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Momenta's (MNTA) Earnings & Revenues Surpass Estimates in Q4
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Following the announcement of fourth-quarter of 2017 results, shares of Momenta Pharmaceuticals Inc. moved up 2.5%.
The company reported earnings per share of 18 cents in the quarter, beating the Zacks Consensus Estimate of 6 cents. The figure, however, was down from 60 cents earned in the year-ago quarter.
Revenues in the quarter came in at $64.6 million and topped the Zacks Consensus Estimate of $62.7 million and was up from $34.2 million in the year-ago quarter.
Momenta’s stock has gained 3.5% in the last six months as against the industry’s decline of 3.3%.
Quarter in Detail
Momenta’s top-line comprises product revenues of $13.4 million earned from Sandoz’s sales of Glatopa, a generic version of Copaxone (20 mg), compared with $15.8 million in the year-ago quarter. The decrease was primarily due to inventory price adjustments owing to Mylan’s entry into the Copaxone market along with a deduction of $0.6 million for reimbursing the company’s share of Glatopa-related legal expenses to Sandoz.
Collaborative research and development revenues came in at $51.2 million, up from $18.4 million in the year-ago quarter. The increase was due to a revenue recognition of $50.0 million upfront payment from CSL in fourth-quarter 2017.
While, research and development expenses were up to $36.1 million from $26.4 million in the year-ago quarter, general and administrative expenses decreased 13.2% to $15.8 million.
Outlook
Momenta expects operating expenses (excluding stock-based compensation and net of collaborative revenues) in the range of $180-$200 million in 2018. Operating expenses in first-quarter 2018 are projected around $45-$55 million.
Momenta expects to generate revenues of $45 million from Mylan as upfront payment on a quarterly basis.
Pipeline Updates
Momenta announced that the FDA has finally approved Sandoz's Abbreviated New Drug Application for Glatopa 40 mg. Both companies suffered a setback with the FDA issuing a warning letter to Pfizer (PFE - Free Report) in February 2017, which is Sandoz’s contracted fill/finish manufacturing partner for Glatopa.
Meanwhile, Momenta continues to progress with its other pipeline candidates. In January 2018, Momenta and Mylan announced plans to initiate a patient clinical trial of M710 — a proposed biosimilar of Eylea — in the first half of 2018. An Investigational New Drug (“IND”) application has been accepted by regulatory body.
The Biologics License Application (“BLA”) for Momenta’s M923, a biosimilar version of Humira, is also ready to be filed with the FDA but the company is looking for a collaboration partner for the same.
Momenta suffered another setback when the company and partner Mylan announced that M834, a proposed biosimilar for Orencia, did not meet its primary pharmacokinetic end points in a phase I study to compare the pharmacokinetics, safety and immunogenicity of M834 to Orencia in normal healthy volunteers. Hence, Momenta and partner Mylan continue to evaluate the next course of action.
Momenta’s novel autoimmune portfolio includes — M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281, an anti-FcRn monoclonal antibody. Momenta successfully completed a phase I single ascending dose study in healthy volunteers for M281. In January 2018, Momenta reported positive top-line data on M281 from a phase I single ascending dose (“SAD”) and multiple ascending dose (“MAD”) study of normal human volunteers. The phase I randomized, double-blind, placebo-controlled study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of M281. The candidate did not exhibit any adverse event, was well tolerated and decreased circulating IgG levels up to 89% with a mean reduction of 84% over the 98-day MAD study. In addition, the SAD portion of the study enrolled five cohorts with a total of 34 healthy adult volunteers and showed that a single dose of M281 achieved up to an 80% reduction of circulating IgG antibodies.
Our Take
Momenta’s fourth-quarter results were better-than-expected driven by the receipt of an upfront payment. 2017 was challenging for the company as it faced approval delays of Glatopa 40 mg and reported disappointing results from a biosimilar candidate.
While the FDA approval of Glatopa 40 mg should relieve Momenta, competition will limit market share gains. We note that Mylan has already won FDA approval for a generic version of Teva Pharmaceuticals (TEVA - Free Report) Copaxone 40 mg. Notably, this is the first generic of Copaxone that has been approved. Since Mylan was one of the first applicants to submit a substantially complete ANDA for glatiramer acetate Injection, 40 mg/mL, containing a Paragraph IV certification, the company and other first filers may be eligible for 180 days of generic drug exclusivity.
Hence, we expect the company to face challenges in the market. Meanwhile, the progress of biosimilars pipeline was encouraging.
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Momenta's (MNTA) Earnings & Revenues Surpass Estimates in Q4
Following the announcement of fourth-quarter of 2017 results, shares of Momenta Pharmaceuticals Inc. moved up 2.5%.
