Momenta Pharmaceuticals Reports Third Quarter 2014 Financial Results
For the third quarter of 2014, the company reported a net loss of
"In the third quarter we continued to make important progress across our complex generics, biosimilars and novel drug programs," said
"In a short amount of time our innovative technology platform has allowed us to develop a robust portfolio of product candidates that we believe have the potential to create significant value for our shareholders in the coming years and beyond," continued
Third Quarter Highlights and Recent Events
M356, generic version of COPAXONE® (glatiramer acetate injection)
The ANDA for 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, pending U.S. FDAapproval.
October 15, 2014, the Supreme Court of the United Statesheard oral arguments on the Teva Pharmaceuticals USAv. Sandoz case. The Supreme Courtis not expected to rule until a later date.
August 28, 2014, Momenta announced that the U.S. FDAaccepted for review the ANDA for a three-times-a-week generic COPAXONE® (glatiramer acetate injection, 40 mg/mL), submitted by Sandoz Inc., Momenta's development and commercialization collaborator for this product candidate. Momenta believes that based on publicly-available information, should the ANDA be approved, it would be eligible for 180-day first-to-file exclusivity under Hatch-Waxman.
Enoxaparin Sodium Injection
In the third quarter of 2014, Momenta earned
$4.7 millionin product revenues from enoxaparin sodium injection based on Sandoz reported net sales of $48 million.
Biosimilar and Potentially Interchangeable Biologics:
Momenta and Baxter are pursuing a global regulatory strategy for M923 (a biosimilar version of Humira®) and have submitted a European clinical trial application, which, upon approval, will allow for clinical initiation shortly thereafter. Acceptance of the clinical trial application triggers two milestones under the Baxter collaboration with an aggregate payment of
Momenta also announced that its development of M834, the Company's second biosimilar indicated for certain autoimmune and inflammatory diseases being developed in collaboration with Baxter, achieved a pre-defined
$7 milliondevelopment milestone in October 2014.
Necuparanib (novel oncology candidate)
October 9, 2014Momenta announced promising top-line results from 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. Necuparanib showed favorable tolerability and encouraging early signals of potential efficacy.
October 2014, the Company initiated patient screening for the Part B component of the Phase 1/2 trial, which is a randomized, controlled study to evaluate the antitumor activity of necuparanib in combination with Abraxane plus gemcitabine, versus Abraxane plus gemcitabine alone.
Novel Autoimmune Drugs
The Company announced it is advancing three novel autoimmune candidates toward clinical development over the next 18 to 24 months including:
- Hyper-sialylated IVIg, or hsIVIg, a high potency alternative to IVIg that in a number of in-vivo models yields a uniform high-activity, anti-inflammatory therapeutic effect at a much lower dose and may enable simpler administration and superior efficacy in certain autoimmune disease indications;
- Selective immunomodulator of Fc receptors, or SIF3, a novel recombinant protein designed to have enhanced avidity and affinity for Fc receptors, potentially making it a potent blocker of this system and treatment for autoimmune disorders where this biological pathway is activated. Momenta plans to advance this program with the goal of developing an IVIg-like efficacy profile at lower doses, potentially reducing the risks associated with plasma-derived products; and
- Anti-FcRn antibody, a fully-human monoclonal antibody that blocks the neonatal Fc receptor (FcRn). FcRn recycles IgG antibodies, enabling a long half-life. Preclinical data demonstrates that blocking the FcRn receptor with Momenta's anti-FcRn antibody effectively inhibits the binding of IgGs and leads to their rapid clearance. Momenta believes these data demonstrate high potential for acute and chronic/intermittent therapies in a broad range of autoantibody driven disease indications.
Third Quarter 2014 Financial Results
Total revenues for the third quarter of 2014 were
Collaborative research and development revenue for the third quarter of 2014 was
Research and development expenses for the third quarter of 2014 were
General and administrative expenses for the third quarter ended
Today, Momenta confirmed its financial guidance for the second half of 2014: Momenta previously projected that total 2014 operating expenses, excluding stock-based compensation and net of collaborative revenues, would be
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 23751819. 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 anticipated initiation of a European clinical trial, expected receipt or timing of milestone payments in its development programs with Baxter, future achievements and related value-creation in the Company's antibody research and development programs and product opportunities. 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 the quarter ended June 30, 2014 filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by Momenta 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. Momenta 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||$ 176,457||$ 245,682|
|Total assets||$ 241,535||$ 316,815|
|Liabilities and Stockholders' Equity|
|Current liabilities||$ 18,615||$ 21,942|
|Deferred revenue, net of current portion||21,863||24,024|
|Other long-term liabilities||701||1,012|
|Total liabilities and stockholders' equity||$ 241,535||$ 316,815|
|Unaudited Condensed Statements of Comprehensive Loss|
|(in thousands, except per share amounts)|
Ended September 30,
Ended September 30,
|Product revenue||$ 4,714||$ 4,774||$ 15,216||$ 11,798|
|Research and development revenue||4,622||5,977||15,855||10,918|
|Total collaboration revenue||9,336||10,751||31,071||22,716|
|Research and development*||27,508||27,435||80,289||71,771|
|General and administrative*||11,103||8,977||34,039||30,202|
|Total operating expenses||38,611||36,412||114,328||101,973|
|Total other income||174||279||638||910|
|Net loss||$ (29,101)||$ (25,382)||$ (82,619)||$ (78,347)|
|Basic and diluted net loss per share||$ (0.56)||$ (0.50)||$ (1.61)||$ (1.54)|
|Weighted average shares used in computing basic and diluted net loss per share||51,545||51,055||51,456||50,813|
|Net loss||$ (29,101)||$ (25,382)||$ (82,619)||$ (78,347)|
|Net unrealized holding gains (losses) on available-for-sale marketable securities||(26)||98||(5)||9|
|Comprehensive loss||$ (29,127)||$ (25,284)||$ (82,624)||$ (78,338)|
|* Non-cash share-based compensation expense included in operating expenses is as follows:|
|Research and development||$ 1,509||$ 1,359||$ 4,755||$ 3,969|
|General and administrative||$ 1,890||$ 1,796||$ 5,760||$ 5,387|
CONTACT: INVESTOR CONTACT:Source:
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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