Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today reported its
financial results for the second quarter ended June 30, 2016.
For the second quarter of 2016, the Company
reported total revenues of $26.4 million, including $20.7 million
in product revenues from Sandoz’s sale of Glatopa® (glatiramer
acetate injection). Momenta reported a net loss of $(21.0) million,
or $(0.31) per share for the second quarter compared to a net loss
of $(2.2) million, or $(0.04) per share for the same period in
2015. At June 30, 2016, the Company had cash, cash equivalents, and
marketable securities of $336.9 million compared to $362.8 million
at March 31, 2016.
“We are pleased with the growth in product
revenues from Glatopa this quarter and look forward to the
potential launch of our Glatopa 40 mg product next year,” said
Craig A. Wheeler, President and Chief Executive Officer of Momenta
Pharmaceuticals. “During the remainder of 2016 we plan to announce
several key milestones including announcing top-line data from a
pivotal trial for M923, a biosimilar candidate of HUMIRA® developed
in collaboration with Baxalta, the initiation of a clinical trial
for M834, a biosimilar candidate of ORENCIA® being developed in
collaboration with Mylan, and completing enrollment of the single
ascending dose portion of our Phase 1 trial for M281, a novel
anti-FcRn antibody candidate.”
Second Quarter Highlights and Recent
Events
Complex Generics:
- In the second quarter of 2016, Momenta recorded $20.7 million
in product revenues from Sandoz’s Glatopa sales.
- The ANDA submitted by Sandoz for a three-times-a-week generic
COPAXONE® 40 mg (glatiramer acetate injection) is under FDA review.
The Company expects to receive tentative regulatory approval in
2016.
- A district court trial challenging four of Teva’s five Orange
Book-listed patents for COPAXONE 40 mg (glatiramer acetate
injection) is scheduled for September 26, 2016.
Biosimilars:
- In April 2016, Momenta and its collaboration partner Baxalta,
now a part of Shire, completed enrollment in the pivotal clinical
trial for M923, a biosimilar candidate of HUMIRA® (adalimumab) and
the companies expect to release results in late 2016. The companies
are targeting first regulatory submission for marketing approval in
2017 and a first commercial launch as early as 2018.
- Momenta’s global collaboration with Mylan to develop,
manufacture and commercialize six of the Company’s biosimilar
candidates is progressing. The companies have prioritized three
lead programs including M834, a biosimilar candidate of ORENCIA®
(abatacept).
Novel Drugs:
Necuparanib (novel oncology
candidate)
- On August 3, 2016, the Data Safety Management Board recommended
that the Company discontinue further accrual in the Phase 2 trial
of necuparanib in pancreatic cancer following the outcome of a
planned interim futility analysis. The Company plans to confirm the
futility analysis and then determine next steps for the necuparanib
program.
Autoimmune Drugs Momenta’s
novel autoimmune portfolio includes two recombinant molecules:
M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281,
an anti-FcRn monoclonal antibody. In June 2016, the Company
initiated a Phase 1 study to evaluate the safety, tolerability,
pharmacokinetics and pharmacodynamics of M281 in healthy subjects.
M230 is in pre-clinical development, and the Company expects to
initiate a clinical trial for M230 in 2017. Momenta is also
developing hyper-sialylated IVIg (hsIVIg), a high potency
alternative to IVIg. The Company continues its efforts to identify
potential collaboration opportunities for the further development
and commercialization of its hsIVIg program.
Second Quarter 2016 Financial
Results
Total revenues for the second quarter of 2016
were $26.4 million compared to $44.9 million for the same period in
2015. Total revenues for the second quarter of 2016 include $20.7
million in product revenue earned from net sales of Glatopa by
Sandoz, compared to $19.2 million in product revenue earned from
net sales of Glatopa by Sandoz for the same period in 2015. Glatopa
was launched in the second quarter of 2015, and Glatopa profit
share for that quarter was reduced by $9.0 million to reimburse
Sandoz for the Company’s share of pre-launch Glatopa-related legal
expenses.
