Y-mAbs Reports Third Quarter 2024 Financial Results and Recent Corporate Developments
Y-mAbs Therapeutics reported Q3 2024 financial results with total DANYELZA net product revenues of $18.5 million, marking a 10% decline from Q3 2023. The company entered into an exclusive license agreement with Nobelpharma for DANYELZA in Japan, securing a $2.0 million upfront payment. Key developments include the extension of DANYELZA's U.S. patent through February 2034 and market expansion into Turkey. Net loss for Q3 2024 was $7.0 million ($0.16 per share), compared to $7.7 million in Q3 2023. The company maintains its 2024 guidance with expected total net revenues between $87-95 million and cash position supporting operations into 2027.
Y-mAbs Therapeutics ha riportato i risultati finanziari del terzo trimestre 2024 con ricavi netti totali del prodotto DANYELZA pari a 18,5 milioni di dollari, segnando una diminuzione del 10% rispetto al terzo trimestre 2023. L'azienda ha stipulato un accordo di licenza esclusivo con Nobelpharma per DANYELZA in Giappone, ricevendo un pagamento iniziale di 2,0 milioni di dollari. Tra i principali sviluppi c'è l'estensione del brevetto di DANYELZA negli Stati Uniti fino a febbraio 2034 e l'espansione del mercato in Turchia. La perdita netta per il terzo trimestre 2024 è stata di 7,0 milioni di dollari (0,16 dollari per azione), rispetto ai 7,7 milioni di dollari nel terzo trimestre 2023. L'azienda mantiene le previsioni per il 2024, con ricavi netti totali attesi tra 87 e 95 milioni di dollari e una posizione di cassa che sostiene le operazioni fino al 2027.
Y-mAbs Therapeutics informó los resultados financieros del tercer trimestre de 2024 con ingresos netos totales de productos DANYELZA de 18,5 millones de dólares, lo que representa una disminución del 10% en comparación con el tercer trimestre de 2023. La compañía firmó un acuerdo de licencia exclusivo con Nobelpharma para DANYELZA en Japón, asegurando un pago inicial de 2,0 millones de dólares. Los principales desarrollos incluyen la extensión de la patente de DANYELZA en EE. UU. hasta febrero de 2034 y la expansión del mercado hacia Turquía. La pérdida neta para el tercer trimestre de 2024 fue de 7,0 millones de dólares (0,16 dólares por acción), en comparación con 7,7 millones de dólares en el tercer trimestre de 2023. La compañía mantiene su guía para 2024, con ingresos netos totales esperados entre 87 y 95 millones de dólares y una posición de tesorería que apoya las operaciones hasta 2027.
Y-mAbs Therapeutics는 2024년 3분기 재무 결과를 보고했으며, DANYELZA의 총 순수익은 1,850만 달러로, 2023년 3분기보다 10% 감소했습니다. 이 회사는 일본에서 DANYELZA에 대한 Nobelpharma와 독점 라이선스 계약을 체결하고 200만 달러의 선불금을 확보했습니다. 주요 개발 내용으로는 2034년 2월까지 DANYELZA의 미국 특허 연장과 터키 시장으로의 확장이 포함됩니다. 2024년 3분기 순손실은 700만 달러(주당 0.16달러)로, 2023년 3분기의 770만 달러에 비해 감소했습니다. 회사는 2024년 예상 순수익을 8,700만 달러에서 9,500만 달러 사이로 유지하며 2027년까지 운영을 지원할 수 있는 현금 위치를 유지하고 있습니다.
Y-mAbs Therapeutics a annoncé les résultats financiers du troisième trimestre 2024 avec des revenus nets totaux du produit DANYELZA de 18,5 millions de dollars, marquant une baisse de 10 % par rapport au troisième trimestre 2023. L'entreprise a conclu un accord de licence exclusif avec Nobelpharma pour DANYELZA au Japon, obtenant un paiement initial de 2,0 millions de dollars. Parmi les développements clés, on trouve l'extension du brevet de DANYELZA aux États-Unis jusqu'en février 2034 et l'expansion vers le marché turc. La perte nette pour le troisième trimestre 2024 était de 7,0 millions de dollars (0,16 dollar par action), contre 7,7 millions de dollars au troisième trimestre 2023. L'entreprise maintient ses prévisions pour 2024, avec des revenus nets totaux attendus compris entre 87 et 95 millions de dollars et une position de trésorerie favorable aux opérations jusqu'en 2027.
