-- Achieved $54.2
million in AYVAKIT®/AYVAKYT® (avapritinib) net product
revenues, representing 90% growth year-over-year, and $56.6 million in total revenues in the third
quarter of 2023 –
-- Approximately 800 patients on AYVAKIT in
the U.S. at the end of the third quarter, more than 35% growth in
treated patients quarter-over-quarter and driven by ISM --
-- Plan to present data from Part 1 of the
HARBOR trial of elenestinib in ISM at ASH 2023 –
CAMBRIDGE, Mass., Oct. 26, 2023 /PRNewswire/ -- Blueprint Medicines
Corporation (NASDAQ: BPMC) today reported financial results and
provided a business update for the third quarter ended September 30, 2023.
"In the first full quarter following AYVAKIT's launch in
indolent systemic mastocytosis, we saw strong and steady growth in
both patients treated and revenue, reflecting a highly favorable
reception to AYVAKIT's unique and compelling clinical profile and
the effectiveness of our ongoing efforts to bring AYVAKIT to all
patients who can benefit from treatment," said Kate Haviland, Chief Executive Officer at
Blueprint Medicines. "Through the end of this year and into 2024,
we anticipate continued steady growth in AYVAKIT revenue driven by
both existing and new prescribers as we execute a disciplined
approach to managing operating expenses and allocating capital to
our most important investments."
Third Quarter 2023 Highlights and Recent Progress
Systemic mastocytosis (SM) and other mast cell
disorders
- Third quarter AYVAKIT net revenue grew 90 percent
year-over-year to $54.2 million, with
$49.1 million coming from the U.S, in
the first full quarter of ISM launch.
Upcoming 2023 Milestones
Blueprint Medicines plans to achieve the following milestones by
the end of 2023:
- Present data from Part 1 of the HARBOR trial
of elenestinib in indolent SM at the American Society of
Hematology conference in December
2023.
Third Quarter 2023 Results
- Revenues: Revenues were $56.6 million for
the third quarter of 2023, including $54.2 million of net
product revenues from sales of AYVAKIT/AYVAKYT and $2.4
million in collaboration revenues. Blueprint
Medicines recorded revenues of $65.9 million in the
third quarter of 2022, including $28.6 million of net
product revenues from sales of AYVAKIT/AYVAKYT and $37.3 million in collaboration and license
revenues.
- Cost of Sales: Cost of sales was $2.8 million for the third quarter of 2023, as
compared to $3.0 million for the
third quarter of 2022. The decrease was primarily due to a decrease
in the cost of collaboration-related sales.
- R&D Expenses: Research and development expenses were
$110.3 million for the third quarter
of 2023, as compared to $128.0
million for the third quarter of 2022. This decrease was
primarily due to a focused approach towards optimizing operational
efficiency across our portfolio as we execute across our top
priority programs and the timing of manufacturing of clinical trial
materials. Research and development expenses included $11.2 million in stock-based compensation
expenses for the third quarter of 2023.
- SG&A Expenses: Selling, general and
administrative expenses were $70.7
million for the third quarter of 2023, as compared to
$57.6 million for the third quarter
of 2022. This increase was primarily due to an increase in
compensation and personnel related costs driven by our first
quarter field force expansion to support the AYVAKIT launch in ISM.
Selling, general, and administrative expenses included $11.9 million in stock-based compensation
expenses for the third quarter of 2023.
- Net Loss: Net loss was $133.7 million for the third quarter of 2023, or
a net loss per share of $2.20, as
compared to a net loss of $133.2
million for the third quarter of 2022, or a net loss per
share of $2.23.
- Cash Position: As of September 30, 2023, cash,
cash equivalents and investments were $827.2 million, as
compared to $1,078.5 million as of December 31,
2022. Our cash and investments provide a durable capital position
which enables us to reach a self-sustainable profile.
Conference Call Information
Blueprint Medicines will host a live conference call and webcast
at 8:00 a.m. ET today to discuss
third quarter 2023 financial results and recent business
activities. The conference call may be accessed by dialing
833-470-1428 (domestic) and referring to conference ID 368229. A
webcast of the call will also be available under "Events and
Presentations" in the Investors & Media section of
the Blueprint Medicines website
at http://ir.blueprintmedicines.com/. The archived webcast
will be available on Blueprint Medicines' website
approximately two hours after the conference call and will be
available for 30 days following the call.
Upcoming Investor Conferences
Blueprint Medicines will participate in the following upcoming
investor conferences:
- Stifel Healthcare Conference on Wednesday, November 15, 2023 at 12:40 pm ET.
