– Fourth Quarter 2022 Total Revenue of $36.3
Million and Full Year 2022 Revenue of $134.0 Million; QINLOCK® Net
Product Revenue Increased 44% to $125.5 Million in 2022 Compared to
2021 –
– Expects to Complete Enrollment in the MOTION
Pivotal Phase 3 Study of Vimseltinib in the First Quarter of 2023
and Announce Top-line Results in the Fourth Quarter of 2023 –
– Plans to Initiate INSIGHT Pivotal Phase 3
Study of QINLOCK Versus Sunitinib in Second-Line GIST Patients with
Mutations in KIT Exon 11 and 17/18 in the Second Half of 2023 Based
on ctDNA Analysis from INTRIGUE Study –
– Generated Gross Proceeds of Approximately
$143.7 Million from Public Offering in January 2023; Cash Expected
to Fund Operating and Capital Expenditures into 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 announced financial results for the
fourth quarter and year ended December 31, 2022 and provided a
corporate update.
“We are exceptionally proud of the progress we made across our
pipeline in 2022, which has set the stage for continued growth and
momentum in 2023 for our commercial, clinical, and preclinical
programs. We are well positioned to achieve our goals thanks to our
strong balance street, which was bolstered by our recent financing
that extended our cash runway into 2026,” said Steve Hoerter,
President and Chief Executive Officer of Deciphera Pharmaceuticals.
“As QINLOCK® continues to become the standard-of-care treatment for
fourth-line GIST around the world, we are excited to initiate the
INSIGHT pivotal Phase 3 study later this year, which seeks to build
upon the substantial clinical benefit in second-line GIST patients
harboring mutations in KIT exon 11 and 17/18 that we observed in
the ctDNA analysis from our INTRIGUE study. We believe that with an
expanded indication in the second-line setting, QINLOCK and
vimseltinib in TGCT combined represent a peak global revenue
opportunity of over one billion dollars. We now expect to complete
enrollment in vimseltinib’s MOTION pivotal Phase 3 study in the
first quarter of 2023, bringing us one step closer to becoming a
company with multiple approved medicines.”
Fourth Quarter 2022 and Early 2023 Highlights and Upcoming
Milestones
QINLOCK® (ripretinib)
- Recorded $32.9 million in QINLOCK net product revenue in the
fourth quarter of 2022, including $25.6 million in U.S. net product
revenue and $7.3 million in international net product revenue, an
increase of 39% from net product revenue of $23.7 million in the
fourth quarter of 2021.
- Included in the National Reimbursement Drug List (NRDL) by
China’s National Healthcare Security Administration (NHSA) for
advanced gastrointestinal stromal tumor (GIST) patients who have
received prior treatment with three or more kinase inhibitors in
the all-comer setting.
- Received approval in New Zealand in December 2022 and in Israel
and Macau in January 2023 for the treatment of adult patients with
GIST who have received prior treatment with three or more kinase
inhibitors, including imatinib.
- Presented data from the INTRIGUE Phase 3 exploratory
circulating tumor DNA (ctDNA) analysis at the American Society of
Clinical Oncology (ASCO) Plenary Series Session on January 24,
2023, which followed the announcement of top-line results earlier
that month.
- Patients with mutations in KIT exon 11 and 17/18 derived
substantially improved clinical benefit with QINLOCK versus
sunitinib.
- QINLOCK demonstrated a median progression free survival (mPFS)
of 14.2 months compared to 1.5 months for the sunitinib arm (hazard
ratio [HR] 0.22, nominal p value <0.0001).
- QINLOCK demonstrated a confirmed objective response rate (ORR)
of 44.4% (n=12 of 27) compared to 0% for sunitinib (nominal p value
0.0001).
- Overall survival (OS) for the QINLOCK arm has not reached a
median, while patients randomized to the sunitinib arm had a median
OS (mOS) of 17.5 months (HR 0.34, nominal p value 0.0061).
- Expects to initiate the INSIGHT pivotal Phase 3 study of
QINLOCK versus sunitinib in second-line GIST patients with
mutations in KIT exon 11 and 17 and/or 18 and the absence of
mutations in KIT exon 9, 13, and/or 14 (also referred to as
patients with mutations in KIT exon 11 and 17/18) in the second
half of 2023.
Vimseltinib
- Expects to complete enrollment for 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), in the first quarter of 2023 and announce top-line results
from the study in the fourth quarter of 2023.
- Expects to present updated data from the Phase 1/2 study of
vimseltinib in the second half of 2023.
DCC-3116
- Expects to initiate a new combination study evaluating
DCC-3116, an investigational switch-control kinase inhibitor of
ULK1/2 designed to inhibit autophagy, in combination with
encorafenib and cetuximab in patients with colorectal cancer in the
second half of 2023. Under the terms of the clinical trial
collaboration and supply agreement with Pfizer, Inc., Deciphera
will sponsor the study and Pfizer will supply encorafenib at no
cost.
