Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq:
YMAB), a commercial-stage biopharmaceutical company focused on the
development and commercialization of novel radioimmunotherapy and
antibody-based therapeutic products for the treatment of cancer,
today reported financial results for the third quarter ended
September 30, 2024.
“The third quarter of this year was one of continued focus and
execution across our DANYELZA commercial business and our novel
SADA PRIT radiopharmaceutical platform development pipeline,” said
Michael Rossi, President and Chief Executive Officer. “Physician
usage of DANYELZA in the U.S. continues to remain very strong for
patients with relapsed/refractory high-risk neuroblastoma. In
addition, we continue to drive ex-U.S. market expansion with our
new exclusive license and distribution agreement with Nobelpharma
in Japan and the launch of our named patient program in Turkey.
From a SADA PRIT pipeline standpoint, we expect to complete Part A
of our GD2-SADA Phase 1 trial this year and present that data in
the first quarter of next year.”
Third Quarter 2024 and Recent Corporate
Highlights
- Effective October 29, 2024, Y-mAbs entered into an exclusive
license and distribution agreement with Nobelpharma for the
development and commercialization of DANYELZA in Japan. Pursuant to
the agreement, the Company recognized an upfront payment of $2.0
million in the fourth quarter of 2024. Y-mAbs is entitled to
receive up to $31.0 million in product and commercial milestone
payments in addition to profit sharing on the commercial sales of
DANYELZA, if successfully approved and commercialized in
Japan.
- Y-mAbs received notification of the accepted patent extension
for DANYELZA, US 9,315,585, through February 2034.
- The Company’s named patient program for DANYELZA launched in
Turkey with partner TRPharm İlaç Sanayi Ticaret A.Ş. and TRPharm
FZ-LLC.
- Y-mAbs presented new clinical and preclinical data from studies
evaluating anti-GD2 therapy naxitamab and the Company’s first
program from its Self-Assembly DisAssembly Radioimmunotherapy
Technology Platform (“SADA PRIT”), GD2-SADA, respectively, in
neuroblastoma in poster presentations at the American Academy of
Cancer Research Special Conference in the Advanced in Pediatric
Cancer Research on September 6-7, 2024 in Toronto, Canada.
- The Company entered into a lease agreement for a term of ten
years and nine months for office space in Princeton, New Jersey,
where the Company plans to transition its headquarters in the first
half of 2025 upon being provided access to the location.
Financial Results
Revenues
Total net revenues for the quarter ended September 30, 2024 were
$18.5 million, a 10% decline over total net revenues for the
quarter ended September 30, 2023 of $20.5 million, which included
$0.5 million in license revenue, primarily driven by decreased net
product revenues in both U.S. and ex-U.S. markets.
Total net revenues for the nine months ended September 30, 2024
were relatively flat compared to the nine months ended September
30, 2023, at $61.2 million and $61.5 million, respectively. The
slight decrease was driven by a $0.7 million decrease in ex-U.S.
DANYELZA net product revenues in the nine months ended September
30, 2024, which was partially offset by increased net product
revenues in the U.S.
The Company’s U.S. DANYELZA net product revenues were $15.3
million and $16.1 million for the three months ended September 30,
2024 and 2023, respectively, representing a 5% decline, primarily
due to an unfavorable price mix, partially offset by increased
volume of 5% vial growth over the same time period.
Y-mAbs’ ex-U.S. DANYELZA net product revenues for the quarter
ended September 30, 2024 were $3.1 million, a 19% decline from $3.9
million in the comparable period in 2023, primarily driven by
decreased volume from Western Europe partially offset by volume
increases in the remaining ex-U.S. territories.
As of September 30, 2024, Y-mAbs had delivered DANYELZA to 68
centers across the U.S. since initial launch, with three new
accounts added in the U.S. in the third quarter of 2024. During the
quarter ended September 30, 2024, approximately 65% of the vials
sold in the U.S. were sold outside of Memorial Sloan Kettering
Cancer Center (“MSK”), compared to 67% in the second quarter ended
June 30, 2024.
The Company did not have license revenue for the quarter ended
September 30, 2024. The Company had license revenues of $0.5
million for the nine months ended September 30, 2024, from its
Latin America distribution partner, Adium, related to price
approval for DANYELZA in Brazil from the Brazilian Medicines Market
Regulation Chamber. The Company had license revenues of $0.5
million for the quarter and nine months ended September 30, 2023
from Adium, recognized upon the September 2023 achievement of
marketing authorization for DANYELZA in Mexico.
