Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $23 million, including net product revenues of $17.4 million, which is consistent with Q1 2024 and an increase from $16.4 million in Q4 2024 [5][16] - Net loss for Q1 2025 was $38.6 million, an improvement from a net loss of $46.6 million in Q1 2024, primarily due to higher license revenues and lower expenses [17] - Cash and cash equivalents as of March 31, 2025, were $194.7 million, down from $250.9 million at December 31, 2024, mainly due to net loss from operations and timing of cash receipts [17] Business Line Data and Key Metrics Changes - Milestone and royalty payments contributed an additional $5.6 million to total revenue for the quarter [6] - The LOTUS-seven study showed a 95.5% overall response rate and a 90.9% complete response rate in 22 efficacy evaluable patients [14] Market Data and Key Metrics Changes - The company is focusing on maintaining its position as a treatment option for third-line plus DLBCL patients, with ongoing trials showing promising data [5][9] - The competitive landscape is highlighted by the potential of ZYNLATA plus glufitamab to be a best-in-class combination in a highly competitive market [6][10] Company Strategy and Development Direction - The company aims to expand the use of ZYNLATA into earlier lines of therapy in DLBCL and indolent lymphomas, believing in the potential for significant patient reach and commercial opportunity [9][10] - Regulatory discussions are planned based on data from 100 patients, aligning with recent examples of bispecific combination therapies [10][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the cash runway extending into the second half of 2026, positioning the company to deliver on upcoming catalysts [20] - The management is encouraged by the promising data from ongoing trials and believes in multiple pathways to achieve peak revenue goals [22] Other Important Information - The LOTUS-five trial is on track to reach the pre-specified number of progression-free survival events by the end of 2025, with top-line data expected thereafter [7][19] - The company is engaged in discussions for potential research collaborations to advance its preclinical assets [8][19] Q&A Session Summary Question: Follow-up time for patients and CR conversion times - Management indicated that follow-up assessments are ongoing, with encouraging complete response rates serving as strong biomarkers for durability [24][27] Question: Competitive strategy and regulatory engagement - Management plans to engage with regulatory authorities after gathering data from approximately 100 patients, assessing the best path forward [29][47] Question: Expected patient numbers at upcoming conferences - Management confirmed that 40 patients have been enrolled, with additional patients expected to be presented at the EHA conference [33][34] Question: LOTUS-five trial data expectations - Management reiterated that the timing for top-line data from the LOTUS-five trial could be late 2025 or early 2026, depending on the number of PFS events [42][43] Question: Discontinuation of the ADCT-602 program - Management clarified that the discontinuation of the ADCT-602 program has minimal financial impact, allowing focus on other research programs [49][50]

Financial Data and Key Metrics Changes - For Q1 2025, total revenue was $2.7 million, a significant decrease from $25.4 million in Q1 2024 [27] - Total operating costs and expenses for Q1 2025 were $17.7 million, down 76% year-over-year from $74.5 million in Q1 2024 [28] - The net loss from continuing operations for Q1 2025 was $16.8 million, or $0.16 per share, compared to a net loss of $49 million, or $0.49 per share, in Q1 2024 [28] Business Line Data and Key Metrics Changes - The company is focused on advancing FG3246 and FG3180 in metastatic castration-resistant prostate cancer (mCRPC) [6] - Roxadustat is being developed for anemia associated with lower-risk myelodysplastic syndromes (MDS), with a Type C meeting request filed with the FDA [8][23] Market Data and Key Metrics Changes - There are approximately 290,000 men diagnosed with prostate cancer annually in the U.S., with 65,000 being drug-treatable patients in the mCRPC stage [9] - The total addressable market for FG3246 in mCRPC is estimated to exceed $5 billion in annual sales [10] Company Strategy and Development Direction - The company is divesting FibroGen China to AstraZeneca, with total consideration expected to increase to approximately $185 million, extending the cash runway into the second half of 2027 [5][26] - The strategic focus is on U.S. pipeline opportunities, particularly FG3246 and FG3180, and advancing clinical trials [4][6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the refined focus and multiple near-term catalysts across clinical programs to create shareholder value [9] - The company anticipates important feedback from the FDA regarding roxadustat and plans to initiate the Phase II monotherapy study for FG3246 and FG3180 in mCRPC [31] Other Important Information - The company recorded cash flow positive results in Q1 2025, generating $7.3 million in cash flow on a consolidated basis [29] - The IND for FG3180 was cleared, allowing it to be used alongside FG3246 in upcoming trials [7][12] Q&A Session Summary Question: Regarding clinical development on FG3246 and market dynamics after Pluvicto approval - Management confirmed that Pluvicto experienced patients will be allowed in the Phase II monotherapy trial to mitigate enrollment challenges [38][39] Question: Comments on recent FDA communications regarding roxadustat - Management reported favorable interactions with the FDA, including timely responses to IND filings and Type C meeting requests [40][42] Question: Feasibility studies in colorectal cancer due to cash infusion from AstraZeneca - Management indicated that while colorectal cancer is a potential opportunity, the immediate focus is on starting the Phase II monotherapy trial [44][45]

