Momenta Pharmaceuticals Reports Third Quarter 2013 Financial Results
For the third quarter of 2013, the company reported a net loss of
"We are excited with the progress of our programs this year," said
Third Quarter Highlights
M356, generic version of Copaxone® (glatiramer acetate injection)
As expected, in the third quarter,
Tevapetitioned for a rehearing of the Federal Circuit's opinion. On October 18, this petition was denied.
ANDAfor M356 continues to be under review by the U.S. FDA.
Enoxaparin Sodium Injection
In the third quarter of 2013, Momenta earned
$4.8 millionin Enoxaparin Sodium Injection product revenues based on Sandoz-reported net sales of $58 million. In the second quarter of 2013, Sandoz reported net sales of $57 million.
Biosimilars and Potentially Interchangeable Biologics:
Momenta continues to advance toward the achievement of collaboration milestones in 2014 for its three biosimilar products under development with Baxter: M923 and M834 — two products targeting autoimmune and inflammatory indications, and M511 — a monoclonal antibody for oncology. The milestones include achievement of technical development criteria and the submission of an Investigational New Drug (IND) application in the second half of 2014 for its lead biosimilar, M923, as well as achievement of development criteria that would generate a license payment and a milestone payment for M511 and M834, respectively, in 2014. The aggregate value of these potential milestones is
- Momenta, with its collaborator, Baxter, continues to evaluate additional products for development.
M402 Phase 1/2 proof-of-concept study
- Momenta continues to dose patients in its Phase 1/2 proof-of-concept study evaluating M402 in combination with Abraxane® (nab-paclitaxel) and gemcitabine in patients with pancreatic cancer. The primary objectives of Part A are to evaluate safety and tolerability of M402 in combination with Abraxane and gemcitabine and to establish the dose of M402 to take forward into Part B. Part B will be a randomized, controlled study to evaluate the antitumor activity of M402 in combination with Abraxane plus gemcitabine, versus Abraxane plus gemcitabine alone. Momenta expects to have data from Part A during the first half of 2014.
Sialylation research program
- Momenta continues to generate data to investigate and validate the biology of sialylated IVIG/Fc to define the specific product, or products, to potentially advance to the clinic, as well as, to inform the company's selection of the indication to potentially take forward into development.
Third Quarter 2013 Financial Results
Total revenue for the third quarter of 2013 was
Research and development expenses for the third quarter of 2013 were
General and administrative expenses for the third quarter of 2013 were
Momenta confirmed its guidance for 2013 for total operating expenses, excluding stock compensation and net of collaborative revenues, averaging approximately
Conference Call Information
Management will host a conference call today,
A live audio webcast of the call will be available on the "Investors" section of the company's web site, 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 web site approximately two hours after the call and will be available 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 and other results of operations, including the quarter ended
Momenta's logo, trademarks, and service marks are the property of
|MOMENTA PHARMACEUTICALS, INC.|
|Unaudited, Condensed Consolidated Balance Sheets|
|Cash and marketable securities||
|Liabilities and Stockholders' Equity|
|Deferred revenue, net of current portion||24,260||27,269|
|Total liabilities and stockholders' equity||
|MOMENTA PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS|
|(in thousands, except per share amounts)|
Ended September 30,
Ended September 30,
|Research and development revenue||5,977||2,523||10,918||7,233|
|Total collaboration revenue||10,751||5,102||22,716||51,193|
|Research and development*||27,435||20,233||71,771||58,805|
|General and administrative*||8,977||10,999||30,202||34,309|
|Total operating expenses||36,412||31,232||101,973||93,114|
|Total other income||279||308||910||950|
|Basic and diluted net loss per share||$ (0.50)||
|Weighted average shares used in computing basic and diluted net loss per share||51,055||50,500||50,813||50,365|
|* Non-cash share-based compensation expense included in operating expenses is as follows:|
|Research and development||$ 1,359||$ 1,530||$ 3,969||$ 4,317|
|General and administrative||$ 1,796||$ 2,019||$ 5,387||$ 5,943|
Lora Pike Momenta Pharmaceuticals, Inc.email@example.com (617) 395-5189
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