Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today reported its
financial results for the fourth quarter and year ended December
31, 2014.
For the fourth quarter of 2014, the company reported a net loss
of $(16.0) million, or $(0.31) per share, compared to a net loss of
$(30.1) million, or $(0.59) per share for the same period in 2013.
For the year ended December 31, 2014, the company reported a net
loss of $(98.6) million, or $(1.91) per share, compared to a net
loss of ($108.4) million, or $(2.13) per share, for the same period
in 2013. At December 31, 2014, the company had cash, cash
equivalents, and marketable securities of $191.5 million compared
to $245.7 million at December 31, 2013.
"2014 was a very productive year for Momenta. We successfully
executed on many of our corporate objectives including the
achievement of multiple development milestones in our biosimilars
collaboration with Baxter, initiation of a Phase 2 clinical study
of necuparanib in pancreatic cancer, and the introduction of three
promising autoimmune pipeline candidates further broadening our
novel drug portfolio," said Craig A. Wheeler, President and Chief
Executive Officer of Momenta Pharmaceuticals.
"In our biosimilars business, Baxter has opted not to elect any
additional biosimilars for development and has terminated their
participation in the M834 program as part of their corporate
restructuring and portfolio review process. Our collaboration with
Baxter on M923, biosimilar HUMIRA, remains strong and we look
forward to discussions in 2015 with potential new partners for
M834, a biosimilar version of ORENCIA, and our additional
biosimilar programs," Wheeler continued.
"We expect 2015 to be another year of forward momentum across
the business and importantly, we remain optimistic that FDA
approval of our once-daily generic Copaxone ANDA is near, and we
are prepared for a commercial launch in 2015."
Fourth Quarter Highlights and Recent Events
Complex Generics: M356, generic version
of Copaxone® (Glatiramer Acetate Injection)
- The ANDA for M356 continues to be under active review by the
U.S. FDA. The company and its collaboration partner, Sandoz, are
prepared for the potential launch of this generic in 2015, pending
U.S. FDA approval.
- On January 20, 2015, the United States Supreme Court vacated
the 2013 decision of the Court of Appeals for the Federal Circuit
which found several of the Copaxone (20 mg/mL injection) patents,
including the one remaining patent which expires on September 1,
2015, invalid for being indefinite. The Supreme Court overturned
the long standing practice whereby the CAFC reviewed a District
Court's claim interpretation without deference to the District
Court's subsidiary factual findings made in the course of claim
interpretation, and has instructed the appeals court to reconsider
the validity of the patent under a standard that gives deference to
a District Court's subsidiary factual findings made in the course
of claim construction, while retaining the "de novo" nature of the
ultimate legal conclusion on claim construction. The appeals court
is expected to rehear the case and issue a new decision within a
year.
- In August 2014, Momenta announced that the U.S. FDA accepted
for review the ANDA for a 40 mg/mL three-times-weekly generic
Copaxone, submitted by Sandoz Inc., Momenta's development and
commercialization collaborator for this product candidate.
Enoxaparin Sodium Injection
- In the fourth quarter of 2014, Momenta earned $4.7 million in
product revenues from enoxaparin sodium injection based on Sandoz
reported net sales of $47 million.
- The Company continues to pursue the patent infringement case
related to Momenta's U.S. Pat. 7,575,886 against Amphastar and
Teva. In a 2012 decision, the Court of Appeals for the Federal
Circuit (CAFC) held that Amphastar's use of Momenta's patented
method is protected by the Hatch Waxman "safe harbor" (Momenta
Pharmaceuticals vs. Amphastar Pharmaceuticals, Inc. Fed. Cir. Aug.
3, 2012). The safe harbor issue is on appeal at the CAFC again
after a summary judgment decision subsequent to the 2012 CAFC
decision. A hearing is expected during the first half of 2015 and a
decision could be expected in 2015.
Biosimilar and Potentially Interchangeable
Biologics:
- Due to Baxter's company restructuring and change to a strong
focus on later stage biosimilar assets, on February 16, 2015,
Baxter terminated its license to M834 under the collaboration
agreement. Baxter also let expire its right to select additional
targets for biosimilar development under the collaboration. Momenta
and Baxter are continuing to collaborate on M923.
- In December 2014, Momenta announced the acceptance of a
Clinical Trial Application (CTA) to initiate a clinical trial for
M923, a biosimilar version of HUMIRA® (adalimumab), in Europe, in
collaboration with Baxter International's biopharmaceutical
business. Acceptance of the CTA triggered two milestone payments
under the Baxter collaboration with an aggregate payment of $12
million. A pharmacokinetic clinical trial has been initiated in
Europe.
