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 2023.
“We delivered $20 million in DANYELZA® (naxitamab-gqgk) net
product sales in the third quarter of 2023, reflecting 59% growth
compared to the same period in 2022, as sales continued trending
upward since our initial launch,” said Mike Rossi, President and
Chief Executive Officer. “Our U.S. commercial team has made
excellent progress by penetrating more high-volume Children’s
Oncology Group (“COG”) sites while our ex-U.S. partners continue to
gain further traction with physicians prescribing DANYELZA across
Europe and China for relapsed or refractory high-risk neuroblastoma
patients.”
Mr. Rossi continued, “Supported by a solid financial foundation,
we have advanced our novel SADA radioimmunotherapy platform with
the continued execution of our Phase 1 GD2-SADA trial and the
recent Investigational New Drug (“IND”) clearance of our CD38-SADA
program. With existing cash and cash equivalents anticipated to
support our business operations as currently planned into 2027, a
growing commercial product in DANYELZA, and a differentiated
radioimmunotherapy platform in SADA, we believe Y-mAbs is on a path
to potentially transform the treatment paradigm for a variety of
cancers and improve patients’ lives.”
Third Quarter 2023 and Recent Corporate
Developments
- On October 18, 2023, Y-mAbs announced that its Board of
Directors appointed Mr. Rossi as President and Chief Executive
Officer, effective November 6, 2023. Thomas Gad, who founded Y-mAbs
in 2015 and has served as Interim Chief Executive Officer since
2022, has transitioned to the role of Vice Chairman of the Board of
Directors and Chief Business Officer.
- On October 17, 2023, the U.S. Food & Drug Administration
(“FDA”) cleared Y-mAbs’ IND for CD38-SADA, marking the second
clinical development program utilizing the Company’s novel SADA
technology platform.
- On October 16, 2023, Y-mAbs announced the publication of the
study of naxitamab-based chemoimmunotherapy in patients with
chemoresistant high-risk neuroblastoma (“HR-NB”) in the journal
Cancers. The study investigated the HITS combination in patients
with high-risk neuroblastoma who did not respond well to induction
therapy. Patients who received HITS immediately after induction had
higher response rates (47% vs. 18%) and superior estimated
three-year overall survival (85% vs. 29%) compared with those who
received the same combination regimen later in the course of
treatment. The publication is entitled, “Early Salvage
Chemo-Immunotherapy with Irinotecan, Temozolomide and Naxitamab
Plus GM-CSF (HITS) for Patients with Primary Refractory High-Risk
Neuroblastoma Provide the Best Chance for Long-Term Outcomes.”
- On October 11, 2023, Y-mAbs showcased three poster
presentations, in addition to an online publication, of DANYELZA at
the 55th Congress of the International Society of Pediatric
Oncology in Ottawa, Canada.
- On September 28, 2023, Y-mAbs received approval of its Mexican
Marketing Authorization Application (“MAA”) by COFEPRIS for
DANYELZA, marking the Company’s second approval in Latin American
with its distribution partner Adium Pharma S.A.
Financial Results
Revenues
DANYELZA net product revenues were $20.0 million and $61.0
million for the third quarter and nine months ended September 30,
2023, which represented increases of 59% and 86%, respectively,
over $12.5 million and $32.8 million in the comparable periods of
2022.
The DANYELZA net product revenues of $20.0 million in the third
quarter of 2023, represented a marginal decline compared to the
second quarter of 2023, primarily driven by modest unevenness in
international revenues after a series of inventory stocking orders
from the Company’s international partners as reported in recent
quarters.
As of September 30, 2023, Y-mAbs has delivered DANYELZA to 57
centers across the U.S. since initial launch, with nine new
accounts added so far in 2023. During the third quarter ended
September 30, 2023, approximately 63% of the vials sold in the U.S.
were sold outside of Memorial Sloan Kettering Cancer Center
(“MSK”), compared to 61% in the second quarter ended June 30,
2023.
