Y-mAbs Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Developments
- Record DANYELZA net product revenues of $23.4 million and $84.3 million for Q4 and FY 2023 represent YoY growth of 42% and 71% respectively.
- Cash and cash equivalents of $78.6 million as of December 31, 2023; Reiterate anticipated cash runway into 2027.
- Y-mAbs announced full year 2024 financial guidance with anticipated DANYELZA net product revenues of $95-100 million and operating expenses of $115-120 million.
- The Company demonstrated proof-of-concept of its SADA PRIT platform in a Phase 1 trial and expects to present mature data from Part A of its Phase 1 GD2-SADA clinical trial in the second half of the year.
- Y-mAbs was added to the NASDAQ Biotechnology Index, appointed a new President and CEO, and received FDA clearance for its CD38-SADA IND.
- The company published a study of naxitamab-based chemoimmunotherapy in patients with refractory high-risk neuroblastoma, showing positive outcomes.
- Y-mAbs showcased DANYELZA at the 55th Congress of the International Society of Pediatric Oncology in Ottawa, Canada.
- The company reported a net loss of $1.0 million for Q4 2023 and a net loss of $21.4 million for FY 2023.
- Y-mAbs had approximately $78.6 million in cash and cash equivalents as of December 31, 2023, supporting operations as planned into 2027.
- None.
Insights
The reported YoY growth in DANYELZA® net product revenues of 42% for Q4 and 71% for FY 2023 is a significant indicator of the company's commercial success and market penetration. The increase in revenues, especially from U.S. sales, suggests a growing acceptance of the product within high-volume centers. This trend is a positive signal for investors, as it reflects not only the product's competitive advantage but also the company's effective sales and marketing strategies. The anticipated cash runway into 2027 implies a stable financial position, reducing the immediate need for additional capital raising that could dilute shareholder value.
However, the absence of license revenues in Q4 2023, compared to the previous year, warrants attention. This could indicate a one-time milestone achieved in the prior year or a shift in the company's revenue composition. The projected net product revenues for 2024, along with controlled operating expenses, suggest a forward-looking strategy focused on sustainable growth. The anticipated total annual cash burn aligns with this strategy, as it is relatively modest in the context of the company's cash reserves and expected revenues.
The inclusion of Y-mAbs in the NASDAQ Biotechnology Index as of December 2023 is a notable development that could potentially increase the stock's visibility among investors and result in greater trading liquidity. Index inclusion often leads to broader analyst coverage and investment by index funds, which can have a stabilizing effect on the stock's trading volume and price.
The company's focus on expanding its SADA PRIT technology platform, as evidenced by the U.S. FDA clearance for the CD38-SADA IND and ongoing clinical trials, positions Y-mAbs at the forefront of innovation in cancer treatment. The successful development and commercialization of these platforms could open up new revenue streams and market opportunities, enhancing the company's long-term growth prospects.
The progress in clinical development, particularly the proof-of-concept for the SADA PRIT platform, is a critical milestone for Y-mAbs. The ability of GD2-SADA to target and bind to tumors in humans has implications for the treatment of various cancers. The mature data expected to be presented from the Phase 1 GD2-SADA clinical trial could significantly impact the medical community's perception of the company's research capabilities and the potential efficacy of its treatments.
The reported higher response rates and estimated three-year overall survival rates for patients with HR-NB who received the HITS combination early in their treatment underscores the clinical relevance of Y-mAbs' therapeutic offerings. Such clinical outcomes can drive further adoption of DANYELZA® and enhance the company's reputation in oncology circles, potentially leading to increased investor confidence in the company's R&D pipeline.
- Record DANYELZA® net product revenues of $23.4 million and
$84.3 million for Q4 and FY 2023 represents YoY growth of 42% and71% , respectively - Cash and cash equivalents of $78.6 million as of December 31, 2023; Reiterate anticipated cash runway into 2027
- Management announces full year 2024 financial guidance
- The Company will host a conference call on Friday, March 1, 2024, at 8:00 a.m. ET
NEW YORK, Feb. 29, 2024 (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 radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today reported financial results for the quarter and full year ended December 31, 2023.
