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 third quarter of 2022.
"The third quarter marked significant progress for DANYELZA. We
are thrilled to report record sales of $12.5 million, a 28%
increase compared to the previous quarter. In addition, DANYELZA
was approved in Israel and submitted for marketing authorization in
Brazil, and we look forward to our partners’ continued efforts to
expand DANYELZA,” said Thomas Gad, President and Interim Chief
Executive Officer. “While we are truly disappointed by the outcome
of the recent ODAC meeting for omburtamab after working tirelessly
to receive breakthrough designation and submit the BLA to the FDA,
we remain steadfast in our commitment to patients and caregivers
who do not have access to an approved treatment, where there is a
clear unmet need. However, while we await FDA’s formal decision on
the BLA, we remain confident knowing that that Y-mAbs has never
been defined by a single program or technology. Our expertise spans
multiple verticals and disciplines, and we continue to invest
confidently in our future with the promise of SADA while looking to
maximize DANYELZA as the cornerstone of a sustainable pediatric
oncology franchise funded by a strong balance sheet with $114.5
million in cash that is sufficient to support our business
operations as currently planned into mid-2024.”
Third Quarter 2022 and Recent Corporate
Developments
- On October 28, Y-mAbs announced
the outcome of the FDA Oncologic Drugs Advisory Committee meeting,
where the committee voted 16 to 0 that the Company had not provided
sufficient evidence to conclude that omburtamab improves overall
survival
- On October 3, Y-mAbs announced
pivotal data from Study 101 for omburtamab in CNS/LM metastasis
from neuroblastoma at the International Society of Pediatric
Oncology (SIOP) annual congress
- On September 26, Y-mAbs announced
a regulatory filing for DANYELZA for the treatment of neuroblastoma
in Brazil by Adium Pharma
- On August 30, Y-mAbs announced
that Takeda received marketing authorization for DANYELZA for the
treatment of neuroblastoma in Israel
- On July 12, Y-mAbs announced
clearance of the IND for GD2-SADA
Financial Results
Revenues
Y-mAbs reported net revenues of $12.5 million and $33.8 million
for the third quarter 2022 and nine months ended September 30,
2022, which represented increases of 40% and 34%, respectively,
over $9.0 million and $25.3 million in the comparable periods of
2021. Net revenues in the nine months ended September 30, 2022
included $1.0 million of license revenue, compared to $2.0 million
of license revenue in the corresponding period in 2021.
DANYELZA product revenue for the third quarter 2022 and nine
months ended September 30, 2022, was $12.5 million and $32.8
million, respectively, which represented increases of 40% and 41%,
respectively, over the corresponding periods in 2021 and an
increase of 28% compared to the second quarter of 2022 DANYELZA
product revenues of $9.8 million. The increase was primarily driven
by an increase in the number of new U.S. patients in treatment
during the third quarter of 2022.
As of September 30, 2022, Y-mAbs has delivered DANYELZA to 43
centers across the United States, corresponding to an increase of
more than 19% in the number of centers since the end of the second
quarter of 2022. During the third quarter of 2022, approximately
40% of the vials sold in the United States were sold outside
Memorial Sloan Kettering (“MSK”), a decrease from the prior quarter
as a result of MSK’s growth of new patients outpacing the growth of
new patients at institutions outside MSK.
Operating Expenses
Research and Development
Research and development expenses were $22.4 million for the
three months ended September 30, 2022, compared to $23.1 million
for the three months ended September 30, 2021. The $0.7 million
decrease reflects decreased spending for clinical trials, partially
offset by increased costs for outsourced manufacturing services.
Having completed the resubmission of the BLA for omburtamab in the
first quarter of 2022, we are focusing on pipeline development
programs for potential DANYELZA label expansion and advancing SADA
constructs into the clinic.
Research and development expenses increased by $7.3 million to
$71.8 million during the nine months ended September 30, 2022,
compared to the prior year period. The $7.3 million increase mainly
reflects an increase in outsourced manufacturing services and
increased personnel costs dedicated to our advancement of DANYELZA,
omburtamab, and the SADA constructs.
Selling, General, and Administration
Selling, general, and administrative expenses decreased by $0.4
million to $13.6 million for the three months ended September 30,
2022, compared to $14.0 million for the three months ended
September 30, 2021. The decrease in selling, general and
administrative expenses was primarily the result of a $2.1 million
decrease in salary and stock-based compensation expense, partially
offset by increased costs related to the commercialization of
DANYELZA.
Selling, general, and administrative expenses increased by $10.7
million to $50.1 million for the nine months ended September 30,
2022, compared to $39.4 million for the nine months ended September
30, 2021. The increase in selling, general, and administrative
expenses was primarily attributable to an $8.9 million increase in
severance and share-based compensation expense related to our
former chief executive officer in the nine months ended September
30, 2022, and to a lesser extent, the commercialization of
DANYELZA.
