– Fourth Quarter 2021 Revenue of $24.2 Million
and Full Year 2021 Revenue of $96.1 Million –
– Launch of QINLOCK® in Europe Underway –
– Pivotal Phase 3 MOTION Study of Vimseltinib
in TGCT Patients Underway; Updated Phase 1/2 Data Expected in 2H
2022 –
– Phase 1 Single Agent Dose Escalation Data for
DCC-3116 Expected in 2H 2022; Initiation of Phase 1 Combination
Dose Escalation Cohorts Expected in 2H 2022 –
– New Development Candidate from Pan-RAF
Research Program Expected in 2022 –
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced
financial results for the fourth quarter and year ended December
31, 2021, and provided a corporate update.
“I am immensely proud of our organization’s achievements in 2021
and believe that we are well positioned for long-term success as we
work towards our expected milestones in 2022,” said Steve Hoerter,
President and Chief Executive Officer of Deciphera Pharmaceuticals.
“While the unexpected results of the INTRIGUE study and subsequent
restructuring at the end of last year were very difficult, we are
fortunate to have a robust pipeline and look to build on the
progress we made across our pipeline last year, as we continue to
execute on our mission of delivering important new medicines to
improve the lives of people with cancer.”
Mr. Hoerter continued, “We have rapidly progressed vimseltinib,
our potential best-in-class inhibitor of CSF1R, to Phase 3
development for the treatment of tenosynovial giant cell tumor, or
TGCT, and we expect to present updated data from the Phase 1/2
study in patients with TGCT in the second half of this year. In
addition, we remain very excited by our first-in-class autophagy
pathway inhibitor, DCC-3116, and plan to present initial data from
the single agent dose escalation portion of the Phase 1 study in
the second half of 2022. We also continue to focus on our next wave
of therapeutic candidates, including our pan-RAF research program,
and expect to nominate a clinical development candidate later this
year.”
Fourth Quarter 2021 Highlights and Upcoming 2022
Milestones
QINLOCK® (ripretinib)
- Recorded $23.7 million in QINLOCK net product revenue in the
fourth quarter of 2021, including $21.5 million in U.S. net product
revenue.
- Received approval of QINLOCK in the European Union, the United
Kingdom, and Switzerland for the treatment of adult patients with
fourth-line gastrointestinal stromal tumor (GIST).
- Launched in Germany in January 2022, and the transition to a
post-approval paid access program in France is expected in the
first half of 2022.
- Presented results of the Phase 3 INTRIGUE study in second-line
GIST at the American Society of Clinical Oncology (ASCO) Plenary
Series Session on January 25, 2022, which followed the announcement
in November 2021 of the top-line results.
- The results showed that the efficacy of QINLOCK and sunitinib
were comparable, although the study did not meet the primary
endpoint of an improvement in progression free survival compared to
sunitinib.
- QINLOCK was generally well tolerated and fewer patients in the
QINLOCK arm experienced Grade 3-4 treatment-emergent adverse events
compared to sunitinib (41.3% vs 65.6%). Patient reported outcome
data also showed a more favorable tolerability profile for patients
on QINLOCK compared to patients on sunitinib.
- Updated National Comprehensive Cancer Network (NCCN) Clinical
Practice Guidelines in Oncology for GIST in January 2022 now
include the use of QINLOCK 150 mg twice daily (BID) after disease
progression if previously treated with QINLOCK 150 mg once daily in
fourth-line GIST patients.
Vimseltinib
- Initiated the pivotal Phase 3 MOTION study of vimseltinib.
MOTION is a two-part, randomized, double-blind, placebo-controlled
study of vimseltinib to assess the efficacy and safety in patients
with TGCT who are not amenable to surgery. The primary endpoint of
the study is objective response rate at week 25 as measured by
RECIST v1.1 by blinded independent central review.
- Announced that vimseltinib was granted fast track designation
by the U.S. Food and Drug Administration (FDA) for the treatment of
patients with 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 demonstrate the
potential to address an unmet medical need.
- Expects to present updated data from the Phase 1/2 study in
TGCT patients in the second half of 2022.
