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Y-mAbs Therapeutics, Inc. (YMAB): Business Model Canvas [Dec-2025 Updated] |
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You're looking at a company at a critical inflection point, and as an analyst who's seen a few market cycles, I can tell you Y-mAbs Therapeutics, Inc. (YMAB) presents a fascinating case study right now. We're digging into the Business Model Canvas of this commercial-stage biopharma, which is balancing the current sales of its rare pediatric cancer drug, DANYELZA, with the massive potential of its SADA radiopharmaceutical platform. Honestly, the numbers tell a compelling story: Q1 2025 revenue hit $20.9 million, putting them on track for a $75 million to $90 million full-year target, all while gearing up for the SERB acquisition later this year. This canvas breaks down exactly how they create value, from their high-touch customer relationships to the significant R&D costs-like the $11.4 million spent in Q1 2025-that fuel their pipeline. Let's map out the mechanics behind this near-term acquisition target and its long-term platform play below.
Y-mAbs Therapeutics, Inc. (YMAB) - Canvas Business Model: Key Partnerships
You're looking at the core relationships that drive Y-mAbs Therapeutics, Inc.'s commercial reach and pipeline development as of late 2025. These partnerships are critical for global expansion and asset development, especially given the pending acquisition by SERB Pharmaceuticals.
The most significant recent development is the definitive merger agreement with SERB Pharmaceuticals, an all-cash transaction valued at approximately \$412 million. SERB is set to commence an all-cash tender offer to purchase all outstanding shares for \$8.60 per share in cash, which represented a 105% premium to the closing share price on August 4, 2025. This transaction was expected to close by the fourth quarter of 2025. Stockholders representing about 16% of Y-mAbs' outstanding shares had already agreed to tender their shares under a support agreement.
The global expansion strategy for DANYELZA relies heavily on regional partners. Here's a breakdown of the key commercial agreements:
| Partner | Territory/Focus | Financial/Scope Detail |
|---|---|---|
| SERB Pharmaceuticals | Pending Acquisition of Y-mAbs | \$412 million equity value; \$8.60 per share offer price; 105% premium. |
| Nobelpharma Co., Ltd. | Exclusive License and Distribution in Japan | Upfront payment of \$2.0 million; up to \$31.0 million in milestone payments, plus profit sharing on commercial sales. |
| Adium Pharma S.A. | Exclusive Distribution in Latin America | Distribution covers 18 Latin American & Caribbean countries, including Brazil, where marketing authorization was granted in May 2023. |
The relationship with Memorial Sloan Kettering Cancer Center (MSK) remains foundational, as researchers there developed DANYELZA, which is exclusively licensed to Y-mAbs, and MSK retains institutional financial interests in the compound and Y-mAbs. While MSK was a key initial prescribing center, the U.S. commercial footprint has broadened significantly. As of March 31, 2025, approximately 72% of the DANYELZA vials sold in the U.S. were sold outside of MSK, an increase from 64% in the fourth quarter ended December 31, 2024.
For the development of the Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy (PRIT) platform, Y-mAbs utilizes various clinical sites, which function similarly to CROs in executing trials. The company is evaluating its SADA PRIT technology in two clinical trials in the U.S. as of early 2025.
- GD2-SADA Phase 1 Trial (Trial 1001): 21 patients had been dosed at six sites as of January 10, 2025.
- CD38-SADA (Trial 1201): Six sites were selected, and three sites were activated by the first quarter of 2025.
These clinical sites are essential for gathering the data needed to advance the platform, including pharmacokinetic and dosimetry data expected in the second quarter of 2025 for Trial 1001.
Y-mAbs Therapeutics, Inc. (YMAB) - Canvas Business Model: Key Activities
You're looking at the core engine room activities for Y-mAbs Therapeutics, Inc. as of late 2025. This period was defined by commercial execution, pipeline advancement, and a major corporate transaction. Honestly, the focus shifted dramatically in the second half of the year.
