– Third Quarter 2023 Total Revenue of $43.3
Million; Net Product Revenue for QINLOCK® (ripretinib)
Increased 29% to $41.8 Million Compared to Third Quarter 2022 –
– Announced Positive Top-line Results for
MOTION Pivotal Phase 3 Study of Vimseltinib for TGCT and Updated
Results from Phase 1/2 Study; NDA Submission Expected in Second
Quarter of 2024 –
– QINLOCK Successfully Launched in Italy –
– Conference Call to be Held Today at 8:00 AM
ET –
Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a
biopharmaceutical company focused on discovering, developing, and
commercializing important new medicines to improve the lives of
people with cancer, today announced financial results for the third
quarter ended September 30, 2023 and provided a corporate
update.
“QINLOCK achieved another record quarter of product revenue with
continued strength in commercial demand,” said Steve Hoerter,
President and Chief Executive Officer of Deciphera Pharmaceuticals.
“With the positive results of the MOTION Phase 3 study of
vimseltinib we reported earlier today, we are now one step closer
to becoming a company with multiple approved products. We look
forward to engaging with regulatory authorities to advance
vimseltinib toward approval and deliver it to the TGCT patients in
need of an effective and well tolerated treatment option."
Third Quarter 2023 Highlights and Upcoming Milestones
QINLOCK® (ripretinib)
- Recorded $41.8 million in QINLOCK net product revenue in the
third quarter of 2023, including $32.7 million in U.S. net product
revenue and $9.1 million in international net product revenue, an
increase of 29% compared to net product revenue of $32.3 million in
the third quarter of 2022. In addition, QINLOCK generated $1.5
million in collaboration revenue including royalties and supply
revenue with Zai Lab, the Company’s partner in Greater China.
- Successfully launched QINLOCK in Italy for the treatment of
fourth-line gastrointestinal stromal tumor (GIST).
- Initiated the INSIGHT Phase 3 study by opening the first sites
for enrollment comparing QINLOCK versus sunitinib in second-line
GIST patients with mutations in KIT exon 11 and 17/18.
Vimseltinib
- Announced positive top-line results from the MOTION pivotal
Phase 3 study of vimseltinib, an investigational, orally
administered, potent, and highly selective switch-control kinase
inhibitor of CSF1R for the potential treatment of tenosynovial
giant cell tumor (TGCT). The study met its primary endpoint in the
intent-to-treat (ITT) population demonstrating statistically
significant and clinically meaningful improvements in objective
response rate (ORR) at Week 25 compared to placebo. In the ITT
population, the ORR at Week 25 was 40% for the vimseltinib arm and
0% for the placebo arm (p-value <0.0001). In addition, the study
met all key secondary endpoints demonstrating statistically
significant and clinically meaningful improvements in tumor volume
score (TVS), range of motion (ROM), physical function, stiffness,
quality of life, and pain compared to placebo. In the ITT
population, the ORR by TVS at Week 25 was 67% for the vimseltinib
arm and 0% for the placebo arm (p<0.0001). Treatment with
vimseltinib also demonstrated an improvement in ROM at Week 25 of
18.4% vs. a 3.8% improvement for placebo (p=0.0077). Treatment with
vimseltinib was well-tolerated in patients with TGCT and the safety
profile was consistent with previously disclosed data. There was no
evidence of cholestatic hepatotoxicity.
- Announced updated results from the Phase 1/2 study of
vimseltinib as of a June 27, 2023 cutoff date demonstrating strong
clinical benefit with best overall response rates of 72% (Phase 1)
and 64% (Phase 2 Cohort A), a favorable long-term safety profile
with no evidence of cholestatic hepatotoxicity and increasing
median treatment duration of 25.1 months (Phase 1) and 21.0 months
(Phase 2 Cohort A). Results from the Phase 1 portion of the study
are being presented in an oral presentation and results from
Cohorts A and B of the Phase 2 portion of the study are being
presented in two poster presentations at the Connective Tissue
Oncology Society 2023 Annual Meeting in Dublin, Ireland on November
1-4, 2023.
- Expects to submit a New Drug Application (NDA) with the U.S.
Food and Drug Administration (FDA) in the second quarter of 2024
and a Marketing Authorisation Application (MAA) with the European
Medicines Agency (EMA) in the third quarter of 2024.
DCC-3116
- Enrollment is ongoing in combination escalation cohorts
evaluating the potential first-in-class ULK inhibitor, DCC-3116, in
combination with binimetinib, trametinib, sotorasib,
encorafenib/cetuximab, and QINLOCK, designed to select recommended
Phase 2 combination dosing for potential expansion cohorts.
