Momenta Pharmaceuticals Reports Second Quarter 2013 Financial Results
For the second quarter of 2013, the company reported a net loss of
"We are extremely pleased with the recent opinion by the Federal Circuit that found several Copaxone® patents
"In addition to the favorable Federal Circuit ruling, our 2013 achievements include advancing our lead biosimilar product M923 toward a planned IND submission in 2014 and executing on objectives for our biosimilars and novel drug programs," continued
Second Quarter Highlights and Recent Progress
M356, generic version of Copaxone® (glatiramer acetate injection)
July 26, the U.S. Court of Appeals for the Federal Circuit(CAFC) issued a written opinion in the patent litigation brought by Teva Pharmaceuticalsagainst Momenta and Sandoz for infringement of nine U.S. patents associated with the submission to the FDAof an Abbreviated New Drug Application (ANDA) for generic Copaxone. The CAFC opinion followed oral arguments conducted in May. The CAFC narrowed the 2012 decision by the District Court for the Southern District of New Yorkand invalidated several asserted patents, including the one non-Orange Book patent set to expire in September 2015.
The CAFC ruling does not vacate the permanent injunctions. The case was remanded back to the District Court in order to modify the permanent injunction to exclude the invalidated patents consistent with the CAFC ruling.
In July, the
District Court for the Southern District of New Yorkgranted Momenta's and Sandoz' motion to dismiss another case asserted by Tevaagainst the company alleging infringement of patents referred to as the "Gad patents" that involve molecular weight markers for Copaxone.
ANDAfor M356 continues to be under review by the U.S. FDA.
Enoxaparin Sodium Injection
In the second quarter of 2013, Momenta earned
$1.6 millionin Enoxaparin Sodium Injection product revenues based on Sandoz-reported net sales of $57 million. The product revenues for Momenta include royalties on the quarter's net sales, less a $3.8 millionannual adjustment to Momenta's share of pre-commercial development expenses under its collaboration with Sandoz.
In June, the
Supreme Court of the United Statesdenied to hear the case of Momenta Pharmaceuticalsvs. Amphastar Pharmaceuticals, Inc.in which the U.S. Court of Appeals for the Federal Circuitheld that Amphastar's use of Momenta's patented method was protected by the "safe harbor" provision from patent infringement under 35 U.S.C. sec. 271(e)(1).
In July, the
District Court of Massachusettsgranted Amphastar and Teva'smotions for summary judgment in the Enoxaparin patent suits as a result of the decision by the Court of Appeals. Momenta is considering options for appeal.
Biosimilars and Potentially Interchangeable Biologics:
- Momenta continues to advance toward achievement of defined 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 are achievement of technical development criteria and the first submission of an Investigational New Drug (IND) application in 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.
- Momenta with its collaborator Baxter continues to evaluate additional products for development.
M402 Phase 1/2 proof-of-concept study
- In April, Momenta amended its Phase 1/2 proof-of-concept study to evaluate 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. Dosing of several cohorts in Part A has been completed, including one with the new regimen of M402 plus Abraxane and gemcitabine. Momenta expects to have data from Part A during the first half of 2014.
Sialylation research program
Rockefeller Universitywas issued the first U.S. patent related to sialylation technology. Momenta is the exclusive licensee of the patent. The patent claims methods of inhibiting inflammation using intravenous immunoglobulin (IVIG)-derived, sialylated Fc regions and expires in 2028.
- Momenta continues to generate data to investigate and validate the biology of sialylated IVIG to inform the company's selection of the indication to potentially take forward into development, as well as to define the specific product, or products, to potentially advance to the clinic.
Second Quarter 2013 Financial Results
Total revenue for the second quarter of 2013 was
Research and development expenses, including stock-based compensation, for the second quarter of 2013 were
General and administrative expenses for the second 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
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|MOMENTA PHARMACEUTICALS, INC.|
|Unaudited, Condensed Consolidated Balance Sheets|
|Cash and marketable securities||$ 300,160||$ 340,603|
|Total assets||$ 357,759||$ 406,629|
|Liabilities and Stockholders' Equity|
|Current liabilities||$ 16,829||$ 18,161|
|Deferred revenue, net of current portion||25,412||27,269|
|Total liabilities and stockholders' equity||$ 357,759||$ 406,629|
|MOMENTA PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS|
|(in thousands, except per share amounts)|
Ended June 30,
Ended June 30,
|Research and development revenue||2,733||2,511||4,940||4,709|
|Total collaboration revenue||4,361||21,863||11,964||46,091|
|Research and development*||21,994||20,011||44,326||38,572|
|General and administrative*||11,516||12,353||21,233||23,310|
|Total operating expenses||33,510||32,364||65,559||61,882|
|Total other income||301||335||630||642|
|Basic and diluted net loss per share||
|Weighted average shares used in computing basic and diluted net loss per share||50,746||50,354||50,690||50,297|
|* Non-cash share-based compensation expense included in operating expenses is as follows:|
|Research and development||$ 1,487||$ 1,432||$ 2,610||$ 2,786|
|General and administrative||$ 1,842||$ 2,025||$ 3,591||$ 3,925|
Lora Pike Momenta Pharmaceuticals, Inc.firstname.lastname@example.org (617) 395-5189
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