Commercialization and global expansion of DANYELZA (naxitamab-gqgk)
Driving sales for DANYELZA remained a primary activity, even as the company realigned its structure in early 2025. The commercial team was focused on maximizing revenue from this lead product, which is the only FDA-approved treatment for relapsed/refractory high-risk neuroblastoma in the bone or bone marrow for patients one year of age and older who have shown a partial response, minor response, or stable disease to prior therapy. The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for Neuroblastoma were updated to include DANYELZA, which is a key commercial support activity.
Here are the net product revenue figures we saw before the acquisition news broke:
| Period Ended | U.S. DANYELZA Net Product Revenues | Ex-U.S. DANYELZA Net Product Revenues | Total Net Product Revenues |
| March 31, 2025 (Q1) | $13.4 million | $7.5 million | $20.9 million |
| June 30, 2025 (Q2) | $14.3 million | $4.7 million | (Part of Total Revenue of $19.5 million) |
The full-year 2025 Total Revenue guidance, set in Q1, was between $75 million and $90 million.
Research and development (R&D) of the SADA PRIT platform
A significant R&D activity involved advancing the Self-Assembly DisAssembly Pre-targeted Radioimmunotherapy (SADA PRIT) platform. This involved optimizing the technology, which was exclusively licensed from Memorial Sloan Kettering Cancer Center (MSK). The company reorganized in January 2025 to create a dedicated Radiopharmaceuticals business unit to accelerate this platform's development.
Key R&D focus areas included:
- Optimizing tumor uptake and determining the optimal therapeutic dose for GD2-SADA.
- Evaluating the administration interval between the GD2-SADA protein and the ${}{177}\text{Lu-DOTA}$ payload.
- Advancing the platform to potentially deliver a variety of payloads against multiple tumor targets.
Executing Phase 1 trials for GD2-SADA and CD38-SADA assets
The execution of two key Phase 1 trials represented critical R&D milestones for Y-mAbs Therapeutics, Inc. in 2025. You had to keep a close eye on these enrollment and data readout timelines.
GD2-SADA (Trial 1001):
- Part A, the dose-escalation phase in adults with solid tumors (including high-risk neuroblastoma), dosed 21 patients to date (as of January 2025).
- Part A preliminary data demonstrated tolerability with no dose-limiting toxicities (DLTs) reported.
- The total planned enrollment across all three parts of the trial was 62 patients (Part A: 18, Part B: 12, Part C: 32).
CD38-SADA (Trial 1201):
- The first patient was dosed in the first quarter of 2025.
- The trial evaluated CD38-SADA pretargeted radioimmunotherapy in patients with Relapsed/Refractory non-Hodgkin Lymphoma.
- By January 2025, six sites had been selected, with three activated for enrollment.
Manufacturing and supply chain management for a specialty oncology product
Managing the supply chain for DANYELZA, a complex, specialized product, is always a high-stakes activity. This included ensuring product availability across U.S. and international markets. The company also planned operational shifts, including the transition of its headquarters to Princeton, New Jersey, in the first half of 2025, which impacts logistics and administrative overhead.
Profitability metrics related to production were also key:
- Gross Margin for Q2 2025 was 86%.
- Gross Margin for the six months ended June 30, 2025, was 86%.
The slight decrease in gross margin in Q2 2025 was attributed to increased cost of production and lower product sales to Western Europe, where sales typically carry a higher gross margin.
Integrating operations with SERB Pharmaceuticals post-acquisition
This became the most significant activity in the latter part of 2025. SERB Pharmaceuticals announced the definitive agreement to acquire Y-mAbs Therapeutics, Inc. on August 5, 2025. The key activities here were executing the transaction and planning for integration.
Transaction specifics that drove this activity:
- Acquisition Equity Value: Approximately $412 million.
- Tender Offer Price: $8.60 per share in cash, representing a 105% premium to the August 4, 2025, closing price.
- Tender Offer Period: Initiated on August 18, 2025, and expired on September 15, 2025.
- Closing Date: The acquisition was completed, and Y-mAbs became a wholly owned subsidiary of SERB on September 16, 2025.
The stated goal of this integration was to strengthen SERB's Rare Oncology portfolio with DANYELZA and incorporate Y-mAbs' oncology expertise.
