Momenta Pharmaceuticals Reports Second Quarter 2012 Financial Results
For the second quarter of 2012, the company reported a net loss of
"We are pleased with the progress we have made in the second quarter advancing our multiple development programs," said
"Our diversified business model positions us well. In the second quarter, royalties from sales of enoxaparin sodium injection provided us with significant cash flow, and we initiated dosing in a Phase 1/2 clinical study of our novel oncology drug candidate M402. In addition, we are pleased to announce that Baxter has selected an additional product for development in our biosimilars collaboration, the third biosimilar product under development. We look forward to working closely with Baxter to address the emerging biosimilars opportunity.
"At the same time, we remain committed to our founding vision to apply advanced analytical technologies to develop novel drugs. We continue to believe that investing in all three areas of our business will build sustainable value for our shareholders," concluded
Second Quarter Highlights and Recent Progress
Complex Generics Program:
Enoxaparin sodium injection
Product revenue of
$19.4 millionfrom enoxaparin sodium injection. These revenues continue to be an important source of cash flow for Momenta.
In June, the District Court issued a claim construction order (also called a Markman decision) in the patent infringement cases against Amphastar/Watson and against
Teva. A Markman decision is considered a critical event in a patent lawsuit, as it defines the disputed patent claim terms and therefore informs many aspects of the litigation. In the order, the Court adopted the Momenta and Sandoz claim term definitions for a substantial majority of the disputed claim terms. The District Courttrial with Amphastar/Watson is scheduled for January 7, 2013and the trial in the Tevacase is scheduled for February 4, 2013.
M356, generic version of Copaxone® (glatiramer acetate injection)
In the second quarter, the
District Court of New Yorkissued a decision in the patent litigation brought against Momenta and Sandoz by Tevain August of 2008. The Court found the Copaxone patents to be valid, enforceable and infringed.
July 26, Momenta and Sandoz filed an appeal to the District Court's decision in the patent infringement lawsuit filed by Tevaagainst Momenta and Sandoz. The appeal process is expected to take 12 to 18 months.
Follow-on Biologics Program:
- Momenta announced today that Baxter selected a third biosimilar product to be developed under the collaboration. Momenta has initiated development of this product, a monoclonal antibody for oncology, which has been designated as M511.
Novel Drug Program:
M402, novel oncology candidate
- Initiated patient dosing in Part A (dose escalation phase) of a two-part Phase 1/2 proof-of-concept trial for M402 in combination with gemcitabine in people with advanced metastatic pancreatic cancer. Momenta expects to have data from Part A in the first half of 2013.
Reported preclinical data during the 2012
American Society for Clinical Oncology(ASCO) Annual Meeting showing M402 in combination with gemcitabine prolonged survival and substantially lowered the incidence of metastasis.
Sialylated IVIG research program
- Continue to advance research efforts toward proof-of-concept for our sialylated intravenous immunoglobulin (IVIG) drug candidate.
Second Quarter 2012 Financial Results
Total revenue for the second quarter of 2012 was
Collaborative revenue for the second quarter of 2012 was
Research and development expenses for the second quarter of 2012 were
General and administrative expenses for the quarter ended
Momenta confirmed its guidance provided on
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 10822254. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through August 9, 2012. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the access code 10822254.
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||$ 372,311||$ 348,438|
|Total assets||$ 445,501||$ 420,909|
|Liabilities and Stockholders' Equity|
|Current liabilities||$ 21,086||$ 16,028|
|Deferred revenue, net of current portion||28,041||1,608|
|Total liabilities and stockholders' equity||$ 445,501||$ 420,909|
|MOMENTA PHARMACEUTICALS, INC.|
|Unaudited Condensed Statements of Comprehensive (Loss) Income|
|(in thousands, except per share amounts)|
Three Months Ended
Six Months Ended
|Product revenues||$ 19,352||$ 83,848||$ 41,382||$ 159,608|
|Research and development revenues||2,511||3,648||4,709||6,060|
|Total collaboration revenues||21,863||87,496||46,091||165,668|
|Research and development*||20,011||14,168||38,572||27,111|
|General and administrative*||12,353||9,205||23,310||17,515|
|Total operating expenses||32,364||23,373||61,882||44,626|
|Operating (loss) income||(10,501)||64,123||(15,791)||121,042|
|Other income (expense):|
|Total other income||335||142||642||229|
|Net (loss) income||$ (10,166)||$ 64,265||$ (15,149)||$ 121,271|
|Net (loss) income per share:|
|Basic||$ (0.20)||$ 1.29||$ (0.30)||$ 2.44|
|Diluted||$ (0.20)||$ 1.26||$ (0.30)||$ 2.39|
|Weighted average shares outstanding:|
|Comprehensive (loss) income||$ (10,206)||$ 64,394||$ (15,082)||$ 121,347|
|*Includes the following share-based compensation expense:|
|Research and development||$ 1,432||$ 1,375||$ 2,786||$ 2,211|
|General and administrative||$ 2,025||$ 1,758||$ 3,925||$ 2,688|
Lora Pike Momenta Pharmaceuticals, Inc.firstname.lastname@example.org (617) 395-5189
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