“Y-mAbs has made significant progress across both the development and commercial fronts of our business resulting in a momentous 2023,” said Mike Rossi, President and Chief Executive Officer. “From a development standpoint, we demonstrated proof-of-concept of our Self-Assembly DisAssembly (“SADA”) Pretargeted Radioimmunotherapy (“PRIT”) platform, showing that GD2-SADA targets and binds to tumors in humans in a Phase 1 trial. We continue to expect to present mature data from Part A of our Phase 1 GD2-SADA clinical trial at a medical meeting in the second half of this year. In addition, we look forward to initiating our CD38-SADA Phase 1 trial this year. While we continue to advance our SADA PRIT platform and programs through clinical development, we are supported by the solid commercial performance of DANYELZA® (naxitamab-gqgk). We achieved record quarterly and annual net product revenues, and sales continue trending upward as more high-volume centers deploy DANYELZA for their patients. Our strong financial foundation and operational performance continue to fuel our mission of providing better and safe therapies for a variety of cancers and improve the lives of patients and their families.”
Fourth Quarter 2023 and Recent Corporate Developments
- In December 2023, Y-mAbs announced that it was added to the NASDAQ Biotechnology Index (NASDAQ: NBI), effective December 18, 2023.
- On October 18, 2023, Y-mAbs announced that its Board of Directors appointed radiopharmaceutical industry veteran Mr. Rossi as President and Chief Executive Officer, effective November 6, 2023. Thomas Gad, who founded Y-mAbs in 2015 and has served as Interim Chief Executive Officer since 2022, transitioned to the role of Vice Chairman of the Board of Directors and Chief Business Officer.
- On October 17, 2023, the U.S. FDA cleared Y-mAbs’ IND for CD38-SADA, marking the second clinical development program utilizing the Company’s novel SADA PRIT technology platform.
- On October 16, 2023, Y-mAbs announced the publication of a study of naxitamab-based chemoimmunotherapy (“HITS”) study in patients with refractory high-risk neuroblastoma (“HR-NB”) in the journal Cancers. The study investigated the HITS combination in patients with HR-NB who did not respond well to induction or refractory therapy. Patients who received HITS immediately after induction had higher response rates (
47% vs.18% ) and superior estimated three-year overall survival (85% vs.29% ), compared with those who received the same combination regimen later in the course of treatment. The publication is entitled, “Early Salvage Chemo-Immunotherapy with Irinotecan, Temozolomide and Naxitamab Plus GM-CSF (HITS) for Patients with Primary Refractory High-Risk Neuroblastoma Provide the Best Chance for Long-Term Outcomes.” - On October 11, 2023, Y-mAbs showcased three poster presentations, in addition to an online publication, of DANYELZA at the 55th Congress of the International Society of Pediatric Oncology in Ottawa, Canada.
Financial Results
Revenues
DANYELZA net product revenues were
As of December 31, 2023, Y-mAbs has delivered DANYELZA to 58 centers across the U.S. since initial launch, with ten new accounts added in 2023.
The Company did not have license revenues in the quarter ended December 31, 2023 and had license revenues of
Operating Costs and Expenses
Cost of Goods Sold
Cost of goods sold was
The Company’s gross margin, excluding the 2023 and 2022 inventory write-downs, increased in the fourth quarter of 2023 to
Research and Development
Research and development expenses were
For the year ended December 31, 2023, research and development expenses were
The
Selling, General, and Administration
Selling, general, and administrative expenses were
For the year ended December 31, 2023, selling, general, and administrative expenses were
Interest and Other Income/(Loss)
Interest and other income/(loss) was relatively unchanged at
Net Loss
Y-mAbs reported a net loss for the quarter ended December 31, 2023, of
Cash and Cash Equivalents
As of December 31, 2023, Y-mAbs had approximately
2024 Financial Guidance
- Anticipated DANYELZA® net product revenues of between
$95 million and$100 million ; - Anticipated operating expenses of between
$115 million and$120 million ; - Anticipated total annual cash burn of between
$15 million and$20 million ; and - Cash and cash equivalents anticipated to continue to support operations as currently planned into 2027.
