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Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) incurred a loss of $1.40 per share in the first quarter of 2023, narrower than the Zacks Consensus Estimate of a loss of $1.97 per share and our estimate of a loss of $2.34 per share.
The first-quarter loss included stock-based compensation expenses, unrealized gain on equity securities and loss on extinguishment of debt. Excluding these items, the adjusted loss was $1.06 per share, narrower than the adjusted loss of $1.49 per share reported in the year-ago quarter. The adjusted loss was also narrower than our estimate of $1.84 per share.
Alnylam recorded total revenues of $319 million in the quarter, which beat the Zacks Consensus Estimate of $308 million. In the year-ago quarter, total revenues were $213 million. Net product revenues were $276.3 million, up 48% year over year on a reported basis and 52% at constant exchange rate (CER), driven by increased patient demand for Givlaari (givosiran), Oxlumo (lumasiran) and the newly approved Amvuttra (vutrisiran). Total revenues beat our estimate of $283.4 million in the reported quarter as well.
Net revenues from collaborators were $36.5 million, up 41% from $25.9 million in the year-ago quarter. Primary drivers were an increase in revenues recognized in connection with licensed programs within the collaboration, as well as increased reimbursable activities with Regeneron (REGN - Free Report) . Alnylam earned collaboration revenues of $20 million from Regeneron in the reported quarter.
Alnylam, in collaboration with REGN, is advancing cemdisiran, an investigational RNAi therapeutic for the treatment of complement-mediated diseases.
Alnylam, in partnership with Regeneron, is also developing ALN-APP for treating early-onset Alzheimer’s disease.
Alnylam earned collaboration revenues of $14.9 million in the reported quarter from Novartis (NVS - Free Report) . Novartis has exclusive and worldwide rights to manufacture and commercialize RNAi therapeutics targeting PCSK9 for the treatment of hypercholesterolemia and other human diseases, including inclisiran.
Alnylam also granted Novartis an exclusive, worldwide license to develop, manufacture and commercialize siRNAs targeting end-stage liver disease, to promote the regrowth of functional liver cells and to provide an alternative to transplantation for patients with liver failure.
Alnylam is entitled to receive license fees from these collaboration agreements.
During the first quarter, Alnylam recorded royalty revenues of $6.5 million, primarily due to increased royalties from third parties driven by sales of Amvuttra. In the year-ago quarter, Alnylam recorded royalty revenues of $0.4 million from NVS.
Shares of Alnylam have plunged 13.5% this year so far compared with the industry’s decline of 6.2%.
Image Source: Zacks Investment Research
Quarter in Detail
Onpattro (patisiran) is approved for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The injection recorded sales of $102.5 million in the first quarter, down 25% on a reported basis. Onpattro sales fell short of the Zacks Consensus Estimate of $135 million as well as our estimate of $119.9 million.
In June 2022, the FDA approved Alnylam’s RNAi therapeutic, Amvuttra (vutrisiran), for the treatment of adult patients with polyneuropathy of hATTR amyloidosis. The European Commission approved Amvuttra for treating hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy in September.
Amvuttra generated sales worth $101.8 million in the first quarter. The initial uptake for the product has been encouraging with new patients starting treatment, as well as several patients switching from Onpattro.
Alnylam’s second product, Givlaari (givosiran), is approved for the treatment of acute hepatic porphyria. In the first quarter of 2023, Givlaari recorded sales of $47.9 million, reflecting a year-over-year increase of 36% on a reported basis and 39% at CER. Givlaari sales fell short of the Zacks Consensus Estimate of $49.6 million but beat our estimate of $43.3 million.
Oxlumo (lumasiran) injection for subcutaneous use was approved in November 2020 for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. The injection recorded global net product revenues of about $24.2 million in the first quarter of 2023, reflecting a year-over-year increase of 66% on a reported basis and 70% at CER. Oxlumo sales also fell short of the Zacks Consensus Estimate of $25 million and missed our estimate of $25.1 million.
Adjusted research and development (R&D) expenses increased 35% year over year to $214.3 million, driven by increases in headcount to support our R&D pipeline along with higher expenses incurred in development and study activities.
Adjusted selling, general and administrative (SG&A) expenses rose 17% year over year to $159.9 million because of higher headcount expenses and supporting the launch activities for Amvuttra.
Cash, cash equivalents and marketable securities as of Mar 31, 2023, amounted to $2.1 billion compared with $2.2 billion at the end of 2022 with the decrease primarily due to Anlnyla’s operating loss in the quarter.
2023 Financial Guidance Reaffirmed
Alnylam maintained its expectations for net product revenues for Onpattro, Amvuttra, Givlaari and Oxlumo in the range of $1,200-$1,285 million for 2023. Our estimate for net product revenues is pegged at $1,222.2 million for 2023.
Net revenues from collaborations and royalties are expected in the range of $100-$175 million (no change). Adjusted R&D and SG&A expenses are anticipated in the band of $1,575-$1,650 million (no change).
The Zacks Consensus Estimate and our estimate for total revenues in 2023 are pegged at $1.37 billion and $1.35 billion, respectively.
Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
In the past 90 days, the consensus estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 14 cents. This year, shares of ADMA Biologics have decreased by 11.8%.
ADMA beat estimates in three out of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 2.88%.
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Alnylam (ALNY) Q1 Earnings Beat, Product Sales Drive Revenues
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) incurred a loss of $1.40 per share in the first quarter of 2023, narrower than the Zacks Consensus Estimate of a loss of $1.97 per share and our estimate of a loss of $2.34 per share.
