- Second Quarter 2021 QINLOCK® Net Product
Revenue of $22.0 Million -
- Top-line Results from INTRIGUE Phase 3 Study
of QINLOCK in Patients with Second-line Gastrointestinal Stromal
Tumor (GIST) Expected in the Fourth Quarter of 2021 -
- First Patient Treated in Phase 1 Study of ULK
Kinase Inhibitor DCC-3116 -
- Data from Vimseltinib in Patients with
Tenosynovial Giant Cell Tumor (TGCT) and Rebastinib in Combination
with Paclitaxel in Platinum-Resistant Ovarian Cancer to be
Presented at the ESMO Congress 2021; Finalization of Pivotal
Development Plans for both Programs Expected in the Second Half of
2021 -
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced
financial results for the first quarter ended June 30, 2021 and
provided a corporate update.
“We made significant progress against our goals in the first
half of the year and we look forward to carrying this momentum
through the rest of 2021,” said Steve Hoerter, President and Chief
Executive Officer of Deciphera. “Building on the successful launch
of QINLOCK for fourth-line GIST in the U.S., this best-in-class
medicine has now been approved in China and Hong Kong and we expect
approval from the European Medicines Agency later this year. In the
fourth quarter, we look forward to reporting top-line data from the
INTRIGUE Phase 3 study in second-line GIST. In addition, we expect
to report updated data from the vimseltinib and rebastinib programs
at the upcoming ESMO congress as well as finalize pivotal
development plans for both programs later this year.”
Mr. Hoerter continued, “We also recently achieved a key
milestone treating the first patient in our Phase 1 trial of
DCC-3116, a first-in-class ULK kinase inhibitor designed to address
mutant RAS and RAF cancers through the inhibition of
autophagy.”
Second Quarter 2021 Highlights and Upcoming
Milestones
- QINLOCK (ripretinib)
- Recorded $22.0 million in QINLOCK net product revenue in the
second quarter of 2021, including $20.7 million in U.S. sales of
QINLOCK and $1.3 million in ex-U.S. sales of QINLOCK.
- Launched commercially in China, via our collaboration with Zai,
for the treatment of adult patients with fourth-line GIST.
- Presented data for QINLOCK patients undergoing intra-patient
dose escalation after disease progression in the INVICTUS Phase 3
study at the American Society of Clinical Oncology (ASCO) Annual
Meeting in June.
- Expects to announce top-line results from the INTRIGUE Phase 3
study in the fourth quarter of 2021.
- Expects potential approval from the European Medicines Agency
(EMA) for QINLOCK in the fourth quarter of 2021.
- Expects to initiate a Phase 1b/2 study of QINLOCK in
combination with binimetinib, a commercially available MEK
inhibitor, in post-imatinib GIST patients in the fourth quarter of
2021.
- Vimseltinib
- Expects to present updated data from the ongoing Phase 1/2
study in patients with TGCT at the European Society for Medical
Oncology (ESMO) Congress 2021 in September.
- Plans to finalize the pivotal development plan for vimseltinib
in patients with TGCT in the second half of 2021.
- Rebastinib
- Expects to present updated data from the ongoing Phase 1b/2
study of rebastinib in combination with paclitaxel in the
platinum-resistant ovarian cancer cohort at the ESMO Congress 2021
in September.
- Plans to finalize the pivotal development plan for rebastinib
in combination with paclitaxel in the second half of 2021.
- DCC-3116
- Initiated the Phase 1 study of DCC-3116 in June 2021. The study
is evaluating DCC-3116 as a single agent and in combination with
trametinib in patients with advanced or metastatic tumors with a
mutant RAS or RAF gene. Currently, expansion cohorts are planned in
patients with advanced or metastatic pancreatic ductal
adenocarcinoma with KRAS or BRAF mutations, non-small cell lung
cancer with KRAS, NRAS, or BRAF mutations, colorectal cancer with
KRAS, NRAS, or BRAF mutations, and melanoma with NRAS or BRAF
mutations.
- Expects to present preclinical data on DCC-3116 in combination
with approved, targeted oncology agents in multiple tumor models at
an upcoming medical meeting in the second half of 2021.
Recent Corporate Updates
- Today announced an agreement with Sprint Bioscience to
exclusively in-license worldwide rights to a research-stage program
targeting VPS34, a key kinase in the autophagy pathway,
strengthening the company’s leading position in the development of
regulators of autophagy for the potential treatment of cancer.
VPS34 is involved in the endosomal trafficking of cellular cargo
targeted for lysosomal degradation in cancer cells. Targeting VPS34
may provide an additional approach to regulating autophagy that is
complementary to inhibition of ULK kinase by blocking
VPS34-mediated immunosuppression in tumors.
