Company Leadership Changes - Sue Smith, Chief Commercial Officer, will be departing the organization [1] - Doug Gentilcore appointed as Senior Vice President, Head of DANYELZA Business Unit [4] - Doug Gentilcore brings over two decades of strategic leadership experience in the pharmaceutical industry [5] Product Information - DANYELZA® (naxitamab-gqgk) is indicated for the treatment of pediatric and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow [1] - DANYELZA® includes a Boxed Warning for serious infusion-related reactions and neurotoxicity [1] - DANYELZA is currently not approved for the treatment of osteosarcoma in any jurisdiction [2] Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic cancer products [3] - The Company's technologies include its investigational SADA PRIT Platform and bispecific antibodies generated using the Y-BiClone platform [3] - The Company's product pipeline includes the anti-GD2 therapy DANYELZA® [3] Future Plans and Expectations - Doug Gentilcore's experience is expected to be instrumental in the continued commercial expansion and growth of DANYELZA beyond pediatric oncology [5]

Core Insights - Y-mAbs Therapeutics, Inc. has established two business units focused on Radiopharmaceuticals and DANYELZA to enhance operational efficiency and commercial growth [2][3][4] - The company reported preliminary estimated unaudited total net revenue of approximately $88 million for the year ended December 31, 2024, aligning with its guidance range [9] - Y-mAbs anticipates a reduction in its workforce by up to 13% as part of its business realignment strategy [6] Business Update - The establishment of the two business units aims to optimize internal resources and enhance the advancement of the SADA PRIT platform while driving the commercial growth of DANYELZA [2][3] - The SADA PRIT platform is designed to improve traditional radioimmunotherapy by delivering high therapeutic doses with minimized off-target exposure [5] - DANYELZA is the only FDA-approved treatment for high-risk relapsed/refractory neuroblastoma in patients aged one year and older, launched commercially in 2021 [5] Pipeline Advancement - The GD2-SADA Phase 1 trial has dosed 21 patients, showing a well-tolerated pre-targeting approach with no dose-limiting toxicities reported [7][8] - The company expects to present data from Part A of the GD2-SADA Phase 1 trial in the second quarter of 2025 [12] - The first patient in the CD38-SADA Phase 1 trial is expected to be dosed in the first quarter of 2025 [8][12] Financial Overview - Preliminary estimated unaudited cash, cash equivalents, and marketable securities as of December 31, 2024, are approximately $67 million, expected to support operations into 2027 [9] - The total cash investment for the full year 2024 is estimated at approximately $11 million, below the company's guidance range [9] Upcoming Events - The company will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025 [11] - Full year 2025 guidance is expected to be provided alongside the full year 2024 earnings report in the first quarter of 2025 [12]

Core Points - Y-mAbs Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on developing and commercializing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [3] - Michael Rossi, the President and CEO of Y-mAbs, will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025 [1] - A live webcast of the presentation will be available on the company's investor relations website and archived for 30 days [2] Company Overview - Y-mAbs utilizes advanced technologies such as the Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy Platform (PRIT) and bispecific antibodies generated through the Y-BiClone platform [3] - The company's product pipeline includes DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma in patients who have had a partial response, minor response, or stable disease to prior therapy [3]

