
Speaker Change: Is there a threshold revenue above which the program will be consistently profitable given.
Speaker Change: Flat sales over the last three quarters.
Speaker Change: You know what is driving this fluctuation in profitability in collaboration loss from quarter to quarter.
Speaker Change: And can we better anticipated fluctuations in our model.
Speaker Change: And then Theres a short follow up.
Speaker Change: After that.
William D. Baird: Sure, I'll comment briefly and then ask Vicki to add color, but, you know, in this fifth line plus setting, we've been fairly flat on the revenue side for the last couple quarters and hovering with a small collaboration revenue or a small share of collaboration losses we saw in this quarter and in that $50 million. 50 million revenue run rate on a quarterly basis. So, you know, we're going to need to see that return to growth to see a consistent path toward collaboration revenue and profitability.
Speaker Change: Sure.
Speaker Change: Comment briefly and then ask.
Speaker Change: Vicki would add color but.
Speaker Change: And this fifth line plus setting we've been fairly flat on the revenue side for the last couple of quarters and hovering with a small collaboration.
Speaker Change: Revenue or small share collaboration loss that we saw in this quarter in that $50 million.
Speaker Change: Got it.
Speaker Change: 50 millions.
Speaker Change: Revenue run rate on a quarterly basis so.
Speaker Change: Yeah.
Speaker Change: We're going to need to see that return to growth to see a consistent path towards collaboration.
William D. Baird: And again, we think we have the plan to do that. I would note, too, that profitability, as we increase revenues, is helped by better and better capacity utilization on the manufacturing side. We have, as is typical of car team manufacturing, a high fixed cost structure. And so the more volume we can push through there, the better the margins will become. So more to come on that front, but certainly, we believe in that path and the levels that we achieved before. We believe this is a profitable business.
Speaker Change: Collaboration revenue and profitability and again, we think we have the plan to do that.
Speaker Change: I would note too that that profitability as we increase revenues.
Speaker Change: Helped by a better and better capacity utilization on the manufacturing side, we have.
Speaker Change: As typical with car T manufacturing high fixed cost structure.
Speaker Change: And so the more volume we can push through there.
Speaker Change: The better the margins will become so more to come on that front, but certainly we believe in that path and that levels that we achieved before.
Speaker Change: We believe this is a profitable business.
William D. Baird: And then just on that manufacturing note, thanks, Chip, for going in that direction. How will the shift to the suspension vector impact profitability? And when should we expect that transition from adherent to suspension to play out in the collaboration profitability line?
Speaker Change: Thank you and then just on that manufacturing and al Thanks chip for going in that direction.
Speaker Change: How old is the ship to suspension vector impact profitability.
Speaker Change: When should we expect that transition from adherent to suspension play out.
Speaker Change: Collaboration profitability line.
William D. Baird: Yeah, so we, as we've shared, we've been approved for suspension, which is great news. And you know, another important point of execution on the manufacturing side, and that helps certainly from a capacity perspective, as well as from an overall cost to treat a patient. That transition from adherent to suspension in terms of the actual impact on cost will happen over time as we use the remaining adherent vector and then make that cut over to suspension. From a technical risk perspective, we're past that, and we're approved for utilization there, which is great news.
Speaker Change: Yes, so we as we've shared we've been approved for suspension, which is great news.
Speaker Change: Another.
Speaker Change: Important.
Speaker Change: The point of execution on the manufacturing side and that helps certainly from a capacity perspective as well as an overall cost to treat a patient that true.
Speaker Change: <unk> from adherent to suspension in terms of the actual impact on costs will.
Speaker Change: It will happen over time is as we use remaining adherent vector and then make that cut over to suspension, but.
Speaker Change: From a technical risk perspective, we're past that and we're approved for utilization, there, which is which is great news.
Matt Ong: Thank you. Our next question comes from the line of Salveen Richter with Goldman Sachs. Your line is now open.
