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Deciphera Pharmaceuticals, Inc. Announces Third Quarter 2020 Financial Results

November 5, 2020 4:01 PM

– U.S. QINLOCK® Net Revenue of $14.7 Million in the First Full Quarter of Launch –

– Marketing Authorisation Application for QINLOCK in Fourth-line GIST Validated by the European Medicines Agency; Commercial Planning for Europe Underway –

– Enrollment for QINLOCK Phase 3 INTRIGUE Study Expected to be Completed in Fourth Quarter 2020 –

– DCC-3014 Phase 1 Study Results in Additional TGCT Patients to be Featured in an Oral Presentation at the CTOS 2020 Virtual Annual Meeting –

– Company to Host Conference Call Today at 4:30 PM ET –

WALTHAM, Mass.--(BUSINESS WIRE)-- Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) today announced financial results and provided a business update for the third quarter ended September 30, 2020.

“The strong U.S. commercial launch of QINLOCK, which is reflected in our first full quarter of results since the approval in May, is a testament to the potential for this new medicine to be a best-in-class treatment for people with GIST,” said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. “During the third quarter, we also made substantial progress in preparing to bring QINLOCK to eligible patients around the world, including the submission and validation of the MAA by the EMA and the establishment of distribution agreements in Canada and Australia.”

Mr. Hoerter continued, “In addition to executing on the successful launch of QINLOCK, we continue to advance our pipeline of promising product candidates. Notably, we look forward to presenting new data from our Phase 1/2 study of DCC-3014 in TGCT patients at the CTOS 2020 Virtual Meeting later this month.”

Third Quarter 2020 Highlights and Recent Business Updates

Upcoming Scientific Congress Presentations

Third Quarter 2020 Financial Results

Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, November 5, 2020 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 6048987. 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 GIST. QINLOCK is also approved in Canada and Australia for fourth-line GIST. For more information, visit www.Deciphera.com and follow us on Twitter (@Deciphera) and LinkedIn.

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 corporate milestone timing, including INTRIGUE enrollment, clinical and other data to be presented at future medical congresses, such as CTOS, and the review of our MAA filing with the EMA, commercial planning for Europe, the potential of QINLOCK to be a best-in-class treatment for GIST, and our cash runway. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “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, 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, 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 September 30, 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, Deciphera Pharmaceuticals, 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)

September 30, 2020

December 31, 2019

Assets

Current assets:

Cash and cash equivalents

$

111,154

$

120,320

Short-term marketable securities

434,171

459,256

Accounts receivable, net

11,814

Inventory

4,596

Prepaid expenses and other current assets

9,723

13,832

Total current assets

571,458

593,408

Long-term marketable securities

38,989

Long-term investments—restricted

2,125

1,510

Property and equipment, net

9,925

6,333

Operating lease assets

37,171

21,158

Total assets

$

659,668

$

622,409

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable

$

10,237

$

19,575

Accrued expenses and other current liabilities

48,941

38,716

Operating lease liabilities

2,010

1,747

Total current liabilities

61,188

60,038

Operating lease liabilities, net of current portion

29,394

15,904

Total liabilities

90,582

75,942

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; 56,641,065 shares and 51,617,639 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively

566

516

Additional paid-in capital

1,260,209

1,033,819

Accumulated other comprehensive income (loss)

39

111

Accumulated deficit

(691,728

)

(487,979

)

Total stockholders' equity

569,086

546,467

Total liabilities and stockholders' equity

$

659,668

$

622,409

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,

2020

2019

2020

2019

Revenues:

Product revenues, net

$

15,164

$

$

19,989

$

Collaboration revenues

285

2,612

25,000

Total revenues

15,449

22,601

25,000

Cost and operating expenses:

Cost of sales

90

98

Research and development

49,213

40,374

146,682

110,974

Selling, general, and administrative

30,143

17,979

84,012

44,379

Total cost and operating expenses

79,446

58,353

230,792

155,353

Loss from operations

(63,997

)

(58,353

)

(208,191

)

(130,353

)

Other income (expense):

Interest and other income, net

296

2,174

4,442

5,368

Interest expense

(17

)

(55

)

Total other income (expense), net

296

2,157

4,442

5,313

Net loss

$

(63,701

)

$

(56,196

)

$

(203,749

)

$

(125,040

)

Net loss per share—basic and diluted

$

(1.13

)

$

(1.28

)

$

(3.68

)

$

(3.12

)

Weighted average common shares outstanding—basic and diluted

56,390,748

43,803,508

55,296,775

40,041,321

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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