Momenta Pharmaceuticals Reports First Quarter 2015 Financial Results
For the first quarter of 2015, the company reported a net loss of
First Quarter Highlights and Recent Events
GlatopaTM, generic version of daily COPAXONE® 20 mg (glatiramer acetate injection)
April 16, 2015, Glatopa was approved by the FDAas the first and only "AP-rated," substitutable generic version of daily COPAXONE 20 mg. The Company earned a $10.0 millionmilestone for the sole approval under its collaboration agreement with Sandoz.
January 20, 2015, the United States Supreme Courtvacated the 2013 decision of the Court of Appeals for the Federal Circuit(CAFC) which found several of the daily COPAXONE (20 mg/mL injection) patents invalid for being indefinite, including the one remaining patent which expires on September 1, 2015. At the request of the appeals court, all parties submitted abbreviated briefs on March 2, 2015. On April 16, 2015Sandoz and Momenta sent the appeals court a request for an expedited decision with appeal to follow based on the FDAapproval of Glatopa. The Company expects the appeals court to issue a decision at any time.
The ANDA for a three-times-a-week generic COPAXONE 40 mg (glatiramer acetate injection), submitted by Sandoz, is under
Enoxaparin Sodium Injection
In the first quarter of 2015, Momenta earned
$2.7 millionin product revenues from enoxaparin sodium injection based on Sandoz reported net sales of $25.9 million.
The Company continues to pursue the patent infringement case related to Momenta's U.S. Pat. 7,575,886 against Amphastar and Teva. In a 2012 decision, the
CAFCvacated a preliminary injunction based on the Hatch Waxman "safe harbor" ( Momenta Pharmaceuticalsvs. Amphastar Pharmaceuticals, Inc. Fed. Cir. Aug. 3, 2012). The safe harbor issue is on appeal and a CAFChearing has been scheduled for May 4, 2015with a decision expected in 2015.
February 2015, Momenta and Baxter initiated a randomized, double-blind, single-dose study in healthy volunteers to compare the pharmacokinetics, safety, tolerability and immunogenicity of M923, a biosimilar version of HUMIRA® (adalimumab), versus HUMIRA. The companies expect to have data from this study in the fourth quarter of 2015. The target date for the first regulatory submission for approval is 2017.
February 16, 2015, Baxter terminated its license to M834, a biosimilar version of ORENCIA® (abatacept). Baxter also let expire its right to select additional targets for biosimilar development under the collaboration.
- Momenta continues to develop M834 and its portfolio of early stage biosimilar candidates and is in active discussions with potential collaboration partners to assist in their development and commercialization.
Necuparanib (novel oncology candidate)
- Momenta's Phase 2 trial to evaluate the antitumor activity of necuparanib in combination with Abraxane® (nab-paclitaxel) plus gemcitabine, versus Abraxane plus gemcitabine alone, is currently enrolling. The Company expects to have clinical data available as early as the end of 2016 or in the first half of 2017.
Mature data from Momenta's Phase 1 study evaluating necuparanib in combination with Abraxane and gemcitabine in patients with metastatic pancreatic cancer will be presented at the upcoming ASCO meeting on
June 1, 2015in Chicago, IL.
Momenta's three novel autoimmune candidates are in preclinical development. These candidates include a hyper-sialylated IVIg (hsIVIg), a high potency alternative to IVIg, and two recombinant molecules: a Selective Immunomodulator of Fc receptors (SIF3) and an anti-FcRn monoclonal antibody. The recombinant molecules have been designed by leveraging the Company's knowledge of the anti-inflammatory effects of IVIg to maximize therapeutic benefit and patient convenience. Momenta believes these programs could have potential in a range of diseases that currently have few treatment options such as autoimmune neuropathies, autoimmune blood disorders and blistering skin diseases. The Company expects to advance the recombinant candidates with a goal of entering the clinic in late 2016, and is pursuing potential partnering opportunities for the further development and commercialization of its hsIVIg program.
First Quarter 2015 Financial Results
Total revenues for the first quarter of 2015 were
Research and development expenses for the first quarter of 2015 were
General and administrative expenses for the quarter ended
Today, Momenta provided guidance that its net cash usage, excluding revenue from the approval and potential launch of Glatopa, and excluding revenue from any potential new collaboration(s), will be approximately
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 15401350. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through
Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for oncology and autoimmune indications.
To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release.
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Forward Looking Statements
Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements about the Company's future net cash usage, revenues and operating expense, timing for Glatopa launch and outcome of the patent litigation relating to Glatopa and the Company's enoxaparin patents, future biosimilar program development plans, timing of presenting additional necuparanib trial data and the timing of clinical trials for the Company's novel drug product candidates. Forward-looking statements may be identified by words such as "anticipate," "believe," "continue," "could," "hope," "target," "project," "goal," "objective," "guidance," "plan," "potential," "predict," "might," "estimate," "expect," "intend," "may," "seek", "should," "will," "would," "look forward" and other similar words or expressions, or the negative of these words or similar words or expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, including those referred to under the section "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2014, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. The Company is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
|MOMENTA PHARMACEUTICALS, INC.|
|Unaudited Condensed Consolidated Balance Sheets|
|Cash and marketable securities||
|Liabilities and Stockholders' Equity|
|Deferred revenue, net of current portion||19,541||25,508|
|Other long-term liabilities||400||551|
|Total liabilities and stockholders' equity||
|Unaudited Condensed Statements of Comprehensive Loss|
|(in thousands, except per share amounts)|
Ended March 31,
|Research and development revenue||5,840||5,973|
|Total collaboration revenue||8,562||10,785|
|Research and development*||22,749||26,692|
|General and administrative*||7,890||11,717|
|Total operating expenses||30,639||38,409|
|Total other income||200||262|
|Basic and diluted net loss per share||
|Weighted average shares used in computing basic and diluted net loss per share||54,492||51,356|
|Net unrealized holding gains (losses) on available-for-sale marketable securities||18||(16)|
|* Non-cash share-based compensation (income) expense included in operating expenses is as follows:|
|Research and development||
|General and administrative||
CONTACT: INVESTOR CONTACT:
Sarah Carmody Momenta Pharmaceuticals1-617-395-5189 IR@momentapharma.com MEDIA CONTACT: Karen Sharma MacDougall Biomedical Communications1-781-235-3060 Momenta@macbiocom.com
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