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 2022.
"Y-mAbs had a successful first quarter. We resubmitted the
omburtamab BLA, bringing us one step closer to the potential
approval and achieving our goal of delivering omburtamab to
children suffering from high-risk neuroblastoma brain tumors,” said
Thomas Gad, Interim Chief Executive Officer. “We are very
encouraged by our first quarter financial results, driven by our
continued execution of the DANYELZA launch which generated revenues
of $10.5 million. Based on the steady progress and a strong first
quarter we anticipate full-year 2022 DANYELZA revenues in the range
of $45-50 million. Our strong balance sheet with $156.7 million in
cash, and anticipated revenues from product sales, is expected to
support us through multiple potentially value-creating catalysts
and into mid-2024.”
First Quarter 2021 and Recent Corporate
Developments
- On April 27, 2022, Y-mAbs
announced a management change. Dr. Claus Moller has stepped down as
Chief Executive Officer and Board Member, and Thomas Gad, the
Company’s Founder, Chairman, and President has assumed the role of
Interim CEO. The Board, under the newly appointed Chairman Dr. Jim
Healy, has begun a search for Dr. Moller’s successor.
- On April 8, 2022, Y-mAbs
presented pre-clinical data from the GD2-SADA construct at the
American Association for Cancer Research (AACR) 2022 Annual
Meeting. Pre-clinical models indicated that treatment with GD2-SADA
increased tumor antigen binding, uptake, and persistence in tumor
tissue in-vivo with activity lasting over 100 days after the
treatment.
- On April 1, 2022, Y-mAbs
announced that on March 31, 2022, the Company completed the
resubmission of its Biologics License Application for omburtamab to
the FDA. The FDA has a 60-day review period to determine whether
the BLA is complete and acceptable for filing.
Financial Results
Revenues
Y-mAbs reported net revenues of $10.5 million for the quarter
ended March 31, 2022, which was a 94% increase over $5.4 million in
the comparable quarter of 2021. Additionally, net revenues were up
9% from the fourth quarter 2021. The Company has now delivered
DANYELZA to 34 centers across the nation, corresponding to an
increase of more than 20% since the end of the fourth quarter of
2021. Approximately 50% of the vials sold in the U.S. are now sold
outside Memorial Sloan Kettering (“MSK”), a notable increase over
the approximately 40% of the vials sold outside MSK in prior
quarters.
Operating Expenses
Research and Development
Research and development expenses were $22.9 million for the
three months ended March 31, 2022, compared to $21.6 million for
the three months ended March 31, 2021. The $1.3 million increase
reflects our increased clinical trial activity and employee-related
costs, partially offset by decreased outsourced manufacturing
expenses. Having completed the resubmission of the BLA for
omburtamab on March 31, 2022, Y-mAbs is focusing pipeline
development on DANYELZA label expansion, omburtamab, and advancing
the SADA constructs into the clinic.
Selling, General, and Administration
Selling, general, and administrative expenses were $13.4 million
for the three months ended March 31, 2022, which was a $1.4 million
increase compared to $12.0 million for the three months ended March
31, 2021. The increase in selling, general, and administrative
expenses was primarily due to costs related to the launch and
commercialization of DANYELZA; which includes a $0.7 million
increase in personnel costs due to the expansion of our commercial
team that is poised to drive further adoption of DANYELZA in 2022
and beyond.
Net Result
Y-mAbs reported a net loss for the quarter ended March 31, 2022,
of $28.1 million, or $0.64 per basic and diluted share, compared to
net income of $33.4 million, or $0.80 per basic share and $0.75 per
diluted share, for the quarter ended March 31, 2021. The decrease
in earnings was primarily driven by a one-time $62.0 million net
gain from the sale of our DANYELZA Priority Review Voucher in the
quarter ended March 31, 2021, partially offset by the favorable
impact of increasing DANYELZA revenues.
Cash and Cash Equivalents
The Company had approximately $156.7 million in cash and cash
equivalents as of March 31, 2022, which, when combined with
anticipated revenues from product sales, is expected to be
sufficient to fund the current operations to mid-2024.
Webcast and Conference Call
Y-mAbs will host a conference call on Tuesday, May 10, 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 13729248.
