Y-mAbs Therapeutics, Inc. (YMAB): Business Model Canvas [11-2024 Updated]

Y-mAbs Therapeutics, Inc. (YMAB) is at the forefront of innovative cancer therapies, specifically targeting pediatric oncology with its groundbreaking approaches. The company's business model canvas reveals a robust framework built on strategic partnerships with leading institutions and pharmaceutical companies, alongside a strong emphasis on research and development of unique therapies. With a commitment to addressing unmet medical needs, Y-mAbs not only aims to enhance patient outcomes but also creates a sustainable revenue model through product sales and licensing agreements. Discover more about how YMAB is reshaping the landscape of cancer treatment below.

Y-mAbs Therapeutics, Inc. (YMAB) - Business Model: Key Partnerships

Collaborations with MSK for product development

Y-mAbs Therapeutics has established significant collaborations with Memorial Sloan Kettering Cancer Center (MSK) for product development. The primary agreements include:

• MSK License Agreement, effective August 20, 2015, which involves royalties based on annual net sales.
• CD33 License Agreement dated November 13, 2017, granting rights for further development.
• Settlement and Assumption and Assignment of License Agreement with MabVax regarding the GD2-GD3 Vaccine.

Under these agreements, Y-mAbs is obligated to pay mid to high single-digit royalties on the net sales of licensed products, with a minimum annual royalty of $80,000.

Licensing agreements with academic institutions

Y-mAbs has entered into various licensing agreements with academic institutions, notably:

• The SADA License Agreement dated April 15, 2020, with MSK and the Massachusetts Institute of Technology (MIT).

These agreements provide Y-mAbs with critical patent rights and intellectual property. Contingent milestone and royalty payments are also part of these licensing arrangements.

Partnerships with pharmaceutical companies for distribution

Y-mAbs has formed partnerships with several pharmaceutical companies to enhance distribution capabilities:

• McKesson, accounting for 48% of product revenue in Q3 2024.
• Cardinal Health, representing 21% of product revenue in Q3 2024.
• Cencora, contributing 15% of product revenue in Q3 2024.

These partnerships are integral to Y-mAbs' strategy to reach broader markets and improve product accessibility.

Agreements with regional distributors (e.g., Takeda, SciClone)

Y-mAbs has secured agreements with regional distributors to facilitate its international expansion, including:

• Takeda for distribution in Israel.
• SciClone for Eastern Asia.
• Adium for Latin America.
• WEP for Western Europe.
• TRPharm for Turkey in 2024.
• Nobelpharma for Japan in 2024.

These agreements are designed to optimize market entry and distribution efficiency across various territories.

Partnership Type	Partner	Revenue Contribution (Q3 2024)
Pharmaceutical Distribution	McKesson	48%
Pharmaceutical Distribution	Cardinal Health	21%
Pharmaceutical Distribution	Cencora	15%
Regional Distribution	Takeda	N/A
Regional Distribution	SciClone	N/A
Regional Distribution	Adium	N/A
Regional Distribution	WEP	N/A
Regional Distribution	TRPharm	N/A
Regional Distribution	Nobelpharma	N/A

Y-mAbs Therapeutics, Inc. (YMAB) - Business Model: Key Activities

Research and development of therapeutic candidates

The primary focus of Y-mAbs Therapeutics, Inc. is on research and development (R&D) of innovative therapeutic candidates, particularly in the field of oncology. For the nine months ended September 30, 2024, the company reported R&D expenses totaling approximately $36.8 million, down from $40.8 million for the same period in 2023, reflecting a 10% decrease in spending.

Key components of R&D expenses include:

Expense Category	Q3 2024 (in thousands)	Q3 2023 (in thousands)	Change (in thousands)	Percentage Change
Outsourced manufacturing	$8,764	$9,529	($765)	(8)%
Clinical trials	$7,671	$4,614	$3,057	66%
Personnel costs	$10,474	$10,903	($429)	(4)%
Professional and consulting fees	$987	$1,003	($16)	(2)%
Stock-based compensation	$4,036	$5,034	($998)	(20)%
Other	$2,595	$2,947	($352)	(12)%

Clinical trials for product approval

Y-mAbs is actively engaged in clinical trials to secure regulatory approvals for its therapeutic candidates. The company has been focusing on advancing its lead product, DANYELZA, through various clinical phases. As of September 30, 2024, the company reported that clinical trial expenses have increased to approximately $7.7 million for the quarter.

