— M281 Phase 2 trials in MG and HDFN active and
enrolling patients —
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 first quarter ended March 31, 2019.
“We continue to focus on operational execution to progress our
ongoing trials of M281 and M254 towards key proof-of-concept data
readouts in 2020,” said Craig A. Wheeler, President and Chief
Executive Officer of Momenta Pharmaceuticals. “Additionally, we
were proud to share new data on our pipeline this quarter with the
publication of preclinical data highlighting both M281’s potential
to alter the treatment landscape in fetal-maternal disorders, and
the ability of our SIFbody platform and Fc multimerization
technology to produce enhanced antibodies across a range of
immunomodulating targets.”
First Quarter 2019 Highlights, Recent Events and
Anticipated Upcoming Milestones
Novel Therapeutics Pipeline:
M281 (anti-FcRn): a fully human anti-neonatal
Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal
antibody (mAb)
- Vivacity-MG, the Company’s Phase 2 study of M281 in generalized
Myasthenia Gravis (gMG), is expected to report top-line results in
2020. Unity, the Company’s global multi-center Phase 2 clinical
study of M281 in Hemolytic Disease of the Fetus and Newborn (HDFN),
is expected to report top-line results in 2021. This follows the
March 2019 announcement that regulatory approvals were obtained in
the U.S., Canada and several EU countries and that the Company
began activating clinical sites.
- In March 2019, the Company published data in the American
Journal of Obstetrics & Gynecology, expanding on its February
2019 presentation at the Society for Maternal-Fetal Medicine 39th
Annual Pregnancy Meeting, which highlighted the ability of M281 to
inhibit transfer of immunoglobulin G from maternal to fetal
circulation in an ex vivo placental perfusion model with minimal
transfer of M281 into fetal circulation.
- The Company plans to initiate a third study of M281 in an
additional autoimmune indication in 2019.
M254 (hsIgG): a hypersialylated immunoglobulin
designed as a high potency alternative for intravenous
immunoglobulin (IVIg)
- In January 2019, the Company announced that the first
subject was dosed in the Phase 1/2 clinical trial in idiopathic
thrombocytopenic purpura (ITP). The multi-part trial is first
enrolling healthy volunteers and includes single and multiple dose
studies, and a randomized cross-over study comparing M254 to IVIg.
Enrollment for this trial is ongoing and preliminary clinical data
is expected in 2020.
M230 (CSL730): a recombinant Fc multimer being
developed in collaboration with CSL
- The Phase 1 clinical trial in healthy volunteers to evaluate
the safety and tolerability of M230 continues. Momenta’s partner,
CSL expects to complete the Phase 1 study by the end of 2019.
SIFbody Platform and Fc Multimerization
Technology:
- The Company presented two posters at the American Association
for Cancer Research (AACR) Annual Meeting in April 2019,
demonstrating the potential of its SIFbody platform and Fc
multimerization technology to significantly enhance the potency and
efficacy of a variety of cell depleting therapeutic antibodies,
including antibodies targeting CD38 and CTLA-4.
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 first quarter of 2019, Momenta recorded $2.4 million in
product revenue from Sandoz’s sales of Glatopa products.
M923: a fully-owned proposed biosimilar to
HUMIRA® (adalimumab)
- In November 2018, the Company announced license agreements
with AbbVie, providing worldwide rights for the launch of M923.
Under the terms of the agreements, and subject to approval by
health regulatory authorities, Momenta may launch M923 worldwide
based on agreed-to launch dates, including in the U.S. in
November 2023. Momenta is currently seeking a
commercialization partner for this product.
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.
- In January 2019, Momenta’s formal notice of termination for all
other biosimilar candidates previously subject to the collaboration
agreement with Mylan became effective.
First Quarter 2019 Financial Results
Revenue: In the first quarter of 2019, the
Company recorded $2.4 million in product revenue from Sandoz’s
sales of Glatopa, net of a deduction of $1.5 million for legal
settlement and royalty payments to Teva Pharmaceutical Industries.
In the first quarter of 2018, the Company recorded $3.5 million in
product revenue, net a deduction of $9.8 million for 50% of Glatopa
40 mg/mL inventory reserved by Sandoz. The decrease in product
revenue from the prior year period was primarily due to continued
competition.
Research and development revenue for the first quarter of 2019
was $1.8 million, compared to $1.3 million in the same quarter in
2018. The increase in research and development revenue of $0.5
million, or 38%, was primarily due to higher revenue recognized on
the collaborative upfront payment from Mylan of $0.6 million,
offset in part by lower reimbursement revenue for Glatopa expenses
of $0.2 million.
