2seventy bio (Ticker: TSVB) reported its financial results and business updates during its First Quarter 2024 Earnings Conference Call. The company announced a strategic shift to concentrate solely on its Abecma product after selling its oncology and autoimmune R&D programs to Regeneron (NASDAQ:REGN) and reducing its workforce by 14%. Abecma's U.S. revenues hit $52 million, aligning with projections. 2seventy bio expects to see a return to growth in the latter half of the year and is aiming for breakeven by 2025. The company also plans significant cost savings and remains within its targeted net cash spend.
Key Takeaways
- 2seventy bio sold its oncology and autoimmune R&D programs to focus on Abecma.
- Abecma U.S. sales reached $52 million, as expected.
- The company anticipates a second-half return to growth and a potential breakeven by 2025.
- Projected cost savings of $150-200 million for 2024 and 2025.
- Net cash spend is expected to stay within $80-100 million.
- Abecma's competitive profile is highlighted for its efficacy and safety in earlier line triple class exposed patients.
- Revenue growth is expected in the third and fourth quarters, with a focus on the third-line treatment setting.
Company Outlook
- 2seventy bio aims for $150-200 million in cost savings over the next two years.
- The company is excited about Abecma's market opportunities, especially with an expanded label.
- A potential path to breakeven is anticipated by 2025 as Abecma's growth resumes.
Bearish Highlights
- The company reduced its workforce by 14% to streamline focus on Abecma.
- Competition in the myeloma field is acknowledged, with CAR-T competitors and bispecifics present in the fifth-line setting.
Bullish Highlights
- The company generated over $100 million in revenue in the previous year's smaller market.
- Abecma has a strong efficacy and safety profile, with consistent manufacturing turnaround time.
- There is enough capacity to meet current demand and room for expansion within existing infrastructure.
Misses
- Revenue impact from the third-line setting launch is not expected until the second half of the year.
Q&A Highlights
- The company addressed the durability of progression-free survival (PFS) concerns, affirming the statistical significance of its data.
- Academic centers are driving overall utilization, with efforts to engage and expand footprint ongoing.
- The possibility of off-site apheresis is being considered to alleviate potential bottlenecks in the supply chain.
2seventy bio's first-quarter call has set a positive tone for the company's future, with a clear focus on maximizing the potential of Abecma. The strategic decisions to divest other R&D programs and streamline operations have positioned the company for anticipated growth in the competitive myeloma treatment market. With a strong product profile and a commitment to cost savings, 2seventy bio is navigating the challenges and opportunities that lie ahead.
InvestingPro Insights
2seventy bio (Ticker: TSVT) has taken significant steps to streamline its business, focusing on the Abecma product. This strategic move comes at a time when the company's financial metrics and market performance are under close scrutiny by investors and analysts. Here's a look at some key data and insights from InvestingPro that could shed light on 2seventy bio's current position and future prospects:
InvestingPro Data:
- The company's market capitalization stands at a modest $230.29 million.
- An impressive gross profit margin of 92.54% for the last twelve months as of Q1 2024 indicates strong profitability potential for its core products.
- Nonetheless, the revenue has declined by 42.9% over the same period, highlighting the challenges faced in the market.
InvestingPro Tips:
- Analysts have noted that 2seventy bio is quickly burning through cash, which is a critical factor for investors to consider given the company's focus on cost savings and a path to breakeven by 2025.
- Despite the recent price uptick over the last six months, the stock has fared poorly over the last month, reflecting the volatility and investor sentiment surrounding the company.
For those looking to delve deeper into the financial health and future outlook of 2seventy bio, InvestingPro offers additional tips and metrics that could be pivotal in making informed investment decisions. There are 10 more InvestingPro Tips available for 2seventy bio at https://www.investing.com/pro/TSVT. To access these insights, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
Full transcript - 2Seventy Bio (TSVT) Q1 2024:
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. [Operator Instructions] 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 with 2seventy bio. Please go ahead.
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 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 a 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. We 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-Hartmann, Chief Medical Officer, is also on the line for questions during the Q&A. And now I will turn it over to Chip. Chip?
