Autolus Therapeutics Q2 2026 Earnings Call Transcript

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Provided by Quartr
August 11, 2026

Key Takeaways

  • Positive Sentiment: AUCATZYL net product revenue rose to $45.7 million in Q2 2026, up from $26.2 million in Q1 and $20.9 million a year earlier. Management raised full-year 2026 revenue guidance to $140 million–$150 million.
  • Positive Sentiment: Commercial expansion is progressing faster than planned, with more than 80 U.S. authorized treatment centers already active by midyear and approximately 20 U.K. centers expected by year-end. Management said most activated centers have already treated patients and reported strong physician adoption.
  • Positive Sentiment: Gross margin improved sharply to 55% from 6% in Q1, driven by higher manufacturing volumes, production at the U.K. Nucleus facility, operating efficiencies, and cost reductions. The company is targeting a 65%–70% gross margin for the mature adult ALL business within roughly 12–18 months.
  • Neutral Sentiment: Management outlined multiple upcoming clinical catalysts, including longer-term CARLYSLE lupus data and initial AUTO8 amyloidosis data by year-end 2026, BOBCAT progressive multiple sclerosis data in 2027, and potential pediatric ALL and lupus nephritis milestones in 2027–2028.
  • Neutral Sentiment: Autolus drew an initial $75 million under a Perceptive Advisors credit facility, with up to $250 million potentially available subject to revenue milestones. Combined with cash, marketable securities, and anticipated revenue, management expects runway into Q2 2028, though the financing increases future debt obligations.
AI Generated. May Contain Errors.
Earnings Conference Call
Autolus Therapeutics Q2 2026
00:00 / 00:00

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Operator

Good day, and thank you for standing by. Welcome to the Autolus Therapeutics second quarter 2026 financial results 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 one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Executive Director of Investor Relations, Amanda Cray. Please go ahead.

Amanda Cray
Amanda Cray
Executive Director of Investor Relations at Autolus Therapeutics

Thank you, DeeDee. Good morning or good afternoon, everyone, and thank you for joining us on today's call. With me, our Chief Executive Officer, Dr. Christian Itin, and Chief Financial Officer, Rob Dolski. I'd like to remind you that during today's call, we will make statements related to our business that are forward-looking under federal securities laws and the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These may include, but are not limited to, statements regarding the status of ongoing commercial launch of AUCATZYL in the U.S. and U.K., Autolus manufacturing, sales, and marketing plans for AUCATZYL, the market potential for AUCATZYL, and the status of clinical trials, development and/or regulatory timelines and market opportunities for obe-cel and our other product candidates.

Amanda Cray
Amanda Cray
Executive Director of Investor Relations at Autolus Therapeutics

These statements are subject to a variety of risks and uncertainties that could cause actual results to differ materially from expectations and reflect our views only as of today. We assume no obligation to update any such forward-looking statements. For a discussion of the material risks and uncertainties that could affect our actual results, please refer to the risks identified in today's press release and in our SEC filings, both available on the investors section of our website. On slide three, you'll see the agenda for today's call. As usual, Christian will provide an overview of our operational highlights. Rob will then discuss the financial results, and Christian will conclude with upcoming milestones and closing remarks. We'll then take questions. With that, I'm happy to turn it over to Christian.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

Thanks, Amanda, and welcome everybody to our second quarter call. We're moving to slide number four. We had a very positive second quarter with strong AUCATZYL sales growth in our second year of launch now. When we look at the AUCATZYL revenue in the second quarter, we're at $45.7 million, which is a substantial increase over the $26 million that we had in the first quarter. For the first half of the year, we reached $71.9 million, which is close to the full year number that we had for our first year of launch last year. We see that the positive experience that the physicians are having with the product in the centers that we're active in, which is also reflected in the data that was collected by the ROCCA Consortium and the real-world database that was presented at the Tandem Meeting.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

