Y-mAbs Announces First Quarter Financial Results and Recent Corporate Developments
Y-mAbs Therapeutics reported a 9% sequential revenue increase to $10.5 million for Q1 2022, driven by DANYELZA® sales. The Company anticipates full-year DANYELZA revenues between $45 million and $50 million. Y-mAbs maintains a solid cash position with $156.7 million as of March 31, 2022, expected to fund operations through mid-2024. However, the Company posted a net loss of $28.1 million for the quarter, a decline from net income of $33.4 million in Q1 2021, primarily due to a one-time gain from a prior sale.
- Revenue increased 94% year-over-year to $10.5 million.
- Strong DANYELZA sales performance with guidance of $45-$50 million for 2022.
- Cash reserves of $156.7 million expected to sustain operations through mid-2024.
- Net loss of $28.1 million for Q1 2022, down from net income of $33.4 million in Q1 2021.
- Completed resubmission to the FDA of omburtamab BLA
- DANYELZA® adoption drove a
9% sequential revenue increase to$10.5 million - Company issues 2022 full-year DANYELZA® revenue guidance of
$45 -$50 million - Strong cash position with
$156.7 million as of March 31, 2022, providing runway through mid-2024 - The Company will host a conference call on Tuesday, May 10, 2022, at 9 a.m. ET
NEW YORK, May 09, 2022 (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 2022.
"Y-mAbs had a successful first quarter. We resubmitted the omburtamab BLA, bringing us one step closer to the potential approval and achieving our goal of delivering omburtamab to children suffering from high-risk neuroblastoma brain tumors,” said Thomas Gad, Interim Chief Executive Officer. “We are very encouraged by our first quarter financial results, driven by our continued execution of the DANYELZA launch which generated revenues of
First Quarter 2021 and Recent Corporate Developments
- On April 27, 2022, Y-mAbs announced a management change. Dr. Claus Moller has stepped down as Chief Executive Officer and Board Member, and Thomas Gad, the Company’s Founder, Chairman, and President has assumed the role of Interim CEO. The Board, under the newly appointed Chairman Dr. Jim Healy, has begun a search for Dr. Moller’s successor.
- On April 8, 2022, Y-mAbs presented pre-clinical data from the GD2-SADA construct at the American Association for Cancer Research (AACR) 2022 Annual Meeting. Pre-clinical models indicated that treatment with GD2-SADA increased tumor antigen binding, uptake, and persistence in tumor tissue in-vivo with activity lasting over 100 days after the treatment.
- On April 1, 2022, Y-mAbs announced that on March 31, 2022, the Company completed the resubmission of its Biologics License Application for omburtamab to the FDA. The FDA has a 60-day review period to determine whether the BLA is complete and acceptable for filing.
Financial Results
Revenues
Y-mAbs reported net revenues of
Operating Expenses
Research and Development
Research and development expenses were
Selling, General, and Administration
Selling, general, and administrative expenses were
Net Result
Y-mAbs reported a net loss for the quarter ended March 31, 2022, of
Cash and Cash Equivalents
The Company had approximately
Webcast and Conference Call
Y-mAbs will host a conference call on Tuesday, May 10, 2022, at 9 a.m. Eastern Time. To participate in the call, please dial 877-407-0792 (domestic) or 201-689-8263 (international) and reference the conference ID 13729248.
A webcast will be available at: https://services.choruscall.com/mediaframe/webcast.html?webcastid=yCAEVjRU
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, 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 The Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about our business model and development, commercialization and product distribution plans; 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; rate and degree of market acceptance and clinical utility as well as pricing and reimbursement levels; retaining and hiring key employees; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property position and strategy; additional product candidates and technologies; collaborations or strategic partnerships and the potential benefits thereof; expectations related to the use of our cash and cash equivalents, and the need for, timing and amount of any future financing transaction; our financial performance, including our estimates regarding revenues, expenses, capital expenditure requirements; developments relating to our competitors and our industry; 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; 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 pandemic caused by the coronavirus known as COVID-19 and its variants such as Delta and Omicron, risks associated with Russia’s recent invasion of Ukraine and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC and in our other SEC filings. 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.
