Momenta Pharmaceuticals Reports Second Quarter 2015 Financial Results
--Launch of GlatopaTM drives second quarter revenue growth--
--Company strengthens balance sheet through
For the second quarter of 2015, the Company reported total revenues of
"Momenta reached a significant milestone in the second quarter of 2015 with the launch of Glatopa, our second approved complex generic product and the first and only generic version of daily COPAXONE® available on the market. We are pleased with Sandoz's execution of the Glatopa launch and encouraged by the strong initial uptake seen thus far," said
Second 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.
June 18, 2015, the U.S. Court of Appeals for the Federal Circuit(CAFC) again found the remaining patent on daily COPAXONE 20 mg at issue in Teva's infringement suit to be invalid.
- Sandoz launched Glatopa on
June 18, 2015. In the second quarter of 2015, Momenta recorded $19.2 millionin product revenues from Glatopa sales, net of a deduction of $9.0 millionfor reimbursement to Sandoz of the Company's share of pre-launch Glatopa-related legal expenses.
- Under its collaboration agreement with Sandoz, Momenta earned a
$10.0 millionmilestone payment upon Glatopa receiving sole FDAapproval and an additional $10.0 millionmilestone payment upon first commercial sale of Glatopa.
- The ANDA for a three-times-a-week generic COPAXONE 40 mg (glatiramer acetate injection), submitted by Sandoz in
August 2014, is under FDAreview.
Enoxaparin Sodium Injection
June 2015, the Company and Sandoz amended their enoxaparin collaboration agreement replacing the royalty payment with a 50% profit share. The amendment was effective April 1, 2015. In the second quarter of 2015, Momenta earned $0.1 millionin product revenues from enoxaparin sales.
- 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). On May 4, 2015, the CAFCheld a hearing on the Company's appeal of summary judgment, and requested the views of the U.S. Solicitor General on the government's interpretation of the safe harbor provision. On July 13, 2015, the U.S. Solicitor General filed its brief providing support of Momenta's interpretation of the "safe harbor". A CAFCdecision is expected in 2015.
- M923, a biosimilar version of HUMIRA® (adalimumab), is currently being studied in a randomized, double-blind, single-dose study in healthy volunteers to compare its pharmacokinetics, safety, tolerability and immunogenicity versus HUMIRA. Momenta and Baxalta (formerly Baxter) 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.
- 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 collaboration partners to assist in their development and commercialization.
July 2, 2015, Momenta filed a petition for Inter Partes Review (IPR) with the Patent Trial and Appeal Board to challenge the validity of Bristol Myers Squibb's ORENCIA subcutaneous formulation U.S. Pat. 8,476,239. The Company expects a decision on institution of the IPR in January 2016.
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 in the first half of 2017.
- Momenta presented updated data from its Phase 1 study evaluating necuparanib in combination with Abraxane and gemcitabine in patients with metastatic pancreatic cancer at the
American Society of Clinical Oncologyannual meeting on June 1, 2015. Necuparanib showed acceptable safety, tolerability, and encouraging signals of activity in the updated Phase 1 dataset.
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.
Second Quarter 2015 Financial Results
Total revenues for the second quarter of 2015 were
Enoxaparin product revenue for the second quarter of 2015 was
Collaborative research and development revenue for the second quarter of 2015 was
Research and development expenses for the second 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 72189957. 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.
Our logo, trademarks, and service marks are the property of
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 operating expenses; program development and partnering plans; timing of clinical trials and receipt 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 March 31, 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||$||377,166||$||191,529|
|Liabilities and Stockholders' Equity|
|Deferred revenue, net of current portion||17,098||25,508|
|Other long-term liabilities||250||551|
|Total liabilities and stockholders' equity||$||463,577||$||256,216|
|Unaudited Condensed Statements of Comprehensive Loss|
|(in thousands, except per share amounts)|
Ended June 30,
Ended June 30,
|Research and development revenue||25,595||5,260||31,436||11,233|
|Total collaboration revenue||44,900||10,950||53,463||21,735|
|Research and development*||33,983||26,089||56,733||52,781|
|General and administrative*||13,329||11,219||21,219||22,936|
|Total operating expenses||47,312||37,308||77,952||75,717|
|Total other income||190||202||390||464|
|Basic and diluted net loss per share||$||(0.04||)||$||(0.51||)||$||(0.41||)||$||(1.04||)|
|Weighted average shares used in computing basic and diluted net loss per share||61,680||51,466||58,106||51,411|
|Net unrealized holding gains (losses) on available-for-sale marketable securities||18||37||36||21|
|* Non-cash share-based compensation expense included in operating expenses is as follows:|
|Research and development||$||3,125||$||1,701||$||910||$||3,246|
|General and administrative||$||3,491||$||1,964||$||1,321||$||3,870|
Sarah Carmody Momenta Pharmaceuticals1-617-395-5189 IR@momentapharma.com MEDIA CONTACT: Karen Sharma MacDougall Biomedical Communications1-781-235-3060 Momenta@macbiocom.com
News Provided by Acquire Media