Y-mAbs reported total revenues of $20.5 million and $61.5
million for the third quarter and nine months ended September 30,
2023, which represented increases of 63% and 82%, respectively,
over $12.5 million and $33.8 million in the comparable periods of
2022. Total revenues in the third quarter and nine months ended
September 30, 2023 included $0.5 million of license revenue
recognized upon the September 2023 achievement of marketing
authorization for DANYELZA in Mexico under the Company’s sublicense
agreement with Adium. There was no license revenue in the third
quarter ended September 30, 2022, and license revenue for the nine
months ended September 30, 2022 was $1.0 million.
Operating Costs and Expenses
Cost of Goods Sold
Cost of goods sold was $2.6 million and $2.5 million for the
third quarter ended September 30, 2023 and 2022, respectively. Cost
of goods sold was $9.3 million and $5.4 million for the nine months
ended September 30, 2023 and 2022, respectively. The increase in
cost of goods sold in both periods was primarily driven by
increased product revenue in the three and nine months ended
September 30, 2023, and inventory write-downs of $0.4 million and
$0.8 million in the three and nine months ended September 30, 2023,
respectively, partially offset by a $1.2 million charge related to
an inventory batch that did not meet the Company’s quality
specifications during the three and nine months ended September 30,
2022.
Excluding the above inventory charges, the Company’s gross
margin decreased slightly in the three and nine months ended
September 30, 2023, compared to the same periods in 2022, due to an
increase in ex-U.S. revenues, which were at lower gross
margins.
Research and Development
Research and development expenses were $15.4 million for the
third quarter ended September 30, 2023, a reduction of 32% compared
to $22.5 million for the third quarter ended September 30, 2022.
The $7.1 million decrease was primarily due to decreased spending
on deprioritized programs, which resulted in a $5.7 million
decrease in outsourced manufacturing, decreased personnel-related
costs, inclusive of stock-based compensation, of $2.0 million, a
$2.0 million decrease in outsourced research and supplies, and a
$0.3 million decrease in clinical trials, partially offset by a
$4.1 million increase in milestones and license acquisition costs
related to the Company’s SADA License Agreement, as the Company
determined that certain time-based clinical milestones within the
agreement are probable of achievement 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, 2023, research and
development expenses were $40.8 million, a reduction of 43%
compared to $71.8 million for the nine months ended September 30,
2022. The $31.0 million decrease was primarily due to decreased
spending on deprioritized programs as described above, resulting in
a $17.9 million decrease related to outsourced manufacturing, a
$6.8 million decrease in outsourced research and supplies, a $3.1
million decrease in clinical trials and a $4.1 million decrease in
personnel-related costs, partially offset by a $4.1 million
increase in milestones and license acquisition costs related to the
Company’s SADA License Agreement, as the Company determined that
certain time-based clinical milestones within the agreement are
probable of achievement based on the availability of necessary data
and the assessment of clinical progress in the third quarter of
2023.
The $2.0 million and $4.1 million decreases in personnel-related
costs during the three and nine months ended September 30, 2023,
respectively, were driven by the headcount reduction as part of
Company’s restructuring plan announced in January 2023, partially
offset by severance charges recognized in conjunction with the
restructuring plan.
Selling, General, and Administration
Selling, general, and administrative expenses were $10.2 million
for the third quarter ended September 30, 2023, a reduction of 25%
compared to $13.6 million for the third quarter ended September 30,
2022. The $3.4 million decrease in selling, general and
administrative expenses was primarily attributable to a $1.9
million decrease in commercialization expenses, incurred in 2022 in
anticipation of the potential omburtamab launch.
For the nine months ended September 30, 2023, selling, general,
and administrative expenses were $33.7 million, a reduction of 33%
compared to $50.1 million for the nine months ended September 30,
2022. The $16.4 million decrease in selling, general and
administrative expenses was primarily attributable to a $10.9
million charge in the nine months ended September 30, 2022 related
to contractual severance-related benefits for the Company’s former
Chief Executive Officer, and, to a lesser extent, a $2.9 million
decrease in commercialization expenses, incurred in 2022 in
anticipation of a potential omburtamab launch.