- Momenta's second biosimilar candidate, M834, a biosimilar
version of ORENCIA® (abatacept) and indicated for certain
autoimmune and inflammatory diseases, achieved a pre-defined
development milestone triggering a $7 million milestone payment
from Baxter in the fourth quarter of 2014.
- Momenta will continue to develop M834 and will seek a new
collaboration partner to assist in development and
commercialization.
- Momenta continues to develop its portfolio of early stage
biosimilar candidates and is in active discussions with potential
collaboration partner(s) to assist in development and
commercialization of its additional candidates.
Novel Drugs: Necuparanib (novel
oncology candidate)
- In October 2014, Momenta announced promising top-line results
from the Part A of the Phase 1/2 study evaluating necuparanib in
combination with Abraxane® (paclitaxel) and gemcitabine in patients
with metastatic pancreatic cancer. The Company plans to present
more mature data in mid-2015.
- Momenta also initiated the Phase 2 component of the necuparanib
trial, which is a randomized, controlled study to evaluate the
antitumor activity of necuparanib in combination with Abraxane plus
gemcitabine, versus Abraxane plus gemcitabine alone. The Company
expects to have clinical data available in the first half of
2017.
- In December 2014, the U.S. FDA granted Fast Track designation
to the investigation of necuparanib as a first-line treatment in
combination with Abraxane® and gemcitabine in patients with
metastatic pancreatic cancer.
Novel Autoimmune Drugs In October 2014, Momenta
introduced three novel autoimmune candidates that are currently in
various stages of preclinical development. These candidates
include a hyper-sialylated IVIg (hsIVIg), a high potency
alternative to IVIg, and two recombinant molecules: a Selective
Immunomodulator of Fc receptors (SIF3) and an anti-FcRn monoclonal
antibody. The recombinant molecules have been designed by
leveraging the Company's knowledge of the anti-inflammatory effects
of IVIg to maximize therapeutic benefit and patient convenience.
Momenta believes these programs could have potential in a range of
diseases that currently have few treatment options such as
autoimmune neuropathies, autoimmune blood disorders and blistering
skin diseases. The Company expects to continue to advance the
recombinant candidates with a goal of entering the clinic in late
2016 and remains in active partnering discussions for its hsIVIg
product.
Fourth Quarter and Year End 2014 Financial
Results Total revenues for the fourth quarter of 2014 were
$21.2 million (including enoxaparin product revenue of $4.7
million), compared to $12.8 million (including enoxaparin product
revenue of $4.9 million) for the same period in 2013. Sandoz
reported fourth quarter 2014 enoxaparin net sales of $47 million
versus $51 million for the fourth quarter 2013. The decrease in
enoxaparin product revenue reflects lower prices. For the
year ended December 31, 2014, total revenue was $52.3 million,
compared to $35.5 million for 2013.
Collaborative research and development revenue for the fourth
quarter of 2014 was $16.4 million, compared to $7.8 million in the
same quarter last year. For the year ended December 31, 2014,
collaborative research and development revenues were $32.3 million,
compared to $18.8 million for the year ended 2013. The increases in
both periods are primarily due to the $12.0 million in M923
technical development milestones earned under the Baxter Agreement
and recognized as revenue in the fourth quarter of 2014. The
$7.0 million milestone payment from Baxter for M834 was received in
the fourth quarter of 2014 and will be recognized as revenue over
the product's development period.
Research and development expenses for the fourth quarter of 2014
were $26.2 million, compared to $32.2 million for the same period
in 2013. The decrease of $6.0 million in research and development
expenses from the fourth quarter of 2013 to the fourth quarter of
2014 was primarily due to lower biosimilars process development and
research costs. For the year ended December 31, 2014,
research and development expenses were $106.5 million, compared to
$104.0 million for the year ended 2013. The increase of $2.5
million in research and development expenses from 2013 to 2014
resulted from increases of: $4.8 million in personnel and
facilities-related expenses; $2.5 million to advance the novel drug
research program; $1.9 million in necuparanib clinical costs; and
$1.0 million in laboratory supplies. These increases were offset by
a decrease of $7.6 million primarily related to lower third-party
process development, contract research costs and consulting fees
incurred for our biosimilars program.
General and administrative expenses for the quarter ended
December 31, 2014, were $11.1 million, compared with $10.8 million
for the same period in 2013. For the year ended December 31, 2014,
general and administrative expenses were $45.2 million, compared to
$41.1 million for the year ended 2013. The increase of $4.1 million
from 2013 to 2014 was primarily due to increases of: $2.5 million
in personnel and facilities-related costs; $0.6 million in
allocated lab supplies; $0.4 million in professional fees; and $0.3
million in allocated depreciation expense.