It builds a very strong foundation for the adoption of the product. I think the continued positive momentum that we're seeing in the market. We also obviously have continued to grow our presence, from a center perspective. We had indicated at the beginning of the year that we would reach in the range of 80 centers for the full year. We're now at the mid-year point, and we're above 80 centers already, and we continue to add centers in the second half of the year as well. When we look to the U.K., we started the launch at the beginning of the year. We do see strong initial adoption, and we obviously continue to also add treatment centers as we go through the remainder of the year. With that, we're going to move to slide number five.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

I think we're at a very good path here and show very good momentum for the goals that we had set for ourselves for 2026. When we look at the net revenue projection that we had for the year, that was originally set at $120 million-$135 million, we're now at a point where we can actually increase our guidance to $140 million-$150 million for the full year. The gross margin development, we've seen a very nice move as we're going from the first to the second quarter. The first quarter was just positive on the gross margin. We now made a very positive step in the second quarter, which is driven by increased volumes in terms of batches that we manufactured at our plant at the Nucleus in the U.K.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

But also a lot of the improvements that we made on the operations as well, both at the manufacturing side as well as the commercial side. All of that actually supports the gross margin development here. That obviously is a key driver towards the company moving towards profitability for this part of our business. When we look at the commercial expansion, we're now in more than 80 centers, as indicated. We continue to grow. We're particularly going to look at areas that may be underserved, where distances to centers are still relatively wide or large, and we want to make sure so that patients have adequate access and have centers within reasonable reach. As we're looking across the U.S., we do see that we actually have a very good distribution across the U.S.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

We'll continue to add, obviously, additional centers in some of the states where we may not be active yet at this point. Moving to slide number six. I think as we're sort of moving through the ramp-up here on the launch, it was very important that we're obviously driving towards a very stable delivery of the product. With that, over time, as we're improving our margins of the product, reach profitability for our business in the relapsed refractory ALL indication. When we look back into last year, the first objective was to really get us to a place where we have very robust, consistent, high-quality product supply and services that we can provide to the centers. We achieved that within the first probably six to nine months during the course of the first year of launch last year.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

We then started to shift our focus onto starting to optimize the processes and really drive for efficiency as well as obviously increasing the volumes. Together, those two parameters are really the key drivers to improve margins, and that's ultimately what gets us to a place where we expect to be in the not-too-distant future to get us to a place where our gross profit margin is going to reach somewhere in the range of 65%-70% for the ALL business. When we look at the development of gross margins, we're still negative in the fourth quarter last year. We were just on the other side, on the positive side in the Q1 this year, and we now have a healthy step up to a 55% gross margin in the second quarter.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

We obviously expect to continue to drive the improvements the optimizations to drive for efficiency, which obviously are key drivers for the company to reach profitability in this line of business. Moving to slide seven, I would like just to briefly summarize where we are from a pipeline perspective. We see obviously a very strong foundation with obe-cel or AUCATZYL in the adult ALL setting. But it obviously also gives us a lot of opportunity in other B-cell-mediated diseases, both on the oncology but also the autoimmune side. As we're going through the news flow that we're expecting for the upcoming periods, I would start out with the key news flow that we're expecting for the end of this year, which is really focused first on the update for the CARLYSLE study at the ACR conference.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

Which gives us an opportunity to really give us a longer-term view on the data and a clear understanding on the durability of the effect that we have seen in the systemic lupus patients. We will then look into additional updates coming from the FELIX study, where we have a few additional analysis plans to be presented by the end of the year. As we're going into the next product opportunity with AUTO8, which is a BCMA CD19 targeting product where we have an initial trial ongoing in light chain amyloidosis, we expect initial data to become available by the end of the year as well. As we're looking into the first part of 2027, the key focus there is going to be on the first data from our BOBCAT study in progressive multiple sclerosis patients. This will be the first dataset out of that study.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

We expect a second dataset to become available second half of next year, where we expect longer follow-ups, more patients, and longer follow-up in that indication. Both obviously important data points as we go through the course of next year. When we then look to the end of next year, we're at the point where we expect to have the first data coming from the pivotal study, the CATULUS study in pediatric ALL. That study is enrolling very well. We expect that study to actually reach the end of enrollment by the end of the year. Then obviously we're getting into the follow-up and then the workup of that data, hopefully towards a filing by the end of next year, early 2028.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

