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Alnylam's (ALNY) Earnings and Revenues Lag Estimates in Q3
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Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) incurred a loss of $3.32 per share in the third quarter of 2022, substantially wider than the Zacks Consensus Estimate of a loss of $1.86. It also missed our estimate of $1.85 per share.
The third-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 $1.58 per share, narrower than the adjusted loss of $1.59 reported in the year-ago quarter. The adjusted loss was also slightly lower than our estimate of $1.59 per share.
Alnylam recorded total revenues of $264.3 million in the quarter, which also missed the Zacks Consensus Estimate of $285.3 million. In the year-ago quarter, total revenues were $187.6 million. Net product revenues were $232.2 million, up 39% year over year on a reported basis and 49% at constant exchange rate (“CER”), driven by increased patient numbers for Onpattro (patisiran) and Givlaari (givosiran), Oxlumo (lumasiran), and the newly approved Amvuttra (vutrisiran).
Total revenues fell short of our estimate of $286.8 million in the reported quarter.
Net revenues from collaborators were $29.3 million, up from $20.1 million from the year-ago quarter primarily due to an increase in revenues recognized in connection with the collaboration agreements with Regeneron (REGN - Free Report) .
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.
During the third quarter, Alnylam recorded royalty revenues of $2.7 million, owing to global sales of Leqvio from its partner, Novartis (NVS - Free Report) . In the year-ago quarter, Alnylam recorded royalty revenues of $0.4 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.
Shares of Alnylam have rallied 18.5% so far this year against the industry’s decline of 24.5%.
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 $145 million in the third quarter, up 20% on a reported basis and 31% at CER year over year, driven by new patient demand. Onpattro sales were almost in line with the Zacks Consensus Estimate of $144.9 million but were lower than our estimate of $171.8 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 $25 million in the third quarter. The initial uptake for the product has been encouraging with new patients starting treatment, as well as several patients switching from Onpattro.
Per the company, as of Sep 30, 2022, more than 2,580 patients (representing 8% sequential growth) have received treatment with Onpattro or Amvuttra worldwide. Total TTR net product revenues were $170.1 in the third quarter.
Alnylam’s second product, Givlaari (givosiran), is approved for the treatment of acute hepatic porphyria. In the third quarter of 2022, Givlaari recorded sales of $46 million, reflecting a year-over-year increase of 43% on a reported basis and 50% at CER. Givlaari sales were almost in line with the Zacks Consensus Estimate of $45.6 million but lower than our estimate of $50.5 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 $16 million in the third quarter of 2022, reflecting a year-over-year increase of 10% on a reported basis and 20% at CER. Oxlumo sales increased 10% sequentially. Oxlumo sales slightly lagged the Zacks Consensus Estimate of $16.4 million but surpassed our estimate of $14.7 million.
Adjusted research and development expenses (R&D) increased 5.6% year-over-year to $192.4 million due to higher expenses incurred in development and study activities.
Adjusted selling, general and administrative expenses (SG&A) rose 32.6% year over year to $160.7 million due to higher headcount expenses and supporting the launch activities for Amvuttra.
2022 Guidance
Alnylam reiterated the net product revenue guidance for 2022 it provided earlier this year.
For 2022, the company expects net product revenues of $870-$930 million for Onpattro, Givlaari, Oxlumo and Amvuttra.
However, net revenues from collaborations and royalties are expected to be $100-$150 million compared with the previously mentioned $175-$225 million. Adjusted R&D and SG&A expenses are anticipated to be $1.39-$1.45 billion, unchanged from that mentioned previously.
Pipeline Updates
Earlier this month, the FDA approved Oxlumo for the treatment of PH1 to lower urinary oxalate and plasma oxalate levels in pediatric and adult patients.
In August 2022, ALNY announced that the phase III APOLLO-B study evaluating Onpattro for the treatment of transthyretin-mediated amyloidosis with cardiomyopathy met its primary end-point of change from baseline in the 6-Minute Walk Test versus placebo at 12 months.
The company plans to file a supplemental new drug application for the label expansion of Onpattro to treat the given indication by the end of 2022.
Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Loss per share estimates for Akero Therapeutics have narrowed 6.9% for 2022 and 4.8% for 2023 in the past 60 days.
Earnings of Akero Therapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. AKRO delivered an earnings surprise of 7.66%, on average.