The company has incurred significant costs related to clinical trials, reflecting its commitment to developing and validating its product pipeline. The increase in clinical trial costs is attributed to ongoing studies and the initiation of new trials for additional indications.

Regulatory compliance and submission processes

To ensure compliance with regulatory requirements, Y-mAbs has established robust processes for submitting applications and maintaining adherence to industry standards. The company has successfully navigated the regulatory landscape to obtain marketing authorization for DANYELZA in multiple regions. In January 2024, it received a $0.5 million regulatory-based milestone payment from Brazil's CMED.

Y-mAbs is also committed to ongoing regulatory engagement and maintaining compliance with post-marketing requirements for its products. The company’s accumulated deficit was reported at $480.3 million as of September 30, 2024.

Commercialization of approved products like DANYELZA

Y-mAbs has achieved significant milestones in the commercialization of DANYELZA, which is critical to its revenue generation strategy. For the nine months ended September 30, 2024, total product revenue from DANYELZA was reported at $60.7 million, slightly down from $60.9 million in 2023.

Product revenue breakdown by geographical location for the nine months ended September 30, 2024 is as follows:

Region	Revenue (in thousands)
United States	$49,165
Western Europe	$2,091
Eastern Asia	$4,474
Latin America	$3,528
Other regions	$1,432

Y-mAbs continues to expand its commercial footprint, with ongoing efforts to enhance market access and establish distribution partnerships globally.

Y-mAbs Therapeutics, Inc. (YMAB) - Business Model: Key Resources

Intellectual property portfolio (licenses and patents)

Y-mAbs Therapeutics has established a strong intellectual property portfolio comprising several key licenses and patents essential for its operations. The company has licensing agreements with Memorial Sloan Kettering Cancer Center (MSK) and Massachusetts Institute of Technology (MIT) for its lead product, DANYELZA, and other candidates. Under the MSK License Agreement, Y-mAbs is required to pay mid to high single-digit royalties based on annual net sales of licensed products and has committed to annual minimum royalties of $80,000. Additionally, the company is obligated to make milestone payments related to clinical, regulatory, and sales achievements.

Experienced R&D personnel and management team

Y-mAbs Therapeutics boasts a skilled team of research and development (R&D) personnel and a seasoned management team. The company has been investing significantly in R&D, with expenses totaling $36.8 million for the nine months ended September 30, 2024, compared to $40.8 million for the same period in 2023. This reflects the company's ongoing commitment to advancing its product pipeline and clinical trials.

Financial resources from equity and licensing revenues

As of September 30, 2024, Y-mAbs reported cash and cash equivalents of $68.1 million, down from $78.6 million at the end of 2023. The company has financed operations through private placements, proceeds from its initial public offering (IPO), and product revenues from DANYELZA, which generated $60.7 million in net product revenue for the nine months ended September 30, 2024. Licensing revenues provided an additional $0.5 million during this period, demonstrating the importance of these financial resources in supporting R&D and operational activities.

Manufacturing capabilities for drug production

Y-mAbs Therapeutics has developed manufacturing capabilities crucial for the production of its therapeutic products. The company's cost of goods sold for the nine months ended September 30, 2024, was $7.4 million, reflecting its operational scale. The gross margin for this period was reported at 88%, up from 85% in the previous year, indicating improved efficiency and profitability in its manufacturing processes.

Key Resource	Details	Financial Impact (2024)
Intellectual Property	Licenses with MSK and MIT; royalties and milestone payments	Mid to high single-digit royalties on net sales; $80,000 minimum royalties
R&D Personnel	Skilled workforce driving product development	$36.8 million in R&D expenses
Financial Resources	Cash and cash equivalents	$68.1 million as of September 30, 2024
Manufacturing Capabilities	Production of DANYELZA and other products	$7.4 million cost of goods sold; 88% gross margin

Y-mAbs Therapeutics, Inc. (YMAB) - Business Model: Value Propositions

Innovative therapies targeting GD2-positive tumors

Y-mAbs Therapeutics focuses on developing innovative therapies that specifically target GD2-positive tumors, which are prevalent in pediatric cancers. Their lead product, DANYELZA (naxitamab), received FDA approval in November 2020 for the treatment of relapsed or refractory high-risk neuroblastoma in pediatric patients. This niche approach aims to address significant unmet medical needs in childhood cancers, offering a therapeutic option for patients who previously had limited choices.