When we look a little further out into 2028, we do expect the phase II data from the LUMINA study in patients with lupus nephritis. There is quite a full set of data that we expect from the various studies going beyond the adult ALL opportunity, which we obviously continue to update you on as well. When we then look briefly on slide number eight, what to expect with regards to the BOBCAT study in progressive MS, we have in Q1 next year targeting the ACTRIMS meeting, which is obviously one of the key venues for MS data. We would, at that point, expect to have a total of 12 patients that we can report data from. We are going to look at safety, at PK/PD data, biomarker data, and certainly early clinical experience.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

Looking for the second half of next year with a total of expected 18 patients, we will then have an opportunity to look at clinical response, particularly with the longer-term follow-ups. We will expect to have imaging data as well as expanding safety PK/PD biomarker data. We will, at that point, look at potential next steps for the program. We believe that when we look at this opportunity in MS, obviously the key clinical scores or EDSS scores, those obviously do contain elements that are either patient- or physician-reported.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

That is also I would actually like to have about 12 months of follow-up with patients to understand that indeed the response is a true reflection of the product's activity, and we do not have an overlay of potential outcomes that are reported that might actually have a component that might be more of a placebo type of effect. With that, I would like to actually move over to slide number nine and hand over to Rob for the financial results.

Rob Dolski
Rob Dolski
CFO at Autolus Therapeutics

Thanks, Christian, and good morning or good afternoon to everyone. I am pleased to review our financial results for what was a strong second quarter of 2026. I will be referring to slide 10 in the presentation. Our total net product revenue for the second quarter of 2026 was $45.7 million. That is compared with $20.9 million in the second quarter of 2025 or compared to $26.2 million in the first quarter of 2026. This quarter reflects sales in both the U.S. and U.K. markets. While the U.K. market is showing strong adoption, it is still early in the launch, and contribution from the U.K. was relatively minor when compared to the U.S. As Christian noted, based on the recent performance, we have increased our net product revenue guidance, and we now expect full-year AUCATZYL revenue of between $140 million and $150 million.

Rob Dolski
Rob Dolski
CFO at Autolus Therapeutics

We were also pleased to see further improvement in gross margin during the quarter to 55%, up from 6% in Q1 and negative in all prior quarters of 2025. The improvement was driven by a combination of increasing commercial production volume, operating model efficiency, and cost reduction initiatives that we undertook beginning earlier this year. We also began, for the first time, clinical production in our Nucleus facility in the second quarter, further improving our cost per batch economics. We expect gross margin to continue to improve towards a peak estimate of 65%-70% in the adult ALL market. Underlying the gross margin, our cost of sales in the second quarter totaled $20.5 million. That is compared to $24.4 million in the same period in 2025. The decrease was primarily driven by the improvements just mentioned, as well as lower inventory reserves and write-offs in the quarter.

Rob Dolski
Rob Dolski
CFO at Autolus Therapeutics

Our research and development expense was roughly flat at $27.9 million for the second quarter of 2026, compared to $27.4 million during the same period in 2025. Selling, general, and administrative expenses increased to $41.2 million for the second quarter of 2026, compared to $30.3 million in the same period in 2025. The increase was primarily due to employment-related costs and professional fees supporting commercialization activities in both the U.S. and U.K. In addition, the quarter also includes certain one-time items, such as termination-related expenses related to the strategic operational efficiency and cost reduction initiative that we announced back in April of this year. Our loss from operations for the second quarter was $43.8 million, as compared to $61.2 million for the same period in 2025.

Rob Dolski
Rob Dolski
CFO at Autolus Therapeutics

Finally, net loss was $39.1 million for the three months ending June 30th, 2026, compared to $47.9 million for the same period in 2025. Last week, we announced that we entered into a strategic financing with Perceptive Advisors for the sale of notes of up to $250 million in aggregate principal amount as part of a five-year interest-only senior credit facility. As part of the transaction, an initial $75 million in principal amount was drawn at closing, and an additional $25 million will be available at our option for up to six months post-closing date. An additional $150 million of subsequent capital may become available in separate tranches upon achievement of certain pre-specified revenue milestones. This financing provides us with additional capital to support key inflection points for the business, including clinical data milestones in our oncology and autoimmune development programs that Christian just walked through.

