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 second quarter of 2023.
"The second quarter of 2023 marked another period of progress
for DANYELZA with continued revenue growth and international
expansion with regulatory approval in Brazil,” said Thomas Gad,
Founder, President, and Interim Chief Executive Officer. “As we
continue patient enrollment in the Phase I GD2-SADA study, we are
pleased to report that we have closed Cohort 1 and Cohort 2 and are
now dosing Cohort 3, and we have administered a 200 mCi dose of
177Lu-DOTA and an interval between dosing of the protein and the
payload of between two to five days. We look forward to presenting
pk and imaging data from this study later this year at our R&D
Day. Upon completion of our reorganization, we estimate our
existing cash and cash equivalents to support our business
operations as currently planned into 2026, positioning us well to
deliver our therapies to more patients both in the U.S. and
worldwide.”
Second Quarter 2023 and Recent Corporate
Developments
- On July 2, 2023, the Company’s partner in China, SciClone
Pharmaceuticals, announced that they had officially launched
DANYELZA.
- On May 26, 2023, Y-mAbs announced interim clinical data from
study 201 with naxitamab in combination with granulocyte-macrophage
colony-stimulating factor (“GM-CSF”) in patients with relapsed or
refractory high-risk neuroblastoma and presented such interim
clinical data at the American Society of Clinical Oncology (“ASCO”)
Annual Meeting on June 2-6, 2023.
- Also at ASCO, Y-mAbs presented the design of its Phase I
clinical study evaluating the Company’s Self-Assembly DisAssembly
Pre-targeted Radioimmunotherapy (“SADA Y-PRIT”) Theranostic
Platform for the treatment of certain GD2-positive solid tumors,
including small cell lung cancer, sarcoma, and malignant
melanoma.
- On May 23, 2023, Y-mAbs announced that the Brazilian Health
Regulatory Agency, Agência Nacional de Vigilância Sanitária
(“ANVISA”) granted marketing authorization for DANYELZA
(naxitamab-gqgk).
- On April 18, 2023, Y-mAbs announced that positive preclinical
data had been presented on naxitamab in triple-negative breast
cancer at the American Association for Cancer Research (“AACR”)
Annual Meeting.
- On April 5, 2023, Y-mAbs announced that the first patient had
been dosed in the Phase I clinical study evaluating the Company’s
SADA Y-PRIT Theranostic Platform for the treatment of certain
GD2-positive solid tumors.
Financial Results
Revenues
Y-mAbs reported DANYELZA net product revenues of $20.8 million
and $41.0 million for the quarter and six months ended June 30,
2023, which represented increases of 112% and 102%, respectively,
over $9.8 million and $20.3 million in the comparable periods of
2022.
The DANYELZA net product revenues for the quarter ended June 30,
2023 represents an increase of 3% compared to the first quarter of
2023. The $0.5 million sequential increase was driven by
international revenues and related royalties, which included $3.5
million of revenues and related royalties for the China commercial
launch inventory stocking order from SciClone, which Y-mAbs does
not anticipate recurring at this level each quarter. This increase
was partly offset by a softening in new U.S. patients in the second
quarter and the Company’s $2.5 million inventory stocking order
from WEP in the first quarter.
As of June 30, 2023, Y-mAbs has delivered DANYELZA to 56 centers
across the U.S., a sequential increase of 6% in the number of
centers since the first quarter of 2023. During the second quarter
of 2023, approximately 61% of the vials sold in the U.S. were sold
outside of Memorial Sloan Kettering Cancer Center (“MSKCC”), which
is in line with the first quarter of 2023.
Operating Expenses
Cost of Goods Sold
Cost of goods sold was $4.6 million and $1.1 million for the
three months ended June 30, 2023 and 2022, respectively. The
increased cost of goods sold was driven by increased product
revenue in the three months ended June 30, 2023 and an inventory
write-down of $0.5 million in the three months ended June 30, 2023.
Cost of goods sold was $6.7 million and $3.0 million for the six
months ended June 30, 2023 and 2022, respectively. The increase in
cost of goods sold was primarily driven by increased product
revenue.
The Company’s gross margin decreased in the three and six months
ended June 30, 2023, compared to the same periods in 2022, as a
result of increased revenues from geographic areas outside of the
United States, which were at a lower gross margin. The Company’s
cost of goods sold includes amounts related to materials,
third-party contract manufacturing, third-party packaging services,
freight, labor costs for personnel involved in the manufacturing
process, third-party royalties for approved products, and indirect
overhead costs.
Research and Development
Research and development expenses were $12.1 million for the
three months ended June 30, 2023, a reduction of 54% compared to
$26.4 million for the three months ended June 30, 2022. The $14.3
million decrease was primarily due to decreased spending on
deprioritized programs in connection with the Company’s previously
announced restructuring plan, resulting in a $6.6 million decrease
related to outsourced manufacturing, a $3.2 million decrease in
personnel-related costs, and a $2.5 million decrease in outsourced
research and supplies.
