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Momenta (MNTA) Reports Narrower-than-Expected Q1 Loss

Momenta Pharmaceuticals Inc. MNTA reported a loss of 35 cents per share in the first quarter of 2016, narrower than both the Zacks Consensus Estimate of a loss of 38 cents and the year-ago loss of 40 cents.

Revenues surged 131.8% to $19.9 million but fell short of the Zacks Consensus Estimate of $27 million.

The Quarter in Detail

Total revenue comprised product revenues of $14.8 million, and research and development revenues of $5.1 million. The company earned product revenues solely from Sandoz's sales of Glatopa (a generic version of Copaxone 20 mg). Since its launch in Jun 2015, Momenta has recognized $58.2 million in product revenues from Sandoz’s sales of the drug.

We note that Sandoz’s Abbreviated New Drug Application (ANDA) for the 40-mg thrice-weekly formulation of Copaxone is currently under FDA review. The companies expect a tentative approval later in 2016.

The company did not earn any revenue from enoxaparin as no contractual profit was earned on Sandoz’s net sales of the drug in the quarter due to a change in collaboration economics from a royalty payment to a 50% profit share, reduced unit sales due to a lower market share, and continued competitive pricing.

Research and development expenses were $28.7 million, up 26.4%, reflecting higher expenses related to biosimilar and novel autoimmune drug programs, personnel-related expenses, and expenses related to the necuparanib study.

General and administrative expenses were $15.6 million, up 98.3% due to higher personnel-related expenses.

2016 Outlook

Momenta expects operating expenses (excluding stock-based compensation and net of collaborative revenues) in the range of $40 million to $45 million for each of the remaining quarters of 2016, lower than the earlier estimate of $45–$55 million.

Pipeline Update

Momenta, in collaboration with Baxalta Inc. BXLT, initiated a pivotal study on a biosimilar version of Humira, M923, for chronic plaque psoriasis. Enrolment in the study was completed in Apr 2016, with data expected in the second half of 2016 or early 2017. The first regulatory submission is expected in 2017 and the first commercial launch in 2018.

Moreover, Momenta inked an exclusive global collaboration agreement with Mylan N.V. MYL in Jan 2016 to develop, manufacture and commercialize six of its current biosimilar candidates, including M834, a biosimilar version of Orencia. The companies received regulatory clearance in Feb 2016 and expect to initiate a clinical trial on M834 in the second half of 2016. Under the agreement, Momenta received an upfront payment of $45.0 million from Mylan in the reported quarter and expects to receive another $60 million in contingent payments later this year.

Meanwhile, enrollment is ongoing in the phase II trial on necuparanib (in combination with Abraxane plus Gemzar versus Abraxane plus Gemzar alone) in pancreatic cancer following the institution of a protocol amendment in Dec 2015, with data expected in the second half of 2017. Data from the phase I study on the candidate are expected to be published or presented at a medical conference in June.

On the other hand, the company’s three novel autoimmune candidates are still in preclinical development, with one of them (M281) expected to enter the clinical stage in 2016. The company has received regulatory clearance to initiate a phase I dosing study on M281 in the forthcoming weeks.

Our Take

Momenta reported mixed results for the first quarter of 2016, with the company posting a narrower-than-expected loss but revenues missing expectations. On the earnings call, management stated that Glatopa has now captured nearly 35% of the once-daily Copaxone 20 mg market, up from 30% at 2015 end.

We note that Glatopa sales have rebounded since the third quarter of 2015 as inventories were worked through. However, Teva has already switched approximately 75% of once-daily Copaxone 20 mg patients to thrice-weekly Copaxone 40 mg. Nevertheless, we are encouraged by the company’s progress with biosimilars in its pipeline.

Momenta currently carries a Zacks Rank #3 (Hold). Shire plc SHPG is a better-ranked stock in the healthcare sector, with a Zacks Rank #2 (Buy).

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