Y-mAbs Announces Second Quarter Financial Results and Recent Corporate Developments
Y-mAbs Therapeutics reported a net revenue of $10.8 million for Q2 2022, a slight decrease of 1% year-over-year, while YTD revenue was $21.3 million, reflecting a 30% increase. DANYELZA® sales rose 42% YTD to $20.3 million. The company has a strong cash position of $133.7 million, expected to fund operations through mid-2024. The FDA has accepted their BLA for omburtamab with a PDUFA date set for November 2022. Management reiterated financial guidance, aiming for DANYELZA revenues between $45-$50 million for the full year.
- DANYELZA product revenue increased by 42% YTD to $20.3 million.
- Strong cash position of $133.7 million, sufficient to fund operations into mid-2024.
- FDA acceptance of BLA for omburtamab with November 2022 PDUFA date.
- Phase 2 naxitamab trial met primary endpoints, indicating strong potential.
- Net loss of $41.1 million in Q2 2022, an increase from $22.9 million in Q2 2021.
- DANYELZA sales in Q2 decreased by 7% compared to Q1 2022.
- Increase in research and development expenses to $26.4 million in Q2 2022.
- Omburtamab BLA Accepted by the FDA with November 2022 PDUFA date
- Announced IND Clearance for the first GD2-SADA construct
- YTD DANYELZA® product revenue
$20.3 million - Management reiterates financial guidance, including 2022 full-year DANYELZA® revenue of
$45 -$50 million - Strong cash position with
$133.7 million as of June 30, 2022, anticipated runway into mid-2024 - The Company will host a conference call on Tuesday, August 9, 2022, at 9 a.m. EST
NEW YORK, Aug. 08, 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 second quarter of 2022.
"The highlight of the second quarter was FDA acceptance of our BLA filing for omburtamab,” said Thomas Gad, President, and Interim Chief Executive Officer. “We are excited about the upcoming PDUFA date, which we believe brings us closer to the potential approval and achieving our goal of delivering omburtamab to children suffering from high-risk neuroblastoma brain tumors. We were also thrilled to announce that the Phase 2 naxitamab chemo-immunotherapy trial met primary endpoints achieving an impressive response rate further underscoring DANYELZA potential in high-risk neuroblastoma. Our strong balance sheet with
Second Quarter 2022 and Recent Corporate Developments
- On July 12, 2022, Y-mAbs announced clearance of the IND for GD2-SADA
- On May 31, 2022, Y-mAbs announced FDA acceptance of the Biologics License Application for OMBLASTYS® (omburtamab) for the treatment of neuroblastoma for priority review
- On May 26, 2022, Y-mAbs announced that the naxitamab chemoimmunotherapy investigational trial for High-Risk Neuroblastoma met its primary endpoint. The data was presented at the American Society of Clinical Oncology (ASCO).
- On April 27, 2022, Y-mAbs announced a management change. Dr. Claus Moller stepped down as Chief Executive Officer and Board Member, and the role of Interim Chief Executive Officer was assumed by Thomas Gad, the Company’s Founder and President, Interim Chief Executive Officer and Head of Business Development and Strategy, and Board Member. 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.
Financial Results
Revenues
Y-mAbs reported net revenues of
We have now delivered DANYELZA to 36 centers across the U.S., corresponding to an increase of
Operating Expenses
Research and Development
Research and development expenses were
Research and development expenses increased by
Selling, General, and Administration
Selling, General, and Administrative expenses increased by
Net Loss
We reported a net loss for the quarter ended June 30, 2022, of
We reported a net loss for the six months ended June 30, 2022, of
Cash and Cash Equivalents
We had approximately
This estimate does not include any assumption for net proceeds received on the anticipated priority review voucher, which we could sell upon the potential approval of omburtamab. In addition, no new partnerships or other new business development-related sources of income are included in the assumptions, potential omburtamab revenues upon approval are also excluded, and the DANYELZA revenues are only assumed to increase modestly each year for the purpose of this analysis of runway.
Financial Guidance
Management reiterates all elements of its financial guidance including:
- DANYELZA® 2022 revenues of
$45 -$50 million ; - Operating expenses of
$162 -167 million; - Total cash burn of
$78 -83 million for 2022; and - Cash position sufficient to fund current operations into mid-2024.
The revenue guidance includes an incremental benefit from international revenues.
Webcast and Conference Call
Y-mAbs will host a conference call on Tuesday, August 9, 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 13730680.
