Y-mAbs Reports Second Quarter 2024 Financial Results and Recent Corporate Developments
- Reported Total DANYELZA Net Product Revenues of
$22.8 million for the second quarter of 2024, representing a 10% YoY increase - Continued geographic expansion of DANYELZA with new market revenues recorded in the second quarter from
Brazil andMexico ; DANYELZA now approved inHong Kong - Part A of Phase 1 GD2-SADA Trial from novel SADA-PRIT radiotherapy platform expected to be completed in the fourth quarter of 2024
- Appointed
Peter Pfreundschuh as the new Chief Financial Officer and radiopharma industry veteranNorman LaFrance , M.D. as Chief Development Officer - Cash and cash equivalents of
$77.8 million held as ofJune 30, 2024 , reflects$0.8 million cash burn in the six months endedJune 30, 2024 ; management reiterates anticipated cash runway into 2027 - Management updates Full Year 2024 Total Net Revenue guidance
- The Company will host a conference call on
Monday, August 12, 2024 , at 8:00 a.m. ET
“We demonstrated commercial progress with DANYELZA in the second quarter of this year while continuing to advance our development pipeline,” said
Second Quarter 2024 and Recent Corporate Highlights
- Appointed
Peter Pfreundschuh as Chief Financial Officer and deepened radiopharmaceutical expertise with the appointment ofNorman LaFrance , M.D. as Chief Development Officer. - Y-mAbs’ distribution partner in
Latin America , Adium, initiated the commercial launch of DANYELZA inBrazil andMexico . - Entered into a distribution agreement with TRPharm İlaç Sanayi Ticaret A.Ş. and
TRPharm FZ-LLC for the named patient program distribution of DANYELZA inTurkey . - Received marketing authorization approval for DANYELZA in
Hong Kong . Y-mAbs’ Asian distribution partner, SciClone Pharmaceuticals, is expected to initiate the commercial launch of DANYELZA inHong Kong this year. - Presented preclinical GD2-SADA data at the
Society of Nuclear Medicine & Molecular Imaging 2024 annual Meeting onJune 8-11, 2024 , inToronto, Canada . - Highlighted new interim analysis of Phase 2 data for naxitamab in several poster presentations and preclinical GD2-SADA data at the 2024
American Society of Clinical Oncology (“ASCO”) Annual Meeting onMay 31-June 4, 2024 , inChicago, IL.
Financial Results
Revenues
Total net product revenues were
DANYELZA total net product revenues of
The Company’s total net product revenue was
As of
The Company did not have license revenue for the quarters ended
Operating Costs and Expenses
Cost of Goods Sold
Cost of goods sold was
Research and Development
Research and development expenses were
Selling, General, and Administration
Selling, general, and administrative expenses were
For the six months ended
Interest and Other Income
Interest and other income were
For the six months ended
Net Loss
Y-mAbs reported a net loss for the three months ended
Cash and Cash Equivalents
As of
2024 Financial Guidance
Management updates its full year 2024 guidance:
- Anticipated Total Net Revenues now 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 Burn 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 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; the Company’s mission of delivering better and safer therapies to patients; 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 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,” “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 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 ability 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
DANYELZA® and Y-mAbs® are registered trademarks of Y-mAbs Therapeutics, Inc.
Investor Contact:
VP, Head of Investor Relations
[email protected]
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 | $ | 77,806 | $ | 78,637 | |||
Accounts receivable, net | 22,191 | 22,454 | |||||
Inventories | 8,498 | 5,065 | |||||
Insurance recovery receivable related to legal settlement | 16,025 | — | |||||
Other current assets | 2,243 | 4,955 | |||||
Total current assets | 126,763 | 111,111 | |||||
Property and equipment, net | 87 | 224 | |||||
Operating lease right-of-use assets | 1,271 | 1,412 | |||||
Intangible assets, net | 2,454 | 2,631 | |||||
Other assets | 13,460 | 12,491 | |||||
TOTAL ASSETS | $ | 144,035 | $ | 127,869 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
LIABILITIES | |||||||
Accounts payable | $ | 10,190 | $ | 6,060 | |||
