Y-mAbs Reports Third Quarter 2024 Financial Results and Recent Corporate Developments
YMAB 11.08.2024
- 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 inJapan recognizing an upfront payment of$2.0 million in the fourth quarter of 2024 - Achieved extension of primary DANYELZA
U.S. patent throughFebruary 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
“The third quarter of this year was one of continued focus and execution across our DANYELZA commercial business and our novel
Third Quarter 2024 and Recent Corporate Highlights
- Effective
October 29, 2024 , Y-mAbs entered into an exclusive license and distribution agreement withNobelpharma for the development and commercialization of DANYELZA inJapan . 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 inJapan . - 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. andTRPharm 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 inPediatric Cancer Research onSeptember 6-7, 2024 inToronto, 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
Total net revenues for the nine months ended
The Company’s
Y-mAbs’ ex-
As of
The Company did not have license revenue for the quarter ended
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
Research and Development
Research and development expenses were
For the nine months ended
Selling, General, and Administrative
Selling, general, and administrative expenses were
For the nine months ended
Interest and Other Income
Interest and other income were
For the nine months ended
Net Loss
Y-mAbs reported a net loss for the quarter ended
For the nine months ended
Cash and Cash Equivalents
As of
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
Investors (domestic): (877) 407-0792
Investors (international): (201) 689-8263
To access the live webcast, please use thislink. 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
DANYELZA® and Y-mAbs® are registered trademarks of
Investor Contact:
| Y-MABS THERAPEUTICS, INC.Consolidated Balance Sheets(unaudited)(In thousands, except share and per share data) | ||||||||
| 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 | ||||
| Three months ended | Nine months ended | |||||||||||||||
| 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 | ||||||||||||
| Nine months ended | ||||||||||||||
| 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 | |||||||||||
| (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 | ||||||||||||
| (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 | ||||||||||
Source: Y-mAbs Therapeutics, Inc.