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Deciphera Pharmaceuticals, Inc. Announces Second Quarter 2020 Financial Results

August 4, 2020 4:05 PM

- QINLOCKTM Approved for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor and U.S. Commercial Launch Underway -

- Reported QINLOCK Net Revenue of $4.8 Million in the First Partial Quarter of Launch -

- Company Expects to Complete Enrollment in Phase 3 INTRIGUE Study in Fourth Quarter 2020 -

- Second Quarter 2020 Ended with Cash, Cash Equivalents and Marketable Securities of $632 Million; Cash Runway Expected into the Second Half of 2022 -

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

WALTHAM, Mass.--(BUSINESS WIRE)-- Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) today announced financial results for the second quarter ended June 30, 2020 and provided an update on clinical and corporate developments.

“The second quarter for Deciphera was a transformational one as we launched our first commercial product following the FDA approval of QINLOCK,” said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. “We are proud to deliver QINLOCK to advanced GIST patients as the first approved therapy designed specifically for their disease. We are encouraged by the initial results from our first partial quarter of commercial sales, which speaks to both the need for a novel therapy such as QINLOCK in GIST, and our preparedness and determination in ensuring that eligible patients who can benefit from QINLOCK have access to this new treatment option.”

Mr. Hoerter continued, “Additionally, we remain focused on advancing our portfolio of innovative medicines to improve the lives of people with cancer and are pleased with the progress of our ongoing pipeline programs, DCC-3014, rebastinib and DCC-3116.”

Recent Business Progress

Regulatory and Commercial Updates

Recent Clinical Highlights and Updates Announced Today

Second Quarter 2020 Financial Results

Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, August 4, 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 3769662. 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, QINLOCKTM 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 and the expected MAA filing with the EMA, the potential benefit of QINLOCK to GIST patients, ensuring appropriate patients have access to QINLOCK 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 June 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 its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

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

Deciphera Pharmaceuticals, Inc.

Consolidated Balance Sheets

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

June 30, 2020

December 31, 2019

Assets

Current assets:

Cash and cash equivalents

$

155,446

$

120,320

Short-term marketable securities

454,890

459,256

Accounts receivable, net

7,384

Inventory

1,389

Prepaid expenses and other current assets

13,977

13,832

Total current assets

633,086

593,408

Long-term marketable securities

21,431

Long-term investments—restricted

2,125

1,510

Property and equipment, net

9,567

6,333

Operating lease assets

20,096

21,158

Total assets

$

686,305

$

622,409

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable

$

12,582

$

19,575

Accrued expenses and other current liabilities

37,333

38,716

Operating lease liabilities

1,424

1,747

Total current liabilities

51,339

60,038

Operating lease liabilities, net of current portion

15,282

15,904

Total liabilities

66,621

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; 56,081,993 shares and 51,617,639 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively

561

516

Additional paid-in capital

1,247,158

1,033,819

Accumulated other comprehensive income (loss)

(8

)

111

Accumulated deficit

(628,027

)

(487,979

)

Total stockholders' equity

619,684

546,467

Total liabilities and stockholders' equity

$

686,305

$

622,409

Deciphera Pharmaceuticals, Inc.

Consolidated Statements of Operations

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

Three Months Ended June 30,

Six Months Ended June 30,

2020

2019

2020

2019

Revenues:

Product revenues, net

$

4,825

$

$

4,825

$

Collaboration revenues

2,265

25,000

2,327

25,000

Total revenues

7,090

25,000

7,152

25,000

Cost and operating expenses:

Cost of sales

8

8

Research and development

46,081

34,811

97,469

70,600

Selling, general, and administrative

29,933

13,164

53,869

26,400

Total cost and operating expenses

76,022

47,975

151,346

97,000

Loss from operations

(68,932

)

(22,975

)

(144,194

)

(72,000

)

Other income (expense):

Interest and other income, net

1,691

1,540

4,146

3,194

Interest expense

(25

)

(38

)

Total other income (expense), net

1,691

1,515

4,146

3,156

Net loss

$

(67,241

)

$

(21,460

)

$

(140,048

)

$

(68,844

)

Net loss per share—basic and diluted

$

(1.20

)

$

(0.56

)

$

(2.56

)

$

(1.81

)

Weighted average common shares outstanding—basic and diluted

55,920,122

38,200,288

54,743,778

38,129,049

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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