Y-mAbs Therapeutics, Inc. (YMAB) - Canvas Business Model: Key Resources
You're looking at the core assets Y-mAbs Therapeutics, Inc. relies on to drive value, and honestly, it boils down to a couple of major things: a commercial product and a platform technology. Let's break down the hard numbers and tangible items that form the foundation of their business right now, as of late 2025.
The most immediate resource is the FDA-approved anti-GD2 antibody, DANYELZA (naxitamab-gqgk), which is the only approved treatment for patients one-year of age and older with high-risk relapsed/refractory neuroblastoma in the bone and bone marrow. This product generated $19.5 million in Total Revenues for the second quarter ended June 30, 2025. This commercial success is protected by significant intellectual property.
Regarding that protection, the primary DANYELZA U.S. patent (US 9,315,585) has an achieved extension, securing exclusivity through February 2034. More specifically, a core U.S. patent in this family is expected to expire on March 25, 2034. This patent runway is a critical, quantifiable resource for revenue stability.
Financially, as of June 30, 2025, Y-mAbs Therapeutics, Inc. held approximately $62.3 million in cash and cash equivalents. This capital position is key for funding ongoing operations and development efforts, especially given the company's stated goal to be capital efficient.
The second major asset is the proprietary Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy (PRIT) technology platform. This platform, exclusively licensed from Memorial Sloan Kettering Cancer Center (MSK), is designed to deliver high therapeutic doses while minimizing off-target exposure. The company realigned operations in early 2025 to create a dedicated Radiopharmaceuticals business unit to advance this platform.
Here's a quick look at the SADA PRIT platform's current clinical focus as of the first half of 2025:
- Platform utilizes a pre-targeted payload delivery method.
- Antibody constructs assemble in tetramers to bind the tumor target.
- Currently evaluating technology in two clinical trials in the U.S.
- Trial 1001 (GD2-SADA) in solid tumors.
- Trial 1201 (CD38-SADA) in relapsed/refractory non-Hodgkin's lymphoma.
Finally, the specialized commercial team for rare pediatric oncology markets is a necessary resource for DANYELZA. Following the January 2025 strategic realignment, Y-mAbs adjusted this team to focus specifically on growth opportunities within the anti-GD2 market. This team is responsible for navigating the specific access and reimbursement challenges inherent in rare disease markets.
You can see the key quantifiable resources laid out here:
| Resource Category | Specific Asset/Metric | Value/Date |
|---|---|---|
| Commercial Product | DANYELZA Net Product Revenues (Q1 2025) | $20.9 million |
| Intellectual Property | DANYELZA Primary U.S. Patent Extension Through | February 2034 |
| Financial Capital | Cash and Equivalents (as of June 30, 2025) | $62.3 million |
| Technology Platform | SADA PRIT Platform Licensing Origin | Exclusively licensed from MSK |
| Commercial Team Focus | DANYELZA Commercial Team Adjustment | Focus on anti-GD2 market growth |
The company is defintely balancing the immediate cash flow from DANYELZA against the long-term potential of the SADA PRIT platform. Finance: draft 13-week cash view by Friday.
Y-mAbs Therapeutics, Inc. (YMAB) - Canvas Business Model: Value Propositions
You're looking at the core reasons why Y-mAbs Therapeutics, Inc. commands attention in the oncology space, especially given the recent merger news. The value propositions center on both their commercial product and their innovative platform technology.
First FDA-approved treatment for relapsed/refractory high-risk neuroblastoma in bone/bone marrow
DANYELZA (naxitamab-gqgk) is the only FDA-approved treatment for patients one-year of age and older with high-risk relapsed/refractory neuroblastoma in the bone/bone marrow. This exclusivity in a critical setting provides immense value to patients and caregivers. The commercial traction supports this, with Y-mAbs Therapeutics, Inc. reporting total net product revenues of $20.9 million for the first quarter of 2025, an 8% year-over-year increase. The U.S. DANYELZA net product revenues for that quarter were $7.5 million. Furthermore, the National Comprehensive Cancer Network updated its guidelines to include DANYELZA as a Category 2A treatment option, which helps drive clinician adoption.