Speaker Change: Thank you.
Speaker Change: Our next question comes from the line of <unk> Richter with Goldman Sachs. Your line is now open.
Matt Ong: Hey, thanks. This is Matt Ong for CellBeam.
Matt Richter: Hey, Thanks, this is Matt on herself.
Matt Richter: You noted meaningful expectation for meaningful growth in the second half could you expand on that or maybe quantify in any way and then could you speak to the current dynamics of the launch and how much of it is competition from bi specifics where car T versus supply constraints.
William D. Baird: You noted meaningful expectations for meaningful growth in the second half. Could you expand on that or maybe quantify it in any way? And then could you speak to the current dynamics of the launch and how much of it is competition from bi-specifics or carbon-based feed versus supply constraints? And then, just a follow-up question, could you talk about expectations for op-ex spend in the rest of 2024 and then 2025? Thank you.
Matt Richter: And then just a follow up question could you just talk about expectations for Opex for the rest of 2024 and 2024. Thank you.
Matt Ong: Sure, I didn't catch the last part of your year to three part question there. Could you say the last part again?
Speaker Change: Sure I didn't catch the last.
Speaker Change: Part of your you had a three part question there could you say that last part again.
Matt Ong: The last part was just OPEX spend in 2024 and 2025.
Speaker Change: Sure.
Speaker Change: Part was just opex spend in 2024 and 2025.
Speaker Change: Yes.
William D. Baird: Yeah. So in terms of meaningful growth. We haven't gotten specific on that, but from these levels, again, it doesn't take a lot in what is a much larger market to be posting meaningful growth. As a reminder, we achieved over $100 million of revenue in the first and second quarters of last year in a much smaller fifth line plus market. So with the expanded label, we feel very excited about the market opportunity and about the data set that stands behind that and our ability to engage with treating physicians and educate them about the product profile, which is different and improved, and which we can get into.
Speaker Change: Alright, great.
Speaker Change: Yes.
Speaker Change: So in terms of.
Speaker Change: The.
Speaker Change: Meaningful growth, we haven't gotten specific on that.
Speaker Change: But from from these levels again.
Speaker Change: It doesn't take a lot in what is a much larger market to be be posted meaningful growth as a reminder.
Speaker Change: We achieved over $100 million of revenue in the.
Speaker Change: First and second quarter of last year at a much smaller decline plus market so with the expanded label.
Speaker Change: We feel very excited.
Speaker Change: About the market opportunity and about the dataset that stands behind that and our ability to.
Speaker Change: To engage our treating physicians and educate on.
Speaker Change: The product profile, which is different that improved and we can get into.
William D. Baird: But that's what I would say in terms of the path to meaningful growth in the second half of the year. I'll turn it to Vicki to comment on the OPEX. Thanks.
Speaker Change: But that's.
Speaker Change: That's what I would say in terms of the path too.
Speaker Change: Meaningful growth in the second half of the year.
Vicki Eatwell: Thanks. And just to address the question on supply constraints, we are not supply constrained. We have enough capacity to meet our existing label, and furthermore, we have the ability to expand capacity within our existing manufacturing infrastructure. Just to turn to your question on OPEX, when we think about spend in 2024, just excluding non-cash OPEX, we're characterizing 2024 as being about half of what 2023 spend was. And as we turn to 2025, I would guide that spend would be about a third of what we would have expected from what we experienced in 2023. So I would use that from a modeling perspective.
Speaker Change: Ill turn it to Vicki to comment on the Opex, Thanks, and just to address the question on supply constraints, we are not supply constrained we have enough.
Vicki Eatwell: On the capacity to meet our existing label and further we have the ability to expand capacity without it within our existing manufacturing infrastructure.
Vicki Eatwell: Just to turn to your question on Opex, when we think about spend in 2024% excluding noncash opex.
Speaker Change: We're characterizing 2024 as being about.
