Autolus Therapeutics (NasdaqGS:AUTL) Q3 2025 Earnings Call November 12, 2025 08:30 AM ET Speaker2Thank you for standing by. Welcome to Autolus Therapeutics' third quarter 2025 financial results conference call. At this time, all participants are on 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. Please ...

Financial Data and Key Metrics Changes - In Q3 2025, CARVYKTI net trade sales reached approximately $524 million, representing an 84% year-over-year increase [7][17] - Total revenues for the quarter were $272 million, driven by collaboration revenue growth of 84% year-over-year [26] - The company reported a net loss of $40 million, with an adjusted net loss of $19 million after excluding non-core items [27][29] - Operating loss improved by 38% to $43 million compared to the same period last year [28] Business Line Data and Key Metrics Changes - CARVYKTI's U.S. net trade sales were $396 million, growing 53% year-over-year and 11% quarter-over-quarter [18] - International sales reached $128 million, nearly five times the amount from the same period last year, representing a 58% quarter-over-quarter increase [18] - The company has treated over 9,000 patients with CARVYKTI, marking it as the strongest CAR-T launch to date [7][15] Market Data and Key Metrics Changes - The U.S. market saw 60% utilization of CARVYKTI in earlier line settings [18] - The number of authorized treatment centers in the U.S. increased to 132, with about one-third being community and regional hospitals [22] - The company launched in 14 markets globally, with strong uptake in Germany, Spain, and Belgium [87] Company Strategy and Development Direction - The company aims to solidify its leadership in cell therapy and expand CARVYKTI into frontline settings [15][16] - Plans include increasing manufacturing capacity to support demand, targeting 10,000 annualized doses [19][41] - The company is focused on educating physicians about CARVYKTI's overall survival benefits and the importance of early treatment [21][46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving profitability for CARVYKTI by the end of 2025 and company-wide profitability in 2026 [16][29] - The company is optimistic about the long-term growth potential in both the U.S. and international markets [15][87] - Management highlighted the importance of effective bridging therapies to mitigate adverse events and improve patient outcomes [66] Other Important Information - The FDA approved an update to CARVYKTI's label to include overall survival benefits [9] - The company is investing in operational efficiency and disciplined expense management to support long-term growth [25][29] Q&A Session Summary Question: How will the company prioritize cash allocation in 2026? - The company plans to maximize the CARVYKTI franchise and invest in manufacturing and CAR-T platform growth [33] Question: What is the status of the Raritan site expansion? - The expansion is on track for completion, with the facility expected to support 10,000 doses annually [36] Question: What are the expectations for authorized treatment centers in 2026? - The company aims to expand coverage to match competitors, targeting over 160 sites [40] Question: How will the company mobilize demand in a supply-constrained environment? - The focus will be on educating physicians about the benefits of early treatment and leveraging community networks [44] Question: What is the impact of loosening REMS requirements? - The changes are expected to facilitate quicker patient transitions back home, enhancing overall patient experience [93] Question: How is the company addressing delayed neurotoxicity? - The company emphasizes the need for effective bridging therapies to manage tumor burden and reduce adverse events [66] Question: What is the outlook for outpatient administration? - Approximately 50% of patients are currently treated in outpatient settings, with expectations for growth [76]

Financial Data and Key Metrics Changes - In Q3 2025, CARVYKTI net trade sales reached approximately $524 million, representing an 84% year-over-year increase [5][16] - Total revenues for the quarter were $272 million, driven by collaboration revenue growth of 84% year-over-year [25] - The company reported a net loss of $40 million, with an adjusted net loss of $19 million after excluding non-core items [25][26] - Operating loss improved by 38% to $43 million compared to the same period last year [26] - The gross margin on net product sales remained consistent at 57% [26] Business Line Data and Key Metrics Changes - CARVYKTI's utilization in the U.S. is primarily in earlier line settings, with 60% of utilization occurring there [16][19] - U.S. net trade sales of CARVYKTI grew 53% year-over-year, while international sales reached $128 million, nearly five times the amount from the same period last year [17] Market Data and Key Metrics Changes - The company has expanded its authorized treatment centers to 132 sites in the U.S., with about one-third being community and regional hospitals [20] - Internationally, the company has launched in 14 markets, with strong uptake in Germany, Spain, and Belgium [22][90] Company Strategy and Development Direction - The company aims to solidify its leadership in cell therapy and expand CARVYKTI into frontline settings [12][14] - Plans for capacity expansion are underway, with expectations to treat over 10,000 patients annually [22][39] - The company is focused on educating physicians about CARVYKTI's overall survival benefits and the importance of early treatment [19][43] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving profitability for CARVYKTI by the end of 2025 and company-wide profitability in 2026 [15][27] - The company anticipates continued strong demand for CARVYKTI, driven by its unique clinical outcomes and operational efficiencies [25][27] Other Important Information - The company has a cash position of nearly $1 billion, allowing for continued investment in core differentiators in cell therapy [15] - The FDA has approved an update to CARVYKTI's label to include overall survival benefits [7] Q&A Session Summary Question: How will the company prioritize cash allocation in 2026? - The company plans to maximize the CARVYKTI franchise and invest in manufacturing and expanding its CAR-T platform [30][31] Question: What is the status of the Raritan site expansion? - The expansion is on track, with completion expected before the end of 2025 [33] Question: What are the expectations for authorized treatment centers in 2026? - The company aims to expand coverage to match competitors, targeting over 160 sites [37][38] Question: How will the company mobilize demand to fulfill new supply? - The focus will be on educating physicians about the benefits of early treatment and leveraging community networks [41][43] Question: What is the impact of loosening REMS requirements? - The changes are expected to facilitate quicker patient transitions back home, enhancing overall patient experience [95] Question: What are the expectations for international growth? - Strong demand is noted in Germany, Spain, and Belgium, with TechLane expected to enhance capacity for European launches [90][91]

