Y-mAbs Q3 2024 Financial Results and Corporate Updates

Y-mAbs Therapeutics, Inc., a biopharmaceutical entity engaged in the commercial development of cancer treatment products, disclosed its financial results for the third quarter ending September 30, 2024. The company, which focuses on radioimmunotherapy and antibody-based therapies, reported a total revenue of $18.5 million for the quarter, reflecting a 10% decrease compared to the same period in the previous year, where revenues stood at $20.5 million.

The President and CEO, Michael Rossi, highlighted significant developments in the company's operations during the third quarter. He noted robust usage of DANYELZA in the U.S. for patients with relapsed or refractory high-risk neuroblastoma. Additionally, the company expanded its market presence internationally. An exclusive license and distribution agreement was signed with Nobelpharma, allowing for the development and commercialization of DANYELZA in Japan. This agreement resulted in an upfront payment of $2.0 million recognized in the fourth quarter of 2024. Y-mAbs is poised to receive up to $31.0 million in future product and commercial milestone payments, alongside profit sharing from commercial sales in Japan.

Furthermore, Y-mAbs extended the U.S. patent for DANYELZA, which will now remain in effect until February 2034. The company also launched a named patient program in Turkey, collaborating with TRPharm İlaç Sanayi Ticaret A.Ş. and TRPharm FZ-LLC to facilitate this expansion.

During the third quarter, Y-mAbs delivered DANYELZA to 68 centers across the U.S., with three new accounts added. Approximately 65% of the vials sold in the U.S. were outside of the Memorial Sloan Kettering Cancer Center, a slight decrease from 67% in the previous quarter.

The company's financial performance for the nine months ending September 30, 2024, showed stable total net revenues of $61.2 million, slightly down from $61.5 million in the same period of 2023. U.S. DANYELZA net product revenues were $15.3 million for the third quarter of 2024, a 5% decline from $16.1 million in the same period the previous year. This decrease was attributed to an unfavorable price mix, partially offset by a 5% increase in volume.

Internationally, DANYELZA net product revenues fell by 19% to $3.1 million compared to $3.9 million in the third quarter of 2023. This was primarily due to decreased volume from Western Europe, although there were volume increases in other territories.

On the cost side, the cost of goods sold amounted to $2.3 million for the third quarter of 2024, down from $2.6 million in the same period the previous year. The cost of goods sold for the first nine months of 2024 was $7.4 million, compared to $9.3 million in 2023.

Research and development expenses for the third quarter of 2024 were $11.2 million, a significant decrease from $15.4 million in the same quarter of 2023. This reduction was primarily due to the recognition of milestone and license acquisition costs in 2023 that did not recur in 2024. For the first nine months of 2024, research and development expenses totaled $36.8 million, down from $40.8 million in the corresponding period of 2023.

Selling, general, and administrative expenses increased to $13.6 million in the third quarter of 2024, up from $10.2 million in the same quarter of 2023. This rise was mainly due to higher personnel costs, including stock-based compensation, and additional legal and professional fees.

Y-mAbs reported a net loss of $7.0 million for the third quarter of 2024, an improvement from the $7.7 million net loss in the third quarter of 2023. For the first nine months of 2024, the net loss was $22.9 million, compared to $20.4 million in the same period of 2023, primarily due to legal settlements incurred during 2024.

As of September 30, 2024, Y-mAbs held $68.1 million in cash and cash equivalents. The company's financial guidance for the full year 2024 remained unchanged, with anticipated total net revenues projected to be between $87 million and $95 million, operating expenses expected to range from $115 million to $120 million, and total annual cash investment forecasted between $15 million and $20 million. The company anticipates that its cash and cash equivalents will support operations through 2027.