Momenta Pharmaceuticals Reports Third Quarter 2012 Financial Results
For the third quarter of 2012, the company reported a net loss of
"Royalty revenues from enoxaparin sodium injection in the third quarter were disappointing and reflected the market realities of a more competitive multi-player dynamic," said
"Today, I am pleased to announce that Momenta has made significant progress in demonstrating that sialylation of Fc enhances anti-inflammatory effects in a preclinical model. This work is consistent with the findings previously published by
Third Quarter Events
Complex Generics Program:
Enoxaparin sodium injection
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In September, Momenta filed a petition to the
U.S. Court of Appeals for the Federal Circuit for rehearing en banc (all active Federal Circuit judges) to reconsider its decision inMomenta Pharmaceuticals vs.Amphastar Pharmaceuticals, Inc ., which issued its opinion in August that Amphastar's use of Momenta's patented method for processing enoxaparin sodium injection was protected by the "safe harbor" provision from patent infringement under 35 U.S.C. sec. 271(e)(1). The Court of Appeals is considering whether to hear the case en banc and their decision could come at any time.
M356, generic version of Copaxone® (glatiramer acetate injection)
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In July, Momenta appealed the District Court's decision in the patent infringement lawsuit filed by
Teva against Momenta and Sandoz. We expect that an appellate decision could be issued in the second half of 2013.
Follow-on Biologics Program:
Baxter collaboration
- Baxter selected the third of up to six biosimilar products to be developed under the collaboration. The three biosimilar products include M923 and M834, which are targeted for the treatment of autoimmune and other inflammatory indications, and M511, a monoclonal antibody for oncology indications. Momenta expects to submit the first IND (Investigational New Drug) application in 2014 for its lead biosimilar, M923.
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 are expected in 2013. M402 is a novel oncology candidate designed to inhibit tumor angiogenesis, progression, and metastasis.
Sialylation research program
- Momenta has made significant progress in demonstrating that sialylation of Fc enhances anti-inflammatory effects in a preclinical model. Momenta is using its proprietary sialylation technology to develop IVIG and IgG-based drugs that address autoimmune and inflammatory diseases.
Third Quarter 2012 Financial Results
Total collaboration revenue for the third quarter of 2012 was
Collaborative research and development revenue for the third quarter of 2012 was
Research and development expenses for the third quarter of 2012 were
General and administrative expenses for the quarter ended
At
Financial Guidance
Momenta confirmed its guidance provided on
Today, Momenta provided guidance for 2013 total operating expenses, excluding stock-based compensation and net of collaborative revenues, of approximately
Conference Call Information
Management will host a conference call and webcast today,
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 49562998. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through
About Momenta
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 2012 and 2013 total operating expense and cash usage, and other results of operations, including the quarter ended
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MOMENTA PHARMACEUTICALS, INC. | ||
Unaudited, Condensed Consolidated Balance Sheets | ||
(in thousands) |
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September 30, 2012 |
December 31, 2011 |
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Assets | ||
Cash and marketable securities |
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Accounts receivable | 4,951 | 28,171 |
Short-term and long-term restricted cash | 19,971 | 17,500 |
Other assets | 35,859 | 26,800 |
Total assets |
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Liabilities and Stockholders' Equity | ||
Current liabilities |
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Deferred revenue, net of current portion | 27,631 | 1,608 |
Other liabilities | 51 | 195 |
Stockholders' equity | 374,723 | 403,078 |
Total liabilities and stockholders' equity |
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MOMENTA PHARMACEUTICALS, INC. | ||||
Unaudited Condensed Statements of Comprehensive (Loss) Income | ||||
(in thousands, except per share amounts) | ||||
Three Months Ended |
Nine Months Ended |
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2012 | 2011 | 2012 | 2011 | |
Collaboration revenues: | ||||
Product revenues |
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Research and development revenues | 2,523 | 3,228 | 7,233 | 9,288 |
Total collaboration revenues | 5,102 | 87,945 | 51,193 | 253,613 |
Operating expenses: | ||||
Research and development* | 20,233 | 16,307 | 58,805 | 43,418 |
General and administrative* | 10,999 | 11,480 | 34,309 | 28,995 |
Total operating expenses | 31,232 | 27,787 | 93,114 | 72,413 |
Operating (loss) income | (26,130) | 60,158 | (41,921) | 181,200 |
Other income (expense): | ||||
Interest income | 308 | 194 | 950 | 498 |
Interest expense | — | (14) | — | (89) |
Total other income | 308 | 180 | 950 | 409 |
Net (loss) income |
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Net (loss) income per share: | ||||
Basic |
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Diluted | $ (0.51) |
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Weighted average shares outstanding: | ||||
Basic | 50,500 | 50,034 | 50,365 | 49,759 |
Diluted | 50,500 | 51,048 | 50,365 | 50,796 |
Comprehensive (loss) income |
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*Includes the following share-based compensation expense: |
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Research and development |
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General and administrative |
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CONTACT:Source:Lora Pike Momenta Pharmaceuticals, Inc. lpike@momentapharma.com (617) 395-5189
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