Rob Dolski
Rob Dolski
CFO at Autolus Therapeutics

We will have a meaningful opportunity to expand into new and larger markets, which we view as significant growth drivers, and the potential additional tranches provide optionality and flexibility as we advance these pipeline programs. Our cash equivalent, and marketable securities at June 30th, 2026, totaled $201.6 million. This excludes the initial drawdown on the Perceptive credit facility, which closed in July. This balance, combined with the anticipated net revenues and the first and second tranches of the credit facility totaling $100 million, provides us with cash runway into the second quarter of 2028. I will now hand back to Christian to wrap things up with expected milestones and conclusions.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

Thanks, Rob. We're moving to slide number 12 for the conclusion. We believe Autolus is well-positioned for value creation. We have, on the one hand, the opportunities on the commercial AUCATZYL product in relapsed/refractory ALL patients on the adult population. We have shown very strong execution. We've seen a very positive market expansion, reached $71.9 million in net revenue for the first half of the year. This has allowed us to increase the guidance for the FY 2026 to $140 million to $150 million in net product revenue. We believe there's significant opportunity to grow the CAR T market share in this indication, and we're building on very strong physician interest, which is also, I think, exemplified by the interest to investigate obe-cel in the first-line setting in ALL in investigator-sponsored trials, which actually have already started.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

We're looking forward to obviously seeing the results of those trials in the upcoming periods. When we then look in terms of the additional opportunities beyond the adult ALL population, we obviously have two pivotal studies ongoing. We have the pediatric ALL study ongoing, the CATULUS study, which is expected to read out by the end of next year. We have also the pivotal study, the LUMINA study, in lupus nephritis ongoing, which is expected to deliver data in 2028. Finally, with the opportunity beyond the classical rheumatology indications in the lupus setting, we're also looking at the opportunity in progressive multiple sclerosis, which gives us, I think, a shot at potentially getting to a very substantial commercial opportunity beyond what we are currently targeting in the oncology setting. This program is ongoing in a phase I study.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

It's the BOBCAT study, and as indicated, we expect to provide data updates during the course of 2027. With that, we believe we actually have a set of interesting data catalysts and updates during the course of 2027, which will set us up well for then the expected opportunity for a launch in pediatric ALL in 2028 and subsequent launches in 2029 on the lupus side. When we look in terms of the overall setup of the company, obviously the foundation that we built is a very strong foundation, both from a manufacturing and from a commercial capability perspective. Obviously, having now experience in more than 80 centers, authorized treatment centers across the U.S. and approaching 20 authorized treatment centers also in the U.K., which provides a very strong foundation for all the new indications that we're also planning and obviously are developing here as well.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

With that, I'd like to actually conclude and open up for questions.

Operator

Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from Salim Syed of Mizuho. Your line is open.

Salim Syed
Salim Syed
Analyst at Mizuho

Great. Good morning, guys. Congrats on the progress. Just one from us on the guide. Christian, Rob, when you look at the high end of the guide, it would imply a slight decline versus the 2Q $45 million revenue. Is that just conservatism on your part, or are you expecting some sort of seasonality or other one-timers to affect the 3Q and 4Q revenue? Thank you.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

Thanks, Salim. Very good question. When we look at the, obviously the first half of the year, we see obviously a pretty significant step-up in Q2. We believe that is in part driven by the positive data that was reported from the real-world experience at the Tandem Meetings. It certainly did drive a very significant increase in registrations onto the program in the second half of the first quarter. Those patients obviously were driving, to quite an extent, I think, the very positive outcome we've seen in Q2. So we think that creates a very good foundation for the rest of the year. There is certainly going to be elements of seasonality that we would expect during the course of the year. Given that, certainly we've seen that to some extent last year.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

It is an element that we're considering, and we believe that the guidance that we're providing is reasonable and certainly has an element of prudence as well.