Novel SADA platform for pre-targeted radioimmunotherapy to minimize off-target toxicity
The Self-Assembly DisAssembly Pre-targeted Radioimmunotherapy (SADA PRIT) platform is engineered to improve upon traditional radioimmunotherapy. The design aims to deliver a high therapeutic dose while minimizing off-target exposure, a key differentiator. This technology utilizes a two-step process where antibody constructs assemble at the tumor target before a radioactive payload is introduced. The investment in this platform is clear, with the Radiopharmaceuticals business unit reflecting a segment loss or investment from operations of $6.1 million in the first quarter of 2025.
The progress on the lead SADA asset, GD2-SADA (Trial 1001), validates the platform's human viability. Part A of the Phase 1 trial demonstrated that GD2-SADA is safe and well-tolerated, with no treatment-related serious adverse events reported.
Here's a snapshot of the commercial and pipeline data supporting the value:
| Metric | Value | Context |
|---|---|---|
| Q1 2025 Total Net Product Revenue | $20.9 million | Driven by DANYELZA sales |
| Projected Full Year 2025 Total Revenue Guidance | $75 million to $90 million | Management reiterated guidance |
| Cash Balance (as of March 31, 2025) | $60.3 million | Expected to support operations into 2027 |
| GD2-SADA Trial 1001 Part A Patients Dosed (as of Jan 2025) | 21 | Dose escalation study |
| Global Pediatric Neuroblastoma Market Size (2024) | USD 2.37 Billion | Market context for DANYELZA |
Potential for a broad pipeline of targeted radiotherapies beyond neuroblastoma (e.g., NHL)
Y-mAbs Therapeutics, Inc. is actively applying the SADA platform to other tumor types. The company dosed the first patient in its Phase 1 clinical trial (Trial 1201) evaluating CD38-SADA pretargeted radioimmunotherapy in patients with relapsed/refractory non-Hodgkin Lymphoma (NHL) in the first quarter of 2025. The company also plans to expand its radiopharmaceutical pipeline to target other high-value oncology areas, including lung, women's, and gastrointestinal cancers. They aim to file an Investigational New Drug (IND) application for their first molecular imaging asset by the end of 2025.
Improved safety profile demonstrated in GD2-SADA Phase 1 trial Part A
The Part A data from Trial 1001 showed that GD2-SADA is safe and well-tolerated. Specifically, the trial demonstrated that the therapy is capable of achieving targeted conjugation with 177Lu-DOTA, leading to significant tumor retention. The completion of Part A, which focused on dose escalation of the GD2-SADA protein, represents a key validation point for the technology in humans.
Access to a critical, life-extending therapy for a rare pediatric cancer
The value proposition here is providing a therapy where the need is dire. Neuroblastoma affects approximately 10.2 children per million under the age of 15, with almost 500 new cases diagnosed annually in the United States. The fact that DANYELZA is the sole FDA-approved option for this high-risk relapsed/refractory population is a major value driver. The company reported a net loss of $5.2 million for the first quarter of 2025, showing continued investment to support this critical commercial operation. The announced definitive merger agreement in August 2025, valuing Y-mAbs at approximately $412 million, underscores the market value placed on securing this critical asset.
- DANYELZA is the only FDA-approved treatment for r/r high-risk neuroblastoma in patients $\ge$ one-year of age.
- The company aims to achieve total revenues between $75 million and $90 million for the full year 2025.
- The SADA platform is positioned to potentially disrupt the radiopharmaceutical industry.
Finance: draft 13-week cash view by Friday.
Y-mAbs Therapeutics, Inc. (YMAB) - Canvas Business Model: Customer Relationships
You're looking at how Y-mAbs Therapeutics, Inc. managed its critical relationships leading up to and through its late-2025 acquisition by SERB Pharmaceuticals. For a company focused on rare cancers, these relationships-from the clinic floor to the shareholder base-are everything.
High-touch, direct sales and medical affairs support for specialized oncology centers
The commercial relationship model for DANYELZA centered on deep engagement with specialized treatment centers. As of March 31, 2025, Y-mAbs Therapeutics had delivered DANYELZA to a total of 70 centers across the U.S. since the initial launch, adding one new account in the first quarter of 2025 alone. This suggests a targeted, high-touch approach to onboarding new prescribers. To support this, the company underwent a strategic realignment in early 2025, which included a "small adjustment" to the commercial team, potentially impacting up to 13% of its total workforce, as it focused resources around growth opportunities in the GD2 market. The responsibility for growing this revenue was placed under the new head of the DANYELZA business unit, Doug Gentilcore, who brought experience from global commercialization roles. Honestly, restructuring the team right before a major transaction like this shows a commitment to maintaining commercial focus until the very end.
