Core Viewpoint - Y-mAbs Therapeutics reported solid financial results for Q1 2025, highlighting growth in DANYELZA net product revenue and advancements in its SADA PRIT platform, while also managing operational costs prudently [2][4][20]. Financial Results - Total net product revenues for Q1 2025 were $20.9 million, an 8% increase from $19.4 million in Q1 2024 [4][7]. - U.S. DANYELZA net product revenues decreased by 28% to $13.4 million, while Ex-U.S. revenues increased by $6.7 million to $7.5 million [8][9]. - Gross profit remained stable at $17.9 million, with gross margins of 86% in Q1 2025 compared to 89% in Q1 2024 [14]. - Operating costs included $11.4 million in R&D expenses, down from $13.3 million in the previous year, and $13.1 million in SG&A expenses, up from $11.4 million [15][16]. - The net loss for Q1 2025 was $5.2 million, or ($0.12) per share, an improvement from a net loss of $6.6 million, or ($0.15) per share, in Q1 2024 [18]. Corporate Developments - The National Comprehensive Cancer Network updated its guidelines to include DANYELZA as a Category 2A treatment option for high-risk neuroblastoma [5]. - The first patient was dosed in the Phase 1 clinical trial (Trial 1201) for CD38-SADA pretargeted radioimmunotherapy in relapsed/refractory non-Hodgkin Lymphoma [5][6]. - The company plans to host a virtual R&D update on May 28, 2025, to discuss clinical data and future strategies [4][12]. Cash Position and Guidance - As of March 31, 2025, Y-mAbs had cash and cash equivalents of $60.3 million, expected to support operations into 2027 [19][25]. - The company reiterated its full-year 2025 revenue guidance of $75 million to $90 million and projected Q2 2025 revenues between $17 million and $19 million [20][21].

Core Viewpoint - Y-mAbs Therapeutics, Inc. announced that naxitamab-gqgk (DANYELZA®) has been recommended as a Category 2A treatment option for high-risk neuroblastoma by the National Comprehensive Cancer Network (NCCN) [1][2] Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company focused on developing and commercializing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [8] - The company’s product pipeline includes DANYELZA (naxitamab-gqgk), which is the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma in patients who have shown a partial response, minor response, or stable disease to prior therapy [8] Product Information - Naxitamab-gqgk (DANYELZA) was granted accelerated approval by the FDA on November 25, 2020, for pediatric patients aged one year and older and adult patients with relapsed or refractory high-risk neuroblastoma [3] - The approval was based on efficacy results from two single-arm, open-label trials [3] - DANYELZA is indicated for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) [6] - The product includes a Boxed Warning for serious infusion-related reactions and neurotoxicity [6] NCCN Guidelines - The NCCN is a not-for-profit alliance of 33 leading cancer centers focused on advancing quality cancer care [4] - The inclusion of DANYELZA in the NCCN Guidelines reinforces its position as a leading anti-GD2 therapy for high-risk neuroblastoma [2]

Core Insights - Y-mAbs Therapeutics, Inc. is set to report its first quarter 2025 results on May 13, 2025, before market opening [1] - A conference call and webcast will be held on the same day at 8:00 a.m. ET to discuss the results, with a live audio webcast available on the company's Investor Relations website [2] Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company focused on developing and commercializing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [3] - The company utilizes advanced technologies such as the Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy Platform (PRIT) and bispecific antibodies from the Y-BiClone platform [3] - Y-mAbs has a broad product pipeline, including DANYELZA® (naxitamab-gqgk), which is the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma in specific patient conditions [3]

Core Insights - Y-mAbs Therapeutics, Inc. presented preclinical and translational pharmacokinetics (PK) data of CD38-SADA at the 2025 AACR Annual Meeting, focusing on its potential for cancer treatment [1][2] Group 1: Presentation Details - The poster titled "Preclinical and translational pharmacokinetic (PK) modeling of the self-assembling and disassembling (SADA) bispecific fusion protein CD38-SADA for first-in-human (FIH) pretargeted radioimmunotherapy (PRIT)" was presented, detailing plasma concentrations of CD38-SADA in animal models [2][5] - The presentation took place on April 27, 2025, from 2:00 p.m. to 5:00 p.m. CT at Poster Section 25 [5] Group 2: Research Findings - The study characterized the concentration- and time-dependent equilibrium between CD38-SADA tetramers and monomers, with the model showing that low molecular weight CD38-SADA monomers cleared from plasma 20 times faster than the tetramers [3] - The preclinical PK model provided insights into the circulating levels of CD38-SADA protein in vivo, which informed the design and initial dosing regimen of the first-in-human Phase 1 Trial 1201 [4] Group 3: Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company focused on developing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [6] - The company's product pipeline includes DANYELZA®, the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma [6] Group 4: CD38-SADA PRIT Technology - CD38-SADA is a bispecific fusion protein that binds to CD38 and Lu-DOTA, facilitating a two-step pre-targeted radioimmunotherapy process [7][8] - The technology has shown robust anti-tumor efficacy in preclinical studies and is currently being investigated in adults with relapsed, progressive, or refractory non-Hodgkin lymphoma [8]

