-- Ended 2018 with a cash position of $449.0 million --
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 fourth quarter and full year ended
December 31, 2018.
“In 2018 we transformed our company to focus on discovering and
developing new therapies to treat rare immune-mediated disorders.
We have since made important progress, as we have commenced two
Phase 2 clinical trials of our anti-FcRn antibody, M281, and dosed
the first healthy volunteer in part 1 of a Phase 1 / 2 clinical
trial of our hypersialylated IgG candidate M254. Meanwhile, our
legacy business continues to provide value in the form of revenue
from the Glatopa franchise and we continue to work with Mylan to
advance the Phase 3 clinical trial of M710, our biosimilar EYLEA
candidate,” said Craig A. Wheeler, President and Chief Executive
Officer of Momenta Pharmaceuticals.
“Looking forward, as we focus on operational execution in the
year ahead, we remain confident in the ability of our
differentiated platforms to produce best-in-class immune-mediated
therapeutics and are well-capitalized to execute on our development
plans,” Wheeler continued.
Fourth Quarter 2018 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)
- The Company has commenced two Phase 2 clinical studies of M281
in gMG and HDFN with topline results anticipated in 2020 and 2021,
respectively. The Company also plans to initiate a third
study of M281 in an additional autoimmune indication in 2019.
- In February 2019, the Company presented research at the Society
for Maternal-Fetal Medicine 39th Annual Pregnancy Meeting in Las
Vegas, NV highlighting the ability of M281 to inhibit transfer of
immunoglobulin G from maternal to fetal circulation in an ex vivo
placental perfusion model.
- In November 2018, the Company announced the publication of
results from a Phase 1 clinical trial of M281 in healthy volunteers
in the peer-reviewed journal Clinical Pharmacology &
Therapeutics.
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 ITP. The multi-part
study will first enroll healthy volunteers and includes single and
multiple dose studies, and a randomized cross-over study comparing
M254 to IVIg. 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.
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 fourth quarter of 2018, Momenta recorded $10.8 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 United States (U.S.) in
November 2023.
M710: a proposed biosimilar to EYLEA®
(aflibercept) candidate being developed in collaboration with
Mylan
- In August 2018, Mylan initiated a pivotal clinical trial in
patients with diabetic macular edema to compare safety, efficacy
and immunogenicity of M710 with EYLEA. In November 2018, Momenta
provided formal notice of termination for all other biosimilar
candidates previously subject to the collaboration agreement with
Mylan.
Corporate:
- In December 2018, Momenta announced the closing of a public
offering of 20.0 million shares of its common stock at the price of
$11.50 per share. Aggregate gross proceeds from the offering
were $230.0 million.
Fourth Quarter and Full Year 2018 Financial
Results
Revenue: In the fourth quarter of 2018, the
Company recorded $10.8 million in product revenue from Sandoz’s
sales of Glatopa, compared to $13.1 million for the same period in
2017. For the year ended December 31, 2018, the Company
recorded $39.7 million in product revenue from Sandoz’s sales of
Glatopa, compared to $66.8 million for the same period in 2017. The
decrease in product revenue of $2.3 million, or 17.6% from the
fourth quarter of 2017 to the fourth quarter of 2018 was primarily
due to continued competition. The decrease in product revenue of
$27.2 million, or 41.3% from the year ended 2017 to the year ended
2018 was primarily due to continued competition and reflects a $9.8
million deduction of our 50% share of GLATOPA 40 mg/mL inventory
written off by Sandoz.