Relationships with key opinion leaders (KOLs) and National Comprehensive Cancer Network (NCCN)
Securing validation from leading oncologists and national bodies is key for adoption in specialized fields. A major relationship milestone achieved was the update to the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for Neuroblastoma to include naxitamab-gqgk (DANYELZA®). This inclusion is a direct result of engagement with KOLs and guideline committees, providing strong support for prescribing physicians. The company also continued to advance its pipeline, dosing the first patient in Trial 1201 (CD38-SADA PRIT) in the first quarter of 2025, which involves engaging clinical investigators at activated sites.
Here's a quick look at the commercial footprint and key data points:
| Metric | Value/Date | Context |
|---|---|---|
| Total U.S. Centers Delivered DANYELZA To (as of 3/31/2025) | 70 centers | Indicates the depth of the specialized customer base. |
| U.S. Vials Sold Outside MSK (Q1 2025) | 72% | Shows increasing adoption outside the initial anchor institution (up from 64% in Q4 2024). |
| U.S. DANYELZA Net Product Revenues (Q2 2025) | $14.3 million | Direct revenue generated from the U.S. customer base. |
| NCCN Guideline Inclusion | DANYELZA (naxitamab-gqgk) | Key endorsement for KOL and physician relationship building. |
Managed access programs (Named Patient Programs) for ex-U.S. markets
For markets outside the U.S., the relationship strategy relied on navigating international regulatory pathways, often utilizing managed access or named patient programs to supply the drug while approvals were pending. The company reported Ex-U.S. DANYELZA net product revenues of $4.7 million for the quarter ended June 30, 2025. This revenue stream confirms ongoing commercial activity and relationship management in international territories, even as the primary focus remained on the U.S. market. The company also noted a potential for marketing approval of DANYELZA in a new ex-U.S. market during 2025, which would deepen these international customer relationships.
Patient advocacy and support programs for a rare pediatric disease
Serving a rare pediatric disease patient population necessitates strong ties with advocacy organizations. While specific Y-mAbs Therapeutics internal program metrics aren't detailed, the company operates in a landscape where advocacy is crucial. For context on the patient community, in September 2025, over 190 organizations signed a letter urging Congress to pass legislation to reauthorize the Rare Pediatric Priority Review Voucher (PRV) program, which had expired in December 2024. This highlights the high level of organized advocacy present for the patient segment Y-mAbs Therapeutics serves.
- Advocacy groups are pushing for reauthorization of the Rare Pediatric PRV program in 2025.
- The PRV program is cited as a vital incentive for developing therapies for rare pediatric diseases.
- Nearly 70% of rare diseases start in childhood.
Investor relations managed through the pending acquisition process
The customer relationship with shareholders transformed entirely in the latter half of 2025. Investor relations shifted from focusing on operational milestones to managing the certainty of the acquisition. On August 5, 2025, Y-mAbs Therapeutics announced a definitive agreement for SERB to acquire the company for an equity value of $412.0 million. The offer was an all-cash tender offer at $8.60 per share, representing a premium of approximately 105% to the closing share price on August 4, 2025. To ensure a smooth transition, stockholders holding approximately 16% of outstanding shares entered into a tender and support agreement. The transaction was expected to close by the fourth quarter of 2025. This provided immediate liquidity and price certainty to the investor base, effectively concluding the public company relationship management phase.
The final cash position as of June 30, 2025, was $62.3 million, which was the capital base supporting operations right before the tender offer commenced.
Y-mAbs Therapeutics, Inc. (YMAB) - Canvas Business Model: Channels
You're looking at how Y-mAbs Therapeutics, Inc. gets its product, DANYELZA, and its pipeline candidates to the right people, which is a mix of direct effort and partner reliance. Here's the quick math on the distribution and engagement points as of mid-2025.