Vicki Eatwell: Half of what 2023 spend was and as we turned to 2025 I would guide that spend would be about a third of what we would have expect of what we experienced in 2023. So I would use that for us from a modeling perspective.
Speaker Change: Thank you.
Kelsey Beatrice Goodwin: Our next question comes from the line of Kelsey Goodwin with Guggenheim Securities. Your line is now open.
Speaker Change: Thank you.
Speaker Change: Our next question comes from the line of Kelsey Goodwin with Guggenheim Securities. Your line is now open.
Kelsey Beatrice Goodwin: Oh, hey, good morning. Thanks for taking my question. First, I guess, can you provide any early commentary on what you're seeing and hearing about the kind of post-label expansion with CARMA 3? And then, I guess, maybe prior to the expansion, in terms of the competition and the headwinds you were facing, you know, previously, were you seeing that mainly from CAR-T competitors or by specifics or a blend and just kind of the market in general, just trying to get a Thanks so much.
Kelsey Beatrice Goodwin: Oh, Hey, good morning, Thanks for taking my question.
Kelsey Beatrice Goodwin: First I guess can you provide any early commentary on what youre seeing and hearing kind of post label expansion with Karma three and then I guess, maybe prior to the expansion in terms of the competition and the headwinds you're facing.
Kelsey Beatrice Goodwin: Previously.
Kelsey Beatrice Goodwin: Are you seeing that mainly from car T competitors or bi specifics or a blend and just kind of the market in general just trying to get a little more color. There. Thanks so much.
William D. Baird: Kelsey, yeah, thanks. Good, good questions.
Kelsey Beatrice Goodwin: Okay.
Speaker Change: Thanks Kelsey thanks.
Speaker Change: Questions I'll take the second one first which is.
Speaker Change: From a competitive perspective.
Speaker Change: As we've said.
Speaker Change: Myeloma is a competitive field and I think.
Speaker Change: Car T competition as well as by specs are all at play in the kind of where we stand which is fifth line plus setting I think it is a bit of a reset as we move into the third line setting.
Speaker Change: Today by specs are not present there.
William D. Baird: I'll take the second one first, which is from a competitive perspective. As we've said, myeloma is a competitive field. And I think CAR T competition as well as specs are all at play in the kind of where we've been, which is the fifth line plus setting. I think it is a bit of a reset as we move into the third line setting. You know, today by specs are not present there.
Speaker Change: And again I think our focus commercially is articulating.
Speaker Change: Beckman story and the data set that we have there and again I think asking.
Speaker Change: And engaging with treating physicians to to look at their own patients and the experience with the product across dimensions of efficacy safety manufacturing reliability all of that so.
Speaker Change: We've got a strong belief set there we.
William D. Baird: And again, I think our focus commercially is articulating the Vecma story and the data set that we have there. And again, I think asking and engaging with treating physicians to look at their own patients and the experience with the product across dimensions of efficacy, safety, manufacturing reliability, all of that. So we've got a strong belief set there. We had a terrific launch meeting with the BMS team last month, and I would say it's early days, so ask me the question on commentary again in a month or two, but we're certainly fired up and ready to go, and out engaging with the treating physician community.
Speaker Change: Had a terrific launch meeting with BMS team last month and.
Speaker Change: I would say it's early days. So ask me the question on commentary again in a month or two but we're.
Speaker Change: We're certainly.
Speaker Change: Fired up and ready to go in and out engaging.
Speaker Change: With the treating physician community.
Yaron Benjamin Werber: Our next question comes from the line of Yaron Werber with TD Cowen. Your line is now open.
Speaker Change: Thank you.
Speaker Change: Our next question comes from the line of Jeremy <unk> with TD Cowen. Your line is now open.
Jaina: Hi, this is Jaina on behalf of Yaron. Thanks for taking our questions. Two parts are from me.