For the six months ended June 30, 2023, research and development
expenses were $25.5 million, a reduction of 48% compared to $49.3
million for the six months ended June 30, 2022. The $23.8 million
decrease was primarily due to decreased spending on deprioritized
programs as described above, resulting in a $12.3 million decrease
related to outsourced manufacturing, a $4.8 million decrease in
outsourced research and supplies, a $2.9 million decrease in
clinical trials and a $2.1 million decrease in personnel-related
costs.
Y-mAbs recorded a restructuring charge of $3.4 million in
research and development expenses during the six months ended June
30, 2023, in connection with the restructuring plan.
Selling, General, and Administration
Selling, general, and administrative expenses were $11.3 million
for the three months ended June 30, 2023, a reduction of 51.1%
compared to $23.1 million for the three months ended June 30, 2022.
The $11.8 million decrease in selling, general and administrative
expenses was primarily attributable to a $10.9 million charge
related to contractual severance related benefits for the Company’s
former Chief Executive Officer in connection with his departure in
the second quarter of 2022.
For the six months ended June 30, 2023, selling, general, and
administrative expenses were $23.5 million, a reduction of 35.6%
compared to $36.5 million for the six months ended June 30, 2022.
The $13.0 million decrease in SG&A expenses was primarily
attributable to the contractual severance-related benefits
described above.
Y-mAbs recorded a restructuring charge of $1.1 million in
selling, general, and administrative expenses during the six months
ended June 30, 2023, in connection with the restructuring plan.
Net Loss
Y-mAbs reported a net loss for the second quarter ended June 30,
2023, of $6.3 million, or ($0.14) per basic and diluted share,
compared to a net loss of $41.1 million, or ($0.94) per basic and
diluted share, for the quarter ended June 30, 2022. For the six
months ended June 30, 2023, the Company reported a net loss of
$12.7 million, or $0.29 per basic and diluted share, compared to a
net loss of $69.2 million, or $1.58 per basic and diluted share,
for the six months ended June 30, 2022. The favorable decrease in
net loss was primarily driven by an increase in DANYELZA U.S.
product revenues in the second quarter and six months ended June
30, 2023, an incremental benefit from expanding into international
markets, decreased research and development cost, and decreased
selling, general and administration cost, partially offset by the
unfavorable impact of restructuring charges, all as noted
above.
Cash and Cash Equivalents
As of June 30, 2023, Y-mAbs had approximately $87.9 million in
cash and cash equivalents which, together with anticipated DANYELZA
product revenues, is expected to support operations as currently
planned into 2026. This estimate reflects the Company’s current
business plan that is supported by assumptions that may prove to be
inaccurate, such that Y-mAbs could use its available capital
resources sooner than it currently expects.
Financial Guidance
Management reiterates its full year 2023 financial guidance, as
updated on May 8, 2023:
- Anticipated DANYELZA® net product revenues expected to be
between $80 million and $85 million;
- Anticipated operating expenses expected to be between $115
million and $120 million;
- Anticipated total annual cash burn expected to be between $40
million and $50 million; and
- Cash and cash equivalents anticipated to support operations as
currently planned into 2026.
Webcast and Conference Call
Y-mAbs will host a conference call on Friday, August 11, 2023,
at 9:00 a.m. EDT. To participate in the call, please use the
following dial-in information.
Investors (domestic): |
877-407-0792 |
Investors (international): |
201-689-8263 |
Conference ID: |
13739908 |
To access a live webcast of the update, please
use this link.
About Y-mAbsY-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
StatementsStatements 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 and beyond, including estimated operating
expenses, total cash burn and DANYELZA product revenue and
sufficiency of cash resources and related assumptions; 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, including with respect to expansion and its
goals; the Company’s plans and strategies, development,
commercialization and product distribution plans, including
potential partnerships; 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 and applications 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 applications, and the timing thereof;
expectations with respect to current and future clinical and
pre-clinical studies and our research and development programs,
including with respect to timing and results; 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’’, “guidance,” 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
macroeconomic conditions, including the conflict between Russia and
Ukraine and sanctions related thereto, 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 ending December 31, 2022, the Company’s
Quarterly Report on Form 10-Q for the quarter ended March 31, 2023
and future filings and reports by the Company including the
Company’s Quarterly Report on Form 10-Q for the quarter ended June
30, 2023. 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.
