CAMBRIDGE, Mass., Aug. 4, 2016 /PRNewswire/ -- Merrimack
Pharmaceuticals, Inc. (Nasdaq: MACK) today announced its second
quarter 2016 financial results. Merrimack will host a live
conference call and webcast today, Thursday,
August 4 at 4:30 p.m., Eastern
time, to provide an update on Merrimack's progress as well
as a summary of these 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 38883620. 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.
ONIVYDE® (irinotecan liposome injection)
Update
ONIVYDE updates include:
- Receipt of positive opinion from the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency for
ONIVYDE in combination with fluorouracil (5-FU) and leucovorin for
the treatment of patients with metastatic adenocarcinoma of the
pancreas who have progressed following treatment with
gemcitabine-based therapy. The CHMP's positive opinion for ONIVYDE
will now be reviewed by the European Commission for marketing
authorization;
- Presentation of new analyses of the Phase 3 NAPOLI-1 data
showing patients treated with the ONIVYDE regimen maintained
similar baseline quality of life at 12 weeks despite the addition
of a second chemotherapeutic agent when compared to 5-FU and
leucovorin alone at the European Society for Medical Oncology
(ESMO) 18th World Congress on Gastrointestinal Cancer; and
- Recognition of $14.8 million of
gross product revenues and $12.9
million of net product revenues from U.S. commercial sales
of ONIVYDE for the second quarter of 2016. This is compared to
$10.0 million of net product revenues
for the first quarter of 2016, which represents an increase of
$2.9 million, or 29%, in net product
revenues over the prior quarter.
Key Recent Events
Merrimack's key recent events include:
- Receipt of Fast Track designation from the U.S. Food and Drug
Administration (FDA) for seribantumab (also known as MM-121) for
development in patients with heregulin-positive, locally advanced
or metastatic non-small cell lung cancer whose disease has
progressed following immunotherapy;
- Presentation of an expanded overall survival analysis from the
seribantumab Phase 2 breast cancer study indicating that
seribantumab decreased risk of death by more than 50% in
HER2-negative, hormone receptor positive breast cancer patients at
the American Association for Cancer Research (AACR) Precision
Medicine Series;
- Initiation of a Phase 1 clinical study of MM-151 in combination
with ONIVYDE plus 5-FU and leucovorin in patients with RAS
wild-type metastatic colorectal cancer;
- Initiation of a leading-edge biomarker-selected, multi-arm
Phase 1 clinical study in metastatic colorectal, non-small cell
lung, and head and neck cancers to evaluate the safety and
tolerability of MM-151 in combination with seribantumab in patients
with heregulin positive tumors, MM-151 in combination with MM-141
in patients with IGF-1-positive tumors, and MM-151 in combination
with a MEK inhibitor (trametinib) in patients with KRAS/NRAS-mutant
tumors;
- Presentation of clinical data on multiple therapeutic
candidates from Merrimack's antibody engineering and
antibody-directed nanotherapeutic (ADN) technology platforms at the
2016 American Society of Clinical Oncology (ASCO) Annual Meeting,
including the final analysis from the Phase 1 clinical study of
MM-151 showing clinical activity in multiple solid tumor types,
including colorectal cancer; and
- Presentation of Merrimack's research and development strategy
at its 2016 Investor Day, including updates on ONIVYDE and MM-151
development, Merrimack's ADN platform and Merrimack's systems
immuno-oncology program.
Upcoming Milestones
Merrimack anticipates the following upcoming clinical
milestones:
- Results in 2017 from the Phase 2 clinical study of ONIVYDE in
previously untreated front-line metastatic pancreatic cancer;
- Results in 2017 from HERMIONE, the Phase 2 clinical study of
MM-302 in patients with HER2-positive metastatic breast cancer that
is designed to support a potential Accelerated Approval application
to the FDA;
- Results in 2018 from the Phase 2 clinical study of MM-121 in
patients with heregulin-positive, locally advanced or metastatic
non-small cell lung cancer that is designed to support a potential
Biologics License Application to the FDA; and
- Results in 2018 from the Phase 2 clinical study of MM-141 in
patients with front-line metastatic pancreatic cancer who have high
serum levels of free IGF-1.