Core Insights - Y-mAbs Therapeutics has initiated its Phase 1 clinical trial (Trial 1201) for the CD38-SADA Pre-targeted Radioimmunotherapy (PRIT) platform aimed at treating relapsed or refractory non-Hodgkin Lymphoma (r/r NHL) [1][3] - The trial focuses on the safety and tolerability of the CD38-SADA: Lu-DOTA Drug Complex, with the first patient successfully administered both the protein and imaging doses [1][2] - The SADA PRIT platform is designed to enhance targeted delivery of therapeutic agents while minimizing radiation exposure to normal tissues [2][6] Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company specializing in novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [5] - The company’s product pipeline includes DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma [5] Technology and Innovation - The CD38-SADA is a bispecific fusion protein that binds to CD38-expressing lymphoma cells and delivers a radioactive payload for localized irradiation [6] - The SADA technology was developed by researchers at MSK and is exclusively licensed to Y-mAbs, indicating a strong collaboration between the two entities [4]

I have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls of investing in this space.Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wr ...

Financial Data and Key Metrics Changes - Total revenue for the full year 2024 was USD 87.7 million, within the guidance range of USD 87 million to USD 95 million [11] - DANYELZA net product revenues for the full year 2024 were USD 85.2 million, with a fourth quarter revenue of USD 24.5 million, representing a 5% increase compared to the same period in 2023 [22][41] - The company ended 2024 with cash and cash equivalents of USD 67.7 million, reflecting a decrease of USD 11.4 million from the previous year [13][47] - The net loss for Q4 2024 was USD 6.8 million, compared to a net loss of USD 1 million in Q4 2023, with a full year net loss of USD 29.7 million [46] Business Line Data and Key Metrics Changes - DANYELZA maintained a steady market share of 15% to 17% in the U.S. anti-GD2 market [11][23] - International DANYELZA net product revenues in Q4 2024 were USD 7.7 million, a 78% increase compared to Q4 2023, driven by the launch of a named patient program in Western Asia [26][42] - The company recorded USD 2 million in licensing revenue for Q4 2024, compared to no licensing revenue in Q4 2023 [43] Market Data and Key Metrics Changes - DANYELZA's estimated total share of the U.S. anti-GD2 market remained steady, with 69 accounts ordering the product as of December 31, 2024 [23] - The company saw continued institutional adoption of DANYELZA, with 7 new hospital formularies added in 2024 [24] Company Strategy and Development Direction - The company announced a strategic realignment to establish two distinct business units: DANYELZA and Radiopharmaceuticals, aimed at accelerating the development of the SADA PRIT platform [14][16] - The focus is on expanding radiopharmaceutical capabilities and improving capital efficiencies while maximizing DANYELZA's potential [15][17] Management's Comments on Operating Environment and Future Outlook - Management acknowledged headwinds from competition, particularly from naxitamab trials, but expressed confidence in DANYELZA's growth potential [12] - The company anticipates total net revenue for 2025 to be between USD 75 million and USD 90 million, with a first quarter guidance of USD 18 million to USD 21 million [48][49] Other Important Information - Research and development expenses decreased to USD 49 million for the year ended December 31, 2024, from USD 54.2 million in 2023 [44] - Selling, general, and administrative expenses increased to USD 54.6 million for the year ended December 31, 2024, primarily due to legal settlements and personnel costs [45] Q&A Session Summary Question: Should we expect a flat trajectory for DANYELZA revenue in 2025? - Management indicated plans to accelerate growth, with some ramp-up expected as they support clinical trials and seek additional market penetration [55] Question: What tissues will be important for dose selection in the upcoming SADA update? - Key areas include the kidney, liver, and bone marrow, with a focus on potential dose-limiting toxicities [63][64] Question: Can you provide a breakdown of the 2025 OpEx guidance? - The OpEx guidance of USD 116 million to USD 121 million excludes cost of goods, with SG&A costs expected to grow slightly from the previous year [68][72] Question: How will investigator-sponsored studies impact DANYELZA revenue? - Continued investment in investigator-sponsored trials is expected to increase market penetration and support additional indications [76][78] Question: What are the market dynamics in neuroblastoma with the introduction of DFMO? - DFMO may provide temporary solutions, but patients will likely return to anti-GD2 therapies as their condition progresses [113] Question: What drives fluctuations in cost of goods sold? - Variations in batch costs and inventory write-offs contribute to fluctuations in cost of goods sold [115][117]

Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB) Q4 2024 Earnings Conference Call March 4, 2025 8:00 AM ET Company Participants Courtney Dugan - Head-IR Michael Rossi - President & CEO Doug Gentilcore - Senior VP & Head of DANYELZA Business Unit Natalie Tucker - Radiopharmaceutical Business Unit Head Peter Pfreundschuh - CFO Conference Call Participants Alec Stranahan - Bank of America Michael Wolf - Morgan Stanley Jeff Jones - Oppenheimer Nicole Germino - Truist Li Watsek - Cantor Fitzgerald William Maughan - Clear ...