Net Loss
Y-mAbs reported a net loss for the third quarter ended September
30, 2023, of $7.7 million, or ($0.18) per basic and diluted share,
compared to a net loss of $27.5 million, or ($0.63) per basic and
diluted share, for the quarter ended September 30, 2022. For the
nine months ended September 30, 2023, the Company reported a net
loss of $20.4 million, or ($0.47) per basic and diluted share,
compared to a net loss of $96.7 million, or ($2.21) per basic and
diluted share, for the nine months ended September 30, 2022. The
favorable decrease in net loss was primarily driven by an increase
in DANYELZA U.S. and international product revenues in the third
quarter and nine months ended September 30, 2023, decreased
research and development cost, and decreased selling, general and
administration cost.
Cash and Cash Equivalents
As of September 30, 2023, Y-mAbs had approximately $86.6 million
in cash and cash equivalents which, together with anticipated
DANYELZA product revenues, is expected to support operations as
currently planned into 2027. 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
The Company is updating and reiterating its full-year 2023
financial guidance, as follows:
- Reiterating anticipated DANYELZA® net product revenues of
between $80 million and $85 million;
- Lowering anticipated operating expenses to between $110 million
and $115 million from previous guidance of between $115 million and
$120 million;
- Lowering anticipated total annual cash burn to between $27
million and $32 million from previous guidance of between $40
million and $50 million; and
- Cash and cash equivalents now anticipated to support operations
as currently planned into 2027 compared to previous cash runway
guidance into 2026.
Webcast and Conference Call
Y-mAbs will host a conference call on Tuesday, November 14,
2023, at 9:00 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 |
Conference ID: |
|
13741478 |
|
|
|
To access a live webcast of the update, please
use this link. Prior to the call and webcast, a slide presentation
pertaining to Y-mAbs’ quarterly earnings will be made available in
the investor relations section of the Company’s website,
www.ymabs.com, shortly before the call begins.
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, cash burn and DANYELZA product revenue and sufficiency of
cash resources and related assumptions; 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 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 Technology and
potential benefits and applications thereof; statements with
respect to DANYELZA as a growing commercial product and SADA as a
differentiated radioimmunotherapy platform positioning the Company
on a path to potentially transform the treatment paradigm for a
variety of cancers and improve patients’ lives; 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 the Company’s research and development
programs, including with respect to timing and results;
expectations related to the timing of the initiation and completion
of regulatory submissions; 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 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 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; the risks related to the Company’s
dependence on third parties including for conduct of clinical
testing and product manufacture; the Company’s inability to enter
into partnerships; the 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, 2022,
the Company’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2023 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®, 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) |
|
|
|
|
|
|
|
As of |
|
September 30, |
|
|
December 31, |
|
2023 |
|
2022 |
ASSETS |
|
|
|
|
|
CURRENT
ASSETS |
|
|
|
|
|
