Y-mAbs Q2 2024 Financial Results and Corporate Updates

Y-mAbs Therapeutics, Inc., a biopharmaceutical company specializing in radioimmunotherapy and antibody-based cancer treatments, has announced its financial results for the second quarter ending June 30, 2024. The company reported total net product revenues of $22.8 million for DANYELZA, marking a 10% year-over-year increase. This growth is attributed to significant international market expansion, particularly in Brazil, Mexico, and Western Europe.

In the second quarter of 2024, DANYELZA, an anti-GD2 therapy for neuroblastoma, was added to the formularies of two additional hospitals. The U.S. sales team continues to penetrate new centers, while international distribution partners have seen increased traction, especially in Eastern Asia and Latin America. Notably, DANYELZA received marketing authorization in Hong Kong, with SciClone Pharmaceuticals set to launch the product there later this year.

The company's innovative Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy (PRIT) platform continues to make progress. Part A of the Phase 1 GD2-SADA trial is expected to be completed by the fourth quarter of 2024. Additionally, the first patient in the CD38-SADA Phase 1 trial for Non-Hodgkin’s Lymphoma is anticipated to be dosed in the latter half of this year.

Recent corporate highlights include the appointment of Peter Pfreundschuh as Chief Financial Officer and Norman LaFrance, M.D., a radiopharma industry veteran, as Chief Development Officer. Y-mAbs' Latin American distribution partner, Adium, initiated the commercial launch of DANYELZA in Brazil and Mexico. Furthermore, a distribution agreement was signed with TRPharm İlaç Sanayi Ticaret A.Ş. and TRPharm FZ-LLC for Turkey.

Financially, Y-mAbs posted a net loss of $9.2 million for the three months ended June 30, 2024, compared to a net loss of $6.3 million for the same period in 2023. The increase is primarily due to legal settlements. The company’s cash and cash equivalents stood at $77.8 million as of June 30, 2024, which, along with projected DANYELZA revenues, is expected to fund operations into 2027.

The company also presented preclinical GD2-SADA data at notable events, including the Society of Nuclear Medicine & Molecular Imaging 2024 annual meeting and the American Society of Clinical Oncology (ASCO) 2024 annual meeting.

For the second quarter, DANYELZA’s international net product revenues rose by 55% to $7.6 million, driven by increased volumes in Western Europe and the new market launches in Brazil and Mexico. However, U.S. revenues decreased by 4% to $15.2 million due to competition and ongoing clinical trial activities. Overall, total net product revenues for the six months ended June 30, 2024, increased by 3% to $42.2 million.

Operating costs were also highlighted. The cost of goods sold decreased to $3.0 million for the quarter, contributing to a favorable gross profit mix from lower vial volumes in international markets. Research and development expenses remained stable at $12.3 million for the quarter. However, selling, general, and administrative expenses rose to $17.2 million, influenced by legal settlements.

Interest and other income for the quarter were $0.6 million, down from $1.1 million in the same period in 2023, mainly due to foreign currency transaction losses. For the six months ended June 30, 2024, interest and other income were $1.1 million, down from $2.2 million for the corresponding period in 2023.

Looking ahead, Y-mAbs has updated its full-year 2024 financial guidance. The company now anticipates total net revenues between $87 million and $95 million, with operating expenses expected to remain between $115 million and $120 million. The annual cash burn is projected to stay between $15 million and $20 million, with cash reserves expected to support operations into 2027.

In summary, Y-mAbs Therapeutics continues to make significant strides in both its commercial and development efforts, particularly with DANYELZA and the SADA-PRIT platform, while maintaining a stable financial outlook.