A webcast will be available at:
https://services.choruscall.com/mediaframe/webcast.html?webcastid=yCAEVjRU
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 its variants such as Delta and Omicron, risks
associated with Russia’s recent invasion of Ukraine 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 for the year ended December 31, 2021 filed with the SEC 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 |
Y-MABS
THERAPEUTICS, INC. |
|
Consolidated
Balance Sheets |
(unaudited) |
(in thousands,
except share data) |
|
|
|
|
|
|
|
|
|
March 31, |
|
December31, |
|
|
2022 |
|
2021 |
ASSETS |
|
|
|
|
|
|
CURRENT
ASSETS |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
156,724 |
|
|
$ |
181,564 |
|
Accounts receivable, net |
|
|
9,324 |
|
|
|
7,712 |
|
Inventories |
|
|
5,588 |
|
|
|
5,512 |
|
Other current assets |
|
|
6,103 |
|
|
|
7,473 |
|
Total current assets |
|
|
177,739 |
|
|
|
202,261 |
|
Property and equipment, net |
|
|
1,697 |
|
|
|
1,847 |
|
Operating lease right-of-use assets |
|
|
3,155 |
|
|
|
3,842 |
|
Intangible assets, net |
|
|
1,618 |
|
|
|
1,663 |
|
Other assets |
|
|
6,838 |
|
|
|
3,170 |
|
TOTAL
ASSETS |
|
$ |
191,047 |
|
|
$ |
212,783 |
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
|
Accounts payable |
|
$ |
14,661 |
|
|
$ |
13,552 |
|
Accrued liabilities |
|
|
12,930 |
|
|
|
12,540 |
|
Operating lease liabilities, current portion |
|
|
1,451 |
|
|
|
1,783 |
|
Total current liabilities |
|
|
29,042 |
|
|
|
27,875 |
|
Accrued milestone and royalty payments |
|
|
2,100 |
|
|
|
2,100 |
|
Operating lease liabilities, long-term portion |
|
|
1,598 |
|
|
|
1,851 |
|
Other liabilities |
|
|
835 |
|
|
|
851 |
|
TOTAL
LIABILITIES |
|
|
33,575 |
|
|
|
32,677 |
|
|
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Preferred stock, $0.0001 par value, 5,500,000 shares authorized
and |
|
|
|
|
|
|
none issued at March 31, 2022 and
December 31, 2021 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value, 100,000,000 shares authorized
at |
|
|
|
|
|
|
March 31, 2022 and December 31, 2021;
43,718,165 and 43,694,716 |
|
|
|
|
|
shares issued at March 31, 2022 and
December 31, 2021, respectively |
|
4 |
|
|
|
4 |
|
Additional paid in capital |
|
|
524,329 |
|
|
|
519,206 |
|
Accumulated other comprehensive income |
|
|
1,682 |
|
|
|
1,371 |
|
Accumulated deficit |
|
|
(368,543 |
) |
|
|
(340,475 |
) |
TOTAL
STOCKHOLDERS’ EQUITY |
|
|
157,472 |
|
|
|
180,106 |
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
191,047 |
|
|
$ |
212,783 |
|
|
|
|
|
|
|
|
Y-MABS
THERAPEUTICS, INC. |
|
Consolidated
Statements of Net Income/(Loss) and Comprehensive
Income/(Loss) |
(unaudited) |
(in thousands,
except share and per share data) |
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
2022 |
|
2021 |
REVENUES |
|
|
|
|
|
|
Product revenue, net |
|
$ |
10,486 |
|
|
$ |
5,383 |
|
Total
revenues |
|
|
10,486 |
|
|
|
5,383 |
|
|
|
|
|
|
|
|
OPERATING
COSTS AND EXPENSES |
|
|
|
|
|
|
Cost of goods sold |
|
|
1,831 |
|
|
|
93 |
|
Research and development |
|
|
22,912 |
|
|
|
21,579 |
|
Selling, general, and administrative |
|
|
13,438 |
|
|
|
11,970 |
|
Total
operating costs and expenses |
|
|
38,181 |
|
|
|
33,642 |
|
Loss from
operations |
|
|
(27,695 |
) |
|
|
(28,259 |
) |
|
|
|
|
|
|
|
OTHER INCOME
/ (LOSS), NET |
|
|
|
|
|
|
Gain from sale of priority review voucher, net |
|
|
— |
|
|
|
62,010 |
|
Interest and other loss |
|
|
(373 |
) |
|
|
(338 |
) |
NET INCOME /
(LOSS) |
|
$ |
(28,068 |
) |
|
$ |
33,413 |
|
|
|
|
|
|
|
|
Other
comprehensive income / (loss) |
|
|
|
|
|
|
Foreign currency translation |
|
|
311 |
|
|
|
435 |
|
COMPREHENSIVE INCOME / (LOSS) |
|
$ |
(27,757 |
) |
|
$ |
33,848 |
|
|
|
|
|
|
|
|
Net income /
(loss) per share attributable to common stockholders, basic |
|
$ |
(0.64 |
) |
|
$ |
0.80 |
|
Weighted
average common shares outstanding, basic |
|
|
43,709,238 |
|
|
|
41,870,759 |
|
Net income /
(loss) per share attributable to common stockholders, diluted |
|
$ |
(0.64 |
) |
|
$ |
0.75 |
|
Weighted
average common shares outstanding, diluted |
|
|
43,709,238 |
|
|
|
44,383,791 |
|
|
|
|
|
|
|
|
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