Deciphera Pharmaceuticals, Inc. /zigman2/quotes/203556943/composite DCPH -0.50% today announced financial results for the fourth quarter and year ended December 31, 2020, and provided a business update.
“We made significant progress in 2020 with the successful launch of QINLOCK, completing enrollment in the Phase 3 INTRIGUE study in second-line GIST patients, and generating promising new data for both vimseltinib and rebastinib,” said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. “We’re incredibly excited by the opportunities ahead for the Company in 2021. Specifically, we look forward to top-line results from the INTRIGUE study and are actively preparing for a potential EMA approval for QINLOCK in fourth-line GIST in the second half of this year.”
Mr. Hoerter continued, “In addition, we remain very excited by the prospects of our maturing pipeline. We are on track to report additional data from and finalize pivotal development plans for both vimseltinib and rebastinib in the second half of this year, and also plan to initiate the Phase 1 study of DCC-3116, our ULK kinase inhibitor for the potential treatment of patients with cancers driven by mutations in RAS or RAF genes, in the second quarter of 2021.”
Fourth Quarter 2020 Highlights and Upcoming Milestones
Fourth Quarter and Full Year 2020 Financial Results
Revenue: Total net revenue for fourth quarter was $19.5 million, which includes U.S. sales of QINLOCK of $18.5 million and ex-U.S. sales of QINLOCK of $1.0 million. In the fourth quarter of 2019, the Company did not generate revenue. Total revenue for the year ended December 31, 2020 was $42.1 million, which includes $39.5 million in sales of QINLOCK and $2.6 million in collaboration revenue. Net product revenues for the year ended December 31, 2020 includes U.S. sales of QINLOCK of $38.0 million and ex-U.S. sales of QINLOCK of $1.5 million. This compares to total revenue of $25.0 million for the year ended December 31, 2019, which was related to the Company’s exclusive license agreement with Zai Lab to advance the development and commercialization of ripretinib in Greater China.
Cost of Sales : Cost of sales were $0.1 million in the fourth quarter of 2020 and $0.2 million for the year ended December 31, 2020. There were no cost of sales in 2019 as no product sales were generated during that period. Cost of sales will not be significant until the initial pre-launch inventory is depleted, and additional inventory is manufactured and sold.
R&D Expenses: Research and development expenses for the fourth quarter of 2020 were $52.3 million, compared to $46.6 million for the same period in 2019, and $199.0 million for the year ended December 31, 2020, compared to $157.6 million for the same period in 2019. The increase was primarily due to personnel costs, preclinical costs, and clinical trial costs related to vimseltinib, rebastinib, DCC-3116, and the Phase 3 INTRIGUE study in second-line GIST. The increase was partially offset by a decrease in clinical trial expenses related to the Phase 3 INVICTUS study in fourth-line and fourth-line plus GIST. Non-cash, stock-based compensation was $17.4 million and $7.9 million for the year ended December 31, 2020 and 2019, respectively.
SG&A Expenses: Selling, general and administrative expenses for the fourth quarter of 2020 were $30.1 million, compared to $23.7 million for the same period in 2019 and $114.1 million for the year ended December 31, 2020, compared to $68.1 million for the same period in 2019. The increase was primarily due to personnel costs as well as external spend associated with commercial preparedness and launch of QINLOCK, increased expenses incurred in connection with Deciphera’s new headquarters that commenced in October 2019, and technology-related costs to support the growth of the business. Non-cash, stock-based compensation was $19.7 million and $12.5 million for the year ended December 31, 2020 and 2019, respectively.
Net Loss: For the fourth quarter of 2020, Deciphera reported a net loss of $62.7 million, or $1.10 per share, compared with a net loss of $67.2 million, or $1.31 per share, for the same period in 2019. Net loss for the year ended December 31, 2020 was $266.5 million, or $4.78 per share, compared with a net loss of $192.3 million, or $4.48 per share, for the year ended December 31, 2019.
Cash Position: As of December 31, 2020, cash, cash equivalents and marketable securities were $561.3 million, compared to $579.6 million as of December 31, 2019. Based on its current operating plans, Deciphera expects its current cash, cash equivalents, and marketable securities together with anticipated product revenues, but excluding any potential future milestone payments or other payments under its collaboration or license agreements, will enable the Company to fund its operating and capital expenditures into the second half of 2022.
