Y-mAbs Reports Fourth Quarter and Full-Year 2022 Financial Results and Recent Corporate Developments
Y-mAbs Therapeutics reported record net product revenues of $16.4 million for Q4 2022, reflecting a 71% year-over-year increase and a 31% sequential rise from Q3 2022. The fourth quarter also saw net revenues of $31.5 million, an 87% increase for the year totaling $65.3 million. The company secured conditional marketing authorization for DANYELZA in China, with plans for a launch in H1 2023. Cash and cash equivalents stood at $105.8 million as of December 31, 2022, anticipated to last until Q1 2026. Guidance for 2023 includes expected DANYELZA revenues of $60-$65 million and operating expenses of $115-$120 million.
- Record DANYELZA net product revenues of $16.4 million in Q4 2022, a 71% YoY increase.
- Conditional marketing authorization granted in China, with a planned launch in H1 2023.
- Cash reserves of $105.8 million expected to support operations into Q1 2026.
- Net loss for the year ended December 31, 2022, increased to $95.6 million from a loss of $55.3 million in 2021.
- Uncertainty in achieving projected revenue growth, reliant on DANYELZA's performance.
- Q4 2022 DANYELZA® record net product revenues of
$16.4 million , driving YoY growth of71% and31% sequential increase compared to Q3 2022 - DANYELZA conditional marketing authorization granted in China
- Management reiterates 2023 financial guidance
- First ever SADA Phase I trial opened
- Cash and cash equivalents of
$105.8 million as of December 31, 2022, anticipated runway into the first quarter 2026 - The Company will host a conference call on Friday, March 31, 2023, at 9 a.m. EST
NEW YORK, March 30, 2023 (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, antibody-based therapeutic products for the treatment of cancer, today reported financial results for the fourth quarter and full year 2022.
“The fourth quarter of 2022 marked another period of significant progress for DANYELZA and set up 2023 to be a very productive year,” said Thomas Gad, President and Interim Chief Executive Officer. “We are thrilled to report record DANYELZA net revenues of
Mr. Gad continued, “We recently implemented a restructuring plan to prioritize resources on the DANYELZA franchise and development of our SADA technology in the fight against cancer. With a
Fourth Quarter 2022 and Recent Corporate Developments
- On February 2, 2023, Y-mAbs announced that the European Medicines Agency agreed to the Company’s Pediatric Investigational Plan for naxitamab
- On January 4, 2023, Y-mAbs announced a restructuring plan including a
35% reduction in workforce and an anticipated28% reduction in annual operating expenses for 2023 - On December 21, 2022, Y-mAbs announced a partnership with WEP Clinical regarding early access program for DANYELZA (naxitamab-gqgk) in Europe
- On December 14, 2022, Y-mAbs announced a new SADA construct, CD38-SADA against non-Hodgkin’s Lymphoma
- On December 8, 2022, Y-mAbs announced that DANYELZA (naxitamab-gqgk) for the treatment of high-risk neuroblastoma was conditionally approved in China
- On December 1, 2022, Y-mAbs announced that the Company had received a complete response letter for omburtamab BLA indicating that the FDA determined that it was unable to approve the BLA in its current form
- On November 17, 2022, Y-mAbs activated its first ever SADA Phase I trial site and by March 11 Memorial Sloan Kettering was activated as the fourth clinical study site planned to enroll Small Cell Lung Cancer, Sarcoma and Melanoma patients
- On October 28, 2022, Y-mAbs announced the outcome of the FDA Oncologic Drugs Advisory Committee meeting, where the committee voted 16 to 0 that the Company had not provided sufficient evidence to conclude that omburtamab improves overall survival
- On October 3, 2022 Y-mAbs announced pivotal data from Study 101 for omburtamab in CNS/LM metastasis from neuroblastoma at the International Society of Pediatric Oncology (“SIOP”) annual congress
Financial Results
Revenues
Y-mAbs reported net revenues of
DANYELZA net product revenue for the fourth quarter of 2022 and year ended December 31, 2022, was
As of December 31, 2022, Y-mAbs has delivered DANYELZA to 48 centers across the United States, corresponding to an increase of
Operating Expenses
Research and Development
Research and development expenses were
Research and development expenses decreased by
Selling, General, and Administration
Selling, general, and administrative expenses decreased by
Selling, general, and administrative expenses increased by
Net Loss
We reported net income for the fourth quarter ended December 31, 2022, of
We reported a net loss for the year ended December 31, 2022, of
Cash and Cash Equivalents
We had approximately
This estimate reflects our current business plan that is supported by assumptions that may prove to be inaccurate, such that we could use our available capital resources sooner than we currently expect.