Webcast and Conference Call
Y-mAbs will host a conference call on Friday, March 1, 2024, at 8:00 a.m. ET. To participate in the call, please use the following dial-in information.
| Investors (domestic): Investors (international): Conference ID: | (877) 407-0792 (201) 689-8263 13744085 |
To access a live webcast of the update, please use this link. Prior to the call and webcast, a slide presentation pertaining to our quarterly earnings will be made available in the investor relations section of our website, www.ymabs.com, shortly before the call begins.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, radioimmunotherapy and antibody-based therapeutic cancer products. The Company’s technologies include its investigational Self-Assembly DisAssembly (“SADA”) Pretargeted Radioimmunotherapy Platform (“PRIT”) and bispecific antibodies generated using the Y-BiClone platform. The Company’s broad and advanced product pipeline includes the anti-GD2 therapy DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow after a partial response, minor response, or stable disease to prior therapy.
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 2024 and beyond, including estimated operating expenses, cash burn and DANYELZA product revenue and sufficiency of cash resources and related assumptions; implied and express statements regarding the future of the Company’s business, including with respect to expansion and its goals; the Company’s plans and strategies, development, commercialization and product distribution plans, including potential partnerships; expectations with respect to the Company’s products and product candidates, including otential territory and label expansion of DANYELZA and the potential market opportunity related thereto and potential benefits thereof, and the potential of the SADA Technology and potential benefits and applications thereof; statements with respect to DANYELZA as a growing commercial product and SADA as a differentiated radioimmunotherapy platform positioning the Company on a path to potentially transform the treatment paradigm for a variety of cancers and improve patients’ lives; 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 applications, and the timing thereof; expectations with respect to current and future clinical and pre-clinical studies and the Company’s research and development programs, including with respect to timing and results; expectations related to the timing of the initiation and completion of regulatory submissions; 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 the Company’s financial condition and need for additional capital; the risks that actual results of the Company’s restructuring plan and revised business plan will not be as expected; risks associated with the Company’s development work; cost and success of the Company’s product development activities and clinical trials; the risks of delay in the timing of the Company’s regulatory submissions or failure to receive approval of its drug candidates; the risks related to commercializing any approved pharmaceutical product including the rate and degree of market acceptance of product candidates; development of sales and marketing capabilities and risks associated with failure to obtain sufficient reimbursement for products; the risks related to the Company’s dependence on third parties including for conduct of clinical testing and product manufacture; the Company’s inability to enter into partnerships; the risks related to government regulation; risks related to market approval, risks associated with protection of the Company’s intellectual property rights; risks related to employee matters and managing growth; risks related to the Company’s common stock, risks associated with macroeconomic conditions, including the conflict between Russia and Ukraine and sanctions related thereto, the state of war between Israel and Hamas and the related risk of a larger regional conflict, 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 ended December 31, 2023, the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 and future filings and reports by the Company. 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.