DCC-3084
- Expects to submit an Investigational New Drug (IND) application
to the FDA for its pan-RAF inhibitor, DCC-3084, by year end
2023.
DCC-3009
- Expects to submit an IND application to the FDA for its pan-KIT
inhibitor, DCC-3009, in the first half of 2024.
Third Quarter 2023 Financial Results
- Revenue: Total revenue for the third quarter of 2023 was
$43.3 million, which includes $41.8 million of net product revenue
of QINLOCK and $1.5 million of collaboration revenue compared to
$36.0 million of total revenue, including $32.3 million of net
product revenue of QINLOCK and $3.7 million of collaboration
revenue, for the same period in 2022.
- Cost of Sales: Cost of sales were $1.3 million in the
third quarter of 2023 compared to cost of sales of $3.3 million for
the third quarter of 2022. In the third quarter of 2022, Deciphera
completed the sale of zero cost inventories of QINLOCK that had
been expensed prior to FDA approval.
- R&D Expenses: Research and development expenses for
the third quarter of 2023 were $62.5 million, compared to $47.5
million for the same period in 2022. The increase was primarily due
to an increase in clinical study costs for QINLOCK and clinical
study costs related to the Phase 1/2 study of DCC-3116. Non-cash,
stock-based compensation was $5.0 million and $5.3 million for the
third quarters of 2023 and 2022, respectively.
- SG&A Expenses: Selling, general, and administrative
expenses for the third quarter of 2023 were $33.3 million, compared
to $30.0 million for the same period in 2022. The increase was
primarily due to an increase in professional, consulting, and other
expenses as well as personnel-related costs. Non-cash, stock-based
compensation was $6.1 million and $7.1 million for the third
quarters of 2023 and 2022, respectively.
- Net Loss: For the third quarter of 2023, Deciphera
reported a net loss of $49.6 million, or $0.58 per share, compared
with a net loss of $43.0 million, or $0.55 per share, for the same
period in 2022.
- Cash Position: As of September 30, 2023, cash, cash
equivalents, and marketable securities were $376.9 million,
compared to $389.4 million as of June 30, 2023. Based on its
current operating plans, Deciphera expects its current cash, cash
equivalents, and marketable securities together with anticipated
product, royalty, and supply revenues, but excluding any potential
future milestones received under its collaboration or license
agreements, will enable the Company to fund its operating and
capital expenditures into 2026.
Conference Call and Webcast
Deciphera will host a conference call and webcast to discuss
this announcement today, October 30, 2023, at 8:00 AM ET. The
conference call may be accessed via this link:
https://register.vevent.com/register/BIc2885b197da74145bfc30deb5fb11858.
A live webcast of the conference call will be available in the
“Events and Presentations” page in the “Investors & News”
section of the Company’s website at
https://investors.deciphera.com/events-presentations. A replay will
be available on the Company’s website approximately two hours after
the conference call and will be available for 30 days following the
call.
About Deciphera Pharmaceuticals
Deciphera is a biopharmaceutical company focused on discovering,
developing, and commercializing important new medicines to improve
the lives of people with cancer. We are leveraging our proprietary
switch-control kinase inhibitor platform and deep expertise in
kinase biology to develop a broad portfolio of innovative
medicines. In addition to advancing multiple product candidates
from our platform in clinical studies, QINLOCK® is Deciphera’s
switch-control inhibitor for the treatment of fourth-line GIST.
QINLOCK is approved in Australia, Canada, China, the European
Union, Hong Kong, Israel, Macau, New Zealand, Singapore,
Switzerland, Taiwan, the United Kingdom, and the United States. For
more information, visit www.deciphera.com and follow us on LinkedIn
and Twitter (@Deciphera).