- Opened enrollment in three Phase 1b combination dose escalation
cohorts and treated the first patient in the fourth quarter of
2022:
- In combination with trametinib, a Food and Drug Administration
(FDA)-approved MEK inhibitor, in patients with advanced or
metastatic solid tumors with RAS, NF1, or RAF mutations.
- In combination with binimetinib, an FDA-approved MEK inhibitor,
in patients with advanced or metastatic solid tumors with RAS, NF1,
or RAF mutations.
- In combination with sotorasib, an FDA-approved KRASG12C
inhibitor, in patients with advanced or metastatic solid tumors
with KRASG12C mutations.
- Expects to present updated data from the single agent dose
escalation phase and initial data from the combination dose
escalation cohorts of the Phase 1/2 study of DCC-3116 in the second
half of 2023.
- Expects to initiate one or more expansion cohorts in the
ongoing Phase 1/2 study of DCC-3116 in the second half of 2023 in
combination with the MEK inhibitors trametinib or binimetinib, or
the KRASG12C inhibitor sotorasib.
- Expects to present preclinical data on new clinical
combinations with DCC-3116 in the first half of 2023.
DCC-3084
- Expects to submit an investigational new drug (IND) application
with the FDA for DCC-3084, a potential best-in-class pan-RAF
inhibitor, in the second half of 2023.
- Expects to present in vitro and in vivo data demonstrating its
preclinical profile as a potent and selective inhibitor of
BRAF/CRAF kinases, with optimized pharmaceutical properties for
development in both single-agent and combination opportunities, in
the first half of 2023.
Kinase Switch-Control Research Engine
- Expects to nominate a new development candidate from
Deciphera’s proprietary discovery engine of novel switch-control
inhibitors in the first half of 2023.
- Expects to present new preclinical data from research programs
at a medical meeting in the first half of 2023.
Corporate Update
- Announced the closing of its underwritten public offering of
7,986,111 shares of its common stock, including 1,041,666 shares
pursuant to the option granted by Deciphera to the underwriters,
which option was exercised in full. The public offering price of
each share of common stock was $18.00. The aggregate gross proceeds
to Deciphera from this offering were approximately $143.7 million,
before deducting underwriting discounts and commissions and other
estimated offering expenses.
Fourth Quarter and Full Year 2022 Financial Results
- Revenue: Total revenue for the fourth quarter of 2022
was $36.3 million, which includes $32.9 million of net product
revenue of QINLOCK and $3.4 million of collaboration revenue
compared to $24.2 million of total revenue, including $23.7 million
of net product revenue of QINLOCK and $0.5 million of collaboration
revenue, for the same period in 2021. Total revenue for the year
ended December 31, 2022 was $134.0 million, which includes $125.5
million of net product revenue of QINLOCK and $8.5 million of
collaboration revenue compared to $96.1 million of total revenue,
including $87.4 million of net product revenue of QINLOCK and $8.8
million of collaboration revenue, for the same period in 2021.
International and total net product revenue for the fourth quarter
includes a one-time reserve for QINLOCK product sales in Germany
due to a change in German law effective as of November 2022
shortening the free pricing period retroactively to six months from
twelve months.
- Cost of Sales: Cost of sales were $3.2 million in the
fourth quarter of 2022, which includes $0.7 million in cost of
product sales, compared to cost of product sales of $0.5 million
for the fourth quarter of 2021. For the year ended December 31,
2022, cost of sales were $8.7 million, including $2.7 million in
cost of product sales, compared to cost of sales of $2.9 million in
2021, including cost of product sales of $1.3 million. In the third
quarter of 2022, the Company completed the sales of zero cost
inventories of QINLOCK that had been expensed prior to FDA
approval.
- R&D Expenses: Research and development expenses for
the fourth quarter of 2022 were $48.1 million, compared to $74.9
million for the same period in 2021, and $187.8 million for the
year ended December 31, 2022 compared to $257.0 million for the
same period in 2021. The decrease was primarily due to lower
clinical study costs related to QINLOCK, including the Phase 3
INTRIGUE study and the Phase 1 study, the discontinuation of the
rebastinib program following the corporate restructuring
implemented in the fourth quarter of 2021, partially offset by an
increase in clinical study costs related to the Phase 3 study of
vimseltinib and the Phase 1/2 study of DCC-3116. Non-cash,
stock-based compensation was $22.2 million and $20.7 million for
the year ended December 31, 2022 and 2021, respectively.
- SG&A Expenses: Selling, general, and administrative
expenses for the fourth quarter of 2022 were $32.2 million,
compared to $37.2 million for the same period in 2021 and $120.2
million for the year ended December 31, 2022, compared to $136.3
million for the same period in 2021. The decrease was primarily due
to a decrease in personnel-related costs and professional and
consultant fees. Non-cash, stock-based compensation was $29.7
million and $25.4 million for the year ended December 31, 2022 and
2021, respectively.