Collaborative research and development revenue
for the second quarter of 2016 was $5.7 million compared to the
$25.6 million recorded in the same quarter last year. In the second
quarter of 2015, the Company earned $20.0 million in milestone
payments under the Sandoz collaboration upon receiving sole FDA
approval and upon the first commercial sale of Glatopa.
Research and development expenses for the second
quarter of 2016 were $33.2 million, compared to $34.0 million for
the same period in 2015. The decrease of $0.8 million, or 2%, from
the 2015 period to the 2016 period was due to decreases of $0.8
million in stock-based compensation expense and $8.4 million for
Mylan’s 50% share of biosimilar collaboration costs, which was
offset by increases of $4.4 million in process and clinical
development costs for M281 and biosimilars under the Company’s
collaboration with Mylan, $2.2 million in non-clinical expenses to
advance the Company’s novel autoimmune programs, $1.0 million in
personnel-related expenses and $0.7 million in necuparanib Phase 2
clinical trial costs.
General and administrative expenses for the
quarter ended June 30, 2016 were $14.9 million, compared with $13.3
million for the same period in 2015. The increase of $1.6 million,
or 12%, was primarily due to an increase of $2.1 million in legal
and professional fees. This increase was offset by a decrease of
$0.5 million for Mylan’s 50% share of biosimilar collaboration
costs.
At June 30, 2016, Momenta had $336.9 million in
cash, cash equivalents and marketable securities.
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
figures. Refer to the section of this press release below entitled
“Non-GAAP Financial Information and Other Disclosures” for further
discussion of this subject.
Today, Momenta reiterated its non-GAAP operating
expense guidance of approximately $40 - $45 million per quarter for
the second half of 2016. Non-GAAP operating expense is total
operating expenses (which is net of Mylan’s share of collaboration
expenses), excluding stock-based compensation expense and net of
collaborative reimbursement revenues from Sandoz and
Baxalta. The quarterly recognition of collaborative revenues
under the Company’s collaborations
with Baxalta and Mylan is expected to
be $2.4 million and $1.8 million per quarter,
respectively.
Conference Call Information
Management will host a conference call and
webcast today at 10:00 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
48928761. A replay of the call will be available approximately two
hours after the conclusion of the call and will be accessible
through August 11, 2016. To access the replay, please dial
(855) 859-2056 (domestic) or (404) 537-3406 (international) and
provide the access code 48928761.
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 and excludes non-cash stock
compensation and is net of collaborative reimbursement revenues
from Sandoz and Baxalta. This non-GAAP financial measure should not
be considered an alternative to GAAP total operating expense and
should not be considered a measure of Momenta’s liquidity. Non-GAAP
financial measures should not be considered as substitutes for
measures calculated in accordance with GAAP and should only be used
to supplement an understanding of Momenta’s operating results as
reported under GAAP. Momenta has not provided a GAAP reconciliation
for its forward-looking non-GAAP 2016 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
does not believe that such a reconciliation would be meaningful to
stockholders.
About Momenta
Momenta Pharmaceuticals is a biotechnology
company specializing in the detailed structural analysis of complex
drugs and is headquartered in Cambridge, MA. Momenta is
applying its technology to the development of generic versions of
complex drugs, biosimilar and potentially interchangeable
biologics, and to the discovery and development of novel
therapeutics for oncology and autoimmune indications.
To receive additional information about Momenta,
please visit the website at www.momentapharma.com, which does
not form a part of this press release.