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, our expectations
and timing regarding the potential for our preclinical and/or
clinical stage pipeline assets to be first-in-class and/or
best-in-class treatments; our Phase 3 INSIGHT study of QINLOCK
versus sunitinib in second-line GIST patients with mutations in KIT
exon 11 and 17/18; the potential for vimseltinib to become our
second approved medicine, plans to submit an NDA for vimseltinib in
the second quarter of 2024 and an MAA in the third quarter of 2024,
and plans to present additional data at upcoming medical
congresses; plans for our ongoing Phase 1/2 studies of DCC-3116;
plans to submit an IND application to the FDA for DCC-3084 by the
end of 2023; plans to submit an IND application to the FDA for
DCC-3009 in the first half of 2024; and cash guidance. The words
“may,” “will,” “could,” “would,” “should,” “expect,” “plan,”
“anticipate,” “intend,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “seek,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release are based on management’s current expectations and beliefs
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, our ability to successfully demonstrate the efficacy
and safety of our drug or drug candidates, the preclinical or
clinical results for our product candidates, which may not support
further development of such product candidates, comments, feedback
and actions of regulatory agencies, our ability to commercialize
QINLOCK and execute on our marketing plans for any drugs or
indications that may be approved in the future, the inherent
uncertainty in estimates of patient populations, competition from
other products, our ability to obtain and maintain reimbursement
for any approved product and the extent to which patient assistance
programs are utilized and other risks identified in our Securities
and Exchange Commission (SEC) filings, including our Quarterly
Report on Form 10-Q for the quarter ended September 30, 2023, and
subsequent filings with the SEC. We caution you not to place undue
reliance on any forward-looking statements, which speak only as of
the date they are made. We disclaim any obligation to publicly
update or revise any such statements to reflect any change in
expectations or in events, conditions or circumstances on which any
such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the
forward-looking statements.
The Deciphera logo, QINLOCK, and the QINLOCK logo are registered
trademarks and Deciphera is a trademark of Deciphera
Pharmaceuticals, LLC.
Deciphera Pharmaceuticals,
Inc.
Consolidated Balance
Sheets
(Unaudited, in thousands,
except share and per share amounts)
September 30, 2023
December 31, 2022
Assets
Current assets:
Cash and cash equivalents
$108,087
$64,741
Short-term marketable securities
230,988
259,745
Accounts receivable, net
27,549
22,429
Inventory
27,105
20,561
Prepaid expenses and other current
assets
23,847
25,482
Total current assets
417,576
392,958
Long-term marketable securities
37,850
14,550
Long-term investments—restricted and other
long-term assets
3,337
3,277
Property and equipment, net
5,864
6,707
Operating lease assets
33,209
36,547
Total assets
$497,836
$454,039
Liabilities and Stockholders'
Equity
Current liabilities:
Accounts payable
$21,453
$18,612
Accrued expenses and other current
liabilities
68,005
64,622
Operating lease liabilities
3,436
3,235
Total current liabilities
92,894
86,469
Operating lease liabilities, net of
current portion
23,272
25,879
Total liabilities
116,166
112,348
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.01 par value per
share; 5,000,000 shares authorized; no shares issued or
outstanding
—
—
Common stock, $0.01 par value per share;
125,000,000 shares authorized; 79,975,625 shares and 67,637,351
shares issued and outstanding as of September 30, 2023 and December
31, 2022, respectively
799
676
Additional paid-in capital
1,762,882
1,575,361
Accumulated other comprehensive income
(loss)
(896)
(983)
Accumulated deficit
(1,381,115)
(1,233,363)
Total stockholders' equity
381,670
341,691
Total liabilities and stockholders'
equity
$497,836
$454,039
Deciphera Pharmaceuticals,
Inc.
Consolidated Statements of
Operations
(Unaudited, in thousands,
except share and per share amounts)
Three Months Ended September
30,
Nine Months Ended September
30,
2023
2022
2023
2022
Revenues:
Product revenues, net
$41,820
$32,318
$112,362
$92,624
Collaboration revenues
1,493
3,656
2,700
5,067
Total revenues
43,313
35,974
115,062
97,691
Cost and operating expenses:
Cost of sales
1,286
3,344
1,947
5,525
Research and development
62,463
47,485
175,524
139,755
Selling, general, and administrative
33,252
30,026
97,311
87,972
Total cost and operating expenses
97,001
80,855
274,782
233,252
Loss from operations
(53,688)
(44,881)
(159,720)
(135,561)
Other income (expense):
Interest and other income, net
4,107
1,838
11,968
2,565
Total other income (expense), net
4,107
1,838
11,968
2,565
Net loss
$(49,581)
$(43,043)
$(147,752)
$(132,996)
Net loss per share—basic and diluted
$(0.58)
$(0.55)
$(1.75)
$(1.82)
Weighted average common shares
outstanding—basic and diluted
85,788,613
78,206,647
84,506,593
73,129,804
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version on businesswire.com: https://www.businesswire.com/news/home/20231030024020/en/
Investor Relations: Maghan Meyers Argot Partners
Deciphera@argotpartners.com 212-600-1902
Media: David Rosen Argot Partners
david.rosen@argotpartners.com 212-600-1902
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