Investor Contact:
Courtney Dugan
VP, Head of Investor Relations
cdu@ymabs.com
| Y-MABS THERAPEUTICS, INC. | |||||||
| Consolidated Balance Sheets | |||||||
| (unaudited) | |||||||
| (in thousands, except share and per share data) | |||||||
| As of | |||||||
| December 31, | December 31, | ||||||
| 2023 | 2022 | ||||||
| ASSETS | |||||||
| CURRENT ASSETS | |||||||
| Cash and cash equivalents | $ | 78,637 | $ | 105,762 | |||
| Accounts receivable, net | 22,454 | 12,531 | |||||
| Inventories | 5,065 | 6,702 | |||||
| Other current assets | 4,955 | 5,452 | |||||
| Total current assets | 111,111 | 130,447 | |||||
| Property and equipment, net | 224 | 604 | |||||
| Operating lease right-of-use assets | 1,412 | 1,739 | |||||
| Intangible assets, net | 2,631 | 2,986 | |||||
| Other assets | 12,491 | 5,680 | |||||
| TOTAL ASSETS | $ | 127,869 | $ | 141,456 | |||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
| LIABILITIES | |||||||
| Accounts payable | $ | 6,060 | $ | 14,175 | |||
| Accrued liabilities | 13,166 | 13,241 | |||||
| Operating lease liabilities, current portion | 902 | 868 | |||||
| Total current liabilities | 20,128 | 28,284 | |||||
| Accrued milestone payments | 5,375 | 2,250 | |||||
| Operating lease liabilities, long-term portion | 517 | 899 | |||||
| Other liabilities | 864 | 802 | |||||
| TOTAL LIABILITIES | 26,884 | 32,235 | |||||
| STOCKHOLDERS’ EQUITY | |||||||
| Preferred stock, | - | - | |||||
| Common stock, | 4 | 4 | |||||
| Additional paid-in capital | 558,002 | 543,929 | |||||
| Accumulated other comprehensive income | 449 | 1,331 | |||||
| Accumulated deficit | (457,470 | ) | (436,043 | ) | |||
| TOTAL STOCKHOLDERS’ EQUITY | 100,985 | 109,221 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 127,869 | $ | 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 December 31, | Years ended December 31, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| REVENUES | |||||||||||||||
| Product revenue, net | $ | 23,363 | $ | 16,447 | $ | 84,319 | $ | 49,267 | |||||||
| License revenue | — | 15,000 | 500 | 16,000 | |||||||||||
| Total revenues | 23,363 | 31,447 | 84,819 | 65,267 | |||||||||||
| OPERATING COSTS AND EXPENSES | |||||||||||||||
| Cost of goods sold | 2,039 | 2,020 | 11,366 | 7,467 | |||||||||||
| License royalties | — | — | 50 | 100 | |||||||||||
| Research and development | 13,388 | 19,787 | 54,219 | 91,572 | |||||||||||
| Selling, general, and administrative | 11,135 | 10,793 | 44,856 | 60,939 | |||||||||||
| Total operating costs and expenses | 26,562 | 32,600 | 110,491 | 160,078 | |||||||||||
| Loss from operations | (3,199 | ) | (1,153 | ) | (25,672 | ) | (94,811 | ) | |||||||
| OTHER INCOME/(LOSS), NET | |||||||||||||||
| Interest and other income/(loss) | 2,406 | 2,310 | 4,806 | (757 | ) | ||||||||||
| LOSS BEFORE INCOME TAXES | (793 | ) | 1,157 | (20,866 | ) | (95,568 | ) | ||||||||
| Provision for income taxes | 195 | — | 561 | — | |||||||||||
| NET INCOME/(LOSS) | $ | (988 | ) | $ | 1,157 | $ | (21,427 | ) | $ | (95,568 | ) | ||||
| Other comprehensive loss | |||||||||||||||
| Foreign currency translation | (1,400 | ) | (3,371 | ) | (882 | ) | (40 | ) | |||||||
| COMPREHENSIVE LOSS | $ | (2,388 | ) | $ | (2,214 | ) | $ | (22,309 | ) | $ | (95,608 | ) | |||
| Net income/(loss) per share attributable to common stockholders, basic | $ | (0.02 | ) | $ | 0.03 | $ | (0.49 | ) | $ | (2.19 | ) | ||||
| Weighted average common shares outstanding, basic | 43,627,270 | 43,668,690 | 43,645,388 | 43,703,663 | |||||||||||
| Net income/(loss) per share attributable to common stockholders, diluted | $ | (0.02 | ) | $ | 0.03 | $ | (0.49 | ) | $ | (2.19 | ) | ||||
| Weighted average common shares outstanding, diluted | 43,627,270 | 44,692,485 | 43,645,388 | 43,703,663 | |||||||||||
FAQ
What were Y-mAbs' DANYELZA net product revenues for Q4 and FY 2023?
What is Y-mAbs' cash and cash equivalents as of December 31, 2023?
What is Y-mAbs' anticipated DANYELZA net product revenues for 2024?
What are Y-mAbs' operating expenses expected to be for 2024?
What is Y-mAbs' total annual cash burn anticipated for 2024?
Will Y-mAbs' cash and cash equivalents support operations as planned into 2027?
