UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On May 7, 2024, Y-mAbs Therapeutics, Inc., announced its financial results for the quarter ended March 31, 2024. A copy of the press release is attached hereto as Exhibit 99.1.
The information furnished pursuant to Item 2.02 on this Form 8-K, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
| Description |
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99.1 |
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104 |
| Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Y-MABS THERAPEUTICS, INC. | |
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Date: May 7, 2024 | By: | /s/ Michael Rossi |
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| Michael Rossi |
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| President and Chief Executive Officer |
Exhibit 99.1
Y-mAbs Reports First Quarter 2024 Financial Results and Recent Corporate Developments
| ● | 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 a 4% 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, NY, May 7, 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 $19.4 million for the quarter ended March 31, 2024, which represented a decrease of 4% over $20.3 million in the comparable period of 2023. Y-mAbs’ U.S. DANYELZA net product revenues were $18.6 million for the quarter ended March 31, 2024, an increase of 11% over $16.8 million in the comparable period of 2023. The Company had international DANYELZA net product revenues of $0.8 million and $3.4 million in the quarters ended March 31, 2024 and 2023, respectively. The decrease in the quarter ended March 31, 2024, compared to the quarter ended March 31, 2023, was a result of a 2023 initial product stocking shipment of $2.5 million to Y-mAbs’ distribution partner, WEP, in connection with an early access program for DANYELZA in Europe. The Company did not have a shipment to WEP in the quarter ended March 31, 2024. Volumes for international shipments can vary from quarter to quarter, and the Company expects a higher volume to resume in future quarters in 2024.
U.S. DANYELZA net product revenues increased 3% compared to the quarter ended December 31, 2023, when excluding the $0.3 million and $1.3 million impact of a Medicaid accrual change in estimate recognized as increases in net product revenues in the quarters ended March 31, 2024 and December 31, 2023, respectively. DANYELZA total net product revenues of $19.4 million in the first quarter of 2024, represented a 17% decrease compared to the fourth quarter of 2023, primarily driven by decreased international revenues.
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 60% of the vials sold in the U.S. were sold outside of Memorial Sloan Kettering Cancer Center (“MSK”), compared to 55% in the fourth quarter ended December 31, 2023.
The Company had license revenues of $0.5 million for the quarter ended March 31, 2024. License revenue for the quarter ended March 31, 2024 arose from the January 2024 acceptance of the Brazilian Medicines Market Regulation Chamber (“CMED”) price for DANYELZA. The Company did not have license revenue for the quarter ended March 31, 2023.
Operating Costs and Expenses
Cost of Goods Sold
Cost of goods sold was $2.1 million for the quarters ended March 31, 2024 and 2023, respectively.
The Company’s gross margin in the quarters ended March 31, 2024 and 2023 remained approximately constant at 89% and 90%, respectively. The Company defines gross margin as net product revenues less cost of goods sold divided by net product revenues.
Research and Development
Research and development expenses were $13.3 million for the quarter ended March 31, 2024, a decrease of 1% compared to $13.4 million for the quarter ended March 31, 2023. The $0.1 million decrease was mainly due to decreased personnel related costs of $2.6 million, inclusive of the impact of the Company’s restructuring charge recorded in the quarter ended March 31, 2023, partially offset by a $2.5 million increase in clinical trial expenses related to the Company’s investments in SADA PRIT Technology in 2024.
Selling, General, and Administration
Selling, general, and administrative expenses were $11.4 million for the quarter ended March 31, 2024, which was a $0.8 million decrease compared to $12.2 million for the quarter ended March 31, 2023. The $0.8 million decrease in selling, general, and administrative expenses was primarily attributable to a decrease in personnel related costs related to the Company’s $1.1 million restructuring charge recorded in the quarter ended March 31, 2023.
Interest and Other Income
Interest and other income was $0.4 million for the quarter ended March 31, 2024, as compared to $1.1 million for the quarter ended March 31, 2023. The decrease of $0.7 million was primarily due to a $0.6 million decrease in foreign currency transaction income.
Net Loss
Y-mAbs reported a net loss for the quarter ended March 31, 2024, of $(6.6) million, or $(0.15) per basic and diluted share, which was relatively flat compared to net loss of $(6.4) million, or $(0.15) per basic and diluted share, for the quarter ended March 31, 2023.
Cash and Cash Equivalents
As of March 31, 2024, Y-mAbs had approximately $75.7 million in cash and cash equivalents which, together with anticipated DANYELZA product revenues, is expected to support operations as currently planned into 2027. This estimate reflects the Company’s current business plan that is supported by assumptions that may prove to be inaccurate, such that Y-mAbs could use its available capital resources sooner than it currently expects. The cash burn for the first quarter of 2024 was $2.9 million.
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
Y-MABS THERAPEUTICS, INC.
Consolidated Balance Sheets
(unaudited)
(In thousands, except share and per share data)
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| March 31, |
| December 31, |
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| | 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 | |
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STOCKHOLDERS’ EQUITY | | | | | | | |
Preferred stock, $0.0001 par value, 5,500,000 shares authorized and none issued at March 31, 2024 and December 31, 2023 | | | — | | | — | |
Common stock, $0.0001 par value, 100,000,000 shares authorized at March 31, 2024 and December 31, 2023; 43,852,638 and 43,672,112 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | | | 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, | | ||||
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| 2024 |
| 2023 |
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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, | | ||||
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| 2024 |
| 2023 |
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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 | |