DCC-3116
- Presented preclinical data at the AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics
demonstrating that DCC-3116 inhibits EGFR inhibitor-induced
autophagy in multiple EGFR-mutant non-small cell lung cancer cell
lines and decreases tumor burden in combination with osimertinib
and afatinib in an EGFR mutant xenograft model.
- Expects to present data in the second half of 2022 from the
single agent dose escalation portion of the Phase 1 study of
DCC-3116 in patients with advanced or metastatic tumors with a
mutant RAS or RAF gene.
- Expects to initiate Phase 1 study dose escalation cohorts in
the second half of 2022 in combination with trametinib, an
FDA-approved MEK inhibitor, in patients with selected mutations in
advanced or metastatic pancreatic ductal adenocarcinoma,
non-small-cell lung cancer (NSCLC), colorectal cancer, and
melanoma.
- Planning underway to add a combination with a KRAS G12C
inhibitor in NSCLC to the ongoing Phase 1 study, subject to
feedback from regulatory authorities, based on positive preclinical
data.
- Expects to present additional preclinical data for DCC-3116 in
2022 and continue to explore preclinical combinations with multiple
additional anti-cancer agents with diverse mechanisms of
action.
Proprietary Drug Discovery Platform
- Expects to nominate a development candidate in 2022 from the
pan-RAF inhibitor research program, using the Company’s novel
switch-control inhibitor platform.
Fourth Quarter and Full Year 2021 Financial Results
- Revenue: Total revenue for the fourth quarter was $24.2
million, which includes $23.7 million of net product revenue of
QINLOCK and $0.5 million of collaboration revenue compared to $19.5
million of total and net product revenue of QINLOCK for the same
period in 2020. Total revenue for the year ended December 31, 2021
was $96.1 million, which includes net sales of QINLOCK of $87.4
million and $8.8 million in collaboration revenue compared to $42.1
million, which includes net sales of QINLOCK of $39.5 million and
$2.6 million in collaboration revenue, for the same period in
2020.
- Cost of Sales: Cost of sales were $0.5 million in the
fourth quarter of 2021 and $2.9 million for the year ended December
31, 2021 compared to $0.1 million and $0.2 million in the same
periods, respectively, in 2020. Cost of sales for newly launched
products will not include the full cost of manufacturing until the
initial pre-launch inventory is depleted, and additional inventory
is manufactured and sold. Deciphera does not expect the cost of
sales as a percentage of net sales of QINLOCK to 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 2022.
- R&D Expenses: Research and development expenses for
the fourth quarter of 2021 were $74.9 million, compared to $52.3
million for the same period in 2020, and $257.0 million for the
year ended December 31, 2021, compared to $199.0 million for the
same period in 2020. The increase was primarily due to the one-time
restructuring charge of $22.2 million of research and development
costs related to employee termination costs and discontinuation
costs. In addition, there was an increase in 2021 in research and
development expenses related to personnel costs, preclinical costs,
and clinical trial costs related to start-up activities for the
Phase 3 MOTION study of vimseltinib. Non-cash, stock-based
compensation was $20.7 million and $17.4 million for the year ended
December 31, 2021 and 2020, respectively.
- SG&A Expenses: Selling, general, and administrative
expenses for the fourth quarter of 2021 were $37.2 million,
compared to $30.1 million for the same period in 2020 and $136.3
million for the year ended December 31, 2021, compared to $114.1
million for the same period in 2020. The increase was primarily due
to the one-time restructuring charge of $4.0 million of selling,
general, and administrative expenses related to employee
termination costs. In addition, personnel costs as well as external
spend related to professional fees, including those associated with
establishing a direct commercial infrastructure and commercial
preparedness in Germany and France to support a launch of QINLOCK
in Europe. Non-cash, stock-based compensation was $25.4 million and
$19.7 million for the year ended December 31, 2021 and 2020,
respectively.
- Net Loss: For the fourth quarter of 2021, Deciphera
reported a net loss of $88.4 million, or $1.51 per share, compared
with a net loss of $62.7 million, or $1.10 per share, for the same
period in 2020. Net loss for the year ended December 31, 2021 was
$300.0 million, or $5.16 per share, compared with a net loss of
$266.5 million, or $4.78 per share, for the year ended December 31,
2020.
