Y-mAbs Reports First Quarter 2023 Financial Results and Recent Corporate Developments and Updates 2023 Financial Guidance
- Q1 2023 DANYELZA® record net product revenues of
$20.3 million , driving YoY growth of93% and a24% sequential increase compared to Q4 2022 - Management updates 2023 financial guidance, now anticipating higher DANYELZA net revenues of
$80 -85 million and lower cash burn of$40 -50 million for FY 2023 - Ongoing patient recruitment in the Phase I SADA trial
- Cash and cash equivalents of
$92.6 million as of March 31, 2023, anticipated cash runway into the first quarter 2026 - The Company will host a conference call on Tuesday, May 9, 2023, at 9 a.m. EST
NEW YORK, May 08, 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 first quarter of 2023.
"The first quarter of 2023 marked a period of significant progress for DANYELZA and we believe has set up 2023 to be a very productive year. We are thrilled to report record DANYELZA net revenues of
First Quarter 2023 and Recent Corporate Developments
- On April 18, 2023, Y-mAbs announced that positive preclinical data on naxitamab in triple-negative breast cancer was presented at the AACR Annual Meeting
- On April 5, 2023, Y-mAbs announced that the first patient had been dosed in the Phase 1 trial of GD2-SADA
- 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.
Financial Results
Revenues
Y-mAbs reported DANYELZA net product revenues of
As of March 31, 2023, Y-mAbs has delivered DANYELZA to 53 centers across the United States, corresponding to a sequential increase of
Operating Expenses
Research and Development
Research and development expenses were
Selling, General, and Administration
Selling, general, and administrative expenses decreased by
Net Loss
We reported a net loss for the first quarter ended March 31, 2023, of (
Cash and Cash Equivalents
We had approximately
Financial Guidance
We are updating our full-year 2023 financial guidance, which now reflects:
- Anticipated DANYELZA® net product revenues now expected to be
$80 -85 million (previously$60 -65 million); - Anticipated operating expenses continues to be expected to be
$115 -120 million; - Anticipated total annual cash burn now expected to be
$40 -50 million (previously$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 Tuesday, May 9, 2023, at 9 a.m. Eastern Time. To participate in the call, please use the following dial-in information.
Investors (domestic): | 888-886-7786 |
Investors (international): | 416-764-8658 |
Conference ID: | 09065062 |
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 and beyond, 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 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’’, “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 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 macroeconomic conditions, including the conflict between Russia and Ukraine and sanctions related thereto, 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 ending December 31, 2022, and future filings and reports by the Company including the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023. 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) | |||||||
As of | As of | ||||||
March 31, | December 31, | ||||||
2023 | 2022 | ||||||
ASSETS | |||||||
CURRENT ASSETS | |||||||
Cash and cash equivalents | $ | 92,629 | $ | 105,762 | |||
Accounts receivable, net | 18,702 | 12,531 | |||||
Inventories | 8,945 | 6,702 | |||||
Other current assets | 3,730 | 5,452 | |||||
Total current assets | 124,006 | 130,447 | |||||
Property and equipment, net | 511 | 604 | |||||
Operating lease right-of-use assets | 1,369 | 1,739 | |||||
Intangible assets, net | 2,898 | 2,986 | |||||
Other assets | 8,661 | 5,680 | |||||
TOTAL ASSETS | $ | 137,445 | $ | 141,456 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
LIABILITIES | |||||||
Accounts payable | $ | 8,843 | $ | 14,175 | |||
Accrued liabilities | 16,222 | 13,241 | |||||
Operating lease liabilities, current portion | 855 | 868 | |||||
Total current liabilities | 25,920 | 28,284 | |||||
Accrued milestone and royalty payments | 2,250 | 2,250 | |||||
Operating lease liabilities, long-term portion | 629 | 899 | |||||
Other liabilities | 817 | 802 | |||||
TOTAL LIABILITIES | 29,616 | 32,235 | |||||
STOCKHOLDERS’ EQUITY | |||||||
Preferred stock, | - | - | |||||
Common stock, | 4 | 4 | |||||
Additional paid in capital | 549,233 | 543,929 | |||||
Accumulated other comprehensive income | 1,025 | 1,331 | |||||
Accumulated deficit | (442,433 | ) | (436,043 | ) | |||
TOTAL STOCKHOLDERS’ EQUITY | 107,829 | 109,221 | |||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 137,445 | $ | 141,456 | |||
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, | ||||||||
2023 | 2022 | |||||||
REVENUES | ||||||||
Product revenue, net | $ | 20,251 | $ | 10,486 | ||||
Total revenues | 20,251 | 10,486 | ||||||
OPERATING COSTS AND EXPENSES | ||||||||
Cost of goods sold | 2,083 | 1,831 | ||||||
Research and development | 13,418 | 22,912 | ||||||
Selling, general, and administrative | 12,251 | 13,438 | ||||||
Total operating costs and expenses | 27,752 | 38,181 | ||||||
Loss from operations | (7,501 | ) | (27,695 | ) | ||||
OTHER INCOME / (LOSS), NET | ||||||||
Interest and other income / (loss) | 1,111 | (373 | ) | |||||
NET LOSS | $ | (6,390 | ) | $ | (28,068 | ) | ||
Other comprehensive income / (loss) | ||||||||
Foreign currency translation | (306 | ) | 311 | |||||
COMPREHENSIVE LOSS | $ | (6,696 | ) | $ | (27,757 | ) | ||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.15 | ) | $ | (0.64 | ) | ||
Weighted average common shares outstanding, basic and diluted | 43,671,589 | 43,709,238 | ||||||