Financial Data and Key Metrics Changes - Total net revenue for Q3 2024 was $18.5 million, down 10% from the same period in 2023, primarily due to a decline in net product revenues in both the U.S. and ex-U.S. markets [11][41] - U.S. DANYELZA net product revenues were $15.3 million, representing a 5% decrease compared to Q3 2023, attributed to a change in estimate from Medicaid claims [27][42] - Ex-U.S. DANYELZA net product revenues were $3.1 million, a 19% decline compared to Q3 2023, driven by decreased volume from the WEP patient access program in Europe [30][43] - The company reported a net loss of $7 million for Q3 2024, compared to a net loss of $7.7 million for Q3 2023 [47] - Cash and cash equivalents at the end of Q3 2024 were $68.1 million, down from $78.6 million at year-end 2023 [49] Business Line Data and Key Metrics Changes - DANYELZA sales performance showed a 5% increase in demand compared to Q2 2024, indicating growing physician adoption [9] - The company added three new U.S. DANYELZA accounts in Q3 2024, bringing the total to 68 accounts since launch [28] - DANYELZA's estimated total share of the U.S. anti-GD2 market remained steady at approximately 15% as of September 30, 2024 [28] Market Data and Key Metrics Changes - The third quarter marked the first recorded sales of DANYELZA in Turkey and continued sales in Brazil and Mexico [31] - In Asia, the partner SciClone is expanding the use of DANYELZA in China and preparing for a launch in Hong Kong [32] Company Strategy and Development Direction - The company is focused on expanding DANYELZA's market presence and has entered into a licensing agreement with Nobelpharma for DANYELZA in Japan, with potential milestone payments of up to $31 million [13] - The company plans to submit a regulatory filing for marketing approval of DANYELZA in Argentina later this year [15] - The SADA PRIT technology platform is being developed to address treatment gaps in various cancers, with ongoing clinical trials [23] Management's Comments on Operating Environment and Future Outlook - Management acknowledged headwinds from competition affecting DANYELZA but expressed confidence in the long-term growth trajectory [8][33] - The company reiterated its full-year 2024 total net revenue guidance to be in the range of $87 million to $95 million, expecting to land in the lower half of that range [50] Other Important Information - The company received notification of an accepted patent extension for DANYELZA, extending the U.S. patent expiration to February 5, 2034 [12] - The company is in the process of evaluating multiple targets for future SADA programs, with updates expected in early 2025 [87] Q&A Session Summary Question: Can you discuss the price mix dynamic for DANYELZA and its future expectations? - Management noted a $1.5 million charge in Q3 related to Medicaid claims, which contributed to a 5% decline in net revenues despite a 5% increase in vials sold [54] Question: What are the key criteria for dose selection in the GD2 SADA study? - Management indicated that the optimal protein dose is being refined based on preclinical pharmacokinetic data, focusing on a dose of 1 milligram per kilogram [55] Question: What are the swing factors for Q4 revenues? - Management expressed confidence in landing within the revenue guidance range, citing adjustments related to sales timing and Medicaid claims [60] Question: How does the company view the competitive landscape for pre-targeting approaches? - Management welcomed the entry of more companies into the pre-targeting space, viewing it as validation for their approach and an opportunity to enhance patient treatment logistics [68] Question: Can you elaborate on the dose-escalation decisions for SADA? - Management clarified that the adjustments in dosing were based on pharmacokinetic modeling rather than tumor type differences, aiming to optimize the balance between tumor targeting and clearance [90]

Core Viewpoint - Y-mAbs Therapeutics, Inc. reported a quarterly loss of $0.16 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.14, indicating a negative earnings surprise of -14.29% [1] Financial Performance - The company posted revenues of $18.46 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 21.03% and down from $20.45 million a year ago [2] - Over the last four quarters, Y-mAbs has surpassed consensus EPS estimates only once [2] Stock Performance - Y-mAbs shares have increased approximately 128% since the beginning of the year, significantly outperforming the S&P 500's gain of 25.2% [3] Future Outlook - The company's earnings outlook will be crucial for assessing future stock performance, particularly in light of management's commentary during the earnings call [4] - Current consensus EPS estimate for the upcoming quarter is -$0.12 on revenues of $25.71 million, and for the current fiscal year, it is -$0.62 on revenues of $92.76 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Y-mAbs belongs, is currently ranked in the top 35% of over 250 Zacks industries, suggesting a favorable industry outlook [8]

