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 of 2023.
"The first quarter of 2023 marked a period of significant
progress for DANYELZA and we believe has set up 2023 to be a very
productive year. We are thrilled to report record DANYELZA net
revenues of $20.3 million in the first quarter of 2023, a 24%
sequential increase compared to the previous quarter and near
doubling year-over-year. The increase allows us to update our FY
2023 DANYELZA revenue guidance from $60-65 million to $80-85
million,” said Thomas Gad, President, and Interim Chief Executive
Officer. “In Q1 2023, we implemented a restructuring plan to
prioritize resources on the DANYELZA franchise and development of
our SADA technology in the fight against cancer. With a 35%
reduction in force and an anticipated 28% reduction in annual
operating expenses for 2023, we emerge leaner and supported by a
robust balance sheet with $92.6 million in cash and cash
equivalents as of March 31, 2023, which we estimate should support
our business operations as currently planned into the first quarter
of 2026. In addition, we achieved a major milestone of treating the
first patient in our GD2-SADA trial in April 2023.”
First Quarter 2023 and Recent Corporate
Developments
- On April 18, 2023, Y-mAbs
announced that positive preclinical data on naxitamab in
triple-negative breast cancer was presented at the AACR Annual
Meeting
- On April 5, 2023, Y-mAbs
announced that the first patient had been dosed in the Phase 1
trial of GD2-SADA
- On February 2, 2023, Y-mAbs
announced that the European Medicines Agency agreed to the
Company’s Pediatric Investigational Plan for naxitamab.
- On January 4, 2023, Y-mAbs
announced a restructuring plan including a 35% reduction in
workforce and an anticipated 28% reduction in annual operating
expenses for 2023.
Financial Results
Revenues
Y-mAbs reported DANYELZA net product revenues of $20.3 million
for the quarter ended March 31, 2023, which reflects a 93% increase
over $10.5 million in the comparable quarter of 2022. The DANYELZA
net product revenues of $20.3 million for the quarter ended March
31, 2023 represents an increase of 24% compared to the fourth
quarter 2022 DANYELZA net product revenues of $16.4 million. The
$3.9 million sequential increase was primarily driven by an
increase in new US patients and an incremental benefit from
international revenues. Our net product revenues from other
countries for the three months ended March 31, 2023 included $2.5
million of product revenue from our distribution partner in
connection with the early access program for DANYELZA in Europe.
These sales reflected an initial inventory stocking and we do not
anticipate recurring sales under this program to be as high in
future quarters, which is reflected in our updated revenue guidance
for 2023.
As of March 31, 2023, Y-mAbs has delivered DANYELZA to 53
centers across the United States, corresponding to a sequential
increase of 10% in the number of centers since the fourth quarter
of 2022. During the first quarter of 2023, approximately 62% of the
vials sold in the United States were sold outside Memorial Sloan
Kettering (“MSK”), an increase from the prior quarter as a result
of growth in new patients at institutions outside MSK outpacing
MSK’s growth of new patients.
Operating Expenses
Research and Development
Research and development expenses were $13.4 million for the
three months ended March 31, 2023, compared to $22.9 million for
the three months ended March 31, 2022. The $9.5 million decrease
was primarily due to the decreased spending on deprioritized
programs, which resulted in decreased costs for outsourced
manufacturing services due to decreased clinical trial activities
in 2023, outsourced research and supplies and spending for clinical
trials, partially offset by increased personnel-related costs,
inclusive of stock-based compensation, which includes an
incremental impact for accrued severance related benefits of $1.1
million and accelerated stock-based compensation expense of $0.9
million associated with our first quarter of 2023 restructuring
charge in connection with the implementation of our restructuring
plan.
Selling, General, and Administration
Selling, general, and administrative expenses decreased by $1.2
million to $12.2 million for the three months ended March 31, 2023,
compared to $13.4 million for the three months ended March 31,
2022. The decrease in selling, general and administrative expenses
was primarily the result of decreased personnel-related costs and
insurance costs. The decrease in personnel-related costs is after
$0.8 million accelerated stock-based compensation expense related
to our reduction in force.
