Y-mAbs Reports Fourth Quarter 2024 Financial Results and Recent Corporate Developments
Rhea-AI Summary
Y-mAbs Therapeutics (YMAB) reported Q4 2024 financial results with total revenues of $26.5 million, up 13% year-over-year, and full-year 2024 revenues of $87.7 million, a 3% increase from 2023.
Key highlights include:
- U.S. DANYELZA revenues declined 12% in Q4 and 3% for full-year 2024
- International DANYELZA revenues grew 78% in Q4 and 16% for full-year 2024
- Cash position of $67.2 million as of December 31, 2024
- Net loss of $6.8 million in Q4 2024 ($0.15 per share)
The company established two business units in January 2025 for Radiopharmaceuticals Platform and DANYELZA commercialization. 2025 guidance projects total revenues between $75-90 million and operating expenses between $116-121 million. Cash runway expected into 2027.
Positive
- 78% growth in international DANYELZA revenue for Q4 2024
- 13% increase in total Q4 2024 revenue to $26.5M
- Cash runway extended into 2027
- New license agreement with Nobelpharma worth up to $33M plus royalties
- DANYELZA patent extension through February 2034
Negative
- 12% decline in U.S. DANYELZA revenue for Q4 2024
- Net loss increased to $6.8M in Q4 2024 vs $1.0M in Q4 2023
- Operating expenses increased year-over-year
- Gross profit decreased due to unfavorable price mix
News Market Reaction 1 Alert
On the day this news was published, YMAB declined 4.43%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
- Reported Total Revenues of
$26.5 million for the fourth quarter of 2024 and$87.7 million for the full year 2024 - The Company established two business units in January 2025 aimed to accelerate the clinical development of its Radiopharmaceuticals Platform and optimize the commercial potential of DANYELZA
- Cash and cash equivalents of
$67.2 million held as of December 31, 2024, reflects$11.4 million Total Annual Cash Investment in the full year 2024 - Management announces Full Year 2025 guidance around Total Revenue, Operating Expenses, and Cash Investment and First Quarter 2025 guidance around Total Revenue
- The Company will host a conference call on Tuesday, March 4, 2025, at 8:00 a.m. ET
NEW YORK, March 04, 2025 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today reported financial results for the fourth quarter and full year ended December 31, 2024.
“We delivered on the strategic priorities we set out to achieve in 2024 across our business,” said Michael Rossi, President and Chief Executive Officer. “In our DANYELZA business, we saw solid ex-U.S. growth in 2024 from our partners. In the U.S., while DANYELZA revenues stabilized in the face of increased competition from new market entrants and clinical trial activity, we remain committed to further penetrating high-volume centers and reaching more patients with high-risk relapsed/refractory neuroblastoma. In our Radiopharmaceutical business, we demonstrated the tolerability and validity of our SADA PRIT platform pre-targeting approach with the preliminary readout from Part A of our GD2-SADA Phase 1 trial, Trial 1001, in solid tumors, and we look forward to providing a complete data readout in the second quarter of this year. With our business realignment announced at the beginning of 2025, we expect to be in position to enhance our ability to execute on our business goals to drive future growth with DANYELZA while accelerating the preclinical and clinical advancement of our SADA PRIT platform and programs.”
Recent Corporate Highlights
- On January 10, 2025, Y-mAbs announced the internal realignment and establishment of two business units: DANYELZA and Radiopharmaceuticals. The business realignment is designed to support the optimization of internal resources and provide flexibility and agility to advance the Company’s novel Self-Assembly DisAssembly Pre-targeted Technology platform (SADA PRIT) programs through clinical development while simultaneously driving commercial growth of DANYELZA.
- In conjunction with the business realignment, Y-mAbs appointed Doug Gentilcore as Senior Vice President, Head of DANYELZA Business Unit. Mr. Gentilcore has over two decades of strategic leadership experience in the pharmaceutical industry.
- Y-mAbs presented translational pharmacokinetics data of GD2-SADA at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Mid-Winter and American College of Nuclear Medicine (ACNM) Annual Meeting on January 31, 2025. The poster titled “Preclinical and Translational Pharmacokinetics of GD2-SADA, a Self-Assembling and Disassembling (SADA) Bispecific Fusion Protein for Pre-targeted Radioimmunotherapy (PRIT)” characterizes the plasma levels of GD2-SADA in animal models over time and a range of doses, while also presenting the concentration- and time-dependent equilibrium between GD2-SADA tetramers and monomers in vitro. Incorporated within translational PK simulations, the data have provided insights into GD2-SADA tumor exposure and plasma elimination, key parameters for minimizing systemic exposure to 177Lutetium-DOTA.
