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 second quarter ended June 30, 2019.
“At Momenta, we are focused on leveraging our team’s expertise
in the engineering of biologics and our deep understanding of
immune biology to develop treatments for rare immune-mediated
disorders,” said Craig A. Wheeler, President and Chief Executive
Officer of Momenta Pharmaceuticals. “We are committed to rapidly
advancing our expanding clinical pipeline with the recent launch of
our third clinical study of nipocalimab in Warm Autoimmune
Hemolytic Anemia, and continued progress in our ongoing trials.
Over the next 12-15 months, we anticipate key readouts from our
clinical candidates, including top-line data in 2020 from our Phase
2 studies of nipocalimab in generalized myasthenia gravis and M254
in Immune Thrombocytopenic Purpura.”
“In connection with the recent Amphastar settlement and our
contractual obligations to GSK, we incurred one-time operating
expenses in the second quarter. Importantly, as these charges are
also connected with long-term cost-savings, these charges do not
impact our forecasted cash runway and we continue to expect our
available funds will take us beyond our clinical read outs in
2020,” said Michelle Robertson, Chief Financial Officer at Momenta
Pharmaceuticals.
Second 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)
- The Company recently announced that it commenced an adaptive
Phase 2/3 clinical study of nipocalimab in Warm Autoimmune
Hemolytic Anemia (wAIHA). This followed acceptance of its
Investigational New Drug (IND) application and the granting of Fast
Track designation in this indication by the U.S. Food and Drug
Administration (FDA). Clinical sites are currently being activated
and patient recruitment is underway. The Company expects to report
top-line data from this study by the end of 2021.
- Vivacity-MG, the Company’s Phase 2 clinical study of
nipocalimab in generalized myasthenia gravis (gMG), continues to
open sites and enroll patients and the Company expects to report
top-line data 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), continues to open sites and enroll patients and the Company
expects to report top-line data in 2021. Nipocalimab has been
granted Fast Track designation by the FDA for this
indication.
- In the second quarter 2019, the Company completed an infusion
study of nipocalimab, supporting improved infusion rates versus the
current two-hour protocol, and confirmed the safety profile
observed in the Phase 1 study. Infusion rates as low as 7.5 minutes
for 30 mg/kg dose or 15 minutes for 60 mg/kg dose were well
tolerated.
M254 (hsIgG): a hypersialylated immunoglobulin designed as a
high potency alternative for intravenous immunoglobulin (IVIg)
- The Company’s Phase 1/2 clinical trial in idiopathic
thrombocytopenic purpura (ITP) is progressing. The multi-part study
has completed Part A, which evaluated M254 in a single ascending
dose (SAD) cohort of healthy volunteers, and has advanced into Part
B, which will evaluate M254 in a 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 for this trial 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 is exploring the use of a subcutaneous formulation,
which is expected to extend Phase 1.
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 second quarter of 2019, Momenta recorded $3.3 million in
product revenue from Sandoz’s sales of Glatopa products.
M923: a fully-owned proposed biosimilar to HUMIRA®
(adalimumab)
- Today, Momenta announced the Company will cease active
development of M923 at this time, due to changes in the market
opportunity associated with Humira patent litigation
settlements.
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 June 2019, Momenta and Sandoz reached a settlement agreement
with Amphastar, resolving all pending litigation between the
parties related to Enoxaparin sodium injection, an FDA-approved,
substitutable generic LOVENOX, which Momenta developed in
collaboration with Sandoz. As a result of the settlement, the
Company paid Amphastar $21.0 million at the end of the second
quarter and expects to recover its $36.1 million bond in the third
quarter 2019.
- 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.
The Company will incur a $3.1 million termination fee in the third
quarter 2019 and will reduce its remaining lease payments through
February 2027 by approximately $62.7 million.
Second Quarter 2019 Financial Results
Revenue: In the second quarter of 2019, the Company recorded
$3.3 million in product revenue from Sandoz’s sales of Glatopa, net
of a deduction of $0.3 million for legal fees. In the second
quarter of 2018, the Company recorded $11.8 million in product
revenue, net a deduction of $0.2 million for legal fees. The
decrease in product revenue from the prior year period was
primarily due to continued competition.
Research and development revenue for the second 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 $0.6
million, or 48%, was primarily due to higher revenue recognized on
the collaborative upfront payment from Mylan of $1.0 million,
offset in part by lower reimbursement revenue for Glatopa expenses
of $0.4 million.
Total revenue for the second quarter of 2019 was $5.2 million
compared to $13.0 million for the same period in 2018.
Operating Expenses: Research and development expenses for the
second quarter of 2019 were $32.1 million, compared to $31.3
million for the same period in 2018. The decrease of $0.8 million,
or 3%, was primarily due to lower personnel costs following the
Company’s workforce reduction in the fourth quarter of 2018 and
lower lease costs, offset by increased costs related to Momenta’s
nipocalimab and M254 clinical trials.
General and administrative expenses for the second quarter of
2019 were $46.6 million, compared with $22.5 million for the same
period in 2018. The increase of $24.1 million, or 107%, was
primarily due to $21.0 million paid to Amphastar in June 2019
reflecting our portion of the required settlement payment.