Our 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
Company’s ability to meet its development goals; expectations
regarding long-term growth and sustainability; future operating
expenses; program development and collaboration plans; timing of
regulatory submissions, regulatory approvals and product launches;
timing of completion of enrollment of the Company’s clinical
trials; timing of clinical trials and the availability and
announcement of clinical data; timing of patent litigation and
other patent-related proceedings and decisions related to such
litigation and proceedings; confirming the futility analysis of
necuparanib; determining next steps for the necuparanib program and
expectations regarding quarterly recognition of consideration under
the Company’s collaborations. Forward-looking statements may
be identified by words such as “continue,” “expect,” “guidance,”
“look forward,” “opportunity,” “plan,” “potential,” “schedule,”
“target,” “will” 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, 2016, 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.
MOMENTA
PHARMACEUTICALS, INC. |
Unaudited
Condensed Consolidated Balance Sheets |
(in thousands) |
|
|
|
June 30, 2016 |
|
December 31, 2015 |
Assets |
|
|
|
|
Cash, cash equivalents and
marketable securities |
|
$ |
336,916 |
|
$ |
350,044 |
Collaboration
receivable |
|
35,862 |
|
21,185 |
Restricted cash |
|
20,660 |
|
20,660 |
Other assets |
|
32,315 |
|
29,151 |
Total assets |
|
$ |
425,753 |
|
$ |
421,040 |
Liabilities and Stockholders’ Equity |
|
|
|
|
Current liabilities |
|
$ |
45,093 |
|
$ |
38,782 |
Deferred revenue, net of
current portion |
|
42,189 |
|
12,213 |
Other long-term
liabilities |
|
3,832 |
|
69 |
Stockholders’ equity |
|
334,639 |
|
369,976 |
Total liabilities and stockholders’
equity |
|
$ |
425,753 |
|
$ |
421,040 |
MOMENTA
PHARMACEUTICALS, INC. |
|
Unaudited
Condensed Statements of Operations and Comprehensive
Loss |
|
(in thousands, except
per share amounts) |
|
|
|
|
|
Three Months Ended June
30, |
|
Six Months Ended June
30, |
|
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
Collaboration
revenues: |
|
|
|
|
|
|
|
|
|
|
Product revenue |
|
$ |
20,692 |
|
$ |
19,305 |
|
$ |
35,492 |
|
$ |
22,027 |
|
Research and development
revenue |
|
5,738 |
|
25,595 |
|
10,788 |
|
31,436 |
|
Total collaboration revenue |
|
26,430 |
|
44,900 |
|
46,280 |
|
53,463 |
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and development* |
|
33,173 |
|
33,983 |
|
61,930 |
|
56,733 |
|
General and administrative* |
|
14,896 |
|
13,329 |
|
30,543 |
|
21,219 |
|
Total operating expenses |
|
48,069 |
|
47,312 |
|
92,473 |
|
77,952 |
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(21,639 |
) |
(2,412 |
) |
(46,193 |
) |
(24,489 |
) |
|
|
|
|
|
|
|
|
|
|
Other income |
|
653 |
|
190 |
|
1,195 |
|
390 |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(20,986 |
) |
$ |
(2,222 |
) |
$ |
(44,998 |
) |
$ |
(24,099 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share |
|
$ |
(0.31 |
) |
$ |
(0.04 |
) |
$ |
(0.66 |
) |
$ |
(0.41 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average shares
used in computing basic and diluted net loss per share |
|
68,532 |
|
61,680 |
|
68,409 |
|
58,106 |
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(20,837 |
) |
$ |
(2,204 |
) |
$ |
(44,716 |
) |
$ |
(24,063 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Non-cash share-based
compensation expense included in operating expenses is as
follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
$ |
2,319 |
|
$ |
3,125 |
|
$ |
4,384 |
|
$ |
910 |
|
General and
administrative |
|
$ |
2,670 |
|
$ |
3,491 |
|
$ |
5,433 |
|
$ |
1,321 |
|
INVESTOR CONTACT:
Sarah Carmody
Momenta Pharmaceuticals
1-617-395-5189
IR@momentapharma.com
MEDIA CONTACT:
Karen Sharma
MacDougall Biomedical Communications
1-781-235-3060
Momenta@macbiocom.com
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