The first-quarter loss included stock-based compensation expenses, unrealized gain on equity securities and loss on extinguishment of debt. Excluding these items, the adjusted loss was $1.06 per share, narrower than the adjusted loss of $1.49 per share reported in the year-ago quarter. The adjusted loss was also narrower than our estimate of $1.84 per share.
Alnylam recorded total revenues of $319 million in the quarter, which beat the Zacks Consensus Estimate of $308 million. In the year-ago quarter, total revenues were $213 million. Net product revenues were $276.3 million, up 48% year over year on a reported basis and 52% at constant exchange rate (CER), driven by increased patient demand for Givlaari (givosiran), Oxlumo (lumasiran) and the newly approved Amvuttra (vutrisiran). Total revenues beat our estimate of $283.4 million in the reported quarter as well.
Net revenues from collaborators were $36.5 million, up 41% from $25.9 million in the year-ago quarter. Primary drivers were an increase in revenues recognized in connection with licensed programs within the collaboration, as well as increased reimbursable activities with Regeneron (REGN - Free Report) . Alnylam earned collaboration revenues of $20 million from Regeneron in the reported quarter.
Alnylam, in collaboration with REGN, is advancing cemdisiran, an investigational RNAi therapeutic for the treatment of complement-mediated diseases.
Alnylam, in partnership with Regeneron, is also developing ALN-APP for treating early-onset Alzheimer’s disease.
Alnylam earned collaboration revenues of $14.9 million in the reported quarter from Novartis (NVS - Free Report) . Novartis has exclusive and worldwide rights to manufacture and commercialize RNAi therapeutics targeting PCSK9 for the treatment of hypercholesterolemia and other human diseases, including inclisiran.
Alnylam also granted Novartis an exclusive, worldwide license to develop, manufacture and commercialize siRNAs targeting end-stage liver disease, to promote the regrowth of functional liver cells and to provide an alternative to transplantation for patients with liver failure.
Alnylam is entitled to receive license fees from these collaboration agreements.
During the first quarter, Alnylam recorded royalty revenues of $6.5 million, primarily due to increased royalties from third parties driven by sales of Amvuttra. In the year-ago quarter, Alnylam recorded royalty revenues of $0.4 million from NVS.
Shares of Alnylam have plunged 13.5% this year so far compared with the industry’s decline of 6.2%.
Image Source: Zacks Investment Research
Quarter in Detail
Onpattro (patisiran) is approved for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The injection recorded sales of $102.5 million in the first quarter, down 25% on a reported basis. Onpattro sales fell short of the Zacks Consensus Estimate of $135 million as well as our estimate of $119.9 million.
In June 2022, the FDA approved Alnylam’s RNAi therapeutic, Amvuttra (vutrisiran), for the treatment of adult patients with polyneuropathy of hATTR amyloidosis. The European Commission approved Amvuttra for treating hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy in September.
Amvuttra generated sales worth $101.8 million in the first quarter. The initial uptake for the product has been encouraging with new patients starting treatment, as well as several patients switching from Onpattro.
Alnylam’s second product, Givlaari (givosiran), is approved for the treatment of acute hepatic porphyria. In the first quarter of 2023, Givlaari recorded sales of $47.9 million, reflecting a year-over-year increase of 36% on a reported basis and 39% at CER. Givlaari sales fell short of the Zacks Consensus Estimate of $49.6 million but beat our estimate of $43.3 million.
Oxlumo (lumasiran) injection for subcutaneous use was approved in November 2020 for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. The injection recorded global net product revenues of about $24.2 million in the first quarter of 2023, reflecting a year-over-year increase of 66% on a reported basis and 70% at CER. Oxlumo sales also fell short of the Zacks Consensus Estimate of $25 million and missed our estimate of $25.1 million.
Adjusted research and development (R&D) expenses increased 35% year over year to $214.3 million, driven by increases in headcount to support our R&D pipeline along with higher expenses incurred in development and study activities.
Adjusted selling, general and administrative (SG&A) expenses rose 17% year over year to $159.9 million because of higher headcount expenses and supporting the launch activities for Amvuttra.
Cash, cash equivalents and marketable securities as of Mar 31, 2023, amounted to $2.1 billion compared with $2.2 billion at the end of 2022 with the decrease primarily due to Anlnyla’s operating loss in the quarter.
2023 Financial Guidance Reaffirmed
Alnylam maintained its expectations for net product revenues for Onpattro, Amvuttra, Givlaari and Oxlumo in the range of $1,200-$1,285 million for 2023. Our estimate for net product revenues is pegged at $1,222.2 million for 2023.
Net revenues from collaborations and royalties are expected in the range of $100-$175 million (no change). Adjusted R&D and SG&A expenses are anticipated in the band of $1,575-$1,650 million (no change).
The Zacks Consensus Estimate and our estimate for total revenues in 2023 are pegged at $1.37 billion and $1.35 billion, respectively.
Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Alnylam Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Alnylam Pharmaceuticals, Inc. Quote
Zacks Rank & Stock to Consider
Alnylam currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the same industry is ADMA Biologics, Inc. (ADMA - Free Report) , carrying a Zacks Ranks #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the consensus estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 14 cents. This year, shares of ADMA Biologics have decreased by 11.8%.
ADMA beat estimates in three out of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 2.88%.