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Alnylam's (ALNY) Earnings and Revenues Lag Estimates in Q2
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Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) incurred a loss of $2.29 per share in the second quarter of 2022, wider than the Zacks Consensus Estimate of a loss of $1.62. The loss includes stock-based compensation expenses and unrealized gain on equity securities. Excluding these items, the adjusted loss was $2.03 per share, wider than the adjusted loss of $1.30 reported in the year-ago quarter.
The company recorded total revenues of $224.8 million in the quarter, which also missed the Zacks Consensus Estimate of $259 million. In the year-ago quarter, total revenues were $220.5 million. Net product revenues were $214 million, up 33% on a reported basis and 40% at constant exchange rate (“CER”) year over year, driven by the global expansion of Onpattro (patisiran) and Givlaari (givosiran), as well as encouraging uptake for Oxlumo (lumasiran), following its launch in the first quarter of 2021.
Net revenues from collaborators were $9 million, down from $84.8 million in the year-ago quarter, primarily due to a decrease in revenues recognized in connection with the collaboration agreements with Regeneron (REGN - Free Report) .
On the second quarter conference call, management stated that it expects to see an increase in collaboration revenues and royalties in the second half of 2022, owing to increased activity from Regeneron programs as well as increased Leqvio (inclisiran) royalties and sales milestones from Novartis (NVS - Free Report) .
During the second quarter, Alnylam also recorded royalty revenues of $2.3 million, owing to the global sales of Leqvio from its partner, Novartis. In the year-ago quarter, Alnylam recorded royalty revenues of $0.3 million from NVS.
Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam.
Alnylam is entitled to receive tiered royalties on the global sales of Leqvio from NVS.
Despite the weaker-than-expected earnings results, shares of Alnylam were up 1.1% on Thursday, following the announcement news. The stock has lost 15.4% so far this year compared with the industry’s decline of 18.6%.
Image Source: Zacks Investment Research
Quarter in Detail
Onpattro (patisiran) is approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The injection recorded sales of $153.4 million in the second quarter, up 35% on a reported basis and 42% at CER year over year, driven by new patient demand. Per the company, as of Jun 30, 2022, more than 2,400 patients (representing 9% sequential patient growth) have received treatment with Onpattro worldwide.
Alnylam’s second product, Givlaari (givosiran), is approved for the treatment of acute hepatic porphyria. In the second quarter of 2022, Givlaari recorded sales of $45.1 million, reflecting an increase of 47% on a reported basis and 53% at CER year over year.
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 $14.9 million in the second quarter of 2022, reflecting a decrease of 9% on a reported basis and a decrease of 4% at CER year over year. Oxlumo sales increased 2.7% sequentially.
Adjusted research and development expenses (R&D) increased 15.1% year-over-year to $195 million due to higher expenses incurred in development and study activities.
Adjusted selling, general and administrative expenses (SG&A) rose 18.8% year-over-year to $150.1 million due to higher headcount expenses and other development costs.
2022 Guidance
Alnylam reiterated its net product revenue guidance for 2022 which was provided earlier this year.
The company continues to expect net product revenues for Onpattro, Givlaari, Oxlumo and Amvuttra in the range of $870-$930 million for 2022.
Net revenues from collaborations and royalties are expected in the range of $175-$225 million. Adjusted R&D and SG&A expenses are anticipated in the band of $1.39-$1.45 billion.
Pipeline Updates
In June 2022, the FDA approved Alnylam’s RNAi therapeutic, Amvuttra (vutrisiran), for the treatment of adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. hATTR is an inherited, often fatal disease caused by mutations in the TTR gene.
Earlier this month, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Amvuttra (vutrisiran), for the treatment of hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.
Alnylam is evaluating patisiran in the pivotal phase III APOLLO-B study for treating ATTR amyloidosis patients with cardiomyopathy. Top-line data from the same is expected in the next three weeks.
In March 2022, FDA accepted the sNDA for Oxlumo (lumasiran) for the reduction of plasma oxalate in the treatment of patients with advanced primary hyperoxaluria type 1. A decision from the regulatory body is expected on Oct 6, 2022.
Alnylam, in collaboration with Regeneron, is advancing cemdisiran, an investigational RNAi therapeutic, for the treatment of complement-mediated diseases.
In June 2022, Alnylam announced positive top-line data from a phase II study evaluatingcemdisiran, for the treatment of immunoglobulin A nephropathy ("IgAN").
Data from the above-mentioned study showed that treatment with cemdisiran led to a 37% mean reduction from baseline in the 24-hour urine protein to creatinine ratio relative to placebo — the primary endpoint of the study.
Alnylam and Regeneron are planning for the phase III development of cemdisiran in IgAN and start the study by late 2022.
Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Precision BioSciences’ loss per share estimates narrowed 5.8% for 2022 and 16.2% for 2023 in the past 60 days.
Earnings of Precision BioSciences have surpassed estimates in each of the trailing four quarters. DTIL delivered an earnings surprise of 76.15%, on average.