Upcoming Scientific Congress Presentations
- ESMO Congress 2021, September 16-21. The
following will be e-poster presentations and will be available
on-demand via the ESMO Congress 2021 website beginning on September
16 at 8:30 AM CEST / 2:30 AM EST.
- QINLOCK
- Ripretinib as ≥4th-line treatment in patients with advanced
gastrointestinal stromal tumor: long-term update from the Phase 3
INVICTUS study.
- Phase 1 study of ripretinib, a broad-spectrum KIT and PDGFRA
inhibitor, in patients with KIT-mutated or KIT-amplified
melanoma.
- Vimseltinib
- Safety and preliminary efficacy of vimseltinib in tenosynovial
giant cell tumor (TGCT).
- Rebastinib
- A Phase 1b/2 study of rebastinib and paclitaxel in
advanced/metastatic platinum-resistant ovarian cancer.
Second Quarter Financial Results
- Revenue: Total revenue for the second quarter of 2021
was $23.6 million, which includes $22.0 million of net product
revenue from sales of QINLOCK and $1.5 million of collaboration
revenue comprised of commercial supply and royalty revenue under
our license agreement with Zai Lab. Total revenue for the second
quarter of 2020 was $7.1 million, which includes $4.8 million of
net product revenue from sales of QINLOCK and $2.3 million of
collaboration revenue.
- Cost of Sales: Cost of sales was $1.3 million in the
second quarter of 2021, which includes $0.4 million in cost of net
product revenue for QINLOCK and $0.9 million in cost of
collaboration revenue. Cost of sales was less than $0.1 million for
the second quarter of 2020. Cost of net product sales is not
expected to be significant until the initial pre-launch inventory
is depleted, and additional inventory is manufactured and
sold.
- R&D Expenses: Research and development expenses for
the second quarter were $60.0 million, compared to $46.1 million
for the same period in 2020. The increase was primarily due to
personnel and preclinical costs and an increase in clinical trial
expenses related to our ongoing Phase 1/2 study of vimseltinib.
Non-cash, stock-based compensation was $5.6 million and $5.3
million for the second quarters of 2021 and 2020,
respectively.
- SG&A Expenses: Selling, general, and administrative
expenses for the second quarter of 2021 were $32.8 million,
compared to $29.9 million for the same period in 2020. The increase
was primarily due to personnel costs as well as external spend
related to professional fees, including those associated with
establishing a targeted commercial infrastructure in key European
markets to support a potential launch of QINLOCK in Europe, if
approved. Non-cash, stock-based compensation was $6.8 million and
$5.3 million for the first quarters of 2021 and 2020,
respectively.
- Net Loss: For the second quarter of 2021, Deciphera
reported a net loss of $70.4 million, or $1.21 per share, compared
with a net loss of $67.2 million, or $1.20 per share, for the same
period in 2020. The increase in net loss was primarily a result of
increased R&D expenses, as described above, partially offset by
a full quarter of product sales during the second quarter of
2021.
- Cash Position: As of June 30, 2021, cash, cash
equivalents, and marketable securities were $451.0 million,
compared to $502.2 million as of March 31, 2021. Based on its
current operating plans, Deciphera expects its current cash, cash
equivalents, and marketable securities together with anticipated
product and royalty revenues, excluding any potential future
milestone payments or other payments under its collaboration or
license agreements, will enable the Company to fund its operating
and capital expenditures into the first half of 2023.
Conference Call and Webcast
Deciphera will host a conference call and webcast to discuss
this announcement today, August 3, 2021 at 4:30 PM ET. To access
the live call by phone please dial (866) 930-5479 (domestic) or
(409) 216-0603 (international); the conference ID is 9943767. A
live audio webcast of the event may also be accessed through the
“Investors” section of Deciphera’s website at www.deciphera.com. A
replay of the webcast will be available for 30 days following the
event.