Research and development revenue for the fourth quarter of 2018
was $32.1 million, compared to $51.2 million in the same quarter in
2017. The decrease in research and development revenue of $19.2
million, or 37.3%, was primarily due to the recognition of an
upfront payment of $50.0 million from CSL, offset in part by an
increase of revenue recognized related to Mylan's upfront payment
of $28.4 million due to the partial termination of the Mylan
collaboration agreement and the resulting determination that
certain performance obligations under the agreement have been
partially satisfied. For the year ended December 31, 2018,
research and development revenue was $35.9 million compared to
$72.1 million recorded in the same period in 2017. The decrease in
research and development revenue of $36.2 million, or 50.2%, was
primarily due to recognition of the $50.0 million upfront payment
from CSL and the $10.0 million commercial milestone from Sandoz
recognized in 2017 that was non-recurring in 2018. This was offset
in part by an increase of revenue recognized related to Mylan's
upfront payment of $28.4 million due to the partial termination of
the Mylan collaboration agreement and the resulting determination
that certain performance obligations under the agreement have been
partially satisfied.
Total revenue for the fourth quarter of 2018 was $42.8 million
compared to $64.6 million for the same period in 2017. For the year
ended December 31, 2018, total revenue was $75.6 million
compared to $138.9 million for the same period in 2017.
Operating Expenses: Total GAAP operating
expenses were $52.5 million in the fourth quarter of 2018. For the
year ended December 31, 2018, total GAAP operating expenses
were $256.9 million.
Research and development expenses for the fourth quarter of 2018
were $28.7 million, compared to $36.1 million for the same period
in 2017. The decrease of $7.4 million, or 20.5%, was primarily due
to decreased spending on the Company's biosimilar programs. For the
year ended December 31, 2018, research and development
expenses were $124.0 million, compared to $149.2 million for the
same period in 2017. The decrease of $25.2 million, or 16.9%, was
due to decreased spending on the Company's biosimilar programs of
$43.5 million. These decreases were partially offset by increases
in spend of $23.9 million on the Company's novel therapeutic
programs.
General and administrative expenses for the fourth quarter of
2018 were $21.5 million, compared with $15.8 million for the same
period in 2017. The increase of $5.7 million, or 36.1%, was
primarily driven by increased legal costs and depreciation. For the
year ended December 31, 2018, general and administrative
expenses were $85.1 million, compared to $82.2 million for the same
period in 2017. The increase of $2.9 million, or 3.5%, was driven
by net of increased rent expense of $3.3 million related to
occupancy of new premises, one-time costs related to our strategic
review of $3.2 million and depreciation of $3.6 million as the
Company evaluated estimates of the useful lives of depreciable
assets, partially offset by decreases of $4.6 million of legal
costs relating to our ongoing litigation and personnel salaries of
$2.3 million due in part to the recent workforce reduction.
Fourth quarter non-GAAP operating expense was $47.2 million,
within the range of previously provided guidance of $45 - $55
million. Full year 2018 non-GAAP operating expense was $219.2
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 $8.2 million, or $0.10 per share for the fourth quarter of
2018 compared to a net income of $13.8 million, or $0.18 per share
for the same period in 2017. For the year ended December 31,
2018, the Company reported a net loss of $176.1 million, or $2.26
per share compared to a net loss of $88.1 million, or $1.20 per
share for 2017.
Cash Position: At December 31, 2018,
Momenta had $449.4 million in cash, cash equivalents and marketable
securities compared to $281.6 million at September 30, 2018,
reflecting the December 2018 common stock financing.
