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Alnylam Pharmaceuticals (ALNY - Free Report) reported preliminary full-year 2023 net product revenues of $1.24 billion, representing 39% growth at a constant exchange rate. The Zacks Consensus Estimate for the same is pegged at $1.83 billion.
The company’s net product revenues comprise sales of its four marketed products, such as Onpattro, Amvuttra, Givlaari and Oxlumo.
In 2023, preliminary global net product revenues for Onpattro and Amvuttra were approximately $355 million and $558 million, respectively, representing a 40% increase year over year. Alnylam reported that more than 4,060 patients worldwide were receiving commercial Onpattro and Amvuttra as of year-end 2023. Full-year Onpattro and Amvuttra sales figures beat our model estimates of $344.3 million and $543.9 million, respectively.
Givlaari and Oxlumo sales, during the same period, were approximately $219 million and $110 million, respectively, up 35% year over year. As of year-end 2023, more than 650 patients worldwide were receiving commercial Givlaari and over 430 patients were receiving commercial Oxlumo. Full-year Givlaari sales figures missed our model estimate of $220 million, while Oxlumo sales beat our model estimate of $106.2 million.
In the fourth quarter of 2023, net product sales of Onpattro and Amvuttra were approximately $79 million and $175 million, respectively, up 10% year over year. Both Onpattro and Amvuttra sales beat the Zacks Consensus Estimate of $73 million and $173 million, respectively. The fourth-quarter 2023 sales figures of Onpattro and Amvuttra also beat our model estimates of $68.7 million and $161.3 million, respectively.
Net product sales of Givlaari and Oxlumo were up about 11% over the year-ago quarter to approximately $59 million and $33 million, respectively. While Givlaari sales matched the consensus estimate, Oxlumo sales beat the consensus mark of $31.6 million. The fourth-quarter 2023 sales figures of Oxlumo also beat our model estimate of $29.1 million. However, Givlaari sales fell short of our model estimate of $60 million.
As of Dec 31, 2023, the company had preliminary cash, cash equivalents and marketable securities of approximately $2.4 billion, maintaining the same cash balance as of Sep 30, 2023.
Over the past year, shares of Alnylam have lost 13.8% compared with the industry’s 11.4% fall.
Image Source: Zacks Investment Research
In October 2023, Alnylam experienced a massive setback after the FDA issued a Complete Response Letter (CRL) in response to the company’s supplemental new drug application (sNDA) for the label expansion of Onpattro to treat the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis.
The CRL was issued to the company because the existing study data do not establish the clinical meaningfulness of Onpattro’s treatment effects for the cardiomyopathy of ATTR amyloidosis. Hence, the sNDA could not be approved in its present form.
Based on the FDA’s CRL, Alnylam has decided to discontinue pursuing an expanded indication for Onpattro in the United States. However, following this development, the company shifted its focus to the phase III HELIOS-B label-expanding study of Amvuttra in the treatment of the cardiomyopathy of ATTR amyloidosis, expecting top-line data in early 2024.
During 2023, the company has reported positive results across several programs and has several upcoming clinical milestones.
The FDA approved Alnylam’s RNAi therapeutic, Amvuttra, for the treatment of adult patients with polyneuropathy of hATTR amyloidosis in June 2022. The European Commission approved Amvuttra for treating hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy in September.
The initial uptake for Amvuttra has been encouraging, with new patients starting treatment as well as several patients switching from Onpattro.
Subject to the success of the HELIOB-B study, Alnylam will submit an application to extend Amvuttra’s label to include a new indication. If approved, the sales of the drug are expected to further shoot up in the upcoming quarters as the eligible patient population for Amvuttra increases.
Sales of both Givlaari and Oxlumo have witnessed strong initial uptake and are expected to continue to gain traction in the market, providing Alnylam with incremental sources of revenue.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has increased from 72 cents to 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 64 cents to 69 cents. Over the past year, shares of PBYI have gained 1.7%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 18 cents. Over the past year, shares of ADMA have gained 25.4%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Acadia’s 2023 loss per share has remained constant at 33 cents. During the same time frame, the consensus estimate for Acadia’s 2024 EPS is pegged at $1.04. Over the past year, shares of ACAD have rallied 79.9%.
ACAD beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average earnings surprise of 20.69%.
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Alnylam (ALNY) Posts Preliminary Q4 & Full-Year '23 Revenues
Alnylam Pharmaceuticals (ALNY - Free Report) reported preliminary full-year 2023 net product revenues of $1.24 billion, representing 39% growth at a constant exchange rate. The Zacks Consensus Estimate for the same is pegged at $1.83 billion.