Financial Guidance
Management reiterated its 2023 financial guidance including:
- Anticipated DANYELZA® net product revenues of
$60 -$65 million ; - Anticipated operating expenses of
$115 -120 million; - Anticipated total annual cash burn of
$50 -55 million; and - Cash and cash equivalents anticipated to support operations as currently planned into the first quarter of 2026.
Webcast and Conference Call
Y-mAbs will host a conference call on Friday, March 31, 2023, at 9 a.m. Eastern Time. To participate in the call, please use the following dial-in information.
Investors (domestic): | 877-407-0792 |
Investors (international): | 201-689-8263 |
Conference ID: | 13736579 |
To access a live webcast of the update, please use this link.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic cancer products. In addition to conventional antibodies, the Company’s technologies include bispecific antibodies generated using the Y-BiClone platform and the SADA platform. The Company’s broad and advanced product pipeline includes one FDA-approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one product candidate at the registration stage, OMBLASTYS® (omburtamab), which targets tumors that express B7-H3.
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 2023, including estimated operating expenses, total cash burn and DANYELZA product revenue and sufficiency of cash resources; the restructuring, including the reduction in workforce and revised business plan, and the expected impacts, expenses and benefits thereof, including potential cost-savings from the reduction in force, expected reduction of operating expenses and any expectations with respect to cost savings to be derived therefrom; implied and express statements regarding the future of the Company’s business; the Company’s plans and strategies, development, commercialization and product distribution plans; expectations with respect to omburtamab; expectations with respect to our 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 Technology, including the development of the first tumor binding dataset and potential benefits thereof; expectations relating to key anticipated development milestones, including potential expansion of international commercialization efforts with respect to DANYELZA development efforts and the SADA Technology, including potential indications and potential application to [a broad set of][all] GD2 positive solid tumors, and the timing thereof; expectations with respect to current and future clinical and pre-clinical studies and our research and development programs; expectations related to the timing of the initiation and completion of regulatory submissions; regulatory, marketing and reimbursement approvals; including satisfaction of conditions to approvals; 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” 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 our financial condition and need for additional capital; the risks that actual results of our restructuring plan and revised business plan will not be as expected; risks associated with our development work; cost and success of our product development activities and clinical trials; the risks of delay in the timing of our regulatory submissions or failure to receive approval of our drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of our product candidates; development of our sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for our products; the risks related to our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; the risks related to government regulation; risks related to market approval, risks associated with protection of our intellectual property rights; risks related to employee matters and managing growth; risks related to our common stock, risks associated with the COVID-19 pandemic; risks associated with the conflict between Russia and Ukraine and sanctions related thereto; including inflation and uncertain global credit and capital markets; and other risks and uncertainties affecting the Company including those described in the “Risk Factors” section included in the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2022, and future filings and reports by the Company including the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. 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®, OMBLASTYS® and Y-mAbs® are registered trademarks of Y-mAbs Therapeutics, Inc.
Contact:
Y-mAbs Therapeutics, Inc.
