Momenta Pharmaceuticals Reports Second Quarter 2014 Financial Results
For the second quarter of 2014, the company reported a net loss of
"We took action to ensure our portfolio would continue moving forward amidst the financial uncertainty of the Copaxone situation," continued
Second Quarter Highlights and Recent Events
M356, generic version of Copaxone (Glatiramer Acetate Injection)
ANDAfor M356 continues to be 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 Courthearing date for the case has been set for October 15, 2014.
May 14, 2014, the U.S. District Court for the District of Columbiadenied Teva'srequest to overturn the FDA'sdenial of its sixth Citizens Petition that sought to prevent generic Copaxone ANDA approval and dismissed the suit.
Enoxaparin Sodium Injection
In the second quarter of 2014, Momenta earned
$5.7 millionin product revenues from enoxaparin sodium injection based on Sandoz reported net sales of $54.2 million.
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. Under its global biosimilar collaboration with Baxter, Momenta expects to achieve milestones with an aggregate value of
$19 millionin the second half of 2014 for products M923 and M834. 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 has made the portfolio decision to discontinue development efforts on M511, a biosimilar program indicated for oncology. Resources previously allocated to M511 will be reallocated to Momenta's earlier-stage biosimilar program portfolio and to broadening Momenta's biosimilars technology base.
Necuparanib (M402 novel oncology candidate)
- Momenta expects to complete the Part A dose escalation component of the Phase 1/2 trial evaluating necuparanib 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 necuparanib in combination with Abraxane plus gemcitabine, versus Abraxane plus gemcitabine alone.
In 2014, Momenta continues to advance its research programs by seeking to identify an Fc-containing recombinant product candidate by the end of the year. The company is also investigating opportunities to partner further development of a sialylated plasma-derived IVIG.
Second Quarter 2014 Financial Results
Total revenues for the second quarter of 2014 were
Collaborative research and development revenue for the second quarter of 2014 was
Research and development expenses for the second quarter of 2014 were
General and administrative expenses for the second quarter ended
Today, Momenta updated its financial guidance for the second half of 2014: Momenta expects total operating expenses, excluding stock-based compensation and net of collaborative revenues, 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 71494254. 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 constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. They include the Company's revenue, expenses, 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, forecasted cash usage and burn, potential equity financing and use of proceeds, and expected results of operations, such as our expected product development and collaboration milestones, and timing for clinical and non-clinical trial results, our plans for future research and development investment, and our other product development plans and expectations. 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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|Unaudited Condensed Consolidated Balance Sheets|
||December 31, 2013|
|Cash and marketable securities||$ 202,276||$ 245,682|
|Total assets||$ 267,688||$ 316,815|
|Liabilities and Stockholders' Equity|
|Current liabilities||$ 19,553||$ 21,942|
|Deferred revenue, net of current portion||21,952||24,024|
|Other long-term liabilities||816||1,012|
|Total liabilities and stockholders' equity||$ 267,688||$ 316,815|
|Unaudited Condensed Statements of Comprehensive Loss|
|(in thousands, except per share amounts)|
|Three Months||Six Months|
|Ended June 30,||Ended June 30,|
|Product revenue||$ 5,690||$ 1,628||$ 10,502||$ 7,024|
|Research and development revenue||5,260||2,733||11,233||4,940|
|Total collaboration revenue||10,950||4,361||21,735||11,964|
|Research and development*||26,089||21,994||52,781||44,326|
|General and administrative*||11,219||11,516||22,936||21,233|
|Total operating expenses||37,308||33,510||75,717||65,559|
|Total other income||202||301||464||630|
|Basic and diluted net loss per share||$ (0.51)||$ (0.57)||$ (1.04)||$ (1.04)|
|Weighted average shares used in computing basic and diluted net loss per share||51,466||50,746||51,411||50,690|
|Net unrealized holding gains (losses) on available-for-sale marketable securities||37||(24)||21||(89)|
|* 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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