Legend Biotech Corporation

Good day, and welcome to the Legend Fourth Quarter 2025 Earnings Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. Instructions will be given at that time. Please note this call is being recorded. I would like to turn the call over to Jessie Young, Vice President of Best Relations and Finance. Please go ahead.

Good morning. This is Jessie Young. Vice President of Investment Relations and Finance at Legend Biotech. Thank you for joining our conference call today to review our fourth quarter of 2025 performance. Prior to this call, we issued a press release announcing our financial results for the quarter. You can find the press release on our IR website at legendbiotech.com. Joining me on today's call are Ying Huang, the company's chief executive officer, Alan Bash, the company's president of Kavikti, and Carlos Santos, the company's chief financial officer. Following the prepared remarks, we will open up the call for Q&A. During today's call, we will be making forward-looking statements, which are subject to risks and uncertainties that may cause our actual results to differ materially from those expressed or implied here within. These forward-looking statements are discussed in greater detail in our SEC filings, which we encourage you to read and can be found under the investor sessions of our company website. In addition, Adjusted net income loss is a non-IFRS metric. This non-IFRS financial measure is in addition to and not a substitute for or superior to measures of financial performance prepared in accordance with IFRS. There are a number of limitations related to the use of this non-IFRS financial measures versus their closest IFRS equivalents. However, we believe that providing information concerning adjusted net income or loss and adjusted net income or loss per share enhances an investor's understanding of our financial performance. We use adjusted net income or loss as a performance metric that guides management in its operation of and planning for the future of the business. In particular, we exclude unrealized gain or loss from foreign exchange rate exchanges. We believe that adjusted net income or loss provides a useful measure of our operating performance from period to period. Our first release includes IFRS to non-IFRS reconciliation for these measures. With that, I will now turn the call over to Ying.

Hello, everyone. Thank you for joining us today. We closed out 2025 as the largest standalone cell therapy company with both commercial scale and next-gen pipeline optionality. And we look forward to becoming a fully scaled CAR T leader this year and presenting new data at upcoming medical conferences this year. We are pleased to have achieved CAR-VT profitability in 2025 and believe we are poised to achieve company-wide profitability in 2026. You'll hear from Alan shortly about the impact that Carvicti has had on a global scale in recent months, but I want you to share a few highlights on this front. During the fourth quarter of 2025, Carvicti net trade sales were approximately $555 million, which is a 66% increase year over year. We have brought hope to patients worldwide with more than 10,000 multiple myeloma patients who have chosen to be treated with Carvicti. And with the physical expansion of the Ryotan facility, we have the installed capacity to support annual production of 10,000 doses across all our manufacturing nodes. Carvicti's launch remains the strongest CAR-T launch to date. The majority of its utilization is now in earlier line settings. Carvicti has a 97% overall manufacturing success rate and is offered in 14 global markets. Not only is CARVICTI raising the bar for manufacturing excellence and site growth, it's also setting new standards for survival outcomes in relapsed refractory multiple myeloma. Recently, at the 67th American Society of Hematology Annual Meeting and the 2026 Tandem Meeting, we presented compelling data on CARVICTI's efficacy and our manufacturing success. Before we dive deeper into this, I want to highlight that we also presented at ASH on LUCA-G39D, our first-in-class allogeneic gamma-delta CAR-T cell therapy targeting CD19 and CD20 in adults with relapsed refractory B-cell non-Hodgkin's lymphoma, or NHL. As you may have seen, we're pleased that it demonstrated manageable safety and encouraging anti-tumor activity. Turning to the recent CARVIC-T presentations, new long-term CARVIC-T data demonstrated durable responses in key subgroups and reinforced the improved outcomes associated with earlier treatment with CARVIC-T. Importantly, triple class exposed multiple myeloma patients with three prior lines of therapy in CARTITUDE 1 and CARTITUDE 4 achieved a median PFS of 50.4 months after single infusion of CARVIC-T. This represents one of the longest PFS outcomes for BCMA targeting CAR-T therapy. Given that more than 50% of patients enrolled in the competing trial had only three prior lines of therapy, we believe the 50.4-month median PFS sets a new standard in this population. Additionally, an analysis of patients with standard risk cybergenetics from CAR-T4 shows that earlier treatment with CAR-VICT improved survival outcomes. reinforcing its curative potential. 80% of the patients remained progression-free and off-treatment after 2.5 years. Off-standard risk patients in CART2-4 who were progression-free at one year, 93% remained alive and progression-free at 2.5 years. Furthermore, translational analysis of patients from CAR-T1 and CAR-T4 demonstrated stronger immune fitness and a more immunocompetent tumor microenvironment for patients earlier in the treatment journey. Again, adding to the body of clinical evidence that earlier treatment with CAR-VT leads to better outcomes. Finally, Commercial CARVICT manufacturing data from July 2024 through October 2025 were analyzed to examine manufacturing outcomes across multiple prior lines of therapy. Overall, 99% of the products were successfully manufactured when using cells from patients with one to three prior lines of therapy with 6.5% out-of-spec product. compared to 97% for the fourth line and beyond, with 9.2% out-of-spec product. Not only are we unconstrained from a capacity standpoint, but we have also made significant progress on our manufacturing success rates. We are reinforcing this message about our manufacturing capabilities and, of course, the importance of earlier treatment and effective bridging therapy in the KOL community. To sum up, we believe these recent presentations from ASH and Tandem further strengthen our robust body of clinical evidence, supporting the long-term benefits of CARVICT in multiple myeloma. This is one of the many reasons why we and our partner, Johnson & Johnson, are moving full steam ahead on our capacity expansion plans. Our partnership with Johnson & Johnson is built to scale CARVICT to its anticipated potential of more than $5 billion in peak annual sales. Beyond current indications of CAR-VICT, we are continuing to advance our earlier line studies to potentially expand our addressable market. Notably, CAR-VICT 5 and 6 studies have both completed enrollment already. Based on the data presented recently, earlier treatment may deliver greater durability at lower lifetime cost. We look forward to sharing data when the number of pre-specified events is reached. Looking ahead at our long-term growth, In addition to moving Carvicti into the frontline, we remain focused on our R&D pipeline besides Carvicti. We have developed a lean approach to leveraging investigator-initiated trials in China, or IIT, to rapidly establish clinical proof-of-concept, and each of our programs is gated by clear evidence thresholds, which avoids inefficient use of capitals. For example, we advanced one of our first in vivo CAR T programs from candidate selection to first patient dosing in six months. We continue to anticipate that we will present clinical data this year. Additionally, we continue to invest in other blood cancer, solid tumor, and autoimmune programs that we view as having transformative potential. Our plan is to file one to two US INDs by the end of this year. In addition to investing in our own in-house R&D efforts, we will be optimistic this year about generating new revenues through business development efforts. To recap, we have several important milestones ahead this year as we look to increase connectivity penetration in earlier lines and advance our next-generation cell therapies. With a cash position of $949 million, we're balancing investment in future growth with disciplined expense management. We are pleased that Carvicti became profitable in 2025 and anticipate company-wide profitability in 2026. And with that, I'll pass it over to Alan to provide an update on Carvicti.