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 fourth quarter and the full year ended
December 31, 2021 and provided recent corporate highlights.
"In recent months, we have achieved significant progress on the
omburtamab BLA, which we expect to resubmit to the FDA by the end
of the first quarter of 2022,” said Dr. Claus Moller, Chief
Executive Officer. “We believe we now have a clear regulatory path
in place and are one step closer to our goal of delivering
omburtamab to children suffering from high-risk neuroblastoma brain
tumors. In parallel, we are continuing to advance SADA, our novel
platform for targeted radioisotope delivery that can potentially be
adapted to various tumor targets. We filed an IND for GD2-SADA, the
first SADA construct for potential use in GD2 positive solid tumors
and are now accelerating pre-clinical testing with plans to submit
at least one IND per year for additional SADA targets. In the
meantime, we are actively pursuing additional collaboration and
partnership opportunities.”
“We are very pleased with our 2021 financial results, especially
with our continued execution of the DANYELZA commercial launch,
which generated revenues of $32.9 million in its first year,” said
Thomas Gad, Founder, Chairman and President. “We continue to be
focused on our oncology programs, supported by a strong balance
sheet. We ended the year with $181.6 million in cash, that is
anticipated to support us through multiple potentially
value-creating catalysts by the end of 2023. We believe that we are
well-positioned to elevate our business and we expect that 2022
will be another productive year for Y-mAbs.”
Fourth Quarter 2021 and Recent Corporate
Developments
- Subsequent to the end of the
fourth quarter, on February 11, 2022, Y-mAbs announced the
completion of a Pre-BLA Meeting with FDA for omburtamab and
confirmed the timeline for resubmission of the omburtamab BLA by
the end of the first quarter of 2022.
- On December 15, 2021, Y-mAbs
announced a pipeline update, including compassionate use data from
an investigational infusion protocol for naxitamab. It was observed
that the protocol may help managing Grade 3 and Grade 4 adverse
events.
- On December 14, 2021, Y-mAbs
appointed Sue Smith to the role of Senior Vice-President, Chief
Commercial Officer, effective January 1, 2022. Ms. Smith brings
more than 25 years of extensive commercial experience including
several successful product launches within cancer, rare diseases,
and endocrinology.
- On October 7, 2021, Y-mAbs
announced that the U.S. Food and Drug
Administration (“FDA”) had granted Rare Pediatric Disease
Designation (“RPDD”) for the Company’s lutetium labeled omburtamab
antibody program for the treatment of medulloblastoma.
Financial Results
Revenues
Y-mAbs reported net revenue of $34.9 million for the year ended
December 31, 2021, which consisted of product revenues of $32.9
million, generated from sales of DANYELZA, our first FDA approved
product, and licensing revenues of $2.0 million related to a
licensing agreement in Latin America. The gross margin for product
revenues was 93% in 2021. Y-mAbs reported net revenues of $20.8
million for the year ended December 31, 2020, related to its
licensing agreements in China and Israel. Y-mAbs did not have
product revenues for the year ended December 31, 2020, as DANYELZA
was not approved by the FDA until late November 2020.
For the fourth quarter of 2021, Y-mAbs incurred net revenues of
$9.6 million, which consisted of product revenues from the sales of
DANYELZA. Sales were up 7.1% from the third quarter 2021, and we
have now delivered DANYELZA to 28 centers across the nation, an
increase of four centers since the third quarter 2021. Treatment
centers outside MSK accounted for approximately 40% of the product
revenues during the fourth quarter of 2021. Y-mAbs incurred net
revenues of $20.8 million for the quarter ending December 31, 2020,
related to its licensing agreements in China and Israel.
Operating Expenses
Research and Development
Y-mAbs is anticipating a BLA resubmission for omburtamab by the
end of the first quarter 2022 and at the same time, the Company is
advancing its antibody constructs through the clinic; predominantly
DANYELZA, omburtamab, and the SADA constructs. Research and
development expenses were $93.2 million for the twelve months ended
December 31, 2021, compared to $93.7 million for the twelve months
ended December 31, 2020. The $0.5 million decrease in research and
development expenses primarily reflects the following main
items:
- $4.8 million decrease in regulatory
affairs expenses; and
- $13.3 million decrease in
milestones and license acquisition costs.
The decreases mentioned above were partially offset by the
following increases:
- $6.2 million increase in outsourced
manufacturing expenses;
- $4.1 million increase in personnel
costs associated with research and development activities; and
- $3.9 million increase in clinical
trial expenses.
Selling, General, and Administration
Selling, general, and administrative expenses were $54.6 million
for the twelve months ended December 31, 2021, compared to $44.8
million for the twelve months ended December 31, 2020,
corresponding to an increase of $9.8 million. The increase in
selling, general, and administrative expenses was primarily due to
a $8.9 million increase in personnel costs, partly associated with
the expansion of our commercial team that is poised to drive
further adoption of DANYELZA in 2022.
Net Result
Y-mAbs reported a net loss of $55.3 million, or ($1.28) per
basic and diluted share, for the year ended December 31, 2021,
compared to a net loss of $119.3 million, or ($2.97) per basic and
diluted share, reported for the year ended December 31, 2020. The
decrease in net loss was primarily caused by the sale in January
2021 of the priority review voucher received upon the approval of
DANYELZA and the DANYELZA revenues generated in 2021, partially
offset by increases in operating expenses related to the
commercialization of DANYELZA in the United States.
For the quarter ended December 31, 2021, Y-mAbs incurred a net
loss of $36.9 million, or ($0.85) per basic and diluted share,
which compares to a net loss of $19.9 million, or ($0.48) per basic
and diluted share, incurred for the quarter ended December 31,
2020. The increase in net loss was primarily caused by the DANYELZA
revenues in 2021 not fully offsetting the licensing income in the
fourth quarter of 2020.