Unique SADA PRIT technology for enhanced efficacy

The company has developed a proprietary technology known as SADA (Site-Activated Drug Antibody) PRIT (Precision RadioImmunoTherapy). This innovative platform enhances the efficacy of their therapeutic candidates by enabling precise targeting of cancer cells while minimizing damage to healthy tissues. The SADA PRIT technology is currently in clinical trials, showcasing Y-mAbs' commitment to advancing treatment methodologies in oncology.

Focus on pediatric cancers with unmet medical needs

Y-mAbs Therapeutics is dedicated to addressing the significant unmet medical needs in pediatric oncology. The company’s strategic focus is on developing therapies specifically for childhood cancers, which often have limited treatment options. Their commitment is reflected in their clinical pipeline, which includes additional candidates targeting other pediatric cancers beyond neuroblastoma, such as osteosarcoma.

Commitment to improving patient outcomes through research

Y-mAbs places a strong emphasis on research and development to improve patient outcomes. As of September 30, 2024, the company reported research and development expenses of $36.8 million for the nine months ended September 30, 2024, a decrease from $40.8 million for the same period in the previous year. This reflects their ongoing investment in clinical trials and development of new therapies.

Financial Data	Q3 2024	Q3 2023	Change
Product Revenue, Net	$18.5 million	$20.5 million	-9.7%
Research and Development Expenses	$11.2 million	$15.4 million	-27.1%
Net Loss	$7.0 million	$7.7 million	-9.1%
Cash and Cash Equivalents	$68.1 million	$78.6 million	-13.5%

Y-mAbs Therapeutics continues to leverage its innovative technologies and focus on pediatric cancers to differentiate itself in the competitive biopharmaceutical market. By addressing specific unmet medical needs and enhancing treatment efficacy, the company aims to improve patient outcomes significantly.

Y-mAbs Therapeutics, Inc. (YMAB) - Business Model: Customer Relationships

Direct engagement with healthcare providers

Y-mAbs Therapeutics maintains strong relationships with healthcare providers through direct engagement initiatives. The company collaborates with oncologists and healthcare professionals to provide updates on product offerings and clinical data related to its leading product, DANYELZA. As of September 30, 2024, DANYELZA generated product revenue of approximately $60.7 million for the nine months ended, showcasing the effectiveness of these engagements in boosting sales.

Educational initiatives for oncologists and patients

Y-mAbs invests in educational initiatives aimed at oncologists and patients to enhance understanding of its products. This includes providing resources, hosting seminars, and participating in conferences. The company has allocated approximately $11.2 million for research and development as part of its outreach efforts during the nine months ended September 30, 2024.

Support programs for patients and caregivers

The company offers comprehensive support programs designed for patients and caregivers. These programs focus on providing information, financial assistance, and emotional support. Y-mAbs has set aside about $3.6 million in patient assistance programs in 2024, which reflects its commitment to patient welfare and retention.

Collaboration with regulatory bodies for compliance

Y-mAbs actively collaborates with regulatory bodies to ensure compliance with healthcare regulations. The company has engaged in multiple licensing agreements with institutions like Memorial Sloan Kettering Cancer Center, which requires ongoing communication to meet compliance standards. As of September 30, 2024, Y-mAbs had accrued liabilities for licensing and royalty payments amounting to $4.8 million.

Key Engagement Areas	Details	Financial Implications
Direct Engagement	Collaborations with healthcare providers	Revenue from DANYELZA: $60.7 million (9 months)
Educational Initiatives	Resources and seminars for oncologists and patients	R&D spending: $11.2 million (9 months)
Support Programs	Programs for patients and caregivers	Assistance funding: $3.6 million (2024)
Regulatory Collaboration	Engagement with regulatory bodies	Accrued liabilities for licensing: $4.8 million

Y-mAbs Therapeutics, Inc. (YMAB) - Business Model: Channels

Direct sales force targeting hospitals and clinics

The direct sales force of Y-mAbs Therapeutics focuses on engaging hospitals and clinics to promote its FDA-approved product, DANYELZA. As of September 30, 2024, product revenue from the United States was reported at $49.165 million for the nine months ended September 30, 2024, indicating a slight increase from $48.756 million in the same period of 2023. This revenue stream is critical as it reflects the effectiveness of the sales force in penetrating the healthcare market.