Speaker Change: Hi, This is Gino on for you Ron Thanks for taking my questions. Two parter from me. So you are saying about real world efficacy may factor ability our points of differentiation for <unk> can you remind us what your current manufacturing success rate in out of spec rate Dr. Rebecca also vein to vein time.
Jaina: So you're saying that real-world efficacy and manufacturability are points of differentiation for ABECMA. Can you remind us what your current manufacturing success rate and out-of-spec rates are for ABECMA? Also, vein-to-vein time. And the second part is, at the ODAC in March, the committee seemed a little bit concerned about PFS for ABECMA not being durable. Do you think this is going to hinder ABECMA uptake in earlier line settings?
William D. Baird: Thank you.
Speaker Change: Second part is on the <unk>.
Speaker Change: In March the committee seemed a little bit concerned about.
Speaker Change: For Beckman not being durable.
Speaker Change: Go ahead, Andrew Backman uptake in earlier line settings. Thank you.
William D. Baird: Yeah, thanks for the question. On manufacturing success rates, we're north of 90% manufacturing in spec. And that's been consistent for quite some time now. So we are always looking to do even better for every patient. And as we move into earlier lines, with cells that have seen less lines of therapy, we're optimistic that that could get even better. And then, from a turnaround time, we've consistently been just a little bit under 30 days. Sorry, can you remind me?
Andrew Backman: Yes, thanks for the question.
Andrew Backman: Manufacturing success rates were north of.
Andrew Backman: 90% manufacturing in spec and that's been.
Andrew Backman: Consistent for.
Quite some time now so.
Andrew Backman: So.
Andrew Backman: Looking to.
Andrew Backman: You do even better for every patient and as we move into earlier lines.
Andrew Backman: With cells that are I've seen less lines of therapy, we're optimistic that that.
Andrew Backman: Could get even better.
Andrew Backman: And then from a turnaround time, we've been consistently.
Andrew Backman: Just.
Andrew Backman: A little bit under 30 days.
Andrew Backman: Turnaround time.
Speaker Change: Sorry can you remind me of the other questions.
Speaker Change: Are you still there.
Operator: Am I unmuted? I was asking about the durability of PFS. Oh, right, from the panel. Yeah, sorry.
Speaker Change: Okay.
You did.
Speaker Change: Asking about durability of PFS.
William D. Baird: Thank you. Yeah, from... We, I think the panel took a study that was focused on PFS and, you know, I think, really dove deep into overall survival and the confounding factors of that study. But, you know, 13 months of PFS versus the standard of care, which demonstrated about four months. We felt that was a statistically significant difference on the pre-specified primary endpoints. So, you know, we feel good about the data. And as you get into subgroup analysis, we believe it looks even better. Anna, can I – I'm sorry, Anna's not in the same room with us. Could you comment further on that one?
Speaker Change: Hello, Ryan panel, yes, sorry, thank you.
Speaker Change: From.
Speaker Change: Okay.
Speaker Change: I think.
Speaker Change: The panel took a study that was.
Speaker Change: Focused on PFS and I think.
Speaker Change: Really dug deep on overall survival and.
Speaker Change: The confounding factors of that study, but.
Speaker Change: 13 months of PFS versus.
Speaker Change: Standard of care, which.
Speaker Change: Demonstrated about four months.
Speaker Change: We that we felt that was statistically significant.
Speaker Change: A statistically significant difference on the pre specified primary endpoint. So we feel good about those data and as.
Speaker Change: As you get into the subgroup analysis.
Speaker Change: We believe it looks even better on a can.
Speaker Change: I'm sorry, not.
Speaker Change: Not in the same room with US could you could you comment further on that one.
Anna Truppel: Yes, thank you so much. And thank you for the good question.
Speaker Change: Yes. Thank you so much and thank you for the good question.
Speaker Change: Because it does discusses the or that could also commended by the biostatistician.
