Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology
company focused on discovering and developing novel biologic
therapeutics to treat rare immune-mediated diseases, today reported
its financial results for the third quarter ended September 30,
2019.
“Our focus in 2019 is on the execution of our clinical programs
as they advance toward proof of concept,” said Craig A. Wheeler,
President and Chief Executive Officer of Momenta Pharmaceuticals.
“Looking ahead to 2020, we anticipate key readouts across our novel
auto- and alloimmune programs, including proof-of-concept data from
M254 in ITP and nipocalimab in MG. Importantly, both of these
agents have the potential to reshape the treatment landscape for a
range of large market, IgG-mediated diseases.”
Third Quarter 2019 Highlights, Recent Events and
Anticipated Upcoming Milestones
Novel Therapeutics Pipeline:
Nipocalimab (M281): a fully human anti-neonatal Fc receptor
(FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody
(mAb)
- Vivacity-MG, the Company’s Phase 2 clinical study of
nipocalimab in generalized myasthenia gravis (gMG), continues to
enroll patients. The Company expects to report top-line data from
this study in the second or third quarter of 2020.
- Unity, the Company’s global multi-center Phase 2 clinical study
of nipocalimab in hemolytic disease of the fetus and newborn
(HDFN), is active and enrolling patients. Nipocalimab has been
granted Fast Track designation by the U.S. Food and Drug
Administration (FDA) for this indication and the Company expects to
report top-line from this study data in 2021.
- Energy, the Company’s adaptive Phase 2/3 clinical study of
nipocalimab in Warm Autoimmune Hemolytic Anemia (wAIHA) commenced
in the third quarter 2019. The Company is activating clinical sites
in both the United States and European Union and is actively
recruiting patients. Nipocalimab has been granted Fast Track
designation by the FDA in this indication and the Company expects
to report top-line data from this study around the end of
2021.
M254 (hsIgG): a hypersialylated immunoglobulin designed as a
high potency alternative for intravenous immunoglobulin (IVIg)
- The Company’s multi-part Phase 1/2 clinical trial in idiopathic
thrombocytopenic purpura (ITP) has completed Part A and is
progressing through Part B, which is evaluating M254 in a single
ascending dose (SAD) cohort of ITP patients. Parts C and D include
a randomized cross-over study comparing M254 to IVIg and a multiple
ascending dose (MAD) study of M254, respectively. Enrollment is
ongoing and the Company expects to report preliminary data from
this study in the first half of 2020.
M230 (CSL730): a recombinant Fc multimer being developed in
collaboration with CSL
- A Phase 1 clinical trial to evaluate the safety and
tolerability of M230 in healthy volunteers is ongoing and Momenta’s
partner, CSL, looks forward to introducing a subcutaneous
formulation into the phase 1 program. We expect to have data
regarding this formulation in the next calendar year.
Legacy Products:
Glatopa® 20 mg and 40 mg: FDA approved generic versions of
COPAXONE 20 mg and 40 mg, developed and commercialized in
collaboration with Sandoz
- In the third quarter of 2019, Momenta recorded $5.6 million in
product revenue from Sandoz’s sales of Glatopa products.
M710: a proposed biosimilar to EYLEA® (aflibercept) candidate
being developed in collaboration with Mylan
- Mylan continues its pivotal clinical trial in patients with
diabetic macular edema to compare safety, efficacy and
immunogenicity of M710 with EYLEA.
Corporate:
- In September 2019, the Company announced the appointment of
Donna Grogan, M.D. to its Board of Directors.
Third Quarter 2019 Financial Results
Revenue:
In the third quarter of 2019, the Company recorded $5.6 million
in product revenue from Sandoz’s sales of Glatopa. In the third
quarter of 2018, the Company recorded $13.6 million in product
revenue, net a deduction of $0.2 million for legal fees and
includes 1.7 million received by Momenta for the Pfizer settlement.
The decrease in product revenue from the prior year period was
primarily due to continued competition.