A live webcast of this presentation will be available by
visiting the Investors & Media 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 the 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 science
into a broad pipeline of precision therapies. Today, we have
brought our approved medicines to patients in the United States and Europe, and we are globally advancing multiple
programs for mast cell disorders, including systemic mastocytosis
and chronic urticaria, breast cancer and other cancers vulnerable
to CDK2 inhibition, as well as EGFR-mutant lung cancer. 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 plans, strategies, timelines and expectations for
Blueprint Medicines' current or future approved drugs and drug
candidates; ; the potential benefits of any of Blueprint Medicines'
current or future approved drugs or drug candidates in treating
patients; and Blueprint Medicines' financial performance, strategy,
goals and anticipated 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: preliminary activity and safety data may not be
representative of more mature data; the risk of delay of any
current or planned clinical trials or the development of Blueprint
Medicines' current or future drug candidates; risks related to
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; preclinical and clinical
results for Blueprint Medicines' drug candidates may not support
further development of such drug candidates either as monotherapies
or in combination with other agents or may impact the anticipated
timing of data or regulatory submissions; the timing of the
initiation of clinical trials and trial cohorts at clinical trial
sites and patient enrollment rates may be delayed or slower than
anticipated; actions of regulatory agencies may affect the
initiation, timing and progress of clinical trials; the success of
Blueprint Medicines' current and future collaborations, financing
arrangements, partnerships or licensing arrangements may impact
Blueprint Medicines' ability to capitalize on the market potential
of its approved drugs and drug candidates; and risks related to
Blueprint Medicines' ability to obtain, maintain and enforce patent
and other intellectual property protection for its products and
current or future drug candidates it is developing. 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.
Blueprint
Medicines Corporation Selected Condensed Consolidated Balance Sheet
Data (in
thousands) (unaudited)
|
|
|
|
September
30,
|
|
December
31,
|
|
|
2023
|
|
2022
|
Cash, cash equivalents
and marketable securities
|
$
|
827,226
|
|
$
|
1,078,472
|
Working capital
(1)
|
|
610,788
|
|
|
863,417
|
Total assets
|
|
1,105,299
|
|
|
1,349,902
|
Liability related to
the sale of future royalties and revenues (2)
|
|
440,147
|
|
|
430,330
|
Term loan
(2)
|
|
238,378
|
|
|
139,083
|
Deferred revenue
(2)
|
|
8,010
|
|
|
18,291
|
Total
liabilities
|
|
902,688
|
|
|
835,225
|
Total stockholders'
equity
|
|
202,611
|
|
|
514,677
|
|
(1) Blueprint Medicines defines
working capital as current assets less current
liabilities.
|
(2) Amounts include both
current and non-current portions of the balances.
|
Blueprint
Medicines Corporation Condensed Consolidated Statements of Operations
and Comprehensive Loss (in thousands, except per share
data) (Unaudited)
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
|
September 30,
|
|
September 30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue,
net
|
|
$
|
54,228
|
|
$
|
28,634
|
|
$
|
133,173
|
|
$
|
80,929
|
Collaboration and
license revenue
|
|
|
2,338
|
|
|
9,843
|
|
|
44,250
|
|
|
56,826
|
License revenue –
Related Party
|
|
|
-
|
|
|
27,500
|
|
|
-
|
|
|
27,500
|
Total
revenues
|
|
|
56,566
|
|
|
65,977
|
|
|
177,423
|
|
|
165,255
|
Cost and operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
sales
|
|
|
2,782
|
|
|
3,000
|
|
|
8,280
|
|
|
12,965
|
Collaboration loss
sharing
|
|
|
1,771
|
|
|
1,665
|
|
|
4,301
|
|
|
7,076
|
Research and
development
|
|
|
110,252
|
|
|
127,981
|
|
|
330,184
|
|
|
359,579
|
Selling, general and
administrative
|
|
|
70,741
|
|
|
57,608
|
|
|
215,826
|
|
|
173,354
|
Total cost and
operating expenses
|
|
|
185,546
|
|
|
190,254
|
|
|
558,591
|
|
|
552,974
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense,
net
|
|
|
(3,808)
|
|
|
(8,396)
|
|
|
(13,624)
|
|
|
(7,527)
|
Other income (expense),
net
|
|
|
(728)
|
|
|
396
|
|
|
(369)
|
|
|
575
|
Total other
expense
|
|
|
(4,536)
|
|
|
(8,000)
|
|
|
(13,993)
|
|
|
(6,952)
|
Loss before income
taxes
|
|
|
(133,516)
|
|
|
(132,277)
|
|
|
(395,161)
|
|
|
(394,671)
|
Income tax
expense
|
|
|
197
|
|
|
886
|
|
|
907
|
|
|
4,200
|
Net loss
|
|
$
|
(133,713)
|
|
$
|
(133,163)
|
|
$
|
(396,068)
|
|
$
|
(398,871)
|
Net loss per
share - basic and diluted
|
|
$
|
(2.20)
|
|
$
|
(2.23)
|
|
$
|
(6.55)
|
|
$
|
(6.70)
|
Weighted-average number
of common shares used
in net loss per share - basic and diluted
|
|
|
60,688
|
|
|
59,758
|
|
|
60,445
|
|
|
59,564
|
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SOURCE Blueprint Medicines Corporation