Alnylam Pharmaceuticals,Inc. ALNY incurred a loss of $1.62 per share in the first quarter of 2020, narrower than the Zacks Consensus Estimate of a loss of $1.89 per share. The loss includes stock-based compensation expenses and unrealized gains on equity securities. Excluding these items, adjusted loss was $1.52 per share, wider than adjusted loss of $1.42 in the year-ago quarter.
The company recorded revenues of 99.5 million, which beat the Zacks Consensus Estimate of $91 million. In the year-ago quarter, revenues were $33.3 million. Net product revenues were $71.9 million, up 174% year over year driven by higher sales of Onpattro (patisiran) and U.S. commercial launch of Givlaari (givosiran). Net revenues from collaborators were $27.5 million, due to revenues recognized under collaborations with Regeneron Pharmaceuticals REGN and Vir Biotechnology VIR.
Quarter in Detail
Onpattro is a lipid complex injection, which was approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in 2018. The injection recorded sales of $66.7 million in the first quarter, up 153.6% year over year driven by patient growth and expansion in new markets. Onpattro revenues rose 20% sequentially as slower growth in the U.S. market was offset by strong growth in international markets.
Givlaari (givosiran) is Alnylam’s second product and was approved for the treatment of acute hepatic porphyria (AHP) in the United States in November last year and in Europe in March 2020. It recorded sales of $5.2 million in the first quarter of 2020, its first full quarter post launch. Alnylam said it is witnessing early impressive demand for Givlaariin the United States and expects contribution from international markets in the second quarter as it will launch the product in Germany.
Adjusted operating costs increased 40% year over year to $261.7 million as a result of increased investment to advance its late-stage pipeline and support ongoing launches of Onpattro and Givlaari.
Alnylam lowered its product revenue expectations for Onpattro by 5% from $285-$315 million to $270-$300 million due to the potential impact of the coronavirus pandemic.
Despite lowering its 2020 sales expectations for Onpattro, Alnylam’s shares were up 2.9% on Wednesday. The company’s share price has risen26.1% this year so far compared with the industry’s increase of 3.7%.
Alnylam expects the most significant impact of the pandemic in the second quarter. It expects sales of Onpattro to decline about 10% sequentially in the second quarter as patient adherence to the regimen will decrease with patients skipping or delaying doses amid coronavirus-related lockdown. However, Alnylam expects improvement in growth in the second half of the year. Net revenues from collaborations are expected in the range of $100 million-$150 million (maintained).
The company also lowered its operating cost guidance for the year. The company expects adjusted operating costs to be in the range of $1 billion-$1.08 billion versus prior expectation of $1.03 billion-$1.13 billion.
Pipeline & Collaboration Updates
The company developed inclisiran for hypercholesterolemia in partnership with The Medicines Company, which was acquired by Novartis NVS in January 2020. Alnylam has submitted regulatory applications for inclisiran to the FDA and the EMA.
The company is also evaluating several other candidates. In April, Alnylam completed a rolling submission of the NDA, seeking approval for lumasiran as a treatment for primary hyperoxaluria type 1 (PH1) in the United States. The company also filed a marketing authorization application (MAA) seeking approval for the candidate in Europe.
Another important pipeline candidate is vutrisiran, a subcutaneously administered investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis. In February 2020, Alnylam completed enrollment in the HELIOS-A phase III study on vutrisiran to treat hereditary ATTR amyloidosis with polyneuropath. Top-line data from the study is expected in early 2021. The company is enrolling patients in the HELIOS-B phase III study in patients with hereditary and wild-type ATTR amyloidosis with cardiomyopathy.
Alnylam is also planning to expand the label of Onpattro for the potential treatment of cardiomyopathy of both hereditary and wild-type ATTR amyloidosis. Aphase III APOLLO-B study in ATTR amyloidosis patients with cardiomyopathy is enrolling patients. However, due to the pandemic, it expects enrolment in the study to be completed in 2021 compared to its earlier expectation of late 2020.
In March Alnylam announced collaboration with Vir to develop/commercialize RNAi therapeutics targeting SARS-CoV-2, the virus that causes COVID-19. On the call, Alnylam mentioned that the companies have selected a candidate (ALN-COV/ VIR-2703) and plan for accelerated filing of an IND at or around year-end 2020 to begin clinical studies.
In April, Alnylam and The Blackstone Group entered into a broad strategic collaboration, which will support Alnylam’s advancement of innovative RNAi medicines with up to $2 billion investment from Blackstone.
Alnylam is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Alnylam Pharmaceuticals Inc Price, Consensus and EPS Surprise
Alnylam Pharmaceuticals Inc price-consensus-eps-surprise-chart | Alnylam Pharmaceuticals Inc Quote
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