Deciphera Pharmaceuticals Announces Fourth Quarter and Full Year 2023 Financial Results
- QINLOCK net product revenue increased by 27% to $159.1 million in 2023 compared to 2022.
- Expects to submit NDA for Vimseltinib in the second quarter of 2024 and MAA in the third quarter of 2024.
- Cash expected to fund operating and capital expenditures into the second half of 2026.
- None.
Insights
The reported increase in QINLOCK net product revenue by 27% in 2023 compared to 2022 is a strong indicator of Deciphera Pharmaceuticals' growing market presence and commercial success. This growth trajectory, particularly the 42% increase in Q4 revenue year-over-year, is likely to be viewed positively by investors, as it reflects both expanding market penetration and effective sales strategies. Moreover, the company's projection that its cash reserves will fund operations into the second half of 2026 provides a measure of financial stability that can reassure stakeholders about the company's short-term liquidity risk.
However, it is essential to scrutinize the R&D and SG&A expenses that have both risen year-over-year. While these increases are aligned with the company's developmental efforts and expansion, they also contribute to the net loss reported for both Q4 and the full year. Investors should weigh the potential long-term benefits of these investments against the short-term financial impacts, particularly the net loss widening from 2022 to 2023. The management's strategy and efficiency in converting these investments into profitable products will be crucial in determining the company's future financial health.
The advancement of vimseltinib towards regulatory submission is a significant milestone for Deciphera Pharmaceuticals, potentially addressing the unmet medical needs in tenosynovial giant cell tumor (TGCT). The positive clinical outcomes and safety profile of QINLOCK in the INTRIGUE study, as published in Nature Medicine, underscore its therapeutic value in treating gastrointestinal stromal tumor (GIST) patients with specific KIT exon mutations. The comparable overall survival rates of QINLOCK and sunitinib, alongside the favorable safety profile, strengthen QINLOCK's position in the market.
From a research and development perspective, the company's pipeline, including investigational drugs like DCC-3116 and DCC-3084, indicates a commitment to innovation. The potential expansion into chronic graft versus host disease (cGVHD) treatment with vimseltinib also highlights the company's strategy to leverage its existing portfolio into new therapeutic areas. These developments could have a profound impact on the company's long-term market position, subject to successful clinical outcomes and regulatory approvals.
Deciphera Pharmaceuticals' strategic partnership with GENESIS Pharma for the distribution of QINLOCK in Central and Eastern Europe is a calculated move to tap into new markets with a combined population of 118 million. This expansion strategy could significantly increase the drug's market footprint and drive future revenue growth. The emphasis on international net product revenue, which contributed to the overall increase in QINLOCK sales, suggests that the company is effectively capitalizing on global market opportunities.
The biopharmaceutical sector is highly competitive and Deciphera's focus on a niche market of rare cancers with its specialized portfolio could provide a competitive edge. However, market dynamics, such as regulatory changes, pricing pressures and competition from other therapies, will play a critical role in shaping the company's market share and profitability. Continuous monitoring of these factors is essential for an accurate assessment of the company's market position and growth potential.
– Fourth Quarter 2023 Total Revenue of
– Expects to Submit NDA for Vimseltinib in the Second Quarter of 2024 and MAA in the Third Quarter of 2024 in Tenosynovial Giant Cell Tumor (TGCT) –
– Results from Exploratory ctDNA Analysis from INTRIGUE Phase 3 Study in 2L GIST Patients with Mutations in KIT Exon 11+17/18 Published in Nature Medicine; Final Overall Survival (OS) Results from INTRIGUE Study in 2L GIST Patients Presented at ASCO GI –
– Cash Expected to Fund Operating and Capital Expenditures into the Second Half of 2026 –
“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)
-
Recorded
$46.7 million $35.3 million U.S. net product revenue and$11.4 million 42% from net product revenue of$32.9 million - Published results in Nature Medicine from an exploratory circulating tumor DNA (ctDNA) analysis of the INTRIGUE Phase 3 study demonstrating the substantial clinical benefit of QINLOCK in second line gastrointestinal stromal tumor (GIST) patients with mutations in KIT exon 11 and 17/18.