Partnerships with distribution companies

Y-mAbs has established strong partnerships with major distribution companies such as McKesson, Cardinal Health, and Cencora. For the three months ended September 30, 2024, McKesson accounted for 48% of total product revenue, while Cardinal Health and Cencora accounted for 21% and 15% respectively. The reliance on these distributors is evident as they play a pivotal role in the logistics and availability of DANYELZA to healthcare providers.

Distribution Partner	Percentage of Revenue (Q3 2024)	Percentage of Revenue (Q3 2023)
McKesson	48%	48%
Cardinal Health	21%	14%
Cencora	15%	18%
WEP	0%	15%

Online platforms for educational resources

Y-mAbs has utilized online platforms to provide educational resources about DANYELZA and its applications. This initiative not only serves to inform healthcare professionals but also enhances the company's visibility and reputation in the oncology community. The company aims to leverage digital channels to disseminate critical information regarding drug efficacy and patient management.

Conferences and medical events for outreach

Participation in conferences and medical events is a cornerstone of Y-mAbs' outreach strategy. These events provide opportunities for direct engagement with healthcare professionals, allowing the company to showcase its products and gather feedback. The company’s presence at these events is crucial for building relationships with potential prescribers and enhancing market penetration.

Y-mAbs Therapeutics, Inc. (YMAB) - Business Model: Customer Segments

Pediatric oncology patients

Y-mAbs Therapeutics primarily targets pediatric oncology patients who are diagnosed with neuroblastoma, a type of cancer that most commonly affects children. The company’s lead product candidate, DANYELZA (naxitamab-gqgk), is specifically approved for the treatment of high-risk neuroblastoma. As of September 30, 2024, the company reported product revenue of $60.7 million from DANYELZA for the nine months ended September 30, 2024. The patient population for this indication is estimated to be approximately 700 children diagnosed annually in the U.S. alone.

Healthcare providers (hospitals, clinics)

Healthcare providers, including hospitals and clinics that specialize in pediatric oncology, are critical customer segments for Y-mAbs. These institutions are responsible for administering DANYELZA to patients. In 2024, the company reported that approximately 45% of its product revenue came from sales through McKesson, a major distributor that services hospitals. The company has established distribution agreements with various healthcare providers, ensuring that DANYELZA is accessible for treatment across a wide range of facilities.

Research institutions and academic partners

Y-mAbs collaborates with research institutions and academic partners to advance its product pipeline and share knowledge. The company has entered into licensing agreements with prestigious institutions such as Memorial Sloan Kettering Cancer Center and the Massachusetts Institute of Technology. These collaborations are essential for conducting clinical trials and developing new therapeutic options. In the nine months ended September 30, 2024, Y-mAbs recognized $500,000 in license revenue related to these partnerships.

Pharmaceutical partners for collaborative development

Pharmaceutical partners are integral to Y-mAbs’ strategy for collaborative development. The company engages in partnerships to enhance its research capabilities and expand its product offerings. For example, Y-mAbs has entered into sublicense agreements with various partners in regions such as Eastern Europe, Latin America, and Asia. This broad network of pharmaceutical partners helps facilitate the global distribution of its products and the development of additional therapies, which contributes to the company’s revenue growth.

Customer Segment	Description	Revenue Impact (2024)	Key Partnerships
Pediatric oncology patients	Children diagnosed with neuroblastoma	$60.7 million from DANYELZA	N/A
Healthcare providers	Hospitals and clinics administering treatments	45% revenue through McKesson	McKesson
Research institutions	Academic partners for clinical trials	$500,000 in license revenue	Memorial Sloan Kettering, MIT
Pharmaceutical partners	Collaborative development and distribution	Revenue from sublicense agreements	Various regional partners

Y-mAbs Therapeutics, Inc. (YMAB) - Business Model: Cost Structure

High R&D expenditures for clinical trials

Y-mAbs Therapeutics has reported substantial expenditures in research and development (R&D), crucial for advancing its clinical trials. For the nine months ended September 30, 2024, total R&D expenses amounted to $36.8 million, a decrease from $40.8 million during the same period in 2023. The breakdown of R&D costs includes:

Expense Category	2024 (in thousands)	2023 (in thousands)
Outsourced manufacturing	$8,764	$9,529
Clinical trials	$7,671	$4,614
Outsourced research and supplies	$400	$825
Personnel costs	$10,474	$10,903
Professional and consulting fees	$987	$1,003
Stock-based compensation	$4,036	$5,034
Information technology expenses	$1,849	$1,851
Other	$2,595	$2,947
Total R&D Expenses	$36,776	$40,831

