Momenta Pharmaceuticals Reports First Quarter 2014 Financial Results
For the first quarter of 2014, the company reported a net loss of
"We and Sandoz are continuing to work toward an
First Quarter Highlights and Recent Events
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.
March 31, 2014, the Supreme Court of the United Statesgranted Teva'srequest for certiorari in our generic Copaxone patent litigation. The Supreme Courtwill likely hear the case in the fourth quarter of 2014.
April 18, 2014, Chief Justice John Robertsdenied Teva'srequest for a stay of the CAFC ruling; Tevasought to prohibit the introduction of an FDA-approved generic Copaxone prior to the Supreme Courtresolution of the case.
Enoxaparin Sodium Injection
In the first quarter of 2014, Momenta earned
$4.8 millionin product revenues from enoxaparin sodium injection based on Sandoz reported net sales of $47.5 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:
Momenta continues to progress its biosimilars portfolio. M923 and M834 are biosimilars for branded biologics indicated for certain autoimmune and inflammatory diseases. M511 is a monoclonal antibody for oncology. Under its global biosimilar collaboration with Baxter, Momenta expects to achieve milestones in the second half of 2014 for products M923 and M834 with an aggregate value of
$19 million. Momenta and Baxter are pursuing a global regulatory strategy for M923 and expect to submit a clinical trial application towards the end of 2014, which would allow clinical initiation in Europe. For M834, the company expects to achieve a pre-defined development milestone in the second half of 2014.
Baxter's option to select up to three additional biosimilars to be included in the collaboration expires in
- Momenta is continuing to develop M511, and may seek a new collaboration partner to assist in its development and commercialization.
M402 novel oncology candidate
- In the next several months, Momenta expects to complete the Part A dose escalation component of the Phase 1/2 trial evaluating M402 in combination with Abraxane® (nab-paclitaxel) and gemcitabine in patients with advanced metastatic pancreatic cancer, and to report clinical data from Part A in the second half of 2014.
- 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.
- In 2014, Momenta continues 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.
- Momenta continues to seek and evaluate research collaborations to provide capabilities to broaden and accelerate its novel drug programs.
First Quarter 2014 Financial Results
Total revenues for the first quarter of 2014 were
Collaborative research and development revenue for the first quarter of 2014 was
Research and development expenses for the first quarter of 2014 were
General and administrative expenses for the quarter ended
Momenta announced the establishment of an "At-The-Market" equity facility. Pursuant to the facility, the company may offer and sell, from time to time, up to an aggregate of
This press release is neither an offer nor a solicitation of an offer to buy or sell securities.
Today, Momenta updated its 2014 financial guidance: 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 24579515. 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 first quarter revenue as indicative of future enoxaparin revenue, potential approval and launch of M356, timing and expectations regarding litigation related to M356, anticipated achievement of development milestones, including milestones under the Baxter collaboration in 2014, cash usage and other results of operations, potential sales under the ATM and the use of proceeds therefrom, our expected product development and collaboration milestones, timing for clinical and non-clinical trial 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 filed on
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|MOMENTA PHARMACEUTICALS, INC.|
|Unaudited Condensed Consolidated Balance Sheets|
||December 31, 2013|
|Cash and marketable securities||
|Liabilities and Stockholders' Equity|
|Deferred revenue, net of current portion||22,830||24,024|
|Other long-term liabilities||915||1,012|
|Total liabilities and stockholders' equity||
|Unaudited Condensed Statements of Comprehensive Loss|
|(in thousands, except per share amounts)|
Ended March 31,
|Research and development revenue||5,973||2,207|
|Total collaboration revenue||10,785||7,603|
|Research and development*||26,692||22,332|
|General and administrative*||11,717||9,716|
|Total operating expenses||38,409||32,048|
|Total other income||262||329|
|Basic and diluted net loss per share||
|Weighted average shares used in computing basic and diluted net loss per share||51,356||50,635|
|Net unrealized holding losses on available-for-sale marketable securities||(16)||(65)|
|* Non-cash share-based compensation expense included in operating expenses is as follows:|
|Research and development||
|General and administrative||
CONTACT: IR CONTACT:Source:
Momenta Pharmaceuticals, Inc.IR@momentapharma.com MEDIA CONTACT: Karen Sharma MacDougall Biomedical Communications1-781-235-3060 Momenta@macbiocom.com
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