- Net Loss: For the fourth quarter of 2022, Deciphera
reported a net loss of $45.9 million, or $0.60 per share, compared
with a net loss of $88.4 million, or $1.51 per share, for the same
period in 2021. Net loss for the year ended December 31, 2022 was
$178.9 million, or $2.37 per share, compared with a net loss of
$300.0 million, or $5.16 per share, for the year ended December 31,
2021.
- Cash Position: As of December 31, 2022, cash, cash
equivalents, and marketable securities were $339.0 million,
compared to $327.6 million as of December 31, 2021. Based on its
current operating plans, Deciphera expects its current cash, cash
equivalents, and marketable securities together with anticipated
product, royalty, and supply revenues, and the net proceeds from
our underwritten public offering completed in January 2023, 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 2026.
Conference Call and Webcast
Deciphera will host a conference call and webcast to discuss
this announcement today, February 7, 2023, at 8:00 AM ET. The
conference call may be accessed via this link:
https://register.vevent.com/register/BId831b7236a304519833842d99a13487f.
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, 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 planned Phase 3 INSIGHT study of
QINLOCK versus sunitinib in second-line GIST patients with
mutations in KIT exon 11 and 17/18; the vimseltinib enrollment and
topline readout for the pivotal Phase 3 MOTION study and our phase
1/2 study of vimseltinib, each in TGCT patients; plans to present
updated data from the single agent dose escalation phase and
initial data from the combination dose escalation cohorts of the
Phase 1/2 study of DCC-3116, plans to initiate one or more
combination cohorts in the Phase 1/2 study of DCC-3116, plans to
initiate a new dose escalation cohort evaluating DCC-3116 in
combination with encorafenib and cetuximab in patients with
colorectal cancer, the benefits anticipated pursuant to our
collaboration and supply agreement with Pfizer, plans to present
additional preclinical data for DCC-3116; plans to submit an IND
for DCC-3084 and present preclinical data for DCC-3084; plans to
nominate a development candidate from our proprietary discovery
engine of novel switch control inhibitors; 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 Annual Report
on Form 10-K for the year ended December 31, 2022, 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.
Deciphera, the Deciphera logo, QINLOCK, and the QINLOCK logo are
registered trademarks of Deciphera Pharmaceuticals, LLC.
Deciphera Pharmaceuticals,
Inc.
Consolidated Balance
Sheets
(Unaudited, in thousands,
except share and per share amounts)
December 31,
2022
2021
Assets
Current assets:
Cash and cash equivalents
$
64,741
$
87,063
Short-term marketable securities
259,745
198,571
Accounts receivable, net
22,429
20,595
Inventory
20,561
14,125
Prepaid expenses and other current
assets
25,482
18,660
Total current assets
392,958
339,014
Long-term marketable securities
14,550
41,950
Long-term investments—restricted and other
long-term assets
3,277
3,110
Property and equipment, net
6,707
8,610
Operating lease assets
36,547
36,800
Total assets
$
454,039
$
429,484
Liabilities and Stockholders'
Equity
Current liabilities:
Accounts payable
$
18,612
$
13,130
Accrued expenses and other current
liabilities
64,622
80,773
Operating lease liabilities
3,235
2,870
Total current liabilities
86,469
96,773
Operating lease liabilities, net of
current portion
25,879
27,991
Total liabilities
112,348
124,764
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; 67,637,351 shares and 58,549,644
shares issued and outstanding as of December 31, 2022 and 2021,
respectively
676
585
Additional paid-in capital
1,575,361
1,358,516
Accumulated other comprehensive income
(983
)
51
Accumulated deficit
(1,233,363
)
(1,054,432
)
Total stockholders' equity
341,691
304,720
Total liabilities and stockholders'
equity
$
454,039
$
429,484
Deciphera Pharmaceuticals,
Inc.
Consolidated Statements of
Operations
(Unaudited, in thousands,
except share and per share amounts)
Three Months Ended December
31,
Twelve Months Ended December
31,
2022
2021
2022
2021
Revenues:
Product revenues, net
$
32,880
$
23,696
$
125,504
$
87,389
Collaboration revenues
3,465
503
8,532
8,759
Total revenues
36,345
24,199
134,036
96,148
Cost and operating expenses:
Cost of sales
3,245
518
8,770
2,932
Research and development
48,066
74,932
187,821
257,040
Selling, general, and administrative
32,195
37,151
120,167
136,253
Total cost and operating expenses
83,506
112,600
316,758
396,225
Loss from operations
(47,160
)
(88,401
)
(182,722
)
(300,077
)
Other income (expense):
Interest and other income, net
1,926
6
4,513
113
Total other income (expense), net
1,926
6
4,513
113
Loss before income tax expense
(45,234
)
(88,395
)
(178,209
)
(299,964
)
Income tax expense
700
722
Net loss
$
(45,934
)
$
(88,395
)
$
(178,931
)
$
(299,964
)
Net loss per share—basic and diluted
$
(0.60
)
$
(1.51
)
$
(2.37
)
$
(5.16
)
Weighted average common shares
outstanding—basic and diluted
76,440,793
58,487,041
75,500,148
58,084,325
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230207005278/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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