November 12, 2025 Third Quarter 2025 Financial Results & Corporate Update This presentation is for investor relations purposes only - Not for product promotional purposes 1 Agenda | 1 | Opening Remarks | | --- | --- | | 2 | Q3 2025 Highlights & Recent Accomplishments | | 3 | Our Pipeline | | 4 | Capitalizing on Market Leadership | | 5 | CARVYKTI® Performance Overview | | 6 | Financial Performance | | 7 | Q&A | Ying Huang, PhD Chief Executive Officer Alan Bash President of CARVYKTI® Carlos Santos Chief Finan ...

Core Viewpoint - CRISPR Therapeutics (CRSP) and Intellia Therapeutics (NTLA) are leading companies in the CRISPR/Cas9 gene editing space, with CRSP being the first to market a CRISPR-based therapy, while NTLA focuses on late-stage in vivo therapies [1][10]. Group 1: CRISPR Therapeutics (CRSP) - CRSP achieved a significant milestone by securing approval for Casgevy (exa-cel) for treating sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT) in late 2023/early 2024, marking the first-ever approval for a CRISPR/Cas9 therapy globally [2][3]. - The commercial uptake of Casgevy has been slow due to the complexity of the treatment process, although VRTX has activated over 65 authorized treatment centers globally, with nearly 90 patients having completed cell collection as of May 1 [4]. - CRSP has multiple other CRISPR candidates in its pipeline, including two CAR-T therapy candidates, CTX112 and CTX131, which are in early-stage studies, with updates expected this year [5]. - Encouraging initial data from an early-stage study on CTX310, an in vivo CRISPR-based gene therapy targeting ANGPTL3 for atherosclerotic heart disease, has raised excitement for CRSP's in vivo programs [6][7]. - Despite the progress, CRSP's pipeline is still in early-stage development, and Casgevy faces competition from chronic therapies like Bristol Myers' Reblozyl and Novartis' Adakveo [8]. Group 2: Intellia Therapeutics (NTLA) - NTLA has shown potential in the biotech space by focusing on in vivo therapies, with two late-stage candidates: lonvo-z for hereditary angioedema (HAE) and nex-z for transthyretin (ATTR) amyloidosis [9][11]. - The pivotal phase III HAELO study for lonvo-z is underway, with enrollment expected to complete by Q3 2025, and regulatory filing planned for the second half of 2026 [12]. - Nex-z is being developed in collaboration with Regeneron Pharmaceuticals and is evaluated in two late-stage studies for ATTR amyloidosis [13]. - NTLA initiated a strategic reorganization to prioritize late-stage candidates, resulting in the cessation of some research programs and a planned workforce reduction of nearly 27% [14]. - A recent setback in the nex-z development due to liver safety concerns has raised questions about the therapy's long-term safety [15]. Group 3: Financial Estimates and Performance - The Zacks Consensus Estimate for CRSP's 2025 sales implies a 7% year-over-year increase, while loss estimates per share are expected to widen by about 28% [16]. - NTLA's 2025 loss per share is expected to improve nearly 20%, with loss estimates for 2025 and 2026 having narrowed over the past 60 days [17]. - Year-to-date, CRSP shares have risen by 19%, while NTLA shares have declined by 18%, compared to a 4% decline in the industry [19]. - CRSP's shares trade at a price/book (P/B) ratio of 2.21, higher than NTLA's 1.27, indicating that CRSP appears more expensive from a valuation standpoint [20]. Group 4: Investment Considerations - Both companies hold a Zacks Rank 3 (Hold), making it challenging to choose one over the other [24]. - CRSP is viewed as a safer investment due to its marketed product and a strong cash balance of $1.9 billion as of March 2025, while NTLA's cash balance was $707 million, raising concerns due to the lack of a stable revenue stream [25]. - Despite setbacks, CRSP's broader pipeline across in vivo and ex vivo therapies offers greater diversification, suggesting potential growth driven by solid fundamentals and positive stock price movement [26].

