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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call reveals a mixed performance with declining U.S. revenues, increased expenses, and a net loss, despite some international growth. The lack of a share repurchase program and cash runway concerns add to the negative sentiment. The Q&A section highlights challenges in patient enrollment and vague responses on expenses and market dynamics. While there is a patent extension and a new licensing agreement, these positives are overshadowed by weak guidance and financial challenges, leading to an overall negative sentiment.
Total Revenue USD 87.7 million for the full year 2024, relatively flat compared to USD 87.7 million in 2023.
DANYELZA Net Product Revenues (Q4 2024) USD 24.5 million, a 5% increase from USD 23.4 million in Q4 2023, driven by strong international markets and an inventory stocking order in China.
U.S. DANYELZA Net Product Revenues (Q4 2024) USD 16.8 million, a 12% decline from USD 19.1 million in Q4 2023, primarily due to an unfavorable price mix, partially offset by a 1% increase in volume.
Ex-U.S. DANYELZA Net Product Revenues (Q4 2024) USD 7.7 million, a 78% increase from USD 4.3 million in Q4 2023, driven by the launch of a named patient program in Western Asia and increased sales in Eastern Asia and Latin America.
Total DANYELZA Net Product Revenues (Full Year 2024) USD 85.2 million, relatively flat compared to USD 84.3 million in 2023.
Licensing Revenue (Q4 2024) USD 2 million, compared to USD 0 for Q4 2023.
Licensing Revenue (Full Year 2024) USD 2.5 million, compared to USD 0.5 million in 2023.
Research and Development Expenses (Q4 2024) USD 12.2 million, down from USD 13.4 million in Q4 2023, primarily due to the recognition of milestone and licensing acquisition costs in 2023.
Research and Development Expenses (Full Year 2024) USD 49 million, a decrease of $5.2 million from USD 54.2 million in 2023.
Selling and General Administrative Expenses (Q4 2024) USD 12.4 million, an increase from USD 11.2 million in Q4 2023, primarily due to increased personnel costs and restructuring charges.
Selling and General Administrative Expenses (Full Year 2024) USD 54.6 million, an increase from USD 44.8 million in 2023, primarily due to legal settlements and increased personnel costs.
Net Loss (Q4 2024) USD 6.8 million or negative $0.15 per share, compared to a net loss of USD 1 million or negative $0.02 per share in Q4 2023.
Net Loss (Full Year 2024) USD 29.7 million or negative $0.67 per share, compared to a net loss of USD 21.4 million or negative $0.49 per share in 2023.
Cash and Cash Equivalents (End of Q4 2024) USD 67.2 million, down from USD 78.6 million at the end of 2023, reflecting a decrease of $11.4 million.
DANYELZA Net Product Revenues: DANYELZA net product revenues for the full year 2024 were $85.2 million, with fourth quarter revenues of $24.5 million, a 5% increase from Q4 2023.
SADA PRIT Platform: Achieved proof of concept with the SADA PRIT platform, with preliminary data from GD2-SADA Phase I trial expected in Q2 2025.
International Market Expansion: DANYELZA's international revenues increased by 78% in Q4 2024, driven by new partnerships and market entries in Western Asia, Eastern Asia, and Latin America.
Business Realignment: Announced a strategic realignment into two distinct business units: DANYELZA and Radiopharmaceuticals, aimed at enhancing operational efficiencies and clinical execution.
Cash Position: Ended 2024 with $67.7 million in cash and cash equivalents, supporting operations into 2027.
Strategic Focus: The realignment aims to accelerate the development of the SADA PRIT platform and maximize DANYELZA's potential.
Earnings Expectations: Y-mAbs Therapeutics, Inc. missed earnings expectations with a reported EPS of -$0.15, compared to expectations of -$0.13.
Competitive Pressures: The company faces headwinds from competition for patients, particularly from naxitamab trials and new market entrants for maintenance therapy.
Regulatory Issues: The company is navigating potential regulatory marketing and reimbursement approvals, which are critical for the success of their products.
Supply Chain Challenges: There are challenges related to the supply chain, particularly in the context of international sales and inventory management.
Economic Factors: The company reported an unfavorable price mix in the U.S. market, contributing to a decline in DANYELZA net product revenues.
Cash Resources: Y-mAbs ended 2024 with $67.7 million in cash and cash equivalents, reflecting a decrease of $11.4 million from the previous year, raising concerns about cash runway.
Operating Expenses: The company reported increased operating expenses, which contributed to a net loss of $29.7 million for the year, raising concerns about financial sustainability.
Business Realignment Strategy: Y-mAbs announced a strategic decision to establish two distinct business units, DANYELZA and Radiopharmaceuticals, to accelerate the development of the SADA PRIT platform and maximize DANYELZA's potential.
Expansion of Radiopharmaceutical Capabilities: The realignment aims to expand radiopharmaceutical capabilities, accelerate clinical execution, and improve capital efficiencies.
DANYELZA Market Strategy: The DANYELZA team will focus on promotion and positioning, with an emphasis on building advocacy among thought leaders.
SADA PRIT Platform Development: The company is committed to advancing the SADA PRIT platform, with updates expected in the second quarter of 2025.
2025 Total Net Revenue Guidance: Y-mAbs anticipates total net revenue for 2025 to be between $75 million and $90 million.
2025 Total Operating Expenses Guidance: Total net operating expenses, including cost of goods sold, are expected to be between $129 million and $134 million for 2025.
2025 Cash Investments Guidance: Total annual cash investments for 2025 are expected to be between $25 million and $30 million.
Q1 2025 Revenue Guidance: Guidance for Q1 2025 total net revenue is between $18 million and $21 million.
Share Repurchase Program: None
The earnings call reveals mixed signals: strong ex-U.S. revenue growth and reduced net loss are positive, but U.S. revenue decline and increased expenses are concerning. The Q&A highlighted seasonality and competitive pressures as challenges. Guidance for Q2 shows a downtrend, but international growth and potential in new markets offer optimism. Overall, the financial outlook is balanced, with no strong catalysts for significant stock movement within the next two weeks.
The earnings call reveals mixed signals: a strong increase in Ex-U.S. revenues but a decline in U.S. revenues. The company faces financial challenges with a net loss and no shareholder return initiatives. Management's optimistic guidance and strategic realignment offer potential upside, but the lack of clarity on regulatory interactions and competitive pressures in the U.S. market counterbalance this. Overall, the sentiment is neutral, with no strong catalysts for significant stock movement in the short term.
The earnings call reveals a mixed performance with declining U.S. revenues, increased expenses, and a net loss, despite some international growth. The lack of a share repurchase program and cash runway concerns add to the negative sentiment. The Q&A section highlights challenges in patient enrollment and vague responses on expenses and market dynamics. While there is a patent extension and a new licensing agreement, these positives are overshadowed by weak guidance and financial challenges, leading to an overall negative sentiment.
The company's financial performance is concerning with a net loss of $29.7 million and declining cash reserves. The lack of a shareholder return plan and unfavorable price mix in the U.S. market further add to the negative sentiment. Despite some international revenue growth, the overall guidance is weak with no clear positive catalysts. The Q&A session highlighted uncertainties and management's vague responses, especially regarding expenses and market dynamics. These factors, coupled with increased operating expenses and lack of strong guidance, suggest a likely negative stock price movement.
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