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 $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 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 7484068. A replay of the call
will be available approximately two hours after the conclusion of
the call and will be accessible through 7484068. 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 focused
on discovering and developing novel biologic therapeutics to treat
rare immune-mediated diseases and advancing its late stage
biosimilars and 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 September
30, 2017, 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) |
|
|
December 31, 2018 |
|
December 31, 2017 |
Assets |
|
|
|
Cash, cash equivalents and
marketable securities |
$ |
449,411 |
|
|
$ |
379,890 |
|
Collaboration
receivable |
11,371 |
|
|
15,048 |
|
Restricted cash |
37,898 |
|
|
23,032 |
|
Other assets |
32,883 |
|
|
41,461 |
|
Total
assets |
$ |
531,563 |
|
|
$ |
459,431 |
|
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current liabilities |
$ |
51,511 |
|
|
$ |
44,487 |
|
Deferred revenue, net of
current portion |
1,774 |
|
|
30,751 |
|
Other long-term
liabilities |
17,270 |
|
|
10,039 |
|
Stockholders' equity |
461,008 |
|
|
374,154 |
|
Total
liabilities and stockholders’ equity |
$ |
531,563 |
|
|
$ |
459,431 |
|
|
|
MOMENTA
PHARMACEUTICALS, INC. |
|
Unaudited Condensed Statements of Operations
and Comprehensive Loss |
|
(in thousands, except per share amounts) |
|
|
Three Months EndedDecember 31, |
|
Year Ended December 31, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Collaboration
revenue: |
|
|
|
|
|
|
|
Product
revenue |
$ |
10,763 |
|
|
$ |
13,369 |
|
|
$ |
39,684 |
|
|
$ |
66,803 |
|
Research and
development revenue |
32,059 |
|
|
51,239 |
|
|
35,905 |
|
|
72,079 |
|
Total
collaboration revenue |
42,822 |
|
|
64,608 |
|
|
75,589 |
|
|
138,882 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and
development |
28,695 |
|
|
36,148 |
|
|
124,004 |
|
|
149,226 |
|
General and
administrative |
21,525 |
|
|
15,827 |
|
|
85,105 |
|
|
82,207 |
|
Other |
— |
|
|
— |
|
|
30,000 |
|
|
— |
|
Restructuring |
2,272 |
|
|
— |
|
|
17,807 |
|
|
— |
|
Total
operating expenses |
52,492 |
|
|
51,975 |
|
|
256,916 |
|
|
231,433 |
|
|
|
|
|
|
|
|
|
Loss from operations |
(9,670 |
) |
|
12,633 |
|
|
(181,327 |
) |
|
(92,551 |
) |
|
|
|
|
|
|
|
|
Other income, net |
1,426 |
|
|
1,126 |
|
|
5,266 |
|
|
4,455 |
|
|
|
|
|
|
|
|
|
Net income (loss) |
$ |
(8,245 |
) |
|
$ |
13,759 |
|
|
$ |
(176,061 |
) |
|
$ |
(88,096 |
) |
|
|
|
|
|
|
|
|
Earnings (net loss) per
share: |
|
|
|
|
|
|
|
Basic |
$ |
(0.10 |
) |
|
$ |
0.18 |
|
|
$ |
(2.26 |
) |
|
$ |
(1.20 |
) |
Diluted |
$ |
(0.10 |
) |
|
$ |
0.18 |
|
|
$ |
(2.26 |
) |
|
$ |
(1.20 |
) |
|
|
|
|
|
|
|
|
Shares used in calculating
net loss per share |
|
|
|
|
|
|
|
Basic |
82,087 |
|
|
74,770 |
|
|
77,845 |
|
|
73,136 |
|
Diluted |
82,087 |
|
|
75,033 |
|
|
77,845 |
|
|
73,136 |
|
|
|
|
|
|
|
|
|
Comprehensive income
(loss) |
$ |
(8,168 |
) |
|
$ |
13,572 |
|
|
$ |
(176,008 |
) |
|
$ |
(88,322 |
) |
|
|
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 EndedDecember 31, |
|
Year EndedDecember 31, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
GAAP operating
expenses |
$ |
52,492 |
|
|
$ |
51,975 |
|
|
$ |
256,916 |
|
|
$ |
231,433 |
|
Adjustments: |
|
|
|
|
|
|
|
Restructuring |
(2,273 |
) |
|
— |
|
|
(17,807 |
) |
|
— |
|
Non-cash
stock compensation expense |
(2,498 |
) |
|
183 |
|
|
(17,414 |
) |
|
(16,127 |
) |
Collaboration expenses that are recorded as revenue and are
reimbursable by collaborators |
(518 |
) |
|
(523 |
) |
|
(2,468 |
) |
|
(7,064 |
) |
Non-GAAP operating
expenses |
$ |
47,203 |
|
|
$ |
51,635 |
|
|
$ |
219,227 |
|
|
$ |
208,242 |
|
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