Core Viewpoint - Y-mAbs Therapeutics, Inc. reported a quarterly loss of $0.15 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.13, marking a 15.38% earnings surprise [1][2] Financial Performance - The company posted revenues of $26.5 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 0.40%, compared to revenues of $23.36 million a year ago [2] - Over the last four quarters, Y-mAbs has not surpassed consensus EPS estimates and has consistently missed revenue estimates [2][3] Stock Performance - Y-mAbs shares have declined approximately 33.7% since the beginning of the year, contrasting with the S&P 500's decline of only 0.5% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.15 on revenues of $24.61 million, and for the current fiscal year, it is -$0.59 on revenues of $104.97 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Y-mAbs belongs, is currently ranked in the top 29% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8]

Drug Development and Approval - DANYELZA (naxitamab-gqgk) received accelerated FDA approval in November 2020 for treating pediatric and adult patients with relapsed or refractory high-risk neuroblastoma [703]. - The ongoing pivotal-stage multicenter trial (Study 201) for DANYELZA aims to enroll a minimum of 80 evaluable patients, with 109 patients currently enrolled and expected completion by March 31, 2027 [704]. - A Phase 2 trial evaluating naxitamab in combination with standard induction therapy for newly diagnosed high-risk neuroblastoma is ongoing, with 12 patients treated so far [707]. - The company is considering advancing a diagnostic tool for GD2 to support potential pivotal trials in GD2-related indications [706]. Financial Performance - The company reported an accumulated deficit of $487.1 million as of December 31, 2024, with a net loss of $29.7 million for the year [721]. - Total revenues increased by $2.9 million, or 3%, from $84.8 million in 2023 to $87.7 million in 2024, driven by a 400% increase in license revenue [766]. - Net product revenue rose from $84.3 million in 2023 to $85.2 million in 2024, with international revenue increasing by $2.7 million, or 16%, while U.S. revenue decreased by $1.8 million, or 3% [768]. - Gross profit decreased from $73.5 million in 2023 to $72.7 million in 2024, resulting in a gross margin decline from 87% to 82% due to a less favorable price mix [774][775]. - The net loss for 2024 was $29.7 million, compared to a net loss of $21.4 million in 2023, representing an increase in loss of $8.2 million, or 38% [766]. Research and Development - Research and development expenses have decreased compared to historical averages, with a focus on the commercialization and potential label extension of DANYELZA [738]. - Research and development expenses decreased by $5.2 million, or 10%, from $54.2 million in 2023 to $49.0 million in 2024, primarily due to a reduction in milestone and license acquisition costs [778][779]. - The transition of DANYELZA manufacturing from Greenville, North Carolina, to Monza, Italy, is expected to occur in the second half of 2026, potentially increasing research and development expenses due to the FDA approval process [738]. - The company has deprioritized several pipeline programs, including the GD2-GD3 Vaccine and CD33 bispecific antibody constructs, to focus on DANYELZA and SADA PRIT technology [715]. Operational Changes - A strategic restructuring plan was completed in May 2023, resulting in a 35% reduction in workforce to extend cash resources and prioritize DANYELZA commercialization [715]. - A business realignment plan announced in January 2025 aims to optimize operations and is expected to reduce the workforce by up to 13% by the first half of 2026 [716]. - The company has deprioritized the development of omburtamab and other product candidates, focusing resources on DANYELZA and SADA PRIT technology [738]. Revenue and Expenses - Selling, general, and administrative expenses primarily include employee-related costs, legal fees, and compliance-related expenses [739]. - Selling, general, and administrative expenses increased by $9.7 million, or 22%, from $44.9 million in 2023 to $54.6 million in 2024, influenced by legal settlements and increased personnel costs [781]. - Cost of goods sold increased by $3.6 million, or 32%, from $11.4 million in 2023 to $15.0 million in 2024, including $0.6 million in inventory write-offs [773]. - License revenue for 2024 totaled $2.5 million, a significant increase from $0.5 million in 2023, primarily due to a new distribution agreement with Nobelpharma [771][772]. Cash Flow and Financing - As of December 31, 2024, the company had cash and cash equivalents of $67.2 million, down from $78.6 million in 2023, and expects this to be sufficient to fund operations into 2027 [785]. - Net cash used in operating activities decreased to $15.7 million in 2024 from $27.2 million in 2023, representing a 42% reduction [787]. - Net cash provided by financing activities increased significantly to $4.3 million in 2024 from $0.1 million in 2023, a 4,211% increase [791]. - The company plans to advance the development of pipeline programs and may need substantial additional funding for ongoing operations [793]. Market and Economic Factors - The company faces potential pricing pressures and inflationary factors that may adversely affect operating results and cash flows [802]. - The company cannot assure that it will be able to obtain additional capital from new financing or collaborations, which may affect its research and development programs [793]. - Total operating lease commitments as of December 31, 2024, amount to $1.883 million, with $942,000 due within one year [799]. - The company has entered into sublicenses and distribution agreements in various regions, including Eastern Europe and Japan, which may impact future revenue [801].