CAMBRIDGE, Mass., Aug. 9, 2017 /PRNewswire/ -- Merrimack
Pharmaceuticals, Inc. (NASDAQ: MACK) today announced its second
quarter 2017 financial results for the period ended June 30, 2017.
"This quarter's progress, with key hires to the executive team
and advancements in the clinic, has reinforced Merrimack's refined
corporate and clinical strategy. With a rich, biomarker-driven
R&D pipeline, including data expected in 2018 for each of our
lead assets – MM-121, MM-141 and MM-310 – and promising preclinical
programs, we are well positioned to execute on our goals," said
Richard Peters, M.D., Ph.D.,
President and Chief Executive Officer.
Second Quarter and Recent Highlights
Key events from the second quarter and more recently
include:
- Expansion of Merrimack's executive team with key
appointments:
-
- Dr. Sergio Santillana, a medical
oncologist and former Chief Medical Officer at Ariad
Pharmaceuticals with extensive industry experience leading a wide
range of clinical development programs, as Chief Medical
Officer;
- Ellen Forest, an experienced
human resources executive and former Director of Human Resources at
Baxalta, as Head of Human Resources; and
- Thomas Needham, a 25-year
industry veteran, experienced dealmaker and former Senior Vice
President of Business Development at C4 Therapeutics, as Chief
Business Officer.
- Completion of enrollment in the Phase 2 randomized,
double-blind, placebo-controlled CARRIE study of MM-141 in
combination with standard of care in previously untreated patients
with metastatic pancreatic cancer who have high serum levels of
free IGF-1. MM-141 is an inhibitor of the PI3K/AKT/mTOR signaling
pathway, targeting the IGF-1 and HER3 receptors. Merrimack expects
to report data in the first half of 2018.
Upcoming Milestones
Merrimack anticipates the following upcoming clinical
milestones:
- Initiation this year of the SHERBOC trial, a Phase 2
randomized, double-blind, placebo-controlled clinical study of
MM-121 added to standard of care in patients with heregulin
positive, hormone receptor positive, HER2 negative metastatic
breast cancer;
- Top-line results in the first half of 2018 from the Phase 2
randomized, double-blind, placebo-controlled CARRIE study of MM-141
in combination with standard of care in previously untreated
patients with metastatic pancreatic cancer who have high serum
levels of free IGF-1;
- Top-line results in the second half of 2018 from the Phase 2
randomized SHERLOC study of MM-121 added to standard of care in
patients with heregulin positive non-small cell lung cancer;
and
- Safety data and the recommended Phase 2 dose in the second half
of 2018 from the Phase 1 clinical study of MM-310 in patients with
solid tumors.
Second Quarter 2017 Financial Results
The following summarizes Merrimack's financial results for the
three months ended June 30, 2017:
- In April, Merrimack received a $575.0
million upfront cash payment from Ipsen in connection with
its asset sale, from which Merrimack fully paid off $175.0 million of outstanding Senior Secured
Notes due in 2022; paid a special cash dividend of $140.0 million to stockholders in May; and
invested approximately $125.0 million
into the further development of its streamlined oncology
pipeline;
- Research and development expenses from continuing operations
for the three months ended June 30,
2017 were $19.8 million,
compared to $27.7 million for the
three months ended June 30, 2016.
This represents a decrease of $7.9
million primarily due to Merrimack's transition to a
refocused clinical and preclinical pipeline and offset by a
one-time charge related to stock-based compensation;
- General and administrative expenses from continuing operations
for the three months ended June 30,
2017 were $14.8 million,
compared to $8.1 million for the
three months ended June 30, 2016.
This represents an increase of $6.7
million, primarily due to costs associated with the
transition following the asset sale, including legal expenses and
stock-based compensation; and
- Net loss attributable to Merrimack's continuing operations for
the three months ended June 30, 2017
was $28.9 million, or $0.22 per share, compared to a net loss
attributable to Merrimack's continuing operations of $51.4 million, or $0.41 per share, for the three months ended
June 30, 2016.
Financial Outlook
Merrimack continues to believe that its unrestricted cash and
cash equivalents of $135.5 million as
of June 30, 2017, together with the
potential net milestone payments anticipated from Shire, will be
sufficient to fund its planned operations into the
second half of 2019.
Conference Call and Webcast
Merrimack will host a live conference call and webcast today,
Wednesday, August 9, 2017 at
8:30 am ET, to provide an update on
its operational progress and a summary of these financial
results.
Investors and the general public are invited to listen to the
call by dialing (877) 564-1301 (domestic) or (224) 357-2394
(international) five minutes prior to the start of the call and
providing the passcode 56140335. A listen-only webcast of the call
can be accessed in the Investors section of Merrimack's website,
investors.merrimack.com, and a replay of the call will be archived
there for six weeks following the call.
