Autolus Therapeutics plc American Depositary Share 2026 Q2 Earnings Call

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.

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 3, 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 4. 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 GBP 45.7 million, which is a substantial increase over the GBP 26 million that we had in the first quarter. For the first half of the year, we reached GBP 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.

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 5.

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.

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.

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 6. 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 6 to 9 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 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.

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 7, 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 American College of Rheumatology 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. 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.

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.

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 8, 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.

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.