• Total Net Revenue: $18.5 million in Q3 2024, down 10% from Q3 2023.
• US Danyelza Net Product Revenues: $15.3 million in Q3 2024, a 5% decrease from Q3 2023.
• Ex-US Danyelza Net Product Revenues: $3.1 million in Q3 2024, a 19% decrease from Q3 2023.
• Total Net Revenue for First Nine Months: $61.2 million, relatively consistent with the same period in 2023.
• Research and Development Expenses: $11.2 million in Q3 2024, down from $15.4 million in Q3 2023.
• Selling, General and Administrative Expenses: $13.6 million in Q3 2024, up from $10.2 million in Q3 2023.
• Net Loss: $7 million in Q3 2024, or negative $0.16 per share, compared to $7.7 million in Q3 2023.
• Cash and Cash Equivalents: $68.1 million as of the end of Q3 2024, down from $78.6 million at year-end 2023.
• Full Year 2024 Revenue Guidance: Expected to be in the range of $87 to $95 million, with revenues likely in the bottom half of that range.

• Warning! GuruFocus has detected 4 Warning Signs with BSP:RAIL3.

Release Date: November 08, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Y-mAbs Therapeutics Inc (NASDAQ:YMAB) reported a 5% increase in Danyelza demand compared to the second quarter of 2024, indicating growing physician adoption.
• The company added three new U.S. Danyelza accounts in the third quarter, expanding its reach.
• Y-mAbs Therapeutics Inc (NASDAQ:YMAB) received a patent extension for Danyelza in the U.S., extending its expiration to February 5th, 2034.
• The company entered an exclusive license agreement with Noble Pharma for the development and commercialization of Danyelza in Japan, with potential milestone payments up to $31 million.
• Y-mAbs Therapeutics Inc (NASDAQ:YMAB) maintained a strong balance sheet with cash and cash equivalents of $68.1 million at the end of the third quarter of 2024.

Negative Points

• Total net revenue for the third quarter of 2024 was $18.5 million, down 10% from the same period in 2023.
• The company experienced a 19% decrease in ex-U.S. net product revenues compared to the third quarter of 2023, primarily due to a decline in volume from the European market.
• Y-mAbs Therapeutics Inc (NASDAQ:YMAB) reported a net loss of $7 million for the quarter ended September 30th, 2024.
• The company faced competition from a new market entrant for maintenance therapy, impacting Danyelza's market share.
• There was a $1.5 million charge in Q3 for Medicaid-related claims, affecting net revenues despite an increase in sales volume.

Q & A Highlights

Q: Can you discuss the price mix dynamics for Danyelza in the quarter and expectations moving forward? A: Sue Smith, Chief Commercial Officer, explained that they took an approximate $1.5 million charge in Q3 for Medicaid-related claims, which led to a 5% decline in net revenues despite a 5% increase in sales volume. Without this adjustment, sales would have been up 4% year-over-year and quarter-over-quarter.

Q: What are the key criteria for dose selection in the GD2 SADA study? A: Michael Rossi, CEO, stated that they started with a 0.3 mg/kg dose and escalated to 3 mg/kg before settling at 1 mg/kg. This decision was based on preclinical PK data, aiming to match blood levels and ensure optimal dosing near the no observed adverse effect level (NOAEL).

Q: What are the swing factors for Q4 revenues, and how confident are you in hitting the lower end of the guidance? A: Peter Pfreundschuh, CFO, expressed confidence in landing within the guidance range of $87 to $95 million, likely in the lower half. He noted that adjustments for cyclone sales, Medicaid, and the Noble licensing deal would have aligned Q3 results with consensus expectations.

Q: Can you comment on the radio sensitivity of the tumor types in the GD2 SADA study? A: Vignesh Rajah, Chief Medical Officer, mentioned that the study includes osteosarcoma, melanoma, soft tissue sarcoma, small cell lung cancer, and adult neuroblastoma. It's too early to determine radiation sensitivity, but they are evaluating dosimetry and responses.

Q: What is your approach to manufacturing with the new headquarters, and how do you see the commercial rollout in Japan? A: Michael Rossi, CEO, stated that they continue to use contract manufacturing for proteins, allowing investment in drug development rather than infrastructure. For Japan, a small clinical trial is planned, with a potential launch in late 2025 or early 2026, though the market is smaller than the US.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.