Net Loss
We reported a net loss for the quarter ended September 30, 2022
of $27.5 million, or $0.63 per basic and diluted share, compared to
a net loss of $28.9 million, or $0.66 per basic and diluted share
for the quarter ended September 30, 2021. The decrease in net loss
was primarily driven by the positive gross profit impact from
increased revenues.
We reported a net loss for the nine months ended September 30,
2022 of $96.7 million, or $2.21 per basic and diluted share,
compared to a net loss of $18.4 million, or $0.43 per basic and
diluted share, for the nine months ended September 30, 2021. Net
loss in the nine months ended September 30, 2021 included a $62.0
million net gain from the sale of our DANYELZA Priority Review
Voucher, after sharing 40% of the net proceeds from the sale with
MSK, pursuant to the terms of our license agreement with MSK. The
increase in net loss in the nine months ended September 30, 2022
also reflects the impact of contractual severance-related benefits
for our former chief executive officer, and increased research and
development expenses, both as noted above, partially offset by the
gross profit impact of DANYELZA’s revenue growth.
Cash and Cash Equivalents
We had approximately $114.5 million in cash and cash equivalents
as of September 30, 2022, and we continue to expect a full-year
2022 cash burn of $78-83 million. Our cash and cash equivalents
balance, when combined with anticipated DANYELZA revenues, is
expected to be sufficient to fund our operations as currently
planned into mid-2024. This estimate is based on our current
business plan, and we have based this estimate on assumptions that
may prove to be wrong, and we could use our available capital
resources sooner than we currently expect.
This estimate does not include any potential product revenues
for omburtamab, if approved, or any potential net proceeds from the
potential receipt and sale of any priority review voucher, which we
expect would be awarded to us if we receive approval of omburtamab.
The estimate assumes receipt of a regulatory milestone payment for
DANYELZA approval in China, but no new partnerships or other new
business development-related sources of income.
Financial Guidance
Management reiterates all elements of its 2022 financial
guidance including, anticipated:
- DANYELZA® product revenues of
$45-$50 million;
- Operating expenses of $162-167
million;
- Total cash burn of $78-83 million;
and
- Cash position sufficient to fund
current operations as planned into
mid-2024.
The DANYELZA revenue guidance includes an incremental benefit
from international revenues. We will review operating expenses
based on final FDA feedback on the omburtamab BLA but expect no
adverse impact on cash runway.
Webcast and Conference Call Y-mAbs will host a
conference call on Tuesday, November 8, 2022, at 4 p.m. Eastern
Time. To participate in the call, please dial 877-300-8521
(domestic) or 412-317-6026 (international) and reference the
conference ID 10172741.
A webcast will be available at:
https://viavid.webcasts.com/starthere.jsp?ei=1579270&tp_key=92279e61e6
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 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, including
statements with respect to the potential approval and utility of
omburtamab, pipeline development programs, potential for DANYELZA
territory expansion, and advancement of SADA; collaborations or
strategic partnerships and the potential benefits thereof;
potential for receipt and sale of a PRV voucher relating to
omurtamab, if approved, and potential net proceeds therefrom;
expectations related to our anticipated cash runway and the
sufficiency of our cash resources; DANYELZA revenue guidance and
other guidance for 2022 and future years, and our financial
performance, including our estimates regarding revenues, expenses
and capital expenditure requirements; 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 COVID-19
pandemic; risks associated with the conflict between Russia and
Ukraine and sanctions related thereto, macroeconomic conditions,
including inflation and volatile global capital markets; 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, including our Quarterly
Report on Form 10-Q for the quarter ended September 30, 2022 to be
filed with the SEC. 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 8505E-mail: info@ymabs.com