230 Park Avenue, Suite 3350
New York, NY 10169
USA
+1 646 885 8505
E-mail: info@ymabs.com
Y-MABS THERAPEUTICS, INC. | |||||||
Consolidated Balance Sheets | |||||||
(unaudited) | |||||||
(In thousands, except share and per share data) | |||||||
December 31, | December 31, | ||||||
2022 | 2021 | ||||||
ASSETS | |||||||
CURRENT ASSETS | |||||||
Cash and cash equivalents | $ | 105,762 | $ | 181,564 | |||
Accounts receivable, net | 12,531 | 7,712 | |||||
Inventories | 6,702 | 5,512 | |||||
Other current assets | 5,452 | 7,473 | |||||
Total current assets | 130,447 | 202,261 | |||||
Property and equipment, net | 604 | 1,847 | |||||
Operating lease right-of-use assets | 1,739 | 3,842 | |||||
Intangible assets, net | 2,986 | 1,663 | |||||
Other assets | 5,680 | 3,170 | |||||
TOTAL ASSETS | $ | 141,456 | $ | 212,783 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
LIABILITIES | |||||||
Accounts payable | $ | 14,175 | $ | 13,552 | |||
Accrued liabilities | 13,241 | 12,540 | |||||
Operating lease liabilities, current portion | 868 | 1,783 | |||||
Total current liabilities | 28,284 | 27,875 | |||||
Accrued milestones | 2,250 | 2,100 | |||||
Operating lease liabilities, long-term portion | 899 | 1,851 | |||||
Other liabilities | 802 | 851 | |||||
TOTAL LIABILITIES | 32,235 | 32,677 | |||||
STOCKHOLDERS’ EQUITY | |||||||
Preferred stock, | — | — | |||||
Common stock, | 4 | 4 | |||||
Additional paid in capital | 543,929 | 519,206 | |||||
Accumulated other comprehensive income | 1,331 | 1,371 | |||||
Accumulated deficit | (436,043 | ) | (340,475 | ) | |||
TOTAL STOCKHOLDERS’ EQUITY | 109,221 | 180,106 | |||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 141,456 | $ | 212,783 |
Y-MABS THERAPEUTICS, INC. | |||||||||||||||
Consolidated Statements of Net Loss and Comprehensive Loss | |||||||||||||||
(unaudited) | |||||||||||||||
(In thousands, except share and per share data) | |||||||||||||||
Three months ended December 31, | Years ended December 31, | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
REVENUES | |||||||||||||||
Product revenue, net | $ | 16,447 | $ | 9,598 | $ | 49,267 | $ | 32,897 | |||||||
License revenue | 15,000 | — | 16,000 | 2,000 | |||||||||||
Total revenues | 31,447 | 9,598 | 65,267 | 34,897 | |||||||||||
OPERATING COSTS AND EXPENSES | |||||||||||||||
Cost of goods sold | 2,020 | 1,461 | 7,467 | 2,304 | |||||||||||
License royalties | — | — | 100 | 210 | |||||||||||
Research and development | 19,787 | 28,757 | 91,572 | 93,245 | |||||||||||
Selling, general, and administrative | 10,793 | 15,138 | 60,939 | 54,571 | |||||||||||
Total operating costs and expenses | 32,600 | 45,356 | 160,078 | 150,330 | |||||||||||
Loss from operations | (1,153 | ) | (35,758 | ) | (94,811 | ) | (115,433 | ) | |||||||
OTHER INCOME / (LOSS), NET | |||||||||||||||
Gain from sale of priority review voucher, net | — | — | — | 62,010 | |||||||||||
Interest and other income/(loss), net | 2,310 | (1,135 | ) | (757 | ) | (1,852 | ) | ||||||||
NET INCOME/(LOSS) | $ | 1,157 | $ | (36,893 | ) | $ | (95,568 | ) | $ | (55,275 | ) | ||||
Other comprehensive income | |||||||||||||||
Foreign currency translation | (3,371 | ) | 1,146 | (40 | ) | 1,897 | |||||||||
COMPREHENSIVE LOSS | $ | (2,214 | ) | $ | (35,747 | ) | $ | (95,608 | ) | $ | (53,378 | ) | |||
Net income/(loss) per share attributable to common stockholders, basic | $ | 0.03 | $ | (0.84 | ) | $ | (2.19 | ) | $ | (1.28 | ) | ||||
Weighted average common shares outstanding, basic | 43,668,690 | 43,664,277 | 43,703,663 | 43,181,808 | |||||||||||
Net income / (loss) per share attributable to common stockholders, diluted | $ | 0.03 | $ | (0.84 | ) | $ | (2.19 | ) | $ | (1.28 | ) | ||||
Weighted average common shares outstanding, diluted | 44,692,485 | 43,664,277 | 43,703,663 | 43,181,808 |
FAQ
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