Le Lézard
Classified in: Health, Science and technology, Business
Subjects: EARNINGS, Conference Call, Webcast

Deciphera Pharmaceuticals Announces Third Quarter 2023 Financial Results


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

 


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