Operating Costs and Expenses
Cost of Goods Sold
Cost of goods sold were $2.3 million and $2.6 million for the
quarter ended September 30, 2024 and 2023, respectively. Cost of
goods sold were $7.4 million and $9.3 million for the nine months
ended September 30, 2024 and 2023, respectively. Cost of goods sold
included lower vial volumes of 1% and 37% in the three and nine
months ended September 30, 2024, compared to the same periods in
2023, respectively. Cost of goods sold also included $0.4 million
and $0.8 million inventory write-downs in the three and nine months
ended September 30, 2023, respectively.
The Company defines gross margin as net product revenues less
cost of goods sold divided by net product revenues. The Company’s
gross margins was relatively unchanged in the quarter ended
September 30, 2024, compared to the comparable periods in 2023. The
Company’s gross margins increased in the nine months ended
September 30, 2024, compared to the comparable period in 2023, due
to a favorable gross profit mix from revenue in international
regions, particularly Eastern Asia that had an inventory stocking
order in the nine months ended September 30, 2024, and inventory
write-downs during the comparable periods in 2023, as noted
above.
Research and Development
Research and development expenses were $11.2 million for the
quarter ended September 30, 2024, a decrease of $4.2 million when
compared with the same period in 2023. The decrease in research and
development expenses was primarily attributable to the recognition
of $4.1 million of milestone and license acquisition costs related
to the Company’s SADA license agreement during the three months
ended September 30, 2023, as certain time-based clinical milestones
within the agreement were determined to be probable based on the
availability of necessary data and the assessment of clinical
progress in the third quarter of 2023.
For the nine months ended September 30, 2024, research and
development expenses were $36.8 million, a decrease of $4.0 million
when compared with the same period in 2023. The decrease in the
research and development expenses was primarily attributable to
recognition of $4.1 million of milestone and license acquisition
costs related to the Company’s SADA license agreement during the
nine months ended September 30, 2023, as noted above.
Selling, General, and Administrative
Selling, general, and administrative expenses were $13.6 million
and $10.2 million for the quarters ended September 30, 2024 and
2023, respectively. The $3.4 million increase in the selling,
general and administrative expenses was primarily attributable to a
$1.2 million increase related to the Company’s former Chief
Financial Officer’s separation and consulting agreements, $1.1
million increase in personnel cost, inclusive of stock-based
compensation and $0.5 million in professional and consulting
fees.
For the nine months ended September 30, 2024, selling, general,
and administrative expenses were $42.3 million, an increase of $8.5
million compared with the same period in 2023. The increase was
primarily attributable to a net impact of $3.6 million related to
the settlement of a shareholder class-action lawsuit in the nine
months ended September 30, 2024, and an additional legal settlement
of $0.2 million in the nine months ended September 30, 2024. The
increase also includes a $1.2 million increase related to our
former Chief Financial Officer’s separation and consulting
agreements, a $1.1 million increase in personnel cost inclusive of
stock-based compensation and $0.8 million in professional and
consulting fees.
Interest and Other Income
Interest and other income were $1.9 million for the quarter
ended September 30, 2024, as compared to $0.2 million for the
quarter ended September 30, 2023. The increase of $1.7 million was
primarily due to a $1.9 million of foreign currency transactional
gains in the three months ended September 30, 2024, partially
offset by a $0.2 million decrease in interest earned on the
Company’s cash and cash equivalents.
For the nine months ended September 30, 2024 and 2023, the
interest and other income was $3.0 and $2.4 million, respectively.
The increase of $0.6 million was primarily due to $1.1 million of
foreign currency transactional gains, partially offset by a $0.3
million decrease in interest earned on the Company’s cash and cash
equivalents.
Net Loss
Y-mAbs reported a net loss for the quarter ended September 30,
2024, of $7.0 million, or ($0.16) per basic and diluted share,
compared to a net loss of $7.7 million, or ($0.18) per basic and
diluted share, for the quarter ended September 30, 2023. The
decrease in net loss for the quarter ended September 30, 2024 was
primarily driven by decreased operating expenses and foreign
currency transactional gains, partially offset by decreased net
product revenue.