Second Quarter 2016 Financial Results
The following summarizes Merrimack's financial results from the
quarter ended June 30, 2016:
- Product revenues from the commercial sale of ONIVYDE, net of
discounts, allowances and reserves, were $12.9 million for the second quarter of 2016,
compared to $10.0 million for the
first quarter of 2016. This represents an increase of $2.9 million, or 29%, over the prior
quarter;
- License and collaboration revenues were $19.3 million for the second quarter of 2016,
compared to $11.3 million for the
first quarter of 2016. This represents an increase of $8.0 million from the prior quarter. This revenue
includes $10.0 million related to a
substantive milestone achieved during the second quarter of 2016 as
well as revenue that was recognized under the proportional
performance revenue recognition model;
- Operating expenses were $61.7
million for the second quarter of 2016 and are made up of
the following:
- $41.0 million of research and
development expenses, including a one-time $10.0 million milestone payment made to
PharmaEngine, as compared to $32.9
million of research and development expenses incurred during
the first quarter of 2016; and
- $20.7 million of selling, general
and administrative expenses as compared to $17.8 million of selling, general and
administrative expenses incurred during the first quarter of
2016;
- Interest expense was $21.1
million for the second quarter of 2016, compared to
$8.6 million for the first quarter of
2016. This $12.5 million increase was
primarily due to a $14.6 million
one-time, non-cash loss related to the induced conversion of an
aggregate principal amount of $64.2
million of Merrimack's convertible notes in April 2016; and
- Net loss attributable to Merrimack for the second quarter of
2016 was $50.8 million, or
$0.40 per share, compared to a net
loss attributable to Merrimack of $38.5
million, or $0.33 per share,
for the first quarter of 2016.
Financial Outlook
In an effort to provide reconciliations to GAAP financial
measures, Merrimack clarifies:
- Previous guidance on the achievement of $46.5 million of net milestones in 2016 related
to ONIVYDE is comprised of the anticipated achievement of
$85.0 million of milestone
obligations from Shire and $38.5
million of offsetting milestone obligations to PharmaEngine.
Of the anticipated $85.0 million of
milestone obligations from Shire, $75.0
million are expected to be classified as substantive
milestones that would increase license and collaboration revenues
and the remaining $10.0 million are
expected to be classified as non-substantive milestones that would
be recognized through Merrimack's proportional performance revenue
recognition model; and
- Previous guidance for aggregate research and development and
selling, general and administrative expenses for 2016, when
calculated in accordance with GAAP, was in the range of
$263.5 million to $283.5 million,
which included the anticipated achievement of $38.5 million of milestone obligations to
PharmaEngine. This corresponds to Merrimack's previously disclosed
guidance that aggregate research and development and selling,
general and administrative expenses, excluding anticipated
milestone obligations to PharmaEngine, a non-GAAP financial
measure, would be in the range of $225.0
million to $245.0 million for 2016.
With respect to its fiscal 2016 guidance, Merrimack:
- Lowers its previously provided expense guidance range by
$20.0 million, such that Merrimack
now anticipates aggregate research and development and selling,
general and administrative expenses for 2016, when calculated in
accordance with GAAP, to be in the range of $243.5 million to $263.5 million. Excluding
anticipated milestone obligations to PharmaEngine of $38.5 million, this corresponds to a range of
$205.0 million to $225.0 million for
2016, which is a non-GAAP financial measure.
A table reconciling guidance for aggregate research and
development and selling, general and administrative expenses,
excluding anticipated milestone obligations to PharmaEngine, a
non-GAAP financial measure, to aggregate research and development
and selling, general and administrative expenses calculated in
accordance with GAAP is included at the end of this press
release.
Upcoming Investor Conferences
Merrimack will attend the following investor conference in the
coming months:
- Morgan Stanley Global Healthcare Conference, September 12th, 2016 in New York City.
A live webcast of the presentation at the Morgan Stanley Global
Healthcare Conference 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 fully integrated biopharmaceutical company that
views cancer as a complex engineering challenge. Through systems
biology, which brings together the fields of biology, computing and
engineering, Merrimack aims to decrease uncertainty in drug
development and clinical validation, and move discovery efforts
beyond trial and error. Such an approach has the potential to make
individualized treatment of patients a reality. Merrimack's first
commercial product, ONIVYDE® (irinotecan liposome
injection), was approved by the U.S. FDA in October 2015. With four additional candidates in
clinical studies, several in preclinical development and multiple
biomarkers designed to support patient selection, Merrimack is
building one of the most robust oncology pipelines in the industry.
For more information, please visit Merrimack's website at
www.merrimack.com or connect on Twitter at @MerrimackPharma.
Cautionary Note on 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, potential registration opportunities,
expectations regarding potential cash inflows, revenue and expenses
and Merrimack's presentations at upcoming investor conferences.
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 products, 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 2, 2016 and other reports Merrimack files
with the SEC.
Merrimack
Pharmaceuticals, Inc.
