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 full year 2022.
“The fourth quarter of 2022 marked another period of significant
progress for DANYELZA and set up 2023 to be a very productive
year,” said Thomas Gad, President and Interim Chief Executive
Officer. “We are thrilled to report record DANYELZA net revenues of
$16.4 million in the fourth quarter of 2022, a 31% sequential
increase compared to the previous quarter. In addition, DANYELZA
was conditionally approved in China, with a planned launch in the
first half of 2023. We look forward to our partners’ continued
efforts to expand DANYELZA globally to offer much-needed treatment
for patients with relapsed/refractory high-risk neuroblastoma in
the bone or bone marrow.”
Mr. Gad continued, “We recently 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 $105.8 million in cash and cash
equivalents as of December 31, 2022, which we estimate should
support our business operations as currently planned into the first
quarter of 2026. We achieved a major milestone of getting our first
unique SADA IND cleared by the FDA and opening up our first ever
SADA Phase I trial late in 2022. We are actively screening patients
initially for Small Cell Lung Cancer, Sarcoma and Melanoma and are
eventually planning to screen more broadly for GD2 positive solid
tumors.”
Fourth Quarter 2022 and Recent Corporate
Developments
- 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
- On December 21, 2022, Y-mAbs
announced a partnership with WEP Clinical regarding early access
program for DANYELZA (naxitamab-gqgk) in Europe
- On December 14, 2022, Y-mAbs
announced a new SADA construct, CD38-SADA against non-Hodgkin’s
Lymphoma
- On December 8, 2022, Y-mAbs
announced that DANYELZA (naxitamab-gqgk) for the treatment of
high-risk neuroblastoma was conditionally approved in China
- On December 1, 2022, Y-mAbs
announced that the Company had received a complete response letter
for omburtamab BLA indicating that the FDA determined that it was
unable to approve the BLA in its current form
- On November 17, 2022, Y-mAbs
activated its first ever SADA Phase I trial site and by March 11
Memorial Sloan Kettering was activated as the fourth clinical study
site planned to enroll Small Cell Lung Cancer, Sarcoma and Melanoma
patients
- On October 28, 2022, 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, 2022 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
Financial Results
Revenues
Y-mAbs reported net revenues of $31.5 million and $65.3 million
for the fourth quarter 2022 and year ended December 31, 2022, which
represented increases of 228% and 87%, respectively, over $9.6
million and $34.9 million in the comparable periods of 2021. Net
revenues in the quarter and year ended December 31, 2022 included
license revenue of $15.0 million and $16.0 million, respectively,
compared to no license revenue in the fourth quarter ended December
31, 2021, and license revenue of $2.0 million for the year ended
December 31, 2021. During the three months and year ended December
31, 2022, we recognized a regulatory-based milestone payment
received of $15.0 million from SciClone Pharmaceuticals
International Ltd. for the conditional approval of DANYELZA in
China.
DANYELZA net product revenue for the fourth quarter of 2022 and
year ended December 31, 2022, was $16.4 million and $49.3 million,
respectively, which represented increases of 71% and 50%,
respectively, over the corresponding periods in 2021 and an
increase of 31% compared to the third quarter 2022 DANYELZA net
product revenues of $12.5 million. The increase was primarily
driven by an increase in the number of new U.S. patients in
treatment during the fourth quarter of 2022.
As of December 31, 2022, Y-mAbs has delivered DANYELZA to 48
centers across the United States, corresponding to an increase of
12% in the number of centers since the third quarter of 2022.
During the fourth quarter of 2022, approximately 53% 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 the growth of new patients at institutions outside MSK outpacing
MSK’s growth of new patients.
Operating Expenses
Research and Development
Research and development expenses were $19.8 million for the
three months ended December 31, 2022, compared to $28.7 million for
the three months ended December 31, 2021. The $8.9 million decrease
reflects decreased spending for clinical trials, outsourced
research and supplies, and costs for outsourced manufacturing
services due to decreased clinical trial activities in 2022. Having
completed the resubmission of the BLA for omburtamab in the first
quarter of 2022, we are now focused on pipeline development
programs for potential DANYELZA label expansion and advancing SADA
constructs into the clinic.
Research and development expenses decreased by $1.6 million to
$91.6 million during the year ended December 31, 2022, compared to
the prior year period. The decrease mainly reflects decreased
clinical trial activities in 2022.
