CAMBRIDGE, Mass., Aug. 9, 2016 /PRNewswire/ -- Blueprint
Medicines Corporation (NASDAQ: BPMC), a leader in discovering and
developing highly selective kinase medicines for patients with
genomically defined diseases, today reported financial results and
provided a business update for the second quarter ended
June 30, 2016.
![Blueprint Medicines Blueprint Medicines](http://photos.prnewswire.com/prnvar/20150605/221118LOGO)
"During the second quarter of 2016, we focused on execution
across our pipeline of discovery and clinical-stage programs," said
Jeff Albers, Chief Executive Officer
of Blueprint Medicines. "We look forward to a number of milestones
in the second half of 2016, including preliminary data readouts for
our three Phase 1 clinical trials, which we believe will
demonstrate both the strength of our platform and our ability to
effectively develop kinase therapies against difficult-to-drug
targets. These data will help inform our clinical plans in the
future, with the goal of developing treatments to dramatically
improve the lives of people with cancer and other life-threatening
diseases."
Corporate Highlights:
- In April 2016, at the American
Association for Cancer Research (AACR) Annual Meeting, Blueprint
Medicines presented new preclinical data demonstrating that its RET
inhibitors, including its drug candidate BLU-667, showed potent
inhibition of activity in RET fusion positive lung adenocarcinoma
and papillary thyroid cancer cell lines as well as medullary
thyroid cancer cell lines driven by an activating RET point
mutation. Blueprint Medicines' RET inhibitors retained in
vitro and in vivo activity against RET resistant mutants
that Blueprint Medicines predicts may arise in patients, which
provides a potential opportunity for a meaningful and durable
clinical response in RET-driven disease. Blueprint Medicines
remains on track to file an IND for BLU-667 by the end of
2016.
- In April 2016, Blueprint
Medicines announced the appointment of Dr. Lynn Seely to its Board of Directors.
- In the third quarter of 2016, Blueprint Medicines achieved a
pre-clinical milestone of $1.0M under
its collaboration with Alexion Pharma Holding (Alexion), which is
expected to be paid during the third quarter of 2016.
Second Quarter 2016 Financial Results:
- Cash Position: As of June 30,
2016, cash, cash equivalents, and investments were
$172.6 million, as compared to
$162.7 million as of December 31, 2015. This increase was primarily
due to the $45.0 million upfront
payment received in March 2016 under
Blueprint Medicines' cancer immunotherapy collaboration with F.
Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (collectively,
Roche), offset by cash used in operating activities.
- Collaboration Revenue: Collaboration revenues were
$7.1 million for the second quarter
of 2016, as compared to $2.7 million
for the second quarter of 2015. This increase was due to increased
activity in Blueprint Medicines' collaboration with Alexion and
Blueprint Medicines entering into a collaboration with Roche in
March 2016.
- R&D Expenses: Research and development expenses were
$21.3 million for the second quarter
of 2016, as compared to $11.2 million
for the same period in 2015. This increase was primarily
attributable to increased manufacturing and clinical expenses
associated with advancing BLU-285 and BLU-554 into clinical trials,
increased pre-clinical expenses associated with advancing BLU-667
towards an IND filing, continuing to build Blueprint Medicines'
platform and advance its discovery pipeline, and increased
personnel-related expenses.
- G&A Expenses: General and administrative expenses
were $4.7 million for the second
quarter of 2016, as compared to $3.8
million for the same period in 2015. This increase was
primarily attributable to increased professional fees.
- Net Loss: Net loss was $18.9
million for the second quarter of 2016, or a basic and
diluted net loss per share available to common stockholders of
$0.70, as compared to a net loss of
$13.0 million for the same period in
2015, or a basic and diluted net loss per share available to common
stockholders of $0.81.
Financial Guidance:
Blueprint Medicines expects that its cash, cash equivalents and
investments balance will be at least $120
million at December 31, 2016.
Blueprint Medicines expects that its existing cash, cash
equivalents and investments will be sufficient to enable it to fund
its operating expenses and capital expenditure requirements into
early 2018.
Clinical Programs:
Blueprint Medicines' lead drug candidates are BLU-285, a
selective inhibitor of both Exon 17 mutant KIT and D842V mutant
PDGFRα, and BLU-554, a selective inhibitor of the FGFR4 receptor.
Enrollment continues to progress in the dose escalation portion of
Blueprint Medicines' Phase 1 clinical trials for BLU-285 in
unresectable, treatment-resistant gastrointestinal stromal tumors
and advanced systemic mastocytosis and BLU-554 in advanced
hepatocellular carcinoma. Blueprint Medicines expects to
share preliminary data from the dose escalation portion of each of
these Phase 1 clinical trials by the end of 2016. For each Phase 1
clinical trial, Blueprint Medicines anticipates that the
preliminary data will include safety, pharmacokinetics and
pharmacodynamic measures across a range of dose levels and any
initial assessments of clinical activity that may be available.
Conference Call Information
Blueprint Medicines will host a live conference call and
audio webcast today at 8:30 a.m. EDT.
The conference call may be accessed by dialing 1-855-728-4793
(domestic) or 1-503-343-6666 (international) and referring to
conference ID 33938424. An audio webcast of the conference call
will also be available in the Investors section of 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.
