Momenta Pharmaceuticals Reports Fourth Quarter and Year End 2012 Financial Results
For the fourth quarter of 2012, the company reported a net loss of
"In 2012, we made significant advances across our development programs," said
Fourth Quarter and Recent Events
Complex Generics Program:
M356, generic version of Copaxone® (glatiramer acetate injection)
ANDAfor M356 is under active review by the U.S. FDA.
In the patent litigation brought by
Teva Pharmaceuticalsagainst Momenta and Sandoz, appellate briefing is expected to be completed in the first quarter. Oral arguments are expected to be heard by the U.S. Court of Appeals for the Federal Circuitin the second quarter of 2013, with the appellate decision expected in the second half of the year.
Enoxaparin Sodium Injection
In the fourth quarter of 2012, Momenta earned
$10.8 millionin product revenues on net sales of enoxaparin sodium injection based on Sandoz reported net sales of $85 million.
November 2012, the U.S. Court of Appeals for the Federal Circuitdenied en banc review of its decision in Momenta Pharmaceuticalsvs. Amphastar Pharmaceuticals, Inc. Momenta plans to file this month a petition for a writ of certiorari for a review by the Supreme Court.
- The stay on the District Court proceedings has been lifted. Amphastar has filed a Motion for Summary Judgment and the Court has set a briefing schedule.
- Three biosimilar products are being developed by Momenta under the collaboration -- M923 and M834, which are targeted for the treatment of autoimmune and other inflammatory indications, and M511, a monoclonal antibody for oncology. Momenta expects to submit an IND (Investigational New Drug) application in 2014 for its lead biosimilar, M923, and is also targeting achievement of development criteria that would generate a license payment or milestone payment for M511 and M834 in 2014.
Novel Drug Program:
M402 novel oncology candidate
- Momenta is conducting a Phase 1/2 proof-of-concept trial for M402 in people with advanced metastatic pancreatic cancer. Data from Part A of the two-part study, which is designed to investigate the safety and antitumor activity of M402, are expected in 2013. M402 is a novel oncology candidate designed to inhibit tumor angiogenesis, progression, and metastasis.
Sialylation research program
- Momenta continues to make significant research progress in demonstrating that the sialylation of Fc enhances anti-inflammatory effects. The company expects to generate more data in 2013 that will guide its research efforts toward optimizing a drug candidate to take into the clinic.
Fourth Quarter and Year End 2012 Financial Results
Total collaboration revenue for the fourth quarter of 2012 was
Collaborative research and development revenue for the fourth quarter of 2012 was
Research and development expenses for the fourth quarter of 2012 were
General and administrative expenses for the quarter ended
Momenta confirmed its guidance provided
Conference Call Information
Management will host a conference call and webcast today at
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 89671238. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through
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 management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, the Company's revenue, expenses, including total operating expenses for 2013, comments regarding fourth quarter revenue as indicative of future enoxaparin revenue, anticipated achievement of milestones under the Baxter collaboration in 2014, and cash usage, and other results of operations, our expected product development and collaboration milestones and timing for clinical and non-clinical results, our plans for future research and development investment, and our other product development plans and expectations constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the
likelihood," "hope," "target," "project," "goals," "potential," "predict," "might," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors referred to in the company's Quarterly Report on Form 10-Q for quarter ended
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|MOMENTA PHARMACEUTICALS, INC.|
|Unaudited Condensed Consolidated Balance Sheets|
|Cash and marketable securities||$ 340,603||$ 348,438|
|Short-term and long-term restricted cash||19,971||17,500|
|Total assets||$ 406,629||$ 420,909|
|Liabilities and Stockholders' Equity|
|Current liabilities||$ 18,161||$ 16,028|
|Deferred revenue, net of current portion||27,269||1,608|
|Other long-term liabilities||712||195|
|Total liabilities and stockholders' equity||$ 406,629||$ 420,909|
|Unaudited Condensed Statements of Comprehensive (Loss) Income|
|(in thousands, except per share amounts)|
Three Months Ended
|Product revenues||$ 10,812||$ 26,148||$ 54,772||$ 270,473|
|Research and development revenues||1,916||3,307||9,149||12,595|
|Research and development*||21,540||21,239||80,345||64,657|
|General and administrative*||9,373||9,714||43,682||38,710|
|Total operating expenses||30,913||30,953||124,027||103,367|
|Operating (loss) income||(18,185)||(1,498)||(60,106)||179,701|
|Other income (expense):|
|Total other income (expense)||508||245||1,458||655|
|Net (loss) income||$ (17,677)||$ (1,253)||$ (58,648)||$ 180,356|
|Net (loss) income per share:|
|Basic||$ (0.35)||$ (0.02)||$ (1.16)||$ 3.62|
|Diluted||$ (0.35)||$ (0.02)||$ (1.16)||$ 3.55|
|Weighted average shares outstanding:|
|Comprehensive (loss) income||$ (17,737)||$ (1,186)||$ (58,456)||$ 180,291|
|*Includes the following share-based compensation expense:|
|Research and development||$ 1,515||$ 1,369||$ 5,832||$ 4,919|
|General and administrative||$ 1,937||$ 1,753||$ 7,880||$ 6,219|
Lora Pike Momenta Pharmaceuticals, Inc.firstname.lastname@example.org (617) 395-5189
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