Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today reported its
financial results for the third quarter ended September 30, 2015.
For the third quarter of 2015, the Company
reported total revenues of $13.8 million, including $8.7 million of
GlatopaTM (glatiramer acetate injection) profit share. For the nine
months ended September 30, 2015, the Company reported total
revenues of $67.3 million, including $27.9 million in product
revenues from Sandoz’s sales of Glatopa. Momenta reported a net
loss of $(30.1) million, or $(0.44) per share for the third quarter
compared to a net loss of $(29.1) million, or $(0.56) per share for
the same period in 2014. For the nine months ended September 30,
2015, the Company reported a net loss of $(54.1) million, or
$(0.88) per share compared to a net loss of $(82.6) million, or
$(1.61) per share for the same period in 2014. At September 30,
2015, the Company had cash, cash equivalents, and marketable
securities of $374.9 million.
“The launch of Glatopa is going according to
plan with Glatopa scripts currently representing approximately 25%
to 30% of the once daily glatiramer acetate market,” said Craig A.
Wheeler, President and Chief Executive Officer of Momenta
Pharmaceuticals. “As the first marketed generic version of a
multiple sclerosis drug, Glatopa is bringing value to both patients
and payors.”
“We continue to advance our biosimilar and novel
drug programs. Our Phase 2 study of necuparanib in pancreatic
cancer is advancing and M923, our biosimilar HUMIRA® candidate, has
entered a pivotal clinical trial,” continued Mr. Wheeler. “Our
ongoing development activities should also allow us to move M834,
our biosimilar ORENCIA® candidate, and our two novel recombinant
autoimmune candidates into the clinic in 2016.”
Third Quarter Highlights and Recent
Events
Complex
Generics:GlatopaTM, generic version of daily
COPAXONE® 20 mg (glatiramer acetate injection)
- Sandoz launched Glatopa on June 18, 2015. In the third quarter
of 2015, Momenta recorded $8.7 million in product revenues from
Sandoz’s Glatopa sales. Glatopa is experiencing positive trade
uptake, although the impact on third quarter sales was limited as
launch inventory continues to be worked through. In the second
quarter of 2015 Momenta’s share of profit on sales of Glatopa was
$28.2 million, and after a deduction of $9.0 million in
reimbursement to Sandoz of the Company’s share of pre-launch
Glatopa-related legal expenses, the Company recorded $19.2 million
in product revenue.
- The ANDA for a three-times-a-week generic COPAXONE 40 mg
(glatiramer acetate injection), submitted by Sandoz, is under FDA
review.
Enoxaparin Sodium Injection
- The Company continues to pursue the patent infringement case
related to Momenta’s U.S. Pat. 7,575,886 against Amphastar and
Actavis. In July 2015, the U.S. Solicitor General, at the request
of the Court of Appeals for the Federal Circuit, filed a brief in
the case that supported Momenta’s interpretation of the scope of
the “safe harbor” provisions under the Hatch Waxman Act. A CAFC
decision is expected in 2015.
Biosimilars:
- In October 2015, Momenta and Baxalta announced the initiation
of a pivotal clinical trial for M923, a biosimilar version of
HUMIRA® (adalimumab). The trial is a randomized, double blind,
active control, multi-center, global study in patients with chronic
plaque psoriasis to compare the safety, efficacy and immunogenicity
of M923 with HUMIRA. The companies are targeting first regulatory
submission in 2017 and a first commercial launch in 2018.
- Momenta continues to develop M834, a biosimilar version of
ORENCIA® (abatacept), and its portfolio of other biosimilar
candidates and is in active discussions with potential partners to
collaborate on the development and commercialization of a portfolio
of its biosimilar candidates.
Novel Drug:Necuparanib
(novel oncology candidate)
- Momenta’s Phase 2 trial to evaluate the antitumor activity of
necuparanib in combination with Abraxane® (nab-paclitaxel) plus
gemcitabine, versus Abraxane plus gemcitabine alone, is enrolling.