Upcoming Investor Conferences
Merrimack will attend the following investor conference:
- Robert W. Baird 2017 Global Healthcare Conference, September 7, 2017 in New York.
A live webcast of the presentation can be accessed by visiting
the Investors section of Merrimack's website at
investors.merrimack.com. A replay of the webcast will be archived
there for two weeks following the presentation.
About Merrimack
Merrimack is a biopharmaceutical company based
in Cambridge, Massachusetts that is outthinking cancer to
ensure that patients and their families live fulfilling lives. Its
mission is to transform cancer care through the smart design and
development of targeted solutions based on a deep understanding of
cancer pathways and biological markers. All of Merrimack's product
candidates, including three in clinical studies and several others
in preclinical development, fit into its strategy of 1)
understanding the biological problems it is trying to solve, 2)
designing specific solutions and 3) developing those solutions for
biomarker-selected patients. This three-pronged strategy seeks to
ensure optimal patient outcomes. For more information, please visit
Merrimack's website at www.merrimack.com.
Forward Looking Statements
To the extent that statements contained in this press release
are not descriptions of historical facts, they are forward-looking
statements reflecting the current beliefs and expectations of
management made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements include any statements about Merrimack's
strategy, future operations, future financial position, future
revenues and future expectations and plans and prospects for
Merrimack, and any other statements containing the words
"anticipate," "believe," "estimate," "expect," "intend," "may,"
"plan," "predict," "project," "target," "potential," "will,"
"would," "could," "should," "continue" and similar expressions. In
this press release, Merrimack's forward-looking statements include,
among others, statements about the timing of availability of
clinical trial data, the initiation of new clinical trials, the
anticipated achievement of milestones and the availability of
funding sufficient to fund Merrimack's operations. Such
forward-looking statements involve substantial risks and
uncertainties that could cause Merrimack's clinical development
programs, future results, performance or achievements to differ
significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include,
among others, the uncertainties inherent in the initiation of
future clinical trials, availability of data from ongoing clinical
trials, expectations for regulatory approvals, development progress
of Merrimack's companion diagnostics, availability of funding
sufficient for Merrimack's foreseeable and unforeseeable operating
expenses and capital expenditure requirements, and other matters
that could affect the availability or commercial potential of
Merrimack's product candidates or companion diagnostics. Merrimack
undertakes no obligation to update or revise any forward-looking
statements. Forward-looking statements should not be relied upon as
representing Merrimack's views as of any date subsequent to the
date hereof. For a further description of the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to Merrimack's business in general, see the "Risk Factors"
section of Merrimack's Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission (SEC) on May 10, 2017 and the other reports Merrimack
files with the SEC.
Merrimack
Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations and Comprehensive
Loss (unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
June 30,
|
|
|
Six Months
Ended
June 30,
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|
(in thousands,
except per share amounts)
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
|
$
|
19,751
|
|
|
$
|
27,695
|
|
|
$
|
41,356
|
|
|
$
|
55,697
|
|
General and
administrative expenses
|
|
|
14,798
|
|
|
|
8,138
|
|
|
|
20,432
|
|
|
|
14,590
|
|
Total costs and
expenses
|
|
|
34,549
|
|
|
|
35,833
|
|
|
|
61,788
|
|
|
|
70,287
|
|
Loss from continuing
operations
|
|
|
(34,549)
|
|
|
|
(35,833)
|
|
|
|
(61,788)
|
|
|
|
(70,287)
|
|
Other income and
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
382
|
|
|
|
122
|
|
|
|
396
|
|
|
|
194
|
|
Interest
expense
|
|
|
(26,762)
|
|
|
|
(15,858)
|
|
|
|
(28,741)
|
|
|
|
(19,148)
|
|
Gain on sale of
asset
|
|
|
1,703
|
|
|
|
—
|
|
|
|
1,703
|
|
|
|
—
|
|
Other expense,
net
|
|
|
(659)
|
|
|
|
(64)
|
|
|
|
(661)
|
|
|
|
(107)
|
|
Net loss from
continuing operations before income tax benefit
|
|
|
(59,885)
|
|
|
|
(51,633)
|
|
|
|
(89,091)
|
|
|
|
(89,348)
|
|
Income tax
benefit
|
|
|
30,239
|
|
|
|
—
|
|
|
|
30,239
|
|
|
|
—
|
|
Net loss from
continuing operations
|
|
|
(29,646)
|
|
|
|
(51,633)
|
|
|
|
(58,852)
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|
|
|
(89,348)
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|
Discontinued
operations:
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|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Income (loss) from
discontinued operations, net of tax
|
|
|
540,485
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|
|
|
675
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|
|
|
539,538
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|
|
|
(268)
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss)
|
|
|
510,839
|
|
|
|
(50,958)
|
|
|
|
480,686
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|
|
|
(89,616)
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Net loss attributable
to non-controlling interest
|
|
|
(724)
|
|
|
|
(208)
|
|
|
|
(1,191)
|
|
|
|
(393)
|
|
Net income (loss)
attributable to Merrimack Pharmaceuticals, Inc.
