Autolus Therapeutics plc

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 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 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.

Thank you, Didi. 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 OCASL in the U.S. and U.K., Otilus manufacturing, sales, and marketing plans for OCASL, the market potential for OCADCIL and the status of clinical trials development and or regulatory timelines and market opportunities for OBSEL and our other product candidates. 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.

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 stronger capsule sales growth in our second year of launch now. When we look at the O'Castle 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 ROCA consortium and the real world database that was presented at the tandem meeting. It builds a very strong foundation for the adoption of the product and 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 UK, we started the launch at the beginning of the year. We do see a strong initial adoption. and we obviously continue to allocate at treatment centers as we go through the remainder of the year. With that, we're going to move to slide number five. I think we're on 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 to 135 million, We're now at a point where we can actually increase our guidance to $140 to $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're 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 UK but also a lot of the improvements that we made on the operational at 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 US, we do see that we actually have a very good distribution across the US and we'll continue to add all of the 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 and with that over time as we're improving our margins of the product reach profitability for our business in the relapsed refractory BAL 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 69 months during the course of the first year of launch last year. We then started to shift our focus onto starting to optimize the processes and really drive for efficiency as well as also 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% to 70% for the ALL business. Now, 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. and we obviously expect to continue to drive the improvements, the optimizations, the drive for efficiency, which obviously are key drivers for the company to reach profitability in this line of business. Moving to slide number seven, I would like just to briefly summarize kind of where we are from a pipeline perspective. We see obviously a very strong foundation with OBSL or Capsule in the adult DLL 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 sort of going through the news flow that we're expecting for the upcoming periods, I would start out with kind of the key news flow that we're expecting for the end of this year, which is really focused first on the update for the Carlyle study at the ACR conference. 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. and 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 sort of 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 data set out of that study. We expect a second data set to become available second half of next year, where we expect longer follow-up, 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 catalyst 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. And then obviously we're getting into the follow-up and then the workup of that data hopefully towards the filing by the end of next year, early 2028. And then when we look a little further out into 2028, we do expect then the phase two data from the Lumina study and in patients with lupus nephritis. So there's quite a full set of data that we expect from the various studies going beyond the adult ALL opportunity, which will 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 and progressive MS, we have in Q1 next year targeting the ACTRMS 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're going to look at safety at PKPD data, biomarker data, and certainly early clinical experience and then 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 a longer term follow up. They will expect to have imaging data as well as expanding safety, PKPD, biomarker data and certainly will at that point look at potential next steps for the program. So 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. And that is also why I would actually like to have about 12 months of follow-up for patients to understand that indeed the response is a true reflection of the product's activity and they don't 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. So with that, I would like to actually move over to slide number nine and hand over to Rob for the financial results.