Cash and cash equivalents |
$ |
86,571 |
|
|
$ |
105,762 |
|
Accounts receivable, net |
|
18,874 |
|
|
|
12,531 |
|
Inventories |
|
7,113 |
|
|
|
6,702 |
|
Other current assets |
|
2,302 |
|
|
|
5,452 |
|
Total current assets |
|
114,860 |
|
|
|
130,447 |
|
Property and equipment, net |
|
296 |
|
|
|
604 |
|
Operating lease right-of-use assets |
|
1,593 |
|
|
|
1,739 |
|
Intangible assets, net |
|
2,720 |
|
|
|
2,986 |
|
Other assets |
|
9,415 |
|
|
|
5,680 |
|
TOTAL
ASSETS |
$ |
128,884 |
|
|
$ |
141,456 |
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
Accounts payable |
$ |
7,610 |
|
|
$ |
14,175 |
|
Accrued liabilities |
|
13,304 |
|
|
|
13,241 |
|
Operating lease liabilities, current portion |
|
898 |
|
|
|
868 |
|
Total current liabilities |
|
21,812 |
|
|
|
28,284 |
|
Accrued milestone payments |
|
5,375 |
|
|
|
2,250 |
|
Operating lease liabilities, long-term portion |
|
725 |
|
|
|
899 |
|
Other liabilities |
|
822 |
|
|
|
802 |
|
TOTAL
LIABILITIES |
|
28,734 |
|
|
|
32,235 |
|
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Preferred
stock, $0.0001 par value, 5,500,000 shares authorized and none
issued at September 30, 2023 and
December 31, 2022 |
|
- |
|
|
|
- |
|
Common
stock, $0.0001 par value, 100,000,000 shares authorized at
September 30, 2023 and December 31, 2022;
43,621,618 and 43,670,109 shares issued at
September 30, 2023 and December 31, 2022,
respectively |
|
4 |
|
|
|
4 |
|
Additional
paid-in capital |
|
554,779 |
|
|
|
543,929 |
|
Accumulated
other comprehensive income |
|
1,849 |
|
|
|
1,331 |
|
Accumulated
deficit |
|
(456,482 |
) |
|
|
(436,043 |
) |
TOTAL
STOCKHOLDERS’ EQUITY |
|
100,150 |
|
|
|
109,221 |
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
128,884 |
|
|
$ |
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 September 30, |
|
Nine months ended September 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
REVENUES |
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
19,954 |
|
|
$ |
12,537 |
|
|
$ |
60,956 |
|
|
$ |
32,820 |
|
License revenue |
|
500 |
|
|
|
— |
|
|
|
500 |
|
|
|
1,000 |
|
Total
revenues |
|
20,454 |
|
|
|
12,537 |
|
|
|
61,456 |
|
|
|
33,820 |
|
OPERATING
COSTS AND EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
2,595 |
|
|
|
2,475 |
|
|
|
9,327 |
|
|
|
5,447 |
|
License royalties |
|
50 |
|
|
|
— |
|
|
|
50 |
|
|
|
100 |
|
Research and development |
|
15,358 |
|
|
|
22,453 |
|
|
|
40,831 |
|
|
|
71,785 |
|
Selling, general, and administrative |
|
10,200 |
|
|
|
13,626 |
|
|
|
33,721 |
|
|
|
50,146 |
|
Total
operating costs and expenses |
|
28,203 |
|
|
|
38,554 |
|
|
|
83,929 |
|
|
|
127,478 |
|
Loss from
operations |
|
(7,749 |
) |
|
|
(26,017 |
) |
|
|
(22,473 |
) |
|
|
(93,658 |
) |
OTHER
INCOME/(LOSS), NET |
|
|
|
|
|
|
|
|
|
|
|
Interest and other income/(loss) |
|
189 |
|
|
|
(1,509 |
) |
|
|
2,400 |
|
|
|
(3,067 |
) |
LOSS BEFORE
INCOME TAXES |
|
(7,560 |
) |
|
|
(27,526 |
) |
|
|
(20,073 |
) |
|
|
(96,725 |
) |
Provision for income taxes |
|
187 |
|
|
|
— |
|
|
|
366 |
|
|
|
— |
|
NET
LOSS |
$ |
(7,747 |
) |
|
$ |
(27,526 |
) |
|
$ |
(20,439 |
) |
|
$ |
(96,725 |
) |
Other
comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation |
|
806 |
|
|
|
1,598 |
|
|
|
518 |
|
|
|
3,331 |
|
COMPREHENSIVE LOSS |
$ |
(6,941 |
) |
|
$ |
(25,928 |
) |
|
$ |
(19,921 |
) |
|
$ |
(93,394 |
) |
Net loss per
share attributable to common stockholders, basic and diluted |
$ |
(0.18 |
) |
|
$ |
(0.63 |
) |
|
$ |
(0.47 |
) |
|
$ |
(2.21 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
43,620,532 |
|
|
|
43,718,351 |
|
|
|
43,651,536 |
|
|
|
43,715,451 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Y mAbs Therapeutics (NASDAQ:YMAB)
過去 株価チャート
から 4 2024 まで 5 2024
Y mAbs Therapeutics (NASDAQ:YMAB)
過去 株価チャート
から 5 2023 まで 5 2024