Financial Performance - Product revenue for the three months ended September 30, 2023, was $18.461 million, a decrease from $19.954 million in the same period last year, representing a decline of approximately 7.5%[17] - Total revenues for the nine months ended September 30, 2023, were $61.190 million, compared to $61.456 million for the same period last year, indicating a slight decrease of about 0.4%[17] - The net loss for the three months ended September 30, 2023, was $6.998 million, compared to a net loss of $7.747 million in the same period last year, showing an improvement of approximately 9.7%[17] - The comprehensive loss for the three months ended September 30, 2023, was $8.081 million, compared to a comprehensive loss of $6.941 million in the same period last year, indicating a decline of about 16.4%[17] - The company reported a net loss per share of $0.16 for the three months ended September 30, 2023, compared to a net loss per share of $0.18 in the same period last year[17] - The net loss for the nine months ended September 30, 2024, was $22,876,000, an increase from a net loss of $20,439,000 for the same period in 2023[22] - The net loss for the three months ended September 30, 2024, was $6,998,000, compared to a net loss of $7,747,000 for the same period in 2023, indicating an improvement of 9.7%[52] - The net loss for the nine months ended September 30, 2024, was $22.8 million, compared to a net loss of $20.4 million in 2023, reflecting a 12% increase in losses[159] Expenses - Research and development expenses for the three months ended September 30, 2023, were $11.168 million, down from $15.358 million in the prior year, reflecting a decrease of approximately 27%[17] - Selling, general, and administrative expenses increased to $13.613 million for the three months ended September 30, 2023, compared to $10.200 million in the same period last year, marking an increase of about 33.6%[17] - Research and development expenses decreased by $4.2 million, or 27%, to $11.2 million for the three months ended September 30, 2024, compared to $15.4 million in 2023[145] - Selling, general, and administrative expenses increased by $3.4 million, or 33%, to $13.6 million for the three months ended September 30, 2024[145] - Total operating costs and expenses increased to $86.4 million for the nine months ended September 30, 2024, from $83.9 million in 2023, an increase of 3%[159] Cash and Liquidity - Cash and cash equivalents decreased to $68,122,000 as of September 30, 2024, from $78,637,000 as of December 31, 2023[29] - The company expects that its cash and cash equivalents will be sufficient to fund operating expenses and capital expenditures for at least the next 12 months[29] - Cash and cash equivalents were $68.1 million as of September 30, 2024, down from $78.6 million as of December 31, 2023[176] - Net cash used in operating activities decreased by $5.4 million, or 28%, to $13.84 million for the nine months ended September 30, 2024, compared to $19.2 million for the same period in 2023[178] - Net cash provided by financing activities was $3.3 million for the nine months ended September 30, 2024, resulting from proceeds from exercised stock options[182] Equity and Stock - Total stockholders' equity decreased to $92.429 million as of September 30, 2023, down from $100.985 million at the end of the previous year, representing a decline of approximately 8.4%[15] - The Company has authorized a total of 105,500,000 shares, with 44,766,802 shares of common stock issued as of September 30, 2024[83][84] - The Company had 10,043,999 stock options outstanding, with a weighted average exercise price of $17.55[95] - Total stock-based compensation expense for the three months ended September 30, 2024 was $4,195,000, an increase of 74% compared to $2,410,000 for the same period in 2023[88] Revenue Sources - The company has funded operations primarily through proceeds from sales of common stock and revenue from DANYELZA sales[28] - Royalty revenue from distribution partners was $1,133,000 for the three months ended September 30, 2024, compared to $427,000 in the same period of 2023, marking a significant increase of 165%[48] - License revenue was $0 for the three months ended September 30, 2024, compared to $0.5 million in the same period of 2023[148] - License revenue remained flat at $0.5 million for both the nine months ended September 30, 2024, and 2023, related to regulatory-based milestone payments[164] Inventory and Assets - Total inventories increased to $27,048,000 as of September 30, 2024, from $17,013,000 as of December 31, 2023, representing a 59.3% increase[53] - The company did not record any inventory write-offs during the three and nine months ended September 30, 2024, contrasting with write-offs of $375,000 and $831,000 for the same periods in 2023[56] - Intangible assets related to DANYELZA amounted to $2,366,000 net as of September 30, 2024, down from $2,631,000 as of December 31, 2023, reflecting a decrease of 10.1%[58] Strategic Developments - The company completed a strategic restructuring plan in May 2023, resulting in a 35% reduction in workforce and recognizing restructuring expenses of $4,482,000 for the nine months ended September 30, 2023[14] - The company has deprioritized the development of radiolabeled omburtamab for CNS-LM and other pipeline programs to focus on DANYELZA and the SADA PRIT platform[123] - A license agreement with Nobelpharma Co., Ltd. for DANYELZA in Japan was signed on October 29, 2024, entitling the company to a non-refundable payment of $2,000,000 and up to $31,000,000 in milestone payments[15] Clinical Trials and Product Development - DANYELZA received accelerated approval from the FDA in November 2020 and is currently being commercialized in the United States, with a patent extension achieved through February 2034[110] - The ongoing pivotal-stage multicenter trial for DANYELZA is designed to satisfy FDA's accelerated approval confirmatory study requirements[111] - The company has 22 active sites in a multi-center Phase 2 trial evaluating naxitamab in combination with standard induction therapy for newly diagnosed high-risk neuroblastoma patients[113] Regulatory and Compliance - The company evaluated the effectiveness of its disclosure controls and procedures as of September 30, 2024, concluding they were effective at a reasonable assurance level[193] - There were no changes in internal control over financial reporting during the quarter ended September 30, 2024, that materially affected or are likely to materially affect internal control over financial reporting[195]