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) |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
2023 |
|
2022 |
ASSETS |
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
Cash and cash equivalents |
$ |
87,909 |
|
|
$ |
105,762 |
|
Accounts receivable, net |
|
19,118 |
|
|
|
12,531 |
|
Inventories |
|
5,187 |
|
|
|
6,702 |
|
Other current assets |
|
3,570 |
|
|
|
5,452 |
|
Total current assets |
|
115,784 |
|
|
|
130,447 |
|
Property and equipment, net |
|
375 |
|
|
|
604 |
|
Operating lease right-of-use assets |
|
1,178 |
|
|
|
1,739 |
|
Intangible assets, net |
|
2,809 |
|
|
|
2,986 |
|
Other assets |
|
12,250 |
|
|
|
5,680 |
|
TOTAL ASSETS |
$ |
132,396 |
|
|
$ |
141,456 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
Accounts payable |
$ |
7,252 |
|
|
$ |
14,175 |
|
Accrued liabilities |
|
16,152 |
|
|
|
13,241 |
|
Operating lease liabilities, current portion |
|
829 |
|
|
|
868 |
|
Total current liabilities |
|
24,233 |
|
|
|
28,284 |
|
Accrued milestones and royalty payments |
|
2,250 |
|
|
|
2,250 |
|
Operating lease liabilities, long-term portion |
|
416 |
|
|
|
899 |
|
Other liabilities |
|
816 |
|
|
|
802 |
|
TOTAL LIABILITIES |
|
27,715 |
|
|
|
32,235 |
|
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Preferred stock, $0.0001 par value, 5,500,000 shares authorized and
none issued at June 30, 2023 and
December 31, 2022 |
|
- |
|
|
|
- |
|
Common stock, $0.0001 par value, 100,000,000 shares authorized at
June 30, 2023 and December 31, 2022; 43,620,192
and 43,670,109 shares issued at June 30, 2023 and
December 31, 2022, respectively |
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
552,369 |
|
|
|
543,929 |
|
Accumulated other comprehensive income |
|
1,043 |
|
|
|
1,331 |
|
Accumulated deficit |
|
(448,735 |
) |
|
|
(436,043 |
) |
TOTAL STOCKHOLDERS’ EQUITY |
|
104,681 |
|
|
|
109,221 |
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
132,396 |
|
|
$ |
141,456 |
|
|
|
|
|
|
|
Y-MABS THERAPEUTICS, INC. |
Consolidated Statements of Net Loss and Comprehensive
Loss |
(unaudited) |
(In thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
REVENUES |
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
20,751 |
|
|
$ |
9,797 |
|
|
$ |
41,002 |
|
|
$ |
20,283 |
|
License revenue |
|
— |
|
|
|
1,000 |
|
|
|
— |
|
|
|
1,000 |
|
Total revenues |
|
20,751 |
|
|
|
10,797 |
|
|
|
41,002 |
|
|
|
21,283 |
|
OPERATING COSTS AND EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
4,649 |
|
|
|
1,140 |
|
|
|
6,732 |
|
|
|
2,972 |
|
License royalties |
|
— |
|
|
|
100 |
|
|
|
— |
|
|
|
100 |
|
Research and development |
|
12,055 |
|
|
|
26,420 |
|
|
|
25,473 |
|
|
|
49,332 |
|
Selling, general, and administrative |
|
11,270 |
|
|
|
23,082 |
|
|
|
23,521 |
|
|
|
36,520 |
|
Total operating costs and expenses |
|
27,974 |
|
|
|
50,742 |
|
|
|
55,726 |
|
|
|
88,924 |
|
Loss from operations |
|
(7,223 |
) |
|
|
(39,945 |
) |
|
|
(14,724 |
) |
|
|
(67,641 |
) |
OTHER INCOME/(LOSS), NET |
|
|
|
|
|
|
|
|
|
|
|
Interest and other income/(loss) |
|
1,100 |
|
|
|
(1,186 |
) |
|
|
2,211 |
|
|
|
(1,558 |
) |
LOSS BEFORE INCOME TAXES |
|
(6,123 |
) |
|
|
(41,131 |
) |
|
|
(12,513 |
) |
|
|
(69,199 |
) |
Provision for income taxes |
|
179 |
|
|
|
— |
|
|
|
179 |
|
|
|
— |
|
NET LOSS |
$ |
(6,302 |
) |
|
$ |
(41,131 |
) |
|
$ |
(12,692 |
) |
|
$ |
(69,199 |
) |
Other comprehensive income/(loss) |
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation |
|
18 |
|
|
|
1,422 |
|
|
|
(288 |
) |
|
|
1,733 |
|
COMPREHENSIVE LOSS |
$ |
(6,284 |
) |
|
$ |
(39,709 |
) |
|
$ |
(12,980 |
) |
|
$ |
(67,466 |
) |
Net loss per share attributable to common stockholders, basic and
diluted |
$ |
(0.14 |
) |
|
$ |
(0.94 |
) |
|
$ |
(0.29 |
) |
|
$ |
(1.58 |
) |
Weighted average common shares outstanding, basic and diluted |
|
43,663,112 |
|
|
|
43,718,748 |
|
|
|
43,667,385 |
|
|
|
43,713,967 |
|
Y mAbs Therapeutics (NASDAQ:YMAB)
Graphique Historique de l'Action
De Août 2024 à Sept 2024
Y mAbs Therapeutics (NASDAQ:YMAB)
Graphique Historique de l'Action
De Sept 2023 à Sept 2024