Anna Truppel: As it was discussed at the ODAC and also commended by the biostatistician, it is to be noted that the PFS analysis has a certain data cut with a certain data maturity and with more follow-up. Of course, there is more censoring in a curve. And it was clearly noted also at the ODAC that there was some censoring before the end. So it is definitely not a mature curve. That's one.
Speaker Change: It is to be noted noted that the PFS analysis has a certain data cuts with also certain data maturity and with more follow up of course.
Anna Truppel: Second, we have two PFS data cuts that are in the public domain. If you look at the second PFS data cut, it seems to be really going apart a bit better. And finally, I'd also like to point out that we're speaking about multiple myeloma patients who, unfortunately, still do not have a cure at this point in time. So therefore, we would expect that at some point in time, patients relapse and then need to go to the next therapy. So that's all from my end on the PFS and the discussion at ODEC.
Speaker Change: There is more censoring in a curve and it was clearly know that also that <unk>. There was some censoring before the end. So it is definitely not the mature curve Thats. One second we have to PFS data cuts that are in the public domain. If you look at the second PFS data called it is it seems to be really going apart a bit better and finally I would like to own.
Speaker Change: You mentioned with speaking about multiple myeloma patients, who unfortunately still do not have a cure at this point in time. So therefore, we would expect that at some point of time patients relapse and that needs to go to the next therapy. So that's all from my end on the on the PFS.
Speaker Change: A discussion of Kodak.
Speaker Change: Okay.
Samantha Lynn Semenkow: Thank you. Our next question comes from the line of Samantha Semenkow with Citi. Your line is now open.
Speaker Change: Thanks Tommy.
Speaker Change: Thank you. Our next question comes from the line of Samantha <unk> with Citi. Your line is now open.
Eric: Hey, this is Eric. I'm on behalf of Sam. Thanks for taking our question. Can you speak to any utilization trends you're seeing across treatment centers where Abecma is the only BCMA CAR T available versus those that offer CAR VIC-T as well, and are you seeing utilization across all activated treatment centers or is it clustered in a subset, and if so, can you characterize that subset?
Speaker Change: Hey, this is Eric on for Sam Thanks for taking our questions.
Eric: Can you speak to any utilization trends youre seeing across treatment centers, where <unk> is the only be CMA carty available versus those that offer Karl back to you as well and are you seeing utilization across all activated treatment centers or is it clustered in a subset and if so can you characterize that subset.
William D. Baird: Yeah, thanks for the question. We obviously track utilization data across all of the centers where we're activated. And those those trends can vary over time. And again, we have centers that have higher rates of utilization and ones that are less. So I would say, you know, the academic centers, the major centers tend to drive a lot of the overall utilization. But from a growth perspective, extending the overall footprint to more geographically remote places in the United States is helpful for those patients where the travel time to receive their CAR T and the follow-up involved matters.
Speaker Change: Yes, thanks for the question.
We track obviously the.
Speaker Change: Innovation data across all of the centers were activated.
Speaker Change: And those those trends can vary over time and again, we have centers that are.
Speaker Change: Sure.
Speaker Change: Or have higher rates of utilization and ones that are.
Speaker Change: Less so I would I would say.
Speaker Change: The academic centers the major centers.
Speaker Change: And to drive a lot of the overall utilization.
Speaker Change: But from a growth perspective, extending the overall footprint to more geographically remote places in the United States.
Speaker Change: It is helpful for those patients where we're travel time.
William D. Baird: And so you know, we think site expansion is an important part of the overall commercial strategy. And again, we're engaging right now with every one of those centers, highlighting the karma three data, you know, the data that are on the label, the real world evidence, and everything else that we're able to do compliantly in a commercial setting. So more to come on that. But again, as we've said it before, we're excited to get back out there with a new and expanded data set.
Speaker Change: To receive their car T and the follow up involved.
Speaker Change: Matters and so we think site expansion is important part of the overall commercial strategy.
Speaker Change: And again, we're engaging right now with every one of those centers highlighting the karma three data.
