– Third Quarter 2021 Revenue of $23.2 Million,
Including QINLOCK® (ripretinib) Net Product Revenue of $21.7
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 –
– Approval from the European Medicines Agency
(EMA) for QINLOCK Expected in the Fourth Quarter of 2021
–
– Initiation of the Phase 3 MOTION Study of
Vimseltinib in Patients with Tenosynovial Giant Cell Tumor (TGCT)
Expected in the Fourth Quarter of 2021; Vimseltinib Granted Fast
Track Designation by the U.S. Food and Drug Administration (FDA)
–
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced
financial results for the third quarter ended September 30, 2021
and provided a corporate update.
“In the third quarter, we made tremendous progress expanding the
reach of QINLOCK for patients with GIST around the world. In
addition to obtaining the approval for this important medicine in
Switzerland and Taiwan, we also received a positive CHMP opinion
for QINLOCK in the EU, with approval expected before the end of the
year. Finally, we remain on track to report top-line results from
the Phase 3 INTRIGUE study in second-line GIST later this
quarter.”
Mr. Hoerter continued, “At the European Society for Medical
Oncology (ESMO) Congress 2021, we shared very encouraging data from
both the vimseltinib and rebastinib programs demonstrating
significant clinical activity in two diseases with high unmet
medical needs. We plan to initiate the Phase 3 MOTION study of
vimseltinib in tenosynovial giant cell tumor this quarter and
expect to initiate a Phase 3 study of rebastinib in combination
with paclitaxel in platinum-resistant ovarian cancer next year. The
body of scientific evidence continues to build supporting the
potential of our first-in-class ULK inhibitor, DCC-3116, to address
a broad spectrum of cancers in which autophagy is upregulated and
believed to play an important role in tumor growth and survival.
The Phase 1/2 study of DCC-3116 is on track and, with the
first-in-class program in this field, we are well positioned to
explore the full potential of inhibiting autophagy in cancer.”
Third Quarter 2021 Highlights and Upcoming Milestones
- QINLOCK(ripretinib)
- Recorded $21.7 million in QINLOCK net product revenue in the
third quarter of 2021, including $20.0 million in U.S. sales of
QINLOCK and $1.7 million in ex-U.S. sales of QINLOCK.
- Presented data at the ESMO Congress 2021:
- An exploratory evaluation of primary and secondary endpoints in
the Phase 3 INVICTUS study, with a cutoff date of January 15, 2021,
an additional 19 months after the primary analysis, demonstrated
consistent progression-free survival (PFS) with no change since the
primary data cut off, and improved median overall survival (OS)
among patients receiving QINLOCK.
- Median PFS was 6.3 months with QINLOCK compared to 1.0 month
with placebo.
- Median OS was 18.2 months with QINLOCK compared to 6.3 months
with placebo.
- Phase 1 study in patients with KIT-mutated or KIT-amplified
melanoma.
- Received approvals in Switzerland and Taiwan for the treatment
of adult patients with advanced GIST who have received prior
treatment with three or more kinase inhibitors, including
imatinib.
- Expects approval from the EMA for QINLOCK in the fourth quarter
of 2021.
- Expects to announce top-line results from the Phase 3 INTRIGUE
study 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
- Presented updated data from the ongoing Phase 1/2 study in
patients with TGCT at the ESMO Congress 2021, showing an
encouraging ORR of 47% across all cohorts and a manageable safety
and tolerability profile.
- Expects to initiate the pivotal Phase 3 MOTION study of
vimseltinib in the fourth quarter of 2021. MOTION is a two-part,
randomized, double-blind, placebo-controlled study of vimseltinib
to assess the efficacy and safety in patients with symptomatic TGCT
who are not amenable to surgery. The primary endpoint of the study
is ORR at week 25 as measured by RECIST v1.1 by blinded independent
central review.
- Granted Fast Track Designation by the FDA for the treatment of
patients with symptomatic TGCT who are not amenable to surgery.
This designation is designed to facilitate the development and
expedite the review of drugs to treat serious conditions and fill
an unmet medical need.
- Rebastinib
- Presented updated data from the ongoing Phase 1b/2 study of
rebastinib in combination with paclitaxel in the platinum-resistant
ovarian cancer (PROC) cohort at the ESMO Congress 2021. Data showed
promising results including median PFS of 9.1 months and an ORR of
38% (confirmed and unconfirmed) in heavily pretreated patients with
PROC.
- Received Orphan Drug Designation in the EU for the treatment of
ovarian cancer based on a positive opinion issued by the EMA
Committee for Orphan Medicinal Products (COMP).
- Announced that the Company has begun planning for a pivotal
study in PROC that is anticipated to start in 2022, subject to
feedback from regulators.
- DCC-3116
- Presented preclinical data at the AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics showing
that DCC-3116 inhibits EGFR inhibitor-induced autophagy in multiple
EGFR-mutant non-small cell lung cancer cell lines and decreased
tumor burden in combination with osimertinib and afatinib in an
EGFR mutant xenograft model.
- Announced plans to present initial data from the dose
escalation phase of the Phase 1 study in 2022.
Third Quarter Financial Results
- Revenue: Total revenue for the third quarter of 2021 was
$23.2 million, which includes $21.7 million of net product revenue
from sales of QINLOCK and $1.5 million of collaboration revenue
comprised primarily of QINLOCK supply and royalty revenue under our
license agreement with Zai Lab. Total revenue for the third quarter
of 2020 was $15.5 million, which included $15.2 million of net
product revenue from sales of QINLOCK and $0.3 million of
collaboration revenue.