Salim Syed
Salim Syed
Analyst at Mizuho

Okay. Thanks so much.

Operator

Thank you. Our next question comes from Matt Phipps of William Blair. Your line is open.

Analyst at William Blair

Great, thanks. This is Madeline on for Matt Phipps. Thanks for taking our question. On gross margins, could you provide any color on how we should think about the trajectory for the rest of the year, and maybe comment on potential timing to achieve that target of 65%-70%, given we're at 55% now? Thank you.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

Thanks, Madeline. Obviously, a very good question. It's an area of significant focus from our side. Elements that obviously contributed to this substantial step up in gross margin in the second quarter, were, on the one hand, obviously, the number of batches that were manufactured through that period. Obviously an increase, as you could see on the commercial side, but we also did actually consolidate our clinical trial manufacturing into the Nucleus. So there is a larger amount of volume that we push through, both on the commercial as well as the clinical side. That obviously helps a lot in terms of the key base costs that we have in the operation, the fixed costs. Within the operation and obviously allows us to sort of actually get to a broader number of batches that can support that.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

In addition, we have been very active on reviewing our entire operating model and looked at every aspect along the manufacturing process to ensure that we actually gain efficiency in the entirety of the manufacturing process, both production as well as product release. Those activities will continue, but we have made some significant changes during the course of the second quarter that we expect to actually have beneficial impact as we continue the rest of the year. Those are kind of the key areas that actually impact and actually did drive this very positive development that we are seeing. We are guiding to 65%-70% for kind of the more mature ALL business, which we expect to reach somewhere in the range of about 12-18 months. That is kind of the ballpark that we are currently seeing in terms of development, and those who will continue to update you on that.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

But obviously an important step that we have taken now, and which allows us to actually build a very strong foundation for the business.

Operator

Thank you. Our next question comes from Yanan Zhu of Wells Fargo. Your line is open.

Yanan Zhu
Yanan Zhu
Analyst at Wells Fargo

Oh, great. Thanks for taking our question and congrats on a great quarter. On the sales side, I was just wondering about your confidence about the next quarter or two. Given what visibility you might have into the third quarter, what is the confidence for another quarter with strong sales, given that you have this 74% jump from the first quarter to the second quarter? The main question is ability to maintain continued sales at the new foundation. Similar, I guess, along the lines of a prior question. If you can comment on market share within the CAR T category, and whether the growth is from switching patients or taking share or growing the market in a way. Thanks.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

Yeah. Hi, Yanan. Thanks for joining. When we look at the kind of future growth, this is very much growing the overall CAR T market share is kind of the key area of focus for us. That's sort of where really most of the drive is to sort of make sure that that's kind of where we're headed with the product. Most of the dynamic we've seen so far has been both obviously within kind of the patient pool that already had prior access to CAR T, but that also included patients that were kind of somewhat outside of the group of patients that were considered to be suitable for CAR T therapy. That's already visible in the data that was presented by the ROCCA Consortium at Tandem Meetings when you look at the patient composition.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

I think we're seeing a very positive dynamic. I think we see good continued activity and demand, and we expect that obviously to continue for the rest of the year and then continue to build momentum in 2027. So we're, I think, in a very good place there. As Salim asked before, there's probably going to be some elements of fluctuations that we may see between the quarters. We're very confident with the guidance we're giving for the full year, and I think we're very optimistic for 2027 as well.

Yanan Zhu
Yanan Zhu
Analyst at Wells Fargo

Great. Thanks.

Operator

Thank you. Our next question comes from Gil Blum of Needham & Company. Your line is open.