Net Loss
We reported a net loss for the first quarter ended March 31,
2023, of ($6.4) million, or ($0.15) per basic and diluted share,
compared to a net loss of ($28.1) million, or ($0.64) per basic and
diluted share, for the quarter ended March 31, 2022. The favorable
improvement in net loss compared to 2022 was primarily driven by
increased DANYELZA revenues and decreased research and development
expenses, partially offset by a $2.8 million incremental impact of
the restructuring charge in the first quarter of 2023.
Cash and Cash Equivalents
We had approximately $92.6 million in cash and cash equivalents
as of March 31, 2023, and we expect a full-year 2023 cash burn of
$40-50 million. Our existing cash and cash equivalents, when
combined with anticipated DANYELZA revenues, which are assumed to
increase by 10% for 2024 and 2025 for the purpose of our analysis
of runway, is expected to be sufficient to fund our operations as
currently planned into 2026. In terms of development activities, we
have assumed that our prioritized programs will be advanced at our
own expense and no new programs are assumed at this point. We
assume no new partnerships or other new business development, and
no further development of the omburtamab program. This
estimate reflects our current business plan that is supported by
assumptions that may prove to be inaccurate, such that we could use
our available capital resources sooner than we currently
expect.
Financial Guidance
We are updating our full-year 2023 financial guidance, which now
reflects:
- Anticipated DANYELZA® net product
revenues now expected to be $80-85 million (previously $60-65
million);
- Anticipated operating expenses
continues to be expected to be $115-120 million;
- Anticipated total annual cash burn
now expected to be $40-50 million (previously $50-55 million);
and
- Cash and cash equivalents
anticipated to support operations as currently planned into the
first quarter of
2026.
Webcast and Conference Call Y-mAbs will host a
conference call on Tuesday, May 9, 2023, at 9 a.m. Eastern Time. To
participate in the call, please use the following dial-in
information.
Investors
(domestic): |
888-886-7786 |
Investors (international): |
416-764-8658 |
Conference ID: |
09065062 |
To access a live webcast of the update, please
use this link.
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 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 2023 and beyond, including estimated operating
expenses, total cash burn and DANYELZA product revenue and
sufficiency of cash resources; the restructuring, including the
reduction in workforce and revised business plan, and the expected
impacts, expenses and benefits thereof, including potential
cost-savings from the reduction in force, expected reduction of
operating expenses and any expectations with respect to cost
savings to be derived therefrom; implied and express statements
regarding the future of the Company’s business; the Company’s plans
and strategies, development, commercialization and product
distribution plans; expectations with respect to omburtamab;
expectations with respect to our products and product candidates,
including potential territory and label expansion of DANYELZA and
the potential market opportunity related thereto and potential
benefits thereof, and the potential of the SADA Technology,
including the development of the first tumor binding dataset and
potential benefits thereof; 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 potential application to GD2 positive solid tumors,
and the timing thereof; expectations with respect to 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 satisfaction of
conditions to approvals; 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 our
financial condition and need for additional capital; the risks that
actual results of our restructuring plan and revised business plan
will not be as expected; 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
macroeconomic conditions, including the conflict between Russia and
Ukraine and sanctions related thereto, 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 ending December 31, 2022, and future
filings and reports by the Company including the Company’s
Quarterly Report on Form 10-Q for the quarter ended March 31, 2023.
