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May 4, 2021, 4:22 p.m. EDT

Deciphera Pharmaceuticals, Inc. Announces First Quarter 2021 Financial Results

- First Quarter 2021 QINLOCK® Net Product Revenue of $20.0 Million; QINLOCK Approved in China and Hong Kong for Fourth-line GIST - - Top-line Results from INTRIGUE Phase 3 Study of QINLOCK in Patients with Second-line GIST Expected in the Fourth Quarter of 2021; Plans to Initiate a Phase 1b/2 Study of QINLOCK in Combination with Binimetinib in Patients with Post-Imatinib GIST - - Updated Data from Phase 1b/2 Study of Rebastinib in Combination with Paclitaxel in Patients with Endometrial Cancer to be Presented at ASCO -- Initiation of Phase 1 Study of DCC-3116, Potential First-in-Class ULK Kinase Inhibitor for the Treatment of Patients with Mutant RAS and RAF Cancers, Expected in the Second Quarter of 2021 –– Company to Host Conference Call Today at 4:30 PM ET –

Deciphera Pharmaceuticals, Inc. /zigman2/quotes/203556943/composite DCPH -0.35% today announced financial results for the first quarter ended March 31, 2021, and provided a corporate update.

“We are excited by the continuing successful commercial launch of QINLOCK in the U.S. as we solidify its position among GIST prescribers and patients and expand access to this important medicine globally. We also remain focused on realizing QINLOCK’s potential in earlier lines of therapy,” said Steve Hoerter, President and Chief Executive Officer of Deciphera. “We expect the INTRIGUE Phase 3 top-line results in the fourth quarter of this year and believe QINLOCK has the potential to transform the treatment of GIST for this larger, second-line patient population. Building on our commitment to fully explore the potential of QINLOCK to benefit patients with GIST, we are excited to announce today our plans to initiate a Phase 1b/2 study combining QINLOCK with binimetinib, an approved MEK inhibitor. Our enthusiasm for this combination is based on compelling pre-clinical data showing that this combination can induce apoptosis and has the potential to deepen and prolong responses.”

Mr. Hoerter continued, “We remain very pleased with the progress and growth for the balance of our pipeline, including the upcoming initiation of the Phase 1 study for our potential first-in-class ULK kinase inhibitor, DCC-3116, in patients with cancers driven by mutant RAS or RAF genes. We look forward to presenting updated data from both the vimseltinib and rebastinib programs in the coming months and plan to finalize registration-enabling studies for both programs before the end of the year.”

First Quarter 2021 Highlights and Upcoming Milestones

  • QINLOCK(ripretinib)

  • Vimseltinib

  • Rebastinib

  • DCC-3116

Upcoming Scientific Congress Presentations

  • 2021 ASCO Annual Meeting, June 4-8. E-poster presentations will be available on-demand via the ASCO Meeting Library beginning on Friday, June 4 at 9:00 AM ET.

First Quarter Financial Results

  • Revenue: Total revenue for the first quarter of 2021 was $25.2 million, which includes $20.0 million of net product revenue from sales of QINLOCK and $5.2 million of collaboration revenue. Net product revenues for the first quarter of 2021 included U.S. sales of QINLOCK of $19.3 million and ex-U.S. sales of QINLOCK of $0.7 million. The Company also recognized $5.0 million in collaboration revenue under its license agreement with Zai Lab based on the approval of QINLOCK in China. In the first quarter of 2020, the Company did not generate product revenue.

  • Cost of Sales : Cost of sales were $0.2 million in the first quarter of 2021. There were no cost of sales in the first quarter of 2020 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 first quarter were $55.7 million, compared to $51.4 million for the same period in 2020. The increase was primarily due to personnel and preclinical costs, partially offset by a decrease in clinical trial expenses related to the INTRIGUE Phase 3 study in second-line GIST and the INVICTUS Phase 3 study in fourth-line and fourth-line plus GIST. Non-cash, stock-based compensation was $5.0 million and $3.3 million for the first quarters of 2021 and 2020, respectively.

  • SG&A Expenses: Selling, general and administrative expenses for the first quarter of 2021 were $30.7 million, compared to $23.9 million for the same period in 2020. The increase was primarily due to personnel costs as well as external spend related to professional fees, including those associated with establishing a targeted commercial infrastructure in key European markets to support a potential launch of QINLOCK in Europe, if approved. Non-cash, stock-based compensation was $6.2 million and $3.7 million for the first quarters of 2021 and 2020, respectively.

