Y-mAbs Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The company has experienced significant growth in recent years, driven by the successful commercialization of its only approved product, DANYELZA, and the advancement of its pipeline of product candidates.

In the fiscal year ended December 31, 2023, Y-mAbs reported annual revenue of $84,819,000 and a net loss of $21,427,000. The company's annual operating cash flow and free cash flow were both $-27,232,000. These financial results reflect the company's ongoing investments in research and development, as well as the costs associated with the commercialization of DANYELZA.

During the first quarter of 2024, Y-mAbs reported total DANYELZA net product revenues of $19,431,000, a 4% decrease compared to the same period in 2023. This decrease was primarily driven by lower product purchases from international markets, which was partially offset by an 11% increase in U.S. DANYELZA net product revenues to $18,610,000. The company also reported $500,000 in license revenue during the first quarter of 2024, compared to no license revenue in the same period of the prior year.

Y-mAbs' research and development expenses for the first quarter of 2024 were $13,267,000, a slight decrease of $151,000 compared to the same period in 2023. This decrease was primarily due to a reduction in personnel costs related to the company's 2023 restructuring, which was partially offset by an increase in clinical trial expenses for the company's SADA PRIT programs. Selling, general, and administrative expenses decreased by $826,000 to $11,425,000 in the first quarter of 2024, also due to the impact of the 2023 restructuring.

The company reported a net loss of $6,629,000, or $0.15 per share, for the first quarter of 2024, compared to a net loss of $6,390,000, or $0.15 per share, in the same period of the prior year. Y-mAbs ended the first quarter of 2024 with $75,749,000 in cash and cash equivalents, a decrease of $2,888,000 from the end of 2023.

Business Overview

Y-mAbs Therapeutics was founded in 2015 and is headquartered in New York. The company's primary focus is the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. Y-mAbs' lead product, DANYELZA, is an antibody-based therapy that targets the GD2 antigen, which is expressed on the surface of neuroblastoma cells.

DANYELZA was approved by the U.S. Food and Drug Administration (FDA) in November 2020 for the treatment, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), of pediatric patients one year of age and older and adult patients with relapsed or refractory, high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. The company began limited sales and shipments of DANYELZA in the United States in February 2021.

In addition to DANYELZA, Y-mAbs is leveraging its proprietary antibody platforms and expertise in the field of antibodies to develop a pipeline of product candidates, including those based on its Self-Assembly, Dis-Assembly, Pretargeted Radioimmunotherapy (SADA PRIT) technology platform. The company's SADA PRIT technology is a two-step pre-targeting approach, where bispecific antibody fragments bind to the tumor before a radioactive payload is subsequently injected.

Y-mAbs' SADA PRIT pipeline includes the GD2-SADA program, which is currently in a Phase 1 clinical trial for the treatment of GD2-positive solid tumors, and the CD38-SADA program, which is expected to enter a Phase 1 clinical trial for the treatment of relapsed or refractory non-Hodgkin lymphoma in 2024.

Risks and Challenges

Y-mAbs faces several risks and challenges in its pursuit of developing and commercializing novel antibody-based cancer treatments. The company's product candidates, including those based on the SADA PRIT technology, are in various stages of clinical development, and there is no guarantee that they will successfully obtain regulatory approval or be commercially successful.

The company also faces competition from other biopharmaceutical companies, including those with more resources and experience. Additionally, Y-mAbs is dependent on its relationships with third-party collaborators, such as Memorial Sloan Kettering Cancer Center, for the development and commercialization of its product candidates, which introduces additional risks and uncertainties.

Financial Condition and Liquidity

As of March 31, 2024, Y-mAbs had $75,749,000 in cash and cash equivalents, a decrease of $2,888,000 from the end of 2023. The company's current ratio, a measure of its ability to meet short-term obligations, was 6.15 as of March 31, 2024, indicating a strong liquidity position.

Y-mAbs' cash burn, as measured by its net cash used in operating activities, was $3,477,000 in the first quarter of 2024, a significant improvement from $13,124,000 in the same period of the prior year. The company has reiterated its full-year 2024 guidance, expecting a cash burn of between $15 million and $20 million and total DANYELZA net product revenues of $95 million to $100 million.

Geographical and Revenue Breakdown

Y-mAbs' DANYELZA product revenue is primarily generated in the United States, which accounted for $18,610,000, or 96%, of the company's total DANYELZA net product revenues of $19,431,000 in the first quarter of 2024. The remaining $821,000, or 4%, of DANYELZA net product revenues were generated in international markets, primarily through the company's distribution partnerships.

The decrease in total DANYELZA net product revenues of 4% in the first quarter of 2024 compared to the same period in 2023 was primarily driven by lower product purchases from international markets, which was partially offset by an 11% increase in U.S. DANYELZA net product revenues. The company's international revenues in the first quarter of 2023 included $2,516,000 from its distribution partner, WEP Clinical, in connection with an early access program for DANYELZA in Europe, which did not recur in the first quarter of 2024.

In addition to product revenue, Y-mAbs reported $500,000 in license revenue in the first quarter of 2024, which was related to a regulatory milestone payment received from its distribution partner, Adium Pharma S.A., in Brazil.

Outlook and Future Prospects

Y-mAbs is well-positioned to continue its growth trajectory, with a strong commercial foundation provided by DANYELZA's success in the U.S. market and a promising pipeline of product candidates, including those based on its SADA PRIT technology.

The company's focus on advancing its SADA PRIT programs, particularly the GD2-SADA and CD38-SADA programs, represents a significant opportunity to expand its addressable market and potentially shift the treatment paradigm for various cancer indications. The positive early data from the ongoing Phase 1 trial of GD2-SADA, which has not shown any dose-limiting toxicities or treatment-related serious adverse events to date, is particularly encouraging.

Y-mAbs' management team has also demonstrated its ability to execute on its strategic priorities, as evidenced by the successful commercialization of DANYELZA and the responsible allocation of capital to fund its research and development efforts. The company's reiteration of its full-year 2024 guidance, including expected total DANYELZA net product revenues of $95 million to $100 million and a cash burn of $15 million to $20 million, further underscores its confidence in its ability to deliver on its objectives.

Conclusion

Y-mAbs Therapeutics is a promising biopharmaceutical company that has successfully navigated the complexities of developing and commercializing novel, antibody-based cancer treatments. The company's approved product, DANYELZA, has demonstrated strong commercial performance in the U.S. market, and its pipeline of SADA PRIT-based product candidates holds significant potential to expand its addressable market and drive future growth.

Despite the inherent risks and challenges associated with the biopharmaceutical industry, Y-mAbs has positioned itself well to continue its trajectory of success. With a strong financial foundation, a focused strategic vision, and a talented management team, the company appears well-equipped to deliver on its objectives and create value for its shareholders.