Chip 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 Abecma. To achieve this, we sold our oncology and autoimmune R&D programs to Regeneron. 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 refocusing. The end result is that we have emerged with a leaner cost structure, cash runway beyond 2027 and time to get Abecma back on track commercially. To that end, we have consistently said that the path to Abecma growth hinges on earlier line approval. We traveled 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 earlier line setting, which opens a much larger addressable patient population. So it’s been a great start to the year and we are now singularly focused on getting Abecma back on track commercially. We are in the early days of launch and expect that it will take into the second half before we see meaningful growth. We’ve talked for some time now about known strengths for Abecma, including strong efficacy that is reproduced in the real world setting, a well-established and manageable safety profile and consistent manufacturing turnaround time at high rates of in spec product. With KarMMa-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 need. 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 the plan. 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. Vicki?
Vicki Eatwell: Thanks, Jeff. First quarter Abecma U.S. revenues, as reported by Bristol-Myers Squibb (NYSE:BMY), 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 KarMMa-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. 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 share of collaboration loss of $1.2 million related to our collaboration with BMS, driven by decreased patient demand in the late line setting. 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 million to $200 million of cost savings in 2024 and 2025, respectively. We anticipate staying within our previously guided net cash spend range of $80 million 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 Abecma returns to growth. With that, I’ll turn it back to Chip.
Chip 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 Abecma to make a meaningful impact for patients in the early line setting and are singularly focused on delivering more time for every myeloma patient we are able to serve. Together with our partners at BMS, this will be a top priority. Second, we’re focused on being careful stewards of investor capital, staying focused on reaching break-even 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?
Operator: Thank you. [Operator Instructions] Our first question comes from the line of Daina Graybosch with Leerink Partners. Your line is now open.
Rabib Chaudhury: Hi. This is Rabib on for Daina. Thank you for the question. The question is related to Abecma profitability. How should we think about Abecma collaboration profitability going forward? Is there a threshold revenue above which the program will be consistently profitable given the flat sales over the last three quarters? 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.
Chip Baird: Sure. I’ll comment briefly and then ask Vicki to add color. But 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 loss as we saw in this quarter in that $50 million revenue run rate on a quarterly basis. So we’re going to need to see that return to growth to see a consistent path towards collaboration revenue and profitability, and again, we think we have the plan to do that. I would note, too, that 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-T 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 that level that we achieved before. We believe this is a profitable business.
Rabib Chaudhury: Thank you. And then just on that manufacturing note, thanks, Chip, for going in that direction. How will the shift to suspension vector impact profitability and when should we expect that transition from adherent to suspension play out in the collaboration profitability line?
Chip Baird: Yes. So, as we’ve shared, we’ve been approved for suspension, which is great news and another important 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 transition from adherent to suspension in terms of the actual impact on cost will happen over time as we use remaining adherent vector and then make that cut over to suspension. But from a technical risk perspective, we’re past that and we’re approved for utilization there, which is great news.
Operator: Thank you. Our next question comes from the line of Salveen Richter with Goldman Sachs. Your line is now open.
Matt Leskowitz: Hey. Thanks. This is Matt on for Salveen. You noted meaningful -- expectations 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 bispecifics or CAR break fee versus supply constraints? And then just a follow-up question, could you talk about expectations for OpEx spend in the rest of 2024 and then 2025? Thank you.
Chip Baird: Sure. I didn’t catch the last part of your -- you had a three-part question there. Could you say the last part again?
Matt Leskowitz: The last part was just OpEx spend in 2024 and 2025?
Chip Baird: Yeah. Okay. Yeah. So, in terms of the 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 quarter and second quarter 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 dataset that stands behind that and our ability to engage with treating physicians and educate on product profile, which is different and improved and we can get into. 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.
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 further, 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 expect -- of what we experienced in 2023. So I would use that from a modeling perspective. Thank you.
Operator: Thank you. Our next question comes from the line of Kelsey Goodwin with Guggenheim Securities. Your line is now open.