Y-mAbs Therapeutics berichtete über die finanziellen Ergebnisse für das dritte Quartal 2024 mit einem Gesamterlös für das Produkt DANYELZA von 18,5 Millionen Dollar, was einem Rückgang von 10 % gegenüber dem dritten Quartal 2023 entspricht. Das Unternehmen hat einen exklusiven Lizenzvertrag mit Nobelpharma für DANYELZA in Japan abgeschlossen und dabei eine Vorauszahlung von 2,0 Millionen Dollar gesichert. Zu den wichtigsten Entwicklungen gehört die Verlängerung des US-Patents von DANYELZA bis Februar 2034 und die Markterweiterung nach Türkei. Der Nettverlust für das dritte Quartal 2024 betrug 7,0 Millionen Dollar (0,16 Dollar pro Aktie), im Vergleich zu 7,7 Millionen Dollar im dritten Quartal 2023. Das Unternehmen hält an seiner Prognose für 2024 fest, mit erwarteten Gesamtnettoerlösen zwischen 87 und 95 Millionen Dollar und einer cash-Position, die den Betrieb bis 2027 unterstützt.
- Secured $2.0 million upfront payment from Nobelpharma deal with potential for $31.0 million in milestone payments
- Extended DANYELZA U.S. patent protection through February 2034
- Geographic expansion with new market entry in Turkey
- Strong cash position of $68.1 million as of September 30, 2024
- Improved gross margins in nine months ended September 30, 2024
- 10% decline in total net revenues compared to Q3 2023
- U.S. DANYELZA revenues decreased 5% due to unfavorable price mix
- 19% decline in ex-U.S. DANYELZA revenues
- Increased selling, general, and administrative expenses by $3.4 million in Q3 2024
- Net loss increased to $22.9 million for nine months ended September 30, 2024, compared to $20.4 million in 2023
Insights
Y-mAbs delivered mixed Q3 results with
The company's guidance remains unchanged, projecting
Geographic expansion continues with new market penetration in Turkey and strategic positioning in Japan through Nobelpharma partnership. DANYELZA's reach now extends to 68 U.S. centers, with
The company's transition to Princeton headquarters in 2025 and continued investment in the SADA PRIT platform demonstrate long-term strategic planning. Market position in neuroblastoma treatment remains strong, with potential upside from pipeline developments expected in Q1 2025.
- Reported Total DANYELZA net product revenues of
$18.5 million for the third quarter of 2024 - Entered into exclusive license and distribution agreement with Nobelpharma for DANYELZA in Japan recognizing an upfront payment of
$2.0 million in the fourth quarter of 2024 - Achieved extension of primary DANYELZA U.S. patent through February 2034
- Continued geographic expansion of DANYELZA with new market revenues recorded in the third quarter from Turkey
- Management reiterates Full Year 2024 guidance around Total Net Revenue, Operating Expenses, and Cash Flow Investment
- The Company will host a conference call on Friday, November 8, 2024, at 8:00 a.m. ET
NEW YORK, Nov. 08, 2024 (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 third quarter ended September 30, 2024.
“The third quarter of this year was one of continued focus and execution across our DANYELZA commercial business and our novel SADA PRIT radiopharmaceutical platform development pipeline,” said Michael Rossi, President and Chief Executive Officer. “Physician usage of DANYELZA in the U.S. continues to remain very strong for patients with relapsed/refractory high-risk neuroblastoma. In addition, we continue to drive ex-U.S. market expansion with our new exclusive license and distribution agreement with Nobelpharma in Japan and the launch of our named patient program in Turkey. From a SADA PRIT pipeline standpoint, we expect to complete Part A of our GD2-SADA Phase 1 trial this year and present that data in the first quarter of next year.”
Third Quarter 2024 and Recent Corporate Highlights
- Effective October 29, 2024, Y-mAbs entered into an exclusive license and distribution agreement with Nobelpharma for the development and commercialization of DANYELZA in Japan. Pursuant to the agreement, the Company recognized an upfront payment of
$2.0 million in the fourth quarter of 2024. Y-mAbs is entitled to receive up to$31.0 million in product and commercial milestone payments in addition to profit sharing on the commercial sales of DANYELZA, if successfully approved and commercialized in Japan. - Y-mAbs received notification of the accepted patent extension for DANYELZA, US 9,315,585, through February 2034.
- The Company’s named patient program for DANYELZA launched in Turkey with partner TRPharm İlaç Sanayi Ticaret A.Ş. and TRPharm FZ-LLC.
- Y-mAbs presented new clinical and preclinical data from studies evaluating anti-GD2 therapy naxitamab and the Company’s first program from its Self-Assembly DisAssembly Radioimmunotherapy Technology Platform (“SADA PRIT”), GD2-SADA, respectively, in neuroblastoma in poster presentations at the American Academy of Cancer Research Special Conference in the Advanced in Pediatric Cancer Research on September 6-7, 2024 in Toronto, Canada.
