WALTHAM, Mass. / Feb 06, 2024 / Business Wire / 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, 2023 and provided a corporate update.
“We are proud of the significant progress we made across our company throughout 2023, particularly in our late-stage programs as we continue on our path to becoming a self-sustaining, fully integrated biotechnology company. I am excited to announce another record quarter of QINLOCK revenue, demonstrating the proven commercial capabilities that position us well as we continue to evolve into a company with multiple approved medicines,” said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. “Looking ahead, we plan to build upon this momentum in 2024 as we work to file regulatory submissions for vimseltinib, which has the potential to be a much-needed treatment option for patients with tenosynovial giant cell tumor, continue enrollment of our INSIGHT Phase 3 study of QINLOCK, and progress our early-stage pipeline of potential first- or best-in-class candidates.”
Fourth Quarter 2023 and Upcoming Milestones
QINLOCK® (ripretinib)
Vimseltinib
DCC-3116
DCC-3084
DCC-3009
Fourth Quarter and Full Year 2023 Financial Results
Conference Call and Webcast
Deciphera will host a conference call and webcast to discuss this announcement today, February 6, 2024, at 8:00 AM ET. The conference call may be accessed here. 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, Iceland, Israel, Liechtenstein, Macau, New Zealand, Norway, Singapore, Switzerland, Taiwan, the United Kingdom, and the United States. For more information, visit www.deciphera.com and follow us on LinkedIn and X (@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, the ability to become a company with multiple approved medicines, plans to continue our geographic expansion of QINLOCK in European and international markets, our Phase 3 INSIGHT clinical study of QINLOCK versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17/18, the timing of our NDA and MAA submission for vimseltinib, plans to present additional data from our Phase 3 MOTION study and Phase 1/2 study of vimseltinib, each in TGCT patients, plans to initiate a Phase 2 study of vimseltinib in patients with cGVHD, subject to FDA feedback, plans for our on-going phase 1/2 study of DCC-3116 and to select a recommended Phase 2 dose for expansion cohort(s), subject to favorable data, initiating a Phase 1 study of DCC-3084 in the first half of 2024, and submitting an IND for DCC-3009 in the first half of 2024 and initiating a Phase 1 study in the second half of 2024, each subject to FDA feedback. 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, 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 and the QINLOCK® word mark and logo are registered trademarks and the Deciphera word mark is a trademark of Deciphera Pharmaceuticals, LLC.
DECIPHERA PHARMACEUTICALS, INC. | ||||||||
CONSOLIDATED BALANCE SHEETS | ||||||||
(In thousands, except share and per share amounts) | ||||||||
| December 31, | |||||||
| 2023 |
| 2022 | |||||
Assets |
|
|
| |||||
Current assets: |
|
|
| |||||
Cash and cash equivalents | $ | 83,507 |
|
| $ | 64,741 |
| |
Short-term marketable securities |
| 222,709 |
|
|
| 259,745 |
| |
Accounts receivable, net |
| 31,952 |
|
|
| 22,429 |
| |
Inventory |
| 21,210 |
|
|
| 20,561 |
| |
Prepaid expenses and other current assets |
| 21,718 |
|
|
| 25,482 |
| |
Total current assets |
| 381,096 |
|
|
| 392,958 |
| |
Long-term marketable securities |
| 46,699 |
|
|
| 14,550 |
| |
Long-term investments—restricted and other long-term assets |
| 8,277 |
|
|
| 3,277 |
| |
Property and equipment, net |
| 5,421 |
|
|
| 6,707 |
| |
Operating lease assets |
| 32,073 |
|
|
| 36,547 |
| |
Total assets | $ | 473,566 |
|
| $ | 454,039 |
| |
Liabilities and Stockholders' Equity |
|
|
| |||||
Current liabilities: |
|
|
| |||||
Accounts payable | $ | 26,476 |
|
| $ | 18,612 |
| |
Accrued expenses and other current liabilities |
| 70,295 |
|
|
| 64,622 |
| |
Operating lease liabilities |
| 3,504 |
|
|
| 3,235 |
| |
Total current liabilities |
| 100,275 |
|
|
| 86,469 |
| |
Operating lease liabilities, net of current portion |
| 22,375 |
|
|
| 25,879 |
| |
Total liabilities |
| 122,650 |
|
|
| 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; 80,503,338 shares and 67,637,351 shares issued and outstanding as of December 31, 2023 and 2022, respectively |
| 805 |
|
|
| 676 |
| |
Additional paid-in capital |
| 1,777,839 |
|
|
| 1,575,361 |
| |
Accumulated other comprehensive income |
| 577 |
|
|
| (983 | ) | |
Accumulated deficit |
| (1,428,305 | ) |
|
| (1,233,363 | ) | |
Total stockholders' equity |
| 350,916 |
|
|
| 341,691 |
| |
Total liabilities and stockholders' equity | $ | 473,566 |
|
| $ | 454,039 |
|
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, | |||||||||||||
| 2023 |
| 2022 |
| 2023 |
| 2022 | |||||||||
Revenues: |
|
|
|
|
|
|
| |||||||||
Product revenues, net | $ | 46,712 |
|
| $ | 32,880 |
|
| $ | 159,074 |
|
| $ | 125,504 |
| |
Collaboration revenues |
| 1,582 |
|
|
| 3,465 |
|
|
| 4,282 |
|
|
| 8,532 | ||
Total revenues | 48,295 | 36,345 | 163,356 | 134,036 | ||||||||||||
Cost and operating expenses: |
|
|
|
|
|
|
| |||||||||
Cost of sales |
| 1,785 |
|
|
| 3,245 |
|
|
| 3,732 |
|
|
| 8,770 |
| |
Research and development |
| 58,599 |
|
|
| 48,066 |
|
|
| 234,123 |
|
|
| 187,821 |
| |
Selling, general, and administrative |
| 39,148 |
|
|
| 32,195 |
|
|
| 136,459 |
|
|
| 120,167 |
| |
Total cost and operating expenses |
| 99,532 |
|
|
| 83,506 |
|
|
| 374,314 |
|
|
| 316,758 |
| |
Loss from operations |
| (51,237 | ) |
|
| (47,160 | ) |
|
| (210,958 | ) |
|
| (182,722 | ) | |
Other income (expense): |
|
|
|
|
|
|
| |||||||||
Interest and other income, net |
| 4,478 |
|
|
| 1,926 |
|
|
| 16,447 |
|
|
| 4,513 |
| |
Total other income (expense), net |
| 4,478 |
|
|
| 1,926 |
|
|
| 16,447 |
|
|
| 4,513 |
| |
Loss before income tax expense |
| (46,759 | ) |
|
| (45,234 | ) |
|
| (194,511 | ) |
|
| (178,209 | ) | |
Income tax expense |
| 431 |
|
|
| 700 |
|
|
| 431 |
|
|
| 722 |
| |
Net loss | $ | (47,190 | ) |
| $ | (45,934 | ) |
| $ | (194,942 | ) |
| $ | (178,931 | ) | |
|
|
|
|
|
|
|
| |||||||||
Net loss per share—basic and diluted | $ | (0.54 | ) |
| $ | (0.60 | ) |
| $ | (2.29 | ) |
| $ | (2.37 | ) | |
Weighted average common shares outstanding—basic and diluted |
| 86,702,025 |
|
|
| 76,440,793 |
|
|
| 85,059,962 |
|
|
| 75,500,148 |
|
Last Trade: | US$25.51 |
Daily Change: | 0.01 0.04 |
Daily Volume: | 549,775 |
Market Cap: | US$2.210B |
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