The company reported earnings per share of 18 cents in the quarter, beating the Zacks Consensus Estimate of 6 cents. The figure, however, was down from 60 cents earned in the year-ago quarter.
Momenta Pharmaceuticals, Inc. Price and Consensus
Momenta Pharmaceuticals, Inc. Price and Consensus | Momenta Pharmaceuticals, Inc. Quote
Revenues in the quarter came in at $64.6 million and topped the Zacks Consensus Estimate of $62.7 million and was up from $34.2 million in the year-ago quarter.
Momenta’s stock has gained 3.5% in the last six months as against the industry’s decline of 3.3%.
Quarter in Detail
Momenta’s top-line comprises product revenues of $13.4 million earned from Sandoz’s sales of Glatopa, a generic version of Copaxone (20 mg), compared with $15.8 million in the year-ago quarter. The decrease was primarily due to inventory price adjustments owing to Mylan’s entry into the Copaxone market along with a deduction of $0.6 million for reimbursing the company’s share of Glatopa-related legal expenses to Sandoz.
Collaborative research and development revenues came in at $51.2 million, up from $18.4 million in the year-ago quarter. The increase was due to a revenue recognition of $50.0 million upfront payment from CSL in fourth-quarter 2017.
While, research and development expenses were up to $36.1 million from $26.4 million in the year-ago quarter, general and administrative expenses decreased 13.2% to $15.8 million.
Outlook
Momenta expects operating expenses (excluding stock-based compensation and net of collaborative revenues) in the range of $180-$200 million in 2018. Operating expenses in first-quarter 2018 are projected around $45-$55 million.
Momenta expects to generate revenues of $45 million from Mylan as upfront payment on a quarterly basis.
Pipeline Updates
Momenta announced that the FDA has finally approved Sandoz's Abbreviated New Drug Application for Glatopa 40 mg. Both companies suffered a setback with the FDA issuing a warning letter to Pfizer (PFE - Free Report) in February 2017, which is Sandoz’s contracted fill/finish manufacturing partner for Glatopa.
Meanwhile, Momenta continues to progress with its other pipeline candidates. In January 2018, Momenta and Mylan announced plans to initiate a patient clinical trial of M710 — a proposed biosimilar of Eylea — in the first half of 2018. An Investigational New Drug (“IND”) application has been accepted by regulatory body.
The Biologics License Application (“BLA”) for Momenta’s M923, a biosimilar version of Humira, is also ready to be filed with the FDA but the company is looking for a collaboration partner for the same.
Momenta suffered another setback when the company and partner Mylan announced that M834, a proposed biosimilar for Orencia, did not meet its primary pharmacokinetic end points in a phase I study to compare the pharmacokinetics, safety and immunogenicity of M834 to Orencia in normal healthy volunteers. Hence, Momenta and partner Mylan continue to evaluate the next course of action.
Momenta’s novel autoimmune portfolio includes — M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281, an anti-FcRn monoclonal antibody. Momenta successfully completed a phase I single ascending dose study in healthy volunteers for M281. In January 2018, Momenta reported positive top-line data on M281 from a phase I single ascending dose (“SAD”) and multiple ascending dose (“MAD”) study of normal human volunteers. The phase I randomized, double-blind, placebo-controlled study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of M281. The candidate did not exhibit any adverse event, was well tolerated and decreased circulating IgG levels up to 89% with a mean reduction of 84% over the 98-day MAD study. In addition, the SAD portion of the study enrolled five cohorts with a total of 34 healthy adult volunteers and showed that a single dose of M281 achieved up to an 80% reduction of circulating IgG antibodies.
Our Take
Momenta’s fourth-quarter results were better-than-expected driven by the receipt of an upfront payment. 2017 was challenging for the company as it faced approval delays of Glatopa 40 mg and reported disappointing results from a biosimilar candidate.
While the FDA approval of Glatopa 40 mg should relieve Momenta, competition will limit market share gains. We note that Mylan has already won FDA approval for a generic version of Teva Pharmaceuticals (TEVA - Free Report) Copaxone 40 mg. Notably, this is the first generic of Copaxone that has been approved. Since Mylan was one of the first applicants to submit a substantially complete ANDA for glatiramer acetate Injection, 40 mg/mL, containing a Paragraph IV certification, the company and other first filers may be eligible for 180 days of generic drug exclusivity.
Hence, we expect the company to face challenges in the market. Meanwhile, the progress of biosimilars pipeline was encouraging.
Zacks Rank
Momenta currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
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