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
FDA-approved switch-control kinase inhibitor for the treatment of
fourth-line gastrointestinal stromal tumor (GIST). QINLOCK is also
approved for fourth-line GIST in Australia, Canada, China, and Hong
Kong. 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 top-line data from our Phase 3 INTRIGUE study
in second-line GIST, plans to initiate a phase 1b/2 study of
QINLOCK with a MEK inhibitor in post-imatinib GIST patients,
potential EMA approval of QINLOCK for the treatment of fourth-line
GIST, finalizing pivotal study plans for vimseltinib in TGCT
patients and for the rebastinib/paclitaxel combination, subject to
favorable data and discussions with regulators, presenting updated
data at ESMO 2021 from the Phase 1/2 study of vimseltinib in TGCT
patients and from the Phase 1b/2 study of rebastinib in combination
with paclitaxel for patients with platinum-resistant ovarian
cancer, presenting e-posters at ESMO 2021 on several other
programs, presenting preclinical data on DCC-3116 in combination
with approved agents in multiple tumor models, planned expansion of
our phase 1 study of DCC-3116 in patients with cancers driven by
mutant RAS/RAF genes; the company’s leading position in the
development of regulators of autophagy for the potential treatment
of cancer and our belief that targeting VPS34 may provide an
additional approach to regulating autophagy that is complementary
to inhibition of ULK kinase by blocking VPS34-mediated
immunosuppression in tumors, and cash runway expectations. 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 the severity and
duration of the impact of COVID-19 on our business and operations,
our ability to successfully demonstrate the efficacy and safety of
our drug candidates and in additional indications for our existing
drug, the preclinical or clinical results for our product
candidates, which may not support further development of such
product candidates, our ability to manage our reliance on
sole-source third parties such as our third party drug substance
and drug product contract manufacturers, 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, our ability to
build and scale our operations to support growth in additional
geographies, 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, our ability to
comply with healthcare regulations and laws, our ability to obtain,
maintain and enforce our intellectual property rights, any or all
of which may affect the initiation, timing and progress of clinical
studies and the timing of and our ability to obtain additional
regulatory approvals, and other risks identified in our Securities
and Exchange Commission (SEC) filings, including our Quarterly
Report on Form 10-Q for the quarter ended June 30, 2021, 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. Any forward-looking statements
contained in this press release represent our views only as of the
date hereof and should not be relied upon as representing our views
as of any subsequent date. We explicitly disclaim any obligation to
update any forward-looking statements.
QINLOCK and the QINLOCK logo are registered trademarks, and
Deciphera and the Deciphera logo are trademarks, of Deciphera
Pharmaceuticals, LLC.
Deciphera Pharmaceuticals,
Inc.
Consolidated Balance
Sheets
(Unaudited, in thousands,
except share and per share amounts)
June 30, 2021
December 31, 2020
Assets
Current assets:
Cash and cash equivalents
$
90,947
$
135,897
Short-term marketable securities
304,405
416,033
Accounts receivable, net
18,608
13,896
Inventory
8,206
5,716
Prepaid expenses and other current
assets
14,977
12,489
Total current assets
437,143
584,031
Long-term marketable securities
55,605
9,375
Long-term investments—restricted
3,102
3,102
Property and equipment, net
9,588
9,583
Operating lease assets
35,128
36,341
Total assets
$
540,566
$
642,432
Liabilities and Stockholders'
Equity
Current liabilities:
Accounts payable
$
14,022
$
12,308
Accrued expenses and other current
liabilities
49,428
55,227
Operating lease liabilities
2,604
2,457
Total current liabilities
66,054
69,992
Operating lease liabilities, net of
current portion
27,856
28,764
Total liabilities
93,910
98,756
Commitments and contingencies
Stockholders' equity:
Common stock, $0.01 par value per share;
125,000,000 shares authorized; 58,033,984 shares and 57,596,144
shares issued and outstanding as of June 30, 2021 and December 31,
2020, respectively
580
576
Additional paid-in capital
1,332,249
1,297,557
Accumulated other comprehensive income
(loss)
26
11
Accumulated deficit
(886,199
)
(754,468
)
Total stockholders' equity
446,656
543,676
Total liabilities and stockholders'
equity
$
540,566
$
642,432
Deciphera Pharmaceuticals,
Inc.
Consolidated Statements of
Operations
(Unaudited, in thousands,
except share and per share amounts)
Three Months Ended June
30,
Six Months Ended June
30,
2021
2020
2021
2020
Revenues:
Product revenues, net
$
22,048
$
4,825
$
42,010
$
4,825
Collaboration revenues
1,525
2,265
6,719
2,327
Total revenues
23,573
7,090
48,729
7,152
Cost and operating expenses:
Cost of sales
1,275
8
1,497
8
Research and development
59,984
46,081
115,665
97,469
Selling, general, and administrative
32,828
29,933
63,575
53,869
Total cost and operating expenses
94,087
76,022
180,737
151,346
Loss from operations
(70,514)
(68,932)
(132,008)
(144,194)
Other income (expense):
Interest and other income, net
81
1,691
277
4,146
Total other income (expense), net
81
1,691
277
4,146
Net loss
$
(70,433)
$
(67,241)
$
(131,731)
$
(140,048)
Net loss per share—basic and diluted
$
(1.21)
$
(1.20)
$
(2.28)
$
(2.56)
Weighted average common shares
outstanding—basic and diluted
57,987,095
55,920,122
57,867,795
54,743,778
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210803005981/en/
Investor Relations: Jen Robinson Deciphera Pharmaceuticals, Inc
jrobinson@deciphera.com 781-906-1112
Media: David Rosen Argot Partners David.Rosen@argotpartners.com
212-600-1902
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