Licensing fees for intellectual property

The company incurs licensing fees associated with its agreements with Memorial Sloan Kettering Cancer Center (MSK) and other institutions. As of September 30, 2024, Y-mAbs had accrued licensing, milestone, and royalty payments amounting to $4.8 million, up from $3.5 million in December 2023. Key licensing agreements include:

• MSK License Agreement: Requires mid to high single-digit royalties based on annual net sales of licensed products.
• Annual minimum royalties of $80,000 are required, which are non-refundable but creditable against future royalties.

Operational costs for manufacturing and administration

Operational costs encompass manufacturing and administrative expenses. For the nine months ended September 30, 2024, the cost of goods sold (COGS) was $7.4 million, a decrease from $9.3 million in 2023. The operational costs also include:

• Accrued manufacturing costs of $4.7 million as of September 30, 2024, compared to $2.5 million in December 2023.
• Selling, general, and administrative expenses amounted to $42.3 million for the nine months ended September 30, 2024, up from $33.7 million in 2023.

Marketing and sales expenses for product promotion

Marketing and sales expenses are critical for promoting Y-mAbs' products, particularly DANYELZA. The selling, general, and administrative expenses for the three months ended September 30, 2024, were $13.6 million, compared to $10.2 million for the same period in 2023. This increase reflects:

• A $1.2 million rise related to the former Chief Financial Officer’s separation and consulting agreements.
• Increased personnel costs totaling $1.1 million, inclusive of stock-based compensation.
• Professional and consulting fees increased by $0.5 million.

Y-mAbs Therapeutics, Inc. (YMAB) - Business Model: Revenue Streams

Product sales from DANYELZA and future therapies

The primary revenue stream for Y-mAbs Therapeutics is generated from the sales of its leading product, DANYELZA. For the nine months ended September 30, 2024, the total product revenue, net was $60.7 million, compared to $61.0 million for the same period in 2023, reflecting a slight decrease of $0.3 million or 0% .

In the three months ended September 30, 2024, product revenue, net amounted to $18.5 million, a decrease of $1.5 million or 7% from $20.5 million in the same quarter of 2023 . The breakdown of product revenue by geographical location is as follows:

Region	Q3 2024 Revenue (in thousands)	Q3 2023 Revenue (in thousands)	9M 2024 Revenue (in thousands)	9M 2023 Revenue (in thousands)
United States	$15,329	$16,072	$49,165	$48,756
Western Europe	$0	$3,047	$2,091	$5,564
Eastern Asia	$1,008	$80	$4,474	$5,384
Latin America	$1,272	$579	$3,528	$579
Other regions	$852	$176	$1,432	$673
Total	$18,461	$19,954	$60,690	$60,956

Licensing revenues from partnerships

Y-mAbs also generates revenue through licensing agreements. In the nine months ended September 30, 2024, the company recognized $0.5 million in license revenue, consistent with the $0.5 million recorded in the corresponding period of 2023 . This revenue is primarily derived from milestone payments associated with the licensing of DANYELZA, including a $0.5 million regulatory-based milestone payment received in January 2024 for price approval in Brazil .

Potential income from Priority Review Vouchers (PRVs)

Y-mAbs Therapeutics has the potential to generate income from the sale of Priority Review Vouchers (PRVs). The company received PRVs upon FDA approval of DANYELZA. While specific figures for PRV sales were not disclosed, these vouchers can be sold to other pharmaceutical companies for significant sums, often ranging from $100 million to $350 million . Such income could provide substantial financial support for ongoing research and development efforts.

Grants and funding for research initiatives

In addition to product sales and licensing revenues, Y-mAbs Therapeutics seeks grants and funding to support its research initiatives. The company has historically relied on various funding sources to finance its research and development activities, though specific amounts for 2024 were not detailed in the available data . The ability to secure grants can significantly impact the financial health of the company, aiding in the advancement of its product pipeline.

Updated on 16 Nov 2024

Resources:

1. Y-mAbs Therapeutics, Inc. (YMAB) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Y-mAbs Therapeutics, Inc. (YMAB)' financial performance, including balance sheets, income statements, and cash flow statements.
2. SEC Filings – View Y-mAbs Therapeutics, Inc. (YMAB)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.