- The Company entered into a lease agreement for a term of ten years and nine months for office space in Princeton, New Jersey, where the Company plans to transition its headquarters in the first half of 2025 upon being provided access to the location.
Financial Results
Revenues
Total net revenues for the quarter ended September 30, 2024 were
Total net revenues for the nine months ended September 30, 2024 were relatively flat compared to the nine months ended September 30, 2023, at
The Company’s U.S. DANYELZA net product revenues were
Y-mAbs’ ex-U.S. DANYELZA net product revenues for the quarter ended September 30, 2024 were
As of September 30, 2024, Y-mAbs had delivered DANYELZA to 68 centers across the U.S. since initial launch, with three new accounts added in the U.S. in the third quarter of 2024. During the quarter ended September 30, 2024, approximately
The Company did not have license revenue for the quarter ended September 30, 2024. The Company had license revenues of
Operating Costs and Expenses
Cost of Goods Sold
Cost of goods sold were
The Company defines gross margin as net product revenues less cost of goods sold divided by net product revenues. The Company’s gross margins was relatively unchanged in the quarter ended September 30, 2024, compared to the comparable periods in 2023. The Company’s gross margins increased in the nine months ended September 30, 2024, compared to the comparable period in 2023, due to a favorable gross profit mix from revenue in international regions, particularly Eastern Asia that had an inventory stocking order in the nine months ended September 30, 2024, and inventory write-downs during the comparable periods in 2023, as noted above.
Research and Development
Research and development expenses were
For the nine months ended September 30, 2024, research and development expenses were
Selling, General, and Administrative
Selling, general, and administrative expenses were
For the nine months ended September 30, 2024, selling, general, and administrative expenses were
Interest and Other Income
Interest and other income were
For the nine months ended September 30, 2024 and 2023, the interest and other income was
Net Loss
Y-mAbs reported a net loss for the quarter ended September 30, 2024, of
For the nine months ended September 30, 2024, the Company reported a net loss of
Cash and Cash Equivalents
As of September 30, 2024, Y-mAbs had approximately
2024 Financial Guidance
Management reiterates its full year 2024 guidance:
- Anticipated Total Net Revenues expected to be between
$87 million and$95 million ; - Anticipated Operating Expenses expected to remain between
$115 million and$120 million ; - Anticipated Total Annual Cash Investment expected to remain between
$15 million and$20 million ; and - Cash and Cash Equivalents anticipated to continue to support operations as currently planned into 2027.
Webcast and Conference Call
Y-mAbs will host a conference call on Friday, November 8, 2024, at 8:00 a.m. ET. To participate in the call, please use the following dial-in information:
Investors (domestic): (877) 407-0792
Investors (international): (201) 689-8263
To access 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”) Pretargeted 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 2024 and beyond, including estimated operating expenses, use of cash and cash equivalents and DANYELZA product revenue and sufficiency of cash resources and related assumptions; expectations with respect to the Company’s future financial performance; 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,” 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 restructuring plan and revised business plan 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, the state of war between Israel and Hamas and the related risk of a larger regional conflict, 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, 2023, and the Company’s Quarterly Report on Form 10-Q for the quarterly periods ended March 31, 2024, and September 30, 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.
