Y-mAbs Reports First Quarter 2024 Financial Results and Recent Corporate Developments
Y-mAbs reported U.S. DANYELZA® net product revenues of $18.6 million, an 11% YoY increase, while Worldwide DANYELZA net product revenues were $19.4 million, a 4% YoY decrease. Cash and cash equivalents stood at $75.7 million with a cash burn of $2.9 million. The Company reiterates full year 2024 financial guidance. First quarter marked highest U.S. demand for DANYELZA® since launch, with significant clinical advancements. Distribution partner initiated commercial launch in Latin America, abstracts to be presented at ASCO Annual Meeting. Financially, total net product revenues decreased by 4% YoY, with U.S. revenues increasing by 11%. Operating expenses and cash burn were within guidance, supporting operations into 2027.
Highest U.S. demand for DANYELZA® since launch
Significant clinical advancements with SADA PRIT Technology platform
Commercial launch in Latin America by distribution partner
4% YoY decrease in Worldwide DANYELZA net product revenues
17% decrease in DANYELZA total net product revenues compared to Q4 2023
Net loss of $(6.6) million for the quarter ended March 31, 2024
Insights
- Reported U.S. DANYELZA® net product revenues of $18.6 million for the first quarter of 2024, representing a YoY increase of
11% - Reported Worldwide DANYELZA net product revenues of
$19.4 million for the first quarter of 2024, representing a4% YoY decrease due to international volumes - Cash and cash equivalents of $75.7 million as of March 31, 2024, and cash burn of only
$2.9 million for the quarter ended March 31, 2024 - Management reiterates full year 2024 financial guidance and anticipated cash runway into 2027
- The Company will host a conference call on Wednesday, May 8, 2024, at 8:00 a.m. ET
NEW YORK, May 07, 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 first quarter ended March 31, 2024.
“We continued to make meaningful progress across our commercial and clinical development initiatives during the first quarter of this year,” said Mike Rossi, President and Chief Executive Officer. “On the commercial front, the first quarter of 2024 marked the highest quarter of U.S. demand for DANYELZA® (naxitamab-gqgk) since its initial launch. Our recorded net product revenues in the first quarter were primarily driven by heightened demand across both new and existing U.S. accounts. DANYELZA remains a leading anti-GD2 therapy, and we continue to believe in its potential to serve patients beyond the high-risk relapse/refractory neuroblastoma market. In addition, we are highly encouraged by the clinical advancement of our Self-Assembly DisAssembly (“SADA”) Pretargeted Radioimmunotherapy (“PRIT”) Technology platform. With the potential to deliver optimal therapy with minimal toxicity, increase physician participation in the patient treatment journey, and leverage existing infrastructure as a potentially isotope-agnostic platform, we believe SADA PRIT has the potential to make a positive and lasting impact on patient care.”
First Quarter 2024 and Recent Corporate Developments
- In April 2024, Y-mAbs’ distribution partner in Latin America, Adium, initiated the commercial launch of DANYELZA in Brazil and Mexico.
- On April 25, 2024, Y-mAbs announced several abstracts to be presented at the 2024 American Society of Clinical Oncology (“ASCO”) Annual Meeting taking place May 31 through June 4, 2024, in Chicago, IL. The Company will be available to comment at booth #35151 on the Exhibition Floor of McCormick Place.
- On March 8, 2024, Bo Kruse, Executive Vice President, Chief Financial Officer, Secretary and Treasurer of Y-mAbs informed the Company of his intention to resign from such offices effective as of the date the Company appoints his successor and such successor commences employment with the Company and to resign from employment with the Company effective July 31, 2024. A search firm has been retained to assist in the recruitment of a new Chief Financial Officer.
- On February 29, 2024, the Board of Directors of Y-mAbs increased the size of the Board from eight to nine directors and elected Mary A. Tagliaferri, M.D., to serve as a Class I director of the Company. Dr. Tagliaferri’s term as a Class I director continues until the Company’s 2025 annual meeting of stockholders.
