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 2021.
“We are very pleased with our first quarter 2021
financial results, as we have been commercializing DANYELZA®
(naxitamab-gqgk) throughout the U.S. since the beginning of
February and we are very pleased with our progress to date. In
addition, we successfully completed a follow-on offering with gross
proceeds of approximately $115 million and netted another $62
million from closing the sale of our Priority Review Voucher, after
sharing the total sales price of $105 million with MSK pursuant to
the terms of our license agreement. With a cash balance of $252
million, we believe we are well positioned to advance our pipeline
in the coming years,” stated Thomas Gad, founder, Chairman and
President.
Dr. Claus Moller, Chief Executive Officer,
continued, “We successfully submitted the European Marketing
Authorization Application for omburtamab to the European Medicines
Agency (“EMA”) in April. In parallel, we are making good progress
in the clinic and have continued to advance the earlier stage
programs in our pipeline, including GPA33-SADA, where we reported
radioactivity uptake with a tumor to blood ratio of 122 in a mouse
model. We are planning for the first SADA IND later this year and
target an IND for GPA33-SADA in 2022.”
Recent Corporate
Developments
- Subsequent to the end of the first quarter, on April 27, 2021,
Y-mAbs announced the submission to EMA of a European Marketing
Authorization Application for omburtamab for the treatment of
pediatric patients with CNS/leptomeningeal metastasis from
neuroblastoma.
- Also subsequent to the end of the first quarter, on April 20,
2021, Y-mAbs announced a regulatory update for resubmission of the
BLA for omburtamab, reconfirming our aim to resubmit the BLA late
in the second quarter or in the third quarter 2021.
- After the close of the first quarter, on April 12, 2021, Y-mAbs
announced data from GPA33-SADA, which in a xenograft model of
colorectal peritoneal carcinomatosis showed radioactivity uptake
with a tumor to blood ratio of 122 measured 24 hours after
injection. An IND for the GPA33-SADA is targeted for next
year.
- On February 22, 2021, Y-mAbs announced the closing of a
follow-on shelf public offering, including the full exercise of the
underwriters’ overallotment option, resulting in gross proceeds to
the Company of approximately $115.0 million.
Financial Results
Y-mAbs reported net income of $33.4 million, or
$0.80 per basic share or $0.75 per diluted share, for the quarter
ended March 31, 2021, compared to a net loss of $26.2 million, or
($0.66) per basic and diluted share, reported for the quarter ended
March 31, 2020. The increased net income was caused by the DANYELZA
revenues and the recording of the net proceeds from monetization of
the DANYELZA Priority Review Voucher.
Revenues
Y-mAbs reported net revenues of $5.4 million for
the quarter ended March 31, 2021 from the sales of DANYELZA. No
revenues were reported for the quarter ended March 31, 2020.
Operating Expenses
Research and DevelopmentResearch and development
expenses were $21.6 million for the three months ended March 31,
2021, compared to $18.6 million for the three months ended March
31, 2020, an increase of $3.0 million. The increase in research and
development expenses primarily reflects the following:
- $2.0 million increase in outsourced manufacturing;
- $2.5 million increase in personnel costs; and
- $0.8 million increase in clinical trials.
These increases were partially offset by a $3.1
million decrease in outsourced research and supplies.
Selling, General, and AdministrationSelling,
general, and administrative expenses were $12.0 million for the
three months ended March 31, 2021, compared to $8.1 million for the
three months ended March 31, 2020, an increase of $3.9 million. The
increase in selling general and administrative expenses primarily
reflects the following:
- $3.3 million increase in personnel costs.
Cash and Cash Equivalents
The Company had approximately $252.3 million in
cash and cash equivalents as of March 31, 2021.
Webcast and Conference Call
The Company will host a conference call on
Friday, May 7, 2021 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 access code 13718796. A webcast
will be available at:
http://public.viavid.com/index.php?id=144412
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical
company focused on the development and commercialization of novel,
antibody-based therapeutic products for the treatment of cancer.
The Company has a broad and advanced product pipeline, including
one FDA approved product, DANYELZA® (naxitamab-gqgk), which targets
tumors that express GD2, and one pivotal-stage product candidate,
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 novel 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.
