Momenta Pharmaceuticals, Inc. (MNTA)

[floblu14]

Momenta Pharmaceuticals Reports Second Quarter 2016 Financial Results


CAMBRIDGE, Mass., Aug. 04, 2016 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today reported its financial results for the second quarter ended June 30, 2016.

For the second quarter of 2016, the Company reported total revenues of $26.4 million, including $20.7 million in product revenues from Sandoz’s sale of Glatopa® (glatiramer acetate injection). Momenta reported a net loss of $(21.0) million, or $(0.31) per share for the second quarter compared to a net loss of $(2.2) million, or $(0.04) per share for the same period in 2015. At June 30, 2016, the Company had cash, cash equivalents, and marketable securities of $336.9 million compared to $362.8 million at March 31, 2016.

“We are pleased with the growth in product revenues from Glatopa this quarter and look forward to the potential launch of our Glatopa 40 mg product next year,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “During the remainder of 2016 we plan to announce several key milestones including announcing top-line data from a pivotal trial for M923, a biosimilar candidate of HUMIRA® developed in collaboration with Baxalta, the initiation of a clinical trial for M834, a biosimilar candidate of ORENCIA® being developed in collaboration with Mylan, and completing enrollment of the single ascending dose portion of our Phase 1 trial for M281, a novel anti-FcRn antibody candidate.”

Second Quarter Highlights and Recent Events

Complex Generics:

In the second quarter of 2016, Momenta recorded $20.7 million in product revenues from Sandoz’s Glatopa sales.
The ANDA submitted by Sandoz for a three-times-a-week generic COPAXONE® 40 mg (glatiramer acetate injection) is under FDA review. The Company expects to receive tentative regulatory approval in 2016.
A district court trial challenging four of Teva’s five Orange Book-listed patents for COPAXONE 40 mg (glatiramer acetate injection) is scheduled for September 26, 2016.
Biosimilars:

In April 2016, Momenta and its collaboration partner Baxalta, now a part of Shire, completed enrollment in the pivotal clinical trial for M923, a biosimilar candidate of HUMIRA® (adalimumab) and the companies expect to release results in late 2016. The companies are targeting first regulatory submission for marketing approval in 2017 and a first commercial launch as early as 2018.
Momenta’s global collaboration with Mylan to develop, manufacture and commercialize six of the Company’s biosimilar candidates is progressing. The companies have prioritized three lead programs including M834, a biosimilar candidate of ORENCIA® (abatacept).
Novel Drugs:

Necuparanib (novel oncology candidate)

On August 3, 2016, the Data Safety Management Board recommended that the Company discontinue further accrual in the Phase 2 trial of necuparanib in pancreatic cancer following the outcome of a planned interim futility analysis. The Company plans to confirm the futility analysis and then determine next steps for the necuparanib program.
Autoimmune Drugs
Momenta’s novel autoimmune portfolio includes two recombinant molecules: M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281, an anti-FcRn monoclonal antibody. In June 2016, the Company initiated a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of M281 in healthy subjects. M230 is in pre-clinical development, and the Company expects to initiate a clinical trial for M230 in 2017. Momenta is also developing hyper-sialylated IVIg (hsIVIg), a high potency alternative to IVIg. The Company continues its efforts to identify potential collaboration opportunities for the further development and commercialization of its hsIVIg program.

Second Quarter 2016 Financial Results

Total revenues for the second quarter of 2016 were $26.4 million compared to $44.9 million for the same period in 2015. Total revenues for the second quarter of 2016 include $20.7 million in product revenue earned from net sales of Glatopa by Sandoz, compared to $19.2 million in product revenue earned from net sales of Glatopa by Sandoz for the same period in 2015. Glatopa was launched in the second quarter of 2015, and Glatopa profit share for that quarter was reduced by $9.0 million to reimburse Sandoz for the Company’s share of pre-launch Glatopa-related legal expenses.

Collaborative research and development revenue for the second quarter of 2016 was $5.7 million compared to the $25.6 million recorded in the same quarter last year. In the second quarter of 2015, the Company earned $20.0 million in milestone payments under the Sandoz collaboration upon receiving sole FDA approval and upon the first commercial sale of Glatopa.

Research and development expenses for the second quarter of 2016 were $33.2 million, compared to $34.0 million for the same period in 2015. The decrease of $0.8 million, or 2%, from the 2015 period to the 2016 period was due to decreases of $0.8 million in stock-based compensation expense and $8.4 million for Mylan’s 50% share of biosimilar collaboration costs, which was offset by increases of $4.4 million in process and clinical development costs for M281 and biosimilars under the Company’s collaboration with Mylan, $2.2 million in non-clinical expenses to advance the Company’s novel autoimmune programs, $1.0 million in personnel-related expenses and $0.7 million in necuparanib Phase 2 clinical trial costs.

General and administrative expenses for the quarter ended June 30, 2016 were $14.9 million, compared with $13.3 million for the same period in 2015. The increase of $1.6 million, or 12%, was primarily due to an increase of $2.1 million in legal and professional fees. This increase was offset by a decrease of $0.5 million for Mylan’s 50% share of biosimilar collaboration costs.

At June 30, 2016, Momenta had $336.9 million in cash, cash equivalents and marketable securities.

http://ir.momentapharma.com/releasedetail.cfm?ReleaseID=982940