Research and development revenue for the third quarter of 2019
was $0.8 million, compared to $1.3 million in the same quarter in
2018. The decrease in research and development revenue of $0.4
million, or 34%, was primarily due to lower reimbursement revenue
for Glatopa expenses.
Total revenue for the third quarter of 2019 was $6.4 million
compared to $14.9 million for the same period in 2018.
Operating Expenses:
Research and development expenses for the third quarter of 2019
were $46.1 million, compared to $30.7 million for the same period
in 2018. The increase of $15.3 million, or 50%, was primarily due
to an increase in manufacturing and clinical trial costs for
nipocalimab and M254, offset in part by lower personnel costs
following the Company's workforce reduction in the fourth quarter
of 2018 and lower lease costs.
General and administrative expenses for the third quarter of
2019 were $20.1 million, compared with $20.4 million for the same
period in 2018. The decrease of $0.4 million, or 2%, was primarily
due to lower depreciation costs.
In July 2019, Momenta entered into an amendment to its office
and laboratory space lease at 320 Bent Street in Cambridge,
Massachusetts, reducing the Company’s footprint at the location.
During the quarter, the Company recognized a noncash gain of $13.7
million, reflecting the reduction in the lease liability and the
related right-of-use asset.
Total GAAP operating expenses were $52.5 million in the third
quarter of 2019. Third quarter 2019 non-GAAP operating expense was
$45.7 million. Non-GAAP operating expense is total operating
expenses, less stock-based compensation expense, restructuring
expense and collaborative reimbursement revenue. See “Non-GAAP
Financial Information and Other Disclosures” and the table below
entitled “Reconciliation of GAAP Results to Non-GAAP Financial
Measures” for a reconciliation of GAAP operating expense to
non-GAAP operating expense.
Net Income (Loss): The Company reported a net loss of $44.5
million, or $0.45 per share for the second quarter of 2019 compared
to a net loss of $50.3 million, or $0.65 per share for the same
period in 2018.
Liquidity: At September 30, 2019, Momenta had $325.9
million in cash, cash equivalents, marketable securities, and
reflects the addition of $36.1 million related to the release of a
bond following a settlement agreement with Amphastar
Pharmaceuticals. This compares to $449.4 million at December 31,
2018 in cash, cash equivalents, and marketable securities.
2019 Financial Guidance
Momenta provides non-GAAP operating expense guidance, which it
believes can enhance an overall understanding of its financial
performance when considered together with GAAP financial measures.
Refer to the section of this press release below entitled “Non-GAAP
Financial Information and Other Disclosures” for further discussion
of this subject.
Non-GAAP operating expense is total operating, less stock-based
compensation expense, restructuring expense and collaborative
reimbursement revenue. Momenta is providing quarterly non-GAAP
operating expense guidance of $50 - $60 million for the fourth
quarter 2019.
Non-GAAP Financial Information and Other Disclosures
Momenta uses a non-GAAP financial measure, non-GAAP operating
expense, to provide operating expense guidance. Momenta believes
this non-GAAP financial measure is useful to investors because it
provides greater transparency regarding Momenta’s operating
performance as it excludes non-cash stock compensation expense,
restructuring expense and collaborative reimbursement revenue. This
non-GAAP financial measure should not be considered a substitute or
an alternative to GAAP total operating expense and should not be
considered a measure of Momenta’s liquidity. Instead, non-GAAP
operating expense should only be used to supplement an
understanding of Momenta’s operating results as reported under
GAAP. Momenta has not provided GAAP reconciliation for its
forward-looking non-GAAP annual or quarterly operating expense
because Momenta cannot reliably predict without unreasonable
efforts the timing or amount of the factors that substantially
contribute to the projection of stock compensation expense, which
is excluded from the forward-looking non-GAAP financial measure.
The Company has provided the estimated reconciling information that
is available without unreasonable effort in the section of this
press release above entitled “2019 Financial Guidance.”