Total revenue for the first quarter of 2019 was $4.1 million
compared to $4.9 million for the same period in 2018.
Operating Expenses: Total GAAP operating
expenses were $52.2 million in the first quarter of 2019.
Research and development expenses for the first quarter of 2019
were $28.0 million, compared to $33.2 million for the same period
in 2018. The decrease of $5.2 million, or 16%, was primarily due to
cost savings following our workforce reduction in the fourth
quarter of 2018 and lower lease costs, offset by increased costs
related to our M281 clinical trials.
General and administrative expenses for the first quarter of
2019 were $24.2 million, compared to $20.6 million for the same
period in 2018. The increase of $3.6 million, or 17%, was primarily
driven by depreciation and legal costs, offset by savings in costs
following our workforce reduction in the fourth quarter of
2018.
First quarter 2019 non-GAAP operating expense was $48.3 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 $44.8 million, or $0.46 per share for the first quarter of
2019 compared to a net loss of $47.6 million, or $0.63 per share,
for the same period in 2018.
Cash Position: At March 31, 2019, Momenta had
$416.5 million in cash, cash equivalents and marketable securities
compared to $449.4 million at December 31, 2018.
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 re-affirms its quarterly non-GAAP
operating expense guidance of $45 - $55 million for 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 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 8949569. A replay of the call
will be available approximately two hours after the conclusion of
the call and will be accessible through 8949569. To access
the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406
(international) and provide the access code 7484068.
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; future legal
proceedings; 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
Annual Report on Form 10-K for the year ended December 31,
2018, 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)
|
March 31, 2019 |
|
December 31, 2018 |
Assets |
|
|
|
Cash, cash equivalents
and marketable securities |
$ |
416,453 |
|
|
$ |
449,411 |
|
Collaboration
receivable |
2,986 |
|
|
11,371 |
|
Restricted cash |
37,898 |
|
|
37,898 |
|
Other assets |
101,113 |
|
|
32,883 |
|
Total
assets |
$ |
558,450 |
|
|
$ |
531,563 |
|
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current liabilities |
$ |
51,580 |
|
|
$ |
51,511 |
|
Deferred revenue, net of
current portion |
743 |
|
|
1,774 |
|
Other long-term
liabilities |
83,569 |
|
|
17,270 |
|
Stockholder’s equity |
422,558 |
|
|
461,008 |
|
Total
liabilities and stockholders’ equity |
$ |
558,450 |
|
|
$ |
531,563 |
|
MOMENTA
PHARMACEUTICALS, INC.
Unaudited Condensed Statements of
Operations and Comprehensive Loss
(in thousands, except per share amounts)
|
Three Months Ended March 31, |
|
2019 |
|
2018 |
Collaboration
revenues: |
|
|
|
Product revenue |
$ |
2,352 |
|
|
$ |
3,521 |
|
Research and
development revenue |
1,761 |
|
|
1,331 |
|
Total
collaboration revenue |
4,113 |
|
|
4,852 |
|
|
|
|
|
Operating expenses: |
|
|
|
Research and
development |
27,972 |
|
|
33,242 |
|
General and
administrative |
24,206 |
|
|
20,612 |
|
Restructuring |
26 |
|
|
— |
|
Total
operating expenses |
52,204 |
|
|
53,854 |
|
|
|
|
|
Loss from operations |
(48,091 |
) |
|
(49,002 |
) |
|
|
|
|
Other income, net |
3,248 |
|
|
1,371 |
|
|
|
|
|
Net loss |
$ |
(44,843 |
) |
|
$ |
(47,631 |
) |
|
|
|
|
Net loss per share: |
|
|
|
Basic and
diluted |
$ |
(0.46 |
) |
|
$ |
(0.63 |
) |
|
|
|
|
Shares used in calculating
net loss per share |
|
|
|
Basic and
diluted |
98,195 |
|
|
75,454 |
|
|
|
|
|
Comprehensive loss |
$ |
(44,501 |
) |
|
$ |
(48,066 |
) |
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 March 31, |
|
2019 |
|
2018 |
|
|
|
|
GAAP operating
expenses |
$ |
52,204 |
|
|
$ |
53,854 |
|
Adjustments: |
|
|
|
Restructuring |
(26 |
) |
|
— |
|
Non-cash
stock compensation expense |
(3,474 |
) |
|
(4,874 |
) |
Collaboration expenses that are recorded as revenue and are
reimbursable by collaborators |
(420 |
) |
|
(583 |
) |
Non-GAAP operating
expenses |
$ |
48,284 |
|
|
$ |
48,397 |
|
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