– Preliminary Unaudited Fourth Quarter 2023
QINLOCK® Net Product Revenue of Approximately $46.0 Million, an
Increase of 40% Compared to the Fourth Quarter of 2022 –
– Expects to Submit Vimseltinib New Drug
Application (NDA) in the Second Quarter of 2024 and Marketing
Authorisation Application (MAA) in the Third Quarter of 2024 in
Tenosynovial Giant Cell Tumor (TGCT); Commercial Launch
Preparations Underway –
– Expects to Initiate a Phase 2
Proof-of-Concept Study of Vimseltinib for the Treatment of Chronic
Graft Versus Host Disease (cGVHD) in the Fourth Quarter of 2024
–
– Preliminary Unaudited Cash, Cash Equivalents,
and Marketable Securities of Approximately $352.0 million as of
December 31, 2023; Cash Runway Extended into the Second Half of
2026 –
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 highlighted its strategic outlook for
2024 and planned 2024 corporate milestones, and announced
preliminary unaudited fourth quarter and full year 2023
revenue.
“2023 was a year of important progress across our organization,
in which we demonstrated our ability to drive commercial growth
while advancing our clinical pipeline and strategically investing
in key earlier-stage programs,” said Steve Hoerter, President and
Chief Executive Officer of Deciphera Pharmaceuticals. “Thanks to
our late-stage clinical execution and global commercial excellence,
we have the potential to reach $1 billion in peak revenue with
QINLOCK and vimseltinib, and we look forward to continuing this
exciting evolution as we work to become a self-sustaining,
multi-product company.”
Planned 2024 corporate milestones and business updates
include:
QINLOCK® (ripretinib)
- Continue enrolling the INSIGHT pivotal Phase 3 clinical study
of QINLOCK versus sunitinib in second-line gastrointestinal stromal
tumor (GIST) patients with mutations in KIT exon 11 and 17/18
only.
- Publication in Nature Medicine in January 2024 of the results
of a ctDNA analysis from the INTRIGUE Phase 3 study demonstrating
substantial clinical benefit of QINLOCK in second-line GIST
patients with mutations in KIT exon 11 and 17/18 only.
- Continue the geographic expansion of QINLOCK in fourth-line
GIST, with planned commercial launches following conclusion of
pricing and reimbursement negotiations in European and
international markets.
- The Company has entered into a supply and distribution
agreement with GENESIS Pharma, a leading regional biopharma
company, in Central and Eastern Europe under which GENESIS Pharma
will be the exclusive distributor of QINLOCK in 14 countries in the
European Union with a combined population of 118 million including
Czech Republic, Greece, Hungary, Romania and Poland.
Vimseltinib
- Submit an NDA to the U.S. Food and Drug Administration (FDA) in
the second quarter of 2024 and a MAA to the European Medicines
Agency in the third quarter of 2024 for vimseltinib, an
investigational, orally administered, potent, and highly selective
switch-control kinase inhibitor of CSF1R, for the potential
treatment of TGCT.
- Present additional results from Part 1 of the pivotal Phase 3
MOTION study of vimseltinib at a medical meeting in the second
quarter of 2024.
- Present updated data from the Phase 1/2 study of vimseltinib in
TGCT in the second half of 2024.
- Initiate a Phase 2 proof-of-concept study of vimseltinib for
the treatment of cGVHD in the fourth quarter of 2024.
Early-Stage Pipeline
DCC-3116
- The Company expects to select a recommended Phase 2 dose for
expansion cohort(s) for DCC-3116, an investigational switch-control
kinase inhibitor of ULK1/2 designed to inhibit autophagy, in
2024.
- The Company has prioritized the development of DCC-3116 in
combination with sotorasib and with QINLOCK and discontinued
development of the encorafenib and cetuximab combination cohort
prior to enrollment in any clinical studies as well as the two MEK
combination cohorts.
DCC-3084
- Initiate a Phase 1 study for DCC-3084, a potential
best-in-class pan-RAF inhibitor, in the first half of 2024.
DCC-3009
- Submit an investigational new drug (IND) application with the
FDA for DCC-3009, a potential best-in-class pan-KIT inhibitor, in
the first half of 2024 and initiate a Phase 1 study in the second
half of 2024.
Preliminary 2023 Financial Results
Based on preliminary unaudited financial information, Deciphera
expects total fourth quarter 2023 revenue to be approximately $47
million and total full year 2023 revenue to be approximately $162
million. QINLOCK net product revenue is estimated to be
approximately $46 million in the fourth quarter 2023, including
approximately $35 million in U.S. net product revenue and
approximately $11 million in international net product revenue, in
addition to approximately $1 million in collaboration revenue.
In addition, preliminary unaudited cash, cash equivalents, and
marketable securities was approximately $352 million as of December
31, 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 milestone payments under its
collaboration or license agreements, will enable the Company to
fund its operating and capital expenditures into the second half of
2026.
Preliminary selected financial information presented in this
release are unaudited, subject to adjustment, and provided as an
approximation in advance of the Company's announcement of complete
financial results expected in February 2024.
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, Iceland, Israel, Liechtenstein, Macau, New
Zealand, Norway, Singapore, Switzerland, Taiwan, the United
Kingdom, and the United States. For more information, visit
www.deciphera.com and follow us on LinkedIn and X (@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, the ability to become a multi-product,
self-sustaining company, plans to continue our geographic expansion
of QINLOCK in European and international markets, plans to publish
clinical data from our Phase 3 INTRIGUE study in second-line GIST
patients with mutations in KIT exon 11 and 17/18, our Phase 3
INSIGHT clinical study of QINLOCK versus sunitinib in second-line
GIST patients with mutations in KIT exon 11 and 17/18, our
expectations regarding the aggregate potential revenue opportunity
for QINLOCK, our ability to expand the market opportunity for
QINLOCK in second-line GIST in our INSIGHT Phase 3 study; the
timing of our NDA and MAA submission for vimseltinib, the potential
revenue opportunity for vimseltinib, if approved, plans to present
additional data from our Phase 3 MOTION study and Phase 1/2 study
of vimseltinib, each in TGCT patients, plans to initiate a Phase 2
study of vimseltinib in patients with cGVHD, subject to FDA
feedback; plans for our on-going phase 1/2 study of DCC-3116 and to
select a recommended Phase 2 dose for at least one potential
expansion cohort, subject to favorable data; initiating a Phase 1
study of DCC-3084 in the first half of 2024, submitting an IND for
DCC-3009 in the first half of 2024 and initiating a Phase 1 study
in the second half of 2024, each subject to FDA feedback;
statements regarding the Company’s preliminary unaudited fourth
quarter, year-end, and net product revenue for the quarter and
year-ended December 31, 2023 and preliminary unaudited cash, cash
equivalents, and marketable securities for the quarter and
year-ended December 31, 2023, 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, risks and
uncertainties related to, 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 and the QINLOCK® word mark and logo are
registered trademarks and the Deciphera word mark is a trademark of
Deciphera Pharmaceuticals, LLC.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240108730185/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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