For the nine months ended September 30, 2024, the Company
reported a net loss of $22.9 million, or ($0.52) per basic and
diluted share, as compared to net loss of $20.4 million, or ($0.47)
per basic and diluted share, for the nine months ended September
30, 2023. The increase in net loss for the nine months ended
September 30, 2024 was primarily driven by the net $3.8 million in
charges related to the Company’s two legal settlements, as
described above.
Cash and Cash Equivalents
As of September 30, 2024, Y-mAbs had approximately $68.1 million
in cash and cash equivalents. Cash utilized in the first three
quarters of 2024 was $10.5 million, which was favorable relative to
the Company’s internal forecasts, and is on track to meet its
corporate guidance for the full year 2024.
2024 Financial Guidance
Management reiterates its full year 2024 guidance:
- Anticipated Total Net Revenues expected to be between $87
million and $95 million;
- Anticipated Operating Expenses expected to remain between $115
million and $120 million;
- Anticipated Total Annual Cash Investment expected to remain
between $15 million and $20 million; and
- Cash and Cash Equivalents anticipated to continue to support
operations as currently planned into 2027.
Webcast and Conference Call
Y-mAbs will host a conference call on Friday, November 8, 2024,
at 8:00 a.m. ET. To participate in the call, please use the
following dial-in information:
Investors (domestic): (877) 407-0792
Investors (international): (201) 689-8263
To access the live webcast, please use this link. Prior to the
call and webcast, a slide presentation pertaining to the Company’s
quarterly earnings will be made available on the Investor Relations
section of the Y-mAbs website, www.ymabs.com, shortly before the
call begins.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical company focused
on the development and commercialization of novel,
radioimmunotherapy and antibody-based therapeutic cancer products.
The Company’s technologies include its investigational
Self-Assembly DisAssembly (“SADA”) Pretargeted Radioimmunotherapy
Platform (“PRIT”) and bispecific antibodies generated using the
Y-BiClone platform. The Company’s broad and advanced product
pipeline includes the anti-GD2 therapy DANYELZA® (naxitamab-gqgk),
the first FDA-approved treatment for patients with relapsed or
refractory high-risk neuroblastoma in the bone or bone marrow after
a partial response, minor response, or stable disease to prior
therapy.
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 2024 and beyond, including estimated operating
expenses, use of cash and cash equivalents and DANYELZA product
revenue and sufficiency of cash resources and related assumptions;
expectations with respect to the Company’s future financial
performance; implied and express statements regarding the future of
the Company’s business, including with respect to expansion and its
goals; expectations with respect to the Company’s plans and
strategies, development, regulatory, commercialization and product
distribution plans, including the timing thereof; expectations with
respect to the Company’s 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 PRIT technology and
potential benefits and applications thereof; expectations relating
to key anticipated development milestones, including potential
expansion and advancement of commercialization and development
efforts, including potential indications, applications and
geographies, and the timing thereof; expectations with respect to
current and future clinical and pre-clinical studies and the
Company’s research and development programs, including with respect
to timing and results; expectations regarding collaborations or
strategic partnerships and the potential benefits thereof; 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’,’ “guidance,” “goal,”
“objective,” 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 the Company’s financial condition and need for
additional capital; the risks that actual results of the Company’s
restructuring plan and revised business plan will not be as
expected; risks associated with the Company’s development work;
cost and success of the Company’s product development activities
and clinical trials; the risks of delay in the timing of the
Company’s or its partners’ regulatory submissions or failure to
receive approval of its drug candidates; the risks related to
commercializing any approved pharmaceutical product including the
rate and degree of market acceptance of product candidates;
development of sales and marketing capabilities and risks
associated with failure to obtain sufficient reimbursement for
products; risks related to the Company’s dependence on third
parties including for conduct of clinical testing and product
manufacture as well as regulatory submissions; the Company’s
ability to enter into new partnerships or to recognize the
anticipated benefits from its existing partnerships; risks related
to government regulation; risks related to market approval, risks
associated with protection of the Company’s intellectual property
rights; risks related to employee matters and managing growth;
risks related to the Company’s common stock, risks associated with
macroeconomic conditions, including the conflict between Russia and
Ukraine and sanctions related thereto, the state of war between
Israel and Hamas and the related risk of a larger regional
conflict, inflation, increased interest rates, uncertain global
credit and capital markets and disruptions in banking systems; and
other risks and uncertainties affecting the Company including those
described in the “Risk Factors” section included in the Company’s
Annual Report on Form 10-K for the fiscal year ended December 31,
2023, and the Company’s Quarterly Report on Form 10-Q for the
quarterly periods ended March 31, 2024, and September 30, 2024, and
future filings and reports by the Company. 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.