Conference Call Information
Management will host a conference call and webcast today at 8:30
am ET to discuss these results and provide an update on the
Company. A live webcast of the conference call may be accessed on
the “Investors” section of the Company’s website,
www.momentapharma.com. Please go to the site at least 15 minutes
prior to the call in order to register, download, and install any
necessary software. An archived version of the webcast will be
posted on the Momenta website approximately two hours after the
call.
To access the call you may also dial (877) 224-9084 (domestic)
or (720) 545-0022 (international) prior to the scheduled conference
call time and provide the access code 3067995.
About Momenta
Momenta Pharmaceuticals is a biotechnology company with a
validated innovative scientific platform focused on discovering and
developing novel therapeutics to treat rare, immune-mediated
diseases and advancing its late stage biosimilar portfolio. The
company is headquartered in Cambridge, MA.
To receive additional information about Momenta, please visit
the website at www.momentapharma.com, which does not form a
part of this press release.
The Company’s logo, trademarks, and service marks are the
property of Momenta Pharmaceuticals, Inc. All other trade
names, trademarks, or service marks are property of their
respective owners.
Forward Looking Statements
Statements in this press release regarding management’s future
expectations, beliefs, intentions, goals, strategies, plans or
prospects, are forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995, including
but not limited to statements about the timing of our regulatory
filings for clinical development and marketing approval; the timing
of regulatory approval and launch of our product candidates;
development timelines; the Company’s ability to meet its
development and strategic goals; market potential and revenue of
our products and product candidates, design, timing and goals of
clinical trials and the availability, timing and announcement of
data and results; the use, efficacy, safety, potency, tolerability,
convenience and commercial potential of our product candidates,
including their potential as best-in-class agents; expectations
regarding accounting treatment for and recognition of consideration
and revenue under the Company’s collaborations; reconciling
information; non-GAAP operating expense guidance; and anticipated
collaborative reimbursement revenue. Forward-looking
statements may be identified by words and phrases such as
“advance,” “anticipate,” ‘being developed,” “believe,” “continue,”
“expect,” “guidance,” “look forward to,” “may,” “plan,” “possible,”
“potential,” “progress,” “propose,” “remains,” “target,” “will,”
“working toward” and other similar words or expressions, or the
negative of these words or similar words or expressions. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors, including those referred to under
the section “Risk Factors” in the Company’s Quarterly Report on
Form 10-Q for the quarter ended June 30, 2019, filed with
the Securities and Exchange Commission, as well as other
documents that may be filed by the Company from time to time with
the Securities and Exchange Commission. As a result of
such risks, uncertainties and factors, the Company’s actual results
may differ materially from any future results, performance or
achievements discussed in or implied by the forward-looking
statements contained herein. The Company is providing the
information in this press release as of this date and assumes no
obligations to update the information included in this press
release or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
INVESTOR CONTACT: |
MEDIA CONTACT: |
Patty Eisenhaur |
Karen Sharma |
Momenta Pharmaceuticals |
MacDougall Biomedical
Communications |
1-617-395-5189 |
1-781-235-3060 |
IR@momentapharma.com |
Momenta@macbiocom.com |
MOMENTA PHARMACEUTICALS, INC.
Unaudited Condensed Consolidated Balance
Sheets
(in thousands)
|
September 30,2019 |
|
December 31, 2018 |
Assets |
|
|
|
Cash, cash equivalents and marketable securities |
$ |
325,862 |
|
|
$ |
449,411 |
|
Collaboration receivable |
5,670 |
|
|
11,371 |
|
Restricted cash |
1,849 |
|
|
37,898 |
|
Other assets |
64,387 |
|
|
32,883 |
|
Total assets |
$ |
397,768 |
|
|
$ |
531,563 |
|
|
|
|
|
Liabilities and Stockholders’
Equity |
|
|
|
Current liabilities |
$ |
40,581 |
|
|
$ |
51,511 |
|
Deferred revenue, net of current
portion |
1,183 |
|
|
1,774 |
|
Other long-term liabilities |
80,080 |
|
|
17,270 |
|
Stockholder’s equity |
275,924 |
|
|
461,008 |
|
Total liabilities and stockholders’ equity |
$ |
397,768 |
|
|
$ |
531,563 |
|
MOMENTA PHARMACEUTICALS, INC.