Kelsey 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 kind of post-label expansion with KarMMa-3? And then I guess maybe prior to the expansion, in terms of the competition and the headwinds you were facing previously, were you seeing that mainly from CAR-T competitors or bispecifics or a blend and just kind of the market in general, just trying to get a little more color there? Thanks so much.
Chip Baird: Kelsey, yeah, thanks. Good questions. 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 bispecs are all at play in 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. Today bispecs are not present there. And again, I think, our focus commercially is articulating the Abecma 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 or 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.
Kelsey Goodwin: Thank you.
Operator: Our next question comes from the line of Yaron Werber with TD Cowen. Your line is now open.
Unidentified Analyst: Hi. This is Gina [ph] on for Yaron. Thanks for taking our questions. Two parter from me. So you’re saying that real-world efficacy and manufacturability are points of differentiation for a 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 then the second part is on the ODAC in March, the committee seemed a little bit concerned about PFS for Abecma not being durable. Do you think that’s going to hinder Abecma uptake in earlier line settings? Thank you.
Chip Baird: Yeah. Thanks for the question. On manufacturing success rates were north of 90% manufacturing in spec and that’s been consistent for quite some time now. So 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 been consistently just a little bit under 30 days turnaround time. Sorry, can you remind me of the other question? Gina, are you still there?
Unidentified Analyst: Am I unmuted? I was asking about durability of PFS and how it’s going to…
Chip Baird: Oh! Right. For the panel. Yeah. Sorry. Thank you. Yeah. From -- we -- I think the panel took a study that was focused on PFS and I think really dove deep on overall survival and the confounding factors of that study. But 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 we feel good about those data, and as you get into subgroup analysis, we believe it looks even better. Anna can -- I’m sorry, Anna is not in the same room with us. Could you comment further on that one?
Anna Truppel-Hartmann: Yes. Thank you so much and thank you for the good question. As it was discussed at the ODAC and also commented by the biostatistician, it is to be noted that the PFS analysis has a certain data cut with also certain data maturity and with more follow-up. Of course, there is more censoring in the curve and it was clearly noted also at the ODAC there was some censoring before the end. So it is definitely not a mature curve. That’s one. 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 like to also mention, 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 discussion at ODAC. C Thanks, Anna.
Operator: Thank you. Our next question comes from the line of Samantha Semenkow with Citi. Your line is now open.
Unidentified Analyst: Hey. This is Eric [ph] on for Sam. Thanks for taking our questions. 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-BEC-T [ph] 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?
Chip Baird: Yeah. Thanks for the question. We track, obviously, the utilization data across all of the centers where we’re activated and 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 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 travel time to receive their CAR-T and the follow-up involved matters. And so 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 KarMMa-3 data, the data that are on the label and 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.
Operator: Thank you. Our next question comes from the line of Vikram Purohit with Morgan Stanley. Your line is now open.
Morgan Gryga: 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 curve in the third-line setting and how this might compare to late-line setting uptake? Thank you.
Chip Baird: Hi, Morgan. Thanks for the question. 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 just triaging the best that we could as a manufacturer and as a sponsor. Today in third-line setting, very different dynamics, more treatment options for those patients, a much larger market. We have, as Vicki highlighted earlier, based on present demand, unlimited capacity. And so that I think 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. And 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, 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.
Operator: Thank you. Our next question comes from the line of John Newman with Canaccord Genuity. Your line is now open.
John 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. Just out of 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. I 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?
Chip Baird: Yeah. John, thanks for the question and comments from the FDA. We’re certainly excited, as you said, with the team’s performance there. It’s any time you solve a bottleneck that a new one is created in a supply chain as complex as CAR-T therapy. And so I think with the approval of suspension vector, with 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 the clinic. That could be apheresis capacity. These are all things that collectively as an industry we’re thinking about. And to the extent that we can influence, we are, those are ultimately 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 going to continue to work to make access and availability for as many patients who can benefit here as we can. And we think 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.
Anna Truppel-Hartmann: Thank you, Chip. I think you answered that very well. Thank you.
Operator: 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.
Chip 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 get after the return to growth for Abecma 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.
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