Cash and Cash Equivalents
The Company had approximately $181.6 million in cash and cash
equivalents as of December 31, 2021.
Webcast and Conference Call
The Company will host a conference call on Friday, February 25,
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 13726652.
A webcast will be available at:
https://viavid.webcasts.com/starthere.jsp?ei=1526062&tp_key=59e1f9cc51
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, 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 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 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.
Contact:
Y-mAbs Therapeutics, Inc.230 Park Avenue, Suite 3350New York, NY
10169USA+1 646 885 8505E-mail: info@ymabs.com |
|
|
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Y-MABS
THERAPEUTICS, INC. |
Consolidated
Balance Sheets |
(unaudited) |
(in thousands,
except share data) |
|
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
2021 |
|
2020 |
ASSETS |
|
|
|
|
|
|
CURRENT
ASSETS |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
181,564 |
|
|
$ |
114,634 |
|
Accounts receivable, net |
|
|
7,712 |
|
|
|
— |
|
Inventories |
|
|
5,512 |
|
|
|
— |
|
Other current assets |
|
|
7,473 |
|
|
|
7,729 |
|
Total current assets |
|
|
202,261 |
|
|
|
122,363 |
|
Property and equipment, net |
|
|
1,847 |
|
|
|
1,825 |
|
Operating lease right-of-use assets |
|
|
3,842 |
|
|
|
4,569 |
|
Intangible assets, net |
|
|
1,663 |
|
|
|
— |
|
Other assets |
|
|
3,170 |
|
|
|
3,290 |
|
TOTAL
ASSETS |
|
$ |
212,783 |
|
|
$ |
132,047 |
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
|
Accounts payable |
|
$ |
13,552 |
|
|
$ |
9,372 |
|
Accrued liabilities |
|
|
12,540 |
|
|
|
8,197 |
|
Operating lease liabilities, current portion |
|
|
1,783 |
|
|
|
1,966 |
|
Total current liabilities |
|
|
27,875 |
|
|
|
19,535 |
|
Accrued milestone and royalty payments |
|
|
2,100 |
|
|
|
2,695 |
|
Operating lease liabilities, long-term portion |
|
|
1,851 |
|
|
|
2,013 |
|
Other liabilities |
|
|
851 |
|
|
|
1,968 |
|
TOTAL
LIABILITIES |
|
|
32,677 |
|
|
|
26,211 |
|
|
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Preferred stock, $0.0001 par value, 5,500,000 shares authorized
and |
|
|
|
|
|
|
none issued at December 31, 2021 and
December 31, 2020 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value, 100,000,000 shares authorized
at |
|
|
|
|
|
|
December 31, 2021 and December 31, 2020;
43,694,716 and 40,688,447 |
|
|
|
|
|
|
shares issued at December 31, 2021 and
December 31, 2020, respectively |
|
|
4 |
|
|
|
4 |
|
Additional paid in capital |
|
|
519,206 |
|
|
|
391,558 |
|
Accumulated other comprehensive income / (loss) |
|
|
1,371 |
|
|
|
(526 |
) |
Accumulated deficit |
|
|
(340,475 |
) |
|
|
(285,200 |
) |
TOTAL
STOCKHOLDERS’ EQUITY |
|
|
180,106 |
|
|
|
105,836 |
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
212,783 |
|
|
$ |
132,047 |
|
|
|
|
|
|
|
|
Y-MABS
THERAPEUTICS, INC. |
Consolidated
Statements of Net Loss and Comprehensive Loss |
(unaudited) |
(in thousands,
except share and per share data) |
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
|
2021 |
|
2020 |
|
|
|
|
|
REVENUES |
|
|
|
|
|
|
Product revenue, net |
|
$ |
32,897 |
|
|
$ |
— |
|
License revenue |
|
|
2,000 |
|
|
|
20,750 |
|
Total
revenues |
|
|
34,897 |
|
|
|
20,750 |
|
|
|
|
|
|
|
|
OPERATING
COSTS AND EXPENSES |
|
|
|
|
|
|
Cost of goods sold |
|
|
2,304 |
|
|
|
— |
|
Licensing royalties |
|
|
210 |
|
|
|
2,203 |
|
Research and development |
|
|
93,245 |
|
|
|
93,697 |
|
Selling, general, and administrative |
|
|
54,571 |
|
|
|
44,785 |
|
Total
operating costs and expenses |
|
|
150,330 |
|
|
|
140,685 |
|
Loss from
operations |
|
|
(115,433 |
) |
|
|
(119,935 |
) |
|
|
|
|
|
|
|
OTHER
INCOME, NET |
|
|
|
|
|
|
Gain from sale of priority review voucher, net |
|
|
62,010 |
|
|
|
— |
|
Interest and other income / (loss), net |
|
|
(1,852 |
) |
|
|
598 |
|
NET
LOSS |
|
$ |
(55,275 |
) |
|
$ |
(119,337 |
) |
|
|
|
|
|
|
|
Other
comprehensive income / (loss) |
|
|
|
|
|
|
Foreign currency translation |
|
|
1,897 |
|
|
|
(576 |
) |
COMPREHENSIVE LOSS |
|
$ |
(53,378 |
) |
|
$ |
(119,913 |
) |
|
|
|
|
|
|
|
Net loss per
share attributable to common stockholders, basic and diluted |
|
$ |
(1.28 |
) |
|
$ |
(2.97 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
|
43,181,808 |
|
|
|
40,118,537 |
|
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