Gil Blum
Gil Blum
Analyst at Needham & Company

Good morning and good afternoon. I would like to add my congratulations on a very strong quarter. Just a couple of quick ones from us. As it relates to the updated ACR for lupus nephritis, we are assuming it is the same number of patients just with longer follow-up, if you have any additional color to give there. As a follow-up, you guys are already at 82 centers, and you are thinking about 80 centers by year-end. How should we think about how many centers you may have by year-end? Thank you.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

Thanks, Gil. Really appreciate the question. With regards to the CARLYSLE study, obviously we are going to have a substantial portion of the patients that will have 12 months and longer follow-up, which we believe is going to be very meaningful and give us a real sense for the quality of the reset that I think we have seen early evidence for in our last data update for the CARLYSLE study. This obviously gives a substantially longer view on those patients, and believe that this is actually going to be, I think, very helpful to understand sort of the magnitude of the clinical benefit that we may be able to induce in the severe lupus patients. That is going to be, I think, the key focus is really the longer-term follow-up and the impact on the clinical outcomes.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

With regards to the centers, as you rightly pointed out, we kind of hit the goal mid-year of being at 80 centers or above. I would assume we are going to be at the 90+ centers by the end of the year. Obviously that gives us a very good reach, and I think will allow us to make sure that the product is properly accessible across the entirety of the U.S. This is really one of the key areas we will continue to work on.

Operator

Thank you. Our next question comes from Simon Baker of Rothschild & Co. Your line is open.

Simon Baker
Simon Baker
Analyst at Rothschild & Co

Thank you for taking my question. Two quick ones, if I may, please. I wonder if you could give us any help on OpEx run rates. It seems that we've had a fairly similar performance in the last two quarters on SG&A. R&D has fluctuated a little bit. I'm just wondering how Q2 or H1 works for those two cost lines as an indicator for the second half. Secondly, a question on capacity. The guidance for this year implies probably about 300 patients treated. Given that volume and given the clinical trial material, which will obviously only increase going forward, I just wondered if you could give us an update on where we are for capacity at the Nucleus as it stands, and we know it's a very modular facility, how that can evolve over the coming years. Thanks so much.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

Thanks, Simon. Very good question. I'll start with the capacity question and then hand over for the OpEx question to Rob. On the capacity side, we're very well set up from a capacity perspective. We have an ability, we believe, at this point, to fully serve the ALL market with our current setup, which is both the actual physical setup as well as from an operator and process perspective. So we're very well set up from a capacity perspective. We have an ability to obviously take on license additional clean rooms, and as we're getting ready to really substantially increase beyond the ALL, which includes both adults and peds, where we're very well set up today. Going beyond, obviously, we can mobilize additional clean rooms at the facility.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

You don't want to do that too early, because at that point, it would actually increase your overall cost of goods, which you don't want to do because your operating costs go up with more capacity that, in that case, might be idle and not properly used. But we have adequate levels of capacity we can mobilize beyond where we're currently set up. From an ALL perspective, we're fully set up for both adults and pediatrics in the territories we're active in and can actually very well manage that. But it also gives you a good sense for the level of improvements we're expecting to see.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

With that, obviously, what's ultimately going to drive as we're increasing the number of batches through the facility, well, actually, how this is going to help us drive down the overall cost per batch, but also increase, obviously, the margins overall for the products. With that, I think we're headed over to the OpEx question, and I think this is one for you, Rob.

Rob Dolski
Rob Dolski
CFO at Autolus Therapeutics

Yep. Thanks for the question, Simon. I'll give you maybe a little bit more color. When you think about our R&D line, if you look at last year even, it's probably on average of $20 million-$29 million per quarter. What you'll see here is some variability around clinical production and when that actually hits in terms of the actual quarter of production and delivery to the sites.

Rob Dolski
Rob Dolski
CFO at Autolus Therapeutics

You saw a step-up from Q1 to Q2 this year that was largely driven by enrollment in studies more than anything in some of the clinical production. Visit associated with that, it's like a one-time event within the study itself. But other than that, I think it's fair to say that we're not expecting any other kind of significant ramp-up or decrease. We're in the middle of executing a lot of this next wave of studies that Christian's walked through.

