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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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Item 2.02. Results of Operations and Financial Condition.
On May 9, 2022, Y-mAbs Therapeutics, Inc., announced its financial results for the quarter ended March 31, 2022. A copy of the press release is attached hereto as Exhibit 99.1.
The information furnished pursuant to Item 2.02 on this Form 8-K, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
|99.1||Press Release, dated May 9, 2022.|
|104||Interactive Data File (embedded within the Inline XBRL document).|
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Y-MABS THERAPEUTICS, INC.|
|Date: May 9, 2022||By:||/s/ Thomas Gad|
|Founder, President, Interim Chief Executive Officer and Head of Business Development & Strategy|
Y-mAbs Announces First Quarter Financial Results and Recent Corporate Developments
|·||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. EST|
New York, NY, May 9, 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 $10.5 million. Based on the steady progress and a strong first quarter we anticipate full-year 2022 DANYELZA revenues in the range of $45-50 million. Our strong balance sheet with $156.7 million in cash, and anticipated revenues from product sales, is expected to support us through multiple potentially value-creating catalysts and into mid-2024.”
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.|
Y-mAbs reported net revenues of $10.5 million for the quarter ended March 31, 2022, which was a 94% increase over $5.4 million in the comparable quarter of 2021. Additionally, net revenues were up 9% from the fourth quarter 2021. The Company has now delivered DANYELZA to 34 centers across the nation, corresponding to an increase of more than 20% since the end of the fourth quarter of 2021. Approximately 50% of the vials sold in the U.S. are now sold outside Memorial Sloan Kettering (“MSK”), a notable increase over the approximately 40% of the vials sold outside MSK in prior quarters.
Research and Development
Research and development expenses were $22.9 million for the three months ended March 31, 2022, compared to $21.6 million for the three months ended March 31, 2021. The $1.3 million increase reflects our increased clinical trial activity and employee-related costs, partially offset by decreased outsourced manufacturing expenses. Having completed the resubmission of the BLA for omburtamab on March 31, 2022, Y-mAbs is focusing pipeline development on DANYELZA label expansion, omburtamab, and advancing the SADA constructs into the clinic.
Selling, General, and Administration
Selling, general, and administrative expenses were $13.4 million for the three months ended March 31, 2022, which was a $1.4 million increase compared to $12.0 million for the three months ended March 31, 2021. The increase in selling, general, and administrative expenses was primarily due to costs related to the launch and commercialization of DANYELZA; which includes a $0.7 million increase in personnel costs due to the expansion of our commercial team that is poised to drive further adoption of DANYELZA in 2022 and beyond.
Y-mAbs reported a net loss for the quarter ended March 31, 2022, of $28.1 million, or $0.64 per basic and diluted share, compared to net income of $33.4 million, or $0.80 per basic share and $0.75 per diluted share, for the quarter ended March 31, 2021. The decrease in earnings was primarily driven by a one-time $62.0 million net gain from the sale of our DANYELZA Priority Review Voucher in the quarter ended March 31, 2021, partially offset by the favorable impact of increasing DANYELZA revenues.
Cash and Cash Equivalents
The Company had approximately $156.7 million in cash and cash equivalents as of March 31, 2022, which, when combined with anticipated revenues from product sales, is expected to be sufficient to fund the current operations to mid-2024.
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
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.
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.
Y-mAbs Therapeutics, Inc.
230 Park Avenue, Suite 3350
New York, NY 10169
+1 646 885 8505
E-mail: [email protected]
Y-MABS THERAPEUTICS, INC.
Consolidated Balance Sheets
(in thousands, except share data)
|March 31,||December 31,|
|Cash and cash equivalents||$||156,724||$||181,564|
|Accounts receivable, net||9,324||7,712|
|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|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|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|
|Preferred stock, $0.0001 par value, 5,500,000 shares authorized and none issued at March 31, 2022 and December 31, 2021||—||—|
|Common stock, $0.0001 par value, 100,000,000 shares authorized at March 31, 2022 and December 31, 2021; 43,718,165 and 43,694,716 shares issued at March 31, 2022 and December 31, 2021, respectively||4||4|
|Additional paid in capital||524,329||519,206|
|Accumulated other comprehensive income||1,682||1,371|
|TOTAL STOCKHOLDERS’ EQUITY||157,472||180,106|
|TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY||$||191,047||$||212,783|
Y-MABS THERAPEUTICS, INC.
Consolidated Statements of Net Income/(Loss) and Comprehensive Income/(Loss)
(In thousands, except share and per share data)
|Three months ended March 31,|
|Product revenue, net||$||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|