Momenta Pharmaceuticals Reports First Quarter 2013 Financial Results
For the first quarter of 2013, the company reported a net loss of
"During the first quarter of 2013, we continued to aggressively pursue the advancement of our programs and achievement of our corporate objectives for the year," said
First Quarter Highlights and Recent Progress
M356, generic version of Copaxone® (glatiramer acetate injection)
ANDAfor M356 continues to be under review by the U.S. Food and Drug Administration.
U.S. Court of Appeals for the Federal Circuit(CAFC) scheduled oral arguments for May 7, 2013in the patent litigation brought by Teva Pharmaceuticalsagainst Momenta and Sandoz. Based on the date of oral arguments, the company expects an appellate decision in the second half of 2013.
Enoxaparin Sodium Injection program update
In the first quarter of 2013, Momenta earned
$5.4 millionin Enoxaparin Sodium Injection product revenues based on Sandoz-reported net sales of $47 million.
In January, Amphastar and Actavis filed a motion for summary judgment in the District Court following the decision last year from the CAFC.
The District Courtis considering Momenta's discovery motions prior to considering Amphastar's motion for summary judgment. Tevain the parallel suit also filed a motion for summary judgment. Oral argument on Teva'smotion is scheduled for May.
In February, Momenta filed a petition for a writ of certiorari for review of the CAFC decision by the
United States Supreme Courtin its patent infringement suit against Amphastar and Actavis. In April, the Supreme Courtasked Amphastar and Actavis to respond to Momenta's filing in May 2013.
Biosimilars and Potentially Interchangeable Biologics:
- Momenta continues to invest in its biosimilar program to advance the three products currently under development: M923, M834 — two products targeting autoimmune and inflammatory indications — and M511 — a monoclonal antibody for oncology. The company is on track to submit an Investigational New Drug (IND) application in 2014 for its lead biosimilar M923, and is also targeting achievement of development criteria that would generate a license payment and a milestone payment for M511 and M834, respectively, in 2014.
M402 Phase 1/2 study amended to add Abraxane®
Momenta has amended its Phase 1/2 proof-of-concept study to add the chemotherapy agent Abraxane® (nab-paclitaxel) into the protocol as part of the standard of care regimen to be administered in combination with Gemzar® (gemcitabine). Momenta made this change to the protocol because, in consultation with clinical key opinion leaders and other experts, it is clear that standard of care is evolving towards the Abraxane/gemcitabine combination as first line therapy for metastatic pancreatic cancer. The overall design of the current study will not change with the addition of Abraxane to the standard of care treatment.
- 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. As a result of the amendment and the lead time required to implement the protocol changes, Momenta now expects to have data from Part A during the first half of 2014.
"We are pleased to be amending the M402 study to include Abraxane based on its promising Phase 3 clinical results," said
Sialylation research program
- Momenta continues to make significant progress investigating the biology of sialylated IVIG to inform the company's selection of the best indication to consider taking forward into its first clinical programs, as well as defining the specific product to advance to the clinic.
First Quarter 2013 Financial Results
Total revenue for the first quarter of 2013 was
Research and development expenses, including stock-based compensation, for the first quarter of 2013 were
General and administrative expenses for the first 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 May 14, 2013.
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||$ 324,204||$ 340,603|
|Total assets||$ 382,688||$ 406,629|
|Liabilities and Stockholders' Equity|
|Current liabilities||$ 15,890||$ 18,161|
|Deferred revenue, net of current portion||26,096||27,269|
|Total liabilities and stockholders' equity||$ 382,688||$ 406,629|
|MOMENTA PHARMACEUTICALS, INC.|
|Unaudited Condensed Statements of Comprehensive Loss|
|(in thousands, except per share amounts)|
Ended March 31,
|Product revenue||$ 5,396||$ 22,029|
|Research and development revenue||2,207||2,199|
|Total collaboration revenue||7,603||24,228|
|Research and development*||22,332||18,562|
|General and administrative*||9,716||10,955|
|Total operating expenses||32,048||29,517|
|Other income (expense):|
|Total other income||329||307|
|Net loss||$ (24,116)||$ (4,982)|
|Basic and diluted net loss per share||$ (0.48)||$ (0.10)|
|Shares used in computing basic and diluted net loss per share||50,635||50,240|
|Comprehensive loss||$ (24,181)||$ (4,875)|
|* Non-cash share-based compensation expense included in operating expenses is as follows:|
|Research and development||$ 1,123||$ 1,355|
|General and administrative||$ 1,748||$ 1,899|
Lora Pike Momenta Pharmaceuticals, Inc.firstname.lastname@example.org (617) 395-5189
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