Momenta Pharmaceuticals Reports Third Quarter 2015 Financial Results
For the third quarter of 2015, the Company reported total revenues of
"The launch of Glatopa is going according to plan with Glatopa scripts currently representing approximately 25% to 30% of the once daily glatiramer acetate market," said
"We continue to advance our biosimilar and novel drug programs. Our Phase 2 study of necuparanib in pancreatic cancer is advancing and M923, our biosimilar
HUMIRA® candidate, has entered a pivotal clinical trial," continued
Third Quarter Highlights and Recent Events
GlatopaTM, generic version of daily COPAXONE® 20 mg (glatiramer acetate injection)
- Sandoz launched Glatopa on
June 18, 2015. In the third quarter of 2015, Momenta recorded $8.7 millionin product revenues from Sandoz's Glatopa sales. Glatopa is experiencing positive trade uptake, although the impact on third quarter sales was limited as launch inventory continues to be worked through. In the second quarter of 2015 Momenta's share of profit on sales of Glatopa was $28.2 million, and after a deduction of $9.0 millionin reimbursement to Sandoz of the Company's share of pre-launch Glatopa-related legal expenses, the Company recorded $19.2 millionin product revenue.
- The ANDA for a three-times-a-week generic COPAXONE 40 mg (glatiramer acetate injection), submitted by Sandoz, is under
Enoxaparin Sodium Injection
- The Company continues to pursue the patent infringement case related to Momenta's U.S. Pat. 7,575,886 against Amphastar and Actavis. In
July 2015, the U.S. Solicitor General, at the request of the Court of Appeals for the Federal Circuit, filed a brief in the case that supported Momenta's interpretation of the scope of the "safe harbor" provisions under the Hatch Waxman Act. A CAFCdecision is expected in 2015.
October 2015, Momenta and Baxalta announced the initiation of a pivotal clinical trial for M923, a biosimilar version of HUMIRA® (adalimumab). The trial is a randomized, double blind, active control, multi-center, global study in patients with chronic plaque psoriasis to compare the safety, efficacy and immunogenicity of M923 with HUMIRA. The companies are targeting first regulatory submission in 2017 and a first commercial launch in 2018.
- Momenta continues to develop M834, a biosimilar version of ORENCIA® (abatacept), and its portfolio of other biosimilar candidates and is in active discussions with potential partners to collaborate on the development and commercialization of a portfolio of its biosimilar candidates.
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 enrolling. The Company expects to have clinical data available in the first half of 2017.
- The Company continues to collect data from the Phase 1 study and plans to publish and/or present updated results following completion of the study.
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: M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281, an anti-FcRn monoclonal antibody. The Company is advancing the recombinant candidates with a goal of entering the clinic in late 2016, and is continuing its efforts to identify and explore potential partnering opportunities for the further development and commercialization of its hsIVIg program.
Third Quarter 2015 Financial Results
Total revenues for the third quarter of 2015 were
Enoxaparin product revenue decreased from
Collaborative research and development revenue for the third quarter of 2015 was
Research and development expenses for the third quarter of 2015 were
General and administrative expenses for the quarter ended
Today, Momenta provided guidance that it expects its operating expenses, excluding stock-based compensation and net of collaborative revenues, to 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 60061735. 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 ability to meet its development goals for 2015; future operating expenses; program development and partnering plans; timing of regulatory submissions and product launches; timing of clinical trials and the availability and announcement of clinical data; and the timing of decisions related to patent litigation and other patent-related proceedings. 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, 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||$||374,869||$||191,529|
|Liabilities and Stockholders' Equity|
|Deferred revenue, net of current portion||14,656||25,508|
|Other long-term liabilities||129||551|
|Total liabilities and stockholders' equity||$||438,206||$||256,216|
|Unaudited Condensed Statements of Comprehensive Loss|
|(in thousands, except per share amounts)|
Ended September 30,
Ended September 30,
|Research and development revenue||5,129||4,622||36,565||15,855|
|Total collaboration revenue||13,795||9,336||67,258||31,071|
|Research and development*||31,733||27,508||88,466||80,289|
|General and administrative*||12,459||11,103||33,678||34,039|
|Total operating expenses||44,192||38,611||122,144||114,328|
|Total other income||347||174||737||638|
|Basic and diluted net loss per share||$||(0.44||)||$||(0.56||)||$||(0.88||)||$||(1.61||)|
|Weighted average shares used in computing basic and diluted net loss per share||68,004||51,545||61,442||51,456|
|Net unrealized holding gains (losses) on available-for-sale marketable securities||(4||)||(26||)||32||(5||)|
|* Non-cash share-based compensation expense included in operating expenses is as follows:|
|Research and development||$||2,122||$||1,509||$||3,031||$||4,755|
|General and administrative||$||2,435||$||1,890||$||3,756||$||5,760|
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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