A webcast will be available at: https://viavid.webcasts.com/starthere.jsp?ei=1555384&tp_key=db740a8735
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 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, including statements with respect to the potential approval of omburtamab, pipeline development programs, potential for DANYELZA label expansion, and advancement of SADA; retaining and hiring key employees, including the search for Dr. Moller’s successor; additional product candidates and technologies; collaborations or strategic partnerships and the potential benefits thereof; expectations related our anticipated cash runway and the sufficiency of our cash resources, and the need for, timing and amount of any future financing transaction; DANYELZA revenue guidance for 2022, and our financial performance, including our estimates regarding revenues, expenses and capital expenditure requirements; 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 COVID-19 pandemic; risks associated with the conflict between Russia and Ukraine and sanctions related thereto, macroeconomic conditions, including inflation and global capital markets; 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, including our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 to be filed with the SEC. 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 data) | ||||||||
| June30, | December31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 133,665 | $ | 181,564 | ||||
| Accounts receivable, net | 7,208 | 7,712 | ||||||
| Inventories | 6,794 | 5,512 | ||||||
| Other current assets | 6,253 | 7,473 | ||||||
| Total current assets | 153,920 | 202,261 | ||||||
| Property and equipment, net | 1,554 | 1,847 | ||||||
| Operating lease right-of-use assets | 2,381 | 3,842 | ||||||
| Intangible assets, net | 1,574 | 1,663 | ||||||
| Other assets | 5,749 | 3,170 | ||||||
| TOTAL ASSETS | $ | 165,178 | $ | 212,783 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| LIABILITIES | ||||||||
| Accounts payable | $ | 11,291 | $ | 13,552 | ||||
| Accrued liabilities | 17,067 | 12,540 | ||||||
| Operating lease liabilities, current portion | 1,092 | 1,783 | ||||||
| Total current liabilities | 29,450 | 27,875 | ||||||
| Accrued milestone and royalty payments | 2,250 | 2,100 | ||||||
| Operating lease liabilities, long-term portion | 1,302 | 1,851 | ||||||
| Other liabilities | 780 | 851 | ||||||
| TOTAL LIABILITIES | 33,782 | 32,677 | ||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 4 | 4 | ||||||
| Additional paid in capital | 537,962 | 519,206 | ||||||
| Accumulated other comprehensive income | 3,104 | 1,371 | ||||||
| Accumulated deficit | (409,674 | ) | (340,475 | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | 131,396 | 180,106 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 165,178 | $ | 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 June 30, | Six months ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| REVENUES | ||||||||||||||||
| Product revenue, net | $ | 9,797 | $ | 8,951 | $ | 20,283 | $ | 14,334 | ||||||||
| License revenue | 1,000 | 2,000 | 1,000 | 2,000 | ||||||||||||
| Total revenues | 10,797 | 10,951 | 21,283 | 16,334 | ||||||||||||
| OPERATING COSTS AND EXPENSES | ||||||||||||||||
| Cost of goods sold | 1,140 | 200 | 2,972 | 293 | ||||||||||||
| License royalties | 100 | 210 | 100 | 210 | ||||||||||||
| Research and development | 26,420 | 19,778 | 49,332 | 41,357 | ||||||||||||
| Selling, general, and administrative | 23,082 | 13,475 | 36,520 | 25,445 | ||||||||||||
| Total operating costs and expenses | 50,742 | 33,663 | 88,924 | 67,305 | ||||||||||||
| Loss from operations | (39,945 | ) | (22,712 | ) | (67,641 | ) | (50,971 | ) | ||||||||
| OTHER INCOME / (LOSS), NET | ||||||||||||||||
| Gain from sale of priority review voucher, net | — | — | — | 62,010 | ||||||||||||
| Interest and other loss | (1,186 | ) | (225 | ) | (1,558 | ) | (563 | ) | ||||||||
| NET INCOME / (LOSS) | $ | (41,131 | ) | $ | (22,937 | ) | $ | (69,199 | ) | $ | 10,476 | |||||
| Other comprehensive income | ||||||||||||||||
| Foreign currency translation | 1,422 | 78 | 1,733 | 513 | ||||||||||||
| COMPREHENSIVE INCOME / (LOSS) | $ | (39,709 | ) | $ | (22,859 | ) | $ | (67,466 | ) | $ | 10,989 | |||||
| Net income / (loss) per share attributable to common stockholders, basic | $ | (0.94 | ) | $ | (0.53 | ) | $ | (1.58 | ) | $ | 0.25 | |||||
| Weighted average common shares outstanding, basic | 43,718,748 | $ | 43,569,482 | 43,713,967 | 42,724,813 | |||||||||||
| Net income / (loss) per share attributable to common stockholders, diluted | $ | (0.94 | ) | $ | (0.53 | ) | $ | (1.58 | ) | $ | 0.23 | |||||
| Weighted average common shares outstanding, diluted | 43,718,748 | 43,569,482 | 43,713,967 | 45,080,419 | ||||||||||||
FAQ
What were Y-mAbs' Q2 2022 financial results?
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