Unaudited Condensed Statements of Operations and
Comprehensive Loss
(in thousands, except per share amounts)
|
Three Months Ended September 30, |
|
Nine Months EndedSeptember 30, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Collaboration revenues: |
|
|
|
|
|
|
|
Product revenue |
$ |
5,551 |
|
|
$ |
13,621 |
|
|
$ |
11,236 |
|
|
$ |
28,921 |
|
Research and development revenue |
840 |
|
|
1,263 |
|
|
4,450 |
|
|
3,846 |
|
Total collaboration revenue |
6,391 |
|
|
14,884 |
|
|
15,686 |
|
|
32,767 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
46,105 |
|
|
30,727 |
|
|
106,208 |
|
|
95,309 |
|
General and administrative |
20,081 |
|
|
20,437 |
|
|
90,896 |
|
|
63,580 |
|
Other operating expense |
— |
|
|
— |
|
|
42,936 |
|
|
30,000 |
|
Restructuring |
19 |
|
|
15,535 |
|
|
177 |
|
|
15,535 |
|
Gain on lease modification |
(13,720 |
) |
|
— |
|
|
(13,720 |
) |
|
— |
|
Total operating expenses |
52,485 |
|
|
66,699 |
|
|
226,497 |
|
|
204,424 |
|
|
|
|
|
|
|
|
|
Loss from operations |
(46,094 |
) |
|
(51,815 |
) |
|
(210,811 |
) |
|
(171,657 |
) |
|
|
|
|
|
|
|
|
Other income, net |
1,551 |
|
|
1,515 |
|
|
7,456 |
|
|
3,841 |
|
Net loss |
$ |
(44,543 |
) |
|
$ |
(50,300 |
) |
|
$ |
(203,355 |
) |
|
$ |
(167,816 |
) |
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.45 |
) |
|
$ |
(0.65 |
) |
|
$ |
(2.06 |
) |
|
$ |
(2.20 |
) |
|
|
|
|
|
|
|
|
Shares used in calculating net
loss per share |
|
|
|
|
|
|
|
Basic and diluted |
98,709 |
|
|
77,229 |
|
|
98,501 |
|
|
76,415 |
|
|
|
|
|
|
|
|
|
Comprehensive loss |
$ |
(44,601 |
) |
|
$ |
(50,163 |
) |
|
$ |
(202,807 |
) |
|
$ |
(167,840 |
) |
MOMENTA PHARMACEUTICALS, INC.
Reconciliation of GAAP Results to Non-GAAP
Financial Measures
(In thousands)
(unaudited)
A reconciliation of historical GAAP operating expenses to
Non-GAAP operating expenses is as follows:
|
Three Months Ended September 30, |
|
Nine Months EndedSeptember 30, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
GAAP operating expenses |
$ |
52,485 |
|
|
$ |
66,699 |
|
|
$ |
226,497 |
|
|
$ |
204,424 |
|
Adjustments: |
|
|
|
|
|
|
|
Restructuring |
(19 |
) |
|
— |
|
|
(177 |
) |
|
— |
|
Non-cash stock compensation expense |
(6,689 |
) |
|
(10,126 |
) |
|
(13,825 |
) |
|
(20,172 |
) |
Collaboration expenses that are recorded as revenue and are
reimbursable by collaborators |
(119 |
) |
|
(632 |
) |
|
(882 |
) |
|
(1,943 |
) |
Non-GAAP operating expenses |
$ |
45,658 |
|
|
$ |
55,941 |
|
|
$ |
211,613 |
|
|
$ |
182,309 |
|
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