Accrued liabilities | 12,788 | 13,166 | |||||
Accrued legal settlement | 19,650 | — | |||||
Operating lease liabilities, current portion | 842 | 902 | |||||
Total current liabilities | 43,470 | 20,128 | |||||
Accrued milestone and royalty payments | 3,950 | 5,375 | |||||
Operating lease liabilities, long-term portion | 432 | 517 | |||||
Other liabilities | 847 | 864 | |||||
TOTAL LIABILITIES | 48,699 | 26,884 | |||||
STOCKHOLDERS’ EQUITY | |||||||
Preferred stock, |
— | — | |||||
Common stock, |
4 | 4 | |||||
Additional paid-in capital | 567,633 | 558,002 | |||||
Accumulated other comprehensive income | 1,047 | 449 | |||||
Accumulated deficit | (473,348 | ) | (457,470 | ) | |||
TOTAL STOCKHOLDERS’ EQUITY | 95,336 | 100,985 | |||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 144,035 | $ | 127,869 | |||
Consolidated Statements of Net Loss and Comprehensive Loss | |||||||||||||||
(unaudited) | |||||||||||||||
(In thousands, except share and per share data) | |||||||||||||||
Three months ended |
Six months ended |
||||||||||||||
2024 |
2023 |
2024 |
2023 |
||||||||||||
REVENUES | |||||||||||||||
Product revenue, net | $ | 22,798 | $ | 20,751 | $ | 42,229 | $ | 41,002 | |||||||
License revenue | — | — | 500 | — | |||||||||||
Total revenues | 22,798 | 20,751 | 42,729 | 41,002 | |||||||||||
OPERATING COSTS AND EXPENSES | |||||||||||||||
Cost of goods sold | 3,014 | 4,649 | 5,111 | 6,732 | |||||||||||
License royalties | — | — | 50 | — | |||||||||||
Research and development | 12,341 | 12,055 | 25,608 | 25,473 | |||||||||||
Selling, general, and administrative | 17,232 | 11,270 | 28,657 | 23,521 | |||||||||||
Total operating costs and expenses | 32,587 | 27,974 | 59,426 | 55,726 | |||||||||||
Loss from operations | (9,789 | ) | (7,223 | ) | (16,697 | ) | (14,724 | ) | |||||||
OTHER INCOME, NET | |||||||||||||||
Interest and other income | 640 | 1,100 | 1,079 | 2,211 | |||||||||||
LOSS BEFORE INCOME TAXES | (9,149 | ) | (6,123 | ) | (15,618 | ) | (12,513 | ) | |||||||
Provision for income taxes | 100 | 179 | 260 | 179 | |||||||||||
NET LOSS | $ | (9,249 | ) | $ | (6,302 | ) | $ | (15,878 | ) | $ | (12,692 | ) | |||
Other comprehensive income/(loss) | |||||||||||||||
Foreign currency translation | 199 | 18 | 598 | (288 | ) | ||||||||||
COMPREHENSIVE LOSS | $ | (9,050 | ) | $ | (6,284 | ) | $ | (15,280 | ) | $ | (12,980 | ) | |||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.21 | ) | $ | (0.14 | ) | $ | (0.36 | ) | $ | (0.29 | ) | |||
Weighted average common shares outstanding, basic and diluted | 44,022,356 | 43,663,112 | 43,900,639 | 43,667,385 | |||||||||||
Consolidated Statements of Cash Flows | |||||||
(unaudited) | |||||||
(In thousands) | |||||||
Six months ended |
|||||||
2024 |
2023 |
||||||
CASH FLOWS FROM OPERATING ACTIVITIES | |||||||
Net loss | $ | (15,878 | ) | $ | (12,692 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization | 312 | 406 | |||||
Stock-based compensation | 7,285 | 8,920 | |||||
Foreign currency and other transactions | 724 | (774 | ) | ||||
Changes in assets and liabilities: | |||||||
Accounts receivable, net | 263 | (6,587 | ) | ||||
Inventories | (3,433 | ) | 1,515 | ||||
Insurance recovery receivable related to legal settlement | (16,025 | ) | — | ||||
Other current assets | 2,712 | 1,402 | |||||
Other assets | (969 | ) | (6,570 | ) | |||
Accounts payable | 3,406 | (6,149 | ) | ||||
Accrued liabilities and other | (1,226 | ) | 2,671 | ||||
Accrued legal settlement | 19,650 | — | |||||
(3,179 | ) | (17,858 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES | — | — | |||||
CASH FLOWS FROM FINANCING ACTIVITIES | |||||||
Proceeds from exercised stock options | 2,346 | — | |||||
NET CASH PROVIDED BY FINANCING ACTIVITIES | 2,346 | — | |||||
Effect of exchange rates on cash and cash equivalents | 2 | 5 | |||||
(831 | ) | (17,853 | ) | ||||
Cash and cash equivalents at the beginning of period | 78,637 | 105,762 | |||||
Cash and cash equivalents at the end of period | $ | 77,806 | $ | 87,909 | |||
SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES | |||||||
Right-of-use assets obtained in exchange for lease obligations | $ | 320 | $ | — | |||
Acquisition of treasury shares upon repayment of secured promissory note | $ | — | $ | 480 | |||
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Source: Y-mAbs Therapeutics, Inc.