- Cost of Sales: Cost of sales was $0.9 million in the
third quarter of 2021, which includes $0.2 million in cost of net
product revenue for QINLOCK and $0.7 million in cost of
collaboration revenue. Cost of sales was $0.1 million for the third
quarter of 2020. Deciphera does not expect that the cost of sales
as a percentage of net product sales of QINLOCK will increase
significantly after the Company has sold all zero cost inventories
and commenced the sales of inventories which will reflect the full
cost of manufacturing. The Company expects to continue to sell the
zero cost inventories of QINLOCK in the U.S. during 2021 and into
2022.
- R&D Expenses: Research and development expenses for
the third quarter were $66.4 million, compared to $49.2 million for
the same period in 2020. The increase was primarily due to
personnel and preclinical costs, and a $4.0 million up-front
payment to Sprint Bioscience (Sprint) pursuant to the terms of the
agreement with Sprint to exclusively in-license worldwide rights to
a research-stage program targeting VPS34, and an increase in
clinical trial expenses related to start-up activities for the
planned Phase 3 MOTION study of vimseltinib and Phase 1b/2 study of
QINLOCK in combination with binimetinib. Non-cash, stock-based
compensation was $5.4 million and $4.5 million for the third
quarters of 2021 and 2020, respectively.
- SG&A Expenses: Selling, general, and administrative
expenses for the third quarter of 2021 were $35.5 million, compared
to $30.1 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 and commercial preparedness in
key European markets to support a launch of QINLOCK in Europe, if
approved. Non-cash, stock-based compensation was $6.4 million and
$5.3 million for the third quarters of 2021 and 2020,
respectively.
- Net Loss: For the third quarter of 2021, Deciphera
reported a net loss of $79.8 million, or $1.37 per share, compared
with a net loss of $63.7 million, or $1.13 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
increased sales volume in the U.S.
- Cash Position: As of September 30, 2021, cash, cash
equivalents, and marketable securities were $392.2 million,
compared to $451.0 million as of June 30, 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, excluding any potential
future milestone payments under the Zai License Agreement, 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, November 2, 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 8178994. 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
switch control inhibitor for the treatment of fourth-line GIST.
QINLOCK is approved in Australia, Canada, China, Hong Kong,
Switzerland, Taiwan, 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 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, plans to initiate pivotal studies for vimseltinib in TGCT
patients and for the rebastinib/paclitaxel combination, subject to
discussions with regulators, the potential benefits of fast track
designation from the FDA, the potential of DCC-3116 to address a
broad spectrum of cancers in which autophagy is upregulated and our
timing for initial data from the dose escalation portion of the
phase 1 study of DCC-3116, the company’s leading position in the
development of regulators of autophagy for the potential treatment
of cancer, 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 September 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.
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)
September 30, 2021
December 31, 2020
Assets
Current assets:
Cash and cash equivalents
$
53,189
$
135,897
Short-term marketable securities
289,081
416,033
Accounts receivable, net
18,049
13,896
Inventory
7,253
5,716
Prepaid expenses and other current
assets
17,722
12,489
Total current assets
385,294
584,031
Long-term marketable securities
49,926
9,375
Long-term investments—restricted
3,102
3,102
Property and equipment, net
10,820
9,583
Operating lease assets
34,276
36,341
Total assets
$
483,418
$
642,432
Liabilities and Stockholders'
Equity
Current liabilities:
Accounts payable
$
13,502
$
12,308
Accrued expenses and other current
liabilities
59,625
55,227
Operating lease liabilities
2,662
2,457
Total current liabilities
75,789
69,992
Operating lease liabilities, net of
current portion
27,172
28,764
Total liabilities
102,961
98,756
Commitments and contingencies (Note 8)
Stockholders' equity:
Common stock, $0.01 par value per share;
125,000,000 shares authorized; 58,327,889 shares and 57,596,144
shares issued and outstanding as of September 30, 2021 and
December 31, 2020, respectively
583
576
Additional paid-in capital
1,345,746
1,297,557
Accumulated other comprehensive income
(loss)
165
11
Accumulated deficit
(966,037)
(754,468)
Total stockholders' equity
380,457
543,676
Total liabilities and stockholders'
equity
$
483,418
$
642,432
Deciphera
Pharmaceuticals, Inc.
Consolidated Statements of
Operations and Comprehensive Loss
(Unaudited, in thousands,
except share and per share amounts)
Three Months Ended September
30,
Nine Months Ended September
30,
2021
2020
2021
2020
Revenues:
Product revenues, net
$
21,682
$
15,164
$
63,692
$
19,989
Collaboration revenues
1,538
285
8,257
2,612
Total revenues
23,220
15,449
71,949
22,601
Cost and operating expenses:
Cost of sales
917
90
2,414
98
Research and development
66,444
49,213
182,109
146,682
Selling, general, and administrative
35,527
30,143
99,102
84,012
Total cost and operating expenses
102,888
79,446
283,625
230,792
Loss from operations
(79,668)
(63,997)
(211,676)
(208,191)
Other income (expense):
Interest and other income, net
(170)
296
107
4,442
Total other income (expense), net
(170)
296
107
4,442
Net loss
$
(79,838)
$
(63,701)
$
(211,569)
$
(203,749)
Net loss per share—basic and diluted
$
(1.37)
$
(1.13)
$
(3.65)
$
(3.68)
Weighted average common shares
outstanding—basic and diluted
58,107,611
56,390,748
57,948,612
55,296,775
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211102006042/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
Deciphera Pharmaceuticals (NASDAQ:DCPH)
Historical Stock Chart
From May 2024 to Jun 2024
Deciphera Pharmaceuticals (NASDAQ:DCPH)
Historical Stock Chart
From Jun 2023 to Jun 2024