At December 31, 2014, Momenta had $191.5 million in cash, cash
equivalents and marketable securities. This cash position includes
$18.3 million in net proceeds from the sale of approximately 1.7
million shares of common stock through the Company's "At the
Market" (ATM) agreement with Stifel, Nicolaus & Company in the
fourth quarter of 2014. 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 Guidance Today, Momenta provided
guidance that its net cash usage, excluding revenue from the
potential launch of M356, and excluding revenue from any potential
new biosimilar collaboration(s), will be approximately $30 million
for the first quarter of 2015, and thereafter, the Company is
seeking to reduce its cash burn through new collaborative
agreements for its biosimilar and/or new drug programs.
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 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 70886529. A replay of the
call will be available approximately two hours after the conclusion
of the call and will be accessible through February 20, 2015.
To access the replay, please dial (855) 859-2056 (domestic) or
(404) 537-3406 (international) and provide the access code
70886529.
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 future net cash usage, revenues
and operating expense, timing for the generic Copaxone ANDA
approval, timing and outcome of the patent litigation relating to
generic Copaxone and the Company's enoxaparin patents, future
biosimilar program development plans, timing of presenting
additional necuparanib trial data and the timing of clinical trials
for the Company's novel drug product
candidates. 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," "target," "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 September 30, 2014, 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) |
|
|
|
|
December 31,
2014 |
December 31,
2013 |
Assets |
|
|
Cash and marketable securities |
$ 191,529 |
$ 245,682 |
Accounts receivable |
7,427 |
13,095 |
Restricted cash |
20,719 |
20,719 |
Other assets |
36,541 |
37,319 |
Total assets |
$ 256,216 |
$ 316,815 |
Liabilities and Stockholders'
Equity |
|
|
Current liabilities |
$ 23,789 |
$ 21,942 |
Deferred revenue, net of current portion |
25,508 |
24,024 |
Other long-term liabilities |
551 |
1,012 |
Stockholders' equity |
206,368 |
269,837 |
Total liabilities and stockholders'
equity |
$ 256,216 |
$ 316,815 |
|
MOMENTA
PHARMACEUTICALS, INC. |
Unaudited Condensed
Statements of Comprehensive Loss |
(in thousands, except per share
amounts) |
|
|
|
|
|
|
Three Months
Ended December 31, |
Year Ended
December 31, |
|
2014 |
2013 |
2014 |
2013 |
Collaboration revenues: |
|
|
|
|
Product revenue |
$ 4,747 |
$ 4,903 |
$ 19,963 |
$ 16,701 |
Research and development revenues |
16,432 |
7,847 |
32,287 |
18,764 |
Total collaboration revenue |
21,179 |
12,750 |
52,250 |
35,465 |
|
|
|
|
|
Operating expenses: |
|
|
|
|
Research and development* |
26,193 |
32,238 |
106,482 |
103,999 |
General and administrative* |
11,125 |
10,848 |
45,164 |
41,057 |
Total operating expenses |
37,318 |
43,086 |
151,646 |
145,056 |
|
|
|
|
|
Operating loss |
(16,139) |
(30,336) |
(99,396) |
(109,591) |
|
|
|
|
|
Other income: |
|
|
|
|
Interest income |
96 |
214 |
548 |
950 |
Other income |
62 |
60 |
248 |
233 |
Total other income |
158 |
274 |
796 |
1,183 |
|
|
|
|
|
Net loss |
$ (15,981) |
$ (30,062) |
$ (98,600) |
$ (108,408) |
|
|
|
|
|
Net loss per share: |
|
|
|
|
Basic and diluted |
$ (0.31) |
$ (0.59) |
$ (1.91) |
$ (2.13) |
|
|
|
|
|
Weighted average shares outstanding: |
|
|
|
|
Basic and diluted |
52,255 |
51,185 |
51,664 |
50,907 |
|
|
|
|
|
Comprehensive loss |
$ (16,017) |
$ (30,157) |
$ (98,641) |
$ (108,494) |
|
|
|
|
|
*Includes the following share-based
compensation expense: |
|
|
|
|
Research and development |
$ 1,449 |
$ 1,551 |
$ 6,204 |
$ 5,520 |
General and administrative |
$ 1,630 |
$ 1,916 |
$ 7,390 |
$ 7,302 |
CONTACT: 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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