Investor Contact:
Courtney DuganVP, Head of Investor Relationscdu@ymabs.com
Y-MABS THERAPEUTICS, INC.Consolidated
Balance Sheets(unaudited)(In
thousands, except share and per share data) |
|
|
|
September 30, |
|
December 31, |
|
|
2024 |
|
2023 |
ASSETS |
|
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
68,122 |
|
|
$ |
78,637 |
|
Accounts receivable, net |
|
|
19,916 |
|
|
|
22,454 |
|
Inventories |
|
|
9,557 |
|
|
|
5,065 |
|
Other current assets |
|
|
1,462 |
|
|
|
4,955 |
|
Total current assets |
|
|
99,057 |
|
|
|
111,111 |
|
Property and equipment, net |
|
|
53 |
|
|
|
224 |
|
Operating lease right-of-use assets |
|
|
1,075 |
|
|
|
1,412 |
|
Intangible assets, net |
|
|
2,366 |
|
|
|
2,631 |
|
Other assets |
|
|
18,366 |
|
|
|
12,491 |
|
TOTAL ASSETS |
|
$ |
120,917 |
|
|
$ |
127,869 |
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
|
Accounts payable |
|
$ |
7,878 |
|
|
$ |
6,060 |
|
Accrued liabilities |
|
|
16,638 |
|
|
|
13,166 |
|
Operating lease liabilities, current portion |
|
|
776 |
|
|
|
902 |
|
Total current liabilities |
|
|
25,292 |
|
|
|
20,128 |
|
Accrued milestones |
|
|
2,000 |
|
|
|
5,375 |
|
Operating lease liabilities, long-term portion |
|
|
299 |
|
|
|
517 |
|
Other liabilities |
|
|
897 |
|
|
|
864 |
|
TOTAL LIABILITIES |
|
|
28,488 |
|
|
|
26,884 |
|
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Preferred stock, $0.0001 par
value, 5,500,000 shares authorized and none issued at
September 30, 2024 and December 31, 2023 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par
value, 100,000,000 shares authorized at
September 30, 2024 and December 31, 2023;
44,766,802 and 43,672,112 shares issued and outstanding at
September 30, 2024 and December 31, 2023,
respectively |
|
|
4 |
|
|
|
4 |
|
Additional paid-in
capital |
|
|
572,807 |
|
|
|
558,002 |
|
Accumulated other
comprehensive income |
|
|
(36 |
) |
|
|
449 |
|
Accumulated deficit |
|
|
(480,346 |
) |
|
|
(457,470 |
) |
TOTAL STOCKHOLDERS’
EQUITY |
|
|
92,429 |
|
|
|
100,985 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
$ |
120,917 |
|
|
$ |
127,869 |
|
|
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, |
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
REVENUES |
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
|
$ |
18,461 |
|
|
$ |
19,954 |
|
|
$ |
60,690 |
|
|
$ |
60,956 |
|
License revenue |
|
|
— |
|
|
|
500 |
|
|
|
500 |
|
|
|
500 |
|
Total revenues |
|
|
18,461 |
|
|
|
20,454 |
|
|
|
61,190 |
|
|
|
61,456 |
|
OPERATING COSTS AND
EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
2,248 |
|
|
|
2,595 |
|
|
|
7,359 |
|
|
|
9,327 |
|
License royalties |
|
|
— |
|
|
|
50 |
|
|
|
50 |
|
|
|
50 |
|
Research and development |
|
|
11,168 |
|
|
|
15,358 |
|
|
|
36,776 |
|
|
|
40,831 |
|
Selling, general, and administrative |
|
|
13,613 |
|
|
|
10,200 |
|
|
|
42,270 |
|
|
|
33,721 |
|
Total operating costs and
expenses |
|
|
27,029 |
|
|
|
28,203 |
|
|
|
86,455 |
|
|
|
83,929 |