- Cash Position: As of December 31, 2021, cash, cash
equivalents, and marketable securities were $327.6 million,
compared to $561.3 million as of December 31, 2020. 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 2024.
Conference Call and Webcast
Deciphera will host a conference call and webcast to discuss
this announcement today, February 8, 2022 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 8293127. 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, the European
Union, Hong Kong, 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 vimseltinib for the pivotal Phase 3 MOTION
study in TGCT patients, the potential for vimseltinib to be a
best-in-class treatment for TGCT, presenting updated vimseltinib
data from our Phase 1/2 study in TGCT patients, initial data from
the dose escalation phase of the Phase 1 study of DCC-3116, plans
to initiate the trametinib combination dose escalation portion of
the Phase 1 study of DCC-3116, plans to expand the ongoing Phase 1
study of DCC-3116 to add a combination with a mutant KRAS G12C
inhibitor in NSCLC patients subject to feedback from regulatory
authorities, plans to present additional pre-clinical data for
DCC-3116, exploration of additional preclinical combinations of
DCC-3116, nominating a development candidate for our pan-RAF
research program, ex-U.S. strategies including executing on our
commercial launch of QINLOCK in fourth-line GIST in Germany and our
plans to transition to a post-approval paid access program in
France, 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 provide access to QINLOCK
in European countries other than Germany and France through other
channels, 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 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, 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.
Deciphera, the Deciphera logo, QINLOCK, and the QINLOCK logo are
registered trademarks of Deciphera Pharmaceuticals, LLC.
DECIPHERA PHARMACEUTICALS,
INC.
CONSOLIDATED BALANCE
SHEETS
(In thousands, except share
and per share amounts)
December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
87,063
$
135,897
Short-term marketable securities
198,571
416,033
Accounts receivable, net
20,595
13,896
Inventory
14,125
5,716
Prepaid expenses and other current
assets
18,660
12,489
Total current assets
339,014
584,031
Long-term marketable securities
41,950
9,375
Long-term investments—restricted
3,110
3,102
Property and equipment, net
8,610
9,583
Operating lease assets
36,800
36,341
Total assets
$
429,484
$
642,432
Liabilities and Stockholders'
Equity
Current liabilities:
Accounts payable
$
13,130
$
12,308
Accrued expenses and other current
liabilities
80,773
55,227
Operating lease liabilities
2,870
2,457
Total current liabilities
96,773
69,992
Operating lease liabilities, net of
current portion
27,991
28,764
Total liabilities
124,764
98,756
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; 58,549,644 shares and 57,596,144
shares issued and outstanding as of December 31, 2021 and 2020,
respectively
585
576
Additional paid-in capital
1,358,516
1,297,557
Accumulated other comprehensive income
(loss)
51
11
Accumulated deficit
(1,054,432
)
(754,468
)
Total stockholders' equity
304,720
543,676
Total liabilities and stockholders'
equity
$
429,484
$
642,432
DECIPHERA PHARMACEUTICALS,
INC.
CONSOLIDATED STATEMENTS OF
OPERATIONS
(In thousands, except share
and per share amounts)
Three Months Ended December
31,
Twelve Months Ended December
31,
2021
2020
2021
2020
Revenues:
Product revenues, net
$
23,696
$
19,472
$
87,389
$
39,461
Collaboration revenues
503
14
8,759
2,626
Total revenues
24,199
19,486
96,148
42,087
Cost and operating expenses:
Cost of sales
518
127
2,932
225
Research and development
74,932
52,288
257,040
198,970
Selling, general, and administrative
37,151
30,070
136,253
114,082
Total cost and operating expenses
112,600
82,485
396,225
313,277
Loss from operations
(88,401
)
(62,999
)
(300,077
)
(271,190
)
Other income (expense):
Interest and other income, net
6
259
113
4,701
Total other income (expense), net
6
259
113
4,701
Net loss
$
(88,395
)
$
(62,740
)
$
(299,964
)
$
(266,489
)
Net loss per share—basic and diluted
$
(1.51
)
$
(1.10
)
$
(5.16
)
$
(4.78
)
Weighted average common shares
outstanding—basic and diluted
58,487,041
57,223,076
58,084,325
55,780,982
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220208005939/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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