|
|
$
|
511,563
|
|
|
$
|
(50,750)
|
|
|
$
|
481,877
|
|
|
$
|
(89,223)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on
available-for-sale securities
|
|
|
—
|
|
|
|
15
|
|
|
|
—
|
|
|
|
1
|
|
Other comprehensive
loss
|
|
|
—
|
|
|
|
15
|
|
|
|
—
|
|
|
|
1
|
|
Comprehensive income
(loss)
|
|
$
|
511,563
|
|
|
$
|
(50,735)
|
|
|
$
|
481,877
|
|
|
$
|
(89,222)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts attributable
to Merrimack Pharmaceuticals, Inc.:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss from
continuing operations
|
|
$
|
(28,922)
|
|
|
$
|
(51,425)
|
|
|
$
|
(57,661)
|
|
|
$
|
(88,955)
|
|
Income (loss) from
discontinued operations, net of tax
|
|
|
540,485
|
|
|
|
675
|
|
|
|
539,538
|
|
|
|
(268)
|
|
Net income (loss)
attributable to Merrimack Pharmaceuticals, Inc.
|
|
$
|
511,563
|
|
|
$
|
(50,750)
|
|
|
$
|
481,877
|
|
|
$
|
(89,223)
|
|
Basic and dilutive
net income (loss) per common share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss from
continuing operations
|
|
$
|
(0.22)
|
|
|
$
|
(0.41)
|
|
|
$
|
(0.44)
|
|
|
$
|
(0.74)
|
|
Net income (loss) from
discontinued operations, net of tax
|
|
|
4.08
|
|
|
|
0.01
|
|
|
|
4.10
|
|
|
|
(0.00)
|
|
Net income (loss) per
share
|
|
$
|
3.86
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|
|
$
|
(0.40)
|
|
|
$
|
3.66
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|
|
$
|
(0.74)
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|
Weighted-average
common shares used per share calculations—basic and
diluted
|
|
|
132,457
|
|
|
|
126,161
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|
|
|
131,528
|
|
|
|
121,112
|
|
Cash dividend paid
per common share
|
|
$
|
1.055
|
|
|
$
|
—
|
|
|
$
|
1.055
|
|
|
$
|
—
|
|
Merrimack
Pharmaceuticals, Inc. Selected Balance Sheet Data
(unaudited)
|
|
|
|
|
|
|
|
|
June
30,
|
|
|
December
31,
|
|
|
(in
thousands)
|
|
2017(1)
|
|
|
2016(1)
|
|
|
Cash and cash
equivalents
|
|
$
|
135,501
|
|
|
$
|
21,524
|
|
|
Working
capital
|
|
|
83,826
|
|
|
|
(30,787)
|
|
|
Total
assets
|
|
|
213,450
|
|
|
|
81,483
|
|
|
Total
liabilities
|
|
|
108,973
|
|
|
|
334,142
|
|
|
Total stockholders'
equity / (deficit)
|
|
|
106,508
|
|
|
|
(251,120)
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) The 2016 amounts in the
above include assets and liabilities held for sale.
|
|
|
Merrimack
Pharmaceuticals, Inc. Selected Cash Flow Data (unaudited)
|
|
|
|
|
|
|
|
|
Six Months Ended
June 30,
|
|
|
(in
thousands)
|
|
2017(1)
|
|
|
2016(1)
|
|
|
Net cash used in
operating activities
|
|
$
|
(95,510)
|
|
|
$
|
(104,426)
|
|
|
Net cash provided by
(used in) investing activities
|
|
|
515,809
|
|
|
|
(63,312)
|
|
|
Net
cash provided by (used in) financing
activities
|
|
|
(306,322)
|
|
|
|
3,623
|
|
|
Net increase
(decrease) in cash and cash equivalents
|
|
$
|
113,977
|
|
|
$
|
(164,115)
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) The amounts in the above
include cash flow from discontinued operations.
|
CONTACT:
Geoffrey M. Grande, CFA
617-441-7602
ggrande@merrimack.com
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content:http://www.prnewswire.com/news-releases/merrimack-reports-second-quarter-2017-financial-results-300501766.html
SOURCE Merrimack Pharmaceuticals, Inc.