Y-MABS THERAPEUTICS, INC. |
Consolidated Balance Sheets |
(unaudited) |
(in thousands, except share data) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
2021 |
|
2020 |
ASSETS |
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
Cash and cash equivalents |
$ |
252,271 |
|
|
$ |
114,634 |
|
Accounts receivable, net |
|
5,997 |
|
|
|
— |
|
Inventories |
|
1,005 |
|
|
|
— |
|
Other current assets |
|
4,736 |
|
|
|
7,729 |
|
Total current assets |
|
264,009 |
|
|
|
122,363 |
|
Property and equipment, net |
|
2,095 |
|
|
|
1,825 |
|
Operating lease right-of-use assets |
|
3,979 |
|
|
|
4,569 |
|
Other assets |
|
4,833 |
|
|
|
3,290 |
|
TOTAL ASSETS |
$ |
274,916 |
|
|
$ |
132,047 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
Accounts payable |
$ |
6,543 |
|
|
$ |
9,372 |
|
Accrued liabilities |
|
8,486 |
|
|
|
8,197 |
|
Operating lease liabilities, current portion |
|
1,971 |
|
|
|
1,966 |
|
Total current liabilities |
|
17,000 |
|
|
|
19,535 |
|
Accrued milestone and royalty payments |
|
2,250 |
|
|
|
2,695 |
|
Operating lease liabilities, long-term portion |
|
1,515 |
|
|
|
2,013 |
|
Other liabilities |
|
1,934 |
|
|
|
1,968 |
|
TOTAL LIABILITIES |
|
22,699 |
|
|
|
26,211 |
|
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Preferred stock, $0.0001 par value, 5,500,000 shares authorized
at |
|
|
|
|
|
March 31, 2021 and December 31, 2020; none
issued at |
|
|
|
|
|
March 31, 2021 and December 31, 2020 |
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value, 100,000,000 shares authorized
at |
|
|
|
|
|
March 31, 2021 and December 31, 2020;
43,548,419 and 40,688,447 |
|
|
|
|
|
shares issued at March 31, 2021 and
December 31, 2020, respectively |
|
4 |
|
|
|
4 |
|
Additional paid in capital |
|
504,091 |
|
|
|
391,558 |
|
Accumulated other comprehensive income / (loss) |
|
(91 |
) |
|
|
(526 |
) |
Accumulated deficit |
|
(251,787 |
) |
|
|
(285,200 |
) |
TOTAL STOCKHOLDERS’ EQUITY |
|
252,217 |
|
|
|
105,836 |
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
274,916 |
|
|
$ |
132,047 |
|
|
|
|
|
|
|
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, |
|
2021 |
|
2020 |
|
|
|
|
REVENUE |
|
|
|
|
|
Product revenue, net |
$ |
5,383 |
|
|
$ |
— |
|
OPERATING COSTS AND EXPENSES |
|
|
|
|
|
Cost of goods sold |
|
93 |
|
|
|
— |
|
Research and development |
|
21,579 |
|
|
|
18,622 |
|
Selling, general, and administrative |
|
11,970 |
|
|
|
8,125 |
|
Total operating costs and expenses |
|
33,642 |
|
|
|
26,747 |
|
Loss from operations |
|
(28,259 |
) |
|
|
(26,747 |
) |
|
|
|
|
|
|
OTHER INCOME |
|
|
|
|
|
Gain from sale of priority review voucher |
|
62,010 |
|
|
|
— |
|
Interest and other income, net |
|
(338 |
) |
|
|
568 |
|
NET INCOME / (LOSS) |
$ |
33,413 |
|
|
$ |
(26,179 |
) |
|
|
|
|
|
|
Other comprehensive income |
|
|
|
|
|
Foreign currency translation |
|
435 |
|
|
|
25 |
|
COMPREHENSIVE INCOME / (LOSS) |
$ |
33,848 |
|
|
$ |
(26,154 |
) |
|
|
|
|
|
|
Net income/(loss) per share attributable to common stockholders,
basic |
$ |
0.80 |
|
|
$ |
(0.66 |
) |
Weighted average common shares outstanding, basic |
|
41,870,759 |
|
|
|
39,753,583 |
|
Net income/(loss) per share
attributable to common stockholders, diluted |
$ |
0.75 |
|
|
$ |
(0.66 |
) |
Weighted average common shares
outstanding, diluted |
|
44,383,791 |
|
|
|
39,753,583 |
|
|
|
|
|
|
|
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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