The company’s net product revenues comprise sales of its four marketed products, such as Onpattro, Amvuttra, Givlaari and Oxlumo.
In 2023, preliminary global net product revenues for Onpattro and Amvuttra were approximately $355 million and $558 million, respectively, representing a 40% increase year over year. Alnylam reported that more than 4,060 patients worldwide were receiving commercial Onpattro and Amvuttra as of year-end 2023. Full-year Onpattro and Amvuttra sales figures beat our model estimates of $344.3 million and $543.9 million, respectively.
Givlaari and Oxlumo sales, during the same period, were approximately $219 million and $110 million, respectively, up 35% year over year. As of year-end 2023, more than 650 patients worldwide were receiving commercial Givlaari and over 430 patients were receiving commercial Oxlumo. Full-year Givlaari sales figures missed our model estimate of $220 million, while Oxlumo sales beat our model estimate of $106.2 million.
In the fourth quarter of 2023, net product sales of Onpattro and Amvuttra were approximately $79 million and $175 million, respectively, up 10% year over year. Both Onpattro and Amvuttra sales beat the Zacks Consensus Estimate of $73 million and $173 million, respectively. The fourth-quarter 2023 sales figures of Onpattro and Amvuttra also beat our model estimates of $68.7 million and $161.3 million, respectively.
Net product sales of Givlaari and Oxlumo were up about 11% over the year-ago quarter to approximately $59 million and $33 million, respectively. While Givlaari sales matched the consensus estimate, Oxlumo sales beat the consensus mark of $31.6 million. The fourth-quarter 2023 sales figures of Oxlumo also beat our model estimate of $29.1 million. However, Givlaari sales fell short of our model estimate of $60 million.
As of Dec 31, 2023, the company had preliminary cash, cash equivalents and marketable securities of approximately $2.4 billion, maintaining the same cash balance as of Sep 30, 2023.
Over the past year, shares of Alnylam have lost 13.8% compared with the industry’s 11.4% fall.
Image Source: Zacks Investment Research
In October 2023, Alnylam experienced a massive setback after the FDA issued a Complete Response Letter (CRL) in response to the company’s supplemental new drug application (sNDA) for the label expansion of Onpattro to treat the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis.
The CRL was issued to the company because the existing study data do not establish the clinical meaningfulness of Onpattro’s treatment effects for the cardiomyopathy of ATTR amyloidosis. Hence, the sNDA could not be approved in its present form.
Based on the FDA’s CRL, Alnylam has decided to discontinue pursuing an expanded indication for Onpattro in the United States. However, following this development, the company shifted its focus to the phase III HELIOS-B label-expanding study of Amvuttra in the treatment of the cardiomyopathy of ATTR amyloidosis, expecting top-line data in early 2024.
During 2023, the company has reported positive results across several programs and has several upcoming clinical milestones.
The FDA approved Alnylam’s RNAi therapeutic, Amvuttra, for the treatment of adult patients with polyneuropathy of hATTR amyloidosis in June 2022. The European Commission approved Amvuttra for treating hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy in September.
The initial uptake for Amvuttra has been encouraging, with new patients starting treatment as well as several patients switching from Onpattro.
Subject to the success of the HELIOB-B study, Alnylam will submit an application to extend Amvuttra’s label to include a new indication. If approved, the sales of the drug are expected to further shoot up in the upcoming quarters as the eligible patient population for Amvuttra increases.
Sales of both Givlaari and Oxlumo have witnessed strong initial uptake and are expected to continue to gain traction in the market, providing Alnylam with incremental sources of revenue.
Alnylam Pharmaceuticals, Inc. Price and Consensus
Alnylam Pharmaceuticals, Inc. price-consensus-chart | Alnylam Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Alnylam currently carries a Zacks Rank #3 (Hold).
Some better-ranked drug/biotech stocks worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) , ADMA Biologics (ADMA - Free Report) and Acadia Pharmaceuticals (ACAD - Free Report) . While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA and ACAD carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has increased from 72 cents to 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 64 cents to 69 cents. Over the past year, shares of PBYI have gained 1.7%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 18 cents. Over the past year, shares of ADMA have gained 25.4%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Acadia’s 2023 loss per share has remained constant at 33 cents. During the same time frame, the consensus estimate for Acadia’s 2024 EPS is pegged at $1.04. Over the past year, shares of ACAD have rallied 79.9%.
ACAD beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average earnings surprise of 20.69%.