Rob Dolski
Rob Dolski
CFO at Autolus Therapeutics

On the SG&A line, the one thing I would call out is predominantly in the first quarter and second quarter of this year, we also were taking some of these one-time charges associated with the restructuring that we announced back in April. So that is incorporated on this line for the total company. Again, if you look to kind of exit last year, we were in kind of a $30 million-$39 million range. And so when you adjust for some of those things, we're still in that ballpark with some very typical year-over-year inflation increases and those kind of things. But fairly stable from that standpoint. Again, we're not expecting any significant ramp-up or decrease other than some of those one-time items, which are largely behind us now with the second quarter.

Simon Baker
Simon Baker
Analyst at Rothschild & Co

That's great. Thanks so much.

Operator

Thank you. Our next question comes from Sebastiaan van der Schoot of Kempen. Your line is open.

Sebastiaan van der Schoot
Analyst at Kempen

Hi, team. Congrats on the excellent quarter. I was wondering whether you could provide some insights into those 80 activated sites. How many of those have actually already treated and have had experience with CAR T? Do you see an acceleration of the time between activation and first patient treatment? Regarding the capacity, you are also evaluating an automated system. When would you implement such a system? Is it already in for adult ALL indication, or would that only be if you also get approvals in autoimmune? Thank you.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

Thanks a lot, Sebastiaan. With regards to the 80 sites, the vast majority of them actually have already treated a patient. We do see that actually that transition from getting activated and actually treating patients tends to be fairly quick. Quite often, actually, the activation is sort of motivated by one or two patients that are suitable for CAR T therapy at the center, and that is really driving the process, and obviously, I think is a key part of the motivation also for centers to get authorized and to get online. We are seeing a very positive dynamic there. Obviously, depending on the level of familiarity with obe-cel, most of the centers obviously that we now actually are adding have not been part of clinical trials with obe-cel before. That obviously is going to be then the first time that we are going to be using the product.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

That is certainly, I think, the dynamic that we are seeing at the stage that we are at. Obviously early on, we had a lot of centers that already had experience, and we basically had all of the seamless roll forward in terms of the experience from the development to the commercial side. Now, most of the centers we are adding on are centers that actually, where obe-cel is going to be a properly new product, that has not been actually used at the center before.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

That also obviously, certainly as the centers start building, does not lead to an acceleration, but a pretty steady pace that we are seeing across these centers from here on forward. That is sort of the expectation. With regards to the capacity question, obviously, as I indicated before to Simon, we are very well set up. Our manufacturing process is actually to quite a significant extent already automated.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

We are going to expect to do another significant change on our current platform, probably over the next 12 to 15 months, which will get us to a very, very high level of automation on the system. Then obviously we are looking at additional technology for future opportunities. But in terms of the ALL setup, we are very well set up and we are basically getting a lot of the gains out of the operational improvements that we are doing in the facility, not just on the actual manufacturing process, but the entirety of the whole chain of events that from the input into the facility, products coming in to all processes through testing, through release, and then obviously the products reaching or being sent back to the treatment centers.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

Every one of those steps actually is currently being evaluated, and we're working on improvements and efficiency gains, and it's been quite significant progress that we've already been able to actually realize and build into the operation at this point in time.

Operator

Thank you. Our next question comes from Rajan Sharma of Goldman Sachs. Your line is open.

Rajan Sharma
Rajan Sharma
Analyst at Goldman Sachs

Hi, thanks for taking my question. Realize it's early, but could you help us understand what the U.K. contribution was to operational revenues in the quarter and what the initial feedback has been on the launch there? Perhaps if you could just help us understand also how we should think about contribution for the remainder of the year, and where you are in terms of center activation. Thank you.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

Yep. Thanks a lot, Rajan. Really good question. When we look, obviously, at the U.K., the U.K. has about, give or take, 60 million people, which is about one sixth of the U.S. population. I think that's a ratio I think that sort of gets you sort of what's the potential ultimately and what's the ultimate patient numbers that you're going to have. They're certainly going to be about that ratio in terms of differential that we're going to expect. We do see a very positive initial momentum. Obviously, we've been active in a substantial number of clinical trials over the years in the U.K. So there's an element of familiarity with the product across a number of the academic centers. We now obviously have activated already a good number of them. We expect to be at around 20 or so by the end of the year.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

That gives us, we believe, a good footprint across the U.K. Now, at this point, when we talk about the U.K., we're really talking about predominantly England. We're in the process of market access in Scotland, that will obviously then expand to the full size of the U.K. as well. So we're in, I think, on very good footing there, very good momentum. We do expect that will actually continue going forward for the second half of the year. So from, I think, an initial perspective, we do believe that we actually have seen very nice momentum. But given the difference in just the population size, we're looking at substantially less than 10% of U.S. sales that we're seeing at this point in time, so that gradually, I think, we'll probably get beyond that.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

It's an early part of the launch, and we just have completed the second quarter of the launch in the U.K.

