Item 7.01 Regulation FD Disclosure.
On February 23, 2023, the Company issued a press
release announcing Roche’s decision to terminate the Collaboration Agreement for convenience. A copy of the press release is being
furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Form 8-K”). The information in this Item 7.01,
including Exhibit 99.1 attached hereto, 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, or the Exchange
Act, except as expressly set forth by specific reference in such filing.
Cautionary Note Regarding Forward-Looking Statements
This 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: expectations concerning the transition process with Roche and Genentech and continued patient access to
GAVRETO, and the anticipated impact of the termination of the collaboration on Blueprint Medicines’ 2023 financial guidance;
Blueprint Medicines’ plans to explore options for the path forward for GAVRETO; the anticipated U.S. launch of AYVAKIT for
indolent systemic mastocytosis; expectations regarding Blueprint Medicines’ pipeline; and Blueprint Medicines’ strategy,
goals and anticipated financial performance, milestones, business plans and focus. The words "aim," "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 Form
8-K 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 Form 8-K, including, without limitation, the actual timing of the transition of responsibilities and
activities related to GAVRETO from Roche and Genentech, and the parties’ ability to successfully execute the transition in an
orderly fashion and without interruptions or changes to patient access to GAVRETO; risks and uncertainties related to the impact of
the COVID-19 pandemic to Blueprint Medicines’ business, operations, strategy, goals and anticipated milestones, including
Blueprint Medicines’ ongoing and planned research and discovery activities, ability to conduct ongoing and planned clinical
trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and
launching, marketing and selling current or future approved products; Blueprint Medicines’ ability to continue to establish
and expand its commercial infrastructure, and successfully launch, market and sell current or future approved products; Blueprint
Medicines’ ability to successfully expand the approved indications for AYVAKIT/AYVAKYT or obtain marketing approval for
AYVAKIT/AYVAKYT in additional geographies in the future; the delay of any current or planned clinical trials or the development of
Blueprint Medicines’ current or future drug candidates; Blueprint Medicines' advancement of multiple early-stage efforts;
Blueprint Medicines' ability to successfully demonstrate the safety and efficacy of its drug candidates and gain approval of its
drug candidates on a timely basis, if at all; the timing and results of preclinical and clinical studies for Blueprint Medicines'
drug candidates, which may not support further development of such drug candidates or may impact the anticipated timing of data,
publications or regulatory submissions; actions of regulatory agencies, which may affect the initiation, timing and progress of
clinical trials; the risk that the partial clinical hold on the VELA trial may or may not be resolved in a timely manner or that
additional adverse events observed could impact the extent of the partial clinical hold or Blueprint Medicines’ resolution of
the partial clinical hold; Blueprint Medicines' ability to obtain, maintain and enforce patent and other intellectual property
protection for AYVAKIT/AYVAKYT or any drug candidates it is developing; Blueprint Medicines' ability to develop and commercialize
companion diagnostic tests for AYVAKIT/AYVAKYT or any of its current and future drug candidates; Blueprint Medicines' ability to
successfully expand its operations and scientific platform and the costs thereof; and the ability to establish, and the success of,
Blueprint Medicines' current and future collaborations, partnerships, financing or licensing arrangements. These and other risks and
uncertainties are described in greater detail in the section entitled "Risk Factors" in Blueprint Medicines' filings with
the Securities and Exchange Commission, including Blueprint Medicines' most recent Annual Report on Form 10-K, as supplemented by
its most recent Quarterly Report on Form 10-Q and any other filings that Blueprint Medicines has made or may make with the
SEC in the future. Any forward-looking statements contained in this Form 8-K represent Blueprint Medicines' views only as of the
date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Blueprint
Medicines explicitly disclaims any obligation to update any forward-looking statements..