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On Track to File ANDA for
M-Enoxaparin in August
CAMBRIDGE, MA — August 10, 2005
– Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology
company developing drugs based on its proprietary sugar sequencing technology,
today announced its financial results for the second quarter and six
months ended June 30, 2005.
For the second quarter of 2005, the Company reported
a net loss of $4.6 million compared with a net loss of $2.9 million
for the same period last year. For the six months ended June 30, 2005,
the Company reported a net loss of $8.4 million compared with a net
loss of $5.5 million for the six months ended June 30, 2004.
At June 30, 2005, the Company held cash, cash equivalents,
and marketable securities of $46.9 million, compared with $53.6 million
at December 31, 2004.
“We are finalizing our abbreviated new drug
application (ANDA) for M-Enoxaparin, our generic version of Lovenox®,”
said Alan Crane, Chief Executive Officer of Momenta. “We reiterate
our expectation that our ANDA will be filed during the month of August.”
“We believe that our proprietary technology
provides us with the unique ability to thoroughly characterize the complex
mixture of sugar chains that comprise Lovenox and to demonstrate that
our generic product meets the FDA requirements for same active ingredients,”
continued Mr. Crane.
M-Enoxaparin is a technology-enabled generic version
of the low molecular weight heparin drug Lovenox. Marketed by Sanofi-Aventis,
Lovenox is widely prescribed for the prevention and treatment of deep
vein thrombosis and treatment of acute coronary syndromes. Worldwide
sales of Lovenox in 2004 were reported to be approximately $2.4 billion,
with a U.S. market share of approximately 85%.
“Subsequent to the close of the second quarter,
we made the strategic decision to raise additional equity capital. On
July 21, 2005, we raised net proceeds of approximately $122.3 million
through the issuance of approximately 4.8 million shares of common stock.
We believe this transaction provides us with a stronger capital base
to pursue near-term product opportunities where we can leverage our
technology advantage, as well as to continue to fund our existing discovery
and development programs,” concluded Mr. Crane.
Revenue for the second quarter of 2005 was $3.4 million,
compared to $2.1 million for the second quarter of 2004. For the six
months ended June 30, 2005, revenue was $7.1 million compared to $3.2
million in the same period of 2004. Revenue in all periods was earned
under the Company’s collaborative agreement with Sandoz, an affiliate
of Novartis AG. Pursuant to the collaboration, Momenta and Sandoz have
agreed to jointly develop, manufacture, and commercialize M-Enoxaparin,
and Sandoz is responsible for funding substantially all of the development,
regulatory, legal and commercialization costs associated with M-Enoxaparin.
Research and development expenses for the second
quarter of 2005 were $5.0 million, compared to $3.5 million for the
same period in 2004. For the six months ended June 30, research and
development expenses were $10.3 million in 2005 compared to $5.7 million
in 2004. The increase in research and development spending was primarily
due to increased headcount and increased manufacturing and other research
expenses.
General and administrative expenses for the second
quarter of 2005 totaled $3.2 million, compared with $1.6 million for
the same period in 2004. For the six months ended June 30, general and
administrative expenses were $5.8 million in 2005 compared to $3.0 million
in 2004. The increase in general and administrative spending was primarily
due to increased professional fees, increased headcount, and additional
insurance coverage and other public company costs.
Conference Call Information
Management will host a conference call on Wednesday, August 10, 2005
at 10:00 am EDT to provide an update on the Company and discuss second
quarter results. To access the call, please dial 866-700-7173 (domestic)
or 617-213-8838 (international) prior to the scheduled conference call
time and provide the access code 19905356. A replay of the call will
be available approximately two hours after the call and will be accessible
through August 17, 2005. To access the replay, please dial 888-286-8010
(domestic) or 617-801-6888 (international) and provide the access code
44855780.
A live audio webcast of the call will be available 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 through September 10, 2005.
About Momenta
Momenta Pharmaceuticals, Inc. is a biotechnology company specializing
in the detailed structural analysis and design of complex sugars for
the development of improved versions of existing drugs, the development
of novel drugs and the discovery of new biological processes. Momenta
is also utilizing its ability to sequence sugars to create technology-enabled
generic versions of sugar-based and biologic drug products. The Company’s
most advanced product candidate is M-Enoxaparin, a technology-enabled
generic version of Lovenox®. Based on its understanding of complex
sugars, Momenta has created a diversified pipeline of near-term product
opportunities, novel development products and discovery candidates.
