Alnylam Pharmaceuticals, Inc. ( ALNY Quick Quote ALNY - Free Report) incurred a loss of $1.71 per share in the first quarter of 2021, narrower than the Zacks Consensus Estimate of a loss of $1.75. The loss includes stock-based compensation expenses and unrealized loss on equity securities. Excluding these items, adjusted loss was $1.64 per share, wider than the adjusted loss of $1.52 reported in the year-ago quarter.
The company recorded total revenues of $177.6 million, which marginally beat the Zacks Consensus Estimate of $177 million. In the year-ago quarter, total revenues were $99.5 million. Net product revenues were $135.8 million, up 88.9% year over year, driven by the addition of new patients on therapy, which is a result of growth in established markets and the global expansion of Onpattro (patisiran) and Givlaari (givosiran), as well as encouraging initial uptake for Oxlumo following its regulatory approval in the fourth quarter of 2020.
Net revenues from collaborators were $41.8 million, up from $27.5 million in the year-ago quarter, primarily due to an increase in revenues recognized in connection with the collaboration agreement with
Regeneron ( REGN Quick Quote REGN - Free Report) .
Shares of Alnylam have rallied 7.5% so far this year against the
industry’s decrease of 0.6%. Quarter in Detail
Onpattro was approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in 2018. The injection recorded sales of $102 million in the first quarter, up 52.9% year over year, driven by new patient demand.
Alnylam’s second product, Givlaari, was approved for the treatment of acute hepatic porphyria (AHP) in the United States in November 2019 and in Europe in March 2020. In the first quarter of 2021, it recorded sales of $24.7 million, reflecting an increase of 12.2% sequentially.
Oxlumo, in its first full quarter following its approval, recorded global net product revenues of about $9.1 million in the first quarter of 2021.
Adjusted research and development expenses (R&D) increased to $161.5 million from $153.5 million in the year-ago quarter. The increase was due to higher investment in late-stage pipeline programs.
Adjusted selling, general and administrative expenses (SG&A) rose to $115.5 million from $108.2 million in the year-ago quarter. The increase was due to higher investments in commercial activities to support the launch of Oxlumo.
Alnylam expects net product revenues for Onpattro, Givlaari and Oxlumo in the range of $610-$660 million.
Net revenues from collaborations and royalties are expected in the range of $150-$200 million. Adjusted R&D and SG&A expenses are anticipated in the band of $1,175-$1,275 million.
The company is developing Leqvio (inclisiran) for hypercholesterolemia in partnership with
Novartis ( NVS Quick Quote NVS - Free Report) . Novartis received marketing authorization for Leqvio from the European Commission in December 2020.
We remind investors that Novartis received a complete response letter from the FDA in December 2020 due to unresolved facility inspection-related conditions at a third-party manufacturing facility in Europe. The company is working closely with the third-party manufacturer and the FDA to obtain approval as soon as possible, and has guided for a resubmission of its new drug application either in the second or third quarter of 2021.
Meanwhile, dosing is ongoing in the phase III ILLUMINATE-C study evaluating Oxlumo in patients with advanced renal disease. Top-line data from the same is expected in mid-2021.
Alnylam is developing fitusiran in partnership with
Sanofi ( SNY Quick Quote SNY - Free Report) for the treatment of hemophilia A or B with and without inhibitors. Zacks Rank
Alnylam currently carries a Zacks Rank #3 (Hold). You can see
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