Financial Results
Revenues
DANYELZA total net product revenues were
U.S. DANYELZA net product revenues increased
As of March 31, 2024, Y-mAbs has delivered DANYELZA to 63 centers across the U.S. since initial launch, with five new accounts added in the first quarter of 2024. During the quarter ended March 31, 2024, approximately
The Company had license revenues of
Operating Costs and Expenses
Cost of Goods Sold
Cost of goods sold was
The Company’s gross margin in the quarters ended March 31, 2024 and 2023 remained approximately constant at
Research and Development
Research and development expenses were
Selling, General, and Administration
Selling, general, and administrative expenses were
Interest and Other Income
Interest and other income was
Net Loss
Y-mAbs reported a net loss for the quarter ended March 31, 2024, of
Cash and Cash Equivalents
As of March 31, 2024, Y-mAbs had approximately
2024 Financial Guidance
Management reiterates its full year 2024 guidance:
- Anticipated total DANYELZA® net product revenues of between
$95 million and$100 million ; - Anticipated operating expenses of between
$115 million and$120 million ; - Anticipated total annual cash burn of 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 Wednesday, May 8, 2024, at 8:00 a.m. ET. To participate in the call, please use the following dial-in information:
| Investors (domestic): | (888) 999-5318 |
| Investors (international): | (848) 280-6460 |
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, cash burn and DANYELZA product revenue and sufficiency of cash resources and related assumptions; implied and express statements regarding the future of the Company’s business, including with respect to expansion and its goals; the Company’s plans and strategies, development, commercialization and product distribution plans; 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; statements with respect to the potential of SADA PRIT to deliver optimal therapy with reduced toxicity, increase physician participation in the patient treatment journey, leverage existing infrastructure as a potentially isotope-agnostic platform and make a meaningful and lasting impact to patient care; expectations relating to key anticipated development milestones, including potential expansion of international commercialization efforts with respect to DANYELZA development efforts and the SADA PRIT Technology, including potential indications and applications, 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 related to the timing of the initiation and completion of regulatory submissions; additional product candidates and technologies; expectations regarding collaborations or strategic partnerships and the potential benefits thereof; expectations related to the use of cash and cash equivalents, and the need for, timing and amount of any future financing transaction; expectations with respect to the Company’s future financial performance; 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,” 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 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; the risks related to the Company’s dependence on third parties including for conduct of clinical testing and product manufacture; the Company’s inability to enter into partnerships; the 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, the Company’s Quarterly Report on Form 10-Q for the quarter ended March 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.
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) | |||||||
| March 31, | December 31, | ||||||
| 2024 | 2023 | ||||||
| ASSETS | |||||||
| CURRENT ASSETS | |||||||
| Cash and cash equivalents | $ | 75,749 | $ | 78,637 | |||
| Accounts receivable, net | 20,588 | 22,454 | |||||
| Inventories | 8,448 | 5,065 | |||||
| Other current assets | 3,482 | 4,955 | |||||
| Total current assets | 108,267 | 111,111 | |||||
| Property and equipment, net | 153 | 224 | |||||
| Operating lease right-of-use assets | 1,179 | 1,412 | |||||
| Intangible assets, net | 2,543 | 2,631 | |||||