Other operating expenses in the second quarter of 2019 included
a $42.9 million charge to be paid between the end of 2020 and 2022,
related to a take-or-pay purchase obligation under Momenta’s
manufacturing agreement with GSK, the supplier of M923. Following
the Company’s decision to cease active development activity
relating to M923, Momenta has incurred these charges as it has
canceled its manufacturing runs scheduled through 2020 and may not
use manufacturing runs scheduled for 2021 and 2022. In the second
quarter of 2018, other operating expenses included $30.0 million
with respect to a contract amendment to the same supply agreement
with GSK.
Total GAAP operating expenses were $121.8 million in the second
quarter of 2019. Second quarter 2019 non-GAAP operating expense was
$117.7 million, reflecting $63.9 million in expenses associated
with the Amphastar settlement and the GSK agreement. 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 $114.0
million, or $1.16 per share for the second quarter of 2019 compared
to a net loss of $69.9 million, or $0.91 per share for the same
period in 2018.
Liquidity: At June 30, 2019, Momenta had $380.2 million in
cash, cash equivalents, marketable securities and restricted cash
released in the third quarter 2019, compared 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 expense, less
stock-based compensation expense, restructuring expense and
collaborative reimbursement revenue. Momenta is providing its
average quarterly non-GAAP operating expense guidance of $45 - $55
million for the remainder of 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
a.m. 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 3896218.
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
Quarterly Report on Form 10-Q for the quarter ended March 31,
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)
|
June 30,2019 |
|
December 31, 2018 |
Assets |
|
|
|
Cash, cash equivalents and marketable securities |
$ |
344,074 |
|
|
$ |
449,411 |
|
Collaboration receivable |
4,398 |
|
|
11,371 |
|
Restricted cash |
37,898 |
|
|
37,898 |
|
Other assets |
93,316 |
|
|
32,883 |
|
Total assets |
$ |
479,686 |
|
|
$ |
531,563 |
|
|
|
|
|
Liabilities and Stockholders’
Equity |
|
|
|
Current liabilities |
$ |
41,755 |
|
|
$ |
51,511 |
|
Deferred revenue, net of current
portion |
1,112 |
|
|
1,774 |
|
Other long-term liabilities |
124,100 |
|
|
17,270 |
|
Stockholder’s equity |
312,719 |
|
|
461,008 |
|
Total liabilities and stockholders’ equity |
$ |
479,686 |
|
|
$ |
531,563 |
|
MOMENTA PHARMACEUTICALS, INC.
Unaudited Condensed Statements of Operations and
Comprehensive Loss
(in thousands, except per share amounts)
|
Three Months Ended June 30, |
|
Six Months EndedJune 30, |
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
Collaboration revenues: |
|
|
|
|
|
|
|
Product revenue |
$ |
3,333 |
|
|
$ |
11,779 |
|
|
$ |
5,685 |
|
|
$ |
15,300 |
|
Research and development revenue |
1,849 |
|
|
1,252 |
|
|
3,610 |
|
|
2,583 |
|
Total collaboration revenue |
5,182 |
|
|
13,031 |
|
|
9,295 |
|
|
17,883 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
32,131 |
|
|
31,340 |
|
|
60,103 |
|
|
64,582 |
|
General and administrative |
46,609 |
|
|
22,531 |
|
|
70,815 |
|
|
43,143 |
|
Other operating expense |
42,936 |
|
|
30,000 |
|
|
42,936 |
|
|
30,000 |
|
Restructuring |
132 |
|
|
— |
|
|
158 |
|
|
— |
|
Total operating expenses |
121,808 |
|
|
83,871 |
|
|
174,012 |
|
|
137,725 |
|
|
|
|
|
|
|
|
|
Loss from operations |
(116,626 |
) |
|
(70,840 |
) |
|
(164,717 |
) |
|
(119,842 |
) |
|
|
|
|
|
|
|
|
Other income, net |
2,657 |
|
|
955 |
|
|
5,905 |
|
|
2,326 |
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(113,969 |
) |
|
$ |
(69,885 |
) |
|
$ |
(158,812 |
) |
|
$ |
(117,516 |
) |
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
Basic and diluted |
$ |
(1.16 |
) |
|
$ |
(0.91 |
) |
|
$ |
(1.61 |
) |
|
$ |
(1.55 |
) |
|
|
|
|
|
|
|
|
Shares used in calculating net
loss per share |
|
|
|
|
|
|
|
Basic and diluted |
98,595 |
|
|
76,543 |
|
|
98,396 |
|
|
76,002 |
|
|
|
|
|
|
|
|
|
Comprehensive loss |
$ |
(113,705 |
) |
|
$ |
(69,611 |
) |
|
$ |
(158,206 |
) |
|
|
$ |
(117,677 |
) |
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 June 30, |
|
Six Months EndedJune 30 |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
GAAP operating expenses |
$ |
121,808 |
|
|
$ |
83,871 |
|
|
$ |
174,012 |
|
|
$ |
137,725 |
|
Adjustments: |
|
|
|
|
|
|
|
Restructuring |
(132 |
) |
|
— |
|
|
(158 |
) |
|
— |
|
Non-cash stock compensation expense |
(3,662 |
) |
|
(5,172 |
) |
|
(7,136 |
) |
|
(10,046 |
) |
Collaboration expenses that are recorded as revenue and are
reimbursable by collaborators |
(343 |
) |
|
(735 |
) |
|
(763 |
) |
|
(1,318 |
) |
Non-GAAP operating expenses |
$ |
117,671 |
|
|
$ |
77,964 |
|
|
$ |
165,955 |
|
|
$ |
126,361 |
|
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