Speaker Change: The data that are on the label.
Speaker Change: And the real world evidence and everything else that we're able to do compliance in the commercial setting so.
Speaker Change: More to come on that but again as we've said it before we're excited to get back out there.
Speaker Change: With the new and expanded dataset.
Vikram Purohit: Thank you. Our next question comes from the line of Vikram Purohit with Morgan Stanley. Your line is now open.
Speaker Change: Thank you. Our next question comes from the line of Vikram <unk> with Morgan Stanley. Your line is now open.
Morgan: Hi, this is Morgan on behalf of Vikram. Thanks for taking our question. So I wanted to ask about your anticipation of the initial launch ramp curve and the third line setting and how this might compare to late line setting uptake. Thank you.
Speaker Change: Hi, This is Morgan on for Vikram. Thanks for taking our question. So I wanted to ask about your anticipation of the initial launch ramp curves and the third line setting and how this might compare to late line setting uptake. Thank you.
William D. Baird: Hi Morgan. Thanks for the question. You know, the fifth line launch was a different dynamic in the sense that there were patients with no treatment options. There was clearly a bolus of patients who had been waiting for that approval, and capacity was limited. And so that resulted in long lines, in terms of wait times, and, you know, just triaging the best that we could as a manufacturer and as a sponsor. But today, in third-line settings, very different dynamics, you know, more treatment options for those patients, a much larger market.
Speaker Change: Hi, Morgan Thanks, Thanks for the question.
Speaker Change: The fifth line launch.
Speaker Change: Was it a different dynamic in the sense that there were patients with no treatment options. There was clearly a bolus of patients who had been waiting for that approval.
Speaker Change: And Ah <unk>.
Speaker Change: Capacity was limited and so that resulted in long lines.
Speaker Change: In terms of wait times and.
Speaker Change: Just triaging the best that we could is it manufactured as a sponsor.
Speaker Change: Today in third line setting is very different.
Speaker Change: Dynamics.
Speaker Change: More treatment options for those patients a much larger market.
William D. Baird: We have, as Vicki highlighted earlier, you know, based on present demand, an unlimited capacity. And so, you know, I think it sets us up well to expand into that market. But it's not the same kind of bolus effect we expected in the fifth line. So again, as we've said, early days here, it will be a return to growth, but we expect, given the lag time between enrollment, AFE, and then revenue, the kind of revenue impact, we don't expect to be able to show until we get into the second half of the year results, third quarter, fourth quarter results.
Speaker Change: We have as Vicki highlighted earlier.
Speaker Change: Based on present demand unlimited capacity.
And so that.
Speaker Change: I think it sets us up well to expand into that market.
Speaker Change: But it's not.
Speaker Change: The same kind of bolus effect, we expanded expected in the first line. So again as we said.
Speaker Change: Early days here it will be.
Speaker Change: <unk> returned to growth, but we expect given the lag time between enrollments.
Speaker Change: And then revenue.
Speaker Change: Kind of the revenue impact, we don't expect to be able to show until we get into second half of the year results third quarter fourth quarter results.
John Lawrence Newman: Our next question comes from the line of John Newman with Canaccord Genuity. Your line is now open.
Speaker Change: Thank you.
Speaker Change: Our next question comes from the line of John Newman with Canaccord Genuity. Your line is now open.
John Lawrence Newman: Hi guys. Thanks for the question and congrats on the really great work that was done for the FDA panel. That was a tough one, but you could tell that you were very well prepared.
John Lawrence Newman: Hi, guys. Thanks for the question and congrats on a really great work that was done for the FDA panel that was a tough one but I can tell you we're very well prepared.
William D. Baird: I just had a question. We've been hearing from some of the physicians at academic centers that they are devoting more resources over time to the apheresis portion of treatment, and some of them have sort of suggested that maybe, in the future, in conjunction with some of the companies, perhaps, some of that apheresis could be done off-site and not in the academic centers. Just wanted to get your thoughts on that and whether it's something that you're sort of considering in conjunction with Bristol as we go forward.