| Other assets | 11,173 | 12,491 | |||||
| TOTAL ASSETS | $ | 123,315 | $ | 127,869 | |||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
| LIABILITIES | |||||||
| Accounts payable | $ | 6,728 | $ | 6,060 | |||
| Accrued liabilities | 9,989 | 13,166 | |||||
| Operating lease liabilities, current portion | 888 | 902 | |||||
| Total current liabilities | 17,605 | 20,128 | |||||
| Accrued milestone and royalty payments | 5,375 | 5,375 | |||||
| Operating lease liabilities, long-term portion | 293 | 517 | |||||
| Other liabilities | 853 | 864 | |||||
| TOTAL LIABILITIES | 24,126 | 26,884 | |||||
| STOCKHOLDERS’ EQUITY | |||||||
| Preferred stock, | — | — | |||||
| Common stock, | 4 | 4 | |||||
| Additional paid-in capital | 562,436 | 558,002 | |||||
| Accumulated other comprehensive income | 848 | 449 | |||||
| Accumulated deficit | (464,099 | ) | (457,470 | ) | |||
| TOTAL STOCKHOLDERS’ EQUITY | 99,189 | 100,985 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 123,315 | $ | 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 March 31, | |||||||
| 2024 | 2023 | ||||||
| REVENUES | |||||||
| Product revenue, net | $ | 19,431 | $ | 20,251 | |||
| License revenue | 500 | — | |||||
| Total revenues | 19,931 | 20,251 | |||||
| OPERATING COSTS AND EXPENSES | |||||||
| Cost of goods sold | 2,097 | 2,083 | |||||
| License royalties | 50 | — | |||||
| Research and development | 13,267 | 13,418 | |||||
| Selling, general, and administrative | 11,425 | 12,251 | |||||
| Total operating costs and expenses | 26,839 | 27,752 | |||||
| Loss from operations | (6,908 | ) | (7,501 | ) | |||
| OTHER INCOME, NET | |||||||
| Interest and other income | 439 | 1,111 | |||||
| LOSS BEFORE INCOME TAXES | (6,469 | ) | (6,390 | ) | |||
| Provision for income taxes | 160 | — | |||||
| NET LOSS | $ | (6,629 | ) | $ | (6,390 | ) | |
| Other comprehensive income/(loss) | |||||||
| Foreign currency translation | 399 | (306 | ) | ||||
| COMPREHENSIVE LOSS | $ | (6,230 | ) | $ | (6,696 | ) | |
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.15 | ) | $ | (0.15 | ) | |
| Weighted average common shares outstanding, basic and diluted | 43,779,456 | 43,671,589 | |||||
| Y-MABS THERAPEUTICS, INC. | |||||||
| Consolidated Statements of Cash Flows | |||||||
| (unaudited) | |||||||
| (In thousands) | |||||||
| Three months ended March 31, | |||||||
| 2024 | 2023 | ||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | |||||||
| Net loss | $ | (6,629 | ) | $ | (6,390 | ) | |
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
| Depreciation and amortization | 159 | 182 | |||||
| Stock-based compensation | 3,846 | 5,304 | |||||
| Foreign currency and other transactions | 492 | (456 | ) | ||||
| Changes in assets and liabilities: | |||||||
| Accounts receivable, net | 1,866 | (6,171 | ) | ||||
| Inventories | (3,383 | ) | (2,243 | ) | |||
| Other current assets | 1,473 | 1,722 | |||||
| Other assets | 1,318 | (2,983 | ) | ||||
| Accounts payable | 176 | (4,771 | ) | ||||
| Accrued liabilities and other | (2,795 | ) | 2,682 | ||||
| NET CASH USED IN OPERATING ACTIVITIES | (3,477 | ) | (13,124 | ) | |||
| CASH FLOWS FROM INVESTING ACTIVITIES | — | — | |||||
| CASH FLOWS FROM FINANCING ACTIVITIES | |||||||
| Proceeds from exercised stock options | 588 | — | |||||
| NET CASH PROVIDED BY FINANCING ACTIVITIES | 588 | — | |||||
| Effect of exchange rates on cash and cash equivalents | 1 | (9 | ) | ||||
| NET DECREASE IN CASH AND CASH EQUIVALENTS | (2,888 | ) | (13,133 | ) | |||
| Cash and cash equivalents at the beginning of period | 78,637 | 105,762 | |||||
| Cash and cash equivalents at the end of period | $ | 75,749 | $ | 92,629 | |||
FAQ
What were the U.S. DANYELZA® net product revenues reported for the first quarter of 2024?
What were the Worldwide DANYELZA net product revenues reported for the first quarter of 2024?
What was the cash and cash equivalents amount as of March 31, 2024?
What was the cash burn for the quarter ended March 31, 2024?
When will Y-mAbs host a conference call to discuss the financial results?