Core Viewpoint - AbbVie has shown resilience in its financial performance despite facing challenges from the loss of exclusivity of its blockbuster drug Humira, with strategic acquisitions and strong growth in other product lines [1][17]. Group 1: Financial Performance - AbbVie’s stock price increased by 16% since November 2023, outperforming the S&P 500 index which returned 9.41% [1]. - Humira's revenue peaked at $21 billion in 2022 but is projected to decline by approximately 38% in 2024 to $8.993 billion due to the entry of biosimilars [2]. - The total revenue for AbbVie in Q4 was $15.1 billion, reflecting a year-over-year growth of 6.1% [6]. Group 2: Product Performance - AbbVie’s immunology drugs, Skyrizi and Rinvoq, have compensated for Humira's losses, with Skyrizi's revenue expected to reach $11.718 billion in 2024, a 50.9% increase, and Rinvoq's revenue projected at $5.971 billion, a 50.5% increase [4]. - The oncology segment, represented by Imbruvica, is facing competition, leading to a revenue decline of 6.9% to $3.347 billion in 2024, but Venclexta and Elahere are showing strong growth [5]. - AbbVie’s neuroscience efforts are yielding a 16.6% growth, driven by Botox Therapeutic and Vraylar [6]. Group 3: Strategic Acquisitions - AbbVie acquired ImmunoGen for $10 billion, enhancing its oncology portfolio with the ADC drug Elahere, approved for platinum-resistant ovarian cancer [1]. - The company also invested $8.7 billion in Cerevel Therapeutics, focusing on neuroscience products [1]. Group 4: Financial Guidance and Valuation - AbbVie adjusted its 2025 earnings guidance, projecting adjusted diluted EPS between $11.99 and $12.19, with a negative impact from acquired IPR&D expenses [7]. - The company maintains a stable operating cash flow between $18 billion and $22 billion annually, providing liquidity and leverage [8][9]. - A discounted cash flow analysis suggests AbbVie is undervalued by approximately 10% based on historical free cash flow margins [11]. Group 5: Market Outlook - AbbVie forecasts that total revenue from Rinvoq and Skyrizi will exceed $31 billion by 2027, indicating a compound annual growth rate of about 21% [4]. - The company’s strong cash generation capabilities and strategic positioning in immunology and oncology suggest a positive outlook despite challenges [17].

Financial Data and Key Metrics Changes - The company ended 2024 with $251 million in cash and cash equivalents, expected to fund operations into the second half of 2026 [24] - ZYNLONTA net product revenues in Q4 2024 were $16.4 million, slightly down from $16.6 million in Q4 2023, while full-year revenues were $69.3 million compared to $69.1 million in 2023 [25] - The net loss for Q4 2024 was $30.7 million, a significant improvement from a net loss of $85 million in Q4 2023, and the full-year net loss was $157.8 million compared to $240.1 million in 2023 [26][27] Business Line Data and Key Metrics Changes - ZYNLONTA achieved commercial brand profitability and maintained its position in the competitive third-line-plus DLBCL market [9] - The company reported a 13% year-over-year reduction in operating expenses on a non-GAAP basis, with a 15% decrease in Q4 due to operational efficiencies [25][12] Market Data and Key Metrics Changes - The company is focusing on expanding ZYNLONTA's use in earlier lines of DLBCL therapy, with potential peak revenues estimated between $600 million to $1 billion in the US [19][32] - The LOTIS-5 trial aims to expand ZYNLONTA's market opportunity in the second-line setting, potentially leading to peak sales of $200 million to $300 million [20] Company Strategy and Development Direction - The company is pursuing a strategy to expand ZYNLONTA's usage beyond current indications, focusing on commercialization efforts in the US and research collaborations for early-stage solid tumor pipelines [28][29] - The management is confident in the potential of ZYNLONTA to transform lymphoma treatment paradigms, particularly in indolent lymphomas, with an estimated peak revenue opportunity of $100 million to $200 million [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's path forward, highlighting the importance of upcoming data readouts in 2025 to support ZYNLONTA's expansion strategy [31] - The competitive landscape is expected to evolve with the introduction of new therapies, but management believes the impact will be limited due to the established position of ZYNLONTA [76] Other Important Information - The company achieved a double-digit reduction in operating expenses for the second consecutive