Selling, General, and Administration
Selling, general, and administrative expenses decreased by $4.3
million to $10.8 million for the three months ended December 31,
2022, compared to $15.1 million for the three months ended December
31, 2021. The decrease in selling, general and administrative
expenses was primarily the result of a $1.8 million decrease in
costs related to the commercialization of DANYELZA as there were
heavy launch costs in the fourth quarter of 2021.
Selling, general, and administrative expenses increased by $6.3
million to $60.9 million for the year ended December 31, 2022,
compared to $54.6 million for the year ended December 31, 2021. The
increase in selling, general, and administrative expenses was
primarily attributable to a $7.8 million increase in severance and
share-based compensation expense related to the termination of our
former chief executive officer.
Net Loss
We reported net income for the fourth quarter ended December 31,
2022, of $1.2 million, or $0.03 per basic and diluted share,
compared to a net loss of $36.9 million, or $0.85 per basic and
diluted share, for the quarter ended December 31, 2021. The
favorable change to net income in 2022 was primarily driven by the
license revenues of $15.0 million, the positive gross profit impact
from increased DANYELZA revenues and the decreased research and
development expenses in 2022.
We reported a net loss for the year ended December 31, 2022, of
$95.6 million, or $2.19 per basic and diluted share, compared to a
net loss of $55.3 million, or $1.28 per basic and diluted share,
for the year ended December 31, 2021. Net loss in the year ended
December 31, 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 for the year
ended December 31, 2022, also reflects the impact of contractual
severance-related benefits for our former chief executive officer,
as noted above, partially offset by the gross profit impact of
DANYELZA’s revenue growth and 2022 license revenues.
Cash and Cash Equivalents
We had approximately $105.8 million in cash and cash equivalents
as of December 31, 2022, and we expect a full-year 2023 cash burn
of $50-55 million. Our existing cash and cash equivalents, when
combined with anticipated DANYELZA revenues, which are assumed to
increase by 10% each year for the purpose of our analysis of
runway, is expected to be sufficient to fund our operations into
the first quarter of 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
Management reiterated its 2023 financial guidance including:
- Anticipated DANYELZA® net product revenues of $60-$65
million;
- Anticipated operating expenses of $115-120 million;
- Anticipated total annual cash burn of $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 Friday, March 31, 2023, at 9 a.m. Eastern Time.
To participate in the call, please use the following dial-in
information.
Investors
(domestic): |
877-407-0792 |
Investors (international): |
201-689-8263 |
Conference ID: |
13736579 |
|
|
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, 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 [a broad set of][all] 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” 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
the COVID-19 pandemic; risks associated with the conflict between
Russia and Ukraine and sanctions related thereto; including
inflation and uncertain global credit and capital markets; and
other risks and uncertainties affecting the Company including those
described in the “Risk Factors” section included in the Company’s
Quarterly Report on Form 10-Q for the quarter ending
September 30, 2022, and future filings and reports by the
Company including the Company’s Annual Report on Form 10-K for the
year ended December 31, 2022. 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) |
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
2022 |
|
2021 |
ASSETS |
|
|
|
|
|
CURRENT
ASSETS |
|
|
|
|
|
Cash and cash equivalents |
