Momenta’s (MNTA) Q2 Loss Narrows Y/Y, Glatopa in Focus

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Momenta Pharmaceuticals Inc. MNTA reported second-quarter 2015 loss of 4 cents per share, much narrower than the Zacks Consensus Estimate of a loss of 39 cents and the year-ago loss of 51 cents.

Revenues were jumped 310% to $44.9 million from the year-ago quarter, surpassing the Zacks Consensus Estimate of $13 million. Total revenue comprised product revenues ($19.3 million), and research and development revenues ($25.6 million).

The Quarter in Detail

Research and development expenses came in at $34 million, up 30.3% from the year-ago quarter. The increase reflects third-party process development costs for the biosimilars programs, pipeline developments costs and share-based compensation expense.

General and administrative expenses were $13.3 million, up 18.8% year over year driven by share-based compensation expenses.

Momenta’s partner Sandoz (a Novartis NVS company) launched Glatopa, a once-daily generic version of Teva’s TEVA Copaxone on Jun 18, 2015. Momenta recorded $19.2 million in product revenues from Glatopa sales in this quarter, net of a deduction of $9 million for reimbursement to Sandoz. Momenta earned a $10 million milestone from Sandoz upon Glatopa’s FDA approval and another $10 million milestone was received upon the first commercial sale of Glatopa.

Meanwhile, Momenta and Sandoz amended their agreement for enoxaparin sodium injection by replacing the royalty payment with a 50% profit share. In the reported quarter, Momenta earned $0.1 million in revenues from sales of Enoxaparin Sodium Injection.

Pipeline Update

Momenta’s three-times-a-week generic version of Teva’s Copaxone is currently under FDA review. The company believes that this formulation can be commercially launched as early as the first quarter of 2017.

Under collaboration with Baxalta Inc. BXLT, Momenta is studying the pharmacokinetics, safety, tolerability and immunogenicity of M923, the biosimilar version of Humira, in healthy volunteers in comparison with Humira. Data should be out by the fourth quarter of 2015 and the first regulatory submission for the candidate is expected in 2017. Momenta said that it is looking for a partner for its biosimilars portfolio.

Additionally, Momenta is enrolling patients in a phase II study to evaluate the anti-tumor activity of necuparanib in combination with Abraxane and Gemzar, versus the Abraxane/Gemzar combination alone. Data from this study should be out by first half of 2017.

Second-Half 2015 Guidance

Momenta expects operating expenses (excluding stock-based compensation and net of collaborative revenues) in the range of $36 million – $40 million per quarter for the second half of 2015.

Our Take

Momenta’s second-quarter 2015 results were encouraging with the company posting narrower-than-expected loss. The approval and launch of Glatopa was a major positive for the company. Being a lower cost alternative and the first and only “AP-rated” substitutable generic version of daily Copaxone 20 mg/mL, Momenta and Sandoz will enjoy the first opportunity of providing a much-needed and affordable treatment option for multiple sclerosis. Additionally, we are pleased with Momenta’s progress on developing necuparanib.

Momenta carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Actelion Ltd. ALIOF, carrying a Zacks Rank #1 (Strong Buy).

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