The Company expects to have clinical data available in the first
half of 2017.
- The Company continues to collect data from the Phase 1 study
and plans to publish and/or present updated results following
completion of the study.
Autoimmune Drugs Momenta’s
three novel autoimmune candidates are in preclinical development.
These candidates include a hyper-sialylated IVIg (hsIVIg), a high
potency alternative to IVIg, and two recombinant molecules: M230, a
Selective Immunomodulator of Fc receptors (SIF3) and M281, an
anti-FcRn monoclonal antibody. The Company is advancing the
recombinant candidates with a goal of entering the clinic in late
2016, and is continuing its efforts to identify and explore
potential partnering opportunities for the further development and
commercialization of its hsIVIg program.
Third Quarter 2015 Financial
Results
Total revenues for the third quarter of 2015
were $13.8 million compared to $9.3 million for the same period in
2014. Total revenues for the third quarter of 2015 includes
$8.7 million in product revenue, which represents 50% of
contractual profit earned from Sandoz’s sale of Glatopa.
Enoxaparin product revenue decreased from $4.7
million for the third quarter of 2014 to zero for the same period
in 2015. The decrease in enoxaparin product revenue was primarily
due to the amendment of the enoxaparin sodium injection
collaboration agreement in June 2015 which replaced Sandoz’
obligation to pay the Company a royalty on net sales with an
obligation to pay 50% of profit on sales. In the third quarter of
2015, Sandoz did not earn a profit on its sales of enoxaparin due
to continued competitive pricing.
Collaborative research and development revenue
for the third quarter of 2015 was $5.1 million, compared to the
$4.6 million recorded in the same quarter last year. The
increase is primarily due to an increase in the quarterly
amortization of the upfront payment under the Baxalta
collaboration.
Research and development expenses for the third
quarter of 2015 were $31.7 million, compared to $27.5 million for
the same period in 2014. The increase of $4.2 million, or 15%, from
the 2014 period primarily resulted from increases of $2.0 million
in nonclinical and manufacturing expenditures to advance the novel
autoimmune programs, $1.8 million in clinical trial expenses as the
necuparanib Phase 2 clinical trial continued to enroll patients and
$0.3 million in share-based compensation expense associated with
performance-based stock awards.
General and administrative expenses for the
quarter ended September 30, 2015, were $12.5 million, compared with
$11.1 million for the same period in 2014. The increase of
$1.4 million, or 13%, from the 2014 period primarily resulted
from increases of $0.8 million in share-based compensation
associated with performance-based stock awards and $0.3 million in
professional fees.
At September 30, 2015, Momenta had $374.9
million in cash, cash equivalents and marketable securities. This
cash position excludes restricted cash of $20.7 million, of
which $17.5 million is reserved as collateral for a
security bond related to enoxaparin legal proceedings,
and $3.2 million for letters of credit related to the
company's two leased facilities.
Financial GuidanceToday,
Momenta provided guidance that it expects its operating expenses,
excluding stock-based compensation and net of collaborative
revenues, to be approximately $40 - $42 million per quarter for the
fourth quarter of 2015.
Conference Call
InformationManagement 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 and will be available for 90 days.
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
60061735. A replay of the call will be available approximately two
hours after the conclusion of the call and will be accessible
through November 11, 2015. To access the replay, please dial
(855) 859-2056 (domestic) or (404) 537-3406 (international) and
provide the access code 60061735.