- Interim data from a Phase 2 clinical trial evaluating naxitamab with granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with relapsed/refractory high-risk neuroblastoma in the journal Nature Communications. The article, titled “The anti-GD2 monoclonal antibody naxitamab plus GM-CSF for relapsed or refractory high-risk neuroblastoma: a phase 2 clinical trial,” details the results of a single-arm, global Phase 2 trial (Trial 201, NCT03363373) of patients with relapsed/refractory high-risk neuroblastoma and residual disease in the bone/bone marrow who received naxitamab on days 1, 3, and 5 (3 mg/kg/day) with GM-CSF (days -4 to 5) every 4 weeks, until a complete response (CR) or partial response (PR) was achieved, followed by 5 additional cycles every 4 weeks. Overall, naxitamab demonstrated statistically significant efficacy with a manageable safety profile.
Fourth Quarter 2024 Key Highlights
- Y-mAbs entered into an exclusive license and distribution agreement with Nobelpharma Co. Ltd. for the development and commercialization of DANYELZA in Japan. Y-mAbs received an upfront payment of
$2.0 million in the fourth quarter of 2024. In addition, Y-mAbs is entitled to receive up to$31.0 million in regulatory-based and sales-based milestone payments in addition to royalty payments on commercial sales of DANYELZA by Nobelpharma, if successfully approved and commercialized in Japan. - Continued commercial success with the named patient program for DANYELZA in Turkey with partner INPHARMUS (formerly named TRPharm İlaç Sanayi Ticaret A.Ş. and TRPharm FZ-LLC).
- Y-mAbs received notification of the accepted patent extension for DANYELZA, US 9,315,585, through February 2034.
Financial Results
Revenues
Total revenues for the quarter ended December 31, 2024 were
Total revenues for the year ended December 31, 2024 were
The Company’s U.S. DANYELZA net product revenues for the quarter and year ended December 31, 2024 were
The Company’s international DANYELZA net product revenues for the quarter and year ended December 31, 2024 were
As of December 31, 2024, Y-mAbs had delivered DANYELZA to 69 centers across the U.S. since initial launch, with 11 new accounts added in the U.S. in 2024. During the quarter ended December 31, 2024, approximately
During the quarter and year ended December 31, 2024, the Company recognized license revenue of
Cost of Goods Sold
Cost of goods sold were
Gross Profit
Gross profit was
Operating Costs and Expenses
Research and Development
Research and development expenses were
Research and development expenses were
Selling, General, and Administrative
Selling, general, and administrative expenses were
For the year ended December 31, 2024, selling, general, and administrative expenses were
Interest and Other (Loss)/Income
The Company experienced interest and other loss of
For the years ended December 31, 2024 and 2023, the interest and other income was
Net Loss
Y-mAbs reported a net loss for the quarter ended December 31, 2024, of
Cash and Cash Equivalents
As of December 31, 2024, Y-mAbs had approximately
2025 Financial Guidance
Management announces its guidance for the full year 2025:
- Anticipated Total Revenues expected to be between
$75 million and$90 million ; - Anticipated Total Operating Costs and Expenses, excluding cost of goods sold, expected to be between
$116 million and$121 million (Total Operating Costs and Expenses including cost of goods sold is anticipated to be between$129 million and$134 million ); - Anticipated Total Annual Cash Investment expected to be between
$25 million and$30 million ; and - Cash and Cash Equivalents anticipated to be sufficient to fund operations as currently planned into 2027.
Management announces its guidance for the first quarter 2025:
- Anticipated Total Revenues expected to be between
$18 million and$21 million .
Webcast and Conference Call
Y-mAbs will host a conference call on Tuesday, March 4, 2025, at 8:00 a.m. ET. To participate in the live conference call, register here:
https://register.vevent.com/register/BIc0434de7d34443d1a7e4c7635d2c9faa
To listen to the live webcast, please use this link. Prior to the call and webcast, a slide presentation pertaining to the Company’s quarterly earnings will be made available on the Investor Relations section of the Y-mAbs website, www.ymabs.com, shortly before the call begins.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, radioimmunotherapy and antibody-based therapeutic cancer products. The Company’s technologies include its investigational Self-Assembly DisAssembly (“SADA”) Pre-targeted Radioimmunotherapy Platform (“PRIT”) and bispecific antibodies generated using the Y-BiClone platform. The Company’s broad and advanced product pipeline includes the anti-GD2 therapy DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow after a partial response, minor response, or stable disease to prior therapy.