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Alnylam's (ALNY) Earnings and Revenues Lag Estimates in Q2
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) incurred a loss of $2.29 per share in the second quarter of 2022, wider than the Zacks Consensus Estimate of a loss of $1.62. The loss includes stock-based compensation expenses and unrealized gain on equity securities. Excluding these items, the adjusted loss was $2.03 per share, wider than the adjusted loss of $1.30 reported in the year-ago quarter.
The company recorded total revenues of $224.8 million in the quarter, which also missed the Zacks Consensus Estimate of $259 million. In the year-ago quarter, total revenues were $220.5 million. Net product revenues were $214 million, up 33% on a reported basis and 40% at constant exchange rate (“CER”) year over year, driven by the global expansion of Onpattro (patisiran) and Givlaari (givosiran), as well as encouraging uptake for Oxlumo (lumasiran), following its launch in the first quarter of 2021.
Net revenues from collaborators were $9 million, down from $84.8 million in the year-ago quarter, primarily due to a decrease in revenues recognized in connection with the collaboration agreements with Regeneron (REGN - Free Report) .
On the second quarter conference call, management stated that it expects to see an increase in collaboration revenues and royalties in the second half of 2022, owing to increased activity from Regeneron programs as well as increased Leqvio (inclisiran) royalties and sales milestones from Novartis (NVS - Free Report) .
During the second quarter, Alnylam also recorded royalty revenues of $2.3 million, owing to the global sales of Leqvio from its partner, Novartis. In the year-ago quarter, Alnylam recorded royalty revenues of $0.3 million from NVS.
Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam.
Alnylam is entitled to receive tiered royalties on the global sales of Leqvio from NVS.
Despite the weaker-than-expected earnings results, shares of Alnylam were up 1.1% on Thursday, following the announcement news. The stock has lost 15.4% so far this year compared with the industry’s decline of 18.6%.
Image Source: Zacks Investment Research
Quarter in Detail
Onpattro (patisiran) is approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The injection recorded sales of $153.4 million in the second quarter, up 35% on a reported basis and 42% at CER year over year, driven by new patient demand. Per the company, as of Jun 30, 2022, more than 2,400 patients (representing 9% sequential patient growth) have received treatment with Onpattro worldwide.
Alnylam’s second product, Givlaari (givosiran), is approved for the treatment of acute hepatic porphyria. In the second quarter of 2022, Givlaari recorded sales of $45.1 million, reflecting an increase of 47% on a reported basis and 53% at CER year over year.
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 $14.9 million in the second quarter of 2022, reflecting a decrease of 9% on a reported basis and a decrease of 4% at CER year over year. Oxlumo sales increased 2.7% sequentially.
Adjusted research and development expenses (R&D) increased 15.1% year-over-year to $195 million due to higher expenses incurred in development and study activities.
Adjusted selling, general and administrative expenses (SG&A) rose 18.8% year-over-year to $150.1 million due to higher headcount expenses and other development costs.
2022 Guidance
Alnylam reiterated its net product revenue guidance for 2022 which was provided earlier this year.
The company continues to expect net product revenues for Onpattro, Givlaari, Oxlumo and Amvuttra in the range of $870-$930 million for 2022.
Net revenues from collaborations and royalties are expected in the range of $175-$225 million. Adjusted R&D and SG&A expenses are anticipated in the band of $1.39-$1.45 billion.
Pipeline Updates
In June 2022, the FDA approved Alnylam’s RNAi therapeutic, Amvuttra (vutrisiran), for the treatment of adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. hATTR is an inherited, often fatal disease caused by mutations in the TTR gene.
Earlier this month, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Amvuttra (vutrisiran), for the treatment of hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.
Alnylam is evaluating patisiran in the pivotal phase III APOLLO-B study for treating ATTR amyloidosis patients with cardiomyopathy. Top-line data from the same is expected in the next three weeks.
In March 2022, FDA accepted the sNDA for Oxlumo (lumasiran) for the reduction of plasma oxalate in the treatment of patients with advanced primary hyperoxaluria type 1. A decision from the regulatory body is expected on Oct 6, 2022.
Alnylam, in collaboration with Regeneron, is advancing cemdisiran, an investigational RNAi therapeutic, for the treatment of complement-mediated diseases.
In June 2022, Alnylam announced positive top-line data from a phase II study evaluatingcemdisiran, for the treatment of immunoglobulin A nephropathy ("IgAN").
Data from the above-mentioned study showed that treatment with cemdisiran led to a 37% mean reduction from baseline in the 24-hour urine protein to creatinine ratio relative to placebo — the primary endpoint of the study.
Alnylam and Regeneron are planning for the phase III development of cemdisiran in IgAN and start the study by late 2022.
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 biotech sector is Precision BioSciences, Inc. (DTIL - Free Report) , sporting a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Precision BioSciences’ loss per share estimates narrowed 5.8% for 2022 and 16.2% for 2023 in the past 60 days.
Earnings of Precision BioSciences have surpassed estimates in each of the trailing four quarters. DTIL delivered an earnings surprise of 76.15%, on average.