Financial Performance - Net product revenue for Q1 2025 was $20.904 million, an increase of 7.6% compared to $19.431 million in Q1 2024[21]. - Total revenues for Q1 2025 were $20.904 million, compared to $19.931 million in Q1 2024, reflecting a growth of 4.9%[21]. - Gross profit for Q1 2025 was $17.903 million, slightly up from $17.834 million in Q1 2024[21]. - The net loss for Q1 2025 was $5.196 million, compared to a net loss of $6.629 million in Q1 2024, showing an improvement of 21.6%[21]. - For the three months ended March 31, 2025, the net loss was $5,196,000, a decrease of 21.5% compared to a net loss of $6,629,000 for the same period in 2024[25]. - The Company reported a net loss of $5,196,000 for the three months ended March 31, 2025, an improvement from a net loss of $6,629,000 in the same period of 2024[55]. - Basic and diluted net loss per share improved to $(0.12) in Q1 2025 from $(0.15) in Q1 2024[55]. - Total revenues for the three months ended March 31, 2025, were $20,904,000, an increase from $19,931,000 in the same period of 2024, representing a growth of approximately 4.9%[104]. Expenses - Research and development expenses decreased to $11.359 million in Q1 2025 from $13.267 million in Q1 2024, a reduction of 14.4%[21]. - Selling, general, and administrative expenses increased to $13.087 million in Q1 2025 from $11.425 million in Q1 2024, an increase of 14.5%[21]. - Stock-based compensation for the three months ended March 31, 2025, was $3,341,000, a decrease of 13.1% from $3,846,000 in the same period of 2024[25]. - The cost of goods sold for the three months ended March 31, 2025, was $3,001,000, compared to $2,097,000 for the same period in 2024, indicating an increase of approximately 43.1%[104]. - Research and development expenses for the DANYELZA segment were $4,926,000 for the three months ended March 31, 2025, down from $5,409,000 in 2024, reflecting a decrease of approximately 8.9%[106]. Assets and Liabilities - Total assets as of March 31, 2025, were $112.613 million, down from $119.904 million as of December 31, 2024[19]. - Total liabilities decreased to $23.156 million as of March 31, 2025, from $27.900 million as of December 31, 2024[19]. - The accumulated deficit increased to $492.332 million as of March 31, 2025, from $487.136 million as of December 31, 2024[19]. - Cash and cash equivalents decreased to $60,310,000 as of March 31, 2025, down from $67,234,000 at the end of 2024, representing a decline of 10.5%[32]. - Accrued liabilities decreased to $13,875,000 as of March 31, 2025, down from $16,406,000 as of December 31, 2024, a reduction of 15.5%[59]. Cash Flow - The net cash used in operating activities was $6,911,000 for Q1 2025, compared to $3,477,000 for Q1 2024, indicating an increase of 98.5%[25]. - The company has experienced negative cash flows from operations since inception, highlighting ongoing financial challenges[29]. - The company expects its cash and cash equivalents to be sufficient to fund operations for at least the next 12 months from the issuance date of the financial statements[32]. Business Operations - The company operates two business units: DANYELZA and Radioimmunotherapy (RIT), following a business realignment strategy announced in January 2025[47]. - The company has funded operations primarily through proceeds from sales of common stock and sales of DANYELZA, along with a Priority Review Voucher obtained upon FDA approval[31]. - The company may seek additional capital through various means, including the sale of securities and collaboration agreements[33]. - The company has adopted a business realignment plan aimed at optimizing operations, which may result in a workforce reduction of up to 13%[107]. Stock and Equity - The company’s stockholders authorized a total of 105,500,000 shares, with 45,250,794 shares of common stock issued as of March 31, 2025[81][82]. - The company has 2,696,825 shares available for grant under the 2018 Equity Incentive Plan as of March 31, 2025[86]. - The company granted 490,396 restricted stock units (RSUs) during the three months ended March 31, 2025, with a weighted average grant price of $6.15[90]. - The total fair value of RSUs vested during the three months ended March 31, 2025, was $1,262,000, compared to $525,000 for the same period in 2024, reflecting an increase of approximately 140.4%[90]. - The company granted 1,255,699 stock options during the three months ended March 31, 2025, with a weighted average exercise price of $6.10[93]. - The total intrinsic value of stock options exercised during the three months ended March 31, 2025, was $199,000, compared to $924,000 in 2024, showing a decrease of approximately 78.5%[94]. Lease and Facilities - The company entered into a lease agreement for new office space in Princeton, New Jersey, with a fixed rent starting at approximately $362,000 in the first year after a nine-month rent-free period[73]. - The company’s weighted average remaining lease term as of March 31, 2025, was 1.28 years, with a weighted average discount rate of 8.4% used to determine operating lease liabilities[78]. - Total operating lease liabilities as of March 31, 2025, were $603,000, a decrease from $820,000 as of December 31, 2024, representing a reduction of approximately 26.5%[78]. - Cash paid for lease liabilities was $244,000 for the three months ended March 31, 2025, down from $251,000 in the same period of 2024[78]. - The company reported total operating lease expenses of $243,000 for the three months ended March 31, 2025, compared to $246,000 for the same period in 2024, reflecting a decrease of approximately 1%[77]. Regulatory and Market Challenges - The company expects to continue facing challenges in the commercialization of DANYELZA and other product candidates due to market acceptance and regulatory hurdles[9].
Y-mAbs(YMAB) - 2025 Q1 - Quarterly Report