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, statements about our business model, including financial outlook for the first quarter and full year 2025 and beyond, including estimated operating expenses, estimated operating expenses excluding cost of goods sold, total annual cash investment and total revenues and sufficiency of cash resources and related assumptions; expectations with respect to the Company’s future financial performance; expectations with respect to the business unit realignment, including the expected impacts and anticipated benefits thereof, including operational flexibility and speed, and acceleration of clinical development within the radiopharmaceutical platform and optimizing the commercial potential of DANYELZA and driving future DANYELZA growth; implied and express statements regarding the future of the Company’s business, including with respect to expansion and its goals; expectations with respect to the Company’s plans and strategies, development, regulatory, commercialization and product distribution plans, including the timing thereof; expectations with respect to the Company’s products and product candidates, including potential territory and label expansion of DANYELZA and the potential market opportunity related thereto and potential benefits thereof, and the potential of the SADA PRIT technology and potential benefits and applications thereof; expectations relating to key anticipated development milestones, including potential expansion and advancement of commercialization and development efforts, including potential indications, applications and geographies, and the timing thereof; expectations with respect to current and future clinical and pre-clinical studies and the Company’s research and development programs, including with respect to timing and results; expectations regarding collaborations or strategic partnerships and the potential benefits thereof; and other statements that are not historical facts. Words such as ‘‘anticipate,’’ ‘‘believe,’’ “contemplate,” ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ “hope,” ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’ “will,” ‘‘would’,’ “guidance,” “goal,” “objective,” “aim,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with the Company’s financial condition and need for additional capital; the risks that actual results of the Company’s business unit realignment will not be as expected; risks associated with the Company’s development work; cost and success of the Company’s product development activities and clinical trials; the risks of delay in the timing of the Company’s or its partners’ regulatory submissions or failure to receive approval of its drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of product candidates; development of sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for products; risks related to the Company’s dependence on third parties including for conduct of clinical testing and product manufacture as well as regulatory submissions; the Company’s ability to enter into new partnerships or to recognize the anticipated benefits from its existing partnerships; risks related to government regulation; risks related to market approval, risks associated with protection of the Company’s intellectual property rights; risks related to employee matters and managing growth; risks related to the Company’s common stock, risks associated with macroeconomic conditions, including the conflict between Russia and Ukraine and sanctions related thereto, inflation, increased interest rates, uncertain global credit and capital markets and disruptions in banking systems; and other risks and uncertainties affecting the Company including those described in the “Risk Factors” section included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and future filings and reports by the Company. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
DANYELZA® and Y-mAbs® are registered trademarks of Y-mAbs Therapeutics, Inc.
| YMABS THERAPEUTICS, INC. | ||||||||
| Consolidated Balance Sheets | ||||||||
| (unaudited) | ||||||||
| (In thousands, except share and per share data) | ||||||||
| December 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 67,234 | $ | 78,637 | ||||
| Accounts receivable, net | 19,688 | 22,454 | ||||||
| Inventories | 7,214 | 5,065 | ||||||
| Other current assets | 4,373 | 4,955 | ||||||
| Total current assets | 98,509 | 111,111 | ||||||
| Property and equipment, net | 42 | 224 | ||||||
| Operating lease right-of-use assets | 817 | 1,412 | ||||||
| Intangible assets, net | 2,276 | 2,631 | ||||||
| Other assets | 488 | 543 | ||||||
| Inventories, long-term | 17,772 | 11,948 | ||||||
| TOTAL ASSETS | $ | 119,904 | $ | 127,869 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| LIABILITIES | ||||||||
| Accounts payable | $ | 6,662 | $ | 6,060 | ||||