Revenue Performance - Total DANYELZA net product revenues for Q3 2024 were $18.5 million, a 10% decline from $20.5 million in Q3 2023[4] - U.S. DANYELZA net product revenues were $15.3 million for Q3 2024, down 5% from $16.1 million in Q3 2023, primarily due to an unfavorable price mix[6] - Ex-U.S. DANYELZA net product revenues for Q3 2024 were $3.1 million, a 19% decline from $3.9 million in Q3 2023, driven by decreased volume from Western Europe[7] - Total revenues for the three months ended September 30, 2024, were $18,461,000, a decrease of 9.7% compared to $20,454,000 for the same period in 2023[26] - Product revenue for the nine months ended September 30, 2024, was $60,690,000, slightly down from $60,956,000 in the same period of 2023[26] Expenses - Research and development expenses for Q3 2024 were $11.2 million, a decrease of $4.2 million compared to Q3 2023[12] - Selling, general, and administrative expenses for Q3 2024 were $13.6 million, an increase of $3.4 million from $10.2 million in Q3 2023[14] - Research and development expenses for the three months ended September 30, 2024, were $11,168,000, compared to $15,358,000 for the same period in 2023, indicating a decrease of 27.1%[26] - Selling, general, and administrative expenses increased to $13,613,000 for the three months ended September 30, 2024, up from $10,200,000 in the same period of 2023, a rise of 33.7%[26] Net Loss and Financial Position - The company reported a net loss of $7.0 million for Q3 2024, compared to a net loss of $7.7 million in Q3 2023[18] - The net loss for the three months ended September 30, 2024, was $6,998,000, compared to a net loss of $7,747,000 for the same period in 2023, reflecting a 9.7% improvement[26] - The company reported a comprehensive loss of $8,081,000 for the three months ended September 30, 2024, compared to a comprehensive loss of $6,941,000 for the same period in 2023[26] Cash and Assets - As of September 30, 2024, the company had approximately $68.1 million in cash and cash equivalents, with cash utilized in the first three quarters of 2024 being $10.5 million[20] - Cash and cash equivalents decreased to $68,122,000 as of September 30, 2024, from $78,637,000 at the end of 2023, representing a decline of 13.3%[25] - Total current assets decreased to $99,057,000 as of September 30, 2024, down from $111,111,000 at December 31, 2023, a reduction of 10.9%[25] Liabilities - Total liabilities increased to $28,488,000 as of September 30, 2024, from $26,884,000 at December 31, 2023, an increase of 5.9%[25] Future Plans and Guidance - Management reiterated full year 2024 guidance with anticipated total net revenues between $87 million and $95 million[21] - The company plans to transition its headquarters to Princeton, New Jersey, in the first half of 2025[3] Share Information - The weighted average common shares outstanding for the three months ended September 30, 2024, were 44,626,943, compared to 43,620,532 for the same period in 2023[26] Licensing Agreement - The company entered into an exclusive license and distribution agreement with Nobelpharma for DANYELZA in Japan, recognizing an upfront payment of $2.0 million in Q4 2024[3]

The market expects Y-mAbs Therapeutics, Inc. (YMAB) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended September 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expect ...

NEW YORK, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced it will report third quarter 2024 financial and operating results before the market open on Friday, November 8, 2024. The Company will hold a conference call and webcast to discuss these resu ...

NEW YORK, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the "Company" or "YmAbs") (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced that its management team will participate in the following upcoming investor conferences: Oppenheimer Targeted Radiopharmaceutical Therapies in Oncology Summit Date: Tuesday, October 8, 2024 T ...