Core Insights - Actinium Pharmaceuticals is advancing Iomab-ACT, a targeted radiotherapy conditioning agent intended to replace traditional chemotherapy agents for CAR-T therapy, with initial clinical data expected in the second half of 2025 [1][2][3] - The Iomab-ACT trial aims to improve patient access and outcomes by reducing CAR-T related toxicities such as ICANS and CRS, which are significant barriers for patients [2][3] - The CAR-T therapy market generated over $4 billion in sales in 2024 and is projected to reach $12 billion by 2030, indicating a substantial market opportunity for Iomab-ACT [1][5] Company Developments - The first patient has been enrolled in the Iomab-ACT trial at the University of Texas Southwestern Medical Center, marking a significant step in the development of this innovative therapy [1][2] - Iomab-ACT targets CD45, selectively depleting immune cells associated with CAR-T toxicities while sparing essential blood components, which could lead to better patient outcomes [2][3] - Initial clinical results from a pilot study showed no patients developed ICANS and minimal CRS, supporting the advancement of Iomab-ACT into commercial trials [2][3] Market Opportunity - The addressable market for Iomab-ACT aligns with the approximately 150,000 patients annually who require conditioning for CAR-T therapies, suggesting a potential blockbuster revenue opportunity if clinical benefits are demonstrated [5] - The pipeline of CAR-T therapies is rapidly expanding, with the patient population expected to nearly double by 2030, further enhancing the market potential for Iomab-ACT [5]

Financial Data and Key Metrics Changes - In Q4 2024, Legend Biotech reported total net sales of CARVYKTI at approximately $334 million, representing a 110% increase year-over-year and a 17% increase from Q3 2024 [13][23] - Total revenues for Q4 were $187 million, consisting of $168 million from collaboration revenue and $18 million from license revenue [24] - The net profit for Q4 was $26 million, or $0.07 per share, compared to a net loss of $145 million, or $0.40 per share, for the same period last year [24][25] - Adjusted net loss for Q4 was $59 million, or $0.16 per share, compared to an adjusted net loss of $89 million, or $0.24 per share, for the same period last year [32] Business Line Data and Key Metrics Changes - CARVYKTI's sales trajectory has been attributed to its unique profile and strong manufacturing and commercial execution, with a significant increase in outpatient administration [15][19] - The company has treated over 5,000 patients with CARVYKTI, creating a comprehensive patient dataset in multiple myeloma [17] Market Data and Key Metrics Changes - In the U.S., the number of certified hospitals to treat with CARVYKTI has increased to 104, with outpatient administration expected to account for a majority of the volume by the end of the year [15][19] - Internationally, sales outside the U.S. reached $31 million, a 138% increase year-over-year, driven by capacity increases and launches in several countries [14] Company Strategy and Development Direction - The company aims to achieve operational breakeven for CARVYKTI by the end of 2025 and company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses [8] - Legend Biotech is expanding its pipeline programs to include blood cancers, next-generation multiple myeloma therapies, solid tumor programs, and autoimmune diseases [20][21] - A new research facility is being built in Philadelphia to support pipeline investments, expected to open later this year [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for CARVYKTI, particularly in the outpatient setting, and highlighted the importance of educating community physicians [108][111] - The company anticipates that supply constraints will be alleviated by the end of 2025, allowing supply to meet demand [124] Other Important Information - The FDA approved the Novartis facility for commercial production of CARVYKTI, with clinical production expected to begin soon [11] - The company has received reimbursement approval for CARVYKTI in Spain, enhancing its market presence [13][101] Q&A Session Summary Question: Safety profile and trial management for CARVYKTI - Management discussed ongoing efforts to manage ICANS and neurotoxicity through predictive biomarkers and upcoming investigator-initiated trials [36][40] Question: Commercial revenue breakdown and demand for CAR-T therapy - The company reported strong receptivity to CARTITUDE-4 data, with nearly 60% of usage converted to earlier lines of therapy [53][55] Question: Share count and pipeline data expectations - The increase in share count was clarified as a result of net profit calculations, and management provided insights into upcoming data from early pipeline programs [58][62] Question: Revenue growth cadence and capacity expectations - Management indicated that Q1 growth may be modest due to seasonal factors, with more significant growth expected in Q2 and Q3 [70] Question: Positioning of CAR-T therapies in solid tumor treatment - Management highlighted ongoing efforts to innovate in solid tumors and the importance of safety and efficacy in driving commercial success [80][81] Question: Demand fulfillment in Europe - The company is working to meet demand in Europe through its facilities, with recent approvals expected to enhance supply capabilities [145]