Y-mAbs Announces First Quarter Financial Results and Recent Corporate Developments
“We are very pleased with our first quarter 2021 financial results, as we have been commercializing DANYELZA® (naxitamab-gqgk) throughout the
Dr.
Recent Corporate Developments
- Subsequent to the end of the first quarter, on
April 27, 2021 , Y-mAbs announced the submission to EMA of a European Marketing Authorization Application for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. - Also subsequent to the end of the first quarter, on
April 20, 2021 , Y-mAbs announced a regulatory update for resubmission of the BLA for omburtamab, reconfirming our aim to resubmit the BLA late in the second quarter or in the third quarter 2021. - After the close of the first quarter, on
April 12, 2021 , Y-mAbs announced data from GPA33-SADA, which in a xenograft model of colorectal peritoneal carcinomatosis showed radioactivity uptake with a tumor to blood ratio of 122 measured 24 hours after injection. An IND for the GPA33-SADA is targeted for next year. - On
February 22, 2021 , Y-mAbs announced the closing of a follow-on shelf public offering, including the full exercise of the underwriters’ overallotment option, resulting in gross proceeds to the Company of approximately$115.0 million .
Financial Results
Y-mAbs reported net income of
Revenues
Y-mAbs reported net revenues of
Operating Expenses
Research and Development
Research and development expenses were
$2.0 million increase in outsourced manufacturing;$2.5 million increase in personnel costs; and$0.8 million increase in clinical trials.
These increases were partially offset by a
Selling, General, and Administration
Selling, general, and administrative expenses were
$3.3 million increase in personnel costs.
Cash and Cash Equivalents
The Company had approximately
Webcast and Conference Call
The Company will host a conference call on
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The Company has a broad and advanced product pipeline, including one FDA approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one pivotal-stage product candidate, 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 novel coronavirus known as COVID-19 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 and in our other
“DANYELZA” and “Y-mAbs” are registered trademarks of
Consolidated Balance Sheets | |||||||
(unaudited) | |||||||
(in thousands, except share data) | |||||||
2021 | 2020 | ||||||
ASSETS | |||||||
CURRENT ASSETS | |||||||
Cash and cash equivalents | $ | 252,271 | $ | 114,634 | |||
Accounts receivable, net | 5,997 | — | |||||
Inventories | 1,005 | — | |||||
Other current assets | 4,736 | 7,729 | |||||
Total current assets | 264,009 | 122,363 | |||||
Property and equipment, net | 2,095 | 1,825 | |||||
Operating lease right-of-use assets | 3,979 | 4,569 | |||||
Other assets | 4,833 | 3,290 | |||||
TOTAL ASSETS | $ | 274,916 | $ | 132,047 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
LIABILITIES | |||||||
Accounts payable | $ | 6,543 | $ | 9,372 | |||
Accrued liabilities | 8,486 | 8,197 | |||||
Operating lease liabilities, current portion | 1,971 | 1,966 | |||||
Total current liabilities | 17,000 | 19,535 | |||||
Accrued milestone and royalty payments | 2,250 | 2,695 | |||||
Operating lease liabilities, long-term portion | 1,515 | 2,013 | |||||
Other liabilities | 1,934 | 1,968 | |||||
TOTAL LIABILITIES | 22,699 | 26,211 | |||||
STOCKHOLDERS’ EQUITY | |||||||
Preferred stock, |
|||||||
— | — | ||||||
Common stock, |
|||||||
shares issued at |
4 | 4 | |||||
Additional paid in capital | 504,091 | 391,558 | |||||
Accumulated other comprehensive income / (loss) | (91 | ) | (526 | ) | |||
Accumulated deficit | (251,787 | ) | (285,200 | ) | |||
TOTAL STOCKHOLDERS’ EQUITY | 252,217 | 105,836 | |||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 274,916 | $ | 132,047 | |||
Consolidated Statements of Net Loss and Comprehensive Loss | |||||||
(unaudited) | |||||||
(in thousands, except share and per share data) | |||||||
Three months ended |
|||||||
2021 | 2020 | ||||||
REVENUE | |||||||
Product revenue, net | $ | 5,383 | $ | — | |||
OPERATING COSTS AND EXPENSES | |||||||
Cost of goods sold | 93 | — | |||||
Research and development | 21,579 | 18,622 | |||||
Selling, general, and administrative | 11,970 | 8,125 | |||||
Total operating costs and expenses | 33,642 | 26,747 | |||||
Loss from operations | (28,259 | ) | (26,747 | ) | |||
OTHER INCOME | |||||||
Gain from sale of priority review voucher | 62,010 | — | |||||
Interest and other income, net | (338 | ) | 568 | ||||
NET INCOME / (LOSS) | $ | 33,413 | $ | (26,179 | ) | ||
Other comprehensive income | |||||||
Foreign currency translation | 435 | 25 | |||||
COMPREHENSIVE INCOME / (LOSS) | $ | 33,848 | $ | (26,154 | ) | ||
Net income/(loss) per share attributable to common stockholders, basic | $ | 0.80 | $ | (0.66 | ) | ||
Weighted average common shares outstanding, basic | 41,870,759 | 39,753,583 | |||||
Net income/(loss) per share attributable to common stockholders, diluted | $ | 0.75 | $ | (0.66 | ) | ||
Weighted average common shares outstanding, diluted | 44,383,791 | 39,753,583 | |||||
Contact:
+1 646 885 8505
E-mail: [email protected]
Source: Y-mAbs Therapeutics, Inc