Upgrade to SI Premium - Free Trial

Deciphera Pharmaceuticals, Inc. Announces Fourth Quarter and Full Year 2021 Financial Results

February 8, 2022 4:05 PM

– Fourth Quarter 2021 Revenue of $24.2 Million and Full Year 2021 Revenue of $96.1 Million –

– Launch of QINLOCK® in Europe Underway –

– Pivotal Phase 3 MOTION Study of Vimseltinib in TGCT Patients Underway; Updated Phase 1/2 Data Expected in 2H 2022 –

– Phase 1 Single Agent Dose Escalation Data for DCC-3116 Expected in 2H 2022; Initiation of Phase 1 Combination Dose Escalation Cohorts Expected in 2H 2022 –

– New Development Candidate from Pan-RAF Research Program Expected in 2022 –

WALTHAM, Mass.--(BUSINESS WIRE)-- Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) today announced financial results for the fourth quarter and year ended December 31, 2021, and provided a corporate update.

“I am immensely proud of our organization’s achievements in 2021 and believe that we are well positioned for long-term success as we work towards our expected milestones in 2022,” said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. “While the unexpected results of the INTRIGUE study and subsequent restructuring at the end of last year were very difficult, we are fortunate to have a robust pipeline and look to build on the progress we made across our pipeline last year, as we continue to execute on our mission of delivering important new medicines to improve the lives of people with cancer.”

Mr. Hoerter continued, “We have rapidly progressed vimseltinib, our potential best-in-class inhibitor of CSF1R, to Phase 3 development for the treatment of tenosynovial giant cell tumor, or TGCT, and we expect to present updated data from the Phase 1/2 study in patients with TGCT in the second half of this year. In addition, we remain very excited by our first-in-class autophagy pathway inhibitor, DCC-3116, and plan to present initial data from the single agent dose escalation portion of the Phase 1 study in the second half of 2022. We also continue to focus on our next wave of therapeutic candidates, including our pan-RAF research program, and expect to nominate a clinical development candidate later this year.”

Fourth Quarter 2021 Highlights and Upcoming 2022 Milestones

QINLOCK® (ripretinib)

Vimseltinib

DCC-3116

Proprietary Drug Discovery Platform

Fourth Quarter and Full Year 2021 Financial Results

Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, February 8, 2022 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 8293127. 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 switch control inhibitor for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, 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 vimseltinib for the pivotal Phase 3 MOTION study in TGCT patients, the potential for vimseltinib to be a best-in-class treatment for TGCT, presenting updated vimseltinib data from our Phase 1/2 study in TGCT patients, initial data from the dose escalation phase of the Phase 1 study of DCC-3116, plans to initiate the trametinib combination dose escalation portion of the Phase 1 study of DCC-3116, plans to expand the ongoing Phase 1 study of DCC-3116 to add a combination with a mutant KRAS G12C inhibitor in NSCLC patients subject to feedback from regulatory authorities, plans to present additional pre-clinical data for DCC-3116, exploration of additional preclinical combinations of DCC-3116, nominating a development candidate for our pan-RAF research program, ex-U.S. strategies including executing on our commercial launch of QINLOCK in fourth-line GIST in Germany and our plans to transition to a post-approval paid access program in France, 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, risks and uncertainties related to our ability to provide access to QINLOCK in European countries other than Germany and France through other channels, 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 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, 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.

Deciphera, the Deciphera logo, QINLOCK, and the QINLOCK logo are registered trademarks of Deciphera Pharmaceuticals, LLC.

DECIPHERA PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

December 31,

2021

2020

Assets

Current assets:

Cash and cash equivalents

$

87,063

$

135,897

Short-term marketable securities

198,571

416,033

Accounts receivable, net

20,595

13,896

Inventory

14,125

5,716

Prepaid expenses and other current assets

18,660

12,489

Total current assets

339,014

584,031

Long-term marketable securities

41,950

9,375

Long-term investments—restricted

3,110

3,102

Property and equipment, net

8,610

9,583

Operating lease assets

36,800

36,341

Total assets

$

429,484

$

642,432

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable

$

13,130

$

12,308

Accrued expenses and other current liabilities

80,773

55,227

Operating lease liabilities

2,870

2,457

Total current liabilities

96,773

69,992

Operating lease liabilities, net of current portion

27,991

28,764

Total liabilities

124,764

98,756

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; 58,549,644 shares and 57,596,144 shares issued and outstanding as of December 31, 2021 and 2020, respectively

585

576

Additional paid-in capital

1,358,516

1,297,557

Accumulated other comprehensive income (loss)

51

11

Accumulated deficit

(1,054,432

)

(754,468

)

Total stockholders' equity

304,720

543,676

Total liabilities and stockholders' equity

$

429,484

$

642,432

DECIPHERA PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share amounts)

Three Months Ended December 31,

Twelve Months Ended December 31,

2021

2020

2021

2020

Revenues:

Product revenues, net

$

23,696

$

19,472

$

87,389

$

39,461

Collaboration revenues

503

14

8,759

2,626

Total revenues

24,199

19,486

96,148

42,087

Cost and operating expenses:

Cost of sales

518

127

2,932

225

Research and development

74,932

52,288

257,040

198,970

Selling, general, and administrative

37,151

30,070

136,253

114,082

Total cost and operating expenses

112,600

82,485

396,225

313,277

Loss from operations

(88,401

)

(62,999

)

(300,077

)

(271,190

)

Other income (expense):

Interest and other income, net

6

259

113

4,701

Total other income (expense), net

6

259

113

4,701

Net loss

$

(88,395

)

$

(62,740

)

$

(299,964

)

$

(266,489

)

Net loss per share—basic and diluted

$

(1.51

)

$

(1.10

)

$

(5.16

)

$

(4.78

)

Weighted average common shares outstanding—basic and diluted

58,487,041

57,223,076

58,084,325

55,780,982

Investor Relations:

Maghan Meyers

Argot Partners

[email protected]

212-600-1902

Media:

David Rosen

Argot Partners

[email protected]

212-600-1902

Source: Deciphera Pharmaceuticals, Inc.

Categories

Business Wire Press Releases

Next Articles