Direct sales force to U.S. hospitals and specialized cancer treatment centers
The commercial channel for DANYELZA in the United States relies on direct engagement with treatment centers. As of March 31, 2025, Y-mAbs Therapeutics had delivered DANYELZA to 70 centers across the U.S. since the initial launch. The company noted a slight expansion in Q1 2025, adding one new account in the U.S. during that quarter. To gauge the breadth of adoption beyond the initial key centers, approximately 72% of the vials sold in the U.S. during the quarter ended March 31, 2025, were sold outside of Memorial Sloan Kettering Cancer Center (MSK), which is an increase from 64% in the fourth quarter ended December 31, 2024. This indicates a growing, albeit still concentrated, utilization base. Following a realignment in early 2025, which included a leadership change and a 'small adjustment' to the commercial team, the focus remained on expanding growth opportunities within the GD2 market.
Distribution agreements with international partners (e.g., Adium, Nobelpharma)
International reach is heavily channeled through distribution partners, which generate license revenue alongside product sales. For the six months ended June 30, 2025, the Company recognized $0.5 million in license revenue related to sales-based milestones from partners, including the Latin America distribution partner, Adium, related to a price approval in Brazil. The growth in Ex-U.S. DANYELZA net product revenues for the quarter ended March 31, 2025, was driven significantly by partners. Specifically, there was a $3.8 million increase in net product revenue in Western Asia due to the named patient program launch in late 2024, alongside growth in Eastern Asia and Latin America. The company also highlighted an enhanced collaboration with SciClone and continued success with the named patient program for DANYELZA in Turkey with partner INPHARMUS (formerly TRPharm). Management anticipated the potential for marketing approval of DANYELZA in a new ex-U.S. market during 2025.
Here is a summary of the noted international channel activity:
| Region/Partner Activity | Metric/Value | Reporting Period/Date |
| License Revenue from Partners (H1 2025) | $0.5 million | Six months ended June 30, 2025 |
| Western Asia Revenue Increase (Partner Program) | $3.8 million increase | Quarter ended March 31, 2025 |
| U.S. DANYELZA Net Product Revenue Decrease | $0.9 million decrease | Quarter ended June 30, 2025 (vs Q2 2024) |
| Ex-U.S. DANYELZA Net Product Revenue Decrease | $2.9 million decrease | Quarter ended June 30, 2025 (vs Q2 2024) |
Specialty pharmacies and distributors for drug delivery
While specific numbers for the specialty pharmacy network for DANYELZA are not explicitly detailed for 2025, the channel relies on these entities for drug delivery, especially given the product's specialized nature. The international distribution agreements mentioned above inherently involve local distributors and specialty channels to reach end-users in those territories. For the U.S. market, the 70 centers reached by the direct sales force are the primary points of administration, which implies these centers either stock the drug directly or utilize a tightly controlled specialty distribution/pharmacy network to manage the cold chain and inventory for DANYELZA.
Clinical trial sites for pipeline product development and patient enrollment
The pipeline development channels utilize a network of clinical trial sites for testing the Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy (PRIT) platform candidates. As of the January 10, 2025 update:
- GD2-SADA (Trial 1001): Dosed 21 patients across six sites in Part A.
- CD38-SADA (Trial 1201): Six sites were selected, with three sites activated.
The company expected to dose the first non-Hodgkin Lymphoma (NHL) patient in Study 1201 in the first quarter of 2025. Data from Part A of the GD2-SADA Phase 1 trial was anticipated for presentation in the second quarter of 2025. The total employee count for Y-mAbs Therapeutics, as of June 30, 2025, was 113 total employees, supporting both commercial and development operations.
Y-mAbs Therapeutics, Inc. (YMAB) - Canvas Business Model: Customer Segments
You're looking at the core groups Y-mAbs Therapeutics, Inc. (YMAB) targets with its commercial and development efforts as of late 2025. It's a focused approach, centered on rare pediatric cancers and leveraging platform technology for broader expansion.
Pediatric oncology specialists and hospitals treating high-risk neuroblastoma.
This segment is the direct customer for DANYELZA (naxitamab-gqgk), the company's commercial product. The focus is on centers capable of administering and managing this specialized therapy for relapsed or refractory high-risk neuroblastoma.
