Medicines Company (MDCO) Q1 Loss Narrows, Inclisiran In Focus
Zacks Investment Research | Apr 25, 2019 11:11PM ET
The Medicines Company (NASDAQ:MDCO) incurred first-quarter 2019 adjusted loss of 62 cents per share, narrower than the Zacks Consensus Estimate of a loss of 64 cents and the year-ago loss of 76 cents.
Shares of The Medicines Company have surged 55.7% so far this year compared with the industry ’s increase of 3.3%.
In first-quarter 2019, the Medicines Company did not generate any revenues. The Zacks Consensus Estimate for the metric was pegged at $4.37 million. However, in the prior-year quarter, the company’s revenues had grossed $7.8 million.
The company divested all its marketed products, namely Angiomax, Vabomere, Orbactiv and Minocin in 2018 as part of its restructuring activities to focus solely on developing its late-stage candidate, inclisiran. This explains the absence of revenues in the first quarter.
Adjusted selling, general and administrative expenses (SG&A) were down 27% year over year to $13.1 million in the reported quarter. Adjusted research and development expenses (R&D) declined 32.4% to $26.4 million.
The Medicines Company’s cash and cash equivalents as of Mar 31, 2019 totaled $199.7 million compared with $238.3 million on Dec 31, 2018. The company believes that this existing cash balance will enable it to fund operating expenses through 2020.
Pipeline Update
The Medicines Company has one promising candidate, inclisiran, (hypercholesterolemia) in its pipeline. The company along with partner Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) is evaluating inclisiran in several phase III ORION studies for treating patients with atherosclerotic cardiovascular disease (“ASCVD”) and elevated bad cholesterol (LDL-cholesterol).
Last week, the Independent Data Monitoring Committee (“IDMC”) recommended continuation of ongoing phase III ORION studies on inclisiran as designed. The same is being conducted without any modification.
The latest suggestion from IDMC came after the regulatory body’s sixth review of unblinded safety and efficacy data from ORION programs on the PCSK9 inhibitor, which the Medicines Company considers to have blockbuster potential.
The companies expect to present top-line data from the ORION analyses early in the third quarter of 2019 and subsequently file for a new drug application (NDA) in the United States as well as a marketing authorization application (MAA) in the EU.
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