01.11.2017 13:05:00

Momenta Pharmaceuticals Reports Third Quarter 2017 Financial Results and Provides Corporate Update

-- Ended third quarter with a strong cash position of $423M --CAMBRIDGE, Mass., Nov. 01, 2017 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) today reported its financial results for the third quarter ended September 30, 2017 and provided a corporate update."We continue to believe in the potential for the approval and launch of Glatopa® 40 mg in late 2017 or early 2018 and that there remains a meaningful market opportunity for this product in the U.S.," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "In the third quarter of 2017, we continued to advance our broad portfolio of biosimilar and novel drug candidates and more recently we were thrilled to announce the promotion of our co-founder, Ganesh Kaundinya, to Chief Operating Officer. We look forward to his continued contributions as we progress our robust portfolio of drug candidates."Third Quarter Highlights and Recent EventsComplex Generics:Glatopa® 20 mg: First FDA-approved, substitutable generic daily COPAXONE® 20 mg (glatiramer acetate injection) for patients with relapsing forms of multiple sclerosis developed in collaboration with SandozIn the third quarter of 2017, Momenta recorded $10.9 million in product revenues from Sandoz's Glatopa 20 mg sales.In the third quarter of 2017, Momenta earned a $10 million milestone payment from Sandoz in connection with Glatopa 20 mg's status at that time as the sole FDA-approved generic of COPAXONE 20 mg in the U.S. two years following its launch.Glatopa 40 mg: Designed to be a generic version of three-times-a-week COPAXONE 40 mg for patients with relapsing forms of multiple sclerosis developed in collaboration with SandozThe Abbreviated New Drug Application (ANDA) submitted by Sandoz is under U.S. Food and Drug Administration (FDA) review. An approval of the application is dependent on the satisfactory resolution of the compliance observations stated in the FDA warning letter issued in February 2017 to Pfizer, the contracted fill/finish manufacturing partner for Glatopa. Pfizer has submitted a comprehensive response to the observations cited in the warning letter. The Company believes that marketing approval from the FDA continues to be possible in late 2017 or early 2018.Biosimilars:M923: a fully-owned proposed biosimilar to HUMIRA (adalimumab)Momenta is working toward the first submission for marketing approval of M923 in late 2017. The Company expects first U.S. market formation for biosimilar versions of HUMIRA to begin in the 2022 - 2023 timeframe subject to marketing approval, patent considerations and litigation timelines.M834: a proposed biosimilar to ORENCIA (abatacept) being developed in collaboration with MylanMomenta today announced that M834 did not meet its primary pharmacokinetic endpoints in a Phase 1 study to compare the pharmacokinetics, safety and immunogenicity of M834 to US- and EU-sourced ORENCIA in normal healthy volunteers. Momenta and Mylan continue to gather and analyze these data to inform the next steps for the program.M710: a biosimilar candidate being developed in collaboration with MylanMomenta and Mylan continue to progress M710 and are targeting a first regulatory submission for clinical development by early 2018.Novel Drugs for Autoimmune Indications:M281 (anti-FcRn): a fully human monoclonal antibody (mAb) targeting the neonatal Fc receptor (FcRn)In August 2017, the Company completed the multiple ascending dose portion of the Phase 1 study in healthy volunteers. The Company plans to report the top-line data from the multiple ascending dose portion of the study in the fourth quarter of 2017.M230 (SIF3): a Selective Immunomodulator of Fc receptors being developed in collaboration with CSLIn September 2017, Momenta announced that it opted into a 50% cost and profit sharing arrangement for all products developed under the CSL agreement, including M230. Under the agreement Momenta will fund 50% of global research and development and U.S. commercialization and manufacturing costs in exchange for 50% of U.S. profits. Royalties remain payable to Momenta for territories outside the U.S. and milestones are reduced.Momenta and CSL have agreed upon a development plan for M230 and CSL is targeting a clinical trial in late 2017, subject to regulatory feedback.M254 (hsIVIg): a robust, controlled sialylation process to generate tetra-Fc-sialylated immunoglobulins with consistent enhanced anti-inflammatory activityThe Company continues to progress the M254 program and expects to initiate an IND-enabling toxicology study in 2017 and is targeting a clinical trial in 2018.Third Quarter 2017 Financial ResultsRevenue: In the third quarter of 2017, the Company recorded $10.9 million in product revenues from Sandoz's sales of Glatopa 20 mg compared to $23.3 million for the same period in 2016. The decrease in product revenues of $12.4 million, or 53%, was primarily due to higher sales deductions for Medicaid rebates, inventory price adjustments relating to Mylan's entry into the COPAXONE market and a deduction of $0.2 million for reimbursement to Sandoz of the Company's share of Glatopa-related legal expenses in the third quarter of 2017. In addition, under the terms of the collaboration agreement with Sandoz, the $10 million commercial milestone payment Momenta earned from Sandoz in the third quarter of 2017 was deducted from net profit prior to the calculation of Momenta's 50% profit share.Research and development revenue for the third quarter of 2017 was $13.2 million compared to $5.8 million recorded in the same quarter last year. The increase in research and development revenue of $7.4 million, or 128%, was primarily due to a $10 million commercial milestone payment earned by the Company on July 1, 2017 in connection with GLATOPA 20 mg/mL's continuing to be the sole FDA-approved generic of COPAXONE at that time and achieving a certain level of contractually defined profits in the United States, partially offset by less revenue due to the termination of the Baxalta Collaboration Agreement, effective December 31, 2016, under which the Company was reimbursed for M923 employee expenses and external costs and for which  Momenta recognized a portion of Baxalta's initial upfront payment in the third quarter of 2016.Total revenues for the third quarter of 2017 were $24.1 million compared to $29.1 million for the same period in 2016.Operating Expenses: Total GAAP operating expenses were $58.6 million in the third quarter of 2017. Research and development expenses for the third quarter of 2017 were $37.9 million, compared to $31.6 million for the same period in 2016. The increase of $6.3 million, or 20%, was primarily due to $12.4 million in increased spending on M923, as the program was transitioned back to Momenta effective December 31, 2016 in connection with the termination of the Baxalta Collaboration Agreement, partially offset by a $3.4 million reduction in spend on the necuparanib program, which was discontinued in August 2016, and a $2.6 million lower spend on M230 ...Full story available on Benzinga.com
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