John Lawrence Newman: Just had a question we've been hearing from some of the physicians academic centers that.
John Lawrence Newman: We are devoting more resources over time to the <unk> portion of treatment and some of them have sort of suggested that maybe in the future in conjunction with <unk>.
John Lawrence Newman: Some of the companies, perhaps some of that <unk> could be done off site and not in the academic centers just wanted to get your thoughts on that and whether it's.
John Lawrence Newman: It is something that you are sort of considering in conjunction with Bristol as we go forward.
William D. Baird: Yeah, John, thanks. Thanks for the question. And it comes from FDA; we were certainly excited, as you said, with the team's performance there. But look, you know, anytime you solve a bottleneck, a new one's created in a supply chain as complex as CAR T therapy. And so I think with the approval of suspension vector and the amount of capacity that we've been able to establish consistently on the drug product side, you start to think about other bottlenecks, and that could be the number of beds in a clinic, or that could be aphoresis capacity.
Speaker Change: Yes, John Thanks, Thanks for the question.
Speaker Change: They've come up with FDA, we are certainly excited as we said with the team's performance there.
Speaker Change: Doug.
Speaker Change: Anytime you solve the bottleneck.
Speaker Change: <unk> created in our supply chain is as complex as car T therapy and so.
Doug: I think with the approval of suspension vector with the amount of capacity they've been able to establish consistently on the drug product side.
Doug: You start to think about other bottlenecks and that could be the number of beds in the clinic that could be a risk.
William D. Baird: These are all things that collectively as an industry, we're thinking about, and to the extent that we can influence, we are. Ultimately, those are decisions that are made by the academic centers and hospitals, et cetera, but it's all part of the broader ecosystem. We've been playing a leading role there for some time, and we're gonna continue to work to provide access to and availability for as many patients who can benefit here as we can, and we think that's That's a big number, and we're going to be at it for quite some time. Anna, I don't know if you have any additional thoughts on that one.
Doug: <unk> capacity. These are all things that collectively as an industry, we are thinking about in <unk>.
Doug: Meant that we can we can influence.
Doug: We are those are ultimately decisions that are made by the academic centers and.
Doug: The hospitals.
Doug: Et cetera, but it's all part of the broader ecosystem.
Doug: <unk> been playing a lead role there for some time.
Doug: And.
Doug: <unk>.
Doug: To continue to work to make.
Doug: The access and availability for as for as many patients who can benefit here as we can and we think.
Doug: That's a big number and we are going to be at it for quite some time.
Speaker Change: I don't know if you have any additional thoughts on that one.
Anna Truppel: Thank you, Chip. I think you answered that very well.
Speaker Change: Thank you chip I think you answered it very well thank you.
William D. Baird: Thank you, and I'm currently showing no further questions at this time. I'd like to hand the call back over to Chip Baird for closing remarks.
Speaker Change: Thank you and I'm currently showing no further questions at this time I would like to hand, the call back over to chip Baird for closing remarks.
William D. Baird: Thank you all for calling in today. If you have questions, we're happy to follow up further and look forward to continuing to pursue the return of growth for VACMA here throughout the balance of the year. Thanks, everyone. Have a great day.
Speaker Change: Okay.
William D. Baird: Thank you all for calling in today, if you have questions. We're happy to follow up further and look forward to.
William D. Baird: Continuing to get after the return to growth for backed by here throughout the balance of the year. Thanks, everyone have a great day.
Operator: This concludes today's conference call. Thank you for your participation. You may now disconnect.
Speaker Change: This concludes today's conference call. Thank you for your participation you may now disconnect.
William D. Baird: Yes.
William D. Baird: Okay.
William D. Baird: [music].
William D. Baird: Okay.
William D. Baird: Okay.
William D. Baird: [music].