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 data) | ||||||||
| March 31, | December31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 156,724 | $ | 181,564 | ||||
| Accounts receivable, net | 9,324 | 7,712 | ||||||
| Inventories | 5,588 | 5,512 | ||||||
| Other current assets | 6,103 | 7,473 | ||||||
| Total current assets | 177,739 | 202,261 | ||||||
| Property and equipment, net | 1,697 | 1,847 | ||||||
| Operating lease right-of-use assets | 3,155 | 3,842 | ||||||
| Intangible assets, net | 1,618 | 1,663 | ||||||
| Other assets | 6,838 | 3,170 | ||||||
| TOTAL ASSETS | $ | 191,047 | $ | 212,783 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| LIABILITIES | ||||||||
| Accounts payable | $ | 14,661 | $ | 13,552 | ||||
| Accrued liabilities | 12,930 | 12,540 | ||||||
| Operating lease liabilities, current portion | 1,451 | 1,783 | ||||||
| Total current liabilities | 29,042 | 27,875 | ||||||
| Accrued milestone and royalty payments | 2,100 | 2,100 | ||||||
| Operating lease liabilities, long-term portion | 1,598 | 1,851 | ||||||
| Other liabilities | 835 | 851 | ||||||
| TOTAL LIABILITIES | 33,575 | 32,677 | ||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Preferred stock, | ||||||||
| none issued at March 31, 2022 and December 31, 2021 | — | — | ||||||
| Common stock, | ||||||||
| March 31, 2022 and December 31, 2021; 43,718,165 and 43,694,716 | ||||||||
| shares issued at March 31, 2022 and December 31, 2021, respectively | 4 | 4 | ||||||
| Additional paid in capital | 524,329 | 519,206 | ||||||
| Accumulated other comprehensive income | 1,682 | 1,371 | ||||||
| Accumulated deficit | (368,543 | ) | (340,475 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 157,472 | 180,106 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 191,047 | $ | 212,783 | ||||
| Y-MABS THERAPEUTICS, INC. | ||||||||
| Consolidated Statements of Net Income/(Loss) and Comprehensive Income/(Loss) | ||||||||
| (unaudited) | ||||||||
| (in thousands, except share and per share data) | ||||||||
| Three months ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| REVENUES | ||||||||
| Product revenue, net | $ | 10,486 | $ | 5,383 | ||||
| Total revenues | 10,486 | 5,383 | ||||||
| OPERATING COSTS AND EXPENSES | ||||||||
| Cost of goods sold | 1,831 | 93 | ||||||
| Research and development | 22,912 | 21,579 | ||||||
| Selling, general, and administrative | 13,438 | 11,970 | ||||||
| Total operating costs and expenses | 38,181 | 33,642 | ||||||
| Loss from operations | (27,695 | ) | (28,259 | ) | ||||
| OTHER INCOME / (LOSS), NET | ||||||||
| Gain from sale of priority review voucher, net | — | 62,010 | ||||||
| Interest and other loss | (373 | ) | (338 | ) | ||||
| NET INCOME / (LOSS) | $ | (28,068 | ) | $ | 33,413 | |||
| Other comprehensive income / (loss) | ||||||||
| Foreign currency translation | 311 | 435 | ||||||
| COMPREHENSIVE INCOME / (LOSS) | $ | (27,757 | ) | $ | 33,848 | |||
| Net income / (loss) per share attributable to common stockholders, basic | $ | (0.64 | ) | $ | 0.80 | |||
| Weighted average common shares outstanding, basic | 43,709,238 | 41,870,759 | ||||||
| Net income / (loss) per share attributable to common stockholders, diluted | $ | (0.64 | ) | $ | 0.75 | |||
| Weighted average common shares outstanding, diluted | 43,709,238 | 44,383,791 | ||||||
FAQ
What were the financial results for Y-mAbs in Q1 2022?
What is the revenue guidance for Y-mAbs DANYELZA in 2022?
How much cash does Y-mAbs have as of March 31, 2022?
What is Y-mAbs' expected cash runway?
