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 $23.4 million and $84.3
million for the quarter and year ended December 31, 2023, which
represented increases of 42% and 71%, respectively, over $16.4
million and $49.3 million in the comparable periods of 2022. The
DANYELZA net product revenues of $23.4 million in the fourth
quarter of 2023, represented a favorable 17% increase compared to
the third quarter of 2023, primarily driven by increased U.S.
sales.
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 $0.5 million for the
year ended December 31, 2023. The Company reported license revenues
of $15.0 million and $16.0 million for the quarter and year ended
December 31, 2022. License revenues for the year ended December 31,
2023 arose from the September 2023 achievement of marketing
authorization for DANYELZA in Mexico under the Company’s sublicense
agreement with Adium. During the quarter and year ended December
31, 2022, the Company recognized a regulatory-based milestone of
$15.0 million from SciClone Pharmaceuticals International Ltd. for
the conditional approval of DANYELZA in China.
Operating Costs and Expenses
Cost of Goods Sold
Cost of goods sold was $2.0 million for the quarters ended
December 31, 2023 and 2022, respectively. The cost of goods sold
was $11.4 million and $7.5 million for the years ended December 31,
2023, and 2022, respectively. The increase in cost of goods sold in
both periods was primarily driven by increased product revenues.
The Company experienced inventory write-downs of $0.8 million and
$1.2 million in the years ended December 31, 2023, and December 31,
2022, respectively.
The Company’s gross margin, excluding the 2023 and 2022
inventory write-downs, increased in the fourth quarter of 2023 to
91% due to the gross margin increase from higher U.S. revenues. The
Company’s gross margin, excluding the 2023 and 2022 inventory
write-downs, remained constant at 87% for the year ended December
31, 2023, compared to the year ended December 31, 2022, which was
the net impact of the gross margin increase from higher U.S.
revenues, offset by increased revenues from geographic areas
outside the U.S., which were at a lower gross margin. The Company
defines gross margin as net product revenues less cost of goods
sold divided by net product revenues.
Research and Development
Research and development expenses were $13.4 million for the
quarter ended December 31, 2023, a reduction of 32% compared to
$19.8 million for the quarter ended December 31, 2022. The $6.4
million decrease was primarily due to decreased spending on
deprioritized programs, which resulted in a $3.1 million decrease
in outsourced manufacturing, a $2.0 million decrease in
personnel-related costs, inclusive of stock-based compensation, and
a $2.2 million decrease in outsourced research and supplies,
partially offset by a $1.2 million increase in clinical trials
expenses.
For the year ended December 31, 2023, research and development
expenses were $54.2 million, a reduction of 41% compared to $91.6
million for the year ended December 31, 2022. The $37.4 million
decrease was primarily due to decreased spending on deprioritized
programs, resulting in a $21.0 million decrease in outsourced
manufacturing, a $9.0 million decrease in outsourced research and
supplies, a $6.1 million decrease in personnel-related costs,
inclusive of stock-based compensation, and a $2.0 million decrease
in clinical trials, partially offset by a $3.8 million increase in
milestones and license acquisition costs primarily related to a
$4.1 million increase in milestones accrued under the Company’s
SADA License Agreement, as the Company determined that achievement
of certain time-based clinical milestones within the agreement are
probable based on the availability of data and the assessment of
clinical progress in the year of 2023.
The $2.0 million and $6.1 million decreases in personnel-related
costs during the quarter and year ended December 31, 2023,
respectively, were driven by the headcount reduction as part of the
Company’s restructuring plan announced in January 2023. The expense
reduction in the year ended December 31, 2023 was partially offset
by severance charges recognized in conjunction with the
restructuring plan.
Selling, General, and Administration
Selling, general, and administrative expenses were $11.1 million
for the quarter ended December 31, 2023, which was a slight
increase compared to $10.8 million for the quarter ended December
31, 2022.
For the year ended December 31, 2023, selling, general, and
administrative expenses were $44.9 million, a reduction of 26%
compared to $60.9 million for the year ended December 31, 2022. The
$16.0 million decrease in selling, general and administrative
expenses was primarily attributable to a $10.9 million charge in
the year ended December 31, 2022 related to contractual
severance-related benefits for the Company’s former Chief Executive
Officer, and, to a lesser extent, a $3.4 million decrease in
commercialization expenses, inclusive of costs of incurred in 2022
in anticipation of a potential omburtamab launch.
Interest and Other Income/(Loss)
Interest and other income/(loss) was relatively unchanged at
$2.4 million as compared to $2.3 million during the quarters ended
December 31, 2023 and 2022, respectively. Interest and other
income/(loss) was $4.8 million of income as compared to $0.8
million of loss for the years ended December 31, 2023 and 2022,
respectively. The $5.6 million favorable change in interest and
other income/(loss), reflects increased interest income for the
year ended December 31, 2023, and was driven by increased money
market fund investment income. The Company recorded impairment
charges totaling $1.4 million related to the write down of two
Secured Promissory Notes during the year ended December 31,
2022.
Net Loss
Y-mAbs reported a net loss for the quarter ended December 31,
2023, of $1.0 million, or ($0.02) per basic and diluted share,
compared to net income of $1.2 million, or $0.03 per basic and
diluted share, for the quarter ended December 31, 2022. The net
income for the quarter ended December 31, 2022, was after $15.0
million of license revenue recognized in the fourth quarter of
2022. For the year ended December 31, 2023, the Company reported a
net loss of $21.4 million, or ($0.49) per basic and diluted share,
compared to a net loss of $95.6 million, or ($2.19) per basic and
diluted share, for the year ended December 31, 2022. The favorable
decrease in net loss for the year ended December 31, 2023, was
primarily driven by an increase in U.S. and international DANYELZA
product revenues for the year ended December 31, 2023, as well as
decreased research and development cost, and decreased selling,
general and administration cost.
Cash and Cash Equivalents
As of December 31, 2023, Y-mAbs had approximately $78.6 million
in cash and cash equivalents which, together with anticipated
DANYELZA product revenues, is expected to support operations as
currently planned into 2027. This estimate reflects the Company’s
current business plan that is supported by assumptions that may
prove to be inaccurate, such that Y-mAbs could use its available
capital resources sooner than it currently expects.
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) 689-826313744085 |
|
|
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
StatementsStatements 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 DuganVP, Head of Investor Relationscdu@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, $0.0001 par value, 5,500,000 shares authorized and
none issued at December 31, 2023 and December 31, 2022 |
|
- |
|
|
|
- |
|
Common stock, $0.0001 par value, 100,000,000 shares authorized at
December 31, 2023 and December 31, 2022; 43,672,112
and 43,670,109 shares issued and outstanding at
December 31, 2023 and December 31, 2022,
respectively |
|
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 |
|
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