year, strengthening its balance sheet through equity financing [12][24] - The management plans to engage regulatory authorities and pursue compendia strategies as data from ongoing trials become available [50] Q&A Session Summary Question: Update on LOTIS-7 - The company has not disclosed the specific forum or timing for sharing LOTIS-7 data but is on track to enroll 40 patients in the second quarter [42] Question: Impact of ADCETRIS Approval - Management believes the approval of ADCETRIS will have limited impact, as physicians have multiple options and may replace older regimens rather than directly compete [44] Question: Regulatory Meetings for LOTIS-7 - Discussions with regulatory authorities are planned once sufficient data is available, likely in the second half of the year [50] Question: Market Opportunity in Indolent Lymphoma - The peak opportunity for indolent lymphomas is estimated to be in the $100 million to $200 million range based on compelling data presented [51] Question: LOTIS-5 and LOTIS-7 Strategy - Both LOTIS-5 and LOTIS-7 are seen as complementary approaches to address different patient needs in the DLBCL market [56] Question: Importance of Upcoming Presentations - Upcoming presentations at AACR are expected to provide differentiating data on the company's ADC platform compared to competitors [60] Question: Compendia Listing and Market Share - Recent additions to NCCN guidelines require approximately 100 patients for compendia listing, which is seen as a benchmark for gaining market share [81] Question: Peak Penetration Timeline - Peak penetration for ZYNLONTA is typically achieved within the first two years post-approval, based on historical trends in the DLBCL setting [86]

Financial Data and Key Metrics Changes - For Q4 2024, total revenue was $3.1 million, down from $3.6 million in Q4 2023, representing a decrease of approximately 14% [38] - For the full year 2024, total revenue was $29.6 million, compared to $46.8 million in 2023, a decline of about 37% [38] - Operating costs and expenses for Q4 2024 were $10.3 million, a significant decrease of 84% from $66.3 million in Q4 2023 [41] - Full year 2024 operating costs were $180 million, down 51% from $369.5 million in 2023 [41] - The net loss from continuing operations for Q4 2024 was $8.7 million, compared to a net loss of $62.5 million in Q4 2023 [42] - For the full year 2024, the net loss was $153.1 million, down from $323 million in 2023 [42] Business Line Data and Key Metrics Changes - Development revenue for Q4 2024 was $0.4 million, down from $2.6 million in Q4 2023 [39] - Drug product revenue for Q4 2024 was $2.7 million, an increase from $1.1 million in Q4 2023 [40] - For the full year 2024, drug product revenue was $27.7 million, compared to $18.8 million in 2023, indicating a growth of approximately 47% [40] Market Data and Key Metrics Changes - The company is focusing on the U.S. market following the divestiture of FibroGen China, which is expected to close by mid-2025 [9][35] - The total addressable market for FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) is estimated to exceed $5 billion annually [13] Company Strategy and Development Direction - The sale of FibroGen China for approximately $160 million is aimed at simplifying operations and extending the cash runway into 2027 [9] - The company is prioritizing the advancement of FG-3246 and FG-3180 in mCRPC, with plans for a Phase 2 monotherapy study [10][12] - Roxadustat is being considered for development in treating anemia associated with lower-risk myelodysplastic syndrome (MDS), with an FDA meeting planned for Q2 2025 [11][33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's refined focus and multiple near-term catalysts across its programs [12] - The company aims to create value for shareholders through a leaner organization focused on high-value oncology indications [46] - The upcoming milestones include the initiation of the Phase 2 study for FG-3246 and the FDA meeting regarding roxadustat [47] Other Important Information - The company has implemented significant cost reduction measures, including a 5% reduction in headcount and a shift to a virtual work environment [43] - The anticipated cash runway extends into 2027, with expectations of being cash flow positive in Q1 2025 [44][45] Q&A Session Summary Question: Can you characterize the level of stringency for the futility analysis coming up in mid-2026? - Management indicated that the futility analysis will assess both safety and efficacy parameters, but specific details were not disclosed [56] Question: What are the qualifications for patients regarding radioligand in the trial? - Patients treated with Pluvicto are eligible for the trial as long as they have not been treated within the prior 28 days [55] Question: Will the company consider new assets or indications given the strong cash balance? - Management stated that the focus remains on advancing FG-3246 and FG-3180, with no plans to branch out into new assets at this time [70] Question: What are the expectations going into the upcoming FDA meeting for roxadustat? - The company aims to leverage previous trial data to avoid additional dose-finding work and seeks to conduct a placebo-controlled trial with about 200 patients [72][76]