Investor Contact:
Courtney Dugan
VP, Head of Investor Relations
cdu@ymabs.com
| Y-MABS THERAPEUTICS, INC. Consolidated Balance Sheets (unaudited) (In thousands, except share and per share data) | ||||||||
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 68,122 | $ | 78,637 | ||||
| Accounts receivable, net | 19,916 | 22,454 | ||||||
| Inventories | 9,557 | 5,065 | ||||||
| Other current assets | 1,462 | 4,955 | ||||||
| Total current assets | 99,057 | 111,111 | ||||||
| Property and equipment, net | 53 | 224 | ||||||
| Operating lease right-of-use assets | 1,075 | 1,412 | ||||||
| Intangible assets, net | 2,366 | 2,631 | ||||||
| Other assets | 18,366 | 12,491 | ||||||
| TOTAL ASSETS | $ | 120,917 | $ | 127,869 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| LIABILITIES | ||||||||
| Accounts payable | $ | 7,878 | $ | 6,060 | ||||
| Accrued liabilities | 16,638 | 13,166 | ||||||
| Operating lease liabilities, current portion | 776 | 902 | ||||||
| Total current liabilities | 25,292 | 20,128 | ||||||
| Accrued milestones | 2,000 | 5,375 | ||||||
| Operating lease liabilities, long-term portion | 299 | 517 | ||||||
| Other liabilities | 897 | 864 | ||||||
| TOTAL LIABILITIES | 28,488 | 26,884 | ||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 4 | 4 | ||||||
| Additional paid-in capital | 572,807 | 558,002 | ||||||
| Accumulated other comprehensive income | (36 | ) | 449 | |||||
| Accumulated deficit | (480,346 | ) | (457,470 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 92,429 | 100,985 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 120,917 | $ | 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 September 30, | Nine months ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| REVENUES | ||||||||||||||||
| Product revenue, net | $ | 18,461 | $ | 19,954 | $ | 60,690 | $ | 60,956 | ||||||||
| License revenue | — | 500 | 500 | 500 | ||||||||||||
| Total revenues | 18,461 | 20,454 | 61,190 | 61,456 | ||||||||||||
| OPERATING COSTS AND EXPENSES | ||||||||||||||||
| Cost of goods sold | 2,248 | 2,595 | 7,359 | 9,327 | ||||||||||||
| License royalties | — | 50 | 50 | 50 | ||||||||||||
| Research and development | 11,168 | 15,358 | 36,776 | 40,831 | ||||||||||||
| Selling, general, and administrative | 13,613 | 10,200 | 42,270 | 33,721 | ||||||||||||
| Total operating costs and expenses | 27,029 | 28,203 | 86,455 | 83,929 | ||||||||||||
| Loss from operations | (8,568 | ) | (7,749 | ) | (25,265 | ) | (22,473 | ) | ||||||||
| OTHER INCOME, NET | ||||||||||||||||
| Interest and other income | 1,916 | 189 | 2,995 | 2,400 | ||||||||||||
| LOSS BEFORE INCOME TAXES | (6,652 | ) | (7,560 | ) | (22,270 | ) | (20,073 | ) | ||||||||
| Provision for income taxes | 346 | 187 | 606 | 366 | ||||||||||||
| NET LOSS | $ | (6,998 | ) | $ | (7,747 | ) | $ | (22,876 | ) | $ | (20,439 | ) | ||||
| Other comprehensive income/(loss) | ||||||||||||||||
| Foreign currency translation | (1,083 | ) | 806 | (485 | ) | 518 | ||||||||||
| COMPREHENSIVE LOSS | $ | (8,081 | ) | $ | (6,941 | ) | $ | (23,361 | ) | $ | (19,921 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.16 | ) | $ | (0.18 | ) | $ | (0.52 | ) | $ | (0.47 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 44,626,943 | 43,620,532 | 44,145,183 | 43,651,536 | ||||||||||||
| Y-MABS THERAPEUTICS, INC. Consolidated Statements of Cash Flows (unaudited) (In thousands) | ||||||||||||||
| Nine months ended September 30, | ||||||||||||||
| 2024 | 2023 | |||||||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||||||||
| Net loss | $ | (22,876 | ) | $ | (20,439 | ) | ||||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||
| Depreciation and amortization | 433 | 574 | ||||||||||||
| Stock-based compensation | 11,480 | 11,330 | ||||||||||||
| Foreign currency and other transactions | (456 | ) | (369 | ) | ||||||||||
| Changes in assets and liabilities: | ||||||||||||||
| Accounts receivable, net | 2,538 | (6,343 | ) | |||||||||||
| Inventories | (4,492 | ) | (411 | ) | ||||||||||
| Other current assets | 3,493 | 2,671 | ||||||||||||
| Other assets | (5,875 | ) | (3,735 | ) | ||||||||||
| Accounts payable | 2,274 | (6,196 | ) | |||||||||||
| Accrued liabilities and other | (363 | ) | 3,722 | |||||||||||
| NET CASH USED IN OPERATING ACTIVITIES | (13,844 | ) | (19,196 | ) | ||||||||||
| CASH FLOWS FROM INVESTING ACTIVITIES | — | — | ||||||||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||||||||
| Proceeds from exercised stock options | 3,325 | — | ||||||||||||
| NET CASH PROVIDED BY FINANCING ACTIVITIES | 3,325 | — | ||||||||||||
| Effect of exchange rates on cash and cash equivalents | 4 | 5 | ||||||||||||
| NET DECREASE IN CASH AND CASH EQUIVALENTS | (10,515 | ) | (19,191 | ) | ||||||||||
| Cash and cash equivalents at the beginning of period | 78,637 | 105,762 | ||||||||||||
| Cash and cash equivalents at the end of period | $ | 68,122 | $ | 86,571 | ||||||||||
| 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
What were Y-mAbs (YMAB) Q3 2024 revenue results?
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What are the terms of Y-mAbs' deal with Nobelpharma for DANYELZA in Japan?
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