  • Net Loss: For the first quarter of 2021, Deciphera reported a net loss of $61.3 million, or $1.06 per share, compared with a net loss of $72.8 million, or $1.36 per share, for the same period in 2020. The decrease in net loss was primarily a result of product sales during the first quarter of 2021, partially offset by an increase in R&D and SG&A expenses as described above.

  • Cash Position: As of March 31, 2021, cash, cash equivalents and marketable securities were $502.2 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 and royalty 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 first half of 2023.

Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, May 4, 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 5470938. 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 Australia, Canada, China, and Hong Kong. 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 timing for top-line data from our Phase 3 INTRIGUE study in second-line GIST, expanding access to QINLOCK globally, the potential of QINLOCK in earlier lines of therapy such as second-line GIST and the potential to transform the treatment for such patients, plans to initiate a phase 1b/2 study of QINLOCK with a MEK inhibitor in post-imatinib GIST patients and the potential for a deeper and prolonged response, plans to present data on patients undergoing intra-patient dose escalation following disease progression from the phase 3 INVICTUS study, potential EMA 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 in patients with cancers driven by mutant RAS/RAF genes; and cash runway expectations. 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 Quarterly Report on Form 10-Q for the quarter ended March 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. 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. Consolidated Balance Sheets (Unaudited, in thousands, except share and per share amounts)

  March 31, 2021   December 31, 2020
Assets      
Current assets:      
Cash and cash equivalents $ 201,648       $ 135,897    
Short-term marketable securities 300,527       416,033    
Accounts receivable, net 21,821       13,896    
Inventory 7,090       5,716    
Prepaid expenses and other current assets 15,546       12,489    
Total current assets 546,632       584,031    
Long-term marketable securities       9,375    
Long-term investments—restricted 3,102       3,102    
Property and equipment, net 9,633       9,583    
Operating lease assets 35,879       36,341    
Total assets $ 595,246       $ 642,432    
Liabilities and Stockholders' Equity      
Current liabilities:      
Accounts payable $ 11,905       $ 12,308    
Accrued expenses and other current liabilities 49,344       55,227    
Operating lease liabilities 2,540       2,457    
Total current liabilities 63,789       69,992    
Operating lease liabilities, net of current portion 28,444       28,764    
Total liabilities 92,233       98,756    
Commitments and contingencies      
Stockholders' equity:      
Common stock, $0.01 par value per share; 125,000,000 shares authorized; 57,901,020 shares and 57,596,144 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively 579       576    
Additional paid-in capital 1,318,157       1,297,557    
Accumulated other comprehensive income (loss) 43       11    
Accumulated deficit (815,766 )     (754,468 )  
Total stockholders' equity 503,013       543,676    
Total liabilities and stockholders' equity $ 595,246       $ 642,432    

Deciphera Pharmaceuticals, Inc. Consolidated Statements of Operations and Comprehensive Loss (Unaudited, in thousands, except share and per share amounts)

  Three Months Ended March 31,
  2021     2020  
Revenues:      
Product revenues, net $ 19,962       $    
Collaboration revenues 5,194       62    
Total revenues 25,156       62    
Cost and operating expenses:      
Cost of sales 222          
Research and development 55,681       51,388    
Selling, general, and administrative 30,747       23,936    
Total cost and operating expenses 86,650       75,324    
Loss from operations (61,494 )     (75,262 )  
Other income (expense):      
Interest and other income, net 196       2,455    
Total other income (expense), net 196       2,455    
Net loss $ (61,298 )     $ (72,807 )  
       
Net loss per share—basic and diluted $ (1.06 )     $ (1.36 )  
Weighted average common shares outstanding—basic and diluted 57,747,168       53,567,434    

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20210504006277/en/

SOURCE: Deciphera Pharmaceuticals, Inc.

Investor Relations:
Jen Robinson
Deciphera Pharmaceuticals, Inc
jrobinson@deciphera.com
781-906-1112

Media:
David Rosen
Argot Partners
David.Rosen@argotpartners.com
212-600-1902

COMTEX_385847475/2456/2021-05-04T16:22:03

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/zigman2/quotes/203556943/composite
US : U.S.: Nasdaq
$ 33.89
-0.12 -0.35%
Volume: 263,256
Oct. 26, 2021 4:00p
P/E Ratio
N/A
Dividend Yield
N/A
Market Cap
$1.97 billion
Rev. per Employee
$120,249
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