|
Loss from operations |
|
|
(8,568 |
) |
|
|
(7,749 |
) |
|
|
(25,265 |
) |
|
|
(22,473 |
) |
OTHER INCOME, NET |
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
|
1,916 |
|
|
|
189 |
|
|
|
2,995 |
|
|
|
2,400 |
|
LOSS BEFORE INCOME TAXES |
|
|
(6,652 |
) |
|
|
(7,560 |
) |
|
|
(22,270 |
) |
|
|
(20,073 |
) |
Provision for income taxes |
|
|
346 |
|
|
|
187 |
|
|
|
606 |
|
|
|
366 |
|
NET LOSS |
|
$ |
(6,998 |
) |
|
$ |
(7,747 |
) |
|
$ |
(22,876 |
) |
|
$ |
(20,439 |
) |
Other comprehensive
income/(loss) |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation |
|
|
(1,083 |
) |
|
|
806 |
|
|
|
(485 |
) |
|
|
518 |
|
COMPREHENSIVE LOSS |
|
$ |
(8,081 |
) |
|
$ |
(6,941 |
) |
|
$ |
(23,361 |
) |
|
$ |
(19,921 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.16 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.52 |
) |
|
$ |
(0.47 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
44,626,943 |
|
|
|
43,620,532 |
|
|
|
44,145,183 |
|
|
|
43,651,536 |
|
|
Y-MABS THERAPEUTICS, INC.Consolidated
Statements of Cash
Flows(unaudited)(In
thousands) |
|
|
|
|
|
|
|
|
|
Nine months ended September 30, |
|
|
2024 |
|
2023 |
CASH FLOWS FROM
OPERATING ACTIVITIES |
|
|
|
|
|
|
Net loss |
|
$ |
(22,876 |
) |
|
$ |
(20,439 |
) |
Adjustments to
reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
Depreciation and amortization |
|
|
433 |
|
|
|
574 |
|
Stock-based compensation |
|
|
11,480 |
|
|
|
11,330 |
|
Foreign currency and other transactions |
|
|
(456 |
) |
|
|
(369 |
) |
Changes in assets
and liabilities: |
|
|
|
|
|
|
Accounts receivable, net |
|
|
2,538 |
|
|
|
(6,343 |
) |
Inventories |
|
|
(4,492 |
) |
|
|
(411 |
) |
Other current assets |
|
|
3,493 |
|
|
|
2,671 |
|
Other assets |
|
|
(5,875 |
) |
|
|
(3,735 |
) |
Accounts payable |
|
|
2,274 |
|
|
|
(6,196 |
) |
Accrued liabilities and other |
|
|
(363 |
) |
|
|
3,722 |
|
NET CASH USED IN
OPERATING ACTIVITIES |
|
|
(13,844 |
) |
|
|
(19,196 |
) |
CASH FLOWS FROM
INVESTING ACTIVITIES |
|
|
— |
|
|
|
— |
|
CASH FLOWS FROM
FINANCING ACTIVITIES |
|
|
|
|
|
|
Proceeds from
exercised stock options |
|
|
3,325 |
|
|
|
— |
|
NET CASH PROVIDED
BY FINANCING ACTIVITIES |
|
|
3,325 |
|
|
|
— |
|
Effect of exchange
rates on cash and cash equivalents |
|
|
4 |
|
|
|
5 |
|
NET DECREASE IN
CASH AND CASH EQUIVALENTS |
|
|
(10,515 |
) |
|
|
(19,191 |
) |
Cash and cash
equivalents at the beginning of period |
|
|
78,637 |
|
|
|
105,762 |
|
Cash and cash
equivalents at the end of period |
|
$ |
68,122 |
|
|
$ |
86,571 |
|
|
|
|
|
|
|
|
SUPPLEMENTAL
DISCLOSURE OF NON-CASH ACTIVITIES |
|
|
|
|
|
|
Right-of-use
assets obtained in exchange for lease obligations |
|
$ |
320 |
|
|
$ |
636 |
|
Acquisition of
treasury shares upon repayment of secured promissory note |
|
$ |
— |
|
|
$ |
480 |
|
|
Y mAbs Therapeutics (NASDAQ:YMAB)
Historical Stock Chart
From Oct 2024 to Nov 2024
Y mAbs Therapeutics (NASDAQ:YMAB)
Historical Stock Chart
From Nov 2023 to Nov 2024