Momenta Pharmaceuticals Reports Fourth Quarter and Year End 2013 Financial Results
For the fourth quarter of 2013, the company reported a net loss of
"We successfully executed on our 2013 corporate objectives and in doing so we have paved the way for value creation across our three businesses," said
Fourth Quarter Highlights and Recent Events
Complex Generics Business:
M356, generic version of Copaxone® (Glatiramer Acetate Injection)
ANDAfor M356 is under active review by the U.S. FDA. The company and its collaboration partner, Sandoz, are preparing for the potential launch of this generic in 2014, pending U.S. FDAapproval.
December 2013, the District Court modified the injunctions to exclude the 2015 invalidated Copaxone patent and the permanent injunction now expires on May 24, 2014.
Enoxaparin Sodium Injection
In the fourth quarter of 2013, Momenta earned
$4.9 millionin product revenues from enoxaparin sodium injection based on Sandoz reported net sales of $51 million.
Momenta continues to pursue the patent infringement case of
Momenta Pharmaceuticalsvs. Amphastar Pharmaceuticals, Inc., where the Federal Circuit ruled that Amphastar's use of Momenta's patented manufacturing method is protected by the Hatch Waxman "safe harbor." In January 2014, Momenta appealed the District Court's final judgment to the Federal Circuit.
Biosimilar and Potentially Interchangeable Biologics Business:
Momenta expects to achieve milestones in the second half of 2014 under its global biosimilar collaboration with Baxter for products M923 and M834. The aggregate value of these potential milestones is
$19 million. M923 and M834 are biosimilars for branded biologics indicated for certain autoimmune and inflammatory diseases. For M923, the company expects to achieve a technical development milestone. In addition, Momenta and Baxter are pursuing a global regulatory strategy for M923 and expect to enter the clinic in Europein the second half of 2014, which also triggers a milestone payment. For M834, the company expects to achieve a pre-defined development milestone.
Baxter's option to select up to three additional biosimilars to be included in the collaboration expires in
- Momenta is continuing to develop M511, a monoclonal antibody for oncology, and may seek a new collaboration partner to assist in its development and commercialization.
December 2013, Michael Franken, M.D., joined Momenta as President, Biosimilars Business to oversee the operational management of the company's biosimilars programs, including the collaboration with Baxter, strategic planning, P&L responsibility, and other supporting activities.
Novel Drug Business:
M402 novel oncology candidate
- Momenta expects to have clinical data in the first half of 2014 from Part A of a Phase 1/2 proof-of-concept trial evaluating M402 in combination with Abraxane® (nab-paclitaxel) and gemcitabine in patients with advanced metastatic pancreatic cancer.
- The open label Phase 1/2 trial has completed several dose escalation cohorts, and based on encouraging signs of tolerability Momenta continues to add cohorts at a higher dose of M402.
- The company plans to initiate Part B of the study by the end of 2014. 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.
- Last month, Momenta researchers presented a poster entitled: "M402 Increases Gemcitabine Uptake into Pancreatic Tumors as a Result of Stromal Matrix Remodeling" at the 2014 Gastrointestinal Cancers Symposium.
- In 2014, Momenta will continue to advance its sialylation technology research program by seeking to identify an Fc-containing recombinant product candidate by the end of the year. The company is investigating opportunities to partner further development of a sialylated plasma-derived IVIG.
December 2013, Momenta entered into an agreement with AnaptysBio to support its research programs. Under the agreement, AnaptysBio will attempt to generate several novel antibodies against a specific therapeutic target using its proprietary SHM-XEL™ platform. If AnaptysBio is successful, Momenta has an option to acquire a predefined number of the antibodies for development as drug candidates.
- Momenta continues to seek and evaluate research collaborations to provide capabilities to broaden and accelerate its novel drug programs.
Fourth Quarter and Year End 2013 Financial Results
Total revenues for the fourth quarter of 2013 were
Collaborative research and development revenue for the fourth quarter of 2013 was
Research and development expenses for the fourth quarter of 2013 were
General and administrative expenses for the quarter ended
Today, Momenta provided guidance that its 2014 total operating expenses, excluding stock-based compensation and net of collaborative revenues, are expected to average
Conference Call Information
Management will host a conference call and webcast today at
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 42665842. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible 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, including total operating expenses for 2014, comments regarding fourth quarter revenue as indicative of future enoxaparin revenue, potential approval and launch of M356, anticipated achievement of development milestones, including milestones under the Baxter collaboration in 2014, and cash usage, and other results of operations, our expected product development and collaboration milestones and timing for clinical and non-clinical results, our plans for future research and development investment, and our other product development plans and expectations constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "hope," "target," "project," "goals," "potential," "predict," "might," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors referred to in the company's Quarterly Report on Form 10-Q for quarter ended
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|Unaudited Condensed Consolidated Balance Sheets|
|Cash and marketable securities||$ 245,682||$ 340,603|
|Total assets||$ 316,815||$ 406,629|
|Liabilities and Stockholders' Equity|
|Current liabilities||$ 21,942||$ 18,161|
|Deferred revenue, net of current portion||24,024||27,269|
|Other long-term liabilities||1,012||712|
|Total liabilities and stockholders' equity||$ 316,815||$ 406,629|
|Unaudited Condensed Statements of Comprehensive Loss|
|(in thousands, except per share amounts)|
|Three Months Ended||Year Ended|
|Product revenue||$ 4,903||$ 10,812||$ 16,701||$ 54,772|
|Research and development revenues||7,847||1,916||18,764||9,149|
|Total collaboration revenue||12,750||12,728||35,465||63,921|
|Research and development*||32,238||21,540||103,999||80,345|
|General and administrative*||10,848||9,373||41,057||43,682|
|Total operating expenses||43,086||30,913||145,056||124,027|
|Other income (expense):|
|Total other income||274||508||1,183||1,458|
|Net loss per share:|
|Basic||$ (0.59)||$ (0.35)||$ (2.13)||$ (1.16)|
|Diluted||$ (0.59)||$ (0.35)||$ (2.13)||$ (1.16)|
|Weighted average shares outstanding:|
|Comprehensive loss||$ (30,157)||$ (17,737)||$ (108,494)||$ (58,456)|
|*Includes the following share-based compensation expense:|
|Research and development||$ 1,551||$ 1,515||$ 5,520||$ 5,832|
|General and administrative||$ 1,916||$ 1,937||$ 7,302||$ 7,880|
Lora Pike Momenta Pharmaceuticals, Inc.firstname.lastname@example.org (617) 395-5189
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