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
StatementsStatements 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 for 2015; future
operating expenses; program development and partnering plans;
timing of regulatory submissions and product launches; timing of
clinical trials and the availability and announcement of clinical
data; and the timing of decisions related to patent litigation and
other patent-related proceedings. Forward-looking statements
may be identified by words such as "anticipate," "believe,"
“continue,” "could," "hope," "target," "project," "goal,"
“objective,” “guidance,” “plan,” "potential," "predict," "might,"
"estimate," "expect," "intend," "may," “seek”, "should," "will,"
"would," "look forward" 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,
2015, 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) |
|
|
|
September 30, 2015 |
|
December 31, 2014 |
Assets |
|
|
|
|
Cash and marketable
securities |
|
$ |
374,869 |
|
$ |
191,529 |
Accounts receivable |
|
11,060 |
|
7,427 |
Restricted cash |
|
20,660 |
|
20,719 |
Other assets |
|
31,617 |
|
36,541 |
Total assets |
|
$ |
438,206 |
|
$ |
256,216 |
Liabilities and Stockholders’ Equity |
|
|
|
|
Current liabilities |
|
$ |
30,159 |
|
$ |
23,789 |
Deferred revenue, net of
current portion |
|
14,656 |
|
25,508 |
Other long-term
liabilities |
|
129 |
|
551 |
Stockholders’ equity |
|
393,262 |
|
206,368 |
Total liabilities and stockholders’
equity |
|
$ |
438,206 |
|
$ |
256,216 |
MOMENTA
PHARMACEUTICALS, INC. |
Unaudited
Condensed Statements of Comprehensive Loss |
(in thousands, except
per share amounts) |
|
|
|
Three Months Ended September
30, |
|
|
Nine Months Ended September
30, |
|
|
|
|
2015 |
|
|
|
2014 |
|
|
2015 |
|
|
|
2014 |
|
Collaboration
revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue |
|
$ |
8,666 |
|
|
$ |
4,714 |
|
|
$ |
30,693 |
|
|
$ |
15,216 |
|
Research and development
revenue |
|
|
5,129 |
|
|
|
4,622 |
|
|
36,565 |
|
|
|
15,855 |
|
Total collaboration revenue |
|
|
13,795 |
|
|
|
9,336 |
|
|
67,258 |
|
|
|
31,071 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development* |
|
|
31,733 |
|
|
|
27,508 |
|
|
88,466 |
|
|
|
80,289 |
|
General and administrative* |
|
|
12,459 |
|
|
|
11,103 |
|
|
33,678 |
|
|
|
34,039 |
|
Total operating expenses |
|
|
44,192 |
|
|
|
38,611 |
|
|
122,144 |
|
|
|
114,328 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(30,397 |
) |
|
|
(29,275 |
) |
|
(54,886 |
) |
|
|
(83,257 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
252 |
|
|
|
112 |
|
|
486 |
|
|
|
452 |
|
Other income |
|
|
95 |
|
|
|
62 |
|
|
251 |
|
|
|
186 |
|
Total other income |
|
|
347 |
|
|
|
174 |
|
|
737 |
|
|
|
638 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(30,050 |
) |
|
$ |
(29,101 |
) |
|
$ |
(54,149 |
) |
|
$ |
(82,619 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share |
|
$ |
(0.44 |
) |
|
$ |
(0.56 |
) |
|
$ |
(0.88 |
) |
|
$ |
(1.61 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
used in computing basic and diluted net loss per share |
|
|
68,004 |
|
|
|
51,545 |
|
|
61,442 |
|
|
|
51,456 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(30,050 |
) |
|
$ |
(29,101 |
) |
|
$ |
(54,149 |
) |
|
$ |
(82,619 |
) |
Net unrealized holding
gains (losses) on available-for-sale marketable securities |
|
|
(4 |
) |
|
|
(26 |
) |
|
32 |
|
|
|
(5 |
) |
Comprehensive loss |
|
$ |
(30,054 |
) |
|
$ |
(29,127 |
) |
|
$ |
(54,117 |
) |
|
$ |
(82,624 |
) |
|
* Non-cash
share-based compensation expense included in operating expenses is
as follows: |
|
Research and
development |
|
$ |
2,122 |
|
|
$ |
1,509 |
|
|
$ |
3,031 |
|
|
$ |
4,755 |
|
General and
administrative |
|
$ |
2,435 |
|
|
$ |
1,890 |
|
|
$ |
3,756 |
|
|
$ |
5,760 |
|
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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