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 3350New York,
NY 10169USA
+1 646 885 8505
E-mail: info@ymabs.com
Y-MABS
THERAPEUTICS, INC. |
Consolidated
Balance Sheets |
(unaudited) |
(In
thousands, except share and per share data) |
|
|
|
|
|
|
|
As
of |
|
As
of |
|
March 31, |
|
December 31, |
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
CURRENT
ASSETS |
|
|
|
|
|
Cash and cash equivalents |
$ |
92,629 |
|
|
$ |
105,762 |
|
Accounts receivable, net |
|
18,702 |
|
|
|
12,531 |
|
Inventories |
|
8,945 |
|
|
|
6,702 |
|
Other current assets |
|
3,730 |
|
|
|
5,452 |
|
Total current assets |
|
124,006 |
|
|
|
130,447 |
|
Property and equipment, net |
|
511 |
|
|
|
604 |
|
Operating lease right-of-use assets |
|
1,369 |
|
|
|
1,739 |
|
Intangible assets, net |
|
2,898 |
|
|
|
2,986 |
|
Other assets |
|
8,661 |
|
|
|
5,680 |
|
TOTAL
ASSETS |
$ |
137,445 |
|
|
$ |
141,456 |
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
Accounts payable |
$ |
8,843 |
|
|
$ |
14,175 |
|
Accrued liabilities |
|
16,222 |
|
|
|
13,241 |
|
Operating lease liabilities, current portion |
|
855 |
|
|
|
868 |
|
Total current liabilities |
|
25,920 |
|
|
|
28,284 |
|
Accrued milestone and royalty payments |
|
2,250 |
|
|
|
2,250 |
|
Operating lease liabilities, long-term portion |
|
629 |
|
|
|
899 |
|
Other liabilities |
|
817 |
|
|
|
802 |
|
TOTAL
LIABILITIES |
|
29,616 |
|
|
|
32,235 |
|
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Preferred
stock, $0.0001 par value, 5,500,000 shares authorized and none
issued at March 31, 2023 and
December 31, 2022 |
|
- |
|
|
|
- |
|
Common
stock, $0.0001 par value, 100,000,000 shares authorized at
March 31, 2023 and December 31, 2022;
43,677,767 and 43,670,109 shares issued at March 31, 2023
and December 31, 2022, respectively |
|
4 |
|
|
|
4 |
|
Additional
paid in capital |
|
549,233 |
|
|
|
543,929 |
|
Accumulated
other comprehensive income |
|
1,025 |
|
|
|
1,331 |
|
Accumulated
deficit |
|
(442,433 |
) |
|
|
(436,043 |
) |
TOTAL
STOCKHOLDERS’ EQUITY |
|
107,829 |
|
|
|
109,221 |
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
137,445 |
|
|
$ |
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 March 31, |
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
REVENUES |
|
|
|
|
|
|
Product revenue, net |
|
$ |
20,251 |
|
|
$ |
10,486 |
|
Total
revenues |
|
|
20,251 |
|
|
|
10,486 |
|
OPERATING
COSTS AND EXPENSES |
|
|
|
|
|
|
Cost of goods sold |
|
|
2,083 |
|
|
|
1,831 |
|
Research and development |
|
|
13,418 |
|
|
|
22,912 |
|
Selling, general, and administrative |
|
|
12,251 |
|
|
|
13,438 |
|
Total
operating costs and expenses |
|
|
27,752 |
|
|
|
38,181 |
|
Loss from
operations |
|
|
(7,501 |
) |
|
|
(27,695 |
) |
OTHER INCOME
/ (LOSS), NET |
|
|
|
|
|
|
Interest and other income / (loss) |
|
|
1,111 |
|
|
|
(373 |
) |
NET
LOSS |
|
$ |
(6,390 |
) |
|
$ |
(28,068 |
) |
Other
comprehensive income / (loss) |
|
|
|
|
|
|
Foreign currency translation |
|
|
(306 |
) |
|
|
311 |
|
COMPREHENSIVE LOSS |
|
$ |
(6,696 |
) |
|
$ |
(27,757 |
) |
Net loss per
share attributable to common stockholders, basic and diluted |
|
$ |
(0.15 |
) |
|
$ |
(0.64 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
|
43,671,589 |
|
|
|
43,709,238 |
|
|
|
|
|
|
|
|
|
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