Momenta was founded in 2001 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.
Forward Looking Statements
Statements in this press release regarding Momenta Pharmaceuticals Inc.’s
future expectations, beliefs, goals, plans or prospects, including statements
relating to results of operations, regulatory filings and current and
future development efforts, may constitute forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of
1995. Momenta’s actual results could differ materially from those
stated or implied in forward-looking statements due to a number of factors,
including those factors contained in Momenta’s Quarterly Report
on Form 10-Q for the quarter ended March 31, 2005 filed with the Securities
and Exchange Commission under the section “Risk Factors That May
Affect Results,” as well as other documents that may be filed
by Momenta from time to time with the Securities and Exchange Commission.
Forward-looking statements include statements regarding Momenta’s
expectations, beliefs, intentions or strategies regarding the future
and can be identified by forward-looking words such as “anticipate”,
“believe”, “could”, “estimate”,
“expect”, “intend”, “may”, “should”,
“will”, and “would” or similar words. Momenta
assumes no obligations to update the information included in 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.
MOMENTA PHARMACEUTICALS, INC.
Unaudited Condensed Balance Sheets
(in thousands)
| Assets |
June 30,
2005 |
December 31,
2004 |
| Cash and marketable securities |
$46,864 |
$53,621 |
| Restricted cash |
1,485 |
1,485 |
| Other assets |
9,890 |
9,224 |
Total Assets
|
$58,239 |
$64,330 |
Liabilities and
Stockholders’ Equity
|
|
|
| Current liabilities |
$6,339 |
$5,962 |
| Other liabilities |
2,065 |
1,375 |
| Stockholders' equity |
49,835 |
56,993 |
Total liabilities,redeemable convertible preferred stock and
stockholders' equity (deficit)
|
$58,239 |
$64,330 |
MOMENTA PHARMACEUTICALS, INC.
Unaudited Condensed Statements of Operations
(in thousands, except per share amounts)
| |
Three Months Ended
June 30,
|
Six
Months Ended
June 30, |
| |
2005 |
2004 |
2005 |
2004 |
| Collaboration Revenue |
$3,364 |
$2,115 |
$7,137 |
$3,151 |
| Operating expenses: |
|
|
|
|
| Research and Development* |
4,999 |
3,508 |
10,288 |
5,748 |
| General and Administrative* |
3,231 |
1,580 |
5,771 |
2,989 |
| Total operating expenses |
8,230 |
5,088 |
16,059 |
8,737 |
| Loss from operations |
(4,866) |
(2,973) |
(8,992) |
(5,586) |
| Other income, net |
286 |
83 |
572 |
114 |
| Net loss |
(4,580) |
(2,890) |
(8,350) |
(5,472) |
| |
|
|
|
|
| Deemed dividend related to
beneficial conversion feature of Series C redeemable convertible
preferred stock |
_ |
_ |
_ |
(20,389) |
| Dividends and accretion to redemption value
of redeemable convertible preferred stock |
_ |
(1,034) |
_ |
(1,852) |
| Net loss attributable to common
stockholders |
$ (4,580) |
$(3,924) |
$(8,350) |
$(27,713) |
| |
|
|
|
|
| Basic and diluted net loss attributable to common
stockholders per common share |
$ (0.18) |
$ (0.79) |
$(0.33) |
$(7.28) |
| Shares used in computing basic and diluted net
loss attributable to common stockholders per common share |
25,116 |
4,985 |
24,992 |
3,808 |
| |
|
|
|
|
| *Includes stock-based compensation of the following: |
|
|
|
|
Research and development
|
$157 |
$108 |
$271 |
$199 |
General and administrative
|
418 |
635 |
731 |
953 |
| Total stock-based compensation |
$575 |
$743 |
$1,002 |
$1,152 |
Contact:
Michael A. Lawless
Momenta Pharmaceuticals, Inc.
617-395-5189
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