-
Presented final OS results from the INTRIGUE Phase 3 clinical study in second-line GIST patients at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium showing that the median OS was similar with QINLOCK (35.5 months) versus sunitinib (31.5 months) (HR 0.86;
95% CI, 0.65 to 1.13; nominal p= 0.275). Treatment with QINLOCK continued to show a favorable safety profile compared to treatment with sunitinib, with fewer patients experiencing Grade 3/4 drug-related treatment emergent adverse events with QINLOCK (27.4% ) compared with sunitinib (57.9% ). The results also showed that patient outcomes in the third line setting were comparable for patients that were treated with either QINLOCK or sunitinib in the second line. The presentation is available on the Company’s website at www.deciphera.com/presentations-publications. -
Entered into a supply and distribution agreement with GENESIS Pharma, a leading regional biopharma company, in Central and
Eastern Europe under which GENESIS Pharma will be the exclusive distributor of QINLOCK in 14 countries in the European Union with a combined population of 118 million includingCzech Republic ,Greece ,Hungary ,Romania , andPoland . - Continue to enroll the INSIGHT Phase 3 study comparing QINLOCK versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17/18.
Vimseltinib
-
Expects to submit a New Drug Application (NDA) with the
U.S. Food and Drug Administration (FDA) in the second quarter of 2024 and a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) in the third quarter of 2024. - Expects to present additional results from Part 1 of the MOTION pivotal Phase 3 study of vimseltinib at a medical meeting in the second quarter of 2024.
- Expects to present updated results from the Phase 1/2 study of vimseltinib in TGCT in the second half of 2024.
- Expects to initiate a Phase 2 proof-of-concept study of vimseltinib for the treatment of chronic graft versus host disease (cGVHD) in the fourth quarter of 2024.
DCC-3116
- Expects to select a recommended Phase 2 dose for expansion cohort(s) for DCC-3116, an investigational switch-control kinase inhibitor of ULK1/2 designed to inhibit autophagy, in 2024.
DCC-3084
- Expects to initiate a Phase 1 study for DCC-3084, a potential best-in-class pan-RAF inhibitor, in the first half of 2024.
DCC-3009
- Expects to submit an Investigational New Drug (IND) application with the FDA for DCC-3009, a potential best-in-class pan-KIT inhibitor, in the first half of 2024 and initiate a Phase 1 study in the second half of 2024.
Fourth Quarter and Full Year 2023 Financial Results
-
Revenue: Total revenue for the fourth quarter of 2023 was
$48.3 million $46.7 million $1.6 million $36.3 million $32.9 million $3.4 million $163.4 $159.1 million $4.3 million $134.0 million $125.5 million $8.5 million -
Cost of Sales: Cost of sales were
$1.8 million $0.9 million $0.7 million $3.7 million $2.0 million $8.7 million $2.7 million -
R&D Expenses: Research and development expenses for the fourth quarter of 2023 were
$58.6 million $48.1 million $234.1 million $187.8 million $21.8 million $22.2 million -
SG&A Expenses: Selling, general, and administrative expenses for the fourth quarter of 2023 were
$39.1 million $32.2 million $136.5 million $120.2 million $28.8 million $29.7 million -
Net Loss: For the fourth quarter of 2023, Deciphera reported a net loss of
$47.2 million $0.54 $45.9 million $0.60 $194.9 million $2.29 $178.9 million $2.37 -
Cash Position: As of December 31, 2023, cash, cash equivalents, and marketable securities were
$352.9 million $339.0 million
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 via this link: https://register.vevent.com/register/BI7a0bbbeb53864df9a854d959bbbae709. 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
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. |
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CONSOLIDATED BALANCE SHEETS |
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(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, |
|
— |
|
|
|
— |
|
|
Common stock, |
|
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. |
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CONSOLIDATED STATEMENTS OF OPERATIONS |
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(Unaudited, in thousands, except share and per share amounts) |
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|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
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|
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 |
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240206553907/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
Source: Deciphera Pharmaceuticals, Inc.
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