$ |
105,762 |
|
|
$ |
181,564 |
|
Accounts receivable, net |
|
12,531 |
|
|
|
7,712 |
|
Inventories |
|
6,702 |
|
|
|
5,512 |
|
Other current assets |
|
5,452 |
|
|
|
7,473 |
|
Total current assets |
|
130,447 |
|
|
|
202,261 |
|
Property and equipment, net |
|
604 |
|
|
|
1,847 |
|
Operating lease right-of-use assets |
|
1,739 |
|
|
|
3,842 |
|
Intangible assets, net |
|
2,986 |
|
|
|
1,663 |
|
Other assets |
|
5,680 |
|
|
|
3,170 |
|
TOTAL
ASSETS |
$ |
141,456 |
|
|
$ |
212,783 |
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
Accounts payable |
$ |
14,175 |
|
|
$ |
13,552 |
|
Accrued liabilities |
|
13,241 |
|
|
|
12,540 |
|
Operating lease liabilities, current portion |
|
868 |
|
|
|
1,783 |
|
Total current liabilities |
|
28,284 |
|
|
|
27,875 |
|
Accrued milestones |
|
2,250 |
|
|
|
2,100 |
|
Operating lease liabilities, long-term portion |
|
899 |
|
|
|
1,851 |
|
Other liabilities |
|
802 |
|
|
|
851 |
|
TOTAL
LIABILITIES |
|
32,235 |
|
|
|
32,677 |
|
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Preferred
stock, $0.0001 par value, 5,500,000 shares authorized and none
issued at December 31, 2022 and
December 31, 2021 |
|
— |
|
|
|
— |
|
Common
stock, $0.0001 par value, 100,000,000 shares authorized at
December 31, 2022 and December 31, 2021;
43,670,109 and 43,694,716 shares issued and outstanding at
December 31, 2022 and December 31, 2021,
respectively |
|
4 |
|
|
|
4 |
|
Additional
paid in capital |
|
543,929 |
|
|
|
519,206 |
|
Accumulated
other comprehensive income |
|
1,331 |
|
|
|
1,371 |
|
Accumulated
deficit |
|
(436,043 |
) |
|
|
(340,475 |
) |
TOTAL
STOCKHOLDERS’ EQUITY |
|
109,221 |
|
|
|
180,106 |
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
141,456 |
|
|
$ |
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 December 31, |
|
Years ended December 31, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
REVENUES |
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
16,447 |
|
|
$ |
9,598 |
|
|
$ |
49,267 |
|
|
$ |
32,897 |
|
License revenue |
|
15,000 |
|
|
|
— |
|
|
|
16,000 |
|
|
|
2,000 |
|
Total
revenues |
|
31,447 |
|
|
|
9,598 |
|
|
|
65,267 |
|
|
|
34,897 |
|
OPERATING
COSTS AND EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
2,020 |
|
|
|
1,461 |
|
|
|
7,467 |
|
|
|
2,304 |
|
License royalties |
|
— |
|
|
|
— |
|
|
|
100 |
|
|
|
210 |
|
Research and development |
|
19,787 |
|
|
|
28,757 |
|
|
|
91,572 |
|
|
|
93,245 |
|
Selling, general, and administrative |
|
10,793 |
|
|
|
15,138 |
|
|
|
60,939 |
|
|
|
54,571 |
|
Total
operating costs and expenses |
|
32,600 |
|
|
|
45,356 |
|
|
|
160,078 |
|
|
|
150,330 |
|
Loss from
operations |
|
(1,153 |
) |
|
|
(35,758 |
) |
|
|
(94,811 |
) |
|
|
(115,433 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
OTHER INCOME
/ (LOSS), NET |
|
|
|
|
|
|
|
|
|
|
|
Gain from sale of priority review voucher, net |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
62,010 |
|
Interest and other income/(loss), net |
|
2,310 |
|
|
|
(1,135 |
) |
|
|
(757 |
) |
|
|
(1,852 |
) |
NET
INCOME/(LOSS) |
$ |
1,157 |
|
|
$ |
(36,893 |
) |
|
$ |
(95,568 |
) |
|
$ |
(55,275 |
) |
Other
comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation |
|
(3,371 |
) |
|
|
1,146 |
|
|
|
(40 |
) |
|
|
1,897 |
|
COMPREHENSIVE LOSS |
$ |
(2,214 |
) |
|
$ |
(35,747 |
) |
|
$ |
(95,608 |
) |
|
$ |
(53,378 |
) |
Net
income/(loss) per share attributable to common stockholders,
basic |
$ |
0.03 |
|
|
$ |
(0.84 |
) |
|
$ |
(2.19 |
) |
|
$ |
(1.28 |
) |
Weighted
average common shares outstanding, basic |
|
43,668,690 |
|
|
|
43,664,277 |
|
|
|
43,703,663 |
|
|
|
43,181,808 |
|
Net income /
(loss) per share attributable to common stockholders, diluted |
$ |
0.03 |
|
|
$ |
(0.84 |
) |
|
$ |
(2.19 |
) |
|
$ |
(1.28 |
) |
Weighted
average common shares outstanding, diluted |
|
44,692,485 |
|
|
|
43,664,277 |
|
|
|
43,703,663 |
|
|
|
43,181,808 |
|
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