| Accrued liabilities | 16,406 | 13,166 | ||||||
| Operating lease liabilities, current portion | 630 | 902 | ||||||
| Total current liabilities | 23,698 | 20,128 | ||||||
| Accrued milestones | 3,200 | 5,375 | ||||||
| Operating lease liabilities, long-term portion | 190 | 517 | ||||||
| Other liabilities | 812 | 864 | ||||||
| TOTAL LIABILITIES | 27,900 | 26,884 | ||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 4 | 4 | ||||||
| Additional paid-in capital | 576,872 | 558,002 | ||||||
| Accumulated other comprehensive income | 2,264 | 449 | ||||||
| Accumulated deficit | (487,136 | ) | (457,470 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 92,004 | 100,985 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 119,904 | $ | 127,869 | ||||
| Y-MABS THERAPEUTICS, INC. | ||||||||||||||||
| Consolidated Statements of Net Loss and Comprehensive Loss | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| (In thousands, except share and per share data) | ||||||||||||||||
| Three months ended December 31, | Year ended December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| REVENUES | ||||||||||||||||
| Net product revenue | $ | 24,495 | $ | 23,363 | $ | 85,185 | $ | 84,319 | ||||||||
| License revenue | 2,000 | — | 2,500 | 500 | ||||||||||||
| Total revenues | 26,495 | 23,363 | 87,685 | 84,819 | ||||||||||||
| COST OF GOODS SOLD | 7,642 | 2,039 | 15,001 | 11,366 | ||||||||||||
| GROSS PROFIT | 18,853 | 21,324 | 72,684 | 73,453 | ||||||||||||
| OPERATING COSTS AND EXPENSES | ||||||||||||||||
| License royalties | 200 | — | 250 | 50 | ||||||||||||
| Research and development | 12,214 | 13,388 | 48,990 | 54,219 | ||||||||||||
| Selling, general, and administrative | 12,375 | 11,135 | 54,645 | 44,856 | ||||||||||||
| Total operating costs and expenses | 24,789 | 24,523 | 103,885 | 99,125 | ||||||||||||
| Loss from operations | (5,936 | ) | (3,199 | ) | (31,201 | ) | (25,672 | ) | ||||||||
| OTHER (LOSS)/INCOME, NET | ||||||||||||||||
| Interest and other (loss)/income | (1,606 | ) | 2,406 | 1,389 | 4,806 | |||||||||||
| LOSS BEFORE INCOME TAXES | (7,542 | ) | (793 | ) | (29,812 | ) | (20,866 | ) | ||||||||
| (Benefits)/provision for income taxes | (752 | ) | 195 | (146 | ) | 561 | ||||||||||
| NET LOSS | $ | (6,790 | ) | $ | (988 | ) | $ | (29,666 | ) | $ | (21,427 | ) | ||||
| Other comprehensive income/(loss) | ||||||||||||||||
| Foreign currency translation | 2,300 | (1,400 | ) | 1,815 | (882 | ) | ||||||||||
| COMPREHENSIVE LOSS | $ | (4,490 | ) | $ | (2,388 | ) | $ | (27,851 | ) | $ | (22,309 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.15 | ) | $ | (0.02 | ) | $ | (0.67 | ) | $ | (0.49 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 44,875,489 | 43,627,270 | 44,328,962 | 43,645,388 | ||||||||||||
| Y-MABS THERAPEUTICS, INC. | |||||||||
| Consolidated Statements of Cash Flows | |||||||||
| (unaudited) | |||||||||
| (In thousands) | |||||||||
| Year ended December 31, | |||||||||
| 2024 | 2023 | ||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | |||||||||
| Net loss | $ | (29,666 | ) | $ | (21,427 | ) | |||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||
| Depreciation and amortization | 535 | 735 | |||||||
| Stock-based compensation | 14,559 | 14,453 | |||||||
| Foreign currency and other transactions | 1,987 | (1,259 | ) | ||||||
| Provision for bad debt | 520 | — | |||||||
| Changes in assets and liabilities: | |||||||||
| Accounts receivable, net | 2,246 | (9,923 | ) | ||||||
| Inventories | (2,149 | ) | 1,637 | ||||||
| Other current assets | 582 | 17 | |||||||
| Inventories, long-term | (5,824 | ) | (6,667 | ) | |||||
| Other assets | 55 | (145 | ) | ||||||
| Accounts payable | (1,385 | ) | (6,856 | ) | |||||
| Accrued liabilities and other | 2,826 | 2,203 | |||||||
| NET CASH USED IN OPERATING ACTIVITIES | (15,714 | ) | (27,232 | ) | |||||
| CASH FLOWS FROM INVESTING ACTIVITIES | — | — | |||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | |||||||||
| Proceeds from exercised stock options | 4,311 | 100 | |||||||
| NET CASH PROVIDED BY FINANCING ACTIVITIES | 4,311 | 100 | |||||||
| Effect of exchange rates on cash and cash equivalents | — | 7 | |||||||
| NET DECREASE IN CASH AND CASH EQUIVALENTS | (11,403 | ) | (27,125 | ) | |||||
| Cash and cash equivalents at the beginning of period | 78,637 | 105,762 | |||||||
| Cash and cash equivalents at the end of period | $ | 67,234 | $ | 78,637 | |||||
| SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | |||||||||
| Cash paid for income taxes | $ | 713 | $ | 367 | |||||
| SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES | |||||||||
| Right-of-use assets obtained in exchange for lease obligations | $ | 320 | $ | 636 | |||||
| Acquisition of treasury shares upon repayment of secured promissory note | $ | — | $ | 480 | |||||
FAQ
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