About Blueprint Medicines
Blueprint Medicines is developing a new generation of
highly selective and potent kinase medicines to improve the lives
of patients with genomically defined diseases. The Company's
approach is rooted in a deep understanding of the genetic blueprint
of cancer and other diseases driven by the abnormal activation of
kinases. Blueprint Medicines is advancing three programs
in clinical development for subsets of patients with
gastrointestinal stromal tumors, hepatocellular carcinoma and
systemic mastocytosis, as well as multiple programs in research and
preclinical development. For more information, please
visit www.blueprintmedicines.com.
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 and timelines for the clinical development of
BLU-285 and BLU-554; the timing of clinical data or proof of
concept for preclinical and clinical programs, including, without
limitation, the timing and type of preliminary clinical data for
Blueprint Medicines' Phase 1 clinical trials for BLU-285 and
BLU-554; the timing of regulatory submissions or filings,
including, without limitation, an investigational new drug
application for BLU-667; expectations regarding Blueprint
Medicines' existing cash, cash equivalents and investments; and
Blueprint Medicines' strategy, business plans and focus. 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 delay of any
current or planned clinical trials or the development of Blueprint
Medicines' drug product candidates, including BLU-285 and BLU-554;
Blueprint Medicines' advancement of multiple early-stage efforts;
Blueprint Medicines' ability to successfully demonstrate the
efficacy and safety of its drug product candidates; the preclinical
and clinical results for Blueprint Medicines' drug product
candidates, which may not support further development of such drug
product candidates; and actions of regulatory agencies, which may
affect the initiation, timing and progress of clinical trials;
Blueprint Medicines' ability to develop and commercialize companion
diagnostics for its current and future drug candidates, including a
companion diagnostic for BLU-554 with Ventana Medical Systems,
Inc.; and the success of Blueprint Medicines' rare genetic disease
collaboration with Alexion Pharma Holding and its cancer
immunotherapy collaboration with F. Hoffmann-La Roche Ltd and
Hoffmann-La Roche Inc. These and other risks and uncertainties are
described in greater detail in the section entitled "Risk Factors"
in Blueprint Medicines' Quarterly Report on Form 10-Q for the
quarter ended March 31, 2016, as
filed with the Securities and Exchange Commission (SEC) on
May 10, 2016, as amended by the Form
10-Q/A filed with the SEC on July 22,
2016, and other filings that Blueprint Medicines 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. Blueprint
Medicines explicitly disclaims any obligation to update any
forward-looking statements.
Blueprint
Medicines Corporation
|
Selected Condensed
Consolidated Balance Sheet Data
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
December 31,
|
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
|
$
|
172,553
|
|
$
|
162,707
|
Unbilled accounts
receivable
|
|
|
3,351
|
|
|
3,414
|
Working capital
(1)
|
|
|
150,366
|
|
|
151,776
|
Total
assets
|
|
|
186,520
|
|
|
178,898
|
Deferred
revenue
|
|
|
53,052
|
|
|
13,640
|
Term loan
payable
|
|
|
5,705
|
|
|
7,338
|
Lease incentive
obligation
|
|
|
3,659
|
|
|
3,948
|
Total stockholders'
equity
|
|
|
112,562
|
|
|
143,979
|
|
|
|
|
|
|
|
(1)
Blueprint Medicines defines working capital as current assets less
current liabilities.
|
Blueprint
Medicines Corporation
|
Condensed
Consolidated Statements of Operations Data
|
(in thousands,
except per share data)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
|
June 30,
|
|
June 30,
|
|
|
|
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Collaboration
revenue
|
|
$
|
7,065
|
|
$
|
2,687
|
|
$
|
13,921
|
|
$
|
3,339
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
21,273
|
|
|
11,243
|
|
|
38,908
|
|
|
20,476
|
General and
administrative
|
|
|
4,688
|
|
|
3,840
|
|
|
9,334
|
|
|
6,610
|
Total operating
expenses
|
|
|
25,961
|
|
|
15,083
|
|
|
48,242
|
|
|
27,086
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense), net
|
|
|
131
|
|
|
(405)
|
|
|
192
|
|
|
(441)
|
Interest
expense
|
|
|
(129)
|
|
|
(179)
|
|
|
(269)
|
|
|
(364)
|
Total other income
(expense)
|
|
|
2
|
|
|
(584)
|
|
|
(77)
|
|
|
(805)
|
Net loss
|
|
$
|
(18,894)
|
|
$
|
(12,980)
|
|
$
|
(34,398)
|
|
$
|
(24,552)
|
Convertible preferred
stock dividends
|
|
|
—
|
|
|
(883)
|
|
|
—
|
|
|
(3,153)
|
Net loss applicable
to common stockholders
|
|
$
|
(18,894)
|
|
$
|
(13,863)
|
|
$
|
(34,398)
|
|
$
|
(27,705)
|
Net loss per share
applicable to common stockholders — basic
and diluted
|
|
$
|
(0.70)
|
|
$
|
(0.81)
|
|
$
|
(1.27)
|
|
$
|
(2.94)
|
Weighted-average
number of common shares used in net loss per
share applicable to
common stockholders — basic and diluted
|
|
|
27,170
|
|
|
17,093
|
|
|
27,129
|
|
|
9,430
|
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SOURCE Blueprint Medicines Corporation