Rajan Sharma
Rajan Sharma
Analyst at Goldman Sachs

Thank you.

Operator

Thank you. Our next question comes from Emily Bodnar of H.C. Wainwright. Your line is open.

Emily Bodnar
Emily Bodnar
Analyst at H.C. Wainwright

Hi. Good morning. Thanks for taking the questions and congrats on the quarter as well. Maybe can you frame the ALARIC readout for us by year-end and what you're kind of looking to see response rate-wise versus BCMA CAR T to maybe want to move this program forward? Thank you.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

Thanks, Emily. On the ALARIC study, this is a study we're conducting with our colleagues at UCL. We are evaluating, obviously, the use of the BCMA program here in the light chain amyloidosis setting. What we're interested in is to see, obviously, a good level of activity, a good safety profile, which is important in these patients, and with that, I think, build the foundation for the program. I think at this point, it's probably too early to guide on how we might want to consider taking the program forward. We're in this phase I study, which is not complete at this point. This is the first data set coming out of the study, and certainly a bit premature to get a good feel for how the program might stack up.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

I think it's worth keeping in mind that the activity that you expect in this indication is very high, and it's probably not going to be straightforward to actually look at differentiation based on response rates in this indication, certainly not on small patient numbers. But I think we want to see a very solid response rate in these patients and a good safety profile. I think those are the two hallmarks and the two pieces of information we're looking for.

Emily Bodnar
Emily Bodnar
Analyst at H.C. Wainwright

Great. Thank you.

Operator

Thank you. Our next question comes from Roger Song of Jefferies. Your line is open.

Analyst at Jefferies

Hi. This is Fiona on for Roger. Congrats on an amazing quarter, and thanks for taking our question. Just following up on the question regarding the activated centers and physician adoption, can you comment on the utilization and repeat behavior from physicians among the centers that is more active or you have more visibility into? Is it more concentrated in certain centers, or is it more widely distributed? Thanks, and I will hop back in the queue.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

Thanks a lot, Fiona. When we look at the centers that we've been active in for a longer period of time now, we do see a very positive adoption across those centers. They do report the patients slightly differently depending on the center. So you might actually have centers that report predominantly through one name, but actually, what's happening behind that name is actually just a broader team that's actually utilizing the product and actually employing it. Other centers actually report on the individual physician basis, and we have better visibility. So we see, but in general, we see a very nice level of adoption across obviously all the CAR T users at the centers.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

One of the key things that we're obviously looking at, and we're certainly working on, is to see that we can expand, ultimately, the number of CAR T users in those centers to really get a much broader adoption in each one of the centers. That's one dimension. The other dimension that we're certainly looking at very carefully is obviously the referral patterns into the centers and obviously to look for ways to support the referrals into the centers as well.

Analyst at Jefferies

Very helpful. Thank you.

Operator

Thank you. I am showing no further questions at this time. I would like to turn it back to Christian Itin for closing remarks.

Christian Itin
Christian Itin
CEO at Autolus Therapeutics

Well, thank you very much for joining us for our Q2 update. Obviously, a very positive quarter, a lot of good momentum, and we are looking forward to keeping you updated and talk to you at the latest at our next quarterly update, but most likely meet in between. Thank you very much and have a great day.

Operator

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

Executives
    • Amanda Cray
      Amanda Cray
      Executive Director of Investor Relations
    • Christian Itin
      Christian Itin
      CEO
    • Rob Dolski
      Rob Dolski
      CFO
Analysts
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