Conference Call and Webcast
Deciphera will host a conference call and webcast to discuss this announcement today, February 9, 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 5826559. 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 FDA-approved switch-control kinase inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST). QINLOCK is also approved for fourth-line GIST in Canada and Australia. 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 regarding 2021 corporate milestones and timing for these goals, including, without limitation, top-line data from our Phase 3 INTRIGUE study in second-line GIST, potential EMA and NMPA approval of QINLOCK for the treatment of fourth-line GIST, finalizing pivotal study plans for vimseltinib (DCC-3014) in TGCT patients and for the rebastinib/paclitaxel combination, presenting updated data from the Phase 1/2 study of vimseltinib (DCC-3014) in TGCT patients, presenting updated data from the Phase 1b/2 study of rebastinib in combination with paclitaxel for patients with endometrial cancer and also from patients with platinum-resistant ovarian cancer, initiating a phase 1 study of DCC-3116; and expanding the geographic reach of QINLOCK. 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 Annual Report on Form 10-K for the year ended December 31, 2020, 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.
QINLOCK and the QINLOCK logo are registered trademarks, and Deciphera and the Deciphera logo are trademarks, of Deciphera Pharmaceuticals, LLC.
|Deciphera Pharmaceuticals, Inc.|
|Cash and cash equivalents||$||135,897||$||120,320|
|Short-term marketable securities||416,033||459,256|
|Accounts receivable, net||13,896||—|
|Prepaid expenses and other current assets||12,489||13,832|
|Total current assets||584,031||593,408|
|Long-term marketable securities||9,375||—|
|Property and equipment, net||9,583||6,333|
|Operating lease assets||36,341||21,158|
|Liabilities and Stockholders' Equity|
|Accrued expenses and other current liabilities||55,227||38,716|
|Operating lease liabilities||2,457||1,747|
|Total current liabilities||69,992||60,038|
|Operating lease liabilities, net of current portion||28,764||15,904|
|Commitments and contingencies|
Common stock, $0.01 par value per share; 125,000,000 shares authorized; 57,596,144
shares and 51,617,639 shares issued and outstanding as of December 31, 2020 and 2019, respectively
|Additional paid-in capital||1,297,557||1,033,819|
|Accumulated other comprehensive income (loss)||11||111|
|Total stockholders' equity||543,676||546,467|
|Total liabilities and stockholders' equity||$||642,432||$||622,409|
|Deciphera Pharmaceuticals, Inc.|
|Year Ended December 31,|
|Product revenues, net||$||39,461||$||—||$||—|
|Cost and operating expenses:|
|Cost of sales||225||—||—|
|Research and development||198,970||157,610||82,887|
|Selling, general, and administrative||114,082||68,116||21,212|
|Total cost and operating expenses||313,277||225,726||104,099|
|Loss from operations||(271,190)||(200,726)||(104,099)|
|Other income (expense):|
|Interest and other income, net||4,701||8,537||4,329|
|Total other income (expense), net||4,701||8,470||4,245|
|Net loss per share—basic and diluted||$||(4.78)||$||(4.48)||$||(2.82)|
|Weighted average common shares outstanding—basic and diluted||55,780,982||42,869,058||35,390,480|
|Deciphera Pharmaceuticals, Inc.|
|Three Months Ended December 31,|
|Product revenues, net||$||19,472||$||—|
|Cost and operating expenses:|
|Cost of sales||127||—|
|Research and development||52,288||46,636|
|Selling, general, and administrative||30,070||23,737|
|Total cost and operating expenses||82,485||70,373|
|Loss from operations||(62,999)||(70,373)|
|Other income (expense):|
|Interest and other income, net||259||3,169|
|Total other income (expense), net||259||3,157|
|Net loss per share—basic and diluted||$||(1.10)||$||(1.31)|
|Weighted average common shares outstanding—basic and diluted||57,223,076||51,260,062|
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SOURCE: Deciphera Pharmaceuticals, Inc.
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