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Deciphera Pharmaceuticals, Inc. Announces Fourth Quarter and Full Year 2020 Financial Results

February 9, 2021 4:01 PM

- Fourth Quarter 2020 QINLOCK® Net Revenue of $19.5 Million and Full Year 2020 QINLOCK Net Revenue of $39.5 Million -

- Top-line Results in INTRIGUE Phase 3 Study of QINLOCK in Patients with Second-line GIST Expected in the Second Half of 2021 -

- Pipeline Candidates, Vimseltinib (DCC-3014), Rebastinib and DCC-3116, Continue to Advance with Significant Clinical Milestones Expected in 2021 -

WALTHAM, Mass.--(BUSINESS WIRE)-- Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) 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

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.

Consolidated Balance Sheets

(in thousands, except share and per share amounts)

December 31,

2020

2019

Assets

Current assets:

Cash and cash equivalents

$

135,897

$

120,320

Short-term marketable securities

416,033

459,256

Accounts receivable, net

13,896

Inventory

5,716

Prepaid expenses and other current assets

12,489

13,832

Total current assets

584,031

593,408

Long-term marketable securities

9,375

Long-term investments—restricted

3,102

1,510

Property and equipment, net

9,583

6,333

Operating lease assets

36,341

21,158

Total assets

$

642,432

$

622,409

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable

$

12,308

$

19,575

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

Total liabilities

98,756

75,942

Commitments and contingencies

Stockholders' equity:

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

576

516

Additional paid-in capital

1,297,557

1,033,819

Accumulated other comprehensive income (loss)

11

111

Accumulated deficit

(754,468)

(487,979)

Total stockholders' equity

543,676

546,467

Total liabilities and stockholders' equity

$

642,432

$

622,409

Deciphera Pharmaceuticals, Inc.

Consolidated Statements of Operations

(in thousands, except share and per share amounts)

Year Ended December 31,

2020

2019

2018

Revenues:

Product revenues, net

$

39,461

$

$

Collaboration revenues

2,626

25,000

Total revenues

42,087

25,000

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

Interest expense

(67)

(84)

Total other income (expense), net

4,701

8,470

4,245

Net loss

$

(266,489)

$

(192,256)

$

(99,854)

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.

Consolidated Statements of Operations

(unaudited, in thousands, except share and per share amounts)

Three Months Ended December 31,

2020

2019

Revenues:

Product revenues, net

$

19,472

$

Collaboration revenues

14

Total revenues

19,486

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

Interest expense

(12)

Total other income (expense), net

259

3,157

Net loss

$

(62,740)

$

(67,216)

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

Investor Relations:

Jen Robinson

Deciphera Pharmaceuticals, Inc

[email protected]

781-906-1112

Media:

David Rosen

Argot Partners

[email protected]

212-600-1902

Source: Deciphera Pharmaceuticals, Inc.

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