-- Expect to achieve high-end of 2022 total
revenue guidance of $180 million to
$200 million and AYVAKIT product
revenue guidance of $108 million to
$111 million --
-- Positioned for significant near-term growth
with potential FDA approval of AYVAKIT® (avapritinib) in indolent
systemic mastocytosis in the middle of 2023 --
-- Anticipate multiple clinical data catalysts
across mast cell disorder, EGFR-mutant non-small cell lung cancer,
and breast cancer programs in 2023 --
-- Kate
Haviland, Chief Executive Officer, to present company
overview and 2023 outlook at 41st Annual J.P. Morgan
Healthcare Conference on Tuesday, January
10 at 4:30 p.m. PT /
7:30 p.m. ET --
CAMBRIDGE, Mass., Jan. 5, 2023
/PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC)
today outlined upcoming portfolio milestones advancing the
company's 2027 Blueprint to achieve Precision at Scale, a five-year
growth strategy to reach broad patient populations by leveraging
its scientific leadership, proven development capability and
integrated business infrastructure.
Kate Haviland, Chief Executive
Officer of Blueprint Medicines, said:
"Entering 2023, Blueprint Medicines is poised to achieve
significant growth and value creation for patients and
shareholders, leveraging our strong enterprise capabilities and
infrastructure.
In the coming year, we plan to scale the impact of
AYVAKIT by addressing the medical needs of a substantially
larger group of patients with an anticipated label expansion in
indolent systemic mastocytosis, where AYVAKIT has the potential to
be a disease modifying therapy and a major treatment advance. Our
experienced team, who is in the field bringing AYVAKIT to patients
with advanced systemic mastocytosis, is ready to expand our efforts
upon FDA approval.
In addition, the data we plan to generate this year will start
to truly characterize the potential of our clinical-stage pipeline
to solve complex medical problems in EGFR-mutant lung cancer and
CDK2-vulnerable breast cancer, which both represent large
established commercial opportunities.
This diverse set of growth drivers, together with our existing
commercial portfolio and proven discovery platform, put us squarely
on the path to achieve our vision for doubling our impact between
now and 2027."
The company's key strategies and upcoming goals are to:
1. Launch AYVAKIT in indolent systemic
mastocytosis (SM), improving treatment options for patients across
the spectrum of the disease and expanding the company's leadership
position in SM.
- Present registrational PIONEER trial data for AYVAKIT in
indolent SM at the American Academy of Allergy, Asthma and
Immunology Annual Meeting in February
2023
- Achieve European Medicines Agency validation of a type II
variation marketing authorization application for AYVAKYT for
indolent SM in the first half of 2023
- Achieve approval from the Food and Drug Administration (FDA)
and initiate the launch of AYVAKIT in indolent SM in the U.S. in
the middle of 2023
- Present HARBOR Part 1 trial data for elenestinib (BLU-263) in
indolent SM in the second half of 2023
2. Advance a robust portfolio of
innovative clinical programs, addressing broader patient
populations, towards registration.
EGFR-driven NSCLC:
- Submit an investigational new drug application to the FDA for
BLU-525 in the first half of 2023
- Present initial CONCERTO trial dose escalation data for BLU-451
in EGFR exon 20-positive NSCLC in the first half of 2023
- Provide an initial clinical data update on SYMPHONY trial
expansion for the combination of BLU-945 and osimertinib in
first-line EGFR L858R-positive NSCLC in the second half of
2023
Breast and other CDK2-vulnerable cancers:
- Present initial VELA trial dose escalation data for BLU-222 in
CDK2-vulnerable cancers in the first half of 2023
3. Grow the R&D pipeline with diverse,
high-value programs from the company's prolific scientific
platform.
- Nominate a development candidate targeting wild-type KIT for
treatment of chronic urticaria in the middle of 2023
J.P Morgan Healthcare Conference Presentation
Information
Kate Haviland, Chief Executive
Officer of Blueprint Medicines, will present a company overview and
2023 outlook at the 41st Annual J.P. Morgan Healthcare Conference
on Tuesday, January 10 at
4:30 p.m. PT / 7:30 p.m. ET. A live webcast of the presentation
and Q&A breakout session will be available by visiting the
"Events and Presentations" section of Blueprint Medicines' website
at http://ir.blueprintmedicines.com. A replay of the webcast will
be archived on Blueprint Medicines' website for 30 days following
each presentation.
About Blueprint Medicines
Blueprint Medicines is a global precision therapy company that
invents life-changing therapies for people with cancer and blood
disorders. Applying an approach that is both precise and agile, we
create medicines that selectively target genetic drivers, with the
goal of staying one step ahead across stages of disease. Since
2011, we have leveraged our research platform, including expertise
in molecular targeting and world-class drug design capabilities, to
rapidly and reproducibly translate our scientific innovation into a
broad pipeline of important approved and investigational precision
therapies aimed at addressing difficult-to-treat cancers and blood
disorders. Today, we are delivering our approved medicines to
patients in the United States,
Europe, and in other geographies
ourselves or through our partners. In addition, we are globally
advancing multiple programs for systemic mastocytosis, lung cancer,
breast cancer, and other genomically defined cancers, and cancer
immunotherapy. For more information, visit
www.BlueprintMedicines.com and follow us on Twitter
(@BlueprintMeds) 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, statements
regarding FDA approval for AYVAKI for the treatment of indolent SM;
plans and timing for presenting data from the PIONEER trial of
AYVAKIT in patients with indolent SM; statements regarding
plans, strategies, timelines and expectations for interactions with
the FDA and other regulatory authorities, statements regarding
plans and expectations for Blueprint Medicines' current or future
approved drugs and drug candidates, including, the results of
ongoing and planned clinical trials; plans to expand Blueprint
Medicines' scientific platform; Blueprint Medicines' plans,
strategies and timelines to nominate development candidates; the
potential benefits of any of Blueprint Medicines' current or future
approved drugs or drug candidates in treating patients; preliminary
selected financial results; 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
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 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 and plans in continuing to establish and expand a
commercial infrastructure, and successfully launching, marketing
and selling 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; 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 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 (SEC), 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 press release
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.
Trademarks
Blueprint Medicines, AYVAKIT, AYVAKYT and associated logos are
trademarks of Blueprint Medicines Corporation.
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SOURCE Blueprint Medicines Corporation