We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Deciphera Pharmaceuticals Inc | NASDAQ:DCPH | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 25.59 | 25.20 | 25.60 | 0 | 01:00:00 |
– Third Quarter 2023 Total Revenue of $43.3 Million; Net Product Revenue for QINLOCK® (ripretinib) Increased 29% to $41.8 Million Compared to Third Quarter 2022 –
– Announced Positive Top-line Results for MOTION Pivotal Phase 3 Study of Vimseltinib for TGCT and Updated Results from Phase 1/2 Study; NDA Submission Expected in Second Quarter of 2024 –
– QINLOCK Successfully Launched in Italy –
– Conference Call to be Held Today at 8:00 AM ET –
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 third quarter ended September 30, 2023 and provided a corporate update.
“QINLOCK achieved another record quarter of product revenue with continued strength in commercial demand,” said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. “With the positive results of the MOTION Phase 3 study of vimseltinib we reported earlier today, we are now one step closer to becoming a company with multiple approved products. We look forward to engaging with regulatory authorities to advance vimseltinib toward approval and deliver it to the TGCT patients in need of an effective and well tolerated treatment option."
Third Quarter 2023 Highlights and Upcoming Milestones
QINLOCK® (ripretinib)
Vimseltinib
DCC-3116
DCC-3084
DCC-3009
Third Quarter 2023 Financial Results
Conference Call and Webcast
Deciphera will host a conference call and webcast to discuss this announcement today, October 30, 2023, at 8:00 AM ET. The conference call may be accessed via this link: https://register.vevent.com/register/BIc2885b197da74145bfc30deb5fb11858. 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, Singapore, 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 Phase 3 INSIGHT study of QINLOCK versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17/18; the potential for vimseltinib to become our second approved medicine, plans to submit an NDA for vimseltinib in the second quarter of 2024 and an MAA in the third quarter of 2024, and plans to present additional data at upcoming medical congresses; plans for our ongoing Phase 1/2 studies of DCC-3116; plans to submit an IND application to the FDA for DCC-3084 by the end of 2023; plans to submit an IND application to the FDA for DCC-3009 in the first half of 2024; 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 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, QINLOCK, and the QINLOCK logo are registered trademarks and Deciphera is a trademark of Deciphera Pharmaceuticals, LLC.
Deciphera Pharmaceuticals, Inc.
Consolidated Balance Sheets
(Unaudited, in thousands, except share and per share amounts)
September 30, 2023
December 31, 2022
Assets
Current assets:
Cash and cash equivalents
$108,087
$64,741
Short-term marketable securities
230,988
259,745
Accounts receivable, net
27,549
22,429
Inventory
27,105
20,561
Prepaid expenses and other current assets
23,847
25,482
Total current assets
417,576
392,958
Long-term marketable securities
37,850
14,550
Long-term investments—restricted and other long-term assets
3,337
3,277
Property and equipment, net
5,864
6,707
Operating lease assets
33,209
36,547
Total assets
$497,836
$454,039
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable
$21,453
$18,612
Accrued expenses and other current liabilities
68,005
64,622
Operating lease liabilities
3,436
3,235
Total current liabilities
92,894
86,469
Operating lease liabilities, net of current portion
23,272
25,879
Total liabilities
116,166
112,348
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; 79,975,625 shares and 67,637,351 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively
799
676
Additional paid-in capital
1,762,882
1,575,361
Accumulated other comprehensive income (loss)
(896)
(983)
Accumulated deficit
(1,381,115)
(1,233,363)
Total stockholders' equity
381,670
341,691
Total liabilities and stockholders' equity
$497,836
$454,039
Deciphera Pharmaceuticals, Inc.
Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share amounts)
Three Months Ended September 30,
Nine Months Ended September 30,
2023
2022
2023
2022
Revenues:
Product revenues, net
$41,820
$32,318
$112,362
$92,624
Collaboration revenues
1,493
3,656
2,700
5,067
Total revenues
43,313
35,974
115,062
97,691
Cost and operating expenses:
Cost of sales
1,286
3,344
1,947
5,525
Research and development
62,463
47,485
175,524
139,755
Selling, general, and administrative
33,252
30,026
97,311
87,972
Total cost and operating expenses
97,001
80,855
274,782
233,252
Loss from operations
(53,688)
(44,881)
(159,720)
(135,561)
Other income (expense):
Interest and other income, net
4,107
1,838
11,968
2,565
Total other income (expense), net
4,107
1,838
11,968
2,565
Net loss
$(49,581)
$(43,043)
$(147,752)
$(132,996)
Net loss per share—basic and diluted
$(0.58)
$(0.55)
$(1.75)
$(1.82)
Weighted average common shares outstanding—basic and diluted
85,788,613
78,206,647
84,506,593
73,129,804
View source version on businesswire.com: https://www.businesswire.com/news/home/20231030024020/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
1 Year Deciphera Pharmaceuticals Chart |
1 Month Deciphera Pharmaceuticals Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions