Item 2.02 Results of Operations and Financial Condition.
On January 3, 2023, Deciphera Pharmaceuticals, Inc. (the "Company") disclosed
that it had a preliminary unaudited amount of net product revenue of
approximately $36 million for the fourth quarter ended December 31, 2022, and
approximately $134 million for the full year ended December 31, 2022. QINLOCK
net product revenue is estimated to be approximately $33 million, including
approximately $26 million in U.S. QINLOCK® (ripretinib) net product revenue and
approximately $7 million in international QINLOCK net product revenue, in
addition to approximately $3 million in collaboration revenue. The Company also
disclosed that it had a preliminary unaudited amount of cash, cash equivalents,
and marketable securities of approximately $339 million as of December 31, 2022,
which is expected to fund the operating and capital expenditure plans into 2025.
These amounts are preliminary and are subject to completion of financial closing
procedures. As a result, these amounts may differ materially from the amounts
that will be reflected in the Company's consolidated financial statements for
the year ended December 31, 2022. A copy of the press release disclosing this
information is furnished as Exhibit 99.1 to this Current Report on Form 8-K and
is incorporated into this Item 2.02 by reference.
The preliminary financial data included in this Current Report on Form 8-K has
been prepared by, and is the responsibility of, the Company's management.
PricewaterhouseCoopers LLP has not audited, reviewed, examined, compiled, nor
applied agreed-upon procedures with respect to the preliminary financial data.
Accordingly, PricewaterhouseCoopers LLP does not express an opinion or any other
form of assurance with respect thereto.
The information in Item 2.02 of this Current Report on Form 8-K is intended to
be furnished and shall not be deemed "filed" for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise
subject to the liabilities of that section, nor shall it be deemed incorporated
by reference in any filing under the Securities Act of 1933, as amended (the
"Securities Act"), or the Exchange Act, except as expressly set forth by
specific reference in such filing.
Item 7.01 Regulation FD Disclosure.
The information provided in Item 2.02 above is incorporated herein by reference.
In addition, on January 3, 2023, the Company issued a separate press release
announcing results of a planned exploratory analysis of data from the Company's
INTRIGUE Phase 3 clinical study using circulating tumor DNA and plans to
initiate the Company's INSIGHT Phase 3 clinical study of QINLOCK versus
sunitinib in second-line gastrointestinal stromal tumor (GIST) patients with
mutations in KIT exon 11 and 17/18 only. A copy of the press release is
furnished as Exhibit 99.2 to this Current Report on Form 8-K.
The information in Item 7.01 of this Current Report on Form 8-K is intended to
be furnished and shall not be deemed "filed" for purposes of Section 18 of the
Exchange Act or otherwise subject to the liabilities of that section, nor shall
it be deemed incorporated by reference in any filing under the Securities Act or
the Exchange Act, except as expressly set forth by specific reference in such
filing.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as amended,
including, without limitation, statements regarding the Company's preliminary
unaudited amount of net product revenue for the fourth quarter and year ended
December 31, 2022 and preliminary unaudited cash, cash equivalents, and
marketable securities for the year ended December 31, 2022, and the Company's
expectations and timing regarding its planned Phase 3 INISGHT study of QINLOCK
versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and
17/18 only. 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. Forward-looking statements are based
on current expectations of management and upon what management believes to be
reasonable assumptions based on information currently available to it, and are
subject to risks and uncertainties. Such risks and uncertainties may cause
actual results to differ materially from the expectations set forth in the
forward-looking statements. Such risks and uncertainties include, but are not
limited to, risks related to preliminary financial results, including the risks
that actual product and collaboration revenues may differ from the Company's
current expectations, and risks that the
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preliminary financial results reported herein reflect information available to
the Company only at this time and may differ from actual results, including in
connection with the Company's completion of financial closing procedures, as
well as other risks detailed in the Company's recent filings on
Forms 10-K and 10-Q with the Securities and Exchange Commission. The Company
undertakes no obligation to update any forward-looking statements to reflect new
information, events or circumstances, or to reflect the occurrence of
unanticipated events.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press Release titled "Deciphera Pharmaceuticals Announces Planned 2023
Corporate Milestones to Support Continued Evolution to Multi-Product
Company" issued by Deciphera Pharmaceuticals, Inc. on January 3, 2023,
furnished herewith.
99.2 Press Release titled "Deciphera Pharmaceuticals Announces Results from
ctDNA Analysis from INTRIGUE Phase 3 Clinical Study Demonstrating
Substantial Clinical Benefit of QINLOCK® in Second-Line GIST Patients with
Mutations in KIT Exon 11 and 17/18 Only" issued by Deciphera
Pharmaceuticals, Inc. on January 3, 2023, furnished herewith.
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document)
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