- As of March 31, 2025, Y-mAbs Therapeutics, Inc. had delivered DANYELZA to 70 centers across the U.S. since initial launch.
- In the first quarter of 2025, one new account was added in the U.S.
- Approximately 72% of the vials sold in the U.S. during Q1 2025 were sold outside of Memorial Sloan Kettering Cancer Center (MSK).
Patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow.
This is the ultimate beneficiary segment, defined by a specific, high-need medical condition. The market size numbers help frame the commercial opportunity for DANYELZA.
| Metric | Value/Statistic | Context |
|---|---|---|
| Annual New Cases (U.S. Estimate) | Approximately 700 to 800 | New cases of neuroblastoma diagnosed in the United States every year. |
| Incidence Rate (Under Age 15) | 10.2 children per million | General population incidence for neuroblastoma. |
| Relapse Rate (High-Risk) | Nearly 50% | Percentage of high-risk neuroblastoma cases that relapse after initial remission. |
| Refractory Rate | 15% | Percentage of cases showing treatment resistance (refractory neuroblastoma). |
The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for Neuroblastoma were updated to include naxitamab-gqgk (DANYELZA®) as a Category 2A treatment, which definitely helps adoption among specialists.
Global specialty pharmaceutical companies (SERB) seeking to acquire rare disease assets.
This segment represents a strategic exit or partnership opportunity, valuing the established commercial asset and rare disease focus of Y-mAbs Therapeutics, Inc. The transaction details quantify the value placed on this customer/acquirer type as of late 2025.
- In August 2025, SERB Pharmaceuticals and Y-mAbs Therapeutics entered a definitive merger agreement.
- The transaction represented an equity value for Y-mAbs Therapeutics, Inc. of approximately $412 million.
- The deal was an all-cash transaction for Y-mAbs Therapeutics, Inc., including its lead commercial oncology asset, DANYELZA (naxitamab-gqgk).
Future oncology segments for SADA platform (e.g., r/r non-Hodgkin Lymphoma).
This segment is targeted by the Radiopharmaceuticals business unit, focusing on patients needing novel treatments based on the investigational Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy (PRIT) Platform.
The initial expansion targets include:
- Patients with Relapsed/Refractory non-Hodgkin Lymphoma (NHL), for whom Y-mAbs Therapeutics, Inc. dosed the first patient in Phase 1 clinical trial (Trial 1201) in the first quarter of 2025.
- Future franchise-expanding opportunities identified as lung cancer, women's cancers, and gastrointestinal cancers.
The company anticipates filing an Investigational New Drug (IND) application for its first molecular imaging asset by the end of 2025, which opens up another potential customer base within diagnostic imaging.
Finance: draft 13-week cash view by Friday.
Y-mAbs Therapeutics, Inc. (YMAB) - Canvas Business Model: Cost Structure
You're looking at the major drains on the cash reserves for Y-mAbs Therapeutics, Inc. as of late 2025. For a commercial-stage biotech, the cost structure is heavily weighted toward supporting the existing product while funding the next generation of pipeline assets.
The High research and development (R&D) expenses are a core cost. For the first quarter of 2025, Y-mAbs Therapeutics, Inc. reported R&D expenses of $11.4 million. This spending fuels the advancement of their novel platforms, like the SADA technology.
Here's a quick view of some key reported costs from the first quarter of 2025:
| Cost Component | Amount (Q1 2025) | Notes |
|---|---|---|
| Research and Development (R&D) Expenses | $11.4 million | Three months ended March 31, 2025. |
| Restructuring Charge | $0.5 million | Reported in Q1 2025. |
| Legal Expense | $0.4 million | Reported in Q1 2025. |
| Total Revenues | $20.9 million | Q1 2025 total revenues. |
| Gross Profit | $17.9 million | Q1 2025. |
The Cost of goods sold (COGS) for DANYELZA manufacturing and supply chain is embedded within the gross profit calculation. Based on the Q1 2025 total revenues of $20.9 million and a gross profit of $17.9 million, the implied COGS for that quarter was $3.0 million ($20.9M - $17.9M). The gross margin for Q1 2025 settled at 86%, down slightly from 89% in the prior year period due to lower U.S. net product revenues. The gross margin for the second quarter of 2025 decreased further due to increased production costs and lower high-margin product sales to Western Europe.