|
|
|
|
|
Condensed
Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
June
30,
|
|
March
31,
|
(in thousands,
except per share amounts)
|
|
2016
|
|
2016
|
Revenues:
|
|
|
|
|
Product revenues,
net
|
$
|
12,851
|
$
|
9,968
|
License and
collaboration revenues
|
|
19,332
|
|
11,313
|
Other
revenues
|
|
1,498
|
|
—
|
Total
revenues
|
|
33,681
|
|
21,281
|
Costs and
expenses:
|
|
|
|
|
Cost of
revenues
|
|
1,872
|
|
711
|
Research and
development expenses
|
|
40,996
|
|
32,882
|
Selling, general and
administrative expenses
|
|
20,680
|
|
17,795
|
Total costs and
expenses
|
|
63,548
|
|
51,388
|
Loss from
operations
|
|
(29,867)
|
|
(30,107)
|
Other income and
expenses, net
|
|
(21,091)
|
|
(8,551)
|
Net loss
|
|
(50,958)
|
|
(38,658)
|
Net loss attributable
to non-controlling interest
|
|
(208)
|
|
(185)
|
Net loss attributable
to Merrimack
|
$
|
(50,750)
|
$
|
(38,473)
|
Other comprehensive
income (loss)
|
|
15
|
|
(14)
|
Comprehensive
loss
|
$
|
(50,735)
|
$
|
(38,487)
|
|
|
|
|
|
Net loss per share
available to common stockholders - basic and diluted
|
$
|
(0.40)
|
$
|
(0.33)
|
Weighted-average
common shares used in computing net loss per share available to
common stockholders - basic and diluted
|
|
126,161
|
|
116,064
|
Merrimack
Pharmaceuticals, Inc.
|
|
|
|
|
Selected Balance
Sheet Data (unaudited)
|
|
|
|
|
|
|
As
of
|
|
As
of
|
|
|
June
30,
|
|
March
31,
|
(in
thousands)
|
|
2016
|
|
2016
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
$
|
82,667
|
$
|
132,390
|
Working
capital
|
|
28,145
|
|
63,318
|
Total
assets
|
|
150,019
|
|
192,932
|
Total
liabilities
|
|
351,577
|
|
410,075
|
Total stockholders'
deficit
|
|
(201,404)
|
|
(217,197)
|
|
|
|
|
|
|
|
|
|
|
Merrimack
Pharmaceuticals, Inc.
|
|
|
|
|
Selected Cash Flow
Data (unaudited)
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
|
|
|
(in
thousands)
|
|
June 30,
2016
|
|
March 31,
2016
|
|
|
|
|
|
Net cash used in
operating activities
|
$
|
(50,903)
|
$
|
(53,523)
|
Net cash provided by
(used in) investing activities
|
|
22,179
|
|
(85,491)
|
Net cash provided by
financing activities
|
|
1,978
|
|
1,645
|
Net decrease in cash
and cash equivalents
|
$
|
(26,746)
|
$
|
(137,369)
|
This press release presents guidance regarding aggregate
research and development and selling, general and administrative
expenses, excluding anticipated milestone obligations to
PharmaEngine, which is a financial measure not calculated in
accordance with GAAP. Merrimack is providing non-GAAP information
that excludes one-time anticipated milestone obligations to
PharmaEngine because of the nature of these items and the impact
they have on the analysis of underlying business performance and
trends, including the fact that these anticipated milestone
obligations to PharmaEngine are entirely offset by anticipated
milestone obligations from Shire. Management believes that
providing information regarding adjusted aggregate research and
development and selling, general and administrative expenses
enhances investors' understanding of Merrimack's performance and of
trends that facilitate comparisons between periods. This
information should be considered in addition to, but not in lieu
of, information prepared in accordance with GAAP. Management also
uses aggregate research and development and selling, general and
administrative expenses, excluding anticipated milestone
obligations to PharmaEngine, to establish budgets and operational
goals and to manage Merrimack's business.
The following is a reconciliation of GAAP guidance to non-GAAP
guidance:
Merrimack
Pharmaceuticals, Inc.
|
|
|
|
|
Reconciliation to
Aggregate Research and Development and Selling, General and
Administrative Expenses, Excluding Anticipated Milestone
Obligations to PharmaEngine (unaudited)
|
|
Year Ended
December 31, 2016
|
|
|
Low
End
|
|
High
End
|
(in
thousands)
|
|
of
Range
|
|
of
Range
|
|
|
|
|
|
Original range of
anticipated aggregate research and development and selling, general
and administrative expenses (GAAP measure)
|
$
|
263,500
|
$
|
283,500
|
Less: expenses
related to one-time anticipated milestone obligations to
PharmaEngine
|
|
(38,500)
|
|
(38,500)
|
Original range of
anticipated aggregate research and development and selling, general
and administrative expenses, excluding anticipated milestone
obligations to PharmaEngine (non-GAAP measure)
|
$
|
225,000
|
$
|
245,000
|
|
|
|
|
|
Lowered range of
anticipated aggregate research and development and selling, general
and administrative expenses (GAAP measure)
|
$
|
243,500
|
$
|
263,500
|
Less: expenses
related to one-time anticipated milestone obligations to
PharmaEngine
|
|
(38,500)
|
|
(38,500)
|
Lowered range of
anticipated aggregate research and development and selling, general
and administrative expenses, excluding anticipated milestone
obligations to PharmaEngine (non-GAAP measure)
|
$
|
205,000
|
$
|
225,000
|
CONTACT:
Investor Contact:
Geoffrey M. Grande, CFA
617-441-7602
ggrande@merrimack.com
Media Contact:
Marianne McMorrow
774-776-1478
mmcmorrow@merrimack.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/merrimack-reports-second-quarter-2016-financial-results-300309438.html
SOURCE Merrimack Pharmaceuticals, Inc.