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Alnylam's (ALNY) Earnings and Revenues Lag Estimates in Q3
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) incurred a loss of $3.32 per share in the third quarter of 2022, substantially wider than the Zacks Consensus Estimate of a loss of $1.86. It also missed our estimate of $1.85 per share.
The third-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 $1.58 per share, narrower than the adjusted loss of $1.59 reported in the year-ago quarter. The adjusted loss was also slightly lower than our estimate of $1.59 per share.
Alnylam recorded total revenues of $264.3 million in the quarter, which also missed the Zacks Consensus Estimate of $285.3 million. In the year-ago quarter, total revenues were $187.6 million. Net product revenues were $232.2 million, up 39% year over year on a reported basis and 49% at constant exchange rate (“CER”), driven by increased patient numbers for Onpattro (patisiran) and Givlaari (givosiran), Oxlumo (lumasiran), and the newly approved Amvuttra (vutrisiran).
Total revenues fell short of our estimate of $286.8 million in the reported quarter.
Net revenues from collaborators were $29.3 million, up from $20.1 million from the year-ago quarter primarily due to an increase in revenues recognized in connection with the collaboration agreements with Regeneron (REGN - Free Report) .
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.
During the third quarter, Alnylam recorded royalty revenues of $2.7 million, owing to global sales of Leqvio from its partner, Novartis (NVS - Free Report) . In the year-ago quarter, Alnylam recorded royalty revenues of $0.4 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.
Shares of Alnylam have rallied 18.5% so far this year against the industry’s decline of 24.5%.
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 $145 million in the third quarter, up 20% on a reported basis and 31% at CER year over year, driven by new patient demand. Onpattro sales were almost in line with the Zacks Consensus Estimate of $144.9 million but were lower than our estimate of $171.8 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 $25 million in the third quarter. The initial uptake for the product has been encouraging with new patients starting treatment, as well as several patients switching from Onpattro.
Per the company, as of Sep 30, 2022, more than 2,580 patients (representing 8% sequential growth) have received treatment with Onpattro or Amvuttra worldwide. Total TTR net product revenues were $170.1 in the third quarter.
Alnylam’s second product, Givlaari (givosiran), is approved for the treatment of acute hepatic porphyria. In the third quarter of 2022, Givlaari recorded sales of $46 million, reflecting a year-over-year increase of 43% on a reported basis and 50% at CER. Givlaari sales were almost in line with the Zacks Consensus Estimate of $45.6 million but lower than our estimate of $50.5 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 $16 million in the third quarter of 2022, reflecting a year-over-year increase of 10% on a reported basis and 20% at CER. Oxlumo sales increased 10% sequentially. Oxlumo sales slightly lagged the Zacks Consensus Estimate of $16.4 million but surpassed our estimate of $14.7 million.
Adjusted research and development expenses (R&D) increased 5.6% year-over-year to $192.4 million due to higher expenses incurred in development and study activities.
Adjusted selling, general and administrative expenses (SG&A) rose 32.6% year over year to $160.7 million due to higher headcount expenses and supporting the launch activities for Amvuttra.
2022 Guidance
Alnylam reiterated the net product revenue guidance for 2022 it provided earlier this year.
For 2022, the company expects net product revenues of $870-$930 million for Onpattro, Givlaari, Oxlumo and Amvuttra.
However, net revenues from collaborations and royalties are expected to be $100-$150 million compared with the previously mentioned $175-$225 million. Adjusted R&D and SG&A expenses are anticipated to be $1.39-$1.45 billion, unchanged from that mentioned previously.
Pipeline Updates
Earlier this month, the FDA approved Oxlumo for the treatment of PH1 to lower urinary oxalate and plasma oxalate levels in pediatric and adult patients.
In August 2022, ALNY announced that the phase III APOLLO-B study evaluating Onpattro for the treatment of transthyretin-mediated amyloidosis with cardiomyopathy met its primary end-point of change from baseline in the 6-Minute Walk Test versus placebo at 12 months.
The company plans to file a supplemental new drug application for the label expansion of Onpattro to treat the given indication by the end of 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 Akero Therapeutics, Inc. (AKRO - Free Report) , which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for Akero Therapeutics have narrowed 6.9% for 2022 and 4.8% for 2023 in the past 60 days.
Earnings of Akero Therapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. AKRO delivered an earnings surprise of 7.66%, on average.