Selling, General, and Administrative (SG&A) costs for the commercial team are substantial for supporting DANYELZA. While Q1 2025 SG&A isn't explicitly isolated in the same way, the latest reported figure shows the scale of these overheads. For the three months ended June 30, 2025, SG&A expenses were $11.3 million. This was a significant decrease from $17.2 million in the same period in 2024, primarily due to the net impact of litigation settlements in Q2 2024 and lower legal expenses.
Clinical trial and regulatory costs for the SADA platform advancement are part of the overall R&D spend, but the changes reflect shifting priorities. For the first quarter of 2025, the R&D decrease versus 2024 was partly due to a $0.7 million decrease in clinical trials because of the timing of completion in the GD2-SADA program. Also, for the six months ended June 30, 2025, R&D expenses saw a total $0.4 million decrease in clinical trials and outsourced research and supplies related to the GD2-SADA program and investment in the SADA PRIT programs.
The Operational restructuring costs from the shift of roles from Denmark to the US were recognized in early 2025. Y-mAbs Therapeutics, Inc. announced a realignment in January 2025, which included moving some roles from Denmark to the U.S. to better coordinate the radiopharmaceutical platform advancement. The financial impact recorded in Q1 2025 included a specific restructuring charge of approximately $0.5 million. This realignment also contributed to a decrease in R&D personnel and stock-based compensation costs, with a $0.9 million decrease noted in both Q1 and Q2 2025 R&D expenses compared to the prior year periods, which was primarily related to this realignment.
Looking at the full-year expectation, Y-mAbs Therapeutics, Inc. reiterated its full-year 2025 guidance for Total Expected Operating Costs and Expenses, which includes anticipated COGS, to be between $116 million and $121 million. Finance: draft updated cash burn projection based on Q2 actuals by next Tuesday.
Y-mAbs Therapeutics, Inc. (YMAB) - Canvas Business Model: Revenue Streams
You're looking at the core income sources for Y-mAbs Therapeutics, Inc. as of late 2025. The business model heavily relies on product sales, specifically DANYELZA, supplemented by partnership income.
The primary driver remains the net product revenues from DANYELZA (naxitamab-gqgk). For the first quarter of 2025, the company reported total revenues of $20.9 million, which was entirely comprised of net product revenues, marking an 8% year-over-year increase. Management reiterated its full-year 2025 total revenue guidance to be between $75 million and $90 million.
To give you a clearer picture of the product revenue breakdown for the first half of 2025, here's how the DANYELZA sales looked:
| Metric | Q1 2025 Amount | Q2 2025 Amount |
| Net Product Revenues (Total) | $20.9 million | $19.5 million |
| U.S. Sales of DANYELZA | $13.4 million | $14.3 million |
| Ex-U.S. Sales of DANYELZA | $7.5 million | Data not explicitly isolated from total for Q2 |
The U.S. DANYELZA net product revenues for the quarter ended March 31, 2025, were $13.4 million, which represented a 28% decrease from the same period in 2024. Conversely, Ex-U.S. DANYELZA net product revenues for Q1 2025 were $7.5 million, a significant increase of $6.7 million from Q1 2024.
Regarding partnership income, license revenue was not reported for the first quarter ended March 31, 2025. However, for the second quarter ended June 30, 2025, the company recognized $0.5 million in license revenue. This amount was earned in prior periods, connected to sales-based milestone achievements by a partner in Israel. This aligns with the type of revenue stream you noted from international distribution partners.
The revenue streams can be summarized by their components as follows:
- Net product revenues from U.S. sales of DANYELZA.
- Net product revenues from ex-U.S. sales of DANYELZA.
- License revenue from international distribution partners, such as the $0.5 million recognized in Q2 2025.
- Potential future milestone payments from ex-U.S. partners.
The total revenues for the first half of 2025 (Q1 plus Q2) reached $40.4 million. The Q2 2025 total revenue was $19.5 million, which beat the high end of the company's guidance range of between $17 million and $19 million for that quarter. Finance: draft 13-week cash view by Friday.
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