Y-MABS
THERAPEUTICS, INC. |
Consolidated
Balance Sheets |
(unaudited) |
(in
thousands, except share data) |
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2022 |
|
2021 |
ASSETS |
|
|
|
|
|
|
CURRENT
ASSETS |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
114,526 |
|
|
$ |
181,564 |
|
Accounts receivable, net |
|
|
9,251 |
|
|
|
7,712 |
|
Inventories |
|
|
6,242 |
|
|
|
5,512 |
|
Other current assets |
|
|
3,225 |
|
|
|
7,473 |
|
Total current assets |
|
|
133,244 |
|
|
|
202,261 |
|
Property and equipment, net |
|
|
1,372 |
|
|
|
1,847 |
|
Operating lease right-of-use assets |
|
|
2,169 |
|
|
|
3,842 |
|
Intangible assets, net |
|
|
1,530 |
|
|
|
1,663 |
|
Other assets |
|
|
5,600 |
|
|
|
3,170 |
|
TOTAL
ASSETS |
|
$ |
143,915 |
|
|
$ |
212,783 |
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
|
Accounts payable |
|
$ |
13,723 |
|
|
$ |
13,552 |
|
Accrued liabilities |
|
|
17,092 |
|
|
|
12,540 |
|
Operating lease liabilities, current portion |
|
|
1,200 |
|
|
|
1,783 |
|
Total current liabilities |
|
|
32,015 |
|
|
|
27,875 |
|
Accrued milestone payments |
|
|
2,250 |
|
|
|
2,100 |
|
Operating lease liabilities, long-term portion |
|
|
1,019 |
|
|
|
1,851 |
|
Other liabilities |
|
|
733 |
|
|
|
851 |
|
TOTAL
LIABILITIES |
|
|
36,017 |
|
|
|
32,677 |
|
Commitments
and contingencies (Note 9) |
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Preferred
stock, $0.0001 par value, 5,500,000 shares authorized and none
issued at |
|
|
|
|
|
|
September 30, 2022 and December 31, 2021 |
|
|
— |
|
|
|
— |
|
Common
stock, $0.0001 par value, 100,000,000 shares authorized at |
|
|
|
|
|
|
September 30, 2022 and December 31, 2021; 43,668,130
and 43,694,716 shares issued |
|
|
|
|
|
and
outstanding at September 30, 2022 and
December 31, 2021, respectively |
|
|
4 |
|
|
|
4 |
|
Additional
paid in capital |
|
|
540,392 |
|
|
|
519,206 |
|
Accumulated
other comprehensive income |
|
|
4,702 |
|
|
|
1,371 |
|
Accumulated
deficit |
|
|
(437,200 |
) |
|
|
(340,475 |
) |
TOTAL
STOCKHOLDERS’ EQUITY |
|
|
107,898 |
|
|
|
180,106 |
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
143,915 |
|
|
$ |
212,783 |
|
|
|
|
|
|
|
|
Y-MABS
THERAPEUTICS, INC. |
Consolidated
Statements of Net Loss and Comprehensive Loss |
(unaudited) |
(in thousands,
except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
REVENUES |
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
|
|
$ |
12,537 |
|
|
$ |
8,965 |
|
|
$ |
32,820 |
|
|
$ |
23,299 |
|
License revenue |
|
|
|
— |
|
|
|
— |
|
|
|
1,000 |
|
|
|
2,000 |
|
Total
revenues |
|
|
|
12,537 |
|
|
|
8,965 |
|
|
|
33,820 |
|
|
|
25,299 |
|
OPERATING
COSTS AND EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
|
2,475 |
|
|
|
550 |
|
|
|
5,447 |
|
|
|
843 |
|
License royalties |
|
|
|
— |
|
|
|
— |
|
|
|
100 |
|
|
|
210 |
|
Research and development |
|
|
|
22,453 |
|
|
|
23,131 |
|
|
|
71,785 |
|
|
|
64,488 |
|
Selling, general, and administrative |
|
|
|
13,626 |
|
|
|
13,988 |
|
|
|
50,146 |
|
|
|
39,433 |
|
Total
operating costs and expenses |
|
|
|
38,554 |
|
|
|
37,669 |
|
|
|
127,478 |
|
|
|
104,974 |
|
Loss from
operations |
|
|
|
(26,017 |
) |
|
|
(28,704 |
) |
|
|
(93,658 |
) |
|
|
(79,675 |
) |
OTHER INCOME
/ (LOSS), NET |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain from sale of priority review voucher, net |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
62,010 |
|
Interest and other loss |
|
|
|
(1,509 |
) |
|
|
(154 |
) |
|
|
(3,067 |
) |
|
|
(717 |
) |
NET
LOSS |
|
|
$ |
(27,526 |
) |
|
$ |
(28,858 |
) |
|
$ |
(96,725 |
) |
|
$ |
(18,382 |
) |
Other
comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation |
|
|
|
1,598 |
|
|
|
238 |
|
|
|
3,331 |
|
|
|
751 |
|
COMPREHENSIVE LOSS |
|
|
$ |
(25,928 |
) |
|
$ |
(28,620 |
) |
|
$ |
(93,394 |
) |
|
$ |
(17,631 |
) |
Net loss per
share attributable to common stockholders, basic and diluted |
|
|
$ |
(0.63 |
) |
|
$ |
(0.66 |
) |
|
$ |
(2.21 |
) |
|
$ |
(0.43 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
|
|
43,718,351 |
|
|
|
43,598,350 |
|
|
|
43,715,451 |
|
|
|
43,019,217 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Y mAbs Therapeutics (NASDAQ:YMAB)
Historical Stock Chart
From Jun 2024 to Jul 2024
Y mAbs Therapeutics (NASDAQ:YMAB)
Historical Stock Chart
From Jul 2023 to Jul 2024